Therapeutic angiogenesis for patients with no-option critical limb ischemia by adipose-derived regenerative cells: TACT-ADRC multicenter trial.

BACKGROUND: Patients with critical limb ischemia (CLI) still have a high rate of lower limb amputation, which is associated with not only a decrease in quality of life but also poor life prognosis. Implantation of adipose-derived regenerative cells (ADRCs) has an angiogenic potential for patients with limb ischemia. OBJECTIVES: We investigated safety, feasibility, and efficacy of therapeutic angiogenesis by cell transplantation (TACT) of ADRCs for those patients in multicenter clinical trial in Japan. METHODS: The TACT-ADRC multicenter trial is a prospective, interventional, open-labeled study. Patients with CLI (Fontaine class III-IV) who have no other option for standard revascularization therapy were enrolled in this study. Thirty-four target ischemic limbs of 29 patients were received freshly isolated autologous ADRCs implantation. RESULTS: The overall survival rate at a post-operative period and at 6 months follow-up was 100% at any time points. As a primary endpoint for efficacy evaluation, 32 limbs out of 34 (94.1%) were free from major amputation for 6 months. Numerical rating scale (from 6 to 1) as QOL score, ulcer size (from 317 mm2 at to 109 mm2), and 6-min walking distance (from 255 to 369 m) improved in 90.6%, 83.3%, and 72.2% patients, respectively. CONCLUSIONS: Implantation of autologous ADRCs could be safe and effective for the achievement of therapeutic angiogenesis in the multicenter settings, as a result in no major adverse event, optimal survival rate, and limb salvage for patients with no-conventional option against critical limb ischemia. TRN: jRCTb040190118; Date: Nov. 24th, 2015.

Rationale and Design of Therapeutic Angiogenesis by Cell Transplantation Using Adipose-Derived Regenerative Cells in Patients With Critical Limb Ischemia　- TACT-ADRC Multicenter Trial.

Background: Despite the growing knowledge regarding optimal treatments for critical limb ischemia (CLI), there are still a considerable number of patients who have to undergo major limb amputation. Intramuscular injection of autologous adipose-derived regenerative cells (ADRCs) in these patients has shown therapeutic potential in improving tissue ischemia, in both preclinical and initial pilot studies. Here, we present a clinical protocol for ADRCs use in a multicenter trial. Methods and Results: The TACT-ADRC multicenter trial is a prospective, interventional, single-arm, open-labeled study at 8 hospitals in Japan, investigating the safety and feasibility of intramuscular injections of ADRCs and testing the hypothesis that this treatment promotes neovascularization and improves major amputation-free survival rates in patients with CLI who have no other treatment option. 40 patients with CLI will be enrolled and followed up from November 2015 to November 2020. Freshly isolated autologous ADRCs will be injected into the target ischemic limbs. Survival rate, adverse events, major limb amputation, ulcer size, 6-min walking distance, numerical rating scale, ankle-brachial pressure index, skin perfusion pressure and digital subtraction angiography will be evaluated at baseline and during 6 months' follow-up. Conclusions: This trial will demonstrate whether implantation of autologous ADRCs is a safe and effective method for therapeutic angiogenesis, resulting in an improvement in major amputation-free survival rates in patients with CLI.

[Right ventricular rupture due to blunt trauma diagnosed by MDCT; report of a case].

The survival rate of cardiac rupture due to blunt trauma is generally low. We experienced a case with right ventricular rupture due to blunt trauma. The patient was a 49-year-old man who was crushed in a traffic accident and transported to a local hospital in a shock state. He was diagnosed with cardiac tamponade due to cardiac rupture, and for pericardial drainage was immediately performed. He was then transferred to our hospital for emergency surgery. His hemodynamics was stable, and he was diagnosed with right ventricular rupture by multi-detector row computed tomography (MDCT). The operation was performed successfully without cardiopulmonary bypass, and his postoperative course was uneventful. MDCT is useful for detecting the rupture site of the heart.

[Acute abdominal aortic occlusion in a patient with a giant thrombus in the left atrium and mitral stenosis; report of a case].

The patient was a 69-year-old male who had had percutaneous transvenous mitral commissurotomy (PTMC) 15 years ago, and had stopped taking warfarin after PTMC. He was transferred to our emergency room( ER) because of sudden severe pain in his both lower legs. We recognized pulselessness in his both femoral arteries, and pallor, paresthesia and poikilothermia in his lower extremities. Electorocardiogram(ECG) showed arterial fibrillation, and computed tomography( CT) showed occlusion of the abdominal aorta just below inferior mesenteric artery( IMA) and both common iliac arteries. By echocardiography, a giant thrombus was detected in the left atrium with severe mitral stenosis. Thrombectomy and angioplasty were performed at about 5 hours after the onset of occlusion, and revascularization was successful. Three days after the operation, we excised the giant thrombus in the left atrium and performed mitral valve replacement because we considered that myonephropathic metabolic syndrome (MNMS) had been prevented. The postoperative course was uneventful and he was discharged on the 27th postoperative day.

Successful staged operation for acute type A aortic dissection with paraplegia.

A 75-year-old man presented with both paraplegia and acute occlusion of the abdominal aorta at onset. Extraanatomical bypass was performed following spinal drainage. After 3 days, the ascending aorta replaced under cardiopulmonary bypass using the extraanatomical bypass graft for arterial cannulation. The abdominal aorta was replaced after 6 months. A staged operation is one of the options for acute aortic dissection with paraplegia and acute occlusion of the abdominal aorta.

Surgical treatment or conservative therapy for stanford type a acute aortic dissection with a thrombosed false lumen.

OBJECTIVES: Optimum treatment for acute aortic dissection (AAD) with a thrombosed false lumen (thrombosed AAD) remains controversial. We evaluated the outcome of thrombosed AAD according to treatment strategy. MATERIALS AND METHODS: We examined 280 patients with AAD, of which 30 had thrombosed AAD. We compared computed tomography findings, cardiac performance, and clinical course in 28 of these patients. Patients were divided into three groups for the comparison: Group E (emergency surgery), Group C (conservative therapy), and Group S (conservative therapy switched to emergency surgery). RESULTS: In Group E (n = 13), one patient died and 12 survived. In Group C (n = 10), all patients were discharged, of which two died of cancer and two of the remaining eight survivors underwent subsequent elective surgery. In Group S (n = 5), one patient died and four survived following surgery. CONCLUSIONS: It was hard to predict re-dissection or rupture following conservative treatment for thrombosed AAD. Basically, we should perform emergency surgery following the diagnosis of thrombosed AAD, particularly in complicated cases such as those with pericardial effusion, tamponade, and large aorta. Conservative therapy has a very limited application in patients with the initial stages of thrombosed AAD.

Reports of four surgical treatments of acute pulmonary embolism with a floating thrombus in the right atrium.

Acute pulmonary embolism (APE) is a serious disease. Recently, multidetector-row computed tomography (MDCT) has proven to be valuable in detecting APE and deep vein thrombosis. APE is classified as massive, submassive, and nonmassive. The incidence of submassive APE and the number of therapeutic approaches for clinically diagnosed critical submassive APE have both increased. However, most strategies for submassive APE have been conservative, e.g., transvenous catheter pulmonary embolectomy, and there are few reports on surgical pulmonary embolectomy. We examined the surgical outcomes in four cases of submassive APE with a floating thrombus in the right atrium (RA) from August 2003 to July 2008. All patients appeared to have no neurological complications and showed an event-free survival of up to 65 months (37 ± 25 months). Surgical pulmonary embolectomy was effective for submassive APE with a floating thrombus in the RA.

Recurrent coarctation of the aorta: a patient with bilateral persistent sciatic arteries.

A 19-year-old female was referred to our department with a diagnosis of recurrent coarctation of the aorta. She had undergone end-to-side anastomosis of the left subclavian artery with the thoracic aorta at 9 days of age and extra-anatomic subclavian-to-femoral bypass grafting at 15 years of age because of hypertensive crisis. A preoperative 4-slice computed tomography (CT) scan demonstrated recurrent obstruction of the aorta and, unexpectedly, an associated anomaly of bilateral persistent sciatic arteries. She underwent a successful patch augmentation of the aorta and is currently leading a normal life without need for antihypertensive medication. Persistent sciatic artery is a rare congenital vascular anomaly and is known to develop aneurysm or critical lower limb ischemia. To our knowledge, this is the first report of a patient with coarctation of the aorta and bilateral persistent sciatic arteries.