Percutaneous suture-mediated patent foramen ovale closure: two-year clinical follow-up

A new echocardiographic index to select patients for PFO suture‐mediated percutaneous closure

“…4 In three recently published observational studies (one multicenter registry, and two singlecenter) the clinically effective closure rate, assessed with TTE or TEE and using the criterion used in the other controlled studies that used traditional devices (i.e., RLS grade ≤1), ranged from 80% to 89%. 4,12,13 This figure, while surprising considering the innovative nature of the technique and the short learning curve time, is however slightly lower than that reported with traditional prostheses which is about 93%-95%. [1][2][3] The technical assumptions of the suture technique are completely different from the traditional double umbrella technique and are based on the ligation of the two septa through a single surgical suture.…”

“…Initial experience indicates that the suture technique is feasible and safe in the majority of septal anatomies and provides an effective closure of PFO in most patients 4 . In three recently published observational studies (one multicenter registry, and two single‐center) the clinically effective closure rate, assessed with TTE or TEE and using the criterion used in the other controlled studies that used traditional devices (i.e., RLS grade ≤1), ranged from 80% to 89% 4,12,13 . This figure, while surprising considering the innovative nature of the technique and the short learning curve time, is however slightly lower than that reported with traditional prostheses which is about 93%–95% 1–3 .…”

“…Patients in whom more than one stitch was required have not been enrolled and data on minimum septa overlapping were available only in 103 patients; however, the statistical strength of the data appears extremely indicative even if the predictive value of the W/SO ratio will necessarily have to be tested in larger case studies. Finally, although favorable data with a follow‐up of 2 years have recently been published, 12 the duration of the follow‐up was relatively short for a procedure that should last a lifetime.…”

Clinical and brain magnetic resonance imaging long-term follow-up in patients with cryptogenic stroke undergoing PFO closure with the NobleStitch EL system. A single-centre experience

“…The main advantage of this technique is the lack of a permanent closure with a device in the heart, which allows all the limitations related to the presence of an obstacle to the percutaneous left heart access to be overcome [1]. Nowadays, suture-mediated PFO closure is increasingly required due to the implementation of the number and the complexity of the electrophysiological and structural techniques [2,[5][6][7]. Gaspardone et al demonstrated the feasibility and safety of this approach in the majority of septal anatomies [6], identifying predictors of low probability of complete closure with a single device in a channel width greater than 5 mm and in a spontaneous large right-to-left shunt [1].…”

“…The NobleStitch EL system has recently been proposed as a safe and effective technique for percutaneous closure of patent fossa ovalis (PFO) in patients with cryptogenic stroke and evidence of paradoxical embolism [ 1 ]. Data on its long-term efficacy are, to date, quite scarce and limited to recurrences of clinically relevant neurological events [ 2 ]. It is unknown whether such a procedure confers protection against novel asymptomatic ischaemic lesions evaluated through appropriate brain imaging.…”