Biventricular versus left ventricular only stimulation: an echocardiographic substudy of the B-LEFT HF trial.

BACKGROUND: The noninferiority of left ventricular pacing alone (LVp) compared with biventricular pacing (BIV) has not been yet definitely documented. In this study, we reviewed all the original echocardiographic measures of the Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial in order to investigate mechanisms underlying LV remodelling with both pacing modalities. METHODS: Patients with New York Heart Association functional class (NYHA) III or IV despite optimal medical therapy, LVEF 35% or less, left ventricular end-diastolic diameter (LVEDD) more than 55 mm, QRS duration at least 130 ms were randomized to BIV or LVp for 6 months. The primary end point was a composite of at least 1 point decrease in NYHA class and at least 5 mm decrease in left ventricular end-systolic diameter (LVESD). An additional end point was a LVp reverse remodelling defined as at least 10% decrease in LVESD. Mitral regurgitation and all echocardiographic measures were reassessed after 6-month follow-up. RESULTS: One hundred and forty-three patients were enrolled. Seventy-six patients were in the BIV and 67 were in the LVp group. Left ventricular volumes decreased significantly without difference between groups (P = 0.8447). Similarly, left ventricular diameters decreased significantly in both groups with a significant decrease in LVESD with BIV (P < 0.0001), but not with LVp (P = 0.1383). LVEF improved in both groups without difference (P = 0.8072). Mitral regurgitation did not improve either with BIV, or with LVp. CONCLUSION: The echocardiographic sub-analysis of B-LEFT study showed the substantial equivalence of LVp in favouring left ventricular reverse remodelling as compared with BIV.

Extraction of a fractured pacemaker lead in the left bundle branch area using a snare via a femoral approach.

We present the first reported case of extraction of a ventricular lead placed in the left bundle branch area with a double-loop design snare via the femoral approach without any complication. It was a 4-month-old lead whose extraction was not possible only with a conventional stylet via an implant vein approach, so we want to show that complete procedural success is possible.

Safety and efficacy of dronedarone from clinical trials to real-world evidence: implications for its use in atrial fibrillation.

Efficacy and safety of dronedarone was shown in the ATHENA trial for paroxysmal or persistent atrial fibrillation (AF) patients. Further trials revealed safety concerns in patients with heart failure and permanent AF. This review summarizes insights from recent real-world studies and meta-analyses, including reports on efficacy, with focus on liver safety, mortality risk in patients with paroxysmal/persistent AF, and interactions of dronedarone with direct oral anticoagulants. Reports of rapidly progressing liver failure in dronedarone-prescribed patients in 2011 led to regulatory cautions about potential liver toxicity. Recent real-world evidence suggests dronedarone liver safety profile is similar to other antiarrhythmics and liver toxicity could be equally common with many Class III antiarrhythmics. Dronedarone safety concerns (increased mortality in patients with permanent AF) were raised based on randomized controlled trials (RCT) (ANDROMEDA and PALLAS), but comedication with digoxin may have increased the mortality rates in PALLAS, considering the dronedarone-digoxin pharmacokinetic (PK) interaction. Real-world data on apixaban-dronedarone interactions and edoxaban RCT observations suggest no significant safety risks for these drug combinations. Median trough plasma concentrations of dabigatran 110 mg during concomitant use with dronedarone are at acceptable levels, while PK data on the rivaroxaban-dronedarone interaction are unavailable. In RCTs and real-world studies, dronedarone significantly reduces AF burden and cardiovascular hospitalizations, and demonstrates a low risk for proarrhythmia in patients with paroxysmal or persistent AF. The concerns on liver safety must be balanced against the significant reduction in hospitalizations in patients with non-permanent AF and low risk for proarrhythmias following dronedarone treatment.

Implantable cardioverter-defibrillator in hypertrophic cardiomyopathy.

Sudden cardiac death (SCD) is the most devastating complication in hypertrophic cardiomyopathy (HCM). The implantable cardioverter-defibrillator (ICD) has proven to be effective in SCD prevention in several clinical scenarios. In HCM population, it has demonstrated to successfully abort life-threatening ventricular arrhythmias despite the extreme morphology characteristic of HCM, often with massive degrees of left ventricular hypertrophy and/or LV outflow tract obstruction. Studies showed a high rate of appropriate intervention in secondary prevention and in primary prevention of patients considered at high risk. This appropriate intervention rate is even more significant considering the young and otherwise healthy patients that compose HCM population. Since SCD incidence in HCM is relatively low, optimal identification of patients at high risk is crucial. Classical strategy of risk stratification based on clinical risk factors has several limitations and has proven to overestimate risk. A new risk prediction model that provides individual 5-year estimated risk appears to be superior to traditional models based on bivariate risk factors. Perioperative complications seem to be similar to those related to the implant of other cardiac devices, while long-term complications have been traditionally in the spotlight. HCM patients are considered more vulnerable to ICD-related complications and inappropriate ICD therapy because of their young age at implant and increased prevalence of atrial fibrillation, but long-term follow-up data on ICD-related complications in general practice is limited. The subcutaneous implantable cardioverter defibrillator seems to be a safe and effective alternative in HCM, although long-term data are scarce.

Treatment of atrial fibrillation in patients with enhanced sympathetic tone by pulmonary vein isolation or pulmonary vein isolation and renal artery denervation: clinical background and study design : The ASAF trial: ablation of sympathetic atrial fibrillation.

BACKGROUND: Hypertension is an important, modifiable risk factor for the development of atrial fibrillation (AF). Even after pulmonary vein isolation (PVI), 20-40% experience recurrent AF. Animal studies have shown that renal denervation (RDN) reduces AF inducibility. One clinical study with important limitations suggested that RDN additional to PVI could reduce recurrent AF. OBJECTIVE: The goal of this multicenter randomized controlled study is to investigate whether RDN added to PVI reduces AF recurrence. METHODS: The main end point is the time until first AF recurrence according to EHRA guidelines after a blanking period of 3 months. Assuming a 12-month accrual period and 12 months of follow-up, a power of 0.80, a two-sided alpha of 0.05 and an expected drop-out of 10% per group, 69 patients per group are required. We plan to randomize a total of 138 hypertensive patients with AF and signs of sympathetic overdrive in a 1:1 fashion. Patients should use at least two antihypertensive drugs. Sympathetic overdrive includes obesity, exercise-induced excessive blood pressure (BP) increase, significant white coat hypertension, hospital admission or fever induced AF, tachycardia induced AF and diabetes mellitus. The interventional group will undergo PVI + RDN and the control group will undergo PVI. RESULTS: Patients will have follow-up for 1 year, and continuous loop monitoring is advocated. CONCLUSION: This randomized, controlled study will elucidate if RDN on top of PVI reduces AF recurrence.

[The change of paradigm in stroke prevention in atrial fibrillation. Challenges and emerging opportunities for the family physician]. / El cambio de paradigma en la prevención de ictus en la fibrilación auricular. Retos y oportunidades emergentes para el médico de familia.

Atrial fibrillation (AF), is the most prevalent sustained arrhythmia in general population, affecting up to 10% in patients of advanced age. AF doubles overall mortality and increases up to 5-6 times the risk of stroke, which have the characteristic of being particularly harmful. The basis of treatment on AF are the rhythm or rate control and the prevention of thromboembolism. For the latter purpose the treatments that have been most effective are oral anticoagulants. For decades and until just a few years ago, the only oral drugs available for this purpose have been the anti-vitamin K, mainly represented in our country by acenocoumarol and lesser extent by warfarin. These drugs have been shown to reduce strokes and mortality compared to placebo and with antiplatelet drugs, so have been and continue to be the standard treatment and the comparator for all antithrombotic drugs in patients with AF. The variability in the therapeutic response, their food and drugs interactions and their narrow therapeutic window that entail the need to frequently monitoring, has led to look for new drugs that, at least maintaining their advantages, where able to avoid some of the drawbacks. Currently we have a number of new drugs that meet these premises, although they have the disadvantage of a higher direct cost. The arrival of these new oral anticoagulants (NOAC) make necessary to know them well, reach a consensus for a correct use and to make changes in the clinical management of these patients when they are used. In this article we review the indications and way of use of the different options (classics and news) of antithrombotic therapy in patients with AF, the situation of anticoagulated patients in our country, the characteristics of the NOAC, its recommendations for use and the challenges to that are subjected family physicians regarding these changes.

Cardiac resynchronization therapy in patients with permanent atrial fibrillation. Is it mandatory to ablate the atrioventricular junction to obtain a good response?

AIM: Current guidelines recommend atrioventricular junction (AVJ) ablation in patients with atrial fibrillation (AF) treated with cardiac resynchronization therapy (CRT). Our study compared the CRT response of patients in sinus rhythm (SR) vs. AF. METHODS AND RESULTS: In this observational, prospective, multicentre study, patients were grouped by intrinsic rhythm. For the first 2 months, the negative chronotropic drug was optimized in the AF group. If ventricular pacing was ≤85%, AVJ ablation was recommended. Responders were defined as patients who survived without requiring heart transplant and had a ≥ 10% reduction in left ventricular end-systolic volume (LVESV) at 12 months after implantation. Of 202 patients included, 156 (77%) were in SR and 46 (23%) had AF. After drug optimization, only 13/46 (28%) of the AF patients required AVJ ablation (AF + AVJ). The percentage of responders was 83/156 (53%) for SR vs. 22/46 (48%) AF (P = 0.4). Among AF patients the response was 16/33 (48%) for AF with non-AVJ ablation vs. 6/13 (46%) AF + AVJ, P = 0.56. The LVESV decreased in all three groups: -30 ± 39 mL, -24 ± 43 mL, and -22 ± 36 mL, respectively (P = 0.75). Mortality was higher in patients with AF compared with SR: 10/46 (21%) vs. 9/156 (5.7%), log rank 10.6, P <0.05. CONCLUSION: Although only 28% of the patients in AF had the AVJ ablated, there were no differences in the percentage of response and echo improvement between patients in SR and AF. However, mortality was higher in patients with AF compared with patients in SR.

A randomized double-blind comparison of biventricular versus left ventricular stimulation for cardiac resynchronization therapy: the Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial.

BACKGROUND: Biventricular (BiV) stimulation is the preferred means of delivering cardiac resynchronization therapy (CRT), although left ventricular (LV)-only stimulation might be as safe and effective. B-LEFT HF is a prospective, multicenter, randomized, double-blind study aimed to examine whether LV-only is noninferior to BiV pacing regarding clinical and echocardiographic responses. METHODS: B-LEFT HF randomly assigned 176 CRT-D recipients, in New York Heart Association class III or IV, with an LV ejection fraction < or =35% and QRS > or =130 milliseconds, to a BiV (n = 90) versus LV (n = 86) stimulation group. Clinical status and echocardiograms were analyzed at baseline and 6 months after CRT-D implant to test the noninferiority of LV-only compared with BiV stimulation. RESULTS: The proportion of responders was in line with current literature on CRT, with improvement in heart failure composite score in 76.2% and 74.7% of patients in BiV and LV groups, respectively. Comparing LV versus BiV pacing, the small differences in response rates and corresponding 95% CI indicated that LV pacing was noninferior to BiV pacing for a series of response criteria (combination of improvement in New York Heart Association and reverse remodeling, improvement in heart failure composite score, reduction in LV end-systolic volume of at least 10%), both at intention-to-treat and at per-protocol analysis. CONCLUSIONS: Left ventricular-only pacing is noninferior to BiV pacing in a 6-month follow-up with regard to clinical and echocardiographic responses. Left ventricular pacing may be considered as a clinical alternative option to BiV pacing.

SmartDelay determined AV optimization: a comparison of AV delay methods used in cardiac resynchronization therapy (SMART-AV): rationale and design.

BACKGROUND: The clinical benefit of cardiac resynchronization therapy (CRT) for patients with moderate-to-severely symptomatic heart failure, left ventricular systolic dysfunction, and ventricular conduction delay is established. However, some patients do not demonstrate clinical improvement following CRT. It is unclear whether systematic optimization of the programmed atrioventricular (AV) delay improves the rate of clinical response. METHODS: SMART-AV is a randomized, multicenter, double-blinded, three-armed trial that will investigate the effects of optimizing AV delay timing in heart failure patients receiving CRT + defibrillator (CRT-D) therapy. A minimum of 950 patients will be randomized in a 1:1:1 ratio using randomly permuted blocks within each center programmed to either DDD or DDDR with a lower rate of 60. The study will include echocardiographic measurements of volumes and function [e.g., left ventricular end-systolic volume (LVESV)], biochemical measurements of plasma biomarker profiles, and functional measurements (e.g., 6-minute hall walk) in CRT-D patients who are enrolled and randomized to fixed AV delay (i.e., 120 ms), AV delay determined by electrogram-based SmartDelay, or an AV delay determined by echocardiography (i.e., mitral inflow). Patients will be evaluated prior to initiation of CRT, 3 and 6 months post-implant. The primary endpoint is the relative change in LVESV at 6 months between the groups. Patient enrollment commenced in May 2008 and the study is registered at clinicaltrials.gov. CONCLUSION: SMART-AV is a randomized, clinical trial designed to evaluate three different methods of AV delay optimization to determine whether systematic AV optimization is beneficial for patients receiving CRT for 6 months post-implant.