The Use of Bovine Pericardial Patches in Vascular Surgery: Where do we Draw the Line in Obtaining Informed Consent?

For a patient undergoing a carotid endarterectomy, induction with propofol, administration of heparin at the time of vessel clamping, use of a bovine pericardial patch for angioplasty, covering the wound with a hydrocolloid dressing and post-operative aspirin administration exposes the patient to animal products at every stage, from the moment they walk through the door. A number of articles have advocated obtaining informed consent when using animal products in healthcare but where should the line be drawn? METHODS: A narrative review of the literature, specifically focussing on secular and religious beliefs about the use of animal products in healthcare. Application of ethical principles and GMC guidance to formulatea discussion with regards to the use of bovine pericardium in vascular surgery. Advanced literature search carried out using Pubmed and Google Scholar databases comparing patch material used forcarotid endarterectomy. RESULTS: Disclosing the use of animal derived constituents in surgery is warranted under Beauchamp and Childress' four principals and highlighted in GMC guidance. Obtaining consent for the use of animalderived constituents at the time of surgery is something that should become a fundamental component of the written consent process and alternatives should be sought where available and practicable. CONCLUSION: This review highlights the evidence available and discusses our current standpoint from both a legal and ethical aspect.

ABOUT PATIENTS, "INVENTORS", JOURNALISTS, SCIENTISTS AND IRBs (TO SAY NOTHING OF THE INSTITUTIONS): CCSVI AND MS.

In this article, the Author analyzes her own experience as a member of the IRB that approved a trial to determine the efficacy of a disobstruction procedure of extracranial veins by means of angioplasty in patients with multiple sclerosis (MS). The so-called "liberation therapy" was proposed by an Italian vascular surgeon, who theorized a condition called "chronic cerebrospinal venous insufficiency" (CCSVI) as playing a role in the pathogenesis of MS. This approval, given after an animated discussion amongst IRB members, lacked any solid scientific evidence of a causal relationship between CCSVI and MS, and was accepted despite the concerns about potential risks associated with the proposed therapy. Undoubtedly, considerable pressure was exerted on IRB by MS sufferers, who rushed off to get the surgery from the many clinics who offered liberation therapy.The remaining sense of bitter has raised a reflection on how to prevent similar future cases.

Have thoracic endografting outcomes improved since US Food and Drug Administration approval?

BACKGROUND: Thoracic endovascular aneurysm repair (TEVAR) is gaining acceptance since Food and Drug Administration approval in 2005. We hypothesize that, compared with open repair (OPEN), mortality and complication rate after TEVAR have continued to improve. METHODS: All patients who underwent thoracic and (or) thoracoabdominal aneurysm repair from 2005 to 2007 in the Nationwide Inpatient Sample were examined. Patients were stratified by TEVAR or OPEN. Demographics, hospital characteristics, and outcomes were analyzed. Multivariable logistic regression models for complications and in-hospital mortality were developed. RESULTS: A weighted total of 7,644 had TEVAR, while 32,948 patients underwent OPEN. The TEVAR utilization increased from 5.5% (2005) to 24.1% (2007). Mortality for all patients undergoing thoracic aneurysm repair decreased yearly (p<0.001). Mortality (TEVAR: 7.3%, OPEN: 9.8%, p<0.001) and complication rate (TEVAR: 24.3%, OPEN: 42.1%, p<0.001) were superior with TEVAR. The unadjusted annual mortality (7%) and complication rate (24%) after TEVAR did not improve each year; however, after risk adjustment, mortality after TEVAR steadily decreased annually. Moreover, risk-adjusted mortality for OPEN has improved since 2005. Multivariate analysis revealed age and ruptured aneurysm were highly predictive of death (p<0.001, respectively), while TEVAR lowered the adjusted odds of death by 18% (p<0.05). CONCLUSIONS: Mortality in patients undergoing repair of thoracic aneurysms has decreased in the United States since Food and Drug Administration approval of stent grafts in 2005. This is due to wider adoption of TEVAR and improved mortality in patients undergoing TEVAR or open repair.