Performance, safety, and biocompatibility of a novel PFO closure device in a long-term porcine model.

Background: As the catheter-based device closure of the patent foramen ovale (PFO) is expanding, novel devices aim to address the limitations of first-generation occluders (e.g. bulk, erosion, dislodgment).

Device safety assessment of bronchoscopic microwave ablation of normal swine peripheral lung using robotic-assisted bronchoscopy.

Introduction: The aim of this study was to assess the safety of bronchoscopic microwave ablation (MWA) of peripheral lung parenchyma using the NEUWAVE™ FLEX Microwave Ablation System, and robotic-assisted bronchoscopy (RAB) using the MONARCH™ Platform in a swine model.

Methods: Computed tomography (CT)-guided RAB MWA was performed in the peripheral lung parenchyma of 17 Yorkshire swine (40-50 kg) and procedural adverse events (AEs) documented. The acute group (day 0,  = 5) received 4 MWAs at 100 W for 1, 3, 5, and 10 min in 4 different lung lobes.

Design and construction of three-dimensional physiologically-based vascular branching networks for respiratory assist devices.

Microfluidic lab-on-a-chip devices are changing the way that diagnostics and drug development are conducted, based on the increased precision, miniaturization and efficiency of these systems relative to prior methods. However, the full potential of microfluidics as a platform for therapeutic medical devices such as extracorporeal organ support has not been realized, in part due to limitations in the ability to scale current designs and fabrication techniques toward clinically relevant rates of blood flow. Here we report on a method for designing and fabricating microfluidic devices supporting blood flow rates per layer greater than 10 mL min for respiratory support applications, leveraging advances in precision machining to generate fully three-dimensional physiologically-based branching microchannel networks.

Current Status and Future Prospects of Transcatheter Mitral Valve Replacement: JACC State-of-the-Art Review.

Mitral regurgitation (MR) is the most prevalent valvular heart disease and, when left untreated, it confers a poorer prognosis. Catheter-based repair therapies face some limitations like their applicability on challenging anatomies and the potential recurrence of significant MR over time. Transcatheter mitral valve replacement (TMVR) has emerged as a less invasive approach potentially overcoming some of the current limitations associated with transcatheter mitral valve repair.

Downstream Paclitaxel Released Following Drug-Coated Balloon Inflation and Distal Limb Wound Healing in Swine.

The authors evaluated the presence of paclitaxel and healing of distal hind limb wounds created in 27 swine using biopsy punches followed by paclitaxel-coated balloon (PCB) use in the iliofemoral arteries of healthy swine. After 14 and 28 days, no differences were seen in time course, appearance, and histopathology of wound healing between the single or triple PCB and uncoated balloon treatment despite clinically relevant paclitaxel concentrations in the skin adjacent to the healing wounds. Presence of paclitaxel downstream from the PCB treatment site does not impair the wound healing response of preexisting distal cutaneous lesions in healthy swine.

Transcatheter Mitral Valve Implantation Systematic Review: Focus on Transseptal Approach and Mitral Annulus Calcification.

Introduction: This systematic review was performed to evaluate the results of transcatheter mitral valve implantation (TMVI) in the native mitral valve.

Evidence Acquisition: Medline, EMBASE, and the Cochrane Central register were systematically searched for studies that reported results of TMVI in mitral valve regurgitation and/or stenosis and mitral annular calcification. To improve the sensitivity of the literature search, we performed citation chasing in Google Scholar, Scopus, and Web of Science.

Early Experience With a Novel Transfemoral Mitral Valve Implantation System in Complex Degenerative Mitral Regurgitation.

Objectives: The aim of this study was to evaluate the feasibility, procedural results, and 6-month outcomes of a novel transfemoral transcatheter mitral valve implantation (TMVI) system (Cephea) in patients with complex primary mitral regurgitation (MR).

Background: TMVI is emerging as an alternative to surgery in patients with severe MR. To date, the great majority of TMVI systems use the transapical surgical approach.

Comparison of Mitral Valve Replacement and Repair for Degenerative Mitral Regurgitation: a Meta-analysis and Implications for Transcatheter Mitral Procedures.

Purpose Of Review: Surgical mitral valve repair is considered superior to replacement to treat primary mitral regurgitation. However, the heterogeneity of cohorts and the lack of consideration of confounding in the published literature raise potential biases. The aim of this study was to pool all available matched data comparing outcomes of mitral valve repair and replacement in the setting of primary mitral regurgitation.

Impact of Coronary Atherosclerosis on Bioresorbable Vascular Scaffold Resorption and Vessel Wall Integration.

The integration of the Absorb bioresorbable vascular scaffold (BVS) into the arterial wall has never been tested in an in vivo model of atherosclerosis. This study aimed to compare the long-term (up to 4 years) vascular healing responses of BVS to an everolimus-eluting metallic stent in the familial hypercholesterolemic swine model of atherosclerosis. The multimodality imaging and histology approaches indicate that the resorption and vascular integration profile of BVS is not affected by the presence of atherosclerosis.

Long-term performance and biocompatibility of a novel bioresorbable scaffold for peripheral arteries: A three-year pilot study in Yucatan miniswine.

Aims: Peripheral arteries are constantly exposed to deformation (elongation, twisting, shortening, compression) making bioresorbable scaffolds (BRS) a potentially attractive therapeutic alternative to metallic stents. We conducted a long-term pilot preclinical study of a novel sirolimus-eluting BRS in peripheral arteries.

Methods And Results: Fourteen BRS were deployed in iliofemoral arteries of seven healthy Yucatan miniswine and examined with imaging, pharmacokinetic, histopathologic, and polymer degradation techniques at 0, 30, 90, 180 days, 1, 2, and 3.

Advances in transcatheter mitral and tricuspid therapies.

Background: While rheumatic mitral stenosis has been effectively treated percutaneously for more than 20 years, mitral and tricuspid regurgitation treatment appear as a contemporary unmet need. The advent of transcatheter therapies offer new treatment options to often elderly and frail patients at high risk for open surgery. We aimed at providing an updated review of fast-growing domain of transcatheter mitral and tricuspid technology.

Experimental Evaluation of a Novel Percutaneous Transseptal Catheter-Based Mitral Valve Replacement Technology.

Background: Transcatheter mitral valve replacement is a novel therapeutic approach aiming to treat patients with severe mitral regurgitation. This study aimed to evaluate the biological and technical performance of a novel transseptal transcatheter mitral valve replacement system (Cephea Valve Technologies, Santa Cruz, CA) in a preclinical model.

Methods: Biological performance and healing response were evaluated following open-heart surgical implantation procedures in 10 sheep utilizing an antegrade transatrial access.

Imaging-assisted nanoimmunotherapy for atherosclerosis in multiple species.

Nanomedicine research produces hundreds of studies every year, yet very few formulations have been approved for clinical use. This is due in part to a reliance on murine studies, which have limited value in accurately predicting translational efficacy in larger animal models and humans. Here, we report the scale-up of a nanoimmunotherapy from mouse to large rabbit and porcine atherosclerosis models, with an emphasis on the solutions we implemented to overcome production and evaluation challenges.

Predictors of adverse outcomes after transcatheter mitral valve replacement.

: Transcatheter mitral valve replacement (TMVR) is still a recent technology with numerous unknowns but also great promises. The risk of complications reported in observational studies have limited its adoption by interventional cardiology and surgical communities. : Some of the major setbacks of TMVR are complications related to the devices and those related to the pathway.

In vitro mechanical behavior and in vivo healing response of a novel thin-strut ultrahigh molecular weight poly-l-lactic acid sirolimus-eluting bioresorbable coronary scaffold in normal swine.

Background: New generation bioresorbable scaffolds (BRS) promise to improve the outcomes of current generation BRS technologies by decreasing wall thickness while maintaining structural strength. This study aimed to compare the biomechanical behavior and vascular healing profile of a novel thin-walled (98 μm) sirolimus-eluting ultrahigh molecular weight BRS (Magnitude, Amaranth Medical) to the Absorb everolimus-eluting bioresorbable vascular scaffold (Abbott Vascular).

Methods And Results: In vitro biomechanical testing showed lower number of fractures on accelerated cycle testing over time (at 21K cycles = 20.

Rate of Drug Coating Dissolution Determines In-Tissue Drug Retention and Durability of Biological Efficacy.

Two different drug-coated balloons (DCBs) possessing different coating formulations were compared for rate of coating dissolution in addition to tissue drug concentration and histological responses of treated vascular tissue to determine if the rate of drug bioavailability to vascular tissue can impact the degree and duration of the observed pharmacological response to locally delivered drug. dissolution comparison demonstrated that a urea/paclitaxel-based coating formulation (IN.PACT™ Admiral™) released drug from solid to soluble phase at a slower and constant rate, yielding approximately 7% solubilized drug in 24 h.

In vivo comparison of key quantitative parameters measured with 3D peripheral angiography, 2D peripheral quantitative angiography and intravascular ultrasound.

The aim of this study was to compare the measures of luminal stenosis between the two-dimensional (2D) and three-dimensional (3D) Quantitative Vessel Analysis (QVA) generated by CAAS QVA software and intravascular ultrasound (IVUS). Invasive contrast angiography is considered gold standard for diagnostic imaging and intervention in both coronary and peripheral arterial disease. However, it is based on 2D images depicting complicated 3D arterial anatomy.

Two-year longitudinal evaluation of a second-generation thin-strut sirolimus-eluting bioresorbable coronary scaffold with hybrid cell design in porcine coronary arteries.

Background: The first commercially available bioresorbable scaffold (BRS) had a strut thickness of 156 microns. As such, it had the potential for delivery challenges and higher thrombogenicity. The aim herein, is to evaluate biomechanical performance, pharmacokinetics and vascular healing of a novel thin strut (100 μm) sirolimus eluting BRS (MeRes-100, Meril Life Sciences, Gujarat, India) against the once clinically used BRS (Absorb BVS, Abbott, Santa Clara, CA) in porcine coronary arteries.

Isolation of pulmonary veins using a thermoreactive implantable device with external energy transfer: Evaluation in a porcine model.

Background: Pulmonary vein isolation (PVI) is a well-established method for the treatment of symptomatic paroxysmal atrial fibrillation, but is only partly successful with a high rate of electrical reconnection. We introduce a novel technique in which PVI is accomplished by noninvasive heating of a dedicated thermoresponse implant inserted into the pulmonary veins (PV), demonstrated in a porcine model.

Methods: A self-expanding nitinol-based implant was positioned in the common inferior PV of 11 pigs, using a fluoroscopy-guided transatrial appendage approach.

First in human evaluation of the vascular biocompatibility and biomechanical performance of a novel ultra high molecular weight amorphous PLLA bioresorbable scaffold in the absence of anti-proliferative drugs: Two-year imaging results in humans.

Objectives: In this first-in-human study, we prospectively studied the vascular compatibility and mechanical performance of a novel bare ultra-high molecular weight amorphous PLLA bioresorbable scaffold (BRS, FORTITUDE®, Amaranth Medical, Mountain View, California) up to two years after implantation using multimodality imaging techniques.

Background: The vascular biocompatibility of polymers used in BRS has not been fully characterized in the absence of anti-proliferative drugs.

Methods: A total of 10 patients undergoing single scaffold implantation were included in the final analysis and were followed up using optical coherence tomography (OCT) at 2-years.

Angiographic classification of patterns of restenosis following femoropopliteal artery intervention: A proposed scoring system.

Objectives: To propose a classification system for characterizing angiographic femoropopliteal artery restenosis patterns associated with common endovascular modalities.

Background: Peripheral artery disease is a worldwide issue affecting millions of people. Despite a myriad of endovascular technologies available to treat peripheral artery disease of the femoropopliteal arteries, restenosis remains a common failure mode.