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Background: Cardiac tamponade caused by temporary right ventricular (RV) pacemaker perforation is a rare but serious complication in transcatheter aortic valve replacement (TAVR)., Aims: To study the incidence of temporary pacemaker related cardiac tamponade in TAVR, and the relation to the type of pacemaker lead used in periprocedural temporary transvenous pacing., Methods: A single center registry of transfemoral TAVRs in 2014-2020. Main inclusion criterion was peri-operative use of a temporary RV pacing lead. Main exclusion criteria were a preoperatively implanted permanent pacemaker or the exclusive use of left ventricular guidewire pacing. Incident cardiac tamponade was classified as pacemaker lead related, or other. Patients were grouped according to type of temporary RV pacing wire., Results: 810 patients were included (age 80.5 ± 7.3 [mean ± standard deviation], female 319, 39.4%). Of these, 566 (69.9%) received a standard RV temporary pacing wire (RV-TPW), and 244 (30.1%) received temporary RV pacing through a permanent, passive pacemaker lead (RV-TPPL). In total, 18 (2.2%) events of cardiac tamponade occurred, 12 (67%) were pacemaker lead related. All pacemaker lead-related cardiac tamponades occurred in the group who received a standard RV-TPW and none in the group who received RV-TPPL (n = 12 [2.1%] vs. n = 0 [0%], p = 0.022). No difference in cardiac tamponade due to other causes was seen between the groups (p = 0.82)., Conclusions: The use of soft-tip RV-TPPL was associated with a lower risk of pacemaker related cardiac tamponade in TAVR. When perioperative pacing is indicated, temporary RV-TPPL may contribute to a significant reduction of cardiac tamponade in TAVR., Competing Interests: Declaration of Competing Interest Dr. Feldt has received consulting/speaker fees from Abbott Vascular, Astra Zeneca, Anteris Technologies and Alleviant Medical. Dr. Dalén, Dr. Kastengren, Dr. Hörnsten, and Dr. Omar report no relationships that could be construed as a conflict of interest. Dr. Rück has served as a proctor for Boston Scientific and has received consulting fees from Medtronic and Edwards. Dr. Meduri has received consulting fees from Boston Scientific, Abbott Vascular, Cardiovalve, Vdyne, Alleviant and Anteris Technologies. Dr. Saleh and Dr. Linder report no relationships that could be construed as a conflict of interest. Dr. Settergren has served as a proctor for Boston Scientific, Abbott Vascular and has received consulting fees from Medtronic, Anteris Technologies, Holistic Medical, Cardiomech and Teleflex., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: Commissural alignment has become an important topic in transcatheter aortic valve replacement (TAVR) because it may improve coronary access, facilitate future valve procedures, and possibly improve valve durability. The efficacy of commissural alignment with ACURATE neo2 has not yet been shown in a large population., Objectives: The authors sought to determine the feasibility and success of attempting commissural alignment in an unselected TAVR population treated with the ACURATE neo2 prosthetic heart valve., Methods: A total of 170 consecutive patients underwent TAVR with a dedicated implantation technique to align the TAVR valve to the native valve. Using right-left overlap and 3-cusp views, valve orientation was adjusted by rotation of the unexpanded valve at the level of the aortic root. Effectiveness was assessed postprocedure as the degree of misalignment determined by analyzing fluoroscopic valve orientation to corresponding cusp orientation on preprocedural computed tomography. Safety endpoints included mortality, stroke/transient ischemic attack, and additional complications through 30 days., Results: Of 170 patients, 167 (98.2%) could be analyzed for alignment, and all 170, for safety outcomes. Most patients (97%) had successful alignment (≤ mild misalignment), with 80% with commissural alignment, while the degrees of misalignment were 17% mild, 1.2% moderate, 1.8% severe., Conclusions: In this large evaluation of a commissural alignment technique, alignment was achieved in nearly all patients without safety concerns or impact to procedure duration. Commissural alignment appears effective and safe across all patients with this novel technique., Competing Interests: Funding Support and Author Disclosures Boston Scientific helped fund this study. Dr Meduri is chief medical officer of Anteris Technologies; has received grants/research support from Boston Scientific; and has received honoraria or consultation fees from Abbott, Alleviant, Boston Scientific, Cardiovalve, VDyne, and XDot. Dr Rück has received grants from Boston Scientific; nonfinancial support from Boston Scientific during the conduct of the study; and personal fees from Boston Scientific and from Edwards Lifesciences, outside the submitted work. Dr Linder has been a proctor for Boston Scientific, and an advisory board member for Medtronic and Chiesi. Dr Settergren has been an advisory board member/consultant/proctor for Boston Scientific, Abbott Vascular, WL Gore, Edwards Lifesciences, Anteris, Holistick Medical, Cardiomech, Smartcella, Segulah, Protembis, and AstraZeneca. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Coronary artery disease (CAD) frequently coexists with severe aortic valve stenosis (AS) in patients planned for transcatheter aortic valve implantation (TAVI). How to manage CAD in this patient population is still an unresolved question. In particular, it is still not known whether fractional flow reserve (FFR) guided revascularization with percutaneous coronary intervention (PCI) is superior to medical treatment for CAD in terms of clinical outcomes., Study Design: The third Nordic Aortic Valve Intervention (NOTION-3) Trial is an open-label investigator-initiated, multicenter multinational trial planned to randomize 452 patients with severe AS and significant CAD to either FFR-guided PCI or medical treatment, in addition to TAVI. Patients are eligible for the study in the presence of at least 1 significant PCI-eligible coronary stenosis. A significant stenosis is defined as either FFR ≤0.80 and/or diameter stenosis >90%. The primary end point is a composite of first occurring all-cause mortality, myocardial infarction, or urgent revascularization (PCI or coronary artery bypass graft performed during unplanned hospital admission) until the last included patient have been followed for 1 year after the TAVI., Summary: NOTION-3 is a multicenter, multinational randomized trial aiming at comparing FFR-guided revascularization vs medical treatment of CAD in patients with severe AS planned for TAVI., Competing Interests: Conflict of interest None reported., (Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Arterial access-site related complications constitute a large proportion of adverse events related to cardiac interventions requiring large-bore devices and have significant implications on morbidity, mortality and hospital cost., Aims: To evaluate the safety and effectiveness of a novel percutaneous plug-based vascular closure device (VCD) in 1000 consecutive patients undergoing transfemoral transcatheter aortic valve implantation (TAVI)., Methods: A single-center observational study evaluating a plug-based VCD (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA) in patients undergoing TAVI at the Karolinska University Hospital, Stockholm, Sweden. The primary outcome was VCD-related major vascular complication according to the criteria of the Valve Academic Research Consortium (VARC)-2., Results: From May 2017 to September 2020 a total of 1000 consecutive patients underwent transfemoral TAVI with arterial access-site management using the MANTA VCD. VARC-2 major vascular complications occurred in 42 (4.2%) patients: 17 (1.7%) patients intraoperatively received a covered stent, 17 (1.7%) patients underwent surgical repair during hospital stay, 3 (0.3%) patients underwent vascular surgery after discharge, 3 (0.3%) patients had major bleeding and 2 (0.2%) patients had symptoms of claudication with conservative treatment. No significant differences in major complications were seen between individual interventionists irrespective of experience with the device. A larger sheath outer diameter to femoral artery inner diameter ratio was the only factor associated with a significant increase of VCD-related major vascular complications., Conclusion: This largest ever real-world evaluation of MANTA for large-bore arteriotomy closure in transfemoral TAVI patients indicates effective and safe arterial access-site management with low complication rates and short learning curve., Clinical Trial Registration: http://www., Clinicaltrials: gov. Unique identifier: NCT04392492., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: Small femoral arteries have been associated with a higher risk of vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We investigated the feasibility and safety of TAVR in patients with small femoral arteries., Methods: In this observational study, we included 82 patients who underwent transfemoral TAVR with the ACURATE neo system using the expandable 14F iSleeve sheath between 2018 and 2019 at Karolinska University Hospital, Sweden. Of these, 41 patients had a minimal femoral artery diameter of ≥5.5 mm (mean 6.5, range 5.5-9.2), and 41 patients had a minimal femoral artery diameter <5.5 mm (mean 4.9, range 3.9-5.4)., Results: There was no significant difference in major vascular and bleeding complications between the small femoral artery group (7%) and the normal femoral artery group (2%) (p=0.62). The total of major and minor vascular complications did not differ significantly according to femoral artery size (17% vs 5%) (p=0.16). The iSleeve sheath was not correlated with any of the complications. The use of the iSleeve sheath was unsuccessful in four patients (5%), of which one patient had a small femoral artery diameter., Conclusion: Transfemoral TAVR with the ACURATE neo system using the iSleeve sheath is a promising method for patients with small femoral arteries even though we found a trend towards higher rates of complications in these patients. The use of expandable sheaths may expand the spectrum of patients that can be treated with transfemoral TAVR, and thus may improve the prognosis in patients with severe aortic valve stenosis., Competing Interests: Competing interests: Boston Scientific funded the study and had a role in study design, but not in data collection and analysis, decision to publish, or preparation of the manuscript. The authors had full responsibility for data collection, data analysis, for writing the manuscript, and for the decision to submit for publication. Some of the authors serve as a proctor/advisory board member for Boston Scientific (NS, MS, RL and AR), Abbott Vascular (MS), WL Gore (MS), Edwards Lifesciences (AR) and Medtronic (MS and A.R)., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Contrast induced encephalopathy (CIE) is a rare side effect to contrast media. The clinical presentation comprises cortical blindness, seizures and focal neurological aberrations. A 72-year old man with aortic stenosis underwent transcatheter aortic valve implantation (TAVI). At the end of the procedure he suffered from sudden onset of seizures. Information from the medical charts revealed information about a similar seizure nine years earlier, also in conjunction with administration of intraarterial contrast. The man recovered within one hour without sequelae. Midazolam and similar agents can be used prophylactically in future exposures to contrast media to lower the risk of recurrence.

Aims: The aim of this study was to assess the performance of a self-expanding valve in bicuspid aortic valve (BAV) stenosis., Methods and Results: An international registry included a total of 712 patients with aortic stenosis treated with the ACURATE neo in bicuspid (n=54; 7.5%) or tricuspid (n=658; 92.4%) anatomy. The overall mean age was 81±5.6 years. At baseline, no significant differences were found between the two groups. BAV more frequently required both predilatation (94.4% vs. 78.1%, p=0.004) and post-dilation (57.4% vs. 38.7%, p=0.007). Moderate perivalvular regurgitation was more frequently found in patients with BAV (7.4% vs. 3.18%, p=0.0001). After propensity score matching (PSM), the rate of predilation and post-dilation was confirmed to be higher in the BAV group (94.4% vs. 66.6%, p=0.001, and 57.4% vs. 37.1%, p=0.034, respectively), while the incidence of moderate perivalvular regurgitation was similar between the two groups (BAV 3.1% vs. 5.5% in tricuspid anatomy, p=0.734). In unmatched cohorts, the 30-day outcome showed a higher rate of stroke in the BAV group (7.4% vs. 1.8%, p=0.001). After adjustment for PSM quintiles, the rate of stroke resulted in being similar (odds ratioadj 1.20, 95% confidence interval [CI]: 0.81-1.76, p=0.819). The other 30-day clinical endpoints were similar between the two populations., Conclusions: This preliminary analysis shows that the use of the ACURATE neo in bicuspid aortic valves is feasible and has acceptable 30-day outcomes. Larger studies are needed to confirm our preliminary findings.

Objectives: To evaluate the feasibility of fully percutaneous closure using a novel collagen-based vascular closure device after transfemoral aortic valve replacement (TAVR)., Background: TAVR is utilized increasingly for the treatment of severe symptomatic aortic stenosis. Vascular complications related to access and closure dominate the adverse event profile of the procedure despite progressively reducing arteriotomy caliber. The advent of a novel collagen-based device (MANTA TM ) and preliminary data suggest this could be used as a routine percutaneous closure device., Methods: A prospective observational study of unselected consecutive patients undergoing TAVR in a single center. Data were collected via hospital electronic records and the SWEDEHEART registry. The primary clinical outcome was closure success and time to hemostasis. Secondary outcomes included VARC-2 defined major and minor vascular and bleeding complications within 30 days using suture-based closure with Prostar-XL within the same center., Results: A consecutive cohort of 346 patients underwent TAVR via the transfemoral approach. Vascular closure with MANTA TM was successful in all with a mean time to hemostasis of 42 sec (SD 115.5, range 0-600). The composite of all-cause mortality and major complications related to the main access site was similar between the groups (1.1% vs 1.9%, P = .61). Major bleeding occurred less frequently with MANTA TM (1.1% vs 7.8%, P = .02)., Conclusion: The novel use of a collagen-based vascular closure device for large caliber arteriotomy is feasible in an unselected population undergoing transfemoral TAVR and appears efficacious compared to percutaneous suture-based closure. These data should prompt larger studies to evaluate efficacy and safety., (© 2018 Wiley Periodicals, Inc.)

Background: Innovative technologies challenge healthcare systems, as evidence on costs and benefits frequently usually are slow to reflect new technology. We investigated these dynamics for Germany, using the emergence of transcatheter aortic valve implementation (TAVI) as an alternative to conventional aortic valve replacements (CAVR)., Objective: We focused on the role of patient co-morbidity-which would be a medical explanation for adopting TAVI-and hospital ownership status, hypothesizing that for-profit facilities are more likely to capitalize on the favorable reimbursement conditions of TAVI., Methods: The analysis uses claims data from the Techniker Krankenkasse, the largest health insurance fund in Germany, for the years 2009-2015, covering 2892 patients with TAVI and 9523 with CAVR. The decision on TAVI versus CAVR was estimated for patient-level data, that is, socioeconomic data as well as co-morbidity. At the hospital level, we included the ownership type. We also controlled for effects of the respective owner (rather than the type of ownership), including a random intercept., Results: While the co-morbidity score of TAVI patients was much higher in the early years, over time, the score almost converged with that of CAVR patients. This is in agreement with emerging evidence that suggests the use of TAVI also leads to better patient outcomes. Our results indicate that the type of ownership does not drive the switch to TAVI. We found little, if any, effect from the respective owner, regardless of ownership type., Conclusion: Overall, the effects of co-morbidity suggest that providers acted responsibly when adopting TAVI while evidence was still emerging.

Introduction: Increased mortality has been observed in those with cardiovascular diseases who are of normal body mass index (BMI) compared to the overweight and the obese. A similar association has been demonstrated in patients undergoing transcatheter aortic valve (TAVI) implantation. However, it still remains unclear whether low or normal BMI itself is unfavourable or whether this is merely a reflection of cardiac cachexia due to severe aortic stenosis. The hypothesis for the study was that weight change prior to TAVI may be associated with increased mortality following the procedure., Subjects, Materials and Methods: Single centre retrospective analysis using the SWEDEHEART registry, national mortality statistics and local hospital database. Body mass index was used as the anthropomorphic measurement and patients grouped by WHO categories and weight change trajectory before and at TAVI. Kaplan-Meier survival was constructed and a Cox proportional hazard model used to evaluate predictors of outcome., Results: Consecutive data on 493 patients with three year follow-up between 2008-2015 were evaluated. Overweight and obese body mass index categories (BMI>25) were associated with improved mortality compared to normal and underweight patients (BMI<25) (log rank p=0.02), hazard ratio of 0.68 (0.50-0.93). Weight loss trajectory was associated with increased mortality compared to stable weight (log rank p=0.01), hazard ratio 1.64 p=0.025., Conclusion: The pre-procedural weight trajectory of patients undergoing TAVI is an important predictor of clinical outcome after TAVI. Patients with stable weight trajectories are associated with improved mortality outcome compared to those with decreasing weight., (Copyright © 2017 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.)