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Study Objective: Assessing if Transcatheter Edge to Edge Repair (TEER) with Mitraclip™ in patients with moderate to severe mitral regurgitation (MR) and cardiogenic shock (CS) improves outcomes compared to medical management alone., Design: A single-center, retrospective study was performed in an urban tertiary referral center., Setting: Rush University Medical Center, United States., Participants: Adult patients presenting with CS and moderate to severe MR between 2012 and 2021 were included., Interventions: Undergoing Mitral TEER with Mitraclip versus medical management alone., Main Outcome Measures: Major adverse cardiovascular events (MACE) defined as cardiovascular death, heart failure admission, stroke, and myocardial infarction assessed at 30 days, 6 months, and 1 year. The secondary outcome was a change in New York Heart Association (NYHA) classification at 30 days and 6 months., Results: There were 28 patients included in the medical management and 33 in the mitral valve TEER groups. There was a decreased MACE in the intervention group at 30 days (24.2 % vs. 46.4 %, p  ≤0.001) and 6 months (27 % vs. 75 %, p  = 0.002), though not at 1 year (29.4 % vs. 41.7 %, p  = 0.42). At 30 days, more patients in the mitral valve TEER group improved to NYHA classes I/II compared to medical management alone (10 [35.7 %] vs. 16 [50 %], p  = 0.043). There were no differences in NYHA classes I/II at 6 months (7 [43.7 %] vs. 13 [54.2 %], p  = 0.63)., Conclusion: Mitral valve TEER using the Mitraclip™ system improves mid-term cardiovascular compared to medical management alone in patients with CS but does not improve mortality., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)

Purpose of Review: Patent foramen ovale (PFO) has been previously linked to left circulation thromboembolism and stroke. This review article aims to discuss the latest evidence, updated societal guidelines, diagnostic algorithms and novel therapeutic devices for PFO closure., Recent Findings: PFO closure for cryptogenic stroke and systemic embolization is supported by a large body of evidence and has a strong societal recommendation. Limited data are available for platypnea-orthodeoxia syndrome, although closure appears to be beneficial. Current data do not support routine closure for migraines and decompression Illness. Development of heart-brain teams can improve identification of patients most likely to benefit from closure, utilizing a combination of imaging test and risk score algorithms. Multiple novel devices aiming at reducing complications and improving the long-term impact of current available devices are being evaluated. PFO closure has significantly progressed over the last years, with new data supporting its superiority in reducing risk of recurrent embolic stroke in patients with PFO-related stroke. Additional clinical data are required to provide further refinements on patient selection and guidance on treatment of specific subgroups., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Severe aortic stenosis is a common valvular heart disease associated with significant mortality and morbidity. Transcatheter aortic valve replacement (TAVR) is an effective treatment for this condition. Less data is available regarding functional and quality-of-life outcomes in patients with severe, low-gradient aortic stenosis following TAVR. This single-center, retrospective study compared changes in New York Heart Association (NYHA) class and Kansas City Cardiomyopathy Questionnaire (KCCQ) scores at 30 days and 1 year in patients with 3 variants of severe, low-gradient aortic stenosis following TAVR. Secondary outcomes included 1-year major adverse cardiovascular event. A total of 170 patients were included. All 3 low-gradient variants had significant improvement in NYHA class and KCCQ overall scores at 30 days and 1 year. There were no significant differences in KCCQ overall scores between the 3 groups and no significant differences in secondary outcomes. Patients with low-gradient aortic stenosis experienced significant improvements in functional and quality-of-life outcomes following TAVR., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

The patent foramen ovale (PFO) is a flap or tunnel-like communication in the atrial septum present in 20% to 34% of the adult population. In most cases, it is a benign finding and poses no health risk. However, some PFOs may provide a conduit for bloodborne materials, such as thrombi, vasoactive substances, or air to pass into the systemic circulation causing a paradoxical embolus. PFOs have been linked with several clinical disease states including cryptogenic stroke, migraine headache, platypnea-orthodeoxia, and decompression illness. Percutaneous PFO closure provides a practical solution to the problem of PFO in carefully selected populations. Recent randomized control trials have demonstrated that PFO closure in patients with cryptogenic stroke is associated with reduced rates of recurrent stroke compared with medical therapy. This translated into a dramatic increase in the number of PFO closure procedures worldwide, primarily for the indication of cryptogenic stroke, with high procedural success and low complication rates. However, there are no randomized clinical trials available to support PFO closure in other clinical conditions. This article reviews potential indications, existing data, and management approaches for PFO closure in disorders other than cryptogenic stroke., (© 2023 The Author(s).)

Exclusion of the left atrial appendage to reduce thromboembolic risk related to atrial fibrillation was first performed surgically in 1949. Over the past 2 decades, the field of transcatheter endovascular left atrial appendage closure (LAAC) has rapidly expanded, with a myriad of devices approved or in clinical development. The number of LAAC procedures performed in the United States and worldwide has increased exponentially since the Food and Drug Administration approval of the WATCHMAN (Boston Scientific) device in 2015. The Society for Cardiovascular Angiography & Interventions (SCAI) has previously published statements in 2015 and 2016 providing societal overview of the technology and institutional and operator requirements for LAAC. Since then, results from several important clinical trials and registries have been published, technical expertise and clinical practice have matured over time, and the device and imaging technologies have evolved. Therefore, SCAI prioritized the development of an updated consensus statement to provide recommendations on contemporary, evidence-based best practices for transcatheter LAAC focusing on endovascular devices., Competing Interests: Declaration of Competing Interest João Cavalcante received consulting fees from Boston Scientific and Abbott. Matthew Price serves on the advisory board and has received consulting, honoraria, and Speakers Bureau fees from Abbott. Brian Whisenant received consulting fees from Boston Scientific and Abbott. Dee Dee Wang is a principal investigator for investigator-initiated research for Boston Scientific and has received consulting fees from Abbott. Jacqueline Saw, David Holmes, Andrew Goldsweig, James Freeman, Thomas Munger, Issam Moussa, Clifford Kavinsky, Matthew Sherwood, Zoltan Turi, and Mark Reisman reported no financial interests., (Copyright © 2023 Society for Cardiovascular Angiography and Interventions Foundation, Heart Rhythm Society and American College of Cardiology. Published by Elsevier Inc. All rights reserved.)

Current estimates suggest that a patent foramen ovale (PFO) may exist in up to 25% of the general population and is a potential risk factor for embolic, ischemic stroke. PFO closure complications include bleeding, need for procedure-related surgical intervention, pulmonary emboli, device malpositioning, new onset atrial arrhythmias, and transient atrioventricular block. Rates of PFO closure complications at a national level in the Unites States remain unknown. To address this, we performed a contemporary nationwide study using the 2016 and 2017 Nationwide Readmissions Database (NRD) to identify patterns of readmissions after percutaneous PFO closure. In conclusion, our study showed that following PFO closure, the most common complications were atrial fibrillation/atrial flutter followed by acute heart failure syndrome, supraventricular tachycardia and acute myocardial infarction., Competing Interests: Declaration of Competing Interest None., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Background Evidence from randomized trials and updated professional society guidelines supports patent foramen ovale (PFO) closure after cryptogenic stroke in select patients. It is unclear how this has been integrated into real-world practice, so we aimed to compare practice patterns between cardiologists and neurologists. Methods and Results In March of 2021, a survey of cardiologists and neurologists who work or previously trained at the University of Pennsylvania Health System assessed practice preferences with respect to PFO closure after stroke. Clinical vignettes isolated specific variables of interest and used a 5-point Likert scale to assess the level of support for PFO closure. Stroke neurologists and interventional cardiologists were compared by Wilcoxon-Mann-Whitney tests. Secondarily, Kruskal-Wallis tests compared stroke neurologists, general neurologists, interventional cardiologists, and general cardiologists. We received 106 responses from 182 survey recipients (31/31 stroke neurologists, 38/46 interventional cardiologists, 20/30 general neurologists, and 17/77 general cardiologists). A similar proportion of stroke neurologists and interventional cardiologists favored PFO closure in a young patient with cryptogenic stroke, 88% and 87%, respectively ( P =0.54). Interventionalists were more likely than stroke neurologists to support closure in the context of an alternative high-risk stroke mechanism, 14% and 0%, respectively ( P =0.003). Stroke neurologists were more likely to oppose closure on the basis of older age ( P =0.01). Conclusions There are key differences between how neurologists and cardiologists approach PFO closure after stroke, particularly when interpreting the stroke etiology and when considering closure beyond the scope of prior trials; this underscores the importance of collaboration between cardiologists and neurologists.

Background: Patent foramen ovale (PFO) is a vestigial congenital cardiovascular structure present in around 25% of adults. In most cases, PFO is entirely benign and requires no treatment. However, it may cause serious complications under certain circumstances., Objective: These evidence-based guidelines from the Society for Cardiovascular Angiography and Interventions (SCAI) aim to support patients, clinicians, and other stakeholders in decisions about management of PFO., Methods: SCAI convened a multidisciplinary guideline panel balanced to minimize potential bias from conflicts of interest. The Evidence Foundation, a registered 501(c)(3) nonprofit organization, provided methodological support for the guideline-development process. Following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, the guideline panel formulated and prioritized clinical questions in population, intervention, comparison, outcome (PICO) format. A separate technical review team of clinical and methodological experts conducted systematic reviews of the evidence, synthesized data, and graded the certainty of the evidence across outcomes. The guideline panel then reconvened to formulate recommendations and supporting remarks informed by the results of the technical review and additional contextual factors described in the GRADE evidence-to-decision framework., Results: The panel agreed on 13 recommendations to address variations on 5 clinical scenarios., Conclusions: Key recommendations address patient selection for PFO closure in the prevention of recurrent PFO-associated stroke, including populations not commonly included in randomized studies, and scenarios where the PFO closure might serve a role in the prevention of other outcomes such as migraine headaches and decompression illness. The panel has also identified future research priorities to advance the field., (© 2022 The Authors.)

The majority of embolic strokes in patients with nonvalvular atrial fibrillation are caused by thrombi in the left atrial appendage. It is projected that strokes related to atrial fibrillation will markedly increase in the future unless effective mitigation strategies are implemented. Systemic anticoagulation has been known to be highly effective in reducing stroke risk in patients with atrial fibrillation. However, bleeding complications and nonadherence are barriers to effective anticoagulation therapy. Surgical and percutaneous left atrial appendage occlusion devices are nonpharmacologic strategies to mitigate the challenges of drug therapy. We present a contemporary review of left atrial appendage occlusion for stroke prevention in nonvalvular atrial fibrillation. A thorough review of the history of surgical and percutaneous left atrial appendage occlusion devices, recent trials, and US Food and Drug Administration milestones of current left atrial appendage occlusion devices are discussed.

Background: Vein sclerosing therapy for varicose veins remains an extremely popular procedure. Cerebrovascular accidents can be a serious complication. A patent foramen ovale (PFO) can act as a conduit to the arterial circulation, which could explain the adverse neurologic consequence of this procedure. This case provides pathologic evidence of this concept., Case Summary: A 66-year-old female presented with syncope after undergoing varicose vein sclerotherapy. A computed tomography angiography of the head and neck in the emergency room revealed an occluded right distal M1 middle cerebral artery. Clot retrieval was performed with final pathology revealing amorphous material consistent with an exogenous agent, polidocanol foam, which was used for the patient's vein sclerotherapy. A transthoracic echocardiogram and transoesophageal echocardiogram showed a PFO, which was ultimately closed percutaneously., Discussion: In a quarter of the population, lack of closure of the intrauterine interatrial shunt leads to the existence of a PFO. This direct communication between the atria provides an anatomical conduit for paradoxical emboli and eventually infarction of affected tissues. While a paradoxical embolism is an uncommon cause of acute arterial occlusion, it can have catastrophic sequelae. Historically, the presence of an arterial thrombus from the venous circulation has been difficult to establish unless the thrombus is visualized in transit through a PFO. Complications from vein sclerotherapy have been reported in the literature and include transient ischaemic attacks and strokes, however, this is the first case to provide pathological proof of a paradoxical embolism, which ultimately resulted in percutaneous closure of the PFO., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Acute right ventricular (RV) failure is challenging to treat and mechanical circulatory support devices are limited. The TandemHeart ProtekDuo (THPD; TandemLife) is a novel percutaneous RV assist device that can provide 4.0 liters per minute of blood flow through venovenous extracorporeal life support. It allows venous drainage from the right atrium and reinfusion of blood into the main pulmonary artery via internal jugular vein access. We aim to provide real-world insight into disease characteristics resulting in the use of THPD for mechanical support and enhance knowledge of best practice regarding clinical management weaning and removal/exit strategies., Methods: We retrospectively collected data of consecutive patients who received a THPD device at our center for acute RV failure between August 2015 and February 2018., Results: Eleven patients were diagnosed with acute RV failure and required placement of THPD. The hospital length of stay ranged from 12 to 223 days. The average length of support ranged from 11 to 154 days. We observed complications such as stroke (18.2%), sepsis (63.6%), massive gastrointestinal bleed (45.5%), and heparin-induced thrombocytopenia (54.5%). These patients received on average 85 units of blood products. Survival was 82% at 30 days and 72% at 180 days. Six of the patients were successfully weaned from the THPD devices and 1 patient required venovenous extracorporeal life support., Conclusions: This real-world experience, despite high morbidity, continues to suggest benefits of THPD for patients with severe acute RV failure.

Left atrial appendage occlusion is utilized as a second line therapy to long-term oral anticoagulation in appropriately selected patients with atrial fibrillation (AF). We examined the feasibility of cryoballoon (CB) pulmonary vein isolation (PVI) subsequent to Watchman device implantation. The study prospectively identified patients with Watchman devices (>90 days old) who underwent CB-PVI ablation between 2018 and 2019. Twelve consecutive patients (male 50%; mean age 71 ± 9 years; CHA 2 DS 2 -VASc score 3.4 ± 1.1) underwent CB-PVI procedures after Watchman device implantation (mean 182 ± 82 days). Acute PVI was achieved in 100% of patients. All patients had evidence of complete (n = 9) or partial (n = 3) endothelialization of the surface of the Watchman device with conductive tissue properties demonstrated during electrophysiologic testing. There were no major procedure-related complications including death, stroke, pericardial effusion, device dislodgment, device thrombus, or new or increasing peri-device leak. Mean peri-device leak size (45-day postimplant: 0.06 ± 0.09 mm vs Post-PVI: 0.04 ± 0.06 mm; p = 0.61) remained unchanged. Two patients had recurrence of AF after the 90-day blanking period (13.2 ± 6.6 months). One patient underwent a redo ablation procedure for recurrent AF. This pilot study suggests the potential feasibility of CB-PVI ablation in patients with chronic Watchman left atrial appendage occlusion devices. Larger prospective studies are needed to confirm the clinical efficacy and safety of this approach., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Transcatheter mitral valve-in-valve implantation (MVIV) has emerged as a viable treatment option in patients at high risk for surgery. Occasionally, despite appropriate puncture location and adequate dilation, difficulty is encountered in advancing the transcatheter heart valve across interatrial septum., Case Summary: We describe a case of a 79-year-old woman with severe chronic obstructive pulmonary disease (COPD), prior surgical bioprosthetic aortic and mitral valve replacement implanted in 2007, atrial fibrillation, and Group II pulmonary hypertension who presented with progressively worsening heart failure symptoms secondary to severe bioprosthetic mitral valve stenosis and moderate-severe mitral regurgitation. Her symptoms had worsened over several months, with multiple admissions at other institutions with treatment for both COPD exacerbation and heart failure. Transoesophageal echocardiogram demonstrated preserved ejection fraction, normal functioning aortic valve, and dysfunctional mitral prosthesis with severe stenosis (mean gradient 13 mmHg) and moderate-severe regurgitation. After a multi-disciplinary heart team discussion, the patient underwent a transcatheter MVIV implantation. During the case, inability in advancing the transcatheter heart valve (THV) across interatrial septum despite adequate septal balloon pre-dilation was successfully managed with the support of a stiff 'buddy wire' anchored in the left upper pulmonary vein using the same septal puncture. The patient tolerated the procedure well and was discharged home., Discussion: Operators should be aware of potential strategies to advance the THV when difficulty is encountered in crossing the atrial septum despite adequate septal preparation. One such strategy is the use of stiff 'buddy wire' for support which avoids the need for more aggressive septal dilatation., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: There is little data on the impact of chronic thrombocytopenia (CTP) on outcomes after transcatheter aortic valve repair (TAVR). Most studies are from single centers and mostly focused on postprocedure thrombocytopenia., Objectives: This study sought to report on the impact of CTP (>1 year) on in-hospital outcomes and healthcare resource utilization after TAVR., Methods: From the National Inpatient Sample (NIS) between 2012 and 2015, we identified patients with CTP who underwent TAVR. A 1:1 propensity-matched cohort was created to examine in-hospital outcomes in patients with and without CTP. The primary outcome was in-hospital mortality. Secondary outcomes included postprocedure complications, length of stay, total cost, and discharge disposition., Results: A matched pair of 4,300 patients with and without CTP were identified. Patients with CTP had higher in-hospital mortality as compared to no CTP patients (6.0 vs. 3.3%, p-value .007), increased postprocedure hemorrhage, platelet and blood transfusion, vascular complications, postop sepsis, and acute kidney injury. With regards to resource utilization, CTP patients had a longer length of stay, higher total cost and were more likely to be discharged to a facility (34.1 vs. 27.6%) other than home (All, p-value <.001). Subanalysis, however, revealed this difference in resource utilization was seen when patients developed postprocedure complications., Conclusion: This study demonstrated higher risk of in-hospital mortality, perioperative complications, and healthcare resource utilization in patients with baseline CTP undergoing TAVR. Further studies are required to investigate ways to improve the management of these patients., (© 2019 Wiley Periodicals, Inc.)

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. The Society for Cardiovascular Angiography and Interventions (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 oversight of SCAI's clinical documents program and has created this manual of standard operating procedures to ensure consistency, methodological rigor, and transparency in the development and endorsement of the society's documents. The manual is intended for use by the publications committee, document writing groups, external collaborators, SCAI representatives, peer reviewers, and anyone seeking information about the SCAI documents program., (© 2020 Wiley Periodicals, Inc.)

Importance: Recent epidemiologic and therapeutic advances have transformed understanding of the role of and therapeutic approach to patent foramen ovale (PFO) in ischemic stroke. Patent foramen ovale is likely responsible for approximately 5% of all ischemic strokes and 10% of those occurring in young and middle-aged adults., Observations: Randomized clinical trials have demonstrated that, to prevent recurrent ischemic stroke in patients with PFO and an otherwise-cryptogenic index ischemic stroke, PFO closure is superior to antiplatelet medical therapy alone; these trials have provided some evidence that, among medical therapy options, anticoagulants may be more effective than antiplatelet agents., Conclusions and Relevance: These new data indicate a need to update classification schemes of causative mechanisms in stroke, developed in an era in which an association between PFO and stroke was viewed as uncertain. We propose a revised general nomenclature and classification framework for PFO-associated stroke and detailed revisions for the 3 major stroke subtyping algorithms in wide use.

Background: Transcatheter left atrial appendage occlusion (LAAO) using Watchman device has been demonstrated to be efficacious in decreasing stroke risk in patients with atrial fibrillation who are not suitable for long-term anticoagulation. Residual leaks are frequently encountered following LAAO procedures and their clinical implications and optimal management remain controversial., Case Summary: In this report, we describe a case of peri-Watchman device leak treated successfully with percutaneous device closure using an Amplatzer Vascular Plug II device., Discussion: The clinical implications of peri-device leaks remain controversial with general consensus to continue anticoagulation along with serial imaging for larger leaks (>5 mm). As an alternative strategy, percutaneous closure of these leaks has been attempted in hope of avoiding anticoagulation and minimizing the risk of stroke and should be studied further., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: The aim of this study was to evaluate the performance of risk stratification models (RSMs) in predicting short-term mortality after transcatheter aortic valve replacement (TAVR)., Methods and Results: MEDLINE and Scopus were queried to identify studies which validated RSMs designed to assess 30-day or in-hospital mortality after TAVR. Discrimination and calibration were assessed using C-statistics and observed/expected ratios (OERs), respectively. C-statistics were pooled using a random-effects inverse-variance method, while OERs were pooled using the Peto odds ratio. A good RSM is defined as one with a C-statistic >0.7 and an OER close to 1.0. Twenty-four studies (n=68,215 patients) testing 11 different RSMs were identified. Discrimination of all RSMs was poor (C-statistic <0.7); however, certain TAVR-specific RSMs such as the in-hospital STS/ACC TVT (C-statistic=0.65) and STT (C-statistic=0.66) predicted individual mortality more reliably than surgical models (C-statistic range=0.59-0.61). A good calibration was demonstrated by the in-hospital STS/ACC TVT (OER=0.99), 30-day STS/ACC TVT (OER=1.08) and STS (OER=1.01) models. Baseline dialysis (OER: 2.64 [1.88, 3.70]; p<0.001) was the strongest predictor of mortality., Conclusions: This study demonstrates that the STS/ACC TVT model (in-hospital and 30-day) and the STS model have accurate calibration, making them useful for comparison of centre-level risk-adjusted mortality. In contrast, the discriminative ability of currently available models is limited.

Background: Left atrial appendage occlusion (LAAO) to prevent stroke in patients with atrial fibrillation has been evaluated in 2 randomized trials; post-approval clinical data are limited., Objectives: The purpose of this study was to describe the National Cardiovascular Data Registry (NCDR) LAAO Registry and present patient, hospital, and physician characteristics and in-hospital adverse event rates for Watchman procedures in the United States during its first 3 years., Methods: The authors describe the LAAO Registry structure and governance, the outcome adjudication processes, and the data quality and collection processes. They characterize the patient population, performing hospitals, and in-hospital adverse event rates., Results: A total of 38,158 procedures from 495 hospitals performed by 1,318 physicians in the United States were included between January 2016 and December 2018. The mean patient age was 76.1 ± 8.1 years, the mean CHA 2 DS 2 -VASc (congestive heart failure, hypertension, 65 years of age and older, diabetes mellitus, previous stroke or transient ischemic attack, vascular disease, 65 to 74 years of age, female) score was 4.6 ± 1.5, and the mean HAS-BLED (hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly) score was 3.0 ± 1.1. The median annual number of LAAO procedures performed for hospitals was 30 (interquartile range: 18 to 44) and for physicians was 12 (interquartile range: 8 to 20). Procedures were canceled or aborted in 7% of cases; among cases in which a device was deployed, 98.1% were implanted with <5-mm leak. Major in-hospital adverse events occurred in 2.16% of patients; the most common complications were pericardial effusion requiring intervention (1.39%) and major bleeding (1.25%), whereas stroke (0.17%) and death (0.19%) were rare., Conclusions: The LAAO Registry has enrolled >38,000 patients implanted with the device. Patients were generally older with more comorbidities than those enrolled in the pivotal trials; however, major in-hospital adverse event rates were lower than reported in those trials., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: To define the national rate of complete heart block (CHB) after transcatheter aortic valve replacement (TAVR) and its impact on procedural mortality, overall cost, and length of hospital stay., Background: CHB leading to permanent pacemaker (PPM) implantation is one of the most common complications post TAVR. National data on the temporal trend of CHB post TAVR are lacking., Methods: We queried the 2012-2014 National Inpatient Sample databases to identify all patients who underwent TAVR. Patients with preoperative pacemakers or implantable cardioverter-defibrillators were excluded. Association between CHB and outcomes, and overall trends in rate of CHB, PPM implantation, and inpatient mortality were examined., Results: Of 35,500 TAVR procedures, 3,675 (10.4%) had CHB. Overall, occurrence of CHB significantly increased from 8.4% in 2012 to 11.8% in 2014 (adjusted OR per year: 1.23; 95% confidence interval [CI]: 1.17-1.29, P trend <0.001). During the same period, PPM implantation increased from 9.5 to 13.7% (adjusted OR per year: 1.22; 95% CI: 1.16-1.28, P trend <0.001). Patients with CHB had higher odds of in-hospital mortality when compared to patients without CHB (5.9% vs. 4.2%, adjusted OR: 1.32; 95% CI: 1.12-1.56; p = 0.001). Moreover, CHB was also associated with longer length of stay (LOS) and higher hospitalization cost., Conclusions: There was a significant increase in rates of CHB and PPM implantation over the study period. Development of CHB was associated with increased in-hospital mortality, LOS, and hospitalization cost., (© 2019 Wiley Periodicals, Inc.)

Until recently, evidence to support Patent Foramen Ovale (PFO) closure for secondary prevention of recurrent stroke has been controversial. Publication of high-quality evidence from randomized clinical trials and the subsequent FDA approval of two devices for percutaneous PFO closure is expected to increase the volume of PFO closure procedures not only in the United States but worldwide. As this technology is disseminated broadly to the public, ensuring the safe and efficacious performance of PFO closure is essential to mitigate risk and avoid unnecessary procedures. This document, prepared by a multi-disciplinary writing group convened by the Society for Cardiovascular Angiography and Interventions and including representatives from the American Academy of Neurology, makes recommendations for institutional infrastructure and individual skills necessary to initiate and maintain an active PFO/stroke program, with emphasis on shared decision making and patient-centered care., (© 2019 Wiley Periodicals, Inc.)

Purpose of Review: Coronary artery disease remains the most common cause of death worldwide. In patients with biomarker-positive acute coronary syndrome, the combination of guideline-directed medical therapy with routine revascularization is associated with improved outcomes. However, the role of routine revascularization in stable ischemic heart disease, in addition to medical therapy, remains a matter of debate. In this review, we aimed to describe the role of revascularization in stable ischemic heart disease., Recent Findings: Revascularization is indicated in patients with stable ischemic heart disease and progressive or refractory symptoms, despite medical management. When guided by ischemia presence, revascularization has failed to show survival benefit, compared with medical therapy alone in multiple clinical trials. On the other hand, revascularization guided by coronary lesion severity, assessed by FFR or iFR, has been shown to offer survival benefit and improvement in symptom severity. PCI-revascularization of unprotected left main disease is feasible with comparable to surgical approach outcomes. Clinical decision to perform revascularization in stable ischemic heart disease necessitates a heart team approach, and no simple algorithm can guide this process. Further studies are required to assess the benefit of routine revascularization, in combination to medical therapy, in this population.

A percutaneous left atrial appendage (LAA) occlusion using a Watchman device was performed in a patient with prior biatrial anastomosis orthotopic heart transplant (OHT). Due to the anatomical changes following biatrial anastomosis, transesophageal echocardiography (TEE) imaging and transseptal puncture become technically challenging. We describe how the standard LAA views on TEE were obtained for device sizing, and how the transseptal puncture was modified to cross the scarred septum. This case demonstrates that LAA occlusion using a Watchman device in biatrial anastomosis OHT is safe and can successfully be done., (© 2018 Wiley Periodicals, Inc.)

Objective: The objective of this study was to analyze the available literature on using transcatheter aortic valve replacement (TAVR) for native aortic regurgitation (AR)., Background: Surgical aortic valve replacement is the gold standard therapy for native AR. TAVR has emerged as an alternative approach in high-risk patients., Methods: MEDLINE, Scopus, and Cochrane CENTRAL were searched for reports of at least 5 patients undergoing TAVR for native AR. Outcomes included 30-day mortality, myocardial infarction, stroke, major bleeding, postprocedural moderate to severe AR, and device success. Pooled estimates were calculated using a random-effects model. Subgroup analysis and a meta-regression were performed to study the effects of study level covariates on outcomes., Results: Nineteen studies (n =998 patients) were included. The rate of procedural success per Valve Academic Research Consortium - 2 (VARC-2) criteria was 86.2% (78.8%-92.2%]. Thirty-day mortality was 11.9% (9.4%-14.7%). Subgroup analysis showed the use of new generation valves was associated with lower 30-day mortality (P = 0.02) and higher device success (P = 0.009) compared with early generation valves. There was no significant difference (P = 0.13) in the rate of 30-day mortality between patients receiving purpose-specific [8.2% (4.3%-13.1%); I2 = 0%] and nonpurpose specific valves [13.0% (8.2%-18.6%); I2 = 25%]. However, device success was higher (P = 0.02) in patients who received purpose-specific valves [96.3% (92.2%-98.9%); I2 = 0%] compared with nonpurpose specific valves [84.4% (75%-91.9%); I2 =46%]., Conclusion: TAVR for native AR is associated with acceptable procedural success but increased early mortality. However, the safety and the efficacy of the procedure increased with newer valves., (© 2018 Wiley Periodicals, Inc.)

The American College of Cardiology collaborated with the American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Valve Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons to develop and evaluate Appropriate Use Criteria (AUC) for the treatment of patients with severe aortic stenosis (AS). This is the first AUC to address the topic of AS and its treatment options, including surgical aortic valve replacement and transcatheter aortic valve replacement. A number of common patient scenarios experienced in daily practice were developed along with assumptions and definitions for those scenarios, which were all created using guidelines, clinical trial data and expert opinion in the field of AS. The '2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines' [1] and its 2017 focused update paper [2] were used as the primary guiding references in developing these indications. The Writing Group identified 95 clinical scenarios based on patient symptoms and clinical presentation, and up to 6 potential treatment options for those patients. A separate, independent Rating Panel was asked to score each indication from 1 to 9, with 1-3 categorized as 'Rarely Appropriate', 4-6 as 'May Be Appropriate' and 7-9 as 'Appropriate'. After considering factors such as symptom status, left ventricular function, surgical risk, and the presence of concomitant coronary or other valve disease, the Rating Panel determined that either surgical aortic valve replacement or transcatheter aortic valve replacement is appropriate in most patients with symptomatic AS at intermediate or high surgical risk; however, situations commonly arise in clinical practice in which the indications for surgical aortic valve replacement or transcatheter aortic valve replacement are less clear, including situations in which one form of valve replacement would appear reasonable when the other is less so, as do other circumstances in which neither intervention is the suitable treatment option. The purpose of this AUC is to provide guidance to clinicians in the care of patients with severe AS by identifying the reasonable treatment and intervention options available based on the myriad clinical scenarios with which patients present. This AUC document also serves as an educational and quality improvement tool to identify patterns of care and reduce the number of rarely appropriate interventions in clinical practice., (© 2018 by the American College of Cardiology Foundation. All rights reserved. For permission please contact healthpermissions@elsevier.com.)

The American College of Cardiology collaborated with the American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Valve Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons to develop and evaluate Appropriate Use Criteria (AUC) for the treatment of patients with severe aortic stenosis (AS). This is the first AUC to address the topic of AS and its treatment options, including surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). A number of common patient scenarios experienced in daily practice were developed along with assumptions and definitions for those scenarios, which were all created using guidelines, clinical trial data, and expert opinion in the field of AS. The 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines(1) and its 2017 focused update paper (2) were used as the primary guiding references in developing these indications. The writing group identified 95 clinical scenarios based on patient symptoms and clinical presentation, and up to 6 potential treatment options for those patients. A separate, independent rating panel was asked to score each indication from 1 to 9, with 1-3 categorized as "Rarely Appropriate," 4-6 as "May Be Appropriate," and 7-9 as "Appropriate." After considering factors such as symptom status, left ventricular (LV) function, surgical risk, and the presence of concomitant coronary or other valve disease, the rating panel determined that either SAVR or TAVR is Appropriate in most patients with symptomatic AS at intermediate or high surgical risk; however, situations commonly arise in clinical practice in which the indications for SAVR or TAVR are less clear, including situations in which 1 form of valve replacement would appear reasonable when the other is less so, as do other circumstances in which neither intervention is the suitable treatment option. The purpose of this AUC is to provide guidance to clinicians in the care of patients with severe AS by identifying the reasonable treatment and intervention options available based on the myriad clinical scenarios with which patients present. This AUC document also serves as an educational and quality improvement tool to identify patterns of care and reduce the number of rarely appropriate interventions in clinical practice., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Interventional catheterization is central to the care of Adults with Congenital Heart Disease (ACHD). Current standards for care provision and training in ACHD intervention are lacking. We sought to examine trends in current practice and training among interventionalists., Methods: We analyzed the results of two separate international surveys in June 2016. One was sent to all active members from the Society of Cardiovascular Angiography and Interventions (SCAI) who self-identified Structural Heart Disease or Congenital Heart Disease as a practice area. The second survey was conducted through the Pediatric Interventional Early Career Society (PICES) aimed at pediatric and adult congenital interventionalists in their first seven years after training. The total survey sample sizes were 1,535 and 112, respectively., Results: Response rates for the SCAI and PICES surveys were 15% (237/1,535) and 75% (84/112), respectively. Most respondents (74%) worked at institutions with pediatric and adult facilities in proximity (major medical centers). While 75% of SCAI respondents believed complex transcatheter procedures should be performed by ACHD-trained interventionalists or multidisciplinary teams, only 32% reported such care is being provided at the present time. Most pediatric and adult cardiologists surveyed (73%) do not believe current interventional fellowships provide adequate training for proficiency in ACHD interventions., Conclusions: ACHD management remains underdeveloped in relative terms, particularly in the United States. Significant gaps in interventional standards of practice and future training needs were recognized by this study. Our survey should serve as an impetus to establish training guidelines for physicians who seek to perform ACHD interventions., (© 2017 Wiley Periodicals, Inc.)

Aortic stenosis (AS) leads to pulmonary hypertension (PH) and right ventricle (RV) failure. Our goal was to describe mortality related to postoperative complications in PH patients undergoing transcatheter aortic valve replacement (TAVR). Ninety-three TAVR patients were analyzed (controls, sPAP < 50 mmHg; cases, sPAP ≥ 50 mmHg). Significant findings in cases included increased mortality (365 days), post-TAVR atrioventricular block (AVB) and acute kidney injury (AKI), and increased mean length of stay (LOS). This novel study highlights complications of PH as independent risk factors for death and significant morbidity post TAVR. Optimization of preoperative volume status and RV afterload reduction, while addressing AVB and AKI, may play a vital role in reducing mortality and LOS.

Chronic mitral regurgitation (MR) is the most common cardiac valvular disease with more than 4 million people in the United States alone suffering from moderate or severe MR. Left untreated, chronic MR results in serious consequences. Surgical correction with mitral valve repair or replacement remains the mainstay of therapy for MR. Nevertheless, a large proportion of patients may not be offered treatment due to concerns over surgical risk. This unmet therapeutic need for a less invasive approach led to a marked explosion in the development of a variety of transcatheter approaches to treat mitral regurgitation in the past decade. The majority of these devices are based on principles learned from surgical mitral valve repair techniques. Inspired by the Alfieri surgical technique, the MitraClip edge-to-edge repair system is the most advanced technique with the highest safety and efficacy to date. In this review, we discuss the current status of the MitraClip repair system in the treatment of mitral regurgitation.