HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Marchand, M. A. Articles by David, T. E. Search for Related Content PubMed PubMed Citation Articles by Marchand, M. A. Articles by David, T. E. Related Collections Valve disease

Ann Thorac Surg 2001;71:S236-S239
© 2001 The Society of Thoracic Surgeons

---

Valvular bioprostheses over 15 years

Fifteen-year experience with the mitral Carpentier-Edwards PERIMOUNT pericardial bioprosthesis

^a Department of Cardiothoracic Surgery and Cardiology, Hôpital Trousseau and Francois Rabelais University, Tours, France
^b Department of Cardiothoracic Surgery and Cardiology, Walsgrave Hospital, Coventry, United Kingdom
^c Department of Cardiothoracic Surgery and Cardiology, Institut de Cardiologie, Montreal, Quebec, Canada
^d Department of Cardiothoracic Surgery and Cardiology, University Hospital, Uppsala, Sweden
^e Department of Cardiothoracic Surgery and Cardiology, University Hospital, Gasthuisberg, Leuven, Belgium
^f Department of Cardiothoracic Surgery and Cardiology, Freeman Hospital, Newcastle Upon Tyne, United Kingdom
^g Department of Cardiothoracic Surgery and Cardiology, Toronto General Hospital, Toronto, Ontario, Canada

Address reprint requests to Dr Marchand, Department of Cardiac Surgery, C.H.U. Trousseau, 37044 Tours Cedex 1, France
e-mail: marchand{at}med.univ-tours.fr

Presented at the VIII International Symposium on Cardiac Bioprostheses, Cancun, Mexico, Nov 3–5, 2000.

	Abstract

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
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 PERIMOUNT valve between 1984 and 1989 at seven institutions. 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: thromboembolism, 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%. Actual 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.

	Introduction

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
The Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis (Edwards Lifesciences, Irvine, CA) is a trileaflet bioprosthetic valve consisting of bovine pericardial leaflets mounted on a flexible frame. The design of the valve was aimed at improving on the limited durability of porcine bioprostheses [1, 2] and the poor performance 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

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
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%) underwent 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 comorbidities 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 replacement 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 disease (21.3%) reported as the most common diagnoses. A total of 123 patients underwent 132 concomitant procedures, 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 96.1% of the population and was obtained through office or hospital visits, letter, telephone interview, or a combination thereof; 3.9% of the patients were lost to follow-up. The guidelines for reporting morbidity and mortality after cardiac valvular surgery [5] were observed in the preparation of this report.

Statistical analysis
Early events ( 30 days postimplantation) were calculated as simple percentages (number of complications divided by number of patients). Linearized rates for late events (> 30 days postoperative) represent the number of complications per 100 patient-years. Kaplan-Meier actuarial analyses including both early and late events were calculated using SAS statistical software. Actual analyses for some events are presented according to the method of Grunkemeier and colleagues [6]. Univariate risk analyses were according to the log-rank and Cox regression analysis methods, with p values based on the log-rank or Wald’s ² test, respectively. Significant risk factors from the univariate analysis were subjected to multivariate risk analyses using the Cox method.

	Results

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Survival
A total of 34 deaths were reported in the operative period for a total operative mortality rate of 7.8%; one was valve-related (0.2%) and was due to thromboembolism. There were184 late deaths for a linearized rate of 5.3%/patient-year. Of these, 76 (2.2%/patient-year) were designated as valve-related; there were 18 instances of sudden death as well as 13 deaths for which the cause was unknown. Cardiac failure (n = 25), which is included here because the status of the valve was unknown at time of death of the patient, was the most prominent cause of valve-related late mortality and accounted for 0.7%/patient-year. Other causes of valve-related death included thromboembolism (n = 8), structural valve deterioration (n = 4), hemorrhage (n = 3), endocarditis (n = 3), and other (n = 2). At 14 years, the overall actuarial survival rate was 37.1% ± 3.3% and the valve-related actuarial survival rate was 63.1% ± 4.4% (Fig 1). Age greater than 65 years at implant and concomitant coronary artery bypass grafting were significant risk factors affecting late survival (p < 0.05).

View larger version (21K): [in this window] [in a new window]   Fig 1. Actuarial survival, overall and valve-related (se = standard error).

Thromboembolic events
Major thromboembolism was defined as those resulting in a permanent neurologic deficit. No case of thrombosis of the valve was reported. A total of 36 patients experienced 42 incidents of major thromboembolic events. (Five events were erroneously reported in the previous publication [4], including four emboli occurring on the day of surgery and one peripheral event resulting from femoral catheter insertion. Those events are not included in this analysis.) The mean age at implant of the patients with thromboembolic events (61.8 years) was not significantly different from that of patients without events (60.7 years). Four patients had two events and 1 patient had three events. Three incidents (0.7%) occurred in the operative period; one resulted in death. A total of 39 incidents occurred in the late postoperative period, 8 of which resulted in death, for a linearized rate of 1.1%/patient-year and an actuarial freedom from major thromboembolic events of 83.8% ± 3.2% at 14 years.

Bleeding events
A total of 30 patients had 40 anticoagulant-related bleeding events requiring hospitalization or transfusion. The mean age of the patients with bleeding events (63.2 years) was not significantly different from that of patients without events (60.6 years). The majority of the events (n = 39) occurred in the postoperative period for a linearized rate of 1.1%/patient-year and resulted in death for 3 patients. At 14 years the actuarial freedom from anticoagulant-related hemorrhage was 86.6% ± 3.2%.

Of the patients still alive at follow-up, 35.3% were on antiplatelet (aspirin) or were not taking any anticoagulant medication as of evaluation. At follow-up, 64% of patients were on warfarin; however, most (78.6%) of these were reported to have rhythm disturbances such as atrial fibrillation or atrial flutter.

Explants
A total of 65 explants occurred in this population, one of which was in the operative period and was due to nonstructural deterioration. In all, 64 explants occurred in the postoperative period for a linearized rate of 1.9%/patient-year. One explant was cardiovascular related and was due to sepsis. In all, 63 explants were considered to be valve related and were due to structural valve deterioration (n = 52), nonstructural deterioration (n = 7), and endocarditis (n = 4). The mean time from implant to explant for any cause was 8.8 ± 3.1 years and ranged from 0.03 to 13.6 years. The actuarial freedom from explant for all causes was 64.1% ± 4.6% at 14 years.

Structural valve deterioration
A total of 56 episodes of structural valve deterioration were reported in this population. Of these, 50 resulted in explant, four resulted in death and two resulted in explant and death within 30 days of explant. Actuarial freedom from SVD at 14 years was 66.3 ± 4.7 years; actual freedom from SVD at 14 years was 81.9% ± 2.4%. Actuarial freedom from explant due to structural valve deterioration at 14 years is 68.8% ± 4.7%; actual freedom from explant due to SVD at 14 years is 83.4% ± 2.3% (Fig 2). Since a constant hazard function does not apply to structural valve deterioration, linearized rates are not meaningful. Structural valve deterioration was specified as calcification in the majority of the cases (73%), followed by leaflet tear (20%) and calcification with leaflet tear (7%). The mean time from implant to calcification of the valve (9.3 ± 2.6 years) was not significantly different (p = 0.35) from the mean time to leaflet tear (10.1 ± 2.3 years). The mean time from implant to explant due to structural valve deterioration was 9.5 ± 2.2 years (range 5.0 to 13.6 years).

View larger version (19K): [in this window] [in a new window]   Fig 2. Actuarial and actual freedom from explant due to structural valve deterioration (se = standard error).

View larger version (22K): [in this window] [in a new window]   Fig 3. Actuarial freedom from structural valve deterioration, by age group (se = standard error).

View larger version (21K): [in this window] [in a new window]   Fig 4. Actual freedom from structural valve deterioration, by age group (se = standard error).

	Comment

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

Cannegieter and colleagues [8] studied a cohort of patients on anticoagulant treatment with mechanical valves (60% aortic) and established a risk of bleeding of 3.1%/patient-year for women and 2.4%/patient-year for men. This result was relatively stable across age except for patients 70 or older, for whom the risk of bleeding was twice as high (5.6%/patient-year). Holper and colleagues [7] reported an actuarial freedom from hemorrhage of 88% ± 4% with a biological valve and of 57% ± 11% with a mechanical valve at 15 years. Despite the relatively large number of patients (64%) who underwent anticoagulant treatment, the rate of major bleeding in the present study (1.1%/patient-year; actuarial freedom 86.6% ± 3.2% at 14 years) was lower than that seen in patients receiving mechanical prostheses [7, 9].

Results for structural valve deterioration from our study include an overall actuarial freedom from explant due to SVD of 90.3% ± 1.8% at 10 years and 68.8% ± 4.7% at 14 years. Actual freedom from explant due to SVD at 10 years was 93.7% ± 1.2% and at 14 years was 83.4% ± 2.3%. Stratification of the data by age group results in a 14-year actuarial freedom from explant due to SVD of 85.9% ± 5.0% and an actual freedom from SVD of 93.8% ± 2.1% for patients aged 65 years or more at implant. Actuarial and actual freedom from explant due to SVD in patients more than 70 years of age was 100% at 13 years.

These results are comparable to other reports concerning this valve. Poirier and colleagues [10] reported an overall freedom from SVD at 10 years of 81% for mitral valve replacement. Murakami and associates [11] reported a freedom from SVD at 10 years of 77% for a patient population with a mean age of 57 years. Neville and colleagues [12] reported extensively on their experience with the Carpentier-Edwards pericardial prosthesis. In the mitral position at 12 years, the freedom from structural valve deterioration was 78% for all patients and was 100% for patients more than 60 years of age. No long-term results are found in the literature concerning others pericardial valves that are currently available, especially those in the mitral position.

The durability of the PERIMOUNT bioprosthesis also compared favorably with that of the new generation of porcine valve. David and colleagues [13] reported a freedom from SVD at 12 years of 82% ± 5% for the Hancock II mitral porcine bioprosthesis for patients with a mean age of 65 years. Jamieson and colleagues [14] compared the second-generation CE Supra-Annular porcine valve and PERIMOUNT and concluded that at 10 years the incidence of SVD was greater for the CE SAV porcine: 75.2% ± 3.7% (versus 95.2% ± 2.1% for pericardial) for patients more than 60 years old, and 64.7% ± 3.3% (versus 84.0% ± 3.7%) for patients 60 years old and younger. Influence of age on durability was particularly underlined.

The results of this large multicenter study show an overall survival rate of 37.1% ± 3.3% and freedom from valve-related death of 63.1% ± 4.4% at 14 years. Following the strict criteria of definition for valve-related deaths, deaths from sudden or unknown causes were conservatively included in the valve-related category. Such results suggest a population, especially in older patients with coronary disease, that presents with a life expectancy shorter than the expected durability of the valve. This concept is well expressed by actual curves as described by Grunkemeier and colleagues [6].

Patient age is a major determinant playing a role in life expectancy, valve durability, and risk of bleeding on anticoagulant treatment. The low incidence of structural valve deterioration has validated the design of the PERIMOUNT pericardial valve. That, combined with the low incidence of anticoagulant-related complications, indicates that when a tissue valve is needed, PERIMOUNT is a reliable choice for patients more than 60 years of age.

	Acknowledgments

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Supported in part by a research grant from Edwards Lifesciences LLC, Irvine, California.

	References

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 

1. Jamieson W.R.E., Miyagishima R.T., Munro A.I., et al. The Carpentier-Edwards Supra-Annular Porcine Bioprosthesis. Clinical Performance to 8 years of a new generation porcine bioprosthesis. J Card Surg 1991;6:562-567.[Medline]
2. Jamieson W.R.E., Allen P., Miyagishima R.T., et al. The Carpentier-Edwards standard porcine bioprosthesis. J Thorac Cardiovasc Surg 1990;99:543-561.[Abstract]
3. Gallo I., Nistal F., Arbe E., Arinano E. Comparative study of primary tissue failure between porcine (Hancock and Carpentier-Edwards) and bovine pericardial (Ionescu-Shiley) bioprostheses in the aortic position at five- to nine-year follow-up. Am J Cardiol 1988;88:812-816.
4. Marchand M., Aupart M.R., Norton R., et al. Twelve-year experience with Carpentier-Edwards PERIMOUNT Pericardial valve in the mitral position: a multicenter study. J Heart Valve Disease 1998;7:292-298.[Medline]
5. Edmunds L.H., Jr, Clark R.E., Cohn L.H., Grunkemeier G.L., Miller D.C., Weisel R.D. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ann Thorac Surg 1996;62:932-935.[Abstract/Free Full Text]
6. Grunkemeier G.L., Jamieson W.R.E., Miller D.G., Starr A. Actuarial vs. actual risk of porcine structural valve deterioration. J Thorac Cardiovasc Surg 1994;108:709-718.[Abstract/Free Full Text]
7. Holper K., Wottke M., Lewe T., et al. Bioprosthetic and mechanical valves in the elderly: benefits and risks. Ann Thorac Surg 1995;60:S443-S446.
8. Cannegieter S.C., Rosendaal F.R., Wintzen A.R., van der Meer F.J.M., Vandenbroucke J.P., Briet E. Optimal oral anticoagulant therapy in patients with mechanical heart valves. N Engl J Med 1995;333:11-17.[Abstract/Free Full Text]
9. Horstkotte D., Schulte H., Bircks W., Strauer B. Unexpected findings concerning thromboembolic complications and anticoagulation after complete 10 year follow-up of patients with St. Jude Medical prostheses. J Heart Valve Disease 1993;2:291-301.[Medline]
10. Poirier N.C., Pelletier L.C., Pellerin M., Carrier M. 15-year experience with the Carpentier-Edwards Pericardial Bioprosthesis. Ann Thorac Surg 1998;66:S57-S61.
11. Murakami T., Kiyoyuki E., Nakano S., et al. Aortic and mitral valve replacement with the Carpentier-Edwards Pericardial Bioprosthesis: 10-year results. J Heart Valve Dis 1996;5:45-49.[Medline]
12. Neville P.H., Aupart M.R., Diemont F.F., Sirinelli A.L., Lemoine E.M., Marchand M.A. Carpentier-Edwards pericardial bioprosthesis in aortic or mitral position: a 12-year experience. Ann Thorac Surg 1998;66:S143-S147.
13. David T.E., Armstrong S., Sun Z. The Hancock II bioprosthesis at 12 years. Ann Thorac Surg 1998;66:S95-S98.
14. Jamieson W.R.E., Marchand M.A., Pelletier C.L., et al. Structural valve deterioration in mitral replacement surgery: comparison of Carpentier-Edwards supra-annular porcine and PERIMOUNT pericardial bioprostheses. J Thorac Cardiovasc Surg 1999;118:297-305.[Abstract/Free Full Text]

This article has been cited by other articles:

				R. O. Bonow, B. A. Carabello, K. Chatterjee, A. C. de Leon Jr, D. P. Faxon, M. D. Freed, W. H. Gaasch, B. W. Lytle, R. A. Nishimura, P. T. O'Gara, et al. ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease) Developed in Collaboration With the Society of Cardiovascular Anesthesiologists Endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons J. Am. Coll. Cardiol., August 1, 2006; 48(3): e1 - e148. [Full Text] [PDF]

				W.R. E. Jamieson, L. H. Burr, R. T. Miyagishima, E. Germann, J. S. MacNab, E. Stanford, F. Chan, M. T. Janusz, and H. Ling Carpentier-Edwards supra-annular aortic porcine bioprosthesis: Clinical performance over 20 years J. Thorac. Cardiovasc. Surg., October 1, 2005; 130(4): 994 - 1000. [Abstract] [Full Text] [PDF]

				F. Filsoufi and D. H. Adams Invited commentary Ann. Thorac. Surg., July 1, 2004; 78(1): 65 - 66. [Full Text] [PDF]

				M. L. Polo, J. J. Legarra, M. Vilar, A. Cabrera, D. Duran, and G. Pradas Early calcification of a Carpentier-Edwards Perimount mitral valve in an elderly woman J. Thorac. Cardiovasc. Surg., November 1, 2002; 124(5): 1043 - 1044. [Full Text] [PDF]

This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Marchand, M. A. Articles by David, T. E. Search for Related Content PubMed PubMed Citation Articles by Marchand, M. A. Articles by David, T. E. Related Collections Valve disease