Impact of Echocardiographic Parameters on Recurrent Stroke in the Randomized REDUCE PFO Cryptogenic Stroke Trial

Author(s):  
Bénédicte Lefebvre ◽  
Suveeksha Naidu ◽  
Ashwin S. Nathan ◽  
Zhen Chen ◽  
Bonnie Ky ◽  
...  
Author(s):  
Gianluca Rigatelli ◽  
Marco Zuin ◽  
Fabio Dell'Avvocata ◽  
Luigi Pedon ◽  
Roberto Zecchel ◽  
...  

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.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Richard W Smalling ◽  
John Carroll ◽  
Jeffrey Saver ◽  
David Thaler ◽  
Todd Bull ◽  
...  

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.


Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Richard Jung ◽  
Benny Kim ◽  
Joseph Massaro ◽  
Anthony J Furlan

Background: Cryptogenic stroke may have several etiologies including paradoxical embolism through a patent foramen ovale (PFO). A cardiac source of embolism may be suggested by multiple infarcts, sometimes hemorrhagic, in different vascular distributions or a cortical wedge shaped infarct. We report the baseline diffusion weighted MRI (DWMRI) characteristics in patients with cryptogenic stroke and a patent foramen ovale (PFO) from the CLOSURE I trial. Methods: CLOSURE I compared device closure versus medical therapy for secondary prevention in patients with cryptogenic TIA or stroke and a PFO. Of 909 patients randomized, 562 patients demonstrated acute infarcts on baseline DWMRI and are included in this analysis. Multivariate proportional hazard Cox regression compared imaging subgroups with remaining randomized patients Results: Single infarcts were found in 62% of patients. Of these, 61% were anterior circulation, 30% posterior, and 8.5% were of uncertain territory. Of the anterior circulation infarcts, 40% were cortical, 36% subcortical, and 24% affected both the cortical and subcortical regions. Of the posterior circulation infarcts, 45% were thalamic or cerebellar. Of 562 patients, 18.5% had a single subcortical lesion <1.5cm in diameter and met the radiological definition of an acute lacunar infarct. Multiple infarcts were found in 38%. Infarcts in a single vascular territory were found in 23%, often in the anterior circulation (66%). Infarcts in multiple vascular territories were found in 15%. Hemorrhagic infarction was present in 9%. Adjusting for patient characteristics, no significant difference in 2 year rate of TIA, stroke or death was found compared to remaining randomized patients. Discussion: The specificity of infarct patterns for embolism in patients with cryptogenic stroke and a PFO is uncertain. We found no significant relationship between lacunar or subcortical infarction and the risk of recurrent TIA or stroke. Baseline infarct patterns on DWMRI in patients with cryptogenic stroke and PFO may not be useful in predicting recurrent stroke risk or determining best prevention therapy.


BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e037573
Author(s):  
Peter Magnusson ◽  
Adam Lyren ◽  
Gustav Mattsson

ObjectiveIn stroke survivors, atrial fibrillation (AF) is typically evaluated solely by short-term ECG monitoring in the stroke unit. Prolonged continuous ECG monitoring or insertable cardiac monitors require substantial resources. Chest and thumb ECG could provide an alternative means of AF detection, which in turn could allow prompt anticoagulation to prevent recurrent stroke. The objective of this study was to assess the yield of newly diagnosed AF during 28 days of chest and thumb ECG monitoring two times per day in cryptogenic stroke.MethodsThis study, Transient ECG Assessment in Stroke Evaluation, included patients who had a stroke from Region Gävleborg, Sweden, between 2017 and 2019. Patients with a recent ischaemic stroke without documented AF (or other reasons for anticoagulation) before or during ECG evaluation in the stroke unit were evaluated using the Coala Heart Monitor connected to a smartphone application for remote monitoring.ResultsThe prespecified number of 100 patients (mean age 67.6±10.8 years; 60% men) was analysed. In nine patients (9%, number needed to screen 11) AF but no other significant atrial arrhythmias (>30 s) was diagnosed. The mean CHA2DS2-VASc score was similar among patients with AF and no AF (4.9±1.1 vs 4.3±1.3; p=0.224) and patients with AF were older (74.3±9.0 vs 66.9±10.8; p=0.049). Patients performed on average 90.1%±15.0% of scheduled transmissions.ConclusionIn evaluation of cryptogenic stroke, 9% of patients had AF detected using chest and thumb ECG two times per day during 1 month. In many stroke survivors, this is a feasible approach and they will be potentially protected from recurrent stroke by anticoagulation treatment.Trial registration numberNCT03301662.


2019 ◽  
Vol 34 (2) ◽  
pp. 47-53
Author(s):  
S. E. Mamchur ◽  
E. A. Ivanitskiy ◽  
O. M. Polikutina ◽  
T. Yu. Chichkova ◽  
I. N. Mamchur ◽  
...  

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.


Author(s):  
Lennox Jerzyna ◽  
Abhisheik Prashar ◽  
George Youssef ◽  
Mark Sader

Abstract Background Percutaneous patent foramen ovale (PFO) closure has been well established in the secondary prevention of cryptogenic stroke with overall low rates of procedural complications. One such complication is PFO closure device thrombus formation which is now rarely reported with newer generation devices. Case Summary We present the unusual case of a 59 year old woman with myelofibrosis who developed late onset recurrent embolic strokes related to Amplatzer PFO closure device thrombus whilst therapeutically anticoagulated on Warfarin. Surgical management was deemed too high risk and our patient was conservatively managed with enoxaparin. Serial trans-thoracic echocardiography demonstrated reduction in thrombus size and the patient had no further neurological events. Discussion Overall the risk of serious complications following percutaneous PFO closure, such as device-associated thrombus, remains low. The risk of thrombus formation in patients with hypercoagulable states is not well characterised. Despite good evidence for the efficacy in preventing recurrent cryptogenic stroke, the role of PFO closure in addition to anticoagulation is unclear. Given this uncertain benefit of PFO closure in anticoagulated patients and the unclear risk profile, patient selection and thorough preprocedural evaluation is vital when assessing the appropriateness of percutaneous PFO closure.


2020 ◽  
Vol 35 (4) ◽  
pp. 284-287
Author(s):  
Á. Lambea Gil ◽  
H. Tejada Meza ◽  
C.R. López Perales ◽  
J. Artal Roy ◽  
J. Marta Moreno

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