scholarly journals A severe right-to-left intracardiac shunt after NobleStitch failure: when a device is needed

2020 ◽  
Vol 4 (5) ◽  
pp. 1-4
Author(s):  
Daniela Trabattoni ◽  
Sebastiano Gili ◽  
Giovanni Teruzzi ◽  
Gloria Tamborini

Abstract Background Transcatheter closure of patent foramen ovale (PFO) has been demonstrated to be superior to medical therapy in stroke prevention in selected patients. Beyond traditional permanent metallic devices, NobleStitch EL, a suture-based system, has been developed as a potential alternative. Case summary A 50-year-old man underwent transcatheter closure of PFO with mild interatrial septal bulging and tunnel-like morphology with a NobleStitch device. A transthoracic echocardiography performed immediately after PFO closure showed residual shunt (RS), which persisted unchanged at staged controls, due to the inability of the delivery system to capture both the septum primum and the septum secundum. A second procedure was performed with the implantation of a Figulla Flex II 27/30 mm device, with no RS detectable at control echocardiography. Discussion The NobleStitch device is interesting in its concept, but several pitfalls may be encountered during its deployment. Opposite to permanent metallic devices, RSs after the procedure are not expected to decrease over time and should be managed with a different approach.

Author(s):  
X. Jin ◽  
Y. M. Hummel ◽  
W. T. Tay ◽  
J. F. Nauta ◽  
N. S. S. Bamadhaj ◽  
...  

Abstract Background Transcatheter atrial septal defect (ASD) and patent foramen ovale (PFO) closure might have opposite short- and long-term haemodynamic consequences compared with restricted interatrial shunt creation, which recently emerged as a potential treatment modality for patients with heart failure with preserved ejection fraction (HFpEF). Given the opposing approaches of ASD and PFO closure versus shunt creation, we investigated the early and sustained cardiac structural and functional changes following transcatheter ASD or PFO closure. Methods In this retrospective study, adult secundum-type ASD and PFO patients with complete echocardiography examinations at baseline and at 1‑day and 1‑year follow-up who also underwent transcatheter closure between 2013 and 2017 at the University Medical Centre Groningen, the Netherlands were included. Results Thirty-nine patients (mean age 48 ± standard deviation 16 years, 61.5% women) were included. Transcatheter ASD/PFO closure resulted in an early and persistent decrease in right ventricular systolic and diastolic function. Additionally, transcatheter ASD/PFO closure resulted in an early and sustained favourable response of left ventricular (LV) systolic function, but also in deterioration of LV diastolic function with an increase in LV filling pressure (LVFP), as assessed by echocardiography. Age (β = 0.31, p = 0.009) and atrial fibrillation (AF; β = 0.24, p = 0.03) were associated with a sustained increase in LVFP after transcatheter ASD/PFO closure estimated by mean E/e’ ratio (i.e. ratio of mitral peak velocity of early filling to diastolic mitral annular velocity). In subgroup analysis, this was similar for ASD and PFO closure. Conclusion Older patients and patients with AF were predisposed to sustained increases in left-sided filling pressures resembling HFpEF following ASD or PFO closure. Consequently, these findings support the current concept that creating a restricted interatrial shunt might be beneficial, particularly in elderly HFpEF patients with AF.


2021 ◽  
Vol 51 (1) ◽  
pp. 63-67
Author(s):  
Björn Edvinsson ◽  
◽  
Ulf Thilén ◽  
Niels Erik Nielsen ◽  
Christina Christersson ◽  
...  

Introduction: Interatrial communication is associated with an increased risk of decompression sickness (DCS) in scuba diving. It has been proposed that there would be a decreased risk of DCS after closure of the interatrial communication, i.e., persistent (patent) foramen ovale (PFO). However, the clinical evidence supporting this is limited. Methods: Medical records were reviewed to identify Swedish scuba divers with a history of DCS and catheter closure of an interatrial communication. Thereafter, phone interviews were conducted with questions regarding diving and DCS. All Swedish divers who had had catheter-based PFO-closure because of DCS were followed up, assessing post-closure diving habits and recurrent DCS. Results: Nine divers, all with a PFO, were included. Eight were diving post-closure. These divers had performed 6,835 dives (median 410, range 140–2,200) before closure, and 4,708 dives (median 413, range 11–2,000) after closure. Seven cases with mild and 10 with serious DCS symptoms were reported before the PFO closure. One diver with a small residual shunt suffered serious DCS post-closure; however, that dive was performed with a provocative diving profile. Conclusion: Divers with PFO and DCS continue to dive after PFO closure and this seems to be fairly safe. Our study suggests a conservative diving profile when there is a residual shunt after PFO closure, to prevent recurrent DCS events.


Angiology ◽  
2018 ◽  
Vol 70 (4) ◽  
pp. 325-331 ◽  
Author(s):  
Simone Vidale ◽  
Filippo Russo ◽  
Carlo Campana ◽  
Elio Agostoni

Cryptogenic strokes account for about 25% to 40% of total ischemic strokes, and 1 of the 3 of these have a patent foramen ovale (PFO). A meta-analysis concerning the effectiveness and safety of PFO closure in cryptogenic strokes or transient ischemic attacks (TIAs) was performed. We systematically searched Medline, Embase, and the Cochrane Library through April 2018. Eligible studies were randomized clinical trials. Primary and secondary end points were, respectively, stroke or TIA and stroke recurrences. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) for all end points using fixed- and random-effects meta-analyses. Data were included from 6 trials involving 3560 patients. In the pooled analysis, PFO closure was superior to medical treatment for both primary (RR: 0.39; 95% CI: 0.18-0.82; P < .02) and secondary end points (RR: 0.58; 95% CI: 0.44-0.76; P < .001). Transcatheter closure significantly increased the risk of new-onset atrial fibrillation (AF; RR: 5.74; P < .001). Percutaneous closure is superior to medical treatment in reducing stroke and TIA recurrence, even if with a significant risk increasing for new-onset AF. These findings suggest that transcatheter closure is indicated in patients with cryptogenic strokes and large PFO.


2014 ◽  
Vol 64 (5) ◽  
pp. 390-394 ◽  
Author(s):  
Luigi Biasco ◽  
Vincenzo Infantino ◽  
Fulvio Orzan ◽  
Silvia Vicentini ◽  
Chiara Rovera ◽  
...  

2021 ◽  
Vol 6 (1) ◽  
pp. 2
Author(s):  
Agnete Teivāne ◽  
Kristaps Jurjāns ◽  
Ainārs Rudzītis ◽  
Krista Lazdovska ◽  
Artūrs Balodis ◽  
...  

Background and Objectives: According to guidelines, patent foramen ovale (PFO) closure is recommended for secondary stroke prevention in patients with cryptogenic stroke. Paradoxial embolism from PFO-mediated right to left shunt has been described as the mechanism of stroke in these cases. The aim of the study was to determine whether PFO closure can be associated with improvement of complaints (headaches, fatigue, heart palpitations, dizziness, and visual impairment) and determine its long-term effectiveness on recurrent stroke risk reduction. Materials and Methods: A total of 103 patients were enrolled in a retrospective study and followed-up by phone up to five years after PFO closure. Standardized survey was conducted about their well-being, recurrent cerebrovascular events, and the use of prescribed medication. Patients were also followed up for residual shunts 24 h, 30 days, 1 year, and 2 years after PFO. The pathogenic ischemic stroke subtypes are determined using CCS (Causative Classification System for Ischemic Stroke). Results: Male patients accounted for 43.7% (n = 45). The mean age was—44.4 ± 13 (18–75). The most probable cause for cryptogenic stroke for 53.4% (n = 55) of patients with possible cardio-aortic embolism was PFO. Residual shunts were mostly observed in patients with Amplatzer occluder—87.5% (n = 14). There was correlation between residual shunt and increased risk of transient ischemic attack recurrence (p = 0.067). Five-years after PFO closure recurrent cerebrovascular events were reported in only 5.1% (n = 5) of patients, this difference is statistically relevant (p < 0.001). Out of 51 patients presented with complaints before PFO closure, 25.5% (n = 13) did not present with any complaints after PFO closure. Conclusions: PFO can be considered a possible risk factor for cryptogenic stroke. PFO closure is effective in reducing recurrent cerebrovascular events. Residual shunt after PFO closure increases the risk of transient ischemic attack recurrence. Amplatzer occluder device is associated with a higher risk for residual shunts after PFO closure. PFO closure can be associated with improvement of complaints.


2009 ◽  
Vol 5 (1) ◽  
pp. 71
Author(s):  
Bernhard Meier ◽  

The relative risk of a thromboembolic event is four-fold higher in the 25–35% of adults with a patent foramen ovale (PFO) and 33-fold higher in patients who also have an atrial septal aneurysm. The American PICSS trial showed a yearly incidence of stroke or death after an initial event of 5% with warfarin and 9% with acetylsalicylic acid. The presence of a PFO more than doubles the mortality rate in patients with clinically relevant pulmonary embolism. The risk of a PFO increases with age. Proof of effectiveness in migraine alleviation is likely to be achievable in a couple of years – much quicker than in prevention of paradoxical embolism. Percutaneous closure of PFO has been performed with various devices at the University Hospital Bern in Switzerland since April 1994, with over 1,000 patients treated. At the last available transoesophageal echocardiogram, a significant residual shunt persisted in 4% with Amplatzer devices and 17% with other devices. During follow-up, a recurrent embolic event was observed in 1.6% of patients per year – less than would be expected under medical treatment. Several randomised multicentre trials comparing catheter closure with medical treatment have been started. The PC and CLOSURE trials are in the follow-up phase; results cannot be expected before 2010, and they may well be ‘falsely’ neutral because the follow-up is rather short for the low-risk patients randomised. In a matched control study on patients with cryptogenic stroke and a PFO, 158 patients were treated medically and 150 concomitant patients underwent percutaneous PFO closure. At four years, PFO closure resulted in a trend towards risk reduction of death, stroke or transient ischaemic attack (TIA) (9 versus 24%; p=0.08) compared with medical treatment. The calculated occurrence of patients with cryptogenic strokes associated with a PFO amounts to somewhere between 100 and 300 per year and per million population, corresponding to more than 10% of yearly coronary angioplasty cases. Coronary and peripheral paradoxical emboli without prior exclusion of competing causes plus the presumed associations between PFO and migraine or decompression illness in divers open additional vast fields of potential indications for catheter closure. Finally, the linearly decreasing prevalence of a PFO with age suggests a weeding out of PFO carriers (unless spontaneous closure is assumed). A PFO represents a lethal threat that increases with age. It can be closed percutaneously in 15 minutes virtually free of complications. The patient can resume unrestricted physical activities a few hours after the intervention.


2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
M F Ramis Barcelo ◽  
C Mas Llado ◽  
A Rodriguez ◽  
I Valadron ◽  
M Noris ◽  
...  

Abstract Introduction Patent foramen ovale (PFO) has been associated with cryptogenic stroke. Percutaneous transcatheter PFO closure has been in development for the last years. In recent studies, it has shown a reduction of recurrent ischemic stroke events. Several manufactures of PFO device closure have developed guidelines for selection of device size based on anatomic measurements obtained through echocardiography. A study showed that according to the guidelines few patients had adequate tissue rim to allow device implantation, and yet almost all the patients had an effective closure. Purpose and methods The aim of this study was to evaluate the characteristics of PFO with transesophageal echocardiogram (TEE) (size, distance between foramen ovale-superior vena cava (FO-SVC) and distance between FO-aortic annulus (FO-AoAn)) and to determinate the correlation between the size of PFO device implanted and the theoretical device size according to the guidelines. We performed a retrospective study among patients who underwent a PFO closure procedure between 2006 and 2018. Results 42 patients were included, 55% male, mean age 56 years and mean BSA 1,83 m². The PFO mean diameter and length were 3 and 13 mm respectively. The majority of PFO were complex: 91% of patients had defects larger than 8mm and 36% had atrial septum aneurism. Characteristic of PFO were measured (Table). In older patients the distance between PFO-SVC and PFO-AoAn was larger and the septum secundum was thicker (p 0.02). The right-to-left shunt was moderated or severe in most cases (75%). The PFO closure device was successfully implanted in all patients. The majority of them received an Amplatzer PFO device (45%) followed by an Hyperion PFO device. The size of the device was 25mm in half of the patients followed by 30mm device. According to the guidelines, in 67% of the cases the wrong size was chosen and the mean size of the device should had been 30mm (SD ±5,2). TEE examination during follow up showed no residual or mild residual shunt in 80% of the patients. Residual shunt was more prevalent with larger devices (p 0.008) Conclusions These results showed that the size of PFO closure device implanted in our population differed from the size recommended by guidelines. Smaller devices have been used. According to our results, larger devices are associated with more residual shunt, which suggests that a different approach may be necessary to establish new protocols for PFO device closure Table Minimal Maximal Mean SD SVC (mm) 10 30 17.55 ±3,7 AoAn (mm) 9 23 14.1 ±3,5 Minimal and maximal distance between PFO-SVC and AoAn


2011 ◽  
Vol 6 (2) ◽  
pp. 173
Author(s):  
Joelle Kefer ◽  

Atrial septal abnormalities are common congenital lesions remaining asymptomatic until adulthood in a great number of patients. The most frequent atrial septal defects in adults are ostium secundum atrial septal defect (ASD) and patent foramen ovale (PFO), both approachable by transcatheter closure using device implantation. The article reviews the different devices available, the technique of implantation and the indications for transcatheter ASD and PFO closure.


2020 ◽  
Vol 69 (1) ◽  
pp. 7-12
Author(s):  
Yi Qi ◽  
Yushun Zhang ◽  
Xiaohui Luo ◽  
Gesheng Cheng ◽  
Yajuan Du ◽  
...  

This study aims to evaluate the potential of percutaneous patent foramen ovale (PFO) closure to improve the headache in patients with migraine and PFO, and discuss the difference between the randomized controlled trials (RCTs) and the single-center studies. Patients of migraine with a large shunt of PFO, who experienced ≥2 headache attacks per month and failed ≥2 categories of standardized medication, underwent PFO closure in First Affiliated Hospital of Xi'an Jiao Tong University. The clinical outcomes, including frequency and duration of headache attacks, Headache Impact Test (HIT-6) score, and Visual Analogue Scale (VAS) score, were evaluated at 3, 6, and 12 months of follow-up after the PFO closure. The different efficacies of the clinical outcomes between patients with and without aura as well as different grades of PFO were also evaluated, respectively. 134 patients with migraine (39 male and 95 female) with PFO were enrolled, whose average age was 39.21±11.37 years. After PFO closure, there was a significant reduction in frequency and duration of headache attacks, HIT-6 score, and VAS score at 3, 6, and 12 months’ follow-up (p<0.001). Migraine was completely relieved in 54 (40.30%) patients during 12 months’ follow-up. The frequency of migraine was reduced by >50% in 44 (32.84%) patients at 3 months’ follow-up and increased to 48 (35.82%) at 12 months’ follow-up. 31.03% patients remained residual shunt after 6 months of closure with varying improvements of headache. This study confirmed that PFO closure can effectively reduce frequency and duration of migraine and improve quality of life, but the definitive indications and long-term effect still need further research.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A.A Molnar ◽  
P Abraham ◽  
G Gulyas ◽  
H Meszaros ◽  
E Straub ◽  
...  

Abstract Introduction Patent foramen ovale (PFO) is a common abnormality affecting more than 20% of the adult population. For most people they are accidental findings; however, in some the PFO can open widely enabling paradoxical embolisation. Randomised controlled trials have demonstrated in patients with cryptogenic stroke that transcatheter closure of PFO with a septal occluder device is associated with reduced rates of recurrent stroke. However, the impact of atrial septal closure on left atrial (LA) and right atrial (RA) structural and functional remodelling is less known. Methods We prospectively enrolled 53 patients with cryptogenic ischemic stroke and PFO eligible for transcatheter PFO closure (mean age 46±11 years, 44% females). National Institute of Health Stroke Score (NIHSS), and the modified Rankin score (mRS) were calculated as markers of clinical severity of the index stroke. Presence of any shunt, atrial volumes and functional parameters were evaluated including LA reservoir, conduit and contraction function before PFO closure and 12 months after procedure. Beyond conventional transthoracic echocardiography (Philips Epiq CVx Ultrasound), two dimensional speckle tracking method was used to assess body surface area-indexed LA maximal volume (LAVmaxi), LA minimal volume (LAVmini), LA volume before left atrial contraction (LApreAi), LA ejection fraction (LAEF), LA reservoir strain (LASres), LA conduit strain (LAScond), LA contraction strain (LAScontr), LA peak systolic strain rates (LASRs), LA peak early diastolic strain rate (LASRe) and LA peak late diastolic strain rate (LASRa) using dedicated software on separate workstation (Cardiac Performance; TomTec Imaging, Unterschleissheim, Germany). Results The index stroke was modest and non-disabling, with an NIHSS 3.37±2.63 and mRS 1.67±1.06. Baseline LA, RA volumes and dimensions were in normal range (LAVi 25.5±9.6 ml/m2; LA length 37.6±6.2 mm; LA width 40.4±7.1 mm; RA length 36.6±6.7 mm; RA width 39.5±8.6 mm). Thirty-seven patient had 12 month clinical follow-up examinations revealing no significant differences (all p values &gt;0.05) in atrial volumes, ejection fraction and strain parameters. LASRa was significantly lower after 12 month (p=0.03; baseline LASRa −1.7±0.7 s–1 vs follow-up LASRa −1.3±0.9 s–1) No new cerebral ischaemic events, aortic erosions, atrial fibrillation, significant residual shunts or device thrombosis and displacement were recorded during the follow-up. Conclusion PFO-associated strokes in young individuals are mainly non-disabling. Our study suggests that transcatheter interatrial closure is effective without promoting unfavourable atrial anatomical remodelling during short-term follow-up, however, it may affect active atrial contraction. Long-term follow-up examinations are needed to investigate the potential late impact of occluders on atrial anatomical, functional remodelling. Funding Acknowledgement Type of funding source: None


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