[Better regulatory framework needed for medical devices]. / Bättre regelverk behövs för medicintekniska produkter - HTA-utredning av läkemedelsavgivande stentar och ballonger vid benartärsjukdom visar på bristerna.

We summarize an HTA report regarding patient values of drug-eluting stents and balloons for treatment of atherosclerotic disease in the lower extremities. We found 17 randomized controlled trials, 4 cohort studies and 13 case series. The total number of studied patients was substantial (about 3,000) but there was a strong heterogeneity regarding site of lesion, symptom pattern, device, drug used and outcome measures, making the analysis difficult and based on relatively small subgroups. We found low certainty of evidence (GRADE ++) for a reduced risk of restenosis in patients with critical ischemia and lesions below the knee, and also a modest beneficial effect on ischemic symptoms in a mixed patient population. However, we also identified a worrying safety signal, with increased risk for amputation in a group of patients with below-the-knee disease and critical ischemia. The results highlight the need for a structured system for validation of medical devices, a system analogous to that currently used for evaluation of new pharmacological products.

24-carat gold, 14-carat gold, or platinum standards in the treatment of critical limb ischemia: bypass surgery or endovascular intervention?

Critical limb ischemia (CLI) remains a poorly understood, rarely reported, and inconsistently treated major global healthcare epidemic. The incidence in the US is estimated at 1% of the population aged 50 years and older and at approximately double that rate in the over-70 age group. These frequencies are expected to increase significantly with the aging population and the expected increase in diabetes. Within 1 year of being diagnosed with CLI, 40% to 50% of the now 20 million US diabetics will experience an amputation, and 20% to 25% will die. The estimate for treating CLI in the US alone is $10 to $20 billion per year, but just a 25% reduction in amputations could save $2.9 to $3.0 billion annually. Infrainguinal bypass surgery (IBS) utilizing autogenous saphenous vein has been considered the "24-carat gold standard" treatment for CLI, but over the last decade, endovascular therapy has emerged to seriously challenge IBS, which has created considerable controversy. Despite an overall lack of "hard" level I data, many interventionists are questioning the role of IBS as a first-line CLI therapy or are at least now considering IBS a "tainted" gold standard ("14-carat"). This review will examine the available evidence, but there should be no doubt regarding the huge global clinical and economic impact of CLI and amputations.

Reporting standards for angioplasty and stent-assisted angioplasty for intracranial atherosclerosis.

BACKGROUND AND PURPOSE: Intracranial cerebral atherosclerosis causes ischemic stroke in a significant number of patients. Technological advances over the past 10 years have enabled endovascular treatment of intracranial atherosclerotic stenosis. The number of patients treated with angioplasty or stent-assisted angioplasty for this condition is increasing. Given the lack of universally accepted definitions, the goal of this document is to provide consensus recommendations for reporting standards, terminology, and written definitions when reporting clinical and radiological evaluation, technique, and outcome of endovascular treatment using angioplasty or stent-assisted angioplasty for stenotic and occlusive intracranial atherosclerosis. SUMMARY OF REPORT: This article was written under the auspices of Joint Writing Group of the Technology Assessment Committee, Society of NeuroInterventional Surgery, Society of Interventional Radiology; Joint Section on Cerebrovascular Neurosurgery of the American Association of Neurological Surgeons and Congress of Neurological Surgeons; and the Section of Stroke and Interventional Neurology of the American Academy of Neurology. A computerized search of the National Library of Medicine database of literature (PubMed) from January 1997 to December 2007 was conducted with the goal to identify published endovascular cerebrovascular interventional data in stenotic intracranial atherosclerosis that could be used as benchmarks for quality assessment. We sought to identify those risk adjustment variables that affect the likelihood of success and complications. This document offers the rationale for different clinical and technical considerations that may be important during the design of clinical trials for endovascular treatment of intracranial stenotic and occlusive atherosclerosis. Included in this guidance document are suggestions for uniform reporting standards for such trials. These definitions and standards are primarily intended for research purposes; however, they should also be helpful in clinical practice and applicable to all publications. CONCLUSIONS: In summary, the definitions proposed represent recommendations for constructing useful research data sets. The intent is to facilitate production of scientifically rigorous results capable of reliable comparisons between and among similar studies. In some cases, the definitions contained here are recommended by consensus of a panel of experts in this writing group for consistency in reporting and publication. These definitions should allow different groups to publish results that are directly comparable.

The Carotid Artery Revascularization and Endarterectomy (CARE) registry: objectives, design, and implications.

This is the first comprehensive national registry that will provide data characterizing contemporary results of carotid endarterectomy (CEA) and carotid artery stenting (CAS). Carotid endarterectomy (CEA) has become the standard revascularization therapy to prevent stroke in patients with carotid artery disease, while carotid artery stenting (CAS) offers a percutaneous alternative in selected patients. Given the rapid growth in the numbers of CAS procedures being performed, there is a critical need for a national program to assess quality outcomes. The Carotid Artery Revascularization and Endarterectomy (CARE) Registry was developed through a multispecialty collaboration resulting in a comprehensive data collection tool for carotid revascularization procedures. The intent of the CARE registry is to collect and analyze clinical data to measure clinical practice, patient outcomes, and enable quality improvement for carotid revascularization. Finally, the CARE Registry satisfies the Center for Medicare and Medicaid Services (CMS) data reporting criteria for reimbursement.

Assessment of coronary bypass surgery and percutaneous transluminal coronary angioplasty.

Coronary bypass surgery developed as another in a line of surgical procedures dating back more than 60 years. The medical profession at first assessed this procedure with time-honored anecdotal techniques. Gradually, for a variety of reasons, improved methods of comparisons worked their way into assessments of bypass surgery. Randomized controlled trials met resistance but have been very influential. Assessment of percutaneous transluminal coronary angioplasty has benefited from the knowledge generated during the last 25 years, but clinicians have been slower to apply the most advanced techniques.