Revascularization Outcome Prediction for A Direct Aspiration-First Pass Technique (ADAPT) from Pre-Treatment Imaging and Machine Learning

A direct aspiration-first pass technique (ADAPT) has recently gained popularity for the treatment of large vessel ischemic stroke. Here, we sought to create a machine learning-based model that uses pre-treatment imaging metrics to predict successful outcomes for ADAPT in middle cerebral artery (MCA) stroke cases. In 119 MCA strokes treated by ADAPT, we calculated four imaging parameters—clot length, perviousness, distance from the internal carotid artery (ICA) and angle of interaction (AOI) between clot/catheter. We determined treatment success by first pass effect (FPE), and performed univariate analyses. We further built and validated multivariate machine learning models in a random train-test split (75%:25%) of our data. To test model stability, we repeated the machine learning procedure over 100 randomizations, and reported the average performances. Our results show that perviousness (p = 0.002) and AOI (p = 0.031) were significantly higher and clot length (p = 0.007) was significantly lower in ADAPT cases with FPE. A logistic regression model achieved the highest accuracy (74.2%) in the testing cohort, with an AUC = 0.769. The models had similar performance over the 100 train-test randomizations (average testing AUC = 0.768 ± 0.026). This study provides feasibility of multivariate imaging-based predictors for stroke treatment outcome. Such models may help operators select the most adequate thrombectomy approach.

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Clot imaging characteristics predict first pass effect of aspiration—first approach to thrombectomy

Interventional Neuroradiology ◽

10.1177/15910199211019174 ◽

2021 ◽

pp. 159101992110191

Author(s):

Muhammad Waqas ◽

Weizhe Li ◽

Tatsat R Patel ◽

Felix Chin ◽

Vincent M Tutino ◽

...

Keyword(s):

Internal Carotid ◽

Validation Cohort ◽

Area Under The Curve ◽

Large Vessel Occlusion ◽

Vessel Occlusion ◽

First Pass Effect ◽

Imaging Characteristics ◽

First Pass ◽

Sensitivity Specificity ◽

Youden’S Index

Background The value of clot imaging in patients with emergent large vessel occlusion (ELVO) treated with thrombectomy is unknown. Methods We performed retrospective analysis of clot imaging (clot density, perviousness, length, diameter, distance to the internal carotid artery (ICA) terminus and angle of interaction (AOI) between clot and the aspiration catheter) of consecutive cases of middle cerebral artery (MCA) occlusion and its association with first pass effect (FPE, TICI 2c-3 after a first attempt). Results Patients ( n = 90 total) with FPE had shorter clot length (9.9 ± 4.5 mm vs. 11.7 ± 4.6 mm, P = 0.07), shorter distance from ICA terminus (11.0 ± 7.1 mm vs. 14.7 ± 9.8 mm, P = 0.048), higher perviousness (39.39 ± 29.5 vs 25.43 ± 17.6, P = 0.006) and larger AOI (153.6 ± 17.6 vs 140.3 ± 23.5, P = 0.004) compared to no-FPE patients. In multivariate analysis, distance from ICA terminus to clot ≤13.5 mm (odds ratio (OR) 11.05, 95% confidence interval (CI) 2.65–46.15, P = 0.001), clot length ≤9.9 mm (OR 7.34; 95% CI 1.8–29.96, P = 0.005), perviousness ≥ 19.9 (OR 2.54, 95% CI 0.84–7.6, P = 0.09) and AOI ≥ 137°^ (OR 6.8, 95% CI 1.55–29.8, P = 0.011) were independent predictors of FPE. The optimal cut off derived using Youden’s index was 6.5. The area under the curve of a score predictive of FPE success was 0.816 (0.728–0.904, P < 0.001). In a validation cohort ( n = 30), sensitivity, specificity, positive and negative predictive value of a score of 6–10 were 72.7%, 73.6%, 61.5% and 82.3%. Conclusions Clot imaging predicts the likelihood of achieving FPE in patients with MCA ELVO treated with the aspiration-first approach.

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Prediction of Streptococcus uberis clinical mastitis treatment success in dairy herds by means of mass spectrometry and machine-learning

Scientific Reports ◽

10.1038/s41598-021-87300-0 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Alexandre Maciel-Guerra ◽

Necati Esener ◽

Katharina Giebel ◽

Daniel Lea ◽

Martin J. Green ◽

...

Keyword(s):

Machine Learning ◽

Mass Spectrometry ◽

Treatment Success ◽

Clinical Mastitis ◽

Supervised Machine Learning ◽

Structural Protein ◽

Cohen’S Kappa ◽

Maldi Tof ◽

Streptococcus Uberis ◽

Cohen's Kappa

AbstractStreptococcus uberis is one of the leading pathogens causing mastitis worldwide. Identification of S. uberis strains that fail to respond to treatment with antibiotics is essential for better decision making and treatment selection. We demonstrate that the combination of supervised machine learning and matrix-assisted laser desorption ionization/time of flight (MALDI-TOF) mass spectrometry can discriminate strains of S. uberis causing clinical mastitis that are likely to be responsive or unresponsive to treatment. Diagnostics prediction systems trained on 90 individuals from 26 different farms achieved up to 86.2% and 71.5% in terms of accuracy and Cohen’s kappa. The performance was further increased by adding metadata (parity, somatic cell count of previous lactation and count of positive mastitis cases) to encoded MALDI-TOF spectra, which increased accuracy and Cohen’s kappa to 92.2% and 84.1% respectively. A computational framework integrating protein–protein networks and structural protein information to the machine learning results unveiled the molecular determinants underlying the responsive and unresponsive phenotypes.

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MRI-based clinical-radiomics model predicts tumor response before treatment in locally advanced rectal cancer

Scientific Reports ◽

10.1038/s41598-021-84816-3 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Andrea Delli Pizzi ◽

Antonio Maria Chiarelli ◽

Piero Chiacchiaretta ◽

Martina d’Annibale ◽

Pierpaolo Croce ◽

...

Keyword(s):

Machine Learning ◽

Rectal Cancer ◽

Treatment Response ◽

Randomized Clinical Trials ◽

Locally Advanced ◽

Neoadjuvant Treatment ◽

Learning Model ◽

Partial Least Square ◽

Machine Learning Model ◽

Pre Treatment

AbstractNeoadjuvant chemo-radiotherapy (CRT) followed by total mesorectal excision (TME) represents the standard treatment for patients with locally advanced (≥ T3 or N+) rectal cancer (LARC). Approximately 15% of patients with LARC shows a complete response after CRT. The use of pre-treatment MRI as predictive biomarker could help to increase the chance of organ preservation by tailoring the neoadjuvant treatment. We present a novel machine learning model combining pre-treatment MRI-based clinical and radiomic features for the early prediction of treatment response in LARC patients. MRI scans (3.0 T, T2-weighted) of 72 patients with LARC were included. Two readers independently segmented each tumor. Radiomic features were extracted from both the “tumor core” (TC) and the “tumor border” (TB). Partial least square (PLS) regression was used as the multivariate, machine learning, algorithm of choice and leave-one-out nested cross-validation was used to optimize hyperparameters of the PLS. The MRI-Based “clinical-radiomic” machine learning model properly predicted the treatment response (AUC = 0.793, p = 5.6 × 10–5). Importantly, the prediction improved when combining MRI-based clinical features and radiomic features, the latter extracted from both TC and TB. Prospective validation studies in randomized clinical trials are warranted to better define the role of radiomics in the development of rectal cancer precision medicine.

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Expectancies as predictors of symptom improvement after antimicrobial therapy for persistent symptoms attributed to Lyme disease

Clinical Rheumatology ◽

10.1007/s10067-021-05760-1 ◽

2021 ◽

Author(s):

Henriët van Middendorp ◽

Anneleen Berende ◽

Fidel J. Vos ◽

Hadewych H. M. ter Hofstede ◽

Bart Jan Kullberg ◽

...

Keyword(s):

Lyme Disease ◽

Treatment Success ◽

Symptomatic Improvement ◽

Post Treatment ◽

Symptom Improvement ◽

Persistent Symptoms ◽

Treatment Expectancies ◽

End Of Treatment ◽

Pre Treatment

Abstract Introduction/Objective Expectancies about symptom improvement or deterioration are reliable predictors of symptom progression and treatment outcomes (symptom resolution or symptomatic improvement) in many (non-)pharmacological studies and treatments. This study examined predictors of symptom improvement after antimicrobial therapy for persistent symptoms attributed to Lyme disease, hypothesizing particularly pre-treatment expectancies regarding symptom improvement to be predictive. Methods A predictive study was performed on pre-treatment and post-treatment individual characteristics, including expectancies, and physical and mental health–related quality of life (HRQoL) from the PLEASE-trial comparing randomized 12-weeks of doxycycline, clarithromycin-hydroxychloroquine, or placebo following 2 weeks of intravenous ceftriaxone. At end-of-treatment (14 weeks after trial start) and follow-up (52 weeks), complete data of 231 and 170 (of initial 280) patients with persistent symptoms temporally related to a history of erythema migrans or otherwise confirmed symptomatic Lyme disease, or accompanied by B. burgdorferi IgG or IgM antibodies, were examined through hierarchical regression analyses. Results In addition to pre-treatment HRQoL, pre-treatment expectancies regarding symptom improvement were consistently associated with stronger physical and mental HRQoL improvements at both end-of-treatment and follow-up (95% CI range: .09;.54, p < .01 to .27;.92, p < .001). Post-treatment expectancies regarding having received antibiotics vs. placebo was associated with more HRQoL improvement at end-of-treatment, but not at follow-up (95% CI-range 1.00;4.75, p = .003 to −7.34; −2.22, p < .001). Conclusions The present study shows that, next to pre-treatment functioning, patients’ pre-treatment and post-treatment expectancies regarding improvement of persistent symptoms attributed to Lyme disease relate to a more beneficial symptom course. Expectancies of patients may be relevant to explain and potentially improve patient outcomes (e.g., by optimized communication about treatment success). Trial registration ClinicalTrials.gov, NCT01207739 (Registration date: 23–09-2010) Key Points• As there is currently no sufficient symptom resolution or symptomatic improvement for many patients with persistent symptoms attributed to Lyme disease, it is relevant to know which factors determine symptom progression and predict heterogeneity in treatment response.• Next to pre-treatment functioning, expectancies regarding symptom improvement and having received antimicrobial study medication are associated with a more beneficial symptom course after both shorter-term and longer-term antimicrobial treatment.• Expectancies are relevant to consider in treatment studies and may be useful in clinical settings to improve symptom course and treatment outcome (e.g., by optimized communication about treatment success).

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A Machine Learning Approach to First Pass Reperfusion in Mechanical Thrombectomy: Prediction and Feature Analysis

Journal of Stroke and Cerebrovascular Diseases ◽

10.1016/j.jstrokecerebrovasdis.2021.105796 ◽

2021 ◽

Vol 30 (7) ◽

pp. 105796

Author(s):

Lohit Velagapudi ◽

Nikolaos Mouchtouris ◽

Richard F. Schmidt ◽

David Vuong ◽

Omaditya Khanna ◽

...

Keyword(s):

Machine Learning ◽

Mechanical Thrombectomy ◽

Feature Analysis ◽

Learning Approach ◽

Machine Learning Approach ◽

First Pass

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A Direct Aspiration First Pass Technique in Japanese Real-World Clinical Setting

Operative Neurosurgery ◽

10.1093/ons/opy349 ◽

2018 ◽

Vol 17 (2) ◽

pp. 115-122 ◽

Cited By ~ 1

Author(s):

Junji Uno ◽

Katsuharu Kameda ◽

Ryosuke Otsuji ◽

Nice Ren ◽

Shintaro Nagaoka ◽

...

Keyword(s):

Subarachnoid Hemorrhage ◽

Real World ◽

Cerebral Blood Volume ◽

Mechanical Thrombectomy ◽

Case Series ◽

Entire Study ◽

Stroke Treatment ◽

Real World Setting ◽

Hemorrhagic Complications ◽

First Pass

Abstract BACKGROUND It is debatable whether mechanical thrombectomy has benefits in a real-world setting outside the more rigid and selective clinical trial environment. OBJECTIVE To evaluate clinical outcomes, efficacy, and safety of mechanical thrombectomy in single-center retrospective cohort case series. METHODS We reviewed prospectively collected data from our large-vessel occlusion stroke database to identify patients undergoing mechanical thrombectomy using Penumbra catheters (Penumbra, Almeida, California) as first-line devices. The primary outcomes were the modified Rankin Scale score at 90 d and recanalization rate. The secondary outcomes included the rates of hemorrhagic complications and mortality. RESULTS The entire study population included 298 patients. Thrombolysis in Cerebral Infarction Scale ≥2b was achieved in 86.6% of patients. Fifty-five patients (18.5%) were outside the 6 hr time window and 82 patients (27.5%) were over 80-yr old. The posterior circulation thrombectomy rate was 12.4%. At 90 d from onset, 49.3% of patients had favorable outcomes. The parenchymal hemorrhage type 2 (PH2) and subarachnoid hemorrhage rates were 2.3% and 11.7%, respectively. In multivariate analyses, cerebral blood flow/cerebral blood volume mismatch (odds ratio [OR] = 9.418; 95% confidence interval [CI], 3.680-27.726; P < .0001), onset to recanalization time (OR = 0.995; 95% CI, 0.991-0.998; P = .0003), and hemorrhagic complications including PH2 and subarachnoid hemorrhage (OR = 0.186; 95% CI, 0.070-0.455; P = .0002) were associated with favorable outcomes. CONCLUSION A direct aspiration first pass technique with an adjunctive device demonstrated high recanalization rates in old Japanese patients. Our patient cohort may reflect the application of endovascular techniques in acute ischemic stroke treatment in a real-world setting.

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Decompressive craniectomy for internal carotid artery and middle carotid artery infarctions: a long-term comparative outcome study

Neurosurgical FOCUS ◽

10.3171/2021.4.focus21123 ◽

2021 ◽

Vol 51 (1) ◽

pp. E10

Author(s):

Jia Xu Lim ◽

Srujana Venkata Vedicherla ◽

Shu Kiat Sukit Chan ◽

Nishal Kishinchand Primalani ◽

Audrey J. L. Tan ◽

...

Keyword(s):

Carotid Artery ◽

Internal Carotid Artery ◽

Decompressive Craniectomy ◽

Functional Outcomes ◽

Internal Carotid ◽

Neurological Status ◽

Inpatient Mortality ◽

Stroke Treatment ◽

Significant Difference ◽

Cox Proportional Hazard Regression

OBJECTIVE Malignant internal carotid artery (ICA) infarction is an entirely different disease entity when compared with middle cerebral artery (MCA) infarction. Because of an increased area of infarction, it is assumed to have a poorer prognosis; however, this has never been adequately investigated. Decompressive craniectomy (DC) for malignant MCA infarction has been shown to improve mortality rates in several randomized controlled trials. Conversely, aggressive surgical decompression for ICA infarction has not been recommended. The authors sought to compare the functional outcomes and survival between patients with ICA infarctions and those with MCA infarctions after DC in the largest series to date to investigate this assumption. METHODS A multicenter retrospective review of 154 consecutive DCs for large territory cerebral infarctions performed from 2005 to 2020 were analyzed. Patients were divided into ICA and MCA groups depending on the territory of infarction. Variables, including age, sex, medical comorbidities, laterality of the infarction, preoperative neurological status, primary stroke treatment, and the time from stroke onset to DC, were recorded. Univariable and multivariable analyses were performed for the clinical exposures for functional outcomes (modified Rankin Scale [mRS] score) on discharge and at the 1- and 6-month follow-ups, and for mortality, both inpatient and at the 1-year follow-up. A favorable mRS score was defined as 0–2. RESULTS There were 67 patients (43.5%) and 87 patients (56.5%) in the ICA and MCA groups, respectively. Univariable analysis showed that the ICA group had a comparably favorable mRS (OR 0.15 [95% CI 0.18–1.21], p = 0.077). Inpatient mortality (OR 1.79 [95% CI 0.79–4.03], p = 0.16) and 1-year mortality (OR 2.07 [95% CI 0.98–4.37], p = 0.054) were comparable between the groups. After adjustment, a favorable mRS score at 6 months (OR 0.17 [95% CI 0.018–1.59], p = 0.12), inpatient mortality (OR 1.02 [95% CI 0.29–3.57], p = 0.97), and 1-year mortality (OR 0.94 [95% CI 0.41–2.69], p = 0.88) were similar in both groups. The overall survival, plotted using the Cox proportional hazard regression, did not show a significant difference between the ICA and MCA groups (HR 0.581). CONCLUSIONS Unlike previous smaller studies, this study found that patients with malignant ICA infarction had a functional outcome and survival that was similar to those with MCA infarction after DC. Therefore, DC can be offered for malignant ICA infarction for life-saving purposes with limited functional recovery.

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First Pass Effect With Neurothrombectomy for Acute Ischemic Stroke: Analysis of the Systematic Evaluation of Patients Treated With Stroke Devices for Acute Ischemic Stroke Registry

Stroke ◽

10.1161/strokeaha.121.035457 ◽

2021 ◽

Author(s):

Ashutosh P. Jadhav ◽

Shashvat M. Desai ◽

Osama O. Zaidat ◽

Raul G. Nogueira ◽

Tudor G. Jovin ◽

...

Keyword(s):

Ischemic Stroke ◽

Carotid Artery ◽

Internal Carotid Artery ◽

Cerebral Infarction ◽

Acute Ischemic Stroke ◽

Clinical Outcomes ◽

Internal Carotid ◽

Systematic Evaluation ◽

Stroke Registry ◽

First Pass

Background and Purpose: Achieving complete revascularization after a single pass of a mechanical thrombectomy device (first pass effect [FPE]) is associated with good clinical outcomes in patients with acute ischemic stroke due to large vessel occlusion. We assessed patient characteristics, outcomes, and predictors of FPE among a large real-world cohort of patients (Systematic Evaluation of Patients Treated with Stroke Devices for Acute Ischemic Stroke registry). Methods: Demographics, clinical outcomes, and procedural characteristics were analyzed among patients in whom FPE (modified Thrombolysis in Cerebral Infarction 2c/3 after first pass) was achieved versus those requiring multiple passes (MP). Modified FPE and modified MP included patients achieving modified Thrombolysis in Cerebral Infarction 2B-3. Primary outcomes included 90-day modified Rankin Scale (mRS) score and mortality. Results: Among 984 Systematic Evaluation of Patients Treated with Stroke Devices for Acute Ischemic Stroke patients, 930 had complete 90-day follow-up. FPE was achieved in 40.5% (377/930) of patients and MP in 20.0% (186/930). Baseline characteristics were similar across all groups. The FPE group had fewer internal carotid artery occlusions compared with MP ( P =0.029). The FPE group had faster puncture to recanalization time ( P ≤0.001), higher rates of 90-day mRS score of 0 to 1 (52.6% versus 38.6%, P =0.003), mRS score of 0 to 2 (65.4% versus 52.0%, P =0.003), and lower 90-day mortality compared with the MP group (12.0% versus 18.7%, P =0.038). Similarly, compared with modified MP patients, the modified FPE group had fewer internal carotid artery occlusions ( P =0.004), faster puncture to recanalization time ( P ≤0.001), and higher rates of 90-day mRS score of 0 to 1 ( P =0.002) and mRS score of 0 to 2 ( P =0.003). Conclusions: Our findings demonstrate that FPE and modified FPE are associated with superior clinical outcomes.

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Abstract 133: Protocol Deviations During and After IV Thrombolysis in Community Hospitals

Stroke ◽

10.1161/str.43.suppl_1.a133 ◽

2012 ◽

Vol 43 (suppl_1) ◽

Author(s):

Eric E Adelman ◽

William J Meurer ◽

Lesli E Skolarus ◽

Allison M Kade ◽

Shirley M Frederiksen ◽

...

Keyword(s):

Antiplatelet Agent ◽

Case Fatality ◽

Post Treatment ◽

Older Age ◽

Stroke Severity ◽

Community Hospitals ◽

Stroke Treatment ◽

Hospital Case ◽

Hospital Factors ◽

Pre Treatment

Background and purpose Protocol deviations (PDs) before and immediately after IV thrombolysis for acute ischemic stroke are common. Patient and hospital factors associated with PDs are not well described. We aimed to determine which patient or hospital factors were associated with pre- and post-treatment PDs in a cohort of community treated thrombolysis patients. Methods The INSTINCT (Increasing Stroke Treatment through Interventional Behavior Change Tactics) study was a multicenter, cluster-randomized controlled trial in 24 Michigan community hospitals evaluating the efficacy of a barrier assessment and educational intervention to increase appropriate tPA use. PDs were defined based on 2007 AHA guidelines with the addition of the 3-4.5 hour treatment window, for which the ECASS III criteria were applied. PDs were categorized as pre-treatment (Pre-PDs), post-treatment (Post-PDs) or both. Multi-level logistic regression models were fitted to determine whether patient and hospital variables were associated with Pre-PDs or Post-PDs. The models included all variables specified a priori to be potentially clinically relevant; Pre-PD was included as a covariate in the model for Post-PD. Results During the study, 557 patients (mean age 70; 52% male; median NIHSS 12) were treated with IV tPA. PDs occurred in 233 (42%) patients: 26% had only Post-PDs, 7% had only Pre-PDs, and 9% had both. The most common PDs included failure to treat post-treatment hypertension (131, 24%), antiplatelet agent within 24 hours of treatment (61, 11%), pre-treatment blood pressure over 185/110 (39, 7%), anticoagulant agent within 24 hours of treatment (31, 6%), and treatment outside the time window (29, 5%). Symptomatic intracranial hemorrhage (SICH) was observed in 7.3% of patients with PDs and 6.5% of patients without any PD. In-hospital case fatality was 12% with and 10% without a PD. The differences in SICH and case fatality were not statistically significant. In the fully adjusted model, older age was significantly associated with Pre-PDs ( Table ). When Post-PDs were evaluated with adjustment for Pre-PDs, age was not associated with PDs; however, Pre-PDs were associated with Post-PDs. Conclusion Older age was associated with increased odds of Pre-PDs in Michigan community hospitals. Pre-PDs were associated with Post-PDs. SICH and in-hospital case fatality were not associated with PDs; however, the low number of such events limited our ability to detect a difference. Stroke severity and hospital factors were not associated with PDs.

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Abstract WP6: Cerebral Mechanical Thrombectomy Device Related Adverse Events: Analysis of the Manufacturer and User Facility Device Experience Database

Stroke ◽

10.1161/str.44.suppl_1.awp6 ◽

2013 ◽

Vol 44 (suppl_1) ◽

Author(s):

Wondwossen G Tekle ◽

Malik M Adil ◽

Derya Uluduz ◽

Basit Rahim ◽

Tauhid Awan ◽

...

Keyword(s):

Adverse Events ◽

Internal Carotid ◽

Reporting Rate ◽

Event Description ◽

Device Malfunction ◽

First Pass ◽

User Facility ◽

Multiple Devices ◽

Thrombectomy Device ◽

Solitaire Fr

Background: There is paucity of knowledge regarding the spectrum of neurothrombectomy(NT) device-related complications. Objective: To report the characteristics and proportions of reported adverse-events(AE) related to NT devices used in endovascular treatment of acute ischemic stroke (AIS). Methods: We identified NT device-related AE reported by voluntary sources, user facility reports, and distributor and manufacturer reports to the Manufacturer and User Facility Device Experience Database(MAUDE) from the year 2004 through 2012 to identify patients. Frequency of specific reported AE and associated factors were extracted from the “event description” on the three NT devices currently in use for AIS treatment -Merci Retriever, Penumbra System, and Solitaire-FR stentriever. Results: A total of 706 reported NT device-related AEs were identified with a continual increase in reporting rate since 2004. Of the 706, device malfunction (kink, twist, difficult advancing, fracture, or retention) was the most common reported complication(56%), followed by hemorrhages(23%), dissection(6.8%), vasospasm(6.2%), and distal embolism(2.7%). Intra-arterial(IA) thrombolytic was used in 70%(111/159), intravenous(IV) thrombolytic in 16%, and both IA and IV in 13% of the reported cases. Middle cerebral artery(MCA) was involved in 56%(220/392), internal carotid artery(ICA) in 16 %, and both MCA and ICA in about 21% of cases where the occluded vessel was reported. Multiple devices were used in majority(71%) of reported cases(n=564). The first “pass”(recanalization-attempt) was associated with 34% of reported adverse event per-device(n= 119), 2-passes(29%), and 3-passes(28%). Recanalization was complete in 52 %(266/513) reported cases, and partial in 14%(71/513). Patients’ condition was unchanged in 63%(220/349), worsened in 29%(101/349), and improved in 8%(28/349) of reported cases. Twenty three percent(77/342) mortality was reported among those patients whose final outcome was known and reported. Conclusions: Reports of NT device-related AE have significantly increased over the last 8 years. Proportionally higher-rates of reported device malfunction do not necessarily represent adverse patient outcomes.

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