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Background/Objectives : To date, data regarding the characteristics and management of obstructive, stable coronary artery disease (CAD) encountered in patients undergoing transcatheter aortic valve implantation (TAVI) are sparse. The aim of the study was to analyze granular details, treatment, and outcomes of patients undergoing TAVI with obstructive, stable CAD from real-world practice. Methods : REVASC-TAVI (Management of myocardial REVASCularization in patients undergoing Transcatheter Aortic Valve Implantation with coronary artery disease) is an investigator-initiated, multicenter registry, which collected data from patients undergoing TAVI with obstructive stable CAD found during the pre-TAVI work-up. Results : A total of 2025 patients from 30 centers worldwide with complete follow-up were included in the registry. Most patients had single-vessel CAD (56.1%). An involvement of proximal coronary tracts was detected in 62.5% of cases, with 12.0% of patients having CAD in left main (LM). Most patients received percutaneous coronary intervention (PCI) (n = 1617, 79.9%), especially those with proximal CAD (90.4%). At 2 years, the rates of all-cause death [Kaplan-Meier (KM) estimates 20.1% vs. 18.8%, p log-rank = 0.86] and of the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure (KM estimates 29.7% vs. 27.5%, p log-rank = 0.82) did not differ between patients undergoing PCI and those who were not. Conclusions : Patients undergoing TAVI with obstructive CAD more commonly had a single-vessel disease and an involvement of proximal coronary tracts. They were commonly treated with PCI, with similar outcomes compared to those treated conservatively., Competing Interests: Thomas Pilgrim received research grants to the institution from Biotronik, Boston Scientific, and Edwards Lifesciences; and speaker/consultancy fees from Medtronic, Boston Scientific, Biotronik, and HighLifeSAS. Ole De Backer received institutional research grants and/or consulting fees from Abbott and Boston Scientific. Lars Sondergaard received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and SMT. Maurizio Taramasso is a consultant for Abbott, Edwards Lifesciences, Boston Scientific, Shenqi Medical, CoreMedic, MEDIRA, 4tech, Simulands, Occlufit, and MTEX. Corrado Tamburino is a consultant for Medtronic. All other authors have nothing to disclose.

Background: Data on the likelihood of left ventricle (LV) recovery in patients with severe LV dysfunction and severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) and its prognostic value are limited., Aims: We aimed to assess the likelihood of LV recovery following TAVI, examine its association with midterm mortality, and identify independent predictors of LV function., Methods: In our multicentre registry of 17 TAVI centres in Western Europe and Israel, patients were stratified by baseline LV function (ejection fraction [EF] >/≤30%) and LV response: no LV recovery, LV recovery (EF increase ≥10%), and LV normalisation (EF ≥50% post-TAVI)., Results: Our analysis included 10,872 patients; baseline EF was ≤30% in 914 (8.4%) patients and >30% in 9,958 (91.6%) patients. The LV recovered in 544 (59.5%) patients, including 244 (26.7%) patients whose LV function normalised completely (EF >50%). Three-year mortality for patients without severe LV dysfunction at baseline was 29.4%. Compared to this, no LV recovery was associated with a significant increase in mortality (adjusted hazard ratio 1.32; p<0.001). Patients with similar LV function post-TAVI had similar rates of 3-year mortality, regardless of their baseline LV function. Three variables were associated with a higher likelihood of LV recovery following TAVI: no previous myocardial infarction (MI), estimated glomerular filtration rate >60 mL/min, and mean aortic valve gradient (mAVG) (expressed either as a continuous variable or as a binary variable using the standard low-flow, low-gradient aortic stenosis [AS] definition)., Conclusions: LV recovery following TAVI and the extent of this recovery are major determinants of midterm mortality in patients with severe AS and severe LV dysfunction undergoing TAVI. Patients with no previous MI and those with an mAVG >40 mmHg show the best results following TAVI, which are at least equivalent to those for patients without severe LV dysfunction. (ClinicalTrials.gov: NCT04031274).

Background: The performance of latest iteration transcatheter aortic valve replacement platforms in patients with small aortic anatomy remains underexplored., Objectives: The aim of this study was to evaluate effectiveness and performance between the self-expanding (SE) Evolut PRO and PRO+ and the balloon-expandable (BE) SAPIEN ULTRA in patients with small aortic annuli., Methods: Data from the OPERA-TAVI (Comparative Analysis of Evolut PRO vs. SAPIEN 3 ULTRA Valves for Transfemoral Transcatheter Aortic Valve Implantation) registry were used, with 1:1 propensity score matching. Primary endpoints included 1-year effectiveness composite (all-cause mortality, disabling stroke, or heart failure hospitalization) and 30-day device-related (hemodynamic structural valve dysfunction and nonstructural valve dysfunction) outcomes., Results: Among 3,516 patients, 251 matched pairs with aortic annular area <430 mm 2 were assessed. The 1-year primary effectiveness outcome did not differ significantly between cohorts (SE 10.8% vs BE 11.2%; P = 0.91). The 30-day device-oriented composite outcome was more favorable in the Evolut PRO group (SE 4.8% vs BE 10.4%; P = 0.027). Notably, SE valve recipients showed higher rates of disabling stroke (SE 4.0% vs BE 0.0%; P < 0.01) and paravalvular leaks (mild or greater: SE 48.5% vs BE 18.6% [P < 0.001]; moderate: SE 4.5% vs BE 1.2% [P = 0.070]). The BE group had higher rates of prosthesis-patient mismatch (moderate or greater: SE 16.0% vs BE 47.1% [P < 0.001]; severe: SE 1.3% vs BE 5.7% [P = 0.197]) and more patients with residual mean gradients >20 mm Hg (SE 1.0% vs BE 13.5%; P < 0.001)., Conclusions: In patients with small aortic annuli, transcatheter aortic valve replacement with latest iteration devices is safe. SE platforms are associated with more favorable device performance in terms of hemodynamic structural and nonstructural dysfunction. Randomized data are needed to validate these findings and guide informed device selection., Competing Interests: Funding Support and Author Disclosures Dr Scotti has served as a consultant for Edwards Lifesciences and NeoChord. Dr Pilgrim has received research, travel, or educational grants to the institution without personal remuneration from Biotronik, Boston Scientific, Edwards Lifesciences, and ATSens; and has received speaker fees and consultancy fees to the institution from Biotronik, Boston Scientific, Edwards Lifesciences, Abbott, Medtronic, Biosensors, and Highlife. Dr Meier has received an institutional grant from Edwards Lifesciences. Dr Barbanti is a consultant for Boston Scientifics, Edwards Lifesciences, and Medtronic. Dr Latib has served on advisory boards for Medtronic, Abbott Vascular, Boston Scientific, Edwards Lifesciences, Shifamed, NeoChord, VDyne, and Philips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Evidence regarding sex-related differences in response to transcatheter aortic valve implantation according to the valve type is lacking. This study sought to evaluate the impact of sex on the treatment effect of Evolut-PRO/PRO+ (PRO) or Sapien 3 Ultra (ULTRA) devices on clinical outcomes. Comparative Analysis of Evolut PRO vs Sapien 3 Ultra Valves for Transfemoral Transcatheter Aortic Valve Implantation (OPERA-TAVI) is a multicenter multinational registry including patients undergoing latest-iteration PRO or ULTRA implantation. Overall, 1174 out of 1897 patients were matched based on valve type and compared according to sex, while 470 males and 630 females were matched and compared according to valve type. Thirty-day and 1-year outcomes were evaluated. In both PRO and ULTRA group, males had a higher comorbidity burden, while females had smaller aortic root. Both 30-day (device success [DS], early safety outcome, permanent pacemaker implantation [PPI], patient-prosthesis mismatch [PPM], paravalvular regurgitation [PVR], bleedings, vascular complications, and all-cause death) and 1-year outcomes (all-cause death, stroke and heart failure hospitalization) did not differ according to sex in both valve groups. However, male sex decreased the likelihood of 30-day DS with ULTRA versus PRO (p for interaction 0.047). A higher risk of 30-day PPI and 1-year stroke, and a lower risk of PPM was observed in PRO versus ULTRA, regardless of sex. In conclusion, sex did not modify the treatment effect of PRO versus ULTRA on clinical outcomes, with the exception of 30-day DS that was decreased in males (versus females) receiving ULTRA (versus PRO)., (Copyright © 2024. Published by Elsevier Inc.)

Background: The optimal timing to perform percutaneous coronary interventions (PCI) in transcatheter aortic valve implantation (TAVI) patients remains unknown., Aims: We sought to compare different PCI timing strategies in TAVI patients., Methods: The REVASC-TAVI registry is an international registry including patients undergoing TAVI with significant, stable coronary artery disease (CAD) at preprocedural workup. In this analysis, patients scheduled to undergo PCI before, after or concomitantly with TAVI were included. The main endpoints were all-cause death and a composite of all-cause death, stroke, myocardial infarction (MI) or rehospitalisation for congestive heart failure (CHF) at 2 years. Outcomes were adjusted using the inverse probability treatment weighting (IPTW) method., Results: A total of 1,603 patients were included. PCI was performed before, after or concomitantly with TAVI in 65.6% (n=1,052), 9.8% (n=157) or 24.6% (n=394), respectively. At 2 years, all-cause death was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (6.8% vs 20.1% vs 20.6%; p<0.001). Likewise, the composite endpoint was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (17.4% vs 30.4% vs 30.0%; p=0.003). Results were confirmed at landmark analyses considering events from 0 to 30 days and from 31 to 720 days., Conclusions: In patients with severe aortic stenosis and stable coronary artery disease scheduled for TAVI, performance of PCI after TAVI seems to be associated with improved 2-year clinical outcomes compared with other revascularisation timing strategies. These results need to be confirmed in randomised clinical trials.

Background: The safety of concomitant percutaneous coronary intervention (PCI) during transcatheter aortic valve implantation (TAVI) setting is still highly debated. This study aimed to assess the safety and the effectiveness of TAVI and PCI performed in the same session compared with TAVI alone., Methods: Patients with severe aortic stenosis and coronary artery disease (CAD) (N.=786) who underwent TAVI from June 2007 to April 2021 were divided into two groups: patients who underwent TAVI alone (N.=633) and patients treated with TAVI and concomitant PCI (N.=153). The propensity-score matching adjustment was used to account for baseline confounding variables., Results: A total of 302 TAVI with CAD patients (151 matched pairs), undergoing either isolated TAVI or TAVI+PCI were compared. In-hospital death (6% vs. 4%; P=0.427), stroke (2% vs. 0.7%; P=0.314), myocardial infarction (MI) (0% vs. 0.7%; P=0.317), major and life-threatening bleeding (14.6% vs. 15.9%; P=0.749), and acute kidney injury (9.3% vs. 10.6%; P=0.700) were similar for both groups. At 3 years, the rates of all-cause death (25.2% vs. 19.2%; P=0.615), the composite endpoints of all-cause death and MI (27.2% vs. 21.2%; P=0.699) and all-cause death, MI, and stroke (28.5% vs. 22.5%; P=0.739) were also comparable between the two groups. Achieving complete coronary revascularization in the TAVI setting did not impact on long-term mortality (P=0.257)., Conclusions: In patients with severe aortic stenosis and CAD, concomitant TAVI and PCI was as safe and effective as TAVI alone up to 3-year follow-up.

Competing Interests: Funding Support and Author Disclosures Dr Barbanti is consultant for Boston Scientifics, Edwards Lifesciences, and Medtronic. Dr Tamburino is consultant for Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Competing Interests: Funding Support and Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: The best management of stable coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is still unclear due to the marked inconsistency of the available evidence., Methods: The REVASC-TAVI registry (Management of Myocardial Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation With Coronary Artery Disease) collected data from 30 centers worldwide on patients undergoing TAVI who had significant, stable CAD at preprocedural work-up. For the purposes of this analysis, patients with either complete or incomplete myocardial revascularization were compared in a propensity score matched analysis, to take into account of baseline confounders. The primary and co-primary outcomes were all-cause death and the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure, respectively, at 2 years., Results: Among 2407 patients enrolled, 675 pairs of patients achieving complete or incomplete myocardial revascularization were matched. The primary (21.6% versus 18.2%, hazard ratio' 0.88 [95% CI, 0.66-1.18]; P =0.38) and co-primary composite (29.0% versus 27.1%, hazard ratio' 0.97 [95% CI, 0.76-1.24]; P =0.83) outcome did not differ between patients achieving complete or incomplete myocardial revascularization, respectively. These results were consistent across different prespecified subgroups of patients (< or >75 years of age, Society of Thoracic Surgeons score > or <4%, angina at baseline, diabetes, left ventricular ejection fraction > or <40%, New York Heart Association class I/II or III/IV, renal failure, proximal CAD, multivessel CAD, and left main/proximal anterior descending artery CAD; all P values for interaction >0.10)., Conclusions: The present analysis of the REVASC-TAVI registry showed that, among TAVI patients with significant stable CAD found during the TAVI work-up, completeness of myocardial revascularization achieved either staged or concomitantly with TAVI was similar to a strategy of incomplete revascularization in reducing the risk of all cause death, as well as the risk of death, stroke, myocardial infarction, and rehospitalization for heart failure at 2 years, regardless of the clinical and anatomical situations.

Background: Head-to-head comparisons of devices for transcatheter aortic valve implantation (TAVI) are mostly limited to 2-arm studies so far. The aim of this study was to compare simultaneously outcomes of the most used, second- and third-generation transcatheter aortic valves in a real-world population., Methods: A total of 2728 patients undergoing TAVI with different second- and third-generation devices, and enrolled in the multicenter, prospective OBSERVANT II study (Observational Study of Effectiveness of TAVI With New Generation Devices for Severe Aortic Stenosis Treatment) from December 2016 to September 2018 were compared according to the transcatheter aortic valve received. Outcomes were adjudicated through a linkage with administrative databases, and adjusted using inverse propensity of treatment weighting. The primary end point was the composite of all-cause death, stroke and rehospitalization for heart failure at 1-year. Rates were reported consecutively for Evolut R, Evolut PRO, SAPIEN 3, ACURATE neo, and Portico groups., Results: The primary end point did not differ among groups (23.9% versus 24.7% versus 21.5% versus 23.7% versus 27.4%, respectively, P =0.56). Permanent pacemaker implantation was significantly lower for patients receiving SAPIEN 3 (19.9% versus 19.3% versus 12.5% versus 14.7% versus 22.1%, respectively, P <0.01) at 1 year. The SAPIEN 3 had lower rates of paravalvular regurgitation (moderate-to-severe grade 10.1% versus 5.0% versus 2.1% versus 13.1% versus 10.8%, respectively, P <0.01) but higher transprosthetic gradients (median mean gradients 7.0 versus 6.0 versus 10.0 versus 7.0 versus 8.0 mm Hg, respectively, P <0.01) after TAVI., Conclusions: Data from real-world practice showed low and comparable rates of complications after TAVI considering all the available devices. Patients receiving SAPIEN 3 valve had lower rates of paravalvular regurgitation and permanent pacemaker implantation, but higher transprosthetic gradients.

New insights into the natural history and pathophysiology of patients with aortic stenosis (AS), coupled with the dramatic evolution of transcatheter aortic valve implantation (TAVI), are fuelling intense interest in the management of asymptomatic patients with severe AS. This patient presenting for elective intervention poses a unique challenge. These patients are not traditionally offered surgical aortic valve replacement or TAVI given their lack of symptoms; however, they are at increased risk given the severity of their AS. Furthermore, clinical experience has shown that symptoms can be challenging to ascertain in many sedentary, deconditioned, and/or elderly patients. In addition, evolving data based on imaging and biomarker evidence of adverse ventricular remodelling, hypertrophy, inflammation, or fibrosis may radically transform existing clinical decision paradigms. However, management of asymptomatic severe AS is otherwise controversial and the decision to intervene requires careful assessment of the benefits and risks in an individual patient. Further randomized trials [EARLY TAVI (NCT03042104), AVATAR (NCT02436655), EVOLVED (NCT03094143)] will help determine future recommendations., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Data on outcomes of transcatheter aortic valve replacement (TAVR) using balloon-expandable valves (BEVs) or self-expandable valves (SEVs) as well as the impact of center valve preference on these outcomes are limited., Objectives: The aim of this study was to compare outcomes of TAVR procedures using third-generation BEVs and SEVs stratified by center valve preference., Methods: In a multicenter registry (n = 17), 13 centers exhibited valve preference (66.6%-90% of volume) and were included. Outcomes were compared between BEVs and SEVs stratified by center valve preference., Results: In total, 7,528 TAVR procedures (3,854 with SEVs and 3,674 with BEVs) were included. The mean age was 81 years, and the mean Society of Thoracic Surgeons score was 5.2. Baseline characteristics were similar between BEVs and SEVs. Need for pacemaker implantation was higher with SEVs at BEV- and SEV-dominant centers (17.8% vs 9.3% [P < 0.001] and 12.7% vs 10.0% [P = 0.036], respectively; HR: 1.51; P for interaction = 0.021), risk for cerebrovascular accident was higher with SEVs at BEV-dominant but not SEV-dominant centers (3.6% vs 1.1% [P < 0.001] and 2.2% vs 1.4% [P = 0.162]; HR: 2.08; P for interaction < 0.01). Aortic regurgitation greater than mild was more frequent with SEVs at BEV-dominant centers and similar with BEVs regardless of center dominance (5.2% vs 2.8% [P < 0.001] and 3.4% vs 3.7% [P = 0.504], respectively). Two-year mortality was higher with SEVs at BEV-dominant centers but not at SEV-dominant centers (21.9% vs 16.9% [P = 0.021] and 16.8% vs 16.5% [P = 0.642], respectively; HR: 1.20; P for interaction = 0.032)., Conclusions: Periprocedural outcomes, aortic regurgitation greater than mild, and 2-year mortality are worse when TAVR is performed using SEVs at BEV-dominant centers. Outcomes are similar regardless of valve type at SEV-dominant centers. The present results stress the need to account for this factor when comparing BEV and SEV outcomes. (The Aortic+Mitral Transcatheter [AMTRAC] Valve Registry; NCT04031274)., Competing Interests: Funding Support and Author Disclosures Dr Van Miegham has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi-Sankyo; and has received advisory fees from Abbott, Boston Scientific, Ancora, Medtronic, PulseCath BV, and Daiichi-Sankyo. Dr Barbanti has received consulting fees from Edwards Lifesciences. Dr Grasso is a proctor for Abbott Vascular. Dr De Backer has received research grants and consulting fees from Abbott and Boston Scientific. Dr Andreas is a proctor for Abbott and Edwards Lifesciences; and has received advisory board fees from Medtronic. Dr Estévez-Loureiro is a consultant for Abbott Vascular and Boston Scientific. Dr Nombela-Franco has received consulting fees from Edwards Lifesciences; and is a proctor for Abbott. Dr Søndergaard has received consulting fees and/or institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and SMT. Dr Amat-Santos is a proctor for Boston Scientific. Dr Finkelstein is a proctor for Edwards Lifesciences and Medtronic; and has received consulting fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures Dr Tamburino is a consultant for Medtronic. Dr Barbanti is a consultant for Medtronic, Edwards Lifesciences, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Objectives: Obesity may increase the risk of vascular complications in transfemoral (TF) transcatheter aortic valve replacement (TAVR) procedures. The transcarotid (TC) approach has recently emerged as an alternative access in TAVR. We sought to compare vascular complications and early clinical outcomes in obese patients undergoing TAVR either by TF or TC vascular access., Methods: Multicentre registry including obese patients undergoing TF- or TC-TAVR in 15 tertiary centres. All patients received newer-generation transcatheter heart valves. For patients exhibiting unfavourable ileo-femoral anatomic characteristics, the TC approach was favoured in 3 centres with experience with it. A propensity score analysis was performed for overcoming unbalanced baseline covariates. The primary end point was the occurrence of in-hospital vascular complications (Valve Academic Research Consortium-2 criteria)., Results: A total of 539 patients were included, 454 (84.2%) and 85 (15.8%) had a TF and TC access, respectively. In the propensity-adjusted cohort (TF: 442 patients; TC: 85 patients), both baseline and procedural valve-related characteristics were well-balanced between groups. A significant decrease in vascular complications was observed in the TC group (3.5% vs 12% in the TF group, odds ratio: 0.26, 95% CI: 0.07-0.95, P = 0.037). There were no statistically significant differences between groups regarding in-hospital mortality (TC: 2.8%, TF: 1.5%), stroke (TC: 1.2%, TF: 0.4%) and life-threatening/major bleeding events (TC: 2.8%, TF: 3.8%)., Conclusions: In patients with obesity undergoing TAVR with newer-generation devices, the TC access was associated with a lower rate of vascular complications. Larger randomized studies are warranted to further assess the better approach for TAVR in obese patients., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery.)

Background: To assess the longitudinal changes in transcatheter aortic valve implantation (TAVI) practice and patients' outcomes in a high-volume Italian center., Methods: We analyzed all patients undergoing TAVI at our Institution from June 2007 to August 2021. We stratified the overall population considering four time periods according to procedural advancements and changes in clinical practice: period 1 (2007-2009, n=107) vs period 2 (2010-2014, n=449) vs period 3 (2015-2019, n=864) vs period 4 (2019-2021, n=638). Baseline and procedural characteristics, and in-hospital outcomes among the four groups were compared., Results: A total of 2058 patients underwent TAVI receiving all the available devices. Patients had a median age of 82 years (78-85) with no differences among time periods. A stepwise reduction of median Society of Thoracic Surgeons mortality risk score (3.7 [2.8-5.3] vs 3.6 [2.6-5.4] vs 3.6 [2.5-5.5] vs 3.3 [2.2-4.9]; p=0.01) was observed. In-hospital all-cause-death (7.5% vs 5.1% vs 2.9% vs 3.0%; p<0.05), major stroke (4.7% vs 0.7% vs 1.0% vs 0.8%; p<0.05), major vascular complications (17.8% vs 8.7% vs 10.5% vs 5.8%; p<0.05) and permanent pacemaker implantation (23.4% vs 12.0% vs 8.7% vs 8.8%; p<0.05) rates significantly lowered over time. Device success markedly improved (80.4% vs 87.1% vs 95.0% vs 96.3%; p<0.05) with significant improvement of paravalvular regurgitation after TAVI (moderate-to-severe 16.8% vs 8.1% vs 0.7% vs 0.2%; mild 61.4% vs 38.2% vs 38.5% vs 25.6%; p<0.05)., Conclusions: All-cause death and in-hospital outcomes of patients undergoing TAVI significantly improved accordingly to technical advancements and changes in clinical practice over 15-year experience.

Objective: To compare vascular complications in patients undergoing percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) using ultrasound guidance (USG) versus fluoroscopy guidance (FSG) for femoral access., Background: In patients undergoing PCI, using the arterial femoral access increases the risk of vascular complications compared using the radial access. USG reduces time to access, number of attempts, and vascular complications compared with FSG, but the efficacy of USG has never been tested in the setting of CTO-PCI., Methods: A total of 197 patients undergoing CTO-PCI using at least a femoral vascular access from November 2015 to September 2020 were screened. The primary outcome was a composite of local hematoma, pseudoaneurysm, retroperitoneal hemorrhage, arteriovenous fistula or hemoglobin drop ≥3 g/dL during hospitalization. The independent association between USG and the primary outcome of interest was explored., Results: The primary outcome occurred in 17.3% of patients. Patients in the USG group had a significantly lower incidence of vascular complications compared with patients in the FSG group (8.5% vs. 21.0%, p = 0.039), driven by a reduction of localized hematomas (3.4% vs 13.0%, p = 0.042). After adjustment for type of CTO approach and heparin dose, USG was significantly associated with a reduced relative risk of the composite primary outcome (adjusted odds ratio 0.16, 95% confidence interval 0.05 to 0.51; p = 0.002)., Conclusion: USG in CTO-PCI is associated with a decreased risk of vascular complications, primarily driven by a reduction in local hematomas, especially in complex CTO-PCI where the larger use of heparin increases the risk of vascular complications., Competing Interests: Declaration of competing interest Corrado Tamburino is consultant for Medtronic and received speaker honoraria from Meril. Davide Capodanno declares consulting fees from Bayer, Daiichi Sankyo, and lecture fees from AstraZeneca, Biotronik, Daiichi Sankyo, Medtronic, Menarini. Alessio La Manna is proctor for Kardia srl, Terumo Italia and GADA spa. The other coauthors do not have any conflict of interest related to this study., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: The coronavirus 2019 (COVID-19) pandemic upset healthcare systems and their logistics worldwide. We sought to assess safety and effectiveness of an optimized logistics for transcatheter aortic valve implantation (TAVI) pathway developed during the COVID-19 pandemic., Methods: This is a retrospective analysis. An optimized TAVI logistics based on performing TAVI work-up and procedure during the same hospitalization was used during the COVID-19 pandemic. In-hospital and 30-day outcomes of patients treated during the pandemic were compared with an historical cohort of patients undergoing TAVI with staged work-up before the pandemic within an homogeneous timeframe., Results: Of 536 patients, 227 (42.4%) underwent TAVI during the COVID-19 pandemic with a reduction of 26.5% compared to the pre-pandemic period (n = 309). The median age was 81 (77-85) years and STS score was 3.4 (2.2-5.6)%. Lower rates of in-hospital major vascular complications (2.2% vs. 8.7%; p < 0.01) and life-threatening bleeding (0.4% vs. 4.2%; p = 0.01) were reported in the COVID-19 period, whereas no difference in acute kidney injury (7.0% vs. 7.4%, p = 0.85) rate was reported between COVID-19 and pre-COVID-19 periods. No difference in 30-day rates of all-cause death (4.0 vs. 4.5, p = 0.75) and of major adverse cardiovascular events (4.0 vs. 6.1, p = 0.26) were reported between COVID-19 and pre-COVID-19 periods., Conclusions: The use of optimized single-hospitalization logistics for TAVI workup and procedure developed during the COVID-19 pandemic, showed to be as safe and effective as the two-stage TAVI pathway previously adopted, allowing the minimization of potential exposure to COVID-19 infection and shortening times to treatment for severely symptomatic patients., (Copyright © 2022. Published by Elsevier B.V.)

Background: The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing., Aims: The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients <70 years old., Methods: All patients undergoing TAVI (n=8,626) from the 18 participating centres between January 2007 and June 2020 were stratified by age (70). For patients <70, the indications for TAVI were extracted from Heart Team discussions and the baseline characteristics and mortality were compared between the two groups., Results: Overall, 640 (7.4%) patients were <70 (9.1% during 2018-2020, p<0.001); the mean age was 65.0±2.3 years. The younger patients were more often male, with bicuspid valves or needing valve-in-valve procedures. They had a higher prevalence of lung disease and diabetes. In 80.7% of cases, the Heart Team estimated an increased surgical risk and TAVI was selected, reflected by an STS score >4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the <70 and >70 groups. In the <70 group, mortality was higher for those referred for TAVI due to an increased surgical risk compared to those referred for other reasons (31.6 vs 24.5%, HR 1.23, p=0.021). Mortality was similar regardless of the STS stratum in patients judged by the Heart Team to be at increased surgical risk (32.6 vs 30.4%, HR 0.98, p=0.715)., Conclusions: Use of TAVI in patients <70 is becoming more frequent. The main reason for choosing TAVI is due to an increased surgical risk not adequately represented by the STS score. The outcomes for these patients are similar to those for older TAVI patients. Dedicated trials of TAVI/SAVR in younger patients are needed to guide decisions concerning expansion of TAVI indications. ((ClinicalTrials.gov: NCT04031274).

Transcatheter aortic valve implantation (TAVI) has revolutionised the treatment of severe, symptomatic aortic stenosis and it is now a proven and effective alternative to surgery for patients regardless of preoperative risk stratification. Nevertheless, the consequent expansion towards younger patients with longer life expectancy focuses attention on long-term considerations. In particular, although the prevalence of coronary artery disease has been shown to decrease with the lowering of estimated risk stratification, the chance of requirement of future coronary interventions after TAVI increases dramatically as a function of patients' life expectancy. To date, however, only a few studies have investigated the feasibility and reproducibility of coronary artery cannulation after TAVI. Different conditions related mainly to aortic root anatomy and specific transcatheter aortic valve (TAV) designs and deployment have been associated with impaired coronary access after TAVI. In the present review, we will examine the conditions that may make coronary access after TAVI more challenging or even impossible.

Objectives: To compare clinical outcomes of balloon-expandable (BE) and self-expanding (SE) transcatheter aortic valves (TAVs) up to 5 years., Background: To date, no robust, comparative data of BE and SE TAVs at long-term are available., Methods: We considered a total of 1,440 patients enrolled in the multicenter OBSERVANT study and undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI) with either supra-annular SE (n = 830, 57.6%) and intra-annular BE (n = 610, 42.4%) valves. Clinical outcomes of the two groups were compared after adjustment using inverse probability of treatment weighting (IPTW) and confirmed by sensitivity analysis with propensity score matching., Results: Patients receiving SE valve showed a higher all-cause mortality at 5 years (Kaplan-Meier estimates 52.3% vs. 47.7%; Hazard ratio [HR] 1.18, 95% confidence interval [CI] 1.01-1.38, p = .04). Landmark analyses showed that there was a not statistically significant reversal of risk excess against the BE group starting from 3 years after TAVI (3-5 years HR 0.97, 95% CI 0.76-1.25, p = .86). Post-procedural, moderate/severe paravalvular regurgitation (PVR)(HR 1.46, 95% CI 1.14-1.87; p < .01) and acute kidney injury (AKI)(HR 3.89, 95% CI 2.47-6.38; p < .01) showed to be independent predictors of 5-year all-cause mortality in multivariable analysis., Conclusions: Considering the intrinsic limitations of the OBSERVANT study, we found that patients undergoing TF-TAVI with a supra-annular SE valve had a higher all-cause mortality compared to those receiving an intra-annular BE valve at 5 years. A late catch up phenomenon of patients receiving the BE valve was observed beyond 3 years. Post-procedural moderate/severe PVR seems to play a crucial role in determining this finding. Comparative studies of new generation devices with longer follow-up are needed to evaluate the benefit of each specific TAV type., (© 2021 Wiley Periodicals LLC.)

Background: Vascular complications still represent an important issue after transcatheter aortic valve implantation (TAVI)., Aims: The aim of this study was to evaluate the effectiveness of upfront use of an adjunctive Angio-Seal (AS) plug-based system on top of suture-based devices (SBDs) for endovascular haemostasis after transfemoral (TF) TAVI., Methods: From January 2019 to April 2020, 332 consecutive patients with preprocedural computed tomography angiography (CTA) assessment underwent fully percutaneous TF-TAVI. The primary outcomes were 30-day major vascular complications and major or life-threatening (LT) bleeding due to endovascular closure system failure. A total of 246 TF-TAVI patients (123 pairs), undergoing either isolated SBD or SBD+AS, were matched using the propensity-score method., Results: At 30 days, patients receiving SBD+AS had lower rates of major/LT bleeding (1.6% vs 8.9%, odds ratio [OR] 0.17, 95% confidence interval [CI]: 0.04-0.78; p<0.01) and major vascular complications (1.6% vs 8.9%, OR 0.17, 95% CI: 0.04-0.78; p<0.01). In addition, the use of SBD+AS was associated with a significant cost saving related to the vascular event (mean difference -315.3 € per patient, 95% CI: -566.4 € to -64.1 €; p=0.01), and a higher probability of next-day discharge (NDD) after TAVI (30.9% vs 16.3%, OR 2.30, 95% CI: 1.25-4.25; p<0.01). No difference in all-cause 30-day mortality was observed (3.3% vs 1.6% for SBD and SBD+AS groups, respectively, OR 0.49, 95% CI: 0.09-2.74; p=0.41)., Conclusions: An upfront combined strategy with an additional AS plug-based device on top of SBDs was shown to reduce major vascular complications and major/LT bleeding due to closure system failure after TF-TAVI. This approach was associated with a cost saving and with a higher probability of NDD compared to the use of isolated SBD. Visual summary. Effectiveness of the upfront combined strategy for endovascular haemostasis in transfemoral transcatheter aortic valve implantation using Angio-Seal on top of a suture-based device (SBD) versus the isolated use of SBD. LT: life-threatening; TF-TAVI: transfemoral transcatheter aortic valve implantation.

Objectives: The aim of this study was to characterize the feasibility of coronary angiography (CA) and percutaneous coronary intervention (PCI) in acute settings among patients who have undergone transcatheter aortic valve replacement (TAVR)., Background: Impaired coronary access after TAVR may be challenging and particularly in acute settings could have deleterious consequences., Methods: In this international registry, data from patients with prior TAVR requiring urgent or emergent CA were retrospectively collected. A total of 449 patients from 25 sites with acute coronary syndromes (89.1%) and other acute cardiovascular situations (10.9%) were included., Results: Success rates were high for CA of the right coronary artery (98.3%) and left coronary artery (99.3%) and were higher among patients with short stent-frame prostheses (SFPs) than in those with long SFPs for CA of the right coronary artery (99.6% vs 95.9%; P = 0.005) but not for CA of the left coronary artery (99.7% vs 98.7%; P = 0.24). PCI of native coronary arteries was successful in 91.4% of cases and independent of valve type (short SFP 90.4% vs long SFP 93.4%; P = 0.44). Guide engagement failed in 6 patients, of whom 3 underwent emergent coronary artery bypass grafting and another 3 died in the hospital. Among patients requiring revascularization of native vessels, independent predictors of 30-day all-cause mortality were prior diabetes, cardiogenic shock, and failed PCI but not valve type or success of coronary engagement., Conclusions: CA or PCI after TAVR in acute settings is usually successful, but selective coronary engagement may be more challenging in the presence of long SFPs. Among patients requiring PCI, prior diabetes, cardiogenic shock, and failed PCI were predictors of early mortality., Competing Interests: Funding Support and Author Disclosures Dr Kim has received proctor and speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, Medtronic, and Meril Lifesciences. Dr Ludwig has received travel compensation from Edwards Lifesciences. Dr Möllmann has received proctor fees and/or speaker honoraria from Abbott, Biotronik, Edwards Lifesciences, and Boston Scientific. Dr Leuschner has received speaker honoraria from Medtronic. Dr Amat-Santos is a proctor for Boston Scientific; Dr Dabrowski has received proctor fees from Boston Scientific; and has received speaker fees from Boston Scientific, Abbott, Edwards Lifesciences, and Medtronic. Dr Rudolph has received proctor fees and/or lecture honoraria from Boston Scientific, Edwards Lifesciences, Medtronic, and Abbott. Dr Toggweiler is a consultant and/or proctor for New Valve Technology/Biosensors, Boston Scientific, Abbott, Medtronic, Carag, and Medira; has received institutional research grants from Boston Scientific and Fumedica; and holds equity in Hi-D Imaging. Dr Frank is a consultant for Edwards Lifesciences and Medtronic; and has received an institutional research grant from Edwards Lifesciences. Dr Webb is a consultant to Edwards Lifesciences; and has received research grants from Abbott, Boston Scientific, and Medtronic. Dr Barbanti is a consultant for Edwards Lifesciences; and an advisory board member for Medtronic. Dr Pilgrim has received research grants to the institution from Biotronik and Boston Scientific; has received speaker fees from Biotronik and Boston Scientific; is a consultant for HighLife SAS; and is a proctor for Medtronic and Boston Scientific. Dr Seiffert is a consultant for JenaValve and Boston Scientific; has received travel compensation from Abbott Vascular, Edwards Lifesciences, JenaValve, Boston Scientific, and Biotronik; and has received speaker honoraria from Medtronic. Dr Werner is a proctor for Medtronic; and has received speaker honoraria from Edwards Lifesciences, Boston Scientific, Medtronic. Dr Allali has received proctor and speaker fees from Boston Scientific. Dr Makkar has received consultant fees from Abbott; and has received research grants and consulting and speaker fees from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr Leuschner has received speaker honoraria from Medtronic. Dr Nef has received proctor or speaker honoraria from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Hamm is an advisory board member for Medtronic. Dr Sinning has received research grants from Boston Scientific, Edwards, and Medtronic; and has received speaker honoraria from Abbott, Abiomed, Boston Scientific, Edwards, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background There is a paucity of outcome data on patients who are morbidly obese (MO) undergoing transcatheter aortic valve replacement. We aimed to determine their periprocedural and midterm outcomes and investigate the impact of obesity phenotype. Methods and Results Consecutive patients who are MO (body mass index, ≥40 kg/m 2 , or ≥35 kg/m 2 with obesity-related comorbidities; n=910) with severe aortic stenosis who underwent transcatheter aortic valve replacement in 18 tertiary hospitals were compared with a nonobese cohort (body mass index, 18.5-29.9 kg/m 2 , n=2264). Propensity-score matching resulted in 770 pairs. Pre-transcatheter aortic valve replacement computed tomography scans were centrally analyzed to assess adipose tissue distribution; epicardial, abdominal visceral and subcutaneous fat. Major vascular complications were more common (6.6% versus 4.3%; P =0.043) and device success was less frequent (84.4% versus 88.1%; P =0.038) in the MO group. Freedom from all-cause and cardiovascular mortality were similar at 2 years (79.4 versus 80.6%, P =0.731; and 88.7 versus 87.4%, P =0.699; MO and nonobese, respectively). Multivariable analysis identified baseline glomerular filtration rate and nontransfemoral access as independent predictors of 2-year mortality in the MO group. An adverse MO phenotype with an abdominal visceral adipose tissue:subcutaneous adipose tissue ratio ≥1 (VAT:SAT) was associated with increased 2-year all-cause (hazard ratio [HR], 3.06; 95% CI, 1.20-7.77; P =0.019) and cardiovascular (hazard ratio, 4.11; 95% CI, 1.06-15.90; P =0.041) mortality, and readmissions (HR, 1.81; 95% CI, 1.07-3.07; P =0.027). After multivariable analysis, a (VAT:SAT) ratio ≥1 remained a strong predictor of 2-year mortality (hazard ratio, 2.78; P =0.035). Conclusions Transcatheter aortic valve replacement in patients who are MO has similar short- and midterm outcomes to nonobese patients, despite higher major vascular complications and lower device success. An abdominal VAT:SAT ratio ≥1 identifies an obesity phenotype at higher risk of adverse clinical outcomes.

Objectives: The purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR)., Background: MR is common in patients undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited., Methods: The registry consisted of 16 TAVR centers (n = 7,303). Outcomes of patients with ≥ moderate versus lesser grade MR after TAVR were compared., Results: In 1,983 (27.2%) patients, baseline MR grade was ≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio [HR]: 1.38; p = 0.008; HR: 1.02; p = 0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p < 0.001). In a propensity score-matched cohort (91 patients' pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p < 0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p = 0.097)., Conclusions: Risk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter [AMTRAC] Valve Registry [AMTRAC]; NCT04031274)., Competing Interests: Funding Support and Author Disclosures Dr. Barbanti has received consultant fees from Edwards Lifesciences. Dr. Grasso has served as a proctor for Abbott Vascular. Dr. De Backer has received research grants and consultant fees from Abbott and Boston Scientific. Dr. Andreas has served as a proctor for Abbott and Edwards Lifesciences; and has received advisory board fees from Medtronic. Dr. Estévez-Loureiro has served as a consultant for Abbott Vascular and Boston Scientific. Dr. Amat-Santos has served as a proctor for Boston Scientific. Dr. Nombela-Franco has received consultant fees from Edwards Lifesciences; and has served as a proctor for Abbott. Dr. Søndergaard has received consultant fees and institutional research from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Van Mieghem has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi-Sankyo; and has received advisory fees from Abbott, Boston Scientific, Ancora, Medtronic, PulseCath BV, and Daiichi-Sankyo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aim: To assess the outcome of nonagenarians patients receiving transcatheter aortic valve replacement (TAVR)., Methods: We aimed to stratify the overall population from an Italian, multicenter, observational project including a total of 3792 consecutive patients who underwent TAVR with CoreValve and Evolut R/PRO devices between April 2009 and October 2018, into four groups according to their age class (≥90 vs. 80-89 years vs. 70-79 vs. <70 years) and to compare outcomes up to 4 years after TAVR., Results: At 4 years, survival estimates showed no difference in terms of overall survival [Kaplan-Meier estimates (KM est.) 49.9 vs. 58.1% vs. 57.0 vs. 69.3%; Plogrank = 0.28] among the four groups. After 2 years from the procedure, landmark analysis showed an age-based difference in overall survival (KM est. 63.8 vs. 75.0% vs. 75.1 vs. 88.7%; Plogrank = 0.025) but no difference in terms of survival from cardiovascular death (KM est. 87.8 vs. 87.4% vs. 86.1 vs. 96.1%; Plogrank = 0.43). Finally, age itself was not correlated with overall mortality at 4 years (hazard ratio 1.06, 95% confidence interval 0.86-1.30, P = 0.591)., Conclusion: TAVR with self-expanding CoreValve and Evolut prostheses was demonstrated to have good long-term outcomes, regardless of the patient's age. At 4 years, no difference in overall mortality was reported among age-based groups, while a higher overall mortality was reported in nonagenarians after 2 years from the procedure. TAVR showed good long-term outcomes even in nonagenarian patients, and it could be the therapy of choice for selected elderly patients., (Copyright © 2020 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Objectives: The aim of this study was to describe baseline characteristics, and periprocedural and mid-term outcomes of patients undergoing transcatheter mitral valve interventions post-transcatheter aortic valve replacement (TAVR) and examine their clinical benefit., Background: The optimal management of residual mitral regurgitation (MR) post-TAVR is challenging., Methods: This was an international registry of 23 TAVR centers., Results: In total, 106 of 24,178 patients (0.43%) underwent mitral interventions post-TAVR (100 staged, 6 concomitant), most commonly percutaneous edge-to-edge mitral valve repair (PMVR). The median interval post-TAVR was 164 days. Mean age was 79.5 ± 7.2 years, MR was >moderate in 97.2%, technical success was 99.1%, and 30-day device success rate was 88.7%. There were 18 periprocedural complications (16.9%) including 4 deaths. During a median follow-up of 464 days, the cumulative risk for 3-year mortality was 29.0%. MR grade and New York Heart Association (NYHA) functional class improved dramatically; at 1 year, MR was moderate or less in 90.9% of patients (mild or less in 69.1%), and 85.9% of patients were in NYHA functional class I/II. Staged PMVR was associated with lower mortality versus medical treatment (57.5% vs. 30.8%) in a propensity-matched cohort (n = 156), but this was not statistically significant (hazard ratio: 1.75; p = 0.05)., Conclusions: For patients who continue to have significant MR, remain symptomatic post-TAVR, and are anatomically suitable for transcatheter interventions, these interventions are feasible, safe, and associated with significant improvement in MR grade and NYHA functional class. These results apply mainly to PMVR. A staged PMVR strategy was associated with markedly lower mortality, but this was not statistically significant. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter Valve Registry [AMTRAC]; NCT04031274)., Competing Interests: Author Disclosures Dr. Barbanti has received consultant fees from Edwards Lifesciences. Dr. De Backer has received research grants and consultant fees from Abbott and Boston Scientific. Dr. Sievert has received institutional honoraria, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Append Medical, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, CardiacDimensions, Cardimed, Celonova, Comed B.V., Contego, CVRx, Dinova, Edwards Lifesciences, Endologix, Hemoteq, Hangzhou Nuomao Medtech, Holistick Medical, Lifetech, Maquet Getinge Group, Medtronic, Mokita, Occlutech, Recor, RenalGuard, Terumo, Vascular Dynamics, Vectorious Medtech, Venus, Venock, and Vivasure Medical. Dr. Grasso has been a proctor for Abbott Vascular. Dr. Andreas has been a proctor for Abbott and Edwards Lifesciences; and has received advisory board fees from Medtronic. Dr. Guerrero has received research grant support from Edwards Lifesciences. Dr. Van Mieghem has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, PulseCath BV, and Daiichi-Sankyo; and advisory fees from Abbott, Boston Scientific, Ancora, Medtronic, PulseCath BV, and Daiichi-Sankyo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aortic stenosis (AS) is one of the most common valvular diseases in developed countries. Transcatheter aortic valve implantation (TAVI) has emerged as alternative to medical treatment or surgical aortic valve replacement (SAVR) in all symptomatic patients with severe AS. In 2002, Cribier performed the first human TAVI through a trans-septal approach in a 57-year-old man with severe AS. Since then, several trials have compared TAVI vs. SAVR over the years. Today, it is superior in terms of mortality to medical therapy in extreme-risk patients, non-inferior or superior to surgery in high-risk patients, and non-inferior to surgery and even superior when transfemoral access is possible in intermediate-risk patients. Interesting results emerged from the latest multicentre trials involving patients with severe AS who were at low risk for death from surgery, demonstrating that this therapy will be offered to younger people in the next future., (Published on behalf of the European Society of Cardiology. © The Author(s) 2020.)

Objectives: The aims of this study were to investigate the feasibility of coronary ostia cannulation after transcatheter aortic valve replacement (TAVR) and to assess potential predictors of coronary access impairment., Background: Certain data concerning the feasibility and reproducibility of coronary cannulation after TAVR are lacking., Methods: RE-ACCESS (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent) was an investigator-driven, single-center, prospective, registry-based study that enrolled consecutive patients undergoing TAVR using all commercially available devices. All patients underwent coronary angiography before and after TAVR. The primary endpoint was the rate of unsuccessful coronary ostia cannulation after TAVR. Secondary endpoints were the identification of factors associated with the inability to selectively cannulate coronary ostia after TAVR., Results: Among 300 patients enrolled in the RE-ACCESS study from December 2018 to January 2020, a total of 23 cases (7.7%) of unsuccessful coronary cannulation after TAVR were documented. This issue occurred in 22 of 23 cases with the use of Evolut R/PRO transcatheter aortic valves (TAVs) (17.9% vs. 0.4%; p < 0.01). In multivariate analysis, the use of Evolut R/PRO TAVs (odds ratio [OR]: 29.6; 95% confidence interval [CI]: 2.6 to 335.0; p < 0.01), the TAV-sinus of Valsalva relation (OR: 1.1 per 1-mm increase; 95% CI: 1.0 to 1.2; p < 0.01), and the mean TAV implantation depth (OR: 1.7 per 1-mm decrease; 95% CI: 1.3 to 2.3; p < 0.01) were found to be independent predictors of unsuccessful coronary cannulation after TAVR. A model combining these factors was demonstrated to predict with very high accuracy the risk for unsuccessful coronary cannulation after TAVR (area under the curve: 0.94; p < 0.01)., Conclusions: Unsuccessful coronary cannulation following TAVR was observed in 7.7% of patients and occurred almost exclusively in those receiving Evolut TAVs. The combination of Evolut TAV, a higher TAV-sinus of Valsalva relation, and implantation depth predicts with high accuracy the risk for unsuccessful coronary cannulation after TAVR. (Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent [RE-ACCESS]; NCT04026204)., Competing Interests: Author Relationship With Industry Dr. Barbanti is a consultant for Edwards Lifesciences; and is an advisory board member for Biotronik. Dr. Tamburino has received speaking honoraria from Medtronic, Abbott Vascular, Edwards Lifesciences, and Boston Scientific. Dr. Webb is a consultant to and has received research funding from Edwards Lifesciences, Abbott Vascular, Boston Scientific, and ViVitro Labs. Dr. Leon has received research grants from Boston Scientific, Edwards Lifesciences, and Medtronic; and is an unpaid member on the scientific advisory boards of Boston Scientific, Edwards Lifesciences, Gore, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to evaluate predictors and safety of next-day discharge (NDD) after transfemoral transcatheter aortic valve implantation (TF-TAVI) in unselected patients receiving either balloon-expandable or self-expanding devices., Methods and Results: From June 2007 to August 2018, 1,232 consecutive patients undergoing TF-TAVI were discharged alive from our institution. They had a mean age of 80.9±5.4 years and an intermediate estimated surgical mortality risk; they received either balloon-expandable (26.1%) or self-expanding prostheses (73.9%). We compared patients discharged within 24 hours from the procedure (n=160, 13.0%) with those discharged later, and accounted for confounding variables through a propensity matching adjustment. After adjustment, no differences in all-cause mortality (1.2% vs 0.0%, for NDD and no-NDD matched groups, respectively, p=0.16) or permanent pacemaker implantation (PPI) after TAVI (0.6% vs 0.6%, respectively) were encountered at 30 days. At one year, no difference in the composite endpoint of all-cause death and heart failure (HF) rehospitalisation was encountered (Kaplan-Meier [KM] estimates 91.9% vs 90.6% for NDD and no-NDD matched groups, respectively, p=0.69). After excluding patients with post-procedural major complications from the unmatched population, prior PPI (OR 2.06, 95% CI: 1.21-3.51; p<0.01) and availability of preprocedural computed tomography angiography (CTA) (OR 1.71, 95% CI: 1.15-2.54; p<0.01) were found to be predictors of NDD after TAVI., Conclusions: NDD in unselected patients after TF-TAVI using either balloon-expandable or self-expanding devices was demonstrated to be a safe strategy up to one year in the absence of procedural complications. Patients with prior PPI and undergoing preprocedural CTA had a higher chance of NDD.

Introduction : Transcatheter aortic valve implantation therapy is spreading rapidly, representing the standard of care in inoperable and high-risk patients, and a valid alternative in intermediate- and low-risk patients with severe symptomatic aortic stenosis. In this subset, the development and validation of noninvasive, quantitative, in vivo imaging modality, to monitor possible valve dysfunction is mandatory, in order to plan timely therapeutic interventions before the onset of symptoms. Areas covered : The implantation of transcatheter heart valves (THV) is increasing rapidly. As a consequence, THV dysfunction will become a major cause of cardiovascular morbidity after TAVI. Emergency repeat aortic valve replacement surgery is associated with a high rate of mortality compared with elective repeat surgery. In this context, early detection of THV dysfunction is therefore highly desirable. The review aims to examine the different diagnostic method to early detect THV dysfunction. Expert opinion : Most promising innovations in the diagnosis of early detection of THV dysfunction are evaluated, and the future outlook is explored. Waiting for upcoming evidence about the utility of CT, CMR, and PET on early detection of THV dysfunction, tailoring echocardiogram follow-up based on patients' characteristics is the desirable approach.

Transcatheter aortic valve-in-valve replacement has been recently reported as a less-invasive alternative to re-do surgery in patients with bioprosthetic valve failure. Although procedural success is achieved in the great majority of patients, this therapy is associated with several potential complications, and coronary occlusion is one of the most feared. This is a rare event, but it is associated with an extremely poor prognosis. In this review, the mechanisms, the identification of patients at high risk, the primary prevention strategies, and treatment of coronary occlusion will be discussed., (Copyright © 2019 Valvo, Costa and Barbanti.)

Transcatheter aortic valve replacement (TAVR) has recently emerged as an effective alternative to medical treatment or surgical aortic valve replacement in all symptomatic patients with severe aortic stenosis and high or prohibitive risk and in intermediate risk when transfemoral access is feasible. Patients undergoing TAVR are often at high risk for either bleeding or cerebrovascular complications, or both, so adjuvant antithrombotic therapies are commonly used before, during and after the procedure. Today, there is no clear evidence on the best antithrombotic regimen in this context. In this review, we will try to go through the mechanisms involved in bleeding and embolic complications and we will discuss the current points of antithrombotic treatment in patients during and after TAVR, with or without oral anticoagulation (OAC) indication.

Background Long-term data on durability of currently available transcatheter heart valves are sparse. We sought to assess the incidence of long-term (8-year) structural valve dysfunction and bioprosthetic valve failure in a cohort of patients with transcatheter aortic valve replacement ( TAVR ) who reached at least 5-year follow-up. Methods and Results Consecutive patients with at least 5-year follow-up available undergoing TAVR from June 4, 2007 to March 30, 2012 were included. Structural valve dysfunction and bioprosthetic valve failure were defined according to newly standardized European Association of Percutaneous Cardiovascular Interventions/ European Society of Cardiology/European Association for Cardio-Thoracic Surgery criteria and reported as cumulative incidence function to account for the competing risk of death. A total of 288 consecutive patients with a mean age of 80.7±5.3 years and with a mean Society of Thoracic Surgery mortality score of 8.1±5.1% were analyzed. Survival rate at 8 years was 29.8%. Mean pressure gradients decreased from 53.3±15.9 mm Hg (pre- TAVR ) to 10.5±4.5 mm Hg (in-hospital post- TAVR ) ( P<0.001). There was a small, not significant, increase in the transaortic gradient throughout follow-up. Bioprosthetic valve failure was observed in a total of 11 patients (8-year cumulative incidence function: 4.51%; 95% confidence interval , 1.95%-8.76%). Severe and moderate structural valve dysfunctions were reported in 7 patients (8-year cumulative incidence function: 2.39%; 95% confidence interval, 0.77%-5.71%) and 13 patients (8-year cumulative incidence function: 5.87%; 95% confidence interval , 3.06%-9.96%), respectively. Aortic valve reintervention (redo TAVR ) was successfully performed in 2 patients (0.7%) presenting with symptomatic severe restenosis and intraprosthetic regurgitation subsequent to endocarditis. Conclusions In an aged population of patients with symptomatic severe aortic stenosis treated with first-generation bioprostheses, TAVR was associated with a survival rate of 30% but low rates of bioprosthetic valve failure and structural valve dysfunction at 8 years.