Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device

Abstract

Background: The use of flow diversion to treat intracranial aneurysms has increased in recent years.

Objective: To assess the safety and angiographic efficacy of the p64 flow modulation device.

Methods: Diversion-p64 is an international, prospective, multicenter, single-arm, study conducted at 26 centers. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. The primary safety endpoint was the incidence of major stroke or neurologic death at 3-6 months, with the primary efficacy endpoint being complete aneurysm occlusion (Raymond-Roy Occlusion Classification 1) on follow-up angiography.

Results: A total of 420 patients met the eligibility criteria and underwent treatment with the p64 flow modulation device (mean age 55±12.0 years, 86.2% female). Mean aneurysm dome width was 6.99±5.28 mm and neck width 4.47±2.28 mm. Mean number of devices implanted per patient was 1.06±0.47, with adjunctive coiling performed in 14.0% of the cases. At the second angiographic follow-up (mean 375±73 days), available for 343 patients (81.7%), complete aneurysm occlusion was seen in 287 (83.7%) patients. Safety data were available for 413 patients (98.3%) at the first follow-up (mean 145±43 days) with a composite morbidity/mortality rate of 2.42% (n=10).

Conclusions: Diversion-p64 is the largest prospective study using the p64 flow modulation device. The results of this study demonstrate that the device has a high efficacy and carries a low rate of mortality and permanent morbidity.

Keywords: aneurysm; flow diverter; stent.

Conflict of interest statement

Competing interests: ABo serves as a consultant for Balt, phenox, and Stryker. MAP serves as proctor and consultant for phenox. HH is a co-founder and shareholder of phenox, femtos, and CONTARA; serves as proctor and consultant for phenox; and declares personal financial interest in Johnson & Johnson and Penumbra. PL, CB, GG, SS, AS, AP, CR, A-PN, XB, AC, CWa, MDO, SY, NPN, CWe have no personal, financial, or institutional interest to report. LSt declares personal financial interest for Medtronic and Terumo. FT serves as a consultant for Balt and Medtronic. CL declares proctoring and consultant services for phenox and also serves as consultant for Penumbra and receives travel and meeting expanses from Acandis and Penumbra. ABe serves as consultant for Microvention and as CEC chairman for phenox for the ARTESp trial. LP declares consulting services for Balt, Cerus Endovascular, Microvention, Perflow, phenox, and Vesalio. MM serves as a proctor for Penumbra and declares support for Procardia and Polimed. TG serves as a proctor for phenox. JK serves as a proctor and consultant for Microvention and phenox with payment to his institution. LSp is a consultant for Balt, Medtronic, Microvention, phenox, and Stryker and also declares support for Balt, Medtronic, Microvention, and Stryker outside of this work. FC serves as a consultant for Balt, Medtronic, and Stryker; receives payment for support of Penumbra; and participates as DSMB/advisory board of Microvention. PK serves as proctor and consultant for phenox and received travel and meeting expenses from phenox. SD declares no other competing interests besides that he was the President of the Central and Eastern European Committee of ESMINT until September 2020. TW serves as consultant for phenox. PS serves as consultant for Penumbra, phenox, and Stryker.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

A 6 mm right-sided, symptomatic paraophthalmic, saccular, aneurysm (A). The aneurysm was treated using a single 4×12 p64 flow modulation device. A satisfactory position of the device (B) was confirmed on unsubtracted images (C). Significant contrast stagnation (D) could be seen at the end of the procedure. Control angiography performed at 4 months postprocedure showed complete occlusion of the aneurysm (E), that was confirmed on delayed angiography performed 10 months post-rocedure (F).