Acquired Cardiovascular Disease

NATIONAL HARBOR, MD. – Measurements of aortic annular geometry, valve calcification, and final device position with two- and three-dimensional echocardiography are predictive of increased risk of leakage after trans-catheter valve implantation, according to a retrospective study.

The study also showed that 3-D transesophageal echocardiography (3-D TEE) does a better job of measuring the aortic annulus, compared with 2-D TEE.

The annular measurement is critical for optimal valve sizing and prevention of paravalvular aortic regurgitation in patients undergoing transcatheter aortic valve replacement (TAVR).

Paravalvular aortic regurgitation (PAR), is a known complication of TAVR, and according to 2-year analysis of the PARTNER trial, PAR after TAVR was associated with increased late mortality ( N. Engl. J. Med. 2012;366:1686-95).

TAVR is in its infancy in the United States, compared with Europe, and experts are studying how and which imaging techniques could yield the best results before, during, and after TAVR (also called TAVI).

"Every center has their preference," said Dr. Praveen Mehrotra, a noninvasive cardiologist and the lead author of the study at Massachusetts General Hospital in Boston. "Some centers use CT and 2-D TEE. At Mass General, we integrate information obtained from 2-D and 3-D TEE."

Meanwhile, the role of 3-D TEE in TAVR hasn’t been adequately explored, added Dr. Mehrotra, who presented his poster at the annual meeting of the American Society of Echocardiography.

Dr. Mehrotra and his colleagues set out to retrospectively identify 2-D and 3-D TEE parameters that could predict significant PAR after TAVR.

They analyzed 2-D and 3-D TEE images from 94 patients undergoing TAVR between June 2008 and December 2011. The images were used to assess three parameters: annulus geometry, aortic valve apparatus calcification, and final device position.

Twenty-one of the patients (22%) showed significant PAR after TAVR, but before postdilation.

In 2-D TEE, the annulus geometry was assessed by measuring the largest anteroposterior annulus dimension at the aortic valve hinge points in mid systole, the authors wrote. Using 3-D TEE, researchers measured or calculated four parameters for the aortic annulus geometry: minor axis, major axis, eccentricity index, and annular area.

The annular dimension measured by 2-D TEE was similar in the PAR (22.8 mm) and No PAR (22.4 mm) groups. But, the 3-D TEE measurements were significantly larger in the PAR group than in the No PAR group, as measured by annular minor axis (23.8 mm vs. 22.7 mm), major axis (27.0 mm vs. 25.3 mm), eccentricity index (0.88 vs. 0.90), and annular area (5.19 cm² vs. 4.52 cm²), the researchers reported.

The annular-prosthesis incongruence (API) index was also significantly higher in patients with PAR (1.07% vs. 0.93%), "indicating valve undersizing in this group," the authors wrote.

Using 3-D TEE, the researchers identified and graded significant areas of calcification in the aortic valve apparatus, which is also very important before TAVR, said Mehrotra.

The final device position was assessed using 2-D TEE images.

The results showed that higher API index, Aortic Valve Apparatus Calcification score, and final position of the device were predictors of significant PAR after TAVR, with odds ratios of 9.4, 3.6, and 1.2, respectively, the authors reported.

"Our study highlights the ability of 2-D and 3-D TEE for accurate annular sizing and optimal valve positioning during TAVR," they wrote.

The takeaway message, said Dr. Mehrotra in an interview, is that "the role of echo is essential before, during, and after TAVR.

He added that 3-D echocardiography has an emerging role in annular sizing. In particular, annular area by 3-D TEE may be more important than the anteroposterior dimension by 2-D TEE for accurate valve sizing, said Dr. Mehrotra. "Technologies like 3-D TEE and cardiac CT can help with preprocedural planning, but they should be used by people who understand how to use them."

While his study focused on 2-D and 3-D TEE, Dr. Mehrotra said he expected more studies begin comparing cardiac CT and 3-D TEE, which is more like, "comparing apples to apples."

In a discussion on TAVR imaging, Dr. Rebecca T. Hahn, director of interventional echocardiography at Columbia University, New York, said that cardiac CT and echocardiography are complementary. However, CT is less user-dependent, compared with 3-D TEE.

Dr. Mehrotra and Dr. Hahn had no relevant financial disclosures.

NATIONAL HARBOR, MD. – Measurements of aortic annular geometry, valve calcification, and final device position with two- and three-dimensional echocardiography are predictive of increased risk of leakage after trans-catheter valve implantation, according to a retrospective study.

The study also showed that 3-D transesophageal echocardiography (3-D TEE) does a better job of measuring the aortic annulus, compared with 2-D TEE.

The annular measurement is critical for optimal valve sizing and prevention of paravalvular aortic regurgitation in patients undergoing transcatheter aortic valve replacement (TAVR).

Paravalvular aortic regurgitation (PAR), is a known complication of TAVR, and according to 2-year analysis of the PARTNER trial, PAR after TAVR was associated with increased late mortality ( N. Engl. J. Med. 2012;366:1686-95).

TAVR is in its infancy in the United States, compared with Europe, and experts are studying how and which imaging techniques could yield the best results before, during, and after TAVR (also called TAVI).

"Every center has their preference," said Dr. Praveen Mehrotra, a noninvasive cardiologist and the lead author of the study at Massachusetts General Hospital in Boston. "Some centers use CT and 2-D TEE. At Mass General, we integrate information obtained from 2-D and 3-D TEE."

Meanwhile, the role of 3-D TEE in TAVR hasn’t been adequately explored, added Dr. Mehrotra, who presented his poster at the annual meeting of the American Society of Echocardiography.

Dr. Mehrotra and his colleagues set out to retrospectively identify 2-D and 3-D TEE parameters that could predict significant PAR after TAVR.

They analyzed 2-D and 3-D TEE images from 94 patients undergoing TAVR between June 2008 and December 2011. The images were used to assess three parameters: annulus geometry, aortic valve apparatus calcification, and final device position.

Twenty-one of the patients (22%) showed significant PAR after TAVR, but before postdilation.

In 2-D TEE, the annulus geometry was assessed by measuring the largest anteroposterior annulus dimension at the aortic valve hinge points in mid systole, the authors wrote. Using 3-D TEE, researchers measured or calculated four parameters for the aortic annulus geometry: minor axis, major axis, eccentricity index, and annular area.

The annular dimension measured by 2-D TEE was similar in the PAR (22.8 mm) and No PAR (22.4 mm) groups. But, the 3-D TEE measurements were significantly larger in the PAR group than in the No PAR group, as measured by annular minor axis (23.8 mm vs. 22.7 mm), major axis (27.0 mm vs. 25.3 mm), eccentricity index (0.88 vs. 0.90), and annular area (5.19 cm² vs. 4.52 cm²), the researchers reported.

The annular-prosthesis incongruence (API) index was also significantly higher in patients with PAR (1.07% vs. 0.93%), "indicating valve undersizing in this group," the authors wrote.

Using 3-D TEE, the researchers identified and graded significant areas of calcification in the aortic valve apparatus, which is also very important before TAVR, said Mehrotra.

The final device position was assessed using 2-D TEE images.

The results showed that higher API index, Aortic Valve Apparatus Calcification score, and final position of the device were predictors of significant PAR after TAVR, with odds ratios of 9.4, 3.6, and 1.2, respectively, the authors reported.

"Our study highlights the ability of 2-D and 3-D TEE for accurate annular sizing and optimal valve positioning during TAVR," they wrote.

The takeaway message, said Dr. Mehrotra in an interview, is that "the role of echo is essential before, during, and after TAVR.

He added that 3-D echocardiography has an emerging role in annular sizing. In particular, annular area by 3-D TEE may be more important than the anteroposterior dimension by 2-D TEE for accurate valve sizing, said Dr. Mehrotra. "Technologies like 3-D TEE and cardiac CT can help with preprocedural planning, but they should be used by people who understand how to use them."

While his study focused on 2-D and 3-D TEE, Dr. Mehrotra said he expected more studies begin comparing cardiac CT and 3-D TEE, which is more like, "comparing apples to apples."

In a discussion on TAVR imaging, Dr. Rebecca T. Hahn, director of interventional echocardiography at Columbia University, New York, said that cardiac CT and echocardiography are complementary. However, CT is less user-dependent, compared with 3-D TEE.

Dr. Mehrotra and Dr. Hahn had no relevant financial disclosures.

NATIONAL HARBOR, MD. – Measurements of aortic annular geometry, valve calcification, and final device position with two- and three-dimensional echocardiography are predictive of increased risk of leakage after trans-catheter valve implantation, according to a retrospective study.

The study also showed that 3-D transesophageal echocardiography (3-D TEE) does a better job of measuring the aortic annulus, compared with 2-D TEE.

The annular measurement is critical for optimal valve sizing and prevention of paravalvular aortic regurgitation in patients undergoing transcatheter aortic valve replacement (TAVR).

Paravalvular aortic regurgitation (PAR), is a known complication of TAVR, and according to 2-year analysis of the PARTNER trial, PAR after TAVR was associated with increased late mortality ( N. Engl. J. Med. 2012;366:1686-95).

TAVR is in its infancy in the United States, compared with Europe, and experts are studying how and which imaging techniques could yield the best results before, during, and after TAVR (also called TAVI).

"Every center has their preference," said Dr. Praveen Mehrotra, a noninvasive cardiologist and the lead author of the study at Massachusetts General Hospital in Boston. "Some centers use CT and 2-D TEE. At Mass General, we integrate information obtained from 2-D and 3-D TEE."

Meanwhile, the role of 3-D TEE in TAVR hasn’t been adequately explored, added Dr. Mehrotra, who presented his poster at the annual meeting of the American Society of Echocardiography.

Dr. Mehrotra and his colleagues set out to retrospectively identify 2-D and 3-D TEE parameters that could predict significant PAR after TAVR.

They analyzed 2-D and 3-D TEE images from 94 patients undergoing TAVR between June 2008 and December 2011. The images were used to assess three parameters: annulus geometry, aortic valve apparatus calcification, and final device position.

Twenty-one of the patients (22%) showed significant PAR after TAVR, but before postdilation.

In 2-D TEE, the annulus geometry was assessed by measuring the largest anteroposterior annulus dimension at the aortic valve hinge points in mid systole, the authors wrote. Using 3-D TEE, researchers measured or calculated four parameters for the aortic annulus geometry: minor axis, major axis, eccentricity index, and annular area.

The annular dimension measured by 2-D TEE was similar in the PAR (22.8 mm) and No PAR (22.4 mm) groups. But, the 3-D TEE measurements were significantly larger in the PAR group than in the No PAR group, as measured by annular minor axis (23.8 mm vs. 22.7 mm), major axis (27.0 mm vs. 25.3 mm), eccentricity index (0.88 vs. 0.90), and annular area (5.19 cm² vs. 4.52 cm²), the researchers reported.

The annular-prosthesis incongruence (API) index was also significantly higher in patients with PAR (1.07% vs. 0.93%), "indicating valve undersizing in this group," the authors wrote.

Using 3-D TEE, the researchers identified and graded significant areas of calcification in the aortic valve apparatus, which is also very important before TAVR, said Mehrotra.

The final device position was assessed using 2-D TEE images.

The results showed that higher API index, Aortic Valve Apparatus Calcification score, and final position of the device were predictors of significant PAR after TAVR, with odds ratios of 9.4, 3.6, and 1.2, respectively, the authors reported.

"Our study highlights the ability of 2-D and 3-D TEE for accurate annular sizing and optimal valve positioning during TAVR," they wrote.

The takeaway message, said Dr. Mehrotra in an interview, is that "the role of echo is essential before, during, and after TAVR.

He added that 3-D echocardiography has an emerging role in annular sizing. In particular, annular area by 3-D TEE may be more important than the anteroposterior dimension by 2-D TEE for accurate valve sizing, said Dr. Mehrotra. "Technologies like 3-D TEE and cardiac CT can help with preprocedural planning, but they should be used by people who understand how to use them."

While his study focused on 2-D and 3-D TEE, Dr. Mehrotra said he expected more studies begin comparing cardiac CT and 3-D TEE, which is more like, "comparing apples to apples."

In a discussion on TAVR imaging, Dr. Rebecca T. Hahn, director of interventional echocardiography at Columbia University, New York, said that cardiac CT and echocardiography are complementary. However, CT is less user-dependent, compared with 3-D TEE.

Dr. Mehrotra and Dr. Hahn had no relevant financial disclosures.

NATIONAL HARBOR, MD. – Measurements of aortic annular geometry, valve calcification, and final device position with two- and three-dimensional echocardiography are predictive of increased risk of leakage after trans-catheter valve implantation, according to a retrospective study.

The study also showed that 3-D transesophageal echocardiography (3-D TEE) does a better job of measuring the aortic annulus, compared with 2-D TEE.

The annular measurement is critical for optimal valve sizing and prevention of paravalvular aortic regurgitation in patients undergoing transcatheter aortic valve replacement (TAVR).

Paravalvular aortic regurgitation (PAR), is a known complication of TAVR, and according to 2-year analysis of the PARTNER trial, PAR after TAVR was associated with increased late mortality ( N. Engl. J. Med. 2012;366:1686-95).

TAVR is in its infancy in the United States, compared with Europe, and experts are studying how and which imaging techniques could yield the best results before, during, and after TAVR (also called TAVI).

"Every center has their preference," said Dr. Praveen Mehrotra, a noninvasive cardiologist and the lead author of the study at Massachusetts General Hospital in Boston. "Some centers use CT and 2-D TEE. At Mass General, we integrate information obtained from 2-D and 3-D TEE."

Meanwhile, the role of 3-D TEE in TAVR hasn’t been adequately explored, added Dr. Mehrotra, who presented his poster at the annual meeting of the American Society of Echocardiography.

Dr. Mehrotra and his colleagues set out to retrospectively identify 2-D and 3-D TEE parameters that could predict significant PAR after TAVR.

They analyzed 2-D and 3-D TEE images from 94 patients undergoing TAVR between June 2008 and December 2011. The images were used to assess three parameters: annulus geometry, aortic valve apparatus calcification, and final device position.

Twenty-one of the patients (22%) showed significant PAR after TAVR, but before postdilation.

In 2-D TEE, the annulus geometry was assessed by measuring the largest anteroposterior annulus dimension at the aortic valve hinge points in mid systole, the authors wrote. Using 3-D TEE, researchers measured or calculated four parameters for the aortic annulus geometry: minor axis, major axis, eccentricity index, and annular area.

The annular dimension measured by 2-D TEE was similar in the PAR (22.8 mm) and No PAR (22.4 mm) groups. But, the 3-D TEE measurements were significantly larger in the PAR group than in the No PAR group, as measured by annular minor axis (23.8 mm vs. 22.7 mm), major axis (27.0 mm vs. 25.3 mm), eccentricity index (0.88 vs. 0.90), and annular area (5.19 cm² vs. 4.52 cm²), the researchers reported.

The annular-prosthesis incongruence (API) index was also significantly higher in patients with PAR (1.07% vs. 0.93%), "indicating valve undersizing in this group," the authors wrote.

Using 3-D TEE, the researchers identified and graded significant areas of calcification in the aortic valve apparatus, which is also very important before TAVR, said Mehrotra.

The final device position was assessed using 2-D TEE images.

The results showed that higher API index, Aortic Valve Apparatus Calcification score, and final position of the device were predictors of significant PAR after TAVR, with odds ratios of 9.4, 3.6, and 1.2, respectively, the authors reported.

"Our study highlights the ability of 2-D and 3-D TEE for accurate annular sizing and optimal valve positioning during TAVR," they wrote.

The takeaway message, said Dr. Mehrotra in an interview, is that "the role of echo is essential before, during, and after TAVR.

He added that 3-D echocardiography has an emerging role in annular sizing. In particular, annular area by 3-D TEE may be more important than the anteroposterior dimension by 2-D TEE for accurate valve sizing, said Dr. Mehrotra. "Technologies like 3-D TEE and cardiac CT can help with preprocedural planning, but they should be used by people who understand how to use them."

While his study focused on 2-D and 3-D TEE, Dr. Mehrotra said he expected more studies begin comparing cardiac CT and 3-D TEE, which is more like, "comparing apples to apples."

In a discussion on TAVR imaging, Dr. Rebecca T. Hahn, director of interventional echocardiography at Columbia University, New York, said that cardiac CT and echocardiography are complementary. However, CT is less user-dependent, compared with 3-D TEE.

Dr. Mehrotra and Dr. Hahn had no relevant financial disclosures.

NATIONAL HARBOR, MD. – Measurements of aortic annular geometry, valve calcification, and final device position with two- and three-dimensional echocardiography are predictive of increased risk of leakage after trans-catheter valve implantation, according to a retrospective study.

The study also showed that 3-D transesophageal echocardiography (3-D TEE) does a better job of measuring the aortic annulus, compared with 2-D TEE.

The annular measurement is critical for optimal valve sizing and prevention of paravalvular aortic regurgitation in patients undergoing transcatheter aortic valve replacement (TAVR).

Paravalvular aortic regurgitation (PAR), is a known complication of TAVR, and according to 2-year analysis of the PARTNER trial, PAR after TAVR was associated with increased late mortality ( N. Engl. J. Med. 2012;366:1686-95).

TAVR is in its infancy in the United States, compared with Europe, and experts are studying how and which imaging techniques could yield the best results before, during, and after TAVR (also called TAVI).

"Every center has their preference," said Dr. Praveen Mehrotra, a noninvasive cardiologist and the lead author of the study at Massachusetts General Hospital in Boston. "Some centers use CT and 2-D TEE. At Mass General, we integrate information obtained from 2-D and 3-D TEE."

Meanwhile, the role of 3-D TEE in TAVR hasn’t been adequately explored, added Dr. Mehrotra, who presented his poster at the annual meeting of the American Society of Echocardiography.

Dr. Mehrotra and his colleagues set out to retrospectively identify 2-D and 3-D TEE parameters that could predict significant PAR after TAVR.

They analyzed 2-D and 3-D TEE images from 94 patients undergoing TAVR between June 2008 and December 2011. The images were used to assess three parameters: annulus geometry, aortic valve apparatus calcification, and final device position.

Twenty-one of the patients (22%) showed significant PAR after TAVR, but before postdilation.

In 2-D TEE, the annulus geometry was assessed by measuring the largest anteroposterior annulus dimension at the aortic valve hinge points in mid systole, the authors wrote. Using 3-D TEE, researchers measured or calculated four parameters for the aortic annulus geometry: minor axis, major axis, eccentricity index, and annular area.

The annular dimension measured by 2-D TEE was similar in the PAR (22.8 mm) and No PAR (22.4 mm) groups. But, the 3-D TEE measurements were significantly larger in the PAR group than in the No PAR group, as measured by annular minor axis (23.8 mm vs. 22.7 mm), major axis (27.0 mm vs. 25.3 mm), eccentricity index (0.88 vs. 0.90), and annular area (5.19 cm² vs. 4.52 cm²), the researchers reported.

The annular-prosthesis incongruence (API) index was also significantly higher in patients with PAR (1.07% vs. 0.93%), "indicating valve undersizing in this group," the authors wrote.

Using 3-D TEE, the researchers identified and graded significant areas of calcification in the aortic valve apparatus, which is also very important before TAVR, said Mehrotra.

The final device position was assessed using 2-D TEE images.

The results showed that higher API index, Aortic Valve Apparatus Calcification score, and final position of the device were predictors of significant PAR after TAVR, with odds ratios of 9.4, 3.6, and 1.2, respectively, the authors reported.

"Our study highlights the ability of 2-D and 3-D TEE for accurate annular sizing and optimal valve positioning during TAVR," they wrote.

The takeaway message, said Dr. Mehrotra in an interview, is that "the role of echo is essential before, during, and after TAVR.

He added that 3-D echocardiography has an emerging role in annular sizing. In particular, annular area by 3-D TEE may be more important than the anteroposterior dimension by 2-D TEE for accurate valve sizing, said Dr. Mehrotra. "Technologies like 3-D TEE and cardiac CT can help with preprocedural planning, but they should be used by people who understand how to use them."

While his study focused on 2-D and 3-D TEE, Dr. Mehrotra said he expected more studies begin comparing cardiac CT and 3-D TEE, which is more like, "comparing apples to apples."

In a discussion on TAVR imaging, Dr. Rebecca T. Hahn, director of interventional echocardiography at Columbia University, New York, said that cardiac CT and echocardiography are complementary. However, CT is less user-dependent, compared with 3-D TEE.

Dr. Mehrotra and Dr. Hahn had no relevant financial disclosures.

NATIONAL HARBOR, MD. – Measurements of aortic annular geometry, valve calcification, and final device position with two- and three-dimensional echocardiography are predictive of increased risk of leakage after trans-catheter valve implantation, according to a retrospective study.

The study also showed that 3-D transesophageal echocardiography (3-D TEE) does a better job of measuring the aortic annulus, compared with 2-D TEE.

The annular measurement is critical for optimal valve sizing and prevention of paravalvular aortic regurgitation in patients undergoing transcatheter aortic valve replacement (TAVR).

Paravalvular aortic regurgitation (PAR), is a known complication of TAVR, and according to 2-year analysis of the PARTNER trial, PAR after TAVR was associated with increased late mortality ( N. Engl. J. Med. 2012;366:1686-95).

TAVR is in its infancy in the United States, compared with Europe, and experts are studying how and which imaging techniques could yield the best results before, during, and after TAVR (also called TAVI).

"Every center has their preference," said Dr. Praveen Mehrotra, a noninvasive cardiologist and the lead author of the study at Massachusetts General Hospital in Boston. "Some centers use CT and 2-D TEE. At Mass General, we integrate information obtained from 2-D and 3-D TEE."

Meanwhile, the role of 3-D TEE in TAVR hasn’t been adequately explored, added Dr. Mehrotra, who presented his poster at the annual meeting of the American Society of Echocardiography.

Dr. Mehrotra and his colleagues set out to retrospectively identify 2-D and 3-D TEE parameters that could predict significant PAR after TAVR.

They analyzed 2-D and 3-D TEE images from 94 patients undergoing TAVR between June 2008 and December 2011. The images were used to assess three parameters: annulus geometry, aortic valve apparatus calcification, and final device position.

Twenty-one of the patients (22%) showed significant PAR after TAVR, but before postdilation.

In 2-D TEE, the annulus geometry was assessed by measuring the largest anteroposterior annulus dimension at the aortic valve hinge points in mid systole, the authors wrote. Using 3-D TEE, researchers measured or calculated four parameters for the aortic annulus geometry: minor axis, major axis, eccentricity index, and annular area.

The annular dimension measured by 2-D TEE was similar in the PAR (22.8 mm) and No PAR (22.4 mm) groups. But, the 3-D TEE measurements were significantly larger in the PAR group than in the No PAR group, as measured by annular minor axis (23.8 mm vs. 22.7 mm), major axis (27.0 mm vs. 25.3 mm), eccentricity index (0.88 vs. 0.90), and annular area (5.19 cm² vs. 4.52 cm²), the researchers reported.

The annular-prosthesis incongruence (API) index was also significantly higher in patients with PAR (1.07% vs. 0.93%), "indicating valve undersizing in this group," the authors wrote.

Using 3-D TEE, the researchers identified and graded significant areas of calcification in the aortic valve apparatus, which is also very important before TAVR, said Mehrotra.

The final device position was assessed using 2-D TEE images.

The results showed that higher API index, Aortic Valve Apparatus Calcification score, and final position of the device were predictors of significant PAR after TAVR, with odds ratios of 9.4, 3.6, and 1.2, respectively, the authors reported.

"Our study highlights the ability of 2-D and 3-D TEE for accurate annular sizing and optimal valve positioning during TAVR," they wrote.

The takeaway message, said Dr. Mehrotra in an interview, is that "the role of echo is essential before, during, and after TAVR.

He added that 3-D echocardiography has an emerging role in annular sizing. In particular, annular area by 3-D TEE may be more important than the anteroposterior dimension by 2-D TEE for accurate valve sizing, said Dr. Mehrotra. "Technologies like 3-D TEE and cardiac CT can help with preprocedural planning, but they should be used by people who understand how to use them."

While his study focused on 2-D and 3-D TEE, Dr. Mehrotra said he expected more studies begin comparing cardiac CT and 3-D TEE, which is more like, "comparing apples to apples."

In a discussion on TAVR imaging, Dr. Rebecca T. Hahn, director of interventional echocardiography at Columbia University, New York, said that cardiac CT and echocardiography are complementary. However, CT is less user-dependent, compared with 3-D TEE.

Dr. Mehrotra and Dr. Hahn had no relevant financial disclosures.

Systematically lengthening the duration of resuscitation efforts for patients who have in-hospital cardiac arrests could improve survival with no adverse impact on neurological status, according to researchers.

In a study of 64,339 patients who had in-hospital cardiac arrests at 435 U.S. hospitals over an 8-year period, this survival benefit was independent of numerous patient factors, wrote Dr. Zachary D. Goldberger of the division of cardiovascular medicine, University of Michigan, Ann Arbor, and his associates. The report was published Sept. 4 in The Lancet.

Importantly, they wrote, neurologic status was not affected by the duration of resuscitation efforts, so patients revived after relatively long CPR attempts of 30 minutes or more were as neurologically intact as were those revived after brief attempts of less than 15 minutes.

"Our most notable result was that long resuscitation attempts might be linked to increased rates of return of spontaneous circulation and survival to discharge," they said.

At present, resuscitation guidelines do not address the issue of when to terminate such efforts, and there are not enough data available to guide practice. "Clinicians are frequently reluctant to continue efforts when return of spontaneous circulation does not occur shortly after initiation of resuscitation, in view of the overall poor prognosis for such patients," the researchers noted.

They examined the issue using information from the Get With The Guidelines?Resuscitation database, the largest registry of in-hospital cardiac arrests in the world. A total of 31,198 patients (48.5%) achieved return of spontaneous circulation, while 33,141 (51.5%) died after termination of resuscitation efforts.

Approximately 80% of patients who survived to hospital discharge had favorable neurologic status. The rate of favorable status did not differ significantly by duration of resuscitation: It was 81.2% for patients in whom resuscitation attempts lasted less than 15 minutes, 80.0% for those in whom resuscitation attempts lasted 15-30 minutes, and 78.4% for those in whom resuscitation attempts lasted longer than 30 minutes.

As expected when there is no consensus on the appropriate duration of resuscitation attempts, the investigators found wide variation among hospitals in this practice.

Overall, the median duration of resuscitation efforts was 17 minutes. When the hospitals were divided into quartiles based on this duration, those in the quartile with the shortest interval had a median duration of 16 minutes, while those in the quartile with the longest interval had a median duration of 25 minutes.

Resuscitation efforts lasted more than 50% longer at hospitals in the longest quartile compared with those in the shortest quartile.

Patients at the hospitals with longer durations of resuscitation efforts had significantly higher overall survival and significantly higher survival to hospital discharge than did those at hospitals with shorter durations of resuscitation efforts, Dr. Goldberger and his colleagues said (Lancet 2012 Sept. 4 [doi:10.1016/S0140-6736(12)60862-9]).

The study findings suggest that standardizing resuscitation procedures and identifying a minimum duration could improve patient survival. "Prolongation of resuscitation attempts by 10 or 15 minutes might have only a slight effect on resources once efforts have already begun, but could improve outcomes," the investigators noted.

"We are unable to provide a specific cutoff from these data and are hesitant to speculate," especially because this was an observational study that cannot establish cause and effect. Moreover, several variables that almost certainly affected the duration of resuscitation efforts were not addressed in this study, such as the quality of chest compressions and the availability at each hospital of percutaneous intervention.

It is even possible that the duration of resuscitation attempts is merely a marker for "more comprehensive care" with longer CPR performed at centers where resuscitation guidelines are reliably implemented, they added.

It should also be noted that this study did not address long-term outcomes in survivors of resuscitation. "The extent to which critically ill patients benefit from survival months to years after cardiac arrest should be the ultimate measure of the usefulness of resuscitation measures," Dr. Goldberger and his associates said.

This study was funded by the American Heart Association, the Robert Wood Johnson Foundation, and the National Heart, Lung, and Blood Institute. Dr. Goldberger reported no financial conflicts of interest, and one of his associates reported ties to Medtronic and United Health Care.

Systematically lengthening the duration of resuscitation efforts for patients who have in-hospital cardiac arrests could improve survival with no adverse impact on neurological status, according to researchers.

In a study of 64,339 patients who had in-hospital cardiac arrests at 435 U.S. hospitals over an 8-year period, this survival benefit was independent of numerous patient factors, wrote Dr. Zachary D. Goldberger of the division of cardiovascular medicine, University of Michigan, Ann Arbor, and his associates. The report was published Sept. 4 in The Lancet.

Importantly, they wrote, neurologic status was not affected by the duration of resuscitation efforts, so patients revived after relatively long CPR attempts of 30 minutes or more were as neurologically intact as were those revived after brief attempts of less than 15 minutes.

"Our most notable result was that long resuscitation attempts might be linked to increased rates of return of spontaneous circulation and survival to discharge," they said.

At present, resuscitation guidelines do not address the issue of when to terminate such efforts, and there are not enough data available to guide practice. "Clinicians are frequently reluctant to continue efforts when return of spontaneous circulation does not occur shortly after initiation of resuscitation, in view of the overall poor prognosis for such patients," the researchers noted.

They examined the issue using information from the Get With The Guidelines?Resuscitation database, the largest registry of in-hospital cardiac arrests in the world. A total of 31,198 patients (48.5%) achieved return of spontaneous circulation, while 33,141 (51.5%) died after termination of resuscitation efforts.

Approximately 80% of patients who survived to hospital discharge had favorable neurologic status. The rate of favorable status did not differ significantly by duration of resuscitation: It was 81.2% for patients in whom resuscitation attempts lasted less than 15 minutes, 80.0% for those in whom resuscitation attempts lasted 15-30 minutes, and 78.4% for those in whom resuscitation attempts lasted longer than 30 minutes.

As expected when there is no consensus on the appropriate duration of resuscitation attempts, the investigators found wide variation among hospitals in this practice.

Overall, the median duration of resuscitation efforts was 17 minutes. When the hospitals were divided into quartiles based on this duration, those in the quartile with the shortest interval had a median duration of 16 minutes, while those in the quartile with the longest interval had a median duration of 25 minutes.

Resuscitation efforts lasted more than 50% longer at hospitals in the longest quartile compared with those in the shortest quartile.

Patients at the hospitals with longer durations of resuscitation efforts had significantly higher overall survival and significantly higher survival to hospital discharge than did those at hospitals with shorter durations of resuscitation efforts, Dr. Goldberger and his colleagues said (Lancet 2012 Sept. 4 [doi:10.1016/S0140-6736(12)60862-9]).

The study findings suggest that standardizing resuscitation procedures and identifying a minimum duration could improve patient survival. "Prolongation of resuscitation attempts by 10 or 15 minutes might have only a slight effect on resources once efforts have already begun, but could improve outcomes," the investigators noted.

"We are unable to provide a specific cutoff from these data and are hesitant to speculate," especially because this was an observational study that cannot establish cause and effect. Moreover, several variables that almost certainly affected the duration of resuscitation efforts were not addressed in this study, such as the quality of chest compressions and the availability at each hospital of percutaneous intervention.

It is even possible that the duration of resuscitation attempts is merely a marker for "more comprehensive care" with longer CPR performed at centers where resuscitation guidelines are reliably implemented, they added.

It should also be noted that this study did not address long-term outcomes in survivors of resuscitation. "The extent to which critically ill patients benefit from survival months to years after cardiac arrest should be the ultimate measure of the usefulness of resuscitation measures," Dr. Goldberger and his associates said.

This study was funded by the American Heart Association, the Robert Wood Johnson Foundation, and the National Heart, Lung, and Blood Institute. Dr. Goldberger reported no financial conflicts of interest, and one of his associates reported ties to Medtronic and United Health Care.

Systematically lengthening the duration of resuscitation efforts for patients who have in-hospital cardiac arrests could improve survival with no adverse impact on neurological status, according to researchers.

In a study of 64,339 patients who had in-hospital cardiac arrests at 435 U.S. hospitals over an 8-year period, this survival benefit was independent of numerous patient factors, wrote Dr. Zachary D. Goldberger of the division of cardiovascular medicine, University of Michigan, Ann Arbor, and his associates. The report was published Sept. 4 in The Lancet.

Importantly, they wrote, neurologic status was not affected by the duration of resuscitation efforts, so patients revived after relatively long CPR attempts of 30 minutes or more were as neurologically intact as were those revived after brief attempts of less than 15 minutes.

"Our most notable result was that long resuscitation attempts might be linked to increased rates of return of spontaneous circulation and survival to discharge," they said.

At present, resuscitation guidelines do not address the issue of when to terminate such efforts, and there are not enough data available to guide practice. "Clinicians are frequently reluctant to continue efforts when return of spontaneous circulation does not occur shortly after initiation of resuscitation, in view of the overall poor prognosis for such patients," the researchers noted.

They examined the issue using information from the Get With The Guidelines?Resuscitation database, the largest registry of in-hospital cardiac arrests in the world. A total of 31,198 patients (48.5%) achieved return of spontaneous circulation, while 33,141 (51.5%) died after termination of resuscitation efforts.

Approximately 80% of patients who survived to hospital discharge had favorable neurologic status. The rate of favorable status did not differ significantly by duration of resuscitation: It was 81.2% for patients in whom resuscitation attempts lasted less than 15 minutes, 80.0% for those in whom resuscitation attempts lasted 15-30 minutes, and 78.4% for those in whom resuscitation attempts lasted longer than 30 minutes.

As expected when there is no consensus on the appropriate duration of resuscitation attempts, the investigators found wide variation among hospitals in this practice.

Overall, the median duration of resuscitation efforts was 17 minutes. When the hospitals were divided into quartiles based on this duration, those in the quartile with the shortest interval had a median duration of 16 minutes, while those in the quartile with the longest interval had a median duration of 25 minutes.

Resuscitation efforts lasted more than 50% longer at hospitals in the longest quartile compared with those in the shortest quartile.

Patients at the hospitals with longer durations of resuscitation efforts had significantly higher overall survival and significantly higher survival to hospital discharge than did those at hospitals with shorter durations of resuscitation efforts, Dr. Goldberger and his colleagues said (Lancet 2012 Sept. 4 [doi:10.1016/S0140-6736(12)60862-9]).

The study findings suggest that standardizing resuscitation procedures and identifying a minimum duration could improve patient survival. "Prolongation of resuscitation attempts by 10 or 15 minutes might have only a slight effect on resources once efforts have already begun, but could improve outcomes," the investigators noted.

"We are unable to provide a specific cutoff from these data and are hesitant to speculate," especially because this was an observational study that cannot establish cause and effect. Moreover, several variables that almost certainly affected the duration of resuscitation efforts were not addressed in this study, such as the quality of chest compressions and the availability at each hospital of percutaneous intervention.

It is even possible that the duration of resuscitation attempts is merely a marker for "more comprehensive care" with longer CPR performed at centers where resuscitation guidelines are reliably implemented, they added.

It should also be noted that this study did not address long-term outcomes in survivors of resuscitation. "The extent to which critically ill patients benefit from survival months to years after cardiac arrest should be the ultimate measure of the usefulness of resuscitation measures," Dr. Goldberger and his associates said.

This study was funded by the American Heart Association, the Robert Wood Johnson Foundation, and the National Heart, Lung, and Blood Institute. Dr. Goldberger reported no financial conflicts of interest, and one of his associates reported ties to Medtronic and United Health Care.

Systematically lengthening the duration of resuscitation efforts for patients who have in-hospital cardiac arrests could improve survival with no adverse impact on neurological status, according to researchers.

In a study of 64,339 patients who had in-hospital cardiac arrests at 435 U.S. hospitals over an 8-year period, this survival benefit was independent of numerous patient factors, wrote Dr. Zachary D. Goldberger of the division of cardiovascular medicine, University of Michigan, Ann Arbor, and his associates. The report was published Sept. 4 in The Lancet.

Importantly, they wrote, neurologic status was not affected by the duration of resuscitation efforts, so patients revived after relatively long CPR attempts of 30 minutes or more were as neurologically intact as were those revived after brief attempts of less than 15 minutes.

"Our most notable result was that long resuscitation attempts might be linked to increased rates of return of spontaneous circulation and survival to discharge," they said.

At present, resuscitation guidelines do not address the issue of when to terminate such efforts, and there are not enough data available to guide practice. "Clinicians are frequently reluctant to continue efforts when return of spontaneous circulation does not occur shortly after initiation of resuscitation, in view of the overall poor prognosis for such patients," the researchers noted.

They examined the issue using information from the Get With The Guidelines?Resuscitation database, the largest registry of in-hospital cardiac arrests in the world. A total of 31,198 patients (48.5%) achieved return of spontaneous circulation, while 33,141 (51.5%) died after termination of resuscitation efforts.

Approximately 80% of patients who survived to hospital discharge had favorable neurologic status. The rate of favorable status did not differ significantly by duration of resuscitation: It was 81.2% for patients in whom resuscitation attempts lasted less than 15 minutes, 80.0% for those in whom resuscitation attempts lasted 15-30 minutes, and 78.4% for those in whom resuscitation attempts lasted longer than 30 minutes.

As expected when there is no consensus on the appropriate duration of resuscitation attempts, the investigators found wide variation among hospitals in this practice.

Overall, the median duration of resuscitation efforts was 17 minutes. When the hospitals were divided into quartiles based on this duration, those in the quartile with the shortest interval had a median duration of 16 minutes, while those in the quartile with the longest interval had a median duration of 25 minutes.

Resuscitation efforts lasted more than 50% longer at hospitals in the longest quartile compared with those in the shortest quartile.

Patients at the hospitals with longer durations of resuscitation efforts had significantly higher overall survival and significantly higher survival to hospital discharge than did those at hospitals with shorter durations of resuscitation efforts, Dr. Goldberger and his colleagues said (Lancet 2012 Sept. 4 [doi:10.1016/S0140-6736(12)60862-9]).

The study findings suggest that standardizing resuscitation procedures and identifying a minimum duration could improve patient survival. "Prolongation of resuscitation attempts by 10 or 15 minutes might have only a slight effect on resources once efforts have already begun, but could improve outcomes," the investigators noted.

"We are unable to provide a specific cutoff from these data and are hesitant to speculate," especially because this was an observational study that cannot establish cause and effect. Moreover, several variables that almost certainly affected the duration of resuscitation efforts were not addressed in this study, such as the quality of chest compressions and the availability at each hospital of percutaneous intervention.

It is even possible that the duration of resuscitation attempts is merely a marker for "more comprehensive care" with longer CPR performed at centers where resuscitation guidelines are reliably implemented, they added.

It should also be noted that this study did not address long-term outcomes in survivors of resuscitation. "The extent to which critically ill patients benefit from survival months to years after cardiac arrest should be the ultimate measure of the usefulness of resuscitation measures," Dr. Goldberger and his associates said.

This study was funded by the American Heart Association, the Robert Wood Johnson Foundation, and the National Heart, Lung, and Blood Institute. Dr. Goldberger reported no financial conflicts of interest, and one of his associates reported ties to Medtronic and United Health Care.

Systematically lengthening the duration of resuscitation efforts for patients who have in-hospital cardiac arrests could improve survival with no adverse impact on neurological status, according to researchers.

In a study of 64,339 patients who had in-hospital cardiac arrests at 435 U.S. hospitals over an 8-year period, this survival benefit was independent of numerous patient factors, wrote Dr. Zachary D. Goldberger of the division of cardiovascular medicine, University of Michigan, Ann Arbor, and his associates. The report was published Sept. 4 in The Lancet.

Importantly, they wrote, neurologic status was not affected by the duration of resuscitation efforts, so patients revived after relatively long CPR attempts of 30 minutes or more were as neurologically intact as were those revived after brief attempts of less than 15 minutes.

"Our most notable result was that long resuscitation attempts might be linked to increased rates of return of spontaneous circulation and survival to discharge," they said.

At present, resuscitation guidelines do not address the issue of when to terminate such efforts, and there are not enough data available to guide practice. "Clinicians are frequently reluctant to continue efforts when return of spontaneous circulation does not occur shortly after initiation of resuscitation, in view of the overall poor prognosis for such patients," the researchers noted.

They examined the issue using information from the Get With The Guidelines?Resuscitation database, the largest registry of in-hospital cardiac arrests in the world. A total of 31,198 patients (48.5%) achieved return of spontaneous circulation, while 33,141 (51.5%) died after termination of resuscitation efforts.

Approximately 80% of patients who survived to hospital discharge had favorable neurologic status. The rate of favorable status did not differ significantly by duration of resuscitation: It was 81.2% for patients in whom resuscitation attempts lasted less than 15 minutes, 80.0% for those in whom resuscitation attempts lasted 15-30 minutes, and 78.4% for those in whom resuscitation attempts lasted longer than 30 minutes.

As expected when there is no consensus on the appropriate duration of resuscitation attempts, the investigators found wide variation among hospitals in this practice.

Overall, the median duration of resuscitation efforts was 17 minutes. When the hospitals were divided into quartiles based on this duration, those in the quartile with the shortest interval had a median duration of 16 minutes, while those in the quartile with the longest interval had a median duration of 25 minutes.

Resuscitation efforts lasted more than 50% longer at hospitals in the longest quartile compared with those in the shortest quartile.

Patients at the hospitals with longer durations of resuscitation efforts had significantly higher overall survival and significantly higher survival to hospital discharge than did those at hospitals with shorter durations of resuscitation efforts, Dr. Goldberger and his colleagues said (Lancet 2012 Sept. 4 [doi:10.1016/S0140-6736(12)60862-9]).

The study findings suggest that standardizing resuscitation procedures and identifying a minimum duration could improve patient survival. "Prolongation of resuscitation attempts by 10 or 15 minutes might have only a slight effect on resources once efforts have already begun, but could improve outcomes," the investigators noted.

"We are unable to provide a specific cutoff from these data and are hesitant to speculate," especially because this was an observational study that cannot establish cause and effect. Moreover, several variables that almost certainly affected the duration of resuscitation efforts were not addressed in this study, such as the quality of chest compressions and the availability at each hospital of percutaneous intervention.

It is even possible that the duration of resuscitation attempts is merely a marker for "more comprehensive care" with longer CPR performed at centers where resuscitation guidelines are reliably implemented, they added.

It should also be noted that this study did not address long-term outcomes in survivors of resuscitation. "The extent to which critically ill patients benefit from survival months to years after cardiac arrest should be the ultimate measure of the usefulness of resuscitation measures," Dr. Goldberger and his associates said.

This study was funded by the American Heart Association, the Robert Wood Johnson Foundation, and the National Heart, Lung, and Blood Institute. Dr. Goldberger reported no financial conflicts of interest, and one of his associates reported ties to Medtronic and United Health Care.

Systematically lengthening the duration of resuscitation efforts for patients who have in-hospital cardiac arrests could improve survival with no adverse impact on neurological status, according to researchers.

In a study of 64,339 patients who had in-hospital cardiac arrests at 435 U.S. hospitals over an 8-year period, this survival benefit was independent of numerous patient factors, wrote Dr. Zachary D. Goldberger of the division of cardiovascular medicine, University of Michigan, Ann Arbor, and his associates. The report was published Sept. 4 in The Lancet.

Importantly, they wrote, neurologic status was not affected by the duration of resuscitation efforts, so patients revived after relatively long CPR attempts of 30 minutes or more were as neurologically intact as were those revived after brief attempts of less than 15 minutes.

"Our most notable result was that long resuscitation attempts might be linked to increased rates of return of spontaneous circulation and survival to discharge," they said.

At present, resuscitation guidelines do not address the issue of when to terminate such efforts, and there are not enough data available to guide practice. "Clinicians are frequently reluctant to continue efforts when return of spontaneous circulation does not occur shortly after initiation of resuscitation, in view of the overall poor prognosis for such patients," the researchers noted.

They examined the issue using information from the Get With The Guidelines?Resuscitation database, the largest registry of in-hospital cardiac arrests in the world. A total of 31,198 patients (48.5%) achieved return of spontaneous circulation, while 33,141 (51.5%) died after termination of resuscitation efforts.

Approximately 80% of patients who survived to hospital discharge had favorable neurologic status. The rate of favorable status did not differ significantly by duration of resuscitation: It was 81.2% for patients in whom resuscitation attempts lasted less than 15 minutes, 80.0% for those in whom resuscitation attempts lasted 15-30 minutes, and 78.4% for those in whom resuscitation attempts lasted longer than 30 minutes.

As expected when there is no consensus on the appropriate duration of resuscitation attempts, the investigators found wide variation among hospitals in this practice.

Overall, the median duration of resuscitation efforts was 17 minutes. When the hospitals were divided into quartiles based on this duration, those in the quartile with the shortest interval had a median duration of 16 minutes, while those in the quartile with the longest interval had a median duration of 25 minutes.

Resuscitation efforts lasted more than 50% longer at hospitals in the longest quartile compared with those in the shortest quartile.

Patients at the hospitals with longer durations of resuscitation efforts had significantly higher overall survival and significantly higher survival to hospital discharge than did those at hospitals with shorter durations of resuscitation efforts, Dr. Goldberger and his colleagues said (Lancet 2012 Sept. 4 [doi:10.1016/S0140-6736(12)60862-9]).

The study findings suggest that standardizing resuscitation procedures and identifying a minimum duration could improve patient survival. "Prolongation of resuscitation attempts by 10 or 15 minutes might have only a slight effect on resources once efforts have already begun, but could improve outcomes," the investigators noted.

"We are unable to provide a specific cutoff from these data and are hesitant to speculate," especially because this was an observational study that cannot establish cause and effect. Moreover, several variables that almost certainly affected the duration of resuscitation efforts were not addressed in this study, such as the quality of chest compressions and the availability at each hospital of percutaneous intervention.

It is even possible that the duration of resuscitation attempts is merely a marker for "more comprehensive care" with longer CPR performed at centers where resuscitation guidelines are reliably implemented, they added.

It should also be noted that this study did not address long-term outcomes in survivors of resuscitation. "The extent to which critically ill patients benefit from survival months to years after cardiac arrest should be the ultimate measure of the usefulness of resuscitation measures," Dr. Goldberger and his associates said.

This study was funded by the American Heart Association, the Robert Wood Johnson Foundation, and the National Heart, Lung, and Blood Institute. Dr. Goldberger reported no financial conflicts of interest, and one of his associates reported ties to Medtronic and United Health Care.

The Food and Drug Administration has declined to approve the oral anticoagulant rivaroxaban as a treatment for patients with acute coronary syndrome, according to a statement issued by Johnson & Johnson.

The agency has issued a complete response letter regarding the supplemental indication for rivaroxaban for use in reducing the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS) that has been under review at the agency, the statement said.

The FDA issues complete response letters for a drug when there are outstanding issues that need to be resolved before approval; the FDA does not make these letters public, and the company statement did not provide any details about the issues that were raised in the FDA letter.

Rivaroxaban, an oral factor Xa inhibitor marketed as Xarelto by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, was initially approved in July 2011 for the prophylaxis of deep vein thrombosis in patients undergoing knee or hip replacement surgery; and in November 2011 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

In December of last year, Janssen submitted the ACS application for rivaroxaban at a dose of 2.5 mg twice a day, to "reduce the risk of thrombotic cardiovascular events in patients with ACS [ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), or unstable angina (UA)] in combination with aspirin alone or with aspirin plus clopidogrel or ticlopidine."

But at a meeting in May, the majority of the FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended against approval for this indication, with those voting no citing a large amount of missing data in ATLAS ACS, the pivotal study, as well as safety concerns, among the reasons for their votes (6 to 4 with one abstention).

In the study of 15,526 people with recent ACS, the risk of the combined end point of a composite of cardiovascular death, MI, or stroke, the primary efficacy end point, was reduced by 15% among those on the 2.5-mg twice-daily dosage who were also on aspirin plus a thienopyridine over those on placebo plus dual therapy (primarily driven by a reduction in CV deaths).

This was a statistically significant difference but with a marginal P value of .039. Among those on 2.5 mg twice a day, major bleeding was significantly higher (1.3%) than in those on placebo (0.4%). Intracranial hemorrhage and hemorrhagic stroke rates were also higher in those on rivaroxaban than in those on placebo (N. Engl. J. Med. 2012;366:9-19).

In an interview, Dr. Sanjay Kaul, one of the panel members who voted against approval, referred to the degree of missing data and the lack of robust data in favor of rivaroxaban in this study, pointing out that fewer than 10 excess events in the treatment arm would have negated the statistically significant treatment advantage.

He also referred to the lack of a dose response (there was a greater benefit with the lower dose), a differential impact of the two doses on cardiovascular mortality and MI that was difficult to explain, and the lack of external evidence supporting an incremental advantage of anticoagulant therapy over antiplatelet therapy.

Although the contents of the FDA’s letter are not made public, "I suspect some, if not all, of these issues likely contributed to the unfavorable verdict," said Dr. Kaul, who is the director of the vascular physiology and thrombosis research laboratory at the Burns and Allen Research Institute, Cedars-Sinai Medical Center, Los Angeles.

"I hope that with proper due diligence, which might involve additional trials, the sponsor will be able to respond satisfactorily to the FDA’s concerns," he added.

In the Johnson & Johnson statement, Dr. Paul Burton, vice president and cardiovascular franchise medical leader at Janssen R&D, said that the company "will continue to work with the FDA to fully address their questions as quickly as possible."

Warfarin and three P2Y12 inhibitors – ticagrelor (Brilinta), prasugrel (Effient), and ticlopidine (Ticlid) – are approved for reducing the risk of thrombotic CV events in patients with ACS.

Dr. Kaul holds stock in Johnson & Johnson, but less than the amount for which a waiver to be on an FDA panel is required.

The Food and Drug Administration has declined to approve the oral anticoagulant rivaroxaban as a treatment for patients with acute coronary syndrome, according to a statement issued by Johnson & Johnson.

The agency has issued a complete response letter regarding the supplemental indication for rivaroxaban for use in reducing the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS) that has been under review at the agency, the statement said.

The FDA issues complete response letters for a drug when there are outstanding issues that need to be resolved before approval; the FDA does not make these letters public, and the company statement did not provide any details about the issues that were raised in the FDA letter.

Rivaroxaban, an oral factor Xa inhibitor marketed as Xarelto by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, was initially approved in July 2011 for the prophylaxis of deep vein thrombosis in patients undergoing knee or hip replacement surgery; and in November 2011 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

In December of last year, Janssen submitted the ACS application for rivaroxaban at a dose of 2.5 mg twice a day, to "reduce the risk of thrombotic cardiovascular events in patients with ACS [ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), or unstable angina (UA)] in combination with aspirin alone or with aspirin plus clopidogrel or ticlopidine."

But at a meeting in May, the majority of the FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended against approval for this indication, with those voting no citing a large amount of missing data in ATLAS ACS, the pivotal study, as well as safety concerns, among the reasons for their votes (6 to 4 with one abstention).

In the study of 15,526 people with recent ACS, the risk of the combined end point of a composite of cardiovascular death, MI, or stroke, the primary efficacy end point, was reduced by 15% among those on the 2.5-mg twice-daily dosage who were also on aspirin plus a thienopyridine over those on placebo plus dual therapy (primarily driven by a reduction in CV deaths).

This was a statistically significant difference but with a marginal P value of .039. Among those on 2.5 mg twice a day, major bleeding was significantly higher (1.3%) than in those on placebo (0.4%). Intracranial hemorrhage and hemorrhagic stroke rates were also higher in those on rivaroxaban than in those on placebo (N. Engl. J. Med. 2012;366:9-19).

In an interview, Dr. Sanjay Kaul, one of the panel members who voted against approval, referred to the degree of missing data and the lack of robust data in favor of rivaroxaban in this study, pointing out that fewer than 10 excess events in the treatment arm would have negated the statistically significant treatment advantage.

He also referred to the lack of a dose response (there was a greater benefit with the lower dose), a differential impact of the two doses on cardiovascular mortality and MI that was difficult to explain, and the lack of external evidence supporting an incremental advantage of anticoagulant therapy over antiplatelet therapy.

Although the contents of the FDA’s letter are not made public, "I suspect some, if not all, of these issues likely contributed to the unfavorable verdict," said Dr. Kaul, who is the director of the vascular physiology and thrombosis research laboratory at the Burns and Allen Research Institute, Cedars-Sinai Medical Center, Los Angeles.

"I hope that with proper due diligence, which might involve additional trials, the sponsor will be able to respond satisfactorily to the FDA’s concerns," he added.

In the Johnson & Johnson statement, Dr. Paul Burton, vice president and cardiovascular franchise medical leader at Janssen R&D, said that the company "will continue to work with the FDA to fully address their questions as quickly as possible."

Warfarin and three P2Y12 inhibitors – ticagrelor (Brilinta), prasugrel (Effient), and ticlopidine (Ticlid) – are approved for reducing the risk of thrombotic CV events in patients with ACS.

Dr. Kaul holds stock in Johnson & Johnson, but less than the amount for which a waiver to be on an FDA panel is required.

The Food and Drug Administration has declined to approve the oral anticoagulant rivaroxaban as a treatment for patients with acute coronary syndrome, according to a statement issued by Johnson & Johnson.

The agency has issued a complete response letter regarding the supplemental indication for rivaroxaban for use in reducing the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS) that has been under review at the agency, the statement said.

The FDA issues complete response letters for a drug when there are outstanding issues that need to be resolved before approval; the FDA does not make these letters public, and the company statement did not provide any details about the issues that were raised in the FDA letter.

Rivaroxaban, an oral factor Xa inhibitor marketed as Xarelto by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, was initially approved in July 2011 for the prophylaxis of deep vein thrombosis in patients undergoing knee or hip replacement surgery; and in November 2011 for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.

In December of last year, Janssen submitted the ACS application for rivaroxaban at a dose of 2.5 mg twice a day, to "reduce the risk of thrombotic cardiovascular events in patients with ACS [ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), or unstable angina (UA)] in combination with aspirin alone or with aspirin plus clopidogrel or ticlopidine."

But at a meeting in May, the majority of the FDA’s Cardiovascular and Renal Drugs Advisory Committee recommended against approval for this indication, with those voting no citing a large amount of missing data in ATLAS ACS, the pivotal study, as well as safety concerns, among the reasons for their votes (6 to 4 with one abstention).

In the study of 15,526 people with recent ACS, the risk of the combined end point of a composite of cardiovascular death, MI, or stroke, the primary efficacy end point, was reduced by 15% among those on the 2.5-mg twice-daily dosage who were also on aspirin plus a thienopyridine over those on placebo plus dual therapy (primarily driven by a reduction in CV deaths).

This was a statistically significant difference but with a marginal P value of .039. Among those on 2.5 mg twice a day, major bleeding was significantly higher (1.3%) than in those on placebo (0.4%). Intracranial hemorrhage and hemorrhagic stroke rates were also higher in those on rivaroxaban than in those on placebo (N. Engl. J. Med. 2012;366:9-19).

In an interview, Dr. Sanjay Kaul, one of the panel members who voted against approval, referred to the degree of missing data and the lack of robust data in favor of rivaroxaban in this study, pointing out that fewer than 10 excess events in the treatment arm would have negated the statistically significant treatment advantage.

He also referred to the lack of a dose response (there was a greater benefit with the lower dose), a differential impact of the two doses on cardiovascular mortality and MI that was difficult to explain, and the lack of external evidence supporting an incremental advantage of anticoagulant therapy over antiplatelet therapy.

Although the contents of the FDA’s letter are not made public, "I suspect some, if not all, of these issues likely contributed to the unfavorable verdict," said Dr. Kaul, who is the director of the vascular physiology and thrombosis research laboratory at the Burns and Allen Research Institute, Cedars-Sinai Medical Center, Los Angeles.

"I hope that with proper due diligence, which might involve additional trials, the sponsor will be able to respond satisfactorily to the FDA’s concerns," he added.

In the Johnson & Johnson statement, Dr. Paul Burton, vice president and cardiovascular franchise medical leader at Janssen R&D, said that the company "will continue to work with the FDA to fully address their questions as quickly as possible."

Warfarin and three P2Y12 inhibitors – ticagrelor (Brilinta), prasugrel (Effient), and ticlopidine (Ticlid) – are approved for reducing the risk of thrombotic CV events in patients with ACS.

Dr. Kaul holds stock in Johnson & Johnson, but less than the amount for which a waiver to be on an FDA panel is required.

CHICAGO ? The new oral anticoagulants for stroke prevention in atrial fibrillation may be garnering all the buzz, but don?t count out the old standby warfarin yet.

"It?s not just a knee-jerk reaction that all patients should be switched to the new agents. It?s dependent upon how well you as a physician are managing your patients on warfarin," Dr. Jack E. Ansell asserted at the annual meeting of the American College of Cardiology.

"Warfarin therapy is all about management. If it?s not managed well, you can compare it to anything, and anything is going to be better. And if it?s managed very well, then it?s very difficult to beat warfarin therapy," said Dr. Ansell, who is the chairman of the department of medicine at Lenox Hill Hospital in New York.

A growing body of evidence indicates that the new standard in high-quality management of warfarin therapy involves patient self-testing of International Normalized Ratios (INR) at home using a fingerstick blood sample and a portable point-of-care device.

As a case in point: Dr. Ansell presented highlights of the new STABLE study, in which he and his coinvestigators conducted a retrospective analysis of the real-world experience of more than 29,000 warfarin-treated patients enrolled in a national commercial comprehensive self-test support service. The study was reported in JACC 2012 March 27 [doi: 10.1016/S0735-1097(12)61865-8]).

Patients who performed frequent self-testing ? meaning more than 80% of their self-testing was done on a weekly basis ? had a mean time spent in the therapeutic INR range (TTR) of 74%. That?s unprecedented, he said.

By comparison, in the pivotal RE-LY randomized trial for dabigatran (Pradaxa), the control group on warfarin had a TTR of 64% (N. Engl. J. Med. 2009;361:1139-51). In the ROCKET-AF trial of rivaroxaban (Xarelto), warfarin controls had a TTR of 55% (N. Engl. J. Med. 2011;365:883-91). And in the ARISTOTLE study of apixaban (Eliquis), an agent expected to soon receive Food and Drug Administration marketing approval, the warfarin control group had a TTR of 62% (N. Engl. J. Med. 2011;365:981-92).

In all these major randomized trials involving the novel oral anticoagulants, patients assigned to warfarin were closely managed, but in traditional fashion ? home self-testing wasn?t involved.

In contrast, in the STABLE study, the overall TTR, including those patients who self-tested variably and inconsistently, was still 69.7%.

"This is important because the cost-effectiveness analyses done with dabigatran and the other new anticoagulants suggest that when you get up to a TTR above 70% with warfarin, the cost-effectiveness of the new agents diminishes and warfarin actually becomes more cost-effective," according to Dr. Ansell.

A particularly impressive finding in STABLE was that patients who did weekly self-testing had a 2.3% incidence of critical value INR results, defined as an INR below 1.5 or greater than 5.0. "This is really a phenomenally low result," he commented. It represented a 48% reduction from the 4.4% incidence in patients with variable self-testing frequency.

Participants in the STABLE study tested themselves at home, but their warfarin dosing was managed by their referring physicians or anticoagulation clinics. Thus, an individual?s TTR reflected the warfarin management expertise of the referral source.

There are several reasons why home monitoring achieves better TTRs and ? as shown in other studies ? lower major bleeding and thrombotic event rates than with usual care or anticoagulation clinics not utilizing patient self-monitoring, Dr. Ansell said.

Home testing is more frequent, timely, and consistent, and the immediate feedback regarding INR results is likely to promote adherence.

A variant of patient self-testing starting to catch on in the United States is patient self-management. This entails teaching patients how to manage their own warfarin dose on the basis of their home INR measurements.

The most recent American College of Chest Physicians clinical practice guidelines on antithrombotic therapy for atrial fibrillation give patient self-management of warfarin therapy a class 2B recommendation, stating, "For patients treated with vitamin K antagonists who are motivated and can demonstrate competency in self-management strategies, including the self-testing equipment, we suggest patient self-management rather than the usual outpatient INR monitoring" (CHEST 2012;141: 2 suppl. e531S-e575S [doi: 10.1378/chest.11-2304]).

Session cochair Dr. Samuel Z. Goldhaber agreed with Dr. Ansell that warfarin still has a place in anticoagulation therapy. The fact that it costs as little as $4 per month while dabigatran, for example, retails for 60 times that amount, is not to be shrugged off in an era of runaway health care spending, he said.

Plus, warfarin, for all its drawbacks, is a known quantity backed by more than a half century of clinical experience.

"Even though warfarin can cause horrible complications, there are no more surprises left about what warfarin can do," observed Dr. Goldhaber, who is a professor of medicine at Harvard Medical School and director of the venous thromboembolism research group at Brigham and Women?s Hospital, Boston.

A potential game changer for warfarin is the possibility that rapid pharmacogenetic testing will enable physicians to improve upon the current method of warfarin dosing.

One advantage warfarin has is that bleeding episodes can be reversed by administration of vitamin K. In contrast, there is as yet no reliable means of reversing major bleeding in patients on the novel anticoagulants. But Dr. Lars Wallentin said this limitation of the new agents is outweighed by the consistent finding that they have lower rates of intracranial hemorrhage than those of warfarin.

"There is no antidote to warfarin that has proven to have any effect in patients with ICH. And there is no evidence as far as I can see that however you control INR you can reach as low a level of ICH as with these new agents. I think this is a specific downside of warfarin that we can?t get away from," said Dr. Wallentin, who is a professor of cardiology at Uppsala (Sweden) University.

The STABLE study was funded by Alere Home Monitoring, Inc. Dr. Ansell is a consultant to the company.

Dr. Goldhaber has served as a consultant to numerous pharmaceutical companies developing cardiovascular medications.

Dr. Wallentin was principal investigator in the ARISTOTLE study of apixaban, funded by Pfizer and Bristol Myers Squibb, and has served as a consultant to those and other pharmaceutical companies.

CHICAGO ? The new oral anticoagulants for stroke prevention in atrial fibrillation may be garnering all the buzz, but don?t count out the old standby warfarin yet.

"It?s not just a knee-jerk reaction that all patients should be switched to the new agents. It?s dependent upon how well you as a physician are managing your patients on warfarin," Dr. Jack E. Ansell asserted at the annual meeting of the American College of Cardiology.

"Warfarin therapy is all about management. If it?s not managed well, you can compare it to anything, and anything is going to be better. And if it?s managed very well, then it?s very difficult to beat warfarin therapy," said Dr. Ansell, who is the chairman of the department of medicine at Lenox Hill Hospital in New York.

A growing body of evidence indicates that the new standard in high-quality management of warfarin therapy involves patient self-testing of International Normalized Ratios (INR) at home using a fingerstick blood sample and a portable point-of-care device.

As a case in point: Dr. Ansell presented highlights of the new STABLE study, in which he and his coinvestigators conducted a retrospective analysis of the real-world experience of more than 29,000 warfarin-treated patients enrolled in a national commercial comprehensive self-test support service. The study was reported in JACC 2012 March 27 [doi: 10.1016/S0735-1097(12)61865-8]).

Patients who performed frequent self-testing ? meaning more than 80% of their self-testing was done on a weekly basis ? had a mean time spent in the therapeutic INR range (TTR) of 74%. That?s unprecedented, he said.

By comparison, in the pivotal RE-LY randomized trial for dabigatran (Pradaxa), the control group on warfarin had a TTR of 64% (N. Engl. J. Med. 2009;361:1139-51). In the ROCKET-AF trial of rivaroxaban (Xarelto), warfarin controls had a TTR of 55% (N. Engl. J. Med. 2011;365:883-91). And in the ARISTOTLE study of apixaban (Eliquis), an agent expected to soon receive Food and Drug Administration marketing approval, the warfarin control group had a TTR of 62% (N. Engl. J. Med. 2011;365:981-92).

In all these major randomized trials involving the novel oral anticoagulants, patients assigned to warfarin were closely managed, but in traditional fashion ? home self-testing wasn?t involved.

In contrast, in the STABLE study, the overall TTR, including those patients who self-tested variably and inconsistently, was still 69.7%.

"This is important because the cost-effectiveness analyses done with dabigatran and the other new anticoagulants suggest that when you get up to a TTR above 70% with warfarin, the cost-effectiveness of the new agents diminishes and warfarin actually becomes more cost-effective," according to Dr. Ansell.

A particularly impressive finding in STABLE was that patients who did weekly self-testing had a 2.3% incidence of critical value INR results, defined as an INR below 1.5 or greater than 5.0. "This is really a phenomenally low result," he commented. It represented a 48% reduction from the 4.4% incidence in patients with variable self-testing frequency.

Participants in the STABLE study tested themselves at home, but their warfarin dosing was managed by their referring physicians or anticoagulation clinics. Thus, an individual?s TTR reflected the warfarin management expertise of the referral source.

There are several reasons why home monitoring achieves better TTRs and ? as shown in other studies ? lower major bleeding and thrombotic event rates than with usual care or anticoagulation clinics not utilizing patient self-monitoring, Dr. Ansell said.

Home testing is more frequent, timely, and consistent, and the immediate feedback regarding INR results is likely to promote adherence.

A variant of patient self-testing starting to catch on in the United States is patient self-management. This entails teaching patients how to manage their own warfarin dose on the basis of their home INR measurements.

The most recent American College of Chest Physicians clinical practice guidelines on antithrombotic therapy for atrial fibrillation give patient self-management of warfarin therapy a class 2B recommendation, stating, "For patients treated with vitamin K antagonists who are motivated and can demonstrate competency in self-management strategies, including the self-testing equipment, we suggest patient self-management rather than the usual outpatient INR monitoring" (CHEST 2012;141: 2 suppl. e531S-e575S [doi: 10.1378/chest.11-2304]).

Session cochair Dr. Samuel Z. Goldhaber agreed with Dr. Ansell that warfarin still has a place in anticoagulation therapy. The fact that it costs as little as $4 per month while dabigatran, for example, retails for 60 times that amount, is not to be shrugged off in an era of runaway health care spending, he said.

Plus, warfarin, for all its drawbacks, is a known quantity backed by more than a half century of clinical experience.

"Even though warfarin can cause horrible complications, there are no more surprises left about what warfarin can do," observed Dr. Goldhaber, who is a professor of medicine at Harvard Medical School and director of the venous thromboembolism research group at Brigham and Women?s Hospital, Boston.

A potential game changer for warfarin is the possibility that rapid pharmacogenetic testing will enable physicians to improve upon the current method of warfarin dosing.

One advantage warfarin has is that bleeding episodes can be reversed by administration of vitamin K. In contrast, there is as yet no reliable means of reversing major bleeding in patients on the novel anticoagulants. But Dr. Lars Wallentin said this limitation of the new agents is outweighed by the consistent finding that they have lower rates of intracranial hemorrhage than those of warfarin.

"There is no antidote to warfarin that has proven to have any effect in patients with ICH. And there is no evidence as far as I can see that however you control INR you can reach as low a level of ICH as with these new agents. I think this is a specific downside of warfarin that we can?t get away from," said Dr. Wallentin, who is a professor of cardiology at Uppsala (Sweden) University.

The STABLE study was funded by Alere Home Monitoring, Inc. Dr. Ansell is a consultant to the company.

Dr. Goldhaber has served as a consultant to numerous pharmaceutical companies developing cardiovascular medications.

Dr. Wallentin was principal investigator in the ARISTOTLE study of apixaban, funded by Pfizer and Bristol Myers Squibb, and has served as a consultant to those and other pharmaceutical companies.

CHICAGO ? The new oral anticoagulants for stroke prevention in atrial fibrillation may be garnering all the buzz, but don?t count out the old standby warfarin yet.

"It?s not just a knee-jerk reaction that all patients should be switched to the new agents. It?s dependent upon how well you as a physician are managing your patients on warfarin," Dr. Jack E. Ansell asserted at the annual meeting of the American College of Cardiology.

"Warfarin therapy is all about management. If it?s not managed well, you can compare it to anything, and anything is going to be better. And if it?s managed very well, then it?s very difficult to beat warfarin therapy," said Dr. Ansell, who is the chairman of the department of medicine at Lenox Hill Hospital in New York.

A growing body of evidence indicates that the new standard in high-quality management of warfarin therapy involves patient self-testing of International Normalized Ratios (INR) at home using a fingerstick blood sample and a portable point-of-care device.

As a case in point: Dr. Ansell presented highlights of the new STABLE study, in which he and his coinvestigators conducted a retrospective analysis of the real-world experience of more than 29,000 warfarin-treated patients enrolled in a national commercial comprehensive self-test support service. The study was reported in JACC 2012 March 27 [doi: 10.1016/S0735-1097(12)61865-8]).

Patients who performed frequent self-testing ? meaning more than 80% of their self-testing was done on a weekly basis ? had a mean time spent in the therapeutic INR range (TTR) of 74%. That?s unprecedented, he said.

By comparison, in the pivotal RE-LY randomized trial for dabigatran (Pradaxa), the control group on warfarin had a TTR of 64% (N. Engl. J. Med. 2009;361:1139-51). In the ROCKET-AF trial of rivaroxaban (Xarelto), warfarin controls had a TTR of 55% (N. Engl. J. Med. 2011;365:883-91). And in the ARISTOTLE study of apixaban (Eliquis), an agent expected to soon receive Food and Drug Administration marketing approval, the warfarin control group had a TTR of 62% (N. Engl. J. Med. 2011;365:981-92).

In all these major randomized trials involving the novel oral anticoagulants, patients assigned to warfarin were closely managed, but in traditional fashion ? home self-testing wasn?t involved.

In contrast, in the STABLE study, the overall TTR, including those patients who self-tested variably and inconsistently, was still 69.7%.

"This is important because the cost-effectiveness analyses done with dabigatran and the other new anticoagulants suggest that when you get up to a TTR above 70% with warfarin, the cost-effectiveness of the new agents diminishes and warfarin actually becomes more cost-effective," according to Dr. Ansell.

A particularly impressive finding in STABLE was that patients who did weekly self-testing had a 2.3% incidence of critical value INR results, defined as an INR below 1.5 or greater than 5.0. "This is really a phenomenally low result," he commented. It represented a 48% reduction from the 4.4% incidence in patients with variable self-testing frequency.

Participants in the STABLE study tested themselves at home, but their warfarin dosing was managed by their referring physicians or anticoagulation clinics. Thus, an individual?s TTR reflected the warfarin management expertise of the referral source.

There are several reasons why home monitoring achieves better TTRs and ? as shown in other studies ? lower major bleeding and thrombotic event rates than with usual care or anticoagulation clinics not utilizing patient self-monitoring, Dr. Ansell said.

Home testing is more frequent, timely, and consistent, and the immediate feedback regarding INR results is likely to promote adherence.

A variant of patient self-testing starting to catch on in the United States is patient self-management. This entails teaching patients how to manage their own warfarin dose on the basis of their home INR measurements.

The most recent American College of Chest Physicians clinical practice guidelines on antithrombotic therapy for atrial fibrillation give patient self-management of warfarin therapy a class 2B recommendation, stating, "For patients treated with vitamin K antagonists who are motivated and can demonstrate competency in self-management strategies, including the self-testing equipment, we suggest patient self-management rather than the usual outpatient INR monitoring" (CHEST 2012;141: 2 suppl. e531S-e575S [doi: 10.1378/chest.11-2304]).

Session cochair Dr. Samuel Z. Goldhaber agreed with Dr. Ansell that warfarin still has a place in anticoagulation therapy. The fact that it costs as little as $4 per month while dabigatran, for example, retails for 60 times that amount, is not to be shrugged off in an era of runaway health care spending, he said.

Plus, warfarin, for all its drawbacks, is a known quantity backed by more than a half century of clinical experience.

"Even though warfarin can cause horrible complications, there are no more surprises left about what warfarin can do," observed Dr. Goldhaber, who is a professor of medicine at Harvard Medical School and director of the venous thromboembolism research group at Brigham and Women?s Hospital, Boston.

A potential game changer for warfarin is the possibility that rapid pharmacogenetic testing will enable physicians to improve upon the current method of warfarin dosing.

One advantage warfarin has is that bleeding episodes can be reversed by administration of vitamin K. In contrast, there is as yet no reliable means of reversing major bleeding in patients on the novel anticoagulants. But Dr. Lars Wallentin said this limitation of the new agents is outweighed by the consistent finding that they have lower rates of intracranial hemorrhage than those of warfarin.

"There is no antidote to warfarin that has proven to have any effect in patients with ICH. And there is no evidence as far as I can see that however you control INR you can reach as low a level of ICH as with these new agents. I think this is a specific downside of warfarin that we can?t get away from," said Dr. Wallentin, who is a professor of cardiology at Uppsala (Sweden) University.

The STABLE study was funded by Alere Home Monitoring, Inc. Dr. Ansell is a consultant to the company.

Dr. Goldhaber has served as a consultant to numerous pharmaceutical companies developing cardiovascular medications.

Dr. Wallentin was principal investigator in the ARISTOTLE study of apixaban, funded by Pfizer and Bristol Myers Squibb, and has served as a consultant to those and other pharmaceutical companies.

MIAMI BEACH – Researchers have developed a way to quickly and objectively assess the risk for aortic valve regurgitation based on the measurement of aortic blood pressures immediately after transcatheter valvevale replacement (TAVR). This new measure, the "aortic regurgitation index," showed significant correlation with periprocedural aortic regurgitation as well as with patients’ 1-year survival following their procedure, Dr. Eberhard Grube said at the ISET 2012 meeting.

Until now, "there has been no way to quantify aortic regurgitation; it’s subjective," said Dr. Grube, professor and chief of cardiology and angiology at the Helios Heart Centre in Siegburg, Germany. The aortic regurgitation index (ARI) allows physicians "to quantify aortic regurgitation periprocedurally by objectively looking at the patient’s hemodynamics, regardless of the subjective evaluation of aortic insufficiency by angiography or by echo," he said. "We can see the ARI and know what we need to do for post-deployment treatment."

Dr. Grube and his associates set the ARI as equal to the patient’s diastolic aortic pressure minus the left ventricular end diastolic pressure, all divided by the aortic systolic pressure, andthen multiplied by 100.

For example, a patient with mild periprocedural aortic regurgitation might have an aortic diastolic pressure of 60 mm Hg, a left ventricular end diastolic pressure of 15 mm Hg, and an aortic systolic pressure of 150 mm Hg, which would produce an ARI of 30, showing that the patient had a low risk for dying during the subsequent year. In contrast, a patient with moderate or severe periprocedural aortic regurgitation could have an aortic diastolic pressure of 40 mm Hg, a left ventricular end diastolic pressure of 20 mm Hg, and an aortic systolic pressure of 120 mm Hg, which would produce an ARI of 16.7, flagging a higher mortality risk in the following year.

His group assessed the prognostic ability of the ARI in a series of 146 patients who underwent TAVR. The group included 124 patients with no or mild aortic regurgitation following TAVR and 22 who showed moderate or severe regurgitation. During 1-year follow-up, the 96 patients with a periprocedural ARI of 25 or greater had an 83% survival rate; the 50 patients with a periprocedural ARI of less than 25 had a survival rate of 54%, a statistically significant difference. The analysis also showed a significant correlation between the ARI and the severity of aortic regurgitation. Among patients with no discerniable regurgitation, the average ARI was about 30, in those with mild regurgitation the average ARI was about 25, in patients with moderate regurgitation the average was about 18, and in patients with severe regurgitation the ARI averaged about 10.

One recently identified key to limiting aortic regurgitation following TAVR is proper valve sizing relative to the patient’s aortic annulus. "Appropriate valve sizing is likely the most important factor that will influence both the degree of perivalvular regurgitation and pacemaker need after TAVR," said Dr. Jeffrey J. Popma in a separate talk at the meeting.

Until recently, many operators used transthoracic echocardiography for annulus sizing, but recently published evidence showed that imaging by CT or by MRI provides superior information, said Dr. Popma, director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston. He cited a British report published last November that compared transthoracic echo, CT, and MRI in 202 patients who underwent TAVR, which found both CT and MRI superior to echo for annulus measurement prior to TAVR (J. Am. Coll. Cardiol. 2011;58:2165-73).

Dr. Grube and Dr. Popma disclosed financial relationships with several medical device manufacturers including Boston Scientific, Medtronic, and Cordis.

MIAMI BEACH – Researchers have developed a way to quickly and objectively assess the risk for aortic valve regurgitation based on the measurement of aortic blood pressures immediately after transcatheter valvevale replacement (TAVR). This new measure, the "aortic regurgitation index," showed significant correlation with periprocedural aortic regurgitation as well as with patients’ 1-year survival following their procedure, Dr. Eberhard Grube said at the ISET 2012 meeting.

Until now, "there has been no way to quantify aortic regurgitation; it’s subjective," said Dr. Grube, professor and chief of cardiology and angiology at the Helios Heart Centre in Siegburg, Germany. The aortic regurgitation index (ARI) allows physicians "to quantify aortic regurgitation periprocedurally by objectively looking at the patient’s hemodynamics, regardless of the subjective evaluation of aortic insufficiency by angiography or by echo," he said. "We can see the ARI and know what we need to do for post-deployment treatment."

Dr. Grube and his associates set the ARI as equal to the patient’s diastolic aortic pressure minus the left ventricular end diastolic pressure, all divided by the aortic systolic pressure, andthen multiplied by 100.

For example, a patient with mild periprocedural aortic regurgitation might have an aortic diastolic pressure of 60 mm Hg, a left ventricular end diastolic pressure of 15 mm Hg, and an aortic systolic pressure of 150 mm Hg, which would produce an ARI of 30, showing that the patient had a low risk for dying during the subsequent year. In contrast, a patient with moderate or severe periprocedural aortic regurgitation could have an aortic diastolic pressure of 40 mm Hg, a left ventricular end diastolic pressure of 20 mm Hg, and an aortic systolic pressure of 120 mm Hg, which would produce an ARI of 16.7, flagging a higher mortality risk in the following year.

His group assessed the prognostic ability of the ARI in a series of 146 patients who underwent TAVR. The group included 124 patients with no or mild aortic regurgitation following TAVR and 22 who showed moderate or severe regurgitation. During 1-year follow-up, the 96 patients with a periprocedural ARI of 25 or greater had an 83% survival rate; the 50 patients with a periprocedural ARI of less than 25 had a survival rate of 54%, a statistically significant difference. The analysis also showed a significant correlation between the ARI and the severity of aortic regurgitation. Among patients with no discerniable regurgitation, the average ARI was about 30, in those with mild regurgitation the average ARI was about 25, in patients with moderate regurgitation the average was about 18, and in patients with severe regurgitation the ARI averaged about 10.

One recently identified key to limiting aortic regurgitation following TAVR is proper valve sizing relative to the patient’s aortic annulus. "Appropriate valve sizing is likely the most important factor that will influence both the degree of perivalvular regurgitation and pacemaker need after TAVR," said Dr. Jeffrey J. Popma in a separate talk at the meeting.

Until recently, many operators used transthoracic echocardiography for annulus sizing, but recently published evidence showed that imaging by CT or by MRI provides superior information, said Dr. Popma, director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston. He cited a British report published last November that compared transthoracic echo, CT, and MRI in 202 patients who underwent TAVR, which found both CT and MRI superior to echo for annulus measurement prior to TAVR (J. Am. Coll. Cardiol. 2011;58:2165-73).

Dr. Grube and Dr. Popma disclosed financial relationships with several medical device manufacturers including Boston Scientific, Medtronic, and Cordis.

MIAMI BEACH – Researchers have developed a way to quickly and objectively assess the risk for aortic valve regurgitation based on the measurement of aortic blood pressures immediately after transcatheter valvevale replacement (TAVR). This new measure, the "aortic regurgitation index," showed significant correlation with periprocedural aortic regurgitation as well as with patients’ 1-year survival following their procedure, Dr. Eberhard Grube said at the ISET 2012 meeting.

Until now, "there has been no way to quantify aortic regurgitation; it’s subjective," said Dr. Grube, professor and chief of cardiology and angiology at the Helios Heart Centre in Siegburg, Germany. The aortic regurgitation index (ARI) allows physicians "to quantify aortic regurgitation periprocedurally by objectively looking at the patient’s hemodynamics, regardless of the subjective evaluation of aortic insufficiency by angiography or by echo," he said. "We can see the ARI and know what we need to do for post-deployment treatment."

Dr. Grube and his associates set the ARI as equal to the patient’s diastolic aortic pressure minus the left ventricular end diastolic pressure, all divided by the aortic systolic pressure, andthen multiplied by 100.

For example, a patient with mild periprocedural aortic regurgitation might have an aortic diastolic pressure of 60 mm Hg, a left ventricular end diastolic pressure of 15 mm Hg, and an aortic systolic pressure of 150 mm Hg, which would produce an ARI of 30, showing that the patient had a low risk for dying during the subsequent year. In contrast, a patient with moderate or severe periprocedural aortic regurgitation could have an aortic diastolic pressure of 40 mm Hg, a left ventricular end diastolic pressure of 20 mm Hg, and an aortic systolic pressure of 120 mm Hg, which would produce an ARI of 16.7, flagging a higher mortality risk in the following year.

His group assessed the prognostic ability of the ARI in a series of 146 patients who underwent TAVR. The group included 124 patients with no or mild aortic regurgitation following TAVR and 22 who showed moderate or severe regurgitation. During 1-year follow-up, the 96 patients with a periprocedural ARI of 25 or greater had an 83% survival rate; the 50 patients with a periprocedural ARI of less than 25 had a survival rate of 54%, a statistically significant difference. The analysis also showed a significant correlation between the ARI and the severity of aortic regurgitation. Among patients with no discerniable regurgitation, the average ARI was about 30, in those with mild regurgitation the average ARI was about 25, in patients with moderate regurgitation the average was about 18, and in patients with severe regurgitation the ARI averaged about 10.

One recently identified key to limiting aortic regurgitation following TAVR is proper valve sizing relative to the patient’s aortic annulus. "Appropriate valve sizing is likely the most important factor that will influence both the degree of perivalvular regurgitation and pacemaker need after TAVR," said Dr. Jeffrey J. Popma in a separate talk at the meeting.

Until recently, many operators used transthoracic echocardiography for annulus sizing, but recently published evidence showed that imaging by CT or by MRI provides superior information, said Dr. Popma, director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston. He cited a British report published last November that compared transthoracic echo, CT, and MRI in 202 patients who underwent TAVR, which found both CT and MRI superior to echo for annulus measurement prior to TAVR (J. Am. Coll. Cardiol. 2011;58:2165-73).

Dr. Grube and Dr. Popma disclosed financial relationships with several medical device manufacturers including Boston Scientific, Medtronic, and Cordis.

MIAMI BEACH – Researchers have developed a way to quickly and objectively assess the risk for aortic valve regurgitation based on the measurement of aortic blood pressures immediately after transcatheter valvevale replacement (TAVR). This new measure, the "aortic regurgitation index," showed significant correlation with periprocedural aortic regurgitation as well as with patients’ 1-year survival following their procedure, Dr. Eberhard Grube said at the ISET 2012 meeting.

Until now, "there has been no way to quantify aortic regurgitation; it’s subjective," said Dr. Grube, professor and chief of cardiology and angiology at the Helios Heart Centre in Siegburg, Germany. The aortic regurgitation index (ARI) allows physicians "to quantify aortic regurgitation periprocedurally by objectively looking at the patient’s hemodynamics, regardless of the subjective evaluation of aortic insufficiency by angiography or by echo," he said. "We can see the ARI and know what we need to do for post-deployment treatment."

Dr. Grube and his associates set the ARI as equal to the patient’s diastolic aortic pressure minus the left ventricular end diastolic pressure, all divided by the aortic systolic pressure, andthen multiplied by 100.

For example, a patient with mild periprocedural aortic regurgitation might have an aortic diastolic pressure of 60 mm Hg, a left ventricular end diastolic pressure of 15 mm Hg, and an aortic systolic pressure of 150 mm Hg, which would produce an ARI of 30, showing that the patient had a low risk for dying during the subsequent year. In contrast, a patient with moderate or severe periprocedural aortic regurgitation could have an aortic diastolic pressure of 40 mm Hg, a left ventricular end diastolic pressure of 20 mm Hg, and an aortic systolic pressure of 120 mm Hg, which would produce an ARI of 16.7, flagging a higher mortality risk in the following year.

His group assessed the prognostic ability of the ARI in a series of 146 patients who underwent TAVR. The group included 124 patients with no or mild aortic regurgitation following TAVR and 22 who showed moderate or severe regurgitation. During 1-year follow-up, the 96 patients with a periprocedural ARI of 25 or greater had an 83% survival rate; the 50 patients with a periprocedural ARI of less than 25 had a survival rate of 54%, a statistically significant difference. The analysis also showed a significant correlation between the ARI and the severity of aortic regurgitation. Among patients with no discerniable regurgitation, the average ARI was about 30, in those with mild regurgitation the average ARI was about 25, in patients with moderate regurgitation the average was about 18, and in patients with severe regurgitation the ARI averaged about 10.

One recently identified key to limiting aortic regurgitation following TAVR is proper valve sizing relative to the patient’s aortic annulus. "Appropriate valve sizing is likely the most important factor that will influence both the degree of perivalvular regurgitation and pacemaker need after TAVR," said Dr. Jeffrey J. Popma in a separate talk at the meeting.

Until recently, many operators used transthoracic echocardiography for annulus sizing, but recently published evidence showed that imaging by CT or by MRI provides superior information, said Dr. Popma, director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston. He cited a British report published last November that compared transthoracic echo, CT, and MRI in 202 patients who underwent TAVR, which found both CT and MRI superior to echo for annulus measurement prior to TAVR (J. Am. Coll. Cardiol. 2011;58:2165-73).

Dr. Grube and Dr. Popma disclosed financial relationships with several medical device manufacturers including Boston Scientific, Medtronic, and Cordis.

MIAMI BEACH – Researchers have developed a way to quickly and objectively assess the risk for aortic valve regurgitation based on the measurement of aortic blood pressures immediately after transcatheter valvevale replacement (TAVR). This new measure, the "aortic regurgitation index," showed significant correlation with periprocedural aortic regurgitation as well as with patients’ 1-year survival following their procedure, Dr. Eberhard Grube said at the ISET 2012 meeting.

Until now, "there has been no way to quantify aortic regurgitation; it’s subjective," said Dr. Grube, professor and chief of cardiology and angiology at the Helios Heart Centre in Siegburg, Germany. The aortic regurgitation index (ARI) allows physicians "to quantify aortic regurgitation periprocedurally by objectively looking at the patient’s hemodynamics, regardless of the subjective evaluation of aortic insufficiency by angiography or by echo," he said. "We can see the ARI and know what we need to do for post-deployment treatment."

Dr. Grube and his associates set the ARI as equal to the patient’s diastolic aortic pressure minus the left ventricular end diastolic pressure, all divided by the aortic systolic pressure, andthen multiplied by 100.

For example, a patient with mild periprocedural aortic regurgitation might have an aortic diastolic pressure of 60 mm Hg, a left ventricular end diastolic pressure of 15 mm Hg, and an aortic systolic pressure of 150 mm Hg, which would produce an ARI of 30, showing that the patient had a low risk for dying during the subsequent year. In contrast, a patient with moderate or severe periprocedural aortic regurgitation could have an aortic diastolic pressure of 40 mm Hg, a left ventricular end diastolic pressure of 20 mm Hg, and an aortic systolic pressure of 120 mm Hg, which would produce an ARI of 16.7, flagging a higher mortality risk in the following year.

His group assessed the prognostic ability of the ARI in a series of 146 patients who underwent TAVR. The group included 124 patients with no or mild aortic regurgitation following TAVR and 22 who showed moderate or severe regurgitation. During 1-year follow-up, the 96 patients with a periprocedural ARI of 25 or greater had an 83% survival rate; the 50 patients with a periprocedural ARI of less than 25 had a survival rate of 54%, a statistically significant difference. The analysis also showed a significant correlation between the ARI and the severity of aortic regurgitation. Among patients with no discerniable regurgitation, the average ARI was about 30, in those with mild regurgitation the average ARI was about 25, in patients with moderate regurgitation the average was about 18, and in patients with severe regurgitation the ARI averaged about 10.

One recently identified key to limiting aortic regurgitation following TAVR is proper valve sizing relative to the patient’s aortic annulus. "Appropriate valve sizing is likely the most important factor that will influence both the degree of perivalvular regurgitation and pacemaker need after TAVR," said Dr. Jeffrey J. Popma in a separate talk at the meeting.

Until recently, many operators used transthoracic echocardiography for annulus sizing, but recently published evidence showed that imaging by CT or by MRI provides superior information, said Dr. Popma, director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston. He cited a British report published last November that compared transthoracic echo, CT, and MRI in 202 patients who underwent TAVR, which found both CT and MRI superior to echo for annulus measurement prior to TAVR (J. Am. Coll. Cardiol. 2011;58:2165-73).

Dr. Grube and Dr. Popma disclosed financial relationships with several medical device manufacturers including Boston Scientific, Medtronic, and Cordis.

MIAMI BEACH – Researchers have developed a way to quickly and objectively assess the risk for aortic valve regurgitation based on the measurement of aortic blood pressures immediately after transcatheter valvevale replacement (TAVR). This new measure, the "aortic regurgitation index," showed significant correlation with periprocedural aortic regurgitation as well as with patients’ 1-year survival following their procedure, Dr. Eberhard Grube said at the ISET 2012 meeting.

Until now, "there has been no way to quantify aortic regurgitation; it’s subjective," said Dr. Grube, professor and chief of cardiology and angiology at the Helios Heart Centre in Siegburg, Germany. The aortic regurgitation index (ARI) allows physicians "to quantify aortic regurgitation periprocedurally by objectively looking at the patient’s hemodynamics, regardless of the subjective evaluation of aortic insufficiency by angiography or by echo," he said. "We can see the ARI and know what we need to do for post-deployment treatment."

Dr. Grube and his associates set the ARI as equal to the patient’s diastolic aortic pressure minus the left ventricular end diastolic pressure, all divided by the aortic systolic pressure, andthen multiplied by 100.

For example, a patient with mild periprocedural aortic regurgitation might have an aortic diastolic pressure of 60 mm Hg, a left ventricular end diastolic pressure of 15 mm Hg, and an aortic systolic pressure of 150 mm Hg, which would produce an ARI of 30, showing that the patient had a low risk for dying during the subsequent year. In contrast, a patient with moderate or severe periprocedural aortic regurgitation could have an aortic diastolic pressure of 40 mm Hg, a left ventricular end diastolic pressure of 20 mm Hg, and an aortic systolic pressure of 120 mm Hg, which would produce an ARI of 16.7, flagging a higher mortality risk in the following year.

His group assessed the prognostic ability of the ARI in a series of 146 patients who underwent TAVR. The group included 124 patients with no or mild aortic regurgitation following TAVR and 22 who showed moderate or severe regurgitation. During 1-year follow-up, the 96 patients with a periprocedural ARI of 25 or greater had an 83% survival rate; the 50 patients with a periprocedural ARI of less than 25 had a survival rate of 54%, a statistically significant difference. The analysis also showed a significant correlation between the ARI and the severity of aortic regurgitation. Among patients with no discerniable regurgitation, the average ARI was about 30, in those with mild regurgitation the average ARI was about 25, in patients with moderate regurgitation the average was about 18, and in patients with severe regurgitation the ARI averaged about 10.

One recently identified key to limiting aortic regurgitation following TAVR is proper valve sizing relative to the patient’s aortic annulus. "Appropriate valve sizing is likely the most important factor that will influence both the degree of perivalvular regurgitation and pacemaker need after TAVR," said Dr. Jeffrey J. Popma in a separate talk at the meeting.

Until recently, many operators used transthoracic echocardiography for annulus sizing, but recently published evidence showed that imaging by CT or by MRI provides superior information, said Dr. Popma, director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston. He cited a British report published last November that compared transthoracic echo, CT, and MRI in 202 patients who underwent TAVR, which found both CT and MRI superior to echo for annulus measurement prior to TAVR (J. Am. Coll. Cardiol. 2011;58:2165-73).

Dr. Grube and Dr. Popma disclosed financial relationships with several medical device manufacturers including Boston Scientific, Medtronic, and Cordis.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.

New credentialing recommendations for TAVR programs released by four leading cardiovascular organizations, serve as a starting point for programs and institutions that want to assess their potential for implementing or maintaining a TAVR program.

"As new technologies begin to be incorporated into cardiovascular practice, it is the responsibility of the medical societies to work together to develop standards for optimal patient care," Dr. Carl L. Tommaso, chair of the writing committee, said in a statement.

The 48-page document, prepared jointly by the American College of Cardiology Foundation, the Society for Cardiovascular Angiography and Interventions, the AATS, and the Society of Thoracic Surgeons, defines operator and institutional requirements for the procedure, and emphasizes the use of multidisciplinary teams, which go beyond the collaboration between interventional cardiologists and cardiac surgeons (www.jtcvs.com/webfiles/images/journals/ymtc/ExpertConsensus.pdf).

"A TAVR program that uses only one specialty is fundamentally deficient, and valve therapy programs should not be established without this multidisciplinary partnership," they wrote.

The document also recommends that irrespective of their specialty, physicians in TAVR programs should all have extensive knowledge of valvular heart disease, and they should be able to interpret images. Meanwhile, facilities should contain a full range of diagnostic imaging, in addition to an active valvular heart disease surgical program and "at least two institutionally based cardiac surgeons experienced in valvular surgery."

The role of an invested hospital administration is also emphasized. "There must be dedication on the part of the hospital to provide these services and support, both financially and with no time constraints on the personnel involved," the authors write.

While they lay out minimum case number requirements for surgeons and interventionalists, the authors predict that simulators are "likely to play a significant role in technical training and proficiency maintenance for these evolving procedures," and the training strategy will evolve as the procedure becomes mainstream. Therefore, there "is the need for this to be a dynamic document that we will revisit in the future as the technology evolves, experience grows, and data accumulate," Dr. R. Morton Bolman, cochair of the document writing committee said in a statement.

Dr. Tommaso and Dr. Bolman had no relevant disclosures.