A Novel Device for Tricuspid Regurgitation Reduction Featuring 3-Dimensional Leaflet and Atraumatic Anchor: Pivot-TR System.

A new device called the Pivot-TR system was designed to treat tricuspid regurgitation with a novel spacer crossing the valve vertically. Its unique atraumatic anchoring system composed of both the elephant long nose and the inferior vena cava spiral anchor, in addition to the relatively easy implantation mechanism, enabled easy retrieval of the system later on. The system showed promising feasibility and safety results in this swine-based animal experiment, which should encourage human translation study.

Percutaneous Left Atrial Appendage Occlusion Yields Favorable Neurological Outcomes in Patients with Non-Valvular Atrial Fibrillation.

BACKGROUND AND OBJECTIVES: Prior studies have shown that stroke patients treated with percutaneous left atrial appendage occlusion (LAAO) for non-valvular atrial fibrillation (NVAF) experience better outcomes than similar patients treated with warfarin. We investigated the impact of percutaneous left atrial appendage closure on post-stroke neurological outcomes in NVAF patients, compared with non-vitamin K antagonist oral anticoagulant (NOAC) therapy. METHODS: Medical records for 1,427 patients in multiple registries and for 1,792 consecutive patients at 6 Korean hospitals were reviewed with respect to LAAO or NOAC treatment. Stroke severity in patients who experienced ischemic stroke or transient ischemic attack after either treatment was assessed with modified Rankin Scale (mRS) scoring at hospital discharge and at 3 and 12 months post-stroke. RESULTS: mRS scores were significantly lower in LAAO patients at 3 (p<0.01) and 12 months (p<0.01) post-stroke, despite no significant differences in scores before the ischemic cerebrovascular event (p=0.22). The occurrences of disabling ischemic stroke in the LAAO and NOAC groups were 36.7% and 44.2% at discharge (p=0.47), 23.3% and 44.2% at 3 months post-stroke (p=0.04), and 13.3% and 43.0% at 12 months post-stroke (p=0.01), respectively. Recovery rates for disabling ischemic stroke at discharge to 12 months post-stroke were significantly higher for LAAO patients (50.0%) than for NOAC patients (5.6%) (p<0.01). CONCLUSIONS: Percutaneous LAAO was associated with more favorable neurological outcomes after ischemic cerebrovascular event than NOAC treatment.

Comparison of clinical outcomes between multiple antithrombotic therapy versus left atrial appendage occlusion with dual antiplatelet therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

BACKGROUND: Complex antithrombotic regimens are recommended for patients with atrial fibrillation (AF) undergoing drug-eluting stent (DES) implantation but carry high bleeding risk. HYPOTHESIS: We aimed to evaluate whether left atrial appendage occlusion (LAAO) with dual antiplatelet therapy (DAPT) improve clinical outcomes when compared with multiple antithrombotic therapy (MAT) in patients with AF undergoing DES implantation. METHODS: Among 475 AF patients who underwent DES, 41 patients treated by LAAO with DAPT and 434 patients on MAT were compared. MAT was defined as any combination of warfarin-based antithrombotic therapy. Among the MAT group, 34.8% were on triple antithrombotic therapy. The primary endpoint was a net adverse clinical event (NACE), a composite of cerebrovascular accident (CVA) and major bleeding. Secondary endpoints were CVA, major bleeding, major adverse cardiac and cerebral event (MACCE), MI, cardiovascular death, and all-cause death. Additional analysis between the new oral anticoagulant (NOAC)-based antithrombotic therapy group (n = 45) and the LAAO group was performed for the same endpoints. To adjust the confounding factors, inverse probability of treatment weighting (IPTW) was applied during the endpoint analysis. RESULTS: The LAAO group showed higher incidences of diabetes mellitus, prior CVA, higher CHA2DS2-VASc score (4.56±1.55 vs. 2.96±1.60; P<0.0001), and higher HAS-BLED score (3.24±1.20 vs. 2.13±0.75; P<0.0001). NACE occurred less frequently in the LAAO group than the MAT group at 24 months (9.4% vs. 15.3%; hazard ratio 0.274; 95% confidence interval 0.136 - 0.553; P = 0.0003), mainly driven by the reduction in major bleeding (2.4% vs. 9.3%; hazard ratio 0.119; 95% confidence interval 0.032 - 0.438; P = 0.001). The LAAO group with greater thrombotic and hemorrhagic risks showed comparable primary/secondary outcomes with the NOAC-based anti-thrombotic therapy group. CONCLUSIONS: Among patients with AF who underwent DES implantation, the LAAO group had better net clinical outcomes for preventing CVA and major bleeding than the MAT group. Further large-scale trials including comparisons with NOACs are warranted.

Septal Reduction Using Transvenous Intramyocardial Cerclage Radiofrequency Ablation: Preclinical Feasibility.

Debulking of left ventricular septal mass is typically accomplished using surgical myectomy, which is morbid, or using transcoronary alcohol septal ablation, which can result in geographic miss and occasional catastrophic nontarget coronary injury. The authors developed and tested operational parameters in vitro and vivo for a device to accomplish transvenous intraseptal radiofrequency ablation to reduce ventricular septal mass using a technique derived from mitral cerclage, which the authors call cerclage ablation. Cerclage ablation appeared feasible in vitro and safe and effective in vivo. Cerclage ablation is an attractive new approach to debulk the interventricular septum in obstructive hypertrophic cardiomyopathy. These data support clinical investigation.

Late clinical outcomes of lambre versus amplatzer occluders for left atrial appendage closure.

INTRODUCTION: The LAmbre (LifeTech Scientific, Shenzhen, China) is a novel occluder for left atrial appendage closure (LAAC) in patients with atrial fibrillation. This study compares late clinical outcomes of LAmbre and the established Amplatzer devices (Abbott, St Paul, MN). METHODS: Between 2012 and 2018, 265 consecutive patients underwent LAAC with LAmbre and Amplatzer devices at a single center. After a 3:1 propensity score matching, 40 (LAmbre) vs 107 (Amplatzer) patients were compared by the primary efficacy endpoint of all-cause stroke, systemic embolism and cardiovascular/unexplained death, the primary safety endpoint of major periprocedural complications and major bleeding events at follow-up, and the combined hazard endpoint, a composite of all the above-mentioned hazards. RESULTS: The mean age 75.6 ± 8.9 (LAmbre) vs 75.5 ± 9.0 (Amplatzer) years, CHA2 DS2 -VASc score 4.8 ± 1.7 vs 4.8 ± 1.7 and HAS-BLED score 3.1 ± 0.9 vs 3.2 ± 0.8 were similar. After 3.6 ± 1.9 vs 2.5 ± 1.4 years, the clinical efficacy (12/146, 8.2% [LAmbre] vs 28/266, 10.5% [Amplatzer]; hazard ratio [HR], 0.73; 95% confidence interval [CI], 0.38-1.40; P = .34) and safety (5/146, 3.4% vs 14/266, 5.3%; HR, 0.47; 95% CI, 0.14-1.6; P = .22), as well as the combined hazard endpoint (15/146, 10.3% vs 36/266, 13.6%; HR, 0.67; 95% CI, 0.36-1.25; P = .21) were comparable. CONCLUSION: In the presented report, in patients with nonvalvular atrial fibrillation, the LAmbre offered similar long-term efficacy and safety in comparison to Amplatzer devices.

Cierre de la orejuela izquierda por ictus pese a la anticoagulación oral (ictus resistente): resultados del registro Amplatzer Cardiac Plug / Left atrial appendage occlusion for stroke despite oral anticoagulation (resistant stroke). Results from the Amplatzer Cardiac Plug registry

INTRODUCCIÓN Y OBJETIVOS: A pesar de la eficacia de los anticoagulantes orales (ACO), algunos pacientes mantienen una alto riesgo residual y presentan ictus aun estando en tratamiento con ACO, y falta evidencia sobre el tratamiento de estos pacientes. El objetivo del estudio es analizar la seguridad y la eficacia del cierre percutáneo de la orejuela izquierda (OI) como prevención secundaria para pacientes con fibrilación auricular no valvular que han experimentado un ictus/accidente isquémico transitorio a pesar de los ACO (ictus resistente [IR]). MÉTODOS: Se estudió a 1.047 pacientes consecutivos con fibrilación auricular no valvular sometidos a cierre percutáneo de la OI incluidos en el registro multicéntrico Amplatzer Cardiac Plug. Se seleccionó a los pacientes con IR como indicación para el cierre de la OI, y se los comparó con pacientes con otras indicaciones. RESULTADOS: En un total de 115 pacientes (11%) se produjo un IR. Las escalas CHA2DS2-VASc y HAS-BLED eran significativamente más altas en el grupo de IR (5,5+/-1,5 frente a 4,3+/-1,6; p <0,001 y 3,9+/-1,3 frente a 3,1+/-1,2; p <0,001). No hubo diferencias significativas en los eventos mayores de seguridad periprocedimiento (el 7,8 frente al 4,5%; p = 0,1). Tras 16,2+/-12,2 meses de seguimiento medio, la tasa anual de ictus/accidente isquémico transitorio observada fue del 2,6% (el 65% de reducción del riesgo) y la tasa anual de hemorragia mayor observada fue del 0% (el 100% de reducción del riesgo) en los pacientes con IR. CONCLUSIONES: Los pacientes con IR sometidos a cierre percutáneo de la OI presentaron resultados de seguridad similares que los pacientes sin IR, con una reducción significativa de los eventos de ictus/accidente isquémico transitorio y hemorragia mayor durante el seguimiento

INTRODUCTION AND OBJECTIVES: Despite the efficacy of oral anticoagulant (OAC) therapy, some patients continue to have a high residual risk and develop a stroke on OAC therapy (resistant stroke [RS]), and there is a lack of evidence on the management of these patients. The aim of this study was to analyze the safety and efficacy of left atrial appendage occlusion (LAAO) as secondary prevention in patients with nonvalvular atrial fibrillation who have experienced a stroke/transient ischemic attack despite OAC treatment. METHODS: We analyzed data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients with nonvalvular atrial fibrillation undergoing LAAO. Patientes with previous stroke on OAC therapy as indication for LAAO were identified and compared with patients with other indications. RESULTS: A total of 115 patients (11%) with RS were identified. The CHA2DS2-VASc and the HAS-BLED score were significantly higher in the RS group (respectively 5.5+/-1.5 vs 4.3+/-1.6; P <.001; 3.9+/-1.3 vs 3.1+/-1.2; P <.001). No significant differences were observed in periprocedural major safety events (7.8 vs 4.5%; P=.1). With a mean clinical follow-up of 16.2+/-12.2 months, the observed annual stroke/transient ischemic attack rate for the RS group was 2.6% (65% risk reduction) and the observed annual major bleeding rate was 0% (100% risk reduction). CONCLUSIONS: Patients with RS undergoing LAAO showed similar safety outcomes to patients without RS, with a significant reduction in stroke/transient ischemic attack and major bleeding events during follow-up. Adequately powered controlled trials are needed to further investigate the use of LAAO in RS patients

Left atrial appendage occlusion for stroke despite oral anticoagulation (resistant stroke). Results from the Amplatzer Cardiac Plug registry.

INTRODUCTION AND OBJECTIVES: Despite the efficacy of oral anticoagulant (OAC) therapy, some patients continue to have a high residual risk and develop a stroke on OAC therapy (resistant stroke [RS]), and there is a lack of evidence on the management of these patients. The aim of this study was to analyze the safety and efficacy of left atrial appendage occlusion (LAAO) as secondary prevention in patients with nonvalvular atrial fibrillation who have experienced a stroke/transient ischemic attack despite OAC treatment. METHODS: We analyzed data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients with nonvalvular atrial fibrillation undergoing LAAO. Patientes with previous stroke on OAC therapy as indication for LAAO were identified and compared with patients with other indications. RESULTS: A total of 115 patients (11%) with RS were identified. The CHA2DS2-VASc and the HAS-BLED score were significantly higher in the RS group (respectively 5.5±1.5 vs 4.3±1.6; P <.001; 3.9±1.3 vs 3.1±1.2; P <.001). No significant differences were observed in periprocedural major safety events (7.8 vs 4.5%; P=.1). With a mean clinical follow-up of 16.2±12.2 months, the observed annual stroke/transient ischemic attack rate for the RS group was 2.6% (65% risk reduction) and the observed annual major bleeding rate was 0% (100% risk reduction). CONCLUSIONS: Patients with RS undergoing LAAO showed similar safety outcomes to patients without RS, with a significant reduction in stroke/transient ischemic attack and major bleeding events during follow-up. Adequately powered controlled trials are needed to further investigate the use of LAAO in RS patients.

Long-term clinical outcomes of Amplatzer cardiac plug versus Amulet occluders for left atrial appendage closure.

OBJECTIVES: To compare long-term clinical outcomes after left atrial appendage closure with the Amplatzer Cardiac Plug (ACP) and Amulet. BACKGROUND: The Amulet was designed to improve clinical outcomes of first-generation ACP. METHODS: Three Amplatzer registries (Bern, Coburg, Zurich), with enrollment of patients from 2009 to 2018, were retrospectively analyzed. The primary safety endpoint was a composite of major peri-procedural complications and major bleedings, the primary efficacy endpoint included stroke, systemic embolism, and cardiovascular/unexplained death. The net clinical benefit was a combination of all above-mentioned hazards. RESULTS: A total of consecutive 563 patients (344 ACP vs. 219 Amulet) with a mean follow-up of 2.9 ± 1.6 and 1.9 ± 0.9 years were included. Mean age (74.4 ± 9.9 [ACP] vs. 74.4 ± 9.1 [Amulet] years), stroke (CHA2 DS2 -VASc score 4.4 ± 1.6 vs. 4.6 ± 1.7), and bleeding risk (HAS-BLED score 3.2 ± 1.1 vs. 3.2 ± 0.9) were comparable. The primary endpoints of efficacy (72/998, 7.2% [ACP] vs. 43/417, 10.3% [Amulet]; hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.44-1.02, p = .062), safety (40/998, 4.0% vs. 18/417, 4.3%; HR, 1.15; 95% CI, 0.53-2.51, p = .72), and the net clinical benefit (101/998, 10.1% vs. 55/417, 13.4%; HR, 0.73; 95% CI, 0.49-1.07, p = .11) were similar. CONCLUSION: In the long term, left atrial appendage closure with first and second-generation Amplatzer devices provided similar efficacy, safety, and net clinical benefit. Clinical outcomes may be rather determined by implantation technique and hemodynamics, but not by the design modifications of the Amulet.

Favorable neurological outcome after ischemic cerebrovascular events in patients treated with percutaneous left atrial appendage occlusion compared with warfarin.

OBJECTIVES: This study sought to investigate neurological disability after ischemic cerebrovascular events in patients treated with left atrial appendage (LAA) occlusion compared with those on warfarin. BACKGROUND: Prior studies demonstrated that cerebrovascular events after LAA occlusion in patients with nonvalvular atrial fibrillation (NVAF) is largely nondisabling. METHODS: From the 1,189 patients in the Korean LAA Occlusion and European Amplatzer Cardiac Plug Multi-Center Registry, 24 patients who experienced ischemic cerebrovascular events after LAA occlusion were enrolled. The neurological outcomes were compared with those in 68 patients who experienced an ischemic cerebrovascular event while on warfarin (Yonsei Stroke Registry). A modified Rankin scale (mRS) score of 3-6 categorized the cerebrovascular event as disabling. The mRS at discharge and at 3 and 12 months postcerebrovascular event in the two groups was compared. RESULTS: The percentages of disabling cerebrovascular events were 37.5% and 58.8% at discharge (P = 0.07), 20.8% and 42.6% at 3 months (P = 0.08), and 12.5% and 39.7% at 12 months (P = 0.02) in the LAA occlusion and warfarin groups, respectively. The mRS was significantly lower in the LAA occlusion group at discharge and at 3 months (P < 0.01) and 12 months (P < 0.01) postcerebrovascular event despite no significant difference in mRS before cerebrovascular events (P = 0.98). Patients in the LAA occlusion group demonstrated a significant reduction in mRS between discharge and 12 months (P < 0.01), unlike patients in the warfarin group (P = 0.10). CONCLUSIONS: Ischemic cerebrovascular events in patients who previously underwent percutaneous LAA occlusion for NVAF were more favorable than in patients on warfarin.

An overview of current and emerging devices for percutaneous left atrial appendage closure.

Atrial fibrillation (AF) is common and is a prominent risk factor for ischemic stroke. Oral anticoagulant (OAC) therapy has been the main strategy for stroke prevention in AF patients; however, OAC therapy carries a bleeding risk and is not tolerated by all patients. Left atrial appendage (LAA) closure offers a non-pharmacological alternative for stroke prevention in patients with non-valvular AF. In this update, an overview of current and emerging LAA occluders is given - with special attention to the key design features of every single device and, if available, preclinical or clinical data.

Coronary microvascular disease and clinical prognosis in deferred lesions: The index of microcirculatory resistance.

While fractional flow reserve (FFR) is a good diagnostic index to assess the myocardial ischemia, coronary flow reserve (CFR) and the index of microcirculatory resistance (IMR) can be used to address microvascular status without any significant epicardial disease. The independent predictors for FFR and IMR are totally different and acts differently on the macro- and micro-vascular dysfunction. In high FFR patients, low CFR and high IMR which indicates the presence of overt microvascular disease demonstrated poor prognosis. Thus, comprehensive physiological assessments using FFR, CFR and IMR could improve the ability to discriminate patients at high risk of future events.

Left atrial appendage occlusion with lambre in atrial fibrillation: Initial European experience.

BACKGROUND: We here report the first European experience with the novel LAmbre left atrial appendage (LAA) occluder, a self-expanding device consisting of an umbrella and a cover connected by a central waist. METHODS AND RESULTS: A total of 60 patients (74.4 ±â€¯8.3 years; 66.7% men; CHA2DS2-VASc: 4.0 ±â€¯1.6, HAS-BLED score: 3.2 ±â€¯1.3) with atrial fibrillation and contraindications to oral anticoagulation underwent left atrial appendage occlusion (LAAO) with the LAmbre device at two German centers between November 2013 and September 2015. Device success defined as correct placement of the device was achieved in all patients (100%). Resizing of the device was necessary in 3 (5%) patients. Device-related complications included 2 (3.3%) pericardial effusions on day 8 and 33 after the index procedure requiring pericardiocentesis. Transesophageal echocardiography at 6 months showed complete sealing of the LAA (residual jet flow of <5 mm) in 51/54 (94.4%) patients. No device-related thrombus was documented. At 12 months transient ischemic attack was observed in 1 patient (1.6%) and minor bleeding in 3 patients (5%). CONCLUSIONS: Although minimizing procedure-related complications remains challenging, LAAO with the LAmbre showed high device success and good mid-term performance regarding prevention of stroke and bleeding.

Magnetocardiography for the diagnosis of non-obstructive coronary artery disease1.

Ischemic heart disease (IHD) remains a major public health burden worldwide. It is estimated that one third of adults in the United States has some form of IHD, including more than 17 million with coronary artery disease (CAD) and nearly 10 million with angina pectoris [1]. Nevertheless, the detection of myocardial ischemia in patients with presumed CAD remains a challenge in contemporary practice.

Impact of left atrial appendage morphology on indication and procedural outcome after interventional occlusion: results from the prospective multicentre German LAARGE registry.

AIMS: Interventional left atrial appendage closure (LAAC) is an emerging alternative to oral anticoagulation (OAC) for stroke prevention in atrial fibrillation (AF) in concomitance with a contraindication for standard OAC. This sub-analysis of the LAARGE registry aimed to investigate differences between different LAA morphologies in a real-world setting. METHODS AND RESULTS: This prospective, multicentre, observational registry included 562 patients from 37 centres with ineligibility for long-term OAC between April 2014 and January 2016. Baseline characteristics, indications, procedural data and complications were registered according to each LAA morphology (i.e., chicken wing, cauliflower, windsock, cactus and atypical morphologies). Implantation success was high across the four typical anatomies (≥97.5%, p=n.s.); only atypical anatomies exhibited a lower success rate (94%). The cactus-shaped LAA was linked to a trend indicating a shorter fluoroscopy time, while the atypical LAA was linked to a significantly prolonged fluoroscopy time (p=0.089 and p=0.025 versus the overall mean, respectively). Periprocedural and intra-hospital complications were generally rare, with no differences among the different morphologies (p=n.s.). CONCLUSIONS: Procedural success as well as the complication rates of LAAC were not different among the four typical LAA morphologies. A lower implantation success rate was only obvious in patients with atypical LAA morphologies.

First-in-human experience of left atrial appendage occlusion with the steerable FuStar sheath.

BACKGROUND: Due the wide variability of left atrial appendage morphology left atrial appendage occlusion (LAAO) remains a challenging procedure. The steerable FuStar delivery sheath was designed to allow both, transseptal access and delivery of percutaneous devices. We here report the first-in-human experience of LAAO with the FuStar sheath. METHODS: Twenty patients (76.6 ± 8.4 years; 12 (60%) males; CHA2 DS2 -VASc score: 5.0 ± 2) with non-valvular fibrillation and contraindications to oral anticoagulation underwent LAAO with the LAmbre device using the FuStar steerable sheath (Lifetech Scientific Corp., Shenzhen, China) at two german centers. RESULTS: Successful device implantation was achieved in all patients (100%). No periprocedural complications were observed. Procedure time, fluoroscopy time, contrast media, and radiation dose were 23.4 min ± 9.2, 11.9 min ± 4.1, 96.2 mL ± 45.7, and 2718.4 cG*cm2 ± 3835.3, respectively. CONCLUSION: This study demonstrates the feasibility and safety of the steerable FuStar sheath for LAAO.

Left atrial appendage angiography is associated with the incidence and number of magnetic resonance imaging-detected brain lesions after percutaneous catheter-based left atrial appendage closure.

BACKGROUND: Percutaneous catheter-based left atrial appendage closure (LAAC) is a procedure being increasingly performed in patients with atrial fibrillation and high bleeding risk. OBJECTIVE: The purpose of this study was to evaluate the incidence of magnetic resonance imaging (MRI)-detected acute brain lesions (ABLs) as well as potential changes in neurocognitive function after percutaneous LAAC in patients with atrial fibrillation. METHODS: Brain MRI at 3 T was performed within 24 hours before and after LAAC along with neurologic (National Institutes of Health Stroke Scale [NIHSS] score) and cognitive (Montreal Cognitive Assessment [MoCA] test) assessment. Acquired MRI sequences included high-resolution diffusion-weighted imaging as well as fluid-attenuated inversion recovery. RESULTS: Successful device implantation was achieved in all 23 patients (age 74.1 ± 10.5 years; 16 male) using the Amulet (n = 18), Occlutech (n = 3), or LAmbre (n = 2) device. Thirty-seven ABLs were detected by MRI in 12 of 23 patients (52%) after LAAC. The number of periprocedural LAA angiographies was significantly higher in patients with ABL than in those without ABL (1.67 ± 0.65 vs 1.18 ± 0.41; P = .048) and was associated with a higher number of ABL (ρ = 0.615; P = .033). Compared to pre-LAAC assessment, post-LAAC MoCA and NIHSS scores revealed similar results. After LAAC, MoCA test (mean 24.1 ± 4.6 vs 23.2 ± 4.6; P = .09) and NIHSS score (mean 1.0 ± 1.7 vs 1.2 ± 1.8; P = .1) were similar between patients with and those without ABL, respectively. CONCLUSION: MRI-detected ABLs are commonly observed after percutaneous LAAC. The number of LAA angiographies is significantly associated with the number of ABLs; however, the clinical implications of ABL have yet to be determined.