Adherence to the CLOSE Protocol and Low Baseline Generator Impedance Are Independent Predictors of Durable Pulmonary Vein Isolation.

Background: Atrial fibrillation (AF) recurrence after pulmonary vein isolation (PVI) is predominantly attributed to pulmonary vein reconnection (PVR). Predictors of AF recurrence have been widely studied; however, data are scarce on procedural parameters that predict chronic PVR. We aimed to study PVR rates and predictors of PVR. Methods: We retrospectively included 100 patients who underwent repeated ablation due to AF recurrence after initial PVI with the CARTO system. PVR was determined during the repeated procedure by electrophysiological evaluation, and initial procedural characteristics predicting PVR were studied, including adherence to the CLOSE protocol, use of high power, first-pass isolation (FPI), and baseline generator impedance (BGI). Results: Thirty-eight patients underwent initial CLOSE-guided PVI, and sixty-two underwent initial non-CLOSE PVI. A repeat procedure was performed 23 ± 16 months after the initial procedure. In total, PVR was found in 192 of 373 PVs (51.5%), and all PVs were isolated in 17/100 (17%) patients. Factors associated with all PVs being isolated were adherence to the CLOSE protocol, a higher power setting, the presence of bilateral FPI, and lower BGI (88% vs. 28%, p < 0.0001; 37.5 W vs. 30 W, p = 0.0276; 88.2% vs. 40.4%, p = 0.0007; and 127.6 Ω vs. 136.6 Ω, p = 0.0027, respectively). In initial procedures with adherence to the CLOSE protocol, the FPI rate was significantly higher (73.7% vs. 25%, p < 0.0001), while there were no significant differences in terms of procedure time and left atrial dwell time (81 vs. 85 min, p = 0.83; and 60 vs. 58 min, p = 0.08, respectively). BGI ≥ 130 Ω (AUC = 0.7403, sensitivity: 77.1%, specificity: 68.8%, p = 0.0032) was associated with a significantly higher probability of PVR (OR = 6.757; p < 0.0001). In multivariable analysis, independent predictors for PVR were non-adherence to the CLOSE protocol and BGI ≥ 130 Ω. Conclusions: Our findings indicate that adherence to the CLOSE protocol and baseline generator impedance < 130 Ω during AF ablation are independent predictors of PVI durability.

Long-Term Durability of High- and Very High-Power Short-Duration PVI by Invasive Remapping: The HPSD Remap Study.

BACKGROUND: High-power short-duration ablation has shown impressive efficacy and safety for pulmonary vein isolation (PVI); however, initial efficacy results with very high power short-duration ablation were discouraging. This study compared the long-term durability of PVI performed with a 90- versus 50-W power setting. METHODS: Patients were randomized 1:1 to undergo PVI with the QDOT catheter using a power setting of 90 or 50 W. Three months after the index procedure, patients underwent a repeat electrophysiology study to identify pulmonary vein reconnections. Patients were followed for 12 months to detect AF recurrences. RESULTS: We included 46 patients (mean age, 64 years; women, 48%). Procedure (76 versus 84 minutes; P =0.02), left atrial dwell (63 versus 71 minutes; P =0.01), and radiofrequency (303 versus 1040 seconds; P <0.0001) times were shorter with 90- versus 50-W procedures, while the number of radiofrequency applications was higher with 90 versus 50 W (77 versus 67; P =0.01). There was no difference in first-pass isolation (83% versus 82%; P =1.0) or acute reconnection (4% versus 14%; P =0.3) rates between 90 and 50 W. Forty patients underwent a repeat electrophysiology study. Durable PVI on a per PV basis was present in 72/78 (92%) versus 68/77 (88%) PVs in the 90- and 50-W energy setting groups, respectively; effect size: 72/78-68/77=0.040, lower 95% CI=-0.051 (noninferiority limit=-0.1, ie, noninferiority is met). No complications occurred. There was no difference in 12-month atrial fibrillation-free survival between the 90- and 50-W groups (P =0.2). CONCLUSIONS: Similarly high rates of durable PVI and arrhythmia-free survival were achieved with 90 and 50 W. Procedure, left atrial dwell, and radiofrequency times were shorter with 90 W compared with 50 W. The sample size is too small to conclude the safety and long-term efficacy of the high and very high-power short-duration PVI; further studies are needed to address this topic. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05459831.

One-Day Interruption of NOAC Is Associated with Low Risk of Periprocedural Adverse Events during Pulmonary Vein Isolation If Combined with Left Atrial Thrombus Exclusion with Computed Tomography.

BACKGROUND: Safety, efficacy, and patient comfort are the expectations during pulmonary vein isolation (PVI). We aimed to validate the combined advantages of pre- and periprocedural anticoagulation with non-vitamin K anticoagulants (NOACs) and rigorous left atrial appendage thrombus (LAAT) exclusion with computed tomography (CT). METHODS: This study included a population of consecutive patients, between March 2018 and June 2020, who underwent cardiac CT within 24 h before PVI to guide the ablation and rule out LAAT. NOAC was omitted 24 h before the ablation. RESULTS: A total of 187 patients (63% male) underwent CT before PVI. None of the patients experienced stroke during or after the procedure. The complication rate was low, with no thromboembolic events and 2.1% of patients experiencing a major bleeding event. CONCLUSIONS: Omitting NOAC 24 h before the ablation might be safe if combined with left atrial thrombus exclusion with computed tomography.

The prevalence of frailty and its effect on the outcome in cardiac resynchronization therapy patients.

Frailty is a complex clinical syndrome associated with aging and comorbidities, which correlates with unfavorable outcomes. However, in heart failure patients, frailty is very common, data is scarce about those, who are eligible for Cardiac Resynchronization Therapy (CRT) implantation. We investigated the incidence of frailty and the association of Frailty Index (FI) with the outcome. Thirty baseline clinical parameters were used by the Rockwood cumulative deficit method to determine patients' FI in our single-center cohort. Based on previous studies, patients with FI ≤ 0.210 were considered as non-frail, those with FI 0.10-0.210 were classified in Frail-1, with FI > 0.10 in Frail-2 groups, respectively. Echocardiographic response after 12 months and all-cause mortality were investigated by frailty groups. Among 1004 included patients, 75 (7%) were considered Non-frail, 271 (27%) grouped in Frail-1, and 658 (66%) in Frail-2 with a median FI of 0.36 (0.28-0.43). Patients in Frail-2 group were older, with more comorbidities compared with non-frail patients or those in Group Frail-1. During the median follow-up time of 4.8 years, 29 (39%) patients died in the Non-frail, 140 (52%) in Frail-1, and 471 (72%) in the Frail-2 groups (log-rank p < 0.001). Group Frail-2 showed an unfavorable outcome compared to the non-frail (HR 2.49, 95%CI 1.92-3.22; p < 0.001) and the Frail-1 group (1.83, 95%CI 1.55-2.16; p < 0.001). In our HFrEF patients eligible for CRT implantation, patients were exceedingly vulnerable with a high prevalence of frailty. The calculated frailty index was associated with outcome and proved to be prevalent in individual risk stratification.

Machine-Learning-Based Prediction of 1-Year Arrhythmia Recurrence after Ventricular Tachycardia Ablation in Patients with Structural Heart Disease.

BACKGROUND: Ventricular tachycardia (VT) recurrence after catheter ablation remains a concern, emphasizing the need for precise risk assessment. We aimed to use machine learning (ML) to predict 1-month and 1-year VT recurrence following VT ablation. METHODS: For 337 patients undergoing VT ablation, we collected 31 parameters including medical history, echocardiography, and procedural data. 17 relevant features were included in the ML-based feature selection, which yielded six and five optimal features for 1-month and 1-year recurrence, respectively. We trained several supervised machine learning models using 10-fold cross-validation for each endpoint. RESULTS: We observed 1-month VT recurrence was observed in 60 (18%) cases and accurately predicted using our model with an area under the receiver operating curve (AUC) of 0.73. Input features used were hemodynamic instability, incessant VT, ICD shock, left ventricular ejection fraction, TAPSE, and non-inducibility of the clinical VT at the end of the procedure. A separate model was trained for 1-year VT recurrence (observed in 117 (35%) cases) with a mean AUC of 0.71. Selected features were hemodynamic instability, the number of inducible VT morphologies, left ventricular systolic diameter, mitral regurgitation, and ICD shock. For both endpoints, a random forest model displayed the highest performance. CONCLUSIONS: Our ML models effectively predict VT recurrence post-ablation, aiding in identifying high-risk patients and tailoring follow-up strategies.

Phenogrouping and risk stratification of patients undergoing cardiac resynchronization therapy upgrade using topological data analysis.

Choosing the optimal device during cardiac resynchronization therapy (CRT) upgrade can be challenging. Therefore, we sought to provide a solution for identifying patients in whom upgrading to a CRT-defibrillator (CRT-D) is associated with better long-term survival than upgrading to a CRT-pacemaker (CRT-P). To this end, we first applied topological data analysis to create a patient similarity network using 16 clinical features of 326 patients without prior ventricular arrhythmias who underwent CRT upgrade. Then, in the generated circular network, we delineated three phenogroups exhibiting significant differences in clinical characteristics and risk of all-cause mortality. Importantly, only in the high-risk phenogroup was upgrading to a CRT-D associated with better survival than upgrading to a CRT-P (hazard ratio: 0.454 (0.228-0.907), p = 0.025). Finally, we assigned each patient to one of the three phenogroups based on their location in the network and used this labeled data to train multi-class classifiers to enable the risk stratification of new patients. During internal validation, an ensemble of 5 multi-layer perceptrons exhibited the best performance with a balanced accuracy of 0.898 (0.854-0.942) and a micro-averaged area under the receiver operating characteristic curve of 0.983 (0.980-0.986). To allow further validation, we made the proposed model publicly available ( https://github.com/tokmarton/crt-upgrade-risk-stratification ).

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.

Zero fluoroscopy ablation for atrioventricular nodal reentrant tachycardia and typical atrial flutter is equally safe and effective with EnSite NavX, Carto3, and Rhythmia mapping systems.

Purpose: Our purpose was to compare the procedural characteristics, success rate, and complication rate of the conventional fluoroscopic (CF) and the zero-fluoroscopic (ZF) approach in patients undergoing catheter ablation of AVNRT or typical atrial flutter (Aflu). Methods: 186 consecutive patients with an indication for AVNRT or Aflu ablation were enrolled. Based on the operator's preference, the patients were assigned to either CF or ZF group. In the ZF group EnSite NavX, Carto3, or Rhythmia EAMS were used for catheter guidance. Results: The median age was 56 (IQR = 42-68) years, 144 patients had AVNRT, and 42 had Aflu ablation. CF approach was chosen in 123 cases, while ZF in 63 cases. ZF approach was used more often in case of AVNRT patients [56 (39%) vs. 7 (17%), p = 0.006] and in the case of female patients [43 (68%) vs. 20 (32%), p = 0.008]. Acute procedural success was obtained in all cases. There was no difference in the complication rate (1 vs. 1, p > 0.99) between the two groups. No difference was found regarding the procedure time between the CF and ZF groups [CF: 55 (46-60) min, ZF 60 (47-65) min; p = 0.487] or in the procedure time for the different EAMS [EnSite NavX: 58 (50-63) min, Carto3: 60 (44.5-66.3) min, Rhythmia: 55 (35-69) min; p = 0.887]. A similar success rate was seen at the 3-month follow-up in the two groups [41 (100%) vs. 96 (97%); p = 0.55]. Discussion: The ZF approach demonstrated non-inferiority in safety and efficacy compared with CF for the AVNRT and Aflu ablations.

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.

Topological data analysis to identify cardiac resynchronization therapy patients exhibiting benefit from an implantable cardioverter-defibrillator.

BACKGROUND: Current guidelines recommend considering multiple factors while deciding between cardiac resynchronization therapy with a defibrillator (CRT-D) or a pacemaker (CRT-P). Nevertheless, it is still challenging to pinpoint those candidates who will benefit from choosing a CRT-D device in terms of survival. OBJECTIVE: We aimed to use topological data analysis (TDA) to identify phenogroups of CRT patients in whom CRT-D is associated with better survival than CRT-P. METHODS: We included 2603 patients who underwent CRT-D (54%) or CRT-P (46%) implantation at Semmelweis University between 2000 and 2018. The primary endpoint was all-cause mortality. We applied TDA to create a patient similarity network using 25 clinical features. Then, we identified multiple phenogroups in the generated network and compared the groups' clinical characteristics and survival. RESULTS: Five- and 10-year mortality were 43 (40-46)% and 71 (67-74)% in patients with CRT-D and 48 (45-50)% and 71 (68-74)% in those with CRT-P, respectively. TDA created a circular network in which we could delineate five phenogroups showing distinct patterns of clinical characteristics and outcomes. Three phenogroups (1, 2, and 3) included almost exclusively patients with non-ischemic etiology, whereas the other two phenogroups (4 and 5) predominantly comprised ischemic patients. Interestingly, only in phenogroups 2 and 5 were CRT-D associated with better survival than CRT-P (adjusted hazard ratio 0.61 [0.47-0.80], p < 0.001 and adjusted hazard ratio 0.84 [0.71-0.99], p = 0.033, respectively). CONCLUSIONS: By simultaneously evaluating various clinical features, TDA may identify patients with either ischemic or non-ischemic etiology who will most likely benefit from the implantation of a CRT-D instead of a CRT-P. Topological data analysis to identify phenogroups of CRT patients in whom CRT-D is associated with better survival than CRT-P. AF atrial fibrillation, CRT cardiac resynchronization therapy, CRT-D cardiac resynchronization therapy defibrillator, CRT-P cardiac resynchronization therapy pacemaker, DM diabetes mellitus, HTN hypertension, LBBB left bundle branch block, LVEF left ventricular ejection fraction, MDS multidimensional scaling, MRA mineralocorticoid receptor antagonist, NYHA New York Heart Association.

Early Application of ECMO after Sudden Cardiac Arrest to Prevent Further Deterioration: A Review and Case Report.

ECMO has become a therapeutic modality for in- and out-of-hospital scenarios and is also suitable as a bridging therapy until further decisions and interventions can be made. Case report: A 27-year-old male patient with mechanical aortic valve prothesis had a sudden cardiac arrest (SCA). ROSC had been achieved after more than 60 min of CPR and eight DC shocks due to ventricular fibrillation (VF). The National Ambulance Service unit transported the patient to our clinic for further treatment. Due to the trauma and therapeutic INR, a CT scan was performed and ruled out bleeding. Echocardiography described severely decreased left ventricular function. Coronary angiography was negative. Due to the therapeutic refractory circulatory and respiratory failure against intensive care, VA-ECMO implantation was indicated. After four days of ECMO treatment, the patient's circulation was stabilized without neurological deficit, and the functions of the end organs were normalized. Cardiac MRI showed no exact etiology behind SCA. ICD was implanted due to VF and SCA. The patient was discharged after 19 days of hospitalization. Conclusion: This case report points out that the early application of mechanical circulatory support could be an outcome-determinant therapeutic modality. Post-resuscitation care includes cardiorespiratory stabilization, treatment of reversible causes of malignant arrhythmia, and secondary prevention.

Automatic non-invasive blood pressure measurement in left ventricular assist device patients with a photoplethysmography assisted device.

INTRODUCTION: Non-invasive measurement of blood pressure in patients with a left ventricular assist device (LVAD) is challenging due to the mechanical properties of these circulatory support devices. Keeping blood pressure in a target range is crucial to reduce the risk of LVAD complications. As current assessment methods require trained personnel resulting in infrequent monitoring, devices for home-based measurements are sorely needed. OBJECTIVES: In this paper, we report a measurement method and a custom-made monitoring device based on photoplethysmography (PPG) enabling automated measurement of the mean arterial pressure (MAP) of patients with LVAD. METHODS: The method and the device were tested on 21 adult patients with LVAD, and the estimated MAP values were compared to MAP values measured simultaneously by a human expert applying the commonly used Doppler-based method. RESULTS: Results of the proposed method showed highly significant correlation with Doppler-based MAP values (R = 0.85 for inflation, p < 0.001; R = 0.96 for deflation, p<0.001). The mean difference of the proposed method to the Doppler-based MAP values was 1.48 ± 5.43 mmHg for inflation and -0.19 ± 2.71 mmHg for deflation. CONCLUSION: The results demonstrate that the proposed method is a promising direction to achieve accurate, automated, non-invasive BP measurement, applicable in home health monitoring for patients with LVAD.

Sex differences in one-year recurrence and all-cause mortality following catheter ablation of ventricular tachycardia in structural heart disease.

Aims: We aimed to establish sex-specific predictors for 1-year VT recurrence and 1-year all-cause mortality in patients with structural heart disease undergoing catheter ablation. Methods: We analyzed data of 299 patients recorded in our structured registry. These included medical history, echocardiography parameters, laboratory results, VT properties, procedural data. Results: Out of the 299 patients, 34 (11%) were female. No significant difference was found between women and men in terms of VT recurrence (p = 0.74) or mortality (p = 0.07). In females, severe mitral regurgitation (MR), tricuspid regurgitation (TR), presentation with incessant VT, and preprocedural electrical storm (ES) were associated with increased risk of VT recurrence. Diabetes, implanted CRT, VT with hemodynamic instability, ES and advanced MR were the risk factors of mortality in women. ACEi/ARB use predicted a favorable outcome in both endpoints among females. In men, independent predictors of VT recurrence were the composite parameter of ES and multiple ICD therapies, presentation with incessant VT, severe MR, while independent predictors of mortality were age, LVEF, creatinine and previously implanted CRT. Conclusion: According to our investigation, there are pronounced sex differences in predictors of recurrence and mortality following VT ablation.

Characteristics of Very High-Power, Short-Duration Radiofrequency Applications.

Introduction: Pulmonary vein isolation is the cornerstone of rhythm-control therapy for atrial fibrillation (AF). The very high-power, short-duration (vHPSD) radiofrequency (RF) ablation is a novel technology that favors resistive heating while decreasing the role of conductive heating. Our study aimed to evaluate the correlations between contact force (CF), power, impedance drop (ID), and temperature; and to assess their role in lesion formation with the vHPSD technique. Methods: Consecutive patients who underwent initial point-by-point RF catheter ablation for AF were enrolled in the study. The vHPSD ablation was performed applying 90 W for 4 s with an 8 ml/min irrigation rate. Results: Data from 85 patients [median age 65 (59-71) years, 34% female] were collected. The median procedure time, left atrial dwelling time, and fluoroscopy time were 70 (60-90) min, 49 (42-58) min, and 7 (5-11) min, respectively. The median RF time was 312 (237-365) sec. No steam pop nor major complications occurred. A total of 6,551 vHPSD RF points were analyzed. The median of CF, maximum temperature, and ID were 14 (10-21) g, 47.6 (45.1-50.4) °C, and 8 (6-10) Ohms, respectively. CF correlated significantly with the maximum temperature (p < 0.0001). A CF of 5 g and above was associated with a significantly higher temperature compared to those lesions with a CF below 5 grams (p < 0.0001). Bilateral first-pass isolation rate was 84%. The 6-month AF-recurrence rate was 7%. Conclusion: The maximum temperature and CF significantly correlate with each other during vHPSD applications. A CF ≥ 5 g leads to better tissue heating and thus might be more likely to result in good lesion formation, although this clinical study was unable to assess actual lesion sizes.

Impact of High-Power and Very High-Power Short-Duration Radiofrequency Ablation on Procedure Characteristics and First-Pass Isolation During Pulmonary Vein Isolation.

Introduction: High-power short-duration (HPSD) radiofrequency ablation has been proposed to produce rapid and effective lesions for pulmonary vein isolation (PVI). We aimed to evaluate the procedural characteristics and the first-pass isolation (FPI) rate of HPSD and very high-power short-duration (vHPSD) ablation compared to the low-power long-duration (LPLD) ablation technique. Methods: One hundred fifty-six patients with atrial fibrillation (AF) were enrolled and assigned to LPLD, HPSD, or vHPSD PVI. The energy setting was 30, 50, and 90 W in the LPLD, HPSD, and vHPSD groups, respectively. In the vHPSD group, 90 W/4 s energy delivery was used in the QMODE+ setting. In the other groups, ablation index-guided applications were delivered with 30 W (LPLD) or 50 W (HPSD). Results: Bilateral PVI was achieved in all cases. Compared to the LPLD group, the HPSD and vHPSD groups had shorter procedure time [85 (75-101) min, 79 (65-91) min, and 70 (53-83) min], left atrial dwelling time [61 (55-70) min, 53 (41-56) min, and 45 (34-52) min], total RF time [1,567 (1,366-1,761) s, 1,398 (1,021-1,711) s, and 336 (247-386) s], but higher bilateral FPI rate (57, 78, and 80%) (all p-values < 0.01). The use of HPSD (OR = 2.72, 95% CI 1.15-6.44, p = 0.023) and vHPSD (OR = 2.90, 95% CI 1.24-6.44, p = 0.014) ablation techniques were associated with a higher probability of bilateral FPI. The 9-month AF-recurrence rate was lower in case of HPSD and vHPSD compared to LPLD ablation (10, 8, and 36%, p = 0.0001). Moreover, the presence of FPI was associated with a lower AF-recurrence rate at 9-month (OR = 0.09, 95% CI 0.04-0.24, p = 0.0001). Conclusion: Our prospective, observational cohort study showed that both HPSD and vHPSD RF ablation shortens procedure and RF time and results in a higher rate of FPI compared to LPLD ablation. Moreover, the use of HPSD and vHPSD ablation increased the acute and mid-term success rate. No safety concerns were raised for HPSD or vHPSD ablation in our study.

Baseline clinical characteristics of heart failure patients with reduced ejection fraction enrolled in the BUDAPEST-CRT Upgrade trial.

AIMS: The BUDAPEST-CRT Upgrade study is the first prospective, randomized, multicentre clinical trial investigating the outcomes after cardiac resynchronization therapy (CRT) upgrade in heart failure (HF) patients with intermittent or permanent right ventricular (RV) pacing with wide paced QRS. This report describes the baseline clinical characteristics of the enrolled patients and compares them to cohorts from previous milestone CRT studies. METHODS AND RESULTS: This international multicentre randomized controlled trial investigates 360 patients having a pacemaker (PM) or implantable cardioverter defibrillator (ICD) device for at least 6 months prior to enrolment, reduced left ventricular ejection fraction (LVEF ≤35%), HF symptoms (New York Heart Association [NYHA] functional class II-IVa), wide paced QRS (>150 ms), and ≥20% of RV pacing burden without having a native left bundle branch block. At enrolment, the mean age of the patients was 73 ± 8 years; 89% were male, 97% were in NYHA class II/III functional class, and 56% had atrial fibrillation. Enrolled patients predominantly had conventional PM devices, with a mean RV pacing burden of 86%. Thus, this is a patient cohort with advanced HF, low baseline LVEF (25 ± 7%), high N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (2231 pg/ml [25th-75th percentile 1254-4309 pg/ml]), and frequent HF hospitalizations during the preceding 12 months (50%). CONCLUSION: When compared with prior CRT trial cohorts, the BUDAPEST-CRT Upgrade study includes older patients with a strong male predominance and a high burden of atrial fibrillation and other comorbidities. Moreover, this cohort represents an advanced HF population with low LVEF, high NT-proBNP, and frequent previous HF events. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT02270840.

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.

Orientation of the right superior pulmonary vein affects outcome after pulmonary vein isolation.

AIMS: Controversial results have been published regarding the influence of pulmonary vein (PV) anatomical variations on outcomes after pulmonary vein isolation (PVI). However, no data are available on the impact of PV orientation on the long-term success rates of point-by-point PVI. We sought to determine the impact of PV anatomy and orientation on atrial fibrillation (AF)-free survival in patients undergoing PVI using the radiofrequency point-by-point technique. METHODS AND RESULTS: We retrospectively included 448 patients who underwent initial point-by-point radiofrequency ablation for AF at our department. Left atrial computed tomography angiography was performed before each procedure. PV anatomical variations, ostial parameters (area, effective diameter, and eccentricity), orientation, and their associations with 24-month AF-free survival were analysed. PV anatomical variations and ostial parameters were not predictive for AF-free survival (all P > 0.05). Univariate analysis showed that female sex (P = 0.025) was associated with higher rates of AF recurrence, ventral-caudal (P = 0.002), dorsal-cranial (P = 0.034), and dorsal-caudal (P = 0.042) orientation of the right superior PV (RSPV), on the other hand, showed an association with lower rates of AF recurrence, when compared with the reference ventral-cranial orientation. On multivariate analysis, both female sex [odds ratio (OR) 1.83, 95% CI 1.15-2.93, P = 0.011] and ventral-caudal RSPV orientation, compared with ventral-cranial orientation, proved to be independent predictors of 24-month AF recurrence (OR 0.37, 95% CI 0.19-0.71, P = 0.003). CONCLUSION: Female sex and ventral-caudal RSPV orientation have an impact on long-term arrhythmia-free survival. Assessment of PV orientation may be a useful tool in predicting AF-free survival and may contribute to a more personalized management of AF.

Predicting the survival benefit of cardiac resynchronization therapy with defibrillator function for non-ischemic heart failure-Role of the Goldenberg risk score.

Aims: Primary prevention of sudden cardiac death (SCD) in non-ischemic heart failure (HF) patients remains a topic of debate at cardiac resynchronization therapy (CRT) implantation requiring individual risk assessment. Using the Goldenberg SCD risk score, we aimed to predict, which non-ischemic HF patients will benefit from the addition of an implantable cardioverter defibrillator (ICD) to CRT at long-term. Methods: Between 2000 and 2018 non-ischemic HF patients undergoing CRT implantation were collected into our retrospective registry. The Goldenberg risk score (GRS) was calculated by the presence of atrial fibrillation, New York Heat Association (NYHA) class > 2, age > 70 years, blood urea nitrogen > 26 mg/dl and QRS > 120 ms. The primary endpoint was all-cause mortality, heart transplantation or left ventricular assist device implantation. Results: From 667 patients, 347 (52%) underwent cardiac resynchronization therapy-pacemaker (CRT-P), 320 (48%) cardiac resynchronization therapy-defibrillator (CRT-D) implantations. During the median follow up time of 4.3 years, 306 (46%) patients reached the primary endpoint (CRT-D 37% vs. CRT-P 63%; p < 0.001). CRT-D patients were younger (64 vs. 69 years; p < 0.001), infrequently females (26 vs. 39%; p < 0.001), and had a lower ejection fraction (27 vs. 29%; p < 0.01) compared to CRT-P patients. After GRS calculation, patients were dichotomized by low (< 3) and high (≥ 3) scores. CRT-D patients with low GRS showed a mortality benefit compared to CRT-P (HR 0.68; 95% CI 0.48-0.96; p = 0.03), high-risk patients did not (HR 0.84; 95% CI 0.62-1.13; p = 0.26). Conclusion: In our non-ischemic cohort, patients with low GRS showed a clear long-term mortality benefit by adding ICD to CRT, however, in high-risk patients no further benefit could be observed.

The role of local impedance drop in the acute lesion efficacy during pulmonary vein isolation performed with a new contact force sensing catheter-A pilot study.

INTRODUCTION: Our pilot study aimed to evaluate the role of local impedance drop in lesion formation during pulmonary vein isolation with a novel contact force sensing ablation catheter that records local impedance as well and to find a local impedance cut-off value that predicts successful lesion formation. MATERIALS AND METHODS: After completing point-by-point radiofrequency pulmonary vein isolation, the success of the applications was evaluated by pacing along the ablation line at 10 mA, 2 ms pulse width. Lesions were considered successful if loss of local capture was achieved. RESULTS: Out of 645 applications, 561 were successful and 84 were unsuccessful. Compared to the unsuccessful ablation points, the successful applications were shorter (p = 0.0429) and had a larger local impedance drop (p<0.0001). There was no difference between successful and unsuccessful applications in terms of mean contact force (p = 0.8571), force-time integral (p = 0.0699) and contact force range (p = 0.0519). The optimal cut-point for the local impedance drop indicating successful lesion formation was 21.80 Ohms on the anterior wall [AUC = 0.80 (0.75-0.86), p<0.0001], and 18.30 Ohms on the posterior wall [AUC = 0.77 (0.72-0.83), p<0.0001]. A local impedance drop larger than 21.80 Ohms on the anterior wall and 18.30 Ohms on the posterior wall was associated with an increased probability of effective lesion creation [OR = 11.21, 95%CI 4.22-29.81, p<0.0001; and OR = 7.91, 95%CI 3.77-16.57, p<0.0001, respectively]. CONCLUSION: The measurement of the local impedance may predict optimal lesion formation. A local impedance drop > 21.80 Ohms on the anterior wall and > 18.30 Ohms on the posterior wall significantly increases the probability of creating a successful lesion.