Sutureless Valve Shows Encouraging Results in Aortic Stenosis Patients

Download this article's Factoid (PDF & PPT for Gold Subscribers)

In patients with aortic valve stenosis or aortic insufficiency, implantation of a sutureless aortic valve is associated with low mortality and morbidity and good hemodynamics at 5 years with no deterioration of the prosthesis, according to a study presented at the American Association for Thoracic Surgery Annual Meeting April 29, 2014, in Toronto, Canada.

The 3f Enable aortic bioprosthesis (Medtronic; Minneapolis, MN), consists of a self-expanding nitinol frame and tubular design leaflet structure and is implanted with no sutures. The device received CE mark approval in 2009 but has yet to be approved by the US Food and Drug Administration. Two other sutureless valves also are available in Europe.

For the prospective, nonrandomized study, researchers led by Thierry Carrel, MD, of University Hospital Bern (Bern, Switzerland), enrolled 141 patients (mean age 76.1; 61.7% female) with aortic valve stenosis or aortic insufficiency who were implanted with the 3f Enable valve at 10 European centers from 2007 to 2009. One-third (33.2%) of patients underwent concomitant procedures including CABG, LAA closure, and mitral annuloplasty.

Long-term Results Promising

At 5 years, rates of all-cause and valve-related mortality were 23% and 6%, respectively. Additionally, morbidity was low with no incidence of structural valve deterioration (table 1).

Table 1. Early and Late Morbidity

Six patients underwent reintervention within 6 months; 2 for endocarditis and 4 for major paravalvular leak. Paravalvular leak occurred predominantly in larger valve sizes.

Patients also had consistently low, single-digit mean systolic gradient—7.4 mmHg at 5 years with an indexed effective orifice area of 0.9 cm²/m².

In isolated AVR cases, aortic cross-clamp time was 48.6 ± 18.9 minutes and cardiopulmonary bypass time was 71.8 ± 25.6 minutes. Long average bypass and cross-clamp times were related to a learning curve of at least 15 cases per person and that the implanting investigator was training others, according to Dr.Carrel. At most experienced centers, cross-clamp time was 36.8 minutes and bypass time was 54.8 minutes.

“Until now, we didn't know the medium- to long-term durability for this new device for fast aortic valve replacement,” Dr. Carrel said in a press statement. “It's very important that this sutureless valve performs very well, long after it's implanted. Patients and physicians alike should be encouraged by [these] data.”

Carrel T. Clinical performance of the 3f Enable sutureless aortic bioprosthesis: five year results. Presented at: American Association for Thoracic Surgery Annual Meeting; April 29, 2014; Toronto, Canada.