Search

Aims: Cardiac contractility modulation (CCM) is a device therapy for heart failure, based on the delivery of high‐voltage biphasic impulses to the right ventricular septum during the myocardial absolute refractory period. This study evaluated the cost‐effectiveness of CCM therapy plus optimal medical therapy (OMT) vs. OMT alone in patients with heart failure with reduced ejection fraction. Methods and results: A Markov model with a lifespan time horizon was developed to assess the cost–utility using the FIX trials as main data sources. A deterministic sensitivity analysis and a probabilistic sensitivity analysis were run to analyse the decision uncertainty in the model through cost‐effectiveness acceptability curve (CEAC) and cost‐effectiveness acceptability frontier (CEAF). Value of information analysis was also conducted computing the expected value of perfect information (EVPI) and the expected value of partial perfect information. The base case results showed that the CCM plus OMT option was highly cost‐effective compared with OMT alone with an incremental cost–utility ratio of €7034/quality‐adjusted life year (QALY). The CEAC and CEAF illustrated that for all willingness to pay levels above €5600/QALY, tested up to €50 000/QALY, CCM plus OMT alternative had the highest probability of being cost‐effective. The EVPI per patient was estimated to be €124 412 on a willingness to pay threshold of €30 000/QALY. Conclusions: For patients with heart failure with reduced ejection fraction, CCM therapy could be cost‐effective when taking a lifetime horizon. Further long‐term, post‐approval clinical studies are needed to verify these results in a real‐world context, particularly concerning the effect of CCM therapy on mortality. [ABSTRACT FROM AUTHOR]

Background and Aims: Transvenous lead extraction (TLE) has become a pivotal part of a comprehensive lead management strategy, dealing with a continuously increasing demand. Nonetheless, the literature about the long‐term impact of TLE on survivals is still lacking. Given these knowledge gaps, the aim of our study was to analyse very long‐term mortality in patients undergoing TLE in public health perspective. Methods: This prospective, single‐centre, observational study enrolled consecutive patients with cardiac implantable electronic device (CIED) who underwent TLE, from January 2005 to January 2021. The main goal was to establish the independent predictors of very long‐term mortality after TLE. We also aimed at assessing procedural and hospitalization‐related costs. Results: We enrolled 435 patients (mean age 70 ± 12 years, with mean lead dwelling time 6.8 ± 16.7 years), with prevalent infective indication to TLE (92%). Initial success of TLE was achieved in 98% of population. After a median follow‐up of 4.5 years (range: 1 month–15.5 years), 150 of the 435 enrolled patients (34%) died. At multivariate analysis, death was predicted by: age (≥77 years, OR: 2.55, CI: 1.8–3.6, p < 0.001), chronic kidney disease (CKD) defined as severe reduction of estimated glomerular filtration rate (eGFR <30 mL/min/1.73 m2, OR: 1.75, CI: 1.24–2.4, p = 0.001) and systolic dysfunction assessed before TLE defined as left ventricular ejection fraction (LVEF) <40%, OR: 1.78, CI 1.26–2.5, p = 0.001. Mean extraction cost was €5011 per patient without reimplantation and €6336 per patient with reimplantation respectively. Conclusions: Our study identified three predictors of long‐term mortality in a high‐risk cohort of patients with a cardiac device infection, undergoing successful TLE. The future development of a mortality risk score before might impact on public health strategy. [ABSTRACT FROM AUTHOR]

Introduction: Brugada syndrome (BrS) has a dynamic ECG pattern that might be revealed by certain conditions such as fever. We evaluated the incidence and management of ventricular arrhythmias (VAs) related to COVID‐19 infection and vaccination among BrS patients carriers of an implantable loop recorder (ILR) or implantable cardioverter‐defibrillator (ICD) and followed by remote monitoring. Methods: This was a multicenter retrospective study. Patients were carriers of devices with remote monitoring follow‐up. We recorded VAs 6 months before COVID‐19 infection or vaccination, during infection, at each vaccination, and up to 6‐month post‐COVID‐19 or 1 month after the last vaccination. In ICD carriers, we documented any device intervention. Results: We included 326 patients, 202 with an ICD and 124 with an ILR. One hundred and nine patients (33.4%) had COVID‐19, 55% of whom developed fever. Hospitalization rate due to COVID‐19 infection was 2.76%. After infection, we recorded only two ventricular tachycardias (VTs). After the first, second, and third vaccines, the incidence of non‐sustained ventricular tachycardia (NSVT) was 1.5%, 2%, and 1%, respectively. The incidence of VT was 1% after the second dose. Six‐month post‐COVID‐19 healing or 1 month after the last vaccine, we documented NSVT in 3.4%, VT in 0.5%, and ventricular fibrillation in 0.5% of patients. Overall, one patient received anti‐tachycardia pacing and one a shock. ILR carriers had no VAs. No differences were found in VT before and after infection and before and after each vaccination. Conclusions: From this large multicenter study conducted in BrS patients, followed by remote monitoring, the overall incidence of sustained VAs after COVID‐19 infection and vaccination is relatively low. [ABSTRACT FROM AUTHOR]

Background: An early, comprehensive rhythm‐control therapy is needed in order to treat atrial fibrillation (AF) effectively and to improve ablation outcomes. Methods: A total of 153 consecutive patients from the CHARISMA registry undergoing AF ablation at eight centers were included. Patients with de novo PVI were classified as having undergone early treatment (ET) if the procedure was performed within 6 months after the first AF episode, and as having undergone delayed treatment (DT) if ablation was performed over 6 months after the first AF episode. Results: One‐hundred fifty‐three patients were enrolled (69.9% male, 59 ± 10 years, 61.4% paroxysmal AF, 38.6% persistent AF). The time from the first AF episode to the ablation procedure was 1034 ± 1483 days. The ET group comprised 36 patients (25.3%), the DT group 60 (39.2%) and Redo cases were 57 (37.3%). During a mean follow‐up of 366 ± 130 days, 18 patients (11.8%) suffered an AF/AT recurrence. More DT patients than ET patients suffered recurrences (15.7% vs. 2.2%, p = 0.0452) and the time to AT/AF recurrence was shorter in the group of patients who received an ablation treatment after 6 months (HR = 6.19, 95% CI: 1.7 to 21.9; p = 0.0474). On multivariate Cox analysis, only hypertension (HR = 4.86, 95% CI: 1.6 to 14.98, p = 0.0062) was independently associated with recurrences. Beyond the hypertension risk factor, ET was associated with a low risk of recurrence; recurrence rate ranged from 0% (ET patients without hypertension) to 25.0% (DT patients with hypertension). Conclusions: An early rhythm‐control ablation therapy in the absence of common risk factors was associated with the lowest rate of recurrences. [ABSTRACT FROM AUTHOR]

Background: Sleep apnea syndrome (SAS) has been reported to be associated with a higher incidence of ventricular arrhythmias. The aim of this study was twofold: (1) to investigate whether in SAS patients receiving an implantable cardioverter defibrillator (ICD) the severity of SAS was associated with the occurrence of ventricular arrhythmias; (2) to assess whether changes in nocturnal apnoic/hypopnoic episodes may favor the occurrence of life‐threatening arrhythmias, that is, sustained ventricular tachycardia (VT)/fibrillation (VF), requiring ICD intervention. Methods: We enrolled 46 patients with documented SAS at polysomnography (apnea/hypopnea index [AHI] > 5) who also had a left ventricle ejection fraction (LVEF) < 35% and, according to primary prevention indications, implanted an ICD (Boston Scientific Incepta) able to daily monitor apnoic/hypopnoic episodes occurring during sleep. Patients were followed at 3‐month intervals. Results: At a mean follow‐up of 18 months, 21 episodes of sustained VT/FV requiring ICD intervention were documented in eight patients (17.4%). Baseline AHI was significantly higher in patients with compared to those without ICD intervention. ICD interventions, however, were not preceded by any worsening of apnoic/hypopnoic episodes. The respiratory disturbance index (RDI) of the week during the event, indeed, was not different from that recorded during the previous 2 weeks (25.4 ± 11, 25.6 ± 10 and 25.1 ± 10, respectively; p =.9). Conclusions: In patients with SAS who received an ICD for primary prevention of sudden death, those with ICD interventions showed a more severe form of the disease at baseline. ICD interventions, however, were not preceded by any significant changes in SAS severity. [ABSTRACT FROM AUTHOR]

Background: Highly localized impedance (LI) measurements during atrial fibrillation (AF) ablation have recently emerged as a viable real‐time indicator of tissue characteristics and durability of the lesions created. We report the outcomes of acute and long‐term clinical evaluation of the new DirectSense algorithm in AF ablation. Methods: Consecutive patients undergoing AF ablation were included in the CHARISMA registry. RF delivery was guided by the DirectSense algorithm, which records the magnitude and time‐course of the impedance drop. The ablation endpoint was pulmonary vein isolation (PVI), as assessed by the entrance and exit block. Results: 3556 point‐by‐point first‐pass RF applications of >10 s duration were analyzed in 153 patients (mean age=59 ± 10 years, 70% men, 61% paroxysmal AF, 39% persistent AF). The mean baseline LI was 105 ± 15 Ω before ablation and 92 ± 12 Ω after ablation (p <.0001). Both absolute drops in LI and the time to LI drop (LI drop/τ) were greater at successful ablation sites (n = 3122, 88%) than at ineffective ablation sites (n = 434, 12%) (14 ± 8 Ω vs 6 ± 4 Ω, p <.0001 for LI; 0.73 [0.41–1.25] Ω/s vs. 0.35[0.22–0.59 Ω/s, p <.0001 for LI drop/τ). No major complications occurred during or after the procedures. All PVs had been successfully isolated. During a mean follow‐up of 366 ± 130 days, 18 patients (11.8%) suffered an AF/atrial tachycardia recurrence after the 90‐day blanking period. Conclusion: The magnitude and time‐course of the LI drop during RF delivery were associated with effective lesion formation. This ablation strategy for PVI guided by LI technology proved safe and effective and resulted in a very low rate of AF recurrence over 1‐year follow‐up. [ABSTRACT FROM AUTHOR]

Aims: The aim of this study is to report heart failure hospitalization (HFH) rates and associated costs within 12 months following implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT‐D) device replacement or upgrade from ICD to CRT‐D. Methods and results: The DEtect long‐term COmplications after icD rEplacement (DECODE) was a prospective, single‐arm, multicentre cohort study that explored complications in ICD/CRT‐D recipients. All clinical and survival data at 12 months were prospectively analysed. For each adjudicated HFH, admission and discharge dates and ICD‐9‐CM diagnosis and procedure codes were recorded. The reimbursement for each HFH was calculated for each diagnosis‐related group code. Between 2013 and 2015, 983 patients (mean age 71 years, male 76%, mean left ventricular ejection fraction 35%, and New York Heart Association Class I/II 75.6%) were enrolled. Patients underwent device replacement (900; 91.6%, 446 ICD/454 CRT‐D) or ICD upgrade to CRT‐D (83; 8.4%). Post‐replacement hospitalizations occurred in 220 patients, with the primary discharge diagnosis identifying cardiovascular causes in 175 patients (80%). Fifty‐five (5.6%) patients experienced at least one HFH. Overall, 91 HFH events occurred (9.6% event rate, 95% confidence interval: 7.7–11.7) in 70 patients; 66 (6.7%) patients died, 40 (60.6%) of cardiovascular causes. The HFH rate was significantly higher following upgrades, and the occurrence of HFH was associated with an 11‐fold increased mortality risk (95% confidence interval: 5.9–20.5, P < 0.0001). Medical diagnosis‐related group accounted for 91.2% of HFH; the mean cost per HFH was €5662 ± 9497, and the mean cost per patient was €9369 ± 12 687. On multivariate analysis, predictors of HFH were atrial fibrillation, chronic kidney disease, and all‐cause hospitalization within 30 days prior to the procedure. Conclusions: In the DECODE registry, HFH and mortality rates in the year following ICD/CRT‐D replacement or upgrade were low. In this particular subset, underlying cardiac disease was the main driver of HFH, mortality, and higher healthcare expenditures. [ABSTRACT FROM AUTHOR]

Longevity of Replaced ICD/CRT-D Introduction The longevity of defibrillators (ICD) is extremely important from both a clinical and economic perspective. We studied the reasons for device replacement, the longevity of removed ICD, and the existence of possible factors associated with shorter service life. Methods and Results Consecutive patients who underwent ICD replacement from March 2013 to May 2015 in 36 Italian centers were included in this analysis. Data on replaced devices were collected. A total of 953 patients were included in this analysis. In 813 (85%) patients the reason for replacement was battery depletion, while 88 (9%) devices were removed for clinical reasons and the remaining 52 because of system failure (i.e., lead or ICD generator failure or a safety advisory indication). The median service life was 5.9 years (25th-75th percentile, 4.9-6.9) for single- and dual-chamber ICD and 4.9 years (25th-75th percentile, 4.0-5.7) for CRT-D. On multivariate analysis, the factors CRT-D device, SC/DC ICD generator from Biotronik, percentage of ventricular pacing, and the occurrence of a system failure were positively associated with a replacement procedure. By contrast, the device from Boston Scientific was an independent protective factor against replacement. Considerable differences were seen in battery duration in both ICD and CRT-D. Specifically, Biotronik devices showed the shortest longevity among ICD and Boston Scientific showed the longest longevity among CRT-D (log-rank test, P < 0.001 for pairwise comparisons). Conclusion Several factors were associated with shorter service life of ICD devices: CRT-D, occurrence of system failure and percentage of ventricular pacing. Our results confirmed significant differences among manufacturers. [ABSTRACT FROM AUTHOR]

ICD Interventions and Mortality. Background: Patients with severe structural heart disease have increased mortality after implantable cardioverter-defibrillator (ICD) shocks. Whether this is limited to ICD shock therapy only or extends also to no-shock therapies, such as antitachycardia pacing (ATP), is unclear. We investigated the impact of different ICD therapies on long-term mortality. Methods:We enrolled 573 patients who underwent ICD implantation at our institution from 2004 to 2011. The population was divided into 3 groups: no device interventions (group 1), ATP interventions (group 2), and shock interventions (group 3). The endpoint was the all-cause mortality. Results: Over a follow-up period of 48 months (range 1-110), 447 (78%) had no device interventions, 71 (12%) had ATP therapy only, and 55 (10%) had at least one shock intervention. All-cause mortality occurred in 94 patients in group 1 (21%), 23 patients (43%) in group 2, and 21 patients (38%) in group 3. At multivariable Cox regression analysis, ATP intervention (HR: 1.8; 95% CI 1.1-3; P < 0.001), shock intervention (HR: 1.39; 95% CI 1.09-1.77; P = 0.008), age (HR: 1.05; 95% CI 1.02-1.07; P < 0.001), and LVEF (HR: 0.95; 95% CI 0.93-0.98; P = 0.001) were predictors of all-cause mortality. No significant difference in mortality was found between group 2 and 3. Conclusion: Patients with ICDs who receive appropriate interventions are at increased risk of mortality. Such risk is not dependent on different types of ICD therapy, such as shocks or ATP. Our data suggest that sustained ventricular arrhythmias per se have a negative impact on prognosis rather than modality of ICD therapy. [ABSTRACT FROM AUTHOR]

The article comments on research related to the removal of cardiac resynchronization therapy (CRT) devices due to infection or system failure and on the removal of a device's transvenous coronary sinus (CS) leads. Removal of CS catheters by manual traction is noted. Reimplantation of the CS lead in the CRT patient is mentioned.