Introduction: Percutaneous thrombectomy in patients with acute limb ischemia (ALI) is a challenging task. Several devices have been approved for this indication, but their effectiveness remains a matter of debate. The aim of this study is to present the first European experience with a new aspiration thrombectomy catheter.
Objectives: The Indigo device (Penumbra) is a vacuum-assisted thrombectomy catheter that enables continuous thrombus aspiration. The catheter is available in 4 different sizes (3, 5, 6 and 8 Fr).
Methods: A retrospective case review of all patients treated with the Indigo device between January 2016 and May 2017 in four European centers was conducted. Main inclusion criterion was acute ischemia of the lower limbs (<14 days). No further exclusion criteria were used. Main measure outcome was technical success, defined as restoration of antegrade blood flow without the need for lysis or alternative thrombectomy/revascularization strategies. Secondary outcomes were any in-hospital major adverse events (myocardial infarction, stroke, or death), need for blood transfusion, and in-hospital reintervention.
Results: Sixty-five cases of ALI were included in this study. In all cases, successful removal of the fresh clot was achieved using either 8, 6, 5 or 3 Fr Indigo aspiration catheters or a combination, without the need for additional tPA lysis. The 3 Fr catheter was able to extend into the arteries of the plantar arch. No perforation, dissection, or neurovascular damage was encountered in any of the cases. Technical success for thrombus removal was 100% for each treated vessel segment. No blood transfusions were necessary. One patient died during in-hospital stay due to heart failure and 1 patient suffered a myocardial infarction. In the post-operative follow-up, reocclusion occurred in 4% in 30 days due to rethromboembolism from secondary causes.
Conclusions: In our experience, the Indigo device with its various size range was an easy, safe, robust, and trackable thrombectomy to remove acute soft clot causing ALI as far down as the arch of the foot. Bleeding risk was obviated because there was no need for lysis. There was no prolonged hospital stay experienced by patients with various comorbidities.