“If I’m putting a pacemaker in 40% of my TAVR patients at a cost of $40,000-$45,000 per patient for the valve and pacemaker, that becomes an issue,” Dr. Thourani said.
Other concerns surrounding TAVR, in addition to reimbursement, include the uncertain long-term impact of residual minimal paravalvular leak, which is common.
“We’re not done talking about paravalvular leak rates. As cardiologists you’re not okay with me giving your patient a minimal paravalvular leak post-SAVR. Are we going to change the bar a little bit for TAVR?” he mused.
Another issue is thrombosis of TAVR valve leaflets, Dr. Thourani continued. In a large patient series reported last year, this event occurred in 0.6% of patients, with an average of 181 days from TAVR to confirmatory abnormal imaging (Circ Cardiovasc Interv. 2015 Apr;8[4]. pii: e001779). Two clinical trials are gearing up to examine various anticoagulant strategies to address the problem.
Despite the various concerns, however, Dr. Thourani is extremely optimistic about TAVR’s future. It’s a booming field, with 396 U.S. TAVR centers as of 2015. The indications appear to be on the verge of expansion. Technical progress continues, with half a dozen TAVR valves in development in addition to the two now FDA approved.
“We have just scratched the surface of what we’re going to do in the management of severe aortic stenosis,” the surgeon promised.
The latest results of minimalist TAVR provide another reason for optimism regarding TAVR’s future.
Emory University surgeons and interventional cardiologists have been pacesetters in the minimalist TAVR approach. The key elements of minimalist TAVR are that the procedure is performed in the cardiac catheterization laboratory via transfemoral access, under conscious sedation, with transthoracic echocardiographic guidance, no Swan-Ganz catheter, and no ICU stay for most patients.
Dr. Thourani presented as-yet unpublished data on a recent series of 111 high–surgical risk patients who underwent minimalist TAVR with implantation of a Sapien 3 valve at Emory. Although their Society of Thoracic Surgeons risk score was 8%, there was zero 30-day mortality in this group. One patient had a major stroke, two had major vascular complications, and the 30-day readmission rate was just 3.8%.
“Can we get to these results universally? We think we can. This is the bar we need to start thinking about,” Dr. Thourani said.
Dr. Thourani reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott, Boston Scientific, Medtronic, and Sorin.