High-Voltage Focal Pulsed Field Ablation to Treat Scar-Related Ventricular Tachycardia: The First-in-Human VCAS Trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F25%3A00010184" target="_blank" >RIV/00023884:_____/25:00010184 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00023001:_____/25:00086086

Výsledek na webu

<a href="https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.125.077025" target="_blank" >https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.125.077025</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1161/CIRCULATIONAHA.125.077025" target="_blank" >10.1161/CIRCULATIONAHA.125.077025</a>

Jazyk výsledku

angličtina

Název v původním jazyce

High-Voltage Focal Pulsed Field Ablation to Treat Scar-Related Ventricular Tachycardia: The First-in-Human VCAS Trial

Popis výsledku v původním jazyce

BACKGROUND: Unlike the tremendous progress made in atrial fibrillation ablation, the greatest unmet clinical need is for innovative ablation treatments for scar-related ventricular tachycardia (VT), particularly given the thick, often fibrotic tissue characteristic of the scarred substrate. A focal pulsed field ablation (PFA) catheter with a novel waveform was designed: high voltage to provide tissue penetration and low energy (using short-duration pulses) to avoid tissue overheating. We present the outcomes of VCAS (Ventricular Catheter Ablation Study), a first-in-human study of this PFA catheter to ablate scar-related VT. METHODS: An investigational 8.5F force-sensing PFA catheter was used for scar-VT ablation in ischemic or nonischemic substrates. Pulsed field lesions consisted of 5 applications, each <200 ms, of a high-voltage (>10 kV) monophasic waveform with QRS synchronization. The PFA catheter was localized by electrical impedance-based navigation. A subcohort of patients without previous cardiac surgery underwent epicardial ventricular mapping at baseline and after endocardial PFA to assess for transmurality of endocardial pulsed field lesions. Study end points included procedural efficiency, safety, and effectiveness to final follow-up of 6 months. RESULTS: At 2 centers, 26 patients underwent ablation: 66 +/- 9 years of age, 4% women, left ventricular ejection fraction 32 +/- 10%, VT storm 42%, previous VT ablation 42%. Acute procedural success, achieved in 24 (92%) patients, required 21 (interquartile range, 14-24) lesions per patient with a transpired ablation time of 31 minutes (19-42). Clinical VT was induced in 14 of 16 patients (88%) before ablation and 1 of 16 patients (6%, P<0.001) after ablation. High-density epi-endo voltage mapping was performed in 10 patients [42%]; of the 9 patients undergoing endocardial-only PFA, transmural tissue homogenization was observed in all 9 (100%) patients. Freedom from recurrent VT/ventricular fibrillation (VT/VF) or implantable cardioverter defibrillator shock was 81.8% (95% CI, 67.1-99.8). Regarding VT/VF burden, the incidence rate of postablation VT/VF significantly decreased from baseline to after PFA by 98% (median [IQR], 6 [1-11] versus 0 [0-0], respectively; P<0.001). Primary safety end points within 180 days occurred in 3 of 26 (11.5%) patients: cardiogenic shock, heart failure hospitalization, and retroperitoneal bleed. CONCLUSIONS: In this first-in-human study, the high-voltage PFA catheter efficiently delivered transmural ventricular lesions to treat scar-related VT.

Název v anglickém jazyce

High-Voltage Focal Pulsed Field Ablation to Treat Scar-Related Ventricular Tachycardia: The First-in-Human VCAS Trial

Popis výsledku anglicky

BACKGROUND: Unlike the tremendous progress made in atrial fibrillation ablation, the greatest unmet clinical need is for innovative ablation treatments for scar-related ventricular tachycardia (VT), particularly given the thick, often fibrotic tissue characteristic of the scarred substrate. A focal pulsed field ablation (PFA) catheter with a novel waveform was designed: high voltage to provide tissue penetration and low energy (using short-duration pulses) to avoid tissue overheating. We present the outcomes of VCAS (Ventricular Catheter Ablation Study), a first-in-human study of this PFA catheter to ablate scar-related VT. METHODS: An investigational 8.5F force-sensing PFA catheter was used for scar-VT ablation in ischemic or nonischemic substrates. Pulsed field lesions consisted of 5 applications, each <200 ms, of a high-voltage (>10 kV) monophasic waveform with QRS synchronization. The PFA catheter was localized by electrical impedance-based navigation. A subcohort of patients without previous cardiac surgery underwent epicardial ventricular mapping at baseline and after endocardial PFA to assess for transmurality of endocardial pulsed field lesions. Study end points included procedural efficiency, safety, and effectiveness to final follow-up of 6 months. RESULTS: At 2 centers, 26 patients underwent ablation: 66 +/- 9 years of age, 4% women, left ventricular ejection fraction 32 +/- 10%, VT storm 42%, previous VT ablation 42%. Acute procedural success, achieved in 24 (92%) patients, required 21 (interquartile range, 14-24) lesions per patient with a transpired ablation time of 31 minutes (19-42). Clinical VT was induced in 14 of 16 patients (88%) before ablation and 1 of 16 patients (6%, P<0.001) after ablation. High-density epi-endo voltage mapping was performed in 10 patients [42%]; of the 9 patients undergoing endocardial-only PFA, transmural tissue homogenization was observed in all 9 (100%) patients. Freedom from recurrent VT/ventricular fibrillation (VT/VF) or implantable cardioverter defibrillator shock was 81.8% (95% CI, 67.1-99.8). Regarding VT/VF burden, the incidence rate of postablation VT/VF significantly decreased from baseline to after PFA by 98% (median [IQR], 6 [1-11] versus 0 [0-0], respectively; P<0.001). Primary safety end points within 180 days occurred in 3 of 26 (11.5%) patients: cardiogenic shock, heart failure hospitalization, and retroperitoneal bleed. CONCLUSIONS: In this first-in-human study, the high-voltage PFA catheter efficiently delivered transmural ventricular lesions to treat scar-related VT.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Circulation

ISSN

0009-7322

e-ISSN

—

Svazek periodika

152

Číslo periodika v rámci svazku

24

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

14

Strana od-do

1691-1704

Kód UT WoS článku

001636650200001

EID výsledku v databázi Scopus

2-s2.0-105025044862