Standard versus atrial fibrillation-specific management strategy (SAFETY) to reduce recurrent admission and prolong survival: pragmatic, multicentre, randomised controlled trial.

BACKGROUND: Patients are increasingly being admitted with chronic atrial fibrillation, and disease-specific management might reduce recurrent admissions and prolong survival. However, evidence is scant to support the application of this therapeutic approach. We aimed to assess SAFETY--a management strategy that is specific to atrial fibrillation. METHODS: We did a pragmatic, multicentre, randomised controlled trial in patients admitted with chronic, non-valvular atrial fibrillation (but not heart failure). Patients were recruited from three tertiary referral hospitals in Australia. 335 participants were randomly assigned by computer-generated schedule (stratified for rhythm or rate control) to either standard management (n=167) or the SAFETY intervention (n=168). Standard management consisted of routine primary care and hospital outpatient follow-up. The SAFETY intervention comprised a home visit and Holter monitoring 7-14 days after discharge by a cardiac nurse with prolonged follow-up and multidisciplinary support as needed. Clinical reviews were undertaken at 12 and 24 months (minimum follow-up). Coprimary outcomes were death or unplanned readmission (both all-cause), measured as event-free survival and the proportion of actual versus maximum days alive and out of hospital. Analyses were done on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTRN 12610000221055). FINDINGS: During median follow-up of 905 days (IQR 773-1050), 49 people died and 987 unplanned admissions were recorded (totalling 5530 days in hospital). 127 (76%) patients assigned to the SAFETY intervention died or had an unplanned readmission (median event-free survival 183 days [IQR 116-409]) and 137 (82%) people allocated standard management achieved a coprimary outcome (199 days [116-249]; hazard ratio 0·97, 95% CI 0·76-1·23; p=0·851). Patients assigned to the SAFETY intervention had 99·5% maximum event-free days (95% CI 99·3-99·7), equating to a median of 900 (IQR 767-1025) of 937 maximum days alive and out of hospital. By comparison, those allocated to standard management had 99·2% (95% CI 98·8-99·4) maximum event-free days, equating to a median of 860 (IQR 752-1047) of 937 maximum days alive and out of hospital (effect size 0·22, 95% CI 0·21-0·23; p=0·039). INTERPRETATION: A post-discharge management programme specific to atrial fibrillation was associated with proportionately more days alive and out of hospital (but not prolonged event-free survival) relative to standard management. Disease-specific management is a possible strategy to improve poor health outcomes in patients admitted with chronic atrial fibrillation. FUNDING: National Health and Medical Research Council of Australia.

The use of wearable cardioverter-defibrillators in Europe: results of the European Heart Rhythm Association survey.

The aim of this European Heart Rhythm Association (EHRA) survey was to collect data on the use of wearable cardioverter-defibrillators (WCDs) among members of the EHRA electrophysiology research network. Of the 50 responding centres, 23 (47%) reported WCD use. Devices were fully reimbursed in 17 (43.6%) of 39 respondents, and partially reimbursed in 3 centres (7.7%). Eleven out of 20 centres (55%) reported acceptable patients' compliance (WCD worn for >90% of time). The most common indications for WCD (8 out of 10 centres; 80%) were covering the period until re-implantation of ICD explanted due to infection, in patients with left ventricular impairment due to myocarditis or recent myocardial infarction and those awaiting heart transplantation. Patient life expectancy of <12 months and poor compliance were the most commonly reported contraindications for WCD (24 of 46 centres, 52.2%). The major problems encountered by physicians managing patients with WCD were costs (8 of 18 centres, 44.4%), non-compliance, and incorrect use of WCD. Four of 17 centres (23.5%) reported inappropriate WCD activations in <5% of patients. The first shock success rate in terminating ventricular arrhythmias was 95-100% in 6 of 15 centres (40%), 85-95% in 4 (26.7%), 75-85% in 2 (13.3%), and <75% in 3 centres (20%). The survey has shown that the use of WCD in Europe is still restricted and depends on reimbursement. Patients' compliance remains low. Heterogeneity of indications for WCD among centres underscores the need for further research and a better definition of indications for WCD in specific patient groups.

Delayed pacemaker requirement after transcatheter aortic valve implantation with a new-generation balloon expandable valve: Should we monitor longer?

OBJECTIVES: To analyze the timing of appearance of conduction abnormalities (CAs) after transcatheter aortic valve implantation (TAVI), to identify predictors of delayed CAs requiring pacemaker (PM) implantation and to provide guidance regarding the duration of telemetry monitoring. BACKGROUND: How long patients remain at risk of development of CAs requiring PM implantation after TAVI and for how long they should be monitored remains unclear but is crucial when considering early discharge. METHODS: Development of CAs was studied in 701 consecutive patients treated with Edwards Sapien 3 valves and monitored with telemetry for 7 days in a single center. After excluding valve-in-valve procedures and patients with previous PM, 606 patients remained for analysis. Predictors of CAs requiring PM and the time of onset of CAs were analyzed. RESULTS: Of 606 patients 76 (12.5%) required a PM after TAVI. CAs requiring PM implantation occurred after 48 h in 22.4% (17 patients) and in 10.5% (8 patients) even after 5 days. Of the patients who developed high grade CAs requiring PM after 48 h, 47.1% had no CAs prior to TAVI, and 23.5% had neither pre-existing CAs nor new-developed CAs within the first 48 h after TAVI. CONCLUSION: After TAVI using a new-generation balloon-expandable valve, delayed development of CAs requiring PM implantation is not uncommon, even after 5 days. More importantly, 23.5% of patients eventually requiring a delayed PM implantation had still no CAs at 48 h after TAVI in this study. These results question the safety of early discharge and support ECG monitoring for a longer time period. The most optimal way to monitor these patients is yet to be determined.

Long-term vagal stimulation for heart failure: Eighteen month results from the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) trial.

BACKGROUND: The NECTAR-HF study evaluated safety and feasibility of vagal nerve stimulation (VNS) for the treatment of heart failure patients. The first six-month randomized phase of the study did not show improvement in left ventricular remodelling in response to VNS. This study reports the 18-month results and provides novel findings aiming to understand the lack of efficacy of VNS, including a new technique assessing the effects of VNS. METHODS: Ninety-six patients were randomized 2:1 to active or inactive VNS for 6months, thereafter VNS was activated for all patients. The primary safety endpoint was 18-month all-cause mortality. RESULTS: Ninety-one patients continued in the long-term evaluation with active VNS. The on-therapy survival estimate at 18months was 95% with a 95% one-sided lower confidence limit of 91%, (better than the predefined criterion). Left ventricular systolic volume decreased in the crossover group (VNS OFF→ON; 144±37 to 139±40, p<0.05) after VNS activation; LVESD (5.02±0.77 to 4.96±0.82, p>0.05) and LVEF (33.2±4.9 to 33.3±6.5, p>0.05) did not change. A new technique to detect subtle heart rate changes during Holter recordings, i.e. "heat maps", revealed that VNS evoked heart rate response in only 13/106 studies (12%) at 6 and 12months with active VNS. CONCLUSIONS: Although a favourable long-term safety profile was found, improvements in the efficacy endpoints were not seen with VNS. A new technique for detecting acute heart rate responses to VNS suggests that the recruitment of nerve fibres responsible for heart rate changes were substantially lower in NECTAR-HF than in pre-clinical models.

Deceleration capacity: A novel predictor for total mortality in patients with non-ischemic dilated cardiomyopathy.

OBJECTIVES: We hypothesized that deceleration capacity (DC), a novel marker of cardiac autonomic modulation, is an independent predictor for mortality in patients with non-ischemic dilated cardiomyopathy (NICM). BACKGROUND: NICM is associated with a high risk for sudden cardiac death (SCD). However there are no clinically established parameters available for risk stratification beyond LVEF. DC has been previously shown to be a strong independent predictor for total mortality in patients after myocardial infarction. METHODS: Holter-ECG recordings of 201 patients NICM (83.1% male, mean age: 61.4years, mean LVEF: 33.3%) were analyzed by the method of phase-rectified-signal-averaging (PRSA) to obtain DC. RESULTS: During a minimum follow-up of 40month 59 patients died. Kaplan Meyer Analysis showed a significantly higher mortality in patients with a DC below 4.5ms (log rank p=0.012) irrespective to the presence of atrial fibrillation. CONCLUSIONS: Impaired DC is a powerful independent predictor for mortality in patients with NICM.

Evidência do fenômeno R sobre T na morte súbita cardíaca registrada no holter de 24 horas / Evidence of R/T phenomenon in sudden death in 24 hours holter

Os autores relatam um caso de morte súbita, registrada na eletrocardiografia dinâmica pelo sistema holter, em um paciente de 43 anos, portador de doença coronária. O evento foi desencadeado após uma extra-sístole ventricular (EV) sobre a onda T. Näo houve nenhuma outra ectopia nas 21 horas de gravaçäo prévias ao evento. Esta EV deu origem a uma taquicardia ventricular extremamente rápida, que degenerou em fibrilaçäo ventricular, em curto período de tempo. Foram observadas discretas alteraçöes do ST-T prévias ao evento. Esta forma de morte súbita é frequente e está associada à doença coronária aguda em muitos casos.