Functional and Quality of Life Outcomes After TAVR in Patients With Low Gradient Aortic Stenosis.

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.

SCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Appendage Closure.

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.

SCAI/HRS expert consensus statement on transcatheter left atrial appendage closure.

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.

Readmission in patients undergoing percutaneous patent foramen ovale closure in the United States.

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.

Clinicians' Approach to Patent Foramen Ovale Closure after Stroke: Comparing Cardiologists and Neurologists.

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.

Left Atrial Appendage Occlusion for Stroke Prevention in Nonvalvular Atrial Fibrillation.

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.

The pivotal role of PFO in paradoxical embolism following venous sclerotherapy: a unique case report with pathological correlations.

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.

Percutaneous Right Ventricular Assist Device Using the TandemHeart ProtekDuo: Real-World Experience.

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.

Cryoballoon Ablation and Bipolar Voltage Mapping in Patients With Left Atrial Appendage Occlusion Devices.

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; CHA2DS2-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.

Case report: percutaneous closure of residual leak following left atrial appendage occlusion.

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.

Hot topics in interventional cardiology: Proceedings from the society for cardiovascular angiography and interventions 2020 think tank.

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 for high-level field-wide discussions. The 2020 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 (CHD). 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 dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

Proposal for Updated Nomenclature and Classification of Potential Causative Mechanism in Patent Foramen Ovale-Associated Stroke.

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.

The NCDR Left Atrial Appendage Occlusion Registry.

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 CHA2DS2-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.

SCAI publications committee manual of standard operating procedures.

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.

Case report: Buddy wire technique to facilitate atrial septal crossing during transcatheter transseptal mitral valve implantation.

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.

Systematic review and meta-analysis of current risk models in predicting short-term mortality after transcatheter aortic valve replacement.

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.