BACKGROUND: There is a paucity of data comparing vitamin K antagonists (VKAs) to direct oral anticoagulants (DOACs) at the time of cardiac implantable electronic device (CIED) surgery. Furthermore, the best management of DOACs (interruption vs continuation) is yet to be determined.
OBJECTIVE: This study aimed to compare the incidence of device-related bleeds and thrombotic events based on anticoagulant type (DOAC vs VKA) and regimen (interrupted vs uninterrupted).
METHODS: This was an observational multicenter study. We included patients on chronic oral anticoagulation undergoing CIED surgery. Patients were matched using propensity scoring.
RESULTS: We included 1,975 patients (age 73.8 ± 12.4 years). Among 1,326 patients on DOAC, this was interrupted presurgery in 78.2% (n = 1,039) and continued in 21.8% (n = 287). There were 649 patients on continued VKA. The matched population included 861 patients. The rate of any major bleeding was higher with continued DOAC (5.2%) compared to interrupted DOAC (1.7%) and continued VKA (2.1%) (P = 0.03). The rate of perioperative thromboembolism was 1.4% with interrupted DOAC, whereas no thromboembolic events occurred with DOAC or VKA continuation (P = 0.04). The use of dual antiplatelet therapy, DOAC continuation, and male sex were independent predictors of major bleeding on a multivariable analysis.
CONCLUSIONS: In this large real-world cohort, a continued DOAC strategy was associated with a higher bleeding risk compared to DOAC interruption or VKA continuation in patients undergoing CIED surgery. However, DOAC interruption was associated with increased thromboembolic risk. Concomitant dual antiplatelet therapy should be avoided whenever clinically possible. A bespoke approach is necessary, with a strategy of minimal DOAC interruption likely to represent the best compromise.

The Implantable Cardioverter-Defibrillator (ICD) is a well-established life-saving therapy for heart failure patients, but due to the risk for unnecessary shocks, deactivation of ICD:s is recommended at the end of life. We aimed to identify i) how many people with HF and an ICD who died in Sweden in 2018 received Specialized Palliative Care (SPC), ii) of those dying outside of hospital, the proportion with deactivated ICDs prior to death for the group as a whole and by SPC access.
We analyzed data from i) the Swedish ICD and Pacemaker Registry to find all who died with an ICD in Sweden in 2018, ii) the Swedish Register of Palliative Care and, iii) the Swedish Causes of Death Certificate Register to find those who died outside of hospital. Clinical records were obtained to assess if ICDs were deactivated before death. Descriptive statistics, t-tests and chi-squared tests were applied. 46/406 (11%) of those who died with an ICD in Sweden in 2018 had SPC access, of whom 50% also had cancer. 86/164 (52%) ICDs were deactivated prior to death in people dying outside of hospital; higher in those accessing SPC (36/46, (78%) SPC access versus 151/360, (42%) no SPC access; p < 0.05).
Half of those with HF and an ICD dying outside of hospital had ICD deactivation prior to death. Those accessing SPC were more likely to have their ICD deactivated but few received SPC, without a comorbid cancer diagnosis.

A previous randomized study demonstrated that the subcutaneous implantable cardioverter defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket. The aim of this analysis was to compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with an SC pocket.
We analysed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. Subcutaneous patients (n = 290) were propensity matched with patients of the IM group (n = 290), and their outcomes were compared. : During a median follow-up of 28 months, device-related complications were reported in 28 (4.8%) patients and inappropriate shocks were reported in 37 (6.4%) patients. The risk of complication was lower in the matched IM group than in the SC group [hazard ratio 0.41, 95% confidence interval (CI) 0.17-0.99, P = 0.041], as well as the composite of complications and inappropriate shocks (hazard ratio 0.50, 95% CI 0.30-0.86, P = 0.013). The risk of appropriate shocks was similar between groups (hazard ratio 0.90, 95% CI 0.50-1.61, P = 0.721). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, and ejection fraction.
Our data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks.
Clinical Trial Registration: ClinicalTrials.gov; NCT02275637.

暂无摘要。

To describe health related quality of life (HRQOL) and symptoms in the SPIRIT trial and determine effects of implantable cardioverter defibrillator (ICD) shocks on HRQOL over 24 months. Ninety participants aged 66 ± 10 years, 96% men, 75% with NYHA class II, with an ICD were randomized to spironolactone 25 mg (N = 44) or placebo (N = 46). HRQOL was measured every 6 months for 24 months using: Patient Concerns Assessment (PCA), Short Form Health Survey-Veterans Version (SF-36V), and Kansas City Cardiomyopathy Questionnaire (KCCQ). Linear mixed modeling compared changes in HRQOL over-time and ANCOVA compared HRQOL between those getting an ICD shock or not. Over 24-months, there were no differences in HRQOL between the spironolactone versus placebo groups. Those with at least one ICD shock reported significantly lower HRQOL and more symptoms at 6- and 24-months. Patients receiving one or more ICD shocks reported significant reductions in HRQOL and higher symptoms.

The most widespread venous sites of access for implantation intravenous implantable cardiac electronic device (CIED) are the cephalic and subclavian vein. Fluoroscopy-guided axillary venous access is an alternative, but efficacy and safety have not been studied under equal conditions. The aim of the present study is to compare the efficacy and safety of fluoroscopy-guided axillary vs cephalic vein access in CIED implant.
Two hundred and forty patients were randomized to receive CIED implantation by the fluoroscopy-guided axillary vein access vs cephalic vein access. The implantation success, the procedure times and the complications were recorded. A comparison of the results of operators was made. The success rate of the randomized venous access was superior in the axillary group than in cephalic (98.3% vs 76.7%, P < .001). Time to access (6.8 ± 3.1 minute vs 13.1 ± 5.8 minutes, P < .001) and implantation duration was significantly shorter in the axillary group than in the cephalic group (42.3 ± 11.6 minutes vs 50.5 ± 13.3 minutes, P < .001). There was no difference in the incidence of complication and inter-operator success rate, complications rate and time to access.
The fluoroscopy-guided axillary venous access is safe and has a better success rate and faster execution time compared with the cephalic vein access. When the results were compared among the study operators, neither in the axillary nor in the cephalic group there were differences in the success rate, the complication rate, and the time to access.
www.clinicaltrials.gov, NCT03860090.

Hospital admissions are frequently preceded by increased pulmonary congestion in heart failure (HF) patients. This study evaluated whether early automated fluid status alert notification via telemedicine improves outcome in HF patients.
Patients recently implanted with an implantable cardioverter defibrillator (ICD) with or without cardiac resynchronization therapy were eligible if one of three conditions was met: prior HF hospitalization, recent diuretic treatment, or recent brain natriuretic peptide increase. Eligible patients were randomized (1:1) to have fluid status alerts automatically transmitted as inaudible text message alerts to the responsible physician or to receive standard care (no alerts). In the intervention arm, following a telemedicine alert, a protocol-specified algorithm with remote review of device data and telephone contact was prescribed to assess symptoms and initiate treatment. The primary endpoint was a composite of all-cause death and cardiovascular hospitalization. We followed 1002 patients for an average of 1.9 years. The primary endpoint occurred in 227 patients (45.0%) in the intervention arm and 239 patients (48.1%) in the control arm [hazard ratio, HR, 0.87; 95% confidence interval (CI), 0.72-1.04; P = 0.13]. There were 59 (11.7%) deaths in the intervention arm and 63 (12.7%) in the control arm (HR, 0.89; 95% CI, 0.62-1.28; P = 0.52). Twenty-four per cent of alerts were not transmitted and 30% were followed by a medical intervention.
Among ICD patients with advanced HF, fluid status telemedicine alerts did not significantly improve outcomes. Adherence to treatment protocols by physicians and patients might be challenge for further developments in the telemedicine field.

OBJECTIVE: Dual-chamber implantable cardioverter-defibrillators (ICDs) may improve specificity and reduce the risk of inappropriate shocks, and enhance atrial arrhythmia (AT/AF) detection to permit stroke prevention compared with single-chamber ICDs, but at additional expense and risk.
RESULTS: Patients (n = 100) receiving primary prevention ICDs at two USA and two Israeli centres were randomized to dual-chamber or single-chamber devices between December 2008 and December 2010 and were followed for 1 year. Programming in both groups included: delayed detection to avoid therapy for non-sustained episodes; high detection cut-off rates to avoid treating slower, better tolerated arrhythmias; minimized right ventricular pacing; and routine use of supraventricular-ventricular tahcycardia discriminators and antitachycardia pacing. The primary outcome was the proportion of patients with inappropriate shocks. One patient in each group (2%) received inappropriate shocks (P = 1.00). Death occurred in two patients in the single-chamber arm, and in none of the patients in the dual-chamber arm (P = 0.15). New AT/AF was detected in 12 patients (24%) in the dual-chamber group, vs. no patients in the single-chamber group (P < 0.001). Among US participants, the mean cost of dual- vs. single-chamber ICD implantation was $16 579 vs. $14 249, respectively (P < 0.001); there was no difference in the quality of life (EQ-5D index difference 0.013, P = 0.769; EQ VAS difference 3.3, P = 0.49).
CONCLUSIONS: When optimal programming is utilized, inappropriate shocks are rare in primary prevention patients with both single- and dual-chamber ICDs. The routine use of dual-chamber ICDs increases the expense without reducing inappropriate shocks or improving the quality of life at 1 year.
BACKGROUND: clinicaltrials.gov Identifier: NCT00787800.

BACKGROUND: Implantable defibrillators (ICD) are highly effective in reducing arrhythmia-related mortality. ICD shock therapy has been shown to increase psychological distress, health care utilization, and is associated with increased mortality. The Protecta ICDs (Medtronic Inc., Minneapolis, MN, USA) have algorithms designed to reduce unnecessary and inappropriate shock therapy.
RESULTS: The PainFree SmartShock™ Technology (PainFree SST) study is a prospective, multicenter, clinical trial with two consecutive phases, a premarket phase safety study and a postmarket phase effectiveness study. We report the results of the PainFree SST safety study. The premarket phase aimed to investigate safety in the first year postimplant, and to determine if the novel algorithms (T-wave discrimination, right ventricular lead noise discrimination and confirmation+) affect appropriate ventricular fibrillation (VF) detection. Patients (total: n = 246 [male 78%, mean age 63 year, primary prevention indication in 76%]) were implanted either with a Protecta XT dual-chamber ICD (n = 114 [46%]) or a defibrillator with cardiac resynchronization therapy (n = 132 [54%]). Appropriate VF detection was measured during VF induction at implantation when the novel algorithms were programmed ON. A two-second delay in VF detection was classified as clinically significant. No delay in VF detection was observed with all algorithms programmed ON. No unanticipated serious adverse device effects occurred during first year postimplant.
CONCLUSIONS: The results of the premarket phase of the PainFree SST trial demonstrate the safety of the Protecta XT defibrillators. Detection of induced VF was not delayed with SmartShock™ algorithms ON.

OBJECTIVE: The rapidly increasing number of patients with implantable cardioverter-defibrillators (ICD) places a large burden on follow-up providers. This study investigated the possibility of longer in-office follow-up intervals in primary prevention ICD patients under remote monitoring with automatic daily data transmissions from the implant memory.
RESULTS: Conducted in 155 ICD recipients with MADIT II indications, the study compared the burden of scheduled and unscheduled ICD follow-up visits, quality of life (SF-36), and clinical outcomes in patients randomized to either 3- or 12-month follow-up intervals in the period between 3 and 27 months after implantation. Remote monitoring (Biotronik Home Monitoring) was used equally in all patients. In contrast to previous clinical studies, no calendar-based remote data checks were performed between scheduled in-office visits. Compared with the 3-month follow-up interval, the 12-month interval resulted in a minor increase in the number of unscheduled follow-ups (0.64 vs. 0.27 per patient-year; P = 0.03) and in a major reduction in the total number of in-office ICD follow-ups (1.60 vs. 3.85 per patient-year; P < 0.001). No significant difference was found in mortality, hospitalization rate, or hospitalization length during the 2-year observation period, but more patients were lost to follow-up in the 12-month group (10 vs. 3; P = 0.04). The SF-36 scores favoured the 12-month intervals in the domains \'social functioning\' and \'mental health\'.
CONCLUSIONS: In prophylactic ICD recipients under automatic daily remote monitoring, the extension of the 3-month in-office follow-up interval to 12 months appeared to safely reduce the ICD follow-up burden during 27 months after implantation.
UNASSIGNED: NCT00401466 (http://www.clinicaltrials.gov/ct2/show/NCT00401466).