No Safety Net: TAVR Can Be Done at Centers Without Surgical Backup, German Study Suggests

PARIS, France—Patients undergoing transcatheter aortic valve replacement at hospitals without on-site cardiac surgery departments have rates of in-hospital mortality and major complications similar to those seen in individuals treated at hospitals with surgical backup, according to a new German analysis.

And although there have been concerns that the absence of cardiac surgery would lead to more liberal selection of patients for TAVR, such as inclusion of young patients or those better served by surgical valve replacement, investigators showed that those treated with TAVR at hospitals without cardiac surgery capabilities were older, had significantly more comorbidities, and had a higher baseline operative risk than those treated at hospitals with surgical backup.

“Close cooperation with the heart team is the key to success,” lead investigator Holger Eggebrecht, MD (Cardiovascular Center Bethanien, Frankfurt, Germany), told TCTMD. “How you construct the heart team, it doesn’t matter so much, as long as you can ensure you have interdisciplinary decision-making.”

Presenting at EuroPCR 2016, Eggebrecht said the data show that hospitals without cardiac surgery departments can work successfully with visiting surgeons, with the whole team ensuring appropriate patient selection for TAVR. “Patients are even older and sicker in the hospital setting without a cardiac surgery department,” he told TCTMD. “The patient selection is actually stricter.”

The study, an analysis of 17,919 patients from the German Quality Assurance Registry (AQUA) on aortic valve replacement, was published simultaneously in the European Heart Journal. 

TAVR Without a Net

The 2012 European Society of Cardiology (ESC) guidelines for valvular heart disease state that TAVR should be restricted to hospitals with cardiology and cardiac surgery departments. However, as Eggebrecht explained, the German Cardiac Society relaxed these recommendations in 2014, allowing hospitals without on-site cardiac surgery to perform TAVR if they have a contract with an external surgical department and interdisciplinary decision-making treatment algorithms in place. 

In their analysis, 17,919 patients underwent TAVR at 97 German hospitals between 2013 and 2014. Of these, 1,332 patients were treated at 22 hospitals without a cardiac surgery department and 16,587 were treated at 75 hospitals with cardiac surgery. Individuals treated at hospitals without surgery were older, were more likely to have NYHA class III or IV heart failure, and were more likely to have coronary artery disease and peripheral vascular disease. 

The rate of in-hospital mortality was not statistically different among patients treated at the hospitals without cardiac surgery compared with those with backup. Intraprocedural complications likely to benefit from emergency cardiac surgery, such as device malposition, embolization, annular rupture, aortic dissection, coronary obstruction, and pericardial tamponade, occurred in 3.4% patients undergoing TAVR at non-surgery hospitals and in 3.9% of patients at hospitals with surgical backup (P = 0.421). In addition, there were no differences in neurologic events, MI, or vascular complications during the in-hospital period, although the rate of new permanent pacemaker implantation was higher in hospitals without cardiac surgery. 

In a matched analysis of patients treated at hospitals with and without surgical backup, there were no significant differences in rates of in-hospital mortality or intraprocedural and postprocedural complications. 

While the ESC guidelines contraindicating TAVR without cardiac surgery were put in place to ensure optimal patient selection and prompt care should complications arise, Eggebrecht acknowledged the political aspects of the debate. Cardiac surgeons are concerned TAVR is taking “business” away, while interventional cardiologists working at large tertiary centers with surgical backup prefer the status quo as it ensures a steady supply of patients. And finally, the interventionalist working at a hospital without surgical backup wants a piece of the pie as well. The situation is not unlike the early days of PCI, he said.

“For myself, I like to work with a surgeon,” he said. “TAVI [TAVR] is shifting. It’s becoming so safe and so predictable, and of course the surgeons want to be involved—and I think that’s important—but to be honest you could perform TAVI without a cardiac surgeon on the table.”

One Death is Too Many

In the US, TAVR without surgical backup is nonexistent as the Centers for Medicare & Medicaid Services (CMS) placed conditions on reimbursement, stating TAVR should take place in a facility using a heart team approach, which includes interventionalists and surgeons experienced in both procedures. CMS states that TAVR should be performed at a hospital with on-site surgical backup, as well as noninvasive imaging technologies and intensive-care facilities. In Canada, where TAVR is performed in approximately two dozen hospitals, all have on-site cardiac surgery departments. 

Speaking with TCTMD, Nicolo Piazza, MD (McGill University, Montreal, Canada), said Germany leads the way in terms of performing TAVR at hospitals without cardiac surgery. However, like the AQUA study shows, these centers do have a working relationship with a visiting cardiac surgeon, as well as a neighboring hospital that provides the surgical equipment, including extracorporeal life support, in case it’s needed. Some centers do perform TAVR without a cardiac surgeon and without the additional surgical equipment present, Piazza noted.  

“Given the low rate of conversion to surgery nowadays—it used to be 1.0% or 1.2% a while back, but it’s gone to less than 0.5%—there is the question about whether or not this is a safe maneuver,” Piazza said, referring to TAVR without on-site surgery. “When something is so catastrophic, and a life can be saved, I think that 0.5% is eventually going to lead to one patient dying who shouldn’t have died. That, for me, is already too much. My viewpoint is that TAVR should be done in places with surgical backup.”

In fact, speaking during the panel discussion, Volkmar Falk, MD (Deutsches Herzzentrum, Berlin, Germany), also questioned the difference in mortality between the two treatment groups. He referred to the propensity-matched analysis, noting that while there was no statistically significant difference in the rate of in-hospital mortality among matched patients, there were numerically more deaths, an outcome that would be devastating to the individual families. 

For Piazza, no matter how good interventional cardiologists are in performing the procedure, there are complications beyond even their control, and for this reason he does not think TAVR without surgical backup will become the norm anytime soon. “Perhaps when some brave individuals do this, when they’ve done a thousand patients and they’ve never had to call surgery, maybe that will be something to look at and consider. But I think for the next 5 years, we’re probably still in the era of requiring cardiac surgery.”  

To TCTMD, Eggebrecht said he suspects the ESC guidelines will eventually relax to allow hospitals to perform TAVR without backup, but stressed that cooperation amongst the heart team, including surgical involvement, remains the key to success. He pointed to the 15,000 TAVR procedures performed in Germany each year, noting this would be impossible unless hospitals without surgical backup are allowed to treat patients. 

• Eggebrecht H, Bestehorn M, Haude M, et al. Outcomes of transfemoral transcatheter aortic valve implantation at hospitals with and without on-site cardiac surgery department: insights from the prospective German aortic valve replacement quality assurance registry (AQUA) in 17,919 patients. Eur Heart J. 2016;Epub ahead of print. 

Disclosures:

•  The study was supported by a grant from the German Cardiac Society.
•  Eggebrecht reports no relevant conflicts of interest.
•  Piazza reports serving as a consultant to and stockholder of HighLife and a consultant to Medtronic.

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