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Few data exist on late vascular complications (VCs) after transfemoral (TF) transcatheter aortic valve implantation (TAVI). The objective of this study was to evaluate the incidence and predictors of late access site VC after TF TAVI. A total of 128 patients (mean age: 80 ± 8 years, women: 52%) who underwent TF TAVI without major VC were included. A femoral US-Doppler evaluation was performed in all patients at a median of 5 (3 to 15) months after the procedure, and 76 patients (59.4%) also had a preprocedural ultrasound (US)-Doppler examination. The impact of baseline and procedural factors (including the use of simple 2 Proglides or complex additional Proglide or Angioseal device on top of the 2 Proglide technique, hemostasis techniques, and the use of balloon dilation for optimizing femoral hemostasis) were evaluated. The follow-up US-Doppler evaluation detected 2 asymptomatic VCs (1.6%), and 5 (3.9%) patients exhibited significant femoral stenosis (peak systolic velocity [PSV] ≥300 cm/s). Female gender (p <0.001) and smaller femoral diameter (p = 0.045) were associated with higher femoral PSV values. In those patients who underwent a pre-TAVI femoral US-Doppler, the median PSV values after TAVI were higher compared with those obtained pre-TAVI (p <0.001), but similar results were found for the contralateral femoral arteries. A complex hemostasis technique or the use of balloon optimization at the puncture site was not associated with any increase in PSV values. In conclusion, percutaneous femoral hemostasis after TAVI was associated with a low rate of late VC. The results were similar irrespective of the hemostasis technique and the use of balloon dilation at the puncture site, but women and a smaller femoral size were associated with increased PSV values. Further studies are needed to determine the optimal femoral hemostasis technique in TAVI procedures., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: The femoral artery is the preferred vascular access to perform transcatheter aortic valve replacement (TAVR). However, the optimal alternative approach has not been elucidated in patients who are not candidates for a transfemoral (TF) access. The objective of this study was to compare the outcomes of TAVR performed by the transcarotid (TC) compared with the TF approach., Methods: This was a single-center study that included 526 consecutive patients who underwent TAVR between 2015 and 2019. TC-TAVR was performed in 127 and TF-TAVR in 399 patients. Postprocedural and 30-day clinical events were evaluated according to main access (TC vs TF) using a multivariate logistic regression model. One-year survival and freedom from neurological events were also evaluated., Results: The prevalence of diabetes, chronic obstructive pulmonary disease, coronary artery disease, and peripheral vascular disease was higher in the TC group. In-hospital mortality (3.2% vs 2.0%, adjusted odds ratio, 1.83; 95% confidence interval, 0.47-7.15; P = .39), and 30-day stroke (2.4% vs 3.3%; odds ratio, 0.84; 95% confidence interval, 0.21-3.41; P = .81), were similar between groups as were other outcomes: procedural success (98.4% vs 97.0%; P = .52), 30-day cumulative mortality (4.8% vs 2.8%; P = .26), major vascular complication (2.4% vs 4.5%; P = .25), and major/life-threatening bleeding (4.7% vs 6.0%; P = .41) (TC vs TF, respectively). No differences were found among groups regarding survival or neurological events at 1-year follow-up., Conclusions: The TC approach is a safe alternate-access strategy for TAVR, and is associated with similar outcomes compared with TF-TAVR, despite a higher disease burden in TC patients., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: To determine the occurrence of vascular complications (VCs) following transfemoral transcatheter aortic valve replacement (TAVR) with new-generation devices according to the use of a crossover technique (COT)., Background: The use of a COT (with/without balloon) has been associated with a reduction of VCs in TAVR patients. However, scarce data support its use with second-generation devices. Also, its potential benefit in obese patients (at high-risk of VCs) has not been elucidated., Methods: A multicenter study including 2214 patients who underwent full percutaneous transfemoral TAVR (COT, 1522 patients; no COT, 692 patients). Thirty-day events were evaluated according to the use of a COT using a multivariate logistic regression model. A subanalysis was performed in obese patients., Results: Primary access major VCs (3.5% COT vs 3.9% no COT; P=.19), major/life-threatening bleeding (3.4% COT vs 2.0% no COT; P=.33), and mortality rates (2.4% COT vs 2.6% no COT; P=.23) were similar between groups. However, minor VCs (11.7% COT vs 5.9% no COT; P<.001) and postprocedural acute renal failure (8.9% COT vs 3.9% no COT; P<.001) were higher in patients undergoing the COT. In the overall cohort, percutaneous closure device failure was more frequent in obese patients (4.0% in the obese group vs 1.9% in the non-obese group; P<.01), but these differences were no longer significant in those undergoing a COT (3.4% in the obese group vs 2.0% in the non-obese group; P=.12). Indeed, in the subset of obese patients, the COT tended to be associated with fewer VCs (3.4% COT vs 5.9% no COT; P=.09)., Conclusions: The use of a COT was not associated with a reduction of major VCs or improved outcomes. However, some patient subsets, such as those with higher body mass index, may benefit from the use of a COT. These findings would suggest the application of a tailored strategy, following a risk-benefit assessment in each TAVR candidate.

Background: Transcarotid transcatheter aortic valve replacement (TAVR) recipients may be exposed to a higher ipsilateral subclinical cerebral ischemic burden compared with the contralateral hemisphere. We sought (1) to compare the cerebral ischemic burden of the 2 hemispheres after transcarotid TAVR, as evaluated by diffusion weighted-magnetic resonance imaging (DW-MRI), and (2) to identify the factors associated with ipsilateral ischemic burden., Methods: This prospective study included 52 patients undergoing transcarotid TAVR, followed by a DW-MRI examination. All DW-MRIs were analyzed offline by a radiologist blinded to the clinical data., Results: TAVR was performed through the left (n = 50) or right (n = 2) carotid artery. Procedural success was achieved in all patients, carotid dissection requiring patch closure occurred in 1 patient, and there were no periprocedural stroke events. At least 1 cerebral ischemic lesion was identified in the ipsilateral and contralateral hemisphere in 84.6% and 63.5% of patients, respectively (P = .005), and the number of ischemic lesions per patient was higher in the ipsilateral vs the contralateral hemisphere (2 [interquartile range, 1-5] vs 1 [interquartile range, 0-3], P = .005). The lesion volume (per lesion) and the average lesion volume (per patient) did not differ between the 2 hemispheres. A larger sheath/catheter size (≥18F vs ≤16F) was associated with a higher ipsilateral ischemic burden (P = .026)., Conclusions: Carotid artery access for TAVR was associated with a higher number of cerebral ischemic lesions in the ipsilateral (vs contralateral) cerebral hemisphere. The use of a larger sheath/delivery system (≥18F) was associated with an increased ipsilateral ischemic burden., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background Some concerns remain regarding the safety of transcarotid and transsubclavian approaches for transcatheter aortic valve replacement. We aimed to compare the risk of 30-day complications and death in transcarotid/transsubclavian versus transfemoral transcatheter aortic valve replacement recipients. Methods and Results Data from 20 studies, including 79 426 patients (16 studies) and 3992 patients (4 studies) for the evaluation of the unadjusted and adjusted impact of the arterial approach were sourced, respectively. The use of a transcarotid/transsubclavian approach was associated with an increased risk of stroke when using unadjusted data (risk ratio [RR], 2.28; 95% CI, 1.90-2.72) as well as adjusted data (odds ratio [OR], 1.53; 95% CI, 1.05-2.22). The pooled results deriving from unadjusted data showed an increased risk of 30-day death (RR, 1.46; 95% CI, 1.22-1.74) and bleeding (RR, 1.53; 95% CI, 1.18-1.97) in patients receiving transcatheter aortic valve replacement through a transcarotid/transsubclavian access (compared with the transfemoral group), but the associations between the arterial access and death (OR, 1.22; 95% CI, 0.89-1.69), bleeding (OR, 1.05; 95% CI, 0.68-1.61) were no longer significant when using adjusted data. No significant effect of the arterial access on vascular complication was observed in unadjusted (RR, 0.84; 95% CI, 0.66-1.06) and adjusted (OR, 0.79; 95% CI, 0.53-1.17) analyses. Conclusions Transcarotid and transsubclavian approaches for transcatheter aortic valve replacement were associated with an increased risk of stroke compared with the transfemoral approach. However, these nonfemoral arterial alternative accesses were not associated with an increased risk of 30-day death, bleeding, or vascular complication when taking into account the confounding factors.

Aims: This study sought to determine the timing and evolution over time of advanced conduction disturbances (CDs) in patients with baseline right bundle branch block (RBBB) undergoing transcatheter aortic valve replacement (TAVR)., Methods and Results: One hundred and ten consecutive patients with pre-existing RBBB were included (out of 1341, 8.2%). All arrhythmias during the hospitalization period were recorded. Follow-up was performed at 30 days, 1 year, and yearly thereafter. Conduction recovery and ventricular pacing percentage (VPP) was evaluated at 30 days in those patients with permanent pacemaker implantation (PPMI). Sixty-one (55.5%) patients suffered advanced CDs [97% complete or high-degree atrioventricular block (CHB/HAVB)], and the vast majority (98%) occurred within the first 3 days post-procedure (intraprocedural: 85%). Fifty-two (47.3%) patients had PPMI (vs. 11.0% in non-RBBB patients, P < 0.001). Ventricular pacing percentage at 1 month was higher in patients with persistent-intraprocedural CHB/HAVB compared to those with transient-intraprocedural or post-procedural CHB/HAVB [99 (interquartile range, IQR 97-100)% vs. 72 (IQR 30-99)%, P = 0.02]. Complete recovery (VPP < 1%) was observed in only one patient (2%) with CHB/HAVB. After hospital discharge, no symptomatic bradyarrhythmias or sudden death occurred within 30 days. Patients with pre-existing RBBB exhibited a higher risk of PPMI at 4-year follow-up (26% vs. 8% in non-RBBB patients, P < 0.001)., Conclusion: In patients with pre-existing RBBB, the vast majority of advanced CDs occurred within the 3 days following TAVR, and most did not recover at 1-month, particularly those with intra-procedural persistent CHB/HAVB. These results should help to determine the hospitalization length and timing of PPMI in RBBB patients undergoing TAVR., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background: Few and controversial data exist on the outcomes of patients with paradoxical low-flow, low-gradient aortic stenosis (PLFLG-AS) following transcatheter aortic valve replacement (TAVR). This study aims to better characterize clinical outcomes and predictors of treatment futility in PLFLG-AS patients undergoing TAVR., Methods: In this multicenter study, 318 patients with PLFLG-AS undergoing TAVR were categorized according to treatment futility, defined as all-cause mortality, poor functional status (NYHA class III-IV) or deterioration in functional class at 1-year follow-up. Clinical outcomes and the factors associated with treatment futility were assessed., Results: The mean age of the patients was 81.0 ± 8.3 years and 50.3% were women. At 1-year follow-up, 17.6% died and 12.9% had heart failure hospitalization. Residual impaired functional capacity (NYHA ≥ II) was present in 54.4% of patients who were alive at 1-year, and 9.8% remained in NYHA III/IV. The primary endpoint was observed in 103 (32.4%) patients, of which 54% died and 46% had a poor or worsening functional class. Factors independently associated with treatment futility were the presence of atrial fibrillation (AF) (OR:1.79, 95%CI, 1.04-3.10), chronic obstructive pulmonary disease (COPD) (OR:2.66, 95%CI, 1.50-4.74) and a lower SVi (OR per each decrease in 10 ml/m 2 :1.89, 95%CI, 1.06-3.45). The risk of treatment futility of patients with AF, COPD and a SVi < 30 ml/m 2 was 66.38% (95%CI, 54.29%-78.48%)., Conclusion: Close to one-third of patients with PLFLG-AS failed to derive a benefit from TAVR. The presence of AF, COPD and a low SVi were predictors of treatment futility. Being able to identify patients less likely to improve after the procedure may help to guide management and improve outcomes in patients with PLFLG-AS., Competing Interests: Declaration of competing interest Dr. Rodés-Cabau has received institutional research grants from Edwards Lifesciencies, Medtronic and Boston Scientific. Dr. Pibarot reports having Core Lab contracts with Edwards Lifesciences for which he receives no direct compensation, and receiving grants from Edwards Lifesciences and Medtronic during the conduct of the study. The rest of authors do not report any potential conflict of interest with respect to the content of this study., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objectives: This study sought to determine, using continuous electrocardiographic monitoring (CEM) pre-transcatheter aortic valve replacement (TAVR), the incidence and type of unknown pre-existing arrhythmic events (AEs) in TAVR candidates, and to evaluate the occurrence and impact of therapeutic changes secondary to the detection of AEs pre-TAVR., Background: Scarce data exist on the arrhythmic burden of TAVR candidates (pre-procedure)., Methods: This was a prospective study including 106 patients with severe aortic stenosis and no prior permanent pacemaker screened for TAVR. A prolonged (1 week) CEM was implanted within the 3 months pre-TAVR. Following heart team evaluation, 90 patients underwent elective TAVR., Results: New AEs were detected by CEM in 51 (48.1%) patients, leading to a treatment change in 14 of 51 (27.5%) patients. Atrial fibrillation or tachycardia was detected in 8 of 79 (10.1%) patients without known atrial fibrillation or tachycardia, and nonsustained ventricular arrhythmias were detected in 31 (29.2%) patients. Significant bradyarrhythmias were observed in 22 (20.8%) patients, leading to treatment change and permanent pacemaker in 8 of 22 (36.4%) and 4 of 22 (18.2%) patients, respectively. The detection of bradyarrhythmias increased up to 30% and 47% among those patients with pre-existing first-degree atrioventricular block and right bundle branch block, respectively. Chronic renal failure, higher valve calcification, and left ventricular dysfunction determined (or tended to determine) an increased risk of AEs pre-TAVR (p = 0.028, 0.052, and 0.069, respectively). New onset AEs post-TAVR occurred in 22.1% of patients, and CEM pre-TAVR allowed early arrhythmia diagnosis in one-third of them., Conclusions: Prolonged CEM in TAVR candidates allowed identification of previously unknown AEs in nearly one-half of the patients, leading to prompt therapeutic measures (pre-TAVR) in about one-fourth of them. Pre-existing conduction disturbances (particularly right bundle branch block) and chronic renal failure were associated with a higher burden of AEs., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The crossover balloon occlusion technique (CBOT) facilitates primary access hemostasis in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The CBOT is usually performed through the contralateral femoral artery. The aim of this study was to evaluate, in patients undergoing TAVR, the safety and feasibility of transradial CBOT using the new Oceanus balloon dilatation catheter (iVascular)., Methods: This multicenter study included 104 patients (mean age, 81 ± 7 years; 43% women) undergoing transfemoral TAVR. A modified CBOT through the radial artery was performed in all patients with the Oceanus balloon catheter. Data regarding transradial CBOT, balloon performance, vascular complications, and 30-day clinical events were recorded., Results: Up to 21% of patients had a height >170 cm and 17% presented with severe aortic/iliofemoral tortuosity. The transradial CBOT (left radial 74%, right radial 26%) was performed using either the 140 cm Oceanus (37.5%) or the 200 cm Oceanus (62.5%) balloon catheter. The balloon reached the femoral artery in all patients, and balloon inflation achieved an appropriate vessel closure in 98%. There were no complications related to the balloon catheter, and only 1 patient (1.0%) suffered a minor vascular complication related to the secondary radial access. The 30-day rates of primary access major vascular complications and death were 3.8% and 1.9%, respectively., Conclusion: In patients undergoing transfemoral TAVR, transradial CBOT with the Oceanus balloon dilatation catheter was feasible and safe. A balloon length up to 200 cm allowed the use of this technique (from right or left radial access) in all patients regardless of patient height or the presence of a challenging vascular anatomy.

Background: Conduction disturbances are the most frequent complication of transcatheter aortic valve replacement (TAVR). However, no data exists regarding the outcomes of intraprocedural high-degree atrioventricular block (HAVB) or complete heart block (CHB) in patients without previous conduction disturbances., Objectives: The aim of this study was to evaluate the outcomes of intraprocedural-HAVB/CHB in patients without previous intraventricular conduction disturbances., Methods: The occurrence of intraprocedural-HAVB/CHB was assessed in 676 consecutive patients undergoing TAVR, and two groups were established according to its duration: persistent-HAVB/CHB (PHAVB/CHB) and transient-HAVB/CHB (THAVB/CHB), not present at the end of the procedure., Results: Intraprocedural-HAVB/CHB occurred in 50 patients (7.4%), being persistent in 32 (64.0%), and transient in 18 (36.0%). The use of Medtronic Corevalve Revalving System (MCRS) and a greater oversizing of the valve increased the risk of intraprocedural-HAVB/CHB (p < 0.001). Permanent pacemaker implantation (PPI) was more frequent in the PHAVB/CHB than in the THAVB/CHB group (96.9% vs. 33.3%; p < 0.001). At 1-month follow-up, the PHAVB/CHB group showed a 98% ventricular pacing rate (VPR) compared to 16% in the THAVB/CHB group (p < 0.001), and similar VPR were observed at 1-year follow-up (98% vs. 37%, p < 0.001). Left ventricular ejection fraction (LVEF) decreased at 1-year follow-up in patients with PHAVB/CHB (-3.9 ± 1.8%, p = 0.003)., Conclusions: In TAVR recipients with no prior intraventricular conduction disturbances, intraprocedural-HAVB/CHB occurred in 7.4% of cases. HAVB/CHB was persistent in most cases and determined a high rate of PPI post-TAVR. Very high VPR at 1- and 12-month follow-up were observed, which in turn was associated with a negative effect on LVEF. These results support early PPI and close follow-up in patients developing intraprocedural-PHAVB/CHB., (© 2019 Wiley Periodicals, Inc.)

Objectives: We sought to assess the position of the CoreValve Evolut R/Pro (Medtronic) with respect to the left coronary artery (LCA) ostium and evaluate the impact of implantation depth on this relationship., Methods: One hundred consecutive patients who received an Evolut R/Pro valve and had an adequate angiography following valve implantation were included. Angiographic measurements included valve implantation depth, the position of the Evolut R/Pro with respect to the LCA, and the distance between the neo-valve cusp and the LCA ostium. Coronary access issues following TAVR were also recorded., Results: Regarding the LCA ostium, the neo-valve of the Evolut R/Pro was supraostial, at the ostial level, and infraostial in 3%, 12%, and 85% of cases, respectively. When beneath the LCA ostium, the mean distance between the neo-valve and the floor of the LCA ostium was 4.1 ± 5.2 mm. An implantation depth ≤6 mm was associated with a higher rate of neo-valve at the ostial level or above (25% vs 4% for implantation depth >6 mm; P=.01). Accessing the coronary arteries was required in 10% of the patients at 12 ± 8 months post TAVR, and selective coronary angiography of the left and right coronary arteries was achieved in 60% and 40% of the cases, respectively., Conclusions: The Evolut R/Pro neo-valve was positioned below the LCA ostium in the vast majority of cases (85%), but an implantation depth ≤6mm was associated with a higher rate of neo-valve positioning at or above the coronary ostia level. Considering the current tendency of very high (aortic) valve implants to avoid conduction disturbances, future studies should determine the impact of high Evolut R/Pro positioning on coronary access issues post TAVR.

The objective of this study was to determine the long-term (>1 year) electrocardiographic (ECG) and clinical outcomes of patients without significant changes in their electrocardiogram after transcatheter aortic valve implantation (TAVI; including patients with pre-existing ECG abnormalities). Among 772 consecutive patients who underwent TAVI in our institution, 397 patients (51%) without new ECG changes were included. TAVI patients were divided into 2 groups according to the presence of pre-existing ECG-conduction disturbances (ECG-CD: 140 patients, non-ECG-CD: 257 patients). Clinical follow-up (median: 35 [22 to 57] months) was complete in all patients but 5 (1.2%), and ECG data were available in 291 patients (84.3% of patients at risk) at a median of 29 (20 to 50) months. In the non-ECG-CD group, most patients (79.8%) remained without significant ECG changes at follow-up, and 16.9% developed first-degree atrioventricular block and/or bundle branch block over time. The rate of permanent pacemaker (PPM) implantation at follow-up was 3.5% (1.1%/year) in the non-ECG-CD group versus 15.7% (5.5%/year) in the ECG-CD group (p <0.001). The presence of pre-existing CD was an independent predictor of PPM at follow-up (hazard ratio [HR] 4.67, 95% confidence interval [CI] 2.15 to 10.16, p <0.001). The ECG-CD group exhibited a higher risk of heart failure hospitalization (non-ECG-CD: 25%, ECG-CD: 29%, log-rank p = 0.01), but not mortality (non-ECG-CD: 50%, ECG-CD: 46%, log-rank p = 0.60) at 5-year follow-up. In conclusion, the ECG remained unchanged in most TAVI recipients without new postprocedural CD. Pre-existing ECG-CD was associated with an increased risk of PPM and heart failure hospitalization at long-term follow-up. These results provide reassuring data in the era of TAVI expanding toward candidates with a longer life expectancy, and highlight the importance of a closer follow-up of those patients with pre-existing ECG-CDs., (Copyright © 2019 Elsevier Inc. All rights reserved.)