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

Abstract

Background: This study describes the long-term survival, risk of reoperation and clinical outcomes of patients undergoing solitary surgical aortic valve replacement (SAVR) with a Carpentier-Edwards Perimount (CE-P) bioprosthetic in Western Denmark. The renewed interest in SAVR is based on the questioning regarding the long-term survival since new aortic replacement technique such as transcatheter aortic-valve replacement (TAVR) probably have shorter durability, why assessment of long-term survival could be a key issue for patients.

Methods: From November 1999 to November 2013 a cohort of a total of 1604 patients with a median age of 73 years (IQR: 69-78) undergoing solitary SAVR with CE-P in Western Denmark was obtained November 2018 from the Western Danish Heart Registry (WDHR). The primary endpoint was long-term survival from all-cause mortality. Secondary endpoints were survival free from major adverse cardiovascular and cerebral events (MACCE), risk of reoperation, cause of late death, patient-prothesis mismatch, risk of AMI, stroke, pacemaker or ICD implantation and postoperative atrial fibrillation (POAF). Time-to-event analysis was performed with Kaplan-Meier curve, cumulative incidence function was performed with Nelson-Aalen cumulative hazard estimates. Cox regression was applied to detect risk factors for death and reoperation.

Results: In-hospital mortality was 2.7% and 30-day mortality at 3.4%. The 5-, 10- and 15-year survival from all-cause mortality was 77, 52 and 24%, respectively. Survival without MACCE was 80% after 10 years. Significant risk factors of mortality were small valves, smoking and EuroSCORE II ≥4%. The risk of reoperation was < 5% after 7.5 years and significant risk factors were valve prosthesis-patient mismatch and EuroSCORE II ≥4%.

Conclusions: Patients undergoing aortic valve replacement with a Carpentier-Edwards Perimount valve shows a very satisfying long-term survival. Future research should aim to investigate biological valves long-term durability for comparison of different SAVR to different TAVR in long perspective.

Keywords: Aortic valve replacement; Carpentier-Edwards Perimount; Long-term survival.

Fig. 1

Flow chart of study population selection. WDHR, Western Danish Heart Registry; AVR, aortic valve replacement; CE-Perimount, Carpentier-Edwards Perimount

Fig. 2

Survival from all-cause mortality of all patients after aortic valve replacement (green line) compared with normal Danish population (orange line) and according to EuroSCOREII (ES2). Green and blue line are very overlapped. Survival for all patients at 1-, 5-, 10- and 15-year from was 93, 77, 52 and 24%, respectively. The 5-, 10-, and 15-year survival for low-risk patients was 78, 52 and 25%, respectively, and for ES2 ≥ 4, 63 and 39% at 5 and 10 years, respectively. The survival of the matched background population in Denmark was 81, 57 and 32% after 5-, 10- and 15-years, respectively

Fig. 3

Survival from major adverse cardiovascular and cerebral events (MACCE) and according to EuroSCORE II (ES2). Log-rank test of ES2 < 4% (blue) and ES2 ≥ 4% (red). The overall 5-, 10- and 15-year survival from MACCE-caused mortality (green) was 89, 80 and 67%, respectively

Fig. 4

Survival according to prosthesis sizes 19–23 (red) and 25–29 (blue). The 1-, 3-, 5-, 10- and 15-year survival for valve 19–23 was 92.4, 85.2, 75.8 and 21.9%, respectively and for size 25–29, 93.2, 86.5, 79.9, 54.9 and 29.7%, respectively. The number of patients presented with VP-PM was 155 and 33 for valve 19–23 and 25–29, respectively

Fig. 5

Cumulative incidence of reoperation according to prosthesis sizes 19–23 (red) and 25–29 (blue). Log-rank test of sizes 19–23 (red) and 25–29 (blue). The risk of reoperation at 7.5 years for the sizes 19–23 and 25–29 is 2.46 and 4.57%, respectively