Abstract Background and Aims The optimal antithrombotic therapy in patients with device-detected atrial fibrillation (DDAF) is unknown. Concomitant vascular disease can modify the benefits and risks of anticoagulation. Methods These pre-specified analyses of the NOAH-AFNET 6 (n = 2534 patients) and ARTESiA (n = 4012 patients) trials compared anticoagulation with no anticoagulation in patients with DDAF with or without vascular disease, defined as prior stroke/transient ischaemic attack, coronary or peripheral artery disease. Efficacy outcomes were the primary outcomes of both trials, a composite of stroke, systemic arterial embolism (SE), myocardial infarction, pulmonary embolism or cardiovascular death, and stroke or SE. Safety outcomes were major bleeding or major bleeding and death. Results In patients with vascular disease (NOAH-AFNET 6, 56%; ARTESiA, 46%), stroke, myocardial infarction, systemic or pulmonary embolism, or cardiovascular death occurred at 3.9%/patient-year with and 5.0%/patient-year without anticoagulation (NOAH-AFNET 6), and 3.2%/patient-year with and 4.4%/patient-year without anticoagulation (ARTESiA). Without vascular disease, outcomes were equal with and without anticoagulation (NOAH-AFNET 6, 2.7%/patient-year; ARTESiA, 2.3%/patient-year in both randomized groups). Meta-analysis found consistent results across both trials (I2heterogeneity = 6%) with a trend for interaction with randomized therapy (pinteraction = .08). Stroke/SE behaved similarly. Anticoagulation equally increased major bleeding in vascular disease patients [edoxaban, 2.1%/patient-year; no anticoagulation, 1.3%/patient-year; apixaban, 1.7%/patient-years; no anticoagulation, 1.1%/patient-year; incidence rate ratio 1.55 (1.10–2.20)] and without vascular disease [edoxaban, 2.2%/patient-year; no anticoagulation, 0.6%/patient-year; apixaban, 1.4%/patient-year; no anticoagulation, 1.1%/patient-year; incidence rate ratio 1.93 (0.72–5.20)]. Conclusions Patients with DDAF and vascular disease are at higher risk of stroke and cardiovascular events and may derive a greater benefit from anticoagulation than patients with DDAF without vascular disease.
Purpose of review Catheter-based ablation for atrial fibrillation is a useful and effective form of rhythm-control therapy for symptomatic patients. This article reviews the ‘real-world’ experience on the outcomes, complications, and costs of atrial fibrillation ablation. Recent findings Currently, real-world outcomes of atrial fibrillation ablation are derived from retrospective analysis of administrative databases or prospective registries from selected centers and patients. The rate of atrial fibrillation recurrence was reported to be as high as 60% and the rate of repeat ablation ranged from ≈10 to 18% within 1 year after ablation. All-cause hospitalizations after atrial fibrillation ablation were frequent, at up to ≈30% within 1 year and with up to half of them related to atrial fibrillation recurrence or repeat procedures. Rates of periprocedural complications were relatively low (≈3%). Female sex was associated with higher risk of complications such as bleeding, vascular injury, and tamponade. Markov models examining the cost-effectiveness of ablation yielded favorable results when success rates of more than 70% were assumed with long time horizons (>5 years). Summary The real-world outcomes of atrial fibrillation ablation are sobering. Confirmation of these findings with prospective, population-based, minimally biased studies is needed. There is a critical need to delineate the downstream economic impact of atrial fibrillation ablation on society to justify its continued delivery and growth.
Introduction: Clinical risk stratification may refine decision-making regarding primary prevention ICDs and provide a comparator for advanced diagnostic tests for prediction of sudden cardiac death. Objective: To identify predictors of appropriate ICD shock competing with mortality using clinical variables. Methods: We studied a prospective, multicenter, population-based cohort with LVEF ≤35% referred for primary prevention ICD in Ontario, Canada. Patients were followed for appropriate ICD shocks at 18 device follow-up centers and for survival via vital status registry. We used a Fine-Gray subdistribution hazard model to develop a risk score for simultaneous prediction of appropriate ICD shock and death. Results: Among 7020 referred, 3445 pts underwent primary prevention ICD implant (80% men, 66 yrs [IQR: 58-73]). During 5918 person-years (PY) follow-up, there were 204 pts with appropriate shock (3.6 per 100 PY) and 292 deaths (4.9 per 100 PY). Competing risk predictors of appropriate shock included nonsu...
Background— Complications after implantable cardioverter-defibrillator (ICD) replacement are often clinically devastating, particularly when infection or reoperation occurs. Identifying factors contributing to complications may permit identification of high-risk individuals that warrant incremental monitoring and therapy to attenuate risk. In addition, replacement may be a discretionary decision in the context of an advisory or borderline device performance and patient, device, and implanter factors that predict adverse outcome may assist in clinical decision-making. Methods and Results— In a prospective, multicenter, population-based registry of all ICD patients at 18 centers in Ontario, Canada, we examined 45-day complication and all-cause mortality rates from February 2007 to August 2009 in patients undergoing ICD generator replacement. Complications were determined longitudinally and were categorized as major or minor. ICD replacement was performed in 1081 of 5176 patients (20.8%) undergoing ICD implantation (age, 64.3±12.7 years; 78.5% men). In patients undergoing ICD replacement, 47 patients (4.3%) had a complication within 45 days, with 47 major complications in 28 patients (2.6%), most commonly infection (n=23), lead revision (n=35), electrical storm (n=14), and pulmonary edema (n=13). Minor complications occurred in 2.3% of patients, most commonly incisional infection (n=10) and pocket hematoma (n=10). On multivariable analysis, risk factors associated with major complications were Canadian Cardiovascular Society angina class (adjusted hazard ratio [HR], 3.70 for class 2 to 4 versus 0 to 1; P =0.027) and multiple previous procedures on the pocket (adjusted HR, 3.35 for >1 versus 1; P =0.058). Risk factors associated with any complication were the use of antiarrhythmic therapy (adjusted HR, 6.29; P =0.001), implanter volume (adjusted HR 10.4 for <60/y versus >120/y, P =0.026), and Canadian Cardiovascular Society angina class (adjusted HR, 3.00 for class 2 to 4 versus 0 to 1; P =0.031). In a Cox model with a time-dependent variable of major complication within 45 days after replacement, major complications after ICD replacement were associated with an increased risk of mortality at 45, 90, and 180 days (adjusted HR, 9.61, 12.69, and 6.41, respectively; P =0.002 to 0.039). Conclusions— Risk factors associated with complications after ICD replacement include the presence of angina, antiarrhythmic therapy, increased number of previous procedures, and low implanter volume. Major complications may be associated with increased risk of subsequent mortality.
It has been observed that replacement of an implantable cardioverter-defibrillator generator in response to a device advisory may be associated with a substantial rate of complications, including death. The risk of lead revision in response to a lead advisory has not been determined previously.Twenty-five implantable cardioverter-defibrillator implantation and follow-up centers from the Canadian Heart Rhythm Society Device Advisory Committee were surveyed to assess complication rates as a result of lead revisions due to the Sprint Fidelis advisory issued in October 2007. As of June 1, 2009, there had been 310 lead failures found in 6237 Sprint Fidelis leads in Canada (4.97%) over a follow-up of 40 months. There were 469 leads to be revised, 66% for confirmed fracture. Of the patients who underwent revision, 95% had a new lead inserted, whereas 4% had a pace/sense lead added. The lead was removed in 248 cases (53%), by simple traction in 61% and by laser lead extraction in 33%. Complications were encountered in 14.5% of the lead revisions; 7.25% of these were major, whereas 7.25% were minor. There were 2 deaths (0.43%). The overall risk of complications (19.8%) was greater in those who underwent lead removal at the time of revision than in those whose leads were abandoned (8.6%; P=0.0008).The overall rate of major complications that arose from lead revision due to the Sprint Fidelis advisory was significant. This must be taken into account when lead revision is planned in those patients who have not yet demonstrated an abnormality in lead performance.
A dilemma arises about the merits of conservative management vs lead replacement and/or extraction when patients with a Medtronic Sprint Fidelis lead undergo generator replacement. Conflicting reports suggest that the fracture rate may increase after generator change.The purpose of this study was to investigate the effect of generator replacement on Fidelis lead performance.The Carelink PLUS cohort is composed of 21,500 Fidelis leads (model 6949) implanted in 1,006 centers. The survival rate for leads that remained active after the first generator replacement was compared with that for a control group with matched lead implant duration, patient age, patient sex, and generator type using the Kaplan-Meier method. The control group's starting point was adjusted to match the implant duration of each lead in the replacement group to allow for the comparison of similarly aged leads.Of the 2,988 implanted leads in each group, there was no statistical difference in the number of lead fractures between cases and controls (replacement, n = 227; no replacement, n = 257; Fisher exact, P = .169). Lead survival analysis demonstrated that lead performance since the first replacement procedure did not differ from that of the matched control group.The Fidelis lead survival rate after generator replacement does not differ from that of the Fidelis leads that have not had replacement. In the event of generator replacement with no manifestation of lead fracture, the lead model, patient age and life expectancy, ejection fraction, comorbidities, ease of extraction, local extraction expertise, and patient preference should be considered to determine the best course of action.
