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Granada J.F.,Skirball Center for Cardiovascular Research | Granada J.F.,Corbic Medical Center | Delgado J.A.,Corbic Research Institute | Uribe M.P.,Corbic Research Institute | And 4 more authors.
JACC: Cardiovascular Interventions

Objectives: We aimed to evaluate the safety and feasibility of a robotic angioplasty system in delivery and manipulation of coronary guidewires, balloons, and stents in patients undergoing elective percutaneous coronary intervention (PCI). Background: A remote-control, robotic-assisted angioplasty system is under development to address some of the procedural challenges and occupational hazards associated with traditional PCI. Methods: Patients with coronary artery disease and clinical indication for elective PCI were enrolled. The coronary angioplasty procedure was performed with the CorPath 200 robotic system (Corindus, Inc., Natick, Massachusetts). The system consists of a remote interventional cockpit and a multicomponent bedside unit that enables the operator to advance, retract, and rotate guidewires and rapid exchange catheters. The primary endpoint was device clinical success (≤30% residual stenosis) without in-hospital major adverse cardiac events. Technical success was defined as the ability of the system to complete all the planned angioplasty steps on the basis of procedural segments. Patients were followed up to 30 days after angioplasty procedure. Results: A total of 8 patients were enrolled in the study. The primary endpoint was achieved in all patients (100%). The technical success of the robotic system was 97.9% in completing 47 of 48 planned steps. There were no device- or procedure-related complications and no in-hospital or 30-day major adverse cardiac events. The operators rated the robotic system performances as equal to or better than manual procedures in 97.5% of the cases. The operator radiation exposure was 97% lower than the levels found at the standard table position. Conclusions: Early clinical experience with a robotic-assisted angioplasty system demonstrated feasibility, safety, and procedural effectiveness comparable to manual operation. In addition, the total operator exposure to radiation was significantly low. A larger study is warranted to verify the safety and effectiveness of robotic-assisted percutaneous coronary intervention. © 2011 American College of Cardiology Foundation. Source

Eppihimer M.J.,Boston Scientific Corporation | Sushkova N.,Boston Scientific Corporation | Grimsby J.L.,Boston Scientific Corporation | Efimova N.,Boston Scientific Corporation | And 6 more authors.
Circulation: Cardiovascular Interventions

Background-Emerging drug-eluting stent technologies are evolving toward the elimination of polymeric component used as the method for modulating drug delivery. Although this technological approach seems to be biologically appealing, the impact of durable polymers and metallic stent surfaces on vascular healing remains unclear. In the present study, we aimed to compare the independent effect of a durable polymer and a metallic stent surface on thrombogenicity and endothelial cell coverage using different in vitro and in vivo experimental models. Methods and Results-Platinum chromium (PtCr) and polyvinylidene fluoride-co-hexafluoropropene (PVDF-HFP)-coated surfaces were evaluated in this study. Thrombogenicity was assessed by exposing all surfaces to human blood under shear flow conditions. The inflammatory potential of the material was evaluated by measuring cytokine release from THP-1 cells exposed to all surfaces for 24 hours. Endothelial cell coverage was evaluated by detection of CD31 after the stents were exposed to human coronary artery endothelial cells for =14 days. Platelet adhesion (P<0.01) and activation (P=0.03) on PVDF-HFP were greater than on PtCr. In vivo, PVDF-HFP revealed more neointimal area (P<0.01) and residual parastrut fibrin (P=0.01) at 30 days compared with PtCr. PtCr displayed higher endothelialization rates and higher vascular endothelial-cadherin expression at 7 and 14 days (P=0.02) compared with PVDF-HFP. Conclusions-Thrombogenicity and vascular healing differ among metallic and polymeric stent surfaces. PVDF-HFP exhibits higher degrees of platelet activation-adhesion and thrombus accumulation in vivo compared with PtCr. PtCr displayed higher degrees of endothelial surface coverage compared with PVDF-HFP surfaces. © 2013 American Heart Association, Inc. Source

Granada J.F.,Skirball Center for Cardiovascular Research | Buszman P.P.,Skirball Center for Cardiovascular Research | Buszman P.P.,Center for Cardiovascular Research and Development
Current Cardiology Reports

The treatment of severe hypertension by the surgical obliteration of the renal sympathetic nerves was proposed almost 80 years ago. This approach, although highly effective in reducing blood pressure was associated with a significant amount of side effects and it was rapidly replaced by better tolerated medical therapy. The rapid progress in catheter based technologies occurring within the last 20 years facilitated the development of the first radio frequency renal artery denervation catheter. At the present time, several small trials have demonstrated the safety and efficacy of this approach among patients with refractory hypertension. Besides its effect on reducing blood pressure, other pleiotropic effects (ie, improving glycemia in diabetic patients) have been proposed. In this review, we discuss the anatomical and physiological rationale for this therapy, provide an update on the latest clinical data available and describe additional emerging technologies in this field. © 2012 Springer Science+Business Media, LLC. Source

Buszman P.P.,Skirball Center for Cardiovascular Research | Tellez A.,Skirball Center for Cardiovascular Research | Afari M.E.,Skirball Center for Cardiovascular Research | Peppas A.,Skirball Center for Cardiovascular Research | And 6 more authors.
JACC: Cardiovascular Interventions

Objectives This study sought to evaluate vascular drug uptake, distribution and response of second-generation paclitaxel coated balloon (PCB) (Cotavance, MEDRAD Interventional, Indianola, Pennsylvania) and compare it with first-generation technology, containing identical excipient and drug concentration. Background Original PCB technologies displayed a heterogeneous deposition of crystalline paclitaxel-iopromide inside the balloon folds, whereas second-generation PCBs consisted of more homogeneous, circumferential coatings. Methods Paclitaxel tissue uptake was assessed in 20 iliofemoral arteries of a domestic swine. Vascular healing response was assessed in the familial hypercholesterolemic model of iliofemoral in-stent restenosis. Three weeks after bare-metal stent implantation, vascular segments were randomly revascularized with first-generation PCBs (n = 6), second-generation PCBs (n = 6), or plain balloon angioplasty (PBA) (n = 6). At 28 days, angiographic and histological evaluation was performed in all treated segments. Results One-hour paclitaxel tissue uptake was 42% higher in the second-generation PCBs (p = 0.03) and resulted in more homogeneous segment-to-segment distribution compared with first-generation PCBs. Both angiography (percentage of diameter stenosis: second-generation 11.5 ± 11% vs. first-generation 21.9 ± 11% vs. PBA 46.5 ± 10%; p < 0.01) and histology (percentage of area stenosis: second-generation 50.5 ± 7% vs. first-generation 54.8 ± 18% vs. PBA 78.2 ± 9%; p < 0.01) showed a decrease in neointimal proliferation in both PCB groups. Histological variance of the percentage of area stenosis was lower in second-generation compared with first-generation PCBs (51.7 vs. 328.3; p = 0.05). The presence of peristrut fibrin deposits (0.5 vs. 2.4; p < 0.01) and medial smooth muscle cell loss (0 vs. 1.7; p < 0.01) were lower in the second-generation compared with first-generation PCBs. Conclusions In the experimental setting, second-generation PCB showed a comparable efficacy profile and more favorable vascular healing response when compared to first-generation PCB. The clinical implications of these findings require further investigation. © 2013 by the American College of Cardiology Foundation. Source

Cheng Y.,Skirball Center for Cardiovascular Research | Aboodi M.S.,Skirball Center for Cardiovascular Research | Annest L.S.,BioVentrix | Wechsler A.S.,Drexel University | And 3 more authors.
Journal of Thoracic and Cardiovascular Surgery

Objective The loss of normal apical rotation is associated with left ventricular (LV) remodeling and systolic dysfunction in patients with congestive heart failure after myocardial infarction. The objective of the present study was to evaluate the effect of epicardial ventricular reconstruction, an off-pump, less-invasive surgical reshaping technique, on myocardial strain, LV twist, and the potential alteration of myocardial fiber orientation in an ovine model of LV anteroapical aneurysm. Methods LV anteroapical myocardial infarction was induced by coil embolization of the left anterior descending artery. Eight weeks after occlusion, epicardial ventricular reconstruction was performed using left thoracotomy under fluoroscopic guidance in 8 sheep to completely exclude the scar. The peak systolic longitudinal/circumferential strains and LV twist were evaluated using speckle tracking echocardiography before (baseline), after device implantation, and at 6 weeks of follow-up. Results Epicardial ventricular reconstruction was completed in all sheep without any complications. Immediately after device implantation, LV twist significantly increased (4.18 ± 1.40 vs baseline 1.97 ± 1.92; P =.02). The ejection fraction had increased 17% and LV end-systolic volume had decreased 40%. The global longitudinal strain increased from -5.3% to -9.1% (P <.05). Circumferential strain increased in both middle and apical LV segments, with the greatest improvement in the inferior lateral wall (from -11.4% to -20.6%, P <.001). These effects were maintained ≤6 weeks after device implantation without redilation. Conclusions Less invasive than alternative therapies, epicardial ventricular reconstruction on the off-pump beating heart can restore LV twist and systolic strain and reverse LV remodeling in an ovine anteroapical aneurysm model. © 2014 by The American Association for Thoracic Surgery. Source

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