<span style="font-size:12pt"><span style="font-family:Aptos,sans-serif">The identification and management of patients at high bleeding risk (HBR) undergoing transcatheter aortic valve implantation (TAVI) are of major importance, but the lack of standardised definitions is challenging for trial design, data interpretation, and clinical decision-making. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) is a collaboration among leading research organisations, regulatory authorities, and physician-scientists from Europe, the USA, and Asia, with a major focus on TAVI-related bleeding. VARC-HBR is an initiative of the CERC (Cardiovascular European Research Center), aiming to develop a consensus definition of TAVI patients at HBR, based on a systematic review of the available evidence, to provide consistency for future clinical trials, clinical decision-making, and regulatory review. This document represents the first pragmatic approach to a consistent definition of HBR evaluating the safety and effectiveness of procedures, devices and drug regimens for patients undergoing TAVI.</span></span>.

Patients who are not candidates for traditional coronary artery bypass grafting (CABG) and amenable only for percutaneous coronary intervention (PCI) with stents can receive the "gold standard" left internal thoracic artery (LITA) to left anterior descending artery (LAD) anastomosis through robotic-assisted CABG and PCI to non-LAD coronary targets. We aimed to analyse clinical outcomes of robotic-assisted CABG. A total of 2,280 consecutive patients who had undergone robotic-assisted CABG between May 2005 and June 2021 were included in our study. Robotic-assisted LITA harvest was followed by LITA-LAD manual anastomosis through a 4 cm left thoracotomy. Hybrid coronary intervention (HCR) consists of stent implantation in a non-LAD coronary artery performed within 7 days after robotic-assisted LITA-LAD. We performed a propensity-adjusted analysis comparison after dividing all robotic-assisted CABG patients into three time periods: 2005-2010, 615 patients; 2011-2016, 904 patients; and 2017-2021, 761 patients. The mean age increased from 64.5 years in the first time period to 65.8 years in the second time period to 68.1 years in the third (p<0.0001). Operative time was progressively reduced in the three periods (6.4; 6.2; 5.5 hours; p<0.001). The incidence of conversion to sternotomy remained similar for each period (1.8%; 1.7%; 1.5%; p=0.53). Thirty-day mortality in the three periods included 9 (1.4%), 9 (1.0%), and 7 (0.9%) patients, respectively (p=0.91), while 8 (0.3%) patients had PCI with stents in the entire group. The mean follow-up for the entire population was 4.2 years. At follow-up, the rates of all-cause death, major adverse cardiac and cerebrovascular events, non-fatal stroke, and repeat revascularisation with stents were significantly decreased from the first to the last period (pË0.0001). Robotic-assisted CABG and HCR provides good long-term outcomes in patients who are not candidates for conventional CABG.

Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking. We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice. Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology. Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all pinteraction>0.10). One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.

Robotic-assisted percutaneous coronary intervention (rPCI) has proven to be feasible and safe. Comparative analyses of rPCI versus manual PCI (mPCI) are scarce. We aimed to investigate procedural aspects and outcomes of rPCI using the second-generation CorPath GRX Vascular Robotic System compared with mPCI in patients with chronic coronary syndrome and non-ST-segment elevation myocardial infarction acute coronary syndrome. From January to April 2021, 70 patients underwent rPCI at the University Heart & Vascular Center Hamburg-Eppendorf and were recruited into the INTERCATH study. By propensity score matching, a control cohort of 210 patients who underwent mPCI from 2015-2021 was identified. Co-primary endpoints were one-year all-cause mortality and major adverse cardiovascular events (MACE) as a composite of cardiovascular death, unplanned target lesion revascularisation, myocardial infarction, and stroke. The median age of the patients (n=280) was 70.7 (25th percentile-75th percentile: 62.0-78.0) years, and 24.6% were female. The Gensini score (28.5 [16.2-48.1] vs 28.0 [15.5-47.0]; p=0.78) was comparable between rPCI versus mPCI. During the PCI procedure, total contrast fluid volume did not differ, whilst longer fluoroscopy times (20.4 min [13.8-27.2] vs 14.4 min [10.4-24.3]; p=0.001) were documented in the rPCI versus mPCI cohort. After 12 months of follow-up, neither all-cause mortality (p=0.22) nor MACE (p=0.25) differed between the groups. rPCI was associated with longer fluoroscopy times compared with mPCI, though without increased use of contrast medium. One-year follow-up revealed no differences in all-cause mortality or MACE, supporting the safety of a robotic-assisted approach.