Pontoppidan J, Nielsen J C, Poulsen S H, Jensen H K, Walfridsson H, Pedersen A K, Hansen P S
Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark.
Heart. 2009 Jun;95(12):994-9. doi: 10.1136/hrt.2008.153965. Epub 2009 Mar 3.
This randomised trial evaluated if patients with atrial fibrillation (AF) and no history of atrial flutter (AFL) had any benefit of prophylactic cavotricuspid isthmus block (CTIB) in addition to circumferential pulmonary vein ablation (CPVA).
149 patients with AF (54% paroxysmal) were randomised to CPVA and CTIB (group CTIB+, n = 73) or CPVA alone (group CTIB-, n = 76). Patients were followed for 12 months with repetitive 7-day Holter monitoring after 3, 6 and 12 months.
Six patients (4%) had cardiac tamponade, and one patient had a stroke. No difference was found in the cumulative AFL-free rate between the two treatment groups (CTIB+: 88% vs CTIB-: 84%, hazard ratio (HR) 0.80, 95% CI (0.34 to 1.90), p = 0.61). There was no difference in the cumulative AF-free rate between the groups (CTIB+: 34% vs CTIB-: 32%, HR 0.93, 95% CI (0.63 to 1.38), p = 0.71). Overall, 33% of the patients were free of AF after a single procedure. Including reprocedures, a complete or partial beneficial effect was noted in 62% of the patients at 12 months. At 12-month follow-up, 24 (50%) patients with documented AF or AFL in the Holter recordings were asymptomatic.
It was not possible to demonstrate any beneficial effect of CTIB in addition to CPVA with regard to AFL or AF recurrences during follow-up. Repetitive long-term Holter monitoring demonstrated a 33% rate of freedom from AF during a 1-year follow-up. Including additional CPVA procedures, a clinical effect was noted in 62% of the patients at 12 months. Patients with AF or AFL recurrences were often asymptomatic.
本随机试验评估了对于无房扑病史的房颤（AF）患者，在进行环肺静脉消融（CPVA）之外，预防性三尖瓣峡部阻滞（CTIB）是否有任何益处。
149例房颤患者（54%为阵发性房颤）被随机分为CPVA联合CTIB组（CTIB +组，n = 73）或单纯CPVA组（CTIB -组，n = 76）。在3、6和12个月后，对患者进行为期12个月的随访，期间重复进行7天的动态心电图监测。
6例患者（4%）发生心脏压塞，1例患者发生中风。两个治疗组之间的累积无房扑率无差异（CTIB +组：88% vs CTIB -组：84%，风险比（HR）0.80，95%置信区间（CI）（0.34至1.90）, p = 0.61）。两组之间的累积无房颤率也无差异（CTIB +组：34% vs CTIB -组：32%，HR 0.93，95% CI（0.63至1.38），p = 0.71）。总体而言，33%的患者单次手术后无房颤发作。包括再次手术，12个月时62%的患者有完全或部分有益效果。在12个月随访时，动态心电图记录中有房颤或房扑记录的24例（50%）患者无症状。
在随访期间，无法证明除CPVA外CTIB对房扑或房颤复发有任何有益效果。重复长期动态心电图监测显示，在1年随访期间无房颤率为33%。包括额外的CPVA手术，12个月时62%的患者有临床效果。房颤或房扑复发的患者通常无症状。
