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在经导管主动脉瓣置换术(TAVR)研究中,使用术前和强化术后物理治疗对有症状的主动脉瓣狭窄患者。(4P-TAVR 研究)。

Use of Pre- and Intensified Postprocedural Physiotherapy in Patients with Symptomatic Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement Study (the 4P-TAVR Study).

机构信息

Department of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.

Department of Cardiac Surgery, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.

出版信息

J Interv Cardiol. 2021 Jan 16;2021:8894223. doi: 10.1155/2021/8894223. eCollection 2021.

Abstract

BACKGROUND

Physiotherapy prior to open-heart surgery lowers the rate of pneumonia and length of the hospital stay. Pneumonia is a major contributor to short-term mortality following transcatheter aortic valve replacement (TAVR). Hence, we hypothesized that pre- and intensified postprocedural physiotherapy in patients undergoing TAVR might impact the net functional and clinical outcome.

METHODS AND RESULTS

The 4P-TAVR study was a prospective, monocentric, randomized trial. The study was designed to compare the efficacy and safety of intensified periprocedural physiotherapy including inspiratory muscle training versus standard postprocedural physiotherapy. Patients were randomized in a 1 : 1 fashion. 108 patients were included and followed up for 90 days after TAVR. While patients in group A (control group: 50 patients, age: 81.7 ± 5.0 years, 52% male) did not receive physiotherapy prior to TAVR, group B (intervention group: 58 patients, age: 82.2 ± 5.82 years, 47% male) participated in intensive physiotherapy. Compared to the control group, patients in the interventional group showed a lower incidence of postinterventional pneumonia (10 [20.0%] vs. 3 [5.1%], =0.016) and had a 3-day shorter mean hospital stay (13.5 ± 6.1 days vs. 10.1 ± 4.7 days, =0.02). The primary composite endpoint of mortality and rehospitalization was not different between the groups.

CONCLUSION

Intensified physiotherapy is safe and has positive effects on clinical outcomes up to 90 days after TAVR but has no impact on the primary combined endpoint of mortality and rehospitalization. Longer follow-up, a multicenter design, and a higher number of subjects are needed to confirm these preliminary results. This trial is registered with DRKS00017239.

摘要

背景

心脏直视手术前的物理疗法可降低肺炎发生率和住院时间。肺炎是经导管主动脉瓣置换术(TAVR)后短期死亡率的主要原因。因此,我们假设 TAVR 患者术前和术后强化物理疗法可能会影响净功能和临床结局。

方法和结果

4P-TAVR 研究是一项前瞻性、单中心、随机试验。该研究旨在比较包括吸气肌训练在内的强化围手术期物理疗法与标准术后物理疗法的疗效和安全性。患者以 1:1 的比例随机分组。共纳入 108 例患者,并在 TAVR 后 90 天进行随访。A 组(对照组:50 例,年龄 81.7±5.0 岁,52%为男性)在 TAVR 前未接受物理疗法,B 组(干预组:58 例,年龄 82.2±5.82 岁,47%为男性)接受强化物理疗法。与对照组相比,干预组患者术后肺炎发生率较低(10 [20.0%] 例比 3 [5.1%] 例,=0.016),平均住院时间缩短 3 天(13.5±6.1 天比 10.1±4.7 天,=0.02)。两组主要复合终点(死亡率和再住院率)无差异。

结论

强化物理疗法安全,并对 TAVR 后 90 天的临床结局有积极影响,但对死亡率和再住院率的主要联合终点无影响。需要更长的随访时间、多中心设计和更多的研究对象来证实这些初步结果。本试验在 DRKS00017239 注册。

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