Effective treatment of paroxysmal atrial fibrillation (AF) is essential for reducing the risk of stroke and heart failure. Cryoballoon (CB) ablation has been developed as an alternative to the use of ...radiofrequency (RF) energy for electrical isolation of the pulmonary veins. Herein, we provide long-term data regarding the efficacy of CB ablation in comparison to RF.
FreezeAF was a randomised non-inferiority study comparing CB ablation with RF ablation for the treatment of patients with drug-refractory paroxysmal AF. Procedural success for the long-term follow-up (30 months) was defined as freedom from AF with an absence of persistent complications.
Of the 315 patients that were randomised and received catheter ablation, 292 (92.7%) completed the 30-month follow-up (147 in the RF group and 145 in the CB group). The baseline characteristics of the RF and CB groups were similar. Single-procedure success was achieved by 40% of patients in the RF group and 42% of the CB group (p < 0.001 for non-inferiority). When including re-do procedures in the analysis, the multiple procedure success rate was 72% in the RF group and 76% in the CB group.
The data provide long-term evidence that CB ablation is non-inferior to RF ablation, with high proportions of patients reporting freedom from AF 30 months after the index procedure.
ClinicalTrials.gov Identifier: NCT00774566 ; first registered October 16, 2008; first patient included October 20, 2008.
There is a lack of data on anticoagulation requirements during ablation of atrial fibrillation (AF). This study compares different oral anticoagulation (OAC) strategies to evaluate risk of bleeding ...and thromboembolic complications.
We conducted a single-centre study in patients undergoing left atrial ablation of AF. Three groups were defined: 1) bridging: interrupted vitamin-K-antagonists (VKA), INR ≤2, and bridging with heparin; 2) VKA: uninterrupted VKA and INR of > 2; 3) DOAC: uninterrupted direct oral anticoagulants. Bleeding complications, thromboembolic events and peri-procedural heparin doses were assessed.
In total, 780 patients were documented. At 48 h, major complications were more common in the bridging group compared to uninterrupted VKA and DOAC groups (OR: 3.42, 95% CI: 1.29-9.10 and OR: 3.01, 95% CI: 1.19-7.61), largely driven by differences in major pericardial effusion (OR: 4.86, 95% CI: 1.56-15.99 and OR: 4.466, 95% CI, 1.52-13.67) and major vascular events (OR: 2.92, 95% CI: 0.58-14.67 and OR: 9.72, 95% CI: 1.00-94.43). Uninterrupted VKAs and DOACs resulted in similar odds of major complications (overall OR: 1.14, 95% CI: 0.44-2.92), including cerebrovascular events (OR: 1.21, 95% CI: 0.27-5.45). However, whereas only TIAs were observed in DOAC and bridging groups, strokes also occurred in the VKA group. Rates of minor complications (pericardial effusion, vascular complications, gastrointestinal hemorrhage) and major/minor groin hemorrhage were similar across groups.
Our dataset illustrates that uninterrupted VKA and DOAC have a better risk-benefit profile than VKA bridging. Bridging was associated with a 4.5× increased risk of complications and should be avoided, if possible.
There is a lack of data on the comparative efficacy and procedural safety of open irrigated radiofrequency (RF) and cryoballoon catheter (CB) ablation for pulmonary vein isolation in patients with ...paroxysmal atrial fibrillation.
In a prospective, noninferiority study, 315 patients were randomly assigned to RF (n=159) or CB (n=156) ablation. The primary end point was freedom from atrial arrhythmia with absence of persistent complications. Patients were largely comparable between groups with more vascular disease in the RF group (8.2% versus 2.6% for CB; P=0.028). The primary end point at 12 months was achieved by 70.7% with RF and 73.6% with CB (multiple procedure success), including 31 redo procedures in each group (19.5% of RF versus 19.9% of CB; P=0.933). For the intention-to-treat population, noninferiority of CB was revealed for the predefined inferiority margin (risk difference, 0.029; 95% confidence interval, -0.074 to 0.132; P<0.001). Rates at 6 months were 63.1% and 64.1% for the RF and CB groups (single procedure success), and noninferiority was confirmed (risk difference, 0.010; 95% confidence interval, -0.097 to 0.116; P=0.002). Periprocedural complications for the index procedure were more frequent in the CB group (5.0% RF, 12.2% CB; P=0.022) with a significant difference in phrenic nerve palsies (0% RF, 5.8% CB; P=0.002).
This large, prospective, randomized, controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00774566.
Leadless pacing is now an established alternative to conventional pacing with subcutaneous pocket and transvenous lead for patients with class I or II single-chamber pacing indication. Available ...12-month follow-up data shows a 48% fewer major complication rate in patients with Micra™ compared to a historical control group in a nonrandomized study
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. There is one system with Food and Drug Administration (FDA) approval and two with the Communauté Européenne (CE) mark. The OPS code for the implantation is 8–83d.3 and the procedure has recently been rated as a “new Examination and Treatment Method (NUB)” in the German DRG system, meaning adequate reimbursement is negotiable with health insurance providers. The systems offer similar generator longevity and programming possibilities as conventional pacemaker systems, including rate response, remote monitoring, and MRI safety. The biggest downsides to date are limitations to single-chamber stimulation, lack of long-time data, and concerns of handling of the system at the end of its life span. However, implant procedure complication rates and procedure times do not exceed conventional pacemaker operations, and proper training and patient selection is provided.
Background
Exercise training has now become established practice in patients with chronic heart failure. Women are often under-represented in intervention studies compared to men. For this reason it ...was our aim to conduct a combined endurance and muscle strength training program to evaluate its effect on clinical performance data and health-related psychosocial factors in women and men.
Methods
One hundred and sixteen women, mean age 69 ± 9 years, body mass index (BMI) 25.8 ± 4.9, and 169 men, mean age 66 ± 9 years, BMI 26.6 ± 3.6 underwent combined endurance/resistance training. The training program lasted 29 ± 7 days and comprised bicycle ergometer training, a 6-min walk test as a training unit and muscle strength training for the lower and upper extremities.
Results
Differences between women and men were found in clinical parameters. In particular, statistically significant differences were revealed between the women and men with regard to cardiopulmonary performance. Quality of life was significantly improved on discharge with regard to both physical and mental health, whereas anxiety and depression showed no significant alteration.
Conclusion
A specialized in-hospital program for women and men combining endurance/resistance training and education is feasible. But our program revealed a very low level of cardiopulmonary performance in women. Women need to be encouraged and motivated to participate in such programs.
Chronic heart failure (CHF) will become one of the greatest medical challenges during the next decades. This is especially true with regard to elderly patients. Besides medical diagnostics and drug ...therapy, efficient treatment of CHF must also include exercise training.
The purpose of our study was 1) to record health-related quality of life (QOL) in elderly patients with CHF and 2) to assess the efficacy of a training program, as well as to evaluate any changes detected during a six month follow-up.
In our non-randomized study, 116 patients, divided according to age into Group 1 (>70 years) and Group 2 (<70 years), took part in a 4-week training program.
There were differences in the clinical parameters and the QOL between the older and the younger patients both after 4 weeks and at the follow-up. After six months, however, the older patients again recorded having an inferior QOL to that of the younger patients.
Elderly patients can also benefit from physical exercise training, with improvement in clinical parameters and QOL. In order to maintain the subjectively improved QOL in the long term, however, continued special heart failure education and support is required.
Background:
There is now evidence that moderate training plays an important role in the treatment of chronic heart failure. No clear instructions exist to date as to how such training programs should ...be carried out.
Aim:
to assess the efficiency of a training program including bicycle ergometer training, moderate muscle strength training and the 6‐min walk test and their influence on quality of life, anxiety and depression.
Methods and results:
Patients (67 male, 21 female) underwent a standardized 4‐week training program. Baseline data: LVEF=31±8%; LVEDD=143±59 ml; peak VO2=13.9±4.6 kg/ml. No adverse side effects could be observed. At discharge LVEF was 37±9%, (P=0.001); LVEDD=131±44ml (P=0.01); and peak VO2=15.4±5.0 kg/ml. Quality of life improved significantly in nearly all domains and in summary score. There were no significant changes in anxiety and depression. There is a negative correlation between the initial workload and changes in physical health (r=−0.42, P=0.001) and only a weak correlation between age and positive changes in physical health (r=0.26, P=0.05).
Conclusions:
A standardized training program including moderate muscle strength training could be performed safely and demonstrated improvement in clinical parameters and quality of life.
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