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Orbital atherectomy for symptomatic lower extremity disease

Korabathina, Ravikiran; Mody, Kanika P; Yu, Jennie; Han, Seol Young; Patel, Ruchika; Staniloae, Cezar S
BACKGROUND: Plaque-debulking technologies have been proposed as alternative treatment options for peripheral arterial disease. Orbital atherectomy (OA), using the DiamondBack360 device, has emerged as one promising modality. METHODS: We evaluated the safety and efficacy of OA in the first 200 lesions treated at our institution. Patient demographics, clinical characteristics, and lesion and procedural variables were collected and analyzed. The primary safety endpoint was the 30-day major adverse events (MAE), including death, myocardial infarction, stroke, unplanned amputation, or target lesion revascularization. Other safety endpoints included access-site complications, occurrence of dissections, perforations, distal embolization, spasm, and hemolysis. The efficacy endpoints were procedural success, need for adjunctive therapy, and improvement in ankle-brachial index. Multivariate analysis was performed to find independent predictors of the safety endpoints. RESULTS: One hundred seventeen (58.5%) lesions were femoral, 31 (15.5%) were popliteal, and 52 (26.0%) were tibial. The procedural success (residual stenosis </=30%) was comparable between the femoral and tibial lesions (86.3% vs. 92.5%, P = 0.18), but significantly lower for the popliteal lesions when compared with femoral and tibial (64.7% vs. 86.3%, P = 0.058, and 64.7% vs. 92.5%, P = 0.007 respectively). MAE at 30-days occurred in 3 (2.2%) procedures, and major access-site complications also occurred in 3 (2.2%). There were 31 (15.5%) dissections; independent predictors were diabetes mellitus (OR: 7.3, P = 0.008), crown-to-RVD ratio <0.6 (OR: 11.6, P = 0.005), and atherectomy time >360 sec (OR: 11.8, P = 0.001). There were 2 (1.0%) distal embolizations, 6 (3.0%) arterial spasms, and no perforations. Laboratory evidence of hemolysis was noted in 33.8% of cases. CONCLUSION: Orbital atherectomy allows for a significant procedural success, limited need for stenting, and favorable safety profile
PMID: 20839344
ISSN: 1522-726x
CID: 141681

Transradial approach to lower extremity interventions

Korabathina, Ravikiran; Yadav, Sidharth S; Coppola, John T; Staniloae, Cezar S
Percutaneous interventions of the coronary and peripheral vessels have historically been performed using a femoral artery approach. There has been increasing recognition of post-procedural bleeding complications and its impact on short- and long-term mortality. Because of its now recognized safety, the transradial approach has recently emerged as a preferred method compared to the transfemoral approach. The limitations associated with the distance from the puncture site to the lesion location are being addressed as new tools are developed for the endovascular treatment of peripheral arterial disease. In this review, we discuss the many facets of the transradial approach to lower extremity endovascular interventions, highlighting its safety and efficacy. Approaches to special populations including individuals with prior surgical bypass, Leriche's syndrome, and those committed to chronic anticoagulation are also reviewed
PMCID:2922311
PMID: 20730066
ISSN: 1178-2048
CID: 112066

Transradial approach to subclavian artery stenting

Yu, Jennie; Korabathina, Ravikiran; Coppola, John; Staniloae, Cezar
BACKGROUND: Subclavian artery angioplasty has been traditionally performed via the transfemoral approach. Transradial access is becoming increasingly used for coronary as well as for certain peripheral vascular beds. We describe our experience with transradial access for subclavian artery stenting. METHODS: We performed a retrospective review of subclavian artery interventions from 2007 to 2009 at our institution. Demographics, clinical data, lesion and procedural characteristics were collected. Safety and efficacy endpoints were recorded, and follow-up was performed at 1 year post intervention. Descriptive statistics were used to analyze the data. RESULTS: Fourteen cases of subclavian artery stenting, including 5 total occlusions, were performed using transradial access. The procedural success was 93%, and there were no complications recorded. All patients remained symptom-free at 1-year follow up. CONCLUSIONS: Subclavian artery stenting can be safely performed via transradial access with success rates comparable to the transfemoral approach
PMID: 20440034
ISSN: 1557-2501
CID: 112067

Transradial peripheral vascular interventions

Coppola, John T; Kurian, Damian C; Staniloae, Cezar S
Recently the importance of post procedure bleeding contributing to both short-term and long-term mortality has lead to a renewed interest in transradial coronary interventions in the United States. It has been long known that the incidence of access site bleeding is dramatically decreased by transradial access but the procedure is only used in 1% of coronary interventions in the United States, far below the rest of the world. In India, Japan and some European centers 50% of interventions are transradial. To extend this benefit of lower incidence of access site complications, we started using a transradial approach for peripheral interventions for the lower extremities, renal and subclavian arteries. By experience, we realized that in many cases the radial approach makes the procedure actually simpler. Also, in many instances, the transradial approach allows discharge of the patient on the same day. In this paper, we describe our approach to lower extremity, renal and subclavian interventional procedures
PMID: 21275291
ISSN: 0019-4832
CID: 141682

Safety and efficacy of transradial aortoiliac interventions

Staniloae, Cezar S; Korabathina, Ravikiran; Yu, Jennie; Kurian, Damian; Coppola, John
BACKGROUND: This study compares transradial approach (TRA) aortoiliac angioplasty/stenting to the transfemoral approach (TFA). METHODS: We reviewed our peripheral database for aortoiliac interventions performed between 2007 and 2009. Demographics, clinical characteristics, procedural, and lesion details were collected. The efficacy endpoints included procedural success, ankle-brachial index (ABI) improvement, and time to discharge. The safety endpoints were as follows: occurrence of intra-/periprocedural complications, 30-day MACE, and access-site complications (minor/major). The subjects were divided into two groups, TRA and TFA, and compared using appropriate statistics. RESULTS: Twenty-seven patients had 33 lesions treated via TRA, and 41 patients had 47 lesions treated via TFA access. Baseline demographic differences between the TRA and TFA groups were similar, including mean Rutherford category (2.9 vs. 2.6, P = 0.31) and preintervention ABI (0.64 vs. 0.67, P = 0.80). There was a significantly higher percentage of total occlusions in the TRA group (27.3 vs. 8.5%, P = 0.03). Dye use (238 vs. 213 mL, P = 0.35) and fluoroscopy time (30 vs. 27 min, P = 0.60) were similar. Procedural success rate was similar (87.9 vs. 97.8%, P = 0.15), as well as the improvement in mean ABI (TRA: 0.64-0.77 and TFA: 0.67-0.85, P = 0.77). The time to discharge was significantly shorter for the TRA group (14.4 vs. 20.9 hr, P = 0.003). There were no 30-day MACE or major access-site complications, but minor access-site complications were lower in the TRA group (0.0 vs. 7.3%, P = 0.28), although nonsignificant. CONCLUSIONS: The TRA to aortoiliac interventions is as safe and effective as the TFA with the advantage of a lower rate of access-site complications and shorter hospitalization time
PMID: 20088010
ISSN: 1522-726x
CID: 112068

Study to determine the clinical significance of hemolysis during orbital atherectomy [Meeting Abstract]

Mody K.; Korabathina R.; Staniloae C.
Introduction: Endovascular therapy using the Diamondback 360 orbital atherectomy system (
EMBASE:70273762
ISSN: 0735-1097
CID: 113819

Ranolazine improves endothelial function in patients with stable coronary artery disease

Deshmukh, Smriti H; Patel, Snehal R; Pinassi, Elsa; Mindrescu, Catalin; Hermance, Eileen V; Infantino, Michael N; Coppola, John T; Staniloae, Cezar S
OBJECTIVES: We investigated the effect of ranolazine on endothelial-dependent vasodilatation (EDV), serum markers of endothelial dysfunction, and inflammation. BACKGROUND: Endothelial dysfunction has been shown to be independently associated with the occurrence of cardiovascular events. We sought to investigate whether ranolazine, a novel antianginal medication with no effect on heart rate or blood pressure, improves endothelial function in patients with stable coronary artery disease (CAD). METHODS: Twenty-seven patients with stable CAD were randomly assigned to either 1000 mg twice daily of ranolazine or to matching placebo for 6 weeks and then crossed over for an additional 6 weeks in a double-blind design. EDV was assessed using reactive hyperemia peripheral arterial tonometry (RH-PAT) at baseline, 6, and 12 weeks. Markers of endothelial dysfunction and inflammation were also evaluated. RESULTS: After 6 weeks, treatment with ranolazine significantly increased the EDV RH-PAT index as compared with baseline (1.85+/-0.42 vs. 2.08+/-0.57, P = 0.037). EDV RH-PAT did not change while on placebo (1.69+/-0.35 vs. 1.78+/-0.41, P = 0.29). In addition, there was a significant drop in asymmetric dimethylarginine levels with ranolazine treatment (0.66+/-0.12 vs. 0.60+/-0.11 micromol/l, P = 0.02) and a near significant decrease in C-reactive protein levels (0.40+/-0.80 vs. 0.30+/-0.61 mg/dl, P = 0.05). CONCLUSION: Ranolazine improves endothelial function, asymmetric dimethylarginine, and C-reactive protein levels in a group of patients with stable CAD. Our results suggest a novel mechanism of action of ranolazine
PMID: 19444092
ISSN: 1473-5830
CID: 112072

Contrast-induced nephropathy and long-term adverse events: cause and effect?

Solomon, Richard J; Mehran, Roxana; Natarajan, Madhu K; Doucet, Serge; Katholi, Richard E; Staniloae, Cezar S; Sharma, Samin K; Labinaz, Marino; Gelormini, Joseph L; Barrett, Brendan J
BACKGROUND AND OBJECTIVES: The relationship of contrast-induced nephropathy (CIN) to long-term adverse events (AEs) is controversial. Although an association with AEs has been previously reported, it is unclear whether CIN is causally related to these AEs. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We obtained long-term (> or =1 yr) follow-up on 294 patients who participated in a randomized, double-blind comparison of two prevention strategies for CIN (iopamidol versus iodixanol). A difference in the incidence of AEs between patients who had developed CIN and those who had not was performed using a chi(2) test and Poisson regression analysis. A similar statistical approach was used for the differences in AEs between those who received iopamidol or iodixanol. Multiple definitions of CIN were used to strengthen and validate the results and conclusions. RESULTS: The rate of long-term AEs was higher in individuals with CIN (all definitions of CIN). After adjustment for baseline comorbidities and risk factors, the adjusted incidence rate ratio for AEs was twice as high in those with CIN. Randomization to iopamidol reduced both the incidence of CIN and AEs. CONCLUSIONS: The parallel decrease in the incidence of CIN and AEs in one arm of this randomized trial supports a causal role for CIN
PMCID:2709519
PMID: 19556381
ISSN: 1555-905x
CID: 112070

N-Acetylcysteine added to volume expansion with sodium bicarbonate does not further prevent contrast-induced nephropathy: results from the cardiac angiography in renally impaired patients study

Staniloae, Cezar S; Doucet, Serge; Sharma, Samin K; Katholi, Richard E; Mody, Kanika R; Coppola, John T; Solomon, Richard
We reviewed data from the multicenter CARE (Cardiac Angiography in Renally Impaired Patients) study to see if benefit could be shown for N-acetylcysteine (NAC) in patients undergoing cardiac angiography who all received intravenous bicarbonate fluid expansion. Four hundred fourteen patients with moderate-to-severe chronic kidney disease were randomized to receive intra-arterial administration of iopamidol-370 or iodixanol-320. All patients were prehydrated with isotonic sodium bicarbonate solution. Each site chose whether or not to administer NAC 1,200 mg twice daily to all patients. Serum creatinine (SCr) levels and estimated glomerular filtration rate were assessed at baseline and 2-5 days after receiving contrast. The primary outcome was a postdose SCr increase 0.5 mg/dL (44.2 mumol/L) over baseline. Secondary outcomes were a postdose SCr increase 25% and the mean peak change in SCr. The NAC group received significantly less hydration (892 +/- 236 mL vs. 1016 +/- 328 mL; P < 0.001) and more contrast volume (146 +/- 74 mL vs. 127 +/- 71 mL; P = 0.009) compared with no-NAC group. SCr increases 0.5 mg/dL occurred in 4.2% (7 of 168 patients) in NAC group and 6.5% (16 of 246 patients) in no-NAC group (P = 0.38); rates of SCr increases 25% were 11.9% and 10.6%, respectively (P = 0.75); mean post-SCr increases were 0.07 mg/dL in NAC group versus 0.11 mg/dL in no-NAC group (P = 0.14). In conclusion, addition of NAC to fluid expansion with sodium bicarbonate failed to reduce the rate of contrast-induced nephropathy (CIN) after the intra-arterial administration of iopamidol or iodixanol to high-risk patients with chronic kidney disease
PMID: 19490358
ISSN: 1540-8183
CID: 112071

Histopathologic changes of the radial artery wall secondary to transradial catheterization

Staniloae, Cezar S; Mody, Kanika P; Sanghvi, Kintur; Mindrescu, Catalin; Coppola, John T; Antonescu, Cristina R; Shah, Sanjay; Patel, Tejas
OBJECTIVE: The immediate effects of transradial access on the radial artery wall are unknown. In this study we sought to assess the histological changes induced by catheterization on the radial artery. METHODS: Thirty-four patients undergoing coronary artery bypass grafting (CABG) had radial arteries harvested to serve as bypass conduits. The proximal and distal ends of the radial artery conduits were sectioned and embedded in paraffin. Both ends of all specimens were evaluated by a blinded pathologist for intimal hyperplasia, medial inflammation, medial calcification, periarterial tissue or fat necrosis, adventitial inflammation, adventitial necrosis, and adventitial neovascularization. Fisher's exact test was used for statistical analysis. RESULTS: Fifteen previously catheterized radial arteries (TRA group) were compared with 19 noncatheterized arteries (NCA group). The distal ends of the TRA group showed significantly more intimal hyperplasia (73.3% vs 21.1%; p = 0.03), periarterial tissue or fat necrosis (26% vs 0%; p = 0.02), and more adventitial inflammation (33.3% vs 0%; p = 0.01) than the distal ends of the NCA group. The distal ends of the TRA group also showed significantly more intimal hyperplasia (73.3% vs 26.6%; p = 0.03) and adventitial inflammation (33.3% vs 0%; p = 0.01) than the proximal ends of the same arteries. There were no histological differences in the proximal ends of the two groups. CONCLUSION: Transradial catheterization induces significant histological changes suggestive of radial artery injury limited to the puncture site in the form of intimal hyperplasia, medial inflammation, and tissue necrosis. Both the proximal and distal ends of the radial artery show a spectrum of atherosclerotic changes independent of its use for transradial catheterization
PMCID:2704894
PMID: 19590587
ISSN: 1178-2048
CID: 112069