Recurrent cerebrovascular events in patients after percutaneous closure of patent foramen ovale.

BACKGROUND: Recent published trials have shown the efficacy of transcatheter closure of patent foramen ovale (PFO) for preventing recurrent cryptogenic cerebrovascular events. However, the risk of recurrent cerebrovascular events (rCVEs) is up to 5.7%, and the etiology is unclear. OBJECTIVE: This study aimed to investigate the risk factors for rCVEs after closure of PFO during long-term follow-up. METHODS: In our center, 282 consecutive patients underwent PFO closure because of a cryptogenic cerebrovascular event between 2006 and 2014. Their Risk of Paradoxical Embolism (RoPE) score was calculated retrospectively. We followed up with the patients by telephone, using hospital records to identify those who suffered from rCVEs. Patients with rCVEs were matched with two control patients of the same sex and RoPE score without rCVEs who underwent PFO closure at approximately the same time. The patients with rCVEs and controls participated in a clinical examination, including contrast transthoracic echocardiography (TTE) and Holter electrocardiography, to investigate the possible cause of rCVEs compared with controls. RESULTS: Fourteen (5%) out of the 282 consecutive patients who underwent PFO closure suffered from rCVEs during a mean follow-up of 8.4 years (1.7 rCVEs per 100 patient-years). The median RoPE score of the patients was 7. Recurrent CVE occurred in 3.2 patients per 100 patient-years in patients with residual shunting compared with 0.8 patients per 100 patient-years in those without residual shunt. These patients were on antiplatelet treatment or without any effective anticoagulant treatment at the time rCVE occurred. The risk ratio of rCVEs in patients with residual shunting was 2.9-times higher than in patients without residual shunting (95% CI: 1.4-6.1) at follow-up visit. Four patients who had the BioSTAR device implanted suffered from an rCVE despite lack of residual shunting. CONCLUSIONS: This study indicates that residual shunting and choice of the device may be the major reasons for rCVEs.

Quality of life after percutaneous closure of patent foramen ovale in patients after cryptogenic stroke compared to a normative sample.

AIMS: Despite the widespread use of percutaneous closure of patent foramen ovale (PFO) in patients after a cryptogenic stroke, little is known about its impact on health-related quality of life (HRQoL). The aim of this study was to assess HRQoL in these patients compared to PFO patients not considered candidates for percutaneous closure, and to a normal population. METHODS AND RESULTS: A total of 402 patients with cryptogenic stroke or transient ischaemic attack (TIA) who had been referred to our center for PFO closure were invited to a long-term clinical follow-up (mean follow-up 5.5 years; range 3-13 years). HRQoL was assessed using the SF-36 Health Survey and data were compared with an age- and gender-matched reference group from the Swedish SF-36 normative database. Fifteen patients had died and 43 did not answer the SF-36. Of the remaining 344 patients, 208 had undergone PFO closure, and 136 had not. The closure group and reference group reported similar HRQoL levels. However, the non-closure group showed significantly lower HRQoL in role limitation - physical, vitality, general health, mental health (p < 0.05) and social functioning (p = 0.05) than the reference group and also had significantly lower scores than the closure group, correcting for age differences, on physical functioning, role limitation - physical, vitality and general health (p < 0.05). CONCLUSIONS: Non-closure patients had lower HRQoL than their counterparts in the normal population and the closure group. Percutaneous PFO closure is associated with a favorable quality of life.

Recurrent stroke in patients with patent foramen ovale: An observational prospective study of percutaneous closure of PFO versus non-closure.

AIMS: Observational studies favor percutaneous closure of patent foramen ovale (PFO) over medical therapy to reduce the risk of recurrent stroke, whereas randomized clinical trials have not shown significant differences. This study aims to compare long-term outcomes of PFO closure versus non-closure. METHODS AND RESULTS: Patients with PFO and stroke considered for PFO closure were invited to a long-term clinical follow-up. Of the 314 patients, 151 (48%) were accepted for closure and 163 (52%) were not accepted (mean age 50 vs. 58 years). The cumulative incidence of all-cause mortality, stroke or transient ischemic attacks (TIAs) for closure vs. non-closure under a mean follow-up time of five years was 10.6% (16 events) vs. 12.9% (21 events), p=0.53. Six patients, 3.7% vs. 3.6%, died in each group, but no deaths were associated with PFO closure, recurrent stroke or TIA. The incidence of recurrent stroke or TIA for closure vs. non-closure was 6.6% (10 events) vs. 9.2% (15 events), p=0.63. The respective event rates for stroke were 3.9% (6 events) vs. 5.5% (9 events), p=0.50 and for TIA, 2.6% (4 events) vs. 3.7% (6 events), p=0.59. CONCLUSION: PFO closure was associated with a low risk of recurrent events; however, compared to the non-closure group, no significant differences could be demonstrated. Careful patient selection can avoid under- as well as over-treatment of PFO patients.

Absence of significant aortic regurgitation seven years after closure of patent foramen ovale.

BACKGROUND: It has been suggested that there is an increase in aortic regurgitation (AR) in the short and medium term after percutaneous closure of patent foramen ovale (PFO). The aim of this study is to determine the long-term effect of percutaneous closure of PFO on the prevalence of AR. METHODS: Patients with cryptogenic stroke or transient ischemic attack who had undergone percutaneous closure of PFO more than five years before the study were invited to an echocardiographic examination. RESULTS: Out of 83 invited patients, 64 accepted the invitation and were examined with echocardiography. Mild AR was found in one patient (2%), but this was already evident in the patient's echocardiographic result before PFO closure. Trace AR was detected in 11 patients (17%). No case of moderate or severe AR was detected. Patients with AR were more often hypertensive (six out of 12 patients with AR, compared to nine of the 52 without AR, p = 0.025), and the indexed sinus of Valsalva was larger in patients with AR (18.6 mm/m2, SD 1.6, as compared to 17.3 mm/m2, SD 1.6, p = 0.02). CONCLUSION: In this long-term study with a minimum follow-up of 5.6 years and a mean of 7.1 years, we found negligible levels of AR. Where present, AR was associated with hypertension and mild dilatation of the aortic root, but there was no indication that device closure per se increased the risk of developing AR.

Multidisciplinary management of patent foramen ovale (PFO) and cryptogenic stroke/TIA.

PURPOSE: Patent foramen ovale (PFO) has been implicated as a risk factor for cryptogenic ischemic stroke (CS). However, there is still a lack of widely accepted, undisputed indications for PFO closure. The present study describes the concept of the multidisciplinary PFO conference and a decision making process for closure versus no closure that was developed into a formalized clinical algorithm, and presents the results of implementing these, in terms of number and proportion of PFO closures as well as repeat referrals. DESIGN: Five specialists in neurology, cardiology, internal medicine, thromboembolism, and echocardiography evaluated the clinical data of 311 patients at PFO conferences during 2006 to 2009. The main criteria for closure were patients with first-ever CS with PFO and atrial septal aneurysm, or patients with recurrent CS and PFO without atrial septal aneurysm. RESULTS: A total of 143 patients (46%) were accepted for closure and 167 patients were rejected. Patients accepted for closure were younger (mean 50 years versus 58 years) (P < 0.001). The acceptance rate for PFO closure was similar throughout these years, with an average of 45%. Three of 167 patients (1.8%) initially rejected for PFO closure were re-referred due to recurrent stroke, and the PFO closure was subsequently performed. CONCLUSION: The acceptance rate of less than 50% in the present study underscores the complex relationship between CS and PFO. Whatever the criteria used for PFO closure, any unit caring for these patients needs to have a rigorous process to avoid overtreatment as well as undertreatment and to ensure that personal preferences and economic incentives do not steer the selection process. Our algorithm provides a stable acceptance rate and a low rate of repeat referrals.

Seven-year follow-up of percutaneous closure of patent foramen ovale.

BACKGROUND: Observational studies favor percutaneous closure of patent foramen ovale (PFO) over medical treatment to reduce recurrent stroke while randomized trials fail to demonstrate significant superiority of percutaneous PFO closure. Few long-term studies are available post PFO closure. This study reports long-term clinical outcomes after percutaneous PFO closure. METHODS: Between 1997 and 2006, 86 consecutive eligible patients with cerebrovascular events, presumably related to PFO, underwent percutaneous PFO closure. All 86 patients were invited to a long-term follow-up, which was carried out during 2011 and 2012. RESULTS: Percutaneous PFO closure was successfully performed in 85 of 86 patients. The follow-up rate was 100%. No cardiovascular or cerebrovascular deaths occurred. Two patients (both women) died from lung cancer during follow-up. Follow-up visits were conducted for 64 patients and the remaining 20 patients were followed up by phone. The mean follow-up time was 7.3 years (5 to 12.4 years). Mean age at PFO closure was 49 years. One patient had a minor stroke one month after PFO closure and a transient ischemic attack (TIA) two years afterwards. One other patient suffered from a TIA six years after closure. No long-term device-related complications were observed. CONCLUSIONS: Percutaneous PFO closure was associated with very low risk of recurrent stroke and is suitable in most patients. We observed no mortality and no long-term device-related complications related to PFO closure, indicating that percutaneous PFO closure is a safe and efficient treatment even in the long term.