Bipolar Radio-frequency Ablation After Standard Unipolar Approach for Ventricular Arrhythmias Originating From the Base of the Heart. The BiUniVA Prospective Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Candidates for redo bipolar ablation
研究概览
简要总结
Treatment of ventricular arrhythmias (VA) originating at the base of the heart may be challenging. Unipolar radio-frequency (RF) ablation is a standard approach to treat VA, however, it fails in 10 to 75% of patients, depending on the localization of VA. The main reason for unipolar ablation failure is the intramural location of the source of VA. In such patients, bipolar ablation may occur effective. However, there are no prospective studies or registries on consecutive patients wilt failed unipolar ablation, therefore, the proportion of candidates for bipolar ablation after failed unipolar approach is not known. Also, invasive electrophysiological parameters associated with successful unipolar and bipolar ablation have not been well established. It has been hypothesised that (1) bipolar ablation fails in 12-75% (mean 30%) of consecutive patients and these patients are candidates for bipolar ablation, (2) local ventricular signal precocity > 20 ms, unipolar signal without R wave and pace mapping 12/12 predict effective unipolar ablation but not bipolar ablation, (3) morphology of VA from surface ECG can identify patients with possible intramural localization, and (4) successful ablation results in improvement of quality of life (QoL).
Aims:
- To assess how many patients after failed unipolar ablation need redo procedure with bipolar ablation (primary end-point)
- To assess which intraprocedural electrophysiological parameters predict success during standard unipolar ablation (secondary endpoint)
- To assess short term efficacy of bipolar ablation (secondary endpoint)
- To assess one-month efficacy of bipolar ablation (secondary endpoint)
- To assess which intraprocedural electrophysiological parameters predict success during redo bipolar ablation (secondary endpoint)
- To evaluate the performance of ECG-based algorithms in predicting the localization / origin of VA, especially of transmural origin (secondary endpoint)
- To assess the effects of ablation on QoL (secondary endpoint)Methods. The study group consists of all consecutive patients who underwent unipolar ablation of VA originating from the base of the heart in the Grochowski Hospital and collaborating centres. All these patients are referred to Grochowski Hospital for further follow-up and treatment if needed, including bipolar ablation if initial unipolar approach failed. In all patients acute and one-month efficacy of unipolar and bipolar ablation is assessed.
详细描述
Treatment of ventricular arrhythmias (VA) originating at the base of the heart may be challenging. Although such sites as right ventricular or left ventricular outflow tracts (RVOT and LVOT) or aortic cusps (AoCusps) are usually easy to access, other VA locations may be difficult to reach. They include arrhythmias originating close to the great cardiac vein (GCV), anterior interventricular vein (AIV) or those coming from above the pulmonary valve (PV). In addition, a significant proportion of these arrhythmias have their source of origin in the mid-myocardium and such sites are difficult to ablate from endocardium or epicardium using standard techniques. It has been estimated that the efficacy of standard unipolar radio-frequency (RF) ablation ranges from 80-90% in patients with typical RVOT arrhythmias to 75% in cases with VA originating from LVOT and as low as 25% in VA coming from the left ventricular (LV) summit.
Unipolar radio-frequency (RF) ablation is a standard approach to treat VA. When it fails, bipolar RF ablation may be an attractive alternative. Using this approach, RF energy travels between the tip of ablation electrode and the tip of another electrode, called return or passive electrode. By proper positioning of the electrodes in two adjacent structures, the site of VA origin may lay between the tips of these electrodes and high density RF current may effectively destroy the tissue responsible for VA. The most frequently used electrode locations for bipolar RF ablation are left pulmonic cusp (LPC), AoCusps, aorto-mitral continuity (AMC) and GCV.
It has been shown in animal model that bipolar ablation causes denser and larger lesions than standard unipolar approach. The lesions are also deeper, more transmural and created without steam pops as compared with unipolar RF ablation. Also, the perpendicular orientation of the electrodes tips as well as irrigated catheters rather than standard catheters are important for bipolar ablation safety and efficacy.
The bipolar approach is usually used when unipolar ablation fails. To date, only case reports and case series have been published showing improved outcome when bipolar ablation was used during redo procedures. However, no prospective registry was performed to establish how many patients with VA originating from the base of the heart require bipolar ablation and which invasive electrophysiological (EP) parameters predict failure of unipolar ablation and the need for bipolar approach. One ongoing registry does include consecutive patients and is heterogenous. In the current guidelines for VT ablation, the bipolar approach is only shortly mentioned as one of new and still experimental approaches. Also the performance of surface ECG criteria to predict intra-mural VA and effects of bipolar ablation of quality of life have not been established.
- Hypothesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Baseline Holter ECG before initial unipolar ablation within 6 months prior to the procedure, performed without antiarrhythmic drugs (beta-blockers allowed).
- •Initial unipolar ablation of VA originating from the base of the heart (R in II, III and aVF) performed according to the standard scheme which includes detailed measurements of EP parameters at each examined and/or ablated site and inspection of all three regions (RVOT with PA, GCV and LVOT/AoCusps/AMC/MA) in cases with unsatisfactory EP parameters or failed ablation at first or second site.
- •Typical indications for ablation: a. > 10 000 PVC in 24-hour Holter ECG or b. > 10% PVC in 24-hour Holter ECG or c. less frequent but symptomatic PVC or d. at least 3 episodes symptomatic non-sustained ventricular tachycardia (nsVT) (>3 QRS evolutions) in Holter ECG, regardless of the amount of PVC or e. sustained ventricular tachycardia (sVT), regardless of nsVT or PVC
- •Written informed consent
排除标准
- •History of > 1 unipolar ablation for VA originating at the base of the heart
- •Lack of properly acquired EP parameters during baseline unipolar ablation
- •Lack of baseline Holter ECG performed < 6 months prior to initial unipolar ablation
- •Absence of typical indication for ablation
- •Lack of written informed consent for participation in the study
结局指标
主要结局
Candidates for redo bipolar ablation
时间窗: 2 years
The number and percentage of patients after failed unipolar ablation who need redo procedure with bipolar ablation
次要结局
- Unipolar recording predicting unipolar ablation success(2 years)
- Acute efficacy of bipolar ablation(2 years)
- Unipolar recording predicting bipolar ablation success(2 years)
- Precosity of signal predicting bipolar ablation success(2 years)
- ECG criteria to predict origin of ventricular arrhythmia(2 years)
- Precosity of signal predicting unipolar ablation success(2 years)
- Pace-mapping predicting success of unipolar ablation(2 years)
- Mid-term efficacy of bipolar ablation(2 years)
- Pace-mapping predicting success of bipolar ablation(2 years)
- Effects of ablation on QoL(2 years)
研究者
Prof. Piotr Kulakowski
Professor
Centre of Postgraduate Medical Education