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Arrhythmic episodes in patients implanted with a cardioverter-defibrillator - results from the Prospective Study on Predictive Quality with Preferencing PainFree ATP therapies (4P).

ABSTRACT: BACKGROUND:Little is known about the ICD performance using enhanced detection algorithms in unselected, non-trial patients. Performance of recent generation ICD equipped with SmartShock™ technology (SST) for detection and conversion of ventricular tachyarrhythmias (VTA) was investigated. METHODS:4P was a prospective, multicenter, observational study conducted in 10 Swiss implanting centers. Patients with a Class I indication according to international guidelines were included and received an ICD with SST. ICD discrimination capability was assessed by evaluating SST performance; therapy efficacy was assessed by rate of VTA conversions by ATP and by rescue shocks. RESULTS:Overall, 196 patients were included in the analysis with a mean duration of follow-up of 27.7?months (452 patient-years of observation). Patient-specific rather than recommended programming was preferred. Device-detected episodes were frequent (5147 episodes in 146 patients, 74.5%). In 44 patients (22.4%), 1274 episodes were categorized as VTA; only 215 episodes were symptomatic. ATP was the first-line therapy and highly effective (99.9% success rate at the episode level, 100.0% at the patient level). Rescue shocks were rare (66 episodes in 28 patients); 7 shocks in 5 patients (2.6%) were inappropriate. Death and hospitalization rates were low. CONCLUSIONS:In a cohort of non-trial, unselected ICD patients, VTA episodes were frequent. The 4P results confirm the robustness of VTA detection by SST and the effectiveness of ATP treatment, hence limiting overall ICD shock burden.

SUBMITTER: Regoli F

PROVIDER: S-EPMC6580638 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Arrhythmic episodes in patients implanted with a cardioverter-defibrillator - results from the Prospective Study on Predictive Quality with Preferencing PainFree ATP therapies (4P).

Regoli François F Graf Denis D Schaer Beat B Duru Firat F Ammann Peter P Stefano Lorenza Mangoni di S LMDS Naegli Barbara B Burri Haran H Zbinden Rainer R Krasniqi Nazmi N Fromer Martin M

BMC cardiovascular disorders 20190617 1

<h4>Background</h4>Little is known about the ICD performance using enhanced detection algorithms in unselected, non-trial patients. Performance of recent generation ICD equipped with SmartShock™ technology (SST) for detection and conversion of ventricular tachyarrhythmias (VTA) was investigated.<h4>Methods</h4>4P was a prospective, multicenter, observational study conducted in 10 Swiss implanting centers. Patients with a Class I indication according to international guidelines were included and ...[more]

PMID: 31208342

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Project description:ObjectiveTo determine whether burden of multiple chronic conditions (MCCs) influences the risk of receiving inappropriate vs appropriate device therapies.DesignRetrospective cohort study.SettingSeven US healthcare delivery systems.ParticipantsAdults with left ventricular systolic dysfunction receiving an implantable cardioverter-defibrillator (ICD) for primary prevention.MeasurementsData on 24 comorbid conditions were captured from electronic health records and categorized into quartiles of comorbidity burden (0-3, 4-5, 6-7 and 8-16). Incidence of ICD therapies (shock and antitachycardia pacing [ATP] therapies), including appropriateness, was collected for 3 years after implantation. Outcomes included time to first ICD therapy, total ICD therapy burden, and risk of inappropriate vs appropriate ICD therapy.ResultsAmong 2235 patients (mean age = 69 ± 11 years, 75% men), the median number of comorbidities was 6 (interquartile range = 4-8), with 98% having at least two comorbidities. During a mean 2.2 years of follow-up, 18.3% of patients experienced at least one appropriate therapy and 9.9% experienced at least one inappropriate therapy. Higher comorbidity burden was associated with an increased risk of first inappropriate therapy (adjusted hazard ratio [HR] = 1.94 [95% confidence interval {CI} = 1.14-3.31] for 4-5 comorbidities; HR = 2.25 [95% CI = 1.25-4.05] for 6-7 comorbidities; and HR = 2.91 [95% CI = 1.54-5.50] for 8-16 comorbidities). Participants with 8-16 comorbidities had a higher total burden of ICD therapy (adjusted relative risk [RR] = 2.12 [95% CI = 1.43-3.16]), a higher burden of inappropriate therapy (RR = 3.39 [95% CI = 1.67-6.86]), and a higher risk of receiving inappropriate vs appropriate therapy (RR = 1.74 [95% CI = 1.07-2.82]). Comorbidity burden was not significantly associated with receipt of appropriate ICD therapies. Patterns were similar when separately examining shock or ATP therapies.ConclusionsIn primary prevention ICD recipients, MCC burden was independently associated with an increased risk of inappropriate but not appropriate device therapies. Comorbidity burden should be considered when engaging patients in shared decision making about ICD implantation.

Project description:BACKGROUND:Despite the high rate of sudden death after myocardial infarction among patients with a low ejection fraction, implantable cardioverter-defibrillators are contraindicated until 40 to 90 days after myocardial infarction. Whether a wearable cardioverter-defibrillator would reduce the incidence of sudden death during this high-risk period is unclear. METHODS:We randomly assigned (in a 2:1 ratio) patients with acute myocardial infarction and an ejection fraction of 35% or less to receive a wearable cardioverter-defibrillator plus guideline-directed therapy (the device group) or to receive only guideline-directed therapy (the control group). The primary outcome was the composite of sudden death or death from ventricular tachyarrhythmia at 90 days (arrhythmic death). Secondary outcomes included death from any cause and nonarrhythmic death. RESULTS:Of 2302 participants, 1524 were randomly assigned to the device group and 778 to the control group. Participants in the device group wore the device for a median of 18.0 hours per day (interquartile range, 3.8 to 22.7). Arrhythmic death occurred in 1.6% of the participants in the device group and in 2.4% of those in the control group (relative risk, 0.67; 95% confidence interval [CI], 0.37 to 1.21; P=0.18). Death from any cause occurred in 3.1% of the participants in the device group and in 4.9% of those in the control group (relative risk, 0.64; 95% CI, 0.43 to 0.98; uncorrected P=0.04), and nonarrhythmic death in 1.4% and 2.2%, respectively (relative risk, 0.63; 95% CI, 0.33 to 1.19; uncorrected P=0.15). Of the 48 participants in the device group who died, 12 were wearing the device at the time of death. A total of 20 participants in the device group (1.3%) received an appropriate shock, and 9 (0.6%) received an inappropriate shock. CONCLUSIONS:Among patients with a recent myocardial infarction and an ejection fraction of 35% or less, the wearable cardioverter-defibrillator did not lead to a significantly lower rate of the primary outcome of arrhythmic death than control. (Funded by the National Institutes of Health and Zoll Medical; VEST ClinicalTrials.gov number, NCT01446965 .).

Project description:Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits.

Dataset Information

Arrhythmic episodes in patients implanted with a cardioverter-defibrillator - results from the Prospective Study on Predictive Quality with Preferencing PainFree ATP therapies (4P).

Publications

Arrhythmic episodes in patients implanted with a cardioverter-defibrillator - results from the Prospective Study on Predictive Quality with Preferencing PainFree ATP therapies (4P).

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