Percutaneous Transcatheter Closure of Patent Foramen Ovale in Patients With Paradoxical Embolism

Martı́n, Francisco; Sánchez, Pedro L.; Doherty, Elizabeth; Colón-Hernández, Pedro; Delgado, Gabriel; Inglessis, Ignacio; Scott, Nandita S.; Hung, Judy; King, Mary Etta; Buonanno, Ferdinando S.; Demirjian, Zareh; Moor, Michael de; Palacios, Igor F.

doi:10.1161/01.cir.0000027819.19722.ee

Cited by 270 publications

(74 citation statements)

References 35 publications

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“…Gore and Associates, Flagstaff, Ariz., USA) and CardioSEAL-STARflex occluder [4]. However, device-based therapies are associated with complications related to the procedure and the implanted devices, including residual shunting, device migration, strut fracture, erosion into surrounding tissue and excessive thrombus formation [5,6,7,8,9,10]…”

Section: Discussionmentioning

confidence: 99%

Experimental Study of the Spider™ Patent Foramen Ovale Occluder

et al. 2011

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Aim: To evaluate the feasibility, safety and efficacy of the Spider™ patent foramen ovale (PFO) occluder for the treatment of PFOs in an animal model. Method: The foramen ovale was punctured to establish an animal model of a PFO. Under fluoroscopic guidance, the PFO was occluded with the Spider PFO occluder. The piglets were electively sacrificed at months 1, 2, 3, 6 and 12 after occlusion for macroscopic and microscopic examination. Results: PFOs were successfully created and occluded percutaneously in 20 piglets. All piglets recovered from the procedure in good condition and completed follow-up. Macroscopic examination of all hearts showed complete closure of the PFO. The position of each device was correct. All devices were completely covered and embedded in pale and smooth tissue. There was no evidence of interference with adjacent structures of the heart or valves. The occluder was partially covered by endocardium after 1 month, almost completely covered by fresh endocardium after 3 months, and embedded within thick fibrous tissues and fresh vessels after 6 months. The tissue covering both occluder discs demonstrated some infiltration of inflammatory cells, including patches of lymphocyte aggregation. This inflammatory cell reaction diminished with increasing distance from the device. Furthermore, the number of inflammatory cells decreased gradually during follow-up and eventually, at 6-month follow-up, the inflammatory response was no longer visible. The 12-month histological findings did not differ from the 6-month findings. Conclusion: Transcatheter closure of PFO with the Spider PFO occluder is effective and safe in an animal model. These results support further investigation of this device in animals and, if the results are confirmed, in human clinical trials.

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Section: Discussionmentioning

confidence: 99%

Experimental Study of the Spider™ Patent Foramen Ovale Occluder

et al. 2011

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“…A recent meta-analysis reported an absolute rate of recurrent ischemic stroke or transient ischemic attack (TIA) in patients with cryptogenic stroke and PFO of 4.0 events per 100 patient-years; the rate of recurrent ischemic stroke was 1.6 events per 100 patient-years [13]. For secondary prevention, treatment options include oral anticoagulants, antiplatelet agents and surgical or percutaneous closure, but there is no consensus about the relative value of these therapeutic measures and thus about the optimal management strategy [13,14,15,16]. …”

Section: Introductionmentioning

confidence: 99%

Risk of Recurrent Cerebrovascular Events in Patients with Cryptogenic Stroke or Transient Ischemic Attack and Patent Foramen Ovale: The FORI (Foramen Ovale Registro Italiano) Study

et al. 2010

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Background: The optimal management of patients with cryptogenic ischemic stroke found to have a patent foramen ovale (PFO) at diagnostic workup remains unclear. The aims of this observational multicenter study were to evaluate: (1) the risk of recurrent cerebrovascular events in patients with cryptogenic minor ischemic stroke or transient ischemic attack (TIA) and PFO who either underwent percutaneous PFO closure or received only medical treatment, and (2) the risk factors associated with recurrent events. Methods: Consecutive patients (aged 55 years or less) with first-ever cryptogenic minor ischemic stroke or TIA and PFO were recruited in 13 Italian hospitals between January 2006 and September 2007 and followed up for 2 years. Results: 238 patients were included in the study (mean age 42.2 ± 10.0 years; 118 males); 117 patients (49.2%) received only antithrombotic therapy while 121 patients underwent percutaneous PFO closure (50.8%). Stroke as the qualifying event was more common in the medical treatment group (p = 0.01). The presence of atrial septal aneurysm and evidence of 20 bubbles or more on transcranial Doppler were more common in the PFO closure group (p = 0.002 and 0.02). Eight patients (6.6%) experienced a nonfatal complication during PFO closure. At the 2-year follow-up, 17 recurrent events (TIA or stroke; 3.6% per year) were observed; 7 of these events (2.9% per year) occurred in the percutaneous PFO closure group and 10 events (4.2% per year) in the medical treatment group. The rate of recurrent stroke was 0.4% per year in patients who underwent percutaneous closure (1 event) and 3.4% per year in patients who received medical treatment (8 events). On multivariate analysis, percutaneous closure was not protective in preventing recurrent TIA or stroke (OR = 0.1, 95% CI = 0.02–1.5, p = 0.1), while it was barely protective in preventing recurrent stroke (OR = 0.1, 95% CI = 0.0–1.0, p = 0.053). Conclusions: The results of this observational, nonrandomized study suggest that PFO closure might be superior to medical therapy for the prevention of recurrent stroke. Periprocedural complications were the trade-off for this clinical benefit. Controlled randomized clinical trials comparing percutaneous closure with medical management are required.

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“…These studies are based on different devices including Amplazer, CardioSeal, PFO-Star, etc. The frequency of residual RLS varied between 1 and 34% in different studies with different lengths of follow-up [62,63]. There was one meta-analysis comparing older device closure trials with medical management.…”

Section: Recurrent Stroke Preventionmentioning

confidence: 99%

Stroke and Patent Foramen Ovale in Young Individuals

Piechowski-Jóźwiak

Bogousslavsky

2012

Eur Neurol

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The importance of patent foramen ovale (PFO) has long been discussed in the literature in relation to different coexisting medical conditions. Many researchers focused on the occurrence of PFO in ischemic stroke patients, especially in the subgroup of young patients with a recurrent event. Unfortunately, before establishing a clear significance of PFO and right-to-left shunting (RLS) in pathogenesis of cerebrovascular disorders, multiple interventional trials have been launched, aimed at PFO closure in heterogeneous populations of patients. Moreover, some closure devices were granted at least partial approval by regulatory agencies for this indication. There is a need for large and unbiased epidemiological studies assessing the role of RLS through the PFO in ischemic stroke. All patients with recurrent ischemic events and PFO should be assessed by multidisciplinary teams, including a stroke neurologist, and all potential and rare causes of stroke should be considered before any decision for closure is made.

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Percutaneous Transcatheter Closure of Patent Foramen Ovale in Patients With Paradoxical Embolism

Cited by 270 publications

References 35 publications

Experimental Study of the Spider™ Patent Foramen Ovale Occluder

Experimental Study of the Spider™ Patent Foramen Ovale Occluder

Risk of Recurrent Cerebrovascular Events in Patients with Cryptogenic Stroke or Transient Ischemic Attack and Patent Foramen Ovale: The FORI (Foramen Ovale Registro Italiano) Study

Stroke and Patent Foramen Ovale in Young Individuals

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