Resultados tras 5 años de cirugía o abordaje percutáneo en coronariopatía grave. Metanálisis de ensayos aleatorizados con reconstrucción del tiempo hasta el evento / Results beyond 5-years of surgery or percutaneous approach in severe coronary disease. Reconstructed time-to-event meta-analysis of randomized trials

Introducción y objetivos: Existe controversia sobre la mejor estrategia de revascularización en la enfermedad coronaria avanzada, incluidas la enfermedad del tronco coronario y la enfermedad multivaso. Varios metanálisis han comparado resultados a 5 años, pero no hay resultados después del quinto año. Se realizaron una revisión sistemática y un metanálisis de ensayos clínicos aleatorizados para comparar los resultados después del quinto año entre la cirugía de revascularización coronaria (CABG) y la intervención coronaria percutánea (ICP) con stents farmacoactivos.MétodosSe analizaron los ensayos clínicos publicados entre 2010 y 2023. El objetivo primario fue la mortalidad por cualquier causa. Las bases de datos originales se reconstruyeron a partir de las curvas de Kaplan-Meier simulando un metanálisis individual. Se realizaron comparaciones en ciertos puntos de corte (5 y 10 años). Se calculó la diferencia del tiempo medio de supervivencia restringida. Se aplicó el modelo de efectos aleatorios y de DerSimonian-Laird.ResultadosSe analizó a 5.180 pacientes. Durante los 10 años de seguimiento, las ICP muestran una mayor incidencia de mortalidad (HR=1,19; IC95%, 1,04-1,32; p=0,008). La ICP muestra un mayor riesgo de mortalidad a 5 años (HR=1,2; IC95%, 1,06-1,53; p=0,008), mientras que no hubo diferencias de 5 a 10 años (HR=1,03; IC95%, 0,84-1,26; p=0,76). La esperanza de vida de los pacientes sometidos a CABG fue ligeramente mayor (2,4 meses más).ConclusionesEntre los pacientes con enfermedad coronaria avanzada, incluidas la enfermedad del tronco coronario y la enfermedad multivaso, hubo mayor mortalidad tras una ICP que tras la CABG a los 10 años de seguimiento. En concreto, la ICP tiene mayor mortalidad durante los primeros 5 años y un riesgo comparable de 5 a 10 años. (AU)

Introduction and objectives: There is controversy about the optimal revascularization strategy in severe coronary artery disease (CAD), including left main disease and/or multivessel disease. Several meta-analyses have analyzed the results at 5-year follow-up but there are no results after the fifth year. We conducted a systematic review and meta-analysis of randomized clinical trials, comparing results after the fifth year, between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) using drug-eluting stents in patients with severe CAD.MethodsWe analyzed all clinical trials between January 2010 and January 2023. The primary endpoint was all-cause mortality. The databases of the original articles were reconstructed from Kaplan-Meier curves, simulating an individual-level meta-analysis. Comparisons were made at certain cutoff points (5 and 10 years). The 10-year restricted median survival time difference between CABG and PCI was calculated. The random effects model and the DerSimonian-Laird method were applied.ResultsThe meta-analysis included 5180 patients. During the 10-year follow-up, PCI showed a higher overall incidence of all-cause mortality (HR, 1.19; 95%CI, 1.04-1.32; P=.008)]. PCI showed an increased risk of all-cause mortality within 5 years (HR, 1.2; 95%CI, 1.06-1.53; P=.008), while no differences in the 5–10-year period were revealed (HR, 1.03; 95%CI, 0.84-1.26; P=.76). Life expectancy of CABG patients was slightly higher than that of PCI patients (2.4 months more).ConclusionsIn patients with severe CAD, including left main disease and/or multivessel disease, there was higher a incidence of all-cause mortality after PCI compared with CABG at 10 years of follow-up. Specifically, PCI has higher mortality during the first 5 years and comparable risk beyond 5 years. (AU)

Long-term outcomes comparison of mitral valve repair or replacement for secondary mitral valve regurgitation. An updated systematic review and reconstructed time-to-event study-level meta-analysis.

BACKGROUND AND AIM: The ideal surgical intervention for secondary mitral regurgitation (SMR), a disease of the left ventricle not the mitral valve itself, is still debated. We performed an updated systematic review and study-level meta-analysis investigating mitral valve repair (MVr) versus mitral valve replacement (MVR) for adult patients with SMR, with or without coronary artery disease (CAD). METHODS: PubMed, CENTRAL and EMBASE were searched for studies comparing MVr versus MVR. Randomized trial or observational studies were considered eligible. Primary endpoint was long-term mortality for any cause. Kaplan-Meier survival curves were reconstructed and compared with Cox linear regression. Landmark analysis and time-varying hazard ratio (HR) were analyzed. Sensitivity analyses included meta-regression and separate sub-analysis. A random effects model was used. RESULTS: Twenty-three studies (MVr=3,727 and MVR=2,839) were included. One study was a randomized trial, and 19 studies were adjusted. The mean weighted follow-up was 3.7±2.8 years. MVR was associated with significative greater late mortality (HR=1.26; 95 % CI, 1.14-1.39; P<0.0001) at 10-year follow-up. There was a time-varying trend showing an increased risk of mortality in the first 2 years after MVR (HR=1.38; 95 % CI, 1.21-1.56; P<0.0001), after which this difference dissipated (HR=0.94; 95 % CI, 0.81-1.09; P=0.41). Separate sub-analyses showed comparable long-term mortality in patients with concomitant coronary surgery ≥90 %, left ventricle ejection fraction ≤40 %, and sub-valvular apparatus preservation rate of 100 %. CONCLUSIONS: Compared to repair, MVR is associated with higher probability of mortality in the first 2 years following surgery, after which the two procedures showed comparable late mortality rate.

Very Long-term Outcome of Bilateral Internal Thoracic Artery in Diabetic Patients: A Systematic Review and Reconstructed Time-To-Event Meta-analysis.

The benefits of single (SITA) and bilateral internal thoracic arteries (BITA) in diabetics undergoing coronary bypass grafting (CABG) are conflicting. We undertook a study-level meta-analysis to compare early and long-term outcomes of both CABG configurations. PubMed, CENTRAL, and EMBASE were searched for studies comparing BITA versus SITA for isolated CABG surgery in diabetics. Randomized trials or observational studies were considered eligible for the analysis. Kaplan-Meier curves of long-term survival were reconstructed and compared with Cox linear regression; incidence rate ratios (IRR) with 95% confidence intervals (CI) for long-term survival were calculated. Landmark analysis and time-varying hazard ratio (HR) were analyzed. Odds ratios (OR) were extracted for early mortality, postoperative stroke, deep sternal wound infection (DSWI), and myocardial infarction (MI). A random effects meta-analysis was performed. Sensitivity analyses included leave-one-out-analyses and meta-regression. Thirteen studies (7332 patients) were included. Overall, at 20-year follow-up, BITA was associated with higher survival (HR = 0.77; 95% CI, 0.71-0.84; P < 0.0001). Time-varying HR and landmark analysis reported BITA was associated with a higher rate of 10-year survival (HR = 0.75, 95% CI 0.68-0.82, P < 0.0001), while from 10 to 20-year follow-up no difference was revealed (HR = 0.99, 95% CI 0.82-1.19, P = 0.93). There was no increase in early mortality, postoperative MI, stroke, or DSWI between the groups. At meta-regression, the higher the age, the higher the long-term overall survival in patients with BITA. In diabetics, the BITA approach is associated with improved 10-year survival with no increase in early mortality, MI, stroke, or DSWI. In the 10-20-year timeframe, BITA and SITA showed comparable survival.

Results beyond 5-years of surgery or percutaneous approach in severe coronary disease. Reconstructed time-to-event meta-analysis of randomized trials.

INTRODUCTION AND OBJECTIVES: There is controversy about the optimal revascularization strategy in severe coronary artery disease (CAD), including left main disease and/or multivessel disease. Several meta-analyses have analyzed the results at 5-year follow-up but there are no results after the fifth year. We conducted a systematic review and meta-analysis of randomized clinical trials, comparing results after the fifth year, between coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) using drug-eluting stents in patients with severe CAD. METHODS: We analyzed all clinical trials between January 2010 and January 2023. The primary endpoint was all-cause mortality. The databases of the original articles were reconstructed from Kaplan-Meier curves, simulating an individual-level meta-analysis. Comparisons were made at certain cutoff points (5 and 10 years). The 10-year restricted median survival time difference between CABG and PCI was calculated. The random effects model and the DerSimonian-Laird method were applied. RESULTS: The meta-analysis included 5180 patients. During the 10-year follow-up, PCI showed a higher overall incidence of all-cause mortality (HR, 1.19; 95%CI, 1.04-1.32; P=.008)]. PCI showed an increased risk of all-cause mortality within 5 years (HR, 1.2; 95%CI, 1.06-1.53; P=.008), while no differences in the 5-10-year period were revealed (HR, 1.03; 95%CI, 0.84-1.26; P=.76). Life expectancy of CABG patients was slightly higher than that of PCI patients (2.4 months more). CONCLUSIONS: In patients with severe CAD, including left main disease and/or multivessel disease, there was higher a incidence of all-cause mortality after PCI compared with CABG at 10 years of follow-up. Specifically, PCI has higher mortality during the first 5 years and comparable risk beyond 5 years.

Long-Term Outcomes Comparison Between Surgical and Percutaneous Coronary Revascularization in Patients With Multivessel Coronary Disease or Left Main Disease: A Systematic Review and Study Level Meta-Analysis of Randomized Trials.

Recent randomized trials comparing coronary artery bypass graft (CABG) with percutaneous coronary intervention (PCI) utilizing drug-eluting stents in patients with left main disease (LMD) and/or multivessel disease (MVD), reported conflicting results. We performed a study level meta-analysis comparing the 2 interventions for the treatment of LMD or MVD. Using electronic databases, we retrieved 6 trials, between January, 2010 and December, 2022. Five-years Kaplan-Meier curves of endpoints where reconstructed. Comparisons were made by cox-linear regression frailty model and by landmark analysis. A random-effect method was applied. A total of 8269 patients were included and randomly assigned to CABG (n = 4135) or PCI (n = 4134). During 5-years follow-up, PCI showed a higher incidence of all-cause mortality (hazard ratio [HR] 1.28; 95% confidence interval [CI], 1.11-1.47; P < 0.0001]), myocardial infarction (HR 1.84; 95% CI, 1.54-2.19; P < 0.0001) and repeat coronary revascularization (HR 1.96; 95% CI, 1.72-2.24; P < 0.0001). There was no long-term difference between the 2 interventions for cardiovascular death (P = 0.14) and stroke (P = 0.20), although the incidence of stroke was higher with CABG within 30-days from intervention (P < 0.0001). PCI was associated with an increased risk for composite endpoints (P < 0.0001) and major cerebral and cardiovascular events. (P < 0.0001). In conclusion, at 5-year follow-up, in patients with LMD and/or MVD there was a significant higher incidence of all-cause mortality, myocardial infarction and repeat revascularization with PCI compared to CABG. The incidence of stroke was higher with CABG during the postprocedural period, but no difference was found during 5-years follow-up. Longer follow-up is mandatory to better define outcome difference between the 2 interventions.

Redo Surgical Aortic Valve Replacement versus Valve-In-Valve Transcatheter Aortic Valve Implantation: A Systematic Review and Reconstructed Time-To-Event Meta-Analysis.

Objective. Valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) has emerged as a useful alternative intervention to redo-surgical aortic valve replacement (Redo-SVAR) for the treatment of degenerated bioprosthesis valve. However, there is no robust evidence about the long-term outcome of both treatments. The aim of this meta-analysis was to analyze the long-term outcomes of Redo-SVAR versus ViV-TAVI by reconstructing the time-to-event data. Methods. The search strategy consisted of a comprehensive review of relevant studies published between 1 January 2000 and 30 September 2022 in three electronic databases, PubMed, Cochrane Central Register of Controlled Trials (CENTRAL) and EMBASE. Relevant studies were retrieved for the analysis. The primary endpoint was the long-term mortality for all death. The comparisons were made by the Cox regression model and by landmark analysis and a fully parametric model. A random-effect method was applied to perform the meta-analysis. Results. Twelve studies fulfilled the eligibility criteria and were included in the final analysis. A total of 3547 patients were included. Redo-SAVR group included 1783 patients, and ViV-TAVI included 1764 subjects. Redo-SAVR showed a higher incidence of all-cause mortality within 30-days [Hazard ratio (HR) 2.12; 95% CI = 1.49−3.03; p < 0.0001)], whereas no difference was observed between 30 days and 1 year (HR = 1.03; 95% CI = 0.78−1.33; p = 0.92). From one year, Redo-SAVR showed a longer benefit (HR = 0.52; 95% CI = 0.40−0.67; p < 0.0001). These results were confirmed for cardiovascular death (HR = 2.04; 95% CI = 1.29−3.22; p = 0.001 within one month from intervention; HR = 0.35; 95% CI = 0.18−0.71; p = 0.003 at 4-years follow-up). Conclusions. Although the long-term outcomes seem similar between Redo-SAVR and ViV-TAVI at a five-year follow-up, ViV-TAVI shows significative lower mortality within 30 days. This advantage disappeared between 30 days and 1 year and reversed in favor of redo-SAVR 1 year after the intervention.

What if Valve-in-Valve TAVR fails? Is surgical re-replacement still an option in high-risk patients? A case report.

Redo surgical aortic valve replacement has been the gold standard for the treatment of degenerated bioprostheses; however it carries an inherent risk associated with a reoperative open heart surgery. Valve-in-Valve transcatheter aortic valve implantation (ViV-TAVI) has emerged as an alternative approach. Few articles in literature review transcatheter aortic valve replacement's failure rates, complications (i.e., valve dislocation, paravalvular leaks) and their surgical management. The rate of reoperations after a percutaneous approach is expected to increase, with the currently rising number of transcatheter procedures worldwide even in patients with a longer life expectancy. Valve dislocation is a rare but serious complication that can severely impact on the outcome of patients. Paravalvular leaks and structural valve degeneration are the most common causes of surgical re-intervention. We present the case of a complex patient with previous surgical aortic valve and ascending aorta replacement who underwent a transfemoral valve-in-valve TAVI for bioprosthesis degeneration, complicated by valve dislocation requiring surgical reoperation.

The early and long-term outcomes of coronary artery bypass grafting added to aortic valve replacement compared to isolated aortic valve replacement in elderly patients: a systematic review and meta-analysis.

In aged population, the early and long-term outcomes of coronary revascularization (CABG) added to surgical aortic valve replacement (SAVR) compared to isolated SAVR (i-SAVR) are conflicting. To address this limitation, a meta-analysis comparing the early and late outcomes of SAVR plus CABG with i-SAVR was performed. Electronic databases from January 2000 to November 2021 were screened. Studies reporting early-term and long-term comparison between the two treatments in patients over 75 years were analyzed. The primary endpoints were in-hospital/30-day mortality and overall long-term survival. The pooled odd ratio (OR) and hazard ratio (HR) with 95% confidence interval (CI) were calculated for in-early outcome and long-term survival, respectively. Random-effect model was used in all analyses. Forty-four retrospective observational studies reporting on 74,560 patients (i-SAVR = 36,062; SAVR + CABG = 38,498) were included for comparison. The pooled analysis revealed that i-SAVR was significantly associated with lower rate of early mortality compared to SAVR plus CABG (OR = 0.70, 95% CI 0.66-0.75; p < 0.0001) and with lower incidence of postoperative acute renal failure (OR = 0.65; 95% CI 0.50-0.91; p = 0.02), need for dialysis (OR = 0.65; 95% CI 0.50-0.86; p = 0.002) and prolonged mechanical ventilation (OR = 0.57; 95% CI 0.42-0.77; p < 0.0001). Twenty-two studies reported data of long-term follow-up. No differences were reported between the two groups in long-term survival (HR = 0.95; 95% CI 0.87-1.03; p = 0.23). CABG added to SAVR is associated with worse early outcomes in terms of early mortality, postoperative acute renal failure, and prolonged mechanical ventilation. Long-term survival was comparable between the two treatments.