Acute Procedural Success Rate Research Articles

Comparison of procedural analgosedation in patients undergoing pulsed field ablation or cryoballoon ablation for atrial fibrillation

Abstract Background Pulsed field ablation (PFA) has emerged as a novel technology that is increasingly applied for the catheter ablation (CA) of atrial fibrillation (AF) with similar efficacy to established, thermal energy sources. Data solely focussing on analgosedation compared to established single-shot modalities, such as cryoballoon (CB) ablation are scarce. Aim The aim of this study was to assess differences of analgosedation requirement, procedural cardiopulmonary stability, and analgosedation-associated complications between PFA and CB ablation. Methods This study was a retrospective single-centre comparison of analgosedation in patients with paroxysmal, persistent, and long-standing persistent AF undergoing pulmonary vein isolation (PVI) with either PFA or CB from March 2021 until April 2022. The primary study endpoints were the requirements of analgosedation medications (propofol, midazolam and sufentanyl), cardiorespiratory stability measured as decreases in oxygen saturation and systolic blood pressure and analgosedation-associated complications. Secondary endpoints were acute procedural success, procedure time and overall complication rates. Results A total of 100 patients were included {PFA n=50, CB n=50, mean age 66 ± 10.6, 61% male patients, 65% paroxysmal AF). The body weight – and procedure time-adjusted requirement of all analgosedation medications was significantly higher in the PFA group compared to CB {Propofol 0.14 ± 0.04 mg/kg/min in PFA versus 0.11 ± 0.04 mg/kg/min in CB (p=0.001); midazolam 0.00086 ± 0.0004 mg/kg/min in PFA versus 0.00063 ± 0.0003 mg/kg/min in CB (p=0.002) and sufentanyl 0.0013 ± 0.0007 µg/kg/min in PFA versus 0.0008 ± 0.0004 µg/kg/min in CB (p<0.0001)}. Procedural cardiorespiratory stability did not differ between groups (maximum blood pressure decrease PFA 53.4 ± 20.9 mmHg, CB 50.3 ± 18.6 mmHg, P=0.28 and maximum decrease in oxygen saturation: PFA group 4.8 ± 5.3 %, CB group 3.5 ± 2.6 %, P=0.12). Analgosedation-associated complications did not differ between both groups (PFA n=1/50 mild aspiration pneumonia, CB n=0/50, p=0.99). There was no significant difference in acute procedural success (100% n=50/50 in both groups, p>0.99), non-analgosedation associated complications (PFA: n=2/50, 4%, CB: n=1/50, 2%, p=0.99) and procedure times (PFA 75 ± 31, CB 84 ± 32 mins, p=0.18) between groups. Conclusions Pulsed field ablation is associated with higher sedation and especially analgesia requirement compared to cryoballoon ablation, however, the safety of analgosedation does not differ significantly to cryoballoon ablation.

Ablation strategy for idiopathic outflow tract premature ventricular complexes: rationale and design of the ABOUT-PVC study, a prospective multicenter study

BackgroundAn idiopathic outflow tract premature ventricular complex (OT-PVC) is a common arrhythmia, and the accuracy of site of origin prediction using the 12-lead electrocardiogram (ECG) algorithm is not high. There are no studies about a systematic strategy that can provide practical help to electrophysiologists in OT-PVC mapping and ablation. This study aims to evaluate the efficacy and safety of the proposed ablation protocol and establish an optimal catheter ablation strategy by simultaneously investigating and synthesizing various indicators observed during the mapping procedure.Methods and designThis study (ABOUT-PVC) was designed as a prospective multicenter study to enroll 210 patients from 11 tertiary university hospitals over an estimated 27 months. Patients with idiopathic OT-PVC requiring catheter ablation will receive the procedure through a proposed ablation strategy and will be followed up for at least 12 months. The primary outcome is the acute procedural success rate. The secondary outcomes are clinical success rate, procedure time, complication rate, symptom relief, and changes in echocardiographic parameters.ConclusionsThe ABOUT-PVC study was designed to investigate the efficacy and safety of the proposed ablation strategy and establish an optimal catheter ablation strategy. We expect this study to overcome the limitations of the ECG prediction algorithms and provide a practical guide to electrophysiologists, increasing the procedure’s success rate and reducing complications and procedure time.

The impact of clinical audits on patient radiation exposure for device procedures

Abstract Background Clinical audits aim to ensure ideal use of ionizing radiation in clinical practice. Since it became mandatory by Swiss law in 2018, such an audit also took place in our Cardiac Pacing and Electrophysiology Division at the University Heart Center. Purpose To establish local diagnostic reference levels (DRLs) for specific procedures and to examine if patient radiation exposure was reduced after the clinical audit. Methods Retrospective cohort study including patients from October 2018 to October 2020 who underwent device implantation, including pacemakers, implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT), or lead extraction / device explantation. Main measures to reduce radiation exposure after the audit were lower pulsed fluoroscopy frame rates and dose characteristics at baseline. Patient radiation exposure was evaluated with the dose-area product (DAP), cumulative dose, fluoroscopy time, and the number of cine acquisitions. Secondary endpoints included the effective dose, the acute procedural success rate and 30-day complications. Data were collected from a dose management system and cross-checked for accuracy with the patient information system. The third quartiles were set as local DRLs. Data before and after the clinical audit were compared. Results A total of 541 patients (45.7 % before the audit, 54.3% after the audit) were included. 28.3% had a conventional pacemaker, 22.0% a leadless pacemaker, 21.1% an ICD, and 17.2% a CRT implantation. Lead extraction / device explantation was undergone by 11.5% of patients. The local DRLs (including all procedures before and after the audit) for the DAP were significantly lower as compared to national DRLs (6.2 dGy.cm2 versus 300 dGy.cm2 for conventional pacemakers; 7.6 dGy.cm2 versus 200 dGy.cm2 for ICDs, 203 dGy.cm2 versus 570 dGy.cm2 for CRTs). After the audit, DAP (Figure 1), cumulative dose, effective dose and the number of cine acquisition significantly decreased for conventional pacemakers (p-value ≤ 0.04), whereas no significant differences were observed for the other procedures. The acute procedural success rate (98.4 vs 98.9%) and the 30-day complications (4.0 vs 7.8%) were not significantly different before and after the audit. Conclusions The clinical audit in our institution led to a significant reduction of radiation exposure for patients during pacemaker implantations. Regarding DRLs, local values were far below national DRLs, which suggests that national DRLs need to be updated more regularly. Our study highlights the importance of clinical audits and the need for more research in this field.

Standalone transcatheter left atrial appendage closure or combined with cryoballoon pulmonary vein isolation

Abstract Background Head-to-head comparisons between stand-alone left atrial appendage closure (LAAC) and a same-procedure LACC + cryoballoon (CB) pulmonary vein isolation (PVI) (combined procedure) are currently lacking. Purpose To compare acute and long-term outcomes between stand-alone LAAC vs a LAAC+CB-PVI combined procedure. Methods All patients undergoing LAAC at our institution, having at least 2 years follow-up, were analyzed to assess the impact of additional CB-PVI. The primary efficacy and safety endpoints of our study were the acute procedural success rate and the peri-procedural complications rate. As secondary endpoints, major bleeding, and ischemic events, as well as sinus rhythm rate at 2 years follow-up were assessed. Results Among 126 LAAC patients meeting inclusion criteria (males=64.2%), n=55 (43.7%) underwent a combined procedure. LAAC-only patients were older (72.5±7.2 vs 68.9±8.6, p<0.05) and less frequently having paroxysmal AF (23.9% vs 47.3%, p<0.05). Baseline CHA2DS2-VASc was similar among groups (3.3±1.3 vs 2.9±1.1, p=0.07) while LAAC-only patients had higher HAS-BLED at enrollment (3.4±1.1 vs 3.0±1.0, p=0.04). Additional CB-PVI was not a risk factor for incomplete LAA occlusion (OR 0.24–3.78, p=0.96), presence of residual lateral flow (OR 0.26–4.05; p=0.96), intraprocedural need for occluder device resizing compared to pre-procedural assessment (OR 0.27–3.05; p=0.884), and peri-procedural complications (OR 0.25–6.74, p=0.749). At 3-month post-procedural trans-esophageal echocardiography, a combined procedure was not associated with higher risk of incomplete occlusion (OR 0.33–1.59, p = 0.432), nor larger peri-device leakages (coefficient k: -0.65–+0.20, p=0.291). Overall and by-group ischemic (red) and bleeding (blue) relative risk reduction from CHA2DS2-VASc and HAS-BLED predicted yearly rates during follow-up was reported in Figure1. Over a median follow-up of 40 [26–56] months, a combined procedure was not a risk factor for major bleeding (OR 0.31–5.48, p=0.715) or ischemic (OR 0.11–3.56, p=0.599) events. As expected, additional CB-PVI was strongly associated with a reduction of AF recurrences (OR 0.16–0.86, p<0.05), after excluding permanent AF patients from the analysis. Conclusion Combined LAAC + CB-PVI procedure does not appear to be a risk factor for worse LAAC-related outcomes, while reducing AF recurrences in non-permanent AF patients.Figure 1

Acute clinical outcomes of patients with HFpEF undergoing atrial fibrillation ablation

Abstract Aim Robust data show that atrial fibrillation (AF) ablation can improve left ventricular function and prevent cardiovascular complications in patients with heart failure and reduced ejection fraction. The effectiveness and safety of AF ablation in patients with heart failure and preserved ejection fraction (HFpEF) is less well characterized. Methods We retrospectively analyzed 785 consecutive patients with normal left ventricular function undergoing AF ablation in a high-volume center including 251 with AF and HFpEF. We compared baseline parameters, procedural details and procedural complications by heart failure status. Results Patients with HFpEF (n=251/785) were older (median age 70 years vs. 64 years; p < 0.05) and more frequently female (48.2% vs. 32.2%; p < 0.05) compared to patients without HF. Symptom severity was comparable with a median European Heart Rhythm Association score of 2 in both groups (p > 0.05). Arterial (71.7% vs. 59.7%, p < 0.05), diabetes (16.7% vs. 9.4%, p < 0.05) and dyslipidemia (41.4% vs. 27.2%, p < 0.05) were more common in patients with AF and HFpEF. Acute pulmonary vein isolation (PVI) was achieved in all patients using cryoballoon or radiofrequency energy with similar frequency in both groups (cryoballoon ablation: 37.8% vs. 41.6%; p > 0.05). A subgroup of patients in both groups additionally underwent cavotricuspid isthmus ablation for coexistent atrial flutter (26% vs. 20.7%; p > 0.05). Procedure times (119.4 ± 47.7 min vs. 120.2 ± 48.3 min; p > 0.05) and fluoroscopy times (15.8 ± 10.4 min vs. 15.5 ± 7.1 min; p > 0.05) were comparable. Overall complication rates did not differ (12.7% vs. 10.3%; p > 0.05). While the incidence of pericardial tamponades was slightly higher (2% vs. 0%), other severe and minor complications showed no significant differences, including stroke/transient ischemic attack (TIA; 0.4% vs. 0.6%), major life-threatening bleeding (0% vs. 0.2%), vascular complications (1.6% vs. 2.1%), phrenic nerve palsy (0.8% vs. 1.5%), and pulmonary vein stenosis (0.4 vs. 0%). The mean in-hospital stay for the procedure was 2 days in both groups (p > 0.05). In-hospital recurrence rates were similar (12.4% vs. 17%; p > 0.05), as was the need for electrical cardioversion before discharge (5.6% vs. 6.6%; p > 0.05). Conclusion Patients with HFpEF undergoing AF ablation were older, more frequently female, and have more comorbidities than patients without heart failure. Acute procedural success and acute complication rates appear low. These data encourage randomized evaluations of the safety and efficacy of ablation-based rhythm control therapy in patients with AF and HFpEF.

Bipolar catheter ablation of left ventricular summit PVC

Abstract Background Premature ventricular contractions (PVC) arising from the left ventricular summit are a challenging arrhythmia to manage, often refractory to conventional radiofrequency ablation. This study aimed to investigate the effectiveness of bipolar ablation as a therapeutic option for PVCs originating from this anatomically complex region. Methods We conducted a retrospective analysis of a prospective ablation registry to identify patients with recurrent, symptomatic PVCs originating from the left ventricular (LV) summit who underwent bipolar ablation. Bipolar ablation involved the use of two ablation catheters, delivering radiofrequency energy from opposite sides of the summit. The catheters were connected by a dedicated adapter, allowing to connect one ablation catheter in position of a return electrode. Procedural success was defined as the elimination of PVCs during the procedure and freedom from PVCs on follow-up monitoring. Results were compared to a similar patient group who had received unipolar ablation of summit-PVCs. Results A total of 12 pts received bipolar ablation between July 2022 and October 2023. Three pts underwent ablation for VT and were excluded. A total of 9 pts (mean age 57±18 years, n=7 [78%] male, BMI 28±5kg/m2) were included in the analysis. All but one had a history of a previous unsuccessful ablation attempt (median 1 [1-2]). In a group of 33 patients undergoing unipolar ablation 8 (32%) had received ≥ 1 previous ablation and were included in the analysis. Baseline parameters did not differ between groups. The acute procedural success rate for bipolar ablation was 89% in bipolar pts and 75% in unipolar pts, with a mean procedural time of 173±33 min, a mean fluoroscopy time of 14±9 min (158±55 min [p=0.478] and 14±12 min [p=0.995] for unipolar pts). Bipolar ablation was performed between the LVOT and RVOT in 6, and between LVOT and the distal CS in 6 pts with 25-35 W. No major complications were detected in bipolar pts while one non-fatal tamponade occurred in the unipolar pts group. Follow-up data at 97 [93-269] days revealed a sustained reduction in PVC burden in bipolar pts (from 18±13% to 7±9%; p=0.026) while unipolar ablation did not show a significant burden reduction (15±6% to 11±10%; p=0.382). The success rate of a relative burden reduction >50% did not differ significantly between the groups (bipolar: 6 pts [67%] 3 pts [38%]; p=0.347). Conclusion Bipolar ablation offers an effective and safe therapeutic approach for PVCs originating from the LV summit. It significantly reduced PVC burden in this analysis. The data suggest that a repeat procedure after a failed summit PVC ablation should only be performed if bipolar ablation is available during the second procedure. Larger studies are warranted to confirm efficacy and safety of this ablation method.

Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results.

Contact force (CF)-sensing radiofrequency (RF) catheters with an ablation index have shown reproducible outcomes for the treatment of atrial fibrillation (AF) in large multicentre studies. A dual-energy (DE) focal CF catheter to deliver RF and unipolar/biphasic pulsed field ablation (PFA), integrated with a three-dimensional (3D) mapping system, can provide operators with additional flexibility. The SmartfIRE study assessed the safety and efficacy of this novel technology for the treatment of drug-refractory, symptomatic paroxysmal AF. Results at 3 months post-ablation are presented here. Pulmonary vein isolation (PVI) was performed using a DE focal, irrigated CF-sensing catheter with the recommendation of PFA at posterior/inferior and RF ablation at the anterior/ridge/carina segments. Irrespective of energy, a tag size of 3 mm; an inter-tag distance ≤6 mm; a target index of 550 for anterior, roof, ridge, and carina; and a target index of 400 for posterior and inferior were recommended. Cavotricuspid isthmus ablation was permitted in patients with documented typical atrial flutter. The primary effectiveness endpoint was acute procedural success. The primary safety endpoint was the rate of primary adverse events (PAEs) within 7 days of the procedure. A prespecified patient subset underwent oesophageal endoscopy (EE; 72 h post-procedure), neurological assessment (NA; pre-procedure and discharge), and cardiac computed tomography (CT)/magnetic resonance angiogram (MRA) imaging (pre-procedure and 3 months post-procedure) for additional safety evaluation, and a mandatory remapping procedure (Day 75 ± 15) for PVI durability assessment. Of 149 patients enrolled between February and June 2023, 140 had the study catheter inserted (safety analysis set) and 137 had ablation energy delivered (per-protocol analysis set). The median (Q1/Q3) total procedure and fluoroscopy times were 108.0 (91.0/126.0) and 4.2 (2.3/7.7) min (n = 137). The acute procedural success rate was 100%. First-pass isolation was achieved in 89.1% of patients and 96.8% of veins. Cavotricuspid isthmus ablations were successfully performed in 12 patients [pulsed field (PF) only: 6, RF only: 5, and RF/PF: 1]. The PAE rate was 4.4% [6/137 patients; 2 pulmonary vein (PV) stenoses, 2 cardiac tamponades/perforations, 1 stroke, and 1 pericarditis]. No coronary artery spasm was reported. No oesophageal lesion was seen in the EE subset (0/31, 0%). In the NA subset (n = 30), microemboli lesions were identified in 2 patients (2/30, 6.7%), both of which were resolved at follow-up; only 1 was symptomatic (silent cerebral lesion, 3.3%). In the CT/MRA subset (n = 30), severe PV narrowing (of >70%) was detected in 2 patients (2/30, 6.7%; vein level 2/128, 1.6%), of whom 1 underwent dilatation and stenting and 1 was asymptomatic; both were associated with high index values and a small inter-tag distance. In the PV durability subset (n = 30), 100/115 treated PVs (87%) were durably isolated and 18/30 patients (60.0%) had all PVs durably isolated. A DE focal CF catheter with 3D mapping integration showed a 100% acute success rate with an acceptable safety profile in the treatment of paroxysmal AF. Prespecified 3-month remapping showed notable PVI durability. ClinicalTrials.gov Identifier: NCT05752487.

Trans-jugular approach for safe and successful cryoablation of para-Hisian/anterior-septal, anterior, and anterior-lateral accessory pathways in children.

Cryoablation of APs localized near the atrioventricular (AV) junction is a well-established ablation strategy in children, and it has proved to be very safe. However, recurrence rates remain considerable for specific accessory pathway (AP) localizations. The aim of this retrospective study was to evaluate the efficacy and safety of a trans-jugular approach for cryoablation of right anterior, anterior-lateral, and anterior-septal APs in children, as compared to the conventional femoral approach. From June 2019 to November 2023, 24 consecutive patients (mean age 13.2 ± 4.6, 12 males (50% of total cohort)) with right anterior-lateral, anterior, and anterior-septal/para-Hisian APs underwent 3D non-fluoroscopic transcatheter cryoablation through the right jugular vein at our Institution. Ablation results were compared with 24 patients for whom a conventional trans-femoral approach was used. Acute procedural success rate was 100% (n = 24/24), with a non-statistically significant difference as compared to the control group (100% vs. 83%, p = 0.1). During follow-up (1.1 years, interquartile range 0.6-1.3), one patient (4%) had a recurrence in the trans-jugular group, as opposed to eight (38%) in the control group (p = 0.006). No permanent complications occurred. 3D cryoablation of right anterior-lateral, anterior, and anterior-septal/para-Hisian APs in children using a trans-jugular approach is extremely effective and safe, resulting in higher chronic success rate compared to the conventional femoral approach.

Two-Year Clinical Outcome of MitraClip Transcatheter Edge-to-Edge Repair From the J-MITRA Registry Data.

The introduction of transcatheter edge-to-edge repair for moderate-to-severe or severe mitral regurgitation (MR) utilizing the MitraClip system became reimbursed and clinically accessible in Japan in April 2018. This study presents the 2-year clinical outcomes of all consecutively treated patients who underwent MitraClip implantation in Japan and were prospectively enrolled in the Japanese Circulation Society-oriented J-MITRA registry. Analysis encompassed 2,739 consecutive patients enrolled in the J-MITRA registry with informed consent (mean age: 78.3±9.6 years, 1,550 males, STS risk score 11.7±8.9), comprising 1,999 cases of functional MR, 644 of degenerative MR and 96 in a mixed group (DMR and FMR). The acute procedure success rate was 88.9%. After MitraClip implantation, >80% exhibited an MR grade ≤2+ and the trend was sustained over the 2 years. Within this observation period, the mortality rate was 19.3% and the rate of heart failure readmissions was 20.6%. The primary composite endpoint, inclusive of cardiovascular death and heart failure readmission, was significantly higher in patients with functional MR than in with degenerative MR (32.0% vs. 17.5%, P<0.001). The 2-year clinical outcomes after MitraClip implantation were deduced from comprehensive data within an all-Japan registry.

Single catheter approach for treatment of premature ventricular contractions.

Catheter ablation has become one of the main treatment strategies in patients with premature ventricular complexes (PVC).The successful mapping and ablation can be performed with an ablation catheter without additional diagnostic catheters. We hypothesize that using a single catheter for PVC ablation may decrease complications, procedure time, and fluoroscopy exposure while maintaining comparable success rates. Sixty-nineconsecutive patients with PVC were treated with a single catheter approach compared to a historical cohort, in which a conventional setup was used. Propensity score matching was conducted with a 1:1 ratio. Outcome parameters included acute procedural success with elimination of all premature ventricular contractions after catheter ablation, procedural data as well as complication rates. Patients treated with a single catheter approach had shorter total procedure (60 minutes [IQR:47,5-69,0 minutes] vs. 90 minutes [IQR60-120 minutes]; p = 0.001) and fluoroscopy times (218 seconds[IQR:110,5-446 seconds] vs. 310 seconds[IQR190-640 seconds]; p = 0.012), which consecutively leads to a reduction of radiation exposure signified by a lower dose area product (155 cGycm² [IQR74.4-334.5 cGycm²] vs. 368.4 cGycm² [IQR:126-905.4 cGycm²]; p value 0.009). Acute procedural success rates were comparable in both groups (54 [84.3%] in the single catheter approach group and 58 [90.6%] in the conventional group; p: 0.287). A single catheter approach for the treatment of PVC is associated with a reduction of procedure- and fluoroscopy time, as well as a lesser radiation exposure, while maintaining equivalent acute success and complication rates compared with a conventionally used catheter setup.

Long-term follow-up of transcatheter closure of congenital coronary cameral fistulas in infants and children: experience from a single center

Abstract Background Transcatheter closure(TCC) has been considered as an effective treatment for anatomically suitable coronary cameral fistulas(CCF).However, limited data are available regarding long-term outcomes TCC of CCF in the pediatric population. Purpose The long-term efficacy and safety of TCC for the management of CCF was investigated in pediatric patients. Methods All pediatric patients(＜18 years old) diagnosed with CCF who were scheduled to undergo TCC between 2005 and 2019 in our center were retrospectively enrolled.CCF anatomic characteristics, procedural techniques, and follow-up outcomes were reviewed. Results 81 patients(42 males, median age 3.24 years) with CCF underwent diagnostic coronary angiography, and 66 patients(median age 3.93 years,median weight 15Kg) underwent attempted TCC of CCF. Immediate successful device implantation was achieved in 62 patients, and immediate complete occlusion was achieved in 44 patients(44/62, 71.0%). The closure procedure was waived in 2 patients because of challenging anatomic structures, and a total of 6 periprocedural complications occurred in 5 patients, including acute myocardial infarction(n=3),procedural-related death(n=1), device embolization(n=1), and rupture of tricuspid chordae tendineae(n=1). The acute procedural success rate was 89.4%(59/66), and the acute complication rate was 9.1%(6/66). Follow-up data were collected for 58 (93.5%) out of 62 patients at a median of 9.3 years(range, 3.0-15.7 years). Among them, 10 adverse events occurred in 9 patients, including 5 follow-up complications(1 aortic valve perforation, 1 coronary thrombosis, 1 progressive aneurysmal dilation after reintervention, 2 new-onset tricuspid prolapse with significant regurgitation), and 5 closure failure with large residual shunts. The long-term adverse event rate was 17.2% (10/58). The angiographic features associated with both acute and long-term adverse were large CCF(P=0.005), and giant coronary artery aneurysm(CAA) (P=0.029). Conclusions TCC of CCF in infants and children appears to be safe and effective. Patients with large CCF and giant CAA may be at higher risk for both acute and long-term adverse events.Patient flow chartClosure strategies of TCC of CCF

Impact of Transcatheter Edge-to-Edge Mitral Valve Repair on Atrial Functional Mitral Regurgitation from the GIOTTO Registry

Atrial functional mitral regurgitation (aFMR) has a peculiar pathophysiology that may have distinctive outcomes. We investigated the impact of transcatheter edge-to-edge repair in aFMR compared with other FMR etiologies. The GIOTTO (GIse registry Of Transcatheter treatment of MR) is a multicenter, prospective study enrolling patients with symptomatic MR treated with MitraClip up to 2020. We categorized patients with FMR as aFMR, ischemic FMR (iFMR), and nonischemic ventricular FMR (niFMR). The clinical end points were defined according to the Mitral Valve Academic Research Consortium. Of 1,153 patients, 6% had aFMR, 47% iFMR, and 47% niFMR. Patients with aFMR were older, mostly women, and had a higher atrial fibrillation rate. They had better left ventricular ejection fraction and smaller left ventricular volumes, with no difference in mitral effective regurgitant orifice area. The acute device and procedural success rates were similar among the groups. At the longest available follow-up (median 478days, interquartile range 91 to 741 days), the rate of MR ≥2+ was similar among the groups. Patients with aFMR had a lower rate of cardiovascular death and heart failure than patients with iFMR (hazard ratio [HR] 0.43, p = 0.02) and niFMR (HR 0.45, p = 0.03). The aFMR etiology remained independently associated with the composite outcome, together with postprocedural MR ≤1+ (HR 0.63, p <0.01) and peripheral arteriopathy (HR 1.82, p = 0.003). The results of this GIOTTO subanalysis suggested that aFMR is less prevalent and associated with better outcomes compared with other causes of FMR treated by transcatheter edge-to-edge repair. Postprocedural MR >1+, peripheral vasculopathy, non-aFMR were independent predictors of worse outcomes.

Abstract 16484: Utility of Steerable Sheaths and Intracardiac Echocardiography for Typical Atrial Flutter Ablation

Introduction: Sheaths (SS) and intracardiac echocardiography (ICE) are being increasingly utilized to improve safety, efficacy, and efficiency of catheter ablation procedures for different arrhythmias. The utility of these tools to guide ablation of typical atrial flutter (AFL) are not well characterized. Hypothesis: The use of SS plus ICE during typical AFL ablation leads to improved procedural and long-term outcomes as well as shorter procedural, fluoroscopy, and total radiofrequency times. Methods: In this retrospective chart review, medical records were abstracted for patients undergoing typical AFL ablation alone between 7/2019-5/2023. Demographics, medical history, and baseline procedural data were collected. Procedural outcomes were achievement of bidirectional block and complications. Long term outcome was recurrence of typical AFL or unblocked cavotricuspid isthmus (CTI) at repeat ablation (for any arrhythmia). Data analyzed with intention-to-treat analysis. Results: 197 patients were identified. The use of SS plus ICE had the shortest procedural time (69.81 ± 34.49 mins, p&lt;0.001), total radiofrequency time (362.91 ± 502.62 secs, p=0.005), and fluoroscopy time (5.28 ± 3.34 mins, p&lt;0.001) (Figure 1). When patients were divided based on SS alone, both procedural and radiofrequency times were shorter with the use of SS vs no SS (81.04 ± 40.37 vs 91.74 ± 37.67 mins, p&lt;0.001; 370.02 ± 460.44 vs 602.27 ± 592.28 secs, p=0.001), however, fluoroscopy time was longer (8.25 ± 7.75 vs 6.60 ± 5.58 mins, p&lt;0.001). There was no difference between acute procedural success rates. Those in SS group were less likely to have recurrent typical AFL or unblocked CTI on redo ablation (0 out of 49 [0%] vs 6 out of 148 [4%]). Conclusion: Typical AFL ablation using SS plus ICE resulted in shorter procedural, total radiofrequency, and fluoroscopy times with similar acute procedural success rates. The use of SS (regardless of ICE) is associated with increased long-term success rate.

Feasibility and safety of Stanford A aortic dissection complete endovascular repair system in a porcine model

BackgroundAcute type A aortic dissection (ATAAD) is a catastrophic disease with high morbidity and mortality. Although open surgery is still the gold standard for the treatment of ATAAD, some patients, with advanced age and multiple comorbidities, can only receive medical management alone. Nowadays, thoracic aortic endovascular repair (TEVAR) provides a potential treatment option for the patient with ATAAD, but traditional stent grafts (SGs), which are not designed for the ATAAD, are inapplicable to the unique anatomy of the aortic arch. Therefore, we innovatively created the BRIDGE system (Chuangxin Medical, Shenzhen, China), a complete endovascular reconstruction system designed to treat ATAAD. This study aimed to evaluate the feasibility and safety of the novel Stanford A aortic dissection complete endovascular reconstruction system in a porcine model.MethodThe BRIDGE system consists of the type A stent system and the type C stent system. Between November 2020 and March 2021, three white swine were utilized in the study. The BRIDGE system was deployed via the transcatheter approach under angiographic guidance. The swine(n = 3) treated with our system were evaluated using angiography before sacrifice 1-month after implantation, which was followed by gross specimen evaluation and histological examination of harvested tissues.ResultThe acute procedure success rate was 100% (3/3). The immediate post-procedural angiography showed that both type A SGs and type C SGs were deployed in satisfactory locations, with patency of the supra-aortic trunk and no endoleak. The cumulative mortality of 30-day was 0% without any adverse events. No device migration or leakage was observed angiographically, before sacrifice. The gross observation confirmed a type A SG covered part of the entry of anonyma. Favorable endothelialization, no thrombogenesis, and slight inflammatory infiltration of the tissues around the device were confirmed by microscopic examinations in all pigs.ConclusionIt was feasible and secure to use Stanford A aortic dissection complete endovascular reconstruction system to implement a transcatheter endovascular repair in a porcine model. With this novel system, treating acute type A aortic dissection may be more efficient and secure in human.

Short-Term Outcomes Following Transcatheter Edge-to-Edge Repair: Insights From the OCEAN-Mitral Registry

BackgroundTranscatheter edge-to-edge repair (TEER) is a less invasive treatment for patients with mitral regurgitation (MR). Limited safety and efficacy data of TEER with MitraClip, including the fourth-generation (G4) system, in a large cohort, are available. ObjectivesThis study aimed to summarize the initial experience of the TEER system in patients with MR from a large registry in Japan. MethodsThe OCEAN (Optimized CathEter vAlvular iNtervention)-Mitral Registry is an ongoing, prospective, investigator-initiated, multicenter, observational registry for patients with primary and secondary MR undergoing transcatheter mitral valve therapies. A total of 21 centers participated in the registry. Patients undergoing TEER were enrolled, and their characteristics, procedural details, and clinical outcomes were recorded. ResultsIn total, 2,150 patients including 1,605 patients (75.0%) with secondary MR, were enrolled between April 2018 and June 2021. The median age was 80 years, and 43.7% were women. The median device and fluoroscopy times were 60 and 26 minutes, respectively. Those with the G4 system (618/2,150 [28.7%]) were significantly shorter than those with the second generation (G2) system (1,532/2,150 [71.3%]). Overall, 94.6% met acute procedural success without significant differences between the 2 systems (G2 94.7% vs G4 94.6%; P = 0.961). ConclusionsThe OCEAN-Mitral registry has demonstrated the short-term outcomes of TEER systems, including the G4 system, in symptomatic patients with primary and secondary MR. The acute procedural success rate in the G2 system was excellent, and that in the G4 system was expected to improve with the multidisciplinary heart valve team approach. (Japanese Registry study of valvular heart diseases treatment and prognosis; UMIN000023653)

Efficacy of Catheter Ablation Using the Electroanatomical System without the Use of Fluoroscopy in Patients with Ventricular Extrasystolic Beats.

Catheter ablation (CA) has become safe and efficient for the treatment of patients with ventricular extrasystolic beats (VEBs). The three-dimensional electroanatomic mapping (EAM) system allows the elimination of fluoroscopy time during CA procedures. Non-fluoroscopy CA is a challenging procedure requiring intimate knowledge of cardiac anatomy in patients with VEBs. The study aimed to evaluate the efficacy and safety of the non-fluoroscopy CA using the EAM system in patients with VEBs. Completely fluoroless CA of VEBs guided by EAM was performed in 86% (94 out of 109) of consecutive patients with VEBs. The remaining 15 patients underwent conventional fluoroscopy-guided CA. Demographic and clinical baseline characteristics, procedure parameters, and following complications were obtained from the medical records. Primary outcomes were the acute procedural success rate, the permanent success rate (6-month follow-up), complications, and procedure time. There were no significant differences between groups regarding baseline characteristics. Acute procedural success was achieved in 85 patients (90%) in the non-fluoroscopy group and in 14 patients (93%) in the fluoroscopy group (ns). A long-term success rate was achieved in 82 patients (87%) in the non-fluoroscopy group and in 14 (82%) patients in the fluoroscopy group (ns). The median procedure time was 85 min in the non-fluoroscopy group and 120 min in the fluoroscopy group (p = 0.029). There was only one major complication in the non-fluoroscopy group (ns). Completely fluoroless CA of VEBs guided by EAM is a feasible, safe, and efficient procedure.

Novel arm-width-expandable transcatheter edge-to-edge repair system: Preclinical experiment and first-in-human study.

The ValveClasp system is a novel transcatheter edge-to-edge repair (TEER) device with an arm-width-expandable clip that allows treatment of patients with only one clip more frequently. This study aimed to evaluate the feasibility and safety of a novel TEER device in porcine models and patients. Fourteen young adult pigs were enrolled. A clip with an expanded arm was implanted under epicardial echocardiography and fluoroscopy guidance. Five patients with at least moderate-to-severe mitral regurgitation underwent TEER using the ValveClasp system to test the safety and effectiveness of the device. The device success rate was 100% (14/14) in the animal experiments, and all clips were deployed at the A2P2 segments, forming a double-orifice mitral valve. Gross observations on day 180 showed a wide and continuous tissue bridge between the leaflets. The acute procedural success rate was 100% (5/5). Only one clip was required in all patients, and all achieved effective postoperative endpoints (grade ≤2+). During 30-day follow-up, no adverse events occurred. All patients'vena Contracta width (from 8.04 0.71 mmto 3.84 ± 1.18 mm, p = 0.012), mitral regurgitation area (from 12.75 ± 3.13 cm2 to 3.50 ± 1.66 cm2 , p = 0.008), and left ventricular end diastolic diameter (from 52.00 ± 2.92 mm to 46.00 ± 3.08 mm, p = 0.040) were considerably decreased, without obvious mitral stenosis. The novel arm-width-expandable ValveClasp device is safe for TEER for treating severe mitral regurgitation.

Early Outcomes of a Next-Generation Balloon-Expandable Transcatheter Heart Valve - The Myval System: A Single-Center Experience From Serbia

Transcatheter aortic valve implantation (TAVI) is one of the most effective treatments for severe aortic valve stenosis (AVS). Different genres and generations of transcatheter heart valves (THVs) are accessible, offering operators an opportunity to choose a patient-tailored device. In this single-center study, we present the outcomes of Serbian patients treated with next-generation Myval THV for severe symptomatic AVS. Myval THV was implanted in all consecutive patients who underwent TAVI at the Dedinje Cardiovascular Institute of Belgrade, Serbia between October 2020 and September 2021. The primary endpoint was device success on day 30. Secondary endpoints included 30-day all-cause mortality, cardiovascular death, stroke, moderate/severe paravalvular leak (PVL), and new permanent pacemaker implantation (PPI). TAVI was performed as per the European Society of Cardiology guidelines. The study comprised thirteen patients, aged 72 ± 13 years with mean EuroSCORE (7.17%) and Society of Thoracic Surgeons (2.72%,) scores who underwent TAVI successfully with 92.3% using the percutaneous approach. Myval THV intermediate and extra-large sizes were implanted in 46% and 15% of patients, respectively. This acute procedure success rate was 100%. The primary composite endpoint of early device success was achieved in all patients. None of the patients had clinically significant aortic regurgitation or moderate/severe PVL. No patient experienced stroke, contrast-induced acute kidney injury, device-related vascular complications, or a new PPI. The all-cause mortality rate at 30 days was 0%. Myval THV system demonstrated a favorable safety/efficacy profile within 30 days post-procedure at a single center in Serbia. This is the first report of my experience with Myval THV from Serbia.

Real-World Outcomes of Fourth-Generation Mitral Transcatheter Repair: 30-Day Results From EXPAND G4

BackgroundThe fourth-generation MitraClip G4 System builds on the previous NTR/XTR system with additional wider clip sizes (NTW and XTW), an independent grasping feature, and an improved clip deployment sequence. ObjectivesThe primary objective of this study was to assess the safety and performance of the MitraClip G4 System within a contemporary real-world setting. MethodsEXPAND G4 is a prospective, multicenter, international, single-arm, postapproval study that enrolled patients with primary (degenerative) mitral regurgitation (MR) and secondary (functional) MR at 60 centers. Follow-up of the full cohort has been conducted through 30 days. Echocardiograms were analyzed by an echocardiography core laboratory. Study outcomes included MR severity, functional capacity measured by NYHA functional class, quality of life measured using the Kansas City Cardiomyopathy Questionnaire, major adverse event rates, and all-cause mortality. ResultsIn EXPAND G4, 1,141 subjects with primary MR and secondary MR were treated from March 2021 to February 2022. Implantation and acute procedural success rates were 98.0% and 96.2%, respectively, with a mean of 1.4 ± 0.6 clips implanted per subject. MR was significantly reduced at 30 days compared with baseline (98% achieved MR ≤ 2+, and 91% achieved MR ≤ 1+; P < 0.0001). Functional capacity and quality of life were substantially improved, with 83% of patients achieving NYHA functional class I or II. Likewise, an 18-point improvement was observed in Kansas City Cardiomyopathy Questionnaire summary scores compared with baseline. The composite major adverse event rate was 2.7%, and the all-cause death rate was 1.3% at 30 days. ConclusionsThis study demonstrates for the first time the effectiveness and safety of MitraClip G4 System at 30 days in a cohort of >1,000 patients with MR in a contemporary, real-world setting.

Acute procedural outcomes of left bundle branch area pacing compared to His-bundle pacing

Abstract Funding Acknowledgements Type of funding sources: None. Background Conduction system pacing (CSP), encompassing left bundle branch area pacing (LBBAP) and His-bundle pacing (HBP), is a novel pacing strategy, which overcomes limitations of conventional right ventricular pacing. Feasibility and early safety of both strategies have been established previously. While HBP is mentioned as an alternative pacing strategy in the latest European and American pacing guidelines, implantation recommendations regarding LBBAP are scarce. Notably, HBP was described to be associated with a significantly higher procedural failure rate compared to LBBAP, making it potentially more contestable. Purpose To compare procedural outcomes after HBP and LBBAP lead implantation. Methods We prospectively assessed 303 consecutive CSP lead implantation attempts at our center from 08/2018 to 11/2022. 81% of all implantations were performed by two high-volume device implanters. Successful conduction system pacing was established according to standard criteria (HBP: QRS morphology, R-wave peak time in V6, programmed stimulation, visibility of a His potential; LBBAP: R-wave peak time in V6, V1-V6-interpeak interval, programmed stimulation or visibility of a left bundle potential) and pacing thresholds (HBP: &amp;lt;4.0V/1.0ms; LBBAP: &amp;lt;2V/0.5ms). Patient selection and the implantation strategy used was at the operator’s discretion. Results Patients with a HBP attempt were younger and had a narrower QRS complex but did not differ with respect to left or right ventricular function and dimension (table showing percentages and median values/interquartile ranges). LBBAP systems were more often implanted in lieu of CRT, whereas HBP systems were more commonly used in case of AV block without heart failure (table). Acute procedural success rate, overall procedure duration and fluoroscopy time were significantly better during LBBAP implantations (all p&amp;lt;0.001). Success rates, sensing values and capture thresholds (@1ms for HBP and @0.5ms for LBBAP) were superior in LBBAP systems, while achieved paced QRS duration was slightly shorter in HBP systems (table, figure 1). Conclusion Success rates and acute procedural outcomes favor implantation of LBBAP compared to HBP systems.