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First clinical experience with the premounted balloon-expandable serpentine stent: Acute angiographic and intermediate-term clinical results

Luis Gruberg, Ehud Grenadier, Hylton Miller, Benjamin Peled, Ariel Roguin, Walter Markiewicz, Rafael Beyar

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Abstract

The beStent-Artist coronary stent is a newly developed, stainless steel coronary stent with a serpentine tubular design and terminal stent markers, premounted on a semicompliant balloon. During this pilot evaluation we aimed to test the acute clinical and angiographic results, short-term (30 days) and 6-month clinical results. A total of 57 stents were used to treat 43 lesions in 40 patients. Deployment strategy included predilatation, stent deployment, balloon repositioning to match the distal end of the balloon to the distal stent marker, and subsequent 12-14 atm postdilatation. There were two cases of stent dislodgment, but no procedural complications. In four cases, stent recrossing with another balloon was necessary. In two of these cases, distal dissections were observed and treated with another stent. The minimal lumen diameter (MLD) increased from 0.84+/0.52 mm at baseline to 2.7+/-0.62 mm at the end of the procedure (a corresponding decrease in diameter stenosis from 78.6 > 16.4 to 18.2+/-10.7%). The acute gain was 1.89+/-0.61mm. No adverse events occurred by 30 days. During six months, 7/40 (18.5%) of patients required target vessel revascularization due to in-stent restenosis. In summary, the premounted beStent-Artist can be delivered and deployed with favorable immediate results and high success rate with favorable long-term recurrent event rates.

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What this paper is about

The beStent-Artist coronary stent is a newly developed, stainless steel coronary stent with a serpentine tubular design and terminal stent markers, premounted on a semicompliant balloon. During this pilot evaluation we aimed to test the acute clinical and angiographic results, short-term (30 days) and 6-month clinical results. A total of 57 stents were used to treat 43 lesions in 40 patients. Deployment strategy included predilatation, stent deployment, balloon repositioning to match the distal end of the balloon to the distal stent marker, and subsequent 12-14 atm postdilatation. There were two cases of stent dislodgment, but no procedural complications. In four cases, stent recrossing with another balloon was necessary. In two of these cases, distal dissections were observed and treated with another stent. The minimal lumen diameter (MLD) increased from 0.84+/0.52 mm at baseline to 2.7+/-0.62 mm at the end of the procedure (a corresponding decrease in diameter stenosis from 78.6 > 16.4 to 18.2+/-10.7%). The acute gain was 1.89+/-0.61mm. No adverse events occurred by 30 days. During six months, 7/40 (18.5%) of patients required target vessel revascularization due to in-stent restenosis. In summary, the premounted beStent-Artist can be delivered and deployed with favorable immediate results and high success rate with favorable long-term recurrent event rates.

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Available abstract

The beStent-Artist coronary stent is a newly developed, stainless steel coronary stent with a serpentine tubular design and terminal stent markers, premounted on a semicompliant balloon. During this pilot evaluation we aimed to test the acute clinical and angiographic results, short-term (30 days) and 6-month clinical results. A total of 57 stents were used to treat 43 lesions in 40 patients. Deployment strategy included predilatation, stent deployment, balloon repositioning to match the distal end of the balloon to the distal stent marker, and subsequent 12-14 atm postdilatation. There were two cases of stent dislodgment, but no procedural complications. In four cases, stent recrossing with another balloon was necessary. In two of these cases, distal dissections were observed and treated with another stent. The minimal lumen diameter (MLD) increased from 0.84+/0.52 mm at baseline to 2.7+/-0.62 mm at the end of the procedure (a corresponding decrease in diameter stenosis from 78.6 > 16.4 to 18.2+/-10.7%). The acute gain was 1.89+/-0.61mm. No adverse events occurred by 30 days. During six months, 7/40 (18.5%) of patients required target vessel revascularization due to in-stent restenosis. In summary, the premounted beStent-Artist can be delivered and deployed with favorable immediate results and high success rate with favorable long-term recurrent event rates.

Key concepts: Medicine, Stent, Balloon, Restenosis, Stenosis, Radiology, Lumen (anatomy), Surgery

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First clinical experience with the premounted balloon-expandable serpentine stent: Acute angiographic and intermediate-term clinical results — Research Paper | ScholarLens