Bioprosthetic aortic valve replacement in elderly patients: Meta-analysis and microsimulation.

OBJECTIVE: To support decision-making in aortic valve replacement (AVR) in elderly patients, we provide a comprehensive overview of outcome after AVR with bioprostheses. METHODS: A systematic review was conducted of studies reporting clinical outcome after AVR with bioprostheses in elderly patients (mean age ≥70 years; minimum age ≥65 years) published between January 1, 2000, to September 1, 2016. Reported event rates and time-to-event data were pooled and entered into a microsimulation model to calculate life expectancy and lifetime event risks. RESULTS: Forty-two studies reporting on 34 patient cohorts were included, encompassing a total of 12,842 patients with 55,437 patient-years of follow-up (pooled mean follow-up 5.0 ± 3.3 years). Pooled mean age was 76.5 ± 5.5 years. Pooled early mortality risk was 5.42% (95% confidence interval [CI], 4.49-6.55), thromboembolism rate was 1.83%/year (95% CI, 1.28-3.61), and bleeding rate was 0.75%/year (95% CI, 0.50-1.11). Structural valve deterioration (SVD) was based on pooled time to SVD data (Gompertz; shape: 0.124, rate: 0.003). For a 75-year-old patient, this translated to an estimated life expectancy of 9.8 years (general population: 10.2 years) and lifetime risks of bleeding of 7%, thromboembolism of 17%, and reintervention of 9%. CONCLUSIONS: The low risks of SVD and reintervention support the use of bioprostheses in elderly patients in need of AVR. The estimated life expectancy after AVR was comparable with the general population. The results of this study inform patients and clinicians about the expected outcomes after bioprosthetic AVR and thereby support treatment decision-making. Furthermore, our results can be used as a benchmark for long-term outcomes after transcatheter aortic valve implantation in patients who were eligible for surgery and other (future) alternative treatments (eg, tissue-engineered heart valves).

Outcomes of Pregnancy After Right Ventricular Outflow Tract Reconstruction With an Allograft Conduit.

BACKGROUND: There is no published evidence on pregnancy after right ventricular outflow tract (RVOT) reconstruction with an allograft. OBJECTIVES: The aim of this study was to describe pregnancy outcomes in women with allografts in the RVOT position. METHODS: A retrospective cohort study of consecutive female patients who received allografts in the RVOT position was conducted. All patients between 18 and 50 years of age were screened for cardiac, obstetric, and fetal outcomes of completed (≥20 weeks' gestation) pregnancies. RESULTS: In total, 196 women met the inclusion criteria, of whom 56 had 89 completed pregnancies. Information could be retrieved in 84 cases (94.4%). Mean maternal age was 29.6 ± 4.3 years, with 80 patients (95.2%) in New York Heart Association functional class I or II. The most common diagnosis was tetralogy of Fallot. All women survived pregnancy. There were 2 cases (2.4%) of heart failure (arrhythmic and diastolic dysfunction), 1 case (1.2%) of infection (chorioamnionitis), and 3 cases (3.6%) of pre-eclampsia. No other cardiac or obstetric events were reported. All children were born alive at a median gestational age of 38.4 weeks (interquartile range: 36.9 to 39.6 weeks), with a median birthweight of 2,930 g (interquartile range: 2,535 to 3,385 g). Seventeen (20.2%) were small for gestational age, and 20 (23.8%) were premature. Neonatal death was reported in 2 children (2.5%). Preconception pulmonary regurgitation was associated with an increased probability of pre-term labor (odds ratio: 2.610; 95% confidence interval: 1.318 to 5.172). Compared with the general Dutch population, pre-term delivery (25.0% vs. 7.4%, p < 0.001) and children small for gestational age (20.2% vs. 10.0%, p = 0.002) were more common. CONCLUSIONS: Women in good cardiac health after RVOT reconstruction with allografts can safely experience pregnancy and labor. The higher incidence of pre-term delivery and children small for gestational age warrants special attention.

Contemporary outcomes after surgical aortic valve replacement with bioprostheses and allografts: a systematic review and meta-analysis.

Many observational studies have reported outcomes after surgical aortic valve replacement (AVR), but there are no recent systematic reviews and meta-analyses including all available bioprostheses and allografts. The objective of this study is to provide a comprehensive and up-to-date overview of the outcomes after AVR with bioprostheses and allografts reported in the last 15 years. We conducted a systematic literature review (PROSPERO register: CRD42015017041) of studies published between 2000-15. Inclusion criteria were observational studies or randomized controlled trials reporting on outcomes of AVR with bioprostheses (stented or stentless) or allografts, with or without coronary artery bypass grafting (CABG) or valve repair procedure, with study population size n ≥ 30 and mean follow-up length ≥5 years. Fifty-four bioprosthesis studies and 14 allograft studies were included, encompassing 55 712 and 3872 patients and 349 840 and 32 419 patient-years, respectively. We pooled early mortality risk and linearized occurrence rates of valve-related events, reintervention and late mortality in a random-effects model. Sensitivity, meta-regression and subgroup analyses were performed to investigate the influence of outliers on the pooled estimates and to explore sources of heterogeneity. Funnel plots were used to investigate publication bias. Pooled early mortality risks for bioprostheses and allografts were 4.99% (95% confidence interval [CI], 4.44-5.62) and 5.03% (95% CI, 3.61-7.01), respectively. The late mortality rate was 5.70%/patient-year (95% CI, 4.99-5.62) for bioprostheses and 1.68%/patient-year (95% CI, 1.23-2.28) for allografts. Pooled reintervention rates for bioprostheses and allografts were 0.75%/patient-year (95% CI, 0.61-0.91) and 1.87%/patient-year (95% CI, 1.52-2.31), respectively. There was substantial heterogeneity in most outcomes. Meta-regression analyses identified covariates that could explain the heterogeneity: implantation period, valve type, patient age, gender, pre-intervention New York Heart Association class III/IV, concomitant CABG, study design and follow-up length. There is possible publication bias in all outcomes. This comprehensive systematic review and meta-analysis provides an overview of the outcomes after AVR with bioprostheses and allografts reported during the last 15 years. The results of this study can support patients and doctors in the prosthetic valve choice and can be used in microsimulation models to predict patient outcomes and estimate the cost-effectiveness of AVR with bioprostheses or allografts compared with current and future heart valve prostheses.