The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Oral 51H

ORAL

ABSTRACTS

Innovative Devices and Futuristic TherapiesRoom 150AB

Thursday, October 20, 2005, 1:56 pm - 2:56 pm(Abstract Nos. 103-106)

TCT-103

Hemoglobin-Based Oxygen Therapeutics in (Elective) Percutaneous (Coronary) Revascularization - The HEMOPURE TrialTon Slagboom1, Robbert de Winter2, Evelyn Regar3, Gerhard Schuler4, Holger Thiele4, Gert-Jan Laarman1, Guy Heyndrickx5, Patrick Serruys3 1Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands2Academisch Medisch Centrum, Amsterdam, The Netherlands3Erasmus Medisch Centrum, Rotterdam, The Netherlands4Herzzentrum Leipzig, Leipzig, Germany5Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium

Background: Because of their ability to perfuse and deliver O2, hemoglobin-based oxygen carriers (HBOC) have been proposed to treat ACS. Evaluation of systemic and coronary hemodynamics is important because of the potential vasoconstrictive effects and colloidal properties of these drugs. Methods: In this randomized, 3-arm (1:1:1), double-blind, placebo-controlled, dose-finding pilot (Phase II) study we assessed the systemic, pulmonary, and coronary hemodynamics of two doses (15g, 30g) of iv HBOC-201 (Biopure Corporation, Cambridge, MA, USA) vs. control (colloidal volume expander) in patients with one-vessel disease scheduled to undergo PCI for UA/NSTEMI. Full systemic hemodynamic assessment was performed including SBP, MAP, and CI. CFR during the 30 minutes of study drug infusion was assessed in a non-target reference vessel (RV). Results: This trial was completed in April 2005 and remains blinded pending final cleaning of the data set. A total of 46 patients (age 38-74, 34 males) were randomized at 5 centers in Europe. Treatment groups were equally matched for age, cardiovascular risk profile and anginal status at screening. At interim analysis, no significant changes in coronary artery (RV) diameter, or coronary flow velocity reserve were observed. Significant changes in systemic hemodynamics were noticed in 2 of the 3 treatment groups. Preliminary data showed critical elevations of blood pressure following CTM administration, in some cases above levels (SBP > 180mmHg) that should not be exceeded in order to minimize the risk of adverse events. A protocol amendment was instituted instructing consistent blood pressure management using vasodilators when necessary. Accordingly, critical blood pressure elevations were markedly reduced (7/30 patients before, 2/16 patients after a protocol amendment). Conclusions: This pilot study is the first step in assessing the safety of a potential new therapeutic agent for treating and managing cardiac ischemic events. The results of an analysis of the final 30-day unblinded systemic and coronary hemodynamic data will be presented.

TCT-104

Percutaneous Septal Sinus Shortening (The PS3 SystemTM): A Novel Procedure for the Treatment of Functional Mitral RegurgitationJason H. Rogers1, John Macoviak2, Patricia Takeda1, Reginald I. Low1 1UC Davis Medical Center, Sacramento, CA;2Ample Medical, Inc., Foster City, CA

Background: Functional mitral regurgitation (FMR) is prevalent and current solutions include ineffective medical therapy or high-risk invasive surgery. Prior research has demonstrated that the septal to lateral (S-L) mitral annular diameter is increased in FMR, and that regurgitation may be ameliorated by reducing this dimension. Specifically, direct S-L shortening has been previously accomplished in an ovine open-chest procedure with acute and chronic reduction of ischemic MR. We describe a novel percutaneous technique (percutaneous septal sinus shortening or

PS3 System) which we have shown to ameliorate FMR in an ovine model. Methods: Sheep underwent rapid right ventricular pacing to obtain moderate to severe FMR with associated decreased LV ejection fraction, LV and LA enlargement. Animals were anesthetized and intubated for the procedure, which was performed primarily under fluoroscopic guidance. Using a novel percutaneous approach (The PS3 SystemTM, Ample Medical, Inc.) based on magnetic catheter techniques to be described in complete detail, a bridge element is positioned between interatrial septal wall and great cardiac vein anchors. By progressively tensioning this bridge element, direct S-L shortening may be achieved. Results: The PS3 System can effectively ameliorate FMR in acute and chronic studies. To date, in 11 sheep, an average 26% reduction in the S-L diameter was achieved (34 mm pre-, 26 mm post-PS3) and an average 2 grade improvement in MR was achieved (2.3+ pre-, trace post-PS3). Complete echocardiographic and clinical characterization will be presented. 30 day chronic studies to date demonstrate persistent MR reduction, S-L shortening, with no migration, erosion or bridge thrombosis. Conclusions: The PS3 System is a novel percutaneous procedure appears to be effective in the amelioration of FMR in an ovine model. This technique has several potential advantages over existing percutaneous methods. The procedure utilizes standard catheter techniques and can be deployed largely under fluoroscopic guidance. In addition, the bridge element allows direct and precise S-L shortening to a diameter optimal for MR reduction.

TCT-105

Effects of Intracoronary Infusion of Peripheral Blood Stem Cells Mobilized with G-CSF on Coronary Flow Reserve and Wall Motion Index: An Intracoronary Doppler Flow Analysis: Interim Data from the Magic Cell-DES TrialJung-Won Suh, Bon-Kwon Koo, Sung-A Chang, Sang-Hoon Na, Hyun-Jae Kang, Hyo-Soo Kim, Dae-Won Sohn, Byung-Hee Oh, Young-Bae Park, Yun-Shik Choi Seoul National University Hospital, Seoul, Republic of Korea

Background In the MAGIC Cell trial data, we suggested that intracoronary infusion of peripheral blood stem cells (PBSC) mobilized with G-CSF improved left ventricular (LV) function. But the parameters which could predict the myocardial recovery after PBSC infusion were not well known. Therefore, we analyzed Doppler parameters and wall motion indices by cardiac MRI. Methods From our old myocardial infarction study (OMI) group (cell infusion n=12, control n=13), the data of Doppler study group (cell infusion n=10, control n=9) were analyzed. Recovery of global and regional LV function and wall motion abnormalities were measured using cardiac MRI before and six months after the coronary intervention with/without cell infusion. Coronary Doppler study was also performed after the procedure and at six month follow up. Results Baseline clinical, angiographic and hemodynamic characteristics were not different between two groups. Mean global wall motion index (GWMI) and regional wall motion index (RWMI) changed over time from1.75±0.43 to 1.67±0.43 (p=0.013) and from 2.30±0.69 to 2.23±0.71 (p=0.096) in the cell infusion group. In the control group, GWMI and RWMI changed from 1.90±0.48 to 1.81±0.56 (p=0.028) and from 2.23±0.58 to 2.35±0.73 (p=0.30). CFR was improved significantly in cell infusion group (1.91±0.68 at baseline & 2.54±0.97 at 6 months, p=0.025), but not in the control group(1.85±0.68 & 2.41±0.51, p=0.13). Doppler flow pattern at the time of initial procedure and RMWI change were analyzed together. In the cell infusion group, baseline average peak velocity(APV,r2=0.22) and hyperemic diastolic-to-systolic flow velocity ratio (DSVR, r2=0.26) showed correlation with change in GWMI and baseline APV (r2=0.68) and hyperemic DSVR (r2=0.25) revealed correlation with change in RWMI. In the control group, there were no significant Doppler parameters correlated with the change in WMI. CFR did not show correlation with change in WMI in both groups. Conclusion Intracoronary infusion of PBSC showed significant

THURSDAY 10/20/05 1:56 PM-2:56 PM (Room 150 AB)

52H The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Oral

ORAL

ABSTRACTS

improvement of WMI and CFR in patients with OMI. Also, the flow pattern was more important parameter than CFR in predicting the myocardial recovery in the PBSC infusion study.

TCT-106

LV Support Device Impella Increases Coronary Blood Flow in Patients with Compromised LV Undergoing AngioplastyMaurice Remmelink, Jan Baan, Jr., Jose P S Henriques, Robbert J de Winter, Karel T Koch, Rene J van der Schaaf, Marije M Vis, Evert W Scholten, Jan G P Tijssen, Jan J Piek Academic Medical Center - University of Amsterdam, Amsterdam, The Netherlands

Background: The left ventricular support device, Impella Recover® LP 2.5 has shown its safety and efficacy in hemodynamically compromised patients. Theoretically, the enhanced flow over the aortic valve and the unloading of the left ventricle could increase coronary perfusion pressure. On the other hand, it could also lead to diminished coronary blood flow (CBF) by a so called “Venturi” effect because of its position close to the coronary ostia. Therefore, our objective was to determine the effects on CBF during left ventricular support by the Impella. Methods: In 5 patients, who underwent an angioplasty with circulatory support by the Impella Recover® LP2.5, CBF was measured after the percutaneous coronary intervention in a non-stenotic coronary artery. The mean left ventricular ejection fraction was 29±6%. At five different support levels (ranging from neutral 0.0 to 2.6 l/min) simultaneous pressure and flow measurements were performed before and after injection of 3cc adenosine for hyperemia using the Wavewire and Flowire. We calculated fractional flow reserve (FFR) and coronary flow velocity reserve (CFVR) and assessed the differences between the support levels using ANOVA analysis. Results: The FFR during hyperemia remained the same at different support levels. The baseline average peak flow velocity (APV) at different support levels remained unchanged. The hyperemic APV increased significantly with increasing support levels (p<0.05). The CFVR was only significantly increased at the highest support level (2.6 l/min) compared to the neutral support level (2.2± 0.7 vs.1.8± 0.6; p=0.01). Conclusions: In conclusion, the left ventricular support device Impella had no effect on FFR and baseline APV. The Impella increased hyperemic APV resulting in an enhanced CFVR at the highest support level in hemodynamically compromised patients, probably secondary to unloading of the left ventricle.

THURSDAY 10/20/05 1:56 PM-2:56 PM (Room 150 AB)