TAVR Risk 'Acceptable' for Pure Aortic Regurgitation?

Transcatheter aortic valve replacement (TAVR) for non-calcific native aortic regurgitation has been shown to be feasible across the spectrum of bioprostheses available, according to a systemic review.

With an all-cause mortality rate of 7% at 30 days, Thomas Pilgrim, MD, of Bern University Hospital in Switzerland, and colleagues concluded that "among selected patients with native pure aortic regurgitation deemed at high risk for surgical aortic valve replacement, [TAVR] is technically feasible and associated with an acceptable risk of early mortality."

There were no instances of cerebrovascular events at 30 days. The investigators reported other short-term adverse event rates in their study published online in JACC: Cardiovascular Interventions as follows:

• Major bleeding in 2%
• Vascular complications in 3%
• Permanent pacemaker implantation in 11%
• Moderate or severe post-procedural aortic regurgitation in 9%

Most patients (79%) got self-expandable prostheses, the rest received balloon-expandable valves. Device success ranged from 74% to 100% among the studies included.

"Experience with first generation transcatheter valves has been disappointing," commented John Webb, MD, and Janarthanan Sathananthan, MD, both of St. Paul's Hospital in Vancouver, in an accompanying editorial. "Balloon expandable valves provide inadequate fixation in the absence of calcification and are rarely suitable in the setting of pure aortic regurgitation. The largest experience to date is with self-expanding CoreValve device (Medtronic Inc., USA). With its large size and limited repositionability good outcomes are certainly possible; although malposition and problematic paravalvular regurgitation are, unfortunately, frequent."

Webb and Sathananthan noted that the second-generation valves -- namely the narrow-waisted Acurate valve, the mechanically expandable and repositionable Lotus and Direct Flow valves -- may hold more promise. "However, experience remains very limited with these devices; although this is encouraging we can only really say that this has demonstrated feasibility," they wrote, deeming the technology still not yet ready for prime time.

To date the bulk of favorable data in the setting of noncalcified aortic regurgitation is with the JenaValve, the only transcatheter valve currently approved for pure aortic regurgitation in Europe, the editorialists added.

Pilgrim's group included thirteen studies (n=237) in their analysis.

A second valve was required for 7% of patients, and another 2.5% had to switch to surgical valve replacement.