Pub Date : 2024-05-04DOI: 10.1093/europace/euae127
Larisa G Tereshchenko, Jonathan W Waks, Christine Tompkins, Albert J Rogers, Ashkan Ehdaie, Charles A Henrikson, Khidir Dalouk, Merritt Raitt, Shivangi Kewalramani, Michael W Kattan, Pasquale Santangeli, Bruce W Wilkoff, Samir R Kapadia, Sanjiv M Narayan, Sumeet S Chugh
Background and Aims Ablation of monomorphic ventricular tachycardia (MMVT) has been shown to reduce shock frequency and improve survival. We aimed to compare cause-specific risk factors of MMVT and polymorphic ventricular tachycardia (PVT)/ventricular fibrillation (VF) and to develop predictive models. Methods The multicenter retrospective cohort study included 2,668 patients (age 63.1±13.0 y; 23% female; 78% white; 43% nonischemic cardiomyopathy, left ventricular ejection fraction 28.2±11.1%). Cox models were adjusted for demographic characteristics, heart failure severity and treatment, device programming, and ECG metrics. Global electrical heterogeneity was measured by spatial QRS-T angle (QRSTa), spatial ventricular gradient elevation (SVGel), azimuth, magnitude (SVGmag), and sum absolute QRST integral (SAIQRST). We compared the out-of-sample performance of the lasso and elastic net for Cox proportional hazards and the Fine-Gray competing risk model. Results During a median follow-up of 4 years, 359 patients experienced their first sustained MMVT with appropriate ICD therapy, and 129 patients had their first PVT/VF with appropriate ICD shock. The risk of MMVT was associated with wider QRSTa (HR 1.16; 95%CI 1.01-1.34), larger SVGel (HR 1.17; 95%CI 1.05-1.30), and smaller SVGmag (HR 0.74; 95%CI 0.63-0.86) and SAIQRST (HR 0.84; 95%CI 0.71-0.99). The best-performing 3-year competing risk Fine-Gray model for MMVT (ROC(t)AUC 0.728; 95%CI 0.668-0.788) identified high-risk (> 50%) patients with 75% sensitivity, 65% specificity, and PVT/VF prediction model had ROC(t)AUC 0.915 (95%CI 0.868-0.962), both satisfactory calibration. Conclusion We developed and validated models to predict the competing risks of MMVT or PVT/VF that could inform procedural planning and future RCTs of prophylactic VT ablation.
{"title":"Competing Risks for Monomorphic versus Non-Monomorphic Ventricular Arrhythmias in Primary Prevention Implantable Cardioverter Defibrillator Recipients: Global Electrical Heterogeneity and Clinical Outcomes (GEHCO) Study","authors":"Larisa G Tereshchenko, Jonathan W Waks, Christine Tompkins, Albert J Rogers, Ashkan Ehdaie, Charles A Henrikson, Khidir Dalouk, Merritt Raitt, Shivangi Kewalramani, Michael W Kattan, Pasquale Santangeli, Bruce W Wilkoff, Samir R Kapadia, Sanjiv M Narayan, Sumeet S Chugh","doi":"10.1093/europace/euae127","DOIUrl":"https://doi.org/10.1093/europace/euae127","url":null,"abstract":"Background and Aims Ablation of monomorphic ventricular tachycardia (MMVT) has been shown to reduce shock frequency and improve survival. We aimed to compare cause-specific risk factors of MMVT and polymorphic ventricular tachycardia (PVT)/ventricular fibrillation (VF) and to develop predictive models. Methods The multicenter retrospective cohort study included 2,668 patients (age 63.1±13.0 y; 23% female; 78% white; 43% nonischemic cardiomyopathy, left ventricular ejection fraction 28.2±11.1%). Cox models were adjusted for demographic characteristics, heart failure severity and treatment, device programming, and ECG metrics. Global electrical heterogeneity was measured by spatial QRS-T angle (QRSTa), spatial ventricular gradient elevation (SVGel), azimuth, magnitude (SVGmag), and sum absolute QRST integral (SAIQRST). We compared the out-of-sample performance of the lasso and elastic net for Cox proportional hazards and the Fine-Gray competing risk model. Results During a median follow-up of 4 years, 359 patients experienced their first sustained MMVT with appropriate ICD therapy, and 129 patients had their first PVT/VF with appropriate ICD shock. The risk of MMVT was associated with wider QRSTa (HR 1.16; 95%CI 1.01-1.34), larger SVGel (HR 1.17; 95%CI 1.05-1.30), and smaller SVGmag (HR 0.74; 95%CI 0.63-0.86) and SAIQRST (HR 0.84; 95%CI 0.71-0.99). The best-performing 3-year competing risk Fine-Gray model for MMVT (ROC(t)AUC 0.728; 95%CI 0.668-0.788) identified high-risk (> 50%) patients with 75% sensitivity, 65% specificity, and PVT/VF prediction model had ROC(t)AUC 0.915 (95%CI 0.868-0.962), both satisfactory calibration. Conclusion We developed and validated models to predict the competing risks of MMVT or PVT/VF that could inform procedural planning and future RCTs of prophylactic VT ablation.","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140841339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-04DOI: 10.1093/europace/euae121
Andreas Rillig, Lars Eckardt, Katrin Borof, A John Camm, Harry J G M Crijns, Andreas Goette, Günter Breithardt, Marc D Lemoine, Andreas Metzner, Laura Rottner, Ulrich Schotten, Eik Vettorazzi, Karl Wegscheider, Antonia Zapf, Hein Heidbuchel, Stephan Willems, Larissa Fabritz, Renate B Schnabel, Christina Magnussen, Paulus Kirchhof
Background and Aims Clinical concerns exist about the potential proarrhythmic effects of the sodium channel blockers flecainide and propafenone (SCB) in patients with cardiovascular disease. SCB were used to deliver early rhythm control (ERC) therapy in EAST-AFNET 4. Methods We analysed the primary safety outcome (death, stroke, or serious adverse events related to rhythm-control therapy) and primary efficacy outcome (cardiovascular death, stroke and hospitalization for worsening of heart failure or acute coronary syndrome) during SCB-intake for ERC patients (n = 1395) in EAST-AFNET 4. The protocol discouraged flecainide and propafenone in patients with reduced left ventricular ejection fraction and suggested stopping therapy upon QRS prolongation >25% on therapy. Results Flecainide or propafenone was given to 689 patients (age 69 (8) years; CHA2DS2-VASc 3.2 (1); 177 with heart failure; 41 with prior myocardial infarction, CABG or PCI; 26 with left ventricular hypertrophy >15 mm; median therapy duration 1,153 [237, 1,828] days). The primary efficacy outcome occurred less often in patients treated with SCB (3/100 (99/3,316) patient-years) than in patients who never received SCB (SCBnever 4.9/100 (150/3,083) patient-years, p < 0.001). There were numerically fewer primary safety outcomes in patients receiving SCB (2.9/100 (96/3,359) patient-years) than in SCBnever patients (4.2/100 (135/3,220) patient-years, adjusted p = 0.015). Sinus rhythm at 2 years was similar between groups (SCB 537/610 (88); SCBnever 472/579 (82)). Conclusion Long-term therapy with flecainide or propafenone appeared to be safe in the EAST-AFNET 4 trial to deliver effective ERC therapy, including in selected patients with stable cardiovascular disease such as coronary artery disease and stable heart failure. Clinical Trial Registration ISRCTN04708680, NCT01288352, EudraCT2010-021258-20, www.easttrial.org
{"title":"Safety and efficacy of long-term Sodium Channel Blocker therapy for Early Rhythm Control: The EAST-AFNET 4 trial","authors":"Andreas Rillig, Lars Eckardt, Katrin Borof, A John Camm, Harry J G M Crijns, Andreas Goette, Günter Breithardt, Marc D Lemoine, Andreas Metzner, Laura Rottner, Ulrich Schotten, Eik Vettorazzi, Karl Wegscheider, Antonia Zapf, Hein Heidbuchel, Stephan Willems, Larissa Fabritz, Renate B Schnabel, Christina Magnussen, Paulus Kirchhof","doi":"10.1093/europace/euae121","DOIUrl":"https://doi.org/10.1093/europace/euae121","url":null,"abstract":"Background and Aims Clinical concerns exist about the potential proarrhythmic effects of the sodium channel blockers flecainide and propafenone (SCB) in patients with cardiovascular disease. SCB were used to deliver early rhythm control (ERC) therapy in EAST-AFNET 4. Methods We analysed the primary safety outcome (death, stroke, or serious adverse events related to rhythm-control therapy) and primary efficacy outcome (cardiovascular death, stroke and hospitalization for worsening of heart failure or acute coronary syndrome) during SCB-intake for ERC patients (n = 1395) in EAST-AFNET 4. The protocol discouraged flecainide and propafenone in patients with reduced left ventricular ejection fraction and suggested stopping therapy upon QRS prolongation &gt;25% on therapy. Results Flecainide or propafenone was given to 689 patients (age 69 (8) years; CHA2DS2-VASc 3.2 (1); 177 with heart failure; 41 with prior myocardial infarction, CABG or PCI; 26 with left ventricular hypertrophy &gt;15 mm; median therapy duration 1,153 [237, 1,828] days). The primary efficacy outcome occurred less often in patients treated with SCB (3/100 (99/3,316) patient-years) than in patients who never received SCB (SCBnever 4.9/100 (150/3,083) patient-years, p &lt; 0.001). There were numerically fewer primary safety outcomes in patients receiving SCB (2.9/100 (96/3,359) patient-years) than in SCBnever patients (4.2/100 (135/3,220) patient-years, adjusted p = 0.015). Sinus rhythm at 2 years was similar between groups (SCB 537/610 (88); SCBnever 472/579 (82)). Conclusion Long-term therapy with flecainide or propafenone appeared to be safe in the EAST-AFNET 4 trial to deliver effective ERC therapy, including in selected patients with stable cardiovascular disease such as coronary artery disease and stable heart failure. Clinical Trial Registration ISRCTN04708680, NCT01288352, EudraCT2010-021258-20, www.easttrial.org","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"98 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140841731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-03DOI: 10.1093/europace/euae124
Anindya Ghosh, Anbarasan Sekar, Chenni S Sriram, Kothandam Sivakumar, Gaurav A Upadhyay, Ulhas M Pandurangi
Objectives To characterize the diagnosis, frequency, and procedural implications of septal venous channel perforation during left bundle branch area pacing (LBBAP). Methods All consecutive patients undergoing LBBAP over an 8-month period were prospectively studied. During lead placement, obligatory septal contrast injection was performed twice, at initiation (implant entry zone) and completion (fixation zone). An intuitive fluoroscopic schema using orthogonal views (LAO/RAO) and familiar landmarks is described. Using this, we resolved zonal distribution (I-VI) of lead position on the ventricular septum and its angulation (post-fixation angle θ). Subjects with/without septal venous channel perforation were compared. Results Sixty-one-patients [Male 57.3%, Median Age (IQR) 69.5(62.5-74.5) years] were enrolled. Septal venous channel perforation was observed in 8 (13.1%) patients [Male 28.5%, Median Age (IQR) 64(50-75) years]. They had higher frequency of, i) right-sided-implant (25% vs. 1.9%, p = 0.04), ii) fixation in zone III at the mid-superior septum (75% vs 28.3%, p = 0.04), iii) steeper angle of fixation- median θ (IQR) [19(10-30)° vs. 5(4-19)°, p = 0.01), and iv) longer median penetrated-lead-length (IQR) [13(10-14.8) vs. 10(8.5-12.5)mm, p = 0.03]. Coronary sinus drainage of contrast was noted in 5 (62.5%) patients. Abnormal impedance drops during implantation (12.5% vs. 5.7%, p = NS) were not significantly different. Conclusion When evaluated systematically, septal venous channel perforation may be encountered commonly after LBBAP. The fiducial reference framework described using fluoroscopic imaging identified salient associated findings. This may be addressed with lead repositioning to a more inferior location and are not associated with adverse consequence acutely or in early follow-up.
目的 探讨左束支区起搏（LBBAP）过程中室间隔静脉通道穿孔的诊断、频率和手术影响。方法 对所有连续接受左束支区起搏的患者进行为期 8 个月的前瞻性研究。在导联置入过程中，必须进行两次室间隔造影剂注射，分别在开始时（植入物进入区）和完成时（固定区）。本文介绍了使用正交视图（LAO/RAO）和熟悉地标的直观透视方案。利用这种方法，我们解决了室间隔上导联位置的区域分布（I-VI）及其角度（固定后角度θ）问题。对有/无室间隔静脉通道穿孔的受试者进行比较。结果 61 名患者[男性占 57.3%，中位年龄（IQR）69.5(62.5-74.5)岁]入选。8名（13.1%）患者[男性 28.5%，中位年龄（IQR）64（50-75）岁]出现了间隔静脉通道穿孔。他们有更高的频率：i）右侧植入（25% vs. 1.9%，P = 0.04）；ii）固定在室间隔中上部的 III 区（75% vs. 28.3%，P = 0.IQR）[19(10-30)° vs. 5(4-19)°，p = 0.01]，以及 iv) 穿透导联长度中位数更长（IQR）[13(10-14.8) vs. 10(8.5-12.5)mm，p = 0.03]。5例（62.5%）患者出现了造影剂冠状窦引流。植入过程中阻抗异常下降（12.5% 对 5.7%，P = NS）没有显著差异。结论 在进行系统评估时，LBBAP术后可能会经常出现室间隔静脉通道穿孔。利用透视成像技术描述的靶标参考框架确定了相关的突出发现。这可以通过将导联重新定位到更靠下的位置来解决，而且不会在急性期或早期随访中造成不良后果。
{"title":"Septal Venous Channel Perforation during Left Bundle Branch Area Pacing: A Prospective Study","authors":"Anindya Ghosh, Anbarasan Sekar, Chenni S Sriram, Kothandam Sivakumar, Gaurav A Upadhyay, Ulhas M Pandurangi","doi":"10.1093/europace/euae124","DOIUrl":"https://doi.org/10.1093/europace/euae124","url":null,"abstract":"Objectives To characterize the diagnosis, frequency, and procedural implications of septal venous channel perforation during left bundle branch area pacing (LBBAP). Methods All consecutive patients undergoing LBBAP over an 8-month period were prospectively studied. During lead placement, obligatory septal contrast injection was performed twice, at initiation (implant entry zone) and completion (fixation zone). An intuitive fluoroscopic schema using orthogonal views (LAO/RAO) and familiar landmarks is described. Using this, we resolved zonal distribution (I-VI) of lead position on the ventricular septum and its angulation (post-fixation angle θ). Subjects with/without septal venous channel perforation were compared. Results Sixty-one-patients [Male 57.3%, Median Age (IQR) 69.5(62.5-74.5) years] were enrolled. Septal venous channel perforation was observed in 8 (13.1%) patients [Male 28.5%, Median Age (IQR) 64(50-75) years]. They had higher frequency of, i) right-sided-implant (25% vs. 1.9%, p = 0.04), ii) fixation in zone III at the mid-superior septum (75% vs 28.3%, p = 0.04), iii) steeper angle of fixation- median θ (IQR) [19(10-30)° vs. 5(4-19)°, p = 0.01), and iv) longer median penetrated-lead-length (IQR) [13(10-14.8) vs. 10(8.5-12.5)mm, p = 0.03]. Coronary sinus drainage of contrast was noted in 5 (62.5%) patients. Abnormal impedance drops during implantation (12.5% vs. 5.7%, p = NS) were not significantly different. Conclusion When evaluated systematically, septal venous channel perforation may be encountered commonly after LBBAP. The fiducial reference framework described using fluoroscopic imaging identified salient associated findings. This may be addressed with lead repositioning to a more inferior location and are not associated with adverse consequence acutely or in early follow-up.","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140842534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-02DOI: 10.1093/europace/euae088
Mattias Duytschaever, Gediminas Račkauskas, Tom De Potter, Jim Hansen, Sebastian Knecht, Thomas Phlips, Johan Vijgen, Daniel Scherr, Gabor Szeplaki, Hugo Van Herendael, Mads Brix Kronborg, Benjamin Berte, Helmut Pürerfellner, Peter Lukac
Aims 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. Methods and results 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 dur
{"title":"Dual energy for pulmonary vein isolation using dual-energy focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 3-month results","authors":"Mattias Duytschaever, Gediminas Račkauskas, Tom De Potter, Jim Hansen, Sebastian Knecht, Thomas Phlips, Johan Vijgen, Daniel Scherr, Gabor Szeplaki, Hugo Van Herendael, Mads Brix Kronborg, Benjamin Berte, Helmut Pürerfellner, Peter Lukac","doi":"10.1093/europace/euae088","DOIUrl":"https://doi.org/10.1093/europace/euae088","url":null,"abstract":"Aims 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. Methods and results 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 &gt;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 dur","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"50 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140841337","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-02DOI: 10.1093/europace/euae118
Prashanthan Sanders, Stewart Healy, Mehrdad Emami, Emily Kotschet, Amber Miller, Jonathan M Kalman
Background and Aims Pulsed field ablation (PFA) for the treatment of atrial fibrillation (AF) potentially offers improved safety and procedural efficiencies compared to thermal ablation. Opportunities remain to improve effective circumferential lesion delivery, safety, and workflow of first generation PFA systems. Here we aim to evaluate the initial clinical experience with a balloon-in-basket, 3D integrated PFA system with a purpose-built form factor for pulmonary vein (PV) isolation. Methods The VOLT CE Mark Study is a premarket, prospective, multi-centre, single-arm study to evaluate the safety and effectiveness of the Volt™ PFA System for the treatment of paroxysmal (PAF) or persistent AF (PersAF). Feasibility sub-study subjects underwent phrenic nerve evaluation, endoscopy, chest CT, and cerebral MRI. Study endpoints were the rate of primary serious adverse event within 7-days and acute procedural effectiveness. Results A total of 32 subjects (age 61.6 ± 9.6 years, 65.6% male, 84.4% PAF) were enrolled and treated in the feasibility sub-study and completed 30-day follow-up. Acute effectiveness was achieved in 99.2% (127/128) of treated PVs (96.9% of subjects, 31/32) with 23.8 ± 4.2 PFA applications/subject. Procedure, fluoroscopy, LA dwell and transpired ablation times were 124.6 ± 28.1, 19.8 ± 8.9, 53.0 ± 21.0, and 48.0 ± 19.9 minutes respectively. Systematic assessments of initial safety revealed no phrenic nerve injury, pulmonary vein stenosis, or esophageal lesions causally related to the PFA system, and 3 subjects with silent cerebral lesions (9.4%). There were no primary serious adverse events. Conclusions The initial clinical use of the Volt PFA System demonstrates acute safety and effectiveness in the treatment of symptomatic, drug refractory AF.
{"title":"Initial Clinical Experience with the Balloon-in-Basket Pulsed Field Ablation System: Acute Results of the VOLT CE Mark Feasibility Study","authors":"Prashanthan Sanders, Stewart Healy, Mehrdad Emami, Emily Kotschet, Amber Miller, Jonathan M Kalman","doi":"10.1093/europace/euae118","DOIUrl":"https://doi.org/10.1093/europace/euae118","url":null,"abstract":"Background and Aims Pulsed field ablation (PFA) for the treatment of atrial fibrillation (AF) potentially offers improved safety and procedural efficiencies compared to thermal ablation. Opportunities remain to improve effective circumferential lesion delivery, safety, and workflow of first generation PFA systems. Here we aim to evaluate the initial clinical experience with a balloon-in-basket, 3D integrated PFA system with a purpose-built form factor for pulmonary vein (PV) isolation. Methods The VOLT CE Mark Study is a premarket, prospective, multi-centre, single-arm study to evaluate the safety and effectiveness of the Volt™ PFA System for the treatment of paroxysmal (PAF) or persistent AF (PersAF). Feasibility sub-study subjects underwent phrenic nerve evaluation, endoscopy, chest CT, and cerebral MRI. Study endpoints were the rate of primary serious adverse event within 7-days and acute procedural effectiveness. Results A total of 32 subjects (age 61.6 ± 9.6 years, 65.6% male, 84.4% PAF) were enrolled and treated in the feasibility sub-study and completed 30-day follow-up. Acute effectiveness was achieved in 99.2% (127/128) of treated PVs (96.9% of subjects, 31/32) with 23.8 ± 4.2 PFA applications/subject. Procedure, fluoroscopy, LA dwell and transpired ablation times were 124.6 ± 28.1, 19.8 ± 8.9, 53.0 ± 21.0, and 48.0 ± 19.9 minutes respectively. Systematic assessments of initial safety revealed no phrenic nerve injury, pulmonary vein stenosis, or esophageal lesions causally related to the PFA system, and 3 subjects with silent cerebral lesions (9.4%). There were no primary serious adverse events. Conclusions The initial clinical use of the Volt PFA System demonstrates acute safety and effectiveness in the treatment of symptomatic, drug refractory AF.","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"7 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140840839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-30DOI: 10.1093/europace/euae113
Nili Schamroth Pravda, Yonatan Shaleve, Ygal Plakht, Gideon Shafir, Tzil Grinberg, Maya Wiessman, Yaron Aviv, Hana Vaknin-Assa, Pablo Codner, Gregory Golovchiner, Alon Barsheshet, Ran Kornowski, Arthur Shiyovich, Ashraf Hamdan
Objective We examined whether thickness of the basal muscular interventricular septum (IVS), as measured by pre-procedural computed tomography (CT), could be used to identify the risk of conduction disturbances following transcatheter aortic valve replacement (TAVR). Background The IVS is a pivotal region of the electrical conduction system of the heart where the atrioventricular conduction axis is located. Methods Included were 78 patients with severe aortic stenosis who underwent CT imaging prior to TAVR. The thickness of muscular IVS was measured in the coronal view, in systolic phases, at 1, 2, 5, and 10 mm below the membranous septum (MS). The primary endpoint was a composite of conduction disturbance following TAVR. Results Conduction disturbances occurred in 24 out of 78 patients (30.8%). Those with conduction disturbances were significantly more likely to have a thinner IVS than those without conduction disturbances at every measured IVS level (2.98 ± 0.52 mm vs. 3.38 ± 0.52 mm, 4.10 ± 1.02 mm vs. 4.65 ± 0.78 mm, 6.11 ± 1.12 mm vs. 6.88 ± 1.03 mm, and 9.72 ± 1.95 mm vs. 10.70 ± 1.55 mm for 1, 2, 5 and 10 mm below MS respectively, p < 0.05 for all). Multivariable logistic regression analysis showed that pre-procedural IVS thickness (<4 mm at 2 mm below the MS) was a significant independent predictor of post-procedural conduction disturbance (adjOR 7.387, 95% CI: 2.003-27.244, p = 0.003). Conclusion Pre-procedural CT assessment of basal IVS thickness is a novel predictive marker for the risk of conduction disturbances following TAVR. The IVS thickness potentially acts as an anatomical barrier protecting the underlying conduction system from mechanical compression during TAVR.
目的 我们研究了经导管主动脉瓣置换术（TAVR）前计算机断层扫描（CT）测量的基底肌性室间隔（IVS）厚度是否可用于识别传导障碍的风险。背景 IVS是心脏电传导系统的关键区域，房室传导轴就位于该区域。方法 纳入 78 例在 TAVR 前接受 CT 成像检查的重度主动脉瓣狭窄患者。在冠状切面上测量了收缩期膜室间隔（MS）下方 1、2、5 和 10 毫米处的肌肉 IVS 厚度。主要终点是 TAVR 术后传导障碍的综合指标。结果 78例患者中有24例（30.8%）出现传导障碍。在每个测量的 IVS 水平上，出现传导障碍的患者 IVS 变薄的可能性明显高于未出现传导障碍的患者（2.98 ± 0.52 mm vs. 3.38 ± 0.52 mm、4.10 ± 1.02 mm vs. 4.65 ± 0.78 mm、6.11 ± 1.12 mm vs. 6.88 ± 1.03 mm、9.72 ± 1.95 mm vs. 10.70 ± 1.55 mm）。多变量逻辑回归分析显示，术前 IVS 厚度（MS 下 2 mm 处为 4 mm）是术后传导障碍的重要独立预测因素（adjOR 7.387，95% CI：2.003-27.244，p = 0.003）。结论 术前 CT 评估基础 IVS 厚度是预测 TAVR 术后传导障碍风险的新标记。IVS 厚度有可能成为一个解剖屏障，在 TAVR 术中保护底层传导系统免受机械压迫。
{"title":"Interventricular Septal Thickness on Cardiac CT as a Novel Risk Factor for Conduction Disturbances in Patients Undergoing Transcatheter Aortic Valve Replacement","authors":"Nili Schamroth Pravda, Yonatan Shaleve, Ygal Plakht, Gideon Shafir, Tzil Grinberg, Maya Wiessman, Yaron Aviv, Hana Vaknin-Assa, Pablo Codner, Gregory Golovchiner, Alon Barsheshet, Ran Kornowski, Arthur Shiyovich, Ashraf Hamdan","doi":"10.1093/europace/euae113","DOIUrl":"https://doi.org/10.1093/europace/euae113","url":null,"abstract":"Objective We examined whether thickness of the basal muscular interventricular septum (IVS), as measured by pre-procedural computed tomography (CT), could be used to identify the risk of conduction disturbances following transcatheter aortic valve replacement (TAVR). Background The IVS is a pivotal region of the electrical conduction system of the heart where the atrioventricular conduction axis is located. Methods Included were 78 patients with severe aortic stenosis who underwent CT imaging prior to TAVR. The thickness of muscular IVS was measured in the coronal view, in systolic phases, at 1, 2, 5, and 10 mm below the membranous septum (MS). The primary endpoint was a composite of conduction disturbance following TAVR. Results Conduction disturbances occurred in 24 out of 78 patients (30.8%). Those with conduction disturbances were significantly more likely to have a thinner IVS than those without conduction disturbances at every measured IVS level (2.98 ± 0.52 mm vs. 3.38 ± 0.52 mm, 4.10 ± 1.02 mm vs. 4.65 ± 0.78 mm, 6.11 ± 1.12 mm vs. 6.88 ± 1.03 mm, and 9.72 ± 1.95 mm vs. 10.70 ± 1.55 mm for 1, 2, 5 and 10 mm below MS respectively, p &lt; 0.05 for all). Multivariable logistic regression analysis showed that pre-procedural IVS thickness (&lt;4 mm at 2 mm below the MS) was a significant independent predictor of post-procedural conduction disturbance (adjOR 7.387, 95% CI: 2.003-27.244, p = 0.003). Conclusion Pre-procedural CT assessment of basal IVS thickness is a novel predictive marker for the risk of conduction disturbances following TAVR. The IVS thickness potentially acts as an anatomical barrier protecting the underlying conduction system from mechanical compression during TAVR.","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140840840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-30DOI: 10.1093/europace/euae112
Teodor Serban, Patrick Badertscher, Jeanne du Fay de Lavallaz, Rui Providencia, Federico Migliore, Giacomo Mugnai, Diego Penela, Laura Perrotta, Michael Kühne, Christian Sticherling, Kyoung-Ryul Julian Chun
Background Arrhythmia-induced Cardiomyopathy (AiCM) represents a subtype of acute heart failure (HF) in the context of sustained arrhythmia. Clear definitions and management recommendations for AiCM are lacking. Purpose The European Heart Rhythm Association Scientific Initiatives Committee (EHRA SIC) conducted a survey to explore the current definitions and management of patients with AiCM among European and non-European electrophysiologists. Methods A 25-item online questionnaire was developed and distributed among EP specialists on the EHRA SIC website and on social media between September 4th and October 5th 2023. Results Of the 206 respondents, 16% were female and 61% were between 30-49 years old. Most of the respondents were EP-Specialists (81%) working at University Hospitals (47%). While most participants (67%) agreed that AiCM should be defined as a left ventricular ejection fraction (LVEF) impairment after new onset of an arrhythmia, only 35% identified a specific LVEF drop to diagnose AiCM with a wide range of values (5-20% LVEF drop). Most respondents considered all available therapies: catheter ablation(93%), electrical cardioversion(83%), antiarrhythmic drugs (76%) and adjuvant HF treatment(76%). 83% of respondents indicated that adjuvant HF treatment should be started at first HF diagnosis prior to antiarrhythmic treatment and 84% agreed it should be stopped within six months after LVEF normalization. Responses for the optimal time point for the first LVEF reassessment during follow-up varied markedly (1 day-6 months after antiarrhythmic treatment). Conclusion This EHRA Survey reveals varying practices regarding AiCM among physicians, highlighting a lack of consensus and heterogenous care of these patients.
{"title":"Definition and Management of Arrhythmia-induced Cardiomyopathy: Findings from the European Heart Rhythm Association Survey","authors":"Teodor Serban, Patrick Badertscher, Jeanne du Fay de Lavallaz, Rui Providencia, Federico Migliore, Giacomo Mugnai, Diego Penela, Laura Perrotta, Michael Kühne, Christian Sticherling, Kyoung-Ryul Julian Chun","doi":"10.1093/europace/euae112","DOIUrl":"https://doi.org/10.1093/europace/euae112","url":null,"abstract":"Background Arrhythmia-induced Cardiomyopathy (AiCM) represents a subtype of acute heart failure (HF) in the context of sustained arrhythmia. Clear definitions and management recommendations for AiCM are lacking. Purpose The European Heart Rhythm Association Scientific Initiatives Committee (EHRA SIC) conducted a survey to explore the current definitions and management of patients with AiCM among European and non-European electrophysiologists. Methods A 25-item online questionnaire was developed and distributed among EP specialists on the EHRA SIC website and on social media between September 4th and October 5th 2023. Results Of the 206 respondents, 16% were female and 61% were between 30-49 years old. Most of the respondents were EP-Specialists (81%) working at University Hospitals (47%). While most participants (67%) agreed that AiCM should be defined as a left ventricular ejection fraction (LVEF) impairment after new onset of an arrhythmia, only 35% identified a specific LVEF drop to diagnose AiCM with a wide range of values (5-20% LVEF drop). Most respondents considered all available therapies: catheter ablation(93%), electrical cardioversion(83%), antiarrhythmic drugs (76%) and adjuvant HF treatment(76%). 83% of respondents indicated that adjuvant HF treatment should be started at first HF diagnosis prior to antiarrhythmic treatment and 84% agreed it should be stopped within six months after LVEF normalization. Responses for the optimal time point for the first LVEF reassessment during follow-up varied markedly (1 day-6 months after antiarrhythmic treatment). Conclusion This EHRA Survey reveals varying practices regarding AiCM among physicians, highlighting a lack of consensus and heterogenous care of these patients.","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140841078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-29DOI: 10.1093/europace/euae116
J De Pooter, L Timmers, S Boveda, S Combes, S Knecht, A Almorad, C De Asmundis, M Duytschaever
Background and Aims Pulmonary Vein Isolation (PVI) is the cornerstone of ablation for atrial fibrillation. Confirmation of PVI can be challenging due to far field electrograms and sometimes requires additional pacing maneuvers or mapping. This prospective multicenter study assessed the agreement between a previously trained automated algorithm designed to determine vein isolation status with expert opinion in real-world clinical setting. Method Consecutive patients scheduled for PVI were recruited at four centers. The ECGenius electrophysiology recording system (CathVision ApS, Denmark) was connected in parallel with the lab’s existing system. Electrograms from a circular mapping catheter were annotated during sinus rhythm at baseline pre-ablation, time of isolation, and post-ablation. The ground truth for isolation status was based on operator opinion. The algorithm was applied to the collected PV signals off-line and compared to expert opinion. The primary endpoint was a sensitivity and specificity exceeding 80%. Results Overall, 498 electrograms (248 at baseline and 250 at PVI) with 5,473 individual PV beats from 89 patients (32 females, 62 ±12 years) were analyzed. The algorithm performance reached an area under curve (AUC) of 92% and met the primary study endpoint with a sensitivity and specificity of 86% and 87%, respectively (p = 0.005; p = 0.004). The algorithm had an accuracy of 87% in classifying the time of isolation. Conclusion This study validated an automated algorithm using machine learning (ML) to assess the isolation status of pulmonary veins in patients undergoing PVI with different ablation modalities. The algorithm reached an AUC of 92% with both sensitivity and specificity exceeding the primary study endpoints.
{"title":"Validation of a Machine Learning Algorithm to Identify Pulmonary Vein Isolation during Ablation Procedures for the Treatment of Atrial Fibrillation: Results of the PVISION Study","authors":"J De Pooter, L Timmers, S Boveda, S Combes, S Knecht, A Almorad, C De Asmundis, M Duytschaever","doi":"10.1093/europace/euae116","DOIUrl":"https://doi.org/10.1093/europace/euae116","url":null,"abstract":"Background and Aims Pulmonary Vein Isolation (PVI) is the cornerstone of ablation for atrial fibrillation. Confirmation of PVI can be challenging due to far field electrograms and sometimes requires additional pacing maneuvers or mapping. This prospective multicenter study assessed the agreement between a previously trained automated algorithm designed to determine vein isolation status with expert opinion in real-world clinical setting. Method Consecutive patients scheduled for PVI were recruited at four centers. The ECGenius electrophysiology recording system (CathVision ApS, Denmark) was connected in parallel with the lab’s existing system. Electrograms from a circular mapping catheter were annotated during sinus rhythm at baseline pre-ablation, time of isolation, and post-ablation. The ground truth for isolation status was based on operator opinion. The algorithm was applied to the collected PV signals off-line and compared to expert opinion. The primary endpoint was a sensitivity and specificity exceeding 80%. Results Overall, 498 electrograms (248 at baseline and 250 at PVI) with 5,473 individual PV beats from 89 patients (32 females, 62 ±12 years) were analyzed. The algorithm performance reached an area under curve (AUC) of 92% and met the primary study endpoint with a sensitivity and specificity of 86% and 87%, respectively (p = 0.005; p = 0.004). The algorithm had an accuracy of 87% in classifying the time of isolation. Conclusion This study validated an automated algorithm using machine learning (ML) to assess the isolation status of pulmonary veins in patients undergoing PVI with different ablation modalities. The algorithm reached an AUC of 92% with both sensitivity and specificity exceeding the primary study endpoints.","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140841336","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-26DOI: 10.1093/europace/euae110
Boldizsar Kovacs, H Immo Lehmann, Martin Manninger, Ardan M Saguner, Piotr Futyma, David Duncker, Julian Chun
Background Stereotactic arrhythmia radioablation (STAR) is a treatment option for recurrent ventricular tachycardia/fibrillation (VT/VF) in patients with structural heart disease (SHD). The current and future role of STAR as viewed by Cardiologists is unknown. Objective To assess the current role, barriers to application and expected future role of STAR. Methods An online survey consisting of 20 questions on baseline demographics, awareness/access, current use, and the future role of STAR was conducted. Results 129 international participants completed the survey (mean age 43±11 years, 25 (16.4%) female). Ninety-one (59.9%) participants were electrophysiologists. Nine participants (7%) were unaware of STAR as a therapeutic option. Sixty-four (49.6%) had access to STAR while 62 (48.1%) had treated/referred a patient for treatment. Common primary indications for STAR were recurrent VT/VF in SHD (45%), recurrent VT/VF without SHD (7.8%) or premature ventricular contraction (PVC, 3.9%). Reported main advantages of STAR were efficacy in the treatment of arrhythmias not amenable to conventional treatment (49%) and noninvasive treatment approach with overall low expected acute and short-term procedural risk (23%). Most respondents have foreseen a future clinical role of STAR in the treatment of VT/VF with or without underlying SHD (72% and 75%, respectively), although only a minority expected a first-line indication for it (7% and 5%, respectively). Conclusions STAR as a novel treatment option of recurrent VT appears to gain acceptance within the cardiology community. Further trials are critical to further define efficacy, patient populations, as well as the appropriate clinical use for the treatment of VT.
背景 立体定向心律失常射频消融术（STAR）是治疗结构性心脏病（SHD）患者复发性室速/室颤（VT/VF）的一种方法。心脏病专家对 STAR 目前和未来的作用尚不清楚。目的 评估 STAR 的当前作用、应用障碍和未来预期作用。方法 进行了一项在线调查，调查内容包括 20 个问题，涉及 STAR 的基线人口统计学、认知/获取、当前使用和未来作用。结果 129 名国际参与者完成了调查（平均年龄为 43±11 岁，女性 25 人（16.4%））。91名参与者（59.9%）是电生理学家。九名参与者（7%）不知道 STAR 是一种治疗方法。64人（49.6%）有机会使用 STAR，62人（48.1%）曾治疗或转介病人接受治疗。STAR 的常见主要适应症是 SHD 复发 VT/VF（45%）、无 SHD 复发 VT/VF （7.8%）或室性早搏（PVC，3.9%）。据报告，STAR 的主要优点是能有效治疗不适合常规治疗的心律失常（49%），以及采用无创治疗方法，预计急性和短期手术风险总体较低（23%）。大多数受访者预计 STAR 将在治疗伴有或不伴有潜在 SHD 的 VT/VF 中发挥临床作用（分别为 72% 和 75%），但只有少数受访者预计 STAR 将成为一线适应症（分别为 7% 和 5%）。结论 STAR 作为复发性 VT 的新型治疗方案似乎已被心脏病学界接受。进一步的试验对于进一步明确疗效、患者人群以及治疗 VT 的适当临床用途至关重要。
{"title":"STereotactic Arrhythmia Radioablation and its implications for modern cardiac ElectroPhysiology: Results of an EHRA Survey","authors":"Boldizsar Kovacs, H Immo Lehmann, Martin Manninger, Ardan M Saguner, Piotr Futyma, David Duncker, Julian Chun","doi":"10.1093/europace/euae110","DOIUrl":"https://doi.org/10.1093/europace/euae110","url":null,"abstract":"Background Stereotactic arrhythmia radioablation (STAR) is a treatment option for recurrent ventricular tachycardia/fibrillation (VT/VF) in patients with structural heart disease (SHD). The current and future role of STAR as viewed by Cardiologists is unknown. Objective To assess the current role, barriers to application and expected future role of STAR. Methods An online survey consisting of 20 questions on baseline demographics, awareness/access, current use, and the future role of STAR was conducted. Results 129 international participants completed the survey (mean age 43±11 years, 25 (16.4%) female). Ninety-one (59.9%) participants were electrophysiologists. Nine participants (7%) were unaware of STAR as a therapeutic option. Sixty-four (49.6%) had access to STAR while 62 (48.1%) had treated/referred a patient for treatment. Common primary indications for STAR were recurrent VT/VF in SHD (45%), recurrent VT/VF without SHD (7.8%) or premature ventricular contraction (PVC, 3.9%). Reported main advantages of STAR were efficacy in the treatment of arrhythmias not amenable to conventional treatment (49%) and noninvasive treatment approach with overall low expected acute and short-term procedural risk (23%). Most respondents have foreseen a future clinical role of STAR in the treatment of VT/VF with or without underlying SHD (72% and 75%, respectively), although only a minority expected a first-line indication for it (7% and 5%, respectively). Conclusions STAR as a novel treatment option of recurrent VT appears to gain acceptance within the cardiology community. Further trials are critical to further define efficacy, patient populations, as well as the appropriate clinical use for the treatment of VT.","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"103 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140801255","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-04-24DOI: 10.1093/europace/euae109
David Žižek, Miha Mrak, Matevž Jan, Anja Zupan Mežnar, Maja Ivanovski, Tadej Žlahtič, Nina Kajdič, Bor Antolič, Luka Klemen, Rafael Skale, Jurij Avramovič Gregorič, Jernej Štublar, Andrej Pernat, Matjaž Šinkovec
Background Primary prevention patients with ischemic cardiomyopathy and chronic total occlusion of an infarct-related coronary artery (IRA-CTO) are at a particularly high risk of implantable cardioverter-defibrillator (ICD) therapy occurrence. Aim To evaluate the efficacy of preventive CTO-related substrate ablation strategy in ischaemic cardiomyopathy patients undergoing primary prevention ICD implantation. Methods The PREVENTIVE VT study was a prospective, multicenter, randomized trial including ischaemic patients with ejection fraction ≤40%, no documented VAs, and evidence of scar related to the coronary CTO. Patients were randomly assigned 1:1 to a preventive substrate ablation before ICD implantation or standard therapy with ICD implantation only. The primary outcome was a composite of appropriate ICD therapy or unplanned hospitalization for VAs. Secondary outcomes included the primary outcome’s components, the incidence of appropriate ICD therapies, cardiac hospitalization, electrical storm, and cardiovascular (CV) mortality. Results Sixty patients were included in the study. During the mean follow-up of 44.7± 20.7 months, the primary outcome occurred in 5 (16.7%) patients undergoing preventive substrate ablation and in 13 (43.3%) patients receiving only ICD (hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.12-0.94; P=0.037). Patients in the preventive ablation group also had fewer appropriate ICD therapies (P=0.039) and the electrical storms (Log rank: P=0.01). While preventive ablation also reduced cardiac hospitalizations (P=0.006), it had no significant impact on CV mortality (P=0.151). Conclusions Preventive ablation of the coronary CTO-related substrate in patients undergoing primary ICD implantation is associated with the reduced risk of appropriate ICD therapy or unplanned hospitalization due to VAs.
{"title":"Impact of preventive substrate catheter ablation on implantable cardioverter-defibrillator interventions in patients with ischaemic cardiomyopathy and infarct-related coronary chronic total occlusion","authors":"David Žižek, Miha Mrak, Matevž Jan, Anja Zupan Mežnar, Maja Ivanovski, Tadej Žlahtič, Nina Kajdič, Bor Antolič, Luka Klemen, Rafael Skale, Jurij Avramovič Gregorič, Jernej Štublar, Andrej Pernat, Matjaž Šinkovec","doi":"10.1093/europace/euae109","DOIUrl":"https://doi.org/10.1093/europace/euae109","url":null,"abstract":"Background Primary prevention patients with ischemic cardiomyopathy and chronic total occlusion of an infarct-related coronary artery (IRA-CTO) are at a particularly high risk of implantable cardioverter-defibrillator (ICD) therapy occurrence. Aim To evaluate the efficacy of preventive CTO-related substrate ablation strategy in ischaemic cardiomyopathy patients undergoing primary prevention ICD implantation. Methods The PREVENTIVE VT study was a prospective, multicenter, randomized trial including ischaemic patients with ejection fraction ≤40%, no documented VAs, and evidence of scar related to the coronary CTO. Patients were randomly assigned 1:1 to a preventive substrate ablation before ICD implantation or standard therapy with ICD implantation only. The primary outcome was a composite of appropriate ICD therapy or unplanned hospitalization for VAs. Secondary outcomes included the primary outcome’s components, the incidence of appropriate ICD therapies, cardiac hospitalization, electrical storm, and cardiovascular (CV) mortality. Results Sixty patients were included in the study. During the mean follow-up of 44.7± 20.7 months, the primary outcome occurred in 5 (16.7%) patients undergoing preventive substrate ablation and in 13 (43.3%) patients receiving only ICD (hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.12-0.94; P=0.037). Patients in the preventive ablation group also had fewer appropriate ICD therapies (P=0.039) and the electrical storms (Log rank: P=0.01). While preventive ablation also reduced cardiac hospitalizations (P=0.006), it had no significant impact on CV mortality (P=0.151). Conclusions Preventive ablation of the coronary CTO-related substrate in patients undergoing primary ICD implantation is associated with the reduced risk of appropriate ICD therapy or unplanned hospitalization due to VAs.","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"27 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140801252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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