Penumbra’s Indigo Lightning 12 System Studied for Computer-Aided Mechanical Aspiration Thrombectomy in Treatment of Acute PE

November 2, 2022—A study sought to evaluate improvement in clinical and echocardiographic parameters after treating acute pulmonary embolism (PE) patients with computer-aided mechanical aspiration thrombectomy using the Indigo Lightning 12 aspiration system (Penumbra, Inc.). The investigators found that the treatment resulted in rapid improvement of vital signs and right heart function, as measured by echocardiography. This was accomplished with a short procedure time and an acceptable safety profile.

Elias Iliadis, MD, presented the findings in a Late-Breaking Clinical Trials session at The VEINS conference, hosted by the VIVA Foundation and held October 30-31, 2022, in Las Vegas, Nevada.

As summarized in the VIVA Foundation press release, this single-center, retrospective review included patients undergoing treatment for acute PE with the Lightning 12 device between August 2020 and February 2022. Clinical and echocardiographic parameters were assessed preprocedure and at 48 hours postprocedure.

Dr. Iliadis reported that 63 patients were treated (49% women, 83% with DVT, 18% with cancer, and 18% with previous PE). Most patients had submassive PE (83%), and 97% were bilateral.

The investigators found the following significant reductions from pretreatment versus posttreatment:

• Clinical variables of heart rate (73% vs 8%)
• Episodes of hypotension (27% vs 3%)
• Hypoxia (16% vs 0%)
• Pulmonary Embolism Severity Index scores (117 vs 83).

There was improvement in echocardiographic parameters, including:

• Pulmonary artery (PA) pressure (54 vs 41 mm Hg)
• Median right ventricular/left ventricular ratio (1.1 vs 1.0)
• PA compliance (0.25 vs 0.47)
• Median acceleration time (71 vs 91 sec)
• Median tricuspid annular plane systolic excursion (14.7 vs 17.6 mm)

Finally, Dr. Iliadis reported that the average thrombectomy time was 18 minutes, and the estimated blood loss was 381 mL. The was one instance of procedure-related bleeding and no procedure-related complications.