Ospedale S. Maria della Pietà, Nola, Italy.
A.O.U.P. "Vittorio Emanuele", Ospedale Ferrarotto, Catania, Italy.
Biomed Res Int. 2018 May 22;2018:1404659. doi: 10.1155/2018/1404659. eCollection 2018.
The aim of the study was to compare the two approaches to chronic right ventricular pacing currently adopted in clinical practice: right ventricular apical (RVA) and non-RVA pacing.
Chronic RVA pacing is associated with an increased risk of atrial fibrillation, morbidity, and even mortality. Non-RVA pacing may yield more physiologic ventricular activation and provide potential long-term benefits and has recently been adopted as standard procedure at many implanting centers.
The Right Pace study was a multicenter, prospective, single-blind, nonrandomized trial involving 437 patients indicated for dual-chamber pacemaker implantation with a high percentage of RV pacing.
RV lead-tip target location was the apex or the interventricular septum. RVA (274) and non-RVA patients (163) did not differ in baseline characteristics. During a median follow-up of 19 months (25th-75th percentiles, 13-25), 17 patients died. The rates of the primary outcome of death due to any cause or hospitalization for heart failure were comparable between the groups (log-rank test, = 0.609), as were the rates of the composite of death due to any cause, hospitalization for heart failure, or an increase in left ventricular end-systolic volume ≥ 15% as compared with the baseline evaluation (secondary outcome, = 0.703). After central adjudication of X-rays, comparison between adjudicated RVA (239 patients) and non-RVA (170 patients) confirmed the absence of difference in the rates of primary ( = 0.402) and secondary ( = 0.941) outcome.
In patients with indications for dual-chamber pacemaker who require a high percentage of ventricular stimulation, RVA or non-RVA pacing resulted in comparable outcomes. This study is registered with ClinicalTrials.gov (identifier: NCT01647490).
本研究旨在比较目前临床实践中采用的两种慢性右心室起搏方法：右心室心尖部（RVA）起搏和非 RVA 起搏。
慢性 RVA 起搏与房颤、发病率甚至死亡率增加相关。非 RVA 起搏可能产生更生理性的心室激活，并提供潜在的长期益处，最近已被许多植入中心采用为标准程序。
Right Pace 研究是一项多中心、前瞻性、单盲、非随机试验，涉及 437 例需要植入双腔起搏器且右心室起搏比例较高的患者。
RV 导联尖端目标位置为心尖部或室间隔。RVA（274 例）和非 RVA 患者（163 例）在基线特征上无差异。在中位随访 19 个月（25 至 75 百分位数，13 至 25）期间，有 17 例患者死亡。两组主要终点（任何原因导致的死亡或因心力衰竭住院）的发生率无差异（对数秩检验，=0.609），任何原因导致的死亡、因心力衰竭住院或与基线评估相比左心室收缩末期容积增加≥15%的复合终点发生率也无差异（次要终点，=0.703）。在对 X 射线进行中心裁决后，比较裁决后的 RVA（239 例）和非 RVA（170 例）患者，证实主要（=0.402）和次要（=0.941）结局的发生率无差异。
在需要高比例心室刺激的双腔起搏器适应证患者中，RVA 或非 RVA 起搏的结果相当。本研究在 ClinicalTrials.gov 注册（标识符：NCT01647490）。
