Leaflet Escape in a New Bileaflet Mechanical Valve

Abstract

Background-Leaflet escape is a mode of structural valve failure for mechanical prostheses. This complication previously has been reported for both monoleaflet and bileaflet valve models. We report 2 leaflet escape occurrences observed in 2 patients who underwent valve replacement with a TRI Technologies valve prosthesis. Methods and Results-At the University of Padua, between November 2000 and February 2002, 36 TRI Technologies valve prostheses (26 aortic and 10 mitral) were implanted in 34 patients (12 women and 22 men) with a mean age of 59.9Ϯ10.3 years (range, 30 to 75 years). There were 5 deaths: 3 in hospital, 1 early after discharge, and 1 late. Two patients experienced a catastrophic prosthetic leaflet escape; the first patient was a 52-year-old man who died 10 days after aortic valve and ascending aorta replacement, and the second was a 58-year-old man who underwent a successful emergency reoperation 20 months after mitral valve replacement. Examination of the explanted prostheses showed in both cases a leaflet escape caused by a leaflet's pivoting system fracture. Prophylactic replacement was then successfully accomplished so far in 12 patients, without evidence of structural valve failure in any of them. Among other significant postoperative complications, we observed 3 major thromboembolisms, 1 hemorrhage, and 1 paravalvular leak. Conclusion-These catastrophes prompted us to interrupt the implantation program, and they cast a shadow on the durability of the TRI Technologies valve prosthesis because of its high risk of structural failure.

Prosthetic Mitral Valve Leaflet Escape

“…It is acknowledged that timely diagnosis and emergent surgical replacement of the prosthetic valve is most important 11). There are a few cases of mitral leaflet escape reported in Korea 12-14).…”

Spontaneous leaflet fracture resulting in embolization from mechanical valve prostheses

“…Following its introduction in 1979, by 2003 >600 cases were known to have valve fractures, often leading to sudden cardiac deaths . In addition to the BSCC valve, there are other valves that carry a higher risk for leaflet fracture and subsequent leaflet escape, of which the most prominent is the ED prosthesis (as illustrated by our case), followed by the TRI Technologies (TRI Technologies Prosthetic Heart Valve, Ltda, Belo Horizonte, Brazil) mechanical valve …”

“…1 In addition to the BSCC valve, there are other valves that carry a higher risk for leaflet fracture and subsequent leaflet escape, of which the most prominent is the ED prosthesis (as illustrated by our case), followed by the TRI Technologies (TRI Technologies Prosthetic Heart Valve, Ltda, Belo Horizonte, Brazil) mechanical valve. [2][3][4][5][6][7][8] The ED prosthesis (Baxter Healthcare Corp., Edwards Division) is a bileaflet mechanical heart valve first introduced and implanted in 1982. After approximately 20,000 valve prostheses were implanted the valve was withdrawn from the market in 1988 after at least 46 cases of leaflet escape were registered by the manufacturer.…”

The Use of Medical Devices in Italy and Europe: Between Legal Obligations, Operational Obstacles and Possible Responsibilities

“…Out of 36 valves implanted 5 deaths were reported and 12 patients had to have the defective valve removed and replaced [21]. Subsequently, the less than perfect duration of aortal endo-prostheses [22] due to the use of unsuitable materials was reported as well as the clouding of artificial crystalline lenses caused by the wear of the polymers and the presence of residual silicone on their surface [23] to the extent that following the recommendation of the Italian Ophthalmologic Society substitution of the implanted devices was prudently adopted [24].…”