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Plaque modification of severely calcified coronary lesions via orbital atherectomy: Single‐center observations from a complex Veterans Affairs cohort

BACKGROUND: Orbital atherectomy (OA) is a known alternative to other atherectomy devices. However, some complex patient demographics (eg, left ventricular ejection fraction <25%) were excluded from the first‐in‐human trial (ORBIT I) and the pivotal FDA device approval trial (ORBIT II) which evalu...

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Detalles Bibliográficos
Autores principales: Desai, Rupak, Mirza, Omer, Martinsen, Brad J., Kumar, Gautam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6295613/
https://www.ncbi.nlm.nih.gov/pubmed/30623053
http://dx.doi.org/10.1002/hsr2.99
Descripción
Sumario:BACKGROUND: Orbital atherectomy (OA) is a known alternative to other atherectomy devices. However, some complex patient demographics (eg, left ventricular ejection fraction <25%) were excluded from the first‐in‐human trial (ORBIT I) and the pivotal FDA device approval trial (ORBIT II) which evaluated the safety and efficacy of OA in severely calcified de novo coronary lesions. This single‐operator cohort study aimed to examine the impact of OA on a real‐world complex Veterans Affairs patient subset. METHODS: Retrospective analysis was completed on 40 consecutive patients with severely calcified coronary lesions who underwent OA prior to drug‐eluting stent placement at the Atlanta Veterans Affairs Medical Center from January 2015 to June 2017. RESULTS: Orbital atherectomy plus drug‐eluting stent placement was successful in all 40 cases. Chocolate focal force balloon angioplasty was the most commonly used post‐atherectomy balloon (N = 34, 85%). Few complications were observed, including one case (2.5%) of perforation and one case (2.5%) of no‐reflow. Neither acute stent thrombosis nor emergent coronary artery bypass grafting was observed. The intravascular ultrasound (IVUS)‐determined median [IQR] pre‐procedure minimum lumen area and post‐procedure minimum stent area (MSA) were 2.8 [2.2, 3.0] mm(2) and 8.7 [7.7, 10.0] mm(2), respectively (P < 0.0001, Mann‐Whitney test). Major adverse cardiovascular events, including all‐cause mortality, at 30 days and at a median [IQR] follow‐up of 197.5 [35.5, 461.3] days, was 5% and 10%, respectively. During that period, one target vessel revascularization (2.5%) was observed. CONCLUSIONS: This study indicates that OA is a useful tool in performing high‐risk percutaneous coronary intervention effectively in VA patients with severely calcified coronary lesions. OA plaque modification in combination with a high utilization rate of IVUS and Chocolate focal force angioplasty facilitates stent delivery and optimal stent expansion, resulting in a large MSA.