Trying to predict the unpredictable: Variations in device-based daily monitored diagnostic parameters can predict malignant arrhythmic events in patients undergoing cardiac resynchronization therapy

Background: The aim of this study was to evaluate the value of device-based diagnostic parameters in predicting ventricular arrhythmias in cardiac resynchronization therapy (CRT) recipients. Methods: Ninety-six CRT-D patients participating in TRUST CRT Trial were analyzed. The inclusion criteria were: heart failure in NYHA ≥ 3 class, QRS ≥ 120 ms, LVEF £ 35% and significant mechanical dyssynchrony. Patients were divided into those with (n = 31, 92 arrhyth­mias) and without (n = 65) appropriate ICD interventions within follow-up of 12.03 ± 6.7 months. Daily monitored device-based parameters: heart rate (HR), thoracic impedance (TI), HR variability and physical activity were analyzed in 4 time windows: within 10, 7, 3 days and 1 day before appropriate ICD interventions. Results: A consistent pattern of changes in three monitored factors was observed prior to ar­rhythmia: 1) a gradual increase of day HR (from 103.43% of reference within 10-day window to 105.55% one day before, all p < 0.05 vs. reference); 2) variations in night HR (104.75% in 3 days, 107.65% one day before, all p < 0.05) and 3) TI decrease (from 97.8% in 10 days to 96.81% one day before, all p < 0.05). The combination of three parameters had better pre­dictive value, which improved further after exclusion of patients with atrial fibrillation (AF). The predictive model combining HR and TI together with LVEF and NT-proBNP was more prognostic than the model involving LVEF and NT-proBNP alone (difference in AUC 0.05, 95% CI 0.0005–0.09, p = 0.04). Conclusions: Daily device-monitored parameters show significant variations prior to ven­tricular arrhythmia. Combination of multiple parameters improves arrhythmia predictive performance by its additive value to baseline risk factors, while presence of AF diminishes it.

Long-term outcomes of cardiac resynchronization therapy are worse in patients who require atrioventricular junction ablation for atrial fibrillation than in those with sinus rhythm

Background: The aim of the study was to assess the impact of atrial fibrillation (AF) with and without the need for atrioventricular junction (AVJ) ablation on outcomes in patients undergoing cardiac resynchronization therapy (CRT).Methods: A single center cohort of 200 consecutive CRT patients was divided into three groups: 1) AF with CRT pacing < 95% in which AVJ ablation was performed (AF-ABL, n = 40; 20%), 2) AF without the need for AVJ ablation (AF-non ABL, n = 40; 20%), 3) sinus rhythm (SR, n = 120; 60%). All patients were assessed before CRT implantation and at 6-month follow-up. Positive clinical response to CRT was considered alive status without the need for heart transplantation and improvement ≥ 1 NYHA after 6 months. The comparative analysis among all study groups with respect to response-rate and long-term survival was performed.Results: The 6-month response-rate in both AF-ABL and AF-nonABL was significantly lower than in SR (52.5 and 50 vs.77.5%, respectively; both p < 0.017), though there were no differences in baseline characteristics among study groups apart from higher baseline NT-proBNP levels in AF-ABL. However, after adjustment for this confounder, and despite optimal CRT pacing burden in study groups, the remote all-cause mortality during median follow-up of 36.1 months was significantly higher in AF-ABL than in SR (adjusted HR = 2.57, 95% CI 1.09–6.02, p = 0.03). What is more, no difference in long-term survival between SR and AF-nonABL was observed.Conclusions: Despite the improvement of CRT pacing burden and thus response-rate up to the level of AF subjects without the need for ablation, the long-term survival of AF patients requiring AVJ ablation remains still worse than in SR

Predictors of ventricular tachyarrhythmia in patients with implantable cardioverter-defibrillator and non-ischemic systolic heart failure

Background: The benefit derived from implantable cardioverter-defibrillators (ICD) in subjects with non-ischemic systolic HF (NICM) is less well-established.Aim: The study aimed to determine the incidence, predictors, and prognostic impact of ventricular arrhythmias in patients with ICD and NICM.Methods: The study sample included 377 consecutive patients with ICD or cardiac resynchronization cardioverter-defibrillators (CRT-D, 74% of patients) and NICM implanted and monitored remotely in a university hospital.Results: During the median (interquartile range [IQR]) follow-up of 1645 (960–2675) days, sustained ventricular arrhythmia occurred in 92 patients (24.4%). Of those, ventricular fibrillation (VF), ventricular tachycardia (VT), and both VT and VF occurred in 10 (10.9%), 72 (78.3%), and 10 (10.9%) patients, respectively. Patients with vs. those without ventricular arrhythmia differed concerning sex, left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left ventricular ejection fraction (LVEF), post-inflammatory etiology, atrial fibrillation/flutter occurrence, and supraventricular arrhythmia (SVT) other than AF/AFL during follow-up. In multivariable Cox regression, LVEDD (hazard ratio [HR], 1.05; 95% confidence interval [CI], 1.003–1.09; P = 0.03), AF/AFL (HR, 1.86; 95% CI, 1.21–2.85; P = 0.004), and SVT (HR, 1.77; 95% CI, 1.10–2.87; P = 0.02) were independent predictors of sustained VT, while AF/AFL (HR, 1.65; 95% CI, 1.07–2.56; P = 0.02) was independent predictor of VF. All-cause mortality in patients with VT/VF was significantly higher than in subjects without sustained ventricular arrhythmias (35.9% vs. 22.4%; P = 0.01).Conclusions: Ventricular arrhythmia occurred in every fourth patient with NICM and ICD during 4.5 years of observation and was associated with significantly worse prognosis than in subjects free of VT/VF. Higher LVEDD, atrial fibrillation/atrial flutter, and supraventricular tachycardia flag patients at risk of ventricular arrhythmia

Atrial fibrillation in cardiac resynchronization recipients with and without prior arrhythmic history. How much of arrhythmia is too much?

Background: The aim of the study was to assess long-term incidence of atrial fibrillation (AF) in cardiac resynchronization (CRT) recipients with and without prior arrhythmic history, factors predisposing to arrhythmia, as well as to evaluate the prognostic power of cumulative arrhythmia burden, duration of the longest episode and the number of episodes. Methods: Device-collected data on AF episodes during 24 months in 96 participants of a randomized CRT-trial were analyzed (15% in NYHA class IV, sinus rhythm, median left ventricular ejection fraction 24% and QRS 169 ms). Blindly adjudicated major adverse car­diac events (MACE) and any-cause death were censoring variables. Results: Two-year incidence of AF was 70%, including 66% of patients without previous AF history. No baseline characteristics distinguished those who developed new onset AF. Percent of time spent in AF, but not number of episodes predicted mortality (adjusted hazard ratio [HR] 1.05 ± 95% confidence interval CI 1.01–1.10) and MACE incidence (HR 1.03 ± 1.01–1.07; p = 0.03). Duration of the longest episode also predicted mortality (HR 1.06 ± 1.01–1.12; both p = 0.03). Prognostic impact of AF load was marked only in patients with slower ventricular response (< 98/min), but was independent from CHADS2 scores, pacing burden, or prior atrioventricular nodal ablation. Conclusions: Seven out of 10 CRT-patients had AF within 2 years, including two-thirds of subjects without arrhythmic history. No baseline features distinguished those who developed new onset AF. Arrhythmia burden and duration of the longest episode, but not number of episodes influenced outcomes in CRT-patients, irrespectively from pacing burden or prior atrioventricular node ablation.

Phrenic Nerve Injury During Cryoballoon-Based Pulmonary Vein Isolation: Results of the Worldwide YETI Registry.

BackgroundCryoballoon-based pulmonary vein isolation (PVI) has emerged as an effective treatment for atrial fibrillation. The most frequent complication during cryoballoon-based PVI is phrenic nerve injury (PNI). However, data on PNI are scarce.MethodsThe YETI registry is a retrospective, multicenter, and multinational registry evaluating the incidence, characteristics, prognostic factors for PNI recovery and follow-up data of patients with PNI during cryoballoon-based PVI. Experienced electrophysiological centers were invited to participate. All patients with PNI during CB2 or third (CB3) and fourth-generation cryoballoon (CB4)-based PVI were eligible.ResultsA total of 17 356 patients underwent cryoballoon-based PVI in 33 centers from 10 countries. A total of 731 (4.2%) patients experienced PNI. The mean time to PNI was 127.7±50.4 seconds, and the mean temperature at the time of PNI was -49±8°C. At the end of the procedure, PNI recovered in 394/731 patients (53.9%). Recovery of PNI at 12 months of follow-up was found in 97.0% of patients (682/703, with 28 patients lost to follow-up). A total of 16/703 (2.3%) reported symptomatic PNI. Only 0.06% of the overall population showed symptomatic and permanent PNI. Prognostic factors improving PNI recovery are immediate stop at PNI by double-stop technique and utilization of a bonus-freeze protocol. Age, cryoballoon temperature at PNI, and compound motor action potential amplitude loss >30% were identified as factors decreasing PNI recovery. Based on these parameters, a score was calculated. The YETI score has a numerical value that will directly represent the probability of a specific patient of recovering from PNI within 12 months.ConclusionsThe incidence of PNI during cryoballoon-based PVI was 4.2%. Overall 97% of PNI recovered within 12 months. Symptomatic and permanent PNI is exceedingly rare in patients after cryoballoon-based PVI. The YETI score estimates the prognosis after iatrogenic cryoballoon-derived PNI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03645577. Graphic Abstract: A graphic abstract is available for this article

A worldwide survey on incidence, management and prognosis of oesophageal fistula formation following atrial fibrillation catheter ablation: The POTTER-AF study.

AIMS Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management and outcome are sparse. METHODS AND RESULTS This international multicenter registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553,729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed at 214 centers in 35 countries. In 78 centers 138 patients (0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (p<0.0001)) were diagnosed with an oesophageal fistula. Periprocedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8%, and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) (odds ratio 7.463 (2.414, 23.072) p<0.001). CONCLUSIONS Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high

Quality of life in patients with a subcutaneous vs. transvenous implantable cardioverter-defibrillator

Background: The implantable cardioverter-defibrillator (ICD) and subcutaneous ICD (S-ICD) are well-accepted life-saving devices for treating potentially lethal ventricular arrhythmia, but little is known about quality of life (QoL) in patients with S-ICD and ICD. Aims: Our study aimed to compare QoL in patients with S-ICD and ICD.Methods: All consecutive patients who had S-ICD implanted between October 2015 and September 2021 were included in the study. A cohort of transvenous ICD (TV-ICD) patients was matched to S-ICD subjects by sex, age, indications for the device, and type of prevention. All patients were requested to fulfill two standardized questionnaires to assess QoL: 36-Item Short Form Health Survey (SF-36) and Minnesota Living with Heart Failure Questionnaire (MLHFQ) 6 months after device implantation. Results: Patients with S-ICD (n = 49) and TV-ICD (n = 49) did not differ regarding baseline characteristics. There were no statistically significant differences between S-ICD and TV-ICD subgroup, both for mental and physical QoL assessed in SF-36 and MLHFQ (all P = NS). The median MLHFQ total score was 24 (9–41) for S-ICD and 28 (14–43) for TV-ICD (P = 0.83). The median total score for the SF-36 questionnaire was 62.5 (29–86) vs. 59 (38–77) for S-ICD and TV-ICD, respectively (P = 0.78). Conclusions: Quality of life after device implantation does not differ significantly between the groups of patients with subcutaneous and conventional implantable cardioverter-defibrillator

Outcomes in patients undergoing cardiac resynchronisation therapy complicated by device-related infective endocarditis

Background: Cardiac device-related infective endocarditis (CDRIE) is one of the most serious complications of cardiac resynchronisation therapy (CRT). Aim: We sought to assess clinical outcomes and their determinants in CRT patients with CDRIE. Methods: A tertiary cardiology centre database was screened to identify all CDRIE cases, diagnosed based on the modified Duke criteria, amongst 765 consecutive CRT implantations performed between 2002 and 2015 (70.8% de novo implantations, 29.2% upgrades). Results: During the median follow-up of 1692 days (range: 457–3067 days) CDRIE was diagnosed in 41 (5.4%) patients. Overall, in-hospital and long-term mortality rates of CDRIE patients were 51.2% and 75.6%, respectively. Among patients with CDRIE, in whom the device was vs. was not explanted, in-hospital death rates were 39.3% (11/28 patients) vs. 76.9% (10/13 patients; p = 0.025). In multivariate regression analysis, device removal was independently associated with significantly lower in-hospital mortality (hazard ratio [HR] 0.09, 95% confidence interval [CI] 0.03–0.35, p = 0.0004). The need for temporary pacing after device removal (HR 5.92, 95% CI 1.13–30.96, p = 0.035), a time period of less than seven days between CDRIE diagnosis and CRT removal (HR 6.69, 95% CI 1.48–30.27, p = 0.01), and the highest serum creatinine level during infection (HR 1.02, 95% CI 1.004–1.03, p = 0.01) were identified as independent predictors of higher in-hospital mortality. Conclusions: Device removal is independently associated with lower mortality in patients with CRT and CDRIE. Early device removal (less than seven days since the diagnosis), the need for temporary pacing after removal and acute renal failure are independent mortality predictors in CRT patients who developed CDRIE