RESUMO
Background: Coronary artery bypass grafting is the standard of care for patients with obstructive left main (LM) coronary disease. In poor surgical candidates, high-risk percutaneous coronary artery intervention (PCI) is an alternative. Methods: We investigated a retrospective cohort of patients who underwent LM PCI from January 2010 to March 2014 (n = 89). Obstructive LM disease was defined as 50% angiographic obstruction of luminal flow, and the primary endpoint was inhospital mortality. Ventricular assist device (VAD) was defined as the use of either intra-aortic balloon pump (IABP) or Impella 2.5 devices before, during, or following PCI. Results: A total of 89 patients with LM PCI were divided into those with (n = 39) and without (n = 50) VAD support. The former group was further divided into those with support from either Impella 2.5 (n = 28) or IABP (n = 11). Age, race, and gender did not differ between patients who received unassisted LM-PCI from those with VAD support (P = 0.142, 1.0, and 0.776, respectively). The angiographic stenosis of atherosclerotic lesions in LM, proximal left anterior descending artery, and other native/surgical coronary vessels was similar between the groups. The duration of hospitalization was significantly longer for patients with VAD support compared to those without (7.19 ± 6.89 vs. 2.78 ± 3.39, P < 0.001). The incidence of cardiogenic shock and inhospital mortality was significantly higher in the VAD group (P = 0.009 and 0.001, respectively). Overall, inhospital mortality was 9% (8/89). The IABP and Impella 2.5 groups had mortality proportions of 46% (5/11) and 11% (3/28), respectively; P = 0.028. For all patients, inhospital mortality was higher for those with versus without cardiogenic shock (56% or 5/9 vs. 4% or 3/80; P < 0.001), and for those with versus without left ventricular systolic function <40% (17% vs. 2%;P < 0.025). Conclusion: In a selected group of patients with LM disease, unsupported PCI appears to be a feasible and safe procedure. In high-risk patients, the use of Impella 2.5 appears to be superior to IABP in LM PCI resulting in favorable short-term outcomes.
RESUMO
PURPOSE: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. METHODS: The VISION trial ( ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance. RESULTS: The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%±15.1% at baseline to 30.3%±11.8% after Pantheris alone (p<0.001) and to 22.4%±9.9% after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5%±13.6% after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy. CONCLUSION: OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.