Multicenter experience with the Evolution RL mechanical sheath for lead extraction using a stepwise approach: Safety, effectiveness, and outcome.

BACKGROUND: In addition to the Evolution RL sheath, tools by Cook Medical (Bloomington, IN, USA), supporting lead extraction (LE), are available. Data on their use are not reported in detail in previous studies. Moreover, data regarding outcome are lacking. The aim was to evaluate the safety and effectiveness of the Evolution sheath (Evolution RL and Evolution Shortie, Cook Medical) by using a stepwise approach with the available extraction tools and the outcome. METHODS: A total of 393 leads in 198 consecutive patients were removed with the Evolution RL sheath and ancillary tools using a stepwise approach. RESULTS: The main indication for LE was infection in 125 (63.1%) cases. The mean implant duration was 95.4 ± 59.7 months. According to our stepwise approach, the Evolution Shortie RL sheath was used in all cases and complete LE was achieved in 24 (12.2%) cases. The Evolution RL was used in 174 (87.8%) cases and the SteadySheath Evolution tissue stabilization sheath (Cook Medical) in 87 (44%) because of tenacious fibrosis anchored targeted leads. Compression coil (OneTie, Cook Medical) was used in 141 (71%) cases. Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 97%, 99%, and 99.5%, respectively. One major complication (0.5%) and 10 (5%) minor complications were encountered. During a mean time follow-up of 12 ± 9 months, 14 (7%) patients died. Predictors of mortality included impaired renal function (HR 5.7; 95% CI 1.9-17.6; P = 0.002), extraction because of infection (hazard ratio [HR] 4.0; 95% confidence interval [CI] 1-18.1; P = 0.045), and diabetes (HR 3.2; 95% CI 1.1-9.8; P = 0.036). CONCLUSIONS: Lead extraction using the Evolution RL bidirectional rotational mechanical sheath and ancillary tools in a systematic stepwise approach was effective and safe.

Remote magnetic with open-irrigated catheter vs. manual navigation for ablation of atrial fibrillation: a systematic review and meta-analysis.

The aim of this study was to determine the efficacy and safety of remote magnetic navigation (RMN) with open-irrigated catheter vs. manual catheter navigation (MCN) in performing atrial fibrillation (AF) ablation. We searched in PubMed (1948-2013) and EMBASE (1974-2013) studies comparing RMN with MCN. Outcomes considered were AF recurrence (primary outcome), pulmonary vein isolation (PVI), procedural complications, and data on procedure's performance. Odds ratios (OR) and mean difference (MD) were extracted and pooled using a random-effect model. Confidence in the estimates of the obtained effects (quality of evidence) was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. We identified seven controlled trials, six non-randomized and one randomized, including a total of 941 patients. Studies were at high risk of bias. No difference was observed between RMN and MCN on AF recurrence [OR 1.18, 95% confidence interval (CI) 0.85 to 1.65, P = 0.32] or PVI (OR 0.41, 95% CI 0.11-1.47, P = 0.17). Remote magnetic navigation was associated with less peri-procedural complications (Peto OR 0.41, 95% CI 0.19-0.88, P = 0.02). Mean fluoroscopy time was reduced in RMN group (-22.22 min; 95% CI -42.48 to -1.96, P = 0.03), although the overall duration of the procedure was longer (60.91 min; 95% CI 31.17 to 90.65, P < 0.0001). In conclusion, RMN is not superior to MCN in achieving freedom from recurrent AF at mid-term follow-up or PVI. The procedure implies less peri-procedural complications, requires a shorter fluoroscopy time but a longer total procedural time. For the low quality of the available evidence, a proper designed randomized controlled trial could turn the direction and the effect of the dimensions explored.

Does left atrial appendage closure with a cardiac plug system reduce the stroke risk in nonvalvular atrial fibrillation patients? A single-center case series.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and it is associated with an increased stroke risk, due mainly to cardiac embolism from the left atrial appendage (LAA). Percutaneous LAA closure is a method to reduce stroke risk in AF without using anticoagulant agents. In this study we report data from an Italian experience with the LAA occluder Amplatzer Cardiac Plug (ACP) device (Aga Medical Corporation, Plymouth, MN, USA). METHODS: The study was designed to evaluate the safety of LAA closure using ACP and the efficacy of the procedure in preventing strokes during a 1-year follow-up. Patients with permanent or paroxysmal AF, high stroke risk, and contraindication to warfarin therapy were selected for the procedure. RESULTS: The LAA closure was attempted in 37 patients and succeeded in 34 cases (91.9%). Four patients experienced serious complications (one cardiac tamponade requiring pericardiocentesis, two device embolizations, one low-rate response AF requiring artificial pacing). During a 1-year follow-up, ischemic stroke occurred in one of 34 patients, resulting in a stroke rate of 2.94%; thus there was a stroke rate reduction of 50.2% and 26.5% compared to the expected stroke rate, according to CHADS2 and CHA2 DS2 VASc score. None of the patients who received ACP experienced major bleeding during the follow-up. CONCLUSION: LAA closure using ACP is a relatively feasible procedure which can be performed by highly experienced operators to reduce stroke rate in patients with AF, high stroke risk, and contraindication to oral anticoagulants.

Rationale and design of the health economics evaluation registry for remote follow-up: TARIFF.

AIMS: The aims of the study are to develop a cost-minimization analysis from the hospital perspective and a cost-effectiveness analysis from the third payer standpoint, based on direct estimates of costs and QOL associated with remote follow-ups, using Merlin@home and Merlin.net, compared with standard ambulatory follow-ups, in the management of ICD and CRT-D recipients. METHODS AND RESULTS: Remote monitoring systems can replace ambulatory follow-ups, sparing human and economic resources, and increasing patient safety. TARIFF is a prospective, controlled, observational study aimed at measuring the direct and indirect costs and quality of life (QOL) of all participants by a 1-year economic evaluation. A detailed set of hospitalized and ambulatory healthcare costs and losses of productivity that could be directly influenced by the different means of follow-ups will be collected. The study consists of two phases, each including 100 patients, to measure the economic resources consumed during the first phase, associated with standard ambulatory follow-ups, vs. the second phase, associated with remote follow-ups. CONCLUSION: Remote monitoring systems enable caregivers to better ensure patient safety and the healthcare to limit costs. TARIFF will allow defining the economic value of remote ICD follow-ups for Italian hospitals, third payers, and patients. The TARIFF study, based on a cost-minimization analysis, directly comparing remote follow-up with standard ambulatory visits, will validate the cost effectiveness of the Merlin.net technology, and define a proper reimbursement schedule applicable for the Italian healthcare system. TRIAL REGISTRATION: NCT01075516.

Closed loop stimulation is effective in improving heart rate and blood pressure response to mental stress: report of a single-chamber pacemaker study in patients with chronotropic incompetent atrial fibrillation.

INTRODUCTION: Closed-loop stimulation (CLS) is a form of rate-adaptive pacing capable of providing an effective pacing rate profile not only during physical exercise but also during mental stress. To test its effectiveness, CLS and accelerometer sensor (AS) rate response were compared intraindividually during a mental stress test (MST). METHODS: Thirty-six patients (mean age 78.9 ± 6.4 years) implanted with a pacemaker with the CLS algorithm (Cylos, Biotronik, Berlin, Germany) underwent MSTs in different pacing configurations: nonrate-adaptive mode (VVI), AS mode (VVIR), and CLS mode, respectively. A modified Stroop test was used in order to induce mental stress. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure, and pacing percentage burden were collected for 5 minutes before, during, and 5 minutes after the test. RESULTS: Mean peak-HR during MST was significantly higher in CLS configuration than in VVIR and VVI modes (92.8 ± 12.6 vs 78.9 ± 6.5 vs 77.8 ± 7.5; P ≤ 0.001). The average HR increase during MST was also higher in CLS configuration than in VVIR and VVI modes (22.7 ± 16.7 vs 8.2 ± 8.6 vs 6.6 ± 6.3; P ≤ 0.001). The percentage of pacing beats during MST was higher in CLS configuration than with the other two algorithms (48.4 ± 17.9 vs 27.4 ± 17.5 vs 25.8 ± 17.6; P ≤ 0.001). The average peak-SBP was significantly higher during MST in CLS mode than in VVIR and VVI configurations (172.6 ± 15.5 vs 156.7 ± 12.2 vs 145.5 ± 13.7; P ≤ 0.001). The mean SBP increase showed a similar behavior (51.8 ± 24.7 vs 18.4 ± 13.7 vs 16.4 ± 10.3; P ≤ 0.001). CONCLUSION: CLS algorithm in a single-chamber device is more effective than AS in detecting an hemodynamic demand due to an emotional stress and supplying a proper HR increase. These results are even more surprising compared to previous data in dual-chamber pacemakers, because they imply that CLS algorithm can provide an appropriate rate-modulation in patients with AF and chronotropic incompetence.

Determinants of worse prognosis in patients with cardiac resynchronization therapy defibrillators. Are ventricular arrhythmias an adjunctive risk factor?

AIMS: Cardiac resynchronization therapy (CRT) is indicated in patients with systolic heart failure (HF), severe left ventricle (LV) dysfunction and interventricular dyssynchrony.In prospective observational research, we aimed to evaluate whether CRT-induced LV reverse remodelling and occurrence of ventricular arrhythmias (VT/VF) independently contribute to prognosis in patients with CRT defibrillators (CRT-D). METHODS: In 95 Italian cardiological centres, after a screening period of 6 months, patients were categorized according to VT/VF occurrence and CRT response, defined as LV end-systolic volume relative reduction >15% or LV ejection fraction absolute increase >5%. The main endpoint was death or HF hospitalizations. RESULTS: Among 1308 CRT-D patients (80% male, mean age 66 years), at 6 months, follow-up 71% were identified as CRT responders and 12% experienced appropriate VT/VF detections. The main endpoint was significantly and independently associated with previous myocardial infarction, New York Heart Association Class, VT/VF occurrence and with CRT response. CRT nonresponder patients who suffered VT/VF in the screening period had a risk of death or HF hospitalizations [HR = 7.82, 95% confidence interval (CI) = 3.95-15.48] significantly (P < 0.001) higher than CRT responders without VT/VF occurrence. This risk is mitigated without VT/VF occurrence (HR = 3.47, 95% CI = 2.03-5.91, P < 0.001) or in case of CRT response (HR = 3.11, 95% CI = 1.44-6.72, P = 0.004). CONCLUSION: Our data show that both CRT response and occurrence of VT/VF independently contribute to the risk of death or HF-related hospitalizations in CRT-D patients. Early VT/VF occurrence may be identified as a marker of disease severity than can be mitigated by CRT response both in terms of all-cause mortality and long-term VT/VF onset. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00147290 and NCT00617175.

Safety and performance of a system specifically designed for selective site pacing.

INTRODUCTION: In the right ventricle, selective site pacing (SSP) has been shown to avoid detrimental hemodynamic effects induced by right ventricular apical pacing and, in the right atrium, to prevent the onset of atrial fibrillation and to slow down disease progression. The purpose of our multicenter observational study was to describe the use of a transvenous 4-French catheter-delivered lead for SSP in the clinical practice of a large number of centers. METHODS: We enrolled 574 patients in whom an implantable device was indicated. In all patients, SSP was achieved by using the Select Secure System™ (Medtronic Inc., Minneapolis, MN, USA). RESULTS: In 570 patients, the lead was successfully implanted. In 125 patients, atrial SSP was performed: in 75 (60%) the lead was placed in the interatrial septum, in 31 (25%) in the coronary sinus ostium, and in 19 (15%) in the Bachman bundle. Ventricular SSP was undertaken in 138 patients: in 105 (76%) the high septal right ventricular outflow tract (RVOT) position was paced, in seven (5%) the high free-wall RVOT, in 25 (18%) the low septal RVOT, and in one (1%) the low free-wall RVOT. In the remaining 307 patients, the His zone was paced: in 87 (28%) patients, direct His-bundle pacing and in 220 (72%) patients para-hisian pacing was achieved. Adequate pacing parameters and a lead-related complication rate of 2.6% were recorded during a follow-up of 20 ± 10 months. CONCLUSIONS: Our results demonstrated that many sites, in the right atrium, in the right ventricle, and in His-bundle region, can be paced using the Select Secure System™.

Electrical storm: Incidence, Prognosis and Therapy.

Implantable defibrillators are lifesavers and have improved mortality rates in patients at risk of sudden death, both in primary and secondary prevention. However, they are unable to modify the myocardial substrate, which remains susceptible to life-threatening ventricular arrhythmias. Electrical storm is a clinical entity characterized the recurrence of hemodynamically unstable ventricular tachycardia and/or ventricular fibrillation, twice or more in 24 hours, requiring electrical cardioversion or defibrillation. With the arrival of the implantable cardioverter-defibrillator, this definition was broadened, and electrical storm is now defined as the occurrence of three or more distinct episodes of ventricular tachycardia or ventricular fibrillation in 24 hours, requiring the intervention of the defibrillator (anti-tachycardia pacing or shock). Clinical presentation can be very dramatic, with multiple defibrillator shocks and hemodynamic instability. Managing its acute presentation is a challenge, and mortality is high both in the acute phase and in the long term. In large clinical trials involving patients implanted with a defibrillator both for primary and secondary prevention, electrical storm appears to be a harbinger of cardiac death, with notably high mortality soon after the event. In most cases, the storm can be interrupted by medical therapy, though transcatheter radiofrequency ablation of ventricular arrhythmias may be an effective treatment for refractory cases.This narrative literature review outlines the main clinical characteristics of electrical storm and emphasises critical points in approaching and managing this peculiar clinical entity. Finally focus is given to studies that consider transcatheter ablation therapy in cases refractory to medical treatment.

Extraction Of Transvenous ICD Leads In An Over-ninety Years Old Patient.

There is a general consensus that once a part of an implanted cardiac device becomes infected, it is usually impossible to cure the infection without completely removing all prosthetic material from the body. Consequently the Heart Rhythm Society (HRS) included the pocket infection or erosion as a class I indication for pacemaker lead exctraction. However, the procedure still carries a high risk of life-threatening complications due to fibrotic attachments between leads, veins, valves or other endocardial structures, notwithstanding specific tools and techniques that have been developed to assist the lead removal, preventing tissue laceration.

Outcomes on safety and efficacy of left atrial appendage occlusion in end stage renal disease patients undergoing dialysis.

BACKGROUND: In patients with end stage renal disease and atrial fibrillation (AF), undergoing chronic dialysis, direct oral agents are contraindicated and warfarin does not fully prevent embolic events while increasing the bleeding risk. The high hemorrhagic risk represents the main problem in this population. Aim of the study was to estimate the safety and efficacy for thromboembolic prevention of left atrial appendage (LAA) occlusion in a cohort of dialysis patients with AF and high hemorrhagic risk. METHODS: Ninety-two dialysis patients with AF who underwent LAA occlusion were recruited. For comparative purposes, two cohorts of dialysis patients with AF, one taking warfarin (oral anticoagulant therapy, OAT cohort, n = 114) and the other not taking any OAT (no-therapy cohort, n = 148) were included in the study. Primary endpoints were (1) incidence of peri-procedural complications, (2) incidence of 2-year thromboembolic and hemorrhagic events, (3) mortality at 2 years. In order to evaluate the effect of the LAA occlusion on the endpoints with respect to the OAT and No-therapy cohorts, a multivariable Cox regression model was applied adjusted for possible confounding factors. RESULTS: The device was successfully implanted in 100% of cases. Two major peri-procedural complications were reported. No thromboembolic events occurred at 2-year follow-up. The adjusted multivariable Cox regression model showed no difference in bleeding risk in the OAT compared to the LAA occlusion cohort in the first 3 months of follow-up [HR 1.65 (95% CI 0.43-6.33)], when most of patients were taking two antiplatelet drugs. In the following 21 months the bleeding incidence became higher in OAT patients [HR 6.48 (95% CI 1.32-31.72)]. Overall mortality was greater in both the OAT [HR 2.76 (95% CI 1.31-5.86)] and No-Therapy [HR 3.09 (95% CI 1.59-5.98)] cohorts compared to LAA occlusion patients. CONCLUSIONS: The study could open the way to a non-pharmacological option for thromboembolic protection in dialysis patients with AF and high bleeding risk.

Temporal patterns of premature atrial complexes predict atrial fibrillation occurrence in bradycardia patients continuously monitored through pacemaker diagnostics.

The frequency of premature atrial complexes (PACs) has been related with atrial fibrillation (AF) occurrence and adverse prognosis. Research objective was to evaluate whether temporal patterns of PACs are directly associated with AF onset in pacemaker patients with continuous monitoring of the atrial rhythm. Overall, 193 pacemaker patients (49% female, 72 ± 9 years old), enrolled in a national registry, were analyzed. Frequency of daily PACs was measured in a 14-day initial observation period, during which patients were in sinus rhythm. In the following period, temporal occurrence and frequency of daily PACs and eventual onset of AF were derived by pacemaker diagnostics. In the run-in period, median PACs frequency was 614 PACs/day (interquartile range 70-3056). Subsequently, in a median follow-up of 6 months, AF occurred in 109 patients, in particular in 37/96 (38.5%) patients with a PAC rate < 614 PACs/day and in 72/97 (74.2%) patients with PAC rate ≥ 614 PACs/day (p < 0.001). In patients with AF occurrence, the number of daily PACs, normalized by dividing for the average of PACs in ten preceding days, progressively increased in the 5 days preceding AF. Cox model predictive analysis showed that the risk of AF was significantly higher in patients with a relative increase of the daily PACs higher than 30% compared with PACs average number in ten preceding days [hazard ratio (95% confidence interval) 3.67 (2.40-5.59), p < 0.001]. PACs frequency increases in the 5 days preceding AF onset. A relative increase of the daily PACs is significantly associated with the risk of AF occurrence.

When water hurts.

Deglutition syncope refers to an uncommon cause of neurally mediated syncope induced by swallowing. We briefly review a case of a 66-year-old man who experienced recurrent syncope episodes during ingestion of beverages, mainly water. Our investigations documented several short asymptomatic episodes of asystole and one prolonged complete atrioventricular block of around 15 seconds associated with the syncopal events, during swallowing. Barium x-ray and manometry evaluations revealed only a nonspecific esophageal dysmotility. An underlying sick-sinus syndrome was found on electrophysiologic study. A DDD pacemaker implantation was performed leading to total disappearance of patient's symptoms.

Overdrive versus conventional or closed-loop rate modulation pacing in the prevention of atrial tachyarrhythmias in Brady-Tachy syndrome: on behalf of the Burden II Study Group.

BACKGROUND: Optimizing dual-chamber pacing to prevent recurrences of atrial tachyarrhythmias (AT) in sinus node dysfunction is still debated. Despite the large number of studies, efficacy of sophisticated preventive algorithms has never been proven. It is not clear whether this is due to imperfect study designs or to a substantial inefficacy of pacing therapies. AIM: To intraindividually compare AT burden between an atrial overdrive and two heart rate modulation approaches: a conventional accelerometric-sensor-based DDDR mode and a contractility-driven rate responsive closed loop (CLS) algorithm. METHODS AND RESULTS: Four hundred fifty-one patients with Brady-Tachy syndrome (BTS), severe bradycardia, and a documented episode of atrial fibrillation were enrolled. One month after implant, each pacing therapy was activated for 3 months in random order. A simple log transformation was used to handle large and skew AT burden distributions. Estimates were adjusted for false-positive AT episodes and reported as geometric means (95% confidence interval). A significantly higher AT burden was observed during overdrive, 0.14% (0.09%, 0.23%) (adjusted, 0.12%[0.07%, 0.20%]). Both DDDR and CLS performed better: respectively, 0.11% (0.07%, 0.17%) (adjusted, 0.08%[0.05%, 0.14%]), 0.06% (0.03%, 0.09%) (adjusted, 0.04%[0.03%, 0.07%]). All the comparisons were statistically significant. During overdrive significantly more patients had AT episodes of duration between 1 minute and 1 hour. No significant differences were observed for longer episodes. CONCLUSIONS: Atrial overdrive showed the worst performance in terms of AT burden reduction and should not be preferred to heart rate modulation approaches that still have to be considered as a first-choice pacing mode in BTS.

Implant success and safety of left atrial appendage occlusion in end stage renal disease patients: Peri-procedural outcomes from an Italian dialysis population.

AIMS: To estimate the safety and the efficacy of the off label left atrial appendage (LAA) occlusion in chronic dialysis patients with atrial fibrillation (AF). In this preliminary paper, we report the design of the study and the data on peri-procedural complications. METHODS: This is a prospective cohort study. Primary endpoints are i) incidence of peri-procedural complications, ii) cumulative incidence of two-year thromboembolic events iii) cumulative incidence of two-year bleedings iiii) mortality at two years. Adverse events and death within 30 days of the procedure were recorded. RESULTS: Fifty patients who underwent LAA occlusion between May 2014 and September 2017 were recruited. Both the mean age of the sample study and the dialysis duration were high [71.8 (9.6) years and 59.4 (78.2) months, respectively]. Most patients (84%) were hypertensive and 62% suffered a previous major bleeding. About half of them presented cardiovascular diseases. CHA2DS2VASCs and HASBLED scores were 4.0 (1.5) and 4.4 (0.9), respectively. Most patients (88%) showed atrial dilatation and 44% left ventricular hypertrophy; 32% had left ventricular ejection fraction <50%. Fifty five percent of patients had permanent AF and 32% paroxysmal AF. All devices were implanted successfully. No deaths or major adverse events were reported during a 30-day follow-up. Three episodes of peri-procedural access site bleeding were reported, requiring no transfusion. CONCLUSIONS: Our preliminary data suggest the feasibility and safety of LAA occlusion in patients undergoing dialysis. Only the follow-up of these patients over time can provide evidence that LAA occlusion is effective in preventing of thromboembolic events in this very high-risk population.

A comparison of 8-mm and open-irrigated gold-tip catheters for typical atrial flutter ablation: Data from a prospective multicenter registry.

BACKGROUND: Cavotricuspid isthmus (CTI) radiofrequency (RF) catheter ablation is the standard treatment for patients suffering from CTI-dependent atrial flutter (AFL). The aim of this study was to compare the use in clinical practice of 8-mm gold-tip catheter (8mmRFC) and open-irrigated gold-tip catheter (irrRFC) for RF typical AFL ablation. METHODS: Patients with typical AFL were treated with 8mmRFC or irrRFC catheters according to investigator preferences. The primary endpoint was the cumulative radiofrequency time (CRFT). Fluoroscopy time, acute and 6-month success rates were secondary endpoints. RESULTS: After excluding 3 patients with left AFL, 157 of the enrolled patients (median age 71.8 [interquartile range, 64.1-76.2], 76% men, 91% in NYHA class ≤II, 65% with no structural heart disease) were analyzed: 74 (47%) subjects were treated with the 8mmRFC and 83 (53%) with the irrRFC. The median CRFT was 3 [2-6] minutes in the 8mmRFC group and 5 [3-7] minutes in the irrRFC group (P = .183). There were no significant differences in ablation success rates, intraprocedural CTI reconnections, audible steam pops, and procedural times. In the 8mmRFC group, a significantly lower fluoroscopy time was observed as compared to the irrRFC group (8 [5-12] vs 15 [10-20] minutes, P < .001). During the follow-up period, AFL recurrences were documented in 3 patients in the 8mmRFC group and 2 in the irrRFC group (P = .655). CONCLUSIONS: The 8mmRFC and the irrRFC performed similarly in routine practice for CTI ablation in terms of cumulative RF time, acute and 6-month success rates. Fluoroscopy time was significantly lower in the 8mmRFC group.

Economic analysis of remote monitoring of cardiac implantable electronic devices: Results of the Health Economics Evaluation Registry for Remote Follow-up (TARIFF) study.

BACKGROUND: Remote monitoring (RM) of cardiac implantable electronic devices has been demonstrated to improve outpatient clinic workflow and patient management. However, few data are available on the socioeconomic impact of RM. OBJECTIVE: The aim of this study was to assess the costs and benefits of RM compared with standard care (SC). METHODS: We used 12-month patient data from the Health Economics Evaluation Registry for Remote Follow-up (TARIFF) study (N = 209; RM: n = 102 (48.81%); SC: n = 107 (51.19%)). Cost comparison was made from 2 perspectives: the health care system (HCS) and patients. The use of health care resources was defined on the basis of hospital clinical folders. Out-of-pocket expenses were reported directly by patients. RESULTS: HCS perspective: The overall mean annual cost per patient in the SC group (€1044.89 ± €1990.47) was significantly higher than in the RM group (€482.87 ± €2488.10) (P < .0001), with a reduction of 53.87% being achieved in the RM group. The primary driver of cost reduction was the cost of cardiovascular hospitalizations (SC: €`886.67 ± €1979.13 vs RM: €432.34 ± €2488.10; P = .0030). Patient and caregiver perspective: The annual cost incurred by patients was significantly higher in the SC group than in the RM group (SC: €169.49 ± €189.50 vs RM: €56.87 ± €80.22; P < .0001). Patients' quality-adjusted life-years were not significantly different between the groups. Provider perspective: The total number of inhospital device follow-up visits was reduced by 58.78% in the RM group. CONCLUSION: RM of patients with cardiac implantable electronic devices (CIEDs) is cost saving from the perspectives of the HCS, patients, and caregivers. Introducing appropriate reimbursements will make RM sustainable even for the provider, i.e. the hospitals which provide the service and encourage widespread adoption of RM.

Electrical Storm: Incidence, Prognosis and Therapy.

The term "electrical storm" indicates a life-threatening clinical condition characterized by the recurrence of hemodynamically unstable ventricular tachycardia and/or ventricular fibrillation, in particular in patients with ICD implanted for primary or secondary prevention. Although there isn't a shared definition of electrical storm, nowadays the most accepted definition refers to three or more separate arrhythmia episodes leading to ICD therapies including antitachycardia pacing or shock occurring over a single 24 hours' time period. Clinical presentation can be dramatic and triggering mechanism are not clear at all yet, but electrical storm is associated with high mortality rates and low patients quality of life, both in the acute phase and in the long term. The first line therapy is based on antiarrhythmic drugs to suppress electrical storm, but in refractory patients, interventions such as catheter ablation or in some cases surgical cardiac sympathetic denervation might be helpful. Anyhow, earlier interventional management can lead to better outcomes than persisting with antiarrhythmic pharmacologic therapy and, when available, an early interventional approach should be preferred.