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Goldenberg I.,University of Rochester | Goldenberg I.,Leviev Heart Center | Goldenberg I.,Tel Aviv University | Kutyifa V.,University of Rochester | And 25 more authors.
New England Journal of Medicine | Year: 2014

BACKGROUND: The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) showed that early intervention with cardiac-resynchronization therapy with a defibrillator (CRT-D) in patients with an electrocardiographic pattern showing left bundle-branch block was associated with a significant reduction in heart-failure events over a median follow-up of 2.4 years, as compared with defibrillator therapy alone. METHODS: We evaluated the effect of CRT-D on long-term survival in the MADIT-CRT population. Post-trial follow-up over a median period of 5.6 years was assessed among all 1691 surviving patients (phase 1) and subsequently among 854 patients who were enrolled in post-trial registries (phase 2). All reported analyses were performed on an intention-to-treat basis. RESULTS: At 7 years of follow-up after initial enrollment, the cumulative rate of death from any cause among patients with left bundle-branch block was 18% among patients randomly assigned to CRT-D, as compared with 29% among those randomly assigned to defibrillator therapy alone (adjusted hazard ratio in the CRT-D group, 0.59; 95% confidence interval [CI], 0.43 to 0.80; P<0.001). The long-term survival benefit of CRT-D in patients with left bundle-branch block did not differ significantly according to sex, cause of cardiomyopathy, or QRS duration. In contrast, CRT-D was not associated with any clinical benefit and possibly with harm in patients without left bundlebranch block (adjusted hazard ratio for death from any cause, 1.57; 95% CI, 1.03 to 2.39; P = 0.04; P<0.001 for interaction of treatment with QRS morphologic findings). CONCLUSIONS: Our findings indicate that in patients with mild heart-failure symptoms, left ventricular dysfunction, and left bundle-branch block, early intervention with CRT-D was associated with a significant long-term survival benefit. (Funded by Boston Scientific; ClinicalTrials.gov numbers, NCT00180271, NCT01294449, and NCT02060110.) Copyright © 2014 Massachusetts Medical Society.


Buber J.,Leviev Heart Center | Luria D.,Leviev Heart Center | Sternik L.,Leviev Heart Center | Raanani E.,Leviev Heart Center | And 7 more authors.
Journal of the American College of Cardiology | Year: 2011

Objectives: The aim of this study was to evaluate whether certain post-Maze left atrial (LA) contractile profiles may pose a risk for ischemic stroke. Background: The mechanical contraction of the left atrium may be modified after the Maze procedure. Whether this imposes a risk for stroke, even in the presence of sinus rhythm and after removal of the LA appendage, is not known. Methods: Clinical, surgery-related, and echocardiographic data from 150 patients who underwent radiofrequency and cryoablation Maze procedures without the use of atrial incisions between 2004 and 2009 and were in sustained sinus rhythm were collected and analyzed. The occurrence of stroke was evaluated by reviewing clinical records. All stroke events were adjudicated by a neurologist. Results: At a mean follow-up time of 24.5 months, 15 patients (10%) had experienced ischemic strokes. Forty-seven patients (31%) had no evidence of LA mechanical contraction at 3 months after surgery (baseline assessment) and on follow-up echocardiography. Multivariate analysis showed that a lack of LA mechanical contraction at baseline was associated with a 5-fold increase in the risk for stroke (p = 0.02) during follow-up. Larger atria imposed a significant risk as well; LA volume index <33 ml/m 2 was associated with a 3-fold risk increase (p = 0.03). These effects were maintained regardless of the lack of mechanical valve implantation and anticoagulation treatment. Conclusions: Absence of LA contraction and LA volume index <33 ml/m 2 result in a significant increase in the risk for thromboembolic stroke after the Maze procedure for patients in sinus rhythm. © 2011 American College of Cardiology Foundation.


Buber J.,Tel Aviv University | Buber J.,Leviev Heart Center | Goldenberg I.,Tel Aviv University | Goldenberg I.,University of Rochester | And 7 more authors.
Journal of the American College of Cardiology | Year: 2012

This study hypothesized that time-dependent statin therapy will reduce the risk of life-threatening ventricular tachyarrhythmias among patients with nonischemic cardiomyopathy (NICM) enrolled in the MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy). Prior studies suggested that statin therapy exerts antiarrhythmic properties among patients with coronary artery disease. However, data regarding the effect of statins on arrhythmic risk among patients with NICM are limited. Multivariate Cox proportional hazards regression modeling was used to assess the effect of statin therapy, evaluated as a time-dependent covariate, on the risk of appropriate defibrillator therapy for fast ventricular tachycardia (VT) (defined as a rate faster than 180 beats/min)/ventricular fibrillation (VF) or death (primary endpoint) and appropriate defibrillator shocks (secondary endpoint) among 821 patients with NICM enrolled in the MADIT-CRT trial. Statin users (n = 499) were older and had a higher prevalence of diabetes and hypertension yet were less frequently smokers. Multivariate analysis showed that time-dependent statin therapy was independently associated with a significant 77% reduction in the risk of fast VT/VF or death (p < 0.001) and with a significant 46% reduction in the risk of appropriate implantable cardioverter defibrillator shocks (p = 0.01). Consistent with these findings, the cumulative probability of fast VT/VF or death at 4 years of follow-up was significantly lower among patients who were treated with statins (11%) as compared with study patients who were not treated with statins (19%; p = 0.006 for the overall difference during follow-up). Statin use was associated with a significant reduction in the risk of life-threatening ventricular tachyarrhythmias among patients with NICM. © 2012 American College of Cardiology Foundation.


Kuperstein R.,Leviev Heart Center | Kuperstein R.,Tel Aviv University | Goldenberg I.,Tel Aviv University | Goldenberg I.,University of Rochester | And 8 more authors.
Circulation: Heart Failure | Year: 2014

Background - Left atrial volume (LAV) is an important marker of heart failure (HF) severity. We hypothesized that LAV independently correlates with clinical outcomes in patients who receive cardiac resynchronization therapy with a defibrillator (CRT-D) and can be used for improved risk assessment in this population. Methods and Results - The benefit of CRT-D versus defibrillator-only therapy in reducing the risk of HF or death was assessed by LAV (dichotomized at the upper quartile >52 mL/m2) among 1785 patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study. Landmark analysis was used to evaluate the relationship between LAV response to CRT-D and subsequent clinical outcomes. Multivariable analysis showed that patients with a higher baseline LAV experienced 69% (P<0.001) and 59% (P=0.02) increased hazard for HF or death and for all-cause mortality, respectively, independently of baseline left ventricular volume. CRT-D was associated with a significant reduction in LAV compared with defibrillator-only therapy (-28% versus -10%, respectively; P<0.001). Landmark analysis showed that after CRT-D implantation each 1% reduction in LAV was independently associated with a corresponding 4% reduction in the hazard of subsequent HF or death (P<0.001). The assessment of LAV change after CRT implantation improved prediction of clinical response to the device compared with assessment of the corresponding changes in left ventricular volume. Conclusions - LAV is an independent correlate of clinical outcomes in mildly symptomatic HF patients treated with CRT-D. CRT exerts pronounced reverse remodeling effects on the left atrium that independently correlate with improved clinical outcomes after device implantation. © 2013 American Heart Association, Inc.


Barsheshet A.,Rabin Medical Center | Barsheshet A.,Tel Aviv University | Barsheshet A.,University of Rochester | Dotsenko O.,University of Rochester | And 3 more authors.
Pediatric Drugs | Year: 2014

Long QT syndrome is a genetic disorder associated with life threatening ventricular arrhythmias and sudden death. This inherited arrhythmic disorder exhibits genetic heterogeneity, incomplete penetrance, and variable expressivity. During the past two decades there have been major advancements in understanding the genotype-phenotype correlations in LQTS. This genotype-phenotype relationship can lead to improved management of LQTS. However, development of genotype-specific or mutation-specific management strategies is very challenging. This review describes the pathophysiology of LQTS, genotype-phenotype correlations, and focuses on the management of LQTS. In general, the treatment of LQTS consists of lifestyle modifications, medical therapy with beta-blockers, device and surgical therapy. We further summarize current data on the efficacy of pharmacological treatment options for the three most prevalent LQTS variants including beta-blockers in LQT1, LQT2 and LQT3, sodium channel blockers and ranolazine for LQT3, potassium supplementation and spironolactone for LQT2, and possibly sex hormone-based therapy for LQT2. © 2014, Springer International Publishing Switzerland.


Suleiman M.,Rambam Medical Center | Goldenberg I.,Leviev Heart Center | Haim M.,Meir Medical Center | Schliamser J.E.,Carmel Medical Center | And 7 more authors.
Heart Rhythm | Year: 2014

Background Elderly patients are underrepresented in clinical trials of device therapy. Objective To provide real-world data regarding outcomes associated with device-based therapy in a large cohort of elderly patients enrolled in the Israeli ICD Registry. Methods Between July 2010 and June 2012, a total of 2807 consecutive patients undergoing implanted cardioverter- defibrillator/cardiac resynchronization therapy-defibrillator (ICD/CRT-D) implantation were prospectively enrolled in the Israeli ICD Registry. For the present analysis, patients were categorized into 3 age groups: ≤60 years (n = 1378 [49%]), 61-75 years (n = 863 [31%]), and >75 years (n = 566 [20%]). Results Elderly patients (>75 years of age) had more comorbid conditions and were more likely to undergo CRT-D implantation (all P <.01). However, the rate of device-related complications associated with surgical reinterventions at 1 year was <3% regardless of age (P =.70 for the comparison among the 3 age groups). Multivariate analysis showed that the risk of heart failure or death and of appropriate ICD therapy for ventricular arrhythmias was significantly increased with increasing age among patients who received an ICD. In contrast, the age-related increase in the risk of all end points was attenuated among patients who received CRT-D devices (all P values for age-by-device-type interactions are <.05). Conclusions In a real-world scenario, elderly patients (>75 years of age) comprise approximately 20% of the ICD/CRT-D recipients and experience a device reintervention rate similar to that of their younger counterparts. Our data suggest that the association between advanced age and adverse clinical outcomes is attenuated in elderly patients implanted with CRT-D devices. © 2014 Heart Rhythm Society.


Healey J.S.,McMaster University | Hohnloser S.H.,Goethe University Frankfurt | Glikson M.,Leviev Heart Center | Neuzner J.,Klinikum Kassel | And 17 more authors.
The Lancet | Year: 2015

Background Defibrillation testing by induction and termination of ventricular fibrillation is widely done at the time of implantation of implantable cardioverter defibrillators (ICDs). We aimed to compare the efficacy and safety of ICD implantation without defibrillation testing versus the standard of ICD implantation with defibrillation testing. Methods In this single-blind, randomised, multicentre, non-inferiority trial (Shockless IMPLant Evaluation [SIMPLE]), we recruited patients aged older than 18 years receiving their first ICD for standard indications at 85 hospitals in 18 countries worldwide. Exclusion criteria included pregnancy, awaiting transplantation, particpation in another randomised trial, unavailability for follow-up, or if it was expected that the ICD would have to be implanted on the right-hand side of the chest. Patients undergoing initial implantation of a Boston Scientific ICD were randomly assigned (1:1) using a computer-generated sequence to have either defibrillation testing (testing group) or not (no-testing group). We used random block sizes to conceal treatment allocation from the patients, and randomisation was stratified by clinical centre. Our primary efficacy analysis tested the intention-to-treat population for non-inferiority of no-testing versus testing by use of a composite outcome of arrhythmic death or failed appropriate shock (ie, a shock that did not terminate a spontaneous episode of ventricular tachycardia or fibrillation). The non-inferiority margin was a hazard ratio (HR) of 1·5 calculated from a proportional hazards model with no-testing versus testing as the only covariate; if the upper bound of the 95% CI was less than 1·5, we concluded that ICD insertion without testing was non-inferior to ICD with testing. We examined safety with two, 30 day, adverse event outcome clusters. The trial is registered with ClinicalTrials.gov, number NCT00800384. Findings Between Jan 13, 2009, and April 4, 2011, of 2500 eligible patients, 1253 were randomly assigned to defibrillation testing and 1247 to no-testing, and followed up for a mean of 3·1 years (SD 1·0). The primary outcome of arrhythmic death or failed appropriate shock occurred in fewer patients (90 [7% per year]) in the no-testing group than patients who did receive it (104 [8% per year]; HR 0·86, 95% CI 0·65-1·14; pnon-inferiority <0·0001). The first safety composite outcome occurred in 69 (5·6%) of 1236 patients with no-testing and in 81 (6·5%) of 1242 patients with defibrillation testing, p=0·33. The second, pre-specified safety composite outcome, which included only events most likely to be directly caused by testing, occurred in 3·2% of patients with no-testing and in 4·5% with defibrillation testing, p=0·08. Heart failure needing intravenous treatment with inotropes or diuretics was the most common adverse event (in 20 [2%] of 1236 patients in the no-testing group vs 28 [2%] of 1242 patients in the testing group, p=0·25). Interpretation Routine defibrillation testing at the time of ICD implantation is generally well tolerated, but does not improve shock efficacy or reduce arrhythmic death. Funding Boston Scientific and the Heart and Stroke Foundation (Ontario Provincial office). © 2015 Elsevier Ltd.


Reichlin T.,Brigham and Women's Hospital | Reichlin T.,University of Basel | Knecht S.,University of Basel | Lane C.,Brigham and Women's Hospital | And 12 more authors.
Heart Rhythm | Year: 2014

Background Good catheter-tissue contact force (CF) is critical for transmural and durable lesion formation during radiofrequency (RF) ablation but is difficult to assess in clinical practice. Tissue heating during RF application results in an impedance decrease at the catheter tip. Objective The purpose of this study was to correlate achieved CF and initial impedance decreases during atrial fibrillation (AF) ablation. Methods We correlated achieved CF and initial impedance decreases in patients undergoing ablation for AF with two novel open-irrigated CF-sensing RF catheters (Biosense Webster SmartTouch, n = 647 RF applications; and Endosense TactiCath, n = 637 RF applications). We then compared those impedance decreases to 691 RF applications with a standard open-irrigated RF catheter (Biosense Webster ThermoCool). Results When RF applications with the CF-sensing catheters were analyzed according to an achieved average CF <5 g, 5-10 g, 10-20 g, and >20 g, the initial impedance decreases during ablation were larger with greater CF. Corresponding median values at 20 seconds were 5 (interquartile range [IQR] 2-7), 8 (4-11), 10 (7-16), and 14 (10-19) with the SmartTouch and n/a, 4 (0-10), 8 (5-12), and 13 (8-18) with the TactiCath (P <.001 between categories for both catheters). When RF applications with the SmartTouch (CF-sensing catheter, median achieved CF 12 g) and ThermoCool (standard catheter) were compared, the initial impedance decrease was significantly greater in the CF-sensing group with median decreases of 10 (6-14) vs 5 (2-10) at 20 seconds (P <.001 between catheters). Conclusion The initial impedance decrease during RF applications in AF ablations is larger when greater catheter contact is achieved. Monitoring of the initial impedance decrease is a widely available indicator of catheter contact and may help to improve formation of durable ablation lesions. © 2014 Heart Rhythm Society.


Potashnik-Peled Y.,Leviev Heart Center
Harefuah | Year: 2011

The recently improved cardiac diagnostic and therapeutic means associated with improved life-expectancy of patients, highlighted the special needs of the worldwide ever-growing numbers of patients with end-stage heart failure and their families. The hospice--palliative treatment approach to end-stage heart failure patients has been well defined and recommended by the World Health Organization (W.H.O.). The principles of this approach is aimed towards achieving a maximum relief of symptoms, avoiding interference (acceleration or delay) with life expectancy; ensuring daily activity and reasonable quality of life, and providing mental and spiritual support to the patients and their close family members. Obviously, it requires a trained multidisciplinary team including a senior physician, a nurse, a psychologist and a social worker. In order to be eligible for hospice and palliative care, endstage systolic heart failure patients should meet defined criteria including: severity of illness (NYHA class IV), clinical deterioration observed within the last six months and unsuitability for advanced therapeutic options. Recently, the Israeli Ministry of Health has adapted the W.H.O. recommendations, instructing all Local health service providers to expand this service and establish it according to well-defined guidelines and standards of care. Accessibility of all end-stage heart failure patients in Israel to this service will critically contribute to their physical and mental comfort, their dignity, and to the benefit of their families.


Shechter M.,Leviev Heart Center
Harefuah | Year: 2011

Hypomagnesemia is common in hospitalized patients, especiaLLy in the eLderLy with coronary artery disease (CAD) and/or those with chronic heart failure. Hypomagnesemia is associated with the risk of hypertension, type 2 diabetes mellitus, increased mortality from all cause and CAD. Higher magnesium intake, however, has been associated with a Lower risk of developing metabolic syndrome, a problem which exists in 25% of American adults. Magnesium supplementation improves myocardial metabolism, inhibits calcium accumulation and myocardial cell death; it improves vascular tone, peripheral vascular resistance, afterload and cardiac output, reduces cardiac arrhythmias and improves lipid metabolism. Magnesium also reduces vulnerability to oxygen-derived free radicals, improves human endothelial function and inhibits platelet function, including platelet aggregation and adhesion, which potentially provides magnesium with physiologic and natural effects similar to adenosine-diphosphate inhibitors, such as clopidogrel. Data on magnesium supplementation in patients with acute myocardial infarction (AMI) are conflicting. ALthough a number of relatively small randomized cLinicaL trials have demonstrated a remarkable reduction in mortality when magnesium is administered to relativeLy high risk AMI patients, two recently published large-scale randomized cLinical trials (the Fourth International Study of Infarct Survival and Magnesium in Coronaries) failed to show any superiority of intravenous magnesium over placebo. Furthermore, the theoretical potential benefits of magnesium supplementation as a cardioprotective agent in CAD patients, its relatively low cost, easy administration, and relatively insignificant adverse effects, gives magnesium a place in treating CAD patients, especially those at high-risk and in life-threatening ventricular arrhythmias, such as Torsades de Points and intractable ventricular tachycardia.

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