MagicTouch PTA Sirolimus-Coated Balloon for Femoropopliteal and Below-the-Knee Disease: 3-Year Outcomes of the XTOSI Trial.

BACKGROUND: Sirolimus-coated balloon (SCB) is a potential treatment option for peripheral arterial disease (PAD). There are currently no long-term clinical data for this novel treatment for PAD. We present the 3-year results of the first-in-human study of MagicTouch PTA SCB for treatment of PAD for both femoropopliteal and below-the-knee arteries. METHODS: The XTOSI pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAD. Assessments through 3 years included freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, amputation-free survival (AFS), overall survival, and ulcer-free status. RESULTS: At 3 years, the overall freedom from CD-TLR was 84.4%, freedom from major amputation was 86.1%, AFS was 63.3%, overall survival was 63.3%, and ulcer-free status in remaining survivors with intact limbs was 100%. For femoropopliteal lesions, at 3 years, the freedom from CD-TLR was 92.9%, freedom from major amputation was 93.3%, AFS was 70%, and overall survival was 70%. For below-the-knee lesions, at 3 years, the freedom from CD-TLR was 77.8%, freedom from major amputation was 81.0%, AFS was 58.6%, and overall survival was 58.6%. CONCLUSIONS: SCB in the XTOSI pilot study showed promising clinical results sustained to 3 years, and no long-term safety concerns were raised. Randomized trials are currently ongoing to investigate the safety and efficacy of SCB for treatment of PAD.

A case of severe polyarteritis nodosa with critical limb threatening ischemia-promising treatment with sirolimus drug-coated angioplasty.

Polyarteritis nodosa (PAN) is a rare form of vasculitis. Acute limb ischemia is a rare presentation and complication of PAN. Plain old balloon angioplasty (POBA) is one of the treatment strategies for addressing PAN-related critical limb threatening ischemia (CLTI). However, recurrence of stenosis and occlusion is frequent, making POBA a poor treatment choice, as evidenced in our described clinical case. Consequently, with consideration of sirolimus's anti-inflammatory and immunosuppressive properties, we used a sirolimus-coated balloon in the treatment of PAN-induced CLTI. A 37-year-old woman first presented with acute limb ischemia as her initial symptom. Diagnostic angiography demonstrated occlusion of her tibial vessels, and POBA was performed to restore perfusion. Later in the course of her illness, she developed foot gangrene despite multiple courses of immunosuppressive drugs and several attempts with POBA to achieve limb salvage. Because of her disease trajectory, a MagicTouch (Concept Medical) sirolimus-coated balloon was deployed to her anterior tibial artery during her third angioplasty. At 17 months after her last angioplasty, she remained ulcer free, and surveillance scans demonstrated occlusion-free tibial vessels. The use of sirolimus-coated balloon angioplasty is a promising treatment approach for successful limb salvage in patients with PAN vasculitis and CLTI.

The Role and Effect of Multimodal Prehabilitation Before Major Abdominal Surgery: A Systemic Review and Meta-Analysis.

BACKGROUND: For patients undergoing abdominal surgery, multimodal prehabilitation, including nutrition and exercise interventions, aims to optimize their preoperative physical and physiological capacity. This meta-analysis aims to explore the impact of multimodal prehabilitation on surgical and functional outcomes of abdominal surgery. METHODS: Medline, Embase and CENTRAL were searched for articles about multimodal prehabilitation in major abdominal surgery. Primary outcomes were postoperative complications with a Clavien-Dindo score ≥3, and functional outcomes, measured by the 6-Minute Walking Test (6MWT). Secondary outcome measures included the quality-of-life measures. Pooled risk ratio (RR) and 95% confidence interval (CI) were estimated, with DerSimonian and Laird random effects used to account for heterogeneity. RESULTS: Twenty-five studies were included, analysing 4,210 patients across 13 trials and 12 observational studies. Patients undergoing prehabilitation had significantly fewer overall complications (RR = 0.879, 95% CI 0.781-0.989, p = 0.034). There were no significant differences in the rates of wound infection, anastomotic leak and duration of hospitalization. The 6MWT improved preoperatively in patients undergoing prehabilitation (SMD = 33.174, 95% CI 12.674-53.673, p = 0.005), but there were no significant differences in the 6MWT at 4 weeks (SMD = 30.342, 95% CI - 2.707-63.391, p = 0.066) and 8 weeks (SMD = 24.563, 95% CI - 6.77-55.900, p = 0.104) postoperatively. CONCLUSIONS: As preoperative patient optimization shifts towards an interdisciplinary approach, evidence from this meta-analysis shows that multimodal prehabilitation improves the preoperative functional capacity and reduces postoperative complication rates, suggesting its potential in effectively optimizing the abdominal surgery patient. However, there is a large degree of heterogenicity between the prehabilitation interventions between included articles; hence results should be interpreted with caution.

Unusual complication of bronchoscopy.

In the last twenty years, the field of bronchoscopy has become increasingly more complex and invasive. It is now widely used in the management of pulmonary diseases and has the benefit of low mortality and complication rates. Overall incidence of complications and mortality reported ranges around 1% and 0.02% respectively. Common complications of bronchoscopy include pulmonary haemorrhage, desaturation, pneumothorax, and pulmonary oedema. However, facial and neck petechiae associated with subcutaneous hemorrhage post-bronchoscopy has not been reported before in the literature. We hereby report two novel cases of facial/neck petechiae post-bronchoscopy as a complication to be recognized by bronchoscopists. It is essential that bronchoscopists recognise such phenomenon as the clinical presentation is visually alarming to both the patient and clinician. It is usually self-resolving. However such presentation after bronchoscopy may trigger extensive and unnecessary investigations from the physician.

Differential AMPK phosphorylation by glucagon and metformin regulates insulin signaling in human hepatic cells.

Insulin and glucagon signaling in the liver are major contributors to glucose homeostasis. Patients with Type 1 and Type 2 diabetes have impaired glycemic control due, in part, to dysregulation of the opposing actions of these hormones. While hyperglucagonemia is a common feature in diabetes, its precise role in insulin resistance is not well understood. Recently, metformin, an AMPK activator, was shown to regulate hepatic glucose output via inhibition of glucagon-induced cAMP/PKA signaling; however, the mechanism for how PKA inhibition leads to AMPK activation in human hepatic cells is not known. Here we show that glucagon impairs insulin-mediated AKT phosphorylation in human hepatic cell line Huh7. This impairment of AKT activation by glucagon is due to PKA-mediated inhibition of AMPK via increased inhibitory phosphorylation of AMPK(Ser173) and reduced activating phosphorylation of AMPK(Thr172). In contrast, metformin decreases PKA activity, leading to decreased pAMPK(Ser173) and increased pAMPK(Thr172). These data support a novel mechanism involving PKA-dependent AMPK phosphorylation that provides new insight into how glucagon and metformin modulate hepatic insulin resistance.