Engineering In Situ Weldable Vascular Devices.

(1) Background: The minimally invasive implantation of medical devices is largely limited by their insertion profile, and, therefore, minimizing them constitutes a leading trend in the field. (2) Methods: This study introduces the in situ welding strategy, whereby the components of the stent grafts used to treat abdominal aortic aneurysms were decoupled, deployed sequentially, and welded together at the aneurysmal site, greatly reducing their insertion profile. Polyurethane elastomers were used to produce the graft and to coat the metallic struts of the stent to render it in vivo weldable. Results: The composition of the polyurethanes was fine-tuned, so to minimize the insertion profiles and optimize the welding properties and the clinical performance of the devices assembled. The stent and graft were deployed successively in pigs via a small 8F introducer, in situ welded, and the patency of the bi-component device was confirmed over a three-month post-implantation period. The strength of the stent/graft welded connection was fully retained, with no de-welding observed. Conclusions: The in situ welding strategy resulted in implantations that were easier to perform and markedly less injurious to tissues and organs, largely expanding the applicability of these ultra-minimally invasive procedures to especially frail segments of the population.

Repeat Kidney Transplant in a Patient With a Double Inferior Vena Cava and Difficult Venous Access: A Case Report.

Many obstacles may complicate renal transplant, the preferred treatment for end-stage renal disease. Anatomic anomalies are of special importance during surgery. Double inferior vena cava is a rare anomaly reported in 0.2% to 3% of the population and may complicate renal transplant in certain cases. We present a case of a 29-year-old man with end-stage renal disease who was scheduled for repeat kidney renal transplant from a living related donor. His transplant posed many challenges to the transplant team. These included (1) difficult access for dialysis, which required transhepatic insertion of a dialysis catheter, (2) anomalous inferior vena cava anatomy with a double inferior vena cava, (3) a blocked right inferior vena cava, and (4) a small blocked bridging vein connecting the right inferior vena cava to an additional left inferior vena cava. A stent was inserted into the bridging vein to allow venous drainage from the graft. During the transplant procedure, the donated kidney was transplanted into the left iliac fossa and anastomosed to the left external iliac vein. The surgery was successful, without major operative or postoperative complications. The patient was discharged with normal renal function and enjoys normal renal function 6 months after surgery. This case emphasizes the importance of pretransplant evaluation and preparation and the need for high index of suspicion for anatomic variants in donors and recipients.

Phase Ib Safety, Two-Dose Study of MultiGeneAngio in Patients with Chronic Critical Limb Ischemia.

Critical limb ischemia (CLI) is the most severe presentation of peripheral arterial disease. We developed cell-based therapy entailing intra-arterial injection of autologous venous endothelial cells (ECs) modified to express angiopoietin 1, combined with autologous venous smooth muscle cells (SMCs) modified to express vascular endothelial growth factor. This combination promoted arteriogenesis in animal models and was safe in patients with limiting claudication. In an open-label, phase Ib study, we assessed the safety and efficacy of this therapy in CLI patients who failed or were unsuitable for surgery or intravascular intervention. Of 23 patients enrolled, 18 with rest pain or non-healing ulcers (Rutherford categories 4 and 5) were treated according to protocol, and 5 with significant tissue loss (Rutherford 6) were treated under compassionate treatment. Patients were assigned randomly to receive 1 × 107 or 5 × 107 (EC-to-SMC ratio, 1:1) of the cell combination. One-year amputation-free survival rate was 72% (13/18) for Rutherford 4 and 5 patients; all 5 patients with Rutherford 6 underwent amputation. Of the 12 with unhealing ulcers at dosing, 6 had complete healing and 2 others had >66% reduction in ulcer size. Outcomes did not differ between the dose groups. No severe adverse events were observed related to the therapy.