Minimalist TAVR without on-site surgery under study

PARIS – The buzzword in transcatheter aortic valve replacement today is “minimalist.” The search is on for ways in which to safely simplify the procedure to reduce the current unsustainably high cost and improve the patient experience.

Among the elements typically involved in minimalist TAVR are performance of the procedure in the cardiac catheterization laboratory via transfemoral access rather than in the costlier operating room, use of conscious sedation rather than general anesthesia, transthoracic echocardiographic guidance, no Swan-Ganz catheter, and no ICU stay for most patients. But these are tepid measures compared with what’s under study in Germany.

The German health care system is engaged in a study of what has to be the ultimate in minimalist TAVR: doing it in hospitals without on-site cardiac surgery. And the short-term results in more than 1,300 German patients treated in such a setting look every bit as good as in patients whose procedure took place in hospitals more conventionally equipped with both cardiology and cardiothoracic surgery departments, Holger Eggebrecht, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“Lack of a cardiac surgery department on site should not be regarded as a contraindication for TAVR,” concluded Dr. Eggebrecht of Agaplesion Bethanien Hospital in Frankfurt, Germany.

Of course, it is deemed an absolute contraindication to TAVR both in the current European Society of Cardiology and U.S. guidelines. But that position was developed in an earlier era when procedural safety had not yet been established. It was based on the expert consensus opinion of physicians drawn mostly from large tertiary centers with both cardiology and cardiac surgery on site. And this absolute contraindication was never supported by any data, he said.

In the United States, arguably the most litigious nation in the world, it’s virtually unthinkable – at least for now – to perform TAVR without a cardiothoracic surgeon on site in the event bailout emergency cardiac surgery should become necessary. But Germany, which boasts universal health care coverage at an affordable cost, operates differently. Indeed, in Dr. Eggebrecht’s study of all 17,919 transfemoral TAVR procedures performed in Germany during 2013 and 2014, fully 22 of the 77 hospitals where the procedures took place had no on-site cardiac surgery department.

He presented a comparison of in-hospital outcomes in the 1,332 German patients (7.4%) whose TAVR took place in hospitals without a cardiac surgery department and the 16,587 patients treated in hospitals with both cardiology and cardiac surgery departments. The data came from the prospective German Quality Assurance Registry on Aortic Valve Replacement, which records in extensive detail all TAVR and surgical replacements in the country. Participation in the registry is mandatory.

The main study finding: Even though patients at no–cardiac surgery hospitals were older, had more comorbid conditions, and were at higher predicted perioperative risk of mortality, the rates of intraprocedural complications, in-hospital strokes, and mortality were similar in the two groups.

Moreover, when Dr. Eggebrecht and coinvestigators performed a case-control substudy involving 555 patient pairs extensively matched on more than a dozen variables, including a requirement for identical scores on validated risk prediction tools for estimating in-hospital mortality, the results were the same as in the full study population.

The key to the high-quality TAVR outcomes documented at hospitals without a cardiac surgery department, Dr. Eggebrecht emphasized, is that in Germany TAVR can be performed only at hospitals where a contractually obligated heart team has signed off on the procedure. At hospitals without a cardiac surgery department, this heart team is composed of in-house cardiologists and visiting cardiac surgeons from collaborating hospitals. In TAVRs at some of these hospitals, a collaborating cardiac surgeon is present for the procedure and brings along a heart-lung machine which is primed and ready to go, if needed, as was the case in just 0.4% of the 1,332 TAVRs. At others, the surgeon is off site.

“I would think our data show that close cooperation within the heart team is the key to successful outcomes, not having a cardiac surgeon on site,” he concluded.

Audience member Volkmar Falk, MD, strode briskly to a microphone and made no effort to hide his incredulity at this project.

“What is the real advantage in not having a surgeon present? I don’t get it,” declared Dr. Falk, professor and director of the department of cardiovascular and vascular surgery at Charité University Hospital in Berlin.

“For a surgeon, this is all quite difficult to understand,” he continued. “If a surgeon has to come to a TAVR rescue from 10 km away, I don’t know how well that works. And if surgeons have to travel with all their equipment in order to be on site, I think this is a logistical nightmare and shouldn’t be done at all.

“All of the studies, all the clinical trials we always discuss, have been done in the setting of hospitals where the procedure was done together with a surgeon on site. That’s why we have these excellent results,” Dr. Falk added.

Dr. Eggebrecht replied, “We’re having a scientific discussion here, and I think our data clearly show that you can construct a successful heart team even though you don’t have a cardiac surgery department on site.”

An Israeli cardiologist in the audience said a similar effort is underway in his country to open up TAVR to hospitals without an on-site cardiac surgeon. His objection is that, at least in Israel, a hospital with no on-site cardiac surgery is a marker for a TAVR center that is low volume, is late to embrace TAVR, and has cardiologists who are probably still early on the procedural learning curve.

Dr. Eggebrecht said that this is not the case in Germany, where some of the most experienced TAVR operators work at sites without a cardiac surgery department.

He reported that his study was partially funded by the German Cardiac Society, and he had no financial conflicts.

Simultaneously with his presentation, the study was published online (Eur Heart J. 2016 May 17. pii: ehw190).

bjancin@frontlinemedcom.com

PARIS – The buzzword in transcatheter aortic valve replacement today is “minimalist.” The search is on for ways in which to safely simplify the procedure to reduce the current unsustainably high cost and improve the patient experience.

Among the elements typically involved in minimalist TAVR are performance of the procedure in the cardiac catheterization laboratory via transfemoral access rather than in the costlier operating room, use of conscious sedation rather than general anesthesia, transthoracic echocardiographic guidance, no Swan-Ganz catheter, and no ICU stay for most patients. But these are tepid measures compared with what’s under study in Germany.

The German health care system is engaged in a study of what has to be the ultimate in minimalist TAVR: doing it in hospitals without on-site cardiac surgery. And the short-term results in more than 1,300 German patients treated in such a setting look every bit as good as in patients whose procedure took place in hospitals more conventionally equipped with both cardiology and cardiothoracic surgery departments, Holger Eggebrecht, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“Lack of a cardiac surgery department on site should not be regarded as a contraindication for TAVR,” concluded Dr. Eggebrecht of Agaplesion Bethanien Hospital in Frankfurt, Germany.

Of course, it is deemed an absolute contraindication to TAVR both in the current European Society of Cardiology and U.S. guidelines. But that position was developed in an earlier era when procedural safety had not yet been established. It was based on the expert consensus opinion of physicians drawn mostly from large tertiary centers with both cardiology and cardiac surgery on site. And this absolute contraindication was never supported by any data, he said.

In the United States, arguably the most litigious nation in the world, it’s virtually unthinkable – at least for now – to perform TAVR without a cardiothoracic surgeon on site in the event bailout emergency cardiac surgery should become necessary. But Germany, which boasts universal health care coverage at an affordable cost, operates differently. Indeed, in Dr. Eggebrecht’s study of all 17,919 transfemoral TAVR procedures performed in Germany during 2013 and 2014, fully 22 of the 77 hospitals where the procedures took place had no on-site cardiac surgery department.

He presented a comparison of in-hospital outcomes in the 1,332 German patients (7.4%) whose TAVR took place in hospitals without a cardiac surgery department and the 16,587 patients treated in hospitals with both cardiology and cardiac surgery departments. The data came from the prospective German Quality Assurance Registry on Aortic Valve Replacement, which records in extensive detail all TAVR and surgical replacements in the country. Participation in the registry is mandatory.

The main study finding: Even though patients at no–cardiac surgery hospitals were older, had more comorbid conditions, and were at higher predicted perioperative risk of mortality, the rates of intraprocedural complications, in-hospital strokes, and mortality were similar in the two groups.

Moreover, when Dr. Eggebrecht and coinvestigators performed a case-control substudy involving 555 patient pairs extensively matched on more than a dozen variables, including a requirement for identical scores on validated risk prediction tools for estimating in-hospital mortality, the results were the same as in the full study population.

The key to the high-quality TAVR outcomes documented at hospitals without a cardiac surgery department, Dr. Eggebrecht emphasized, is that in Germany TAVR can be performed only at hospitals where a contractually obligated heart team has signed off on the procedure. At hospitals without a cardiac surgery department, this heart team is composed of in-house cardiologists and visiting cardiac surgeons from collaborating hospitals. In TAVRs at some of these hospitals, a collaborating cardiac surgeon is present for the procedure and brings along a heart-lung machine which is primed and ready to go, if needed, as was the case in just 0.4% of the 1,332 TAVRs. At others, the surgeon is off site.

“I would think our data show that close cooperation within the heart team is the key to successful outcomes, not having a cardiac surgeon on site,” he concluded.

Audience member Volkmar Falk, MD, strode briskly to a microphone and made no effort to hide his incredulity at this project.

“What is the real advantage in not having a surgeon present? I don’t get it,” declared Dr. Falk, professor and director of the department of cardiovascular and vascular surgery at Charité University Hospital in Berlin.

“For a surgeon, this is all quite difficult to understand,” he continued. “If a surgeon has to come to a TAVR rescue from 10 km away, I don’t know how well that works. And if surgeons have to travel with all their equipment in order to be on site, I think this is a logistical nightmare and shouldn’t be done at all.

“All of the studies, all the clinical trials we always discuss, have been done in the setting of hospitals where the procedure was done together with a surgeon on site. That’s why we have these excellent results,” Dr. Falk added.

Dr. Eggebrecht replied, “We’re having a scientific discussion here, and I think our data clearly show that you can construct a successful heart team even though you don’t have a cardiac surgery department on site.”

An Israeli cardiologist in the audience said a similar effort is underway in his country to open up TAVR to hospitals without an on-site cardiac surgeon. His objection is that, at least in Israel, a hospital with no on-site cardiac surgery is a marker for a TAVR center that is low volume, is late to embrace TAVR, and has cardiologists who are probably still early on the procedural learning curve.

Dr. Eggebrecht said that this is not the case in Germany, where some of the most experienced TAVR operators work at sites without a cardiac surgery department.

He reported that his study was partially funded by the German Cardiac Society, and he had no financial conflicts.

Simultaneously with his presentation, the study was published online (Eur Heart J. 2016 May 17. pii: ehw190).

bjancin@frontlinemedcom.com

PARIS – The buzzword in transcatheter aortic valve replacement today is “minimalist.” The search is on for ways in which to safely simplify the procedure to reduce the current unsustainably high cost and improve the patient experience.

Among the elements typically involved in minimalist TAVR are performance of the procedure in the cardiac catheterization laboratory via transfemoral access rather than in the costlier operating room, use of conscious sedation rather than general anesthesia, transthoracic echocardiographic guidance, no Swan-Ganz catheter, and no ICU stay for most patients. But these are tepid measures compared with what’s under study in Germany.

The German health care system is engaged in a study of what has to be the ultimate in minimalist TAVR: doing it in hospitals without on-site cardiac surgery. And the short-term results in more than 1,300 German patients treated in such a setting look every bit as good as in patients whose procedure took place in hospitals more conventionally equipped with both cardiology and cardiothoracic surgery departments, Holger Eggebrecht, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“Lack of a cardiac surgery department on site should not be regarded as a contraindication for TAVR,” concluded Dr. Eggebrecht of Agaplesion Bethanien Hospital in Frankfurt, Germany.

Of course, it is deemed an absolute contraindication to TAVR both in the current European Society of Cardiology and U.S. guidelines. But that position was developed in an earlier era when procedural safety had not yet been established. It was based on the expert consensus opinion of physicians drawn mostly from large tertiary centers with both cardiology and cardiac surgery on site. And this absolute contraindication was never supported by any data, he said.

In the United States, arguably the most litigious nation in the world, it’s virtually unthinkable – at least for now – to perform TAVR without a cardiothoracic surgeon on site in the event bailout emergency cardiac surgery should become necessary. But Germany, which boasts universal health care coverage at an affordable cost, operates differently. Indeed, in Dr. Eggebrecht’s study of all 17,919 transfemoral TAVR procedures performed in Germany during 2013 and 2014, fully 22 of the 77 hospitals where the procedures took place had no on-site cardiac surgery department.

He presented a comparison of in-hospital outcomes in the 1,332 German patients (7.4%) whose TAVR took place in hospitals without a cardiac surgery department and the 16,587 patients treated in hospitals with both cardiology and cardiac surgery departments. The data came from the prospective German Quality Assurance Registry on Aortic Valve Replacement, which records in extensive detail all TAVR and surgical replacements in the country. Participation in the registry is mandatory.

The main study finding: Even though patients at no–cardiac surgery hospitals were older, had more comorbid conditions, and were at higher predicted perioperative risk of mortality, the rates of intraprocedural complications, in-hospital strokes, and mortality were similar in the two groups.

Moreover, when Dr. Eggebrecht and coinvestigators performed a case-control substudy involving 555 patient pairs extensively matched on more than a dozen variables, including a requirement for identical scores on validated risk prediction tools for estimating in-hospital mortality, the results were the same as in the full study population.

The key to the high-quality TAVR outcomes documented at hospitals without a cardiac surgery department, Dr. Eggebrecht emphasized, is that in Germany TAVR can be performed only at hospitals where a contractually obligated heart team has signed off on the procedure. At hospitals without a cardiac surgery department, this heart team is composed of in-house cardiologists and visiting cardiac surgeons from collaborating hospitals. In TAVRs at some of these hospitals, a collaborating cardiac surgeon is present for the procedure and brings along a heart-lung machine which is primed and ready to go, if needed, as was the case in just 0.4% of the 1,332 TAVRs. At others, the surgeon is off site.

“I would think our data show that close cooperation within the heart team is the key to successful outcomes, not having a cardiac surgeon on site,” he concluded.

Audience member Volkmar Falk, MD, strode briskly to a microphone and made no effort to hide his incredulity at this project.

“What is the real advantage in not having a surgeon present? I don’t get it,” declared Dr. Falk, professor and director of the department of cardiovascular and vascular surgery at Charité University Hospital in Berlin.

“For a surgeon, this is all quite difficult to understand,” he continued. “If a surgeon has to come to a TAVR rescue from 10 km away, I don’t know how well that works. And if surgeons have to travel with all their equipment in order to be on site, I think this is a logistical nightmare and shouldn’t be done at all.

“All of the studies, all the clinical trials we always discuss, have been done in the setting of hospitals where the procedure was done together with a surgeon on site. That’s why we have these excellent results,” Dr. Falk added.

Dr. Eggebrecht replied, “We’re having a scientific discussion here, and I think our data clearly show that you can construct a successful heart team even though you don’t have a cardiac surgery department on site.”

An Israeli cardiologist in the audience said a similar effort is underway in his country to open up TAVR to hospitals without an on-site cardiac surgeon. His objection is that, at least in Israel, a hospital with no on-site cardiac surgery is a marker for a TAVR center that is low volume, is late to embrace TAVR, and has cardiologists who are probably still early on the procedural learning curve.

Dr. Eggebrecht said that this is not the case in Germany, where some of the most experienced TAVR operators work at sites without a cardiac surgery department.

He reported that his study was partially funded by the German Cardiac Society, and he had no financial conflicts.

Simultaneously with his presentation, the study was published online (Eur Heart J. 2016 May 17. pii: ehw190).

bjancin@frontlinemedcom.com