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Background: Left ventricular outflow tract (LVOT) obstruction is a common, often fatal complication of transcatheter mitral valve replacement (TMVR). Laceration of the anterior mitral leaflet to prevent outflow obstruction (LAMPOON) was safe and effective at preventing LVOT obstruction at 30 days in the National Heart, Lung, and Blood Institute LAMPOON trial., Objectives: The authors report the 5-year outcomes of intentional anterior mitral leaflet laceration before SAPIEN 3 TMVR, in patients at risk of LVOT obstruction., Methods: The National Heart, Lung, and Blood Institute LAMPOON trial was a prospective, multicenter, single-arm safety and feasibility study of LAMPOON and transseptal SAPIEN 3 TMVR in annuloplasty rings (valve-in-ring) or native mitral annular calcification (MAC) (valve-in-MAC). All subjects had high predicted risk for LVOT obstruction. Subjects were not excluded for excessive frailty or comorbidity. The primary endpoints were technical success and safety at 30 days. Secondary clinical and echocardiographic endpoints were assessed at 1 year and clinical follow-up at 5 years., Results: Thirty subjects were enrolled between June 2017 and June 2018, equally between the valve-in-MAC and valve-in-ring arms. At 30 days, LAMPOON was successful in all 30 subjects, with no strokes, 1 (3%) death, and 1 (3%) moderate LVOT obstruction. Eighteen (65%) survived to 1 year, and 7 (25%) survived to 5 years. Six (20%) were hospitalized for heart failure in the first year. From baseline to 1 year, there was a 24-point improvement in Kansas City Cardiomyopathy Questionnaire score and a 60-m improvement in 6-minute walk distance. There was no significant change in N-terminal pro-brain natriuretic peptide. At 1 year, LVOT gradients remained low., Conclusions: LAMPOON enabled TMVR despite the risk for LVOT obstruction. There were no long-term complications associated with LAMPOON. The selection of inoperable patients limited assessment of long-term survival following TMVR. (NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation; NCT03015194)., Competing Interests: Funding Support and Author Disclosures This work was supported by the Division of Intramural Research, NHLBI, National Institutes of Health (Z01-HL006040), and by the intramural programs of the participating centers. The NHLBI and Edwards Lifesciences have a collaborative research and development agreement on transcatheter modification of mitral valve leaflets, including joint financial support of this study. Drs Khan, Rogers, and Lederman are coinventors on patents, assigned to the National Institutes of Health, for catheter devices to lacerate valve leaflets. Dr Khan is a proctor for Edwards Lifesciences and Medtronic; and has equity in Transmural Systems. Dr Greenbaum is a proctor for Edwards Lifesciences, Medtronic, and Abbott Vascular; and has equity in Transmural Systems and Excision Medical. Dr Babaliaros is 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 Rogers is a consultant for Edwards Lifesciences, Boston Scientific, Abbott, Anteris, and Medtronic; serves on advisory boards for Medtronic and Boston Scientific; and has equity in Transmural Systems. Dr Eng is on the Speakers Bureau for Edwards Lifesciences and Medtronic. Dr Foerst is a proctor for Edwards Lifesciences and Medtronic. Dr Paone is proctor for Edwards Lifesciences and has equity in Medtronic. Dr Lederman is the principal investigator on a cooperative research and development agreement between the National Institutes of Health and Edwards Lifesciences for transcatheter modification of the mitral valve. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Background: A prior Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry-based analysis reported similar 1-year clinical outcomes with small (20-mm) vs large (≥23-mm) balloon-expandable valves (BEV)., Objectives: The aim of this study was to describe mid-term 3-year clinical outcomes for small vs large BEV and the relationship between discharge echocardiographic mean gradient (MG) and different definitions of prothesis-patient mismatch (PPM) with clinical outcomes., Methods: Using the TVT Registry with Centers for Medicare and Medicaid Services linkage, a propensity-matched analysis of patients receiving 20- vs ≥23-mm BEVs was performed. Spline curves and Kaplan-Meier plots with adjusted HRs determined the relationship between MG and 3-year mortality., Results: In total, 316,091 patients were analyzed; after propensity matching, 8,100 pairs of each group were compared. The 20-mm BEV was associated with higher MGs compared with ≥23-mm BEVs (16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg; P < 0.0001). At 3 years, there was no difference in mortality between 20- and ≥23-mm BEVs (31.5% vs 32.5%, respectively; HR: 0.97; 95% CI: 0.90-1.05). Compared with an MG of 10 to 30 mm Hg, an MG <10 mm Hg (HR: 1.25; 95% CI:1.22-1.27) was associated with increased 3-year mortality. Measured severe PPM and predicted no PPM were associated with increased 3-year mortality (33.5% vs 32.9% vs 32.1%; P < 0.0001) and (33.5% vs 31.1% vs 30%; P < 0.0001), respectively. Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF)., Conclusions: Patients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes., Competing Interests: Funding Support and Author Disclosures Dr Eng is a clinical proctor for Medtronic and Edwards Lifesciences. Dr Khalili has received a research grant from Edwards Lifesciences; and has received speaker fees from Abbott Vascular. Dr Vavalle is a consultant for Edwards Lifesciences. Dr Southard has received personal fees from Edwards Lifesciences and Boston Scientific. Dr Hahn has received speaker fees from Boston Scientific, Baylis Medical, Edwards Lifesciences, and Medtronic; has received consulting fees from Abbott Structural, Edwards Lifesciences, Gore Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio; holds equity with Navigate; and is chief scientific officer of the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr Wang has received research grant support from Boston Scientific; and is a consultant for Edwards Lifesciences, Abbott Vascular, Boston Scientific, and Materialise. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Statistical analyses were performed by Edwards Lifesciences. The views or opinions presented here do not represent those of the American College of Cardiology, the Society of Thoracic Surgeons, or the TVT Registry., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Elevated aortic valve gradients are common after transcatheter aortic valve implantation for degenerated surgical aortic valve replacement bioprostheses, but their clinical impact is uncertain., Methods: A total of 12 122 patients who underwent transcatheter aortic valve implantation-in-surgical aortic valve replacement from November 2011 to December 2019 in the Society of Thoracic Surgery/American College of Cardiology Transvalvular Therapeutics Registry were included. The primary outcome was a composite of 1-year all-cause mortality, stroke, myocardial infarction, or valve reintervention. Secondary outcomes included 1-year all-cause mortality, readmission, and change from baseline 12-question self-administered Kansas City Cardiomyopathy Questionnaire-Overall Summary Score. Due to nonlinearity observed with restricted cubic splines analysis, a Cox regression analysis with aortic valve mean gradient modeled as a spline-continuous variable (with 20 mm Hg as a cutoff) was used to study the 1-year composite outcome and mortality., Results: The composite outcome occurred most frequently in patients with aortic valve mean gradient ≥30 and <10 mm Hg, as compared with those with 10 to 20 and 20 to 30 mm Hg ranges (unadjusted rates, 13.9%, 12.1%, 7.5%, and 6.5%, respectively; P =0.002). When the mean aortic valve gradient was ≥20 mm Hg, higher gradients were associated with greater risk of the 1-year composite outcome (adjusted hazard ratio, 1.02 [1.02-1.03] per mm Hg; P <0.001) and 1-year mortality (adjusted hazard ratio, 1.02 [1.00-1.03] per mm Hg; P =0.007). Whereas when the mean aortic valve gradient was <20 mm Hg, higher gradients were not significantly associated with the composite outcome (adjusted hazard ratio, 0.99 [0.98-1.003] per mm Hg; P =0.12) but were associated with lower 1-year mortality (adjusted hazard ratio, 0.98 [0.97-0.99] per mm Hg; P =0.007)., Conclusions: The relationship between postprocedural aortic valve mean gradient after transcatheter aortic valve implantation-in-surgical aortic valve replacement and clinical outcomes is complex and nonlinear, with relatively greater adverse events occurring at low and high gradient extremes. Further study of factors mediating the relationship between postprocedural gradients and clinical outcomes, including low-flow states, is necessary., Competing Interests: Dr Kleiman served as investigator and part of steering and screening committees for Medtronic, Abbott, Edwards, and Boston Scientific. Will be serving on the Transvalvular Steering Therapeutic Steering committee beginning 2023. Dr Vemulapalli received grants from the American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health (RO1 and SBIR), Cytokinetics, Abbott Vascular, Food and Drug Administration. He has received consulting fees or honorariums from Medtronic, Edwards Lifesciences, and the American College of Physicians. Dr Kapadia received stock options for Anteris and Navigate.

Background: Adequate valve performance after surgical mitral valve repair with an annuloplasty ring is not always sustained over time. The risk of repeat mitral valve surgery may be high in these patients. Transcatheter mitral valve-in-ring (MViR) is emerging as an alternative for high-risk patients., Objectives: The authors sought to assess contemporary outcomes of MViR using third-generation balloon-expandable aortic transcatheter heart valves., Methods: Patients who underwent MViR and were enrolled in the STDS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry between August 2015 and December 2022 were analyzed., Results: A total of 820 patients underwent MViR at 236 sites, mean age was 72.2 ± 10.4 years, 50.9% were female, mean STS score was 8.2% ± 6.9%, and most (78%) were in NYHA functional class III to IV. Mean left ventricular ejection fraction was 47.8% ± 14.2%, mean mitral gradient was 8.9 ± 7.0 mm Hg, and 75.5% had ≥ moderate mitral regurgitation. Access was transseptal in 93.9% with 88% technical success. All-cause mortality at 30 days was 8.3%, and at 1 year, 22.4%, with a reintervention rate of 9.1%. At 1-year follow-up, 75.6% were NYHA functional class I to II, Kansas City Cardiomyopathy Questionnaire score increased by 25.9 ± 29.1 points, mean mitral valve gradient was 8.4 ± 3.4 mm Hg, and 91.7% had ≤ mild mitral regurgitation., Conclusions: MViR with third-generation balloon-expandable aortic transcatheter heart valves is associated with a significant reduction in mitral regurgitation and improvement in symptoms at 1 year, but with elevated valvular gradients and a high reintervention rate. MViR is a reasonable alternative for high-risk patients unable undergo surgery who have appropriate anatomy for the procedure. (STS/ACC TVT Registry Mitral Module [TMVR]; NCT02245763)., Competing Interests: Funding Support and Author Disclosures As this analysis was restricted to the Edwards Lifesciences SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra Resilis transcatheter heart valves, statistical analyses were performed by Edwards Lifesciences. The views or opinions presented here do not represent those of the American College of Cardiology (ACC), Society of Thoracic Surgeons (STS), or the STS/ACC TVT Registry. Dr Guerrero has received institutional research grant support from Abbott Structural Heart and Edwards Lifesciences. Dr Bapat has received speaker/consultancy fees and research grant support from Edwards Lifesciences, Medtronic, Boston Scientific, Abbott, and 4C Medical. Dr Mahoney has served as a consultant for Edwards Lifesciences and Medtronic. Dr Eng has served as a clinical proctor for Edwards Lifesciences and Medtronic. Dr Yadav has served as a consultant for Edwards Lifesciences, Medtronic Inc., Abbott Vascular, and Shockwave Medical. Dr Coylewright has received research funding from Boston Scientific and Edwards Lifesciences; and consulting fees from Medtronic, Abbott, Occlutech, Boston Scientific, and Edwards Lifesciences. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; has served as national principal investigator for Portico (Abbott) and Acurate (Boston Scientific) U.S. investigation device exemption trials; has received personal proctoring fees from Edwards Lifesciences; and has received travel support from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Szerlip has served as National Principal Investigator for trial sponsored by Edwards Lifesciences; has served on steering committees for trials by Abbott and Medtronic; and has served as speaker for Medtronic, Abbott, and Edwards Lifesciences. Dr Nazif has received consulting fees or honoraria from Boston Scientific, Medtronic, Opsens Medical, Teleflex, and Encompass Technologies and institutional research support from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott. Dr. Kodali is a consultant for Admedus, Meril Lifesciences, JenaValve, Abbott Vascular; and has equity in Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, Supira, and Admedus. Dr. George has served as a consultant for Cardiomech, Atricure, Valcare Medical, Mitremedical, Ethicon, Zimmer Biomet, Durvena, and Vdyne. Drs Greenbaum and Babaliaros have received institutional research support from Abbott Vascular, Ancora Heart, Edwards Lifesciences, Gore Medical, Jena Valve, Medtronic, Polares Medical, Transmural Systems, and 4C Medical; received consulting fees from Abbott Vascular, Edwards Lifesciences, and Medtronic; and have equity interest in Transmural Systems. Dr Whisenant has served as a consultant for Edwards Lifesciences. Dr Thourani has been an advisor for Abbott Vascular, ARtivion, Atricure, Boston Scientific, Edwards Lifesciences, Medtronic, and Shockwave. Dr McCabe has served as a consultant for Edwards, Medtronic, Boston Scientific, and Cardiovascular System Inc; and has equity in ConKay Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Reintervention is commonly required postsurgical mitral valve replacement (SMVR) or repair due to bioprosthetic valve and annuloplasty ring degeneration. However, redo SMVR is associated with a high risk of morbidity and mortality. Postsurgical transcatheter mitral valve replacement (TMVR) is a safe and less-invasive alternative that has repeatedly been shown to be associated with improved survival and lower rates of complications compared with redo SMVR. Comprehensive patient evaluation and thorough procedural planning are key to successful TMVR., Competing Interests: Disclosures M.H. Eng is a clinical proctor for Edwards Lifesciences and Medtronic. He is on the speaker’s panel for LivaNova. H.K. Fang is on the speaker’s bureau for Abbott. He is a consultant for Atricure and Edwards Lifesciences. The other authors have no conflict of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Mitral valve dysfunction is prevalent amongst older patients. Of those not suitable for surgical therapy, mitral transcatheter edge-to-edge repair (TEER) can treat as large proportion of patients, many are not suitable TEER candidates. As such, orthotopic transcatheter mitral valve replacement (TMVR) is an important innovation but it faces significant challenges. Orthotopic TMVR requires a prosthesis with stable anchoring, adequate sealing, minimal footprint in the left ventricle and long term durability. Multidisciplinary expertise in advanced imaging, surgery, heart failure are needed for success., Competing Interests: Disclosure M.H. Eng is a clinical proctor for Edwards Lifesciences and Medtronic. He is on the speaker’s panel for LivaNova. F. Zahr receives research and educational grants and is a consultant for Edwards Lifesciences, United States and Medtronic., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Mitral valve endocarditis complicated by peri-mitral annular destruction requires surgical intervention. We present a case where surgery was not an option. A 45-year-old man who developed an enlarging left ventricle pseudoaneurysm, left ventricle to left atrium fistula and red blood cell hemolysis as sequalae of mitral valve endocarditis was not a surgical candidate. Patient underwent a hybrid repair of left ventricle pseudoaneurysm via a transapical and transseptal approach. The body of pseudoaneurysm was coiled trans-apically whereas the neck of pseudoaneurysm was reached and coiled via a transseptal approach. The left ventricle to left atrium fistula was closed via an Amplatz muscular ventricle septal occluder. The pseudoaneurysm was fully obliterated, patient symptoms improved and was discharged with stable hemoglobin levels., Competing Interests: Declaration of competing interest Dr. Marvin Eng is a consultant for Edwards Lifesciences and Medtronic. All other authors have nothing to disclose., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures Dr Eng has been a consultant for Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Background: Despite the rapid adoption of transcatheter aortic valve replacement since its approval, the frequency and outcomes of aortic valve reintervention after transcatheter aortic valve replacement are poorly understood., Methods: Valve reinterventions, either surgical transcatheter aortic valve explantation or repeat transcatheter aortic valve replacement, between 2012 and 2019 were queried using the Society of Thoracic Surgeons Database and the Transcatheter Valve Therapy Registry through the Michigan Statewide quality collaborative. The reintervention frequency and clinical outcomes including observed-to-expected mortality ratio using Society of Thoracic Surgeons Predicted Risk of Mortality were reviewed., Results: Among 9694 transcatheter aortic valve replacement recipients, a total of 87 patients (0.90%) received a reintervention, consisting of 34 transcatheter aortic valve explants and 53 repeat transcatheter aortic valve replacement procedures. The transcatheter aortic valve explant group demonstrated a higher Society of Thoracic Surgeons Predicted Risk of Mortality. Reintervention cases increased from 0 in 2012 and 2013 to 26 in 2019. The proportion of transcatheter aortic valve explants among all reinterventions increased and was 65% in 2019. Self-expandable devices had a higher reintervention rate than balloon-expandable devices secondary to a higher transcatheter aortic valve explant frequency (0.58% [23/3957] vs 0.19% [11/5737]; P = .001), whereas repeat transcatheter aortic valve replacement rates were similar (0.61% [24/3957] vs 0.51% [29/5737]; P = .51). Among patients with transcatheter aortic valve explants, contraindications to repeat transcatheter aortic valve replacement included unfavorable anatomy (75%), need for other cardiac surgery (29%), other structural issues by transcatheter aortic valve device (18%), and endocarditis (12%). For transcatheter aortic valve explant and repeat transcatheter aortic valve replacement, the 30-day mortality was 15% and 2% (P = .032) and the observed-to-expected mortality ratio was 1.8 and 0.3 (P = .018), respectively., Conclusions: Aortic valve reintervention remains rare but is increasing. The clinical impact of surgical device explantation was substantial, and the proportion of transcatheter aortic valve explants was significantly higher in patients with a self-expandable device., (Copyright © 2021 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: Acute MR due to mechanical mitral valve (MV) complications frequently results in cardiogenic shock and requires emergency surgical intervention. There was limited evidence for alternative treatment like MitraClip for patients at prohibitive surgical risk. We aimed to study the technical features and outcomes of emergency transcatheter edge-to-edge repair (TEER) using the MitraClip system for patients with cardiogenic shock (CS) secondary to acute mitral regurgitation (MR) and mechanical MV complication., Material and Methods: We performed institutional review and systemic literature review to identify all TEER for CS patients due to acute mitral regurgitation and mechanical MV complication. Clinical endpoints included device success rate assessed at the end of procedure, ability to wean off MCS, all-cause and cardiovascular mortality at 30-day., Results: Eight patients were identified from institutional review. Detail anatomical analysis found that patients with mechanical MV complications related to myocardial infarction had a lower transseptal height achieved during MitraClip (3.6 ± 0.1 cm vs 4.3 ± 0.3 cm, p = 0.03) than those not related. Pooled analysis for cases from institutional review (n = 8) and systemic literature review (n = 16) was performed. The device success rate was 68.8 %. Seventy-five percent (n = 18) cases required mechanical circulatory support (MCS), and 94.4 % were able to wean off MCS. At 30-day, the cardiovascular mortality was 4.5 % and the all-cause mortality was 9.1 %., Conclusions: In CS patients due to acute MR and mechanical MV complications, TEER with/without MCS was feasible with a reasonable device success rate., Competing Interests: Declaration of competing interest Dr. Frisoli is a clinical proctor for Abbott. Dr. O'Neill is a consultant to Abiomed. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To describe outcomes of patients who underwent transcatheter aortic valve replacement (TAVR) in a native valve or failed bioprosthetic valve or transcatheter heart valve (THV) and a transcatheter mitral valve replacement procedure (TMVR; valve-in-valve [mViV], valve-in-ring [mViR], and valve in mitral annulus calcification [ViMAC]) either concomitantly (same procedure) or staged (different procedures)., Background: Patient characteristics, procedural details, and outcomes of concomitant or staged TAVR and TMVR procedures are largely unknown., Methods: Data were extracted from the STS/ACC TVT Registry™ for patients undergoing concomitant or staged TAVR and TMVR with SAPIEN XT, SAPIEN 3, or SAPIEN 3 Ultra (Edwards Lifesciences) THVs. Descriptive results were reported for procedural, index hospitalization, 30-day, and 1-year outcomes., Results: A total of 257 patients underwent TAVR and TMVR in concomitant (n = 135) or staged (n = 122) procedures. Device success was 82.9% and 83.9% for concomitant TAVR and TMVR procedures and 83.8% and 82.5% for staged TAVR and TMVR procedures. Significant improvements in aortic and mitral valve function remained stable through 1 year. All-cause mortality for concomitant and staged groups was 14.7% and 10.5% at 30 days, and 32.8% and 24.6% at 1 year, respectively. Stroke rate for concomitant and staged groups was 0.8% and 3.6% at 30 days and 3.9% and 5.6% at 1 year, respectively. Improvements from baseline to 1 year in NYHA class and KCCQ overall summary scores were observed for all patients., Conclusions: Concomitant or staged transcatheter treatment of patients with aortic and mitral valve disease can be performed in select high-risk patients in experienced centers., (© 2022 Wiley Periodicals LLC.)

Objectives: To study the safety and efficacy of AngioVac for left-sided transcatheter vacuum-assisted mass extraction (TVME)., Background: The AngioVac system is approved for right-sided TVME and has emerged as an effective and safe alternative for open surgical treatment. The use of the AngioVac device for aspiration of left-sided TVME has been limited., Methods: Consecutive patients from two Michigan centers who underwent left-sided TVME were included. Data on patient demographics, procedural information, in-hospital and follow-up events were collected through electronic medical records review. Technical success was defined as aspirating of 70%-100% of the material., Results: Ten patients (mean age 58.3 [±17.3] years, 50% male) were included. Indications for TMVE were in large for recurrent embolic events. All patients underwent bilateral cerebro-embolic protection using the Sentinel device. The total mean procedure time was 192.5 (±47.5) min of which the meantime for active aspiration (bypass time) was 9.3 (±4.2) min. The circuit configuration was: arteriovenous (AV) in four cases and arterioarterial (AA) in six cases. Successful aspiration was achieved in 80% of cases. No complications were reported (range follow-up 1-16 months)., Conclusions: Our small case series demonstrates the feasibility and safety of the AngioVac system in left-sided mass extraction. Larger trials are needed to further demonstrate its effectiveness and safety and potentially apply for on-label use., (© 2022 Wiley Periodicals LLC.)

Purpose of Review: Repeat surgery for failed mitral valve prostheses and repairs are fraught with high rates of morbidity and mortality. Therefore, clinicians have evolved transcatheter technology as an alternative therapy. This review serves as an update as the field has moved out of the early learning curve of treating postsurgical mitral valve failures., Recent Findings: Mitral valve-in-valve procedures have higher rates of technical success and better in-hospital and 1-year mortality rates than mitral valve-in-ring cases. The higher rates of complications, including left ventricular outflow tract obstruction, paravalvular leak, valve embolization, and need for a 2nd valve, may explain these outcomes. Mitral valve-in-ring procedures have attenuated outcomes as compared to valve-in-valve. Clinicians should be cognizant of the nuanced complexities and the potential for suboptimal outcomes in using balloon-expandable valves for mitral valve-in-ring procedures., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: As transcatheter aortic valve replacement (TAVR) procedures increase, more data is available on the development of conduction abnormalities requiring permanent pacemaker (PPM) implantation post-TAVR. Mechanistically, new pacemaker implantation and incidence of associated tricuspid regurgitation (TR) post-TAVR is not well understood. Studies have evaluated the predictability of patient anatomy towards risk for needing permanent pacemaker (PPM) post-TAVR; however, little has been reported on new PPM and TR in patients post-TAVR., Methods: This retrospective study identified patients at our health system who underwent PPM following TAVR from January 2014 to June 2018. Data from both TAVR and PPM procedures as well as patient demographics were collected. Echocardiographic data before TAVR, between TAVR and PPM placement, and the most recent echocardiogram at the time of chart review were analyzed., Results: Of 796 patients who underwent TAVR between January 2014 and June 2018, 89 patients (11%) subsequently required PPM. Out of the 89 patients who required PPM implantation, 82 patients had pre-TAVR and 2-year post-TAVR echocardiographic imaging data. At baseline, 22% (18/82) of patients had at least moderate TR. At 2-year post-TAVR echocardiographic imaging follow-up; 27% (22/82) of patients had at least moderate TR. Subgroup analysis was performed according to the TAVR valve size implanted. In patients who received a TAVR device < 29 mm in diameter in size, 25% (11/44) had worsening TR. In patients who received a TAVR device ≥ 29 mm in diameter, 37% (14/38) had worsening TR., Conclusion: We have demonstrated a patient population that may be predisposed to developing worsening TR and right heart function after TAVR and Pacemaker implantation., (© 2021 Wiley Periodicals LLC.)

We report a case of a 59-year-old male in post-myocardial infarction cardiogenic shock undergoing left atrial venous arterial extracorporeal membrane oxygenation (LAVA-ECMO) as a bridge to transplantation. The unique feature of this ECMO configuration is use of a single trans-septal cannula to provide biventricular unloading and use of a single arterial access., Competing Interests: Disclosures: M.B.B. is a consultant for Abbott Vascular, Abiomed, Cardiovascular System, Chiesi and Zoll. K.A. is a consultant and speaker for Boston Scientific, Teleflex Medical, Abbott Vascular, and CSI. J.C. is a consultant for Medtronic and Abbott. M.H. E. is a clinical proctor for Edwards Lifesciences and Medtronic. W.W.N. has received grant support from Edwards Lifesciences and Abiomed. For the remaining authors, there are no conflicts of interest to report., (Copyright © ASAIO 2021.)

Evidence-based recommendations for clinical practice are intended to help health care providers and patients make decisions, minimize inappropriate practice variation, promote effective resource use, improve clinical outcomes, and direct future research. SCAI has been engaged in the creation and dissemination of clinical guidance documents since the 1990s. These documents are a cornerstone of the Society's education, advocacy, and quality improvement initiatives. The Publications Committee is charged with the oversight of SCAI's clinical documents program and has published the first iteration of this manual of standard operating procedures in 2019 to ensure consistency, methodological rigor, and transparency in the development and endorsement of the Society's documents. The manual has been updated based on feedback from the implementation of the original version to add specificity and expand the breadth of available document formats. The manual is intended for reference by the Publications Committee, document writing groups, external collaborators, SCAI representatives, peer reviewers, and anyone seeking information about the SCAI documents program., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© 2022 Published by Elsevier Inc. on behalf of the Society for Cardiovascular Angiography and Interventions Foundation.)

Pelvic venous disorders are inter-related pathologic conditions caused by reflux and obstruction in the pelvic veins. It can present a spectrum of clinical features based on the route of transmission of venous hypertension to either distal or caudal venous reservoirs. Imaging can help to visualize pelvic vascular and visceral structures to rule out other gynecologic, gastrointestinal, and urologic diseases. Endovascular treatment, owing to its low invasive nature and high success rate, has become the mainstay in the management of pelvic venous disorders. This article reviews the pathophysiology, clinical presentations, and diagnostic and therapeutic approaches to pelvic venous disorders., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Paravalvular leaks (PVLs) are challenging lesions that require a comprehensive understanding of surgical and transcatheter heart therapies, multimodality imaging, and transcatheter techniques. Approach to a transcatheter heart valve (THV) or surgical prosthesis for PVL differs in terms of options and varies according to the location (aortic or mitral). A suggested framework for transcatheter PVL repair is defect localization, access planning, defect crossing, sheath delivery. and occluder deployment. Careful planning facilitates success, but operators begin the case with a flexible mindset because many initial strategies may not succeed., Competing Interests: Disclosure M.H. Eng is a clinical proctor for Edwards Lifesciences and Medtronic. A.B. Greenbaum is a proctor for Edwards Lifesciences, and Medtronic. He is a consultant with equity in Transmural Systems. His employer has research contracts for investigation of aortic and mitral devices from Edwards Lifesciences, Abbott Vascular, Medtronic, and Boston Scientific. K. Fang is a consultant to Abbott Vascular and Atricure., (Copyright © 2022. Published by Elsevier Inc.)

Competing Interests: Funding Support and Author Disclosures Dr Villablanca has served as a consultant for Edwards Lifesciences and Teleflex. Dr O'Neill is a consultant to and has received research support from Edwards Lifesciences. Dr Frisoli has served as a proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr Wang has served as a consultant to Edwards Lifesciences, Abbott, NeoChord, and Boston Scientific; and has received research grant support from Boston Scientific assigned to her employer, the Henry Ford Health System. Dr Eng has served as a proctor for Medtronic and Edwards Lifesciences. Dr O'Neill has served as a consultant for Abiomed, Edwards Lifesciences, Medtronic, Boston Scientific, Abbott Vascular, and St. Jude Medical; and has served on the Board of Directors of Neovasc. 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 Frisoli has served as a proctor for Edwards Lifesciences, Boston Scientific, Abbott, and Medtronic. Dr B. O’Neill has served as a consultant for and received research grant from Edwards Lifesciences. Dr Lee is a consultant for HeartFlow. Dr Villablanca is a consultant for Edwards Lifesciences and Teleflex. Dr Wang has served as a consultant to Edwards Lifesciences, Boston Scientific, and Materialize; and has received research grant support from Boston Scientific. Dr Eng has served as clinical proctor for Edwards Lifesciences. Dr W.W. O’Neill has served as a consultant to Abiomed, Medtronic, and Boston Scientific.

Background: Cerebrovascular events that occur during structural and interventional procedures are a well known risk which is associated with increased mortality. The FDA has approved the use of the Sentinel device in TAVR. Hereby we report on our experience on the safety and efficacy of using Sentinel in a patient population undergoing non-TAVR transcatheter procedures., Methods: Retrospective analysis of a single center experience with using the Sentinel device for non-TAVR transcatheter procedures., Results: We identified 33 patients (average age was 73.8 years, 36.7% females, and 30% with history of a prior stroke) felt to be at high risk for cerebroembolic events that underwent Sentinel device placement. Sentinel placement was successful in all patients. Examples of high risk features included high atheroma burden in the aortic arch, left sided valve vegetations, intra-cardiac thrombi and severe left sided valve calcifications/thrombi. No patients developed periprocedural stroke or vascular complications., Conclusion: Overall, the use of Sentinel for non-TAVR indications appears feasible and safe. The use of cerebral protection devices should be studied further in non-TAVR patients to establish its role and its benefits, especially with expanding the number of non-TAVR transcatheter interventions., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Severe tricuspid regurgitation renders patients frail, and surgical treatment is associated with high mortality. Because most of the tricuspid regurgitation patients are functional and have significant annular dilation, large coaptation gaps are seen. This anatomy is best addressed with transcatheter tricuspid valve replacement (TTVR), and promising therapies are under clinical investigation. Most TTVR devices are in early clinical development with one transcatheter heart valve in pivotal trial; TTVR is expected to significantly affect tricuspid regurgitation and survival., Competing Interests: Disclosures Marvin H. Eng, MD is a clinical proctor for Edwards Lifesciences and Medtronic. V. Babaliaros is a consultant for Edwards Lifesciences. A.B. Greenbaum is a consultant to Edwards Lifesciences, Medtronic, and Abbott., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Transcathetertherapy has expanded the treatment options for patients with heart valve disease. Interventional therapy for aortic, mitral, and pulmonic valve disease is well established; however, catheter-based approaches to tricuspid regurgitation (TR) are still in early stages of development. For some of the interventional concepts to TR, including the edge-to-edge-repair, transcatheter annuloplasty, the tricuspid spacer, and caval valves, procedural feasibility and favorable early clinical outcome have been demonstrated in small compassionate case series. This article reviews the pathophysiological background and current evidence for caval valve implantation and examines the potential role of this approach for the treatment of severe TR., Competing Interests: Disclosure A. Lauten: Consultant to P&F TricValve, receives research support from Edwards Lifesciences. H. Dreger reports grants from Edwards Lifesciences. H.R. Figulla is a consultant to P&F TricValve and the founder of JenaValve; K. Stangle reports grants from Edwards Lifesciences and speaker and proctor fees from Abbott, Edwards Lifesciences and Medtronic. M. Laule reports grants from Edwards Lifesciences and Berlin Institute of Health and speaker and proctor fees from Abbott, Edwards Lifesciences, and Medtronic. Marvin H. Eng is a proctor for Edwards Lifesciences and Medtronic., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Tricuspid valve surgery has high mortality for first-time operations and repeat surgery is fraught with even higher rates. When failed tricuspid surgical prostheses and repairs are present, physicians look toward transcatheter tricuspid valve replacement (TTVR) as a tangible solution. Using balloon-expandable bioprosthetic valves in an off-label fashion, tricuspid valve-in-valve (TViV) procedures can be performed reliably; however, valve-in-ring cases are more nuanced and have higher risks of paravalvular leak and valve malpositioning. TTVR specific issues include THV anchoring, management of preexisting pacing leads, postprocedure thromboembolic prophylaxis, and possible tricuspid reintervention., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Multisystem inflammatory syndrome (MIS) is a rare entity that usually presents with a constellation of symptoms such as fever, hypotension, gastrointestinal symptoms, cardiac dysfunction, or dermatological involvement, representing an inflammatory state. During the ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, several cases of multisystem inflammatory syndrome in children (MIS-C) have been described in the literature. The Centers for Disease Control and Prevention (CDC) has acknowledged the increasing incidence of the same entity in adults, referred to as multisystem inflammatory syndrome in adults (MIS-A). This case series describes four patients who presented to the Monmouth Medical Center in New Jersey with symptoms suggestive of MIS-A associated with SARS-CoV-2 infection and their clinical outcomes. All patients were within the age group of 20-40 years with no underlying medical condition. The period between SARS-CoV-2 infection and the development of MIS-A varied from 10 days through a month. Presentations ranged from a mild flu-like illness to shock requiring vasopressors. A positive SARS-CoV-2 antibody test was essential for the diagnosis. Inflammatory markers, such as ferritin, D-dimer, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and interleukin-6 (IL-6), were elevated on admission. The Use of immunomodulatory agents, namely steroids and intravenous immunoglobulin (IVIG), resulted in positive clinical outcomes. Inflammatory markers and imaging on admission did not appear to predict the disease course. A positive SARS-CoV-2 polymerase chain reaction (PCR) did not appear to influence the response to treatment. Given the high probability of MIS-A with negative viral testing, the use of both antibody and viral testing with the addition of inflammatory markers may be essential to diagnose this SARS-CoV-2-associated condition., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2021, Vyas et al.)

Objective/background: Small balloon expandable valves have higher echocardiographic transvalvular gradients and rates of prosthesis-patient mismatch (PPM) compared to larger valves. However, the impact of these echocardiographic findings on clinical outcomes is unknown. We sought to determine the clinical outcomes of 20 mm SAPIEN 3 (S3 BEV) compared to larger S3 BEV in relation to echocardiographic hemodynamics., Methods: Using the STS/ACC transcatheter valve registry, we performed a propensity-matched comparison of patients undergoing treatment of native aortic valve stenosis using transfemoral, balloon-expandable implantation of 20 mm and ≥ 23 mm S3 BEVs. Baseline and procedure characteristics, echocardiographic variables and survival were analyzed. Multivariable logistic regression was used to identify predictors of 1-year mortality., Results: After propensity matching of the 20 mm and ≥ 23 mm SAPIEN 3 valves, 3,931 pairs with comparable baseline characteristics were identified. Small valves were associated with significantly higher echocardiographic gradients at discharge (15.7 ± 7.1 mmHg vs. 11.7 ± 5.5 mmHg, p < 0.0001) and severe PPM rates (21.5% vs. 9.7%, p < 0.0001). There was no significant difference in 1-year all-cause mortality (20 mm: 13.0% vs. ≥23 mm: 12.7%, p = 0.72) or other major adverse event rates and outcomes between the two cohorts. Based on a multivariable analysis, elevated discharge mean gradient (>20 mmHg), severe PPM and the use of 20 mm versus ≥23 mm were not independent predictors of 1-year mortality., Conclusion: SAPIEN 3 20 mm valves were associated with higher echocardiographic gradients, and severe PPM rates compared to larger valves but these factors were not associated with significant differences in 1-year all-cause mortality or rehospitalization., (© 2021 Wiley Periodicals LLC.)

Background: Due to elevated surgical risk, transcatheter mitral valve replacement (TMVR) is used as an alternative for treating failed bioprosthetic valves, annuloplasty repairs and mitral annular calcification (MAC). We report the procedural and longitudinal outcomes for each subtype: Mitral valve-in-valve (MVIV), mitral valve-in-ring (MViR), and valve-in-MAC (ViMAC)., Methods: Consecutive patients undergoing TMVR from October 2013 to December 2019 were assessed. Patients at high risk for left ventricular outflow tract obstruction had either alcohol septal ablation or intentional laceration of the anterior leaflet (LAMPOON)., Results: Eight-eight patients underwent TMVR; 38 MViV, 31 MViR, and 19 ViMAC procedures were performed. The median Society of Thoracic Surgery 30-day predicted risk of mortality was 8.2% (IQR 5.2, 19.9) for all. Sapien 3 (78%) and transseptal access (98%) were utilized in most cases. All-cause in-hospital mortality, technical, and procedural success were 8%, 83%, and 66% respectively. Median follow up was 1.4 years (IQR 0.5-2.9 years) and overall survival was 40% at 4 years. Differential survival rates were observed with MViV doing the best, followed by MViR and ViMAC having a <20% survival at 4 years. After adjusting for co-variates, MViV procedure was the strongest predictor of survival (HR 0.24 [95% CI 0.079-0.7])., Conclusion: TMVR is performed in at high-risk patients with attenuated long-term survival. MViV has the best success and survival rate, but long-term survival in MViR and ViMAC is guarded., (© 2021 Wiley Periodicals LLC.)

The Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high-level field-wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co-moderated by a member of SCAI's Emerging Leader Mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward., (© 2021 Wiley Periodicals LLC.)