Long-Term Outcomes of Transcatheter vs Surgical Aortic Valve Replacement: Meta-analysis of Randomized Trials.

Background: We aimed to perform a meta-analysis of randomized trials comparing long-term outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) for severe aortic stenosis. The short-term efficacy and safety of TAVR are proven, but long-term outcomes are unclear. Methods: We included randomized controlled trials comparing TAVR vs SAVR at the longest available follow-up. The primary end point was death or disabling stroke. Secondary end points were all-cause mortality, cardiac mortality, stroke, pacemaker implantation, valve thrombosis, valve gradients, and moderate-to-severe paravalvular leaks. The study is registered with PROSPERO (CRD42023481856). Results: Seven trials (N = 7785 patients) were included. Weighted mean trial follow-up was 5.76 ± 0.073 years. Overall, no significant difference in death or disabling stroke was observed with TAVR vs SAVR (HR, 1.02; 95% CI, 0.93-1.11; P = .70). Mortality risks were similar. TAVR resulted in higher pacemaker implantation and moderate-to-severe paravalvular leaks compared to SAVR. Results were consistent across different surgical risk profiles. As compared to SAVR, self-expanding TAVR had lower death or stroke risk (P interaction = .06), valve thrombosis (P interaction = .06), and valve gradients (P interaction < .01) but higher pacemaker implantation rates than balloon-expandable TAVR (P interaction < .01). Conclusions: In severe aortic stenosis, the long-term mortality or disabling stroke risk of TAVR is similar to SAVR, but with higher risk of pacemaker implantation, especially with self-expanding valves. As compared with SAVR, the relative reduction in death or stroke risk and valve thrombosis was greater with self-expanding than with balloon-expandable valves.

Efficacy and Safety of P2Y12 monotherapy vs standard DAPT in patients undergoing percutaneous coronary intervention: meta-analysis of randomized trials.

BACKGROUND: Debates persist regarding the optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in coronary artery disease (CAD). Recent trials have introduced a novel approach involving P2Y12 inhibitor monotherapy with ticagrelor or clopidogrel, after a short DAPT. However, the effectiveness and safety of this strategy remains to be established. We aimed to perform a meta-analysis comparing monotherapy with P2Y12 inhibitors versus standard DAPT in patients undergoing PCI at 12 months. METHODS: Multiple databases were searched. Six RCTs with a total of 24877 patients were included. The primary endpoint was all-cause mortality at 12 months of follow-up. The secondary endpoints were cardiovascular mortality, myocardial infarction, probable or definite stent thrombosis, stroke events, and major bleeding. The study is registered with PROSPERO (CRD42024499529). RESULTS: Monotherapy with P2Y12 inhibitor ticagrelor significantly reduced both allcause mortality (HR 0.71, 95 CI [0.55-0.91], P = 0.007) and cardiovascular mortality (HR 0.66, 95% CI [0.49-0.89], P = 0.006) compared to standard DAPT. In contrast, clopidogrel monotherapy did not demonstrate a similar reduction. The decrease in mortality associated with ticagrelor was primarily due to a lower risk of major bleeding (HR 0.56, 95% CI [0.43-0.72], P < 0.001), while the risk of myocardial infarction (MI) remained unchanged (HR 0.90, 95% CI [0.73-1.11], P = 0.32). The risk of stroke was found to be similar across treatments. CONCLUSIONS: In comparison to standard DAPT, P2Y12 inhibitor monotherapy with ticagrelor may lead to a reduced mortality. The clinical benefits are driven by a reduction of bleeding risk without ischemic risk trade-off.

Effectiveness of virtual reality on pain and anxiety in patients undergoing cardiac procedures: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Cardiac procedures often induce pain and anxiety in patients, adversely impacting recovery. Pharmachological approaches have limitations, prompting exploration of innovative digital solutions like virtual reality (VR). Although early evidence suggests a potential favourable benefit with VR, it remains unclear whether the implementation of this technology can improve pain and anxiety. We aimed to assess by a systematic review and meta-analysis the effectiveness of VR in alleviating anxiety and pain on patients undergoing cardiac procedures. METHODS: Our study adhered to the PRISMA method and was registered in PROSPERO under the code CRD42024504563. The search was carried out in the PubMed, Web of Science, Scopus, and the Cochrane Library databases in January 2024. Four randomized controlled trials were included (a total of 382 patients). Risk of bias was employed to assess the quality of individual studies, and a random-effects model was utilized to examine the overall effect. RESULTS: The results showed that VR, when compared to the standard of care, had a statistically significant impact on anxiety (SMD = -0.51, 95 % CI: -0.86 to -0.16, p = 0.004), with a heterogeneity I2 = 57 %. VR did not show a significant difference in terms of pain when compared to standard care (SMD= -0.34, 95 % CI: -0.75 to -0.07, p = 0.10). The included trials exhibited small sample sizes, substantial heterogeneity, and variations in VR technology types, lengths, and frequencies. CONCLUSIONS: VR effectively lowers anxiety levels in patients undergoing cardiac procedures, however, did not show a statistically significant difference on pain.