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阵发性和早期持续性心房颤动经导管和微创消融术后的生活质量:SCALAF 试验结果。

Quality of life after catheter and minimally invasive surgical ablation of paroxysmal and early persistent atrial fibrillation: results from the SCALAF trial.

机构信息

Department of Cardiology, Isala Heart Center, Dr. Van Heesweg 2, 8025 AB, Zwolle, The Netherlands.

Department of Cardiothoracic Surgery, Isala Heart Center, Zwolle, The Netherlands.

出版信息

Clin Res Cardiol. 2020 Feb;109(2):215-224. doi: 10.1007/s00392-019-01504-z. Epub 2019 Jun 24.

Abstract

AIMS

In the SCALAF trial, catheter-based pulmonary vein isolation (PVI) was as effective in long-term prevention of atrial fibrillation (AF) as minimally invasive thoracoscopic PVI and left atrial appendage ligation (MIPI). Catheter ablation (CA) resulted in significantly less major complications as compare to MIPI. We report quality of life (QOL) outcome in these patients.

METHODS

In this study, 52 patients with symptomatic paroxysmal or early persistent AF were randomized to either MIPI or CA. QOL was assessed at baseline, 3, 6, and 12 months follow-up using the SF-36 Health Survey Questionnaire. AF-related symptoms were quantified at each follow-up visit using the European Heart Rhythm Association (EHRA) score.

RESULTS

Median age was 57 years and 78% was male. Paroxysmal AF was present in 74%. At 3 months follow-up, physical role limitations (88.2 ± 29.5; versus 40.9 ± 44.0; P = 0.001, respectively) and bodily pain scores (95.5 ± 8.7; versus 76.0 ± 27.8; P = 0.021, respectively) were significantly higher after CA compared to MIPI, indicating less limitation in daily activity caused by physical problems and less pain after CA than after MIPI. AF symptoms assessed by the EHRA scores improved significantly at 3, 6, 12, and 24 months compared to baseline in both treatment groups (P < 0.001), with no significant differences between treatment groups.

CONCLUSIONS

CA and MIPI ablation of AF both resulted in an improvement in several QOL measurements, although CA resulted in significantly less physical problems and bodily pain 3 months after treatment compared to MIPI.

CLINICAL TRIAL NUMBER

ClinicalTrials.gov identifier: NCT00703157.

摘要

目的

在 SCALAF 试验中,导管消融肺静脉隔离(PVI)在预防心房颤动(AF)方面的长期效果与微创胸腔镜 PVI 和左心耳结扎(MIPI)一样有效。与 MIPI 相比,导管消融(CA)导致的主要并发症明显减少。我们报告这些患者的生活质量(QOL)结果。

方法

在这项研究中,52 名有症状的阵发性或早期持续性 AF 患者被随机分配到 MIPI 或 CA 组。使用 SF-36 健康调查问卷在基线、3、6 和 12 个月随访时评估 QOL。在每次随访时使用欧洲心脏病学会(EHRA)评分量化 AF 相关症状。

结果

中位年龄为 57 岁,78%为男性。74%为阵发性 AF。在 3 个月随访时,CA 组的体力活动受限评分(88.2±29.5;与 MIPI 组的 40.9±44.0;P=0.001)和躯体疼痛评分(95.5±8.7;与 MIPI 组的 76.0±27.8;P=0.021)显著更高,表明 CA 后体力活动受限和躯体疼痛较 MIPI 少。EHRA 评分评估的 AF 症状在 3、6、12 和 24 个月随访时均较基线显著改善(P<0.001),两组间无显著差异。

结论

CA 和 MIPI 消融 AF 均导致多项 QOL 测量得到改善,尽管 CA 组在治疗后 3 个月时的体力活动受限和躯体疼痛明显少于 MIPI 组。

临床试验编号

ClinicalTrials.gov 标识符:NCT00703157。

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