Mario Luzi

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.

Atrial tachyarrhythmias in primary and secondary prevention ICD recipients : Clinical and prognostic data

Background: Atrial fibrillation (AF) is the most common sustained arrhythmia encountered in clinical practice. The natural history of this disturbance and its effect on survival is still not known in patients with implantable cardioverter defibrillators (ICDs).

Pulmonary vein isolation cryoablation for patients with persistent and long-standing persistent atrial fibrillation: Clinical outcomes from the real-world multicenter observational project

BACKGROUND Pulmonary vein isolation (PVI) is a cornerstone ablation strategy in the management of patients with atrial fibrillation (AF). Consensus guidelines and statements recommend PVI during the index catheter ablation procedure in patients with paroxysmal and persistent AF. OBJECTIVE The objective of this analysis was to evaluate patients with persistent and long-standing persistent AF who were treated with the cryoballoon ablation catheter by PVI technique. METHODS Consecutive patients with drug-refractory symptomatic persistent and long-standing persistent AF who underwent cryoballoon catheter ablation by a PVI-only procedure were prospectively included in this single-arm multicenter evaluation. Data on procedural characteristics, safety, and long-term freedom from AF recurrence were analyzed. RESULTS Four hundred eighty-six subjects (mean age 60.8 ± 9.3 years; 389 (80%) men; 434 (89.3%) with persistent AF; 52 (10.7%) with long-standing persistent AF; left atrial diameter 44.6 ± 6.2 mm) underwent cryoballoon ablation in 35 Italian centers. The mean procedure time (skin-to-skin) was 109.9 ± 52.9 minutes, and the mean fluoroscopy time was 29.6 ± 14.5 minutes. Periprocedural complications were observed in 21 subjects (4.3%), and the acute PVI success rate was 97.6% across all patients. Using a 90-day blanking period, the single procedure Kaplan-Meier estimates of AF event-free survival were 63.9% at 12 months and 51.5% at 18 months. CONCLUSION In this multicenter evaluation of cryoballoon ablation, the PVI procedure was safe, effective, and efficient with regard to the treatment of patients with persistent and long-standing persistent AF. The reasonable mid-term success rates agree with current clinical studies that establish PVI as a cornerstone index ablation strategy.

Left Ventricular Reverse Remodeling Elicited by a Quadripolar Lead: Results from the Multicenter Per4mer Study.

To understand the impact of a quadripolar left ventricular (LV) lead on reverse remodeling and phrenic nerve stimulation (PNS) in congestive heart failure patients treated by cardiac resynchronization therapy at 8‐month follow‐up (FU).

The effects of gender on electrical therapies for the heart: procedural considerations, results and complications: A report from the XII Congress of the Italian Association on Arrhythmology and Cardiostimulation (AIAC)

Use of cardiac implantable devices and catheter ablation is steadily increasing in Western countries following the positive results of clinical trials. Despite the advances in scientific knowledge, tools development, and techniques improvement we still have some grey area in the field of electrical therapies for the heart. In particular, several reports highlighted differences both in medical behaviour and procedural outcomes between female and male candidates. Women are referred later for catheter ablation of supraventricular arrhythmias, especially atrial fibrillation, leading to suboptimal results. On the opposite females present greater response to cardiac resynchronization, while the benefit of implantable defibrillator in primary prevention seems to be less pronounced. Differences on aetiology, clinical profile, and development of myocardial scarring are the more plausible causes. This review will discuss all these aspects together with gender-related differences in terms of acute/late complications. We will also provide useful hints on plausible mechanisms and practical procedural aspects.

Economic impact of remote monitoring after implantable defibrillators implantation in heart failure patients: an analysis from the EFFECT study

Aims Heart failure (HF) patients with implantable cardioverter-defibrillators (ICD) require admissions for disease management and out-patient visits for disease management and assessment of device performance. These admissions place a significant burden on the National Health Service. Remote monitoring (RM) is an effective alternative to frequent hospital visits. The EFFECT study was a multicentre observational investigation aiming to evaluate the clinical effectiveness of RM compared with in-office visits standard management (SM). The present analysis is an economic evaluation of the results of the EFFECT trial. Methods and results The present analysis considered the direct consumption of healthcare resources over 12-month follow-up. Standard tariffs were applied to hospitalizations, in-office visits and remote device interrogations. Economic comparisons were also carried out by means of propensity score (PS) analysis to take into account the lack of randomization in the study design. The analysis involved 858 patients with ICD or CRT-D. Of these, 401 (47%) were followed up via an SM approach, while 457 (53%) were assigned to RM. The rate of hospitalizations was 0.27/year in the SM group and 0.16/year in the RM group (risk reduction =0.59; P = 0.0004). In the non-adjusted analysis, the annual cost for each patient was €817 in the SM group and €604 in the RM group (P = 0.014). Propensity score analysis, in which 292 RM patients were matched with 292 SM patients, confirmed the results of the non-adjusted analysis (€872 in the SM group vs. €757 in the RM group; P < 0.0001). Conclusion There is a reduction in direct healthcare costs of RM for HF patients with ICDs, particularly CRT-D, compared with standard monitoring. Clinical Trial Registration http://clinicaltrials.gov/Identifier, NCT01723865.

Remote Monitoring for Implantable Defibrillators: A Nationwide Survey in Italy

Background Remote monitoring (RM) permits home interrogation of implantable cardioverter defibrillator (ICD) and provides an alternative option to frequent in-person visits. Objective The Italia-RM survey aimed to investigate the current practice of ICD follow-up in Italy and to evaluate the adoption and routine use of RM. Methods An ad hoc questionnaire on RM adoption and resource use during in-clinic and remote follow-up sessions was completed in 206 Italian implanting centers. Results The frequency of routine in-clinic ICD visits was 2 per year in 158/206 (76.7%) centers, 3 per year in 37/206 (18.0%) centers, and 4 per year in 10/206 (4.9%) centers. Follow-up examinations were performed by a cardiologist in 203/206 (98.5%) centers, and by more than one health care worker in 184/206 (89.3%) centers. There were 137/206 (66.5%) responding centers that had already adopted an RM system, the proportion of ICD patients remotely monitored being 15% for single- and dual-chamber ICD and 20% for cardiac resynchronization therapy ICD. Remote ICD interrogations were scheduled every 3 months, and were performed by a cardiologist in 124/137 (90.5%) centers. After the adoption of RM, the mean time between in-clinic visits increased from 5 (SD 1) to 8 (SD 3) months (P<.001). Conclusions In current clinical practice, in-clinic ICD follow-up visits consume a large amount of health care resources. The results of this survey show that RM has only partially been adopted in Italy and, although many centers have begun to implement RM in their clinical practice, the majority of their patients continue to be routinely followed-up by means of in-clinic visits.

The effects of gender on electrical therapies for the heart: Procedural considerations, results and complications

Use of cardiac implantable devices and catheter ablation is steadily increasing in Western countries following the positive results of clinical trials. Despite the advances in scientific knowledge, tools development, and techniques improvement we still have some grey area in the field of electrical therapies for the heart. In particular, several reports highlighted differences both in medical behaviour and procedural outcomes between female and male candidates. Women are referred later for catheter ablation of supraventricular arrhythmias, especially atrial fibrillation, leading to suboptimal results. On the opposite females present greater response to cardiac resynchronization, while the benefit of implantable defibrillator in primary prevention seems to be less pronounced. Differences on aetiology, clinical profile, and development of myocardial scarring are the more plausible causes. This review will discuss all these aspects together with gender-related differences in terms of acute/late complications. We will also provide useful hints on plausible mechanisms and practical procedural aspects.

Entirely Subcutaneous Implantable Defibrillator Safest Option in a Young Girl With Ventricular Tachycardia and Ebstein Anomaly

A 16-year-old female patient with Ebstein anomaly was admitted to the hospital for 2 episodes of hemodynamically unstable ventricular tachycardia (VT; Figure 1). Two months earlier, she had undergone surgical tricuspid valve replacement with a biological prosthetic valve and cavopulmonary anastomosis (Figure 2). Both VT episodes were treated with external direct current cardioversion, and the patient was then referred to our center to attempt VT ablation. Unfortunately, the fact that the right ventricle (RV) was papyraceous and the free ventricular wall was thin would have exposed the patient to a high risk of catheter perforation. Because transvenous implantable cardioverter-defibrillator (ICD) implantation had the same risk of cardiac perforation, and access to the right cardiac chambers had been made unfeasible by cavopulmonary anastomosis, subcutaneous (S)-ICD implantation was considered. In assessing the patient’s adequacy for …

Unexpected challenging case of coronary sinus lead extraction

An 84-year-old woman implanted with cardiac resynchronization therapy defibrillator underwent transvenous lead extraction 4 mo after the implant due to pocket infection. Atrial and right ventricular leads were easily extracted, while the attempt to remove the coronary sinus (CS) lead was unsuccessful. A few weeks later a new extraction procedure was performed in our center. A stepwise approach was used. Firstly, manual traction was unsuccessfully attempted, even with proper-sized locking stylet. Secondly, mechanical dilatation was used with a single inner sheath placed close to the CS ostium. Finally, a modified sub-selector sheath was successfully advanced over the electrode until it was free of the binding tissue. The post-extraction lead examination showed an unexpected fibrosis around the tip. No complications occurred during the postoperative course. Fibrous adhesions could be found in CS leads recently implanted requiring non-standard techniques for its transvenous extraction.