Multimodal cerebral arteriovenous malformation treatment: a 12-year experience and comparison of key outcomes to ARUBA

2020 ◽  
Vol 133 (6) ◽  
pp. 1792-1801 ◽  
Author(s):  
Benjamin Pulli ◽  
Paul H. Chapman ◽  
Christopher S. Ogilvy ◽  
Aman B. Patel ◽  
Christopher J. Stapleton ◽  
...  
Keyword(s):  
Natural History ◽  
Clinical Outcomes ◽  
Medical Management ◽  
Arteriovenous Malformations ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Randomized Controlled ◽  
Brain Arteriovenous Malformations ◽  
Brain Avms

OBJECTIVECurative treatment of unruptured brain arteriovenous malformations (AVMs) remains controversial after the only randomized controlled trial, A Randomized Trial of Unruptured Brain Arteriovenous Malformations (ARUBA), was halted prematurely because interim analysis revealed superiority of the medical management group. In contrast, meta-analyses of retrospective cohorts suggest that intervention is much safer than was found in ARUBA.METHODSThe authors retrospectively analyzed 318 consecutive adult patients with brain AVMs treated at their institution with embolization, surgery, and/or proton beam radiosurgery. Analysis was performed in 142 ARUBA-eligible patients (baseline modified Rankin Scale [mRS] score 0–1, no history of hemorrhage), and results were compared to primary and secondary outcomes from ARUBA, as well as to natural history cohorts.RESULTSThe annualized stroke rate (hemorrhagic or ischemic) in this cohort was 1.8%, 4.9% in the first 12 months and 0.8% after the first 12 months, which was lower than in natural history studies and the ARUBA medical management arm (p = 0.001). The primary ARUBA endpoint of symptomatic stroke was reached in 13 patients (9.2%), which compares favorably to the ARUBA intervention arm (39.6%, p = 0.0001) and is similar to the ARUBA medical management arm (9.2%, p = 1.0). The secondary ARUBA endpoint (mRS score ≥ 2 at 5 years of follow-up) was reached in 14.3% of patients, compared to 40.5% in the ARUBA intervention arm (p = 0.002) and 16.7% in the ARUBA medical management arm (p = 0.6).CONCLUSIONSThis multimodal approach to the selection and treatment of patients with brain AVMs yields good clinical outcomes with key safety endpoints (stroke, death, and mRS score 0–1) better than the ARUBA intervention arm and similar to the ARUBA medical arm at 5 years of follow-up. Results compare favorably to natural history cohorts at longer follow-up times. This suggests that tertiary care centers with integrated programs, expertise in patient selection, and individualized treatment approaches may allow for better clinical outcomes than reported in ARUBA. It supports current registry studies and merits consideration of future randomized controlled trials in patients with brain AVMs.

scholarly journals A Randomized, Controlled Trial Comparing Autologous Matrix-Induced Chondrogenesis (AMIC®) to Microfracture: Analysis of 1- and 2-Year Follow-Up Data of 2 Centers

2013 ◽  
Vol 7 (1) ◽  
pp. 133-143 ◽  
Author(s):  
Sven Anders ◽  
Martin Volz ◽  
Hubert Frick ◽  
Jörg Gellissen
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Outcomes ◽  
Controlled Trial ◽  
Collagen Type I ◽  
Cartilage Defects ◽  
Type I ◽  
Randomized Controlled ◽  
First Results ◽  
Post Operation

Microfracture (MFx) is currently the recommended option for the treatment of small cartilage defects but is not regarded as suitable for the treatment of defects larger than 2.5 cm2. To extent its applicability to medium-sized defects MFx has been combined with a collagen type I/III matrix (Chondro-Gide®). This technique is called Autologous Matrix-Induced Chondrogenesis (AMIC®) and meanwhile a clinically established treatment option for localized full-thickness small- to medium-sized cartilage defects. Despite its more spreading clinical use, clinical data published so far are limited to mainly case report series.In this study, we report the first results of a randomized, controlled trial assessing the efficacy and safety of AMIC®versus MFx. Patients enrolled in 2 centers were included in this analysis. 38 patients (aged 21-50 years, mean defect size 3.4 cm2) were randomized and treated either with MFx, with sutured AMIC®or glued AMIC®. Clinical outcomes (modified Cincinnati and ICRS score) could be assessed in 30 patients at 1-year and 27 patients at 2-years post-operation. Improvements in both scores were seen at 1-and 2-years post-operation, irrespective of the technique used. MRI assessment revealed a satisfactory and homogenous defect filling in the majority of patients. No treatment-related adverse events were reported.This interim analysis confirms the mid-term results for AMIC®reported in literature. It demonstrates clearly that clinical outcomes at 1-year post-operation are maintained at 2-years. Therefore we consider enhancing MFx with Chondro-Gide®is a valid and safe cartilage repair option for small- to medium-sized cartilage defects of the knee.

Brain arteriovenous malformations

Neurology ◽  
2020 ◽  
Vol 95 (20) ◽  
pp. 917-927 ◽  
Author(s):  
Ching-Jen Chen ◽  
Dale Ding ◽  
Colin P. Derdeyn ◽  
Giuseppe Lanzino ◽  
Robert M. Friedlander ◽  
...  
Keyword(s):  
Natural History ◽  
Minimally Invasive ◽  
Arteriovenous Malformations ◽  
Cerebral Arteries ◽  
Treatment Strategies ◽  
Latency Period ◽  
Management Options ◽  
Brain Arteriovenous Malformations ◽  
Risk Of Hemorrhage ◽  
Brain Avms

Brain arteriovenous malformations (AVMs) are anomalous direct shunts between cerebral arteries and veins that convalesce into a vascular nidus. The treatment strategies for AVMs are challenging and variable. Intracranial hemorrhage and seizures comprise the most common presentations of AVMs. However, incidental AVMs are being diagnosed with increasing frequency due to widespread use of noninvasive neuroimaging. The balance between the estimated cumulative lifetime hemorrhage risk vs the risk of intervention is often the major determinant for treatment. Current management options include surgical resection, embolization, stereotactic radiosurgery (SRS), and observation. Complete nidal obliteration is the goal of AVM intervention. The risks and benefits of interventions vary and can be used in a combinatorial fashion. Resection of the AVM nidus affords high rates of immediate obliteration, but it is invasive and carries a moderate risk of neurologic morbidity. AVM embolization is minimally invasive, but cure can only be achieved in a minority of lesions. SRS is also minimally invasive and has little immediate morbidity, but AVM obliteration occurs in a delayed fashion, so the patient remains at risk of hemorrhage during the latency period. Whether obliteration can be achieved in unruptured AVMs with a lower risk of stroke or death compared with the natural history of AVMs remains controversial. Over the past 5 years, multicenter prospective and retrospective studies describing AVM natural history and treatment outcomes have been published. This review provides a contemporary and comprehensive discussion of the natural history, pathobiology, and interventions for brain AVMs.

scholarly journals Natural history of brain arteriovenous malformations: a systematic review

2014 ◽  
Vol 37 (3) ◽  
pp. E7 ◽  
Author(s):  
Isaac Josh Abecassis ◽  
David S. Xu ◽  
H. Hunt Batjer ◽  
Bernard R. Bendok
Keyword(s):  
Natural History ◽  
Arteriovenous Malformations ◽  
Venous Drainage ◽  
Cerebral Arteriovenous Malformations ◽  
Brain Arteriovenous Malformations ◽  
Increased Risk ◽  
Risk Of Rupture ◽  
History Of ◽  
Arterial Aneurysms

Object The authors aimed to systematically review the literature to clarify the natural history of brain arteriovenous malformations (BAVMs). Methods The authors searched PubMed for one or more of the following terms: natural history, brain arteriovenous malformations, cerebral arteriovenous malformations, and risk of rupture. They included studies that reported annual rates of hemorrhage and that included either 100 patients or 5 years of treatment-free follow-up. Results The incidence of BAVMs is 1.12–1.42 cases per 100,000 person-years; 38%–68% of new cases are first-ever hemorrhage. The overall annual rates of hemorrhage for patients with untreated BAVMs range from 2.10% to 4.12%. Consistently implicated in subsequent hemorrhage are initial hemorrhagic presentation, exclusively deep venous drainage, and deep and infrantentorial brain location. The risk for rupture seems to be increased by large nidus size and concurrent arterial aneurysms, although these factors have not been studied as thoroughly. Venous stenosis has not been implicated in increased risk for rupture. Conclusions For patients with BAVMs, although the overall risk for hemorrhage seems to be 2.10%–4.12% per year, calculating an accurate risk profile for decision making involves clinical attention and accounting for specific features of the malformation.

1244 THE NATURAL HISTORY OF NOCTURIA AMONG MEN ALLOCATED TO PLACEBO: RESULTS FROM A RANDOMIZED CONTROLLED TRIAL WITH ONE YEAR FOLLOW-UP

2012 ◽  
Vol 187 (4S) ◽  
Author(s):  
Kari A.O. Tikkinen ◽  
Jari Haukka ◽  
Rufus Cartwright ◽  
Camille P. Vaughan ◽  
Alayne D. Markland ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Natural History ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
History Of ◽  
One Year

scholarly journals Assessing Patient Progress in Psychological Therapy Through Feedback in Supervision: the MeMOS* Randomized Controlled Trial (*Measuring and Monitoring clinical Outcomes in Supervision: MeMOS)

2017 ◽  
Vol 45 (3) ◽  
pp. 209-224 ◽  
Author(s):  
Kate M. Davidson ◽  
Michelle L. Rankin ◽  
Amelie Begley ◽  
Suzanne Lloyd ◽  
Sarah J.E. Barry ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Controlled Trial ◽  
Psychological Therapy ◽  
Randomized Controlled ◽  
Supervision Process ◽  
Therapy Services ◽  
Continuous Feedback ◽  
Giving Feedback ◽  
Therapy Sessions

Background: Psychological therapy services are often required to demonstrate their effectiveness and are implementing systematic monitoring of patient progress. A system for measuring patient progress might usefully ‘inform supervision’ and help patients who are not progressing in therapy. Aims: To examine if continuous monitoring of patient progress through the supervision process was more effective in improving patient outcomes compared with giving feedback to therapists alone in routine NHS psychological therapy. Method: Using a stepped wedge randomized controlled design, continuous feedback on patient progress during therapy was given either to the therapist and supervisor to be discussed in clinical supervison (MeMOS condition) or only given to the therapist (S-Sup condition). If a patient failed to progress in the MeMOS condition, an alert was triggered and sent to both the therapist and supervisor. Outcome measures were completed at beginning of therapy, end of therapy and at 6-month follow-up and session-by-session ratings. Results: No differences in clinical outcomes of patients were found between MeMOS and S-Sup conditions. Patients in the MeMOS condition were rated as improving less, and more ill. They received fewer therapy sessions. Conclusions: Most patients failed to improve in therapy at some point. Patients’ recovery was not affected by feeding back outcomes into the supervision process. Therapists rated patients in the S-Sup condition as improving more and being less ill than patients in MeMOS. Those patients in MeMOS had more complex problems.

A neuropsychologically-based intervention with increased follow-up support for employed women with multiple sclerosis: a pilot randomized controlled trial

2020 ◽  
Vol 34 (10) ◽  
pp. 1292-1302
Author(s):  
Marnina B Stimmel ◽  
Jenna N Cohen ◽  
Shonna J Schneider ◽  
Jeffrey G Portnoy ◽  
Elizabeth K Seng ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Care Coordinator ◽  
Randomized Controlled ◽  
Employed Women ◽  
Recommendation Adherence

Objective: To evaluate feasibility and acceptability of a neuropsychologically-based vocational intervention with increased follow-up support for women with multiple sclerosis. Design: Single-blinded parallel-group randomized controlled trial with 12-month follow-up. Setting: Tertiary-care multiple sclerosis center. Participants: Forty-nine employed women with multiple sclerosis meeting criteria on measures of cognitive dysfunction (Symbol Digit Modalities Test), fatigue (Fatigue Severity Scale), and/or depression (Beck Depression Inventory/Patient Health Questionnaire). Interventions: Participants received either neuropsychological testing and phone feedback regarding findings and tailored recommendations (standard-care treatment), or testing, in-person feedback, and two calls from a care-coordinator (experimental treatment). Measures: Feasibility measures included enrollment and attrition rates, and compliance to recommendations at 12-months between groups. Acceptability was evaluated by participants’ report of benefit from interventions. Secondary analyses included evaluation of symptom changes (cognition, fatigue, depression) from baseline to 12-months. Results: Of 49 women meeting screening measure thresholds, 44 were randomized to treatment groups (attrition: standard-care = 8, experimental = 6), and 30 completed the study (standard-care = 14, experimental = 16). Recommendation adherence rates did not significantly differ between standard-care and experimental groups (31% vs 49%). However, 16/16 experimental participants at least partially completed given recommendations as compared to 8/14 in the standard-care group. Participants across groups (97%) reported benefit from participation. No significant differences in symptom outcomes between groups at 12-months. Conclusion: In-person feedback and care-coordinator calls were feasible and acceptable additions to a neuropsychological intervention and may serve to increase recommendation adherence. Given high drop-out rate, particularly prior to testing, future research may explore avenues to improve completion rates and maximize benefits of such interventions.

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