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Introduction Despite considerable advances in the last decade, major adverse events remain a concern after transcatheter aortic valve implantation (TAVI). The aim of this study was to provide a detailed overview of their underlying causes and contributing factors in order to identify key domains for quality improvement. Methods This observational, prospective registry included all patients undergoing TAVI between 31 December 2015 and 1 January 2020 at the St. Antonius Hospital in Nieuwegein and the University Medical Centre in Utrecht. Outcomes of interest were all-cause mortality, stroke, major bleeding, life-threatening or disabling bleeding, major vascular complications, myocardial infarction, severe acute kidney injury and conduction disturbances requiring permanent pacemaker implantation within 30 days after TAVI, according to the Valve Academic Research Consortium‑2 criteria. Results Of the 1250 patients who underwent TAVI in the evaluated period, 146 (11.7%) developed a major complication. In 54 (4.3%) patients a thromboembolic event occurred, leading to stroke in 36 (2.9%), myocardial infarction in 13 (1.0%) and lower limb ischaemia in 11 (0.9%). Major bleeding occurred in 65 (5.2%) patients, most frequently consisting of acute cardiac tamponade (n = 25; 2.0%) and major access-site bleeding (n = 21; 1.7%). Most complications occurred within 1 day of the procedure. Within 30 days a total of 54 (4.3%) patients died, the cause being directly TAVI-related in 30 (2.4%). Of the patients who died from causes that were not directly TAVI-related, 14 (1.1%) had multiple hospital-acquired complications. Conclusion A variety of underlying mechanisms and causes form a wide spectrum of major threats affecting early safety in 11.7% of patients undergoing TAVI in a contemporary cohort of real-world patients.

Objectives: The purpose of this analysis was to compare target-lesion failure (TLF) of a permanent polymer zotarolimus-eluting stent (PP-ZES) versus a polymer-free amphilimus-eluting stent (PF-AES) in diabetics. Background:The improvement of outcomes with new-generation drug-eluting stent as seen in the general population is less pronounced among diabetics. The PF-AES introduces an elution-technology with potential enhanced performance in diabetics. Methods:In this subanalysis of the ReCre8 trial, patients were randomized to either a PP-ZES or PF-AES after stratification for diabetes and troponin status. The primary device-oriented endpoint was TLF, a composite of cardiac death, target-vessel myocardial infarction and target-lesion revascularization.Results: In the ReCre8 trial, 304 (20%) patients were diabetic and 96 (6%) had insulin-dependent diabetes mellitus. There was no statistically significant difference between the two study arms regarding the primary endpoint (PP-ZES 7.2% vs. PF-AES 4.0%; p = .21), although the composite of net adverse clinical events was higher in the PP-ZES arm (15.7 vs. 8.0%; p = .035). Stent thrombosis was low in both groups with no cases in the PP-ZES arm and 1 case in the PF-AES arm (p = .32). Regarding insulin-treated diabetics, TLF was higher in the PP-ZES arm (14.9 vs. 2.1%; p = .022).Conclusions: Diabetics could potentially benefit from a dedicated stent, releasing sirolimus with a lipophilic carrier (amphilimus-formulation). Future trials should confirm the potential benefit of a PF-AES in this population.

Background Multiple scores have been proposed to guide risk stratification after percutaneous coronary intervention. This study assessed the performance of the PRECISE-DAPT, PARIS and CREDO-Kyoto risk scores to predict post-discharge ischaemic or bleeding events. Methods A total of 1491 patients treated with latest-generation drug-eluting stent implantation were evaluated. Risk scores for post-discharge ischaemic or bleeding events were calculated and directly compared. Prognostic performance of both risk scores was assessed with calibration, Harrell’s c‑statistics net reclassification index and decision curve analyses. Results Post-discharge ischaemic events occurred in 56 patients (3.8%) and post-discharge bleeding events in 34 patients (2.3%) within the first year after the invasive procedure. C‑statistics for the PARIS ischaemic risk score was marginal (0.59, 95% confidence interval (CI) 0.51–0.68), whereas the CREDO-Kyoto ischaemic risk score was moderate (0.68, 95% CI 0.60–0.75). With regard to post-discharge bleeding events, CREDO-Kyoto displayed moderate discrimination (c-statistic 0.67, 95% CI 0.56–0.77), whereas PRECISE-DAPT (0.59, 95% CI 0.48–0.69) and PARIS (0.55, 95% CI 0.44–0.65) had a marginal discriminative capacity. Net reclassification index and decision curve analysis favoured CREDO-Kyoto-derived bleeding risk assessment. Conclusion In this contemporary all-comer population, PARIS and PRECISE-DAPT risk scores were not resilient to independent testing for post-discharge bleeding events. CREDO-Kyoto-derived risk stratification was associated with a moderate predictive capability for post-discharge ischaemic or bleeding events. Future studies are warranted to improve risk stratification with more focus on robustness and rigorous testing.

Background The prevalence of coronary artery disease (CAD) in patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation (TAVI) is high. However, the importance of a percutaneous coronary intervention (PCI) prior to TAVI has been matter of debate. Importantly, patients undergoing TAVI are characterized by high age often accompanied by highly calcified coronary arteries, increasing the risk of severe periprocedural complications. Moreover, patients with a severe aortic valve stenosis are limited in their ability to compensate for these life-threatening complications. Together with the necessity of dual antiplatelet therapy after PCI, this may explain a possible negative effect of PCI in this patient population. However, there is still insufficient evidence regarding the importance of PCI in patients undergoing TAVI. Purpose The aim of this systematic review and meta-analysis was to assess the need for PCI in patients with significant CAD undergoing TAVI. Methods A systematic search was conducted to identify studies comparing optimal medical treatment only versus PCI in patients with significant CAD undergoing TAVI. Endpoints were all-cause mortality, cardiac death, stroke, myocardial infarction, and major bleeding which were assessed at 30 days, one year, and beyond one year following TAVI. Results A total of 14 studies was included in this meta-analysis, including 3838 patients of which 1806 patients (47.1%) underwent PCI before TAVI. All-cause mortality was not significantly different between optimal medical treatment only and PCI at 30 days (OR: 1.27; 95% CI, 0.91–1.77; p=0.17; I2=0%), at one year (OR: 0.91; 95% CI, 0.64–1.29; p=0.59; I2=45%), and beyond one year (OR 0.68; 95% CI, 0.42–1.08; p=0.10; I2=49%). Cardiac death and myocardial infarction was similar across the groups at 30 days (OR cardiac death: 1.94; 95% CI, 0.36–10.56; p=0.45; I2=28%; OR myocardial infarction: 0.50; 95% CI, 0.13–1.91; p=0.31; I2=0%), and at one year (OR cardiac death: 0.77; 95% CI, 0.19–3.13; p=0.72; I2=84%; OR myocardial infarction: 0.74; 95% CI, 0.21–2.66; p=0.64; I2=18%). Stroke did not significantly differ between PCI and optimal medical treatment groups at 30 days (OR: 0.77; 95% CI, 0.31–1.92; p=0.57; I2=0%). However, patients that underwent TAVI without preceding PCI had significantly lower risk of major bleeding at 30 days (OR: 0.66; 95% CI, 0.46–0.94; p=0.022; I2=0%). Conclusion This systematic review and meta-analysis showed no significant differences in clinical outcomes between patients with and without PCI prior to TAVI at both short- and long-term follow-up, apart from a higher risk of major bleeding within 30 days in patients undergoing PCI before TAVI. Funding Acknowledgement Type of funding sources: None.