Original article: cardiovascular
Repeated thromboembolic and bleeding events after mechanical aortic valve replacement

https://doi.org/10.1016/S0003-4975(00)02683-7Get rights and content

Abstract

Background. The choice of a valve substitute in young adults requires a decision balancing the risks of long-term anticoagulation versus reoperation(s). This article analyzes the long-term risk and determinants of thromboembolic (TE) and bleeding (BLE) complications after mechanical aortic valve replacement (AVR).

Methods. From December 1963 to January 1974, 249 patients survived a mechanical AVR at our institution. Mean age was 41.8 ± 12.4 years and 81% (n = 202) were male. Ball valves were implanted in 24% (n = 61) and disc valves in 76% (n = 188). Patients were anticoagulated with vitamin K antagonists and dipyridamole. A total of 4,855 patient–years was available for analysis. Mean follow-up was 19.5 ± 9.4 years and was 100% complete. Analyses were performed with Kaplan-Meier and multivariable Cox regression methods.

Results. One hundred and two patients had one TE or BLE postoperative event and 58 patients had two postoperative events. Six patients had more than five postoperative events. Freedom from a first postoperative event was 74.8% ± 2.9%, 55.3% ± 3.5%, and 46.8% ± 4.0% at 10, 20, and 30 years, respectively. Freedom from a second postoperative event was 45.4% ± 5.4%, 29% ± 6.0%, and 23.2% ± 7.1% at 10, 20, and 30 years, respectively. Multivariate predictors for TE or BLE complications were ball valve (Odds Ratio (OR) = 2.9), postoperative endocarditis (OR = 2.2), and any surgery (OR = 2.2). The incidence of events was highest the first 5 postoperative years.

Conclusions. The risk of adverse events is highest the first 5 postoperative years. Once an event has occurred, the risk for a second event is increased. The incidence and frequency of events is substantial and should be considered in the choice of a valve substitute.

Section snippets

Patient selection

December 1963 was the start of the aortic valve replacement program at our institution and we studied the first 10 years of this program (December 1963 through January 1, 1974). A total of 312 patients underwent aortic valve replacement during this time. Reoperations, urgent, or combined procedures were included. Operative mortality before 1971 was 33% (44 of 132 patients) and from 1971 to 1974 it was 10.5% (19 of 180 patients). Causes of hospital death are mentioned in Table 1. Since none of

Late mortality

Overall actuarial survival among hospital survivors was 80.3% ± 2.6%, 57.4% ± 3.1%, and 33.6% ± 4.2% at postoperative years 10, 20, and 30, respectively (Fig 1). The linearized incidence rate was 3.2% ± 0.3% per year. Causes of death are shown in Table 3. Multivariate independent risk factors for death were age [hazard ratio increase of 1.0 per year (95% CI 1.0 to 1.1)], male gender [hazard ratio 1.7 (95% CI 1.1 to 2.7)], operation before 1970 [hazard ratio 1.6 (95% CI 1.1 to 2.4)], and

Overall TE and major BLE complications (global incidence)

In agreement with previous publications, the global incidence of TE or BLE complications was fairly high 4, 8, 9, 10, 11, 12. In this series, only 46.8% of the patients remained free from a first TE or BLE event at 30 years postoperatively. However, the linearized incidence rate for a first event in this series was 3% per patient–year, which compares favorably with reported incidence rates of 3% to 5% for the Starr-Edwards valve 4, 9, and an overall incidence of approximately 3.5% for the

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