From the Guidelines
The Penumbra device is associated with a range of complications, including symptomatic intracranial hemorrhage, vessel perforation, dissection, and vasospasm, which can occur in approximately 10-13% of cases 1.
Complications of the Penumbra Device
The Penumbra device, used for mechanical thrombectomy in acute ischemic stroke, has several potential complications. These include:
- Symptomatic intracranial hemorrhage, which can occur in approximately 11% of patients, as reported in the pivotal Penumbra trial 1
- Vessel perforation, dissection, and vasospasm during catheter navigation
- Embolization to previously unaffected territories, which can happen when clot fragments dislodge during the procedure
- Device-related complications, such as catheter fracture or separation, although these are rare with modern iterations
- Access site complications, including groin hematoma, pseudoaneurysm, or arteriovenous fistula
- Reperfusion injury, which can occur after successful clot removal, causing edema and potential hemorrhagic transformation
- Contrast-induced nephropathy, particularly in patients with pre-existing renal dysfunction
- Allergic reactions to contrast media, although these are uncommon
Clinical Outcomes
Despite these potential complications, the Penumbra system has demonstrated effectiveness in restoring blood flow and improving clinical outcomes when used by experienced neurointerventionalists within the recommended time windows 1. The use of the Penumbra device has been shown to result in favorable clinical outcomes, with 25% of patients achieving a modified Rankin Scale (mRS) score of 0-2, and a mortality rate of 33% 1. It is essential to carefully weigh the potential benefits and risks of the Penumbra device in individual patients, taking into account their specific clinical characteristics and circumstances.
From the Research
Complications of the Penumbra Device
- The risk of symptomatic intracranial hemorrhage was 10% as reported in the study 2
- Modified Rankin Scale (mRS) score of ≤ 2 was 25% in the pivotal single-arm prospective trial 2
- All-cause mortality at 90 days was 15.5% in the COMPLETE registry results 3
- The occurrence of intracranial hemorrhage at 24 hours was determined by an imaging core lab in the COMPLETE registry 3
- Mortality rates and NIHSS upon discharge were compared between patients treated with the Penumbra system and those treated with intraarterial thrombolysis (IAT) 4
- All cause mortality at 90 days was 3/20 patients treated with the Penumbra system and 2/20 patients treated with IAT 4
- Overall mortality was high (50%) in patients with acute ischemic stroke due to large vessel occlusion and preinterventional intracranial hemorrhage who underwent mechanical thrombectomy 5
- Periprocedural and outcome results did not differ between patients with and without preinterventional intracranial hemorrhage 5
- No stroke events or device-related complications were reported in the routine use of the Penumbra thrombectomy device in myocardial infarction 6