Background: Coronary access (CA) after transcatheter aortic valve replacement (TAVR) with supra-annular transcatheter heart valves (THV) can be challenging. Specific Evolut R/Pro and Acurate Neo THVs orientations are associated with reduced neo-commissure overlap with coronary ostia, while SAPIEN 3 THV cannot be oriented. With the ALIGN-ACCESS study (TAVR With Commissural Alignment Followed by Coronary Access), we investigated the impact of commissural alignment on the feasibility of CA after TAVR. Methods: We performed coronary angiography after TAVR with intra-annular SAPIEN 3, supra-annular Evolut R/Pro, and Acurate Neo THVs in 206 patients. Evolut THVs were implanted aiming for commissure alignment. Alignment of Acurate Neo was retrospectively assessed in 36, intentionally attempted in 26 cases. The primary end point was the rate of unfeasible and nonselective CA after TAVR. Results: Thirty-eight percent of patients received SAPIEN 3, 31.1% Evolut Pro/R, 30.1% Acurate Neo THV. Final valve orientation was favorable to commissural alignment in 85.9% of Evolut and 69.4% of Acurate Neo cases (with intentional alignment successful in 88.5%). Selective CA was higher for SAPIEN 3 than for aligned and misaligned supra-annular THVs (95% versus 71% versus 46%, P <0.001). Cannulation of at least one coronary was unfeasible with 11% misaligned supra-annular, 3% aligned supra-annular, and 0% SAPIEN 3 THVs. Independent predictors of unfeasible/nonselective CA were implantation of a misaligned supra-annular THV (odds ratio, 4.59 [95% CI, 1.81–11.61]; P <0.01), sinus of Valsalva height (odds ratio, 0.83 [95% CI, 0.7–0.98]; P =0.03), and THV–sinus of Valsalva relation (odds ratio, 1.06 [95% CI, 1.02–1.1]; P <0.01). Conclusions: Commissural alignment improves the rate of selective CA after TAVR with supra-annular THVs. Nevertheless, aligned supra-annular THVs carry higher risk of unfeasible/nonselective CA than SAPIEN 3. Patients with a misaligned supra-annular THV, low sinus of Valsalva, and higher THV–sinus of Valsalva relation are at highest risk of impaired CA after TAVR.

Background: Conduction disturbances after transcatheter aortic valve replacement (TAVR) are often transient. Limited data exist on anatomic factors predisposing to pacemaker dependency after TAVR. We sought to assess the rate and the possible predictors of pacemaker dependency after TAVR. Methods: Consecutive patients undergoing pacemaker implantation up to 30 days after TAVR between May 2014 and September 2019 were included. Baseline electrocardiographic, computed tomography, and procedural characteristics were collected, including valve implantation depth and membranous septum length, an anatomic surrogate of the distance between the aortic annulus and the His bundle. Pacemaker dependency at 30 days and 1 year and all-cause mortality during follow-up were evaluated. Results: Of 728 TAVR patients, 112 (53.5% men; median age, 81 years) underwent pacemaker implantation after TAVR. Of these, 44.6% (50 of 112) were pacemaker dependent at 30 days and 46.7% (36 of 77) at 1 year. By multivariate analysis, independent predictors of 30-day pacemaker dependency included left ventricular outflow tract calcifications under the left coronary cusp (odds ratio, 5.69 [95% CI, 1.45–22.31]; P =0.013) and a difference between membranous septum length and implantation depth (ΔMSID) ≥3 mm (odds ratio, 7.58 [95% CI, 2.07–27.78]; P =0.002). Conversely, membranous septum length and implantation depth alone were not associated with pacemaker dependency (odds ratio, 0.79 [95% CI, 0.60–1.05]; P =0.11 and odds ratio, 1.11 [95% CI, 0.99–1.24]; P =0.08). At a median follow-up of 28.1 (11.7–48.6) months, pacemaker-dependent patients did not show a worse survival ( P =0.26). Conclusions: Less than half of the patients undergoing pacemaker implantation after TAVR are pacemaker-dependent at midterm follow-up. ΔMSID ≥3 mm and the presence of left ventricular outflow tract calcifications under the left coronary cusp, but not membranous septum length nor implantation depth alone, are predictive of long-term pacemaker dependency after TAVR, thus influencing device selection and programming.

Objective To evaluate the role of the microaxial percutaneous mechanical circulatory support device (Impella® pump) implantation pre‐percutaneous coronary intervention (PCI) versus during/after PCI in cardiogenic shock (CS) and high‐risk PCI populations. Background A better understanding of the safety and effectiveness of the Impella and the role of timing of this support initiation in specific clinical settings is of utmost clinical relevance. Methods A total of 365 patients treated with Impella 2.5/CP in the 17 centers of the IMP‐IT Registry were included. Through propensity‐score weighting (PSW) analysis, 1‐year clinical outcomes were assessed separately in CS and HR‐PCI patients, stratified by timing of Impella support. Results Pre‐procedural insertion was associated with an improvement in 1‐year survival in patients with CS due to acute myocardial infarction (AMI) treated with PCI (p = .04 before PSW, p = .009 after PSW) and HR‐PCI (p < .01 both before and after PSW). Among patients undergoing HR‐PCI, early Impella support was also associated with a lower rate of the composite of mortality, re‐hospitalization for heart failure, and need for left‐ventricular assist device/heart transplantation at 1‐year (p = .04 before PSW, p = .01 after PSW). Furthermore, Impella use during/after PCI was associated with an increased in‐hospital life‐threatening and severe bleeding among patients with AMI‐CS receiving PCI (7 vs. 16%, p = .1) and HR‐PCI (1 vs. 9%, p = .02). Conclusions Our findings suggested a survival benefit and reduced rates of major bleeding when a pre‐PCI Impella implantation instead of during‐after procedure was used in the setting of HR‐PCI and AMI‐CS.

The impact of sex on pathophysiological processes, clinical presentation, treatment options, as well as outcomes of degenerative aortic stenosis remain poorly understood. Female patients are well represented in transfemoral aortic valve implantation (TAVI) trials and appear to derive favorable outcomes with TAVI. However, higher incidences of major bleeding, vascular complications, and stroke have been reported in women following TAVI. The anatomical characteristics and pathophysiological features of aortic stenosis in women might guide a tailored planning of the percutaneous approach. We highlight whether a sex‐based TAVI management strategy might impact on clinical outcomes. This review aimed to evaluate the impact of sex from diagnosis to treatment of degenerative aortic stenosis, discussing the latest evidence on epidemiology, pathophysiology, clinical presentation, therapeutic options, and outcomes. Furthermore, we focused on technical sex‐oriented considerations in TAVI including the preprocedural screening, device selection, implantation strategy, and postprocedural management.

Objective The aim of the study is to describe the real-world use of the P2Y₁₂ inhibitor cangrelor as a bridging strategy in patients at high thrombotic risk after percutaneous coronary intervention (PCI) and referred to surgery requiring perioperative withdrawal of dual antiplatelet therapy (DAPT). Materials and Methods We collected data from nine Italian centers on patients with previous PCI who were still on DAPT and undergoing nondeferrable surgery requiring DAPT discontinuation. A perioperative standardized bridging protocol with cangrelor was used. Results Between December 2017 and April 2019, 24 patients (mean age 72 years; male 79%) were enrolled. All patients were at high thrombotic risk after PCI and required nondeferrable intermediate to high bleeding risk surgery requiring DAPT discontinuation (4.6 ± 1.7 days). Cangrelor infusion was started at a bridging dose (0.75 µg/kg/min) 3 days before planned surgery and was discontinued 6.6 ± 1.5 hours prior to surgical incision. In 55% of patients, cangrelor was resumed at 9 ± 6 hours following surgery for a mean of 39 ± 38 hours. One cardiac death was reported after 3 hours of cangrelor discontinuation prior to surgery. No ischemic outcomes occurred after surgery and up to 30-days follow-up. The mean hemoglobin drop was <2 g/dL; nine patients received blood transfusions consistent with the type of surgery, but no life-threatening or fatal bleeding occurred. Conclusion Perioperative bridging therapy with cangrelor is a feasible approach for stented patients at high thrombotic risk and referred to surgery requiring DAPT discontinuation. Larger studies are warranted to support the safety of this strategy. ^* These authors contributed equally to this work. Received: 16 October 2019 Accepted: 02 November 2020 Publication Date: 23 December 2020 (online) © 2020. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/) Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany

The use of percutaneous right ventricular assist devices (pRVADs) to support patients with right ventricular (RV)-predominant cardiogenic shock (CS) refractory to optimal medical therapy is increasing progressively, and the Impella RP is the first FDA-approved pRVAD in such a clinical scenario. The aim of the present study is to report the outcomes of patients treated with Impella RP in the IMP-IT (IMPella Mechanical Circulatory Support Device in Italy) registry, a multicenter registry that evaluated the trends in use and clinical outcomes of the Impella in the setting of CS and high-risk percutaneous coronary intervention in Italy. A total of 15 patients who received Impella RP were enrolled. In 40% of the patients, the main cause was ST-segment elevation myocardial infarction. A total of 40% of patients required biventricular support with a left Impella. Device-related complications were reported in 46.7% of patients. Overall, the in-hospital mortality was 46.7%, whereas the one-year mortality was 53.3%. The composite rate of all-cause death, heart failure (HF) hospitalization, left ventricular assist device (LVAD) and heart transplant at one year was 60%. The Impella RP has favorable survival outcomes in RV-predominant cardiogenic shock. However, the device-related complications are frequent and should be carefully weighed when considering escalation to Impella RP.