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Prague, Czech Republic

Neuzil P.,Na Homolce Hospital | Reddy V.Y.,Homolka Hospital | Reddy V.Y.,Mount Sinai School of Medicine
Current Cardiology Reports | Year: 2015

Traditional transvenous approach for permanent cardiac pacing can be associated with significant acute and chronic complications related partly to either the insertion of transvenous lead or subcutaneous placement of pacemaker device. We summarize the current status of a novel self-contained leadless cardiac pacemaker in the first-in-human and subsequent series of feasibility studies in patients indicated for ventricular rate-responsive pacing (VVI). Using a femoral venous approach, the device is implanted at the right ventricular apical septum region. We describe the technical and clinical characterization of this innovative technology. Two different systems of leadless pacemakers are currently implanted to the patients. Up to now, the electrical parameters, such as pacing thresholds, sensing parameters, and pacing impedances, either improved or remained stable within the accepted range. In this chapter, we also discuss the potential benefit for the future, but in summary, all available data demonstrate the feasibility of leadless cardiac pacing. © 2015, Springer Science+Business Media New York. Source

Reddy V.Y.,Mount Sinai School of Medicine | Reddy V.Y.,St Johns Health Center | Holmes D.,Mayo Medical School | Doshi S.K.,St Johns Health Center | And 2 more authors.
Circulation | Year: 2011

Background- The Watchman Left Atrial Appendage System for Embolic Protection in Patients With AF (PROTECT AF) randomized trial compared left atrial appendage closure against warfarin in atrial fibrillation (AF) patients with CHADS2 1. Although the study met the primary efficacy end point of being noninferior to warfarin therapy for the prevention of stroke/systemic embolism/cardiovascular death, there was a significantly higher risk of complications, predominantly pericardial effusion and procedural stroke related to air embolism. Here, we report the influence of experience on the safety of percutaneous left atrial appendage closure. Methods and Results- The study cohort for this analysis included patients in the PROTECT AF trial who underwent attempted device left atrial appendage closure (n=542 patients) and those from a subsequent nonrandomized registry of patients undergoing Watchman implantation (Continued Access Protocol [CAP] Registry; n=460 patients). The safety end point included bleeding- and procedure-related events (pericardial effusion, stroke, device embolization). There was a significant decline in the rate of procedure- or device-related safety events within 7 days of the procedure across the 2 studies, with 7.7% and 3.7% of patients, respectively, experiencing events (P=0.007), and between the first and second halves of PROTECT AF and CAP, with 10.0%, 5.5%, and 3.7% of patients, respectively, experiencing events (P=0.006). The rate of serious pericardial effusion within 7 days of implantation, which had made up >50% of the safety events in PROTECT AF, was lower in the CAP Registry (5.0% versus 2.2%, respectively; P=0.019). There was a similar experience-related improvement in procedure-related stroke (0.9% versus 0%, respectively; P=0.039). Finally, the functional impact of these safety events, as defined by significant disability or death, was statistically superior in the Watchman group compared with the warfarin group in PROTECT AF. This remained true whether significance was defined as a change in the modified Rankin score of 1, 2, or 3 (1.8 versus 4.3 events per 100 patient-years; relative risk, 0.43; 95% confidence interval, 0.24 to 0.82; 1.5 versus 3.7 events per 100 patient-years; relative risk, 0.41; 95% confidence interval, 0.22 to 0.82; and 1.4 versus 3.3 events per 100 patient-years; relative risk, 0.43; 95% confidence interval, 0.22 to 0.88, respectively). Conclusion- As with all interventional procedures, there is a significant improvement in the safety of Watchman left atrial appendage closure with increased operator experience. CLINICAL TRIAL REGISTRATION-: URL: http://clinicaltrials.gov. Unique identifier: NCT00129545. Copyright © 2011 American Heart Association. All rights reserved. Source

Miller M.A.,Mount Sinai School of Medicine | Gangireddy S.R.,Mount Sinai School of Medicine | Doshi S.K.,Pacific Heart Institute | Aryana A.,Mercy Heart and Vascular Institute | And 6 more authors.
Heart rhythm : the official journal of the Heart Rhythm Society | Year: 2014

BACKGROUND: Pericardial suture ligation of the left atrial appendage (LAA) may be an alternative to endoluminal devices for stroke prevention in patients with atrial fibrillation, but multicenter safety and efficacy data in high-risk patients with contraindications to oral anticoagulation are lacking.OBJECTIVE: The purpose of this study was to report the outcomes of consecutive cases of pericardial suture ligation of the LAA in high-risk patients performed at 4 centers.METHODS: The cohort included 41 consecutive patients who underwent LAA closure with the LARIAT system. Epicardial and transeptal access was obtained, and the epicardial snare was advanced over an endo-epicardial magnetic-tipped guidewire to close the LAA. Transesophageal echocardiography was used to confirm LAA exclusion.RESULTS: Mean age was 75 ± 10 years, mean CHADS2 score was 3.0 ± 1.3, and mean HAS-BLED score was 4.4 ± 1.4. These patients accumulated 24.6 person-years of follow-up. Acute LAA closure was achieved in 38 patients (93%). Transesophageal echocardiography or computerized tomographic angiography performed up to 3.3 ± 0.8 months after the procedure demonstrated LAA leakage in 24% of patients. One patient (2%) had a transient ischemic attack, and 8 (20%) developed pericardial effusions requiring pericardiocentesis. Four cases (9%) were complicated by perforation of the LAA, with 2 of these patients requiring open surgical correction.CONCLUSION: This multicenter experience revealed that pericardial suture ligation with the LARIAT system is technically feasible and acutely efficacious. However, additional improvements are required to minimize the rate of pericardial complications. A randomized study is warranted to accurately define the long-term efficacy and safety profile of percutaneous epicardial suture ligation. Copyright © 2014. Published by Elsevier Inc. Source

Miller M.A.,The New School | Neuzil P.,Homolka Hospital | Dukkipati S.R.,The New School | Reddy V.Y.,The New School
Journal of the American College of Cardiology | Year: 2015

Despite significant advances in battery longevity, lead performance, and programming features since the first implanted permanent pacemaker was developed, the basic design of cardiac pacemakers has remained relatively unchanged over the past 50 years. Because of inherent limitations in their design, conventional (transvenous) pacemakers are prone to multiple potential short- and long-term complications. Accordingly, there has been intense interest in a system able to provide the symptomatic and potentially lifesaving therapies of cardiac pacemakers while mitigating many of the risks associated with their weakest link - the transvenous lead. Leadless cardiac pacing represents the future of cardiac pacing systems, similar to the transition that occurred from the use of epicardial pacing systems to the familiar transvenous systems of today. This review summarizes the current evidence and potential benefits of leadless pacing systems, which are either commercially available (in Europe) or under clinical investigation. © 2015 American College of Cardiology Foundation. Source

Reddy V.Y.,Mount Sinai School of Medicine | Mobius-Winkler S.,University of Leipzig | Miller M.A.,Mount Sinai School of Medicine | Neuzil P.,Homolka Hospital | And 4 more authors.
Journal of the American College of Cardiology | Year: 2013

Objectives The purpose of this study was to assess the safety and efficacy of left atrial appendage (LAA) closure in nonvalvular atrial fibrillation (AF) patients ineligible for warfarin therapy. Background The PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation) trial demonstrated that LAA closure with the Watchman device (Boston Scientific, Natick, Massachusetts) was noninferior to warfarin therapy. However, the PROTECT AF trial only included patients who were candidates for warfarin, and even patients randomly assigned to the LAA closure arm received concomitant warfarin for 6 weeks after Watchman implantation. Methods A multicenter, prospective, nonrandomized study was conducted of LAA closure with the Watchman device in 150 patients with nonvalvular AF and CHADS2 (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, and prior stroke or transient ischemic attack) score ≥1, who were considered ineligible for warfarin. The primary efficacy endpoint was the combined events of ischemic stroke, hemorrhagic stroke, systemic embolism, and cardiovascular/unexplained death. Results The mean CHADS2 score and CHA2DS2-VASc (CHADS2 score plus 2 points for age ≥75 years and 1 point for vascular disease, age 65 to 74 years, or female sex) score were 2.8 ± 1.2 and 4.4 ± 1.7, respectively. History of hemorrhagic/bleeding tendencies (93%) was the most common reason for warfarin ineligibility. Mean duration of follow-up was 14.4 ± 8.6 months. Serious procedure- or device-related safety events occurred in 8.7% of patients (13 of 150 patients). All-cause stroke or systemic embolism occurred in 4 patients (2.3% per year): ischemic stroke in 3 patients (1.7% per year) and hemorrhagic stroke in 1 patient (0.6% per year). This ischemic stroke rate was less than that expected (7.3% per year) based on the CHADS2 scores of the patient cohort. Conclusions LAA closure with the Watchman device can be safely performed without a warfarin transition, and is a reasonable alternative to consider for patients at high risk for stroke but with contraindications to systemic oral anticoagulation. (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology [ASAP]; NCT00851578).© 2013 by the American College of Cardiology Foundation Published by Elsevier Inc. Source

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