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Background: The main drawback of current available drug coated balloons (DCB) is that a certain percentage of the coated drug is lost in the bloodstream during its delivery to the target lesion. We integrated the nanoparticle-mediated drug delivery technology and polydimethylsiloxane (PDMS) as a new excipient to facilitate an efficient drug delivery and uptake by endothelial cells. The present study aimed to evaluate the efficacy of the new DCB., Method and Results: The novel DCB were coated with 5.6mg of paclitaxel-incorporated nanoparticles using PDMS. The efficacy of the new DCB was examined in rabbit iliac stent model (n=12) and in the swine in-stent restenosis model (n=8) by quantitative coronary angiography (QCA) and optical coherence tomography (OCT). At 28days follow-up in the swine in-stent restenosis model, the area stenosis was significantly lower in DCB group as compared with that of the control group in OCT analysis (0.31±0.05 vs 0.49±0.06, p=0.04) though there was no significant differences observed in the rabbit iliac stent model in QCA and OCT analysis., Conclusion: The study results indicated that the paclitaxel-incorporated nanoparticle-coated balloon using PDMS has an inhibitory effect for the proliferation of smooth muscle cell in a swine coronary in-stent restenosis model., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: The present study aimed to develop a swine coronary bifurcation model., Background: In human coronary bifurcation lesion, atherosclerotic plaques are usually observed in the lateral wall, whereas the flow divider regions are spared. There is currently no suitable coronary bifurcation animal model, on which a new stent can be tested., Methods: We developed a novel directional heat injury catheter, which comprised of a non-compliant balloon catheter (diameter: 3.0mm, length: 15mm), and two electrode cables, that were attached to either side of the balloon catheter. The technique was performed on 4 healthy pigs, and assessed in 7 lesions. We inflated the balloon at the main bifurcation branch, following which a high frequency generator was used to transmit heat to the opposite side of the electrode, towards the bifurcation carina (duration: 5min, frequency: 2 times). We performed a post-angiography 28days after the pre-angiography, to observe the distribution of neointima. The neointimal area was divided into the carina side and the opposite side of carina, and the 2 sides were compared., Results: The neointimal area at the opposite side of the carina was significantly larger than the carina side (1.51±0.40mm 2 vs. 0.95±0.27mm 2 , p<0.0001). The percentage of area of stenosis on the opposite side of carina was also higher than that on the carina side (55.4±7.0% vs. 34.9±4.2%, p<0.0001)., Conclusions: We successfully developed a novel swine coronary bifurcation model using directional heat injury catheter., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) is an established therapy for patients who are inoperable or at high risk for open heart surgery. The retrograde transfemoral approach is the most widely used and is the first choice in TAVI. However, existence of peripheral vascular disease or a small iliofemoral artery often limits the application of the transfemoral approach. Transvenous antegrade transseptal TAVI is an attractive option, but has already been abandoned due to its technical complexities., Methods and Results: We have previously described a novel technique to simplify antegrade transseptal balloon aortic valvuloplasty, which utilizes a custom-made Inoue balloon catheter with two stylets. The technique is named as the looped Inoue balloon technique, and its feasibility and efficacy were proven in an animal model and a clinical case. We applied this technique to TAVI. The present study aimed to assess the feasibility of the looped Inoue balloon technique for TAVI in two healthy pigs. The valve implantation was successful in both pigs, although the pigs died soon after the implantation (2 and 24h). The causes of death were access site bleeding (Case 1) and migration of the prosthetic valve (Case 2)., Conclusions: Although several improvements and further studies are required, the study results indicate that antegrade TAVI using the looped Inoue balloon technique is feasible., (Copyright © 2016. Published by Elsevier Ltd.)

Objectives: The study aimed to assess the feasibility of a novel device and technique for antegrade percutaneous balloon aortic valvuloplasty (BAV) in a swine model., Background: BAV is currently being applied more frequently compared to the past with the advent of transcatheter aortic valve replacement. Although the antegrade BAV approach offers several advantages over the retrograde approach, the antegrade approach is technically more complicated and demanding., Methods: We developed a novel balloon catheter and a technique to simplify the antegrade BAV. The balloon catheter was designed to make a loop in left atrium by inserting two different sized stylets. The balloon catheter was easily dropped into the left ventricle via the mitral valve while maintaining the loop. The balloon catheter was advanced to the ascending aorta by holding the two stylets. Then, the balloon was inflated. We named the technique as the looped Inoue balloon technique. The feasibility of the looped Inoue balloon technique was assessed in a healthy swine with a body weight of 40 kg by four independent operators. Every operator conducted the procedure twice., Results: The procedural success rate was 100% in all operators. The average procedure time was 170 ± 35 sec. No procedure related complications were noted., Conclusions: The study results indicate that the antegrade BAV using the looped Inoue balloon technique is feasible and may simplify the antegrade approach., (Copyright © 2013 Wiley Periodicals, Inc.)