JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
Medical Centers, AMAGASAKI, Japan; 2Kansai Rosai Hospital, Cardiovascular Center, Amagasaki city, Japan; 3Kokura Memorial Hospital; 4Morinomiya Hospital, Osaka, Japan; 5Minneapolis Heart Institute Foundation; 6Saiseikai Central Hospital, Kyoto, Japan; 7 Saiseikai Yokohama-city Eastern Hospital; 8AstraZeneca; 9Nagoya Kyoritsu Hospital, Nagoya, Japan; 10Kyoto university Hospital, Kyoto, Japan; 11University of North Carolina Hospital; 12Fukuoka, Japan; 13 Sant’Eugenio Hospital, Rome, Italy; 14Juntendo University Nerima Hp., Tokyo, Japan; 15Hospital of León; 16Kanazawa Cardiovascular Hospital, Ishikawa, Japan; 17shinshu university hospital, Matsumoto, Japan; 18Tokai University, Isehara, Japan; 19Sant’Eugenio Hospital, Rome, Italy; 20Hofstra Northwell School of Medicine
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(n¼50) at 11 centers around the United States. Procedural measurements collected included fluoroscopic toxicity (mGy), total contrast volume (mL), and total fluoroscopy time (min). RESULTS Results demonstrated a 63% reduction in median fluoroscopic exposure across all procedures (p<0.05). Effective dose measurements in Pantheris treated lesions was 463.10mSv, contrast 140.43mL, and total fluoroscopy time 23.7 9.3min.
BACKGROUND Octogenarians presenting with peripheral artery disease (PAD) is increasing because of the aging population in the developed countries. Endovascular therapy (EVT) is widespread because of the low invasiveness and comparable durability to bypass surgery (BSX) for aortoiliac (AI) lesions. However, safety and efficacy of EVT in octogenarians remain to be elucidated. The aim of this study was to investigate the safety and efficacy of EVT for AI lesions in PAD for octogenarians. METHODS This study is a sub-analysis of REAL-AI, a large scale multicenter, retrospective registry. A total of 1861 limbs from 1735 consecutive patients (mean age 719 years; 84 % male) who underwent successful EVT for octogenarians with PAD presenting with intermittent claudication (IC) due to AI lesions between January 2005 and December 2009 were enrolled. The patients were divided into two groups by the age (<80 and S80). The safety outcome measures were perioperative complications including 30-day mortality and bleeding events. The efficacy outcome measures were primary patency, all cause death, major adverse cardiovascular events (MACE) defined by all-cause death, myocardial infraction or stroke, and major adverse limb events (MALE) defined by any repeat revascularization for limb, or leg amputation. Outcome measures were estimated by the KaplanMeier method and between-group differences were assessed with the log-rank test. RESULTS Prevalence of dislipidemia, diabetes mellitus were significantly lower, and heart failure was significantly higher in octogenarians (p¼0.028, p¼0.043, and p¼0.022, respectively). During followup, perioperative complications occurred more (8.0%) in the octogenarians than in the non-octogenarians (4.2%, p¼0.002). Neither the primary patency (83.0% vs. 76.8%; log rank p¼ 0.227), nor the incidence of MALE (36.4% vs. 27.7%; log rank p¼ 0.065) was different for five years between the octogenarians and the non-octogenarians. Allcause death for five years was significantly higher in the octogenarians than in the non-octogenarians (29.5% vs. 13.4%; log rank p<0.001). MACE for five years was also high in the octogenarians (30.3% vs. 18.8%; log rank p¼ 0.001). CONCLUSION Despite the higher incidence of perioperative complications and mortality in octogenarians than in non-octogenarians, efficacy of EVT for PAD presenting with intermittent claudication due to aortoiliac lesions was comparable between them. CATEGORIES ENDOVASCULAR: Peripheral Vascular Disease and Intervention TCT-789 Optical coherence tomography (OCT) enables the reduction in fluoroscopic exposure during endovascular atherectomy Tom Davis1 1 Detroit, Michigan, United States BACKGROUND Interventional physicians have the highest rates of radiation exposure within the medical profession, due in large part to fluoroscopy – a gold standard for visualization in endovascular procedures. The cumulative effects of fluoroscopy exposure are only now becoming evident, with recent data correlating increased radiation exposure with increases in the risk of cancer. Recently, an optical coherence tomography (OCT) guided revascularization device (Pantheris, Avinger Inc.) was approved by the FDA for the treatment of PAD. OCT guided atherectomy revascularization allows for debulking of disease using OCT to guide the operator and effectively reduce the need for angiographic fluoroscopy. The goal of this study was to compare radiation use in procedures using OCT-guidance vs those under fluoroscopic guidance. METHODS Retrospective radiation exposure measurements were collected from 102 patients undergoing revascularization in SFA and popliteal lesions. Matched patient cohorts were compared between OCT-guided atherectomy (n¼52) and fluoroscopic guided atherectomy
CONCLUSION OCT guided atherectomy enabled physicians to significantly reduce both patient and operator fluoroscopy exposure as compared to other non-imaging devices. Changes in practice could lead to reduced fluoroscopic radiation exposure during endovascular procedures. CATEGORIES ENDOVASCULAR: Peripheral Vascular Disease and Intervention TCT-790 Cardiac Arrest Triage score best predicts mortality after intervention in patients with massive and submassive pulmonary embolism Taishi Hirai,1 DeShon Jones,2 Steven Tate,3 Kathryn Dryer,4 Lyn Santiago,5 Dana Edelson,6 Janet Friant,7 Sandeep Nathan,8 Atman Shah,9 Jonathan Paul,10 John Blair11 1 Loyola University Medical Center, Maywood, Illinois, United States; 2 Medical University of Silesia, 3rd Department of Cardiology; 3 HOSPITAL CENTRAL MILITAR; 4Teikyo university school of medicine; 5 University of Texas Medical School at Houston; 6University of Chicago; 7 University of Chicago, Chicago, Illinois, United States; 8University of Chicago Medical Center, Chicago, Illinois, United States; 9University of Chicago, Chicago, Illinois, United States; 10University of Chicago, Chicago, Illinois, United States; 11Northwestern University, Chicago, Illinois, United States BACKGROUND Pharmacomechanical therapy (PMT) for massive (M) and submassive (SM) pulmonary embolism (PE) include techniques for clot lysis while minimizing the dose of fibrinolytic therapy. Although available data have demonstrated that PMT results in improved right ventricular function, and reduced pulmonary pressures and thrombus burden, long-term outcomes and predictors of poor outcome are not well-studied. We hypothesized that existing and novel risk predictors would help better predict poor outcomes after PMT for M and SM PE. METHODS We conducted retrospective analysis of all patients who underwent intervention for M or SM PE at a single quaternary care institution from 2010 to 2016. The Cardiac Arrest Triage (CART) score was compared to Pulmonary Embolism Severity Index (PESI) by ROC and Kaplan-Meier (KM) survival analysis was performed using optimal cut-offs. RESULTS We studied 58 patients (mean age 56 16, male 41%, CAD 8.6%, COPD 6.9%, mean PESI 11242, mean CART 12.5 9.7, 28% massive PE) . Thirty day mortality was 24% and overall mortality was 36% (mean follow up 379 days). Treatments included rheolytic thrombectomy in 16%, directed thrombolysis in 33%, and ultrasound assisted thrombolysis in 34%. There were no differences in outcome
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based on technique. CART had better AUC compared to PESI (0.76 vs 0.71). (Figure 1) CART> 24 had highest specificity: 97% and LR+: 14 and CART<12 had lowest LR-: 0.38. Patients with higher CART had significantly higher mortality rate on KM analysis (Figure 2).
December 2014 at our lab. To compare we collected data from a year prior (May 2013 to December 2013) when femoral approach was the norm at our practice. Transpedal group had 204 patients while the tranfemoral group had 199. RESULTS Patient characteristics and overall disease severity (TASC and Rutherford class) were similar between the two groups. The arterial access success rate was 94% in transpedal group vs 100% of femoral. Once the access was obtained, the procedural success rate was similar in both groups. Total of 3 patients required additional femoral access in the pedal group. No major complications were associated with transpedal approach and the access site patency was 100% at one month ultrasound follow up. In femoral group 13 large hematomas (6.5%) and one retroperitoneal bleed requiring transfusion was reported. Transpedal
Transfemoral
p value
Contrast Dose (ml)
44+11
68+13
<0.0001
Radiation dose (mGy)
25
48
<0.0001
Fluoro time (min)
5.48
9.35
<0.001
CONCLUSION Transpedal approach may be a safer alternative to traditional transfemoral approach with high success rate and reduced radiation dose, contrast use and complications. Patient comfort and shorter recovery time are other significant benefits of this approach. Long term follow up data on intervention site patency and clinical outcomes are not available in our analysis but we believe the choce of access site should not make a significant difference in those parameters. CATEGORIES ENDOVASCULAR: Peripheral Vascular Disease and Intervention TCT-792 Non-Invasive Hemodynamics Poorly Predict Disease Severity and Response to Endovascular Therapy in Patients with Critical Limb Ischemia Jihad Mustapha,1 Michael Jaff,2 George Adams,3 Larry Diaz,4 Robert Beasley,5 Theresa McGoff,6 Sara Finton,7 Carmen Heaney,8 Larry Miller,9 Fadi Saab10 1 Metro Heart & Vascular Institute, Wyoming, Michigan, United States; 2 Massachusetts General Hospital, Boston, Massachusetts, United States; 3University of North Carolina - Chapel Hill, Wake Forest, North Carolina, United States; 4Metro Health Hospital, Ada, Michigan, United States; 5Mount Sinai Medical Center, Miami, Florida, United States; 6 Icahn School of Medicine at Mount Sinai; 7Creighton University Medical Center; 8Metro Health Hospital, Wyoming, Michigan, United States; 9Miller Scientific Consulting, Arden, North Carolina, United States; 10Creighton University Medical Center
CONCLUSION Compared to PESI, CART score better predicts mortality in M or SM PE patients undergoing PMT. CART is a useful risk stratification tool for these high-risk patients. CATEGORIES ENDOVASCULAR: Peripheral Vascular Disease and Intervention TCT-791 A Single Center Experience of Transpedal vs Transfemoral approach for Infrainguinal Endovasuclar Interventions Sooraj Shah,1 Joseph Puma,2 Olivier Bertrand,3 Tak Kwan4 1 Montefiore Medical Center, New York, New York, United States; 2 ApexNano Medical; 3Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec City, Quebec, Canada; 4Mount Sinai Beth Israel, New York, New York, United States BACKGROUND Sole transpedal access for infrainguinal endovascular intervention is a relatively new technique recently described by our group. Traditional femoral approach is still widely used despite associated significant complications. We describe a retrospective analysis with comparison of the two approaches in our practice. METHODS We collected data of all infrainguinal endovascular intervention done by transpedal approach between May 2014 and
BACKGROUND Critical limb ischemia (CLI), defined as Rutherford 4-6 with multilevel/multivessel involvement, is end-stage peripheral arterial disease (PAD). Ankle and toe-brachial indices (ABI, TBI) and toe pressure (TP) are frequently utilized to diagnose and evaluate PAD and CLI. Limb hemodynamic values of 0.5 for ABI, 0.5 for TBI, and 50 mmHg TP are typically considered thresholds for diagnosing CLI. Historically, ABI, TBI, and TP thresholds have been exclusion criteria for studies of infrapopliteal (IP) CLI therapies. Limited evidence exists regarding the correlation between ABI/TBI values and the clinical presentation and treatment response of a CLI patient. These noninvasive hemodynamic studies (NIHS) were evaluated to determine their reliability to predict disease severity and response to endovascular treatment (EVT). METHODS 76 CLI patients enrolled in The Peripheral RegIstry of Endovascular Clinical OutcoMEs (PRIME) were evaluated. PRIME is a prospective multicenter outcomes registry focused on minimally invasive EVT for advanced PAD and CLI. Analyzed patients were Rutherford 4-6 with angiographically proven severe below-the-knee disease. Patients underwent baseline NIHS and EVT with 30 to 90 day follow-up NIHS. RESULTS Mean age: 74, 68% male. Most common comorbidities were dyslipidemia, hypertension, and diabetes (95%, 91%, 67%, respectively). 86% had ABI > 0.5, 28% TBI > 0.5, and 50% TP > 50 mmHg. 3 months after successful EVT, limb salvage rates, wound healing and Rutherford class improvement were similar among patients with baseline TP lower or higher than 50 mmHg (p¼NS). Despite clinical