Ablation of atrial fibrillation after the retirement age: considerations on safety and outcome

Background: Although the incidence of atrial fibrillation (AF) progressively increases with age, the vast majority of AF ablation is done in middle-aged patients. We evaluated the feasibility and safety of catheter ablation in patients older than 65years of age with paroxysmal and persistent AF. Methods: Out of a total of 230 consecutive AF ablation procedures, 45 patients were older than 65years of age and underwent 53 procedures. The ablation strategy consisted of wide-area circumferential lines around both ipsilateral pulmonary veins using a three-dimensional mapping system. Results: The mean age was 69 ± 3.5years (35 males). The mean duration for AF was 8.7 ± 6.5years. Thirty-nine had paroxysmal and six persistent AF despite use of 1.38 ± 0.77 antiarrhythmic drugs. All patients had a structurally normal heart. Eleven had systemic hypertension. Mean procedure time was 187 ± 33min. Acute procedural success rate with abolition of all pulmonary vein potentials was achieved in all patients. Pericardial tamponade requiring percutaneous drainage occurred in one (1.9%) patient. There were no cardioembolic events. Among the 43 patients whose clinical outcome was assessed at 6months, 34 (79%) had a significant reduction (>90%) of the total symptomatic AF burden, compared to pre-ablation, with a complete lack of symptomatic AF in 32 (74%) patients. The success rate was higher for patients with paroxysmal versus persistent AF (81 vs. 67%). Six patients (11%) underwent repeat procedures. Conclusions: Catheter ablation is a safe and effective treatment for patients over the age of 65years with symptomatic, drug-refractory AF. Therefore, patients should not be excluded from undergoing AF catheter ablation on the basis of age alon

Combination vinorelbine and capecitabine for metastatic breast cancer using a non-body surface area dosing scheme

Purpose : This study sought to determine the maximum tolerated dose of flat-dosed vinorelbine in combination with capecitabine in patients with metastatic breast cancer. At the time of study initiation, it was anticipated that vinorelbine would be developed as an oral capsule. A flat dosing scheme of both drugs was used to facilitate development of the oral regimen, and because neither drug’s clearance is associated with body surface area (BSA), pharmacokinetic and pharmacogenetic endpoints were explored. Experimental Design : Capecitabine was administered orally at 3,000 mg/day on days 1–14. The starting dose of vinorelbine was 20 mg intravenously on days 1 and 8 of a 21-day cycle. The vinorelbine dose was escalated until dose limiting toxicity (DLT). Vinorelbine pharmacokinetics were measured after the first dose. Patients underwent genotype analysis for polymorphisms in the CYP3A5 gene, and the erythromycin breath test (ERMBT), a phenotypic test of CYP3A enzyme activity. Results : Twenty five eligible patients were enrolled. Hematologic DLT was seen at the 50 and 45 mg vinorelbine doses; thus the recommended dose is 40 mg on days 1 and 8. Response rate was 30%, and disease stabilization rate was 64% (all dose levels included). Vinorelbine clearance was not associated with ERMBT, BSA, or age. CYP3A5 genotype in this small sample did not have an obvious relationship to clearance or toxicity. Conclusions : A non-BSA based dosing scheme of capecitabine and vinorelbine is safe and efficacious. BSA did not affect vinorelbine clearance. We recommend future studies with capecitabine and/or vinorelbine to compare the safety and efficacy of flat dosed versus BSA-dosed treatment.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/46933/1/280_2005_Article_132.pd

The Role of Device Diagnostic Algorithms in the Assessment and Management of Patients with Systolic Heart Failure: A Review

Hospitalization due to heart failure (HF) exacerbation represents a major burden in health care and portends a poor long-term prognosis for patients. As a result, there is considerable interest to develop novel tools and strategies to better detect onset of volume overload, as HF hospitalizations may be reduced if appropriate interventions can be promptly delivered. One such innovation is the use of device-based diagnostic parameters in HF patients with implantable cardioverter defibrillators (ICD) and/or cardiac resynchronization therapy (CRT) devices. These diagnostic algorithms can effectively monitor and detect changes in patients' HF status, as well as predict one's risk of HF hospitalization. This paper will review the role of these device diagnostics parameters in the assessment and management of HF patients in ambulatory settings. In addition, the integration of these novel algorithms in existing HF disease management models will be discussed

Defibrillator Shocks and Their Impact on Objective and Subjective Patient Outcomes: Results from the Painfree SST Clinical Trial

BACKGROUND: The impact of ICD shock on device-measured activity and patient reported outcomes is unknown. OBJECTIVE: The purpose of this study was to analyze the acute and long-term effects of ICD shock on objective behavioral data (i.e., device-based physical activity) and subjective patient reported outcomes (e.g., quality of life and shock anxiety). METHODS: The PainFree SST clinical trial included 2,770 patients with a single or dual-chamber ICD, or cardiac resynchronization defibrillator (CRT-D) who were followed for 22 ± 9 months. Participants completed measures of quality of life (EuroQol 5-D [EQ5D]) and shock anxiety (Florida Shock Anxiety Scale [FSAS]) at baseline, bi-annual visits, and monthly for 6 months following an ICD shock. Daily physical activity data were obtained from a built-in device accelerometer. RESULTS: Average daily activity was 185.3 ± 119.4 minutes/day. Activity was significantly reduced after an ICD shock (p<0.0001) and recovered to a normal level after approximately 90 days. ICD shock was also associated with decreased quality of life (EQ5D Health Score) and increased EQ5D anxiety scores, but it did not impact mobility, self-care, activity, or pain. Similarly, shock anxiety (FSAS) increased in shocked patients and remained significantly elevated at 24 months, regardless of appropriate or inappropriate shock delivery. CONCLUSIONS: ICD shocks have a long-lasting, adverse impact on both objective, device-measured physical activity and subjective patient reported outcomes of quality of life and shock anxiety. Successful management of ICD patients requires attention to clinically relevant behavioral and psychological outcomes to expedite recovery and return to activities of daily living

Inappropriate shocks in single-chamber and subcutaneous implantable cardioverter-defibrillators: a systematic review and meta-analysis

Aims: Single-chamber (VR-ICD) and subcutaneous (S-ICD) implantable cardioverter-defibrillators are effective to protect patients against sudden death but expose them to higher risk of inappropriate shock (IS). We sought to quantify the annual rate and influencing factors of ISs in VR- and S-ICDs from the literature. Methods and results: PubMed, Embase, and Cochrane Library were searched for full text articles with IS rates. Poisson distribution estimated proportion of patients with ISs; rates were annualized based on follow-up duration. Random effects meta-analysis accounted for study-to-study variation. Out of 3264 articles, 16 qualified for the meta-analysis. Across studies, 6.4% [95% confidence interval (CI) 5.1-7.9%] of patients received an IS per year. Meta-regression analyses demonstrated that IS rates were lower in more recent studies [rate ratio (RR) per year: 0.93, 95% CI: 0.87-0.98; P = 0.01] and trended lower in studies with longer follow-up (RR per year: 0.78, 95% CI: 0.60-1.01; P = 0.06). Use of S-ICDs (RR: 1.81, 95% CI: 0.86-3.81; P = 0.12) and ventricular tachycardia zone programmed on (RR: 1.13, 95% CI: 0.65-1.97; P = 0.66) were not associated with a significantly increased change in risk. The IS rate observed in one of the more recent studies was significantly lower than predicted after accounting for covariates (RR: 0.29, 95% CI: 0.14-0.60; P < 0.001). Conclusions: A comprehensive review of the literature shows that 6.4% of patients with ICDs experienced their first IS annually. One of the 16 studies was better than predicted with the lowest reported rate (1.9%) and could not be explained by timing of the study or other covariates

Estimating the incidence of atrial fibrillation in single-chamber implantable cardioverter defibrillator patients

BACKGROUND Atrial arrhythmias are associated with major adverse cardiovascular events. Recent reports among implantable cardioverter defibrillator (ICD) patients have demonstrated a high prevalence of atrial fibrillation (AF), predominantly in dual-chamber recipients. AF incidence among patients with single-chamber systems (approximately 50% of all ICDs) is currently unknown. The objective was to estimate the prevalence of new-onset AF among single-chamber ICD patients by observing the rates of new atrial tachycardia (AT)/AF among a propensity scoring matched cohort of dual-chamber ICD patients from the PainFree SST study, to better inform screening initiatives. METHODS Among 2,770 patients enrolled, 1,862 single-chamber, dual-chamber, and cardiac resynchronization therapy (CRT) subjects with no prior history of atrial tachyarrhythmias were included. Daily AT/AF burden was estimated using a propensity score weighted model against data from dual-chamber ICDs. RESULTS Over 22 ± 9 months of follow-up, the estimated incidence of AT/AF - lasting at least 6 minutes, 6 hours and 24 hours per day - in the single-chamber cohort was 22.0%, 9.8% and 6.3%, whereas among dual-chamber patients, the prevalence was 26.6%, 13.1%, and 7.1%, respectively. Initiation of oral anticoagulation (OAC) was estimated to occur in 9.8% of the propensity matched single-chamber cohort, which was higher than the actual observed rate of 6.0%. Stroke and transient ischemic attack (TIA) occurred at low rates in all device subgroups. CONCLUSIONS Atrial arrhythmias occur frequently, and significant underutilization of anticoagulation is suggested in single-chamber ICD recipients. Routine screening for AF should be considered among single-chamber ICD recipients. This article is protected by copyright. All rights reserved