Article Text
Abstract
Background A higher number of recanalization attempts reduces the efficacy of endovascular thrombectomy (EVT) for acute ischemic stroke secondary to large vessel occlusion (LVO). We assessed the impact of switching EVT techniques after a failed first pass on procedural and clinical outcomes.
Methods This multicenter international study, conducted between January 2013 and December 2022, included patients undergoing EVT for anterior circulation LVO (internal carotid artery or M1 segments) with failed first pass recanalization. Propensity score matching identified a 1:1 matched cohort of patients in whom EVT technique was changed after a failed first pass and those with the same technique repeated. The primary outcome was successful recanalization at second attempt defined as Thrombolysis in Cerebral Ischemia (TICI) score of 2B or higher. Secondary outcomes were 90-day modified Rankin Score (mRS) and postprocedural hemorrhage.
Results Among 2167 patients, converting to an alternative technique after a failed first pass was associated with higher odds of successful recanalization (adjusted OR (aOR)=1.5, p=0.041), and higher odds of mRS 0–2 at 90 days (aOR=1.6, p=0.005) without additional risk of symptomatic hemorrhage (p=0.379). Using a propensity score matched cohort of 490 patients, technique conversion at second attempt increased odds of successful recanalization at second attempt (aOR=1.32, p=0.006) and 90-day mRS 0–2 (aOR=1.38, p=0.008).
Conclusions Early conversion to an alternative EVT technique after a failed first pass recanalization in patients with AIS is associated with better technical success and clinical outcomes.
- Stroke
Data availability statement
Data are available upon reasonable request. Not applicable.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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WHAT IS ALREADY KNOWN ON THIS TOPIC
A higher number of thrombectomy passes is consistently associated with worse clinical outcomes. Randomized trials and real-world data did not show differences in technical or clinical outcomes based on the frontline thrombectomy technique used, including contact aspiration, stent retriever thrombectomy, and a combination of both. Choice of thrombectomy technique and decision to switch to an alternative technique remains at the discretion of the operator.
WHAT THIS STUDY ADDS
This study provides evidence that switching to an alternative EVT technique after a failed first pass is associated with higher odds of successful recanalization and better functional outcomes at 90 days without increasing the risk of symptomatic intracranial hemorrhage or mortality. The study demonstrates that different technique-to-technique conversion pairs can significantly impact the success of the procedure, with specific conversions yielding higher odds of successful recanalization depending on the initial technique used.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
This study suggests that early conversion to an alternative EVT technique following a failed first pass should be considered to improve the likelihood of successful recanalization and better patient outcomes. It highlights the need for developing clear guidelines on technique switching during EVT, which could influence clinical decision-making and potentially reduce the number of total EVT attempts, thereby minimizing procedure time and associated risks.
Introduction
Endovascular thrombectomy (EVT) is the standard of care for patients with acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO).1–4 EVT techniques include contact aspiration (ASP), stent retriever thrombectomy (SR), and the combination of ASP and SR (combined approach).5 Although the initial randomized control trials predominantly used strent retrievers,1–4 subsequent trials and real-world data showed that frontline ASP was non-inferior to stent retriever in terms of technical outcomes and functional outcomes at 90 days.6–10 The recently completed VECTOR trial did not show superiority of the combined technique over ASP only for patients with anterior circulation LVO with susceptibility vessel sign on preoperative imaging.11 In 30–45% of thrombectomy cases,12 recanalization is achieved with a single EVT pass; however, in the remaining cases, operators will pursue additional passes to achieve recanalization. Data support that at least three attempts are to be considered before risk-to-benefit ratio of the procedure is to be re-evaluated7 13; however, there is no guidance on whether a futile first pass should warrant switching to an alternative EVT technique. Here, we evaluated the effect of switching EVT technique after failed first pass using a propensity score matched cohort of patients undergoing EVT with the same or different technique at second pass.
Methods
Study population
Data were reviewed from the Stroke Thrombectomy and Aneurysm Registry (STAR),14 and included 29 stroke centers between January 2013 and December 2022. We included patients undergoing EVT for anterior circulation LVO (ICA or M1) requiring at least two EVT attempts. See online supplemental file 1 for detailed inclusion criteria. Data were curated from review of medical records for clinical variables and independent review of radiographic data for the Alberta Stroke Program Early CT Score (ASPECTS) and modified Thrombolysis in Cerebral Infarction (mTICI) score. Procedural notes were reviewed for procedural and technical variables, including thrombectomy technique and devices. The study was approved by the local institutional review board at each institution and follows the guidelines set forth by the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. The STAR registry is approved by the institutional review board at the Medical University of South Carolina (Protocol ID: 00090704). Patient consent was waived given the study limited to chart reviews. The data were obtained retrospectively and collected according to a standardized protocol. Verification, de-identification, and attestation of data accuracy were performed by investigators at each contributing institution. Individual patient data from each contributing institution were pooled by investigators at the Medical University of South Carolina where they were validated for accuracy and completeness.
Supplemental material
Inclusion and exclusion criteria
The study included adult patients (18 years of age or older) undergoing MT for AIS with occlusion of the internal carotid artery (ICA) or M1 segment of the middle cerebral artery with failed first attempt recanalization and required at least one additional MT pass using stent retriever, aspiration, or the primary combined approach (Solumbra or equivalent) irrespective of use of balloon guide catheter. Failure of first pass was defined as TICI score 0–2A after the first pass. Patients with tandem occlusions were excluded. A thrombectomy pass is defined as successful delivery of an aspiration catheter to the face of the clot followed by aspiration for direct aspiration technique or deployment and retrieval of the stent retriever for the stent retriever or primary combined approach. If a catheter could not be delivered to the face of the clot due to tortuosity or the stent retriever could not be deployed, this is not considered a failed attempt.
Patients were excluded if detailed technical and procedural outcomes were missing for each attempt, if they had successful first pass recanalization, or they were lost to follow-up before 90 days. None of the patients underwent rescue angioplasty or stenting in the first two attempts.
Data variables
Clinical data included demographics such as age and sex, medical history (hypertension, diabetes mellitus, atrial fibrillation, and hyperlipidemia), premorbid modified Rankin Scale (mRS) score, National Institutes of Health Stroke Scale (NIHSS) score at admission, Alberta Stroke Program Early CT Score (ASPECTS), primary occluded vessel location (ICA or M1), use of intravenous thrombolysis, onset to arterial puncture time, procedure time, use of a balloon guide catheter, number of thrombectomy attempts, modified Thrombolysis in Cerebral Infarction (mTICI) score, and type of MT technique (ASP, SR, or combined technique).
Outcome measures
The primary outcome was successful recanalization, defined as mTICI score 2b, 2c, or 3. Secondary outcomes included 90-day mRS score (dichotomized to good outcome (0–2) and poor outcome (3–6)), and 90-day mortality. Safety outcomes were defined as symptomatic intracranial hemorrhage (sICH) defined as ICH with neurological worsening of ≥4 points on NIHSS score.
Statistical analysis
Statistical analyses were performed using JMP Pro (version 16.0; SAS Institute, Cary, NC). For parametric variables with normal distribution, mean and SD are reported. For parametric variables that do not follow a normal distribution, median and IQR (25th–75th percentile) were reported. For categorical variables, percentage is reported. Categorical variables were analyzed using the Pearson χ2 test. Continuous variables were compared by Student’s t-test, ANOVA with Bonferroni correction, or Mann-Whitney test as appropriate. There was no plan for imputation of the missing data. Among patients with unsuccessful first pass thrombectomies, variables and outcomes were compared between those who had the same technique and those who had another technique on the second attempt irrespective of the frontline technique. Variables and outcomes were compared by stratifying patients based on frontline and conversion techniques. Regression models were constructed to compute the adjusted odds ratios (aORs) for outcome measures. Models were adjusted by age, sex, pre-morbid mRS, atrial fibrillation, intravenous thrombolysis (IV-tPA), NIHSS at admission, ASPECTS, primary occluded vessel location, balloon guide catheter use, and AIS onset to arterial puncture time. Models were used with a stepwise backpropagation design and model coefficients were tested using Omnibus Test of Model Coefficients. We then used the nearest-neighbor algorithm in JMP Pro to identify a propensity score matched cohort between patients with the same versus an alternative technique at second pass using 1:1 matching based on the following covariates: age, sex, smoking status, pre-morbid mRS, comorbidities (atrial fibrillation, hypertension, diabetes), NIHSS on admission, ASPECTS, location of vessel occlusion, use of IV-tPA, onset to puncture time, and use of balloon guide catheter. Variables were balanced with a standardized mean difference (SMD)<0.02. Differences were considered significant at p<0.05.
Results
Study population
Among 10 229 patients with AIS reviewed, 2167 had failed first pass EVT and met inclusion criteria for this study (online supplemental figure 1). Among this subpopulation, 1733 (80%) patients were treated with the same technique at the second pass compared with 434 (20%) patients in whom an alternative technique was used (table 1). Patients treated with the same technique had shorter AIS onset to groin puncture time and lower rate of concurrent ICA and M1 occlusions, but otherwise comparable baseline variables compared with the alternative technique group (table 1).
Patient outcomes
Treatment with an alternative technique at second pass was not associated with longer procedure time, but resulted in a significantly lower number of total attempts required to achieve successful recanalization (table 1). On logistic regression (figure 1A), converting to an alternative technique was associated with higher odds of successful recanalization at the second attempt (aOR=1.5, 95% CI 1.04 to 2.2, p=0.041), and higher odds of good outcome at 90 days (aOR=1.6, 95% CI 1.15 to 2.2, p=0.005) without additional risk of symptomatic hemorrhage (p=0.379) or mortality (aOR=0.744, p=0.107, figure 1A).
Outcomes in propensity score matched cohort
Using propensity score matching for the main covariates between the two treatment groups, the same effect was replicated (figure 1B, table 2). Online supplemental table 1 shows adequate balance between the two groups in terms of clinical and technical covariates without significant difference between the groups (n=245/group). Switching to an alternative technique at second pass was associated with higher odds of successful recanalization (OR=1.32, 95% CI 1.08 to 1.61, p=0.006), higher odds of good outcome at 90 days (OR=1.38, 95% CI 1.08 to 1.75, p=0.008), and lower odds of 90-day mortality (OR=0.72, 95% CI 0.53 to 0.97, p=0.03). The total procedure time was comparable between groups and there were no additional odds of hemorrhage with use of an alternative technique (figure 1B). Even when controlling for technical variables including successful recanalization and hemorrhagic complications within the matched cohort (table 3), converting to an alternative technique was still associated with higher odds of good outcome at 90 days (aOR=1.66, 95% CI 1.04 to 2.65, p=0.03). There were no differences in safety outcomes between patients with the same or an alternative technique at second pass, including any post-procedural hemorrhage, symptomatic hemorrhage, vessel perforation, or vessel dissection (table 2).
Successful Recanalization by second line technique
We then studied the effect of different technique-to-technique conversion pairs on the odds of successful recanalization at the second attempt using the same technique as the reference group (figure 1C, online supplemental table 2). If aspiration was used as the frontline technique, conversion to a combined approach but not to stent retriever only was associated with higher odds of successful recanalization. If either a stent retriever or combined approach was used as the frontline technique, only conversion to aspiration was associated with higher odds of successful recanalization (figure 1C).
Discussion
We demonstrate that converting to an alternative EVT after a failed first pass is associated with increased odds of successful recanalization and good functional outcome without increased risk of ICH or longer procedure times. Data from randomized trials and real-world registries demonstrated non-inferiority of aspiration thrombectomy versus stent retriever or a combined approach as first line EVT techniques.6 9 15 16 However, first pass success is estimated to occur in 45% of cases based on a recent meta-analysis.12 Additional EVT passes are routinely performed to achieve successful recanalization, and successful recanalization at additional attempts continues to have a favorable impact on functional outcomes. Yet, a longer procedure time and more attempts led to a lower likelihood of good outcomes and higher rates of sICH, especially beyond three total attempts.7 13 Therefore, successful recanalization with the minimum number of attempts remains the practice goal. Following the first pass, there are currently no data to support whether switching to an alternative technique affects the success of the procedure or the functional outcome.
Our current study demonstrates that following a failed first pass, switching to an alternative technique is associated with higher rates of success at second pass, and better overall EVT outcomes without additional risks of intracranial hemorrhage compared with repeated passes with the same technique. These data support that early technique conversion is associated with a higher rate of technical success and clinical benefit.7 13 The biomechanics of thrombus retrieval are different for each EVT procedure, and unique vascular morphology and thrombus characteristics also vary among all patients. Conversion to a different technique exposes the thrombus to different biomechanical forces. From a cost-effectiveness standpoint, however, converting to a different technique may be associated with increased costs if additional devices are needed. Our data also show that not all technique conversions provide additional benefit on technical outcomes. Following frontline stent retriever, use of contact aspiration and not a combined approach led to higher odds of success whereas following failed aspiration, use of a combined approach rather than stent retriever alone led to higher technical success compared with additional aspiration attempts. In cases using a frontline combined approach, use of aspiration at the second attempt led to higher odds of technical success. Failure of the first pass after aspiration could be related to mismatch between catheter size and parent vessel or failure to approximate the thrombus within the catheter. With stent retriever, failure of the first pass could be related to clot length or tortuosity of the occluded segment.17 Notably, the experience of the operator is likely to factor into this decision making and is hard to take into consideration objectively. Experienced operators are likely to have a better idea on when to switch to alternative techniques based on tortuosity, clot hardness, and expansion of the stent retriever. This, however, could not be objectively quantified in this work.
Although the literature on switching thrombectomy techniques after a failed first pass remains limited, there are a plethora of studies on the predictors of failure of thrombectomy at the first pass, which has a clear impact on functional outcomes.12 18 19 Among factors correlated with first pass success, clot composition likely plays a significant role; fibrin-rich clots, which are dense and have a higher proportion of platelets and fibrin, are more resistant to retrieval and are associated with lower rates of first-pass success.20 However, detailed histological composition could not be performed before the procedure, thus several studies used imaging markers to predict the clot composition. These markers include hyperdense MCA sign, clot perviousness, susceptibility vessel sign (SVS), among others.11 21 SVS sign is often associated with friable red blood cell rich clots. The most recent is the VECTOR trial, which demonstrated that, in patients with susceptibility vessel imaging, using a combined approach did not provide superiority over aspiration when it pertains to technical outcomes.11 Clot perviousness refers to post-contrast increase in the density of the clot on CT imaging thought to be related to higher red blood cell density and lower fibrin density. In a secondary analysis of the COMPASS trial, higher clot perviousness was associated with better first pass success with aspiration rather than stent retriever thrombectomy.21 On the contrary, fibrin-rich clots are thought to be more resistant to aspiration and favor the use of stent retriever thrombectomy.22 In addition, the location of the thrombus could also influence the efficacy of different thrombectomy techniques in first pass success.23 24 For instance, secondary analysis in the ASTER2 trial suggested that longer segment clots that span the ICA terminus and MCA were most effectively treated with a combined approach.24 Notably, as reviewed by Sgreccia et al,24 studies showing higher technical success (successful recanalization) for a combined technique in ICA terminus and MCA occlusions did not translate to differences in functional outcomes.
Finally, switching EVT techniques can lead to increased costs due to the necessity of additional devices compared with those used in the first pass. This is particularly relevant when changing from an aspiration technique to a stent retriever or combined approach, where the incremental cost of adding a stent retriever is significant. The same applies for conversion from a stent retriever to direct aspiration if a large-bore catheter was not already used. However, the transition from a combined technique to direct aspiration is likely to incur minimal additional costs, as direct aspiration primarily relies on aspiration catheters, which are already part of the combined technique setup. Differentiating these scenarios is crucial for evaluating the cost-effectiveness of technique-switching strategies, emphasizing that while some switches may be financially burdensome, others could be cost-neutral or even cost-saving. Future research should focus on a detailed cost-benefit analysis of different EVT technique transitions, factoring in not only the direct costs of devices but also the potential savings from improved patient outcomes and reduced procedure times.
Limitations
The retrospective nature of this study has inherent selection bias. Radiographic outcomes were not core-lab adjudicated. Years of experience of operators could not be evaluated, which could affect the choice of the same or an alternative technique at the second attempt. In addition, the reason for converting to the EVT technique and the etiology of AIS were not available for all patients. There was no standard protocol for when to switch technique between sites. Although clot volume and vessel tortuosity may be related to EVT outcomes,5 17 these were not investigated.
Conclusions
In patients with AIS and anterior circulation LVO undergoing MT in whom the first thrombectomy attempt was unsuccessful, conversion to an alternative thrombectomy technique at the second attempt was associated with better technical success and functional outcomes without additional procedural risk.
Data availability statement
Data are available upon reasonable request. Not applicable.
Ethics statements
Patient consent for publication
Acknowledgments
We would like to thank all investigators for their efforts in contributing to the Stroke Thrombectomy and Aneurysm Registry (STAR). The data that support the findings of this study are available from the corresponding author on reasonable request. We thank Dr Feras Kobaissy for assistance with graphics.
References
Supplementary materials
Supplementary Data
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Footnotes
X @mahdisowlat, @PascalJabbourMD, @Ansaar_Rai, @Starke_neurosurgery, @AdamArthurMD, @jmascite, @rocrossa, @DrMichaelLevitt, @pnavia, @PeterKa80460001, @rdeleacymd
Contributors HM, SY, AMS, and AMA planned the initial study. The remaining authors commented on study design and contributed data. HM, SSE, and MMS performed data analysis. HM and AMA wrote the first draft of the manuscript, and ar ethe guarantors of the work. All remaining authors edited the manuscript and approved the final version.
Funding The data registry was supported in Penumbra Inc, Stryker and Medtronic. The funding sources did not participate in any part of the study, from study conception to manuscript preparation.
Competing interests Dr Hidetoshi Matsukawa received a lecture fee from Daiichi-Sankyo and Stryker and consulting services fee from B. Braun. Dr Kazutaka Uchida received a lecture fee from Daiichi-Sankyo, Bristol-Myers Squibb, Stryker, and Medtronic. Dr. Charles Matouk: Consultant for Stryker, Medtronic, Microvention, Penumbra, and Silk Road Medical. Speaker for Penumbra and Silk Road Medical. Contact PI for NIH Grant R21NS128641. Dr Sami Al Kasab: grant from Stryker for RESCUE-ICAS registry. Dr Ilko L Maier: speakers honoraria from Pfizer and Bristol-Myers Squibb. Dr Robert M Starke: RMS research is supported by the NREF, Joe Niekro Foundation, Brain Aneurysm Foundation, Bee Foundation, Department of Health Biomedical Research Grant(21K02AWD-007000) and by National Institute of Health(R01NS111119-01A1) and(UL1TR002736, KL2TR002737) through the Miami Clinical and Translational Science Institute, from the National Center for Advancing Translational Sciences and the National Institute on Minority Health and Health Disparities. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. RMS has an unrestricted research grant from Medtronic and Balt and has consulting and teaching agreements with Penumbra, Abbott, Medtronic, Balt, InNeuroCo, Cerenovus, Naglreiter, Tonbridge, Von Medical, and Optimize Vascular. Dr Marios-Nikos Psychogios: Grants from the Swiss National Science Foundation(SNF) for the DISTAL trial(33IC30_198783) and TECNO trial(32003B_204977), Grant from Bangerter-Rhyner Stiftung for the DISTAL trial. Unrestricted Grants for the DISTAL trial from Stryker Neurovascular Inc., Phenox GmbH, Penumbra Inc. and Rapid Medical Inc., Sponsor-PI SPINNERS trial(Funded by a Siemens Healthineers AG Grant), Research agreement with Siemens Healthineers AG, Local PI for the ASSIST, EXCELLENT, TENSION, COATING, SURF and ESCAPE-NEXT trials. Speaker fees: Stryker Neurovascular Inc., Medtronic Inc., Penumbra Inc., Acandis GmbH, Phenox GmbH, Siemens Healthineers AG. Dr Edgar Samaniego: Consultant for Medtronic, Microvention, Cerenovus, and Rapid Medical. Dr Adam S. Arthur: Consultant for Arsenal, Balt, Johnson and Johnson, Medtronic, Microvention, Penumbra, Perfuze, Scientia, Siemens, Stryker. Research support from Balt, Medtronic, Microvention, Penumbra and Siemens, Shareholder Azimuth, Bendit, Cerebrotech, Endostream, Magneto, Mentice, Neurogami, Neuros, Perfuze, Revbio, Scientia, Serenity, Synchron, Tulavi, Vastrax, VizAI. Dr Hugo Cuellar: Dr. Hugo Cuellar: Consultant for Medtronic, Penumbra and Microvention. Dr Daniele G. Romano: Consultant for Penumbra, Balt, Microvention, Phenox. Dr Omar Tanweer: Consulting Agreements: Viz.AI, Inc., Penumbra, Inc, Balt, Inc, Stryker Inc, Imperative Inc. Proctor: Microvention Inc, Medtronic Inc.Educational/Research Grants: Q’apel Inc, Steinberg Foundation. Dr Adam Polifka: Consultant for Depuy Synthes and Stryker. Dr. Min S. Park: Consultant for Medtronic. Dr Michael R Levitt: Unrestricted educational grants from Medtronic and Stryker; consulting agreement with Medtronic, Aeaean Advisers and Metis Innovative; equity interest in Proprio, Cerebrotech, Apertur, Stereotaxis, Fluid Biomed, and Hyperion Surgical; editorial boards of Journal of NeuroInterventional Surgery and Frontiers in Surgery. Dr Richard Williamson: Consultant for Medtronic, Stryker, and Synaptive Medical. Dr. Pedro Navia: Consultant for Penumbra, Medtronic, Stryker, Cerenovus and Balt. Dr Peter Kan: Grants from the NIH(1U18EB029353-01) and unrestricted educational grants from Medtronic and Siemens. Consultant for Imperative Care and Stryker Neurovascular. Stock ownership in Vena Medical. Dr Reade De Leacy: Research grants from Siemens Healthineers and Kaneka medical. Consultant for Cerenovus, Stryker Neurovascular and Scientia Vascular. Minor equity interest Vastrax, Borvo medical, Synchron, Endostream, Von Vascular. Dr Shakeel A Chowdhry: Consultant and proctor for Medtronic and Microvention. Dr Shinichi Yoshimura received a lecture fee from Stryker, Medtronic, Johnson & Johnson, Kaneka Medics. Dr Alejandro Spiotta: Research support from Penumbra, Stryker, Medtronic, RapidAI, Avail. Consultant for Penumbra, Stryker, Terumo, and RapidAI. Equity Avail.
Provenance and peer review Not commissioned; externally peer reviewed.
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