Left Atrial Appendage Occlusion vs Standard of Care After Ischemic Stroke Despite Anticoagulation.

Importance: Patients with atrial fibrillation (AF) who have ischemic stroke despite taking oral anticoagulation therapy (OAT) have a very high risk of recurrence. Left atrial appendage occlusion (LAAO) is a mechanical stroke prevention strategy that may provide additional protection in patients with thromboembolic events under OAT. Objective: To compare percutaneous LAAO with continuing OAT alone regarding stroke prevention in patients with AF who had a thromboembolic event despite taking OAT. Design, Setting, and Participants: This cohort study was a propensity score-matched comparison of the STR-OAC LAAO cohort, an international collaboration of 21 sites combining patients from multiple prospective registries of patients who underwent LAAO between 2010 and 2022. STR-OAC LAAO cohort patients who had follow-up longer than 3 months were propensity score-matched to a previously published control cohort comprising patients from an established international collaboration of investigator-initiated prospective studies. This control cohort included patients with nonvalvular AF, recent ischemic stroke or transient ischemic attack, and follow-up longer than 3 months who were taking OAT before the index event. Analyses were adjusted for imbalances in gender, age, hypertension, diabetes, and CHA2 DS2-VASc score. Exposure: Left atrial appendage occlusion vs continuation of oral anticoagulation therapy alone (control group). Main Outcomes and Measures: The primary outcome was time to first ischemic stroke. Results: Four hundred thirty-three patients from the STR-OAC LAAO cohort (mean [SD] age, 72 [9] years; 171 [39%] females and 262 [61%] males; mean [SD] CHA2 DS2-VASc score, 5.0 [1.6]) were matched to 433 of 1140 patients (38%) from the control group. During 2-year follow-up, 50 patients experienced ischemic stroke: an annualized event rate of 2.8% per patient-year in the STR-OAC LAAO group vs 8.9% per patient-year in the control group. Left atrial appendage occlusion was associated with a lower risk of ischemic stroke (hazard ratio, 0.33; 95% CI, 0.19-0.58; P < .001) compared with the control group. After LAAO, OAT was discontinued in 290 patients (67%), and the remaining 143 patients (33%) continued OAT after LAAO as an adjunctive therapy. Conclusions and Relevance: In patients with nonvalvular AF and a prior thromboembolic event despite taking OAT, LAAO was associated with a lower risk of ischemic stroke compared with continued OAT alone. Randomized clinical trial data are needed to confirm that LAAO may be a promising treatment option for this population with a very high risk of stroke.

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.

Left Atrial Appendage Occlusion in Patients With Anticoagulation Failure vs Anticoagulation Contraindication.

BACKGROUND: Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO. OBJECTIVES: This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data. METHODS: The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores. RESULTS: Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT. CONCLUSIONS: LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT.

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.

Persistent and Recurrent Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes.

BACKGROUND: Scarce data exist on the evolution of device-related thrombus (DRT) after left atrial appendage closure (LAAC). OBJECTIVES: This study sought to assess the incidence, predictors, and clinical impact of persistent and recurrent DRT in LAAC recipients. METHODS: Data were obtained from an international multicenter registry including 237 patients diagnosed with DRT after LAAC. Of these, 214 patients with a subsequent imaging examination after the initial diagnosis of DRT were included. Unfavorable evolution of DRT was defined as either persisting or recurrent DRT. RESULTS: DRT resolved in 153 (71.5%) cases and persisted in 61 (28.5%) cases. Larger DRT size (OR per 1-mm increase: 1.08; 95% CI: 1.02-1.15; P = 0.009) and female (OR: 2.44; 95% CI: 1.12-5.26; P = 0.02) were independently associated with persistent DRT. After DRT resolution, 82 (53.6%) of 153 patients had repeated device imaging, with 14 (17.1%) cases diagnosed with recurrent DRT. Overall, 75 (35.0%) patients had unfavorable evolution of DRT, and the sole predictor was average thrombus size at initial diagnosis (OR per 1-mm increase: 1.09; 95% CI: 1.03-1.16; P = 0.003), with an optimal cutoff size of 7 mm (OR: 2.51; 95% CI: 1.39-4.52; P = 0.002). Unfavorable evolution of DRT was associated with a higher rate of thromboembolic events compared with resolved DRT (26.7% vs 15.1%; HR: 2.13; 95% CI: 1.15-3.94; P = 0.02). CONCLUSIONS: About one-third of DRT events had an unfavorable evolution (either persisting or recurring), with a larger initial thrombus size (particularly >7 mm) portending an increased risk. Unfavorable evolution of DRT was associated with a 2-fold higher risk of thromboembolic events compared with resolved DRT.

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.

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.

Predictors of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion.

BACKGROUND: Device-related thrombus (DRT) has been considered an Achilles' heel of left atrial appendage occlusion (LAAO). However, data on DRT prediction remain limited. OBJECTIVES: This study constructed a DRT registry via a multicenter collaboration aimed to assess outcomes and predictors of DRT. METHODS: Thirty-seven international centers contributed LAAO cases with and without DRT (device-matched and temporally related to the DRT cases). This study described the management patterns and mid-term outcomes of DRT and assessed patient and procedural predictors of DRT. RESULTS: A total of 711 patients (237 with and 474 without DRT) were included. Follow-up duration was similar in the DRT and no-DRT groups, median 1.8 years (interquartile range: 0.9-3.0 years) versus 1.6 years (interquartile range: 1.0-2.9 years), respectively (P = 0.76). DRTs were detected between days 0 to 45, 45 to 180, 180 to 365, and >365 in 24.9%, 38.8%, 16.0%, and 20.3% of patients. DRT presence was associated with a higher risk of the composite endpoint of death, ischemic stroke, or systemic embolization (HR: 2.37; 95% CI, 1.58-3.56; P < 0.001) driven by ischemic stroke (HR: 3.49; 95% CI: 1.35-9.00; P = 0.01). At last known follow-up, 25.3% of patients had DRT. Discharge medications after LAAO did not have an impact on DRT. Multivariable analysis identified 5 DRT risk factors: hypercoagulability disorder (odds ratio [OR]: 17.50; 95% CI: 3.39-90.45), pericardial effusion (OR: 13.45; 95% CI: 1.46-123.52), renal insufficiency (OR: 4.02; 95% CI: 1.22-13.25), implantation depth >10 mm from the pulmonary vein limbus (OR: 2.41; 95% CI: 1.57-3.69), and non-paroxysmal atrial fibrillation (OR: 1.90; 95% CI: 1.22-2.97). Following conversion to risk factor points, patients with ≥2 risk points for DRT had a 2.1-fold increased risk of DRT compared with those without any risk factors. CONCLUSIONS: DRT after LAAO is associated with ischemic events. Patient- and procedure-specific factors are associated with the risk of DRT and may aid in risk stratification of patients referred for LAAO.

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.

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.

State-of-the-art Structural Interventions in Heart Failure.

Heart failure (HF) is a leading cause of hospitalisation and healthcare costs worldwide. Acute decompensated heart failure accounts for more than 1 million hospitalisations in the US. Despite advances in the quality of acute and chronic HF disease management, gaps in knowledge about effective interventions to support the transition of care for patients with HF remain. Despite multiple trials of promising therapies, standard care consists of decongestion with IV diuretics and haemodynamic support with vasodilators and inotropes and this has remained largely unchanged during the past 45 years. Newer advances in medical innovations and structural heart disease interventions have now given promise to improved survival, outcomes and quality of life for patients with advanced HF of multiple aetiologies. In this article, we focus on structural interventions in the treatment of patients with HF.

Adult Congenital Interventions in Heart Failure.

Congenital heart disease (CHD) is the most common birth defect, occurring in approximately 0.8% to 1.0% of neonates. Advances in medical and surgical therapies for children with CHD have resulted in a growing population of patients reaching adulthood, with survival rates exceeding 85%. Many of these patients, especially if managed inappropriately, face the prospect of future complications including heart failure and premature death. For adults with uncorrected or previously palliated CHD, percutaneous therapies have become the primary treatment for many forms of CHD. In this article, we discuss the role of transcatheter interventions in the treatment of adults with CHD.

Patent Foramen Ovale: Stroke and Device Closure.

Patent foramen ovale (PFO) is a common finding in healthy adults and has long been implicated in cryptogenic stroke. The pathogenesis is hypothesized to be caused by microemboli gaining access into the systemic circulation via a PFO. Proposed treatment options include medical therapy and/or PFO closure. Despite numerous studies and several randomized trials, much debate persists regarding the efficacy of this approach in reducing the risk of recurrent stroke in cryptogenic stroke patients. This article reviews the association between PFO and cryptogenic stroke, as well as current evidence for PFO device closure.

Percutaneous mitral valve repair: The MitraClip device.

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.

TAVR update: Contemporary data from the UK TAVI and US TVT registries.

The introduction of transcatheter aortic valve replacement (TAVR in US - TAVI in Europe) has resulted in a paradigm shift in the treatment of patients with severe aortic stenosis. Although three randomized trials and multiple single-center and multicenter registry studies have been published, the profile and longer-term outcome of patients undergoing transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis have been limited. The recently published reports from the United Kingdom (UK)(1) and United States (US)(2) TAVR registries add tremendously to the currently available literature. These studies provide an excellent model to clinicians that would aid in the proper patient selection and help in guiding discussions with patients who are undergoing TAVR. The present review discusses the recently published UK and US TAVR registry data.