RESUMEN
BACKGROUND: The optimal anticoagulation strategy for patients with bioprosthetic valves and atrial fibrillation remains uncertain. We conducted a meta-analysis using updated evidence comparing direct anticoagulants (DOACs) and vitamin K antagonists (VKAs) in patients with bioprosthetic valves and atrial fibrillation. METHODS: Medline and Embase were searched through March 2021 to identify randomized controlled trials (RCTs) and observational studies investigating the outcomes of DOAC therapy and VKA therapy in patients with bioprosthetic valves and atrial fibrillation. The outcomes of interest were all-cause death, major bleeding, and stroke or systemic embolism. RESULTS: Our analysis included 4 RCTs and 6 observational studies enrolling a total of 6405 patients with bioprosthetic valves and atrial fibrillation assigned to a DOAC group (n = 2142) or a VKA group (n = 4263). Pooled analysis demonstrated the similar rates of all-cause death (hazard ratio [HR], 0.90; 95% confidence interval [CI], 0.77-1.05; P = .18; I2 = 0%) in the DOAC and VKA groups. However, the rate of major bleeding was significantly lower in the DOAC group (HR, 0.66; 95% CI, 0.48-0.89; P = .006; I2 = 0%), whereas the rate of stroke or systemic embolism was similar in the 2 groups (HR, 0.72; 95% CI, 0.44-1.17; P = .18; I2 = 39%). CONCLUSIONS: DOAC might decrease the risk of major bleeding without increasing the risk of stroke or systemic embolism or all-cause death compared with VKA in patients with bioprosthetic valves and atrial fibrillation.
Asunto(s)
Fibrilación Atrial , Embolia , Accidente Cerebrovascular , Humanos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/tratamiento farmacológico , Anticoagulantes/efectos adversos , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Hemorragia/inducido químicamente , Administración Oral , Vitamina K , Estudios Observacionales como AsuntoRESUMEN
OBJECTIVE: Although current guidelines generally recommend watchful waiting strategy for patients with asymptomatic severe aortic stenosis until symptoms develop, early surgery for asymptomatic aortic stenosis remains controversial. This study aimed to compare the outcomes of early surgery versus conservative strategy for patients with asymptomatic severe aortic stenosis. METHODS: MEDLINE and EMBASE were searched through February 2020 to identify clinical trials that investigated early surgery and conservative strategy for patients with asymptomatic severe aortic stenosis. From each study, we extracted the hazard ratio of all-cause mortality and cardiovascular mortality. Subgroup analyses were conducted by dividing into severe aortic stenosis (peak aortic jet velocity ≥4.0 m/s, mean aortic pressure gradient ≥40 mm Hg, or aortic valve area ≤1.0 cm2) and very severe aortic stenosis (peak aortic jet velocity ≥4.5 m/s, mean pressure gradient ≥50 mm Hg, or aortic valve area ≤0.75 cm2) groups. RESULTS: One randomized controlled trial and 7 observational studies were identified. Pooled analyses demonstrated that all-cause mortality and cardiovascular mortality for early surgery were significantly lower compared with conservative strategy (hazard ratio, 0.49; 95% confidence interval, 0.36-0.68; P < .0001, hazard ratio, 0.42; 95% confidence interval, 0.22-0.82; P = .01, respectively). Subgroup analyses showed significant reduction for early surgery in all-cause mortality (severe aortic stenosis: hazard ratio, 0.52; 95% confidence interval, 0.35-0.78; P = .001, very severe aortic stenosis: hazard ratio, 0.38; 95% confidence interval, 0.17-0.85; P = .02). CONCLUSIONS: We demonstrated that early surgery was associated with significant reduction in all-cause and cardiovascular mortality in patients with severe aortic stenosis. Further randomized trials are warranted to confirm our findings.
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Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Tratamiento Conservador/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Modelos de Riesgos Proporcionales , Índice de Severidad de la Enfermedad , Volumen Sistólico , Factores de TiempoRESUMEN
Background: Despite the rapid adoption of transcatheter aortic valve replacement (TAVR), aortic valve reintervention, particularly surgical TAVR valve explantation (TAVR explant), has not been well described. Methods: MEDLINE, Embase, and Web of Science were searched through July 2021 to identify observational studies and case series reporting clinical outcomes of TAVR explant. Data on the frequency of TAVR explant, patient demographic characteristics, clinical indications, operative data, and perioperative outcomes were extracted. Study-specific estimates were combined using one-group meta-analysis in a random-effects model. Results: A total of 10 studies were identified that included 1690 patients undergoing a TAVR explant. The frequency of TAVR explant among TAVR recipients was 0.4% (95% confidence interval [CI], 0.2%-0.6%). The mean patient age was 73.7 years (95% CI, 72.9-74.6 years). The mean Society of Thoracic Surgeons predicted risk of mortality was 5.9% (95% CI, 2.9%-8.8%) at the index TAVR and 8.1% (95% CI, 5.4%-10.8%) at TAVR explant. The mean time from implant to explant was 345.0 days (95% CI, 196.7-493.3 days). Among patients with documented device type, 59.8% (95% CI, 43.5%-76.0%) had a balloon-expandable valve and 40.2% (95% CI, 24.0%-56.5%) had a self-expandable valve. Concomitant procedures during TAVR explant were performed in 52.9% of patients (95% CI, 33.8%-72.0%), and the most common concomitant procedure was aortic repair (28.5%; 95% CI, 14.0%-42.9%). The 30-day mortality after TAVR explant was 16.7% (95% CI, 12.2%-21.2%). Conclusions: TAVR explant in patients with a failing TAVR appears to be rare; however, the clinical impact of TAVR explant is substantial. Implanters must be mindful of the need for a lifetime management strategy in younger and lower-risk patients when choosing the valve type for the initial procedure.
RESUMEN
OBJECTIVE: Although endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) significantly decreases perioperative mortality compared with open surgical repair (OSR), we have not concluded superiority between EVAR and OSR beyond the perioperative period. The aim of this study was to compare phase-specific survival after EVAR vs OSR. METHODS: The review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Embase and MEDLINE were searched up to November 2019 to identify randomized controlled trials and propensity score-matched studies that investigated ≥2-year all-cause mortality (primary outcome) after EVAR vs OSR for intact infrarenal AAA. For each study, the hazard ratio (HR) with 95% confidence interval (CI) of mortality for EVAR vs OSR was calculated using survival curves for the following specific phases: early term (0-2 years after repair), midterm (2-6 years after repair), long term (6-10 years after repair), and very long term (≥10 years after repair). The risk ratio (RR) in the perioperative (in-hospital or 30-day) period was also extracted. Phase-specific HRs or RRs were separately pooled using the random effects model. Sensitivity analyses were performed by removing one study at a time to confirm that our findings were not derived from any single study. Funnel plot asymmetry was also examined using the linear regression test. RESULTS: Our search identified four randomized controlled trials and seven propensity score-matched studies enrolling a total of 106,243 AAA patients assigned to EVAR (n = 53,123) or OSR (n = 53,120). The mortality after EVAR compared with OSR was significantly lower in the perioperative period (RR, 0.39; 95% CI, 0.29-0.51; P < .00001) and similar in the early-term period (HR, 0.93; 95% CI, 0.84-1.03; P = .16). Notably, significantly higher mortality was observed in the EVAR group compared with the OSR group in the midterm period (HR, 1.15; 95% CI, 1.03-1.29; P = .01). However, similar mortality was observed between the EVAR group and the OSR group in the long-term (HR, 1.06; 95% CI, 0.96-1.17; P = .27) and very-long-term (HR, 1.17; 95% CI, 0.93-1.47; P = .19) periods. In sensitivity analyses, the significant benefit of EVAR in the perioperative period and that of OSR in the midterm period were not changed. No funnel plot asymmetry was identified in all analyses. CONCLUSIONS: Compared with OSR, EVAR was associated with lower perioperative mortality and higher mortality in the midterm period for intact infrarenal AAA. The superiority of EVAR was absent in the early-term period, and the inferiority of EVAR in the midterm period disappeared in the long-term and very-long-term periods.