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.

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.

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.

Relevance of supraventricular runs detected after cerebral ischemia

Neurology ◽  
2017 ◽  
Vol 89 (15) ◽  
pp. 1545-1552 ◽  
Author(s):  
Mark Weber-Krüger ◽  
Constanze Lutz ◽  
Antonia Zapf ◽  
Raoul Stahrenberg ◽  
Joachim Seegers ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cerebral Ischemia ◽  
Ecg Monitoring ◽  
Holter Ecg ◽  
Acute Cerebral Ischemia ◽  
Temporal Phenomenon ◽  
Long Term Follow Up ◽  
Recurrent Strokes

Objective:Prolonged ECG monitoring after stroke frequently reveals short paroxysmal atrial fibrillation (pAF) and supraventricular (SV) runs. The minimal duration of atrial fibrillation (AF) required to induce cardioembolism, the relevance of SV runs, and whether short pAF results from cerebral damage itself are currently being debated. We aimed to study the relevance of SV runs and short pAF detected by prolonged Holter ECG after cerebral ischemia during long-term follow-up.Methods:Analysis is from the prospective Find-AF trial (ISRCTN46104198). We included patients with acute cerebral ischemia. Those without AF on admission received 7-day Holter ECG monitoring. We differentiated patients with AF on admission (AF-adm), with pAF (>30 seconds), with SV runs (>5 beats but <30 seconds in a 24-hour ECG interval), and without SV runs (controls). During follow-up, those with baseline pAF received another 7-day Holter ECG to examine AF persistence.Results:A total of 254 of 281 initially included patients were analyzed (mean age 70.0 years, 45.3% female). Forty-three (16.9%) had AF-adm. A total of 211 received 7-day Holter ECG monitoring: 27 (12.8%) had pAF, 67 (31.8%) had SV runs, and 117 (55.5%) were controls. During a mean 3.7 years of follow-up, the SV runs group had more recurrent strokes (p = 0.04) and showed numerically more novel AF (12% vs 5%, p = 0.09) than the controls. Seventy-five percent of the patients with manifest pAF detected after cerebral ischemia still had AF during follow-up (50% paroxysmal, 50% persisting/permanent).Conclusions:Patients with cerebral ischemia and SV runs had more recurrent strokes and numerically more novel AF during follow-up and could benefit from further prolonged ECG monitoring. pAF detected after stroke is not a temporal phenomenon.

scholarly journals Patent foramen ovale closure following cryptogenic stroke or transient ischaemic attack: Long-term follow-up of 301 cases

2015 ◽  
Vol 86 (6) ◽  
pp. 1078-1084 ◽  
Author(s):  
Mikaeil Mirzaali ◽  
Maureen Dooley ◽  
Dylan Wynne ◽  
Nina Cooter ◽  
Lorraine Lee ◽  
...  
Keyword(s):  
Transient Ischaemic Attack ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Foramen Ovale ◽  
Long Term Follow Up ◽  
Ischaemic Attack

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.

Low Morbidity after Extracranial-Intracranial Bypass Operation. The Danish Extracranial-Intracranial Bypass Study: A Nationwide Survey

2018 ◽  
Vol 45 (5-6) ◽  
pp. 252-257 ◽  
Author(s):  
Paul von Weitzel-Mudersbach ◽  
Grethe Andersen ◽  
Sverre Rosenbaum
Keyword(s):  
Clinical Symptoms ◽  
Recurrent Stroke ◽  
Stroke Rate ◽  
Bypass Operation ◽  
Perioperative Stroke ◽  
Bypass Patency ◽  
Long Term Follow Up ◽  
The Mean

Background: Patients with symptomatic atherosclerotic carotid artery occlusion (SACAO) have a high risk of a recurrent stroke. Extracranial-intracranial bypass (EC-IC bypass) has been shown not to improve outcome compared with medical treatment alone because long-term prevention of recurrent stroke in operated patients was offset by high perioperative stroke rates. We report our experience with EC-IC bypass operated at an experienced high-volume centre. Methods: We conducted a nationwide observational study of EC-IC bypass patients operated in the years 2007–2016 due to SACAO with ongoing clinical symptoms or progression on MRI and severe haemodynamic failure (SHF). Perioperative stroke and death within 30 days after the operation, ipsilateral stroke, bypass patency, transient ischaemic attack, and all-stroke events and deaths during long-term follow-up were registered prospectively. Results: EC-IC bypass was performed in 48 patients with SHF and SACAO. The mean age was 64 (45–83) years. The mean follow-up was 3.6 years. The stroke rate after 30 days was 4.2%. No further ipsilateral strokes occurred during follow-up. Clinical symptoms arrested in all patients. Bypass patency rate was 94%. Conclusions: The perioperative stroke rate in EC-IC bypass operation, performed at a highly experienced centre, was low. During long-term follow-up, no ipsilateral stroke occurred. Consequently, EC-IC-bypass should still be considered for selected patients with SACAO, if operation can be carried out in experienced centres with low perioperative morbidity.

scholarly journals Penetrance of hypertrophic cardiomyopathy and outcome in sarcomeric mutation carriers

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
M Lorenzini ◽  
G Norrish ◽  
E Field ◽  
J.P Ochoa ◽  
M Cicerchia ◽  
...  
Keyword(s):  
Hypertrophic Cardiomyopathy ◽  
Gene Mutations ◽  
Standard Of Care ◽  
Current Standard ◽  
Mutation Carriers ◽  
Disease Penetrance ◽  
Long Term Follow Up ◽  
Few Data

Abstract Background Predictive genetic screening of the first degree relatives of patients with hypertrophic cardiomyopathy (HCM) caused by sarcomere protein (SP) gene mutations is current standard of care, but there are few data on long-term outcomes in mutation carriers without HCM. Purpose To establish the role of sex and genotype in HCM penetrance as well as the rate of major adverse clinical events in SP mutation carriers and following the diagnosis of HCM. Methods Retrospective analysis of consecutive adult and paediatric SP mutation carriers identified during family screening and who did not fulfill diagnostic criteria for HCM at first evaluation. Results 321 individuals from 170 families [median age first evaluation 15.2 years (IQR 7.3–32.6); 153 (47.7%) males] were evaluated. Causal SP genes were: MYBPC3 (n=133 (41.4%)), MYH7 (n=77 (24.0%)), TNNI3 (n=51 (15.9%)), TNNT2 (n=40 (12.5%)), TPM1 (n=9 (2.8%)), MYL2 (n=6 (1.9%)), and ACTC1 (n=1 (0.3%)); 4 (1.3%) carried multiple mutations. After a median follow up of 7.4 years (IQR 2.5–12.7), 89 (27.7%) patients developed HCM. Disease penetrance at the age of 50 years was 47% (95% CI 38%-56%). One hundred and fifty three (47.7%) individuals underwent cardiac magnetic resonance (CMR) imaging; among those diagnosed with HCM, 22/89 (24.7%) fulfilled criteria on CMR but not echocardiography. In a multivariable model adjusted for genotype, follow up duration and evaluation with CMR, independent predictors of HCM development were male sex (HR 3.11; CI 1.82–5.32) and abnormal ECG (HR 7.87; CI 4.43–13.97). Patients with MYH7 and multiple mutations were more likely to develop HCM than those with MYBPC3 mutations (HR 2.03; CI 1.04–3.96 and HR 10.13; CI 1.40–72.92, respectively). Disease penetrance was lowest in carriers of TNNI3 mutations (HR 0.13; CI 0.03–0.48). There were no major adverse events in individuals without HCM. Following the diagnosis of HCM, the combined rate of all-cause death, appropriate defibrillator shock or resuscitated cardiac arrest was 1.1%/year [median follow up 4.0 years (IQR 2.1–8.9)]. Conclusions Approximately 50% of SP mutation carriers develop HCM by the age of 50 and become prone to disease complications during long-term follow-up. Sex, MYH7 mutations and the presence of an abnormal ECG are associated with a higher risk of disease development. CMR should be employed systematically in long-term screening. HCM penetrance by sex Funding Acknowledgement Type of funding source: None

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