Patrice Wendling

MINNEAPOLIS – Some day physicians will be able to order detailed vitamin D assay panels much like the lipid panels used today to assess cholesterol.

We’re just not there yet.

“Where we’re at today with 25-hydroxyvitamin D measurement is where we were at 50 or 60 years ago with lipid measurement ... but I believe vitamin D assay panels are coming,” said Dr. Neil C. Binkley of the Institute on Aging at the University of Wisconsin, Madison.

Patrice Wendling/IMNG Medical Media

Part of the problem with 25-hydroxyvitamin D [25(OH)D] measurement is that it has not yet been standardized, and there is no agreement on which cut points should be used by laboratories and assay manufacturers.

In its 2011 report that set for the first time Recommended Dietary Allowances for calcium and vitamin D, the Institute of Medicine declared an “urgent clinical and public health need” to reassess laboratory ranges for 25(OH)D to avoid problems of overtreatment and undertreatment.

The IOM committee concluded that the prevalence of vitamin D deficiency in North Americans has been overestimated by some because of the use of “inappropriate cut points” that greatly exceed levels identified in the report (J. Clin. Endocrinol. Metab. 2011;96:53-8).

Substantial progress has been made in the past decade, thanks in large part to the work of Dr. Graham Carter and DEQAS, the Vitamin D External Quality Assessment Scheme, Dr. Binkley said at the annual meeting of the American Society for Bone and Mineral Research. DEQAS provides serum samples on a quarterly basis to laboratories that wish to check the accuracy of their assays, and statistically trims the data to produce an all-laboratory trimmed mean (ALTM), standard deviation, and coefficient of variation for all major methodologies. Recent DEQAS data show, however, that ALTMs can vary substantially, even among groups striving to improve the quality of their program, he said.

In 2010, the National Institutes of Health Office of Dietary Supplements also launched the international vitamin D standardization program dedicated to standardizing 25(OH)D measurement to the National Institute of Standards and Technology (NIST) reference procedures. The program recently began quantitating DEQAS materials with real values assigned by NIST, and is also working on standardizing measurements for 25(OH)D2 and D3, the C-3 epimer of 25(OH)D2 and D3, and 24,25(OH)2D, he said.

“This, I think, is a substantial positive development; however, despite these efforts some scatter is going to persist in 25(OH)D measurement,” Dr. Binkley said.
The reason for this is that analyses will pick up components of a sample other than the analyte – a phenomenon known as the matrix effect. Given the number of vitamin D metabolites that exist, it’s not surprising that assays have trouble identifying one analyte from other similar analytes, he explained.

One of those confounders is the C-3 epimer (3-epi) of 25(OH)D3, which was previously thought to exist in infants only and, as such, wasn’t of much concern, but is now known to be present at variable, albeit low, levels in virtually all human serum (J. Clin. Endocrinol. Metab. 2012;97:163-8). Since 3-epi has the same molecular structure and molecular weight as 25(OH)D, it’s not surprising that it can add “noise” to your 25(OH)D result, Dr. Binkley said.

Another confounder is 24,25(OH)2D3, which has historically been considered as simply an inactivating step in the 25(OH)D degradation pathway on the way to calcitroic acid. As such, many feel it isn’t worth measuring, he said. Recent studies, however, have found that 24,25(OH)2D3 possesses physiologic effects on cartilage and bone, and that once again, it is present at variable levels in adults up to about 10% of the 25(OH)D level.

“Three of our current immunoassays that I know of have 100% cross-reactivity with 24,25-dihydroxyvitamin D3, so when you’re measuring 25-hydroxyvitamin D, you are also measuring 24,25-dihydroxyvitamin D3,” he said.
A more recent study reports that patients with high levels of serum 24,25-dihydroxyvitamin D3 may have a less robust response to vitamin D3 (J. Steroid. Biochem. Mol. Biol. 2011;126:72-7).

Finally, two additional studies find that vitamin D3 is more potent at increasing 25(OH)D than is vitamin D2, but what may be more important is whether current assays can measure the two equally, Dr. Binkley said. Indeed, unpublished data he presented clearly show that a newer immunoassay was not up to the task.

“By prescribing ergocalciferol, we clinicians are needlessly making life more difficult for our laboratory colleagues” and unnecessarily confounding assay methodologies, he said.

Dr. Binkley reported that he had no relevant financial disclosures.

MINNEAPOLIS – Some day physicians will be able to order detailed vitamin D assay panels much like the lipid panels used today to assess cholesterol.

We’re just not there yet.

“Where we’re at today with 25-hydroxyvitamin D measurement is where we were at 50 or 60 years ago with lipid measurement ... but I believe vitamin D assay panels are coming,” said Dr. Neil C. Binkley of the Institute on Aging at the University of Wisconsin, Madison.

Patrice Wendling/IMNG Medical Media

Part of the problem with 25-hydroxyvitamin D [25(OH)D] measurement is that it has not yet been standardized, and there is no agreement on which cut points should be used by laboratories and assay manufacturers.

In its 2011 report that set for the first time Recommended Dietary Allowances for calcium and vitamin D, the Institute of Medicine declared an “urgent clinical and public health need” to reassess laboratory ranges for 25(OH)D to avoid problems of overtreatment and undertreatment.

The IOM committee concluded that the prevalence of vitamin D deficiency in North Americans has been overestimated by some because of the use of “inappropriate cut points” that greatly exceed levels identified in the report (J. Clin. Endocrinol. Metab. 2011;96:53-8).

Substantial progress has been made in the past decade, thanks in large part to the work of Dr. Graham Carter and DEQAS, the Vitamin D External Quality Assessment Scheme, Dr. Binkley said at the annual meeting of the American Society for Bone and Mineral Research. DEQAS provides serum samples on a quarterly basis to laboratories that wish to check the accuracy of their assays, and statistically trims the data to produce an all-laboratory trimmed mean (ALTM), standard deviation, and coefficient of variation for all major methodologies. Recent DEQAS data show, however, that ALTMs can vary substantially, even among groups striving to improve the quality of their program, he said.

In 2010, the National Institutes of Health Office of Dietary Supplements also launched the international vitamin D standardization program dedicated to standardizing 25(OH)D measurement to the National Institute of Standards and Technology (NIST) reference procedures. The program recently began quantitating DEQAS materials with real values assigned by NIST, and is also working on standardizing measurements for 25(OH)D2 and D3, the C-3 epimer of 25(OH)D2 and D3, and 24,25(OH)2D, he said.

“This, I think, is a substantial positive development; however, despite these efforts some scatter is going to persist in 25(OH)D measurement,” Dr. Binkley said.
The reason for this is that analyses will pick up components of a sample other than the analyte – a phenomenon known as the matrix effect. Given the number of vitamin D metabolites that exist, it’s not surprising that assays have trouble identifying one analyte from other similar analytes, he explained.

One of those confounders is the C-3 epimer (3-epi) of 25(OH)D3, which was previously thought to exist in infants only and, as such, wasn’t of much concern, but is now known to be present at variable, albeit low, levels in virtually all human serum (J. Clin. Endocrinol. Metab. 2012;97:163-8). Since 3-epi has the same molecular structure and molecular weight as 25(OH)D, it’s not surprising that it can add “noise” to your 25(OH)D result, Dr. Binkley said.

Another confounder is 24,25(OH)2D3, which has historically been considered as simply an inactivating step in the 25(OH)D degradation pathway on the way to calcitroic acid. As such, many feel it isn’t worth measuring, he said. Recent studies, however, have found that 24,25(OH)2D3 possesses physiologic effects on cartilage and bone, and that once again, it is present at variable levels in adults up to about 10% of the 25(OH)D level.

“Three of our current immunoassays that I know of have 100% cross-reactivity with 24,25-dihydroxyvitamin D3, so when you’re measuring 25-hydroxyvitamin D, you are also measuring 24,25-dihydroxyvitamin D3,” he said.
A more recent study reports that patients with high levels of serum 24,25-dihydroxyvitamin D3 may have a less robust response to vitamin D3 (J. Steroid. Biochem. Mol. Biol. 2011;126:72-7).

Finally, two additional studies find that vitamin D3 is more potent at increasing 25(OH)D than is vitamin D2, but what may be more important is whether current assays can measure the two equally, Dr. Binkley said. Indeed, unpublished data he presented clearly show that a newer immunoassay was not up to the task.

“By prescribing ergocalciferol, we clinicians are needlessly making life more difficult for our laboratory colleagues” and unnecessarily confounding assay methodologies, he said.

Dr. Binkley reported that he had no relevant financial disclosures.

MINNEAPOLIS – Some day physicians will be able to order detailed vitamin D assay panels much like the lipid panels used today to assess cholesterol.

We’re just not there yet.

“Where we’re at today with 25-hydroxyvitamin D measurement is where we were at 50 or 60 years ago with lipid measurement ... but I believe vitamin D assay panels are coming,” said Dr. Neil C. Binkley of the Institute on Aging at the University of Wisconsin, Madison.

Patrice Wendling/IMNG Medical Media

Part of the problem with 25-hydroxyvitamin D [25(OH)D] measurement is that it has not yet been standardized, and there is no agreement on which cut points should be used by laboratories and assay manufacturers.

In its 2011 report that set for the first time Recommended Dietary Allowances for calcium and vitamin D, the Institute of Medicine declared an “urgent clinical and public health need” to reassess laboratory ranges for 25(OH)D to avoid problems of overtreatment and undertreatment.

The IOM committee concluded that the prevalence of vitamin D deficiency in North Americans has been overestimated by some because of the use of “inappropriate cut points” that greatly exceed levels identified in the report (J. Clin. Endocrinol. Metab. 2011;96:53-8).

Substantial progress has been made in the past decade, thanks in large part to the work of Dr. Graham Carter and DEQAS, the Vitamin D External Quality Assessment Scheme, Dr. Binkley said at the annual meeting of the American Society for Bone and Mineral Research. DEQAS provides serum samples on a quarterly basis to laboratories that wish to check the accuracy of their assays, and statistically trims the data to produce an all-laboratory trimmed mean (ALTM), standard deviation, and coefficient of variation for all major methodologies. Recent DEQAS data show, however, that ALTMs can vary substantially, even among groups striving to improve the quality of their program, he said.

In 2010, the National Institutes of Health Office of Dietary Supplements also launched the international vitamin D standardization program dedicated to standardizing 25(OH)D measurement to the National Institute of Standards and Technology (NIST) reference procedures. The program recently began quantitating DEQAS materials with real values assigned by NIST, and is also working on standardizing measurements for 25(OH)D2 and D3, the C-3 epimer of 25(OH)D2 and D3, and 24,25(OH)2D, he said.

“This, I think, is a substantial positive development; however, despite these efforts some scatter is going to persist in 25(OH)D measurement,” Dr. Binkley said.
The reason for this is that analyses will pick up components of a sample other than the analyte – a phenomenon known as the matrix effect. Given the number of vitamin D metabolites that exist, it’s not surprising that assays have trouble identifying one analyte from other similar analytes, he explained.

One of those confounders is the C-3 epimer (3-epi) of 25(OH)D3, which was previously thought to exist in infants only and, as such, wasn’t of much concern, but is now known to be present at variable, albeit low, levels in virtually all human serum (J. Clin. Endocrinol. Metab. 2012;97:163-8). Since 3-epi has the same molecular structure and molecular weight as 25(OH)D, it’s not surprising that it can add “noise” to your 25(OH)D result, Dr. Binkley said.

Another confounder is 24,25(OH)2D3, which has historically been considered as simply an inactivating step in the 25(OH)D degradation pathway on the way to calcitroic acid. As such, many feel it isn’t worth measuring, he said. Recent studies, however, have found that 24,25(OH)2D3 possesses physiologic effects on cartilage and bone, and that once again, it is present at variable levels in adults up to about 10% of the 25(OH)D level.

“Three of our current immunoassays that I know of have 100% cross-reactivity with 24,25-dihydroxyvitamin D3, so when you’re measuring 25-hydroxyvitamin D, you are also measuring 24,25-dihydroxyvitamin D3,” he said.
A more recent study reports that patients with high levels of serum 24,25-dihydroxyvitamin D3 may have a less robust response to vitamin D3 (J. Steroid. Biochem. Mol. Biol. 2011;126:72-7).

Finally, two additional studies find that vitamin D3 is more potent at increasing 25(OH)D than is vitamin D2, but what may be more important is whether current assays can measure the two equally, Dr. Binkley said. Indeed, unpublished data he presented clearly show that a newer immunoassay was not up to the task.

“By prescribing ergocalciferol, we clinicians are needlessly making life more difficult for our laboratory colleagues” and unnecessarily confounding assay methodologies, he said.

Dr. Binkley reported that he had no relevant financial disclosures.

CHICAGO – After a meteoric rise that peaked in 2006, Medicare reimbursements for noninvasive diagnostic imaging fell by 21% in 2010, a new analysis shows.

But Medicare's total payments in 2010 were still 60% greater than what it paid a decade earlier.

"I think we in radiology can hope that this big cut in payments will convince the feds and payers that enough has been taken out of imaging and hopefully no more cuts will occur in the future year," Dr. David C. Levin said at the annual meeting of the Radiological Society of North America. "Unfortunately, I don’t think we can hang our hats on that hope."

Even without the so-called "fiscal cliff" around the corner, federal policy makers began cutting reimbursement for imaging services starting with the Deficit Reduction Act in 2006. Imaging has been identified in recent years as the most rapidly growing of all physician services, and it is well known that radiologists are highly compensated, he said.

As a result, efforts have been made by the Centers for Medicare and Medicaid Services to rein in reimbursements for imaging. This trend continues in the recently released final rules for the Hospital Outpatient Prospective Payment System (HOPPS).

To track these trends, the investigators used the Medicare Part B Physician/Supplier Procedure Summary Master Files for 2000-2010. These files provide data on volume and allowed reimbursements for every procedure code. All noninvasive diagnostic imaging codes, covering all specialties and all places of service, were selected and aggregated.

From 2000 to 2006, Medicare Part B payments to physicians for noninvasive diagnostic imaging rose from $5.9 billion to $11.9 billion – a 101% increase over those years.

There was a sharp reversal in 2007 when the Deficit Reduction Act first took effect, followed by a slight rise in 2008 and progressive declines to $9.45 billion in 2010, representing a 21% decrease from 2006, said Dr. David Levin, founder of the Center for Research on Utilization of Imaging Services (CRUISE) at Thomas Jefferson University Hospital in Philadelphia.

"That’s obviously a huge hit," he said.

When looked at by specialty, radiologists’ payments from Medicare rose 81% from $2.93 billion in 2000 to $5.3 billion in 2006, before dropping 11% to $4.7 billion in 2010.

Cardiologists, the second-largest group of imaging providers, suffered more than radiologists, Dr. Levin said. Their payments fell 33% to $1.9 billion in 2010, after rising 126% from $1.3 billion in 2000 to $2.9 billion in 2006.

Medicare spent $2.3 billion on imaging services to all other physicians in 2006, a 115% increase from $1.1 billion in 2000, before throttling back 17% to $1.9 billion in 2010.

Medicare payments to independent testing facilities increased 124% from 2000 to 2006, before declining 37% from 2006 to 2010.

The Deficit Reduction Act was the biggest reason for the drop in Part B payments for noninvasive diagnostic imaging – but other factors played a role, particularly in the progressive declines seen after 2007, Dr. Levin said.

Those factors include the Multiple Payment Procedure Reduction, the Centers for Medicare and Medicaid Services’ practice expense revaluation that cut the hourly rate for noninvasive diagnostic imaging from $204 to $135, an increase in the assumed equipment utilization rate from 50% to 75%, and a decrease in the volume of advanced imaging.

Finally, there was the bundling of codes for transthoracic echocardiogram, radionuclide myocardial infusion imaging, abdominal and pelvic computed tomography, and coronary CT angiography. "These had tremendous impacts," he added.

Dr. Levin reported serving as a consultant for HealthHelp and as a director for Outpatient Imaging Affiliates. CRUISE is funded in part by the American College of Radiology.

CHICAGO – After a meteoric rise that peaked in 2006, Medicare reimbursements for noninvasive diagnostic imaging fell by 21% in 2010, a new analysis shows.

But Medicare's total payments in 2010 were still 60% greater than what it paid a decade earlier.

"I think we in radiology can hope that this big cut in payments will convince the feds and payers that enough has been taken out of imaging and hopefully no more cuts will occur in the future year," Dr. David C. Levin said at the annual meeting of the Radiological Society of North America. "Unfortunately, I don’t think we can hang our hats on that hope."

Even without the so-called "fiscal cliff" around the corner, federal policy makers began cutting reimbursement for imaging services starting with the Deficit Reduction Act in 2006. Imaging has been identified in recent years as the most rapidly growing of all physician services, and it is well known that radiologists are highly compensated, he said.

As a result, efforts have been made by the Centers for Medicare and Medicaid Services to rein in reimbursements for imaging. This trend continues in the recently released final rules for the Hospital Outpatient Prospective Payment System (HOPPS).

To track these trends, the investigators used the Medicare Part B Physician/Supplier Procedure Summary Master Files for 2000-2010. These files provide data on volume and allowed reimbursements for every procedure code. All noninvasive diagnostic imaging codes, covering all specialties and all places of service, were selected and aggregated.

From 2000 to 2006, Medicare Part B payments to physicians for noninvasive diagnostic imaging rose from $5.9 billion to $11.9 billion – a 101% increase over those years.

There was a sharp reversal in 2007 when the Deficit Reduction Act first took effect, followed by a slight rise in 2008 and progressive declines to $9.45 billion in 2010, representing a 21% decrease from 2006, said Dr. David Levin, founder of the Center for Research on Utilization of Imaging Services (CRUISE) at Thomas Jefferson University Hospital in Philadelphia.

"That’s obviously a huge hit," he said.

When looked at by specialty, radiologists’ payments from Medicare rose 81% from $2.93 billion in 2000 to $5.3 billion in 2006, before dropping 11% to $4.7 billion in 2010.

Cardiologists, the second-largest group of imaging providers, suffered more than radiologists, Dr. Levin said. Their payments fell 33% to $1.9 billion in 2010, after rising 126% from $1.3 billion in 2000 to $2.9 billion in 2006.

Medicare spent $2.3 billion on imaging services to all other physicians in 2006, a 115% increase from $1.1 billion in 2000, before throttling back 17% to $1.9 billion in 2010.

Medicare payments to independent testing facilities increased 124% from 2000 to 2006, before declining 37% from 2006 to 2010.

The Deficit Reduction Act was the biggest reason for the drop in Part B payments for noninvasive diagnostic imaging – but other factors played a role, particularly in the progressive declines seen after 2007, Dr. Levin said.

Those factors include the Multiple Payment Procedure Reduction, the Centers for Medicare and Medicaid Services’ practice expense revaluation that cut the hourly rate for noninvasive diagnostic imaging from $204 to $135, an increase in the assumed equipment utilization rate from 50% to 75%, and a decrease in the volume of advanced imaging.

Finally, there was the bundling of codes for transthoracic echocardiogram, radionuclide myocardial infusion imaging, abdominal and pelvic computed tomography, and coronary CT angiography. "These had tremendous impacts," he added.

Dr. Levin reported serving as a consultant for HealthHelp and as a director for Outpatient Imaging Affiliates. CRUISE is funded in part by the American College of Radiology.

CHICAGO – After a meteoric rise that peaked in 2006, Medicare reimbursements for noninvasive diagnostic imaging fell by 21% in 2010, a new analysis shows.

But Medicare's total payments in 2010 were still 60% greater than what it paid a decade earlier.

"I think we in radiology can hope that this big cut in payments will convince the feds and payers that enough has been taken out of imaging and hopefully no more cuts will occur in the future year," Dr. David C. Levin said at the annual meeting of the Radiological Society of North America. "Unfortunately, I don’t think we can hang our hats on that hope."

Even without the so-called "fiscal cliff" around the corner, federal policy makers began cutting reimbursement for imaging services starting with the Deficit Reduction Act in 2006. Imaging has been identified in recent years as the most rapidly growing of all physician services, and it is well known that radiologists are highly compensated, he said.

As a result, efforts have been made by the Centers for Medicare and Medicaid Services to rein in reimbursements for imaging. This trend continues in the recently released final rules for the Hospital Outpatient Prospective Payment System (HOPPS).

To track these trends, the investigators used the Medicare Part B Physician/Supplier Procedure Summary Master Files for 2000-2010. These files provide data on volume and allowed reimbursements for every procedure code. All noninvasive diagnostic imaging codes, covering all specialties and all places of service, were selected and aggregated.

From 2000 to 2006, Medicare Part B payments to physicians for noninvasive diagnostic imaging rose from $5.9 billion to $11.9 billion – a 101% increase over those years.

There was a sharp reversal in 2007 when the Deficit Reduction Act first took effect, followed by a slight rise in 2008 and progressive declines to $9.45 billion in 2010, representing a 21% decrease from 2006, said Dr. David Levin, founder of the Center for Research on Utilization of Imaging Services (CRUISE) at Thomas Jefferson University Hospital in Philadelphia.

"That’s obviously a huge hit," he said.

When looked at by specialty, radiologists’ payments from Medicare rose 81% from $2.93 billion in 2000 to $5.3 billion in 2006, before dropping 11% to $4.7 billion in 2010.

Cardiologists, the second-largest group of imaging providers, suffered more than radiologists, Dr. Levin said. Their payments fell 33% to $1.9 billion in 2010, after rising 126% from $1.3 billion in 2000 to $2.9 billion in 2006.

Medicare spent $2.3 billion on imaging services to all other physicians in 2006, a 115% increase from $1.1 billion in 2000, before throttling back 17% to $1.9 billion in 2010.

Medicare payments to independent testing facilities increased 124% from 2000 to 2006, before declining 37% from 2006 to 2010.

The Deficit Reduction Act was the biggest reason for the drop in Part B payments for noninvasive diagnostic imaging – but other factors played a role, particularly in the progressive declines seen after 2007, Dr. Levin said.

Those factors include the Multiple Payment Procedure Reduction, the Centers for Medicare and Medicaid Services’ practice expense revaluation that cut the hourly rate for noninvasive diagnostic imaging from $204 to $135, an increase in the assumed equipment utilization rate from 50% to 75%, and a decrease in the volume of advanced imaging.

Finally, there was the bundling of codes for transthoracic echocardiogram, radionuclide myocardial infusion imaging, abdominal and pelvic computed tomography, and coronary CT angiography. "These had tremendous impacts," he added.

Dr. Levin reported serving as a consultant for HealthHelp and as a director for Outpatient Imaging Affiliates. CRUISE is funded in part by the American College of Radiology.

MILWAUKEE – Although female sex is associated with a higher rate of complications, women did not have significantly lower long-term survival after endovascular abdominal aortic aneurysm repair in a review of the Mayo Clinic AAA Registry.

At 30 days, 24% of women experienced complications after EVAR, compared with 15% of men (P value = .003). On the other hand, death at 30 days was similar (2.5% vs. 1.5%; P = .41), as was combined early or late death (hazard ratio 1.1 vs. 1.0; P = .36), Dr. Peter Gloviczki reported at the annual meeting. of the Midwestern Vascular Society.

He highlighted a prospective analysis from Albany (N.Y.) Medical College showing that women had significantly higher mortality than did men (3.2% vs. 0.96%, P less than .005) and more frequent colon ischemia, native arterial rupture, and type 1 endoleaks after elective EVAR. There were no sex-related differences, however, for any of these outcomes following elective open repair, emergency EVAR, or surgery (Vasc Surg. 2012 Apr;55:906-13. Epub 2012 Feb. 8).

In the Mayo Clinic analysis, urgent presentation, age over 70 years, and high comorbidity scores were all significantly associated with complications and higher mortality, said Dr. Gloviczki, president of the Society for Vascular Surgery (SVS) and chair emeritus of vascular and endovascular surgery, Mayo Clinic, Rochester, Minn.

The retrospective analysis included 1,002 consecutive patients with abdominal aortic aneurysm (AAA) treated with EVAR at Mayo Clinic from January 1997 to June 30, 2011. Of these, 871 were male (87%) and 131 female (13%). The majority (919) of cases were elective (92%), 43 symptomatic (4%), and 40 ruptured AAA (4%). Patients’ average age was 76 years (range 51-99 years).

Thirty-day mortality was 1% in the elective group, compared with 2.3% in the symptomatic AAA group and 12.5% in the ruptured AAA group (both P less than .0001), he said.

In contrast to the Albany analysis, early mortality after elective repair was similar between men and women (0.75% vs. 2.61%; P = .09). This was further confirmed by multivariate analysis (hazard ratio for all-cause death 1.16; P = .40), despite an increased risk in women for complications (HR 1.67; P = .001) and reinterventions (HR 1.96; P = .002).

High-risk patients, defined by an SVS comorbidity score greater than 10, had significantly higher 30-day mortality after elective EVAR than did low-risk patients (2.33% vs. 0.18%; P = .004).

This was driven by a significantly higher rate of early complications in the high-risk group (19.3% vs. 11.4%), particularly myocardial infarction (1.6% vs. 0.18%) and acute renal failure requiring temporary dialysis (3.26% vs. 1.09%; P less than .05 for all), Dr. Gloviczki observed.

At an average follow-up of 3.2 years, overall survival was significantly higher in patients undergoing elective EVAR vs. symptomatic or ruptured repair (64% vs. 50% and 56%; P less than .001), and in low-risk vs. high-risk elective patients (72% vs. 51%; P less than .001).

Both 30-day mortality and complications significantly increased with age after elective repair, he said.

Overall, there were five late ruptures and nine late conversions, for a complication-free 5-year survival of 64% in the elective group. He noted that access-related difficulties are driving the higher early complication rate in women, but that other factors like age and comorbidities may be at play.

When asked what’s changed in his patient selection and aneurysm size cutoff, Dr. Gloviczki said that in younger patients, surgeons may want to intervene earlier if the aneurysm appears likely to increase in size and is suitable for an endograft, but that overall, age alone should not drive patient selection.

"What this study showed me is that characterizing patients as high risk vs. low risk is important, in addition to age," he said. "As you could see, there was an increased mortality in age, but when we looked at high-risk and low-risk criteria, we only lost one patient in the low-risk group. So age alone does not put you into a high-risk category, it is your additional cardiac, pulmonary and renal disease that does."

Dr. Gloviczki reported no conflicts.

MILWAUKEE – Although female sex is associated with a higher rate of complications, women did not have significantly lower long-term survival after endovascular abdominal aortic aneurysm repair in a review of the Mayo Clinic AAA Registry.

At 30 days, 24% of women experienced complications after EVAR, compared with 15% of men (P value = .003). On the other hand, death at 30 days was similar (2.5% vs. 1.5%; P = .41), as was combined early or late death (hazard ratio 1.1 vs. 1.0; P = .36), Dr. Peter Gloviczki reported at the annual meeting. of the Midwestern Vascular Society.

He highlighted a prospective analysis from Albany (N.Y.) Medical College showing that women had significantly higher mortality than did men (3.2% vs. 0.96%, P less than .005) and more frequent colon ischemia, native arterial rupture, and type 1 endoleaks after elective EVAR. There were no sex-related differences, however, for any of these outcomes following elective open repair, emergency EVAR, or surgery (Vasc Surg. 2012 Apr;55:906-13. Epub 2012 Feb. 8).

In the Mayo Clinic analysis, urgent presentation, age over 70 years, and high comorbidity scores were all significantly associated with complications and higher mortality, said Dr. Gloviczki, president of the Society for Vascular Surgery (SVS) and chair emeritus of vascular and endovascular surgery, Mayo Clinic, Rochester, Minn.

The retrospective analysis included 1,002 consecutive patients with abdominal aortic aneurysm (AAA) treated with EVAR at Mayo Clinic from January 1997 to June 30, 2011. Of these, 871 were male (87%) and 131 female (13%). The majority (919) of cases were elective (92%), 43 symptomatic (4%), and 40 ruptured AAA (4%). Patients’ average age was 76 years (range 51-99 years).

Thirty-day mortality was 1% in the elective group, compared with 2.3% in the symptomatic AAA group and 12.5% in the ruptured AAA group (both P less than .0001), he said.

In contrast to the Albany analysis, early mortality after elective repair was similar between men and women (0.75% vs. 2.61%; P = .09). This was further confirmed by multivariate analysis (hazard ratio for all-cause death 1.16; P = .40), despite an increased risk in women for complications (HR 1.67; P = .001) and reinterventions (HR 1.96; P = .002).

High-risk patients, defined by an SVS comorbidity score greater than 10, had significantly higher 30-day mortality after elective EVAR than did low-risk patients (2.33% vs. 0.18%; P = .004).

This was driven by a significantly higher rate of early complications in the high-risk group (19.3% vs. 11.4%), particularly myocardial infarction (1.6% vs. 0.18%) and acute renal failure requiring temporary dialysis (3.26% vs. 1.09%; P less than .05 for all), Dr. Gloviczki observed.

At an average follow-up of 3.2 years, overall survival was significantly higher in patients undergoing elective EVAR vs. symptomatic or ruptured repair (64% vs. 50% and 56%; P less than .001), and in low-risk vs. high-risk elective patients (72% vs. 51%; P less than .001).

Both 30-day mortality and complications significantly increased with age after elective repair, he said.

Overall, there were five late ruptures and nine late conversions, for a complication-free 5-year survival of 64% in the elective group. He noted that access-related difficulties are driving the higher early complication rate in women, but that other factors like age and comorbidities may be at play.

When asked what’s changed in his patient selection and aneurysm size cutoff, Dr. Gloviczki said that in younger patients, surgeons may want to intervene earlier if the aneurysm appears likely to increase in size and is suitable for an endograft, but that overall, age alone should not drive patient selection.

"What this study showed me is that characterizing patients as high risk vs. low risk is important, in addition to age," he said. "As you could see, there was an increased mortality in age, but when we looked at high-risk and low-risk criteria, we only lost one patient in the low-risk group. So age alone does not put you into a high-risk category, it is your additional cardiac, pulmonary and renal disease that does."

Dr. Gloviczki reported no conflicts.

MILWAUKEE – Although female sex is associated with a higher rate of complications, women did not have significantly lower long-term survival after endovascular abdominal aortic aneurysm repair in a review of the Mayo Clinic AAA Registry.

At 30 days, 24% of women experienced complications after EVAR, compared with 15% of men (P value = .003). On the other hand, death at 30 days was similar (2.5% vs. 1.5%; P = .41), as was combined early or late death (hazard ratio 1.1 vs. 1.0; P = .36), Dr. Peter Gloviczki reported at the annual meeting. of the Midwestern Vascular Society.

He highlighted a prospective analysis from Albany (N.Y.) Medical College showing that women had significantly higher mortality than did men (3.2% vs. 0.96%, P less than .005) and more frequent colon ischemia, native arterial rupture, and type 1 endoleaks after elective EVAR. There were no sex-related differences, however, for any of these outcomes following elective open repair, emergency EVAR, or surgery (Vasc Surg. 2012 Apr;55:906-13. Epub 2012 Feb. 8).

In the Mayo Clinic analysis, urgent presentation, age over 70 years, and high comorbidity scores were all significantly associated with complications and higher mortality, said Dr. Gloviczki, president of the Society for Vascular Surgery (SVS) and chair emeritus of vascular and endovascular surgery, Mayo Clinic, Rochester, Minn.

The retrospective analysis included 1,002 consecutive patients with abdominal aortic aneurysm (AAA) treated with EVAR at Mayo Clinic from January 1997 to June 30, 2011. Of these, 871 were male (87%) and 131 female (13%). The majority (919) of cases were elective (92%), 43 symptomatic (4%), and 40 ruptured AAA (4%). Patients’ average age was 76 years (range 51-99 years).

Thirty-day mortality was 1% in the elective group, compared with 2.3% in the symptomatic AAA group and 12.5% in the ruptured AAA group (both P less than .0001), he said.

In contrast to the Albany analysis, early mortality after elective repair was similar between men and women (0.75% vs. 2.61%; P = .09). This was further confirmed by multivariate analysis (hazard ratio for all-cause death 1.16; P = .40), despite an increased risk in women for complications (HR 1.67; P = .001) and reinterventions (HR 1.96; P = .002).

High-risk patients, defined by an SVS comorbidity score greater than 10, had significantly higher 30-day mortality after elective EVAR than did low-risk patients (2.33% vs. 0.18%; P = .004).

This was driven by a significantly higher rate of early complications in the high-risk group (19.3% vs. 11.4%), particularly myocardial infarction (1.6% vs. 0.18%) and acute renal failure requiring temporary dialysis (3.26% vs. 1.09%; P less than .05 for all), Dr. Gloviczki observed.

At an average follow-up of 3.2 years, overall survival was significantly higher in patients undergoing elective EVAR vs. symptomatic or ruptured repair (64% vs. 50% and 56%; P less than .001), and in low-risk vs. high-risk elective patients (72% vs. 51%; P less than .001).

Both 30-day mortality and complications significantly increased with age after elective repair, he said.

Overall, there were five late ruptures and nine late conversions, for a complication-free 5-year survival of 64% in the elective group. He noted that access-related difficulties are driving the higher early complication rate in women, but that other factors like age and comorbidities may be at play.

When asked what’s changed in his patient selection and aneurysm size cutoff, Dr. Gloviczki said that in younger patients, surgeons may want to intervene earlier if the aneurysm appears likely to increase in size and is suitable for an endograft, but that overall, age alone should not drive patient selection.

"What this study showed me is that characterizing patients as high risk vs. low risk is important, in addition to age," he said. "As you could see, there was an increased mortality in age, but when we looked at high-risk and low-risk criteria, we only lost one patient in the low-risk group. So age alone does not put you into a high-risk category, it is your additional cardiac, pulmonary and renal disease that does."

Dr. Gloviczki reported no conflicts.

LAS VEGAS – The number of hysterectomies in the United States appears to be on the decline, despite a 10% increase in minimally invasive cases.

Based on updated surveillance data, an estimated 479,229 hysterectomies were performed in the United States in 2009, of which 24% used a laparoscopic approach.

Patrice Wendling/IMNG Medical Media

By comparison, there were 518,828 hysterectomies in 2005, 14% of which were laparoscopic: 64% were abdominal and 22% were vaginal (Obstet. Gynecol. 2009;114:1041-8).

Whether this represents a real decline in hysterectomies is unclear, Dr. Sarah Cohen of Brigham and Women’s Hospital in Boston said at the 41st AAGL Global Congress.

The current analysis included oncologic cases, whereas the 2005 analysis looked only at gynecologic hysterectomies for benign disease.

On the other hand, both analyses are based on the Nationwide Inpatient Sample (NIS), which represents a 20% stratified random sample of discharges from all community hospitals in the United States. It is the largest national all-payer database of hospital discharges, but that’s where it stops.

"It’s possible that there are a number of nonsurgical options being offered to patients; however, I do think this also represents the increase in outpatient surgeries being offered, and the Nationwide Inpatient Sample databases aren’t able to account for those," she said. "Particularly, we may be underestimating laparoscopic and vaginal procedures that are being done in ambulatory settings."

Hysterectomy is the most common nonobstetric surgical procedure among women, with 600,000 typically cited as the annual number of procedures.

Dr. Cohen and her colleagues sought to verify this number using ICD-9 codes in the 2009 NIS – the most recent year available – to abstract information about any patient who underwent a hysterectomy during her hospitalization, including oncologic cases. Obstetric hysterectomies were excluded. The data were then weighted to give national estimates.

The mean patient age was 48 years, and the predominant indications were uterine fibroids (47%) and menstrual disorders (45%). Adnexal surgery occurred in 57% of cases.

Abdominal hysterectomy made up 58% of cases and vaginal hysterectomy 17% in the updated analysis, compared with 64% and 22% in the 2005 NIS, Dr. Cohen said.

In regression analysis, factors associated with laparoscopic surgery compared with abdominal surgery were younger age, white race, an indication of prolapse, menstrual disorder or endometriosis, living in an urban area, having a high income, having private insurance, and living in the Western United States.

When the regressions were repeated to compare laparoscopic with vaginal surgery, factors favoring the laparoscopic approach were age 40-49, black race, any nonprolapse indication, concomitant adnexal surgery, living in an urban area, having a high income, having private insurance, and living in the Northeastern United States.

Based on a systematic review of the literature, seven articles have been published in the past 5 years regarding hysterectomy surveillance, Dr. Cohen observed.

Although the NIS database may be incomplete, the bidirectional trends of falling overall numbers and rising laparoscopic procedures appear to be holding. An analysis of the 2003 NIS revealed 602,457 hysterectomies, with the abdominal route the most common at 66%, followed by the vaginal (22%) and laparoscopic (12%) routes (Obstet. Gynecol. 2007;110:1091-5).

Dr. Cohen said it’s critical to continue evaluating trends in hysterectomy performance, particularly with increasing outpatient minimally invasive procedures, and that he and his colleagues plan to incorporate state-level ambulatory surgery databases to capture outpatient procedures. They also will perform subgroup analyses of benign and oncologic cases, and look at factors associated with concomitant adnexal procedures.

Dr. Cohen reported no relevant financial disclosures.

LAS VEGAS – The number of hysterectomies in the United States appears to be on the decline, despite a 10% increase in minimally invasive cases.

Based on updated surveillance data, an estimated 479,229 hysterectomies were performed in the United States in 2009, of which 24% used a laparoscopic approach.

Patrice Wendling/IMNG Medical Media

By comparison, there were 518,828 hysterectomies in 2005, 14% of which were laparoscopic: 64% were abdominal and 22% were vaginal (Obstet. Gynecol. 2009;114:1041-8).

Whether this represents a real decline in hysterectomies is unclear, Dr. Sarah Cohen of Brigham and Women’s Hospital in Boston said at the 41st AAGL Global Congress.

The current analysis included oncologic cases, whereas the 2005 analysis looked only at gynecologic hysterectomies for benign disease.

On the other hand, both analyses are based on the Nationwide Inpatient Sample (NIS), which represents a 20% stratified random sample of discharges from all community hospitals in the United States. It is the largest national all-payer database of hospital discharges, but that’s where it stops.

"It’s possible that there are a number of nonsurgical options being offered to patients; however, I do think this also represents the increase in outpatient surgeries being offered, and the Nationwide Inpatient Sample databases aren’t able to account for those," she said. "Particularly, we may be underestimating laparoscopic and vaginal procedures that are being done in ambulatory settings."

Hysterectomy is the most common nonobstetric surgical procedure among women, with 600,000 typically cited as the annual number of procedures.

Dr. Cohen and her colleagues sought to verify this number using ICD-9 codes in the 2009 NIS – the most recent year available – to abstract information about any patient who underwent a hysterectomy during her hospitalization, including oncologic cases. Obstetric hysterectomies were excluded. The data were then weighted to give national estimates.

The mean patient age was 48 years, and the predominant indications were uterine fibroids (47%) and menstrual disorders (45%). Adnexal surgery occurred in 57% of cases.

Abdominal hysterectomy made up 58% of cases and vaginal hysterectomy 17% in the updated analysis, compared with 64% and 22% in the 2005 NIS, Dr. Cohen said.

In regression analysis, factors associated with laparoscopic surgery compared with abdominal surgery were younger age, white race, an indication of prolapse, menstrual disorder or endometriosis, living in an urban area, having a high income, having private insurance, and living in the Western United States.

When the regressions were repeated to compare laparoscopic with vaginal surgery, factors favoring the laparoscopic approach were age 40-49, black race, any nonprolapse indication, concomitant adnexal surgery, living in an urban area, having a high income, having private insurance, and living in the Northeastern United States.

Based on a systematic review of the literature, seven articles have been published in the past 5 years regarding hysterectomy surveillance, Dr. Cohen observed.

Although the NIS database may be incomplete, the bidirectional trends of falling overall numbers and rising laparoscopic procedures appear to be holding. An analysis of the 2003 NIS revealed 602,457 hysterectomies, with the abdominal route the most common at 66%, followed by the vaginal (22%) and laparoscopic (12%) routes (Obstet. Gynecol. 2007;110:1091-5).

Dr. Cohen said it’s critical to continue evaluating trends in hysterectomy performance, particularly with increasing outpatient minimally invasive procedures, and that he and his colleagues plan to incorporate state-level ambulatory surgery databases to capture outpatient procedures. They also will perform subgroup analyses of benign and oncologic cases, and look at factors associated with concomitant adnexal procedures.

Dr. Cohen reported no relevant financial disclosures.

LAS VEGAS – The number of hysterectomies in the United States appears to be on the decline, despite a 10% increase in minimally invasive cases.

Based on updated surveillance data, an estimated 479,229 hysterectomies were performed in the United States in 2009, of which 24% used a laparoscopic approach.

Patrice Wendling/IMNG Medical Media

By comparison, there were 518,828 hysterectomies in 2005, 14% of which were laparoscopic: 64% were abdominal and 22% were vaginal (Obstet. Gynecol. 2009;114:1041-8).

Whether this represents a real decline in hysterectomies is unclear, Dr. Sarah Cohen of Brigham and Women’s Hospital in Boston said at the 41st AAGL Global Congress.

The current analysis included oncologic cases, whereas the 2005 analysis looked only at gynecologic hysterectomies for benign disease.

On the other hand, both analyses are based on the Nationwide Inpatient Sample (NIS), which represents a 20% stratified random sample of discharges from all community hospitals in the United States. It is the largest national all-payer database of hospital discharges, but that’s where it stops.

"It’s possible that there are a number of nonsurgical options being offered to patients; however, I do think this also represents the increase in outpatient surgeries being offered, and the Nationwide Inpatient Sample databases aren’t able to account for those," she said. "Particularly, we may be underestimating laparoscopic and vaginal procedures that are being done in ambulatory settings."

Hysterectomy is the most common nonobstetric surgical procedure among women, with 600,000 typically cited as the annual number of procedures.

Dr. Cohen and her colleagues sought to verify this number using ICD-9 codes in the 2009 NIS – the most recent year available – to abstract information about any patient who underwent a hysterectomy during her hospitalization, including oncologic cases. Obstetric hysterectomies were excluded. The data were then weighted to give national estimates.

The mean patient age was 48 years, and the predominant indications were uterine fibroids (47%) and menstrual disorders (45%). Adnexal surgery occurred in 57% of cases.

Abdominal hysterectomy made up 58% of cases and vaginal hysterectomy 17% in the updated analysis, compared with 64% and 22% in the 2005 NIS, Dr. Cohen said.

In regression analysis, factors associated with laparoscopic surgery compared with abdominal surgery were younger age, white race, an indication of prolapse, menstrual disorder or endometriosis, living in an urban area, having a high income, having private insurance, and living in the Western United States.

When the regressions were repeated to compare laparoscopic with vaginal surgery, factors favoring the laparoscopic approach were age 40-49, black race, any nonprolapse indication, concomitant adnexal surgery, living in an urban area, having a high income, having private insurance, and living in the Northeastern United States.

Based on a systematic review of the literature, seven articles have been published in the past 5 years regarding hysterectomy surveillance, Dr. Cohen observed.

Although the NIS database may be incomplete, the bidirectional trends of falling overall numbers and rising laparoscopic procedures appear to be holding. An analysis of the 2003 NIS revealed 602,457 hysterectomies, with the abdominal route the most common at 66%, followed by the vaginal (22%) and laparoscopic (12%) routes (Obstet. Gynecol. 2007;110:1091-5).

Dr. Cohen said it’s critical to continue evaluating trends in hysterectomy performance, particularly with increasing outpatient minimally invasive procedures, and that he and his colleagues plan to incorporate state-level ambulatory surgery databases to capture outpatient procedures. They also will perform subgroup analyses of benign and oncologic cases, and look at factors associated with concomitant adnexal procedures.

Dr. Cohen reported no relevant financial disclosures.

LAS VEGAS  – Ultrasound-guided radiofrequency ablation offers women a new, noninvasive treatment option for painful uterine fibroids.

"I actually think this changes the entire outlook," Dr. Scott Chudnoff said at the AAGL Global Congress. "The beauty of this is the simplicity. The risk is so low.

"I’ve been coming to AAGL for years and what I love about it is seeing the new technology on the horizon, and this is the first one in a few years that is a real game changer for the organization and for gynecology in general," he said in an interview.

He presented data from an international, phase III, single-arm study evaluating the safety and efficacy of the Acessa system to treat moderate to severe bleeding in 135 consecutive women, ages 30-54 years, with symptomatic fibroids.

The results prompted the Food and Drug Administration to clear Acessa for the treatment of uterine leiomyoma on Nov. 6, 2012, just as the AAGL Congress kicked off.

Acessa is already in use in Canada and Europe, and shrinks fibroids using radiofrequency energy delivered via an electrode array inserted into the fibroid under intra-abdominal laparoscopic ultrasound guidance.

One in five women may have fibroids during their childbearing years, and they are present in half of all women by aged 50 years. Many are asymptomatic, but fibroids are also one of the leading causes of hysterectomy.

The last time there was a change in fibroid treatment options was more than 5 years ago with the arrival of MRI-guided focused ultrasound ablation, but the data on this have been somewhat disappointing, said Dr. Chudnoff, director of obstetrics and gynecology and women’s health at Montefiore Medical Center in New York.

There are a range of medical therapies, but they primarily target the symptomatology and not the fibroid itself. Uterine artery embolization is a fantastic procedure, but it’s a global destruction process of the entire uterus, and there are concerns regarding future fertility, he observed. Hysteroscopic fibroid resection is useful for submucosal fibroids, but access is often difficult and women typically have other types of fibroids as well.

Finally, there’s myomectomy, "a bloody, invasive procedure that more often than not dooms the patient to having a Cesarean section and carries a recurrence rate of about 80%," Dr. Chudnoff said.

"So what do you tell your 35-year-old patient that comes into your office and says, ‘What can you do for me?’ " Dr. Chudnoff said. "That’s where I think this comes in. It is that opportunity to get in there early before patients become extremely symptomatic and treat these fibroids with fibroid-directed therapy.

"If in 5 or 10 years they get new fibroids, I can treat them again, but there’s a big difference between doing this and doing a myomectomy again or having to do a hysterectomy in a post-myomectomy patient. Those are disasters," he said.

Women in the trial had clinical menorrhagia (160-500 cc of menstrual blood loss per cycle), no more than six fibroids (mean, five), and a total uterine volume of 300 cc or less. Fibroid types were 193 subserosals, 347 intramurals, 39 transmurals, and 164 submucosals. The trial did not include pedunculated fibroids or type 0 fibroids because of concerns that ablation near the base of the stalk could result in secondary potential complications such as superinfections, he said.

In all, 674 fibroids were treated with Acessa, 96.2% on an outpatient basis. Patients returned to normal activity in an average of 7-10 days, and went back to work at a median of 9 days (range 0-29 days).

Patient-reported symptom severity scores on the validated Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL) questionnaire decreased from a mean of 61.4 at baseline to 28.7 at 3 months, 28.6 at 6 months, and was significant at 26.4 at 12 months (P value less than .001), Dr. Chudnoff reported.

At the same time, mean quality of life scores on the UFS-QOL improved from 37.1 at baseline to 75.2, 78.1, and 80 (P less than .0001 at 12 months).

"What’s important to note is that patients continue to improve and [this] persists at high levels," he said.

Mean scores on the EuroQoL-5 dimensions (EQ-5D) measure also increased from 70.7 at baseline to 84.9 at 3 months, 84.6 at 6 months, and were significant at 85.7 at 12 months (P less than .0001).

There were five (3.7%) device-related adverse events: lower abdominal pain, pelvic abscess, two superficial uterine serosal burns, and post-treatment bleeding.

One patient underwent uterine artery embolization after withdrawing from the trial before her 6-month follow-up visit, resulting in a reintervention rate of 0.7%.

In separate presentations at the meeting, fellow Acessa investigators reported significant decreases at 3 and 12 months in mean uterine volume of 16% and 25% and in mean fibroid volume of 38% and 44.3%. Clinically significant reductions in menstrual bleeding were observed in 69% of women (mean 101.6 cc).

Reductions in alkaline hematin levels were associated with fibroid shrinkage. The mean alkaline hematin level was 271.5 mL at baseline, decreasing by 31% at 3 months, 41% at 6 months, and 38% at 12 months (all P less than .0001).

During a discussion of the study, Dr. Chudnoff said quality of life was not directly related to the size of fibroid shrinkage, but observed that all women who experienced fibroid shrinkage had symptom relief.

Finally, when asked about the overall effectiveness of the procedure, 98% of patients said they would recommend Acessa to a friend, 95% said they were satisfied with the treatment, and 94% thought it was effective, he reported.

Dr. Chudnoff and his coauthors reported serving as principal investigators for Halt Medical, which sponsored the study. One coauthor is also a consultant for Halt.

LAS VEGAS  – Ultrasound-guided radiofrequency ablation offers women a new, noninvasive treatment option for painful uterine fibroids.

"I actually think this changes the entire outlook," Dr. Scott Chudnoff said at the AAGL Global Congress. "The beauty of this is the simplicity. The risk is so low.

"I’ve been coming to AAGL for years and what I love about it is seeing the new technology on the horizon, and this is the first one in a few years that is a real game changer for the organization and for gynecology in general," he said in an interview.

He presented data from an international, phase III, single-arm study evaluating the safety and efficacy of the Acessa system to treat moderate to severe bleeding in 135 consecutive women, ages 30-54 years, with symptomatic fibroids.

The results prompted the Food and Drug Administration to clear Acessa for the treatment of uterine leiomyoma on Nov. 6, 2012, just as the AAGL Congress kicked off.

Acessa is already in use in Canada and Europe, and shrinks fibroids using radiofrequency energy delivered via an electrode array inserted into the fibroid under intra-abdominal laparoscopic ultrasound guidance.

One in five women may have fibroids during their childbearing years, and they are present in half of all women by aged 50 years. Many are asymptomatic, but fibroids are also one of the leading causes of hysterectomy.

The last time there was a change in fibroid treatment options was more than 5 years ago with the arrival of MRI-guided focused ultrasound ablation, but the data on this have been somewhat disappointing, said Dr. Chudnoff, director of obstetrics and gynecology and women’s health at Montefiore Medical Center in New York.

There are a range of medical therapies, but they primarily target the symptomatology and not the fibroid itself. Uterine artery embolization is a fantastic procedure, but it’s a global destruction process of the entire uterus, and there are concerns regarding future fertility, he observed. Hysteroscopic fibroid resection is useful for submucosal fibroids, but access is often difficult and women typically have other types of fibroids as well.

Finally, there’s myomectomy, "a bloody, invasive procedure that more often than not dooms the patient to having a Cesarean section and carries a recurrence rate of about 80%," Dr. Chudnoff said.

"So what do you tell your 35-year-old patient that comes into your office and says, ‘What can you do for me?’ " Dr. Chudnoff said. "That’s where I think this comes in. It is that opportunity to get in there early before patients become extremely symptomatic and treat these fibroids with fibroid-directed therapy.

"If in 5 or 10 years they get new fibroids, I can treat them again, but there’s a big difference between doing this and doing a myomectomy again or having to do a hysterectomy in a post-myomectomy patient. Those are disasters," he said.

Women in the trial had clinical menorrhagia (160-500 cc of menstrual blood loss per cycle), no more than six fibroids (mean, five), and a total uterine volume of 300 cc or less. Fibroid types were 193 subserosals, 347 intramurals, 39 transmurals, and 164 submucosals. The trial did not include pedunculated fibroids or type 0 fibroids because of concerns that ablation near the base of the stalk could result in secondary potential complications such as superinfections, he said.

In all, 674 fibroids were treated with Acessa, 96.2% on an outpatient basis. Patients returned to normal activity in an average of 7-10 days, and went back to work at a median of 9 days (range 0-29 days).

Patient-reported symptom severity scores on the validated Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL) questionnaire decreased from a mean of 61.4 at baseline to 28.7 at 3 months, 28.6 at 6 months, and was significant at 26.4 at 12 months (P value less than .001), Dr. Chudnoff reported.

At the same time, mean quality of life scores on the UFS-QOL improved from 37.1 at baseline to 75.2, 78.1, and 80 (P less than .0001 at 12 months).

"What’s important to note is that patients continue to improve and [this] persists at high levels," he said.

Mean scores on the EuroQoL-5 dimensions (EQ-5D) measure also increased from 70.7 at baseline to 84.9 at 3 months, 84.6 at 6 months, and were significant at 85.7 at 12 months (P less than .0001).

There were five (3.7%) device-related adverse events: lower abdominal pain, pelvic abscess, two superficial uterine serosal burns, and post-treatment bleeding.

One patient underwent uterine artery embolization after withdrawing from the trial before her 6-month follow-up visit, resulting in a reintervention rate of 0.7%.

In separate presentations at the meeting, fellow Acessa investigators reported significant decreases at 3 and 12 months in mean uterine volume of 16% and 25% and in mean fibroid volume of 38% and 44.3%. Clinically significant reductions in menstrual bleeding were observed in 69% of women (mean 101.6 cc).

Reductions in alkaline hematin levels were associated with fibroid shrinkage. The mean alkaline hematin level was 271.5 mL at baseline, decreasing by 31% at 3 months, 41% at 6 months, and 38% at 12 months (all P less than .0001).

During a discussion of the study, Dr. Chudnoff said quality of life was not directly related to the size of fibroid shrinkage, but observed that all women who experienced fibroid shrinkage had symptom relief.

Finally, when asked about the overall effectiveness of the procedure, 98% of patients said they would recommend Acessa to a friend, 95% said they were satisfied with the treatment, and 94% thought it was effective, he reported.

Dr. Chudnoff and his coauthors reported serving as principal investigators for Halt Medical, which sponsored the study. One coauthor is also a consultant for Halt.

LAS VEGAS  – Ultrasound-guided radiofrequency ablation offers women a new, noninvasive treatment option for painful uterine fibroids.

"I actually think this changes the entire outlook," Dr. Scott Chudnoff said at the AAGL Global Congress. "The beauty of this is the simplicity. The risk is so low.

"I’ve been coming to AAGL for years and what I love about it is seeing the new technology on the horizon, and this is the first one in a few years that is a real game changer for the organization and for gynecology in general," he said in an interview.

He presented data from an international, phase III, single-arm study evaluating the safety and efficacy of the Acessa system to treat moderate to severe bleeding in 135 consecutive women, ages 30-54 years, with symptomatic fibroids.

The results prompted the Food and Drug Administration to clear Acessa for the treatment of uterine leiomyoma on Nov. 6, 2012, just as the AAGL Congress kicked off.

Acessa is already in use in Canada and Europe, and shrinks fibroids using radiofrequency energy delivered via an electrode array inserted into the fibroid under intra-abdominal laparoscopic ultrasound guidance.

One in five women may have fibroids during their childbearing years, and they are present in half of all women by aged 50 years. Many are asymptomatic, but fibroids are also one of the leading causes of hysterectomy.

The last time there was a change in fibroid treatment options was more than 5 years ago with the arrival of MRI-guided focused ultrasound ablation, but the data on this have been somewhat disappointing, said Dr. Chudnoff, director of obstetrics and gynecology and women’s health at Montefiore Medical Center in New York.

There are a range of medical therapies, but they primarily target the symptomatology and not the fibroid itself. Uterine artery embolization is a fantastic procedure, but it’s a global destruction process of the entire uterus, and there are concerns regarding future fertility, he observed. Hysteroscopic fibroid resection is useful for submucosal fibroids, but access is often difficult and women typically have other types of fibroids as well.

Finally, there’s myomectomy, "a bloody, invasive procedure that more often than not dooms the patient to having a Cesarean section and carries a recurrence rate of about 80%," Dr. Chudnoff said.

"So what do you tell your 35-year-old patient that comes into your office and says, ‘What can you do for me?’ " Dr. Chudnoff said. "That’s where I think this comes in. It is that opportunity to get in there early before patients become extremely symptomatic and treat these fibroids with fibroid-directed therapy.

"If in 5 or 10 years they get new fibroids, I can treat them again, but there’s a big difference between doing this and doing a myomectomy again or having to do a hysterectomy in a post-myomectomy patient. Those are disasters," he said.

Women in the trial had clinical menorrhagia (160-500 cc of menstrual blood loss per cycle), no more than six fibroids (mean, five), and a total uterine volume of 300 cc or less. Fibroid types were 193 subserosals, 347 intramurals, 39 transmurals, and 164 submucosals. The trial did not include pedunculated fibroids or type 0 fibroids because of concerns that ablation near the base of the stalk could result in secondary potential complications such as superinfections, he said.

In all, 674 fibroids were treated with Acessa, 96.2% on an outpatient basis. Patients returned to normal activity in an average of 7-10 days, and went back to work at a median of 9 days (range 0-29 days).

Patient-reported symptom severity scores on the validated Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL) questionnaire decreased from a mean of 61.4 at baseline to 28.7 at 3 months, 28.6 at 6 months, and was significant at 26.4 at 12 months (P value less than .001), Dr. Chudnoff reported.

At the same time, mean quality of life scores on the UFS-QOL improved from 37.1 at baseline to 75.2, 78.1, and 80 (P less than .0001 at 12 months).

"What’s important to note is that patients continue to improve and [this] persists at high levels," he said.

Mean scores on the EuroQoL-5 dimensions (EQ-5D) measure also increased from 70.7 at baseline to 84.9 at 3 months, 84.6 at 6 months, and were significant at 85.7 at 12 months (P less than .0001).

There were five (3.7%) device-related adverse events: lower abdominal pain, pelvic abscess, two superficial uterine serosal burns, and post-treatment bleeding.

One patient underwent uterine artery embolization after withdrawing from the trial before her 6-month follow-up visit, resulting in a reintervention rate of 0.7%.

In separate presentations at the meeting, fellow Acessa investigators reported significant decreases at 3 and 12 months in mean uterine volume of 16% and 25% and in mean fibroid volume of 38% and 44.3%. Clinically significant reductions in menstrual bleeding were observed in 69% of women (mean 101.6 cc).

Reductions in alkaline hematin levels were associated with fibroid shrinkage. The mean alkaline hematin level was 271.5 mL at baseline, decreasing by 31% at 3 months, 41% at 6 months, and 38% at 12 months (all P less than .0001).

During a discussion of the study, Dr. Chudnoff said quality of life was not directly related to the size of fibroid shrinkage, but observed that all women who experienced fibroid shrinkage had symptom relief.

Finally, when asked about the overall effectiveness of the procedure, 98% of patients said they would recommend Acessa to a friend, 95% said they were satisfied with the treatment, and 94% thought it was effective, he reported.

Dr. Chudnoff and his coauthors reported serving as principal investigators for Halt Medical, which sponsored the study. One coauthor is also a consultant for Halt.

Survival rates remained high 1 year after implantation with the transcatheter aortic CoreValve in the postmarket ADVANCE study, initial results show.

At 1 year, overall survival was 82.1% and cardiovascular survival 88.2%. This compares with survival rates of 87.4% and 91.7% at 6 months and 95.5% and 96.6% at 30 days, principal investigator Dr. Axel Linke reported at Transcatheter Cardiovascular Therapeutics 2012.

"I think they’re outstanding," he said in an interview. "If you put it into the perspective of the PARTNER A and B cohorts [in the pivotal trial in the Sapien transcatheter valve system], our mortality rate is, in absolute values, 8 to 13% lower."

One explanation is that the 1,015-patient, postmarket ADVANCE study sought out centers experienced with transcatheter aortic valve implantation (TAVI). The 44 centers in Western Europe, Asia, and South America were required to have performed at least 40 TAVI procedures, with some German centers having done as many as 500, to be certified by a TAVI proctor and to have a heart team in place.

"Clearly, our centers were out of the learning curve," remarked Dr. Linke of the University of Leipzig (Germany) Heart Center.

By comparison, some centers in the PARTNER trial of the Edwards Lifesciences Sapien valve contributed just six or seven patients and were selected based on their experience with general cardiologic intervention, he observed.

The 1-year survival rates in ADVANCE also surpass those from early registries, notably the French Aortic National CoreValve and Edwards Registry, where the initial experience with TAVI was associated with interventional mistakes, which were linked to early mortality, Dr. Linke said.

The CoreValve System has been implanted in more than 30,000 patients since its approval in the European Union in 2007, but is limited to investigational use in the United States and Japan.

No details were presented regarding mortality in various subgroups or complications such as stroke, paravalvular leaks or left bundle branch block (LBBB). A recent analysis raised concerns about LBBB, showing that one-third of 202 consecutive patients with no prior conduction disturbances developed new-onset LBBB after TAVI with a balloon-expandable valve (Sapien or Sapien XT). Although it resolved in 37.7% by hospital discharge and 57.3% at 6- to 12-month follow-up, patients with persistent LBBB had a significantly higher incidence of syncope and complete atrioventricular block requiring a permanent pacemaker (J. Am. Coll. Cardiol. 2012;60:1743-52 [doi:10.1016/j.jacc.2012.035]).

Dr. Linke said they will look at LBBB in more detailed analyses expected from ADVANCE in the coming weeks, but that there’s been no evidence of a problem with LBBB in earlier follow-up in ADVANCE or from other CoreValve users.

"Survival curves are absolutely identical up to the 6-month follow-up, so there’s no reason to believe they should be worse afterwards, although I can’t be exactly sure right now," he said, adding that in the publication, survival curves from patients with and without new-onset LBBB "started to diverge very early."

Quality of life data from ADVANCE, reported in a separate poster session at the meeting, showed significant benefits with the CoreValve, even among higher-risk patients.

Scores on the European Quality of Life–5 Dimensions (EQ-5D), which ranges from 0 (death) to 1 (perfect health), improved from 0.62 at baseline to 0.72 at 1 month, where it remained at 6 months, both highly significant differences from baseline.

On the Short Form Health Survey–12 (SF-12), scores at baseline, 1 month, and 6 months were 32.8, 39, and 39.7 for the physical component and 46.2, 48.5, and 50 for the mental component.

"Basically, whatever is gained, is gained very early from the baseline to the 1-month follow-up in the majority of the cases," said Dr. Linke.

The 322 higher-risk patients entering the study with a logistic EuroSCORE of more than 20 had significantly worse baseline health-related quality of life than did those with a EuroSCORE of 10 or less, but experienced significant improvements after TAVI on the EQ-5D at 1 month and on both components of the SF-12 at 6 months, all significant changes.

The access route used during TAVI had no impact on quality of life improvement at 6 months.

Dr. Linke reported serving as an adviser or consultant for Medtronic, which sponsored the study.

Survival rates remained high 1 year after implantation with the transcatheter aortic CoreValve in the postmarket ADVANCE study, initial results show.

At 1 year, overall survival was 82.1% and cardiovascular survival 88.2%. This compares with survival rates of 87.4% and 91.7% at 6 months and 95.5% and 96.6% at 30 days, principal investigator Dr. Axel Linke reported at Transcatheter Cardiovascular Therapeutics 2012.

"I think they’re outstanding," he said in an interview. "If you put it into the perspective of the PARTNER A and B cohorts [in the pivotal trial in the Sapien transcatheter valve system], our mortality rate is, in absolute values, 8 to 13% lower."

One explanation is that the 1,015-patient, postmarket ADVANCE study sought out centers experienced with transcatheter aortic valve implantation (TAVI). The 44 centers in Western Europe, Asia, and South America were required to have performed at least 40 TAVI procedures, with some German centers having done as many as 500, to be certified by a TAVI proctor and to have a heart team in place.

"Clearly, our centers were out of the learning curve," remarked Dr. Linke of the University of Leipzig (Germany) Heart Center.

By comparison, some centers in the PARTNER trial of the Edwards Lifesciences Sapien valve contributed just six or seven patients and were selected based on their experience with general cardiologic intervention, he observed.

The 1-year survival rates in ADVANCE also surpass those from early registries, notably the French Aortic National CoreValve and Edwards Registry, where the initial experience with TAVI was associated with interventional mistakes, which were linked to early mortality, Dr. Linke said.

The CoreValve System has been implanted in more than 30,000 patients since its approval in the European Union in 2007, but is limited to investigational use in the United States and Japan.

No details were presented regarding mortality in various subgroups or complications such as stroke, paravalvular leaks or left bundle branch block (LBBB). A recent analysis raised concerns about LBBB, showing that one-third of 202 consecutive patients with no prior conduction disturbances developed new-onset LBBB after TAVI with a balloon-expandable valve (Sapien or Sapien XT). Although it resolved in 37.7% by hospital discharge and 57.3% at 6- to 12-month follow-up, patients with persistent LBBB had a significantly higher incidence of syncope and complete atrioventricular block requiring a permanent pacemaker (J. Am. Coll. Cardiol. 2012;60:1743-52 [doi:10.1016/j.jacc.2012.035]).

Dr. Linke said they will look at LBBB in more detailed analyses expected from ADVANCE in the coming weeks, but that there’s been no evidence of a problem with LBBB in earlier follow-up in ADVANCE or from other CoreValve users.

"Survival curves are absolutely identical up to the 6-month follow-up, so there’s no reason to believe they should be worse afterwards, although I can’t be exactly sure right now," he said, adding that in the publication, survival curves from patients with and without new-onset LBBB "started to diverge very early."

Quality of life data from ADVANCE, reported in a separate poster session at the meeting, showed significant benefits with the CoreValve, even among higher-risk patients.

Scores on the European Quality of Life–5 Dimensions (EQ-5D), which ranges from 0 (death) to 1 (perfect health), improved from 0.62 at baseline to 0.72 at 1 month, where it remained at 6 months, both highly significant differences from baseline.

On the Short Form Health Survey–12 (SF-12), scores at baseline, 1 month, and 6 months were 32.8, 39, and 39.7 for the physical component and 46.2, 48.5, and 50 for the mental component.

"Basically, whatever is gained, is gained very early from the baseline to the 1-month follow-up in the majority of the cases," said Dr. Linke.

The 322 higher-risk patients entering the study with a logistic EuroSCORE of more than 20 had significantly worse baseline health-related quality of life than did those with a EuroSCORE of 10 or less, but experienced significant improvements after TAVI on the EQ-5D at 1 month and on both components of the SF-12 at 6 months, all significant changes.

The access route used during TAVI had no impact on quality of life improvement at 6 months.

Dr. Linke reported serving as an adviser or consultant for Medtronic, which sponsored the study.

Survival rates remained high 1 year after implantation with the transcatheter aortic CoreValve in the postmarket ADVANCE study, initial results show.

At 1 year, overall survival was 82.1% and cardiovascular survival 88.2%. This compares with survival rates of 87.4% and 91.7% at 6 months and 95.5% and 96.6% at 30 days, principal investigator Dr. Axel Linke reported at Transcatheter Cardiovascular Therapeutics 2012.

"I think they’re outstanding," he said in an interview. "If you put it into the perspective of the PARTNER A and B cohorts [in the pivotal trial in the Sapien transcatheter valve system], our mortality rate is, in absolute values, 8 to 13% lower."

One explanation is that the 1,015-patient, postmarket ADVANCE study sought out centers experienced with transcatheter aortic valve implantation (TAVI). The 44 centers in Western Europe, Asia, and South America were required to have performed at least 40 TAVI procedures, with some German centers having done as many as 500, to be certified by a TAVI proctor and to have a heart team in place.

"Clearly, our centers were out of the learning curve," remarked Dr. Linke of the University of Leipzig (Germany) Heart Center.

By comparison, some centers in the PARTNER trial of the Edwards Lifesciences Sapien valve contributed just six or seven patients and were selected based on their experience with general cardiologic intervention, he observed.

The 1-year survival rates in ADVANCE also surpass those from early registries, notably the French Aortic National CoreValve and Edwards Registry, where the initial experience with TAVI was associated with interventional mistakes, which were linked to early mortality, Dr. Linke said.

The CoreValve System has been implanted in more than 30,000 patients since its approval in the European Union in 2007, but is limited to investigational use in the United States and Japan.

No details were presented regarding mortality in various subgroups or complications such as stroke, paravalvular leaks or left bundle branch block (LBBB). A recent analysis raised concerns about LBBB, showing that one-third of 202 consecutive patients with no prior conduction disturbances developed new-onset LBBB after TAVI with a balloon-expandable valve (Sapien or Sapien XT). Although it resolved in 37.7% by hospital discharge and 57.3% at 6- to 12-month follow-up, patients with persistent LBBB had a significantly higher incidence of syncope and complete atrioventricular block requiring a permanent pacemaker (J. Am. Coll. Cardiol. 2012;60:1743-52 [doi:10.1016/j.jacc.2012.035]).

Dr. Linke said they will look at LBBB in more detailed analyses expected from ADVANCE in the coming weeks, but that there’s been no evidence of a problem with LBBB in earlier follow-up in ADVANCE or from other CoreValve users.

"Survival curves are absolutely identical up to the 6-month follow-up, so there’s no reason to believe they should be worse afterwards, although I can’t be exactly sure right now," he said, adding that in the publication, survival curves from patients with and without new-onset LBBB "started to diverge very early."

Quality of life data from ADVANCE, reported in a separate poster session at the meeting, showed significant benefits with the CoreValve, even among higher-risk patients.

Scores on the European Quality of Life–5 Dimensions (EQ-5D), which ranges from 0 (death) to 1 (perfect health), improved from 0.62 at baseline to 0.72 at 1 month, where it remained at 6 months, both highly significant differences from baseline.

On the Short Form Health Survey–12 (SF-12), scores at baseline, 1 month, and 6 months were 32.8, 39, and 39.7 for the physical component and 46.2, 48.5, and 50 for the mental component.

"Basically, whatever is gained, is gained very early from the baseline to the 1-month follow-up in the majority of the cases," said Dr. Linke.

The 322 higher-risk patients entering the study with a logistic EuroSCORE of more than 20 had significantly worse baseline health-related quality of life than did those with a EuroSCORE of 10 or less, but experienced significant improvements after TAVI on the EQ-5D at 1 month and on both components of the SF-12 at 6 months, all significant changes.

The access route used during TAVI had no impact on quality of life improvement at 6 months.

Dr. Linke reported serving as an adviser or consultant for Medtronic, which sponsored the study.

MUNICH -- In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY) at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said.

Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve.

Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.

MUNICH -- In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY) at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said.

Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve.

Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.

MUNICH -- In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY) at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said.

Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve.

Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.

MUNICH -- In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY) at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said.

Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve.

Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.

MUNICH -- In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY) at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said.

Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve.

Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.

MUNICH -- In-hospital mortality and complications following transcatheter aortic valve implantation in the real-world setting are comparable with those achieved in randomized controlled studies, according to data from the first large-scale national registry capturing surgical and catheter-based procedures.

"In high-risk patients, the in-hospital mortality with TAVI is at least as good, if not better, as with the surgical approach," said Dr. Christian Hamm, who presented data from 13,860 patients in the German Aortic Valve Registry (GARY) at the annual congress of the European Society of Cardiology.

Patrice Wendling/IMNG Medical Media

In-hospital mortality was 2.2% for conventional aortic valve replacement surgery alone, 4.6% for conventional surgery with coronary artery bypass grafting (CABG), 5.5% for TAVI using a transvascular approach, and 7.8% for TAVI with a transapical approach.

After adjusting for the expected higher risk profile of TAVI patients, the risk of in-hospital death was not increased with transvascular TAVI, compared with surgery alone, although there was a trend toward increased risk with transapical TAVI in both younger patients and those aged 75 years and older, said Dr. Hamm, medical director of the Kerckhoff Heart and Thorax Centre, Bad Nauheim, Germany.

When asked by the media whether the higher mortality may be diminishing use of the transapical approach, GARY coauthor Dr. Friedrich-Wilhelm Mohr said that similar rates have been seen in the source registry and that these patients tend to have slightly more comorbidities and vascular disease.

"The current data in 2012 do not show a pull back," said Dr. Mohr, medical director of the Leipzig (Germany) Heart Center. "It’s almost the same situation as here: two-thirds transfemoral and one-third transapical."

Consistent with earlier observations, the rate of cerebrovascular events was lowest in patients undergoing surgery without CABG at 2.2% and was "in the range of 3.5%" for all other groups, Dr. Hamm reported.

Discussant Dr. Olaf Wendler said it’s convincing that cerebrovascular complications are lower than in the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, which reported a 5% major stroke rate among TAVI patients at 30 days.

"This may be less of a problem than we thought about transcatheter-valve treatment in the past," he said. "However, again we don’t have all the details, definitions of the adverse events, and we don’t have a clear idea of how adverse events were adjudicated in this registry."

Rates of vascular complications and new onset atrioventricular (AV) blockage were highest after transvascular TAVI, while renal failure was most common after the transapical approach, said Dr. Wendler, professor at King’s College Hospital in London.

Specifically, vascular complications were reported in 12% of the transvascular patients, compared with 2.5% for the transapical approach, 2% for surgery plus CABG, and 1% for those patients who received surgery alone.

Residual postimplant aortic regurgitation, which has been linked to long-term TAVI outcome, "seemed to be excellent because more than 90% of patients had no or grade I regurgitation," Dr. Hamm said.

Only 7% of transvascular and 3% of transapical patients had grade II regurgitation, and only 1% of transapical and no transvascular patients had grade III or IV regurgitation.

Although between-valve comparisons were limited since the CoreValve was not implanted transapically, grade I or II aortic regurgitation was more common with the CoreValve (70%) than with the Edwards prosthesis (45.7%).

Despite the increasing shift of TAVI in lower-risk patients, data from GARY show that TAVI is being performed predominantly in high-risk patients, as recommended in various guidelines, Dr. Hamm said.

Participation in GARY is voluntary, with 92 of 99 German centers currently taking part. As of July 2012, more than 26,000 patients were included, of whom 23% were TAVI patients.

The current analysis included 13,860 patients from 53 cardiac surgery units and 69 cardiology units. Of these patients, 6,523 underwent surgery alone, 3,462 surgery plus CABG, 2,694 transvascular TAVI, and 1,181 transapical TAVI.

At baseline, TAVI patients were significantly older than surgical patients (average of 81 years transvascular and 80.3 years transapical vs. 68 years surgical); had significantly more comorbidities including atrial fibrillation, hypertension, and diabetes; and were significantly more likely to have a left ventricular ejection fraction below 30%.

Roughly half of elderly patients more than 75 years of age now receive TAVI in Germany, which is quite impressive and by far a higher number than any other country worldwide, said Dr. Wendler.

German investigators also have developed a novel risk scoring system called the AKL score, which, unlike the logistic EuroSCORE or Society of Thoracic Surgeons (STS) risk score, is based only on patients with aortic valve disease.

"The EuroSCORE, as many of us know, is not very suitable in this scenario," Dr. Hamm said.

When the GARY authors compared observed vs. expected in-hospital mortality based on patients’ EuroSCORE, the observed risk for mortality was much lower than predicted by the EuroSCORE.

When the same analysis was performed using the AKL score, however, the observed and expected mortality outcomes were very similar, suggesting the "AKL score much better reflects the real outcome of the patients," he said.

Dr. Wendler remarked that in low-risk patients, however, the observed in-hospital mortality was higher than what was predicted, "questioning if this is the right treatment for this group of patients."

GARY is supported by the German Heart Foundation and unrestricted grants from heart valve manufacturers. Dr. Hamm disclosed honoraria from Medtronic and Edwards Lifesciences and participation in clinical trials with Medtronic, Edwards, Symetis, and JenaValve.

Dr. Mohr reported no conflicts of interest. Dr. Wendler reported research ties with Edwards and consulting for Edwards and St. Jude Medical.

MINNEAPOLIS – A new automated assay can measure concentrations of both 24,25-dihydroxyvitamin D2 and D3 in human serum.

Current assays based on competitive binding experiments can differentiate between 24,25-dihydroxyvitamin D₃ and D₂, but are time consuming and not easily automated. Also, immunoassays fail to differentiate between 25-hydroxyvitamin D and 24,25-dihydrxoxyvitamin D.

The new, high-throughput mass spectrometry–based assay – developed by researchers at the Mayo Clinic – is able to quantify both analytes.

Patrice Wendling/IMNG Medical Media

Knowledge of the serum concentrations of both 24,25(OH)₂D and 25(OH)D₃ is particularly important in establishing reduced activity of the primary vitamin D degradation enzyme CYP24A1 in patients with mutations in the CYP24A1 (cytochrome P450 24-hydroxylase A1) gene.

"A lot of physicians want this metabolite to be measured just in case a person might be a candidate for more extensive genotyping studies ... They also want to know the reference range in normal individuals," lead author and research fellow Hemamalini Ketha, Ph.D., said in an interview.

Researchers at the Roswell Park Cancer Institute in Buffalo, N.Y., recently reported that single nucleotide polymorphisms in CYP24A1 may be related to the higher prevalence of estrogen receptor–negative breast cancer in African American women – a group known to have lower levels of vitamin D (Breast Cancer Res. 2012;14:R58).

Dr. Ketha and her colleagues at the Mayo Clinic in Rochester, Minn., used a liquid chromatography tandem mass spectrometry method to measure serum 24,25(OH)₂D concentrations in 92 serum samples from men and women with a wide range of 25(OH)D concentrations.

The limit of detection for 24,25(OH)₂D₃ was 0.08 ng/mL; the limit for 24,25(OH)₂D₂ was 0.5 ng/mL, Dr. Ketha reported in a poster at the annual meeting of the American Society for Bone and Mineral Research.

The mean concentration of 25(OH)D in the serum samples was 29.36 ng/mL and was 2.59 ng/mL for 24,25(OH)₂D₃.

Serum 24,25(OH)₂D concentrations were linearly correlated with serum 25(OH)D concentrations (R² = 0.75), she said.

No correlation was observed, however, between 24,25(OH)₂D₃ and 1,25(OH)₂D₃ (R² = 0.0005).

"For diagnostic purposes, the interpretation of concentrations of serum 24,25(OH)₂D₃ should therefore take the concomitant 25(OH)D₃ concentrations into account," the authors concluded.

Dr. Ketha said the assay is rapid and reproducible, and that the Mayo Clinic is planning to make it commercially available through its endocrinology clinical laboratory.

He said he had no relevant financial disclosures. The research was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Ketha said she had no relevant financial disclosures.

MINNEAPOLIS – A new automated assay can measure concentrations of both 24,25-dihydroxyvitamin D2 and D3 in human serum.

Current assays based on competitive binding experiments can differentiate between 24,25-dihydroxyvitamin D₃ and D₂, but are time consuming and not easily automated. Also, immunoassays fail to differentiate between 25-hydroxyvitamin D and 24,25-dihydrxoxyvitamin D.

The new, high-throughput mass spectrometry–based assay – developed by researchers at the Mayo Clinic – is able to quantify both analytes.

Patrice Wendling/IMNG Medical Media

Knowledge of the serum concentrations of both 24,25(OH)₂D and 25(OH)D₃ is particularly important in establishing reduced activity of the primary vitamin D degradation enzyme CYP24A1 in patients with mutations in the CYP24A1 (cytochrome P450 24-hydroxylase A1) gene.

"A lot of physicians want this metabolite to be measured just in case a person might be a candidate for more extensive genotyping studies ... They also want to know the reference range in normal individuals," lead author and research fellow Hemamalini Ketha, Ph.D., said in an interview.

Researchers at the Roswell Park Cancer Institute in Buffalo, N.Y., recently reported that single nucleotide polymorphisms in CYP24A1 may be related to the higher prevalence of estrogen receptor–negative breast cancer in African American women – a group known to have lower levels of vitamin D (Breast Cancer Res. 2012;14:R58).

Dr. Ketha and her colleagues at the Mayo Clinic in Rochester, Minn., used a liquid chromatography tandem mass spectrometry method to measure serum 24,25(OH)₂D concentrations in 92 serum samples from men and women with a wide range of 25(OH)D concentrations.

The limit of detection for 24,25(OH)₂D₃ was 0.08 ng/mL; the limit for 24,25(OH)₂D₂ was 0.5 ng/mL, Dr. Ketha reported in a poster at the annual meeting of the American Society for Bone and Mineral Research.

The mean concentration of 25(OH)D in the serum samples was 29.36 ng/mL and was 2.59 ng/mL for 24,25(OH)₂D₃.

Serum 24,25(OH)₂D concentrations were linearly correlated with serum 25(OH)D concentrations (R² = 0.75), she said.

No correlation was observed, however, between 24,25(OH)₂D₃ and 1,25(OH)₂D₃ (R² = 0.0005).

"For diagnostic purposes, the interpretation of concentrations of serum 24,25(OH)₂D₃ should therefore take the concomitant 25(OH)D₃ concentrations into account," the authors concluded.

Dr. Ketha said the assay is rapid and reproducible, and that the Mayo Clinic is planning to make it commercially available through its endocrinology clinical laboratory.

He said he had no relevant financial disclosures. The research was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Ketha said she had no relevant financial disclosures.

MINNEAPOLIS – A new automated assay can measure concentrations of both 24,25-dihydroxyvitamin D2 and D3 in human serum.

Current assays based on competitive binding experiments can differentiate between 24,25-dihydroxyvitamin D₃ and D₂, but are time consuming and not easily automated. Also, immunoassays fail to differentiate between 25-hydroxyvitamin D and 24,25-dihydrxoxyvitamin D.

The new, high-throughput mass spectrometry–based assay – developed by researchers at the Mayo Clinic – is able to quantify both analytes.

Patrice Wendling/IMNG Medical Media

Knowledge of the serum concentrations of both 24,25(OH)₂D and 25(OH)D₃ is particularly important in establishing reduced activity of the primary vitamin D degradation enzyme CYP24A1 in patients with mutations in the CYP24A1 (cytochrome P450 24-hydroxylase A1) gene.

"A lot of physicians want this metabolite to be measured just in case a person might be a candidate for more extensive genotyping studies ... They also want to know the reference range in normal individuals," lead author and research fellow Hemamalini Ketha, Ph.D., said in an interview.

Researchers at the Roswell Park Cancer Institute in Buffalo, N.Y., recently reported that single nucleotide polymorphisms in CYP24A1 may be related to the higher prevalence of estrogen receptor–negative breast cancer in African American women – a group known to have lower levels of vitamin D (Breast Cancer Res. 2012;14:R58).

Dr. Ketha and her colleagues at the Mayo Clinic in Rochester, Minn., used a liquid chromatography tandem mass spectrometry method to measure serum 24,25(OH)₂D concentrations in 92 serum samples from men and women with a wide range of 25(OH)D concentrations.

The limit of detection for 24,25(OH)₂D₃ was 0.08 ng/mL; the limit for 24,25(OH)₂D₂ was 0.5 ng/mL, Dr. Ketha reported in a poster at the annual meeting of the American Society for Bone and Mineral Research.

The mean concentration of 25(OH)D in the serum samples was 29.36 ng/mL and was 2.59 ng/mL for 24,25(OH)₂D₃.

Serum 24,25(OH)₂D concentrations were linearly correlated with serum 25(OH)D concentrations (R² = 0.75), she said.

No correlation was observed, however, between 24,25(OH)₂D₃ and 1,25(OH)₂D₃ (R² = 0.0005).

"For diagnostic purposes, the interpretation of concentrations of serum 24,25(OH)₂D₃ should therefore take the concomitant 25(OH)D₃ concentrations into account," the authors concluded.

Dr. Ketha said the assay is rapid and reproducible, and that the Mayo Clinic is planning to make it commercially available through its endocrinology clinical laboratory.

He said he had no relevant financial disclosures. The research was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Ketha said she had no relevant financial disclosures.