Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE).

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).

Cardiac resynchronization therapy in heart failure patients with less severe left ventricular dysfunction.

Cardiac resynchronization therapy is beneficial in heart failure patients with LVEF ≤35% and electrical dyssynchrony. However, its effects among patients with less severe LV dysfunction have not been established. Recent post-hoc analyses of landmark CRT trials suggest that CRT benefit may be present in patients with LVEF >35% and is associated with improvement in cardiac reverse remodelling, all-cause mortality, and need for heart failure hospitalizations. This review summarizes the currently available literature regarding the potential impact of CRT in patients with more modest reductions in LVEF.

The use of telescoping guide catheters for coronary sinus cannulation and sub-selecting tributaries in left ventricular lead placement.

INTRODUCTION: Failure to enter the coronary sinus (CS) with a guiding catheter and entering its tributaries remains challenging in left ventricle (LV) pacing lead implants for cardiac resynchronization therapy (CRT). A dual telescoping catheter system (8F outer/6F inner) is designed to provide the ability to adjust the catheter curve size, shape and/or reach to the patients' anatomy avoiding the need for catheter change. METHODS: Five different designs for CS cannulation were randomly tested in 64 patients scheduled for CRT device implant. RESULTS: In 33 consecutive patients three adaptable telescoping guiding catheter systems were tested per patient, the adaptable catheters had higher overall cannulation success rates (68, 63 and 62%) compared to the fixed shape catheter (46%) and an greater cannulation success rate when the CS location was not known (70, 53 and 72% vs 33% for the fixed shape). In a second group of 31 CRT patients the two telescoping catheters had similar high levels of success (71-80%), with or without using the inner catheter. CONCLUSIONS: The telescopic system is adaptable to a wide range of anatomical variations in patients and can result in a higher CS cannulation success rate due to its adjustability in the RA in search for the CS ostium. On top of this the inner catheter allows for sub-selecting the CS tributaries.

Tailoring cardiac resynchronization therapy using interventricular asynchrony. Validation of a simple model.

This study explores the use of interventricular asynchrony (interVA) for optimizing cardiac resynchronization therapy (CRT), an idea emerging from a simple pathway model of conduction in the ventricles. Measurements were performed in six dogs with chronic left bundle branch block (LBBB) and in 29 patients of the Pacing Therapies for Congestive Heart Failure (PATH-CHF)-I study. In the dogs, intraventricular asynchrony (intraVA) was determined using left ventricular (LV) endocardial activation maps. In dogs and patients, the maximum rate of rise of LV pressure (LV dP/dt(max)) and the pulse pressure (PP) and interVA [time delay between upslope of LV and right ventricular (RV) pressure curves] were measured during LV, RV, and biventricular (BiV) pacing with various atrioventricular (AV) delays. Measurements in the canine hearts supported the pathway model in that optimal resynchronization occurred at approximately 50% reduction of intraVA and at an interVA value halfway that during LBBB and LV pacing. In patients with significant hemodynamic response during pacing (n = 22), intrinsic interVA and interVA at peak improvement (interVA(p)) varied widely between patients (from -83 to -15 ms and from -42 to +31 ms, respectively). However, the model predicted individual interVA(p) accurately (SD of +/-6 ms and +/-12 ms for LV dP/dt(max) and PP, respectively). At equal interVA, LV and BiV pacing produced equal hemodynamic response, but in 11 of 22 responders, BiV pacing reduced interVA insufficiently to reach the maximum hemodynamic response. LV pacing at short AV delay proved to result in better hemodynamics than predicted by the model, indicating that additional factors determine hemodynamics during LV preexcitation. Guided by a simple pathway model, interVA measurements accurately predict optimal hemodynamic performance in individual CRT patients.

Comparative prospective randomized efficacy testing of different guiding catheters for coronary sinus cannulation in heart failure patients.

INTRODUCTION: The efficacy of different shapes of guiding catheters for coronary sinus (CS) cannulation was evaluated at implant of a cardiac resynchronization therapy device that required transvenous placement of a pacing lead in a coronary vein on the left ventricle. METHODS AND RESULTS: Comparative testing of 5 different guiding catheter shapes was attempted in 29 consecutive patients. Four newer guiding catheters were tested in a prospective randomized manner with a reference standard catheter always tested in the last place. All of the new catheters included a distal shape that consisted of a single curve or a compound set of curves at the catheter tip, followed by a catheter shaft design which fell into one of two classes: (1). straight shaft catheters and (2). curved shaft catheters. The curved shaft class of catheters, two new and one standard, achieved higher (16/23 (70%), 17/23 (74%) and 17/22 (77%)) CS cannulation success rates than the straight shaft class catheters ((13/23 (56%) and 12/23 (52%)). The pairing of two catheters, one from each class in a single patient, or both from the curved shaft class resulted in a combined CS cannulation success rate of up to 96%. Two of the catheters were more effective from a left hand insertion than from a right hand insertion site. CONCLUSIONS: The ability to switch between guiding catheters with different shapes and compound curves can improve the CS cannulation success rate. The selection of guiding catheters should be influenced by the intended use of the catheter either from the left or from the right hand side.

Acute effects of cardiac resynchronization therapy on left ventricular Doppler indices in patients with congestive heart failure.

BACKGROUND: Patients with heart failure frequently exhibit intraventricular conduction delays, which contribute to asynchronous contraction patterns and impaired hemodynamic performance. Cardiac resynchronization therapy (CRT) with biventricular (BV) and left ventricular (LV) pacing has been shown to improve both hemodynamic and clinical performance. This study investigated the effects of CRT on LV Doppler indices in these patients. METHODS AND RESULTS: Thirty-two patients with advanced heart failure (New York Heart Association class > or =III, QRS >120 milliseconds, PR interval >150 milliseconds) were studied 4 weeks after implantation of a CRT system. Doppler echocardiography was conducted in 3 separate CRT modes, right ventricular, LV, and BV stimulation at 3 different atrioventricular delays. CRT resulted in significant improvement of Doppler parameters such as filling time (FT, 313 +/- 111 milliseconds at baseline --> 363 +/- 154 milliseconds [BV], P <.05), aortic velocity time integral (AO(VTI) 23.2 +/- 7.4 cm at baseline --> 26.8 +/- 8.8 cm [LV], P <.05), and the myocardial performance index (MPI, 1.21 +/- 0.51 at baseline --> 0.85 +/- 0.34 [BV], P <.05). The most improvement was observed with LV and BV stimulation at short and intermediate atrioventricular delays (80-120 milliseconds), independent of ischemic or idiopathic origin. CONCLUSIONS: CRT improves hemodynamic performance in patients with heart failure with intraventricular conduction delays. Doppler echocardiography allows noninvasive evaluation of acute CRT effects in patients with heart failure. In particular, FT, AO(VTI), and MPI are useful parameters for noninvasive follow-up and optimization of pacing parameters.