Outcomes of Transcatheter Aortic Valve Implantation Comparing Medtronic's Evolut PRO and Evolut R: A Systematic Review and Meta-Analysis of Observational Studies.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has become a broadly acceptable alternative to AV surgery in patients with aortic stenosis (AS). New valve designs are becoming available to address the shortcomings of their predecessors and improve clinical outcomes. METHODS: A systematic review and meta-analysis was carried out to compare Medtronic's Evolut PRO, a new valve, with the previous Evolut R design. Procedural, functional and clinical endpoints according to the VARC-2 criteria were assessed. RESULTS: Eleven observational studies involving N = 12,363 patients were included. Evolut PRO patients differed regarding age (p < 0.001), sex (p < 0.001) and STS-PROM estimated risk. There was no difference between the two devices in terms of TAVI-related early complications and clinical endpoints. A 35% reduction of the risk of moderate-to-severe paravalvular leak (PVL) favoring the Evolut PRO was observed (RR 0.66, 95%CI, [0.52, 0.86] p = 0.002; I2 = 0%). Similarly, Evolut PRO-treated patients demonstrated a reduction of over 35% in the risk of serious bleeding as compared with the Evolut R (RR 0.63, 95%CI, [0.41, 0.96]; p = 0.03; I2 = 39%), without differences in major vascular complications. CONCLUSIONS: The evidence shows good short-term outcomes of both the Evolut PRO and Evolut R prostheses, with no differences in clinical and procedural endpoints. The Evolut PRO was associated with a lower rate of moderate-to-severe PVL and major bleeding.

Comparative performance of transcatheter aortic valve-in-valve implantation versus conventional surgical redo aortic valve replacement in patients with degenerated aortic valve bioprostheses: systematic review and meta-analysis.

The objective of this report was to directly compare, by means of a systematic review and meta-analysis, redo surgical aortic valve replacement (re-sAVR) with valve-in-valve transcatheter aortic valve implantation (ViV TAVI) for patients with failed degenerated aortic bioprostheses. Multiple databases were screened for all available reports comparing ViV TAVI with re-sAVR in patients with failing degenerated aortic bioprostheses. The primary outcome was all-cause mortality determined from the longest available survival data. Five observational studies (n = 342) were included in the meta-analysis; patients in the ViV TAVI group were older and had a higher baseline risk compared to those in the re-sAVR group. Although there was no statistical difference in procedural mortality [risk ratio (RR) 0.74, 95% confidence interval (CI) 0.18-2.97; P = 0.67], 30-day mortality (RR 1.29, 95% CI 0.44-3.78; P = 0.64) and cardiovascular mortality (RR 0.91, 95% CI 0.30-2.70; P = 0.86) at a mean follow-up period of 18 months, cumulative survival analysis favoured surgery with borderline statistical significance (ViV TAVI versus re-sAVR: hazard ratio 1.91, 95% CI 1.03-3.57; P = 0.039). ViV TAVI was associated with a significantly lower rate of permanent pacemaker implantations (RR 0.37, 95% CI 0.20-0.68; P = 0.002) and shorter intensive care unit (P < 0.001) and hospital stays (P = 0.020). In contrast, re-sAVR offered superior echocardiographic outcomes: lower incidence of patient-prosthesis mismatch (P = 0.008), fewer paravalvular leaks (P = 0.023) and lower mean postoperative aortic valve gradients in the prespecified analysis (P = 0.017). The ViV TAVI approach is a safe and feasible alternative to re-sAVR that may offer an effective, less invasive treatment for patients with failed surgical aortic valve bioprostheses who are inoperable or at high risk. Re-sAVR should remain the standard of care, particularly in the low-risk population, because it offers superior haemodynamic outcomes with low mortality rates.

Systematic review and meta-analysis of randomized controlled trials assessing safety and efficacy of posterior pericardial drainage in patients undergoing heart surgery.

OBJECTIVES: To investigate the potential beneficial effects of posterior pericardial drainage in patients undergoing heart surgery. METHODS: Multiple online databases and relevant congress proceedings were screened for randomized controlled trials assessing the efficacy and safety of posterior pericardial drainage, defined as posterior pericardiotomy incision, chest tube to posterior pericardium, or both. Primary endpoint was in-hospital/30 days' cardiac tamponade. Secondary endpoints comprised death or cardiac arrest, early and late pericardial effusion, postoperative atrial fibrillation (POAF), acute kidney injury, pulmonary complications, and length of hospital stay. RESULTS: Nineteen randomized controlled trials that enrolled 3425 patients were included. Posterior pericardial drainage was associated with a significant 90% reduction of the odds of cardiac tamponade compared with the control group: odds ratio (95% confidence interval) 0.13 (0.07-0.25); P < .001. The corresponding event rates were 0.42% versus 4.95%. The odds of early and late pericardial effusion were reduced significantly in the intervention arm: 0.20 (0.11-0.36); P < .001 and 0.05 (0.02-0.10); P < .001, respectively. Posterior pericardial drainage significantly reduced the odds of POAF by 58% (P < .001) and was associated with significantly shortened (by nearly 1 day) overall length of hospital stay (P < .001). Reductions in postoperative complications translated into significantly reduced odds of death or cardiac arrest (P = .03) and numerically lower odds of acute kidney injury (P = .08). CONCLUSIONS: Posterior pericardial drainage is safe and simple technique that significantly reduces not only the prevalence of early pericardial effusion and POAF but also late pericardial effusion and cardiac tamponade. These benefits, in turn, translate into improved survival after heart surgery.