Cardiac tamponades related to interventional electrophysiology procedures are associated with higher risk of short-term hospitalization for pericarditis but favourable long-term outcome.

AIMS: To investigate the association of iatrogenic cardiac tamponades as a complication of invasive electrophysiology procedures (EPs) and mortality as well as serious cardiovascular events in a nationwide patient cohort during long-term follow-up. METHODS: From the Swedish Catheter Ablation Registry between 2005 and 2019, a total of 58 770 invasive EPs in 44 497 patients were analysed. From this, all patients with periprocedural cardiac tamponades related to invasive EPs were identified (n = 200; tamponade group) and matched (1:2 ratio) to a control group (n = 400). Over a follow-up of 5 years, the composite primary endpoint-death from any cause, acute myocardial infarction, transitory ischaemic attack (TIA)/stroke, and hospitalization for heart failure-revealed no statistically significant association with cardiac tamponade [hazard ratio (HR) 1.22 (95% CI, 0.79-1.88)]. All single components of the primary endpoint as well as cardiovascular death revealed no statistically significant association with cardiac tamponade. Cardiac tamponade was associated with a significantly higher risk with hospitalization for pericarditis [HR 20.67 (95% CI, 6.32-67.60)]. CONCLUSION: In this nationwide cohort of patients undergoing invasive EPs, iatrogenic cardiac tamponade was associated with an increased risk of hospitalization for pericarditis during the first months after the index procedure. In the long-term, however, cardiac tamponade revealed no significant association with mortality or other serious cardiovascular events.

Effect of Catheter Ablation vs Antiarrhythmic Medication on Quality of Life in Patients With Atrial Fibrillation: The CAPTAF Randomized Clinical Trial.

Importance: Quality of life is not a standard primary outcome in ablation trials, even though symptoms drive the indication. Objective: To assess quality of life with catheter ablation vs antiarrhythmic medication at 12 months in patients with atrial fibrillation. Design, Setting, and Participants: Randomized clinical trial at 4 university hospitals in Sweden and 1 in Finland of 155 patients aged 30-70 years with more than 6 months of atrial fibrillation and treatment failure with 1 antiarrhythmic drug or ß-blocker, with 4-year follow-up. Study dates were July 2008-September 2017. Major exclusions were ejection fraction <35%, left atrial diameter >60 mm, ventricular pacing dependency, and previous ablation. Interventions: Pulmonary vein isolation ablation (n = 79) or previously untested antiarrhythmic drugs (n = 76). Main Outcomes and Measures: Primary outcome was the General Health subscale score (Medical Outcomes Study 36-Item Short-Form Health Survey) at baseline and 12 months, assessed unblinded (range, 0 [worst] to 100 [best]). There were 26 secondary outcomes, including atrial fibrillation burden (% of time) from baseline to 12 months, measured by implantable cardiac monitors. The first 3 months were excluded from rhythm analysis. Results: Among 155 randomized patients (mean age, 56.1 years; 22.6% women), 97% completed the trial. Of 79 patients randomized to receive ablation, 75 underwent ablation, including 2 who crossed over to medication and 14 who underwent repeated ablation procedures. Of 76 patients randomized to receive antiarrhythmic medication, 74 received it, including 8 who crossed over to ablation and 43 for whom the first drug used failed. General Health score increased from 61.8 to 73.9 points in the ablation group vs 62.7 to 65.4 points in the medication group (between-group difference, 8.9 points; 95% CI, 3.1-14.7; P = .003). Of 26 secondary end points, 5 were analyzed; 2 were null and 2 were statistically significant, including decrease in atrial fibrillation burden (from 24.9% to 5.5% in the ablation group vs 23.3% to 11.5% in the medication group; difference -6.8% [95% CI, -12.9% to -0.7%]; P = .03). Of the Health Survey subscales, 5 of 7 improved significantly. Most common adverse events were urosepsis (5.1%) in the ablation group and atrial tachycardia (3.9%) in the medication group. Conclusions and Relevance: Among patients with symptomatic atrial fibrillation despite use of antiarrhythmic medication, the improvement in quality of life at 12 months was greater for those treated with catheter ablation compared with antiarrhythmic medication. Although the study was limited by absence of blinding, catheter ablation may offer an advantage for quality of life. Trial Registration: clinicaltrialsregister.eu Identifier: 2008-001384-11.

A decade of catheter ablation of cardiac arrhythmias in Sweden: ablation practices and outcomes.

AIMS: Catheter ablation is considered the treatment of choice for many tachyarrhythmias, but convincing 'real-world' data on efficacy and safety are lacking. Using Swedish national registry data, the ablation spectrum, procedural characteristics, as well as ablation efficacy and reported adverse events are reported. METHODS AND RESULTS: Consecutive patients (≥18 years of age) undergoing catheter ablation in Sweden between 01 January 2006 and 31 December 2015 were included in the study. Follow-up (repeat ablation and vital status) was collected through 31 December 2016. A total of 26 642 patients (57 ± 15 years, 62% men), undergoing a total of 34 428 ablation procedures were included in the study. In total, 4034 accessory pathway/Wolff-Parkinson-White syndrome (12%), 7358 AV-nodal re-entrant tachycardia (21%), 1813 atrial tachycardia (5.2%), 5481 typical atrial flutter (16%), 11 916 atrial fibrillation (AF, 35%), 2415 AV-nodal (7.0%), 581 premature ventricular contraction (PVC, 1.7%), and 964 ventricular tachycardia (VT) ablations (2.8%) were performed. Median follow-up time was 4.7 years (interquartile range 2.7-7.0). The spectrum of treated arrhythmias changed over time, with a gradual increase in AF, VT, and PVC ablation (P < 0.001). Decreasing procedural times and utilization of fluoroscopy with time, were seen for all arrhythmia types. The rates of repeat ablation differed between ablation types, with the highest repeat ablation seen in AF (41% within 3 years). The rate of reported adverse events was low (n = 595, 1.7%). Death in the immediate period following ablation was rare (n = 116, 0.34%). CONCLUSION: Catheter ablations have shifted towards more complex procedures over the past decade. Fluoroscopy time has markedly decreased and the efficacy of catheter ablation seems to improve for AF.

Cryoballoon vs. radiofrequency ablation for atrial fibrillation: a study of outcome and safety based on the ESC-EHRA atrial fibrillation ablation long-term registry and the Swedish catheter ablation registry.

AIMS: Pulmonary vein isolation (PVI), the standard for atrial fibrillation (AF) ablation, is most commonly applied with radiofrequency (RF) energy, although cryoballoon technology (CRYO) has gained widespread use. The aim was to compare the second-generation cryoballoon and the irrigated RF energy regarding outcomes and safety. METHODS AND RESULTS: Of 4657 patients undergoing their first AF ablation, 982 with CRYO and 3675 with RF energy were included from the Swedish catheter ablation registry and the Atrial Fibrillation Ablation Long-Term registry of the European Heart Rhythm Association of the European Society of Cardiology. The primary endpoint was repeat AF ablation. The major secondary endpoints included procedural duration, tachyarrhythmia recurrence, and complication rate. The re-ablation rate after 12 months was significantly lower in the CRYO vs. the RF group, 7.8% vs. 11%, P = 0.005, while freedom from arrhythmia recurrence (30 s duration) did not differ between the groups, 70.2 % vs. 68.2%, P = 0.44. The result was not influenced by AF type and lesion sets applied. In the Cox regression analysis, paroxysmal AF had significantly lower risk for re-ablation with CRYO, hazard ratio 0.56 (P = 0.041). Procedural duration was significantly shorter with CRYO than RF, (mean ± SD) 133.6 ± 45.2 min vs. 174.6 ± 58.2 min, P < 0.001. Complication rates were similar; 53/982 (5.4%) vs. 191/3675 (5.2%), CRYO vs. RF, P = 0.806. CONCLUSION: The lower re-ablation rates and shorter procedure times observed with the cryoballoon as compared to RF ablation may have important clinical implications when choosing AF ablation technique despite recognized limitations with registries.

Cardioversion of atrial fibrillation does not affect obstructive sleep apnea.

BACKGROUND: Sleep apnea is common in patients with atrial fibrillation, but the effect of the cardioversion of atrial fibrillation to sinus rhythm on central and obstructive apneas is mainly unknown. The primary aim of the study was to analyze the association between cardioversion of atrial fibrillation and sleep apneas, to investigate whether obstructive or central sleep apneas are reduced following cardioversion. A secondary objective was to study the effect on sleep quality. METHODS: Twenty-three patients with atrial fibrillation were investigated using overnight polysomnography, including esophagus pressure monitoring and ECG, before and after the cardioversion of persistent atrial fibrillation. RESULTS: Obstructive sleep apnea occurred in 17/23 patients (74%), and central sleep apnea in 6/23 patients (26%). Five patients had both obstructive and central sleep apnea. Sinus rhythm at follow-up was achieved in 16 patients. The obstructive apnea-hypopnea index, central apnea-hypopnea index, and the number of patients with obstructive or central sleep apnea did not differ before and after restoration of sinus rhythm. Sleep time, sleep efficiency, time in different sleep stages, and subjective daytime sleepiness were normal and unaffected by cardioversion. CONCLUSIONS: Both obstructive and central sleep apneas are highly prevalent in patients with persistent atrial fibrillation. Obstructive sleep apneas are unaffected by the cardioversion of atrial fibrillation to sinus rhythm. The sleep pattern is normal and unaffected by cardioversion in patients with atrial fibrillation. CLINICAL TRIAL REGISTRATION: Trial number NCT00429884.

U22 protocol as measure of symptomatic improvement after catheter ablation of atrial fibrillation.

INTRODUCTION: Left atrial catheter ablation is useful as symptomatic treatment in selected patients with atrial fibrillation (AF). Evaluation requires measurement of arrhythmia-related symptoms. Many of the published protocols have drawbacks and have been used in AF only, with no possible comparison to other ablations that compete for the same resources. U22 is a published protocol that quantifies paroxysmal tachycardia symptoms through scales with 11 answer alternatives, translated into discrete numerical scales 0-10. It has been shown to reflect the clinical improvement after ablation of supraventricular tachycardia. Here we report the use of U22 in measuring improvement after catheter ablation for AF. MATERIAL AND METHODS: A total of 105 patients underwent first-time ablation for AF and answered U22 and SF-36 forms at baseline and follow-up 304 (SD 121) days after ablation. Independently, the patients underwent a clinical follow-up. All decisions regarding medication and reablation were taken without knowledge of the symptom scores. Results. The U22 scores for well-being, arrhythmia as cause for impaired well-being, derived time-aspect score for arrhythmia, and discomfort during attack detected relevant improvements of symptoms after the ablation. U22 showed larger improvement in patients undergoing only one procedure than in patients who later underwent repeated interventions, thus reflecting the independent clinical decision for reablation. CONCLUSION: U22 quantifies the symptomatic improvement after AF ablation with adequate internal consistency and construct validity. U22 mirrors aspects of the arrhythmia symptomatology other than SF-36.

The predictive value of C-reactive protein on recurrence of atrial fibrillation after cardioversion with or without treatment with atorvastatin.

BACKGROUND: The aim of this study was to investigate whether high-sensitivity C-reactive protein (hsCRP) levels prior to cardioversion (CV) predict recurrence of atrial fibrillation (AF) in patients randomized to treatment with either atorvastatin or placebo 30 and 180 days after CV. METHODS: This was a prespecified substudy of 128 patients with persistent AF randomized to treatment with atorvastatin 80 mg/day or placebo, initiated 14 days before CV, and continued 30 days after CV. HsCRP levels were measured at randomization, at the time of CV, and 2 days and 30 days after CV. RESULTS: In univariate analysis of those who were in sinus rhythm 2h after CV, hsCRP did not significantly (odds ratio [OR] 1.11, 95% confidence interval [CI] 0.99-1.25) predict recurrence of AF at 30 days. However, after adjusting for treatment with atorvastatin, hsCRP predicted the recurrence of AF (OR 1.14, 95% CI 1.01-1.27). In a multivariate logistic regression analysis with gender, age, body mass index (BMI), smoking, cholesterol, and treatment with atorvastatin as covariates, the association was still significant (OR 1.14, 95% CI 1.01-1.29). Six months after CV, hsCRP at randomization predicted recurrence of AF in both univariate analysis (OR 1.30, 95% CI 1.06-1.60) and in multivariate logistic regression analysis (OR 1.33, 95% CI 1.06-1.67). CONCLUSION: HsCRP was associated with AF recurrence one and six months after successful CV of persistent AF. However, the association at one month was significant only after adjusting for atorvastatin treatment.

Markers of fibrinolysis as predictors for maintenance of sinus rhythm after electrical cardioversion.

INTRODUCTION: Inflammation, endothelial dysfunction and metabolic pathways provide possible links between the inflammatory and hypofibrinolytic states in atrial fibrillation. Our aim was to explore the role of mass concentrations of PAI-1 and tPA, activities of PAI-1 and tPA as predictors of recurrence of atrial fibrillation adjusted for CRP. MATERIALS AND METHODS: The study included 129 patients with persistent atrial fibrillation. Laboratory analyses were performed including PAI-1 activity, PAI-1 mass, tPA activity, tPA mass and CRP in baseline. Patients were then randomized to atorvastatin (40 mg, two tablets once daily) or placebo, initiated at least 14 days before the elective cardioversion. Further samples and follow-up were made at day 2 and 30 days after cardioversion. RESULTS: In univariate logistic regression no fibrinolytic variable was significantly correlated with rhythm in day 30. In multivariate analysis lower PAI-1 mass was significantly associated with sinus rhythm in all models including fibrinolytic variables, CRP, metabolic components, age, hypertension and smoking. After adding treatment allocation to the fully adjusted model, PAI-1 mass remained significantly associated with sinus rhythm both at day 2 and 30 (OR 0.98; 95% CI 0.95-1.00). CONCLUSIONS: No fibrinolytic component alone was found to be a predictor of recurrence of atrial fibrillation. In multivariate models lower PAI-1 mass was associated with sinus rhythm even after adjusting for CRP, markers of the metabolic syndrome and treatment with atorvastatin. Our findings suggest a patophysiological link between AF and PAI-1 mass but the relation to inflammation remains unclear.

Symptomatic improvement after catheter ablation of supraventricular tachycardia measured by the arrhythmia-specific questionnaire U22.

INTRODUCTION: The main indication for ablation of supraventricular tachycardia is symptomatic relief. Generic measures of quality of life are not suitable for direct evaluation of arrhythmia-related symptoms, and a specific tool is needed. The questionnaire U22 quantifies symptoms associated with arrhythmic events. It uses discrete 0-10 scales for quantification of influence of arrhythmia on well-being, intensity of discomfort, type of dominant symptom, and a time aspect that summarizes duration and frequency of spells. We evaluated U22 in a well defined group of patients with paroxysmal supraventricular tachycardia, undergoing an intervention with a distinct end-point and a high success rate. METHODS: Symptoms in patients with accessory pathway and atrioventricular nodal re-entrant tachycardia scheduled for ablation were measured with U22 and SF-36 on admission. The evaluation was repeated after 6 months. RESULTS: Altogether 58 patients successfully ablated in 2006-2008 completed the four forms (U22 and SF-36 at base-line and follow-up, 210 ± 35 days after ablation). The score for well-being (0-10; 10 being best) increased from 5.9 ± 2.6 to 7.9 ± 1.9 (P < 0.0005). The score for arrhythmia as cause for impairment in well-being (0-10; 10 being highest) decreased from 7.5 ± 2.8 to 2.0 ± 3.1 (P < 0.0005). The time aspect score (0-10) decreased from 4.7 ± 1.5 to 1.4 ± 1.8 (P < 0.0005). The two SF-36 summary measures PCS and MCS increased from 46.9 ± 9.4 to 48.4 ± 10.7 and from 44.9 ± 12.5 to 49.1 ± 9.9 (P = 0.04 and 0.002). CONCLUSION: After successful ablation of accessory pathway and atrioventricular nodal re-entrant tachycardia, the U22 protocol detected a relevant increase in arrhythmia-related well-being. Modest improvement in general well-being was detected by the SF-36 protocol.

U22, a protocol to quantify symptoms associated with supraventricular tachycardia.

BACKGROUND: The main indication for ablation of supraventricular tachyarrhythmias (SVTA) is symptomatic relief. Specific paroxysmal symptoms cannot be quantified with general measures of quality of life, such as with the SF-36 questionnaire. U22 is a new protocol which measures the effects of arrhythmia on well-being, the intensity of discomfort during an episode, the type and temporal characteristics of dominant symptoms, and the duration and frequency of episodes. Discrete 0-10 scales are used. Unlike SF-36, U22 can be used in individual patients. METHODS: U22 and SF-36 protocols were used in the symptomatic evaluation of 88 patients (mean age = 49.6 +/- 16.4 years; 43 men), who underwent catheter ablation of SVTA. RESULTS: The U22 scores (SD) for (a) well-being (10 being best), (b) effects of arrhythmia on well-being (10 being worst), and (c) discomfort during arrhythmia (10 being worst) were 5.6 (2.7), 7.5 (2.8), and 8.0 (2.4), respectively. For comparison, the physical and mental component summaries of SF-36 were 45.3 (11.0) and 45.2 (12.1), respectively, slightly lower than the expected normal of 50. The intensity of dominant symptom scored by U22 was 9.7 (1.2), 10 being worst. In 29% of patients > or =4 symptoms were equally dominant. Multiple dominant symptoms in U22 were associated with a low general well-being in SF-36. CONCLUSION: We found U22 useful to quantify symptoms associated with SVTA.

Atorvastatin and persistent atrial fibrillation following cardioversion: a randomized placebo-controlled multicentre study.

AIMS: To evaluate the effect of atorvastatin in achieving stable sinus rhythm (SR) 30 days after electrical cardioversion (CV) in patients with persistent atrial fibrillation (AF). METHODS AND RESULTS: The study included 234 patients. The patients were randomized to treatment with atorvastatin 80 mg daily (n = 118) or placebo (n = 116) in a prospective, double-blinded fashion. Treatment was initiated 14 days before CV and was continued 30 days after CV. The two groups were well-balanced with respect to baseline characteristics. Mean age was 65 +/- 10 years, 76% of the patients were male and 4% had ischaemic heart disease. Study medication was well-tolerated in all patients but one. Before primary endpoint 12 patients were excluded. In the atorvastatin group 99 patients (89%) converted to SR at electrical CV compared with 95 (86%) in the placebo group (P = 0.42). An intention-to-treat analysis with the available data, by randomization group, showed that 57 (51%) in the atorvastatin group and 47 (42%) in the placebo group were in SR 30 days after CV (OR 1.44, 95%CI 0.85-2.44, P = 0.18). CONCLUSION: Atorvastatin was not statistically superior to placebo with regards to maintaining SR 30 days after CV in patients with persistent AF.

Long-term follow-up of patients treated with ICD: benefit in patients with preserved left ventricular function.

OBJECTIVE: Most major defibrillator trials have short follow-up and may neither capture the benefit for those with preserved function nor the progressive nature of advanced heart disease. We intended to investigate the long-term outcome in an unselected population of patients treated with ICD. DESIGN: We followed 124 consecutive patients that received an ICD during 1993-2002 at our institution for a median of 6.1 years. Information about heart disease, index arrhythmia, follow-up and death was extracted from medical records. RESULTS: The crude mortality was 26% (32/124). One- and two-year mortality was 6% and 12%, estimated 5- and 10-year mortality 20% and 33%. The cause of death was heart failure in 75% of deaths. The ejection fraction was below 35% in 91% of the 32 patients who died. We estimated that 28% of the patients received lifesaving therapy. The relative number of saved lives and complications was not related to the ejection fraction. CONCLUSION: Patients with preserved left ventricular function are excellent candidates for ICD, with life-saving ICD therapies in a substantial proportion, low mortality and good quality of life.

Reduction of fluoroscopy duration in radiofrequency ablation obtained by the use of a non-fluoroscopic catheter navigation system.

AIMS: Radiofrequency (RF) ablation requires placement of several catheters at critical positions. The catheters are positioned with fluoroscopy, resulting in a significant radiation exposure. We have investigated to what degree an intracardiac navigation system reduces the fluoroscopy duration in different groups of routine RF ablations. METHODS AND RESULTS: The fluoroscopy time was evaluated in 365 consecutive routine RF ablations, performed between 2002 and 2005. An intracardiac navigation system (LocaLisa, Medtronic) was used from 2003. The data were prospectively entered into a database and subsequently retrieved, and the procedures classified as being performed with fluoroscopy only or with the aid of the LocaLisa system. After introduction of the LocaLisa system, the median fluoroscopy time decreased from 24 to 10 min in the 141 atrioventricular nodal re-entry tachycardia (AVNRT) ablations and from 43 to 28 min in the 71 atrial flutter (AFl) ablations (P<0.005 for both). In the 145 Wolff-Parkinson-White (WPW) ablations, a decrease from 27 to 23 min was observed (P=0.03). The decrease in AVNRT and AFl, but not in WPW was associated with the introduction of the LocaLisa system. CONCLUSION: The use of the LocaLisa system during RF ablations significantly reduced the fluoroscopy time in AVNRT and AFl ablations, by a median of 58% and 46%, respectively.

Injury tolerance and response of the ankle joint in dynamic dorsiflexion.

Forced dorsiflexion in frontal vehicle crashes is considered a common cause of injury to the ankle joint. Although a few studies have been published on the dynamic fracture tolerance of the ankle in dorsiflexion, this work reexamines the topic with increased statistical power, adds an evaluation of articular cartilage injury, and utilizes methods to detect the true time of fracture. The objective of this study was to measure the response and injury tolerance of the human ankle in a loading condition similar to that found in a vehicle crash with toepan intrusion. A test fixture was constructed to apply forefoot impacts to twenty cadaveric lower limbs, that were anatomically intact distal to the femur mid-diaphysis. Specimen instrumentation included implanted tibial and fibular load cells, accelerometers, angular rate sensors, and an acoustic sensor. Following the tests, specimens were radiographed and dissected to determine the extent of injury. Eleven of the twenty specimens sustained fracture of the ankle joint. Fractures of the medial malleolus were the most common, while two specimens sustained bimalleolar fractures, and two a talar neck fracture. Other injuries included ligament tears, osteochondral fractures, and cartilage abrasions. Analysis of the acoustic emission indicated that fracture did not always occur at the peak ankle moment. Based on the results of this study, an ankle joint moment of 59 N-m represents a 25% risk of ankle fracture in dorsiflexion for a 50(th) percentile male. When applied to the Thor-Lx dummy, the 25% risk of injury occurs at 36 degrees of dorsiflexion as measured by the ankle potentiometer.