Abstract 72: Procedural and Long Term Safety of PFO Closure in Cryptogenic Stroke: Insights from the RESPECT Trial

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Richard W Smalling ◽  
John Carroll ◽  
Jeffrey Saver ◽  
David Thaler ◽  
Todd Bull ◽  
...  
Keyword(s):  
Medical Management ◽  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Dropout Rate ◽  
Small Subset ◽  
Post Procedure ◽  
Venous Thromboembolic Events ◽  
Pfo Closure

Background: Complications of percutaneous patent foramen ovale (PFO) closure using the Amplatzer TM PFO Occluder were reported in 2012 after a median follow-up of 2.1 years. The FDA requested an analysis of long-term device safety observed in the Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) trial. Methods: We randomized patients with cryptogenic stroke and PFO in a 1:1 ratio between PFO closure and medical management alone (MM). Post procedure medical management in the closure arm was 30 days of aspirin and clopidogrel followed by 5 months of aspirin alone and continued medical therapy as per the site neurologist. Medical treatment in the MM arm was a guideline-directed antiplatelet regimen or warfarin. An independent data and safety monitoring board adjudicated all adverse events as serious (SAE) or non-serious, and as procedure, device or protocol related. Results: We enrolled 980 patients (mean age, 45.9 years) at 69 sites who were followed for a median of 5.9 years (IQR 4.2-8.0). Follow-up was unequal – 3141 patient-years in the closure arm vs. 2669 in the MM arm, due to a higher dropout rate in the MM arm. There was less warfarin use in the closure arm vs. the MM arm (109 vs 578 patient-years). There were no study-related deaths. Two patients had procedure-related ischemic strokes (7 days and 3 months post-procedure). SAEs were equally distributed between the two arms: 13.7 in the closure arm vs. 12.4 per 100 patient-years in the MM arm, p=0.17. There was no device thrombus or erosion. The incidence of post procedure AF was not increased in the closure arm. Venous thromboembolic events (VTE) occurred at a higher rate in the closure arm, 0.87 per 100 patient-years vs. 0.22 in the MM arm, p=0.0008. In univariable logistic regression modeling, a remote history of DVT prior to randomization was a significant predictor of VTEs in the closure arm. No VTEs occurring beyond 6 months were attributed to the procedure or the device. Conclusions: These new long-term data reaffirm that the Amplatzer TM PFO Occluder has a low rate of procedure (2.4%) and device (2%) related SAE’s. A small subset of cryptogenic stroke patients have an underlying proclivity to VTE and may need long-term anticoagulation.

scholarly journals Recurrent Stroke after Transcatheter PFO Closure in Cryptogenic Stroke or Tia: Long-Term Follow-Up

2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Elisabetta Mariucci ◽  
Andrea Donti ◽  
Luisa Salomone ◽  
Marta Marcia ◽  
Marta Guidarini ◽  
...  
Keyword(s):  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Vascular Risk Factor ◽  
Vascular Risk ◽  
Long Term Follow Up ◽  
Recurrent Strokes ◽  
Few Data ◽  
Pfo Closure

Background. There are few data on the mechanism of recurrent neurological events after transcatheter closure of patent foramen ovale (PFO) in cryptogenic stroke or TIA. Methods. We retrospectively reviewed PFO closure procedures for the secondary prevention of cryptogenic stroke/TIA performed between 1999 and 2014 in Bologna, Italy. Results. Written questionnaires were completed by 402 patients. Mean follow-up was 7 ± 3 years. Stroke recurred in 3.2% (0.5/100 patients-year) and TIA in 2.7% (0.4/100 patients-year). Ninety-two percent of recurrent strokes were not cryptogenic. Recurrent stroke was noncardioembolic in 69% of patients, AF related in 15% of patients, device related in 1 patient, and cryptogenic in 1 patient. AF was diagnosed after the procedure in 21 patients (5.2%). Multivariate Cox’s proportion hazard model identified age ≥ 55 years at the time of closure (OR 3.16, p=0.007) and RoPE score < 7 (OR 3.21, p=0.03) as predictors of recurrent neurological events. Conclusion. Recurrent neurological events after PFO closure are rare, usually noncryptogenic and associated with conventional vascular risk factors or AF related. Patients older than 55 years of age and those with a RoPE score < 7 are likely to get less benefit from PFO closure. After transcatheter PFO closure, lifelong strict vascular risk factor control is warranted.

scholarly journals EFFICACY OF ATRIAL FIBRILLATION DETECTION IN CRYPTOGENIC STROKE ACCORDING TO DATA OF IMPLANTABLE LOOP RECORDERS: PILOT STUDY

2019 ◽  
Vol 34 (2) ◽  
pp. 47-53
Author(s):  
S. E. Mamchur ◽  
E. A. Ivanitskiy ◽  
O. M. Polikutina ◽  
T. Yu. Chichkova ◽  
I. N. Mamchur ◽  
...  
Keyword(s):  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Ecg Monitoring ◽  
Group Iii ◽  
External Monitoring ◽  
Group I ◽  
Monitoring Group ◽  
Group Ii

Aim. To estimate the efficacy of invasive and non-invasive long-term ECG monitoring in comparison with conventional follow-up for the detection of silent atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) in patients with a cryptogenic stroke.Methods. The randomized, prospective, two-center study enrolled 36 patients who suffered cryptogenic stroke (CS) or transient ischemic attack (TIA) without past history of AF/AFL/AT. Patients were randomized in a 1:1:1 ratio to one of the three ECG monitoring strategies: standard arrhythmia monitoring (group I, n=12), ECG-monitoring with implantable loop recorder (group II, n=12), and ambulatory noninvasive ECG monitoring (group III, n=12). The primary endpoint was the time to the first detection of AF/AFL/AT. Patients, assigned to the group I, underwent an assessment at scheduled and unscheduled visits and received ambulatory ECG monitoring 28 days and 1 year after randomization. Patients in the group II underwent implantation of Reveal XT (Medtronic, USA) with the daily remote data transmission to CareLink Network. In the group III, for long-term external monitoring, Spyder system (WEB Biotechnology, Singapore) was used for up to 28 days.Results. During the first 28 days of observation, there were no significant differences in AF detection rates between groups I, II, and III: 0 (0%), 1 (8%), and 2 (17%) cases, respectively, р=0.537. During the year of observation, AF/AFL/AT episodes were detected in 1 case (8%) in the group I, 6 cases (50%) in the group II, and 2 cases (17%) in the group III, p=0.0486. The mean time from enrollment into the study to detection of the first AF/AFL/AT episode was 67 days (15; 97) in all groups. In the groups II and III, the first arrhythmia episodes were detected by monitoring devices on days 24 and 6, respectively. In most cases, arrhythmia episodes detected by long-term monitoring were asymptomatic. Recurrent stroke or TIA events occurred in group I and III (1 case in each group), but not in the group with implantable cardiac monitors. Subgroup analysis showed that significantly higher AF/AFL/AT detection rate was associated with stroke, CHA2DS2VASc score ≥2, and the presence of hypertension. For the 12 months of follow-up, the mean AF burden in the group II was 0.4 (0.2; 0.5) hours per day (1.6%). In the patients with recurrent stroke, AF burden was 3.2% compared to 0.9% in the rest of patients.Conclusion. Detection of silent AF with implantable cardiac monitors is superior to standard and long-term external monitoring in cryptogenic stroke patients.

Abstract 71: PFO Closure Reduces Long Term Recurrence of Ischemic Stroke: Final Primary and Secondary Population Results From the RESPECT Multicenter Trial

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
David Thaler ◽  
John Carroll ◽  
Jeffrey Saver ◽  
Richard Smalling ◽  
Lee MacDonald ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Treatment Effect ◽  
Recurrent Stroke ◽  
Multicenter Trial ◽  
Current Standard ◽  
Main Trial ◽  
Multicenter Rct ◽  
Pfo Closure

Introduction: In the intention-to-treat (ITT) analysis of the Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) trial, a trend favoring PFO closure in the primary analytic period (median follow-up 2.1y) was statistically significant with longer follow-up (median 5.9y). Hypotheses: Populations with less clinical trial noise [Per Protocol (PP), As Treated (AT), Device in Place (DIP)] will show > benefit, consistent with a genuine treatment effect of closure. Analysis of strokes without known mechanisms (per ASCOD) or occurring while patients are less subject to non-PFO stroke mechanisms (<60y) will show heightened treatment effect. Methods: RESPECT was a prospective, multicenter, RCT comparing patients assigned 1:1 to PFO closure (Amplatzer PFO Occluder) or to medical management (MM) alone. Data were collected through May 2016. Results: We enrolled 980 patients who were followed for a median of 5.9y (IQR 4.2-8.0, range 0-11). All primary endpoint events were nonfatal ischemic strokes. The efficacy outcome in the ITT population significantly favored device closure over MM alone (HR: 0.55, 95% CI: 0.305 to 0.999, log-rank p=0.046) and was equal (PP) or magnified in the other populations analyzed by treatment actually received. It was also greater if events were excluded when they occurred after patients reached 60y or had a known (non-PFO) mechanism (Table). Conclusions: The final data from RESPECT, after long-term follow-up, show that the benefit of PFO closure seen in the ITT population is magnified in populations that account for treatment crossover and that include the age range in which recurrent ischemic strokes are predominantly cryptogenic. These secondary analyses reinforce the main trial finding that PFO closure with the Amplatzer PFO Occluder is superior to medical therapy alone in preventing recurrent ischemic stroke.

Abstract 4513: Efficacy And Safety Of Percutaneous Patent Foramen Ovale Closure In Patients With Thrombophilia

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Pablo Rengifo-Moreno ◽  
Ignacio Cruz-Gonzalez ◽  
Roberto J Cubeddu ◽  
Maria Sanchez-Ledezma ◽  
Mingming Ning ◽  
...  
Keyword(s):  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Rank Test ◽  
Foramen Ovale ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Cerebral Ischemic ◽  
Pfo Closure

Background: The presence of a patent foramen ovale (PFO) is associated with higher rates of cryptogenic stroke. In patients with hypercoagulable states, the incidence of recurrent cerebral ischemic events may be greatly increased if a PFO is present. Percutaneous PFO closure is an alternative therapeutic approach for patients with both conditions who are not candidates for long-term anticoagulation, or have developed recurrent neurological events despite medical therapy. Methods: Between January 1995 to February 2007, 424 consecutive patients with PFO and cryptogenic stroke underwent percutaneous PFO closure. Of these, we identified 112 (26%) patients with a hypercoagulable disorder. We compared the safety and long-term outcome of percutaneous PFO closure in these two groups of patients. Results: Patients with thrombophilia were older (51.7±13 vs 48.3±14 years, p = 0.025), yet no different regarding baseline demographics or echocardiographic characteristics. Percutaneous PFO closure was successful in all the patients. There were no differences in the type of device used (Amplatzer: 53.6 vs 50%, Cardioseal 39.3 vs 41.7%, Sideris 7.1 vs 8.3%; p= 0.78). At median follow-up of 14.3 months (interquartile range: 6.1–31.4 months) there rate of stroke/TIA was similar for both groups (1.7 vs 1.6%, log rank test p = 0.35). At follow-up echocardiography, the rate of complete PFO closure was greater in the thrombophilic patients (97.3 vs 91.7%, p=0.04). Conclusions: Percutaneous PFO closure is safe and effective in preventing recurrent ischemic cerebral events in patients with thrombophilia.

Abstract WP422: Mechanisms of Recurrent Ischemic Stroke Under Medical versus Device Therapy: Long Term Follow-up in the RESPECT PFO Trial

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
David E Thaler ◽  
John Carroll ◽  
Jeffrey Saver ◽  
Richard Smalling ◽  
Diane Book ◽  
...  
Keyword(s):  
Recurrent Events ◽  
Statistical Significance ◽  
Cryptogenic Stroke ◽  
Standard Of Care ◽  
Primary Analysis ◽  
Intention To Treat ◽  
Long Term Follow Up ◽  
Pfo Closure

Introduction: The RESPECT trial evaluated the superiority of patent foramen ovale (PFO) closure over standard-of-care medical management (MM) in patients with PFO and cryptogenic stroke (CS). Hypothesis: Analysis of stroke mechanisms and topography of recurrent events will provide insight into the clinical efficacy of PFO closure. Methods: RESPECT is a prospective, multicenter, randomized event-driven trial of PFO closure vs. MM in patients with CS and PFO. Patients were randomized to treatment in a 1:1 ratio. The primary results were analyzed and reported when the target of 25 events were adjudicated (NEJM 2013; 368:1092-100). At that time, mean follow-up was 2.6 years, range 0-8.1 years. Prospective follow-up has continued. Recurrent strokes were assigned phenotypes using the ASCOD system by investigators blinded to treatment assignment. Results: 980 subjects were randomized to PFO closure (n=499) or MM (n=481). The primary analysis in the intention-to-treat population after a mean follow-up of 2.6 years exhibited a hazard ratio of 0.49 favoring closure that did not reach statistical significance (p=0.08). The per-protocol cohort demonstrated a significant reduction in the primary endpoint in favor of closure (HR 0.37, p=0.03). Among the initial 25 recurrent ischemic strokes, MM patients more often had superficial or multiple-penetrator territory infarcts (12 vs 4) and infarcts of larger size (69% vs 14%, p=0.06). Since the primary results report, follow-up has continued for an additional 3.5 years and additional recurrent infarcts have been observed. Long-term stroke rates, phenotyping, and topography will be presented. Conclusions: Our prior reports suggest that PFO closure was associated with prevention of stroke subtypes particularly associated with PFO, including superficial and larger infarcts. Long-term safety, efficacy, and stroke mechanisms, with >4000 patient-years of follow-up will be presented.

scholarly journals Importance of Persistent Right-to-Left Shunt After Patent Foramen Ovale Closure in Cryptogenic Stroke Patients

2020 ◽  
Vol 47 (4) ◽  
pp. 244-249
Author(s):  
Lu He ◽  
Gesheng Cheng ◽  
Yajuan Du ◽  
Yushun Zhang
Keyword(s):  
Transient Ischemic Attack ◽  
Patent Foramen Ovale ◽  
Valsalva Maneuver ◽  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
Ischemic Attack ◽  
Pfo Closure

Percutaneous closure of patent foramen ovale (PFO) is widely performed to prevent recurrent stroke or transient ischemic attack in patients with cryptogenic stroke. However, the influence of different degrees of right-to-left shunting (RLS) has rarely been reported. We retrospectively evaluated the cases of 268 patients with cryptogenic stroke who underwent PFO closure at our hospital from April 2012 through April 2015. In accordance with RLS severity, we divided the patients into 2 groups: persistent RLS during normal breathing and the Valsalva maneuver (n=112) and RLS only during the Valsalva maneuver (n=156). Baseline characteristics, morphologic features, and procedural and follow-up data were reviewed. The primary endpoint was stroke or transient ischemic attack. More patients in the persistent group had multiple or bilateral ischemic lesions, as well as a larger median PFO diameter (2.5 mm [range, 1.8–3.9 mm]) than did patients in the Valsalva maneuver group (1.3 mm [range, 0.9–1.9 mm]) (P &lt;0.001). Atrial septal aneurysm was more frequent in the persistent group: 25 patients (22.3%) compared with 18 (11.5%) (P=0.018). Three patients in the persistent group had residual shunting. The annual risk of recurrent ischemic stroke was similar between groups: 0.298% (persistent) and 0.214% (Valsalva maneuver). Our findings suggest that patients with persistent RLS have more numerous severe ischemic lesions, larger PFOs, and a higher incidence of atrial septal aneurysm than do those without. Although our persistent group had a greater risk of residual shunting after PFO closure, recurrence of ischemic events did not differ significantly from that in the Valsalva maneuver group.

P3710Long term follow-up in a real-world study cohort after patent foramen ovale closure

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
C Hamm ◽  
O Doerr ◽  
M Haas ◽  
L Schulz ◽  
T Koerschgen ◽  
...  
Keyword(s):  
Real World ◽  
Patent Foramen Ovale ◽  
Recurrent Stroke ◽  
Controlled Trials ◽  
Foramen Ovale ◽  
Randomized Controlled ◽  
Cerebrovascular Occlusive Disease ◽  
Pfo Closure

Abstract Background Patent foramen ovale (PFO) closure is the treatment of choice after cryptogenic stroke according recent evidence. The indication is based on results of several randomized controlled trials; however, the results of these trials may not be extrapolated to a real-world clinical setting. Therefore, the aim of the present study was to evaluate long-term outcome regarding recurrent stroke, migraine, and/or peripheral embolism in patients after PFO closure. Methods We retrospectively analyzed outcomes of consecutive patients undergoing PFO closure from 2011 to 2018 at two interventional sites with respect to periprocedural events occurring during hospitalization and long-term follow-up. Follow-up data were collected from outpatient visits or telephone interviews. Results The analysis included 214 consecutive patients (mean age 52 years; 58% male). The follow-up rate was 96% and the mean follow-up time was 38 (SD 22) months. The index vascular event leading to PFO closure was stroke (n=190; 89%), including patients with repetitive stroke (n=36), embolic myocardial infarction (n=21), and migraine (n=3). One quarter (24.6%) of the population studied had an atrial septal aneurysm (>15 mm). Procedural success was achieved in 98%. There were no procedure-related strokes or deaths. Periprocedural complications occurred in 16 patients (7%): two cases of pericardial tamponade, seven complications at the access site mainly caused by bleeding, two cases of transient atrial fibrillation, and five other complications. The Amplatz Septal Occluder™ was used in two thirds (64.5%) of the cases and the Gore Cardioform™ device in one third (28.6%). Four (2%) patients died during follow-up. None of these patients experienced a recurrent stroke. Ten (5%) other patients experienced a recurrent stroke. Patients with recurrent stroke events were older than patients without recurrent stroke (mean 62.6 [SD 8.8] years vs. mean 52.2 [SD 13.8] years; p=0.015) and had a higher rate of preexisting cerebrovascular occlusive disease (5 [50%] vs. 10 [6%]; p<0.0001). There was no difference in risk for recurrent stroke between patients with one prior stroke and more than one stroke before PFO closure (p=0.71). Atrial fibrillation occurred in 6.6% of the patients during follow-up, but only one of these patients had recurrent stroke. No other anatomic and vascular risk factors or antithrombotic treatments were identified as being predictive of embolic events after closure. Conclusion In this real-world PFO closure cohort the recurrent stroke rate is low, although it is higher than reported in the recent randomized controlled trials. Recurrent strokes after PFO closure may reflect additional comorbid risk factors such as age or cerebrovascular occlusive disease that are unrelated to the potential for paradoxical embolism.

scholarly journals Coronary artery aneurysms: outcomes following medical, percutaneous interventional and surgical management

Open Heart ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. e001440
Author(s):  
Shameer Khubber ◽  
Rajdeep Chana ◽  
Chandramohan Meenakshisundaram ◽  
Kamal Dhaliwal ◽  
Mohomed Gad ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Surgical Management ◽  
Medical Management ◽  
Cox Regression ◽  
Artery Bypass ◽  
Management Strategies ◽  
Coronary Artery Aneurysms ◽  
Kaplan Meier

BackgroundCoronary artery aneurysms (CAAs) are increasingly diagnosed on coronary angiography; however, controversies persist regarding their optimal management. In the present study, we analysed the long-term outcomes of patients with CAAs following three different management strategies.MethodsWe performed a retrospective review of patient records with documented CAA diagnosis between 2000 and 2005. Patients were divided into three groups: medical management versus percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We analysed the rate of major cardiovascular and cerebrovascular events (MACCEs) over a period of 10 years.ResultsWe identified 458 patients with CAAs (mean age 78±10.5 years, 74.5% men) who received medical therapy (N=230) or underwent PCI (N=52) or CABG (N=176). The incidence of CAAs was 0.7% of the total catheterisation reports. The left anterior descending was the most common coronary artery involved (38%). The median follow-up time was 62 months. The total number of MACCE during follow-up was 155 (33.8%); 91 (39.6%) in the medical management group vs 46 (26.1%) in the CABG group vs 18 (34.6%) in the PCI group (p=0.02). Kaplan-Meier survival analysis showed that CABG was associated with better MACCE-free survival (p log-rank=0.03) than medical management. These results were confirmed on univariate Cox regression, but not multivariate regression (OR 0.773 (0.526 to 1.136); p=0.19). Both Kaplan-Meier survival and regression analyses showed that dual antiplatelet therapy (DAPT) and anticoagulation were not associated with significant improvement in MACCE rates.ConclusionOur analysis showed similar long-term MACCE risks in patients with CAA undergoing medical, percutaneous and surgical management. Further, DAPT and anticoagulation were not associated with significant benefits in terms of MACCE rates. These results should be interpreted with caution considering the small size and potential for selection bias and should be confirmed in large, randomised trials.

scholarly journals A Modified Anatomical-Functional-RoPE (AF-RoPE) Score Improves Patient Selection for Patent Foramen Ovale Closure

2018 ◽  
Vol 12 ◽  
Author(s):  
Gianluca Rigatelli ◽  
Marco Zuin ◽  
Fabio Dell'Avvocata ◽  
Luigi Pedon ◽  
Roberto Zecchel ◽  
...  
Keyword(s):  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Stepwise Logistic Regression ◽  
Foramen Ovale ◽  
Stroke Patients ◽  
Stepwise Logistic Regression Analysis ◽  
Grade 5 ◽  
Risk Patients ◽  
Selection For ◽  
Pfo Closure

Background: RoPE score calculator has been proposed to stratify the patients in whom PFO may be considered not a confounding but presumably a causative factor.Objectives To implement the RoPE score calculator.Methods.  We reviewed the medical data of 1040 consecutive patients (mean age 47.3±17.1 years) prospectively enrolled in two centres over a 13 years period for management of PFO in order to select anatomic and functional parameters to be incorporated in a modified RoPE score. A scoring system (AF-RoPE) was build up and applied in a prospective blind fashion to a cohort of  406 consecutive patients (mean age 43.6 ±17. 5 years, 264 females)  with cryptogenic stroke and PFO comparing its performance with the standard RoPE.Results. Multiple stepwise logistic regression analysis demonstrated that right-to-left  (R-L) shunt at rest (OR 5.9), huge ASA (> 20 mm) (OR 3.9), long tunnelized PFO (> 12 mm) (OR 3.5), and massive R-L shunt (grade 5 by TCD) (OR 1.9) conferred the highest risk of recurrent stroke. The AF-RoPE score  resulted in a more precise separation of patients with RoPE score 8-10. Patients with AF-RoPE score > 11 had more stroke recurrences and more diffuse area of stroke on MRI in the medical history than those ranging 10 to 7 or less.Conclusion. The AF-RoPE score discriminates cryptogenic stroke patients who are more likely to develop recurrent stroke compared with a RoPE score between 8-10.  These highest risk patients may be more likely to benefit from PFO closure.

scholarly journals Outcome and Complications of MR Guided Focused Ultrasound for Essential Tremor: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 12 ◽  
Author(s):  
Mohit Agrawal ◽  
Kanwaljeet Garg ◽  
Raghu Samala ◽  
Roopa Rajan ◽  
Vikas Naik ◽  
...  
Keyword(s):  
Essential Tremor ◽  
Focused Ultrasound ◽  
Rating Scale ◽  
Meta Analysis ◽  
Post Procedure ◽  
Standard Mean Difference ◽  
Significant Difference ◽  
Long Term Follow Up

Background: Magnetic resonance guided focused ultrasound (MRgFUS) is a relatively novel technique to treat essential tremor (ET). The objective of this review was to analyze the efficacy and the safety profile of MRgFUS for ET.Methods: A systematic literature review was done. The post procedure changes in the Clinical Rating Scale for Tremor (CRST) score, hand score, disability and quality of life scores were analyzed.Results: We found 29 studies evaluating 617 patients. DTI based targeting was utilized in six cohorts. A significant difference was observed in the pooled standard mean difference between the pre and postoperative total CRST score (p-value &lt; 0.001 and 0.0002), hand score (p-value 0.03 and 0.02); and the disability at 12 months (p-value 0.01). Head pain and dizziness were the most in procedure complications. The immediate pooled proportion of ataxia was 50%, while it was 20% for sensory complications, which, respectively, declined to 31 and 13% on long term follow up. A significant reduction (p = 0.03) in immediate ataxia related complications was seen with DTI targeting.Conclusion: MRgFUS for ET seems to be an effective procedure for relieving unilateral tremor. Use of DTI based targeting revealed a significant reduction in post procedure ataxia related complications as compared to traditional targeting techniques. Analysis of other complications further revealed a decreasing trend on follow up.

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