Overall failure rate was 3.3% which was contributed by extreme tortuosity, angulation, and severe calcification. Stent implantation was successful in 151 out of 156 patients with success rate of 96.7%. GEC was delivered across the lesion using buddy wire technique (9.6%), balloon-assisted tracking (BAT) in 30.1%, and balloon-assisted sliding and tracking (BLAST) in 4.5% of patients. Lesions were modified using aggressive pre-dilatation in 87.8%, followed by cutting balloon in 10.9%. Mean diameter of stents was 34.2 ± 14.4 mm while mean length of stents was 31.2 ± 10.2 mm. The mean depth of intubation was 4.2 ± 1.9 cm. The right coronary artery (39.2%) was most commonly intervened artery followed by left anterior descending (LAD) (30.8%), left circumflex (LCX) (19.9%), multivessels (7.6%), and saphenous vein graft in 2.5%. The commonest indication for its use was tortuosity (30.1%) followed by calcification (21.1%), angulation (18.8%), chronic total occlusion (17.9%), distally located lesion (8.3%), and anomalous origin of vessel in 3.8%. Results: The mean age of the enrolled patients was 61.2 ± 8.67 years. The clinical, angiographic and procedural data of all 156 patients were evaluated to assess safety and efficacy of Guidezilla extension catheter (GEC). Study endpoints were target lesion crossing, procedural success, and complications. Medical College, Kanpur, Uttar Pradesh, India among which Guidezilla™ catheter (Boston Scientific, Natick, MA, USA) was used in 156 patients. Methods: The present retrospective, single-center study included 13,157 consecutive patients who underwent percutaneous coronary intervention (PCI) through both transfemoral and transradial routes from January 2015 to July 2019 at LPS Institute of Cardiology, G.S.V.M. Guidezilla catheter, acting as an extension of guide catheter system (mother-in-child catheter), helps to overcome these complexities by enhancing backup during complex intervention. “Given the challenging patient population, the high technical success rate in this most demanding PCI environment is particularly notable.Background: Lesion characteristics (anatomy, calcification, tortuosity and angulation), vessel morphology, and lack of support add complexity of coronary intervention. “Considering the complexity of both anatomy and procedural strategy in this study, the very favorable success achieved underscores the need for an ‘interventional toolbox’ that features an array of enabling device technologies that include guidewires, guide catheter extensions and microcatheters,” said David Kandzari, director of interventional cardiology and chief of the Piedmont Heart Institute and Cardiovascular Service Line in Atlanta and one of the CTO-PCI study’s principal investigators. It is found in nearly 20% of patients who are undergoing diagnostic coronary angiography for suspected ischemic heart disease, according to Teleflex. We feel privileged to be a partner in this effort.”ĬTOs are complete blockages in coronary arteries that result in a regional reduction of coronary blood flow. “Interventional cardiologists who have evolved the techniques for these difficult procedures need innovative, enabling devices they can absolutely count on. “The CTO-PCI IDE study confirmed the safety and effectiveness of a range of these products in very complex CTO cases,” Teleflex medical director Christopher Biller said in a news release. Successful guidewire recanalization was achieved in 93.3% of cases with procedural success in over 75% of cases. Teleflex (NYSE:TFX) today announced that it received FDA clearance for expanded indication for its specialty catheters and coronary guidewires for use in crossing chronic total occlusion percutaneous coronary interventions (CTO PCI).ĭevices that are included in the expanded indication are the Teleflex GuideLiner V3 catheter, TrapLiner catheter, Turnpike catheters, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire and R350 guidewire.Įach device was evaluated as part of the CTO-PCI study, which was a peer-reviewed, prospective, single-arm IDE study that enrolled 150 patients across 13 investigational centers in the U.S.
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