ACC 2017, 3/30/2017 – Poor Outcomes for Bioresorbable Stents in Small Coronary Arteries
Bioresorbable Stent Comparable to Xience at Two Years, With Concerns
Stephen Ellis, M.D., professor of medicine and director of interventional cardiology at Cleveland Clinic, discusses the two year outcomes of the ABSORB III trial of Absorb vs. Xience. The late-breaking trial was presented at ACC 2017. Read the article on the ABSORB III results. Watch a VIDEO with Gregg Stone, M.D., “Poor Outcomes for Bioresorbable Stents in Small Coronary Arteries.”
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CorPath robotic system for bifurcation lesions with placement of the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) (Abbott Vascular)
Reporter: Aviva Lev-Ari, PhD, RN
UPDATED on 4/8/2017
BVS Stent Pulled From European Market – Bioresorbable stent will still be available in a clinical registry setting
CardioBrief, April 06, 2017
Abbott Laboratories sent a letter to European physicians informing them that the Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS “will only be available for use in clinical registry setting at select sites/institutions.”
The company’s action comes in response to an avalanche of bad news for the controversial device. Last fall 3-year results from the ABSORB II trial uncovered a significantly higher rate of target vessel MI. More recently, 2-year results from the pivotal ABSORB III trial confirmed those findings, showing a significant increase in target lesion failure. At the same time the FDA said that it was investigating the stent.
Robotic Radial Bifurcation Bioresorbable Vascular Scaffold (BVS) PCI placement of Abbott Vascular’s Absorb GT1
A remote-controlled robotic system was designed to address some of the procedural challenges and occupational hazards associated with traditional percutaneous coronary intervention (PCI) in addition to enhancing the degree of precision and control for the interventional procedure. We report the first large-scale, multicenter study evaluating the safety and efficacy of a novel robotic system for PCI.
It demonstrates the capabilities of the technology including double-wire intervention, successful BVS delivery, and the ability to re-cross through a scaffold-strut for branch vessel ostium dilatation. More experience with this technology will potentially add to its utilization in more complex lesions.
Safety and Feasibility of Robotic Percutaneous Coronary Intervention PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) Study
Objectives The aim of this study was to evaluate the safety as well as the clinical and technical effectiveness of robotic-assisted percutaneous coronary intervention.
Background Robotic systems have been suggested to enhance the performance of cardiovascular procedures, as well as to provide protection from the occupational hazards that are associated with interventional practice.
Methods Patients with coronary artery disease and clinical indications for percutaneous intervention were enrolled. The coronary intervention was performed with the CorPath 200 robotic system, which consists of a remote interventional cockpit and a bedside disposable cassette that enables the operator to advance, retract, and rotate guidewires and catheters. The primary endpoints were clinical procedural success, defined as <30% residual stenosis at the completion of the robotic-assisted procedure without major adverse cardiovascular events within 30 days, and device technical success, defined as the successful manipulation of the intracoronary devices using the robotic system only.
Results A total of 164 patients were enrolled at 9 sites. Percutaneous coronary intervention was completed successfully without conversion to manual operation, and device technical success was achieved in 162 of 164 patients (98.8%). There were no device-related complications. Clinical procedural success was achieved in 160 of 164 patients (97.6%), whereas 4 (2.4%) had periprocedural non–Q-wave myocardial infarctions. No deaths, strokes, Q-wave myocardial infarctions, or revascularization occurred in the 30 days after the procedures. Radiation exposure for the primary operator was 95.2% lower than the levels found at the traditional table position.
Conclusions This pivotal multicenter study with a robotic-enhanced coronary intervention system demonstrated the safety and feasibility of the system. The robotic remote-control procedure met the expected technical and clinical performance, with significantly lower radiation exposure to the operator. (Evaluation of the Safety and Effectiveness of the CorPath 200 System in Percutaneous Coronary Interventions [PCI] [PRECISE]; NCT01275092)
1. Weisz G, Metzger DC, Caputo RP, et al. Safety and feasibility of robotic percutaneous coronary intervention. J Am Coll Cardiol 2013;61:1596–1600.
J Am Coll Cardiol 2013;61:1596–1600.
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