August 26, 2016
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TAVR confers improved mortality vs. surgery for patients at intermediate risk or lower

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A self-expanding transcatheter aortic valve replacement system outperformed surgical aortic valve replacement for survival in patients at lower risk for surgery, according to a study published in JAMA Cardiology.

Michael J. Reardon, MD, from Houston Methodist DeBakey Heart & Vascular Center, and colleagues investigated whether patients with aortic stenosis and a Society of Thoracic Surgeons predicted risk of mortality (PROM) score of 7% or less would benefit from the self-expanding TAVR system (CoreValve, Medtronic) compared with surgery.

Michael J. Reardon, MD

Michael J. Reardon

The researchers conducted a retrospective analysis of data from the CoreValve US Pivotal High-Risk Trial of patients with STS PROM score of 7% or less who underwent TAVR (n = 202) or surgery (n = 181). Median STS PROM score was 5.3% for both the TAVR and surgery groups.

Mortality lower

All-cause mortality rates were 15% (95% CI, 8.9-20) among lower-risk recipients of the self-expanding TAVR system at 2 years vs. 26.3% (95% CI, 19.7-33) for surgical AVR (log-rank P = .01), according to the researchers.

Rate of stroke at 2 years was similar between the groups (TAVR, 11.3%; surgery, 15.1%; log-rank P = .5).

Both groups showed improvement in self-reported quality of life by the Kansas City Cardiomyopathy Questionnaire summary score (TAVR, 20; surgical AVR, 18.6; P = .71, both P < .001 compared with baseline), and there was no significant difference in medical benefit at 2 years, defined as Kansas City Cardiomyopathy Questionnaire summary score of at least 60 with a decrease from baseline less than 10 points (TAVR, 51%; surgical AVR, 44.4%; P = .28), Reardon and colleagues wrote.

“Surgical [AVR] was associated with more life-threatening bleeding, [atrial fibrillation], acute kidney injury and patient-prosthesis mismatch, all of which have been associated with increased early and longer-term mortality,” the researchers wrote. “Survival is influenced by the balance of these effects, which tend to favor TAVR in this analysis.”

However, they wrote, “although the data are drawn from a prospective, randomized trial ... we did not perform any matching procedures to account for the few baseline differences.”

Technical goals

Reardon told Cardiology Today’s Intervention that in low-risk patients, the key is “how best to achieve the correct valve in the correct place with little to no [paravalvular leak] every time.

“Generation matters, as both the balloon-expandable (Sapien family of products, Edwards Lifesciences) and self-expanding valve have improved substantially from their initial introduction,” he said. “Both have advantages and disadvantages and there are no current data to say one is better than the other.”

Two balloon-expandable valves (Sapien 3 and Sapien XT, Edwards) recently received from the FDA an indication for use in intermediate-risk patients, while the latest-generation self-expanding valve (CoreValve Evolut R, Medtronic), received a CE mark for that indication. – by James Clark

Disclosure: The original trial was funded by Medtronic. Reardon reports receiving fees from Medtronic for providing educational services. Please see the full study for a list of the other researchers’ relevant financial disclosures.