Safety and efficacy of the Pipeline Flex embolization device with Shield Technology for the acute treatment of ruptured internal carotid artery pseudoaneurysms: a multi-institution case series

Michael T Bounajem; Evan Joyce; Jonathan P Scoville; Joshua Seinfeld; Jessa Hoffman; Jonathan A Grossberg; Vanesha Waiters; Andrew C White; John Nerva; Jan-Karl Burkhardt; Daniel A Tonetti; Kareem El Naamani; M Reid Gooch; Pascal Jabbour; Stavropoula Tjoumakaris; Santiago Ortega Gutierrez; Michael R Levitt; Michael Lang; William J Ares; Sohum Desai; Justin R Mascitelli; Craig J Kilburg; Karol P Budohoski; William T Couldwell; Bradley A Gross; Ramesh Grandhi

doi:10.3171/2023.2.FOCUS233

Safety and efficacy of the Pipeline Flex embolization device with Shield Technology for the acute treatment of ruptured internal carotid artery pseudoaneurysms: a multi-institution case series

Neurosurg Focus. 2023 May;54(5):E4. doi: 10.3171/2023.2.FOCUS233.

Authors

Michael T Bounajem¹, Evan Joyce¹, Jonathan P Scoville¹, Joshua Seinfeld², Jessa Hoffman², Jonathan A Grossberg³, Vanesha Waiters⁴, Andrew C White⁵, John Nerva⁶, Jan-Karl Burkhardt⁷, Daniel A Tonetti⁸, Kareem El Naamani⁹, M Reid Gooch⁹, Pascal Jabbour⁹, Stavropoula Tjoumakaris⁹, Santiago Ortega Gutierrez¹⁰, Michael R Levitt¹¹, Michael Lang¹², William J Ares¹³, Sohum Desai¹⁴, Justin R Mascitelli¹⁵, Craig J Kilburg¹, Karol P Budohoski¹, William T Couldwell¹, Bradley A Gross¹², Ramesh Grandhi¹

Affiliations

¹ 1Department of Neurosurgery, Clinical Neuroscience Center, University of Utah, Salt Lake City, Utah.
² 2Department of Neurosurgery, University of Colorado Anschutz Medical Campus, Aurora, Colorado.
³ 3Department of Neurosurgery, Emory University, Atlanta, Georgia.
⁴ 4Morehouse School of Medicine, Atlanta, Georgia.
⁵ 5Department of Endovascular Surgical Neuroradiology/Neuroendovascular Surgery, University of Texas Southwestern Medical School, Dallas, Texas.
⁶ 6Department of Neurosurgery, Medical College of Wisconsin, Milwaukee, Wisconsin.
⁷ 7Department of Neurosurgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
⁸ 8Department of Neurosurgery, Cooper Medical School of Rowan University, Camden, New Jersey.
⁹ 9Department of Neurosurgery, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania.
¹⁰ 10Department of Neurology, Carver College of Medicine, University of Iowa, Iowa City, Iowa.
¹¹ 11Department of Neurological Surgery, University of Washington, Harborview Medical Center, Seattle, Washington.
¹² 12Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
¹³ 13Department of Neurosurgery, North Shore University Health System, Arlington Heights, Illinois.
¹⁴ 14Department of Surgery, University of Texas Rio Grande Valley School of Medicine, Edinburg, Texas; and.
¹⁵ 15Department of Neurosurgery, University of Texas Health Science Center at San Antonio, Texas.

PMID: 37127036
DOI: 10.3171/2023.2.FOCUS233

Abstract

Objective: Ruptured blister, dissecting, and iatrogenic pseudoaneurysms are rare pathologies that pose significant challenges from a treatment standpoint. Endovascular treatment via flow diversion represents an increasingly popular option; however, drawbacks include the requirement for dual antiplatelet therapy and the potential for thromboembolic complications, particularly acute complications in the ruptured setting. The Pipeline Flex embolization device with Shield Technology (PED-Shield) offers reduced material thrombogenicity, which may aid in the treatment of ruptured internal carotid artery pseudoaneurysms.

Methods: The authors conducted a multi-institution, retrospective case series to determine the safety and efficacy of PED-Shield for the treatment of ruptured blister, dissecting, and iatrogenic pseudoaneurysms of the internal carotid artery. Clinical, radiographic, treatment, and outcomes data were collected.

Results: Thirty-three patients were included in the final analysis. Seventeen underwent placement of a single device, and 16 underwent placement of two devices. No thromboembolic complications occurred. Four patients were maintained on aspirin alone, and all others were treated with long-term dual antiplatelet therapy. Among patients with 3-month follow-up, 93.8% had a modified Rankin Scale score of 0-2. Complete occlusion at follow-up was observed in 82.6% of patients.

Conclusions: PED-Shield represents a new option for the treatment of ruptured blister, dissecting, and iatrogenic pseudoaneurysms of the internal carotid artery. The reduced material thrombogenicity appeared to improve the safety of the PED-Shield device, as this series demonstrated no thromboembolic complications even among patients treated with only single antiplatelet therapy. The efficacy of PED-Shield reported in this series, particularly with placement of two devices, demonstrates its potential as a first-line treatment option for these pathologies.

Keywords: PED-Shield; Pipeline embolization device; flow diversion; ruptured aneurysm; single antiplatelet therapy.

MeSH terms

Aneurysm, False* / etiology
Aneurysm, False* / therapy
Blister
Carotid Artery, Internal
Cerebral Angiography
Embolization, Therapeutic*
Humans
Iatrogenic Disease
Intracranial Aneurysm* / therapy
Platelet Aggregation Inhibitors
Retrospective Studies
Thromboembolism*
Treatment Outcome

Substances

Platelet Aggregation Inhibitors