Led by vascular surgery, vascular interventions are increasingly performed by women.

Guidelines for hospital privileges in vascular and endovascular surgery: Recommendations of the Society for Vascular Surgery

Carotid artery stenting versus endarterectomy for carotid stenosis – Authors' reply

Dartmouth Atlas of Vascular Health Care review: Impact of hospital volume, surgeon volume, and training on outcome

Primarily on the basis of data derived from the Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial,1 the US Food and Drug Administration (FDA) has approved the use of carotid stents (CASs) in high-risk patients. The SAPPHIRE trial was published and much heralded as a randomized trial demonstrating that CASs were not inferior to carotid endarterectomy (CEA). Yet, the more recent Endarterectomy Versus Angioplasty in Patients with Symptomatic Carotid Stenosis randomized trial of CASs compared with CEA had to be stopped because the stroke rate with stents was so high that it triggered the safety guidelines of the study design.2 How can we explain the striking difference in outcome between these 2 studies, and how did it happen that the FDA was so convinced of the quality and validity of the SAPPHIRE trial that it granted approval for CASs? An examination of the SAPPHIRE trial—its conduct, data collection and analysis, the circumstances of publication, the presentation to the FDA Advisory Panel, and its consequent approval—is the primary focus of this article. This is a case study of the flaws in our system for the evaluation and approval of medical devices that warrant serious reflection on our ability to properly create and act on accurate information and live up to our commitment to evidence-based decision making. Response by Samuelson et al p 1601 As it now stands, existing studies leave us with the unfortunate but not unreasonable conclusion that no scientific basis exists for the use of CASs as approved by the FDA, and in the absence of change, there is every reason to doubt the capability of our current system to protect the public from unnecessary risk in the future. Although this article focuses on just 1 example of how our systems …

Presidential address: Practice patterns in vascular surgery—Implications for the certification and training of vascular surgeons

Critique of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST): Flaws in CREST and its Interpretation

Two articles were published in February 2001 that will have a significant impact on our understanding of human development, the pathogenesis of many human diseases, and the discovery of new therapies for many disorders.1 2 These articles deal with the mapping of the human genome. Two different entities, one a publicly traded company (Celera) and the other the Human Genome Project (HGP, sponsored and funded by NIH), published somewhat different versions of the human genome. The HGP began in 1990 (although extensive sequencing of the human genome began in 1995) and cost approximately $3 billion, while the Celera effort began in 1998.1 2 The HGP involved multiple laboratories in the United States and abroad. The 2 projects produced maps that differ from each other in terms of completeness, order of some genetic markers, and the ability to search the database for specific DNA sequences. A comparison of some features of both projects is in Table 1⇓. The challenge of sequencing the 3 billion base pairs of the human genome required the development of unique tools and approaches. Celera constructed a facility capable of high-throughput sequencing at a rate of 175 000 reads per day and conducted sequencing 24 hours a day, 7 days a week. The HGP divided the sequencing task among several large laboratories with demonstrated expertise in large-scale DNA sequencing. The strategy employed by the HGP focused on subcloning the human genome into bacterial artificial chromosomes (BAC), which were then sequenced and properly arranged.1 Each BAC could hold an insert of 150 000 bases on average. Celera used a shotgun whole genome approach to sequencing, which involved generating many small, random fragments of DNA for sequencing.2 After the sequence was determined, advanced computational algorithms combined with publicly available mapping and sequence information …

Outcomes of endovascular lower extremity interventions depend more on indication than physician specialty

Based on the strength of randomized trials from the 1990s, major societal guidelines recommend carotid endarterectomy (CEA) for severe (≥70%), symptomatic carotid stenosis if an operative stroke/death rate of <6% can be maintained (history and major trials in carotid revascularization are summarized in the online-only Data Supplement).1–4 Though the benefit is less evident, most guidelines also recommend consideration of CEA for 50% to 69% symptomatic stenosis.2–4 There are subtle differences in recommendations regarding carotid artery stenting (CAS) in symptomatic patients. Some guidelines stipulate that CEA should be preferred over CAS in patients with severe (≥70%) symptomatic carotid stenosis,2,5 especially if >70 years old,4 whereas others position CAS as an alternative.1,3 Though the risk of operative stroke/death is higher with CAS, major randomized clinical trials (RCTs) report event rates under the recommended 6% cutoff for both treatment modalities. Regarding asymptomatic disease, CEA is recommended for patients with stenosis ≥60% to 70% in highly selected patients as long as operative stroke/death rates <3% can be maintained.1 A predicted life expectancy of at least 3 to 5 years has also been suggested.2 The 3% threshold has been easily met by CEA cohorts in the CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial; 1.4%)6 and the ACT1 (Asymptomatic Carotid Trial; 1.7%),7 suggesting that an even lower threshold may be appropriate. Controversially, some guidelines have recommended that CAS can be considered in highly selected patients with asymptomatic carotid stenosis ≥60% to 70%,1,4,8 whereas others argue that the evidence remains insufficient.2 The lack of consensus in the management of asymptomatic carotid stenosis is reflective of an ongoing need for high-quality RCT data to guide practice. ### CEA Operative Stroke Risk and High Risk Designation Most clinical trials in carotid revascularization have focused …

Carotid artery stenting—evolution of a technique to rival carotid endarterectomy

Background Endovascular intervention has only recently been used for the treatment of carotid disease. The 30-day outcome of 226 endovascular carotid interventions for atherosclerosis performed since August 1993 is presented. Methods All patients were symptomatic apart from four (2 per cent) who underwent intervention before coronary artery bypass. The last presenting symptom was transient ischaemic attack (TIA) (40 per cent), amaurosis fugax (31 per cent), retinal artery occlusion (3 per cent) and stroke (24 per cent). A moderate stenosis (50–69 per cent; North American Symptomatic Carotid Endarterectomy Trial technique) was present in 24 patients (11 per cent), a severe stenosis (70–95 per cent) in 144 (64 per cent), and a preocclusive stenosis (more than 95 per cent) in 58 (26 per cent). The contralateral internal carotid artery was significantly diseased (greater than 70 per cent) or occluded in 65 patients (29 per cent). All patients were pretreated with aspirin; 5000 units heparin and 1·2 mg atropine were given during the procedure. Initially, stents were reserved for treating residual stenosis after angioplasty (16 of 108 procedures). Later, a change was made to primary stenting (116 procedures). A femoral approach was used for all patients. Results At 30 days there were four deaths (2 per cent) and eight disabling strokes (4 per cent) (death and disabling stroke rate 5 per cent; death and all-strokes rate 8 per cent). For angioplasty and selective stenting the death and disabling stroke rate and the death and all-strokes rate were 6 and 9 per cent respectively, compared with 5 and 8 per cent for primary stenting (P not significant). However, there was a significant difference between the incidence of all adverse events (31 versus 11 per cent) as a result of fewer TIAs associated with primary stenting. During the same interval, 300 carotid endarterectomies (similar indications and severity of disease) were performed. There were six deaths (2 per cent) and eight disabling strokes (3 per cent) (death and disabling stroke rate 5 per cent; death and all-strokes rate 6 per cent). The complications of both endovascular intervention and conventional endarterectomy seem to be improving with time. Conclusion These data confirm the feasibility of endovascular carotid intervention and highlight the need for a large randomized trial comparing it with conventional surgery. The benefit of stents and cerebral protection systems also requires further investigation.

Differential outcomes of carotid stenting and endarterectomy performed exclusively by vascular surgeons in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST)

The society for cardiovascular angiography and interventions (SCAI) think tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community for high-level field-wide discussions. The 2020 think tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease (CHD). Each session was moderated by a senior content expert and co-moderated by a member of SCAI's emerging leader mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialogue from a broader base, and thereby aid SCAI and the industry community in developing specific action items to move these areas forward.

In the near future it is likely that surgeons, anesthesiologists, and interventional radiologists and cardiologists will care for increasing numbers of patients undergoing carotid endarterectomy (CEA) and carotid angioplasty and stenting (CAS). Perhaps the most important factor in assuring technically acceptable interventions is the availability of an experienced team with demonstrable low periprocedural morbidity and mortality and a proper understanding of both vascular principles and cerebral physiology. Although different monitoring techniques have proven successful during both surgical and endovascular carotid interventions, the advantages of periprocedural transcranial Doppler (TCD) monitoring, such as its sensitivity for recording blood flow velocities and microembolism in real-time, are convincing. Because of its high temporal resolution, it provides additional information about the cerebral circulation, especially during cross-clamping, clamp release, and balloon inflation and deflation, respectively. If made audible during the procedure, it also provides unique information concerning cerebral micro-embolization. In CEA, TCD monitoring gives a better understanding of the pathophysiology of complications and makes the operation safer. In CAS, it gives insight into the clinical relevance of cerebral embolism and the possible effects of protection devices.

Analyzing Medical Claims Data to Identify Health Care Provider Specialties Diagnosing Frontotemporal Dementia