Mitral annular reduction with subablative therapeutic ultrasound

Abstracts / Cardiovascular Revascularization Medicine 11 (2010) 269–280 patients who received heparin and those who did not (45% vs. 40%, P=.5). Independent predictors of thrombocytopenia were lower body weight, cardiogenic shock, and duration of IABP support. The incidence of both major bleeding and in-hospital death was higher among patients who developed thrombocytopenia than among those who did not (13.8% vs. 4.2%, P=.01 and 28% vs. 16%, P=.02, respectively). However, after controlling for confounding variables, thrombocytopenia was not an independent predictor of either major bleeding [odds ratio (OR) 2.2, 95% confidence interval (CI) 0.8–6.4, P=.1] or in-hospital death (OR 1.5, 95% CI 0.8–2.9, P=.3). Conclusions: Among patients undergoing IABP in the CCU, thrombocytopenia appears to be unrelated to concomitant heparin use and is not associated with an increased risk of major bleeding or in-hospital death.

doi:10.1016/j.carrev.2010.03.031

Mitral annular reduction with subablative therapeutic ultrasound Hasan Jilaihawi a, Renu Virmani b, Hiroshi Nakagawa c, Anique Ducharme a, Yan Fen Shi a, Naima Carter-Monroe b, Elena Ladich b, Atsushi Ikeda c, Anita Asgar a, Raoul Bonan a a Montreal Heart Institute, Montreal, QC, Canada b CV Path Institute, Gaithersburg, MD c Heart Rhythm Institute, Oklahoma, OK Objectives: To evaluate the potential for mitral annular size reduction using a novel device utilizing therapeutic ultrasound (TU). Background: Delivering energy at sub-ablative temperatures appears to produce contraction of the mitral valve annulus (MA) and may reduce mitral regurgitation by improving leaflet coaptation. It was hypothesized that therapeutic ultrasound (TU) from the ReCor (ReCor Inc., Ronkonkoma, NY, USA) device could result in such MA size reduction. Methods: The ReCor device was studied in a closed chest procedure in a canine animal model. Under fluoroscopy, a 12-Fr TU balloon catheter (ReCor) was advanced to the left atrium (transeptal approach). The TU balloon (24 mm diameter) was inflated with contrast saline and positioned at the MA. TU energy (9 MHz) was delivered circumferentially. The TU balloon was applied against the posterior mitral annulus, and position was monitored through specific fluoroscopic and/or intracardiac US recordings. Five TU applications were delivered (up to 130 W for up to 120 s). Transthoracic echocardiogram and Doppler flow were obtained to measure the MA diameter (short and long axes) and mitral flow before, immediately after, and at 1, 2, 3, and 4 weeks after ablation. Results: Thirty-five dogs were studied. Complications observed included one device-related death following ventricular fibrillation at the end of the second TU application. In addition, there were two other non–devicerelated deaths: one anesthesia related and one following a retroperitoneal hematoma necessitating early sacrifice. There was no significant damage to the mitral leaflets or the coronary arteries. Relative to baseline, mitral valve annular diameter reduction (based on maximal dimension) was 8.4% immediately postprocedure (n=32, Pb.001), 8.6% at 1 week (n=20, Pb.001), 8.8% at 2 weeks (n=20, Pb.001), 9.3% at 3 weeks (n=20, Pb.001), 10.8% at 4 weeks (n=22, Pb.001), 8.6% at 3 months (n=12, Pb.001), and 5.7% at 6 months (n=9, Pb.001). In eight dogs sacrificed after TU (two at 7 days and six at 6 months), histology showed minor endocardial thickening of the left atrium close to the MA and histology showed an increase in elastin associated with tissue thickening at the annular level. Transmission electron microscopy demonstrated a decrease in diameter of individual collagen fibers in treated regions compared to controls. Conclusion: Therapeutic ultrasound (TU) energy application to the mitral annulus is feasible percutaneously. A reduction in annular dimensions occurs immediately and appears to be durable without peri-annular damage. doi:10.1016/j.carrev.2010.03.032

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Clinical results of first-generation zotarolimus-eluting stents endeavor in the treatment of bare metal stent restenosis Arvydas Baranauskas, Giedrius Davidavicius, Vytautas Abraitis, Gintautas Bieliauskas, Valdas Bilkis, Aleksandras Laucevicius, Eugenijus Kosinskas Vilnius University Hospital Santariskiu Klinikos, Vilnius, Lithuania Background: Treating in-stent restenosis still remains a great challenge for the interventional cardiologist. Our aim was to evaluate the efficacy of firstgeneration zotarolimus-eluting stents (ZES) (Endeavor, Medtronic) in the treatment of bare metal stent (BMS) restenosis. Methods: Fifty-one consecutive patients with angiographically significant BMS restenosis were enrolled into the prospective, nonrandomised, singlecentre clinical study. In-stent restenosis was treated with ZES. The primary end point was target lesion revascularization (TLR) at 1 year. Secondary end points included major adverse cardiac events (MACE) and angiographic instent late lumen loss (LL) by QCA at 1 year. Baseline characteristics included mean age of 61.65±8.4 years, 76.4% male, 13.7% diabetes. Reference vessel diameter before PCI (RVD) and lesion length were 2.81±0.53 and 15.05±9.38 mm, respectively; RVD after ZES implantation was 3.31±0.42 mm; acute gain, 1.84±0.68 mm. One hundred percent procedural success was achieved. Lifelong ASA and 12 months of clopidogrel were prescribed to all patients. Results: MACE rate at 1 year was 25.5%, including sudden cardiac death (n=1), culprit lesion not related to MI (n=1), and TLR (n=11; 21.6%). Indications for TLR were as follows: Q wave or non-Q-wave MI (n=4), unstable angina (n=4), ischemia-driven TLR (n=3). Angiographic findings included in-stent restenosis (n=6; 11.75%) and total stent occlusion (n=5; 9.8%), one of which was classified as subacute stent thrombosis. At 1 year, in-stent LL was 0.95±0.66 mm. Conclusions: Although according to published data first-generation ZES Endeavor has demonstrated decent results in the treatment of de novo coronary lesions, in our small study ZES failed to show safety and efficacy in the treatment of high-risk lesions—BMS restenosis, with high MACE, TLR rates, and LL of 0.95±0.66 mm. doi:10.1016/j.carrev.2010.03.033

Imaging modalities Evaluation of sirolimus-eluting stents and Titan2 bio-active stents performance by optical coherence tomography: a window on the importance of nitric oxide for strut coverage Roberto Baglini, Andrea Amaducci, Xiao Wan, Jessica Lee IsMeTT, UPMC, Palermo, Italy Background: Lack of stent strut coverage has emerged as a main factor affecting stent performance in terms of restenosis and thrombosis propensity. Patients and methods: Two groups of patients were retrospectively collected from our database. Group 1: 18 patients (14 males, 4 females, mean age 68±15 years) with a single sirolimus-eluting stent on mid-LAD (followup 15±8 months), and Group 2: 15 patients (10 males, 5 females, mean age 69.8±15.4 years) with a single Titan2 stent (nitric oxide stratified) on midLAD. All these patients underwent new coronary angiography and optical coherence tomography (OCT). Results: Clinical data: Follow-up was 1.8±0.6 years (range 5–26 months) in Group 1 and 1.7±0.9 years (range 5–28 months) in Group 2. No significant difference was encountered between the two groups of patients for the usual coronary risk factors. No patient had had any episode of stent thrombosis in either Group 1 or Group 2. Eleven patients in Group 1 were on double antiplatelet oral therapy (aspirin and clopidogrel), while all patients in Group 1 had clopidogrel interrupted after 1 month. Angiographic data: No significant difference existed between Group 1 and Group 2 either in terms of stent initial diameter and length (3.2±0.4 vs. 3.1±0.5 and 23±12 vs. 23±8 mm, respectively) or in the type of coronary stenosis (Group 1: B2 in 50%, C in 50%; Group 2: B1 in 10%, B2 in 40%, and C in 50%). The initial luminal gain was not different in Groups 1 and 2 (2.2±0.3