Flowdiverters (FDs) have demonstrated increasing safety and efficacy in the treatment of a variety of unruptured and ruptured intracranial aneurysms.1–4Since the approval of the first commercially available FD (the Pipeline embolization device [PED], Medtronic Neurovascular), which received the Conformité Européenne mark in 2008 and FDA approval in 2011, numerous new generations and devices have been developed to continue expanding the clinical indications for FDs and improving patient outcomes.5–7Although the underlying mechanism of action of all FDs is similar, differences are noted in their intrinsic design, construction materials, and deployment techniques. Remarkably, given the wide variety of devices available and the growing experience with their use, it is now understood that devices with more wires have a greater and consistent flow-diverting effect across vessels with different anatomical characteristics and dimensions.8
The p64 flow modulation device (p64, Phenox) consists of 64 nitinol wires and 2 radiopaque platinum wires that allow visibility in vivo. The device is compatible with a 0.027-inch inner diameter microcatheter and is the only FD that is mechanically detached, which allows it to be completely unsheathed and resheathed.8The p48 movable wire flow modulation device (p48 MW, Phenox) has 48 interwoven nitinol wires filled with a platinum core to ensure visibility under fluoroscopy. It is designed for vessels with smaller diameters (1.75–3.5 mm). Deployment can be performed through a 0.021-inch inner diameter microcatheter, and unlike the p64, it is not mechanically detached (a radiopaque marker identifies the point at which the device can be resheathed).9Additionally, it has an independent nitinol movable wire with an atraumatic distal tip that can be placed distal or proximal for additional support or avoidance of specific vascular territories during deployment. Both devices have been continually improved up to the current generation, which comes with an incorporated, newly developed, glycan-based multilayer hydrophilic polymeric coating (HPC, Phenox) that reduces thrombogenicity when applied to nitinol surfaces.10
The p64 and the newer p48 MW are not yet available in the US, but have been increasingly used mainly in Europe, demonstrating optimistic results.11–14Hence, we performed a systematic review and meta-analysis of the literature evaluating the safety and efficacy of the p48 MW and p64 in the treatment of intracranial aneurysms.
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Protocol and Guidance
This systematic review used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement to report the search results.15The protocol for this systematic review was registered on the International Prospective Register of Systematic Reviews (PROSPERO) with the registration no. CRD42022381104 (https://www.crd.york.ac.uk/prospero/).
Eligibility Criteria
Original studies reporting on at least 10 patients with intracranial aneurysms treated using the p64 and p48 MW FDs were deemed eligible for inclusion. The exclusion criteria were 1) irrelevant articles; 2) articles not in English, German, Spanish, or Greek; 3) studies with patients treated with other FDs; 4) studies in which FDs were not used for the treatment of intracranial aneurysms; 5) in vitro, animal, and cadaveric studies; 6) narrative or systematic reviews and meta-analyses; 7) editorials, letters to the editor, and comments that did not provide primary patient data; and 8) conference abstracts or abstracts with no published full text. No search filters were used. All eligible studies were assessed for overlap based on the authors, center, and country. In overlapping cohorts, the one with the largest number of participants was included in this review.
Search Strategy and Study Selection
Two independent reviewers (J.V.S. and M.M.C.) searched through MEDLINE (via PubMed), Scopus, Embase, Web of Science, and Cochrane Central Register of Controlled Trials databases to identify eligible studies; the end-of-search date was November 24, 2022. Covidence reference and article manager software was used for all search and study selection stages.16The search strategies were developed and structured for each of the curated databases. Search terms targeting our top results were refined with field labels and search rules for each database, such as stemming, wild cards, or truncation. The complete search strategy can be found inSupplemental Table 1. A third reviewer (G.S.S.) resolved any disagreements.
Data Collection Process
Two reviewers (J.V.S. and G.S.S.) independently extracted the data from the eligible studies included using a standardized, prepiloted electronic form. Any disagreements were resolved through discussion between the two reviewers, and a third reviewer (M.M.S.) became involved when no consensus was reached. We extracted the following data from each study: 1) study characteristics (first author, publication year, design, country, study period, and number of patients), 2) patient characteristics (age, sex, and pretreatment modified Rankin Scale [mRS] score), 3) aneurysm characteristics (number of ruptured and unruptured aneurysms, location, morphology, and dimensions), 4) procedure characteristics (type of FD implanted, success of implantation, use of adjunctive coils, and technical events experienced), 5) efficacy outcomes (complete aneurysm occlusion and retreatment), and 6) safety outcomes (periprocedural ischemic/hemorrhagic complications and mortality).
Outcomes and Prioritization
The primary efficacy outcome was the proportion of complete angiographic occlusion at the last follow-up. Complete occlusion was defined as Raymond-Roy class 1 and O’Kelly-Marotta grade D, according to the self-adjudicated or core-lab adjudicated reports by the authors.17,18Secondary efficacy outcomes were the rate of technical success, the rate of adjunctive coil usage, and the retreatment rate. The primary safety outcomes were the composite safety rate (including intra- and postprocedural complications) and the all-cause mortality rate. Intra- and postprocedural complications included ischemic events (thromboembolic events and vessel occlusions) and hemorrhagic events (any intracranial bleeding event) that caused permanent morbidity.
Quality of Evidence Assessment
Two reviewers (M.M.C. and G.S.S.) used the Newcastle-Ottawa Quality Assessment Scale (NOS) for cohort studies to assess the methodological quality of the studies included.19Because there were no studies comparing cohorts, the items "selection of the nonexposed cohort" and "comparability" were excluded from the scale, resulting in a maximum score of 6 points. In the items assessing follow-up, the cutoffs were set a priori at ≥ 12 months and > 80%.
Data Synthesis
Continuous variables were summarized as means ± standard deviation (SD), whereas categorical variables were summarized as percentages and frequencies. We estimated all relative rates based on available data for the variables of interest, and available data were handled according to the principles of theCochrane Handbook.20A random-effects meta-analysis of proportions was performed with a generalized linear mixed model to calculate pooled rates and 95% confidence intervals (CIs) for each outcome. Statistical heterogeneity across studies was assessed with the I2test (> 50% implies significant heterogeneity), while heterogeneity between subgroups was assessed using Cochran’s Q test.21此外,我们进行了灵敏度分析or the population treated exclusively by the devices with surface modification (p64 HPC, p64 MW HPC, and p48 MW HPC). All analyses and plots were generated using R statistical software (version 4.1.3) and RStudio.
Results
研究选择和Characteristics
Three hundred nineteen documents were identified, and 165 duplicates were removed. As a result of the initial screening by title and abstract, there were 102 potentially eligible documents. Of these, 1 document could not be retrieved. In the full-text evaluation, 32 documents were excluded for the following reasons: ineligible outcomes, ineligible population, insufficient data available, ineligible intervention, ineligible study type, and ineligible language (Supplemental Table 2). Ultimately, 20 studies from the final systematic search were included (Fig. 1).
Flowchart of study selection. Data added to the PRISMA template (from Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews.BMJ. 2021;372:n71) under the terms of the Creative Commons Attribution (CC BY 4.0) License (https://creativecommons.org/licenses/by/4.0/).
Ten studies were conducted in Germany,9,11,14,22–282 in France,8,293 in Belgium12,13(1 shared a location with Portugal30), 2 in Mongolia,31,32and the remaining in Argentina,25Bulgaria,33and Italy.34Details about the location of the studies are shown inFig. 2. Most studies (n = 16) evaluated the performance of the p64,8,9,11,12,22–28,30–34while 4 evaluated the p48 MW.13,14,29,35只有1study was prospective and had core-lab adjudication of reported outcomes.8The number of participants per study ranged from 11 to 520. The characteristics of all the studies are presented inTable 1.
World map indicating the number of studies from the various countries where the included studies were published. The majority of studies were published in Germany (n = 10), followed by Belgium (n = 3), France (n = 2), and Mongolia (n = 2). One study was published in the following countries: Portugal, Italy, Bulgaria, and Argentina. The map was created using mapchart.net.
Characteristics of the included studies
| Authors & Year | Study Design (country) | Device, No. of Devices Implanted | Mean Age (range), yrs | Females (%) | Total No. of Aneurysms, Status¶ | Aneurysm Size (mm), Neck Size (mm) | Nonsaccular Morphology | Locations (%) | Technical Details |
|---|---|---|---|---|---|---|---|---|---|
| Fischer et al., 201522 | SC retro (Germany) | p64, 1.1 per aneurysm | 58* (26–79) | 86 (71) | 124 unruptured, 6 ruptured (nonacute) | 4 (1–20), 3* (1–11) | 0 | 25% ICA paraophthalmic, 19% ICA sup hypophyseal, 14% ICA PCoA, 8% ICA paraclinoid, 8% ICA ant choroidal, 8% ACA, 6% ICA cavernous, 3% MCA, 3% VA, 3% basilar artery, 2% SCA, 2% PCA, 1% PICA | 4% balloon-assisted angioplasty, 2% devices could not be deployed ("excessive friction") |
| Bhogal et al., 201723 | SC retro cohort (Germany) | p64, 1.0 per aneurysm | 59.3 (27–77) | 15 (71) | 21 unruptured | 2.8 (2–6), 2.1 (1–4) | 0 | 100% ACA | 5% adjunctive stenting |
| Briganti et al., 201734 | MC retro cohort (Italy) | p64, 0.8 per aneurysm | 57 (40–79) | 30 (75) | 35 unruptured, 5 ruptured (nonacute)† | 9.0* (2–26), 5 (1.5–12) | 4 fusiform | 44% ICA paraophthalmic, 20% ICA PCoA, 14% ICA cavernous, 6% ACA, 6% basilar artery, 4% PICA, 2% MCA, 2% SCA, 2% PCA | 2% detachment failure, 2% poor device aperture |
| Bhogal et al., 20179 | SC retro case series (Germany) | p64, 1.0 per aneurysm | 61.4 (27–73) | 6 (50) | 12 unruptured | 3.1 (2–10), 2.5 (1–4) | 0 | 100% MCA | None |
| Morais et al., 201730 | 2-center retro cohort (Belgium & Portugal) | p64, 1.0 per aneurysm | 54 (27–89) | 22 (56) | 46 unruptured, 2 ruptured (nonacute) | 6.2 (1–24.7), 3.4 (1.5–11) | 0 | 27% ICA paraophthalmic, 25% ICA cavernous, 19% ICA PCoA, 17% MCA, 6% ICA ant choroidal, 4% basilar artery, 2% VA | 17% foreshortening |
| Bhogal et al., 201924 | SC retro cohort (Germany) | p64, 1.2 per aneurysm | 52.5 (27–73) | 15 (57) | 26 unruptured | 3.4 (1–7), 2.9 (1–6) | 0 | 100% ICA ant choroidal | 8% adjunctive stenting |
| Bhogal et al., 201825 | SC retro case series (Germany) | p64, 1.0 per aneurysm | 58.3 (14–76) | NR | 11 unruptured | 2.5 (2–4), NR | 0 | 100% MCA | None |
| Bhogal et al., 202135 | SC retro case series (Argentina) | p48 MW, 1.0 per aneurysm | 55 (34–84) | 20 (80) | 21 unruptured, 4 ruptured (acute) | 4.3 (1–20), 2.9 (1.5–8) | 1 blister, 8 dissecting | 36% MCA, 28% ACA, 12% PICA, 12% PCA, 8% pericallosal, 4% ICA bifurcation | 4% poor device placement |
| Aguilar Pérez et al., 202111 | SC retro cohort (Germany) | p64, 1.1 per aneurysm | 55.9 (14–83) | 388 (73) | 571 unruptured, 46 ruptured (nonacute) | 4.8 (1–27), NR | 0 | 25% ICA paraophthalmic, 18% ICA sup hypophyseal, 16% ICA PCoA, 12% MCA, 10% ACA, 6% ICA ant choroidal, 5% ICA cavernous, 5% ICA supraclinoid, 4% ICA bifurcation | NR |
| AlMatter et al., 202014 | SC retro cohort (Germany) | p48 MW, 1.0 per aneurysm | 57 (29–83) | 62 (83) | 66 unruptured, 11 ruptured (nonacute) | 3.5 (1–17), 2.7 (1–7) | 0 | 51% ACA, 29% MCA, 6% PCA, 5% SCA, 3% ICA cavernous, 3% ICA PCoA, 3% basilar artery, 1% PICA | None |
| De Beule et al., 202112 | SC retro cohort (Belgium) | p64, 1.0 per aneurysm | 57 (30–89) | 87 (80) | 104 unruptured, 5 ruptured (nonacute) | 8.1(出),NR | 7 dissecting | 36% ICA paraophthalmic, 21% ICA cavernous, 20% ICA PCoA, 6% ICA sup hypophyseal, 4% ICA supraclinoid, 4% VA, 2% ACA, 2% PICA, 2% basilar artery, 2% SCA, 1% ICA ant choroidal | 4% balloon-assisted angioplasty |
| Petrov et al., 202132 | SC retro case series (Mongolia) | p64 MW HPC, 0.8 per aneurysm | 57* (40–77) | 26 (89) | 46 unruptured | 3.7* (1–19), 3.3 (1.5–12) | 0 | 35% ICA sup hypophyseal, 28% ICA paraophthalmic, 13% ICA supraclinoid, 4% ICA cavernous, 4% ICA paraclinoid, 4% ICA PCoA, 4% ICA ant choroidal, 4% MCA, 2% ACA | 2% each (adjunctive stenting & balloon-assisted angioplasty), 2% proximal fishmouthing, 7% distal migration of device |
| Sirakov et al., 202033 | SC retro cohort (Bulgaria) | p64, 1.0 per aneurysm | 54.8 (27–80) | 40 (55) | 63 unruptured, 9 ruptured (nonacute) | 13.1 (5–31), NR | 12 fusiform | 50% ICA paraophthalmic, 19% ICA PCoA, 13% ICA cavernous, 4% VA, 4% basilar artery, 4% PCA, 3% MCA, 3% SCA | 6% incorrect device seizing that required intraprocedural replacement |
| Bhogal et al., 202231 | SC retro cohort (Mongolia) | p64 MW HPC, 1.0 per aneurysm | 51 (29–63) | 13 (86) | 18 unruptured, 1 ruptured (acute) | 8.4 (1–26), 5.4 (1.1–17) | 0 | 32% ICA paraophthalmic, 11% ICA cavernous, 11% ICA sup hypophyseal, 11% ICA supraclinoid, 11% ACA, 11% MCA, 5% ICA paraclinoid, 5% ICA ant choroidal, 5% ICA bifurcation | 5% balloon-assisted angioplasty, 5% distal fishmouthing, 5% device twisting |
| Hellstern et al., 202127 | SC retro cohort (Germany) | p64, 1.0 per aneurysm | 55.1 (29–76) | 45 (83) | 54 unruptured | 3.6 (0.8–18), NR | 0 | 33% PICA, 30% basilar artery, 26% SCA, 6% VA, 6% PCA | 2% device dislocation from delivery system |
| Bonafe et al., 20228 | MC prospective cohort (France) | p64, 1.1 per aneurysm | 55 (24–88) | 362 (86) | 392 unruptured, 28 ruptured (nonacute) | 6.9 (1–32), 4.4 (1–15) | 16个水泡,4解剖,5梭状,4 segmental disease | 59% ICA paraophthalmic, 17% ICA PCoA, 12% ICA cavernous, 4% ICA ant choroidal, 4% MCA, 3% ACA, 1% ICA bifurcation | 1% difficulty of device detachment from delivery system |
| Pierot et al., 202129 | 2-center retro cohort (France) | p48 MW HPC, 1.0 per aneurysm | 55.6 (25–82) | 17 (60) | 13 unruptured, 6 ruptured (acute), 10 ruptured (nonacute) | NR,‡ NR§ | 0 | 34% ACA, 28% MCA, 14% PCA, 10% basilar artery, 7% pericallosal, 3% ICA cavernous, 3% PICA | 3% adjunctive stenting, 3% device migration into the aneurysm, a new device had to be deployed |
| Van den Bergh et al., 202113 | MC retro cohort (Belgium) | p48 MW, 1.1 per aneurysm | 55.1 (29–73) | 17 (77) | 19 unruptured, 2 ruptured (acute), 4 ruptured (nonacute) | 5 (2–20), NR | 0 | 44% MCA, 28% pericallosal, 16% ACA, 8% ICA PCoA, 4% PCA | 4% balloon-assisted血管成形术,4%complete device expansion, 4% distal device migration |
| Winters et al., 202128 | MC retro cohort (Germany) | p64 MW HPC, 1.0 per aneurysm | 56.4 (24–82) | 21 (65) | 28 unruptured, 2 ruptured (acute) | 6.9 (3–50), 4.3 (2–20) | 1 blister, 1 dissecting, 1 fusiform | 32% ICA paraophthalmic, 19% ICA cavernous, 19% ICA supraclinoid, 13% basilar artery, 10% VA, 3% ICA PCoA, 3% MCA | 6% adjunctive stenting, 9% balloon-assisted angioplasty |
| Hellstern et al., 202226 | SC retro cohort (Germany) | p64 MW HPC, 1.1 per aneurysm | 58.1 (21–84) | 77 (75) | 132 unruptured | 4.8, 3.4 | 0 | 23% MCA, 20% ICA paraophthalmic, 19% ICA sup hypophyseal, 14% ICA PCoA, 11% ACA, 9% ICA cavernous, 3% ICA ant choroidal | 1% adjunctive stenting, 5% device foreshortening, 8% incomplete device expansion |
ACA = anterior cerebral artery; ant = anterior; MC = multicenter; NR = not reported; PCA = posterior cerebral artery; PCoA = posterior communicating artery; PICA = posterior inferior cerebellar artery; retro = retrospective; SC = single-center; SCA = superior cerebellar artery; sup = superior; VA = vertebral artery.
Median.
Aneurysm status considering patients.
Maximum aneurysm diameter was < 7 mm in 20 cases and ≥ 7 mm in 9 aneurysms.
Neck size was < 4 mm in 20 aneurysms and ≥ 4 mm in 8 aneurysms (1 aneurysm had no neck).
Acute < 48 hours, nonacute > 7 days.
Patient, Aneurysm, and Treatment Characteristics
总共有1781 1957个动脉瘤患者included in our aggregate meta-analysis; of these, 149 patients harboring 156 aneurysms were treated with the p48 MW FD. Patient ages ranged from 20 to 89 years, and 78.7% were female. The mean number of FDs implanted per aneurysm ranged between 0.8 and 1.2. In some cases, 1 FD was implanted to treat more than 1 aneurysm in the same vessel. Only 141 aneurysms (7.2%) were ruptured. Nonsaccular morphology, including fusiform, blister-like, dissecting, and segmental disease, was present in 3.2%. Aneurysm size ranged between 0.8 and 50 mm, and neck size ranged between 1 and 20 mm. Most aneurysms were located in the anterior circulation (93.1%). Previous treatment with coils, clips, or a combination of endovascular techniques (assisted or intrasaccular techniques) was performed in 14.9% of the aneurysms.
All procedures were performed under general anesthesia with perioperative heparinization. The use of bi- and tri-axial catheter systems was variable. Most procedures were performed uneventfully regarding technical events. The intraprocedural technical events reported included detachment difficulties, excessive friction advancing the device, opening issues, foreshortening, fishmouthing, migration, twisting, and failure to deliver. These events were encountered in 4% (n = 54) of the procedures. Additionally, balloon-assisted angioplasty was performed in 2%. Details about the technical events during the procedures can be found inTable 1.
In most studies, patients were maintained on dual antiplatelet therapy (DAPT) before the procedure and continued the same regimen between 3 and 12 months after the procedure. However, in 2 studies, patients received single antiplatelet therapy (SAPT) with 10 mg of prasugrel daily preprocedure.26,31For these patients, the same regimen was maintained after the procedure for at least 6 months, after which they were switched to 100 mg of aspirin (ASA) daily. Details regarding antiplatelet regimens can be found inTable 2.
Antiplatelet regimen in each study
| Authors & Year | Antiplatelet Regimen | Comments | |
|---|---|---|---|
| Preprocedure | Postprocedure | ||
| Fischer et al., 201522 | DAPT at least 1 day before | DAPT 1 yr | Patients w/ clopidogrel resistance were switched to ticagrelor |
| Bhogal et al., 201723 | DAPT at least 1 day before | DAPT 1 yr | Patients w/ clopidogrel resistance were switched to ticagrelor |
| Briganti et al., 201734 | DAPT at least 5 days before | DAPT 6 mos for ant circulation cases & 1 yr for posterior circulation | Patients treated in subacute phase of SAH received a loading dose of clopidogrel (600 mg) 4 hrs preprocedure |
| Bhogal et al., 20179 | DAPT at least 1 day before | DAPT (ASA plus ticagrelor) 1 yr | Patients w/ clopidogrel resistance were switched to ticagrelor |
| Morais et al., 201730 | DAPT loading dose (300 mg clopidogrel & 320 mg ASA) 1 day before & on day of procedure | DAPT 1 yr | |
| Bhogal et al., 201924 | DAPT at least 3 days before or DAPT loading dose (500 mg ASA & 600 mg clopidogrel) 1 day before | DAPT 1 yr | |
| Bhogal et al., 201825 | DAPT at least 7 days before | DAPT 3 mos, then SAPT | |
| Bhogal et al., 202135 | DAPT at least 7 days before | DAPT 6 mos, then SAPT | In ruptured cases, patients able to take oral medications, loading doses of ASA (500 mg) & prasugrel (60 mg) were given on morning preprocedure; in those unable to take oral medications, an IV bolus dose of weight-adjusted tirofiban was given on the table; subsequent loading doses of prasugrel via NG tube (60 mg) & IV ASA (500 mg) were given at end of procedure |
| Aguilar Pérez et al., 202111 | DAPT at least 7 days before | DAPT 6 mos for ant circulation cases & 1 yr for posterior circulation | Patients treated in subacute phase of SAH received a loading dose of clopidogrel (600 mg) 4 hrs preprocedure |
| AlMatter et al., 202014 | DAPT at least 2 days before | DAPT 1 yr | |
| De Beule et al., 202112 | DAPT at least 2 days before | DAPT 6 mos | |
| Petrov et al., 202132 | DAPT at least 5 days before | NR | |
| Sirakov et al., 202033 | DAPT at least 4 days before | DAPT 6 mos | |
| Bhogal et al., 202231 | SAPT (10 mg prasugrel daily) at least 5 days before | SAPT (10 mg prasugrel daily) for at least 6 mos, then switched to ASA 100 mg for 2 yrs | During switch from prasugrel to ASA, patients received both drugs for 3 days |
| Hellstern et al., 202127 | DAPT at least 5 days before; alternatively, a DAPT loading dose (500 mg ASA & either 600 mg clopidogrel or 180 mg ticagrelor or 30 mg prasugrel) 1 day before | DAPT (ASA & either 75 mg clopidogrel or 2× 90 mg ticagrelor or 10 mg prasugrel daily) 1 yr | From 2015, DAPT consisted of ASA & ticagrelor to avoid issues due to nonresponders to clopidogrel & to achieve a stronger DAPT; prasugrel was given in case of insufficient DAPT under ticagrelor or in case of intolerance to ticagrelor; patients w/ an anticipated increased risk of ischemic complications (e.g., if many perforating arteries were covered w/ an undersized p64) were given 2× 3000 IU heparin daily for 4–6 wks after flow diversion treatment |
| Bonafe et al., 20228 | DAPT at least 1 day before | NR | |
| Pierot et al., 202129 | DAPT at least 2–7 days before | DAPT (clopidogrel + ASA) 3–6 mos, DAPT (ticagrelor + ASA) 3 mos, SAPT (prasugrel 10 mg) 6 mos (only 1 case) | Ruptured aneurysms, several situations were encountered: cases treated w/in 48 hrs received prasugrel 20 mg a day preprocedure & 10 mg day of procedure; cases treated several days after initial bleeding (15 & 25 days after) received ticagrelor 180 mg + ASA 75 mg 2 days before |
| Van den Bergh et al., 202113 | DAPT at least 1 day before | DAPT 6 mos | |
| Winters et al., 202128 | DAPT loading dose (500 mg ASA together w/ either 180 mg ticagrelor, 30 mg prasugrel, or 300 mg clopidogrel) at least 1 day before | DAPT (100 mg ASA daily & either 90 mg ticagrelor every 12 hrs [twice a day], 10 mg prasugrel daily, or 75 mg clopidogrel daily) 1 yr | Clopidogrel, as the 2nd antiplatelet drug, was chosen only in patients who had already been treated w/ clopidogrel on an earlier occasion; ticagrelor or prasugrel was chosen in patients who required DAPT for 1st time, as platelet function testing is not routinely performed in all institutions, & both agents are not associated w/ high-on-treatment platelet reactivity, as is the case for clopidogrel |
| Hellstern et al., 202226 | SAPT loading dose (30 mg prasugrel) at least 3 days before procedure, followed by doses of 10 mg daily | SAPT (10 mg prasugrel daily) 6 mos; after that, patient was switched to 100 mg ASA daily | During switch from prasugrel to ASA, patients received both drugs for 3 days |
IV = intravenous; NG = nasogastric; SAH = subarachnoid hemorrhage.
Quality of Evidence Assessment
修改号得分的平均值为5.4±0.7。只有1study was prospective.8The detailed quality assessment for each included study is shown inSupplemental Table 3. Visual assessment of the funnel plots identified publication bias (Supplemental Fig. 1,Fig. 2). The results from Egger’s tests did not show publication bias in the associated outcomes (Supplemental Table 4).
合成p64 FD的结果
The complete occlusion rate of the p64 FD at final follow-up was 77% (95% CI 68%–85%;Fig. 3A). The length of angiographic follow-up ranged between 3 and 14.5 months. The rate of technical success implanting the FD was 99% (95% CI 97%–100%;Supplemental Fig. 3A). Adjunctive coiling was used in 7% (95% CI 4%–12%) of the aneurysms (Fig. 3B). Sensitivity analysis considering only the studies that implanted the p64 HPC showed a complete occlusion rate of 65% (95% CI 47%–80%;Supplemental Fig. 3B). Of note, the cumulative retreatment rate was 1% (95% CI 0%–4%;Supplemental Fig. 3C).
Meta-analysis of studies reporting outcomes after implantation of the p64 FD. Forest plots compare the proportion of patients in each study with a reported complete aneurysm occlusion (among 1462 aneurysms, the pooled occlusion rate was 77%) (A), the proportion of adjunctive coiling use (among 1184 aneurysms, the pooled use of adjunctive coils was 7%) (B), and the proportion of ischemic and hemorrhagic complications associated with the procedure (among 1632 patients, the pooled rate of complications was low [2%]) (C).
The rate of the composite safety outcome was 2% (95% CI 1%–4%;Fig. 3C). Fischer et al. reported two thromboembolic events (pontine ischemic infarcts) due to DAPT interruption against medical advice. Both events occurred during the first 30 days postimplantation.22Briganti et al. reported one permanent ischemic event due to in-stent thrombosis.34Morais et al. reported one ischemic event found on postprocedure day 7; that patient experienced central facial palsy and dysarthria that required invasive management.30Aguilar Perez et al. reported two hemorrhagic events that produced clinical deterioration.11In one case, wire perforation of the pericallosal artery produced massive intracerebral bleeding and death; in the other, the retrieval of a migrated coil into the superior branch of the left middle cerebral artery (MCA) caused intracranial bleeding. Additionally, on later follow-up, four in-stent thromboses causing permanent mRS score worsening and one large intracerebral hemorrhage (most likely due to transformation of an ischemic lesion) after treatment of a pericallosal aneurysm were reported. De Beule et al. reported one ischemic event due to acute in-stent thrombosis and one hemorrhagic event due to distal wire perforation, both producing permanent neurological deficits.12Sirakov et al. reported one delayed rupture of a giant, wide-necked, ophthalmic aneurysm of the right internal carotid artery (ICA). The patient reported a thunderclap headache 9 days after the procedure and the rupture was confirmed with imaging; management was successful, but the patient remained with deficits.33Hellstern et al. reported four ischemic complications with permanent deficits and one fatal hemorrhagic complication on the day of discharge.27Bonafe et al. reported eight major ischemic complications that left clinical deficits (seven intraprocedure and one postprocedure), one aortic dissection that led to myocardial infarction and death, and one subdural hematoma (thought to be caused by antiplatelet medications) that caused death.8Additionally, at follow-up 1 patient showed mRS score worsening after a minor stroke. Winters et al. reported one delayed aneurysm rupture 2.5 weeks after FD implantation that caused a high-flow carotid cavernous fistula that was successfully treated.28Hellstern et al. reported seven ischemic events that left minor neurological deficits and one intraparenchymal hemorrhage 2 months after the procedure.26Sensitivity analysis evaluating the studies that used the p64 HPC showed a composite safety outcome rate of 4% (95% CI 1%–17%;Supplemental Fig. 3D). Finally, the overall mortality rate was 0.49% (95% CI 0%–1%).
Synthesis of Results of the p48 MW FD
The complete occlusion rate at final follow-up was 67% (95% CI 49%–81%;Fig. 4A). The length of angiographic follow-up ranged between 2 and 13.1 months. The rate of technical success implanting the FD was 100%. Adjunctive coiling was used in 4% (95% CI 0%–24%) of the aneurysms (Fig. 4B). Sensitivity analysis evaluating the studies using the p48 MW HPC showed a complete occlusion rate of 71% (95% CI 50%–86%;Supplemental Fig. 4A); of note, the retreatment rate was 3% (95% CI 1%–12%;Supplemental Fig. 4B).
Meta-analysis of studies reporting outcomes after implantation of the p48 MW FD. Forest plots compare the proportion of patients in each study with a reported complete aneurysm occlusion (among 136 aneurysms, the pooled occlusion rate was 67%) (A), the proportion of adjunctive coiling use (among 156 aneurysms, the pooled use of adjunctive coils was 4%) (B), and the proportion of ischemic and hemorrhagic complications associated with the procedure (among 149 patients, the pooled rate of complications was 3%) (C).
The rate of the composite safety outcome was 3% (95% CI 1%–11%;Fig. 4C). AlMatter et al. reported one case of minor ischemia with neurological deficits and one death due to apnea (no intracranial hemorrhage or ischemia was found).14Pierot et al. reported one ischemic event due to the migration of a previously placed FD; neurological deficits remained in the patient at discharge.29Van den Bergh et al. reported two microwire vessel perforations (one patient recovered with neurological sequelae and the other died) and one vessel rupture after dilation with a compliant balloon due to incomplete device expansion.13Sensitivity analysis evaluating the studies that used the p48 MW HPC showed a composite safety outcome rate of 2% (95% CI 0%–6%;Supplemental Fig. 4C). Finally, the overall mortality rate was 2% (95% CI 1%–6%).
Discussion
This systematic review and meta-analysis of 20 studies demonstrated that treatment with the p64 and p48 MW devices is feasible with low rates of periprocedural ischemic and hemorrhagic complications. Complete aneurysm occlusion after implantation of the p64 was found in 77%, while after implantation of the p48 MW the rate was 67%. The rate of ischemic and hemorrhagic complications was 2% for the p64 and 3% for the p48 MW. Finally, the mortality rates were 0.49% and 2% for the p64 and p48 MW, respectively. Given the evolution and emergence of new endovascular devices for the treatment of intracranial aneurysms and the limited availability of certain flow-diverting devices to specific regions of the world, this study offers valuable information about the safety and efficacy of another tool in the armamentarium of the neurovascular surgeon.
Safety
The overall complication rate for the p64 FD was 2%, while the overall mortality rate was 0.49%. Although it has been suggested that the denser coverage of the p64 FD may result in more ischemic complications,11our findings regarding these complications are similar and, in some cases, showed lower rates than previous studies or meta-analyses for other FDs. Considering the older generation of the PED, a meta-analysis by Texakalidis et al. reported a 6.6% rate of symptomatic thrombotic episodes and a 3% rate of hemorrhagic events,36whereas for the PED Flex (Medtronic Neurovascular), Bhatia et al. reported a major complication rate of 1.8% and mortality rate of 0.8% in their meta-analysis.37A systematic review on the flow redirection endoluminal device (FRED, MicroVention) reported a morbidity rate of 3.9% and mortality rate of 1.4%.38Also, a prospective study evaluating the performance of the Surpass Streamline FD (Stryker Neurovascular) found permanent morbidity in 6% and mortality in 2.7% of the patients.39A meta-analysis of the Derivo embolization device (Acandis GmbH & Co.) found that the rate of periprocedural ischemic and hemorrhagic complications was 4.9% and the mortality rate was 2.1%.40Finally, Florez et al. performed a meta-analysis of the Silk FD (Balt) and found rates of thromboembolic and hemorrhagic complications of 6.1% and 1.6%, respectively, and a 2.8% mortality rate.41Of note, most studies we evaluated treated aneurysms located in the anterior circulation (93.1%), which might explain the lower incidence of complications in our study, considering that (in general) aneurysms located in the posterior circulation are associated with higher rates of complications.39,42
Notably, the complication rate in the p64 with surface modification was slightly higher (4%), which seems counterintuitive considering the inclusion of an antithrombogenic coating to reduce platelet aggregation. Of the 4 studies that reported outcomes with surface-modified devices, Hellstern et al. was the only study that used an SAPT protocol, in which the postprocedural ischemia occurred mainly in patients with MCA or MCA bifurcation aneurysms.26Both aspects are risk factors for ischemic events and could have contributed to the high rate of complications reported by the authors. However, it is important to emphasize that 3 of the patients who had an ischemic complication were not compliant with the SAPT regimen.26Overall, although we found that the p64 has a safe profile, further studies are needed to evaluate the safety of the newer-generation FDs with surface modification and the potential use of SAPT in these cases.
The overall complication rate for the p48 MW FD was 3%, and the mortality rate was 2%. The literature on the p48 MW FD is still limited, but morbidity and mortality rates were comparable to other low-profile FDs. A systematic review of the Silk Vista Baby FD (Balt) found that major stroke occurred in 1.2% of cases, stent thrombus formation or branch occlusion in 5.5%, and deaths in 2.5% (1.8% procedure-associated).43A recent meta-analysis evaluating the FRED Jr. (MicroVention) reported a 5.3% stroke rate, 0.4% hemorrhagic event rate, and 0% mortality.44Furthermore, a meta-analysis evaluating the outcomes after flow diversion in distal anterior circulation aneurysms found a 5.4% morbidity rate with a 2.2% mortality rate.45Notably, the implantation of FDs in arteries with smaller diameters is technically challenging due to distal navigation, and the risk of treatment-related complications is potentially higher due to the coverage of bifurcation branches and perforators, and in some cases, even in-stent thrombosis.31Considering these risks, the impact of adequate antiplatelet therapy is significant, and it has been previously shown that premature discontinuation is associated with a higher rate of complications.46Finally, although the lower rate of complications (2%) in the studies that used devices with surface modification might suggest a favorable safety profile of this technology, larger studies are needed to confirm these findings and optimize the selection of the antiplatelet regimen.
Efficacy
The occlusion rate after treatment with the p64 FD was 77%, which is within the range (74.9%–86.6%) of previously published meta-analyses and single-arm studies evaluating other FDs.38–40,47A relevant study to consider is a meta-analysis by Fiorella et al., in which the authors evaluated the outcomes of flow diversion in unruptured small- and medium-sized intracranial aneurysms located in the ICA and found a 74.9% rate of complete occlusion at 12 months.47Notably, the cumulative occlusion rate reported in this study had a correction factor for the studies that reported self-adjudicated outcomes.47The findings in this study converge with our results, considering that most of the aneurysm sizes in the studies we included were < 12 mm and were mostly located in the anterior circulation. However, most studies (n = 19) from our analysis presented self-adjudicated outcomes, which can potentially overestimate the rates of complete occlusion.48Furthermore, the high variability in the follow-up times of the included studies (range 2–13.1 months) has to be considered, given that higher occlusion rates are observed with longer follow-ups. Notably, the rate of adjunctive coiling in the studies we included was low (4%), which favors evaluation of the direct efficacy of the FD as there was limited influence of adjunctive techniques. In comparison, the occlusion rate of the group treated with the surface-modified device (p64 HPC) was lower (65%), but the mean follow-up time ranged from 5.1 to 6.4 months. Similarly, the adjunctive coiling in these patients remained low (3.6%). Overall, the efficacy profile of the p64 is consistent with the results reported after the implantation of other FDs, and our findings confirm that flow diversion is a reliable and reproducible technique.
The overall complete occlusion rate with the p48 MW was 67%, which is comparable to the 66.7% reported in a meta-analysis evaluating the FRED Jr. but lower than the 72.1% reported rate with the Silk Vista Baby FD.43,44Furthermore, a large meta-analysis evaluating the performance of FDs in unruptured distal anterior circulation aneurysms found 82.7% complete occlusion at final follow-up. Similar to the p64 studies, the variability in the length of follow-up evaluations for these patients was considerable between studies. Additionally, the rate of adjuvant coiling was low. From the studies included in the pooled rate, AlMatter et al.14and Van den Bergh et al.13reported low occlusion rates (51% and 53%, respectively). These authors suggested that this finding might be explained by the reduced metal density of this low-profile device (48 vs 64 wires) and/or the extended use of DAPT due to local institutional protocol at one of the centers.13,14However, some of the advantages of using low-profile FDs for distal aneurysms are the possibility of using 0.021-inch microcatheters for delivery and avoiding device oversize or overlap. Finally, the occlusion rate with the p48 MW HPC was slightly higher (71%), which seems promising as more experience is gained in treating distal aneurysms and the best antiplatelet regimens for ruptured and unruptured cases are defined.
Antiplatelet Therapy: DAPT and SAPT
The implantation of FDs necessitates the use of DAPT to prevent intrastent thrombosis or other thromboembolic events;49however, the response to antiplatelet medications is heterogenous, with some patients hyperresponsive and others hyporesponsive, potentially increasing the risks of hemorrhagic and ischemic complications. As a result, the development of surface modifications such as the HPC seems promising to avoid the need for DAPT. Among the 5 FDs with antithrombogenic surface modifications available, only the p64 and p48 MW HPC include instructions for use with SAPT.26Previous reports have been published evaluating the feasibility and safety of SAPT after the implantation of surface-modified FDs.50–54Their results confirm feasibility, but safety was not significantly improved under this regimen. In the 2 studies we included, the SAPT regimen consisted of 10 mg of prasugrel daily for 6 months and then a switch to daily ASA.26,31作者报道比较安全的结果uncoated FDs with DAPT and mentioned the need for further studies to confirm their outcomes.
Limitations
We acknowledge that our study has limitations. First, the studies were mainly retrospective and single-center experiences with an imbalance across sample sizes (range 11–520 participants), which contributed to the heterogeneity of the results. Second, outcome reporting was heterogenous, with variable definitions of the ischemic and hemorrhagic events and various studies excluding data on follow-up duration and posttreatment morbidity. We note that almost two-thirds of patients can present with ischemic infarcts after the procedure as shown on diffusion-weighted imaging without any clinical symptoms;55we did not consider those patients for the pooled proportion of the safety composite outcome. Third, the angiographic outcomes were mostly self-adjudicated and measured at different time points. Fourth, the inclusion of studies that treated patients with newer devices with an antithrombotic coating could have introduced additional confounders into our analysis due to the variation in the antiplatelet therapy prescribed. Fifth, regarding the data, we found significant heterogeneity across some outcomes. However, although we report several limitations, our meta-analysis is the first to evaluate the p48 MW and p64 FDs for treating intracranial aneurysms.
Conclusions
This systematic review and meta-analysis found that the p64 and p48 MW have acceptable efficacy and favorable safety profiles. Both devices, however, have been primarily used in Europe thus far. Although the addition of antithrombotic coatings seems promising, more data are needed to confirm their potential benefits. Furthermore, we suggest future studies are needed to evaluate the efficacy and safety of SAPT after implantation of surface-modified FDs.
Disclosures
Dr. Burkhardt reports receiving personal fees for consulting from MicroVention, Cerenovous, Stryker, Medtronic, Q’Apel Medical, and Longeviti Neruo Solutions outside the submitted work.
Author Contributions
Conception and design: Burkhardt, Vivanco-Suarez, Salem, Covell, Srinivasan. Acquisition of data: Burkhardt, Vivanco-Suarez, Salem, Sioutas, Covell. Analysis and interpretation of data: Burkhardt, Vivanco-Suarez, Covell, Jankowitz, Srinivasan. Drafting the article: Burkhardt, Vivanco-Suarez, Salem, Sioutas, Covell, Srinivasan. Critically revising the article: Burkhardt, Vivanco-Suarez, Salem, Sioutas, Srinivasan. Reviewed submitted version of manuscript: Burkhardt, Vivanco-Suarez, Salem, Sioutas, Covell, Srinivasan. Approved the final version of the manuscript on behalf of all authors: Burkhardt. Statistical analysis: Vivanco-Suarez. Administrative/technical/material support: Burkhardt, Vivanco-Suarez. Study supervision: Burkhardt, Vivanco-Suarez, Srinivasan.
Supplemental Information
Online-Only Content
Supplemental material is available online.
Supplemental Tables and Figures.//www.prize-show.com/doi/suppl/10.3171/2023.2.FOCUS22648.
References
-
1 ↑
ChancellorB,RazE,ShapiroM,et al.Flow diversion for intracranial aneurysm treatment: trials involving flow diverters and long-term outcomes.开云体育app官方网站下载入口.2020;86(suppl 1):S36-S45.
-
2 ↑
WagnerK,SrivatsanA,MohantyA.et al.Cognitive outcomes after unruptured intracranial aneurysm treatment with flow diversion.J Neurosurg.2021;134(1):33–38.
-
3
AlgraAM,LindgrenA,VergouwenMDI,et al.程序上的临床并发症,病死率risks, and risk factors in endovascular and neurosurgical treatment of unruptured intracranial aneurysms: a systematic review and meta-analysis.JAMA Neurol.2019;76(3):282–293.
-
4 ↑
LiS,ZengC,TaoW,et al.The safety and efficacy of flow diversion versus conventional endovascular treatment for intracranial aneurysms: a meta-analysis of real-world cohort studies from the past 10 years.AJNR Am J Neuroradiol.2022;43(7):1004–1011.
-
5 ↑
VranicJE,HarkerP,StapletonCJ,et al.Impact of endoluminal flow diverter number on aneurysm treatment outcomes: a multicenter study.Stroke Vasc Interv Neurol.2022;2(3):e000188.
-
6
ten BrinckMFM,ShimanskayaVE,AquariusR,et al.Outcomes after flow diverter treatment in subarachnoid hemorrhage: a meta-analysis and development of a clinical prediction model (OUTFLOW).Brain Sci.2022;12(3):394.
-
7 ↑
DandapatS,Mendez-RuizA,Martínez-GaldámezM,et al.Review of current intracranial aneurysm flow diversion technology and clinical use.Review. J Neurointerv Surg.2021;13(1):54–62.
-
8 ↑
BonafeA,PerezMA,HenkesH,et al.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.J Neurointerv Surg.2022;14(9):898–903.
-
9 ↑
BhogalP,AlMatterM,BäznerH,GanslandtO,HenkesH,Aguilar PérezM.Flow diversion for the treatment of MCA bifurcation aneurysms—a single centre experience.Front Neurol.2017;820.
-
10 ↑
Lenz-HabijanT,BroddeM,KehrelBE,et al.Comparison of the thrombogenicity of a bare and antithrombogenic coated flow diverter in an in vitro flow model.Cardiovasc Intervent Radiol.2020;43(1):140–146.
-
11 ↑
Aguilar PérezM,HenkesE,HellsternV,et al.Endovascular treatment of anterior circulation aneurysms with the p64 flow modulation device: mid- and long-term results in 617 aneurysms from a single center.Oper Neurosurg (Hagerstown).2021;20(4):355–363.
-
12 ↑
De BeuleT,BoulangerT,HeyeS,van RooijWJ,van ZwamWH,StockxL.p64 flow diverter: results in 108 patients from a single center.Interv Neuroradiol.2021;27(1):51–59.
-
13 ↑
Van den BerghFRA,De BeuleT,van RooijWJ,et al.The p48 flow diverter: first clinical results in 25 aneurysms in three centers.Interv Neuroradiol.2021;27(3):339–345.
-
14 ↑
AlMatterM,HenkesE,SirakovA,et al.The p48 MW flow modulation device for treatment of unruptured, saccular intracranial aneurysms: a single center experience from 77 consecutive aneurysms.CVIR Endovasc.2020;3(1):39.
-
15 ↑
PageMJ,McKenzieJE,BossuytPM.et al.The PRISMA 2020 statement: an updated guideline for reporting systematic reviews.BMJ.2021;372(71):n71.
-
17 ↑
O’KellyCJ,KringsT,FiorellaD,MarottaTR.A novel grading scale for the angiographic assessment of intracranial aneurysms treated using flow diverting stents.Interv Neuroradiol.2010;16(2):133–137.
-
18 ↑
RoyD,MilotG,RaymondJ.Endovascular treatment of unruptured aneurysms.Stroke.2001;32(9):1998–2004.
-
19 ↑
WellsGA,SheaB,O’ConnellD,et al.The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses.Ottawa Hospital Research Institute.Accessed March 17, 2023.https://www.ohri.ca/programs/clinical_epidemiology/oxford.asp
-
20 ↑
HigginsJPT,ThomasJ,集lerJ.et al, eds.Cochrane Handbook for Systematic Reviews of Interventions.Version 6.3. Cochrane;2022.Updated February 2022.Accessed March 17, 2023.https://training.cochrane.org/handbook
-
21 ↑
HigginsJP,ThompsonSG.Quantifying heterogeneity in a meta-analysis.Stat Med.2002;21(11):1539–1558.
-
22 ↑
FischerS,Aguilar-PérezM,HenkesE,et al.Initial experience with p64: a novel mechanically detachable flow diverter for the treatment of intracranial saccular sidewall aneurysms.AJNR Am J Neuroradiol.2015;36(11):2082–2089.
-
23 ↑
BhogalP,Martinez MorenoR,GanslandtO,BäznerH,HenkesH,PerezMA.Use of flow diverters in the treatment of unruptured saccular aneurysms of the anterior cerebral artery.J Neurointerv Surg.2017;9(3):283–289.
-
24 ↑
BhogalP,GanslandtO,BäznerH,HenkesH,Aguilar PerezM.治疗未破裂,囊状,前choroidal artery aneurysms with flow diversion: a single centre experience.Clin Neuroradiol.2019;29(3):459–465.
-
25 ↑
BhogalP,MartinezR,GansladtO,BäznerH,HenkesH,AguilarM.Management of unruptured saccular aneurysms of the M1 segment with flow diversion: a single centre experience.Clin Neuroradiol.2018;28(2):209–216.
-
26 ↑
HellsternV,Aguilar PérezM,HenkesE,et al.Use of a p64 MW flow diverter with hydrophilic polymer coating (HPC) and prasugrel single antiplatelet therapy for the treatment of unruptured anterior circulation aneurysms: safety data and short-term occlusion rates.Cardiovasc Intervent Radiol.2022;45(9):1364–1374.
-
27 ↑
HellsternV,Aguilar-PérezM,HenkesE,et al.Endovascular treatment of posterior circulation saccular aneurysms with the p64 flow modulation device: mid-and long-term results in 54 aneurysms from a single center.Front Neurol.2021;12711863.
-
28 ↑
WintersH,SchüngelMS,ScherlachC,et al.First experience of three neurovascular centers with the p64MW-HPC, a low-profile flow diverter designed for proximal cerebral vessels with antithrombotic coating.Front Neurol.2021;12724705.
-
29 ↑
PierotL,SoizeS,CappucciM,ManceauPF,RivaR,EkerOF.Surface-modified flow diverter p48-MW-HPC: preliminary clinical experience in 28 patients treated in two centers.J Neuroradiol.2021;48(3):195–199.
-
30 ↑
MoraisR,MineB,BruyèrePJ,NaeijeG,LubiczB.Endovascular treatment of intracranial aneurysms with the p64 flow diverter stent: mid-term results in 35 patients with 41 intracranial aneurysms.Neuroradiology.2017;59(3):263–269.
-
31 ↑
BhogalP,PetrovA,RentsenkhuG,et al.Early clinical experience with the p48MW HPC and p64MW HPC flow diverters in the anterior circulation aneurysm using single anti-platelet treatment.Interv Neuroradiol.2022;28(3):266–276.
-
32 ↑
PetrovA,RentsenkhuuG,NotaB,et al.Initial experience with the novel p64MW HPC flow diverter from a cohort study in unruptured anterior circulation aneurysms under dual antiplatelet medication.Interv Neuroradiol.2021;27(1):42–50.
-
33 ↑
SirakovS,SirakovA,BhogalP,et al.The p64 flow diverter-mid-term and long-term results from a single center.Clin Neuroradiol.2020;30(3):471–480.
-
34 ↑
BrigantiF,LeoneG,UggaL,et al.Mid-term and long-term follow-up of intracranial aneurysms treated by the p64 Flow Modulation Device: a multicenter experience.J Neurointerv Surg.2017;9(1):70–76.
-
35 ↑
BhogalP,BleiseC,ChudykJ,et al.The p48MW flow diverter-initial human experience.Clin Neuroradiol.2021;31(1):135–145.
-
36 ↑
TexakalidisP,BekelisK,AtallahE,TjoumakarisS,RosenwasserRH,JabbourP.Flow diversion with the pipeline embolization device for patients with intracranial aneurysms and antiplatelet therapy: a systematic literature review.Clin Neurol Neurosurg.2017;161:78–87.
-
37 ↑
BhatiaKD,KortmanH,OrruE,KlostranecJM,PereiraVM,KringsT.Periprocedural complications of second-generation flow diverter treatment using Pipeline Flex for unruptured intracranial aneurysms: a systematic review and meta-analysis.J Neurointerv Surg.2019;11(8):817–824.
-
38 ↑
WaqasM,DossaniRH,AlkhaldiM,et al.Flow redirection endoluminal device (FRED) for treatment of intracranial aneurysms: a systematic review.Interv Neuroradiol.2022;28(3):347–357.
-
39 ↑
WakhlooAK,LylykP,de VriesJ.et al.Surpass flow diverter in the treatment of intracranial aneurysms: a prospective multicenter study.AJNR Am J Neuroradiol.2015;36(1):98–107.
-
40 ↑
MonteiroA,BurkeSM,BaigAA,et al.A systematic review and meta-analysis of the Derivo Embolization Device: a novel surface-modified flow diverter for intracranial aneurysm treatment.J Neurointerv Surg.2022;14(11):1125–1129.
-
41 ↑
FlorezWA,Garcia-BallestasE,Quiñones-OssaGA,et al.Silk® flow diverter device for intracranial aneurysm treatment: a systematic review and meta-analysis.Neurointervention.2021;16(3):222–231.
-
42 ↑
BrinjikjiW,MuradMH,LanzinoG,CloftHJ,KallmesDF.Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis.Stroke.2013;44(2):442–447.
-
43 ↑
HanelRA,CortezGM,BenaliaVHC,et al.Patient outcomes after treatment of brain aneurysm in small diameter vessels with the silk vista baby flow diverter: a systematic review.Interv Neuroradiol.Published online April 7, 2022.doi:10.1177/15910199221091645
-
44 ↑
El NaamaniK,SaieghFA,ChenCJ,et al.Treatment of cerebral aneurysms with the FRED Jr flow-diverting stent: a case series and meta-analysis.Clin Neurol Neurosurg.2022;223:107483.
-
45 ↑
CagnazzoF,FantiA,LefevrePH,et al.Distal anterior cerebral artery aneurysms treated with flow diversion: experience of a large-volume center and systematic review of the literature.J Neurointerv Surg.2021;13(1):42–48.
-
46 ↑
CagnazzoF,PerriniP,DargazanliC,et al.Treatment of unruptured distal anterior circulation aneurysms with flow-diverter stents: a meta-analysis.AJNR Am J Neuroradiol.2019;40(4):687–693.
-
47 ↑
FiorellaD,GacheL,FrameD,ArthurAS.流的分流器有多安全有效treatment of unruptured small/medium intracranial aneurysms of the internal carotid artery? Meta-analysis for evidence-based performance goals.J Neurointerv Surg.2020;12(9):869–873.
-
48 ↑
De LeacyRA,FargenKM,MascitelliJR,et al.Wide-neck bifurcation aneurysms of the middle cerebral artery and basilar apex treated by endovascular techniques: a multicentre, core lab adjudicated study evaluating safety and durability of occlusion (BRANCH).J Neurointerv Surg.2019;11(1):31–36.
-
49 ↑
BhogalP,Lenz-HabijanT,BannewitzC,et al.Thrombogenicity of the p48 and anti-thrombogenic p48 hydrophilic polymer coating low-profile flow diverters in an in vitro human thrombin generation model.Interv Neuroradiol.2020;26(4):488–493.
-
50 ↑
ManningNW,CheungA,PhillipsTJ,WenderothJD.Pipeline shield with single antiplatelet therapy in aneurysmal subarachnoid haemorrhage: multicentre experience.J Neurointerv Surg.2019;11(7):694–698.
-
51
RiceH,Martínez GaldámezM,HoltmannspötterM.et al.Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study.J Neurointerv Surg.2020;12(11):1107–1112.
-
52
Aguilar-PerezM,HellsternV,AlMatterM,et al.The p48 flow modulation device with hydrophilic polymer coating (HPC) for the treatment of acutely ruptured aneurysms: early clinical experience using single antiplatelet therapy.Cardiovasc Intervent Radiol.2020;43(5):740–748.
-
53
GuzzardiG,GalbiatiA,StancaC,et al.Flow diverter stents with hydrophilic polymer coating for the treatment of acutely ruptured aneurysms using single antiplatelet therapy: preliminary experience.Interv Neuroradiol.2020;26(5):525–531.
-
54 ↑
LobsienD,ClajusC,BehmeD,et al.动脉瘤治疗在急性SAH hydrophilic-coated flow diverters under single-antiplatelet therapy: a 3-center experience.AJNR Am J Neuroradiol.2021;42(3):508–515.
-
55 ↑
BondKM,BrinjikjiW,MuradMH,KallmesDF,CloftHJ,LanzinoG.Diffusion-weighted imaging-detected ischemic lesions following endovascular treatment of cerebral aneurysms: a systematic review and meta-analysis.AJNR Am J Neuroradiol.2017;38(2):304–309.
