Characterization and financial impact of implantable cardioverter-defibrillator patients without interventions 5 years after implantation

Background: Implantable cardioverter defibrillators (ICD's) are increasingly used for primary and secondary prevention of sudden cardiac death. However, data on how many ICD patients indeed receive appropriate ICD therapy during long-term follow-up is scarce. Aim: The aim of our study was to determine the number of patients without appropriate ICD therapy 5 years after ICD implantation, to identify predicting factors, to assess the occurrence of late first ICD therapy and to quantify the financial impact of ICD therapy in a real-world setting. Design: Prospective observational study. Methods: We prospectively enrolled 322 consecutive ICD patients. Baseline data were collected at implantation and patients were followed for a median of 7.3 years (IQR 5.8-9.2 years). Time to first appropriate ICD therapy (either antitachycardia pacing or cardioversion) was documented. Results: Five years after implantation, 139 patients (43%) had not received appropriate ICD therapy. In multivariable analysis, a primary prevention indication and negative electrophysiological studies prior to ICD implantation were independent predictors of freedom from ICD therapy. Of the patients without ICD therapy, 5 years after implantation, 25% had experienced inappropriate ICD shocks. Two hundred and seven devices (1.5 devices per patient) were needed for the 139 patients without ICD intervention within 5 years, accounting for €31 784 per patient. During an additional follow-up of 3 years, 12% of the patients with unused ICD received a late first appropriate ICD therapy. Conclusions: About half of the ICD patients receive appropriate ICD therapy within 5 years after implantation. Furthermore, there is a significant proportion of patients receiving late first shocks after five initially uneventful year

Holter monitoring for syncope: diagnostic yield in different patient groups and impact on device implantation

Background: Holter monitoring is routinely used in patients referred for the evaluation of syncope, but its diagnostic value in different patient groups is unclear, as is its impact on device implantation (pacemaker or cardioverter-defibrillator). Aim: To determine the diagnostic yield of Holter monitoring in the routine evaluation of syncope, and its impact on subsequent device implantation. Design: Retrospective record review. Methods: We reviewed all Holter studies in patients referred with syncope between 2000 and 2005. Strict criteria were applied to determine whether a study was diagnostic. The diagnostic value of Holter monitoring (overall and in five subgroups: age, gender, structural heart disease, ejection fraction, medication) and its impact on the implantation of devices, were determined. Results: Of 4877 Holter studies, 826 were performed in patients with syncope (age 72 ± 15 years): 71 (8.6%) were considered to explain the syncope. Structural heart disease, ejection fraction and age were significant predictors of a diagnostic study (all p < 0.01), whereas gender and cardiac medication were not. A device was implanted in 33 patients (4.4%) whose initial Holter did not explain their syncope, after mean 7 months, whereas 45 patients (5.4%) received a pacemaker based on the Holter results (p = 0.32). Discussion: The overall diagnostic yield of Holter monitoring in the evaluation of syncope was 8.6%, with dramatic differences between subgroups. Our data suggest that the impact of Holter monitoring on device implantation is generally overestimate

Optimization of imaging before pulmonary vein isolation by radiofrequency ablation: breath-held ungated versus ECG/breath-gated MRA

Isolation of the pulmonary veins has emerged as a new therapy for atrial fibrillation. Pre-procedural magnetic resonance (MR) imaging enhances safety and efficacy; moreover, it reduces radiation exposure of the patients and interventional team. The purpose of this study was to optimize the MR protocol with respect to image quality and acquisition time. In 31 patients (23-73years), the anatomy of the pulmonary veins, left atrium and oesophagus was assessed on a 1.5-Tesla scanner with four different sequences: (1) ungated two-dimensional true fast imaging with steady precession (2D-TrueFISP), (2) ECG/breath-gated 3D-TrueFISP, (3) ungated breath-held contrast-enhanced three-dimensional turbo fast low-angle shot (CE-3D-tFLASH), and (4) ECG/breath-gated CE-3D-TrueFISP. Image quality was scored from 1 (structure not visible) to 5 (excellent visibility), and the acquisition time was monitored. The pulmonary veins and left atrium were best visualized with CE-3D-tFLASH (scores 4.50 ± 0.52 and 4.59 ± 0.43) and ECG/breath-gated CE-3D-TrueFISP (4.47 ± 0.49 and 4.63 ± 0.39). Conspicuity of the oesophagus was optimal with CE-3D-TrueFISP and 2D-TrueFISP (4.59 ± 0.35 and 4.19 ± 0.46) but poor with CE-3D-tFLASH (1.03 ± 0.13) (p < 0.05). Acquisition times were shorter for 2D-TrueFISP (44 ± 1s) and CE-3D-tFLASH (345 ± 113s) compared with ECG/breath-gated 3D-TrueFISP (634 ± 197s) and ECG/breath-gated CE-3D-TrueFISP (636 ± 230s) (p < 0.05). In conclusion, an MR imaging protocol comprising CE-3D-tFLASH and 2D-TrueFISP allows assessment of the pulmonary veins, left atrium and oesophagus in less than 7 min and can be recommended for pre-procedural imaging before electric isolation of pulmonary vein

Fluctuation of left ventricular thresholds and required safety margin for left ventricular pacing with cardiac resynchronization therapy

AIMS: Fluctuations in left ventricular (LV) thresholds with cardiac resynchronization therapy (CRT) are unknown. The LV capture management (LVCM) algorithm automatically measures LV thresholds on a daily basis and offers the opportunity to analyse threshold fluctuations. METHODS AND RESULTS: A total of 282 patients implanted with a Medtronic Concerto CRT-D device were prospectively studied. Device data were collected at periodic visits, including daily thresholds from the preceding 14 days and weekly threshold ranges since implantation, acquired by the LVCM algorithm up to 12 months' follow-up. Overall, LV thresholds remained relatively stable, with 189/208 (91%) patients having a maximum increase in threshold of > or = 1.0 V at any time between their 1 and 6 month visits and 127/135 (94%) between the 6 and 12 month visits. However, increase in threshold was significantly affected by LV threshold amplitude. Of the 170 patients with a 1 month threshold of > or = 2.0 V, 159 (94%) had increases of >1.0 V up to their 6 month visit, whereas 8/38 (21%) patients with or = 2.0 V) LV thresholds, a safety margin of 1.0 V is sufficient to ensure LV capture if phrenic nerve stimulation is an issue, and may be even lower in devices with auto-adaptive capture management algorithms. However, the margin should be greater in patients with higher thresholds because of larger fluctuations. Left ventricular capture management may be particularly useful in these patients to ensure LV capture without sacrificing device longevity

Effects of Verapamil and Ibutilide on Atrial Fibrillation and Postfibrillation Atrial Refractoriness

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/74890/1/j.1540-8167.2002.00151.x.pd

Prospective Assessment of Sex-Related Differences in Symptom Status and Health Perception Among Patients With Atrial Fibrillation.

We prospectively assessed sex-specific differences in health perception, overall symptom status, and specific symptoms in a large cohort of patients with atrial fibrillation. We performed a prospective multicenter observational cohort study of 1553 patients with atrial fibrillation. Patients completed questionnaires about personal characteristics, comorbidities, and symptoms on a yearly basis. Mean age was 70±11 years among women and 67±12 years among men. Health perception on a visual analogue scale ranging from 0 to 100 (with higher scores indicating better health perception) was significantly lower in women than in men (70 [interquartile range: 50-80] versus 75 [interquartile range: 60-85]; javax.xml.bind.JAXBElement@29592a5d &lt;0.0001). More women than men had any symptoms (85.0% versus 68.3%; javax.xml.bind.JAXBElement@7ac0b4e4 &lt;0.0001), palpitations (65.2% versus 44.4%; javax.xml.bind.JAXBElement@41229466 &lt;0.0001), dizziness (25.6% versus 13.5%; javax.xml.bind.JAXBElement@61871784 &lt;0.0001), dyspnea (35.7% versus 21.8%; javax.xml.bind.JAXBElement@16cc22b &lt;0.0001), and fatigue (25.3% versus 19.1%; javax.xml.bind.JAXBElement@7ef43176 =0.006). At 1-year follow-up, symptoms decreased in both sexes but remained more frequent in women (49.1% versus 32.6%, javax.xml.bind.JAXBElement@2b200b6a &lt;0.0001). In multivariable adjusted longitudinal regression models, female sex remained an independent predictor for lower health perception (ß=-4.8; 95% CI, -6.5 to -3.1; javax.xml.bind.JAXBElement@72c212bd &lt;0.0001), any symptoms (odds ratio [OR]: 2.6; 95% CI, 2.1-3.4; javax.xml.bind.JAXBElement@15d8fb54 &lt;0.0001), palpitations (OR: 2.6; 95% CI, 2.1-3.2; javax.xml.bind.JAXBElement@4af80718 &lt;0.0001), dizziness (OR: 2.9; 95% CI, 2.1-3.9; javax.xml.bind.JAXBElement@61282e76 &lt;0.0001), dyspnea (OR: 2.1; 95% CI, 1.6-2.8; javax.xml.bind.JAXBElement@31d9f14 &lt;0.0001), fatigue (OR: 1.6; 95% CI, 1.2-2.2; javax.xml.bind.JAXBElement@51cdd678 =0.0008), and chest pain (OR: 1.8; 95% CI, 1.3-2.6; javax.xml.bind.JAXBElement@5b87db9e =0.001). Women with atrial fibrillation have a substantially higher symptom burden and lower health perception than men. These relationships persisted after multivariable adjustment and during prospective follow-up

Impact of Female Sex on Clinical Outcomes in the FIRE AND ICE Trial of Catheter Ablation for Atrial Fibrillation

BACKGROUND: Data on predictors of long-term clinical outcomes after catheter ablation of atrial fibrillation (AF) are limited. We sought to assess the association of baseline covariates with clinical outcomes in the 750 patients with drug-refractory paroxysmal AF enrolled in FIRE AND ICE. METHODS: In a 2-part analysis, univariate and multivariable Cox regression models were first used to identify baseline patient characteristics predictive of catheter ablation efficacy determined by the clinical end points of (1) atrial arrhythmia recurrence (primary efficacy failure), (2) cardiovascular rehospitalization, and (3) repeat ablation. Propensity score stratification methods were then used to account for differences in baseline characteristics between sexes. RESULTS: Female sex (hazard ratio [HR], 1.37; 95% confidence interval [CI], 1.08-1.73; P=0.010) and prior direct current cardioversion (HR, 1.40; 95% CI, 1.07-1.82; P=0.013) were independently associated with atrial arrhythmia recurrence. Female sex (HR, 1.36; 95% CI, 1.02-1.80; P=0.035) and hypertension (HR, 1.48; 95% CI, 1.09-2.00; P=0.013) independently predicted cardiovascular rehospitalization. A longer history of AF (HR, 1.03; 95% CI, 1.00-1.06; P=0.039) increased the rate of repeat ablation. Women continued to have higher rates of primary efficacy failure and cardiovascular rehospitalization after propensity score adjustment, with adjusted HRs of 1.51 (95% CI, 1.16-2.18; P&lt;0.05) and 1.40 (95% CI, 1.15-2.17; P&lt;0.05), respectively. CONCLUSIONS: After catheter ablation of paroxysmal AF, female sex was associated with an almost 40% increase in the risks of primary efficacy failure and cardiovascular rehospitalization. Primary efficacy failure was also adversely impacted by a history of direct current cardioversion, whereas hypertension had a negative impact on cardiovascular rehospitalization. History of AF was the only predictor of repeat ablation

Predicting Early Mortality Among Implantable Defibrillator Patients Treated With Cardiac Resynchronization Therapy

Background: The beneficial effects of a cardiac resynchronization defibrillator (CRT-D) in patients with heart failure, low left ventricular ejection fraction (LVEF), and wide QRS have clearly been established. Nevertheless, mortality r

Cryoballoon pulmonary vein isolation as first-line treatment of typical atrial flutter: long-term outcomes of the CRAFT trial

\ua9 The Author(s) 2024.Background: CRAFT was an international, multicentre, randomised controlled trial across 11 sites in the United UK and Switzerland. Given the evidence that pulmonary vein triggers may be responsible for atrial flutter (AFL) as well as atrial fibrillation (AF), we hypothesised that cryoballoon pulmonary vein isolation (PVI) would provide greater symptomatic arrhythmia reduction than cavotricuspid isthmus (CTI) ablation, whilst also reducing the subsequent burden of AF. Twelve-month outcomes were previously reported. In this study, we report the extended outcomes of the CRAFT study to 36 months. Methods: Patients with typical AFL and no evidence of AF were randomised 1:1 to cryoballoon PVI or radiofrequency CTI. All patients received an implantable loop recorder (ILR) for continuous cardiac rhythm monitoring. The primary outcome was time-to-symptomatic arrhythmia recurrence &gt; 30 s. Secondary outcomes included time-to-first-AF episode ≥ 2 min. The composite safety outcome included death, stroke and procedural complications. Results: A total of 113 patients were randomised to cryoballoon PVI (n = 54) or radiofrequency CTI ablation (n = 59). Ninety-one patients reconsented for extended follow-up beyond 12 months. There was no difference in the primary outcome between arms, with the primary outcome occurring in 12 PVI vs 11 CTI patients (HR 0.97; 95% CI 0.43–2.20; p = 0.994). AF ≥ 2 min was significantly less frequent in the PVI arm, affecting 26 PVI vs 36 CTI patients (HR 0.48; 95% CI 0.29–0.79; p = 0.004). The composite safety outcome occurred in 5 PVI and 6 CTI patients (p = 0.755). Conclusion: Cryoballoon PVI shows similar efficacy to radiofrequency CTI ablation in reducing symptomatic arrhythmia recurrence in patients presenting with isolated typical AFL but significantly reduces the occurrence of subsequent AF. Graphical Abstract: (Figure presented.)

Design of the Swiss Atrial Fibrillation Cohort Study (Swiss-AF): structural brain damage and cognitive decline among patients with atrial fibrillation.

Several studies found that patients with atrial fibrillation (AF) have an increased risk of cognitive decline and dementia over time. However, the magnitude of the problem, associated risk factors and underlying mechanisms remain unclear. This article describes the design and methodology of the Swiss Atrial Fibrillation (Swiss-AF) Cohort Study, a prospective multicentre national cohort study of 2400 patients across 13 sites in Switzerland. Eligible patients must have documented AF. Main exclusion criteria are the inability to provide informed consent and the presence of exclusively short episodes of reversible forms of AF. All patients undergo extensive phenotyping and genotyping, including repeated assessment of cognitive functions, quality of life, disability, electrocardiography and cerebral magnetic resonance imaging. We also collect information on health related costs, and we assemble a large biobank. Key clinical outcomes in Swiss-AF are death, stroke, systemic embolism, bleeding, hospitalisation for heart failure and myocardial infarction. Information on outcomes and updates on other characteristics are being collected during yearly follow-up visits. Up to 7 April 2017, we have enrolled 2133 patients into Swiss-AF. With the current recruitment rate of 15 to 20 patients per week, we expect that the target sample size of 2400 patients will be reached by summer 2017. Swiss-AF is a large national prospective cohort of patients with AF in Switzerland. This study will provide important new information on structural and functional brain damage in patients with AF and on other AF related complications, using a large variety of genetic, phenotypic and health economic parameters