Transcatheter left atrial appendage (LAA) occlusion is an alternative strategy for stroke prevention in patients with atrial fibrillation (AF).
This study sought to determine the incidence, ...predictors, and prognosis of thrombus formation on devices in patients with AF who were treated with LAA closure.
The study retrospectively analyzed data from patients treated with 2 LAA closure devices seen in 8 centers in France from February 2012 to January 2017.
A total of 469 consecutive patients with AF underwent LAA closure (272 Watchman devices Atritech, Boston Scientific, Natick, Massachusetts and 197 Amplatzer devices St. Jude Medical, Minneapolis, Minnesota). Mean follow-up was 13 ± 13 months, during which 339 (72.3%) patients underwent LAA imaging at least once. There were 98 major adverse events (26 thrombi on devices, 19 ischemic strokes, 2 transient ischemic attacks, 18 major hemorrhages, 33 deaths) recorded in 89 patients. The incidence of device-related thrombus in patients with LAA imaging was 7.2% per year. Older age (hazard ratio HR: 1.07 per 1-year increase; 95% confidence interval CI: 1.01 to 1.14; p = 0.02) and history of stroke (HR: 3.68; 95% CI: 1.17 to 11.62; p = 0.03) were predictors of thrombus formation on the devices, whereas dual antiplatelet therapy (HR: 0.10; 95% CI: 0.01 to 0.76; p = 0.03) and oral anticoagulation at discharge (HR: 0.26; 95% CI: 0.09 to 0.77; p = 0.02) were protective factors. Thrombus on the device (HR: 4.39; 95% CI: 1.05 to 18.43; p = 0.04) and vascular disease (HR: 5.03; 95% CI: 1.39 to 18.23; p = 0.01) were independent predictors of ischemic strokes and transient ischemic attacks during follow-up.
Thrombus formation on the device is not uncommon in patients with AF who are treated by LAA closure. Such events are strongly associated with a higher risk of ischemic stroke during follow-up. (REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion RELEXAO; NCT03279406)
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The number of cardiac implantable electronic device (CIED) implantations has increased over recent years as a result of population growth, increasing life expectancy, adoption of guidelines, and ...better access to healthcare. Transvenous lead extraction (TLE), as a part of an overall lead management strategy, has also been increasing, not only as a consequence of this growth, but also because of increasing rates of infection, lead failure, awareness of indications for lead management, and development of extraction tools. Clinical research is essential for understanding efficacy and risks of TLE, which has important implications regarding decision-making and therapeutic strategies in patients who are candidates for this procedure. Data on TLE have mainly come from retrospective series, with variable reporting of endpoints. Recently, the ELECTRa registry conducted by the European Heart Rhythm Association (EHRA), has reported the largest prospective experience on lead extraction published to date in 3555 patients recruited from 19 European countries. There remain unresolved issues, which is a strong incentive for conducting further specifically-designed clinical trials to answer important questions in this area. In addition to clinical studies, national registries are potentially useful for evaluating epidemiology of TLE as well as for quality control and understanding resource implications. Standardization of definitions and reporting of parameters are paramount in order to analyse, compare, and pool data for scientific purposes. Expert consensus statements on lead extraction have been published by the Heart Rhythm Society (HRS) in 2009 and 2017, and by EHRA in 2012. Experience from the ELECTRa registry has been valuable for identifying challenges faced with conducting scientific studies in this field, and provides a framework for future endeavours.
This writing group has been commissioned by EHRA to provide recommendations for designing scientific studies, reports and registries relating to lead extraction.
Cryoballoon ablation (Cryoballoon) has emerged as a new alternative for the treatment of symptomatic drug-refractory atrial fibrillation (AF). Whether the results of Cryoballoon are more reproducible ...than those of radiofrequency (RF) ablation remains to be proved.
A total of 860 consecutive patients undergoing a first ablation procedure for paroxysmal AF (467 treated with RF and 393 treated with Cryoballoon) were selected from a prospective multicentre survey of AF ablation (FrenchAF). Radiofrequency and Cryoballoon were compared regarding mid-term efficacy and safety. During a median follow-up of 14 months (interquartile range 8-23), patients treated with Cryoballoon displayed similar rates of freedom from atrial arrhythmia relapse in centres performing this technique (68-80% at 18 months). However, in centres performing RF, a greater heterogeneity in procedural results was observed (46-79% were free from atrial arrhythmia relapse at 18 months). On multivariate analysis, Cryoballoon (HR = 0.47, 95% CI 0.35-0.65, P < 0.001) and annual AF ablation caseload (HR = 0.87 per every 100 AF ablation procedures per year; 95% CI 0.80-0.96, P = 0.003) were independent predictors of procedural success. However, on sensitivity analysis, according to the ablation method, annual AF ablation caseload predicted only sinus rhythm maintenance in the subgroup of patients treated with RF. Analysis of interoperator results with Cryoballoon and RF confirmed lower reproducibility of RF, but suggested that besides caseload, other operator-related factors may play a role.
Cryoballoon seems to be less operator-dependent and more reproducible than RF in the setting of paroxysmal AF ablation.
The Nanostim leadless pacemaker (LP) met the primary endpoints in an investigational device exemption trial, and was shown to be fully retrievable percutaneously. In October 2016, St Jude Medical ...issued a worldwide alert of a battery malfunction that caused lost pacing output and LP communication.
To report the battery failure mechanism and incidence and the worldwide patient management, including device retrieval experiences.
The affected LP battery is a custom lithium-carbon monofluoride cell. These were returned after failure and underwent analysis assessing electronics and battery performance. Data were collected in ongoing clinical studies when LPs were abandoned or retrieved.
Of 1423 LPs implanted worldwide, there were 34 battery failures, occurring at 2.9 ± 0.4 years with no instances of associated patient injury. Analysis of returned batteries revealed an increase in battery resistance caused by insufficient electrolyte availability at the cathode/anode interface. A total of 66 of 73 retrieval attempts were successful (90.4%; implant duration range: 0.2-4.0 years). The LP docking button was inaccessible in 6 patients, and the docking button detached from the LP during retrieval in 1 patient. There was 1 case of arteriovenous fistula and another case of the LP docking button migrating into the pulmonary artery. There were also 115 non-LP retrieval patients after the advisory who received an additional pacemaker, with no adverse device-to-device interactions reported.
As with standard pacers, LPs can have critical battery failures. Chronic retrieval of LPs is safe and efficacious.
Abstract
Aims
Although cryoballoon pulmonary vein isolation is a well-established treatment for paroxysmal atrial fibrillation (AF), it’s role in persistent AF is unclear. We examined procedural ...success and long-term outcomes of cryoablation in persistent and longstanding persistent AF.
Methods and results
International multicentre registry from three UK and eight European centres. Consecutive patients undergoing cryoablation for persistent AF included. Procedural data, complications, and follow-up were prospectively recorded. Patients were followed-up at 3, 6, and 12 months with an electrocardiogram with open access to arrhythmia nurses thereafter. Ambulatory monitoring was dictated by symptoms. Success was defined as freedom from AF or atrial tachycardia lasting >30 s off antiarrhythmic drugs (AADs). Six hundred and nine consecutive cryoablation procedures. Mean procedure and fluoroscopy times were 95 ± 65 and 13 ± 10 min. Single procedure success rates were 368/602 (61%) off AADs over a median of 2.4 (1.0–4.0) years. Arrhythmia-free survival off AADs was 64% and 57% for persistent and longstanding persistent AF at 24 months of follow-up (P = 0.02). Rate of repeat ablations was 20% in persistent and 32% in longstanding persistent AF (P = 0.006). Cox regression analyses showed a significant association between duration of AF and left atrial diameter and arrhythmia recurrence hazard ratio (HR) 1.05, P-value 0.01 and HR 1.02, P-value 0.004.
Conclusion
Cryoablation for persistent AF is safe, fast and has good outcomes at long-term follow-up. Cryoablation is reasonable as a first line option for these patients. Short procedure times may help increase capacity of cardiac units to meet the rising demand for AF ablation. Randomised control trials are needed to compare outcomes with different techniques.
Sleep apnea (SA) is associated with cardiovascular diseases and is highly prevalent in patients with pacemakers (PMs).
To validate a transthoracic impedance sensor with an advanced algorithm (sleep ...apnea monitoring) for identifying severe SA.
Patients with indications for PM (VVI/DDD) were enrolled regardless of symptoms suggesting SA. Severe SA diagnosis was acknowledged when the full polysomnography gave an apnea-hypopnea index (PSG-AHI) of ≥30 events/h. The PSG-AHI was compared with the respiratory disturbance index evaluated by the SAM algorithm (SAM-RDI) compiled from the device during the same diagnosis night, and the performance of the device and the SAM algorithm was calculated to identify patients with severe SA. The agreement between methods was assessed by using Bland and Altman statistics.
Forty patients (mean age 73.8 ± 19.1 years; 67.5% men; body mass index 27.7 ± 4.4 kg/m2) were included. Severe SA was diagnosed by PSG in 56% of the patients. We did not retrieve SAM-RDI data in 14% of the patients. An optimal cutoff value for the SAM-RDI at 20 events/h was obtained by a receiver operator characteristic curve analysis, which yielded a sensitivity of 88.9% (95% confidence interval CI 65.3%–98.6%), a positive predictive value of 88.9% (95% CI 65.3%–98.6%), and a specificity of 84.6% (95% CI 54.6%–98.1%) (n = 31). The Bland-Altman limits of agreement for PSG-AHI (in events per hour) were −14.1 to 32.4.
The results suggest that an advanced algorithm using PM transthoracic impedance could be used to identify SA in patients with PMs outside the clinic or at home.
Background
While prior Micra trials demonstrated a high implant success rate and favorable safety and efficacy results, changes in implant populations and safety over time is not well studied. The ...objective of this analysis was to report the performance of Micra in European and Middle Eastern patients and compare to the Micra Investigational Device Exemption (IDE) and Micra Post Approval Registry (PAR) studies.
Methods
The prospective, single‐arm Micra Acute Performance European and Middle Eastern (MAP EMEA) registry was designed to further study the performance of Micra in patients from EMEA. The primary endpoint was to characterize acute (30‐day) major complications. Electrical performance was analyzed. The major complication rate through 12 months was compared with the IDE and PAR studies.
Results
The MAP EMEA cohort (n = 928 patients) had an implant success rate of 99.9% and were followed for an average of 9.7 ± 6.5 months. Compared to prior studies, MAP EMEA patients were more likely to have undergone dialysis and have a condition which precluded the use of a transvenous pacemaker (p < .001). Within 30 days of implantation, the MAP EMEA cohort had a major complication rate of 2.59%. Mean pacing thresholds were low and stable through 12 months (0.61 ± 0.40 V at 0.24 ms at implant and 12 months). Through 12 months post‐implantation, the major complication rate for MAP EMEA was not significantly different from IDE (p = .56) or PAR (p = .79).
Conclusion
Despite patient differences over time, the Micra leadless pacemaker was implanted with a high success rate and low complication rate, in‐line with prior reports.
The MAP EMEA study has shown that implantation of the Micra leadless pacemaker continues to remain a highly effective and safe procedure. This remains the case in both a traditional cohort of patients being considered for TV‐PPM and more specialized groups, such as those with renal impairment/hemodialysis, prior CIED infection or where conditions exist that preclude the use of TV‐PPM.
Early randomized controlled trials (RCTs) demonstrated the health benefits of omega-3 fatty acids (n-3), whereas recent RCTs were negative. We now address the issue, focusing on the temporal changes ...having occurred: most patients in recent RCTs are no longer n-3 deficient and the vast majority are now treated with statins. Recent RCTs testing n-3 against arrhythmias suggest that n-3 reduce the risk only in patients not taking a statin. Other recent RCTs in secondary prevention were negative although, in a post-hoc analysis separating statin users and non-users, non-significant protection of n-3 was observed among statin non-users whereas statin users had no effect. Recent RCTs testing statins - after the implementation of the New Clinical Trial Regulation in 2007 - are negative (or flawed) suggesting that the lack of effect of n-3 cannot be attributed to a parallel protection by statins. Finally, statins favor the metabolism of omega-6 fatty acids (n-6), which in turn inhibits n-3 and, contrary to n-3, they increase insulin resistance and the risk of diabetes. Thus, n-3 and statins are counteractive at several levels and statins appear to inhibit n-3.
Background Outcomes of catheter ablation of atrial fibrillation (AF) are variable and the predictors of success require further elucidation since the identification of correctable risk factors could ...help to optimize therapy. We aimed to assess the impact of body mass index (BMI) in the overall safety and efficacy of catheter ablation of AF, with emphasis on the use of cryoballoon ablation and novel oral anticoagulants. Methods and Results There were 2497 consecutive patients undergoing catheter ablation of AF in 7 European high volume centers were stratified according to BMI (normal weight <25 kg/m
, pre-obese 25-30 kg/m
, obesity 30-35 kg/m
, and morbid obesity ≥35 kg/m
) and comparisons of procedural outcomes evaluated. Pre-obese and obese patients presented more comorbidities (hypertension, diabetes mellitus, and sleep apnea), and had higher rates of non-paroxysmal AF ablation procedures. The rate of atrial 12-month arrhythmia relapse increased alongside with BMI (35.2%, 35.7%, 43.6%, and 48.0%
<0.001). During a median follow-up of 18.8 months (interquartile range 11-28), after adjusting for all baseline differences, BMI was an independent predictor of relapse (hazard ratio=1.01 per kg/m
; 95% CI 1.01-1.02;
=0.002), adding incremental predictive value to obstructive sleep apnea. BMI was not a predictor for any of the reported complications. Using novel oral anticoagulants and cryoballoon ablation was safe and efficacy was comparable with vitamin-K antagonists and radiofrequency ablation. Conclusions Obese patients present with a more adverse comorbidity profile, more advanced forms of AF, and have lower chances of being free from AF relapse after ablation. Use of novel oral anticoagulants and cryoballoon ablation may be an option in this patient group.
Although the implantable cardioverter-defibrillator (ICD) remains the main therapy for Brugada syndrome (BrS), it does not reduce life-threatening ventricular arrhythmia. Based on pathophysiologic ...mechanisms, hydroquinidine (HQ) has been suggested for effective prevention of arrhythmia.
The purpose of this study was to provide evidence-based data supporting HQ use to prevent life-threatening ventricular arrhythmia in high-risk patients with BrS.
We performed a prospective multicenter randomized (HQ vs placebo) double-blind study with two 18-month crossover phases in patients with BrS and implanted with an ICD.
Among the 50 patients enrolled (mean age 47.0 ± 11.4 years, 42 84% male), 26 (52%) fully completed both phases. Thirty-four (68%) presented HQ-related side effects, mainly gastrointestinal, which led to discontinuation of the therapy in 13 (26%). HQ lengthened the QTc interval (409 ± 32 ms vs 433 ± 37 ms; P = .027) and increased repolarization dispersion as evaluated by Tpe max in precordial leads (89 ± 15 ms vs 108 ± 27 ms; P <.0001) with no significant changes in J-point elevation. During the 36-month follow-up, 1 appropriate ICD shock (0.97% event per year), 1 self-terminating ventricular fibrillation, and 1 inappropriate ICD shock occurred under placebo therapy. No arrhythmic events were reported under HQ therapy.
Although HQ seems to be effective in preventing life-threatening ventricular arrhythmia, it could not be an alternative for ICD implantation. Its frequent side effects greatly reduce its probable compliance and therefore do not reveal a significant effect. HQ increases repolarization dispersal with no changes in BrS pattern, which could indicate a more complex action of HQ than its I
blocking effect alone.
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