The Journal of cardiovascular surgery · 2023
Mechanical thrombectomy in acute limb ischemia: ad Interim results of the INDIAN UP Trial.
Многоцентровое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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de Donato Gianmarco, Pasqui Edoardo, Ruffino Maria A, Sponza Massimo, Spinazzola Angelo, Guzzardi Giuseppe, Intrieri Francesco, Savio Daniele, Palasciano Giancarlo, INDIAN UP Trial group
Аннотация
BACKGROUND: Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischemia (ALLI) is becoming a fundamental alternative to surgical and intra-arterial thrombolysis. The INDIAN UP trial represents the second phase of the Italian national multicenter trial evaluating the safety and effectiveness of the device in the treatment of ALLI.
METHODS: To assess vessel patency, the TIPI (Thrombo-aspiration In Peripheral Ischemia), is used. The TIPI flow in three different moments: at presentation, immediately after thromboaspiration, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularization TIPI 2 - 3. Safety and clinical success rate were collected at one month follow-up.
RESULTS: A total of 250 patients were enrolled. The mean age was 72.2±13.1 years and 72.1% were male. Rutherford grade on enrolment was I in 10.8%, IIa in 34.9%, and IIb in 54.4%. Primary technical success (TIPI 2-3 flow) was achieved in 90.8% of patients. Adjunctive procedures were needed in 158 cases. After all interventions, assisted primary technical success was 96.4%. No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, survival rate was 97.2%, limb salvage was 97.6%. Primary patency was 89.6% and 13 (5.4%) reinterventions were registered.
CONCLUSIONS: The updated results of the INDIAN UP trial have confirmed the high value of the mechanical thromboaspiration device Indigo Penumbra in the treatment of ALLI in a large variety of clinical and anatomical settings.
METHODS: To assess vessel patency, the TIPI (Thrombo-aspiration In Peripheral Ischemia), is used. The TIPI flow in three different moments: at presentation, immediately after thromboaspiration, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularization TIPI 2 - 3. Safety and clinical success rate were collected at one month follow-up.
RESULTS: A total of 250 patients were enrolled. The mean age was 72.2±13.1 years and 72.1% were male. Rutherford grade on enrolment was I in 10.8%, IIa in 34.9%, and IIb in 54.4%. Primary technical success (TIPI 2-3 flow) was achieved in 90.8% of patients. Adjunctive procedures were needed in 158 cases. After all interventions, assisted primary technical success was 96.4%. No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, survival rate was 97.2%, limb salvage was 97.6%. Primary patency was 89.6% and 13 (5.4%) reinterventions were registered.
CONCLUSIONS: The updated results of the INDIAN UP trial have confirmed the high value of the mechanical thromboaspiration device Indigo Penumbra in the treatment of ALLI in a large variety of clinical and anatomical settings.