TAVR in Pure Aortic Insufficiency: Yes or No?

Courtesy of Dr. Agustín Vecchia.

Surgery is the treatment of choice for patients with symptomatic aortic insufficiency and/or ventricular dilatation or decreased ventricular function. The broad implementation of transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis, the emergence of new devices, and the experience acquired by operators have brought this treatment to off-label indications such as bicuspid valves, valve-in-valve implantation in prostheses, and selected cases of pulmonary, mitral, or tricuspid valve prostheses. Nowadays, case series of risk patients undergoing percutaneous treatment for pure aortic insufficiency have been reported.

This study sought to collect and summarize all available evidence on TAVR in patients with pure aortic insufficiency. To that end, Medline, Embase, and Scopus were systematically scrutinized for case reports of at least 5 patients with these characteristics. The primary outcome of interest was all-cause mortality.

Thirteen reports including 237 patients were included in the analysis. Self-expandable prostheses were used in 79% of patients, whereas the remaining 21% of patients were treated with a balloon-expandable valves.

Device success ranged between 74% and 100%. Seventeen (7%) patients required the implantation of a second valve and 6 (2.5%) patients had to undergo surgical aortic valve replacement.

• All-cause mortality at 30 days was 7% (95% confidence interval [CI]: 3% to 13%).
• Cerebrovascular events were very rare (95% CI: 0% to 1%).
• Major bleeding and vascular complications took place in 2% (95% CI: 0% to 7%), and 3% (95% CI: 1% to 7%) of cases, respectively.
• Permanent pacemaker implantation was required in 11% of patients (95% CI: 5% to 19%).
• The rate of moderate to severe leak was 9% (95% CI: 0% to 28%).
• A second valve was globally required in 7% of cases, but that rate was 19% in two out of five case series featuring CoreValve prostheses.

Authors concluded that among selected patients with high surgical risk, TAVR is technically feasible and associated with an acceptable peri-procedural mortality rate.

Editorial

This is the largest case series of patients with aortic insufficiency who underwent TAVR. It should be noted that less than a third of all patients received the only device approved for this treatment (JenaValve, CE mark), and that success rates were relatively low for Medtronic CoreValve, the most popular valve. The conclusion that new-generation valves with specific anchoring systems will perform better in these scenarios is only logical.

The first report of TAVR using JenaValve included 5 patients with severe aortic insufficiency, and no death or stroke was reported at 30 days. Similar outcomes were observed in subsequent studies, including a total of 51 patients with equally promising device performance.

It should also be noted that the number of studies included in this revision was scarce, and studies were heterogeneous in terms of TAVR devices used, desired outcome, access, and technique used, thus hindering comparison across reports and joint analysis of all evidence.

In conclusion, the most important finding in this study may be the proven technical feasibility of the device, which offers heart teams all around the world a treatment alternative that will remain off-label and aimed at a very select group of patients.

Courtesy of Dr. Agustín Vecchia. Buenos Aires German Hospital, Argentina.

Original title: Transcatheter Aortic Valve Replacement for the Treatment of Pure Native Aortic Valve Regurgitation. A Systematic Review.

Reference: Anna Franzone et al. J Am Coll Cardiol Intv. 2016;9(22):2308-2317.

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