Incidence, implications, and management of sense-B-noise failure in subcutaneous cardioverter-defibrillator patients: insights from a large multicentre registry.

AIMS: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) offer potentially distinct advantages over transvenous defibrillator systems. Recent randomized trials showed significantly lower lead failure rates than transvenous ICD. Still, S-ICDs remain associated with the risk of inappropriate shocks (IAS). While previous studies have reported varying causes of IAS, this study explores a rare cause of IAS, referred to as 'sense-B-noise.' It was recently described in case series, but its incidence has not been studied in a large cohort of S-ICD patients. METHODS AND RESULTS: We retrospectively reviewed data from patients implanted with S-ICD models 1010, A209, and A219 between October 2009 and July 2023 across nine centres in Europe and the USA. The analysis concentrated on determining the incidence and understanding the implications of sense-B-noise events. Sense-B-noise represents a rare manifestation of distinct electrogram abnormalities within the primary and alternate sensing vectors. Data were collected from medical records, device telemetry, and manufacturer reports for investigation. This registry is registered on clinicaltrials.gov (NCT05713708). Subcutaneous implantable cardioverter-defibrillator devices of the 1158 patients were analysed. The median follow-up time for all patients was 46 (IQR 23-64) months. In 107 patients (9.2%) ≥1 IAS was observed during follow-up. Sense-B-noise failure was diagnosed in six (0.5 and 5.6% of all IAS) patients, in all patients, the diagnosis was made after an IAS episode. Median lead dwell time in the affected patients was 23 (2-70) months. To resolve the sense-B-noise defect, in three patients reprogramming to the secondary vector was undertaken, and two patients underwent system removal with subsequent S-ICD reimplantation due to low amplitude in the secondary vector. In one patient, the secondary vector was initially programmed, and subsequently, an S-ICD system exchange was performed due to T-wave-oversensing IAS episodes. CONCLUSION: This multicentre analysis' findings shed light on a rare but clinically highly significant adverse event in S-ICD therapy. To our knowledge, we provide the first systematic multicentre analysis investigating the incidence of sense-B-noise. Due to being difficult to diagnose and limited options for resolution, management of sense-B-noise is challenging. Complete system exchange may be the only option for some patients. Educating healthcare providers involved in S-ICD patient care is crucial for ensuring accurate diagnosis and effective management of sense-B-noise issues.

The clinical and economic impact of extended battery longevity of a substernal extravascular implantable cardioverter defibrillator.

INTRODUCTION: The extravascular implantable cardioverter defibrillator (EV ICD) has extended projected battery longevity compared to the subcutaneous implantable cardioverter defibrillator (S-ICD). This study used modeling to characterize the need for generator changes, long-term complications, and overall costs for both the EV ICD and S-ICD in healthcare systems of various countries. METHODS: Battery longevity data were modeled using a Markov model from averages reported in device labeling for the S-ICD and with engineering estimates based on real life usage from EV ICD Pivotal Study patient data to introduce variability. Clinical demographic data were derived from published literature. The primary outcomes were defined as the number of generator replacement surgeries, complications, and total healthcare system costs due to battery depletion over the expected lifetime of patients receiving EV ICD or S-ICD therapy. RESULTS: Average modeled battery longevity was determined to be 7.3 years for the S-ICD versus 11.8 years for the EV ICD. The probability of a complication after a replacement procedure was 1.4%, with an operative mortality rate of 0.02%. The use of EV ICD was associated with 1.4-1.6 fewer replacements on average over an expected patient lifetime as compared to S-ICD and a 24.3%-26.0% reduction in cost. A one-way sensitivity analysis of the model for the US healthcare system found that use of an EV ICD resulted in a reduction in replacement surgeries of greater than 1 (1.1-1.6) along with five-figure cost savings in all scenarios ($18 602-$40 948). CONCLUSION: The longer projected battery life of the EV ICD has the potential to meaningfully reduce long-term morbidity and healthcare resources related to generator changes from the perspective of multiple diverse healthcare systems.

Epidemiology, Mechanisms, and Management of Atrial Fibrillation in Cardiac Amyloidosis.

Cardiac amyloidosis (CA) is a restrictive disease that results from intramyocardial amyloid deposition due to immunoglobulin light chain or transthyretin proteins. Up to two-third of CA patients have atrial fibrillation (AF) due to electromechanical, autonomic, and hemodynamic disturbances. AF in CA carries particularly increased risk of thromboembolism, prompting anticoagulation therapy irrespective of CHA2DS2VASc score. However, CA is also associated with enhanced bleeding risk that warrants thorough assessment of bleeding profile before initiation of anticoagulation. Management of AF in CA is challenging because these patients poorly tolerate rate control agents, while cardiomyopathy precludes most antiarrhythmic agents, leaving amiodarone as the preferred antiarrhythmic drug. The effectiveness of direct current cardioversion in restoring sinus rhythm in CA is comparable with that in the general population, although intraprocedural complication rates could be higher. Transesophageal echocardiogram should be performed prior to direct current cardioversion, given high incidence of intracardiac thrombus in these patients. Finally, the data on catheter ablation is limited.

Influence of "high" defibrillation thresholds on patient survival and impact of system modification.

OBJECTIVE: To test whether a high defibrillation threshold (DFT) marks patients with poor outcomes which are improved when DFT is decreased by system modification (subcutaneous coil implant; SM). BACKGROUND: The electrical substrate generating fast ventricular arrhythmias may generate poor outcomes among patients treated with implantable cardioverter-defibrillators (ICDs), even when arrhythmias are treated successfully. Since patients with high DFTs have increased mortality, we contrasted survival among patients with high DFT treated with and without SM. METHODS: We studied consecutive patients undergoing ICD implantation and DFT testing at Cleveland Clinic over a 14-year period. High DFT was defined as successful defibrillation by shock strength >25 J or ≤10 J of maximal device output. Mortality was recorded using the Social Security Death Index. Survival was compared among those high DFT patients receiving SM versus the remainder. RESULTS: Out of 6353 patients tested, 191 (3%) had high DFT (32.1 ± 3.7 J) versus 13.9 ± 4.9 J in the remainder ("acceptable DFT," p < .001). One hundred twenty-one high DFT patients (63%; 33.3 ± 3.4 J) underwent SM, which significantly decreased DFT (24.8 ± 5.9 J; p < .001). Seventy patients (37%; 30.3 ± 3.3 J) did not undergo SM. During follow-up, 38% (2363/6162; 7.8 yrs) patients with acceptable DFT died versus 48% high DFT patients (91/191; 5.6 yrs.; p < .001). Concomitantly, 48% patients with SM (58/121) died, as compared to 47% patients (33/70) without SM (p = .91); median follow-up 4.9 yrs). CONCLUSION: Patients with high DFT have a higher mortality than those with acceptable DFT. The additional subcutaneous coil implant decreases DFT to an acceptable range but does not appear to improve survival. The electrical substrate underlying high DFT appears to determine survival.

Comparative Effectiveness of Implantable Defibrillators for Asymptomatic Brugada Syndrome: A Decision-Analytic Model.

Background Optimal management of asymptomatic Brugada syndrome (BrS) with spontaneous type I electrocardiographic pattern is uncertain. Methods and Results We developed an individual-level simulation comprising 2 000 000 average-risk individuals with asymptomatic BrS and spontaneous type I electrocardiographic pattern. We compared (1) observation, (2) electrophysiologic study (EPS)-guided implantable cardioverter-defibrillator (ICD), and (3) upfront ICD, each using either subcutaneous or transvenous ICD, resulting in 6 strategies tested. The primary outcome was quality-adjusted life years (QALYs), with cardiac deaths (arrest or procedural-related) as a secondary outcome. We varied BrS diagnosis age and underlying arrest rate. We assessed cost-effectiveness at $100 000/QALY. Compared with observation, EPS-guided subcutaneous ICD resulted in 0.35 QALY gain/individual and 4130 cardiac deaths avoided/100 000 individuals, and EPS-guided transvenous ICD resulted in 0.26 QALY gain and 3390 cardiac deaths avoided. Compared with observation, upfront ICD reduced cardiac deaths by a greater margin (subcutaneous ICD, 8950; transvenous ICD, 6050), but only subcutaneous ICD improved QALYs (subcutaneous ICD, 0.25 QALY gain; transvenous ICD, 0.01 QALY loss), and complications were higher. ICD-based strategies were more effective at younger ages and higher arrest rates (eg, using subcutaneous devices, upfront ICD was the most effective strategy at ages 20-39.4 years and arrest rates >1.37%/year; EPS-guided ICD was the most effective strategy at ages 39.5-51.3 years and arrest rates 0.47%-1.37%/year, and observation was the most effective strategy at ages >51.3 years and arrest rates <0.47%/year). EPS-guided subcutaneous ICD was cost-effective ($80 508/QALY). Conclusions Device-based approaches (with or without EPS risk stratification) can be more effective than observation among selected patients with asymptomatic BrS. BrS management should be tailored to patient characteristics.

Assessment of the knowledge level and experience of healthcare personnel concerning CPR and early defibrillation: an internal survey.

BACKGROUND: In-hospital cardiac arrest (IHCA) is a major public health problem with significant mortality. Rapid cardiopulmonary resuscitation and early defibrillation is extremely connected to patient outcome. In this study, we aimed to assess the effects of a basic life support and defibrillation course in improving knowledge in IHCA management. METHODS: We performed a prospective observational study recruiting healthcare personnel working at Azienda Ospedaliero Universitaria Pisana, Pisa, Italy. Study consisted in the administration of two questionnaires before and after BLS-D course. The course was structured as an informative meeting and it was held according to European Resuscitation Council guidelines. RESULTS: 78 participants completed pre- and post-course questionnaires. Only 31.9% of the participants had taken part in a BLS-D before our study. After the course, we found a significative increase in the percentage of participants that evaluated their skills adequate in IHCA management (17.9% vs 42.3%; p < 0.01) and in the correct use of defibrillator (38.8% vs 67.9% p < 0.001). However, 51.3% of respondents still consider their preparation not entirely appropriate after the course. Even more, we observed a significant increase in the number of corrected responses after the course, especially about sequence performed in case of absent vital sign, CPR maneuvers and use of defibrillator. CONCLUSIONS: The training course resulted in significant increase in the level of knowledge about the general management of IHCA in hospital staff. Therefore, a simple intervention such as an informative meetings improved significantly the knowledge about IHCA and, consequently, can lead to a reduction of morbidity and mortality.

Procedural sedation for direct current cardioversion: a feasibility study between two management strategies in the emergency department.

BACKGROUND: A cardiologist-only approach to procedural sedation with midazolam in the setting of elective cardioversion (DCC) for AF has already been proven as safe as sedation with propofol and anaesthesiologist assistance. No data exist regarding the safety of such a strategy during emergency procedures. The aim of this study is to compare the feasibility of sedation with midazolam, administered by a cardiologist, to an anaesthesiologist-assisted protocol with propofol in emergency DCC. METHODS: Single centre, prospective, open blinded, randomized study including all consecutive patients admitted to the Emergency Department requiring urgent or emergency DCC. Patients were randomized in a 1:1 fashion to either propofol or midazolam treatment arm. Patients in the midazolam group were managed by the cardiologist only, while patients treated with propofol group underwent DCC with anaesthesiologist assistance. RESULTS: Sixty-nine patients were enrolled and split into two groups. Eighteen patients (26.1%) experienced peri-procedural adverse events (bradycardia, severe hypotension and severe hypoxia), which were similar between the two groups and all successfully managed by the cardiologist. No deaths, stroke or need for invasive ventilation were registered. Patients treated with propofol experienced a greater decrease in systolic and diastolic blood pressure when compared with those treated with midazolam. As the procedure was shorter when midazolam was used, the median cost of urgent/emergency DCC with midazolam was estimated to be 129.0 € (1st-3rd quartiles 114.6-151.6) and 195.6 € (1st-3rd quartiles 147.3-726.7) with propofol (p < .001). CONCLUSIONS: Procedural sedation with midazolam given by the cardiologist alone was feasible, well-tolerated and cost-effective in emergency DCC.

Adherence to oral anticoagulant treatment and risk factor assessment six months after DC-conversion of atrial fibrillation.

Objective. We wanted to study the adherence of oral anticoagulant treatment in patients 6 months after elective DC-cardioversion and to observe possible increases in CHA2DS2-VASc scores and new adverse outcomes. Design. Consecutive patients admitted for elective DC-cardioversion at Haukeland University Hospital during the period from June 2017 to April 2018 were screened. Only patients who had a DC-cardioversion performed were included. Baseline information was collected from hospital records and follow up information was gathered through a structured phone interview and the prescription database. Results. Of the 125 patients screened, 38 were excluded as DC-cardioversion was not performed. The included patients were contacted 6 months later, out of whom 77 (84%) responded. Three patients had discontinued oral anticoagulation therapy, but only one patient had done so in violation of Guidelines. Two patients had continued oral anticoagulant treatment despite lack of indication. Of the responding patients 89% were compliant, estimated by a Proportion of Days Covered > 80%. Three patients experienced a thromboembolic event, despite being on anticoagulation. The mean CHA2DS2-VASc score increased from 3.0 ± 1.4 to 3.3 ± 1.5, (p < .001). Less than half maintained sinus rhythm, the remaining had either atrial fibrillation (n = 30, 40%) or were unsure of their current rhythm (n = 9, 12%). A third received new cardiac interventions during follow up. Conclusion. We found an excellent adherence to Guidelines recommended therapy amongst our patients. CHA2DS2-VASc scores increased significantly during the 6-month observation period. From this we conclude there is a need for structured follow up to assess new risk factors.

Echocardiographic assessment of left atrial morphology and function to predict maintenance of sinus rhythm after electrical cardioversion in patients with non-valvular persistent atrial fibrillation and normal function or mild dysfunction of left ventricle.

BACKGROUND: The aim of this study was to assess whether echocardiographic measurements of left atrial (LA) morphology and function could predict sinus rhythm maintenance after electrical cardioversion among patients with atrial fibrillation (AF) and normal function or mild dysfunction of the left ventricle (LV). METHODS: One hundred seventeen patients with persistent AF who underwent successful electrical cardioversion were prospectively enrolled. Echocardiography was performed one day subsequent to successful cardioversion. Patients were followed up clinically and electrocardiographically at 1, 6, and 12 months. At 12 months, 61 (52%) patients had maintained sinus rhythm (SR). RESULTS: Compared to patients who maintained SR, those with AF recurrence had larger LAs, worse LA systolic function, and increased LV filling pressure. On multivariate stepwise logistic regression, E/A ratios (odds ratio [OR] 0.550, 95% confidence interval [CI] 0.341-0.886; p = 0.014) and E/e' ratios (OR 0.871, 95% CI 0.771-0.985; p = 0.027) were significant predictors of AF recurrence. On receiver operator characteristic curve analysis of AF recurrence at 12 months, the area under curve for both E/A and E/e' ratios were 0.726. With an E/A cutoff of 2.2, the sensitivity for predicting AF recur-rence at 12 months was 72%, and specificity was 73%. With an E/e' cutoff of 9.17, the sensitivity for predicting AF recurrence at 12 months was 72%, and specificity was 74%. CONCLUSIONS: Left ventricular filling pressure assessed with E/A and E/e' ratios predict AF recurrence after electrical cardioversions among patients with AF and normal function of LV.

Impact of defibrillation threshold testing on burden of heart failure hospitalizations.

Background: Defibrillation threshold testing (DT) following implantable cardioverter defibrillator (ICD) implantation has not shown to improve mortality. However, the impact of DT on burden of heart failure (HF) hospitalisations has not been well defined.Methods: We studied retrospectively consecutive patients who underwent ICD implantation or generator change between 2008 and 2014. Primary outcome was burden of HF hospitalisations within 30 days following implantation. Secondary outcomes were mortality, stroke, and ICD shock within 30 days and one-year mortality.Results: Three hundred and eleven of 501 patients (62%) were in DT+ group versus 190 (38%) were in DT- group. The percentage of new implantations was higher in DT+ group than in DT- group (69% vs 39%, p < .001) but the distributions of NYHA function classes were similar between two groups. The burden of HF hospitalisations at 30-days was significantly higher in DT+ group than in DT- group (17.4% vs 4.7%, HR 0.842, 95% CI 0.774-0.915, p < .0001). No difference in mortality, stroke or ICD shocks was found between two groups at 30 days and mortality at 1 year.Conclusions: DT after new ICD or generator replacement was associated with increased HF hospitalisation rates at 30 days after ICD implant in a non-trial HF population. However, there was no association between DT and mortality, stroke and ICD shocks at 30 days or mortality at 1 year. The increased burden of HF hospitalisation in this observational study requires validation by randomised studies.

Association of Physician Specialty With Long-Term Implantable Cardioverter-Defibrillator Complication and Reoperations Rates.

Background Patients undergoing implantable cardioverter-defibrillator (ICD) implantations have high rates of long-term device-related complications and reoperations. Whether physician specialty training is associated with differences in long-term outcomes following ICD implantation is unclear. Methods and Results We linked data from the National Cardiovascular Data Registry ICD Registry with Medicare fee-for-service claims to identify physicians who performed ≥10 index ICDs from 2006 to 2009. We used data from the American Board of Medical Specialties to group the specialty of the implanting physician into mutually exclusive categories: electrophysiologists, interventional cardiologists, general cardiologists, thoracic surgeons, and other specialties. Primary outcomes were long-term device-related complications requiring reoperations or hospitalizations and reoperations for reasons other than complications. We compared the cumulative incidence rates and case-mix adjusted rates of long-term outcomes of index ICD implantations across physician specialties. Our analysis had a median follow-up of 47 months and included 107 966 index ICD implantations. Electrophysiologists had the lowest rates of incident long-term device-related complications (14.1%; interventional cardiologists, 15.3%; general cardiologists, 15.4%; thoracic surgeons, 16.4%; other specialists, 15.2%; P<0.001) and reoperations for reasons other than complications (electrophysiologists, 16.7%; interventional cardiologists, 17.0%; general cardiologists, 18.0%; thoracic surgeons, 18.4%; other specialists, 18.0%; P<0.001). Compared with patients whose ICDs were implanted by electrophysiologists, patients with implantations performed by nonelectrophysiologists were at higher risk of having long-term device-related complications (relative risk for interventional cardiologists: 1.16 [95% CI, 1.08-1.25]; general cardiologists: 1.13 [1.08-1.18]; thoracic surgeons: 1.20 [1.06-1.37]; all P<0.001, but not other specialists: 1.08 [0.99-1.17]; P=0.07). Compared to patients with implantations performed by electrophysiologists, patients with implantations performed by general cardiologists and thoracic surgeons were at higher risk of reoperation for noncomplication causes (relative risk for general cardiologists: 1.10 [1.05-1.15]; thoracic surgeons: 1.16 [1.00-1.33]; both P<0.05). Conclusions Patients with ICD implantations performed by electrophysiologists had the lowest risks of having long-term device-related complications and reoperations for noncomplication causes. Consideration of physician specialty before ICD implantation may represent an opportunity to minimize long-term adverse outcomes.

Outcomes and costs of remote patient monitoring among patients with implanted cardiac defibrillators: An economic model based on the PREDICT RM database.

BACKGROUND: Remote monitoring of implantable cardioverter-defibrillators has been associated with reduced rates of all-cause rehospitalizations and mortality among device recipients, but long-term economic benefits have not been studied. METHODS AND RESULTS: An economic model was developed using the PREDICT RM database comparing outcomes with and without remote monitoring. The database included patients ages 65 to 89 who received a Boston Scientific device from 2006 to 2010. Parametric survival equations were derived for rehospitalization and mortality to predict outcomes over a maximum time horizon of 25 years. The analysis assessed rehospitalization, mortality, and the cost-effectiveness (expressed as the incremental cost per quality-adjusted life year) of remote monitoring versus no remote monitoring. Remote monitoring was associated with reduced mortality; average life expectancy and average quality-adjusted life years increased by 0.77 years and 0.64, respectively (6.85 life years and 5.65 quality-adjusted life years). When expressed per patient-year, remote monitoring patients had fewer subsequent rehospitalizations (by 0.08 per patient-year) and lower hospitalization costs (by $554 per patient year). With longer life expectancies, remote monitoring patients experienced an average of 0.64 additional subsequent rehospitalizations with increased average lifetime hospitalization costs of $2784. Total costs of outpatient and physician claims were higher with remote monitoring ($47 515 vs $42 792), but average per patient-year costs were lower ($6232 vs $6244). The base-case incremental cost-effectiveness ratio was $10 752 per quality-adjusted life year, making remote monitoring high-value care. CONCLUSION: Remote monitoring is a cost-effective approach for the lifetime management of patients with implantable cardioverter-defibrillators.

Sex Differences in Advanced Heart Failure Therapies.

This in-depth review of sex differences in advanced heart failure therapy summarizes the existing literature on implantable cardioverter defibrillators, biventricular pacemakers, mechanical circulatory support, and transplantation with a focus on utilization, efficacy/clinical effectiveness, adverse events, and controversies. One will learn about the controversies regarding efficacy/clinical effectiveness of implantable cardioverter defibrillators and understand why these devices should be implanted in women even if there are sex differences in appropriate shocks. Individuals will learn about the sex differences with biventricular pacemakers with respect to ventricular remodeling and reduction in heart failure hospitalizations/mortality, as well as, possible mechanisms. We will demonstrate sex differences in heart transplantation and waitlist survival. Despite similar survival for women and men with left ventricular assist devices, there are sex differences in adverse events. These devices do successfully bridge women and men to transplant, yet women are less likely than men to have a left ventricular assist at time of listing and time of transplantation. Finally, one will learn about the concerns regarding poor outcome for men who receive female donor hearts and discover this may not be due to sex, but rather size. More research is needed to better understand sex differences and further improve advanced heart failure therapy for both women and men.

A Decision Tree-Based Survival Analysis of Patients with a History of Inappropriate Implantable Cardioverter-Defibrillator Therapy.

Implantable cardioverter-defibrillators (ICDs) improve survival in patients who are at risk of sudden death. However, inappropriate therapy is commonly given to ICD recipients, and this situation may be associated with an increased risk of death. This study aimed to construct a risk stratification scheme by using decision tree analysis in patients who received inappropriate ICD therapy.Mortality was calculated from a retrospective data analysis of a multicenter cohort involving 417 ICD recipients. Inappropriate therapy was defined as therapy for nonventricular arrhythmias, including sinus tachycardia, supraventricular tachycardia, atrial fibrillation/flutter, oversensing, and lead failure. Inappropriate therapy included antitachycardia pacing, cardioversion, and defibrillation. The prognostic factors were identified by a Cox proportional hazards regression analysis, and we constructed a decision tree.During an average follow-up of 5.2 years, 48 patients (12%) had all-cause death. A multivariate Cox hazard model revealed that the age (hazard ratio [HR] 1.06, P < 0.001), ln B-type natriuretic peptide (BNP) (HR 1.47, P = 0.02), nonsinus rhythm at implantation (HR 2.70, P < 0.05), and inappropriate therapy occurring during sedentary/awake conditions (HR 3.51, P = 0.001) correlated with an increased risk of mortality. An inappropriate therapy due to abnormal sensing (HR 0.16, P = 0.04) decreased the risk of mortality. Furthermore, a decision tree analysis stratified the patients well by using 4 covariates: BNP, activity at the time of inappropriate therapy, mechanism of inappropriate therapy, and baseline rhythm at ICD implantation (log-rank test, P < 0.0001).We identified the predictors of mortality in inappropriate ICD therapy recipients and constructed a risk stratification scheme by using decision tree analysis.

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.

Facility-Level Variation and Clinical Outcomes in Use of Cardiac Resynchronization Therapy With and Without an Implantable Cardioverter-Defibrillator.

BACKGROUND: Little is known about real-world facility-level preferences for cardiac resynchronization therapy devices with (CRT-D) and without (CRT-P) defibrillator backup. We quantify this variation at the facility level and exploit this variation to compare outcomes of patients receiving these 2 devices. METHODS AND RESULTS: Claims data from fee-for-service Medicare beneficiaries were used to identify new CRT-P and CRT-D implants, 2006 to 2012. We modeled factors associated with receipt of each device, and compared mortality, hospitalizations, and reoperations for patients receiving each using both logistic regression and instrumental variable analysis to account for confounding. Among 71 459 device recipients (CRT-P, 11 925; CRT-D, 59 534; 31% women), CRT-P recipients were older, more likely to be women, and had more comorbidities. Variation in device selection among facilities was substantial: After adjustment for patient characteristics, the odds of receiving a CRT-P (versus CRT-D) device were 7.6× higher for a patient treated at a facility in the highest CRT-P use quartile versus a facility in the lowest CRT-P use quartile. Logistic modeling suggested a survival advantage for CRT-D devices but with falsification end points indicating residual confounding. By contrast, in the instrumental variable analysis using facility variability as the proposed instrument, clinical characteristics and falsification end points were well balanced, and 1-year mortality in patients who received CRT-P versus CRT-D implants did not differ, while CRT-P patients had a lower probability of hospitalizations and reoperations in the year following implant. CONCLUSIONS: CRT-P versus CRT-D selection varies substantially among facilities, adjusted for clinical factors. After instrumental variable adjustment for clinical covariates and facility preference, survival was no different between the devices. Therefore, CRT-P may be preferred for Medicare beneficiaries considering new CRT implantation.

Sacubitril/valsartan or an implantable cardioverter-defibrillator in heart failure with reduced ejection fraction patients: a cost-effectiveness analysis.

AIMS: The availability of novel drugs might affect the modern interplay between pharmacological and device therapy of heart failure with reduced ejection fraction (HFrEF). The aim of this study was to assess the cost-effectiveness of sacubitril/valsartan as compared with an implantable cardioverter-defibrillator (ICD) on top of optimal medical therapy in patients with HFrEF. METHODS: Data from 2000 adults with demographic and clinical characteristics similar to those in the PARADIGM-HF were derived as inputs for a four-state Markov model simulated HFrEF. Probabilities of all-cause mortality, heart failure hospitalization and ICD-related complications along with quality of life data and costs, discounted at 3%, from an Italian healthcare payer perspective were projected over a 10-year time horizon. Sensitivity analyses on key inputs were performed. RESULTS: According to the model, sacubitril/valsartan would lead to 5.85 life years saved, whilst reducing by more than 20% the risk of heart failure hospitalizations for 1000 patients with HFrEF over 10 years. Estimated incremental costs with sacubitril/valsartan were -&OV0556;13 302 associated with incremental 0.14 quality-adjusted life years gained, yielding an incremental cost-effectiveness ratio of -&OV0556;98 500 per quality-adjusted life year gained for the base-case consistent with a dominant, cost-saving and clinically superior treatment strategy. Sacubitril/valsartan was dominant in more than 80% of the scenarios explored with sensitivity analyses. CONCLUSION: The findings of this model suggest that in patients with HFrEF sacubitril/valsartan would be cost-effective by increasing survival at lower costs compared with an ICD. Sensitivity analyses confirmed the cost-effectiveness of sacubitril/valsartan that remained dominant across most of the ranges of the variables tested.

Safety and Effectiveness of Medical Device Therapy.

When enough females and males are enrolled in clinical trials, much more relevant information is available on potential sex differences in device safety and effectiveness. Unfortunately, females have largely been underrepresented in clinical studies of cardiac medical device therapies for heart failure. In this chapter, sex differences in heart failure characteristics and cardiac electrophysiology and their influence on the safety, effectiveness, and application of implantable cardioverter defibrillators (ICDs), subcutaneous ICDs (S-ICDs), and cardiac resynchronization therapy (CRT) will be discussed. In this way, the research community will hopefully become more appreciative of the potential differences in device effects between females and males.