Bridging the gap in the symptomatic heart failure patient journey: insights from the Italian scenario.

BACKGROUND: The prognosis for heart failure (HF) patients remains poor, with a high mortality rate, and a marked reduction in quality of life (QOL) and functional status. This study aims to explore the ongoing needs of HF management and the epidemiology of patients followed by Italian HF clinics, with a specific focus on cardiac contractility modulation (CCM). RESEARCH DESIGN AND METHODS: Data from patients admitted to 14 HF outpatients clinics over 4 weeks were collected and compared to the results of a survey open to physicians involved in HF management operating in Italian centers. RESULTS: One hundred and five physicians took part in the survey. Despite 94% of patients receive a regular follow-up every 3-6 months, available therapies are considered insufficient in 30% of cases. Physicians reported a lack of treatment options for 23% of symptomatic patients with reduced ejection fraction (EF) and for 66% of those without reduced EF. Approximately 3% of HF population (two patients per month per HF clinic) meets the criteria for immediate CCM treatment, which is considered a useful option by 15% of survey respondents. CONCLUSIONS: Despite this relatively small percentage, considering total HF population, CCM could potentially benefit numerous HF patients, particularly the elderly, by reducing hospitalizations, improving functional capacity and QOL.

Predictors of Zero X-Ray Ablation for Supraventricular Tachycardias in a Nationwide Multicenter Experience.

BACKGROUND: This multicenter, prospective study evaluated the determinants of zero-fluoroscopy (ZFL) ablation of supraventricular tachycardias. METHODS AND RESULTS: Four hundred thirty patients (215 male, 55.4±22.1 years) with indication to electrophysiological study or ablation of supraventricular tachycardias were enrolled. All participating physicians agreed to follow the as low as reasonably achievable policy. A procedure was defined as ZFL when no fluoroscopy was used. The total fluoroscopy time inversely correlated to the number of procedures previously performed by each operator since study start (r=-0.112; P=0.02). Two hundred eighty-nine procedures (67.2%) were ZFL; multivariable analysis identified as predictors of ZFL: procedure after the 30th for each operator, compared with procedures up to the ninth (P=0.011; hazard ratio, 3.49; 95% confidence interval [CI], 1.79-6.80); the type of arrhythmia (P=0.031; electrophysiological study and atrioventricular nodal reentry tachycardia ablation having the highest probability of ZFL; hazard ratio, 6.87; 95% CI, 2.08-22.7 and hazard ratio, 2.02; 95% CI, 1.04-3.91, respectively); the operator's (P=0.002) and patient's age (P=0.009). Among operators, achievement of ZFL varied from 0% to 100%; 8 (22.8%) operators achieved ZFL in <25% of their procedures; 17 (48.6%) operators achieved ZFL in >75% of their procedures. The probability of ZFL increased by 2.8% (hazard ratio, 0.98; 95% CI, 0.97-0.99) as patient's age decreased by 1 year. Acute procedural success was obtained in all cases. CONCLUSIONS: The use of 3-dimensional mapping system completely avoided the use of fluoroscopy in most cases, with very low fluoroscopy time in the remaining and high safety and effectiveness profiles. Achievement of ZFL was predicted by the type of arrhythmia, operator's experience, and patient's age.

Accelerometer-based atrioventricular synchronous pacing with a ventricular leadless pacemaker: Results from the Micra atrioventricular feasibility studies.

BACKGROUND: Micra is a leadless pacemaker that is implanted in the right ventricle and provides rate response via a 3-axis accelerometer (ACC). Custom software was developed to detect atrial contraction using the ACC enabling atrioventricular (AV) synchronous pacing. OBJECTIVE: The purpose of this study was to sense atrial contractions from the Micra ACC signal and provide AV synchronous pacing. METHODS: The Micra Accelerometer Sensor Sub-Study (MASS) and MASS2 early feasibility studies showed intracardiac accelerations related to atrial contraction can be measured via ACC in the Micra leadless pacemaker. The Micra Atrial TRacking Using A Ventricular AccELerometer (MARVEL) study was a prospective multicenter study designed to characterize the closed-loop performance of an AV synchronous algorithm downloaded into previously implanted Micra devices. Atrioventricular synchrony (AVS) was measured during 30 minutes of rest and during VVI pacing. AVS was defined as a P wave visible on surface ECG followed by a ventricular event <300 ms. RESULTS: A total of 64 patients completed the MARVEL study procedure at 12 centers in 9 countries. Patients were implanted with a Micra for a median of 6.0 months (range 0-41.4). High-degree AV block was present in 33 patients, whereas 31 had predominantly intrinsic conduction during the study. Average AVS during AV algorithm pacing was 87.0% (95% confidence interval 81.8%-90.9%), 80.0% in high-degree block patients and 94.4% in patients with intrinsic conduction. AVS was significantly greater (P <.001) during AV algorithm pacing compared to VVI in high-degree block patients, whereas AVS was maintained in patients with intrinsic conduction. CONCLUSION: Accelerometer-based atrial sensing is feasible and significantly improves AVS in patients with AV block and a single-chamber leadless pacemaker implanted in the right ventricle.

Use of fluoroscopy in clinical electrophysiology in Europe: results of the European Heart Rhythm Association Survey.

Despite the advent of non-fluoroscopic technologies, fluoroscopy remains the cornerstone of imaging in most interventional electrophysiological procedures, from diagnostic studies to ablation interventions and device implantation. The purpose of the European Heart Rhythm Association survey was to provide an insight into regulatory policies and physicians' clinical practice when using fluoroscopy during ablation procedures and device implantation. The survey has shown that only 50% of the participating centres worked with low frame rates (3-6 frames per second) and that the left anterior oblique projection, with higher radiation exposure for the physician, is used for nearly every ablation target. Although three-dimensional imaging systems may reduce the radiation exposure, most centres never used these systems for standard ablation procedures and a trend is that non-fluoroscopy technologies are even less frequently used than in 2012, when the use of robotic systems was still rare. Even less costly equipment such as lead gloves, lead glass cabins, or radiation absorbing pads are still not routinely used.

Management of malfunctioning and recalled pacemaker and defibrillator leads: results of the European Heart Rhythm Association survey.

The aim of this survey was to describe the different strategies regarding the management of malfunctioning and recalled pacemaker and defibrillator leads across Europe. A questionnaire has been designed to assess the current practice and physician's approach to the management of leads which are faulty, unnecessary, and/or recalled. Responses to the questionnaire were received from 34 hospitals-members of the European Heart Rhythm Association (EHRA) electrophysiology (EP) research network. The survey involved both very high and low volume implanting centres, with 85% of the responding centres performing lead extraction. The survey provides a panoramic view of operator's decision making in the field of malfunctioning, recalled, and redundant leads and outlines a common point of view on lead abandonment and factors influencing the decision about lead extraction. The main factors strongly influencing the decision making were patient's age (59%), the presence of the damaged leads (44%), and the lead dwelling time (44%). Regarding the lead abandonment, the main concern (61%) was the potential greater difficulty associated with lead extraction in the future. High volume extracting centres showed a greater propensity to removing the malfunctioning or recalled leads compared with low volume or non-extracting centres. This EP Wire survey gives a snapshot of the operators' approaches and options regarding redundant, malfunctioning, and recalled lead management and may form the basis for future prospective research on this topic.

Current implantable cardioverter-defibrillator programming in Europe: the results of the European Heart Rhythm Association survey.

The purpose of this European Heart Rhythm Association (EHRA) survey was to examine the current practice on the choice of implantable cardioverter-defibrillator (ICD) type, use of defibrillation testing, and ICD programming for detection and therapy of ventricular arrhythmias. In accordance with recent guidelines and the results of observational studies, the majority of EHRA research network centres reported a high utilization rate of dual-chamber ICDs in the presence of symptomatic and asymptomatic sinus node dysfunction, biventricular ICD in high-degree atrioventricular block and QRS duration <120 ms, and a limited use of defibrillation testing either in primary and secondary prevention settings. Activation of the long ventricular tachycardia (VT) detection window, slow VT zone, antitachycardia pacing before shock for slow and fast VT, and atrial tachyarrhythmia discrimination were considered useful in ICD programming for the majority of patients.

Multicenter experience with extraction of the Riata/Riata ST ICD lead.

BACKGROUND: In November 2011, the Food and Drug Administration issued a class I recall of Riata and Riata ST implantable cardioverter-defibrillator leads. Management recommendations regarding the recall have remained controversial. OBJECTIVE: Data regarding the safety and feasibility of extraction of Riata implantable cardioverter-defibrillator leads are limited. METHODS: We performed a retrospective study of patients undergoing extraction of Riata/Riata ST leads at 11 centers. RESULTS: Between July 2003 and April 2013, 577 Riata/Riata ST leads were extracted from 577 patients (Riata 467, [84%]; Riata ST 89, [16%]). Complete procedural success achieved in 99.1%. The cohort was 78% men, with a mean age of 60 years and a mean left ventricular ejection fraction of 34% ± 14%. The mean implant duration was 44.7 months (range 0-124.6 months). The majority of leads extracted were for infection (305 [53.0%]) and 220 (35.7%) for lead malfunction. Evaluation for lead integrity was performed in 295 cases. Of these, 34.9% were found to have externalized cables. Implant duration was significantly longer in leads with externalized cables (P < .0001). No difference in lead integrity was noted between Riata and Riata ST leads (11.7% vs. 17.7% failure; P = .23). Among leads in which cable externalization was noted, laser sheaths were used more frequently (P = .01). Major complications included 3 superior vena cava/right ventricular perforations requiring surgical intervention with 1 death 12 days after the procedure and 1 pericardial effusion requiring percutaneous drainage (0.87%). CONCLUSION: Extraction of the Riata/Riata ST leads can be challenging, and leads with externalized cables may require specific extraction techniques. Extraction of the Riata/Riata ST leads can be performed safely by experienced operators at high-volume centers with a complication rate comparable to published data.