Hybrid Score to Predict OTVA-SOO in Patients with Wide Basal QRS

Официальное название

A Hybrid Score to Predict the Origin of Outflow Tract Ventricular Arrhythmias in Patients with Intraventricular Conduction Disorders or Paced Rhythm

Обзор

Outflow tract ventricular arrhythmia (OTVA) is the most common type of ventricular arrhythmia, and catheter ablation (CA) is the primary treatment option for patients experiencing symptoms. Accurately identifying the origin site of OTVA is essential for effective catheter ablation, minimizing procedural risks, and enhancing treatment success. However, most studies that developed algorithms or scoring systems for distinguishing OTVA origins excluded participants with structural heart disease and those with paced rhythms from their study groups. A recent prospective evaluation of a hybrid score (HS) that integrates both clinical and ECG data to predict OTVA-SOO, including patients with cardiac implantable electronic devices and those with structural heart disease in our study. The presented study aimed to assess the effectiveness of the previously described hybrid algorithm in predicting OTVA-SOO in a patient population characterized by a wide basal QRS due to intraventricular conduction defects or paced rhythms. The Hybrid Score The Hybrid Score (HS), involves a sum of points based on clinical and ECG characteristics. Points are assigned as follows: one point each for being over 50 years old, male, and having arterial hypertension. ECG-based points are allocated according to QRS transition: 3 points for a transition in V1, 2 points for V2, 1 point for V3 if the R-wave in V3 is greater than 1 mV; 1 point is subtracted if V3 has an R-wave less than 1 mV, and further deductions or additions apply for transitions up to V6. A score ≤ 1 suggests an RVOT origin, whereas ≥ 2 suggests an LVOT origin. ECGs were recorded with a standard configuration at a 25 mm/s sweep speed. Premature Ventricular Contraction (PVC) Ablation Activation mapping of spontaneous OTVAs was conducted. The procedure aimed to abolish spontaneous OTVAs, with the site of ablation marking the site of origin (SOO). Collected data * Patient Information and Consent (procedure must be done within 60 days of consent) * Demographics (age, gender, etc.) * Vital signs (length, weight, etc.) * Medical history, including cardiovascular risk factors, cardiomyopathy and drugs * ECG data * Echocardiographic data (left ventricular ejection fraction and left ventricular end-diastolic diameter) * Procedure data (number of radiofrequency applications, site of effective ablation, total radiofrequency time, total fluoro time, points mapping, procedure time) * Adverse Events

Вмешательства

• Диагностический тест ECG and clinical score
  The Hybrid Score (HS), detailed in previous literature involves a sum of points based on clinical and ECG characteristics. Points are assigned as follows: one point each for being over 50 years old, male, and having arterial hypertension. ECG-based points are allocated according to QRS transition: 3 points for a transition in V1, 2 points for V2, 1 point for V3 if the R-wave in V3 is greater than 1 mV; 1 point is subtracted if V3 has an R-wave less than 1 mV, and further deductions or additions

Первичные конечные точки

• Hybrid score performance [Срок оценки: At the moment of interventional procedure]

Вторичные конечные точки (1)

• Safety [Срок оценки: 1 month after the procedure date]

Критерии участия

Критерии включения

• ventricular arrhythmia with a morphology indicating an outflow tract origin and a wide basal QRS complex
• a QRS width greater than 110 ms was considered wide
• willing and capable of providing written informed consent to the study

Критерии исключения

• catether ablation procedure was unsuccessful
• infrequent arrhythmia requiring ablation guided by pacemapping.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 3 центра

• Maria Cecilia Hospital — Cotignola
• Niguarda Ca Granda Hospital — Milan
• Cisanello University Hospital (Pisa, Italy) — Pisa

Испания · 2 центра

• Teknon Medical Center — Barcelona
• Hospital Universitario Puerta del Mar — Cadiz

Бельгия · 1 центр

• Vrije Universiteit Brussel — Brussels

Публикации

• Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhyth PMID 36017572
• Anderson RD, Kumar S, Parameswaran R, Wong G, Voskoboinik A, Sugumar H, Watts T, Sparks PB, Morton JB, McLellan A, Kistler PM, Kalman J, Lee G. Differentiating Right- and Left-Sided Outflow Tract Ventricular Arrhythmias: Classical ECG Signatures and Prediction Algorithms. Circ Arrhythm Electrophysiol. 2019 Jun;12(6):e007392. doi: 10.1161/CIRCEP.119.007392. Epub 2019 Jun 4. PMID 31159581

Идентификаторы

NCT: NCT06602635 · Hybrid-score OTVA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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