Feasibility and Safety of Robotic Peripheral Vascular Interventions: Results of the RAPID Trial

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• 作者：Ehtisham Mahmud ; MD^a ; ^{emahmud@ucsd.edu" class="auth_mail" title="E-mail the corresponding author} ; Florian Schmid ; MD^b ; Peter Kalmar ; MD^b ; Hannes Deutschmann ; MD^b ; Franz Hafner ; MD^c ; Peter Rief ; MD^c ; Marianne Brodmann ; MD^c
• 关键词：interventions ; peripheral artery disease ; PVI ; robotic assisted
• 刊名：JACC: Cardiovascular Interventions
• 出版年：2016
• 出版时间：10 October 2016
• 年：2016
• 卷：9
• 期：19
• 页码：2058-2064
• 全文大小：1099 K

文摘

The goal of this study was to evaluate the feasibility and safety of a robotic-assisted platform (CorPath 200, Corindus Vascular Robotics, Waltham, Massachusetts) for treating peripheral artery disease.

id="absSec_2">Background

id="abspara0010">A robotic-assisted platform for percutaneous coronary intervention is available for treating coronary artery disease.

id="absSec_3">Methods

id="abspara0020">In this prospective single-arm trial, patients with symptomatic peripheral artery disease (Rutherford class 2 to 5) affecting the femoropoplital artery were enrolled. Endpoints evaluated were: 1) device technical success, defined as successful cannulation of the target vessel with the robotic system; 2) device safety, defined as absence of device related serious adverse event (hospitalization, prolonged hospitalization, life threatening, or resulted in death); and 3) clinical procedural success, defined as <50% residual stenosis without an unplanned switch to manual assistance or device-related serious adverse event in the periprocedural period.

id="absSec_4">Results

id="abspara0025">The study enrolled 20 subjects (65.5 ± 9.3 years of age; 70% male) with primarily Rutherford class 2 to 3 (90%) symptoms. A total of 29 lesions (lesion length: 33.1 ± 15.5 mm) were treated with the majority (89.7%) being located in the superficial femoral artery. Device technical success, safety and clinical procedural success were all 100% with provisional stenting required in 34.5% of lesions. Fluoroscopy time (7.1 ± 3.2 min) and contrast use (73.3 ± 9.2 ml) compared favorably with studies in similar patient cohorts. There were no adverse events associated with the use of the robotic system.

id="absSec_5">Conclusions

id="abspara0030">These data demonstrate the feasibility and safety of using a robotic-assisted platform for performing peripheral arterial revascularization.