Fifteen-Year Experience With the Mitral Carpentier-
Edwards PERIMOUNT Pericardial Bioprosthesis
Michel A. Marchand, MD, Michel R. Aupart, MD, Robert Norton, MD,
Ira R. A. Goldsmith, FRCS, L. Conrad Pelletier, MD, Michel Pellerin, MD,
Thomas Dubiel, MD, Willem J. Daenen, MD, Paul Herijgers, MD,
Filip P. Casselman, MD, Michael P. Holden, FRCS, and Tirone E. David, MD
Department of Cardiothoracic Surgery and Cardiology, Ho ˆ pital Trousseau and Francois Rabelais University, Tours, France,
Department of Cardiothoracic Surgery and Cardiology, Walsgrave Hospital, Coventry, United Kingdom, Department of
Cardiothoracic Surgery and Cardiology, Institut de Cardiologie, Montreal, Quebec, Canada, Department of Cardiothoracic Surgery
and Cardiology, University Hospital, Uppsala, Sweden, Department of Cardiothoracic Surgery and Cardiology, University
Hospital, Gasthuisberg, Leuven, Belgium, Department of Cardiothoracic Surgery and Cardiology, Freeman Hospital, Newcastle
Upon Tyne, United Kingdom, and Department of Cardiothoracic Surgery and Cardiology, Toronto General Hospital, Toronto,
Ontario, Canada
Background. This multicenter study concerning the
mitral PERIMOUNT valve previously reported clinical
results at 12 years; this report updates the performance to
15 years postoperatively.
Methods. The 435 patients (mean age 60.7 11.6 years;
41.1% male) underwent implantation with the PERI-
MOUNT valve between 1984 and 1989 at seven institu-
tions. Follow-up was complete for 96.1% of the cohort.
The mean follow-up was 8.1 4.4 years (range 0 to 15.4
years) for a total of 3492 patient-years.
Results. There were 34 (7.8%) operative deaths, one
(0.2%) valve related. The late mortality rate was 5.3%/
patient-year (2.2%/patient-year valve related). At 14
years, the overall actuarial survival rate was 37.1% 3.3%
(63.1% 4.4% valve related). Actuarial freedom from
complications at 14 years was as follows: thromboembo-
lism, 83.8% 3.2% (1.1%/patient-year); hemorrhage,
86.6% 3.2% (1.1%/patient-year); and explant due to
structural valve deterioration (SVD), 68.8% 4.7%. Ac-
tual freedom from explant due to SVD was 83.4% 2.3%.
Rates of structural failure decreased with increasing age
at implant.
Conclusions. The Carpentier-Edwards PERIMOUNT
Pericardial Bioprosthesis is a reliable choice for a tissue
valve in the mitral position, especially in patients more
than 60 years of age.
(Ann Thorac Surg 2001;71:S236 –9)
© 2001 by The Society of Thoracic Surgeons
T
he Carpentier-Edwards PERIMOUNT Pericardial
Bioprosthesis (Edwards Lifesciences, Irvine, CA) is a
trileaflet bioprosthetic valve consisting of bovine pericar-
dial leaflets mounted on a flexible frame. The design of
the valve was aimed at improving on the limited dura-
bility of porcine bioprostheses [1, 2] and the poor perfor-
mance of the first-generation pericardial valves [3]. This
large multicenter study previously reported the longest-
term results available for this bioprosthesis at 12 years
[4]; this report updates the clinical performance at 15
years.
Material and Methods
Between 1984 and 1989, the PERIMOUNT mitral valve
was implanted in 435 patients from seven centers in
Europe and Canada. Of these patients, 333 (76.6%) un-
derwent isolated mitral valve replacement and 102
(23.4%) underwent double valve replacement consisting
of aortic and mitral PERIMOUNT valves. A total of 179
(41.1%) were male and 256 (58.9%) were female. Mean
age at implant was 60.7 11.6 years (range 8.3 to 82.3
years).
Preoperatively, 340 patients (78.2%) were in New York
Hart Association functional class III or IV, and 82 (18.9%)
were in class II. Reportedly, 269 (61.8%) patients had no
preexisting conditions; however, the most common co-
morbidities were coronary artery disease/prior CABG/MI
in 111 patients (25.5%). Atrial fibrillation was present in
48.8% of the population. Prior mitral valve repair or replace-
ment occurred in 15.1% and 11.4% of the population,
respectively. The most common etiology was rheumatic
disease (53.9%), followed by degenerative disease (22.4%),
with insufficiency (44.4%), stenosis (25.7%), and mixed dis-
ease (21.3%) reported as the most common diagnoses. A
total of 123 patients underwent 132 concomitant proce-
dures, the majority of which (48.5%) were coronary artery
bypass grafting.
The mean follow-up was 8.1 4.4 years (range 0 to 15.4
years) for a total of 3492 patient-years. Mean follow-up
for patients who were still alive was 11.8 1.5 years
(range 9.0 to 15.4 years). Follow-up was complete for
Presented at the VIII International Symposium on Cardiac Bioprostheses,
Cancun, Mexico, Nov 3–5, 2000.
Address reprint requests to Dr Marchand, Department of Cardiac
Surgery, C.H.U. Trousseau, 37044 Tours Cedex 1, France; e-mail:
marchand@med.univ-tours.fr.
© 2001 by The Society of Thoracic Surgeons 0003-4975/01/$20.00
Published by Elsevier Science Inc PII S0003-4975(01)02550-4