Effect of early catheter ablation of atrial fibrillation in patients with heart failure.

INTRODUCTION: According to current guidelines, pulmonary vein isolation as first-line therapy should be considered for patients with atrial fibrillation (AF), however, optimal timing of the procedure is still unknown in patients with heart failure (HF). We aimed to evaluate the effect of early catheter ablation (CA) in patients with HF and left ventricular ejection fraction (LVEF) below 50%. METHODS: We analyzed data from a structured registry comprising 227 patients with paroxysmal or persistent AF and HF with LVEF < 50% who underwent radiofrequency CA between 2015 and 2022. Early CA was defined as a procedure performed within 12 months of AF diagnosis. The median follow-up duration was 1748 (1176.3-2353.5) days, with a minimum follow-up of 365 days. Our endpoints were AF recurrence after a 3-months blanking period and all-cause mortality. RESULTS: Among the 227 patients with a median age of 64.3 years, 97 (42.7%) experienced AF recurrence and 55 (24.2%) died during the follow-up period. The median LVEF was 40% for early CA and 38% for delayed CA (p = .053). Early CA significantly reduced AF recurrence (HR = 0.25 [0.15-0.42], p < .001), however, the timing of procedure did not affect all-cause mortality (p = .16). These findings were consistent regardless of AF subtype or the burden of comorbidities, as assessed by the CHA2DS2-VASc score. CONCLUSION: The timing of CA of AF appears to be an important factor in patients with HF. Early CA reduced AF recurrence, although it does not impact all-cause mortality. We found similar results regardless of AF subtype or burden of comorbidities.

Benefits of upgrading right ventricular to biventricular pacing in heart failure patients with atrial fibrillation.

AIMS: Recommendations on cardiac resynchronization therapy (CRT) in patients with atrial fibrillation or flutter (AF) are based on less robust evidence than those in sinus rhythm (SR). We aimed to assess the efficacy of CRT upgrade in the BUDAPEST-CRT Upgrade trial population by their baseline rhythm. METHODS AND RESULTS: Heart failure patients with reduced ejection fraction (HFrEF) and previously implanted pacemaker (PM) or implantable cardioverter defibrillator (ICD) and ≥20% right ventricular (RV) pacing burden were randomized to CRT with defibrillator (CRT-D) upgrade (n = 215) or ICD (n = 145). Primary [HF hospitalization (HFH), all-cause mortality, or <15% reduction of left ventricular end-systolic volume] and secondary outcomes were investigated. At enrolment, 131 (36%) patients had AF, who had an increased risk for HFH as compared with those with SR [adjusted hazard ratio (aHR) 2.99; 95% confidence interval (CI) 1.26-7.13; P = 0.013]. The effect of CRT-D upgrade was similar in patients with AF as in those with SR [AF adjusted odds ratio (aOR) 0.06; 95% CI 0.02-0.17; P < 0.001; SR aOR 0.13; 95% CI 0.07-0.27; P < 0.001; interaction P = 0.29] during the mean follow-up time of 12.4 months. Also, it decreased the risk of HFH or all-cause mortality (aHR 0.33; 95% CI 0.16-0.70; P = 0.003; interaction P = 0.17) and improved the echocardiographic response (left ventricular end-diastolic volume difference -49.21 mL; 95% CI -69.10 to -29.32; P < 0.001; interaction P = 0.21). CONCLUSION: In HFrEF patients with AF and PM/ICD with high RV pacing burden, CRT-D upgrade decreased the risk of HFH and improved reverse remodelling when compared with ICD, similar to that seen in patients in SR.

Upgrade of right ventricular pacing to cardiac resynchronization therapy in heart failure: a randomized trial.

BACKGROUND AND AIMS: De novo implanted cardiac resynchronization therapy with defibrillator (CRT-D) reduces the risk of morbidity and mortality in patients with left bundle branch block, heart failure and reduced ejection fraction (HFrEF). However, among HFrEF patients with right ventricular pacing (RVP), the efficacy of CRT-D upgrade is uncertain. METHODS: In this multicentre, randomized, controlled trial, 360 symptomatic (New York Heart Association Classes II-IVa) HFrEF patients with a pacemaker or implantable cardioverter defibrillator (ICD), high RVP burden ≥ 20%, and a wide paced QRS complex duration ≥ 150 ms were randomly assigned to receive CRT-D upgrade (n = 215) or ICD (n = 145) in a 3:2 ratio. The primary outcome was the composite of all-cause mortality, heart failure hospitalization, or <15% reduction of left ventricular end-systolic volume assessed at 12 months. Secondary outcomes included all-cause mortality or heart failure hospitalization. RESULTS: Over a median follow-up of 12.4 months, the primary outcome occurred in 58/179 (32.4%) in the CRT-D arm vs. 101/128 (78.9%) in the ICD arm (odds ratio 0.11; 95% confidence interval 0.06-0.19; P < .001). All-cause mortality or heart failure hospitalization occurred in 22/215 (10%) in the CRT-D arm vs. 46/145 (32%) in the ICD arm (hazard ratio 0.27; 95% confidence interval 0.16-0.47; P < .001). The incidence of procedure- or device-related complications was similar between the two arms [CRT-D group 25/211 (12.3%) vs. ICD group 11/142 (7.8%)]. CONCLUSIONS: In pacemaker or ICD patients with significant RVP burden and reduced ejection fraction, upgrade to CRT-D compared with ICD therapy reduced the combined risk of all-cause mortality, heart failure hospitalization, or absence of reverse remodelling.

Incidence and predictors of stroke and silent cerebral embolism following very high-power short-duration atrial fibrillation ablation.

AIMS: Cerebral thrombo-embolism is a dreaded complication of pulmonary vein isolation (PVI) for atrial fibrillation; its surrogate, silent cerebral embolism (SCE) can be detected by diffusion-weighted brain magnetic resonance imaging (bMRI). Initial investigations have raised a concern that very high-power, short-duration (vHPSD; 90 W/4 s) temperature-controlled PVI with the QDOT Micro catheter may be associated with a higher incidence of SCE compared with low-power long-duration ablation. We aimed to assess the incidence of procedural complications of vHPSD PVI with an emphasis on cerebral safety. METHODS AND RESULTS: We enrolled 328 consecutive patients undergoing their PVI procedure using vHPSD. A subgroup of 61 consecutive patients underwent diffusion-weighted bMRI within 24 h of the procedure, and incidence and predictors of SCE were studied. The mean procedure time and left atrial dwell time for the overall cohort were 69.6 ± 24.1 and 46.5 ± 21.5 min, respectively. First-pass isolation was achieved in 82%. No stroke or transient ischaemic attack occurred. Silent cerebral embolism was identified in 5 of 61 patients (8.2%). Silent cerebral embolism following procedures was significantly associated with lower baseline generator impedance (105.8 vs. 112.6 Ω, P < 0.0001) and with intermittent loss of catheter-tissue contact during ablation (14.1% vs. 6.1%, P < 0.0001). CONCLUSION: Very high-power, short-duration PVI is a safe technique with an excellent acute success rate. Silent cerebral embolism incidence in our cohort was below the previously reported range, with no clinically overt cerebral complications. Lower baseline generator impedance and loss of contact during ablation may contribute to a higher risk of SCEs.

Conduction system pacing, a European survey: insights from clinical practice.

AIMS: The field of conduction system pacing (CSP) is evolving, and our aim was to obtain a contemporary picture of European CSP practice. METHODS AND RESULTS: A survey was devised by a European CSP Expert Group and sent electronically to cardiologists utilizing CSP. A total of 284 physicians were invited to contribute of which 171 physicians (60.2%; 85% electrophysiologists) responded. Most (77%) had experience with both His-bundle pacing (HBP) and left bundle branch area pacing (LBBAP). Pacing indications ranked highest for CSP were atrioventricular block (irrespective of left ventricular ejection fraction) and when coronary sinus lead implantation failed. For patients with left bundle branch block (LBBB) and heart failure (HF), conventional biventricular pacing remained first-line treatment. For most indications, operators preferred LBBAP over HBP as a first-line approach. When HBP was attempted as an initial approach, reasons reported for transitioning to utilizing LBBAP were: (i) high threshold (reported as >2 V at 1 ms), (ii) failure to reverse bundle branch block, or (iii) > 30 min attempting to implant at His-bundle sites. Backup right ventricular lead use for HBP was low (median 20%) and predominated in pace-and-ablate scenarios. Twelve-lead electrocardiogram assessment was deemed highly important during follow-up. This, coupled with limitations from current capture management algorithms, limits remote monitoring for CSP patients. CONCLUSIONS: This survey provides a snapshot of CSP implementation in Europe. Currently, CSP is predominantly used for bradycardia indications. For HF patients with LBBB, most operators reserve CSP for biventricular implant failures. Left bundle branch area pacing ostensibly has practical advantages over HBP and is therefore preferred by many operators. Practical limitations remain, and large randomized clinical trial data are currently lacking.

Randomized comparison of atrioventricular node re-entry tachycardia and atrial flutter catheter ablation with and without fluoroscopic guidance: ZeroFluoro study.

AIMS: Interventional cardiology procedures may expose patients and staff to considerable radiation doses. We aimed to assess whether exposure to ionizing radiation during catheter ablation of supraventricular tachycardia (SVT) can be completely avoided. METHODS AND RESULTS: In this prospective randomized study, patients with SVT (atrioventricular re-entrant tachycardia n = 94, typical atrial flutter n = 29) were randomly assigned in a 1:1 ratio to catheter ablation with conventional fluoroscopic guidance (CF group) or with the EnSite Precision mapping system [zerofluoro (ZF) group]. Acute procedural parameters, increased stochastic risk of cancer incidence and 6-month follow-up data were assessed. Between May 2019 and August 2020, 123 patients were enrolled. Clinical parameters were comparable. Median procedural time was 60.0 and 58.0 min, median fluoroscopy time and estimated median effective dose were 240 s vs. 0 and 0.38 mSv vs. 0 and arrhythmia recurrence was 5% and 7.9% in the CF and ZF groups, respectively. The acute success rate was 98.4% in both groups. No procedure-related complications were reported. At an average age of 55.5 years and median radiation exposure of 0.38 mSv, the estimate of increased incidence was approximately 1 in 14 084. The estimated mortality rate was 1 per 17 857 exposed persons. CONCLUSIONS: The procedural safety and efficacy of the zero-fluoroscopic approach are similar to those of conventional fluoroscopy-based ablation for atrioventricular nodal re-entrant tachycardia and atrial flutter. Under the assumption of low radiation dose, the excessive lifetime risk of malignancy in the CF group due to electrophysiology procedure is reasonably small, whilst totally reduced in zero fluoroscopy procedures.

Effect of single ventricular premature contractions on response to cardiac resynchronization therapy.

BACKGROUND: We lack data on the effect of single premature ventricular contractions (PVCs) on the clinical and echocardiographic response after cardiac resynchronization therapy (CRT) device implantation. We aimed to assess the predictive value of PVCs at early, 1 month-follow up on echocardiographic response and all-cause mortality. METHODS: In our prospective, single-center study, 125 heart failure patients underwent CRT implantation based on the current guidelines. Echocardiographic reverse remodeling was defined as a ≥ 15% improvement in left ventricular ejection fraction (LVEF), end-systolic volume (LVESV), or left atrial volume (LAV) measured 6 months after CRT implantation. All-cause mortality was investigated by Wilcoxon analysis. RESULTS: The median number of PVCs was 11,401 in those 67 patients who attended the 1-month follow-up. Regarding echocardiographic endpoints, patients with less PVCs develop significantly larger LAV reverse remodeling compared to those with high number of PVCs. During the mean follow-up time of 2.1 years, 26 (21%) patients died. Patients with a higher number of PVCs than our median cut-off value showed a higher risk of early all-cause mortality (HR 0.97; 95% CI 0.38-2.48; P = 0.04). However, when patients were followed up to 9 years, its significance diminished (HR 0.78; 95% CI 0.42-1.46; P = 0.15). CONCLUSIONS: In patients undergoing CRT implantation, lower number of PVCs predicted atrial remodeling and showed a trend for a better mortality outcome. Our results suggest the importance of the early assessment of PVCs in cardiac resynchronization therapy and warrant further investigations.

Selection of an impedance- or magnetic field-based electro-anatomical mapping platform does not affect outcomes of outflow tract premature ventricular complex manual ablation.

Comparative data are virtually missing about the performance of different electro-anatomical mapping (EAM) system platforms on outflow tract (OT) premature ventricular complex (PVC) ablation outcomes with manual ablation catheters. We aimed to compare the acute success-, complication-, and long-term recurrence rates of impedance-based (IMP) and magnetic field-based (MAG) EAM platforms in manual OT PVC ablation. Single-centre, propensity score matched data of 39-39 patients ablated for OT PVCs in 2015-17 with IMP or MAG platforms were analysed. Acute success rate, peri-procedural complications, post-ablation daily PVC burden, and long-term recurrence rates were compared on intention-to-treat basis. Acute success rate was similar in the IMP and MAG group (77 vs. 82%, p = 0.78). There was a single case of femoral pseudo-aneurysm and no cardiac tamponade occurred. PVC burden fell significantly from baseline 24.0% [15.0-30.0%] to 3.3% [0.25-10.5%] (p < 0.001) post-ablation, with no difference between EAM platforms (IMP: 2.6% [0.5-12.0%] vs. MAG: 4.0% [2.0-6.5%]; p = 0.60). There was no significant difference in recurrence-free survival of the intention-to-treat cohort of the IMP and MAG groups (54 vs. 60%, p = 0.82, respectively) during 12 months of follow-up. Ablation with the aid of both impedance- and magnetic field-based EAM platforms can considerably reduce OT PVC burden and give similar acute- and long-term freedom from arrhythmia.

Preventive or Deferred Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy and Implantable Defibrillator (BERLIN VT): A Multicenter Randomized Trial.

BACKGROUND: Catheter ablation for ventricular tachycardia (VT) reduces the recurrence of VT in patients with implantable cardioverter-defibrillators (ICDs). The appropriate timing of VT ablation and its effects on mortality and heart failure progression remain a matter of debate. In patients with life-threatening arrhythmias necessitating ICD implantation, we compared outcomes of preventive VT ablation (undertaken before ICD implantation to prevent ICD shocks for VT) and deferred ablation after 3 ICD shocks for VT. METHODS: The BERLIN VT study (Preventive Ablation of Ventricular Tachycardia in Patients With Myocardial Infarction) was a prospective, open, parallel, randomized trial performed at 26 centers. Patients with stable ischemic cardiomyopathy, a left ventricular ejection fraction between 30% and 50%, and documented VT were randomly assigned 1:1 to a preventive or deferred ablation strategy. The primary outcome was a composite of all-cause death and unplanned hospitalization for either symptomatic ventricular arrhythmia or worsening heart failure. Secondary outcomes included sustained ventricular tachyarrhythmia and appropriate ICD therapy. We hypothesized that preventive ablation strategy would be superior to deferred ablation strategy in the intention-to-treat population. RESULTS: During a mean follow-up of 396±284 days, the primary end point occurred in 25 (32.9%) of 76 patients in the preventive ablation group and 23 (27.7%) of 83 patients in the deferred ablation group (hazard ratio, 1.09 [95% CI, 0.62-1.92]; P=0.77). On the basis of prespecified criteria for interim analyses, the study was terminated early for futility. In the preventive versus deferred ablation group, 6 versus 2 patients died (7.9% versus 2.4%; P=0.18), 8 versus 2 patients were admitted for worsening heart failure (10.4% versus 2.3%; P=0.062), and 15 versus 21 patients were hospitalized for symptomatic ventricular arrhythmia (19.5% versus 25.3%; P=0.27). Among secondary outcomes, the proportions of patients with sustained ventricular tachyarrhythmia (39.7% versus 48.2%; P=0.050) and appropriate ICD therapy (34.2% versus 47.0%; P=0.020) were numerically reduced in the preventive ablation group. CONCLUSIONS: Preventive VT ablation before ICD implantation did not reduce mortality or hospitalization for arrhythmia or worsening heart failure during 1 year of follow-up compared with the deferred ablation strategy. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02501005.

Long-term survival following upgrade compared with de novo cardiac resynchronization therapy implantation: a single-centre, high-volume experience.

AIMS: Patients with a pacemaker or implantable cardioverter-defibrillator are often considered for cardiac resynchronization therapy (CRT). However, limited comprehensive data are available regarding their long-term outcomes. METHODS AND RESULTS: Our retrospective registry included 2524 patients [1977 (78%) de novo, 547 (22%) upgrade patients] with mild to severe symptoms, left ventricular ejection fraction ≤35%, and QRS ≥ 130ms. The primary outcome was the composite of all-cause mortality, heart transplantation (HTX), or left ventricular assist device (LVAD) implantation; secondary endpoints were death from any cause and post-procedural complications. In our cohort, upgrade patients were older [71 (65-77) vs. 67 (59-73) years; P < 0.001], were less frequently females (20% vs. 27%; P = 0.002) and had more comorbidities than de novo patients. During the median follow-up time of 3.7 years, 1091 (55%) de novo and 342 (63%) upgrade patients reached the primary endpoint. In univariable analysis, upgrade patients exhibited a higher risk of mortality/HTX/LVAD than the de novo group [hazard ratio (HR): 1.41; 95% confidence interval (CI): 1.23-1.61; P < 0.001]. However, this difference disappeared after adjusting for covariates (adjusted HR: 1.12; 95% CI: 0.86-1.48; P = 0.402), or propensity score matching (propensity score-matched HR: 1.10; 95% CI: 0.95-1.29; P = 0.215). From device-related complications, lead dysfunction (3.1% vs. 1%; P < 0.001) and pocket infections (3.7% vs. 1.8%; P = 0.014) were more frequent in the upgrade group compared to de novo patients. CONCLUSION: In our retrospective analysis, upgrade patients had a higher risk of all-cause mortality than de novo patients, which might be attributable to their more significant comorbidity burden. The occurrence of lead dysfunction and pocket infections was more frequent in the upgrade group.

Similar outcomes with manual contact force ablation catheters and traditional catheters in the treatment of outflow tract premature ventricular complexes.

AIMS: Unlike in atrial fibrillation ablation, there is a lack of appropriately sized and properly designed studies regarding outflow tract (OT) premature ventricular complex (PVC) ablation outcomes with contact force sensing (CFS) catheters. We aimed to compare the acute success-, complication-, and long-term recurrence rates of manual CFS catheters with traditional irrigated catheters (T) in OT PVC ablation. METHODS AND RESULTS: Single-centre, propensity-matched data of 75-75 patients ablated for right-sided OT (RVOT) or left-sided OT (LVOT) PVCs in 2015-17 with CFS or T catheters were compared. Acute success rate, peri-procedural complications, post-procedural daily PVC burden, and long-term recurrence rates were compared on intention-to-treat basis. Acute success rate equalled 80% in both groups, with no difference in force values in the CFS group comparing successful or failed cases [12.0 (8.75-17.0) vs. 16.0 (10.25-22.25) g, P = 0.21]. There were three cases of pseudo-aneurysm and one cardiac tamponade. PVC burden fell significantly from baseline 22 (15-30)% to 2 (0-10)% (P < 0.0001), with no difference between catheter types [CFS: 1 (0-7)% vs. T: 4 (1-12) %; P = 0.21]. There was no significant difference in recurrence-free survival of CFS and T catheters (58 vs. 59%, P = 0.29) during 12 months of follow-up, respectively. Recurrence in the CFS group did not differ either by the force exerted below or above the median value of 12 g (P = 0.66). CONCLUSION: Both types of catheters can effectively reduce OT PVC burden with minimal serious complication rates. Ablation with CFS or T catheters gives similar acute- and long-term results.

Catheter ablation or medical therapy to delay progression of atrial fibrillation: the randomized controlled atrial fibrillation progression trial (ATTEST).

AIMS: Delay of progression from paroxysmal to persistent atrial fibrillation (AF) is an important measure of long-term success of AF treatment. However, published data on the impact of catheter ablation on AF progression are limited. This study evaluates whether radiofrequency (RF) catheter ablation delays the progression of AF compared with antiarrhythmic drug (AAD) treatment using current AF management guidelines. METHODS: This prospective, randomized, controlled, two-arm, open-label trial was conducted at 29 hospitals and medical centres across 13 countries. Patients were randomized 1 : 1 to RF ablation or AAD treatment. The primary endpoint was the rate of persistent AF/atrial tachycardia (AT) at 3 years. RESULTS: After early study termination following slow enrolment, 255 (79%) of the planned 322 patients were enrolled (RF ablation, n = 128, AAD, n = 127); 36% of patients in the RF ablation group and 41% in the AAD group completed 3 years of follow-up. For the primary endpoint, the Kaplan-Meier estimate of the rate of persistent AF/AT at 3 years was significantly lower with RF ablation [2.4% (95% confidence interval (CI), 0.6-9.4%)] than with AAD therapy [17.5% (95% CI, 10.7-27.9%); one-sided P = 0.0009]. Patients ≥65 years were ∼4 times more likely to progress to persistent AF/AT than patients <65 years, suggesting RF ablation can delay disease progression [hazard ratio: 3.87 (95% CI, 0.88-17.00); P = 0.0727]. Primary adverse events were reported for eight patients in the RF ablation group. CONCLUSIONS: Radiofrequency ablation is superior to guideline-directed AAD therapy in delaying the progression from paroxysmal to persistent AF.

Implementation of a zero fluoroscopic workflow using a simplified intracardiac echocardiography guided method for catheter ablation of atrial fibrillation, including repeat procedures.

OBJECTIVE: Pulmonary vein isolation (PVI) is the cornerstone of the interventional treatment of atrial fibrillation (AF). Traditionally, during these procedures the catheters are guided by fluoroscopy, which poses a risk to the patient and staff by ionizing radiation. Our aim was to describe our experience in the implementation of an intracardiac echocardiography (ICE) guided zero fluoroscopic (ZF) ablation approach to our routine clinical practice. METHODS: We developed a simplified ICE guided technique to perform ablation procedures for AF, with the aid of a 3D electroanatomical mapping system. The workflow was implemented in two phases: (1) the Introductory phase, where the first 16 ZF PVIs were compared with 16 cases performed with fluoroscopy and (2) the Extension phase, where 71 consecutive patients (including repeat procedures) with ZF approach were included. Standard PVI (and redoPVI) procedures were performed, data on feasibility of the ZF approach, complications, acute and 1-year success rates were collected. RESULTS: In the Introductory phase, 94% of the procedures could be performed with complete ZF with a median procedure time of 77.5 (73.5-83) minutes. In one case fluoroscopy was used to guide the ICE catheter to the atrium. There was no difference in the complication, acute and 1-year success rates, compared with fluoroscopy guided procedures. In the Extension phase, 97% of the procedures could be completed with complete ZF. In one case fluoroscopy was used to guide the transseptal puncture and in another to position the ICE catheter. Acute success of PVI was achieved in all cases, 64.4% patients were arrhythmia free at 1-year. Acute major complications were observed in 4 cases, all of these occurred in the redo PVI group and consisted of 2 tamponades, 1 transient ischemic attack and 1 pseudoaneurysm at the puncture site. The procedures were carried out by all members of the electrophysiology unit in the Extension phase, including less experienced operators and electrophysiology fellows (3 physicians) under the supervision of the senior electrophysiologist. Consequently, procedure times became longer [90 (75-105) vs 77.5 (73.5-85) min, p = 0.014]. CONCLUSIONS: According to our results, a ZF workflow of AF ablations can be successfully implemented into the routine practice of an electrophysiology laboratory, without compromising safety and effectivity.

Machine learning-based mortality prediction of patients undergoing cardiac resynchronization therapy: the SEMMELWEIS-CRT score.

AIMS: Our aim was to develop a machine learning (ML)-based risk stratification system to predict 1-, 2-, 3-, 4-, and 5-year all-cause mortality from pre-implant parameters of patients undergoing cardiac resynchronization therapy (CRT). METHODS AND RESULTS: Multiple ML models were trained on a retrospective database of 1510 patients undergoing CRT implantation to predict 1- to 5-year all-cause mortality. Thirty-three pre-implant clinical features were selected to train the models. The best performing model [SEMMELWEIS-CRT score (perSonalizEd assessMent of estiMatEd risk of mortaLity With machinE learnIng in patientS undergoing CRT implantation)], along with pre-existing scores (Seattle Heart Failure Model, VALID-CRT, EAARN, ScREEN, and CRT-score), was tested on an independent cohort of 158 patients. There were 805 (53%) deaths in the training cohort and 80 (51%) deaths in the test cohort during the 5-year follow-up period. Among the trained classifiers, random forest demonstrated the best performance. For the prediction of 1-, 2-, 3-, 4-, and 5-year mortality, the areas under the receiver operating characteristic curves of the SEMMELWEIS-CRT score were 0.768 (95% CI: 0.674-0.861; P < 0.001), 0.793 (95% CI: 0.718-0.867; P < 0.001), 0.785 (95% CI: 0.711-0.859; P < 0.001), 0.776 (95% CI: 0.703-0.849; P < 0.001), and 0.803 (95% CI: 0.733-0.872; P < 0.001), respectively. The discriminative ability of our model was superior to other evaluated scores. CONCLUSION: The SEMMELWEIS-CRT score (available at semmelweiscrtscore.com) exhibited good discriminative capabilities for the prediction of all-cause death in CRT patients and outperformed the already existing risk scores. By capturing the non-linear association of predictors, the utilization of ML approaches may facilitate optimal candidate selection and prognostication of patients undergoing CRT implantation.

Biventricular pacing during cardiac magnetic resonance imaging.

AIMS: We aimed to assess the effect of cardiac resynchronization on left ventricular (LV) function, volumes, geometry, and mechanics in order to demonstrate reverse remodelling using cardiac magnetic resonance (CMR) with resynchronization on. METHODS AND RESULTS: New York Heart Association (NYHA) Class II-III patients on optimal medical therapy with LV ejection fraction (LVEF) ≤35%, and complete LBBB with broad QRS (>150 ms) were prospectively recruited. Cardiac magnetic resonance examination was performed at baseline and at 6-month follow-up, applying both biventricular and AOO pacing. The following data were measured: conventional CMR parameters, remodelling indices, global longitudinal, circumferential, radial strain, global dyssynchrony [mechanical dispersion (MD) defined as the standard deviation of time to peak longitudinal/circumferential strain in 16 LV segments], and regional dyssynchrony (maximum differences in time between peak septal and lateral transversal displacement). Thirteen patients (64 ± 7 years, 38% male) were enrolled. Comparing the baseline and follow-up CMR parameters measured during biventricular pacing, significant increase in LVEF, and decrease in LV end-diastolic volume index (LVEDVi) and LV end-systolic volume index (LVESVi) were found. Left ventricular remodelling indices, global longitudinal, circumferential, and radial strain values showed significant improvement. Circumferential MD decreased (20.5 ± 5.5 vs. 13.4 ± 3.4, P < 0.001), while longitudinal MD did not change. Regional dyssynchrony drastically improved (362 ± 96 vs. 104 ± 66 ms, P < 0.001). Applying AOO pacing resulted in an immediate deterioration in LVEF, LVESVi, circumferential strain, global and regional dyssynchrony. CONCLUSION: Cardiac magnetic resonance imaging during biventricular pacing is feasible and enables a more precise quantification of LV function, morphology, and mechanics. As a result, it may contribute to a better understanding of the effects of resynchronization therapy and might improve responder rate in the future.

Quality of life predicting long-term outcomes in cardiac resynchronization therapy patients.

AIMS: While improvement in quality of life (QoL) has been widely reported in cardiac resynchronization therapy (CRT) patients, its predictive value is not well-understood. We aimed to assess the predictive role of baseline QoL on long-term heart failure (HF) or death events in mild HF patients enrolled in Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT). METHODS AND RESULTS: A total of 1791 of 1820 patients had their QoL evaluated at baseline, using the EuroQol-5 dimensions (EQ-5D) and the Kansas City Cardiomyopathy Questionnaires (KCCQ). Kaplan-Meier survival analyses and multivariate Cox models were utilized. Issues within any of the domains of the baseline EQ-5D questionnaire (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were associated with long-term mortality (median follow-up 5.6 years) (all P < 0.05). Heart failure or death events were predicted by issues in baseline mobility [hazard ratio (HR) = 1.41, P < 0.001], usual activities (HR = 1.41, P < 0.001), and anxiety/depression (HR = 1.21, P = 0.035). The risk of HF events alone was significantly higher in patients with baseline mobility issues (HR = 1.42, P < 0.001) or usual activity (HR = 1.35, P = 0.003). Every 10% increase in the visual analogue scale (0-100) was associated with an 8% lower risk of all-cause mortality (P = 0.006), and a 6% lower risk of HF/death (P = 0.002). Mobility issues also predicted echocardiographic reverse remodelling (-33.08 mL vs. -31.17 mL, P = 0.043). Using the KCCQ, patients in the lower tertile of the clinical summary or physical limitations score had a significantly higher risk of long-term HF or death (P < 0.05). CONCLUSION: In mild HF patients enrolled in MADIT-CRT, multiple baseline QoL questionnaire domains were predictors of echocardiographic remodelling, long-term all-cause mortality, and HF events.

Repeat procedure is a new independent predictor of complications of atrial fibrillation ablation.

AIMS: Atrial fibrillation (AF) ablation has made huge progress with respect to innovation, efficacy, and safety, however, complications are still present. Recent studies examined various predictors of complications. However, limited data exist regarding the role of a repeat procedure. Our aim was the prospective evaluation of the incidence and predictors of complications related to AF ablation procedures in consecutive patients, including repeat procedures. METHODS AND RESULTS: All ablation procedures for AF between January 2013 and December 2015 were analysed in our electrophysiology laboratory. During the study period 1243 procedures were analysed [394 female, median age 62 (55-69)]. Overall complication rate was 6.84%, major complication rate was 2.82%. Major complications were the following: 18 pericardial tamponades; 5 pseudoaneurysms; 1 arteriovenous fistula; 6 thromboembolic cerebrovascular events; 3 pulmonary vein stenosis; and 2 atrioventricular blocks. No atrio-oesophageal fistula or procedure related death occurred. Univariate analysis for overall complications showed that age ≥ 65 years (P = 0.0231), female gender (P = 0.0438), hypertension (P = 0.0488), CHA2DS2-VASc score ≥ 2 (P = 0.0156), and previous AF ablation procedure (P < 0.0001) is associated with higher risk for adverse events. Multivariate analysis showed that the only independent predictor of overall complications was previous AF ablation procedure (P < 0.0001). Similarly, the only predictor of major complications was previous AF ablation procedure (P < 0.0001). CONCLUSION: Incidence of complications associated with AF ablation in our high volume electrophysiology laboratory is similar to other cohorts. The only independent predictor of complications was previous AF ablation procedure in our series.

Long-term single-centre large volume experience with transseptal endocardial left ventricular lead implantation.

AIMS: The aim of our study was to investigate the long-term efficacy and safety of transseptal endocardial left ventricular lead implantation (TELVLI). METHODS AND RESULTS: Transseptal endocardial left ventricular lead implantation was performed in 54 patients (44 men, median age 69, New York Heart Association III-IV stage) between 2007 and 2017 in a single centre. In 36 cases, the transseptal puncture (TP) was performed via the femoral vein, and in 18 cases, the TP and also the left ventricular (LV) lead placement were performed via the subclavian vein. An electrophysiological deflectable catheter was used to reach the LV wall through the dilated TP hole. The LV lead implantation was successful in all patients. A total of 54 patients were followed up for a median of 29 months [interquartile range (IQR) 8-40 months], the maximum follow-up time was 94 months. Significant improvement in the LV ejection fraction was observed at the 3-month visit, from the median of 27% (IQR 25-34%) to 33% (IQR 32-44%), P < 0.05. Early lead dislocation was observed in three cases (5%), reposition was performed using the original puncture site in all. The patients were maintained on anticoagulation therapy with a target international normalized ratio between 2.5 and 3.5. Four thromboembolic events were noticed during follow-up. A total of 27 patients died, with a median survival of 15 months (IQR 6-40). CONCLUSION: The TELVLI is an effective approach for cardiac resynchronization therapy (CRT) however it is associated with a substantial thromboembolic risk (7%).

Update in Electrical Storm Therapy.

BACKGROUND: Electrical storm (ES) is a major life-threatening event, which announces a possible negative outcome and poor prognosis and poses challenging questions concerning etiology and management. DATA SOURCES: A literature search was conducted through MEDLINE and EMBASE (past 30 years until the end of September 2018) using the following search terms: ES, ventricular fibrillation, ventricular tachycardia, ablation, and implantable defibrillator. Clinicaltrials.gov was also consulted for studies that are ongoing or completed. Additional articles were identified through bibliographical citations. AREA OF UNCERTAINTY: There is no homogeneous attitude, and therapeutic strategies vary widely. THERAPEUTIC ADVANCES: The aim of this review is to define the concept of ES, to review the incidence and prognostic implications, and to describe the most common strategies of therapeutic advances and trends. The management strategy should be decided after an accurate risk stratification is done in initial evaluation according to hemodynamic tolerability and presence of triggers and comorbidities. General care should be provided in an intensive cardiovascular care unit. The cornerstone of acute medical therapy used in ES is mainly represented by amiodarone and beta-blockers. Deep sedation and mechanical ventilation should provide comfort for treatment administration. First-choice drugs are benzodiazepines and short-acting analgesics. General care may also include thoracic epidural anesthesia to modulate neuroaxial efferents to the heart and to decrease sympathetic hyperactivity. We include a special focus on ablation as a reliable tool to target the mechanism of arrhythmia, finally building an up-to-date standardization. CONCLUSIONS: ES management needs a complex assessment and interpretation of a critical situation in a life-threatening condition. Optimal implantable cardioverter-defibrillator-reprogramming, antiarrhythmic drug therapy and sedation are in first-line approach. Catheter ablation is the elective therapy and plays a central key role in the treatment of ES if possible in combination with hemodynamic support.

De novo implantation vs. upgrade cardiac resynchronization therapy: a systematic review and meta-analysis.

Patients with conventional pacemakers or implanted defibrillators are often considered for cardiac resynchronization therapy (CRT). Our aim was to summarize the available evidences regarding the clinical benefits of upgrade procedures. A systematic literature search was performed from studies published between 2006 and 2017 in order to compare the outcome of CRT upgrade vs. de novo implantations. Outcome data on all-cause mortality, heart failure events, New York Heart Association (NYHA) Class, QRS narrowing and echocardiographic parameters were analysed. A total of 16 reports were analysed comprising 489,568 CRT recipients, of whom 468,205 patients underwent de novo and 21,363 upgrade procedures. All-cause mortality was similar after CRT upgrade compared to de novo implantations (RR 1.19, 95% CI 0.88-1.60, p = 0.27). The risk of heart failure was also similar in both groups (RR 0.96, 95% CI 0.70-1.32, p = 0.81). There was no significant difference in clinical response after CRT upgrade compared to de novo implantations in terms of improvement in left ventricular ejection fraction (ΔEF de novo - 6.85% vs. upgrade - 9.35%; p = 0.235), NYHA class (ΔNYHA de novo - 0.74 vs. upgrade - 0.70; p = 0.737) and QRS narrowing (ΔQRS de novo - 9.6 ms vs. upgrade - 29.5 ms; p = 0.485). Our systematic review and meta-analysis of currently available studies reports that CRT upgrade is associated with similar risk for all-cause mortality compared to de novo resynchronization therapy. Benefits on reverse remodelling and functional capacity improved similarly in both groups suggesting that CRT upgrade may be safely and effectively offered in routine practice. CLINICAL TRIAL REGISTRATION: Prospero Database-CRD42016043747.