In an interview, the Sorin Group's U.S. medical director touted multiple studies that were presented at a recent cardiology conference, which found that the company's sutureless surgical aortic valve replacement (SAVR) is superior to transcatheter aortic valve replacements (TAVR). The new information comes amid growing debate within the cardiology community about which treatment paradigm is better in intermediate-risk patients.
TAVRs like Medtronic's ($MDT) CoreValve and Edwards Lifesciences' ($EW) Sapien XT are hailed as one of the device industry's biggest breakthroughs. By using minimally invasive surgical techniques, they have made treatment an option for patients too frail for open-heart surgery who previously had no options.
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| Perceval SAVR--Courtesy of Sorin |
Like all SAVRs, Sorin's CE-marked Perceval aortic valve requires open-heart surgery for implantation. The self-anchoring device does not require sutures, which sets it apart from all but two valves, Medtronic's FDA-approved 3f Aortic Bioprosthesis and the CE-marked Edwards Intuity Elite.
Between TAVR and SAVR, "physicians are trying to determine which modality is the best for which patient population," said Dr. Brian Duncan, Sorin's U.S. medical director. TAVRs were originally confined to use in only the highest risk patients, but as more data becomes available, they are being used in some intermediate-risk patients. As a result, the risk profile between patients on the two modalities sometimes overlaps, Duncan said.
Duncan pointed to an independent study of registry data from more than 2,000 European patients presented at the annual meeting of the American Association for Thoracic Surgery in Seattle, saying it showed that compared to TAVR, the Perceval had an increased rate of device success at the time of implantation using a composite measure of mortality, successful positioning and hemodynamic performance. Perceval patients had a lower 30-day mortality rate than those who received TAVR but were at higher risk of permanent pacemaker implantation.
Another independent prospective study compared intermediate- to high-risk patients on the Perceval to TAVR patients and those using aortic valves requiring sutures. The Perceval group had the lowest 30-day mortality rate (3.4%), while the TAVR group had the highest (9.8%); the rate for patients using traditional sutured valves was 5.8%. After two years, the difference between the survival rates among the two SAVR groups was not quite statistically significant, and above 90%, while that for the TAVR group was 79.5%.
The main advantage of a sutureless valve like the Perceval over traditional SAVRs is that implantation times are decreased. "That means procedures' times are decreased, and that translates into better outcomes for patients and lowers costs for the hospital," Duncan said. The Perceval product website says that patients using the device spent less time in the intensive care unit and received less transfused blood than those using traditional sutured valves.
Sorin is counting on the Perceval to turn around a cardiac surgery unit that barely grew during the first quarter of 2015, according to the company's earnings release. Tissue heart valve revenue fell 4.6%, in part due to a temporary production limitation in production capacity for the Perceval.
Company officials previously said the manufacturing issue cost the company about €5 million ($5.58 million) in the second half of 2014 and limited sales of the Perceval to about half of what was hoped for.
Sorin has completed enrollment of its investigational trial for U.S. approval of the Perceval. It is aiming to accomplish that by the end of the year, Chief Financial Officer Demetrio Mauro said during the Q4 2014 earnings call.
To a large extent, the device's success will hinge on surgeons' preference for its sutureless technology over TAVRs. That is an opinion that's still being formed and subject to change based on the latest data. Duncan said the guidelines for using TAVRs or SAVRs in intermediate-risk patients "are in evolution right now."