At CSI UCSF Congress, Achille Gaspardone (Hospital of Sant’Eugenio, Rome, Italy) presented a comprehensive report on closure of patent foramen ovale (PFO) and related atrial septal defect using the NobleStitch EL suture based closure system. The data was collected from 10 centres throughout Italy and one centre in Sweden from January 2016 through August 2017, and was gathered from more than 190 patients, from procedures performed by 14 interventional cardiologists.
These patients were undergoing PFO closure for stroke, transient Ischaemic attack, pulmonary embolism, decompression illness and migraine with positive MR+. All patients were successfully treated with the NobleStitch EL closure system.
Gaspardone compared the NobleStitch EL data for closure rate, and adverse events (complications) using the same criteria listed in the recently published RESPECT and CLOSE clinical studies that were recently published in The New England Journal of Medicine. According to a press release, the NobleStitch EL demonstrated a superior closure rate to both the Gore Helix and AGA Amplatzer for closure with a zero residual shunt rate at 12 months follow-up. Additionally, the NobleStitch EL had no complications compared to the 4.2% complication rate found in the RESPECT trial and a 12.8% complication rate found in the CLOSE trial.
He also presented a comparison to the previous PFO closure studies CLOSURE 1 and PC Trial and demonstrated a superior closure rate than found in the CLOSURE 1 study and equivalent closure rate to the PC Trial and more importantly the NobleStitch EL which had no complications compared to the CLOSURE 1 16.9% complication rate and the PC Trial 21% complication rate.
Gaspardone stated: “This initial registry included all patients treated and included the learning curve cases at each centre. Unlike the afore mentioned studies using the umbrella based devices which were performed primarily by physicians with extensive experience implanting the umbrellas over many years, The NobleStitch EL registry data was collected with many users performing their very first cases. The NobleStitch EL is a simple, safe and effective way to close the septal defects without leaving behind a large metal prosthesis in the heart and without the risk of known complications of the umbrella implants which include, atrial fibrillation, migration, erosion, left ventricular thrombosis and nickel allergy.”
“Although we have experience with more than 300 cases with this technology, we still continue to improve our techniques and outcomes with each new case, and I expect to see even greater increase in the positive data presented so far. Personally, if it were my family member or myself, as it is with all my patients, the NobleStitch EL suture would always be my first choice to close PFO,” he added.