Mid-term results of a case series on branched xenopericardial roll graft replacement to treat aortic arch/arch graft infection.

Objectives: We conducted this case series to evaluate the feasibility and mid-term outcomes of orthotopic aortic arch reconstruction using xenopericardial grafts to treat native aortic arch/arch graft infection.

Methods: Between 2010 and 2023, adopting a multidisciplinary approach, we treated consecutive patients with aortic arch/arch graft infection by orthotopic branched xenopericardial roll graft replacement and tissue filling. The end points of the study were the graft reinfection and graft-related complications such as pseudoaneurysm formation, thromboembolism, graft stenosis, graft calcification and death.

Percutaneous Deep Venous Arterialization by Balloon Angioplasty without Stent Implantation for Patients with Chronic Limb-Threatening Ischemia Undergoing Hemodialysis: A Retrospective Cohort, Single-Center, Single-Arm Study.

Purpose: This retrospective, single-center study aimed to determine the efficacy of percutaneous deep venous arterialization in patients on hemodialysis with chronic limb-threatening ischemia.

Materials And Methods: Twenty-one consecutive limbs on hemodialysis with chronic limb-threatening ischemia were treated with percutaneous deep venous arterialization using balloon angioplasty following a failed pedal arterial reconstruction between May 2021 and June 2022. An arteriovenous fistula near the ankle joint was created to ensure sufficient venous flow reversal to the pedal veins.

Editor's Choice - Impact of Infrapopliteal Revascularisation Establishing In Line Flow to the Wound in Patients with Chronic Limb Threatening Ischaemia.

Objective: This study aimed to determine the impact of infrapopliteal (IP) revascularisation establishing in line flow to the wound (IFW) on wound healing in chronic limb threatening ischaemia (CLTI), using a core laboratory assessment for wounds and in line flow.

Methods: The Wound directed Angiosome RevasculaRIsation apprOach to patients with cRitical limb iSchaemia (WARRIORS) multicentre observational study enrolled patients with CLTI with tissue loss undergoing IP revascularisation in Japan, with scheduled two year follow up. The primary outcome measure was complete wound healing, defined as achievement of complete epithelialisation of all wounds without major amputation.

Efficacy of autologous platelet-rich plasma gel in patients with hard-to-heal diabetic foot ulcers: a multicentre study in Japan.

Objective: To evaluate the healing outcome of a platelet-rich plasma (PRP) gel prepared using TKKT01 (a wound care device to prepare the PRP gel) in patients with hard-to-heal diabetic foot ulcers (DFUs) and who showed an inadequate response to ≥4 weeks of standard of care (SoC).

Method: This open-label, single-arm, multicentre study was conducted in 15 centres in Japan. Eligible patients received PRP gel treatment twice a week for eight weeks, followed by a final evaluation after the completion of week 8 (day 57).

Poor short-term outcomes for prognostic high-risk patients with chronic limb-threatening ischemia undergoing endovascular therapy.

Background: The prognosis of chronic limb-threatening ischemia (CLTI) is poor, with an expected life expectancy of 2 or more years, which significantly influences treatment decisions. However, death may occur at the early stages of treatment for wound healing, and aggressive treatment may limit the quality of life of such patients. In patients with CLTI undergoing endovascular therapy (EVT), the Wound, Ischemia, and foot Infection (WIfI) clinical stage, male sex, older age, non-ambulatory status, low body mass index, and dialysis have been reported as predictors of mortality risk.

Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries.

Background: Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited.

Methods: The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.

Percutaneous deep venous arterialization with balloon angioplasty salvaged a life-threatening critical limb in a hemodialysis patient after repeated pedal angioplasty failed: A case report.

Chronic limb-threatening ischemia (CLTI) with severe below-the-ankle (BTA) lesions is often difficult to revascularize with endovascular treatment (EVT) and surgical treatment. We present a case of successful limb salvage using percutaneous deep venous arterialization (pDVA) in a patient with CLTI whose BTA lesion reconstruction failed. A 57-year-old man with diabetes mellitus and end-stage renal failure on maintenance hemodialysis was referred to our hospital because of gangrene in the second and third toes of his left foot.

Pathology of Critical Limb Ischemia; Comparison of Plaque Characteristics Between Anterior and Posterior Tibial Arteries.

Aims: Though the number of patients with peripheral arterial disease (PAD) and critical limb ischemia (CLI) is increasing, few histopathological studies of PAD, particularly that involving below-the-knee arteries, has been reported. We analyzed the pathology of anterior tibial artery (ATA) and posterior tibial artery (PTA) specimens obtained from patients who underwent lower extremity amputation due to CLIMethods: Dissected ATAs and PTAs were subjected to ex-vivo soft X-ray radiography, followed by pathological examination using 860 histological sections. This protocol was approved by the Ethics Review Board of Nihon University Itabashi Hospital (RK-190910-01) and Kyorin University Hospital (R02-179).

A novel low-density lipoprotein/fibrinogen apheresis method for chronic limb-threatening ischemia in patients with poor options for revascularization: A multicenter, single-arm clinical trial.

Introduction: Low-density lipoprotein (LDL) apheresis is a treatment option for patients with unhealed chronic limb-threatening ischemia (CLTI) after revascularization. The newly developed AS-25 is a direct hemoperfusion-type apheresis device that differs from conventional LDL apheresis therapy and is designed to specifically adsorb both LDL-C and fibrinogen. We evaluate the efficacy and safety of AS-25.

Social isolation in patients with chronic limb-threatening ischemia: a cross-sectional study.

Assistance by family members or friends plays important roles in the course of treating patients with chronic limb-threatening ischemia (CLTI), both during hospitalization and after discharge. The aim of this study was to reveal the prevalence of social isolation and to explore relevant clinical backgrounds in patients with CLTI presenting with tissue loss and requiring revascularization. We analyzed 413 patients registered in a multicenter study in whom revascularization were scheduled for CLTI with tissue loss.

Two stages of salvaging an extensively necrotic foot with chronic limb-threatening ischemia by arterialization of great saphenous vein and free latissimus dorsi musculocutaneous flap transfer for wound coverage with the arterialized vein as the recipient vessel: A case report.

Patients with chronic limb-threatening ischemia (CLTI) without other options for adequate arterial revascularization could undergo deep (or distal) venous arterialization for limb salvage. Additionally, patients with extensive foot wound with CLTI sometimes require free flap transfer for limb salvage. We herein report a case of successful reconstructive limb-salvage surgery for an extensively necrotic foot with CLTI, using a two-stage operation involving venous arterialization using foot-perforating veins and subsequent free flap transfer (with preservation of the arterialized vein).

Evidence of nutritional vascular formation from the "nutrient flap" in a patient with no-option chronic limb-threatening ischemia: An indocyanine green fluorescence imaging study.

The concept of a "nutrient flap," in which ischemic tissue is nourished by a transferred well-perfused flap, has been advocated for use since the early days of free flap procedures. Several studies have reported cases of no-option chronic limb-threatening ischemia salvaged by nutrient free flap transfer. However, it has been difficult to prove the actual dynamic flow and nutritional vascular formation.

Injury Precipitating Tissue Loss and Time to Referral to a Vascular Center in Patients with Chronic Limb-Threatening Ischemia.

Aim: This study aimed to report injury precipitating tissue loss and to provide updated information on the time from tissue loss occurrence to referral to a vascular center for patients who developed chronic limb-threatening ischemia (CLTI) in Japan.

Methods: We examined 450 patients who developed CLTI with tissue loss and were registered in a multicenter prospective study between October 2017 and June 2020. They were referred to the participating vascular centers for revascularization.

Hard-to-heal wound treatment medical devices: clinical trial protocol in Japan.

In consultation with academia and the Pharmaceuticals and Medical Devices Agency (PMDA), we have developed guidance for drafting protocols for clinical trials concerning medical devices for the healing of hard-to-heal wounds without ischaemia. The guidance summarises the validity of single-arm trials for hard-to-heal wounds, the definition of hard-to-heal wounds without ischaemia, methods of patient enrolment and clinical endpoints. This review focuses on the logical thinking process that was used when establishing the guidance for improving the efficiency of clinical trials concerning medical devices for hard-to-heal wounds.

Challenges and Management in Wound Care.

Wounds have been one of the most prominent pathologies since the beginning of humanity. For the last 5 decades, a drastic improvement of healing has been observed, thanks to new medical devices based on fluid aspiration capacities and the development of negative pressure wound therapy. Negative-pressure wound therapy was initially designed for a double action, fluid aspiration and mechanical stimulation of wound edges by a foam.

An international consensus on device-related pressure ulcers: SECURE prevention.

and colleagues present the findings of their review, ccna2@juno.com.

Negative pressure wound therapy with instillation: International consensus guidelines update.

The use of negative pressure wound therapy with instillation and dwell time (NPWTi-d) has gained wider adoption and interest due in part to the increasing complexity of wounds and patient conditions. Best practices for the use of NPWTi-d have shifted in recent years based on a growing body of evidence and expanded worldwide experience with the technology. To better guide the use of NPWTi-d with all dressing and setting configurations, as well as solutions, there is a need to publish updated international consensus guidelines, which were last produced over 6 years ago.

Convolutional neural networks for wound detection: the role of artificial intelligence in wound care.

Objective: Telemedicine is an essential support system for clinical settings outside the hospital. Recently, the importance of the model for assessment of telemedicine (MAST) has been emphasised. The development of an eHealth-supported wound assessment system using artificial intelligence is awaited.

Branched xenopericardial roll graft replacement of an infected aortic arch graft.

Which graft material is the optimal graft material for the treatment of aortic graft infections is still a matter of controversy. We used a branched xenopericardial roll graft to replace an infected aortic arch graft as a "rescue" operation. The patient is alive and well 37 months postoperatively without recurrence of the infection and any surgical complication.

Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI) - A Joint USA-Japanese Perspective.

For more than 10 years, the Harmonization by Doing (HBD) program, a joint effort by members from academia, industry and regulators from the United States of America (USA) and Japan, has been working to increase timely regulatory approval for cardiovascular devices through the development of practical global clinical trial paradigms. Consistent with this mission and in recognition of the increasing global public health effects of critical limb ischemia (CLI), academic and government experts from the USA and Japan have developed a basic framework of global clinical trials for endovascular devices for CLI. Despite differences in medical and regulatory environments and complex patient populations in both countries, we developed a pathway for the effective design and conduct of global CLI device studies by utilizing common study design elements such as patients' characteristics and study endpoints, and minimizing the effect of important clinical differences.