Clinical and organizational management of cardiac implantable electronic device replacements: an Italian Survey promoted by AIAC (Italian Association of Arrhythmology and Cardiac Pacing).

AIMS: The aim of this survey was to assess the management and organization of cardiac implantable electronic device (CIED) replacement in Italy. METHODS: A questionnaire consisting of 24 questions on organizational aspects and on the peri-procedural management of anticoagulant therapies and antibiotic prophylaxis was sent via the Internet to 154 Italian arrhythmia centers. RESULTS: A total of 103 out of 154 centers completed the questionnaire (67% response rate). In 43% of the centers, the procedures were performed under day-case admission, in 40% under ordinary admission, and in 17% under either day-case or ordinary admission. The most frequent reason (66%) for choosing ordinary admission rather than day-case admission was to obtain full reimbursement. Although warfarin therapy was continued in 73% of the centers, nonvitamin K oral anticoagulants were discontinued, without bridging, 24 h or less prior to replacement procedures in 88%. Prophylactic antibiotic therapy was systematically administered in all centers; in 97%, the first antibiotic dose was administered 1-2 h prior to procedures. Local antibacterial envelopes were also used in 43% of the centers in patients with a higher risk of device infection. CONCLUSION: This survey provides a representative picture of how CIED replacements are organized and managed in current Italian clinical practice. The choice of the type of hospitalization (short versus ordinary) was more often motivated by economic reasons (reimbursement of the procedure) than by clinical and organizational factors. Peri-procedural management of anticoagulation and prophylactic antibiotic therapy was consistent with current scientific evidence.

Initial experience with the subcutaneous implantable cardioverter-defibrillator with the real costs of hospitalization analysis in a single Polish center.

BACKGROUND: The recent introduction of an entirely subcutaneous implantable cardioverter-defibril-lator (S-ICD) represents an important progress in the defibrillation technology towards a less invasive approach. This is a single-center observational study of S-ICD implantations in Poland. METHODS: The S-ICD was implanted in 11 patients with standard indications for an ICD. Patients in whom the device was implanted were evaluated for adverse events and device function at hospital discharge. All hospitalization costs were calculated and summed up for all patients. Costs were divided into following categories: medical materials, pharmaceuticals, operating theatre staff, cardiology depart-ment staff, laboratory tests, non-laboratory tests and additional non-medical costs. RESULTS: The mean age of patients was 51.6 ± 16.4 years, 9 were men and 2 were women. Four pa-tients had atrial fibrillation as the basal rhythm, 1 patient had atrial flutter and 6 patients had sinus rhythm. All patients had at least one condition that precluded the use of a traditional ICD system or the S-ICD was preferred due to other conditions, i.e. a history complicated transvenous ICD therapy (18%), anticipated higher risk of infection (27%), lack or difficult vascular access (18%), young age and anticipated high cumulated risk of lifetime device therapy (36%). The mean duration of the im-plantation procedure was 2 h. One patient developed a postoperative pocket hematoma. Mean total time of hospitalization was 28 (6-92) days. Average cost of hospitalization per patient was 21,014.29 EUR (minimal = 19,332.71 EUR and maximal = 24,824.14 EUR). CONCLUSIONS: S-ICD implantation appears to provide a viable alternative to transvenous ICD, espe-cially for patients without pacing requirements.

The Impact of Cryoballoon Versus Radiofrequency Ablation for Paroxysmal Atrial Fibrillation on Healthcare Utilization and Costs: An Economic Analysis From the FIRE AND ICE Trial.

BACKGROUND: This study sought to assess payer costs following cryoballoon or radiofrequency current (RFC) catheter ablation of paroxysmal atrial fibrillation in the randomized FIRE AND ICE trial. METHODS AND RESULTS: A trial period analysis of healthcare costs evaluated the impact of ablation modality (cryoballoon versus RFC) on differences in resource use and associated payer costs. Analyses were based on repeat interventions, rehospitalizations, and cardioversions during the trial, with unit costs based on 3 national healthcare systems (Germany [€], the United Kingdom [£], and the United States [$]). Total payer costs were calculated by applying standard unit costs to hospital stays, using International Classification of Diseases, 10th Revision diagnoses and procedure codes that were mapped to country-specific diagnosis-related groups. Patients (N=750) randomized 1:1 to cryoballoon (n=374) or RFC (n=376) ablation were followed for a mean of 1.5 years. Resource use was lower in the cryoballoon than the RFC group (205 hospitalizations and/or interventions in 122 patients versus 268 events in 154 patients). The cost differences per patient in mean total payer costs during follow-up were €640, £364, and $925 in favor of cryoballoon ablation (P=0.012, 0.013, and 0.016, respectively). This resulted in trial period total cost savings of €245 000, £140 000, and $355 000. CONCLUSIONS: When compared with RFC ablation, cryoballoon ablation was associated with a reduction in resource use and payer costs. In all 3 national healthcare systems analyzed, this reduction resulted in substantial trial period cost savings, primarily attributable to fewer repeat ablations and a reduction in cardiovascular rehospitalizations with cryoballoon ablation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Identifier: NCT01490814.

Healthcare Utilization and Expenditures Associated With Appropriate and Inappropriate Implantable Defibrillator Shocks.

BACKGROUND: In patients with implantable cardioverter-defibrillators, healthcare utilization (HCU) and expenditures related to shocks have not been quantified. METHODS AND RESULTS: We performed a retrospective cohort study of patients with implantable cardioverter-defibrillators identified from commercial and Medicare supplemental claims databases linked to adjudicated shock events from remote monitoring data. A shock event was defined as ≥1 spontaneous shocks delivered by an implanted device. Shock-related HCU was ascertained from inpatient and outpatient claims within 7 days following a shock event. Shock events were adjudicated and classified as inappropriate or appropriate, and HCU and expenditures, stratified by shock type, were quantified. Of 10 266 linked patients, 963 (9.4%) patients (61.3±13.6 years; 81% male) had 1885 shock events (56% appropriate, 38% inappropriate, and 6% indeterminate). Of these events, 867 (46%) had shock-related HCU (14% inpatient and 32% outpatient). After shocks, inpatient cardiovascular procedures were common, including echocardiography (59%), electrophysiology study or ablation (34%), stress testing (16%), and lead revision (11%). Cardiac catheterization was common (71% and 51%), but percutaneous coronary intervention was low (6.5% and 5.0%) after appropriate and inappropriate shocks. Expenditures related to appropriate and inappropriate shocks were not significantly different. CONCLUSIONS: After implantable cardioverter-defibrillator shock, related HCU was common, with 1 in 3 shock events followed by outpatient HCU and 1 in 7 followed by hospitalization. Use of invasive cardiovascular procedures was substantial, even after inappropriate shocks, which comprised 38% of all shocks. Implantable cardioverter-defibrillator shocks seem to trigger a cascade of health care. Strategies to reduce shocks could result in cost savings.

The Impact of First Procedure Success Rate on the Economics of Atrial Fibrillation Ablation.

OBJECTIVES: The purpose of this study was to compare health care costs associated with repeat ablation of atrial fibrillation (AF) with health care costs associated with a successful first procedure. BACKGROUND: Catheter ablation has become established as a rhythm control strategy for symptomatic paroxysmal and persistent AF. The economic impact of ablation is not completely understood, and it may be affected by repeat procedures performed for recurrent AF. METHODS: The source of data was the MarketScan (Truven Health, Ann Arbor, Michigan) administrative claims dataset from April 2008 to March 2013, including U.S. patients with private and Medicare supplemental insurance. Patients who underwent an outpatient atrial ablation procedure and a diagnosis of AF were identified. Total health care cost was calculated for 1 year before and after the ablation. Patients were categorized as having undergone a repeat ablation if an additional ablation was performed in the following year. RESULTS: Of 12,027 patients included in the study, repeat ablation was performed in 2,066 (17.2%) within 1 year. Patients with repeat ablation had higher rates of emergency department visits (43.4% vs. 32.2%; < 0.001) and subsequent hospitalization (35.6% vs. 21.5%; p < 0.001), after excluding hospitalizations for the repeat procedure. Total medical cost was higher for patients with repeat ablation ($52,821 vs. $13,412; p < 0.001), and it remained 46% higher even after excluding the cost associated with additional ablations ($19,621 vs. $13,412; p < 0.001). CONCLUSIONS: Health care costs are significantly higher for patients with a repeat ablation for AF than for patients with only a single ablation procedure, even though both groups have similar baseline characteristics. The increased costs persist even after excluding the cost of the repeat ablation itself. These results emphasize the economic benefit of procedural success in AF ablation.

Cost-Effectiveness and Clinical Effectiveness of the Risk Factor Management Clinic in Atrial Fibrillation: The CENT Study.

BACKGROUND: Atrial fibrillation (AF) imposes a substantial cost burden on the healthcare system. Weight and risk factor management (RFM) reduces AF burden and improves the outcomes of AF ablation. OBJECTIVES: This study sought to evaluate the cost and clinical effectiveness of integrating RFM into the overall management of AF. METHODS: Of 1,415 consecutive patients with symptomatic AF, 825 patients had body mass index ≥27 kg/m2. After screening for exclusion criteria, the final cohort comprised 355 patients: 208 patients who opted for RFM and 147 control subjects and were followed by 3 to 6 monthly clinic review, 7-day Holter monitoring, and AF Symptom Score. A decision analytical model calculated the incremental cost-effectiveness ratios of cost per unit of global well-being gained and unit of AF burden reduced. RESULTS: There were no differences in baseline characteristics or follow-up duration (p = NS). Arrhythmia-free survival was better in the RFM compared with control subjects (Kaplan-Meier: 79% vs. 44%; p < 0.001). At follow-up, RFM group had less unplanned specialist visits (0.19 ± 0.40 vs. 1.94 ± 2.00; p < 0.001), hospitalizations (0.74 ± 1.3 vs. 1.05 ± 1.60; p = 0.03), cardioversions (0.89 ± 1.50 vs. 1.51 ± 2.30; p = 0.002), emergency presentations (0.18 ± 0.50 vs. 0.76 ± 1.20; p < 0.001), and ablation procedures (0.60 ± 0.69 vs. 0.72 ± 0.86; p = 0.03). Antihypertensive (0.53 ± 0.70 vs. 0.78 ± 0.60; p = 0.04) and antiarrhythmic (0.26 ± 0.50 vs. 0.91 ± 0.60; p = 0.003) use declined in RFM. The RFM group had an increase of 0.1930 quality-adjusted life years and a cost saving of $12,094 (incremental cost-effectiveness ratios of $62,653 saved per quality-adjusted life years gained). CONCLUSIONS: A structured physician-directed RFM program is clinically effective and cost saving.

Detect Long-term Complications After ICD Replacement (DECODE): Rationale and Study Design of a Multicenter Italian Registry.

The replacement of implantable cardioverter-defibrillators (ICDs) may give rise to considerable clinical consequences, the importance of which is underrated by the medical community. Replacement-related adverse events are difficult to identify and require monitoring of both short-term complications and long-term patient outcome. The aim of this study is to perform a structured evaluation of both short- and long-term adverse events and a cost analysis of consecutive ICD replacement procedures. Detect Long-term Complications After ICD Replacement (DECODE) is a prospective, single-arm, multicenter cohort study designed to estimate long-term complication rates (at 12 months and 5 years) in patients undergoing ICD generator replacement. The study will also evaluate predictors of complications, patient management before and during the replacement procedure in clinical practice, and the costs related to use of health care resources. About 800 consecutive patients with standard indications for ICD generator replacement will be enrolled in this study. The decision to undertake generator replacement/upgrade will be made according to the investigators' own judgment (which will be recorded). Patients will be followed for 60 months through periodic in-hospital examinations or remote monitoring. Detailed data on complications related to ICD replacement in current clinical practice are still lacking. The analysis of adverse events will reveal the value of new preventive strategies, thereby yielding both clinical and economic benefits. Moreover, assessment of complication rates after ICD replacement in a real-life setting will help estimate the actual long-term cost of ICD therapy and assess the real impact of increasing ICD longevity on cost-effectiveness.

Impact of cardiac magnetic resonance imaging on cardiac device and surgical therapy: a prospective study.

Cardiac magnetic resonance (CMR) imaging may allow more appropriate selection of patients for cardiac device implantation and/or cardiac surgery. In this prospective observational study we evaluated the impact of CMR imaging on cardiac device and surgical therapy. All CMR examinations performed in a single centre over a 2 year period were prospectively recorded in a dedicated database under 4 clinical pathways [cardiomyopathy, viability, tumour/mass and arrythmogenic right ventricular cardiomyopathy (ARVC)]. Baseline data entered included planned cardiac device implantation and/or cardiac surgical intervention. Patients were contacted 6 months following CMR to evaluate the impact of CMR on planned therapy. Cost savings due to CMR were calculated as the number of surgical or device procedures averted following CMR scanning multiplied by their respective cost weights. Of 732 CMR examinations performed, the clinical pathway was cardiomyopathy in 488 (67 %), ARVC in 118 (16 %), viability in 92 (12 %) and tumour/mass in 34 (5 %). Six month follow-up was available in 666/732 patients. Following CMR, 56/150 (37 %) of patients with an initial plan for device implantation or cardiac surgery, did not undergo the planned intervention (P < 0.001, one-sample exact binomial test). Of 516 patients without an initial device or surgical plan, 33 (6 %) CMR resulted in device implantation or cardiac surgery (P < 0.001, Chi squared). Overall, the estimated saving due to CMR-guided management changes was AUD$737,270. CMR has a significant impact on patient management and offers potential cost savings with respect to selection of device and surgical therapy for cardiac disease.

Characterization and financial impact of implantable cardioverter-defibrillator patients without interventions 5 years after implantation.

BACKGROUND: Implantable cardioverter defibrillators (ICD's) are increasingly used for primary and secondary prevention of sudden cardiac death. However, data on how many ICD patients indeed receive appropriate ICD therapy during long-term follow-up is scarce. AIM: The aim of our study was to determine the number of patients without appropriate ICD therapy 5 years after ICD implantation, to identify predicting factors, to assess the occurrence of late first ICD therapy and to quantify the financial impact of ICD therapy in a real-world setting. DESIGN: Prospective observational study. METHODS: We prospectively enrolled 322 consecutive ICD patients. Baseline data were collected at implantation and patients were followed for a median of 7.3 years (IQR 5.8-9.2 years). Time to first appropriate ICD therapy (either antitachycardia pacing or cardioversion) was documented. RESULTS: Five years after implantation, 139 patients (43%) had not received appropriate ICD therapy. In multivariable analysis, a primary prevention indication and negative electrophysiological studies prior to ICD implantation were independent predictors of freedom from ICD therapy. Of the patients without ICD therapy, 5 years after implantation, 25% had experienced inappropriate ICD shocks. Two hundred and seven devices (1.5 devices per patient) were needed for the 139 patients without ICD intervention within 5 years, accounting for € 31,784 per patient. During an additional follow-up of 3 years, 12% of the patients with unused ICD received a late first appropriate ICD therapy. CONCLUSION: About half of the ICD patients receive appropriate ICD therapy within 5 years after implantation. Furthermore, there is a significant proportion of patients receiving late first shocks after five initially uneventful years.

Implantation and patient profiles for pacemakers and cardioverter-defibrillators in France (2008-2009).

BACKGROUND: An ageing population and the extension of indications will in all probability result in an increasing number of cardiac device implantations. METHODS: Patients implanted in 2008 and 2009 were identified by means of the French National Hospital Discharge database to establish the implantation rate and the National Health Insurance (NHI) Information System database for patient profiles (76% of the population). RESULTS: Of the 64,306 pacemaker implantations (1003.7 per million inhabitants [pmi]) in 2009, 21.4% were single chamber, 75.4% double chamber and 3.2% triple chamber (CRT-P). Of the 9028 cardioverter-defibrillator implantations (140.8 pmi) in 2009, 30.1% were single chamber, 27.5% double chamber and 42.5% triple chamber (CRT-D), accounting for 65% of cardiac resynchronization therapy (CRT) implants. Among NHI beneficiaries, 58.6% of cardioverter-defibrillators were implanted for primary prevention. Between 2008 and 2009, CRT-P implantations increased by 8.8% and CRT-D implantations by 29.3%. Regional variations in implantation rates were observed regarding single-chamber pacemakers (15-33%) and CRT-D among CRT (46.2-73.8%). Pacemaker implantations cost €158.4 million overall, 4.5% of which was for CRT-P; cardioverter-defibrillator implantations cost €96 million, 49% of which was for CRT-D. For NHI beneficiaries, 11.9% of CRT-P patients and 6.5% of CRT-D patients already had a device of the same type implanted in the 3 preceding years. CONCLUSION: The results confirm the increase in cardioverter-defibrillator implantations in France. The implantation rate remains lower than that in the USA but falls within the European average. Reasons behind significant regional variations in implantation rates need further study.

The effectiveness and cost effectiveness of public-access defibrillation.

Many sudden cardiac deaths are due to ventricular fibrillation (VF). The use of defibrillators in hospitals or by outpatient emergency medical services (EMS) personnel can save many cardiac-arrest victims. Automated external defibrillators (AEDs) permit defibrillation by trained first responders and laypersons. AEDs are available at most public venues, and vast sums of money are spent installing and maintaining these devices. AEDs have been evaluated in a variety of public and private settings. AEDs accurately identify malignant ventricular tachyarrhythmias and frequently result in successful defibrillation. Prompt application of an AED shows a greater number of patients in VF compared with initial rhythms documented by later-arriving EMS personnel. Survival is greatest when the AED is placed within 3 to 5 minutes of a witnessed collapse. Community-based studies show increased cardiac-arrest survival when first responders are equipped with AEDs rather than waiting for paramedics to defibrillate. Wide dissemination of AEDs throughout a community increases survival from cardiac arrest when the AED is used; however, the AEDs are utilized in a very small percentage of all out-of-hospital cardiac arrests. AEDs save very few lives in residential units such as private homes or apartment complexes. AEDs are cost effective at sites where there is a high density of both potential victims and resuscitators. Placement at golf courses, health clubs, and similar venues is not cost effective; however, the visible devices are good for public awareness of the problem of sudden cardiac death and provide reassurance to patrons.

Transoesophageal echocardiography and cardioversion: feasibility of a combined approach in clinical practice.

BACKGROUND: Atrial fibrillation, the most common clinically important arrhythmia, is often treated by external cardioversion preceeded by transoesophageal echo (TOE) which are usually performed as separate procedures. We performed TOE and cardioversion as a combined procedure to evaluate its safety and feasibility. METHOD: 173 patients were referred for a combined procedure; 154 underwent a combined TOE and cardioversion. We evaluated the safety and the duration of hospital stay in this group of patients. A cost analysis was performed comparing 32 patients (Group 1) who had a combined procedure in the first 6 months, with 18 patients who had two separate procedures (Group 2) in the 6 months preceeding this. RESULTS: Analysis of 154 patients who underwent the combined procedure demonstrated a median time from admission to discharge of 9h with a mean procedure time of 36 min. No significant technical problems were identified with the combined procedure as a single sedation. Total admission time, TOE to discharge time (p<0.0001) and procedural costs were lower in Group 1. CONCLUSION: Combined TOE and cardioversion is an effective and safe procedure that permits a patient to have a single sedation with a short hospital stay with decreased health costs.

Tratamento do paciente com risco de morte súbita cardíaca: utilização de fármacos e implante de desfibrilador automático / Treatment of patients with sudden cardiac death risk: drugs or implantable defibrillators?

Em 1998, morreram subitamente, nos Estados Unidos, mais de 450 mil pessoas, o que corresponde a mais de 60 por cento de todas as mortes de origem cardíaca. A maioria das mortes súbitas cardíacas ocorre por arritmia, principalmente fibrilação ventricular (70 por cento), precedida (62 por cento) ou não (8 por cento) de taquicardias ventriculares. Para reduzir esses números, há três estratégias: prevenção das condições que favorecem seu aparecimento, medidas que evitem as arritmias potencialmente letais ou recuperação pronta dos atingidos por essas arritmias. Pode-se, portanto, prevenir o aparecimento do primeiro episódio ou tratá-lo imediatamente quando ocorrer (prevenção primária), evitar seu reaparecimento ou tratá-lo (prevenção secundária). Na prevenção secundária, quando não existem causas transitórias ou removíveis, a principal escolha, baseada em mega-ensaios comparativos, tem sido o implante de cardioversor-desfibrilador automático. Mas, pelo seu alto custo, há necessidade de se identificar subgrupos com pouco benefício, comparativamente à amiodarona. Meta-análise recente desses ensaios sugere que, em cardiopatas isquêmicos com fração de ejeção superior a 35 por cento, não há evidências de vantagens do desfibrilador sobre a amiodarona. Quanto às cardiomiopatias não-isquêmicas, ainda faltam estudos que nos auxiliem a decidir. Isso também ocorre na prevenção primária, que, obrigatoriamente, tem que atingir população muito maior. Ainda não há evidências importantes de benefício adicional do desfibrilador para alguns subgrupos, principalmente os de fração de ejeção não tão reduzida, em taquicardias ventriculares hemodinamicamente bem toleradas ou, ainda, em síncopes sem indução de arritmias ventriculares sustentadas no estudo eletrofisiológico. Até que mais evidências surjam, para esses casos a amiodarona associada à otimização do controle clínico pode continuar a ser uma opção terapêutica válida.

Treatment of malignant ventricular arrhythmias with the automatic implantable cardioverter defibrillator.

Twenty-eight patients with malignant ventricular arrhythmias were treated with the automatic implantable cardioverter-defibrillator (AICD) in a 14-month period. Thirteen patients were resuscitated from a ventricular fibrillation (VF) episode. Fifteen patients presented with ventricular tachycardia (VT) refractory to medical therapy. The etiology was coronary artery disease in 23 of 28 patients (82%), dilated cardiomyopathy in 2 of 28 patients (7%), sarcoidosis in 2 of 28 patients, and 1 patient in 28 had lupus erythmatosis. The mean left ventricular ejection fraction was 29%. A total of 27 of 28 patients (96%) patients had inducible ventricular tachycardia using programmed stimulation. The patients considered for AICD implant failed a mean of 3.6 antiarrhythmic drugs. Rate counting and defibrillating leads were inserted through a lateral thoracotomy in 17 patients and a mediansternotomy incision in 11 patients in conjunction with another cardiac procedure in 10 patients. The generators were positioned in a subcutaneous pocket beneath the left costal margin. There were no operative deaths. The mean follow-up was 6.7 months (range 1 to 14) with no VT/VF deaths in patients with defibrillators. The study demonstrated that AICD is an effective device for prevention of sudden cardiac death.