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Research Article
Originally Published 19 February 2019
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Impact of Balloon Guide Catheter Use on Clinical and Angiographic Outcomes in the STRATIS Stroke Thrombectomy Registry

Osama O. Zaidat, MD, MS [email protected], Nils H. Mueller-Kronast, MD, Ameer E. Hassan, DO, Diogo C. Haussen, MD, Ashutosh P. Jadhav, MD, PhD, Michael T. Froehler, MD, PhD, Reza Jahan, MD, … Show All … , Mohammad Ali Aziz-Sultan, MD, Richard P. Klucznik, MD, Jeffrey L. Saver, MD, Frank R. Hellinger Jr, MD, PhD, Dileep R. Yavagal, MD, Tom L. Yao, MD, Rishi Gupta, MD, Coleman O. Martin, MD, Hormozd Bozorgchami, MD, Ritesh Kaushal, MD, Raul G. Nogueira, MD, Ravi H. Gandhi, MD, Eric C. Peterson, MD, Shervin Dashti, MD, PhD, Curtis A. Given II, MD, Brijesh P. Mehta, MD, Vivek Deshmukh, MD, Sidney Starkman, MD, Italo Linfante, MD, Scott H. McPherson, MD, Peter Kvamme, MD, Thomas J. Grobelny, MD, Muhammad Shazam Hussain, MD, Ike Thacker, MD, Nirav Vora, MD, Peng Roc Chen, MD, Stephen J. Monteith, MD, Robert D. Ecker, MD, Clemens M. Schirmer, MD, PhD, Eric Sauvageau, MD, Alex Bou Chebl, MD, Colin P. Derdeyn, MD, Lucian Maidan, MD, Aamir Badruddin, MD, Adnan H. Siddiqui, MD, PhD, Travis M. Dumont, MD, Abdulnasser Alhajeri, MD, Muhammad A. Taqi, MD, Khaled Asi, MD, Jeffrey Carpenter, MD, Alan Boulos, MD, Gaurav Jindal, MD, Ajit S. Puri, MD, Rohan Chitale, MD, Eric M. Deshaies, MD, David Robinson, MD, David F. Kallmes, MD, Blaise W. Baxter, MD, Mouhammed Jumaa, MD, Peter Sunenshine, MD, Aniel Majjhoo, MD, Joey D. English, MD, PhD, Shuichi Suzuki, MD, Richard D. Fessler, MD, Josser Delgado-Almandoz, MD, Jerry C. Martin, MD, and David S. Liebeskind, MD on behalf of the STRATIS InvestigatorsAuthor Info & Affiliations
Stroke
Volume 50, Number 3
https://doi.org/10.1161/STROKEAHA.118.021126
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Abstract

Background and Purpose—

Mechanical thrombectomy has been shown to improve clinical outcomes in patients with acute ischemic stroke. However, the impact of balloon guide catheter (BGC) use is not well established.

Methods—

STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter study of patients with large vessel occlusion treated with the Solitaire stent retriever as first-line therapy. In this study, an independent core laboratory, blinded to the clinical outcomes, reviewed all procedures and angiographic data to classify procedural technique, target clot location, recanalization after each pass, and determine the number of stent retriever passes. The primary clinical end point was functional independence (modified Rankin Scale, 0–2) at 3 months as determined on-site, and the angiographic end point was first-pass effect (FPE) success rate from a single device attempt (modified Thrombolysis in Cerebral Infarction, ≥2c) as determined by a core laboratory. Achieving modified FPE (modified Thrombolysis in Cerebral Infarction, ≥2b) was also assessed. Comparisons of clinical outcomes were made between groups and adjusted for baseline and procedural characteristics. All participating centers received institutional review board approval from their respective institutions.

Results—

Adjunctive technique groups included BGC (n=445), distal access catheter (n=238), and conventional guide catheter (n=62). The BGC group had a higher rate of FPE following first pass (212/443 [48%]) versus conventional guide catheter (16/62 [26%]; P=0.001) and distal access catheter (83/235 [35%]; P=0.002). Similarly, the BGC group had a higher rate of modified FPE (294/443 [66%]) versus conventional guide catheter (26/62 [42%]; P<0.001) and distal access catheter (129/234 [55%]; P=0.003). The BGC group achieved the highest rate of functional independence (253/415 [61%]) versus conventional guide catheter (23/55 [42%]; P=0.007) and distal access catheter (113/218 [52%]; P=0.027). Final revascularization and mortality rates did not differ across the groups.

Conclusions—

BGC use was an independent predictor of FPE, modified FPE, and functional independence, suggesting that its routine use may improve the rates of early revascularization success and good clinical outcomes.

Clinical Trial Registration—

URL: https://www.clinicaltrials.gov. Unique identifier: NCT02239640.

Introduction

The number of positive clinical trials demonstrating the efficacy of a therapeutic intervention for acute ischemic stroke secondary to large vessel occlusion exceeds that of any other disease in recent medical history. Results from several randomized clinical trials have demonstrated greater clinical efficacy from mechanical thrombectomy (MT), leading to adoption of MT as standard of care.1–7 Despite major strides in reducing disability from large vessel occlusion strokes with stent retrievers, 30% to 65% of patients remain physically disabled.1–6 Even fewer patients have managed to return to normal neurological and physical functions.1–6
In addition to the selection of patients with viable tissue, the main determinant of achieving good clinical outcomes is complete vessel recanalization and rapid tissue reperfusion.8–10 The rate of successful recanalization from the first pass to complete tissue reperfusion is associated with improved functional neurological recovery.9 However, despite significant technological advances, the rate of the first-pass effect (FPE) is estimated at 25% to 50%.9 Different adjunctive techniques during stent retriever thrombectomy have been implemented to further augment complete revascularization rates, such as proximal flow arrest using a balloon guide catheter (BGC), proximal large-bore conventional guide catheter (CGC), or distal access catheter (DAC) with lesion or regional aspiration.11–14
Here, we evaluate the influence of guide catheter selection in the largest Solitaire (Medtronic, Irvine, CA) stent retriever, prospective, multicenter registry,15 with independent imaging and technical core laboratories blinded to the clinical outcomes.

Methods

Study Design and Inclusion Criteria

Key Inclusion Criteria

The STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) registry was a prospective, multicenter, nonrandomized, observational registry evaluating the use of Solitaire revascularization devices (Solitaire; Medtronic, Irvine, CA) and MindFrame Capture Low Profile revascularization devices (MindFrame; Medtronic, Irvine, CA) in patients experiencing an acute ischemic stroke because of large vessel occlusion in 1000 patients at 55 US centers between August 2014 and June 2016. All participating centers received institutional review board approval from their respective institutions.
The primary STRATIS registry methods and results have been published previously.15 Briefly, the key inclusion criteria were (1) confirmed symptomatic large vessel occlusion, (2) use of Medtronic market-released neurothrombectomy device as the initial device for thrombus removal, (3) stroke onset-to-puncture within 8 hours, (4) premorbid modified Rankin Scale (mRS) score ≤1, and (5) pretreatment National Institutes of Health Stroke Scale score of 8 to 30. STRATIS is registered with https://www.clinicaltrials.gov as NCT02239640.
In this prespecified subgroup analysis, subjects were excluded for (1) missing technique core laboratory assessment (n=7), (2) posterior circulation occlusions, as BGC are less likely to be used in these cases (n=45), (3) proximal carotid lesion that was intervened on with balloon angioplasty, stenting, or both (n=123), (4) intracranial atherosclerotic lesions that were intervened on with balloon angioplasty, stenting, or both (n=26), and (5) use of combined DAC+BGC approaches as the adjunctive technique on the initial attempt (n=37). Patient consent was obtained no later than 7 days after hospital discharge.
All imaging and angiographic data were interpreted by the independent STRATIS imaging and angiography core laboratory for modified Thrombolysis in Cerebral Infarction (mTICI) and the Alberta Stroke Program Early CT Score (ASPECTS).16 The SWIFT PRIME trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke) definitions for puncture, symptomatic intracranial hemorrhage, and vessel segments were applied.6

Technique Core Laboratory

An independent technique core laboratory (O.O.Z.), blinded to the clinical outcomes, reviewed all procedural reports and angiographic imaging data to classify procedural technique, abstract the site-adjudicated target clot location and recanalization after each pass, and determine the number of stent retriever passes.
The adjunctive efficiency techniques were classified into 3 main adjunctive techniques (Figure 1A): (1) BGC only, (2) proximal large-bore CGC/long sheath, and (3) intermediate DAC as adjacent as possible to the clot face.
Figure 1. Adjunctive techniques in the STRATIS Registry. A, Illustration of middle cerebral artery clot treated with Solitaire stent retriever. The different adjunctive techniques are shown. B, Study flowchart. Some subjects met multiple exclusion criteria, and hence individual category N do not sum to total of exclusions. BGC indicates balloon guide catheter; CGC, conventional guide catheter; DAC, distal access catheter; and STRATIS, Systematic Evaluation of Patients Treated with Neurothrombectomy Devices for Acute Ischemic Stroke.

Outcome Measures

Clinical Outcomes

The primary clinical efficacy outcome was the rate of functional independence at 90 days post-procedure, as defined by mRS score 0 to 2. Safety evaluations included incidence of neurological deterioration events (defined as worsening of the National Institutes of Health Stroke Scale by 4 points), symptomatic intracranial hemorrhage, procedure- or device-related serious adverse events, and all-cause mortality ≤90 days post-procedure.

Angiographic and Procedural Outcomes

The primary angiographic outcome was the rate of FPE following the initial adjunctive technique approach. FPE was defined as achieving near-complete revascularization (mTICI≥2c) after single-device and adjunctive technique approach. Achieving mTICI ≥2b after single-device/adjunctive technique approach or modified FPE was also assessed between groups and between lesion locations.
Secondary outcome measures (blinded core laboratory–adjudicated angiographic measures) included rate of distal embolization, embolization into new territory, and final mTICI rate. Puncture-to-reperfusion, defined as time from puncture to achieving mTICI ≥2b or procedure completion, was also compared between the groups.

Statistical Analysis

Continuous variables are presented as mean, SD, and median with interquartile range, whereas categorical variables are presented with frequency distributions. Tests involving 2 independent subgroups are presented using t tests or Wilcoxon rank-sum test for continuous variables and Pearson χ2 or Fisher exact test for categorical variables. Simultaneous comparisons of >2 subgroups used ANOVA for continuous variables and Pearson χ2 test for categorical variables. Comparisons of clinical outcomes were made between subgroups (based on occlusion site) and adjusted for baseline and procedural characteristics (See Tables I and II in the online-only Data Supplement). For analyses involving adjustment for baseline covariates, logistic regression was used for binary and ordinal outcomes, with contrasts between subgroups presented when pairwise comparisons among >2 subgroups were made. Results of logistic regressions are presented using odds ratios with 2-sided 95% CIs.
All statistical tests were 2 sided, with P <0.05 considered statistically significant. Statistical analyses were conducted using SAS, version 9.3 (SAS Institute, Cary, NC), and R, version 3.2 (R Foundation for Statistical Computing, Vienna, Austria).
All supporting data from this study are available within the article and its corresponding online-only Data Supplement.

Results

Adjunctive Technique Analysis Results

Baseline Features and Demographics in Different Adjunctive Techniques

A total of 745 patients met the inclusion criteria for this analysis (Figure 1B). BGC as an adjunctive technique to stent retrieval was used in 445 (60%) patients, DAC was used in 238 (32%) patients, and CGC was used in 62 (8%) patients. Baseline characteristics were mostly similar between the groups (Table 1). The DAC group had lower baseline ASPECTS compared with the BGC group (P=0.023), and general anesthesia use was lower compared with both the BGC (P=0.001) and the CGC groups (P=0.028). There were also more frequent internal carotid artery occlusions noted in the DAC group compared with the BGC group (P=0.018), although the onset-to-puncture time was shorter in the DAC group compared with the BGC (P=0.061) or CGC group (P=0.033).
Table 1. Demographic and Baseline Variables—Differences Between Various Adjunctive Techniques
CharacteristicBGC Only (n=445)CGC Only (n=62)DAC Only (n=238)P Value
BGC vs CGCBGC vs DACCGC vs DAC
Age, y68.5±15.5 (445); 71.0 [60–81]70.1±15.4 (62); 70.5 [63–82]69.5±14.4 (238); 71.5 [61–79]0.3910.7070.599
Sex: male222/445 (49.9%)30/62 (48.4%)119/238 (50.0%)0.8240.9770.820
Medical history
 Atrial flutter/fibrillation206/445 (46.3%)26/62 (41.9%)97/238 (40.8%)0.5190.1630.865
 Systemic hypertension324/445 (72.8%)49/62 (79.0%)181/238 (76.1%)0.2980.3580.620
 Diabetes mellitus110/445 (24.7%)12/62 (19.4%)76/238 (31.9%)0.3550.0440.053
 Coronary artery disease126/445 (28.3%)14/62 (22.6%)73/238 (30.7%)0.3440.5180.211
 Hyperlipidemia189/445 (42.5%)26/62 (41.9%)111/238 (46.6%)0.9360.2960.508
 Peripheral artery disease14/445 (3.1%)2/62 (3.2%)13/238 (5.5%)0.9730.1390.472
 Current/prior tobacco use225/445 (50.6%)25/62 (40.3%)100/238 (42.0%)0.1310.0330.811
Clinical characteristics
 Prestroke mRS score   0.1230.1230.514
  0319/445 (71.7%)48/62 (77.4%)186/238 (78.2%)   
  1113/445 (25.4%)10/62 (16.1%)44/238 (18.5%)
 Initial qualifying NIHSS17.2±5.4 (445); 17.0 [13–21]17.4±5.6 (62); 17.5 [14–22]17.6±5.5 (238); 18.0 [13–22]0.7900.4170.862
 Baseline ASPECTS8.3±1.6 (366); 9.0 [(8–9) to (0–10)]8.4±1.4 (52); 9.0 [(8–9) to (4–10)]8.2±1.4 (184); 8.0 [(8–9) to (3–10)]0.9940.0230.174
 IV-tPA delivered284/445 (63.8%)43/62 (69.4%)148/238 (62.2%)0.4180.6190.296
 IA-tPA delivered30/445 (6.7%)8/62 (12.9%)17/238 (7.1%)0.0840.8440.144
 General anesthesia used92/445 (20.7%)11/62 (17.7%)76/238 (31.9%)0.5910.0010.028
 Vessel treated on first pass   0.6760.0180.332
  ICA83/445 (18.7%)14/62 (22.6%)69/238 (29.0%)   
  MCA-M1271/445 (60.9%)33/62 (53.2%)129/238 (54.2%)
  MCA-M2/M391/445 (20.4%)15/62 (24.2%)40/238 (16.8%)
 Stroke onset to puncture, min225.5±101.2 (440); 205.0 [145.5–291]240.0±96.7 (61); 224.0 [163–301]210.3±95.4 (238); 183.5 [140–276]0.2240.0610.033
Data are n/N (%) or mean±SD (N); median [IQR]. ASPECTS indicates Alberta Stroke Program Early CT Score; BGC, balloon guide catheter; CGC, conventional guide catheter; DAC, distal access catheter; ICA, internal carotid artery; IQR, interquartile range; IV, intravenous; MCA, middle cerebral artery; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; and tPA, tissue-type plasminogen activator.

Angiographic and Clinical Outcomes

The BGC group had a higher rate of FPE (mTICI≥2c) after the first device pass (212/443 [48%]) than the CGC group (16/62 [26%]; P=0.001) and the DAC group (83/235 [35%]; P=0.002) as shown in Table 2 and Figure 2A. Similarly, the BGC group had a higher rate of modified FPE (mTICI≥2b) after the first device pass (294/443 [66%]) than the CGC group (26/62 [42%]; P<0.001) and the DAC group (129/234 [55%]; P=0.003). Final revascularization was not significantly different among the 3 groups.
Table 2. Clinical and Angiographic Outcome Differences Between Various Adjunctive Techniques
OutcomeBGC Only (N=445)CGC Only (N=62)DAC Only (N=238)P Value
BGC vs CGCBGC vs DACCGC vs DAC
Clinical outcomes
 mRS score 0–1 at 90 d190/415 (45.8%)17/55 (30.9%)94/218 (43.1%)0.0430.5560.124
 mRS score 0–2 at 90 d253/415 (61.0%)23/55 (41.8%)113/218 (51.8%)0.0070.0270.184
Safety outcomes
 All-cause mortality at 90 d69/415 (16.6%)11/55 (20.0%)32/218 (14.7%)0.6510.4700.390
 Symptomatic ICH6/415 (1.4%)03/218 (1.4%)0.3570.9910.991
Angiographic outcomes
 Primary outcome      
  FPE (mTICI ≥2c after first pass)212/443 (47.9%)16/62 (25.8%)83/235 (35.3%)0.0010.0020.158
  mFPE (mTICI ≥2b after first pass)294/443 (66.4%)26/62 (41.9%)129/235 (54.9%)<0.0010.0030.069
Final mTICI*   0.5070.5200.765
 356/373 (15.0%)4/55 (7.3%)21/190 (11.1%)   
 2b276/373 (74.0%)45/55 (81.8%)153/190 (80.5%)
 2a28/373 (7.5%)4/55 (7.3%)12/190 (6.3%)
 14/373 (1.1%)01/190 (0.5%)
 09/373 (2.4%)2/55 (3.6%)3/190 (1.6%)
Final mFPE*332/373 (89.0%)49/55 (89.1%)174/190 (91.6%)0.9850.3390.570
No. of device passes1.7±1.1 (445); 1.0 [1–2]2.2±1.7 (62); 2.0 [1–3]2.0±1.4 (238); 2.0 [1–3]0.0060.0040.367
Rescue device used8.1% (36/445)17.7% (11/62)15.1% (36/238)0.0140.0040.614
>3 Solitaire passes4.7% (21/445)3.2% (2/62)4.2% (10/238)0.5970.7570.727
Vessel cutoff in downstream territory*191/373 (51.2%)37/55 (67.3%)110/190 (57.9%)0.0260.1330.211
Emboli to new territory*4/373 (1.1%)1/55 (1.8%)1/190 (0.5%)0.6310.5140.348
Puncture to revascularization, min42.4±25.66 (427); 34.0 [25–55]57.5±33.79 (57); 46.0 [32–86]39.1±25.84 (232); 33.0 [22–50.5]0.0010.041<0.001
Data are n/N (%) or mean±SD (N); median [IQR]. BGC indicates balloon guide catheter; CGC, conventional guide catheter; DAC, distal access catheter; FPE, first-pass effect; IA, intra-arterial; ICH, intracranial hemorrhage; IQR, interquartile range; mFPE, modified first-pass effect; mRS, modified Rankin Scale; and mTICI, modified Thrombolysis in Cerebral Infarction.
*
Assessed by image core laboratory.
Figure 2. Angiographic and clinical outcomes by adjunctive technique in the STRATIS Registry. A, Rate of first-pass effect based on adjunctive technique approach defined as near-complete recanalization after first pass, modified Thrombolysis in Cerebral Infarction (mTICI) ≥2c, or mTICI ≥2b. B, Distribution of modified Rankin Scale scores at 90 d according to adjunctive technique. BGC indicates balloon guide catheter; CGC, conventional guide catheter; DAC, distal access catheter.
When comparing 90-day clinical outcomes, the BGC group achieved a higher rate of functional independence, as measured by mRS 0 to 2 (253/415 [61%]) versus the CGC group (23/55 [42%]; P=0.007) and the DAC group (113/218 [52%]; P=0.027), as shown in Table 2 and Figure 2B. However, the near-complete neurological outcome (mRS, 0–1) at 90 days was only significant when compared with CGC but not to DAC (Table 2). All-cause mortality at 90 days did not differ between the groups (69/415 [17%] for BGC, 11/55 [20%] for CGC, and 32/218 [15%] for DAC; Table 2). BGC use remained an independent predictor of achieving good clinical outcome at 90 days (P=0.031) after adjusting for age, initial qualifying National Institutes of Health Stroke Scale, ASPECTS, occlusion location, use of intravenous tPA (tissue-type plasminogen activator), use of IA-tPA, sex, use of general anesthesia, and onset-to-puncture time using logistic regression analysis (Table I in the online-only Data Supplement). As a check on the multivariable logistic regression modeling used to assess the adjusted effect of BGC on clinical outcomes, propensity scoring was also used to adjust for baseline characteristics. Including the same terms used in the multivariable model to construct the propensity scores and stratifying the analysis accordingly, the odds ratio for the effect of BGC on mRS 0 to 2 was 1.78 (95% CI, 1.12–2.84; P=0.015)—a similar result to the multivariable logistic regression analysis.
However, the BGC was not an independent predictor of achieving near-normal neurological function (mRS, 0–1) at 90 days (Table II in the online-only Data Supplement). Predictors of FPE are presented in Table III in the online-only Data Supplement.

Discussion

Our study evaluated the effects of different adjunctive techniques (BGC, CGC, or DAC) on clinical and angiographic outcomes of MT in the large, prospective, multicenter STRATIS registry with the use of independent, blinded imaging, and technical core laboratories. This is the largest prospective study with core lab–adjudicated technique and independent of clinical outcome. We found that BGC significantly improved rates of functional independence and early revascularization, even after adjusting for baseline and procedural characteristics. These results highlight the benefits of BGC as an adjunctive technique during MT.
Our results affirm prior findings on the impact of BGC in several large retrospective studies and smaller cohort studies. In the North American SOLITAIRE Stent Retriever Acute Stroke registry, patients treated with the Solitaire stent retriever demonstrated improved rates of good clinical outcome and revascularization success with BGC compared with non-BGC patients.12 In the SWIFT PRIME trial of anterior circulation occlusion, patients treated with intravenous tPA alone were compared with those treated with intravenous tPA and the Solitaire stent retriever.17 In 87 patients treated with MT, the BGC subgroup demonstrated smaller final infarct volumes and improved revascularization. In another recent study of 102 BGC patients, angiographic and clinical outcomes were significantly better than 81 non-BGC patients regardless of clot location.18 Multiple in vitro studies have demonstrated reduced clot fragmentation and distal embolization with BGC,19,20 and an in vitro model showed that BGCs are less likely than CGCs to lead to elastic clot fragmentation.20 Therefore, one explanation for improved outcomes in BGC patients is higher achievement of successful recanalization and lower prevalence of distal embolization and embolization into new territory.
BGCs have larger catheters (7–9F) in relation to CGCs or DACs, which may make some neurointerventionalists reluctant to use BGCs. Vascular complications at the entry site have been reported when using larger catheters, including groin or retroperitoneal hematoma and femoral artery bleeding.21 However, the risk of groin complications does not outweigh the benefits of improved recanalization rates and clinical outcomes for BGC-treated patients.12 There are also technical complications when using a BGC in difficult arches and in patients with low tolerance to temporary flow arrest.17,22 A 2017 meta-analysis noted that patients treated with BGCs tended to be younger than those treated without a BGC, suggesting a bias toward treating patients with more tortuous arches without a BGC.22 As such, further studies investigating complication rates in older patients treated with BGCs are warranted.

Unique Observations

Our study had several unique qualities and observations, including shorter procedure time associated with the DAC approach. This is consistent with findings from registries of the direct-aspiration-only approach with no stent retriever.23 The ASTER trial (The Contact Aspiration vs Stent Retriever for Successful Revascularization Study)—a recent randomized trial between BGC and DAC (with no stent retriever)—documented similar rates of reperfusion but with a trend toward higher Thrombolysis in Cerebral Infarction 3 and better clinical outcomes in BGC-treated patients.24 Second, rates of functional independence in our study were significantly higher with the BGC approach, both in univariate analyses and after adjusting for age, initial qualifying National Institutes of Health Stroke Scale, ASPECTS, occlusion location (to adjust for any bias with internal carotid artery terminus occlusion), intravenous tPA use, IA-tPA use, sex, general anesthesia use, and time from onset to puncture. Third, over one-third of patients underwent DAC. In the North American SOLITAIRE Stent Retriever Acute Stroke registry, <10% of stent retriever cases were treated with DAC as an initial approach.11,25 This increase in DAC as a treatment method may be explained by recent advances in intermediate DAC technology, which has lead to improved flexibility and trackability, resulting in possible shorter procedure times and increased efficacy.

Limitations

These are observational findings from a prospective study with a prespecified study design. The registry design has limitations in that cases were not randomly allocated to each technique, creating the potential for bias. Furthermore, we did not collect data on failure to place the BGC or DAC in the intended location. Operator and center effects may present additional limitations because an imbalance may exist in the degree of experience with procedures and the preferential use of BGC between centers or operators, as suggestive of the low number of patients in the non-BGC groups. It is possible that in cases of tortuous anatomies, operators chose not to use BGCs, in which case the other groups may have included more challenging cases.
There were imbalances in baseline variables in the DAC group compared with the BGC group, such as lower ASPECTS scores, higher proportion of general anesthesia, and higher incidence of carotid occlusion. Stroke onset-to-puncture time was shorter in the DAC group compared with the CGC group. Although the results are adjusted for these potential selection biases, it is possible that differential baseline characteristics influenced the results.
In addition, adjunctive technique analysis is limited by its relation to site-reported clinical outcome, although the central technique laboratory was blinded to the clinical outcome. FPE was chosen as the primary revascularization outcome, given interventionalists’ tendencies to switch stent retriever or adjunctive device after 1 or 2 passes; on the contrary, the grading was not blinded to the technique, which may have created bias.
Another limitation is the lack of standardization of the DAC technique, which may be related to the current technology and ability to consistently track these devices to the clot face. Furthermore, the final revascularization score was graded by the core imaging laboratory, but the first-pass results were graded by the technique core laboratory. Future studies should establish a mechanism to blind the core laboratory to the technique and provide core laboratories with clear labeling of angiography images after each device pass or attempt.
Finally, technical advances are constantly occurring, and smaller numbers of patients are treated with CGC only as evidenced in this analysis. Newer and enhanced intermediate catheters have been introduced since the STRATIS study; hence, outcomes may change accordingly.

Conclusions

In the STRATIS registry, the use of a BGC as an adjunctive efficiency technique improved the rate of early revascularization, as measured with FPE (mTICI≥2c) and modified FPE (mTICI≥2b) after single device pass and achieved high rate of 90-day functional independence.

Acknowledgments

We acknowledge Medtronic for editing assistance.

Supplemental Material

File (str_stroke-2018-021126_supp1.pdf)

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Published In

Go to Stroke
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Stroke
Volume 50 • Number 3 • March 2019
Pages: 697 - 704
PubMed: 30776994

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© 2019 American Heart Association, Inc.

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History

Received: 24 July 2018
Revision received: 7 December 2018
Accepted: 9 January 2019
Published online: 19 February 2019
Published in print: March 2019

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Keywords

  1. animals
  2. brain ischemia
  3. humans
  4. stroke
  5. thrombectomy

Subjects

  1. Cerebrovascular Procedures
  2. Embolism
  3. Ischemic Stroke
  4. Quality and Outcomes

Authors

Affiliations

Osama O. Zaidat, MD, MS [email protected]
From the Mercy Health St. Vincent Mercy Hospital, Toledo, OH (O.O.Z.)
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Nils H. Mueller-Kronast, MD
Advanced Neuroscience Network/Tenet South Florida, Coral Springs (N.H.M.-K., R.K.)
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Ameer E. Hassan, DO
Valley Baptist Medical Center, Harlingen, TX (A.E.H.)
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Diogo C. Haussen, MD
Emory University School of Medicine, Atlanta, GA (D.C.H.)
Grady Memorial Hospital, Atlanta, GA (D.C.H., R.G.N.)
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Ashutosh P. Jadhav, MD, PhD
University of Pittsburgh Medical Center, PA (A.P.J.)
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Michael T. Froehler, MD, PhD
Vanderbilt University Medical Center, Nashville, TN (M.T.F., R.C.)
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Reza Jahan, MD
University of California, Los Angeles, CA (R.J., J.L.S., S.S., D.S.L.)
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Mohammad Ali Aziz-Sultan, MD
Brigham and Women’s Hospital, Boston, MA (M.A.A-S.)
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Richard P. Klucznik, MD
Methodist Hospital, Houston, TX (R.P.K.)
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Jeffrey L. Saver, MD
University of California, Los Angeles, CA (R.J., J.L.S., S.S., D.S.L.)
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Frank R. Hellinger Jr, MD, PhD
Florida Hospital Neuroscience Institute, Winter Park (F.R.H., R.H.G.)
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Dileep R. Yavagal, MD
University of Miami Miller School of Medicine/Jackson Memorial Hospital, FL (D.R.Y., E.C.P.)
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Tom L. Yao, MD
Norton Neuroscience Institute, Norton Healthcare, Louisville, KY (T.L.Y., S.D.)
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Rishi Gupta, MD
WellStar Neurosciences Network, WellStar Kennestone Regional Medical Center, Marietta, GA (R.G.)
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Coleman O. Martin, MD
St. Luke’s Hospital of Kansas City, MO (C.O.M.)
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Hormozd Bozorgchami, MD
Oregon Health and Science University Hospital, Portland (H.B.)
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Ritesh Kaushal, MD
Advanced Neuroscience Network/Tenet South Florida, Coral Springs (N.H.M.-K., R.K.)
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Raul G. Nogueira, MD
Grady Memorial Hospital, Atlanta, GA (D.C.H., R.G.N.)
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Ravi H. Gandhi, MD
Florida Hospital Neuroscience Institute, Winter Park (F.R.H., R.H.G.)
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Eric C. Peterson, MD
University of Miami Miller School of Medicine/Jackson Memorial Hospital, FL (D.R.Y., E.C.P.)
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Shervin Dashti, MD, PhD
Norton Neuroscience Institute, Norton Healthcare, Louisville, KY (T.L.Y., S.D.)
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Curtis A. Given II, MD
Baptist Health Lexington/Central Baptist, KY (C.A.G.)
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Brijesh P. Mehta, MD
South Broward Hospital, Hollywood, FL (B.P.M.)
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Vivek Deshmukh, MD
Providence St. Vincent Medical Center, Portland, OR (V.D.)
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Sidney Starkman, MD
University of California, Los Angeles, CA (R.J., J.L.S., S.S., D.S.L.)
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Italo Linfante, MD
Baptist Hospital of Miami, FL (I.L.)
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Scott H. McPherson, MD
St. Dominic’s–Jackson Memorial Hospital, MS (S.H.M.)
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Peter Kvamme, MD
University of Tennessee Medical Center, Knoxville (P.K.)
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Thomas J. Grobelny, MD
Advocate Christ Medical Center, Oak Lawn, IL (T.J.G.)
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Muhammad Shazam Hussain, MD
Cleveland Clinic, OH (M.S.H.)
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Ike Thacker, MD
Baylor University Medical Center, Dallas, TX (I.T.)
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Nirav Vora, MD
OhioHealth Riverside Methodist Hospital, Columbus (N.V.)
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Peng Roc Chen, MD
Memorial Hermann Texas Medical Center, Houston (P.R.C.)
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Stephen J. Monteith, MD
Swedish Medical Center First Hill Campus, Seattle, WA (S.J.M.)
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Robert D. Ecker, MD
Maine Medical Center, Portland, ME (R.D.E.)
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Clemens M. Schirmer, MD, PhD
Geisinger Clinic, Danville, PA (C.M.S.)
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Eric Sauvageau, MD
Baptist Medical Center Jacksonville, FL (E.S.)
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Alex Bou Chebl, MD
Baptist Hospital Louisville, KY (A.B.C.)
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Colin P. Derdeyn, MD
Barnes Jewish Hospital, St. Louis, MO (C.P.D.)
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Lucian Maidan, MD
Mercy San Juan Medical Center and Mercy General, Carmichael, CA (L.M.)
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Aamir Badruddin, MD
Presence St. Joseph Medical Center, Joliet, IL (A.B.)
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Adnan H. Siddiqui, MD, PhD
Buffalo General Medical Center, NY (A.H.S.)
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Travis M. Dumont, MD
University of Arizona Medical Center, Tucson (T.M.D.)
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Abdulnasser Alhajeri, MD
University of Kentucky Hospital, Lexington (A.A.)
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Muhammad A. Taqi, MD
Los Robles Medical Center, Thousand Oaks, CA (M.A.T.)
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Khaled Asi, MD
Aurora Hospital, Milwaukee, WI (K.A.)
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Jeffrey Carpenter, MD
West Virginia University/Ruby Memorial Hospital, Morgantown (J.C.)
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Alan Boulos, MD
Albany Medical Center, NY (A.B.)
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Gaurav Jindal, MD
University of Maryland Medical Center, Baltimore (G.J.)
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Ajit S. Puri, MD
University of Massachusetts Memorial Medical Center, Worcester (A.S.P.)
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Rohan Chitale, MD
Vanderbilt University Medical Center, Nashville, TN (M.T.F., R.C.)
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Eric M. Deshaies, MD
Crouse Hospital, Syracuse, NY (E.M.D.)
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David Robinson, MD
Virginia Mason Medical Center, Seattle, WA (D.R.)
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David F. Kallmes, MD
Mayo Clinic, Rochester, MN (D.F.K.)
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Blaise W. Baxter, MD
Erlanger Medical Center, Chattanooga, TN (B.W.B.)
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Mouhammed Jumaa, MD
ProMedica Toledo Hospital, OH (M.J.)
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Peter Sunenshine, MD
Banner University Medical Center, Phoenix, AZ (P.S.)
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Aniel Majjhoo, MD
McLaren Flint, MI (A.M.)
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Joey D. English, MD, PhD
California Pacific Medical Center, San Francisco (J.D.E.)
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Shuichi Suzuki, MD
University of California, Irvine (S.S.)
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Richard D. Fessler, MD
St. John Providence Hospital, Detroit, MI (R.D.F.)
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Josser Delgado-Almandoz, MD
Abbott Northwestern Hospital, Minneapolis, MN (J.D-A.)
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Jerry C. Martin, MD
and Carolinas Medical Center, Charlotte, NC (J.C.M.).
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David S. Liebeskind, MD
University of California, Los Angeles, CA (R.J., J.L.S., S.S., D.S.L.)
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on behalf of the STRATIS Investigators
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Notes

Guest Editor for this article was Ajay K. Wakhloo, MD, PhD.
The online-only Data Supplement is available with this article at Supplemental Material.
Correspondence to Osama O. Zaidat, MD, MS, Mercy Health St. Vincent Mercy Hospital, 2222 Cherry St, M200, Toledo, OH 43608. Email [email protected]

Disclosures

Dr Zaidat reports research grant support from Stryker, Genentech, and Medtronic Neurovascular (modest); honoraria from Codman, Stryker, Penumbra, and Medtronic Neurovascular (modest); is an expert witness (modest); ownership interest in Galaxy Therapeutics, LLC (modest); and is a consultant/advisory board member at the National Institutes of Health (NIH) StrokeNet, Penumbra, Medtronic Neurovascular, Codman, and Stryker (modest). Dr Mueller-Kronast is a modest consultant for Medtronic Neurovascular. A.E. Hassan is a consultant and speaker for GE Healthcare, Medtronic, Stryker, MicroVention, Penumbra, and Genentech. Dr Froehler serves as a consultant for Balt USA, Medtronic, Stryker, NeurVana, Control Medical, and Vizai and has received research funding from Medtronic, Stryker, MicroVention, EndoPhys, and Penumbra. Dr Jahan serves as a consultant for Medtronic Neurovascular and Medina Medical. Dr Ali Aziz-Sultan is a proctor for Covidien and participates in training other physicians in the use of the embolic agent Onyx and the Pipeline embolization device. Dr Klucznik serves as a proctor and speaker for Medtronic. Dr Saver is an employee of the University of California, which has patent rights in retrieval devices for stroke; has received contracted payments for services as a scientific consultant advising on rigorous trial design and conduct to Medtronic/Covidien, Stryker, Neuravi/Cerenovus, and Boehringer Ingelheim (prevention only); and has received contracted stock options for services as a scientific consultant advising on rigorous trial design and conduct to Rapid Medical. Dr Hellinger is on the Speakers’ Bureau for Medtronic and serves as a consultant to Penumbra and Cordis Neurovascular (Johnson and Johnson). Dr Yavagal receives modest honoraria from Medtronic, serves as an expert witness for Goldberg Segalla (modest), serves as a PI for the STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) Registry (Medtronic), and received modest consulting fees from Medtronic, Neural Analytics, Rapid Medical, Cerenovus, and Johnson & Johnson, and is a consultant for Neuroanalystics (no compensation). Dr Yao serves as a consultant/proctor to Medtronic. Dr Gupta serves as a speaker for Genentech (modest); as a consultant to Medtronic (modest), Cerenovous (modest), and Stryker Neurovascular (significant); and as a consultant for Rapid Medical. Dr Bozorgchami is a modest consultant for Cerenovus, Stryker, and Neuravi. Dr Nogueira serves as a consultant to Genentech (modest), Medtronic (modest), Stryker Neurovascular (modest), Penumbra (no compensation), Neuravi/Cerenovus (modest), and Phenox (modest), Biogen (modest), and Anaconda (modest). Dr Given is on the Speakers’ Bureau and receives honoraria from Medtronic and Stryker. Dr Starkman is a site investigator in multicenter trials supported by Stryker and Covidien. Dr Linfante serves as a consultant and is on the Speakers’ Bureau for Medtronic Neurovascular, Codman, and Stryker. Dr Hussain is on the Clinical Events Committee for Pulsar. Dr Thacker serves as a consultant/proctor to Medtronic. Dr Schirmer has received honoraria from the American Association of Neurological Surgeons and Toshiba and has ownership interest in NTI and receives research support from NIH/NINDS. Dr Chebl has received honoraria from Medtronic. Dr Derdeyn reports ownership interest in Pulse Therapeutic, Honoraria from Bayer and W. L. Gore and Associates, and research grants (all clinical trial DSMBs) from Penumbra and Rapid Medical. Dr Siddiqui serves as a consultant to Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Cerenovus, Claret Medical, Corindus, Inc, Endostream Medical, Guidepoint Global Consulting, Imperative Care, Integra, Medtronic, MicroVention, Northwest University, Penumbra, Rapid Medical, Rebound Therapeutics Corp, Serenity Medical, Inc, Silk Road Medical, StimMed, Stryker, Three Rivers Medical, VasSol, and W. L. Gore and Associates and has ownership interest in Amnis Therapeutics, Apama Medical, BlinkTBI, Cardinal Health, Cerebrotech Medical Systems, Claret Medical, Cognition Medical, Endostream Medical, Ltd, Imperative Care, Rebound Therapeutics Corp, Rist Therapeutics Corp, Serenity Medical, Inc, Silk Road Medical, StimMed, Synchron, Three Rivers Medical, and Viseon Spine and receives modest compensation from MUSC. Dr Taqi serves as a consultant to Stryker Neurovascular. Dr Puri has been a consultant on a fee-per-hour basis and has received research grants from Medtronic Neurovascular and Stryker Neurovascular. Dr Chitale has received research funding from MicroVention and Medtronic. Dr Deshaies is a consultant for ev3/Medtronic Neurovascular, MicroVention, and Integra. Dr Kallmes is founder of Marblehead Medical, LLC, is an advisor to Boston Scientific, and receives research support Stryker and Neuravi. Dr Baxter is on the Speakers’ Bureau, has received honoraria, has ownership interest, and serves as a consultant to Penumbra and is a consultant for Stryker, Medtronic, Route 92, and Vizai. Dr Sunenshine serves as a consultant/proctor to Medtronic. Dr English has received honoraria from Medtronic, Stryker Neurovascular, and Penumbra. Dr Delgado-Almandoz is a significant consultant for Medtronic Neurovascular and Penumbra. Dr Liebeskind has received an NIH grant and serves as a consultant to Stryker and Medtronic. The other authors report no conflicts.

Sources of Funding

This study was sponsored by Medtronic.

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Impact of Balloon Guide Catheter Use on Clinical and Angiographic Outcomes in the STRATIS Stroke Thrombectomy Registry
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