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This article was originally published in The Gray Sheet

Executive Summary

CARBOMEDICS' CPHV HEART VALVE GLIDES PAST PANEL with a unanimous recommendation for approval on April 13. In a six-to-zero vote, FDA's circulatory system devices panel recommended approval of the pyrolitic carbon mechanical heart valve at a meeting in Washington, D.C. Carbomedics, a unit of Sulzermedica, is seeking FDA approval to market the bileaflet prosthesis as a replacement for mitral, aortic, tricuspid and pulmonic cardiac valves. A premarket approval application for the CPHV was accepted for filing by FDA in 1991. Bruce Perler, MD, Johns Hopkins University, Baltimore, the lead panel reviewer of the CPHV PMA, commended the "excellent clinical documentation and...nearly 100% clinical followup" in the company's 1,036-patient, 14-site study. Panel Chair Gabriel Gregoratos, MD, University of California at Davis, Sacramento, also praised the study, adding that he was disappointed only by the "lack of any type of control" group in the PMA. Comparative data on other heart valves that was gathered by the company but not included in the PMA would have provided "much more solid scientific grounds" on which to base an approval recommendation, Gregoratos stated. The CPHV valve consists of a pyrolitic carbon orifice assembly, two valves made of pyrolitic carbon coated over a graphite substrate, and a polyester cloth sewing ring that incorporates a titanium band. The device is designed so that the valves can be rotated in the orifice assembly. Jack Copeland, MD, a CPHV investigator from the University of Arizona, Tucson, said he considers the device to be a "second generation bileaflet [valve] that has a few advantages to the St. Jude valve," which is the most widely used mechanical heart valve. He cited the ability to rotate the valve as "the principle advantage" of the CPHV. In addition, Carbomedics says the titanium band provides greater stiffness and radiopacity to the valve. Of the 1,036 patients in the study, 509 had valves placed in the aortic position, 396 had mitral valve implants, 127 had simultaneous aortic and mitral replacements, and four had CPHVs implanted in the tricuspid. No patients received valves in the pulmonic position. The overall patient survival rate was 93% one month after CPHV implantation, 89% after one year, and 85% after three years, the company reported. Patients were followed for a mean of 19.2 months. David Naftel, PhD, University of Alabama at Birmingham, a consultant for Carbomedics, cited "similarities in survival statistics" in the CPHV study and studies of St. Jude Medical's pyrolitic heart valve. Naftel reported CPHV complication rates for the 845 patients who received a prosthetic heart valve for the first time (primary placement). Thromboembolism occurred in 20 cases (2.4%), hemolysis in seven patients (0.8%), and thrombosed valves in three cases (0.4%). In addition, 10 patients developed valve endocarditis (1.2%), fourteen experienced perivalvular leak (1.7%), and 30 had anticoagulation therapy-related hemorrhage (3.6%). Reoperation was performed on 14 patients (1.7%), 10 of which had the CPHV valve explanted (1.2%). No cases of valve failure were reported. Regarding hemodynamic performance in primary placement patients, the study demonstrated an "improvement in New York Heart Association functional class," Naftel said. Prior to CPHV valve placement, "85% were either class III or class IV"; the number in these classes dropped to 2-3% by three years after surgery, Naftel said. In addition, echodoppler evaluation of aortic valves revealed "similar [hemodynamic performance] across the [valve] sizes" when compared with published studies of St. Jude Medical bileaflet heart valves, the company said. Valve size ranges from 19-31 mm for aortic valves and 23-33 mm for mitral valves. The panel conditioned its approval recommendation only on one labeling change: the inclusion of a statement that CPHV "safety and efficacy in tricuspid and pulmonic valve positions has not been shown." The labeling modification was recommended after Diane MacCulloch, the FDA reviewer of the CPHV PMA, explained that the agency established a policy in 1991 that requires manufacturers to state in labeling that valve safety and effectiveness has been shown only in the aortic and mitral positions if data is lacking on tricuspid and pulmonic use. Prosthetic valves typically are placed in the mitral or aortic positions because blood pressure is higher in those areas.

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