Long-Term Clinical Outcomes of the Carpentier-Edwards Perimount Pericardial Bioprosthesis in Chinese Patients with Single or Multiple Valve Replacement in Aortic, Mitral, or Tricuspid Positions

Abstract

Objectives: To report the safety and efficacy results of a 9- to 15-year follow-up investigation among patients who had received Carpentier-Edwards Perimount (CE-P) bovine pericardial bioprostheses (Edwards Lifesciences, Irvine, CA, USA) for valve replacement. Methods: This retrospective study investigated freedom from structural valve deterioration (SVD) as well as survival and reoperation among different age and etiology groups in patients who were implanted with a CE-P bioprosthesis at Guangdong General Hospital between 2001 and 2007. Kaplan-Meier survival analysis and multivariate Cox proportional hazards regression were performed. Results: The mean age of the patients (N = 225) was only 61.2 ± 11.5 years at valve replacement. More than half of the patients (55.1%) had rheumatic heart disease. The survival rates were 86.46, 81.58, and 74.42% at 5 years, 64.39, 66.19, and 55.85% at 10 years, and 48.37, 57.33, and 46.54% at 15 years for the groups with mitral valve replacement (MVR), aortic valve replacement (AVR), and double valve replacement (DVR), respectively. The median time to freedom from SVD was 12.5, 13.2, and 11.2 years, respectively, for patients with MVR, AVR, and DVR. A higher age at valve replacement was a significant risk factor for SVD in all patients (p < 0.01). Conclusions: Good long-term clinical results of CE-P valves have been demonstrated in Chinese patients >60 years.

Long-term survival after Carpentier-Edwards Perimount aortic valve replacement in Western Denmark: a multi-centre observational study

“…It does however interfere with their true long-term survival analysis and durability of the CE-P valve. It is noteworthy that our survival is consistent with other studies; overall 5-, 10-and 15-year survival rate in China (81.58 66.19 and 57.33% [10]), overall 10-and 15-year survival rate in France (52.4 and 31.1% [9]), overall 5-, 10-and 15-year survival rate in a Canadian study (78, 55 and 34% [21]) and others [23]. We also investigated the survival from MACCE-cause mortality in order to more comprehensive describe the valve durability in combination with all causes of late death (Fig.…”

“…After patients surpass the general risk of the operation the first 30 days, the survival rate matches to the Danish population for 10 years. We may assume that the CE-P valves durability is being challenged by this point, which can also be supported by literature describing the development of SVD in CE-P at 9.24% after 10 years [ 10 ], and 18% after 15 years [ 7 ]. The Danish population is matched according to the mean age of our baseline (Median: 73 years, range: 20–91) which matches previous reports [ 3 , 7 – 9 , 19 , 21 , 22 ], and 12% of the cohort being < 65 years.…”

“…The greatest weakness of bioprosthetic valves is their limited durability, as they are all in time subject to structural valve deterioration (SVD; calcification, pannus formation, cusp tears, or flail) as well as the risk of non-SVD (regurgitation, prosthesis malposition, patient-prosthesis mismatch, late embolization, and prosthetic endocarditis) which applies to all valves [1,[3][4][5][6][7]. The rate of SVD correlates with age, degenerating faster in younger patients [1,6,[8][9][10]. Patients operated with SAVR have several risks of postoperative complications [11] including, but not limited to, acute renal failure [12,13], major life-threatening bleeding [12,14,15], permanent pacemaker [12][13][14][15], postoperative atrial fibrillation (POAF) [12,[16][17][18] and stroke [12][13][14].…”

A single-center 14-year follow-up study of the BalMedic® bovine pericardial bioprosthetic valve

“…Even considering the level of healthcare service, the severity of patient condition at first visit, patient awareness of self-care, and economic conditions in China, survival analysis showed that the 10-year survival rate is satisfied compared to its foreign counterparts on average, especial in AVR and DVR (12)(13)(14)(15). The more comparable result is from Chinese local patients replaced with Perimount bovine pericardial bioprosthetic valves (14). In this study, the 5-year overall survival rate of AVR/MVR/DVR were 81.58%, 86.46% and 74.42% respectively.…”

Use of the BalMedic bovine pericardial bioprosthetic valve in China: a new light on the horizon?

“…Direct comparison with a similar Chinese cohort (n=225; mean age 61.2 years), treated with the Carpentier-Edwards Perimount (CE-P) bovine pericardial prosthesis, shows very similar results after 5 years (6). But after 10 years, the survival rates seem to favor the BalMedic bioprosthesis for aortic (80.6% vs. 66.2%) and double valve (82.9% vs. 55.9%) replacement.…”