Cardiac Contractility Modulation Therapy in Patients with Amyloid Cardiomyopathy and Heart Failure, Case Report, Review of the Biophysics of CCM Function, and AMY-CCM Registry Presentation.

Cardiac amyloidosis may result in an aggressive form of heart failure (HF). Cardiac contractility modulation (CCM) has been shown to be a concrete therapeutic option in patients with symptomatic HF, but there is no evidence of its application in patients with cardiac amyloidosis. We present the case of TTR amyloidosis, where CCM therapy proved to be effective. The patient had a history of multiple HF hospitalizations due to an established diagnosis of wild type TTR-Amyloidosis with significant cardiac involvement. Since he was highly symptomatic, except during continuous dobutamine and diuretic infusion, it was opted to pursue CCM therapy device implantation. At follow up, a significant improvement in clinical status was reported with an increase of EF, functional status (6 min walk test improved from zero meters at baseline, to 270 m at 1 month and to 460 m at 12 months), and a reduction in pulmonary pressures. One year after device implantation, no other HF hospital admission was needed. CCM therapy may be effective in this difficult clinical setting. The AMY-CCM Registry, which has just begun, will evaluate the efficacy of CCM in patients with HF and diagnosed TTR amyloidosis to bring new evidence on its potential impact as a therapeutic option.

Prospective Study of Tricuspid Regurgitation Associated With Permanent Leads After Cardiac Rhythm Device Implantation.

BACKGROUND: Tricuspid regurgitation (TR) has been associated with cardiac rhythm device (CRD) implantation with intracardiac lead insertion. However, data on the incidence of postdevice TR are limited and largely from retrospective studies. We hypothesized that permanent lead implantation would be associated with an increase in TR. METHODS: We prospectively included consecutive patients with a clinical indication for CRD. Patients underwent transthoracic echocardiography 1 month before and 1 year after CRD implantation. RESULTS: A total of 328 patients were prospectively enrolled (69 ± 15 years, 38% female). Echocardiograms before and 1 year after CRD were available in 290 patients (15 died, 23 lost to follow-up). Compared with baseline, there was a significant change in TR grade 1 year after CRD insertion (no/trivial TR: 66% vs 29%; mild TR: 29% vs 61%; moderate TR: 3% vs 8%; severe TR 2% vs 2%; P < 0.001 for an increase in TR by at least 1 grade). Compared with baseline, there was a higher prevalence of moderate or severe TR in the 247 patients with CRD without cardiac resynchronization therapy (4% vs 10%, P = 0.004), but no progression in the 43 patients who received cardiac resynchronization therapy (14% vs 11%, P = 1). Multivariable analysis in the patients with less than moderate TR at baseline (n = 274) showed that only a history of atrial fibrillation was independently associated with progression to moderate or severe TR after correction for baseline TR grade (P = 0.013). CONCLUSIONS: One year after endocardial lead insertion, there was a 5% increase in the prevalence of moderate or severe TR, which may be clinically relevant.

Ranolazine for rhythm control in atrial fibrillation: A systematic review and meta-analysis.

BACKGROUND/OBJECTIVES: Available pharmacological options for rhythm control strategy in atrial fibrillation (AF) are limited by sub-optimal efficacy and potentially serious adverse events. The aim of the present meta-analysis is to determine the efficacy and safety of ranolazine for AF management. METHODS: The present meta-analysis was conducted according to current recommendations (CRD42016039000). Two large medical databases (MEDLINE and Scopus) were systematically searched and from that eight randomized clinical trials and two non-randomized observational studies were identified. The primary endpoint was to determine the efficacy of ranolazine to prevent AF episodes. Secondary efficacy endpoints were: efficacy in converting AF to sinus rhythm, time to conversion, and reduction in AF burden. Safety endpoints included death, serious adverse events, and QTc prolongation. RESULTS: Ranolazine was found to be effective in reducing the risk of AF when compared to control (OR 0.47; 95% CI 0.29-0.76; p=0.003). Subgroup analysis showed a larger effect size in post-operative AF (OR 0.29; 95% CI 0.11-0.77; p=0.03) when compared to no post-operative AF (OR 0.70; 95% CI 0.54-0.83; p=0.005). Ranolazine increased the chances of successful cardioversion when added to amiodarone over amiodarone alone (OR 3.11; 95% CI 1.42-6.79; p=0.004) while significantly reducing time to conversion (SMD -2.83h; 95% CI -4.69--0.97h; p<0.001). Overall risks of death, adverse events, and QTc prolongation were comparable between ranolazine and control group. CONCLUSIONS: Ranolazine is an effective option when used for rhythm control strategy in AF. The use of ranolazine seems to be safe and associated with few adverse events.

Prospective study of tricuspid valve regurgitation associated with permanent leads in patients undergoing cardiac rhythm device implantation: Background, rationale, and design.

Given the increasing numbers of cardiac device implantations worldwide, it is important to determine whether permanent endocardial leads across the tricuspid valve can promote tricuspid regurgitation (TR). Virtually all current data is retrospective, and indicates a signal of TR being increased after permanent lead implantation. However, the precise incidence of moderate or greater TR post-procedure, the exact mechanisms (mechanical, traumatic, functional), and the hemodynamic burden and clinical effects of this putative increase in TR, remain uncertain. We have therefore designed a multicenter, international, prospective study of 300 consecutive patients (recruitment completed, baseline data presented) who will undergo echocardiography and clinical assessment prior to, and at 1-year post device insertion. This prospective study will help determine whether cardiac device-associated TR is real, what are its potential mechanisms, and whether it has an important clinical impact on cardiac device patients.

Feasibility of a cardiologist-only approach to sedation for electrical cardioversion of atrial fibrillation: a randomized, open-blinded, prospective study.

BACKGROUND/OBJECTIVES: Sedation with propofol should be administered by personnel trained in advanced airway management. To overcome this limitation, the use of short acting benzodiazepines by cardiologists spread widely, causing concerns about the safety of this procedure in the absence of anesthesiology assistance. The aim of the study was to compare feasibility of a cardiologist-only approach with an anesthesiologist-assisted sedation protocol during elective direct-current cardioversion (DCC) of persistent atrial fibrillation (AF). METHODS: This prospective, open-blinded, randomized study included 204 patients, which were admitted for scheduled cardioversion of persistent AF, and randomized in a 1:1 fashion to either propofol or midazolam treatment arm. Patients in the propofol group underwent DCC with anesthesiologist assistance, while patients in the midazolam group saw the cardiologist as the only responsible for both sedation and DCC. RESULTS: Twenty-three adverse events occurred: 13 in the propofol group and 10 in the midazolam group (p=NS). Most of them were related to bradyarrhythmias and respiratory depressions. There was no need of intubation or other advanced resuscitation techniques in any of these patients. No differences were found regarding procedure tolerability and safety endpoints between the two groups. DCC procedures with anesthesiology support were burdened by higher delay from scheduled time and higher costs. CONCLUSIONS: Sedation with midazolam administered by cardiologist-only appears to be as safe as sedation with propofol and anesthesiologist assistance. Adverse events were few in both groups and easily handled by the cardiologist alone. A cardiologist-only approach to sedation provides less procedural delay, thus being easier to schedule and correlated with fewer costs.

Prevention of infections in cardiovascular implantable electronic devices beyond the antibiotic agent.

The increase in incidence/prevalence of infections of implantable pacemakers and defibrillators (implantable cardioverter defibrillator, ICD) is outweighing that of the implanting procedures, mainly favored by the changes in patient profile. Despite the high impact on patient's outcome and related costs for healthcare systems, we lack specific evidence on the preventive measures with the exception of antibiotic prophylaxis. The aim of this study is to focus on common approaches to pacemaker/ICD implantation to identify the practical preventive strategies and choices that can (potentially) impact on the occurrence of this feared complication. After a brief introduction on clinical presentation, pathogenesis, and risk factors, we will present the results from a survey on the preventive strategies adopted by different operators from the 25 centers of the Emilia Romagna region in the northern Italy (4.4 million inhabitants). These data will provide the basis for reviewing available literature on this topic and identifying the gray areas. The last part of the article will cover the available evidence about pacemaker/ICD implantation, focusing on prophylaxis of pacemaker/ICD infection as a 'continuum' starting before the surgical procedure (from indications to patient preparation), which follows during (operator, room, and techniques) and after the procedure (patient and device follow-up). We will conclude by evaluating the relationship between adherence to the available evidence and the volume of procedures of the implanting centers or operators' experience according to the results of our survey.