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Competing Interests: Funding Support and Author Disclosures Dr Chung is a consultant for Medtronic and Abbott. Dr Khan is a consultant/proctor for Abbott, Edwards Lifesciences, and Medtronic; holds equity in Transmural Systems; and has received institutional educational grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Phillips. 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 Dr Khan has been a consultant for Transmural Systems; and has received educational grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Phillips. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

In this issue of Structural Heart , high-impact presentations from Transcatheter Valve Therapies 2023 are reviewed. Dr Jaffar Khan provided updates on the current understanding of left ventricular outflow tract obstruction in the field of transcatheter mitral valve replacement, highlighting known predictors of obstruction, a generally agreed-upon strategy for preprocedure assessment, and a host of management strategies in various stages of development and study., Competing Interests: J. Khan reports a relationship with Edwards Lifesciences Corporation, Medtronic, Abbott Vascular Inc, Boston Scientific Corp, and Philips that includes funding grants; he also reports a relationship with Transmural Systems that includes consulting or advisory. The other author had no conflicts to declare., (© 2024 The Author(s).)

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: Sarcomatoid renal cell carcinoma (RCC) is defined by the presence of any amount of sarcomatoid components admixed with other RCC histologic subtypes. Our investigation utilizes a large, diverse set of sarcomatoid RCC patients to summarize clinical, demographic, and pathological factors along with demographic disparities that may affect the prognosis and survival of sarcomatoid RCC patients., Methods: The Surveillance, Epidemiology, and End Results (SEER) database was employed to compile data from 2000 to 2018 from 2695 patients diagnosed with sarcomatoid RCC., Results: The mean age for sarcomatoid RCC diagnosis is 62.8 years. Males (68.2%) and White patients (82.6%) were more likely to be diagnosed with sarcomatoid RCC. Among the 64.4% of tumors with known size, 35.4% were less than 7 cm, 27.6% were 7.1 to 10 cm, and 36.4% were larger than 10 cm. Among the 95.8% of patients with known stage, 15.3% were localized, 28.9% were regionalized, and 55.8% were found in distant sites. Among the 44.2% of cases with known metastases site, lung was found to be the most common metastatic site.. Surgery was the most common treatment (70.9%). While the overall 5-year survival was 18.1%, it was 27.1% among patients who underwent surgery. Independent risk factors for mortality include age > 60 years, distant stage, and tumor size > 10 cm, per our multivariate analysis., Conclusion: Sarcomatoid RCC most commonly affects White males in their seventh decade. Increased age, distant stage, and size > 10 cm tumor size have associations with unfavorable prognosis. Surgery is associated with better survival outcomes in localized disease and multimodal therapy (surgery with adjuvant chemoradiation was associated with better survival.)., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Pulmonary nocardiosis is a rare pulmonary infection with high morbidity and mortality. Limited real-world data on pulmonary nocardiosis patients are available from developing countries like Pakistan., Methods: This retrospective observational study was conducted at the Aga Khan University Hospital, Karachi, Pakistan, from August 2003 to June 2020. Demographics, immune status, underlying diseases, laboratory data, treatment, and outcomes of all nocardiosis patients were recorded in predesigned proforma., Results: Sixty-six patients with smear/culture-proven pulmonary nocardiosis were identified. Most patients (83.3%) were treated with trimethoprim-sulfamethoxazole alone or in combination with other medicines. The overall mortality rate in our study was 33.3% (n = 22/66). Factors significantly associated with mortality were respiratory failure (p < 0.001), raised procalcitonin levels (p = 0.01), concomitant fungal infections (p = 0.01), concomitant TB (p = 0.03), and patients on combination therapy (p < 0.001). Respiratory failure (odds ratio [OR] 46.94 [95% confidence intervals [CI]: 5.01-439.03] p < 0.001), concomitant fungal infection (OR 17.09 [95% CI: 1.47-197.88] p- = 0.02) and patients on combination therapy (OR 6.90 [95% CI: 1.23-38.61] p = 0.02) were also identified as independent risk factors for mortality on multivariate analysis., Conclusions: This study provides essential information on the clinical characteristics and risk factors, outcomes, and factors associated with mortality for pulmonary nocardial infections., (Copyright © 2022 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.)

Transcaval aortic access is a versatile electrosurgical technique for large-bore arterial access through the wall of the abdominal aorta from the adjoining inferior vena cava. Although counterintuitive, its relative safety derives from the recognition that interstitial hydraulic pressure exceeds venous pressure, so arterial bleeding harmlessly decompresses into the nearby caval venous hole. Transcaval access has been performed in thousands of patients for transcatheter aortic valve replacement and endovascular thoracic aneurysm repair and to avoid limb ischemia in percutaneous mechanical circulatory support. Transcaval access may have value compared with transaxillary or subclavian access and with surgical transcarotid access when standard transfemoral access is not optimal. The dissemination of transcaval access and closure techniques has been hampered by the unavailability of commercially marketed devices. This state-of-the-art review details exemplary transcaval technique, patient selection, computed tomographic planning, step-by-step access and closure, management of complications, and procedural troubleshooting in special situations. These contemporary best practices can help operators gain or maintain proficiency., Competing Interests: Funding Support and Author Disclosures This work was supported by the Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health (grant Z01-HL006040) (to Dr Lederman). All authors are coinventors of patents, assigned to the National Institutes of Health, for transcaval- or electrosurgery-related devices. Drs Greenbaum and Babaliaros have received institutional research support from Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, JenaValve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical; have received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic; and have equity interest in Transmural Systems. Dr Rogers is a consultant and physician proctor for Edwards Lifesciences, Medtronic, and Boston Scientific; is an advisory board member for Medtronic; and holds equity interest in Transmural Systems. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Background: Transcatheter aortic valve replacement (TAVR)-related coronary artery obstruction prediction remains unsatisfactory despite high mortality and novel preventive therapies., Objectives: This study sought to develop a predictive model for TAVR-related coronary obstruction in native aortic stenosis., Methods: Preprocedure computed tomography and fluoroscopy images of patients in whom TAVR caused coronary artery obstruction were collected. Central laboratories made measurements, which were compared with unobstructed patients from a single-center database. A multivariate model was developed and validated against a 1:1 propensity-matched subselection of the unobstructed cohort., Results: Sixty patients with angiographically confirmed coronary obstruction and 1,381 without obstruction were included. In-hospital death was higher in the obstruction cohort (26.7% vs 0.7%; P < 0.001). Annular area and perimeter, coronary height, sinus width, and sinotubular junction height and width were all significantly smaller in the obstructed cohort. Obstruction was most common on the left side (78.3%) and at the level of the coronary artery ostium (92.1%). Coronary artery height and sinus width, but not annulus area, were significant risk factors for obstruction by logistic regression but performed poorly in predicting obstruction. The new multivariate model (coronary obstruction IF cusp height > coronary height, AND virtual valve-to-coronary distance ≤4 mm OR culprit leaflet calcium volume >600 mm 3 ) performed well, with an area under the curve of 0.93 (sensitivity = 0.93, specificity = 0.84) for the left coronary artery and 0.94 (sensitivity = 0.92, specificity = 0.96) for the right., Conclusions: A novel computed tomography-based multivariate prediction model that can be implemented routinely in real-world practice predicted coronary artery obstruction from TAVR in native aortic stenosis., Competing Interests: Funding Support and Author Disclosures This work was supported by a research grant from Medtronic to MedStar Cardiovascular Research Network and MedStar Health. Dr Kamioka has served as a proctor for Edwards Lifesciences. Dr Ludwig has received grant support from the German Heart Foundation; and received travel compensation from Edwards Lifesciences. Dr. Sinning has received speaker honoraria and research grants from Abbott, Abiomed, Medtronic, Boston Scientific, and Edwards Lifesciences; and served as a proctor for Medtronic and Boston Scientific. Dr Fuku has served as a proctor for Edwards Lifesciences and Medtronic. Dr Iyer has served as a proctor for Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Rodriguez has served as a speaker for Medtronic, Abbott, and Edwards Lifesciences. Dr Montorfano has served as a proctor for Edwards Lifesciences, Boston Scientific, and Abbott. Dr Ancona has received consulting fees from Abbott and Abiomed. Dr Ahmad has served as a proctor for Edwards Lifesciences. Dr Ruggiero has served as a proctor for Abbott and Edwards Lifesciences; served as a consultant for Abbott, Edwards Lifesciences, and RegenX-Bio; and received research support from Ancora Heart and Bard. Dr Weissman has served as the director of an academic cardiac computed tomography core lab with institutional contracts with Ancora Heart and LivaNova. Dr Waksman has served on the advisory board for Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd; has served as a consultant for Abbott Vascular, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, and Venous MedTech; has received institutional grant support from Amgen, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; and is an investor in MedAlliance and Transmural Systems Inc. Dr Rogers has served as a proctor and consultant for Boston Scientific, Edwards Lifesciences, and Medtronic; has served on the advisory board for Medtronic; and holds equity interest in Transmural Systems Inc. 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. All rights reserved.)

Background: Left ventricular (LV) contractility and compliance are derived from pressure-volume (PV) loops during dynamic preload reduction, but reliable simultaneous measurements of pressure and volume are challenging with current technologies. We have developed a method to quantify contractility and compliance from PV loops during a dynamic preload reduction using simultaneous measurements of volume from real-time cardiovascular magnetic resonance (CMR) and invasive LV pressures with CMR-specific signal conditioning., Methods: Dynamic PV loops were derived in 16 swine (n = 7 naïve, n = 6 with aortic banding to increase afterload, n = 3 with ischemic cardiomyopathy) while occluding the inferior vena cava (IVC). Occlusion was performed simultaneously with the acquisition of dynamic LV volume from long-axis real-time CMR at 0.55 T, and recordings of invasive LV and aortic pressures, electrocardiogram, and CMR gradient waveforms. PV loops were derived by synchronizing pressure and volume measurements. Linear regression of end-systolic- and end-diastolic- pressure-volume relationships enabled calculation of contractility. PV loops measurements in the CMR environment were compared to conductance PV loop catheter measurements in 5 animals. Long-axis 2D LV volumes were validated with short-axis-stack images., Results: Simultaneous PV acquisition during IVC-occlusion was feasible. The cardiomyopathy model measured lower contractility (0.2 ± 0.1 mmHg/ml vs 0.6 ± 0.2 mmHg/ml) and increased compliance (12.0 ± 2.1 ml/mmHg vs 4.9 ± 1.1 ml/mmHg) compared to naïve animals. The pressure gradient across the aortic band was not clinically significant (10 ± 6 mmHg). Correspondingly, no differences were found between the naïve and banded pigs. Long-axis and short-axis LV volumes agreed well (difference 8.2 ± 14.5 ml at end-diastole, -2.8 ± 6.5 ml at end-systole). Agreement in contractility and compliance derived from conductance PV loop catheters and in the CMR environment was modest (intraclass correlation coefficient 0.56 and 0.44, respectively)., Conclusions: Dynamic PV loops during a real-time CMR-guided preload reduction can be used to derive quantitative metrics of contractility and compliance, and provided more reliable volumetric measurements than conductance PV loop catheters., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Transcatheter aortic valve replacement (TAVR) is increasingly being performed in younger and lower surgical risk patients. Given the longer life expectancy of these patients, the bioprosthetic valve will eventually fail, and aortic valve reintervention may be necessary. Although currently rare, redo-TAVR will likely increase in the future as younger patients are expected to outlive their transcatheter bioprosthesis. This review provides a contemporary overview of the indications, procedural planning, implantation technique, and outcomes of TAVR in failed transcatheter bioprosthetic aortic valves., Competing Interests: Funding Support and Author Disclosures Dr Tarantini has received lecture fees from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific. Dr Sathananthan is a consultant to Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Khan is an inventor on patents, assigned to the National Institutes of Health, on leaflet laceration technology. Dr Van Mieghem has received research grant support from Abbott Vascular, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, Daiichi Sankyo, Abiomed, PulseCath BV, Siemens, and Pie Medical. Dr Latib is an advisory and/or consultant for Medtronic, Abbott, Boston Scientific, Edwards Lifesciences, Philips, NeoChord, Shifamed, and Vahaticor. Dr Waksman is on the advisory board for Abbott, Boston Scientific, Medtronic, Philips IGT, and Pi-Cardia Ltd; is a consultant for Abbott, Biotronik, Boston Scientific, Cordis, Medtronic, Philips IGT, Pi-Cardia Ltd, Swiss Interventional Systems/SIS Medical AG, Transmural Systems Inc, and Venous MedTech; has received grant support from AstraZeneca, Biotronik, Boston Scientific, Chiesi, Medtronic, and Philips IGT; is on the Speakers Bureau for AstraZeneca; and is an investor for MedAlliance and Transmural Systems Inc. Dr De Backer has received institutional research grants and consulting fees from Abbott and Boston Scientific. Dr Rogers is a consultant and proctor for Medtronic and Edwards Lifesciences; is on the advisory board for Medtronic; has equity interest in Transmural Systema; and is a coinventor on patents, assigned to National Institutes of Health, for transcatheter electrosurgery devices. Dr Søndergaard has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic and SMT. Dr Tang is a physician proctor and consultant for Medtronic; is a consultant and physician advisory board member for Abbott Structural Heart; is a physician advisory board member for JenaValve; and is a consultant for NeoChord. 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 Supported by Emory Structural Heart and Valve program intramural funds and by National Institutes of Health (NIH) grant Z01-HL006040. Dr Babaliaros has institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific; is a consultant for Edwards Lifesciences and Abbott Vascular; and has equity interest in Transmural Systems. Drs Gleason, Xie, and Byku have institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. Dr Khan is a proctor for Edwards Lifesciences and Medtronic; and is a coinventor on patents, assigned to the NIH, on devices for electrosurgical tissue laceration. Dr Bruce is a coinventor on patents, assigned to the NIH, on devices for electrosurgical tissue laceration. Dr Grubb is a consultant for Edwards Lifesciences and Medtronic; and has institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. Dr Paone has institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific; and is a proctor for Edwards Lifesciences. Dr Lederman is a coinventor on patents, assigned to the NIH, on devices for electrosurgical tissue laceration. Dr Greenbaum has institutional research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific; is a proctor for Edwards Lifesciences and Medtronic; and has equity interest in Transmural Systems. Dr Rogers has reported that he has no relationships relevant to the contents of this paper to disclose.

Transcatheter electrosurgery is a versatile tool that can be used to cut cardiac tissue without the need for a sternotomy, cardiopulmonary bypass, and cardioplegia. With adequate imaging and suitable anatomy, any cardiac tissue can be cut. Thus, transcatheter electrosurgery can provide bespoke therapies for complex patients who often have no other good treatment options. In this review, we will discuss the common applications for electrosurgical tissue traversal and laceration, including transcaval access, BASILICA, LAMPOON, and ELASTA-Clip, summarizing the evidence and the key technical steps for each., (Copyright © 2022. Published by Elsevier Inc.)

Background: Transcatheter mitral valve repair is beneficial in patients with mitral regurgitation (MR), left ventricular dysfunction, and persistent symptoms despite maximally tolerated medical therapy., Objectives: The aim of this study was to evaluate the safety and feasibility of transcatheter mitral cerclage ventriculoplasty in patients with MR and either heart failure with reduced ejection fraction or preserved ejection fraction and in subjects with prior edge-to-edge repair but persistent or recurrent symptomatic MR., Methods: The National Heart, Lung, and Blood Institute Division of Intramural Research Transcatheter Mitral Cerclage Ventriculoplasty Early Feasibility Study (NCT03929913) was an investigator-initiated prospective multicenter study. The primary endpoint was technical success measured at exit from the catheterization laboratory. Follow-up included heart failure quality-of-life assessments and serial imaging with echocardiography and cardiac computed tomography., Results: Nineteen subjects consented and underwent cerclage, 63% with heart failure with reduced ejection fraction and 37% with heart failure with preserved ejection fraction, with ischemic cardiomyopathy in 26% and nonischemic cardiomyopathy in 74%. There were no procedural deaths, strokes, or transient ischemic attacks or other major cardiovascular adverse events. The primary endpoint was met in 17 subjects. Cerclage induced sustained reductions in mitral regurgitant volume (-41%) and effective orifice area (-33%) after a median of 337 days. Cerclage resulted in improvements in 6-minute walking distance (+78 m) and Kansas City Cardiomyopathy Questionnaire Overall Summary Score (+22 points) at 30 days that were maintained after a median of 265 days. New complete heart block developed in 6 of 17 subjects. Three deaths occurred on postprocedural days 79, 159, and 756, unrelated to cerclage., Conclusions: Transcatheter mitral cerclage ventriculoplasty resulted in significant and sustained improvements in mitral regurgitation and in heart failure quality-of-life assessments., Competing Interests: Funding Support and Author Disclosures This work is supported by the NHLBI DIR (grant Z01-HL006040) and by an NHLBI small business innovation research contract (HHSN268201500008C) to Transmural Systems. Dr Rogers is a consultant and physician proctor for Edwards Lifesciences and Medtronic; is a Medtronic advisory board member; and has an equity interest in Transmural Systems. Drs Rogers and Lederman are coauthors on patents, assigned to the National Institutes of Health, for cerclage-related devices. Drs Babaliaros and Greenbaum have received institutional research support from Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, Jena Valve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical; have received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic; and have equity interest in Transmural Systems. Dr Foerst is a physician proctor for Edwards Lifesciences and Medtronic. Dr Gleason has received institutional research support from Edwards Lifesciences, Medtronic, and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Objectives: The aim of this study was to compare transcaval and transaxillary artery access for transcatheter aortic valve replacement (TAVR) at experienced medical centers in contemporary practice., Background: There are no systematic comparisons of transcaval and transaxillary TAVR access routes., Methods: Eight experienced centers contributed local data collected for the STS/ACC TVT Registry (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry) between 2017 and 2020. Outcomes after transcaval and axillary/subclavian (transaxillary) access were adjusted for baseline imbalances using doubly robust (inverse propensity weighting plus regression) estimation and compared., Results: Transcaval access was used in 238 procedures and transaxillary access in 106; for comparison, transfemoral access was used in 7,132 procedures. Risk profiles were higher among patients selected for nonfemoral access but similar among patients requiring transcaval and transaxillary access. Stroke and transient ischemic attack were 5-fold less common after transcaval than transaxillary access (2.5% vs 13.2%; OR: 0.20; 95% CI: 0.06-0.72; P = 0.014) compared with transfemoral access (1.7%). Major and life-threatening bleeding (Valve Academic Research Consortium 3 ≥ type 2) were comparable (10.0% vs 13.2%; OR: 0.66; 95% CI: 0.26-1.66; P = 0.38) compared with transfemoral access (3.5%), as was blood transfusion (19.3% vs 21.7%; OR: 1.07; 95% CI: 0.49-2.33; P = 0.87) compared with transfemoral access (7.1%). Vascular complications, intensive care unit and hospital length of stay, and survival were similar between transcaval and transaxillary access. More patients were discharged directly home and without stroke or transient ischemic attack after transcaval than transaxillary access (87.8% vs 62.3%; OR: 5.19; 95% CI: 2.45-11.0; P < 0.001) compared with transfemoral access (90.3%)., Conclusions: Patients undergoing transcaval TAVR had lower rates of stroke and similar bleeding compared with transaxillary access in a contemporary experience from 8 US centers. Both approaches had more complications than transfemoral access. Transcaval TAVR access may offer an attractive option., Competing Interests: Funding Support and Author Disclosures This work was supported by the Emory Structural Heart and Valve program intramural funds, and by National Institutes of Health Z01-HL006040. Drs Babaliaros and Greenbaum have served as consultants for Edwards Lifesciences and Abbott Vascular; have an employer with research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific; and own equity interest in Transmural Systems. Drs Lederman and Rogers are coinventors on device patents, assigned to the National Institutes of Health, for closure of transcaval access ports. Dr Rogers has served as consultant and physician proctor for Edwards Lifesciences and Medtronic; has been on the advisory board for Medtronic; and has equity interest in Transmural Systems. Dr Mahoney has served as a proctor and consultant and has received institutional research support from Edwards Lifesciences, Medtronic, and Abbott. Dr Foerst has served as a proctor for Edwards Lifesciences and Medtronic. Dr Depta has served as a consultant or advisory board member for Edwards Lifesciences, Boston Scientific, Abbott, V-Wave-Ltd, and WL Gore & Associates. Dr Muhammad has served as a proctor and consultant for Edwards Lifesciences and Medtronic. Dr McCabe has served as a consultant and has received honoraria from Boston Scientific, Cardiovascular Systems Inc, Edwards Lifesciences, and Medtronic. Dr Pop is a consultant for Edwards Lifesciences and Shockwave Medical. Dr Khan has served as a proctor for Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Competing Interests: Funding Support and Author Disclosures Dr Reineke has a consultancy agreement with Abbott; has received proctoring fees from Abbott; and has received travel expenses from Abbott. Dr Pilgrim has received institutional research grants and speaker fees from Biotronik and Boston Scientific; and is a consultant for HighLife SAS. Dr. Khan has served as a proctor for Edwards Lifesciences and Medtronic; and is co-inventor on patents, assigned to the National Institutes of Health, on devices for electrosurgical leaflet laceration. Dr Windecker has received research and educational grants to the institution from Abbott, Amgen, AstraZeneca, Bristol Myers Squibb, Bayer, Biotronik, Boston Scientific, Cardinal Health, CardioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Guerbet, InfraRedx, Johnson & Johnson, Medicure, Medtronic, Novartis, Polares, OrPha Suisse, Pfizer, Regeneron, Sanofi, Sinomed, Terumo, and V-Wave; serves as an unpaid advisory board member and/or an unpaid member of the steering or executive groups of trials funded by Abbott, Abiomed, Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Novartis, Polares, Sinomed, Terumo, V-Wave, and Xeltis (but has not received personal payments from pharmaceutical companies or device manufacturers); and is a member of the steering or executive committee groups of several investigator-initiated trials that receive funding from industry without impact on his personal remuneration. Dr Lanz has received a research grant from Boston Scientific to his institution. Dr Praz has received travel expenses from Edwards Lifesciences, Abbott Vascular, and Polares Medical. All other authors have reported that they have no relationships relevant to the contents to disclose.

Objectives: A growing number of Neurology Departments have appointed a Neurology Vice Chair for Education (NVCE), yet the roles and responsibilities of an NVCE have not been previously described in the literature., Methods: A group of current NVCEs developed a survey that was sent to all NVCEs in the US via a secure, anonymous survey. Questions included roles and responsibilities, sources of support, metrics to determine success, faculty development, basic demographics and education scholarship engagement., Results: Response rate was 27 of 45 NVCEs (60%). Among the respondents, 70% have been in the role 5 years or less and the NVCE role existed for 5 years or less in 60% of departments. Eighteen percent were provided with a written job description, and 63% never received any job description. Most common responsibilities included overseeing student (78%), resident (78%), and fellowship (74%) education, participation in education section of an annual report (67%) and oversight of education scholarship (59%). Fifty-two percent reported no specific funding for the NVCE role. Most were prior program directors (59%), male (61%) and White (85%)., Conclusions: The NVCE role is new, and few have written job descriptions or specific funding for the role. They oversee education across the continuum of learners in their departments, communicate the education mission in an annual report and oversee educational scholarship. Most were not formally trained for the role and previously served in other education leadership roles. These data will be useful to programs in creating job descriptions and goals for the NVCE role., (Copyright © 2021 Elsevier B.V. All rights reserved.)

The SAPIEN 3 is the only transcatheter heart valve commercially available for compassionate transcatheter mitral valve replacement in patients with previous mitral surgical rings and mitral annular calcification (valve in ring [VIR] and valve in mitral annular calcification [VIM]). Reported outcomes have been inconsistent or poor. The review provides an overview of the authors' approach to achieve largely consistent results despite the intrinsic limitations of SAPIEN 3 VIM and VIR. The approach includes bedside modifications of the valve implant, the delivery system, and of the cardiac substrate itself. Until purpose-built devices are readily available, VIR and VIM procedures will require aggressive multidisciplinary cooperation, meticulous planning and execution, and postprocedure management by experienced, high-volume operators., Competing Interests: Funding Support and Author Disclosures This work was supported by the Emory Structural Heart and Valve program intramural funds, and by National Institutes of Health Grant No. Z01-HL006040. Dr Babaliaros has served as a consultant for Edwards Lifesciences and Abbott Vascular; has an employer with research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific; and owns equity interest in Transmural Systems. Dr Lederman has served as the principal investigator on a cooperative research and development agreement between National Institutes of Health and Edwards Lifesciences for transcatheter modification of the mitral valve. Drs Lederman, Khan, and Rogers are co-inventors on patents, assigned to the National Institutes of Health, on devices for electrosurgical leaflet laceration. Drs Khan and Rogers have served as proctors for Edwards Lifesciences and Medtronic. Mr Kohli has served as a consultant for Abbott Laboratories. Dr Paone has served as a consultant and proctor for Edwards Lifesciences. Dr Lisko’s employer has contracts for BASILICA analysis with Medtronic and Edwards Lifesciences. Dr Greenbaum has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott Vascular; owns an equity interest in Transmural Systems; and has an employer with research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. 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.)

All bioprosthetic valves, both surgical and transcatheter, have a finite lifespan before their leaflets inevitably degenerate, leading to stenosis or regurgitation. As younger, low-risk patients receive a transcatheter aortic valve, it is expected that they will most likely outlive their bioprosthetic valve. The heterogeneity of studies regarding surgical valve durability makes the interpretation of the data challenging. Leaflet thickening is seen in transcatheter heart valves but currently there is no evidence that it leads to premature valve deterioration or clinical events. Standardized definitions of structural valve deterioration should allow for comparisons between future clinical trials to assess the durability of different transcatheter heart valves., (Copyright © 2021 Elsevier Inc. All rights reserved.)

The median cost of attending medical school is rising annually, and with it, student debt. Neurology residents have stepped up during the pandemic to answer the call of a health system at its breaking point. In this article, we outline how this escalating problem of student debt affects the neurology pipeline, the wellbeing and career decisions of current neurology trainees and practicing neurologists and through it, and the gap in healthcare. We describe currently available options for loan repayment and call for advocacy and legislation to address this mounting burden as a means to improve neurological care in the United States., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Transcatheter aortic valve replacement (TAVR) is approved for all patient risk profiles and is an option for all patients irrespective of age. However, patients enrolled in the low- and intermediate-risk trials were in their 70s, and those in the high-risk trials were in their 80s. TAVR has never been systematically tested in young (<65 years), low-risk patients. Unanswered questions remain, including the safety and effectiveness of TAVR in patients with bicuspid aortic valves; future coronary access; durability of transcatheter heart valves; technical considerations for surgical transcatheter heart valve explantation; management of concomitant conditions such as aortopathy, mitral valve disease, and coronary artery disease; and the safety and feasibility of future TAVR-in-TAVR. The authors predict that balancing these questions with patients' clear preference for less invasive treatment will become common. In this paper, the authors consider each of these questions and discuss risks and benefits of theoretical treatment strategies in the lifetime management of young patients with severe aortic stenosis., Competing Interests: Funding Support and Author Disclosures Dr. Waksman is an advisory board member for Amgen, Boston Scientific, Cardioset, Cardiovascular Systems, Medtronic, Philips, and Pi-Cardia; is a consultant for Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems, Medtronic, Philips, and Pi-Cardia; has received grant support from AstraZeneca, Biotronik, Boston Scientific, and Chiesi; is on the Speakers Bureau for AstraZeneca and Chiesi; and is an investor in MedAlliance. Dr. Rogers is an advisory board member for Medtronic; is a consultant and proctor for Edwards Lifesciences and Medtronic; and holds equity interest in Transmural Systems. 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/purpose: The MANTA vascular closure device (VCD) is the first commercially available dedicated closure device for large-bore femoral arterial access-site closure and was approved by the United States Food and Drug Administration (FDA) in February 2019. Real-world data on the most commonly reported complications and modes of failure associated with the MANTA closure device are limited. We analyzed post-marketing surveillance data from FDA's Manufacturer and User Facility Device Experience (MAUDE) database for the MANTA VCD (Teleflex, Wayne, Pennsylvania)., Methods/materials: Post-marketing surveillance data from the FDA MAUDE database from February 2019 through March 2020 were analyzed, yielding 170 reports., Results: Of the 170 reports of major complications involving MANTA devices, 141 reports involved either injury (136) or death (5) related to the device. Of the 141 reports, bleeding was the most common adverse outcome described (45), followed by vessel occlusion (30) and vessel dissection (21). Device malfunction incidents (29 reports) were reported in 4 main categories: failed deployment (16 reports), malposition of the collagen (9), insufficient information (3), and device dislocation (1)., Conclusions: Our analysis of the MAUDE database demonstrates that in real-world practice, the MANTA VCD was found to be associated with complications, including death, vascular injury, and difficulties with the device itself. Ongoing user education, proctoring, and pre-procedural patient selection are important to minimize risks associated with the MANTA VCD., Competing Interests: Declaration of competing interest Evan Shlofmitz received honoraria from Abbott Vascular and Opsens Medical. Gary Mintz received honoraria from Boston Scientific and Philips. Ron Waksman has served on the advisory board and as a consultant for Philips. All other authors have no relevant disclosures., (Copyright © 2020. Published by Elsevier Inc.)

Background/purpose: This sub-analysis of the prospective Low Risk TAVR (LRT) trial determined anatomical characteristics associated with hypoattenuated leaflet thickening (HALT), which may contribute to early transcatheter heart valve (THV) degeneration., Methods/materials: The LRT trial enrolled 200 low-risk patients between February 2016 and February 2018. All subjects underwent baseline and 30-day CT studies, analyzed by an independent core laboratory. Additional measurements, namely THV expansion, eccentricity, depth, and commissural alignment, were made by consensus of three independent readers. HALT was observed only in the Sapien 3 THV, so Evolut valves were excluded from this analysis., Results: In the LRT trial, 177 subjects received Sapien 3 THVs, of whom 167 (94.3%) had interpretable 30-day CTs and were eligible for this analysis. Twenty-six subjects had HALT (15.6%). Baseline characteristics were similar between groups. There was no difference in THV size implanted and baseline aortic-root geometry between groups. In patients who developed HALT, THV implantation depth was shallower than in patients who did not develop HALT (2.6 ± 1.1 mm HALT versus 3.3 ± 1.8 mm no-HALT, p = 0.03). There were more patients in the HALT group with commissural malalignment (40% vs. 28%; p = 0.25), but this did not reach statistical significance. In a univariable regression model, no predetermined variables were shown to independently predict the development of HALT., Conclusions: This study did not find anatomical or THV implantation characteristics that predicted the development of HALT at 30 days. This study cannot exclude subtle effects or interaction between factors because of the small number of events., Competing Interests: Declaration of competing interest All other authors have no conflicts of interest to disclose., (Copyright © 2020. Published by Elsevier Inc.)

Background/purpose: Coronary artery calcification is a marker of advanced atherosclerosis and a predictor of adverse clinical outcomes. Rotational atherectomy (RA) can effectively modify calcified lesions, optimizing procedural outcomes. We interrogated the most commonly reported adverse events involving rotational atherectomy systems (Rotablator and Rotapro) by analyzing post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database., Methods/materials: We queried MAUDE from September 1, 2016, through December 31, 2019. After excluding duplicate reports, we included 363 reports for Rotablator and 63 reports for Rotapro in the final analysis., Results: Percentages represent the proportion of total submitted MAUDE reports. The most commonly reported complications for Rotablator and Rotapro included dissection (2.7% and 6.3%, respectively) and perforation (4.1% and 19%, respectively). The most commonly reported device-related issues included detachment or structural damage, or both, for Rotablator (39.1%) and entrapment of the device component for Rotapro (47.6%). The most commonly damaged device component was the Rotawire, whereas the most commonly entrapped device component was the Rotaburr for both device configurations. Rotablator and Rotapro device-related complications were most commonly reported for the left anterior descending artery., Conclusion: An analysis of the MAUDE database demonstrates that in real-world practice, RA devices are associated with important complications. Ongoing surveillance of safety profiles, patient outcomes, and failure modes of RA devices is warranted. Our analysis provides important insights into the mechanisms of failure of RA devices and associated complications but cannot verify causality., Competing Interests: Declaration of competing interest RW –Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. TR – Proctor and Consultant: Medtronic, Edwards Lifesciences; Advisory Board: Medtronic; Equity interest: Transmural Systems. All other authors: None., (Copyright © 2020. Published by Elsevier Inc.)

Objectives: This study sought to determine the safety of the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure., Background: Transcatheter aortic valve replacement causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality. BASILICA is a procedure to prevent coronary obstruction. Safety and feasibility in a large patient cohort is lacking., Methods: The international BASILICA registry was a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement. Valve Academic Research Consortium-2 definitions were used to adjudicate events., Results: Between June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. Valve Academic Research Consortium-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, between native and bioprosthetic valves, and with the use of cerebral embolic protection., Conclusions: BASILICA is safe, with low reported rates of stroke and death. BASILICA is feasible in the real-world setting, with a high procedure success rate and low rates of coronary artery obstruction., Competing Interests: Funding Support and Author Disclosures This work was supported by National Heart, Lung, and Blood Institute grant Z01-HL006061. Drs. Khan, Rogers, and Lederman are co-inventors on patents, assigned to National Institutes of Health, on catheter devices to lacerate valve leaflets. Dr. Khan has served as a proctor for Edwards Lifesciences and Medtronic. Dr. Babaliaros has served as a consultant for Edwards Lifesciences, Abbott Vascular, and Transmural Systems; and his employer has research contracts for clinical investigation of transcatheter aortic and mitral devices from Edwards Lifesciences, Abbott Vascular, Medtronic, St. Jude Medical, and Boston Scientific. Dr. Greenbaum has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott Vascular; and owns equity in Transmural Systems. Dr. Depta has served as a consultant and on the advisory board for Edwards Lifesciences, Boston Scientific, and W.L. Gore and Associates. Dr. McCabe has received honoraria from and served as a consultant for Medtronic and Edwards Lifesciences. Dr. Muhammad has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott. Dr. Mahoney has served as a consultant and proctor for Edwards Lifesciences and Medtronic. Dr. Shah has served as a proctor Edwards Lifesciences; and has received educational grants from Edwards Lifesciences, Abbott, and Medtronic. Dr. Chhatriwalla has served on the Speakers Bureau for Abbott Vascular, Edwards Lifesciences, and Medtronic; has served as a consultant for Boston Scientific and Silk Road Medical; has received research grant support from Boston Scientific; and has served as a proctor for Edwards Lifesciences and Medtronic. Dr. Leonardi has served as a proctor for Edwards Lifesciences. Dr. Khalil has served as a proctor for Medtronic and Edwards Lifesciences. Dr. Tang has served as a physician proctor for Medtronic; and has served as a consultant for Medtronic, Abbott Structural Heart, and W.L. Gore and Associates. Dr. Herrmann has received institutional research funding from Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic; and has received consulting and speaking honoraria from Edwards Lifesciences and Medtronic. Dr. Fail has served as a proctor for Medtronic. Dr. Pop has served as consultant for Edwards Lifesciences. Dr. Lederman has served as the principal investigator on a Cooperative Research and Development Agreement between the National Institutes of Health and Edwards Lifesciences on transcatheter modification of the mitral valve. Dr. Waksman has served as a consultant for Medtronic and Abbott Vascular; and has received grant support from Abbott Vascular. Dr. Rogers has served as a consultant or proctor for Edwards Lifesciences and Medtronic; and owns equity in Transmural Systems. 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. All rights reserved.)

Objectives: The purpose of this study was to evaluate tip-to-base intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) in patients undergoing transcatheter mitral valve replacement (TMVR) in annuloplasty rings or surgical mitral valves., Background: LAMPOON is an effective adjunct to TMVR that prevents left ventricular outflow tract obstruction (LVOTO). Laceration is typically performed from the base to the tip of the anterior mitral leaflet. A modified laceration technique from leaflet tip to base may be effective in patients with a prosthesis that protects the aortomitral curtain., Methods: This is a multicenter, 21-patient, consecutive retrospective observational cohort. Patients underwent tip-to-base LAMPOON to prevent LVOTO and leaflet overhang, or therapeutically to lacerate a long anterior mitral leaflet risking or causing LVOTO. Outcomes were compared with findings from patients in the LAMPOON investigational device exemption trial with a prior mitral annuloplasty., Results: Twenty-one patients with a annuloplasty or valve prosthesis-protected mitral annulus underwent tip-to-base LAMPOON (19 preventive, 2 rescue). Leaflet laceration was successful in all and successfully prevented or treated LVOTO in all patients. No patients had significant LVOTO upon discharge. There were 2 cases of unintentional aortic valve injury (1 patient underwent emergency transcatheter aortic valve replacement and 1 patient underwent urgent surgical aortic valve replacement). In both cases, the patients had a supra-annular ring annuloplasty, and the retrograde aortic guiding catheter failed to insulate the guidewire lacerating surface from the aortic root. All patients survived to 30 days. Compared with classic retrograde LAMPOON, there was a trend toward shorter procedure time., Conclusions: Tip-to-base laceration is a simple, effective, and safe LAMPOON variant applicable to patients with an appropriately positioned mitral annular ring or bioprosthetic valve. Operators should take care to insulate the lacerating surface from adjacent structures., Competing Interests: Funding Support and Author Disclosures This work was supported by the Emory Structural Heart and Valve program intramural funds and by National Institutes of Health Grant No. Z01-HL006040. Dr. Lisko’s employer has contracts for BASILICA analysis with Medtronic and Edwards Lifesciences. Dr. Babaliaros has served as a consultant for Edwards Lifesciences and Abbott Vascular; has an employer with research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific; and owns equity interest in Transmural Systems. Drs. Khan and Rogers have served as a proctor for Edwards Lifesciences and Medtronic. Drs. Khan, Lederman, and Rogers are co-inventors on patents, assigned to the National Institutes of Health, on devices for electrosurgical leaflet laceration. Dr. Paone has served as a consultant and proctor for Edwards Lifesciences. Dr. McCabe has served as consultant for Edwards Lifesciences, Boston Scientific, and Teleflex. Dr. Grubb has served as a speaker, proctor, and principal investigator for Edwards Lifesciences; served as a speaker, proctor, and advisory board member for Boston Scientific; and served as a speaker, proctor, principal investigator, advisory board member, and national principal investigator for Medtronic. Dr. Lederman has served as the principal investigator on a cooperative research and development agreement between National Institutes of Health and Edwards Lifesciences for transcatheter modification of the mitral valve. Dr. Greenbaum has served as a proctor for Edwards Lifesciences, Medtronic, and Abbott Vascular; owns an equity interest in Transmural Systems; and has an employer with research contracts for clinical investigation of transcatheter aortic, mitral, and tricuspid devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021. Published by Elsevier Inc.)

Objectives: The aim of this study was to test the hypothesis that transcatheter electrosurgery might allow intentional detachment of previously placed MitraClip(s) from the anterior leaflet to recreate a single mitral orifice for transcatheter mitral valve implantation (TMVI), leaving the retained MitraClip(s) securely fastened to the posterior leaflet and without interfering with the mitral bioprosthesis., Background: Patients with severe mitral regurgitation or stenosis despite edge-to-edge mitral repair with the MitraClip typically have few therapeutic options because the resultant double orifice precludes TMVI. Transcatheter electrosurgery may allow detachment of failed MitraClip(s) from the anterior leaflet to recreate a single orifice for TMVI., Methods: This was a single-center, 5-patient, consecutive, retrospective observational cohort. Patients underwent transcatheter electrosurgical laceration and stabilization of failed MitraClip(s) to recreate a single orifice, leaving the MitraClip(s) securely fastened to the posterior leaflet. Subsequently, patients underwent TMVI with an investigational device, the Tendyne mitral bioprosthesis, on a compassionate basis. Patients were followed up to 30 days., Results: MitraClip detachment from the anterior leaflet and Tendyne implantation were successful in all patients. All patients survived to discharge. All patients were discharged with grade 0 central mitral regurgitation. Two patients had moderate perivalvular mitral regurgitation that did not require reintervention. During the follow-up period of 30 days, there were no deaths, cases of valve dysfunction, or reintervention. There was no evidence of erosion or bioprosthetic valve dysfunction attributable to the retained MitraClip(s) still attached to the posterior leaflet., Conclusions: Transcatheter electrosurgical detachment of failed MitraClips from the anterior leaflet followed by TMVI is technically feasible and safe at 30 days. Longer term study is needed to determine the clinical benefit of this approach and new algorithms for TMVI sizing following electrosurgical laceration and stabilization of a failed MitraClip to avoid perivalvular leak., (Copyright © 2020. Published by Elsevier Inc.)

During the novel coronavirus disease 2019 (COVID-19) pandemic, many hospitals have been asked to postpone elective and surgical cases. This begs the question, "What is elective in structural heart disease intervention?" The recently proposed Society for Cardiovascular Angiography and Interventions/American College of Cardiology consensus statement is, unfortunately, non-specific and insufficient in its scope and scale of response to the COVID-19 pandemic. We propose guidelines that are practical, multidisciplinary, implementable, and urgent. We believe that this will provide a helpful framework for our colleagues to manage their practices during the surge and peak phases of the pandemic. General principles that apply across structural heart disease interventions include tracking and reporting cardiovascular outcomes, "healthcare distancing," preserving vital resources and personnel, shared decision-making between the heart team and hospital administration on resource-intensive cases, and considering delaying research cases. Specific guidance for transcatheter aortic valve replacement and MitraClip procedures varies according to pandemic phase. During the surge phase, treatment should broadly be limited to those at increased risk of complications in the near term. During the peak phase, treatment should be limited to inpatients for whom it may facilitate discharge. Keeping our patients and ourselves safe is paramount, as well as justly rationing resources., Competing Interests: Declaration of competing interest Jaffar Khan – Proctor: Edwards Lifesciences, Medtronic. Toby Rogers – Advisory Board: Medtronic; Consultant and Proctor: Medtronic, Edwards Lifesciences. Ron Waksman – Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. All other authors – None., (Copyright © 2020. Published by Elsevier Inc.)

Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. All other authors – None.

Background/purpose: The Sentinel Cerebral Protection System (Boston Scientific, Marlborough, Massachusetts) is indicated for use as a cerebral protection device to capture and remove embolic material during transcatheter aortic valve procedures and was approved by the US Food and Drug Administration (FDA) in 2017. Robust data on the most commonly reported complications and modes of failure associated with the Sentinel device are limited., Methods/materials: We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from 2017 through 2019, yielding 43 reports., Results: Of the 43 reports of major complications involving Sentinel devices, 23 involved either death (3) or injury (20) related to the device. The 3 deaths were due to stroke, while 18 of the 20 injuries were reported as stroke. The other 20 reports were related to device modes of failure. Modes of failure were due to damaged device (5), difficulty retrieving/resheathing the device (5); package contamination (4), difficulty deploying the device (3), and, finally, complications with preparation (3)., Conclusions: Our analysis of the MAUDE database demonstrates that in real-world practice, the Sentinel Cerebral Protection System may be associated with complications, including death, stroke, vascular injury, and difficulties with the device itself. The MAUDE database serves as an important tool for both physicians and manufacturers to optimize performance and clinical outcomes., Competing Interests: Declaration of competing interest Ron Waksman – Advisory Board: Amgen, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Consultant: Amgen, Biotronik, Boston Scientific, Cardioset, Cardiovascular Systems Inc., Medtronic, Philips, Pi-Cardia Ltd.; Grant Support: AstraZeneca, Biotronik, Boston Scientific, Chiesi; Speakers Bureau: AstraZeneca, Chiesi; Investor: MedAlliance. Toby Rogers – Consultant and Proctor Medtronic; Proctor: Edwards Lifesciences. Jaffar M. Khan – Proctor: Medtronic; Proctor: Edwards Lifesciences. All other authors: None., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background/purpose: Women are underrepresented in cardiovascular clinical studies. Black women have a higher ischemic heart disease mortality risk than their white counterparts. However, there exist limited outcome data comparing black women and white women after percutaneous coronary intervention (PCI). The aim of this retrospective analysis was to evaluate for racial disparities in 1-year major adverse cardiovascular events (MACE) in women undergoing PCI., Methods/materials: Within our PCI database, we identified 4776 female patients who underwent PCI between 2003 and 2016. Of those, 1916 were black and 2860 were white. Endpoints included MACE, death, myocardial infarction, target vessel revascularization (TVR) and stent thrombosis (ST) at 30 days and 1 year. A proportional Cox hazard model analysis was performed to assess outcomes after adjustment for confounding factors., Results: Black women presented at a younger age and had a significantly higher prevalence of risk factors. Periprocedural and in-hospital outcomes were similar in the 2 groups. At 30 days and 1 year, the rates of myocardial infarction, TVR and ST were significantly higher in black women. After adjustment for baseline differences, only ST appears to be more likely to occur in black women than in white women., Conclusions: In this large cohort of women with coronary artery disease undergoing PCI, we observed racial disparities primarily in baseline characteristics indicative of need for interventions to achieve early diagnosis and better prevention in black women. Future directions should include efforts to identify and better characterize the factors underlying and contributing to cardiovascular outcomes in women after PCI., Summary: In this real-world analysis from a large cohort of women with coronary artery disease undergoing percutaneous coronary intervention at a US tertiary-care center, racial disparities were observed, especially in baseline characteristics, indicating late presentation., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objectives: This study sought to test safety and exploratory effectiveness of a dedicated transcaval closure device (TCD)., Background: Transcaval access enables delivery of large-caliber devices to the aorta in patients ineligible for transfemoral arterial access. Closure of aortocaval fistulae using off-label nitinol cardiac occluders has been shown to be safe, but persistent aortocaval fistulae at exit from the catheterization lab and bleeding complications were common in a prospective study., Methods: Preclinical testing of the TCD was performed in 24 Yorkshire swine, including 10 under good laboratory practice conditions. Subsequently, subjects undergoing transcatheter aortic valve replacement for symptomatic severe aortic stenosis, ineligible for transfemoral arterial access, were enrolled in a U.S. Food and Drug Administration-approved early feasibility study of the TCD (Transmural Systems, Andover, Massachusetts). Independently adjudicated endpoints included technical, device, and procedural success, incorporating in-hospital and 30-day clinical and imaging follow-up., Results: Transcaval access and closure in swine confirmed that at 30 days, TCDs were almost entirely endothelialized. Subsequently, 12 subjects were enrolled in the early feasibility study. Transcaval access, transcatheter aortic valve replacement, and aortocaval fistula closure was successful in all 12 subjects. The primary endpoint of technical success was met in 100% of subjects. Complete closure of the transcaval access tract was achieved in 75% of subjects at exit from the catheterization lab and in 100% of subjects at 30 days. There were zero modified Valve Academic Research Consortium-2 major vascular complications and zero Valve Academic Research Consortium-2 life-threatening or major bleeding complications related to transcaval access or the TCD., Conclusions: The TCD achieved complete closure of the transcaval access tract in most subjects at exit from the catheterization lab and essentially eliminated transcaval-related bleeding. Dedicated devices for transcaval access and closure could enable more widespread adoption of transcaval techniques without fear of bleeding complications. (Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement; NCT03432494)., (Published by Elsevier Inc.)

Objectives: To test custom-shape guiding catheter curves intended to simplify aortic valve leaflet laceration., Background: Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA) is an adjunct to transcatheter aortic valve replacement. It can be technically demanding using popular coronary guiding catheters and catheter-in-guide coaxial systems. New elephant-trunk shaped Pachyderm Left (PAL1,PAL2,PAL3, Launcher, Medtronic) and Right (PJR4) guiding catheters match the geometric requirements to engage aortic cusp hinge points. We evaluate whether these catheters ease BASILICA compared with conventional-shape coronary guiding catheters used in the BASILICA IDE trial., Methods: This is a single-center, consecutive, retrospective observational cohort of patients who underwent BASILICA for risk of TAVR-induced coronary obstruction defined as virtual valve-to-coronary distance <4 mm, immediately upon commercial availability of the new Pachyderm shaped catheters. Clinical, procedural, and angiographic details were abstracted from medical records of their index procedure, and were compared to adjudicated findings in the BASILICA IDE trial., Results: Nine leaflets in 6 patients were traversed and lacerated using BASILICA and Pachyderm curve guiding catheters for traversal, including three solo left and three doppio left and right leaflets. Leaflet traversal was universally successful. Leaflet time-to-leaflet traversal was shorter using Pachyderm catheters compared with the BASILICA IDE trial (8.3 min (5.6-15) vs 45 min (20, 61), p = 0.016). There were no deaths, strokes, or vascular complications., Conclusions: The new Pachyderm shaped guiding catheters significantly hastened the leaflet time-to-traversal during BASILICA TAVR. We recommend they be used instead of conventional coronary-shaped guiding catheters., (Published by Elsevier Inc.)

Coronary artery obstruction is an uncommon but devastating complication of transcatheter aortic valve replacement (TAVR). Computed tomography appears to be a sensitive but nonspecific predictor of coronary artery obstruction. Transcatheter approaches to prevent and treat coronary artery obstruction, such as "snorkel" stenting, are unsatisfactory because of serious early and late ischemic complications. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is an early-stage transcatheter procedure to prevent coronary artery obstruction. It works by splitting the native or bioprosthetic leaflets so that they splay after TAVR and preserve coronary artery inflow. Because of the paucity of suitable alternatives, there is interest in the BASILICA technique despite its infancy. This tutorial review summarizes current thinking about how to predict and prevent coronary artery obstruction using BASILICA. First, the authors depict the main pathophysiological mechanisms of TAVR-associated coronary artery obstruction, along with the factors thought to contribute to coronary obstruction. Next, the authors provide a step-by-step guide to analyzing pre-procedural computed tomographic findings to assess obstruction risk and, if desirable, to plan BASILICA. Next, the authors describe the mechanisms underlying transcatheter electrosurgery. Finally, they provide step-by-step guidance on how to perform the procedure, along with a required equipment list., (Published by Elsevier Inc.)

Objectives: The BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR) investigational device exemption trial was a prospective, multicenter, single-arm safety and feasibility study., Background: Coronary artery obstruction is a rare but devastating complication of transcatheter aortic valve replacement (TAVR). Current stent-based preventative strategies are suboptimal. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction during TAVR (BASILICA) is a novel transcatheter technique performed immediately before TAVR to prevent coronary artery obstruction., Methods: Subjects with severe native or bioprosthetic aortic valve disease at high or extreme risk for surgery, and at high risk of coronary artery obstruction, were included. The primary success endpoint was successful BASILICA and TAVR without coronary obstruction or reintervention. The primary safety endpoint was freedom from major adverse cardiovascular events. Data were independently monitored. Endpoints were independently adjudicated. A core laboratory analyzed computed tomography images., Results: Between February 2018 and July 2018, 30 subjects were enrolled. Primary success was met in 28 (93%) subjects. BASILICA traversal and laceration was successful in 35 of 37 (95%) attempted leaflets. There was 100% freedom from coronary obstruction and reintervention. Primary safety was met in 21 (70%), driven by 6 (20%) major vascular complications related to TAVR but not BASILICA. There was 1 death at 30 days. There was 1 (3%) disabling stroke and 2 (7%) nondisabling strokes. Transient hemodynamic compromise was rare (7%) and resolved promptly with TAVR., Conclusions: BASILICA was feasible in both native and bioprosthetic valves. Hemodynamic compromise was uncommon. Safety was acceptable and needs confirmation in larger studies. BASILICA appears effective in preventing coronary artery obstruction from TAVR in subjects at high risk., (Published by Elsevier Inc.)

Transcatheter mitral valve replacement (TMVR) is a promising strategy for patients with mitral valve disease and no surgical options. Left ventricular outflow tract (LVOT) obstruction is a life-threatening complication of TMVR. Although there are no commercially available devices to prevent LVOT obstruction, the risk of it can be reduced by careful preprocedure planning and the use of novel modifications to commercially available devices. This article summarizes current techniques to prevent LVOT obstruction with an emphasis on electrosurgical strategies., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background/purpose: Optical coherence tomography (OCT) is a high-resolution intravascular imaging modality used to assess coronary arteries and as an adjunctive tool for optimization of percutaneous coronary interventions. Overall, the rate of complications and adverse events related to intravascular imaging is low. Limited data exist on the most commonly reported complications and modes of failure related to the use of OCT. Therefore, we analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to assess the reported complications and failure modes for OCT and reviewed techniques to optimize device use., Methods/materials: The MAUDE database was queried for all event reports involving coronary OCT devices. Two independent reviewers identified 49 device reports included in the final analysis. Modes of failure and device-related patient complications were assessed., Results: Of the 49 cases with reported device-related issues, 6.1% involved malfunction prior to insertion of the OCT catheter, and 30.6% of reported events did not result in an associated patient-related adverse event. The most commonly reported adverse events included coronary dissection and difficulty removing the catheter within a previously stented segment. No events of contrast-induced nephropathy were reported., Conclusions: Findings from the MAUDE database highlight the modes of device-related events associated with OCT. Device issues are uncommon, and as a result, users should be aware of optimal techniques to prevent and minimize adverse events related to device use., (Copyright © 2019 Elsevier Inc. All rights reserved.)