Sutureless aortic valve replacement shows promise at 1 year

Patients with severe aortic stenosis who received a sutureless aortic valve replacement experienced high rates of device success and low complication rates in a late-breaking clinical trial presented at the American Association for Thoracic Surgery Annual Meeting.

Theodor Fischlein, MD, of Klinikum Nürnberg in Germany, and colleagues evaluated the safety and efficacy of the Perceval sutureless aortic valve (Sorin Biomedica) in 628 consecutive patients. The primary safety endpoint was mortality and morbidity, and the primary efficacy endpoint was improvement to clinical status end hemodynamic performance. The researchers presented 1-year data at the conference.

Theodor Fischlein

Fischlein told Cardiology Today that the Perceval device includes a biological bovine pericardium valve that has been treated to reduce risk for calcification. The valve is self-expanding due to an elastic nitinol alloy stent consisting of rings and struts that both support the valve and maintain its position once implanted without the need for a permanent suture.

The valve had an implant success rate of 95%. Researchers observed low rates of cardiac mortality (2.5% for early mortality and 4.6% at 1 year), stroke (0.8% for early stroke and 2.2% at 1 year), major paravalvular leak (0%) and valve explant (0.9% for early explant and 1% at 1 year). Fischlein noted that the low cardiac mortality rate occurred despite a high-risk patient population, with 40% aged 80 years or older and a mean Society of Thoracic Surgeons (STS) score of 7.2.

The majority of patients treated with the valve (77.5%) also exhibited an improvement to clinical status, as indicated by improvement by one or more NYHA classes. This change remained stable during the course of follow-up, Fischlein noted during a presentation.

Patients also exhibited a significant, stable reduction in transvalvular gradient, which resulted in an improvement to left ventricular mass at up to 1 year after implantation (P < .01).

In a separate presentation at AATS 2015, Fischlein and colleagues presented the results of a propensity-score analysis comparing sutureless and transcatheter aortic valve replacement across two multicenter registries. The analysis included data from 2,177 patients with severe, symptomatic aortic stenosis, including 292 treated with a sutureless valve and 1,885 who underwent TAVR.

Multivariable analysis of this population, after propensity-score adjustment, indicated a trend toward reduced mortality risk with the sutureless valve (OR = 0.41; 95% CI, 0.16-1.06) and significantly lower risk for moderate or worse aortic regurgitation (OR = 0.05; 95% CI, 0.01-0.38), as well as increased likelihood of device success (OR = 8.7; 95% CI, 3.01-25.1). However, the researchers also observed an increased risk of the need for permanent pacemaker implantation (OR = 2.31; 95% CI, 1.29-4.13). They concluded that both sutureless valve replacement and TAVR are “reasonable alternative treatments” for this patient population.

“[Sutureless valves] would be a very good alternative for aortic valve replacement due to fast implantation,” Fischlein told Cardiology Today. “It is an ideal procedure for combined procedures, [repeat] procedures, patients at risk of prosthesis-patient mismatch, small annuli, calcified aortic roots and obese patients. Perceval is a big step forward for all minimally invasive approaches.”

– by Adam Taliercio

References:

D’Onofrio A, et al. Abstract #86.

Haverich A, et al. Abstract #88.

Both presented at: The American Association for Thoracic Surgery Annual Meeting; April 25-29; Seattle.

Disclosure: Fischlein reports financial relationships with ClearFlow, Epygon and Sorin.