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Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study)

Babaev, Anvar; Zavlunova, Susanna; Attubato, Michael J; Martinsen, Brad J; Mintz, Gary S; Maehara, Akiko
OBJECTIVE: The Tissue Removal Assessment with Ultrasound of the SFA and Popliteal (TRUTH) study assessed the performance of the orbital atherectomy system (OAS) to treat femoropopliteal arteries, including determining its effect on plaque removal. METHODS: Patients with symptomatic femoropopliteal peripheral arterial disease were treated with the OAS followed by adjunctive balloon angioplasty (BA). Intravascular ultrasound (IVUS) images were collected pre- and post-OAS and post-OAS BA. Patients were followed through 12 months post-procedure. RESULTS: Twenty-nine lesions were treated with OAS-BA in 25 patients. The mean maximum balloon inflation pressure was 5.2 +/- 1.2 atm. Virtual histology IVUS (VH-IVUS) analysis revealed at the maximum calcium ablation site that calcium reduction was responsible for 86% of the lumen area increase. The minimum lumen area increased from 4.0 mm2 to 9.1 mm2 (<.0001), and the percentage of area stenosis decreased from 76.9% to 43.0% (<.0001) after OAS-BA. At 12 months, the target lesion revascularization rate was 8.2%, and ankle-brachial index and Rutherford classification improved significantly from baseline through follow-up. CONCLUSION: The VH-IVUS analysis reveals that OAS modifies the calcified component of the plaque burden. It is hypothesized that calcium modification by OAS changes the lesion compliance, allowing for low pressure adjunctive BA. The clinical outcomes were favorable through 12-month follow-up.
PMCID:4647186
PMID: 26490645
ISSN: 1938-9116
CID: 1810532

Effect of left versus right radial artery approach to coronary angiography on radiation exposure in patients with predictors of transradial artery access failure [Meeting Abstract]

Shah, Binita; Burdowski, Joseph; Guo, Yu; de Villa, Bryan Velez; Huynh, Andrew; Farid, Meena; Maini, Mansi; Serrano-Gomez, Claudia; Fallahi, Arzhang; Staniloae, Cezar S; Attubato, Michael; Feit, Frederick; Slater, James; Coppola, John
ISI:000363329000373
ISSN: 1558-3597
CID: 1830572

Periprocedural glycemic control in patients with diabetes mellitus undergoing coronary angiography with possible percutaneous coronary intervention

Shah, Binita; Berger, Jeffrey S; Amoroso, Nicholas S; Mai, Xingchen; Lorin, Jeffrey D; Danoff, Ann; Schwartzbard, Arthur Z; Lobach, Iryna; Guo, Yu; Feit, Frederick; Slater, James; Attubato, Michael J; Sedlis, Steven P
Periprocedural hyperglycemia is an independent predictor of mortality in patients who underwent percutaneous coronary intervention (PCI). However, periprocedural management of blood glucose is not standardized. The effects of routinely continuing long-acting glucose-lowering medications before coronary angiography with possible PCI on periprocedural glycemic control have not been investigated. Patients with diabetes mellitus (DM; n = 172) were randomized to continue (Continue group; n = 86) or hold (Hold group; n = 86) their clinically prescribed long-acting glucose-lowering medications before the procedure. The primary end point was glucose level on procedural access. In a subset of patients (no DM group: n = 25; Continue group: n = 25; and Hold group: n = 25), selected measures of platelet activity that change acutely were assessed. Patients with DM randomized to the Continue group had lower blood glucose levels on procedural access compared with those randomized to the Hold group (117 [97 to 151] vs 134 [117 to 172] mg/dl, p = 0.002). There were two hypoglycemic events in the Continue group and none in the Hold group, and no adverse events in either group. Selected markers of platelet activity differed across the no DM, Continue, and Hold groups (leukocyte platelet aggregates: 8.1% [7.2 to 10.4], 8.7% [6.9 to 11.4], 10.9% [8.6 to 14.7], p = 0.007; monocyte platelet aggregates: 14.0% [10.3 to 16.3], 20.8% [16.2 to 27.0], 22.5% [15.2 to 35.4], p <0.001; soluble p-selectin: 51.9 ng/ml [39.7 to 74.0], 59.1 ng/ml [46.8 to 73.2], 72.2 ng/ml [58.4 to 77.4], p = 0.014). In conclusion, routinely continuing clinically prescribed long-acting glucose-lowering medications before coronary angiography with possible PCI help achieve periprocedural euglycemia, appear safe, and should be considered as a strategy for achieving periprocedural glycemic control.
PMCID:4018663
PMID: 24630791
ISSN: 0002-9149
CID: 881802

Characteristics of plaque disruption by intravascular ultrasound in women presenting with myocardial infarction without obstructive coronary artery disease

Iqbal, Sohah N; Feit, Frederick; Mancini, G B John; Wood, David; Patel, Rima; Pena-Sing, Ivan; Attubato, Michael; Yatskar, Leonid; Slater, James N; Hochman, Judith S; Reynolds, Harmony R
BACKGROUND: In a prospective study, we previously identified plaque disruption (PD: plaque rupture or ulceration) in 38% of women with myocardial infarction (MI) without angiographically obstructive coronary artery disease (CAD), using intravascular ultrasound (IVUS). Underlying plaque morphology has not been described in these patients and may provide insight into the mechanisms of MI without obstructive CAD. METHODS: Forty-two women with MI and <50% angiographic stenosis underwent IVUS (n = 114 vessels). Analyses were performed by a blinded core laboratory. Sixteen patients had PD (14 ruptures and 5 ulcerations in 18 vessels). Plaque area, % plaque burden, lumen area stenosis, eccentricity, and remodeling index were calculated for disrupted plaques and largest plaque by area in each vessel. RESULTS: Disrupted plaques had lower % plaque burden than the largest plaque in the same vessel (31.9% vs 49.8%, P = .005) and were rarely located at the site of largest plaque (1/19). Disrupted plaques were typically fibrous and were not more eccentric or remodeled than the largest plaque in the same vessel. CONCLUSIONS: Plaque disruption was often identifiable on IVUS in women with MI without obstructive CAD. Plaque disruption in this patient population occurred in fibrous or fibrofatty plaques and, contrary to expectations based on prior studies of plaque vulnerability, did not typically occur in eccentric, outwardly remodeled, or soft plaque in these patients. Plaque disruption rarely occurred at the site of the largest plaque in the vessel. These findings suggest that the pathophysiology of PD in women with MI without angiographically obstructive CAD may be different from MI with obstructive disease and requires further investigation.
PMID: 24766982
ISSN: 0002-8703
CID: 941662

Effectiveness of fluorography versus cineangiography at reducing radiation exposure during diagnostic coronary angiography

Shah, Binita; Mai, Xingchen; Tummala, Lakshmi; Kliger, Chad; Bangalore, Sripal; Miller, Louis H; Sedlis, Steven P; Feit, Frederick; Liou, Michael; Attubato, Michael; Coppola, John; Slater, James
Coronary angiography is the gold standard for defining obstructive coronary disease. However, radiation exposure remains an unwanted hazard. Patients referred for coronary angiography with abdominal circumference <45 inches and glomerular filtration rate >60 ml/min were randomized to the fluorography (n = 25) or cineangiography (n = 25) group. Patients in the fluorography group underwent coronary angiography using retrospectively stored fluorography with repeat injection under cineangiography only when needed for better resolution per operator's discretion. Patients in the cineangiography group underwent coronary angiography using routine cineangiography. The primary end point was patient radiation exposure measured by radiochromic film. Secondary end points included the radiation output measurement of kerma-area product and air kerma at the interventional reference point (Ka,r) and operator radiation exposure measured by a dosimeter. Patient radiation exposure (158.2 mGy [76.5 to 210.2] vs 272.5 mGy [163.3 to 314.0], p = 0.001), kerma-area product (1,323 muGy.m(2) [826 to 1,765] vs 3,451 muGy.m(2) [2,464 to 4,818], p <0.001), and Ka,r (175 mGy [112 to 252] vs 558 mGy [313 to 621], p <0.001) were significantly lower in the fluorography compared with cineangiography group (42%, 62%, and 69% relative reduction, respectively). Operator radiation exposure trended in the same direction, although statistically nonsignificant (fluorography 2.35 muGy [1.24 to 6.30] vs cineangiography 5.03 muGy [2.48 to 7.80], p = 0.059). In conclusion, the use of fluorography in a select group of patients during coronary angiography, with repeat injection under cineangiography only when needed, was efficacious at reducing patient radiation exposure.
PMCID:3959232
PMID: 24513469
ISSN: 0002-9149
CID: 851832

Radiation exposure during coronary angiography via transradial or transfemoral approaches when performed by experienced operators

Shah, Binita; Bangalore, Sripal; Feit, Frederick; Fernandez, Gregory; Coppola, John; Attubato, Michael J; Slater, James
BACKGROUND: Studies demonstrate an increase in radiation exposure with transradial approach (TRA) when compared with transfemoral approach (TFA) for coronary angiography. Given the learning curve associated with TRA, it is not known if this increased radiation exposure to patients is seen when procedures are performed by experienced operators. METHODS: We retrospectively evaluated 1,696 patients who underwent coronary angiography with or without percutaneous coronary intervention (PCI) by experienced operators at a tertiary center from October 2010 to June 2011. Experienced operators were defined as those that perform >75 PCIs/year with >95% of cases performed using the TRA or TFA approach for >/=5 years. The outcomes of interest were dose area product (DAP) and fluoroscopy time (FT). RESULTS: Of the 1,696 patients, 1,382 (81.5%) were performed by experienced femoral operators using TFA and 314 (18.5%) were performed by experienced radial operators using TRA. Most of these cases (65.4%) were diagnostic only (870 TFA and 240 TRA) with both DAP (6040 [3210-8786] vs 5019 [3377-6869] muGy.m, P = .003] and FT [6.2 [4.0-10.3] vs 3.3 [2.6-5.0] minutes, P < .001) significantly higher using TRA versus TFA. For procedures involving PCI, despite similar baseline patient, procedural and lesion characteristics, DAP and FT remained significantly higher using TRA versus TFA (19,649 [11,996-25,929] vs 15,395 [10,078-21,617] muGy.m, P = .02 and 22.1 [13.3-31.0] vs. 13.8 [9.8-20.3] minutes, P < .001). CONCLUSIONS: In a contemporary cohort of patients undergoing coronary angiography by experienced operators, TRA was associated with higher radiation exposure when compared with TFA.
PMCID:3733462
PMID: 23453094
ISSN: 0002-8703
CID: 231322

Response to letter regarding article, "Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison Analysis of 117,762 patient-years of follow-up from randomized trials" [Letter]

Bangalore, Sripal; Fusaro, Mario; Amoroso, Nicholas; Attubato, Michael J; Feit, Frederick; Slater, James; Kumar, Sunil; Bhatt, Deepak L
PMID: 23534060
ISSN: 0009-7322
CID: 539012

Effectiveness of Fluoroscopy-Save versus Cinematography at Reducing Radiation Exposure During Diagnostic Coronary Angiography: A Randomized Controlled Trial [Meeting Abstract]

Shah, Binita; Mai, Xingchen; Tummala, Lakshmi; Kliger, Chad; Feit, Frederick; Bangalore, Sripal; Liou, Michael; Attubato, Michael; Coppola, John; Slater, James
ISI:000310210101128
ISSN: 0735-1097
CID: 185732

Response to Letters Regarding Article, "Mechanisms of Myocardial Infarction in Women Without Angiographically Obstructive Coronary Artery Disease" [Letter]

Reynolds, Harmony R.; Lqbal, Sohah N.; Slater, James N.; Feit, Frederick; Pena-Sing, Ivan; Attubato, Michael J.; Yatskar, Leonid; Kalhorn, Rebecca T.; Hochman, Judith S.; Srichai, Monvadi B.; Axel, Leon; Mancini, G. B. John; Wood, David A.; Lobach, Iryna V.
ISI:000307472600005
ISSN: 0009-7322
CID: 2961882

Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials

Bangalore, Sripal; Kumar, Sunil; Fusaro, Mario; Amoroso, Nicholas; Attubato, Michael J; Feit, Frederick; Bhatt, Deepak L; Slater, James
BACKGROUND: Drug-eluting stents (DES) have been in clinical use for nearly a decade; however, the relative short- and long-term efficacy and safety of DES compared with bare-metal stents (BMS) and among the DES types are less well defined. METHODS AND RESULTS: PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for randomized clinical trials, until March 2012, that compared any of the Food and Drug Administration-approved durable stent and polymer DES (sirolimus-eluting stent [SES], paclitaxel-eluting stent [PES], everolimus-eluting stent [EES], zotarolimus-eluting stent [ZES], and ZES-Resolute [ZES-R]) with each other or against BMS for de novo coronary lesions, enrolling at least 100 patients and with follow-up of at least 6 months. Short-term (PES approximately ZES>BMS), with a >42% probability that EES had the lowest target-vessel revascularization rate. There was no increase in the risk of any long-term safety outcomes, including stent thrombosis, with any DES (versus BMS). In addition, there was reduction in myocardial infarction (all DES except PES versus BMS) and stent thrombosis (with EES versus BMS: Rate ratio, 0.51; 95% credibility interval, 0.35-0.73). The safest DES appeared to be EES (>86% probability), with reduction in myocardial infarction and stent thrombosis compared with BMS. Short-term outcomes were similar to long-term outcomes, with SES, ZES-R, and everolimus-eluting stent being the most efficacious and EES being the safest stent. CONCLUSIONS: DES are highly efficacious at reducing the risk of target-vessel revascularization without an increase in any safety outcomes, including stent thrombosis. However, among the DES types, there were considerable differences, such that EES, SES, and ZES-R were the most efficacious and EES was the safest stent.
PMID: 22586281
ISSN: 0009-7322
CID: 169510