Response rate in cardiac resynchronization therapy patients implanted with a left ventricular quadripolar lead and the MultiPoint™ pacing feature early activated. QUARTO III.

BACKGROUND: Although cardiac resynchronization therapy (CRT) is beneficial in most heart failure patients, up to 40% do not respond to CRT. It has been suggested that multipoint left ventricle pacing (MPP) would increase the response rate. AIM: To assess the CRT response rate at 6 months in patients implanted with a CRT device with the MPP feature activated early after the implant. METHODS: This was a multicentre, prospective, open-label and non-randomized study. The primary endpoint was response to biventricular pacing defined as >15% relative reduction in left ventricular end-systolic volume (LVESV) comparing echocardiography measurements performed at baseline and 6 months by a core laboratory. Among secondary endpoints the combined endpoint of mortality or all-cause hospitalizations was evaluated. Primary study endpoint and clinical outcomes were compared to a Quarto II control cohort. RESULTS: Totally, 105 patients were included. The response rate was 64.6% (97.5% lower confidence bound 53%). Mean relative reduction in LVESV was 25.3%, and mean absolute increase in LVEF was 9.4%. The subjects with device programmed using anatomical approach showed a trend towards higher responder rate than those using the electrical approach (72% vs. 61.1%, p = 0.32). Finally, the combined incidence of mortality and or all-cause hospitalizations at 6 month was 12.4%. CONCLUSIONS: Early activation of MPP was not associated to an advantage increasing echocardiography responders to CRT at 6 months of follow-up. Nevertheless, patients programmed using widest pacing cathodes had a numerically higher responder rate. Finally, early activation of MPP was associated to a low incidence of clinical endpoints at 6 months of follow-up.

Cryoballoon Ablation for Persistent and Paroxysmal Atrial Fibrillation: Procedural Differences and Results from the Spanish Registry (RECABA).

Introduction: Cryoballoon ablation (CBA) has become a standard treatment for paroxysmal atrial fibrillation (PaAF) but limited data is available for outcomes in patients with persistent atrial fibrillation (PeAF). Methods: We analyzed the first 944 patients included in the Spanish Prospective Multi-center Observation Post-market Registry to compare characteristics and outcomes of patients undergoing CBA for PeAF versus PaAF. Results: A total of 944 patients (57.8 ± 10.4 years; 70.1% male) with AF (27.9% persistent) were prospectively included from 25 centers. PeAF patients were more likely to have structural heart disease (67.7 vs. 11.4%; p < 0.001) and left atrium dilation (72.6 vs. 43.3%; p < 0.001). CBA of PeAF was less likely to be performed under general anesthesia (10.7 vs. 22.2%; p < 0.001), with an arterial line (32.2 vs. 44.6%; p < 0.001) and assisted transeptal puncture (11.9 vs. 17.9%; p = 0.025). During an application, PeAF patients had a longer time to −30 °C (35.91 ± 14.20 vs. 34.93 ± 12.87 s; p = 0.021) and a colder balloon nadir temperature during vein isolation (−35.04 ± 9.58 vs. −33.61 ± 10.32 °C; p = 0.004), but received fewer bonus freeze applications (30.7 vs. 41.1%; p < 0.001). There were no differences in acute pulmonary vein isolation and procedure-related complications. Overall, 76.7% of patients were free from AF recurrences at 15-month follow-up (78.9% in PaAF vs. 70.9% in PeAF; p = 0.09). Conclusions: Patients with PeAF have a more diseased substrate, and CBA procedures performed in such patients were more simplified, although longer/colder freeze applications were often applied. The acute efficacy/safety profile of CBA was similar between PaAF and PeAF patients, but long-term results were better in PaAF patients.

Primary results of the Spanish Cryoballoon Ablation Registry: acute and long-term outcomes of the RECABA study.

Cryoablation is safe and effective for the treatment of atrial fibrillation (AF) in controlled clinical trials, but contemporary real-world usage and outcomes are limited. The Report of the Spanish Cryoballoon Ablation Registry (RECABA) was designed to evaluate acute and 12-month outcomes of cryoballoon ablation for the treatment of AF in Spain. Patients from 27 Spanish centers were prospectively enrolled. Patients were treated with cryoballoon ablation and managed according to standard of care protocols at each center. The primary endpoint was ≥ 30 s freedom from AF at 12-month after a 3-month blanking period. Secondary endpoints included a description of patient characteristics, cryoablation procedural strategy and safety, and predictors of efficacy. In total, 1742 patients (71.4% PAF, 68.8% male, mean age 58.02 ± 10.40 years, 76.1% overweight or obese, CHA2DS2-VASc index 1.40 ± 1.28) were enrolled. Patients received 7.2 ± 2.67 cryo-applications. PV potentials could be detected in 61% of the PVs during ablation, with a mean time to block of 52.9 ± 37.02 s. Acute PVI was observed in 97% of PVs with 75.8% isolated with the first cryo-application. Mean procedural time was 113 ± 41 min. Acute complications occurred in 4.4% of the cases. With follow-up in 1628 patients, AF-free survival was 78.5% (PAF: 80.6% vs PersAF 73.3%; p < 0.001). Left atrium enlargement, female sex, non-PAF, and early recurrence were independent predictors of AF recurrence (p < 0.05). RECABA provides detailed insight into current dosing practices and demonstrates cryoablation is safe and effective in real-world use.ClinicalTrials.gov number: NCT02785991.

Comparison of radiofrequency catheter ablation of drivers and circumferential pulmonary vein isolation in atrial fibrillation: a noninferiority randomized multicenter RADAR-AF trial.

BACKGROUND: Empiric circumferential pulmonary vein isolation (CPVI) has become the therapy of choice for drug-refractory atrial fibrillation (AF). Although results are suboptimal, it is unknown whether mechanistically-based strategies targeting AF drivers are superior. OBJECTIVES: This study sought to determine the efficacy and safety of localized high-frequency source ablation (HFSA) compared with CPVI in patients with drug-refractory AF. METHODS: This prospective, multicenter, single-blinded study of 232 patients (age 53 ± 10 years, 186 males) randomized those with paroxysmal AF (n = 115) to CPVI or HFSA-only (noninferiority design) and those with persistent AF (n = 117) to CPVI or a combined ablation approach (CPVI + HFSA, superiority design). The primary endpoint was freedom from AF at 6 months post-first ablation procedure. Secondary endpoints included freedom from atrial tachyarrhythmias (AT) at 6 and 12 months, periprocedural complications, overall adverse events, and quality of life. RESULTS: In paroxysmal AF, HFSA failed to achieve noninferiority at 6 months after a single procedure but, after redo procedures, was noninferior to CPVI at 12 months for freedom from AF and AF/AT. Serious adverse events were significantly reduced in the HFSA group versus CPVI patients (p = 0.02). In persistent AF, there were no significant differences between treatment groups for primary and secondary endpoints, but CPVI + HFSA trended toward more serious adverse events. CONCLUSIONS: In paroxysmal AF, HFSA failed to achieve noninferiority at 6 months but was noninferior to CPVI at 1 year in achieving freedom of AF/AT and a lower incidence of severe adverse events. In persistent AF, CPVI + HFSA offered no incremental value. (Radiofrequency Ablation of Drivers of Atrial Fibrillation [RADAR-AF]; NCT00674401).

Variation in quality of life with type of atrial fibrillation.

INTRODUCTION AND OBJECTIVES: Atrial fibrillation (AF) is one of the most common arrhythmias. It is classified according to its presentation as either paroxysmal, persistent or permanent. The presence of this arrhythmia has been associated with a decrease in patients' health-related quality of life (HRQoL). The Atrial Fibrillation-Quality of Life (AF-QoL) questionnaire, which is specifically for use in patients with AF, has recently been developed and validated. The aim of this study was to use this questionnaire to investigate differences in HRQoL associated with different types of AF. METHODS: This prospective observational multicenter study was performed in a regular clinical context in Spain. The AF-QoL questionnaire was administered to study patients, who were diagnosed as having one of the three types of AF. RESULTS: The study involved 341 patients with AF, 43% of whom had persistent AF, while 37% had paroxysmal AF, and 20% had permanent AF. Although the type of AF had no significant effect on the overall AF-QoL score, patients with permanent AF had the highest scores on the psychological dimension (i.e. better HRQoL). In addition, an increased frequency of symptoms, more emergency department visits, and poorer functioning were also associated with significant differences in HRQoL in AF patients. CONCLUSIONS: Use of the AF-QoL questionnaire showed that the HRQoL of AF patients was influenced by the clinical characteristics of the disease but not, except on the psychological dimension, by the type of AF.

Validation of the AF-QoL, a disease-specific quality of life questionnaire for patients with atrial fibrillation.

AIMS: To assess the performance of AF-QoL, a quality of life questionnaire for patients with atrial fibrillation (AF). METHODS AND RESULTS: Observational, prospective, multicentre study in 29 Spanish centres. Three patients' groups were identified at baseline visit: AF patients receiving a new therapeutic intervention according to physician criteria (intervention group); AF clinically stable patients according to physician evaluation (clinically stable group); and patients in a stable condition for more than 1 year after a myocardial infarction (control group). All patients were > or = 18 years. Follow-up visit was at 1 month (clinically stable group) and 3 +/- 1 months (intervention group). Sociodemographic and clinical information was gathered. AF-QoL, SF-36, and patient self-perception of general health status were administered. A total of 417 patients was included. Mean (SD) age was 61.2 (12.4), 31.4% women. AF-QoL mean overall score in AF patients (43.6) was lower (worse health-related quality of life, HRQoL) than in the control group (51.7) (P < 0.05). At baseline, patients with higher frequency of symptoms (P < 0.05) and worse NYHA functional class (P < 0.01) reported lower AF-QoL scores. AF-QoL and SF-36 correlated in all of their domains (r = 0.14-0.8, P < 0.01). AF-QoL showed good internal consistency (0.92) and test-retest reliability (0.86). CONCLUSION: AF-QoL is a valid and reliable HRQoL measure. Further investigation is recommended before using it in clinical practice.

Development of a questionnaire to measure health-related quality of life (HRQoL) in patients with atrial fibrillation (AF-QoL).

BACKGROUND: The Health-Related Quality of Life (HRQoL) assessment in atrial fibrillation (AF) patients has traditionally been carried out in a poorly standardised fashion, or via the use of non disease-specific HRQoL questionnaires. The development of a HRQoL questionnaire with a good measuring performance will allow for a standardised assessment of the impact of this disease on the patient's daily living. METHODS: A bibliography review was conducted to identify the most relevant domains of daily living in AF patients. Subsequently, a focus group was created with the aid of cardiologists, and 17 patients were interviewed to identify the most-affected HRQoL domains. A qualitative analysis of the interview answers was performed, which was used to develop a pilot questionnaire administered to a 112-patient sample. Based on patient responses, an analysis was carried out following the statistical procedures defined by the Classical Test Theory (CTT) and the Item Response Theory (IRT). Reliablility was assessed via Cronbach's coefficient alpha and item-total score correlations. A factorial analysis was performed to determine the number of domains. For each domain, a Rasch analysis was carried out, in order to reduce and stand hierarchically the questionnaire items. RESULTS: By way of the bibliography review and the expert focus group, 10 domains were identified. The patient interviews allowed for the identification of 286 items that later were downsized to 40 items. The resultant preliminary questionnaire was administered to a 112-patient sample (pilot study). The Rasch analysis led to the definition of two domains, comprising 7 and 11 items respectively, which corresponded to the psychological and physical domains (18 items total), thereby giving rise to the initial AF-QoL-18 questionnaire. Cronbach's coefficient alpha was acceptable (0.91). CONCLUSION: An initial HRQoL questionnaire, AFQoL-18, has been developed to assess HRQoL in AF patients.

Detection of ventricular fibrillation in the presence of cardiopulmonary resuscitation artefacts.

Providing cardiopulmonary resuscitation (CPR) to a patient in cardiac arrest introduces artefacts into the electrocardiogram (ECG), corrupting the diagnosis of the underlying heart rhythm. CPR must therefore be discontinued for reliable shock advice analysis by an automated external defibrillator (AED). Detection of ventricular fibrillation (VF) during CPR would enable CPR to continue during AED rhythm analysis, thereby increasing the likelihood of resuscitation success. This study presents a new adaptive filtering method to clean the ECG. The approach consists of a filter that adapts its characteristics to the spectral content of the signal exclusively using the surface ECG that commercial AEDs capture through standard patches. A set of 200 VF and 25 CPR artefact samples collected from real out-of-hospital interventions were used to test the method. The performance of a shock advice algorithm was evaluated before and after artefact removal. CPR artefacts were added to the ECG signals and four degrees of corruption were tested. Mean sensitivities of 97.83%, 98.27%, 98.32% and 98.02% were achieved, producing sensitivity increases of 28.44%, 49.75%, 59.10% and 64.25%, respectively, sufficient for ECG analysis during CPR. Although satisfactory and encouraging sensitivity values have been obtained, further clinical and experimental investigation is required in order to integrate this type of artefact suppressing algorithm in current AEDs.