Investigation of outcomes following transcatheter edge to edge repair of the mitral valve versus medical management alone in patients with cardiogenic shock and mitral regurgitation.

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.

Updates on Patent Foramen Ovale (PFO) Closure.

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.

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.

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.

Patent Foramen Ovale Closure for Nonstroke Indications.

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.

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.

SCAI Guidelines for the Management of Patent Foramen Ovale.

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.

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.

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.

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.