The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) concluded that addition of transfemoral carotid artery stenting to intensive medical therapy (IMT) among patients wit...The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) concluded that addition of transfemoral carotid artery stenting to intensive medical therapy (IMT) among patients with high-grade Asymptomatic Carotid Artery Stenosis (AsxCS) led to a significantly lower risk of periprocedural stroke/death or postprocedural ipsilateral stroke within 4 years as compared with IMT alone. In contrast, addition of carotid endarterectomy (CEA) did not lead to statistically significant benefit. The current article critically reviews the results of CREST-2 and shows that with a longer follow-up, CEA + IMT may show a significant benefit compared with IMT alone (similarly with carotid artery stenting + IMT). Secondly, it provides the rationale showing why IMT alone may not provide adequate stroke prevention for patients with severe (70% to 99%) AsxCS. Thirdly, it compares CREST-2 with another recent randomized controlled trial comparing CEA + optimized medical treatment vs optimized medical treatment alone for patients with AsxCS and low-to-intermediate risk symptomatic carotid stenosis, the European Carotid Surgery Trial-2. Furthermore, it discusses the flaws and limitations in European Carotid Surgery Trial-2. Finally, it provides the rationale to refute the often-quoted argument that the vast majority of AsxCS patients are offered an unnecessary intervention. There is now Level I Evidence suggesting that a carotid intervention + IMT may be superior to IMT alone for the management of AsxCS patients.
Patient and stakeholder engagement is increasingly emphasized in clinical research, yet practical guidance on how to operationalize engagement in high-acuity, multicenter surgical trials remains limited. We describe the...Patient and stakeholder engagement is increasingly emphasized in clinical research, yet practical guidance on how to operationalize engagement in high-acuity, multicenter surgical trials remains limited. We describe the design and early implementation of a structured engagement strategy within the IMPROVE-AD (Improving Outcomes in Vascular Disease-Aortic Dissection) trial. IMPROVE-AD is a pragmatic, multicenter randomized trial comparing optimal medical therapy alone with optimal medical therapy plus thoracic endovascular aortic repair for uncomplicated type B aortic dissection. A formal patient engagement committee, supported by a stakeholder engagement core, was established to integrate patient perspectives into trial design and conduct. Engagement activities included inputs on trial design, recruitment strategies, participant-facing materials, and communication approaches. Observations were derived from the early implementation of these activities. Stakeholder engagement informed several aspects of trial development and implementation. Early engagement contributed to the refinement of trial design elements, including the prioritization of clinical endpoints over surrogate measures. During trial implementation, patient engagement committee input supported the revision of informed consent language, development of public-facing materials, and refinement of recruitment messaging, with an emphasis on clarity, transparency, and clinical equipoise. Access to aggregated screening and enrollment data enabled the identification of potential barriers to recruitment and underrepresentation. These observations are descriptive. A formal evaluation of the impact of engagement on enrollment, retention, or other trial outcomes has not yet been conducted. Structured stakeholder engagement can be incorporated into the design and conduct of a high-acuity, multicenter randomized trial and may inform communication, recruitment, and implementation strategies. Although the full model described here is resource intensive, selected elements may be adaptable across diverse research settings. Further work is needed to evaluate the impact of engagement and to identify scalable approaches.
Aortic dissection is a devastating diagnosis associated with high morbidity and mortality. After surgical or medical treatment, guideline-based imaging surveillance and clinical follow-up are critical. Despite this, rate...Aortic dissection is a devastating diagnosis associated with high morbidity and mortality. After surgical or medical treatment, guideline-based imaging surveillance and clinical follow-up are critical. Despite this, rates of follow-up remain significantly low, which poses a considerable threat if complications are not recognized and addressed. Our qualitative study of patients post-dissection identified multiple barriers to maintaining follow-up after dissection repair, including patient-level perceptions as well as broader socioeconomic, psychosocial, and system-level factors. We conducted a review on the existing literature surrounding poor surveillance, highlighting known deficits and barriers at multiple entry points for patients with aortic dissection. Some factors include cost, travel distance, social resources, patient education, anxiety and depression, posttraumatic stress disorder, and clinic design. These findings highlight important opportunities for future research, quality improvement, and system-level innovation aimed at improving follow-up in this vulnerable patient population.
Advances in the management of aortic dissection have been driven by rapid innovation in endovascular technology, improved imaging, and multidisciplinary care models. Critical to translating these innovations into broader...Advances in the management of aortic dissection have been driven by rapid innovation in endovascular technology, improved imaging, and multidisciplinary care models. Critical to translating these innovations into broader clinical practices are the US Food and Drug Administration and the Centers for Medicare & Medicaid Services. These organizations' regulatory and reimbursement policies shape device development, patient safety, and access to care. Although the overall mission of the US Food and Drug Administration and Centers for Medicare & Medicaid Services is to provide a structured evaluation and safe introduction of new technologies, as well as evidence-based adoption as standard of care, these frameworks may also contribute to disparities in access to advanced therapies. This review examines the historical evolution of aortic dissection treatment and generation of clinical evidence through the lens of US Food and Drug Administration and Centers for Medicare & Medicaid Services policy and discusses how complementary, yet fragmented, oversight models influence innovation, outcomes, and equity in contemporary aortic dissection care.
Dissection morphology is important when considering landing zones for thoracic endovascular aortic repair. Landing proximally in a healthy aorta, free of dissection and intramural hematoma, is generally recommended. For...Dissection morphology is important when considering landing zones for thoracic endovascular aortic repair. Landing proximally in a healthy aorta, free of dissection and intramural hematoma, is generally recommended. For the most common location of the proximal entry tear near the left subclavian artery, this generally requires landing in zone 2. However, zone 2 landing is associated with higher rates of stroke and need for left subclavian revascularization. Distal landing zone 5 is associated with much higher rates of spinal cord ischemia, without significant benefit over zone 4 or bare metal stent extension so should be avoided, especially for treatment of uncomplicated dissections.
Cocaine and amphetamine use is strongly associated with Type B aortic dissection (TBAD). This disproportionately affects younger patients, who are more likely to present with complicated disease and experience greater po...Cocaine and amphetamine use is strongly associated with Type B aortic dissection (TBAD). This disproportionately affects younger patients, who are more likely to present with complicated disease and experience greater postoperative morbidity. Stimulant-positive patients are often underrepresented or excluded from prospective trials evaluating optimal medical therapy, thoracic endovascular aortic repair, and perioperative management. Ethical concerns, medicolegal risk, stigma, and barriers to follow-up have further constrained trial participation, resulting in reliance on retrospective data and an absence of standardized management guidance. A literature review was conducted investigating the clinical presentation, medical and surgical management of stimulant-positive patients presenting with uncomplicated TBAD. We focused on anesthetic and ethical challenges unique to this population and explored the role of multidisciplinary care teams in perioperative care. Stimulant use precipitates acute sympathetic activation, labile hypertension, and increased aortic wall stress, complicating medical and procedural management. Routine stimulant screening may improve risk stratification and guide antihypertensive selection. Perioperative management should be guided by clinical evidence of intoxication rather than toxicology results. Nonurgent procedures should be deferred only in cases of active intoxication. Early multidisciplinary involvement-including addiction medicine, social work, and case management-may address barriers to medication adherence, reduce recurrence risk, and improve continuity of care. Stimulant-associated TBAD represents a distinct clinical entity requiring tailored medical, surgical, anesthetic, and psychosocial strategies. Standardized screening practices, evidence-based perioperative management, and integrated multidisciplinary care pathways may improve outcomes. Prospective studies and professional society guidance are needed to define best practices for this high-risk population.
Historically, management of uncomplicated Type B aortic dissection (uTBAD) involved impulse control via medical therapies. Recent advances in endovascular treatment modalities, such as thoracic endovascular aortic repair...Historically, management of uncomplicated Type B aortic dissection (uTBAD) involved impulse control via medical therapies. Recent advances in endovascular treatment modalities, such as thoracic endovascular aortic repair, have given way to a new paradigm for management, prompting contemporary randomized trials. However, studies evaluating early morbidity and failure of medical management in uTBAD remain sparse, as these patients frequently convert to complicated disease before trial enrollment, limiting societal recommendations and standardized treatment protocols. This focused, narrative review examines contemporary issues in the management of uTBAD, with emphasis on protocolized medical therapy, mechanisms, and predictors of early failure, and the clinical spectrum of progression to complicated TBAD. Evidence related to rupture, malperfusion syndromes, aneurysmal degeneration, dissection extension, effusions, and respiratory complications associated with medical management is summarized. Up to one-third of individuals initially classified as uTBADs develop early complications. Protocolized anti-impulse pathways improve efficiency, reduce length of stay, and lower costs but do not eliminate progression to complicated disease. Radiographic and clinical features such as large entry tears and false lumen pressurization indicate patients are at higher risk of experiencing adverse aorta-related events. Upfront thoracic endovascular aortic repair may reduce late rupture risk, but carries procedural risks that complicate timing and trial inclusion. uTBAD is a dynamic disease that may progress to complicated TBAD during medical management. Improved risk stratification, monitoring, and timely rescue interventions are essential. Dedicated study of early medical failure and pragmatic trial designs are needed to refine treatment paradigms and optimize outcomes.
An initial presentation of severe chest or back pain with uncontrolled hypertension in the absence of cardiac etiology is synonymous with aortic dissection. For aortic dissections that do not involve the ascending aorta,...An initial presentation of severe chest or back pain with uncontrolled hypertension in the absence of cardiac etiology is synonymous with aortic dissection. For aortic dissections that do not involve the ascending aorta, malperfusion, or rupture, initial treatment with blood pressure management is favored to reduce short- and mid-term morbidity and mortality. Although medical management with surveillance remains broadly recommended for uncomplicated Type B aortic dissection, stent graft placement has emerged as a potential "disease-modifying" intervention. However, the following questions remain: What disease and patient features represent a cohort with the highest risk of downstream complications? And, can early thoracic endovascular aortic stent placement mitigate these risks? We reviewed the impact of recurrent pain and uncontrolled hypertension for uncomplicated Type B aortic dissection. Overall, available data are from observational studies or case series, with inconsistent terminology and conflicting results. We suggest that persistent pain or hypertension should not be used as an automatic trigger for surgery, but rather a prompt to aggressively evaluate for conversion of uncomplicated disease to complicated disease with malperfusion or impending rupture. Indication for surgical treatment in this setting should clearly be documented as conversion to complicated dissection.
Type B aortic dissection (TBAD) and Type B intramural hematoma (IMH) are 2 pathologies that fall within acute aortic syndromes. Complication risk in TBAD is determined by false lumen hemodynamics, whereas IMH progression...Type B aortic dissection (TBAD) and Type B intramural hematoma (IMH) are 2 pathologies that fall within acute aortic syndromes. Complication risk in TBAD is determined by false lumen hemodynamics, whereas IMH progression is driven more by morphologic factors. However, it is still debated as to how these high-risk features, in the absence of complications, should affect their management. To synthesize current evidence and evaluate whether TBAD-analogous treatment protocols are most appropriate for Type B IMH, a narrative review was conducted of guidelines, retrospective cohorts, registries, and studies assessing optimal medical therapy and thoracic endovascular aortic repair (TEVAR). The focus was on high-risk features, intervention timing, and guideline discordance. IMH demonstrates greater early-phase instability. Optimal medical therapy, for low-risk cases, and TEVAR, for complicated pathology, are effective for both IMH and TBAD. However, high-risk IMH assessment and course pose greater variability. There are low-quality evidence and reports for early prophylactic TEVAR in high-risk IMH and TBAD. Surveillance recommendations are similar but supported by weaker IMH evidence. Despite overlapping initial medical management strategies in low-risk cases, Type B IMH requires a management approach that is not fully analogous to TBAD. Its unique risk factors and unpredictable course require individualized decision making rather than protocolized care at the current state of evidence. Harmonized risk criteria, optimized intervention timing, and concrete prospective studies are needed to strengthen IMH-specific management.
Clinical equipoise-genuine uncertainty within the expert community regarding the relative merits of competing treatments-forms the ethical and scientific foundation of randomized controlled trials. The growing adoption o...Clinical equipoise-genuine uncertainty within the expert community regarding the relative merits of competing treatments-forms the ethical and scientific foundation of randomized controlled trials. The growing adoption of thoracic endovascular aortic repair (TEVAR) for uncomplicated type B aortic dissection (uTBAD) has increasingly challenged the principle of clinical equipoise in the treatment algorithm of uTBAD. Optimal medical therapy remains the accepted standard in the treatment of uTBAD. However, the expanding role of TEVAR has led some clinicians and institutions to view early intervention as beneficial, despite the lack of definitive comparative data. Randomized controlled trials, such as INSTEAD, INSTEAD-XL, and ADSORB, have demonstrated that TEVAR promotes false-lumen thrombosis and remodeling, but have not shown a clear survival benefit over optimal medical therapy. Retrospective studies frequently suggest favorable aortic remodeling and improved survival with TEVAR, yet these associative findings cannot establish causality and fall short of the evidentiary strength required to resolve treatment uncertainty. Contemporary guidelines reflect this ambiguity by endorsing aggressive medical therapy with selective TEVAR for anatomically high-risk patients. In the absence of definitive data, practice patterns have been shaped by institutional culture. Persistent uncertainties underscore the need for a definitive randomized trial. These unresolved questions underscore the persistence of clinical equipoise and the ethical necessity for a definitive randomized trial. Equipoise is challenged by institutional culture, specialty bias, referral patterns, patient expectations, and device marketing. Clinical equipoise in uTBAD will be resolved by adequately powered trials demonstrating improvement in patient-centered outcomes. Surrogate measures of aortic remodeling are insufficient.
Uncomplicated Type B aortic dissection (uTBAD) treatment is changing, and the evidence driving this change is scarce. The decision to offer upfront thoracic endovascular aortic repair (TEVAR) or medical therapy varies si...Uncomplicated Type B aortic dissection (uTBAD) treatment is changing, and the evidence driving this change is scarce. The decision to offer upfront thoracic endovascular aortic repair (TEVAR) or medical therapy varies significantly among providers, driven more by individual preference than scientific evidence. The IMPROVE-AD trial is a randomized, multidisciplinary, prospective, controlled, superiority trial designed to compare treatment efficacy; functional outcomes; quality of life; and costs in patients with uTBAD undergoing upfront TEVAR or medical therapy with selective TEVAR for deterioration during follow-up. In all, 60 clinical sites in the United States and Canada will enroll 1,100 patients with uTBAD, who are candidates for both treatment options and randomized in a 1:1 ratio. The primary efficacy endpoint of the trial is all-cause mortality and major aortic complications at 4 years. The IMPROVE-AD trial is the only ongoing North America-based large pragmatic trial comparing upfront TEVAR to medical therapy with selective TEVAR in patients with uTBAD. This landmark comparative effectiveness trial aims to provide Level I data to clarify the appropriate role for both treatment strategies and inform clinical practice.
Carotid artery stenting (CAS) is now established as a less invasive alternative to carotid endarterectomy for patients with carotid artery stenosis. Over the past two decades, stent technologies have undergone significan...Carotid artery stenting (CAS) is now established as a less invasive alternative to carotid endarterectomy for patients with carotid artery stenosis. Over the past two decades, stent technologies have undergone significant refinements to improve navigability, conformability, and plaque coverage while aiming to reduce periprocedural complications and enhance long-term durability. Current devices are broadly categorized as open-cell, closed-cell, and dual-layer micromesh stents. Open-cell designs provide excellent flexibility in tortuous anatomy but may be limited by reduced plaque scaffolding. Closed-cell stents improve vessel coverage yet sacrifice some adaptability. Dual-layer micromesh stents combine both principles, seeking to prevent plaque prolapse and distal embolization, with encouraging results from prospective studies and registries. Randomized trials such as CREST and ACT-1 have established the overall noninferiority of CAS compared with carotid endarterectomy, while observational data suggest potential advantages of newer micromesh designs. Nonetheless, clinical outcomes remain closely linked to operator expertise, anatomical complexity, and embolic protection strategies. In contemporary practice, CAS represents a validated treatment option, and individualized stent selection based on device-specific characteristics and patient anatomy is essential to optimize procedural safety and long-term stroke prevention.
St John E, Stone DH, Stillman DR
… +2 more, Scully RE, Columbo JA
Semin Vasc Surg
· 2026 Mar · PMID 41866682
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Full text
Vascular specialists are increasingly confronted with clinical dilemmas surrounding the optimal role for carotid revascularization in an elderly patient population. Specifically, while carotid revascularization has been...Vascular specialists are increasingly confronted with clinical dilemmas surrounding the optimal role for carotid revascularization in an elderly patient population. Specifically, while carotid revascularization has been demonstrated to reduce the risk of ischemic stroke in appropriately selected patients, its application in elderly patients, particularly those who are asymptomatic, remains a focus of debate. This controversy stems largely from the exclusion of such older patients from the seminal trials that established the efficacy of revascularization over medical management. Furthermore, early studies have also highlighted concerns regarding elevated perioperative risk, prevalence of competing comorbidities, and limited life expectancy in this patient population, calling into question the marginal benefit of a revascularization procedure. However, more recent evidence suggests that with careful patient selection, elderly individuals can experience comparable outcomes to their younger counterparts. In particular, both carotid endarterectomy and transcarotid artery revascularization have demonstrated favorable safety and effectiveness profiles in octogenarians, and both appear to outperform transfemoral carotid artery stenting in terms of perioperative stroke/death risk. Importantly, contemporary risk assessment tools, including those incorporating frailty and anatomical complexity, highlight that age alone should likely not preclude intervention. Instead, these tools can be utilized to aid in performing an individualized and comprehensive risk assessment to inform shared decision making. In this review article, we will explore current controversies, supporting evidence, and important considerations when caring for older patients, specifically those over the age of 80 who are considering carotid revascularization.
Carotid disease incidence, prevelence, treatment and outcomes differ by gender and race. This article reviews the available data on outcomes and suggests next steps for research to eliminate these disparities.Carotid disease incidence, prevelence, treatment and outcomes differ by gender and race. This article reviews the available data on outcomes and suggests next steps for research to eliminate these disparities.
Traditional carotid revascularization outcome measures often overlook meaningful changes in outcomes important to patients. Patient-reported outcomes are being used more often to assess how diseases and treatments affect...Traditional carotid revascularization outcome measures often overlook meaningful changes in outcomes important to patients. Patient-reported outcomes are being used more often to assess how diseases and treatments affect these outcomes, with these insights gathered through patient-reported outcome measures (PROMs). This narrative review summarizes the PROM instruments applied in carotid revascularization studies, highlights key findings regarding quality of life (QoL) before and after intervention, and examines methodological challenges inherent to PROM implementation. Generic PROMs are most often used in carotid revascularization research, with most studies describing QoL changes after carotid endarterectomy in symptomatic patients using the generic 36-Item Short Form Survey PROM. Symptomatic patients can expect a return to baseline QoL by 1 year after intervention. Trial data suggest carotid artery stenting confers a short-term QoL benefit with equivalency to carotid endarterectomy by 1 year. There is insufficient high-quality data to evaluate QoL and revascularization for asymptomatic patients, compare best medical therapy with intervention, or compare the effect of surgical technique on QoL. Interpretation of PROM and QoL data in carotid revascularization research to date is limited by heterogeneity in study methodology and PROM choice and validation. Most PROMs used in carotid revascularization are not validated and lack consensus for testing intervals, patient stratification, and the type of PROM that best reflects patient perceptions. Future work should emphasize the development of carotid disease-specific PROMs to best capture patient-reported outcomes and guide clinical decision making.
Changes to the National Coverage Determination for carotid stenting now mandates a documented shared decision-making (SDM) interaction between the provider and patient as a prerequisite for reimbursement. Historically, f...Changes to the National Coverage Determination for carotid stenting now mandates a documented shared decision-making (SDM) interaction between the provider and patient as a prerequisite for reimbursement. Historically, formalized SDM tools to facilitate these discussions have been underutilized in clinical practice among vascular surgeons. Therefore, our objective was to conduct a contemporary review of currently available information surrounding SDM and decision support instruments for patients with carotid disease. To do this, we performed a review of the literature for publications related to SDM or decision aid development for patients with carotid artery disease. Eight studies met inclusion criteria. We determined that patients with carotid disease generally preferred to take an active role in the decision-making process. Factors such as patient understanding of their disease and perceived benefit of the therapy can impact SDM discussions and the ultimate therapeutic decision. The decision aid information and corresponding visual format can influence patient understanding and choice. Furthermore, research describing any SDM and patient preferences regarding transcarotid artery revascularization is lacking. Accordingly, continued development of a disease-specific validated decision aid for patients with carotid stenosis will improve SDM discussions and ensure value-based patient decisions.
The CREST-2 trial was designed to clarify the contemporary role of carotid revascularization in the management of high-grade asymptomatic carotid stenosis in the setting of increasingly effective medical therapy. Trial e...The CREST-2 trial was designed to clarify the contemporary role of carotid revascularization in the management of high-grade asymptomatic carotid stenosis in the setting of increasingly effective medical therapy. Trial execution occurred during a period of rapid evolution in risk-factor management and device technology, raising important questions about how changes in standards of care should influence stroke-prevention strategies. Participants received protocol-driven intensive medical management focused on stringent control of systolic blood pressure and low-density lipoprotein, with adjustments made as guidelines evolved. In the stenting arm, CREST-2 applied rigorous credentialing to ensure procedural expertise. Enrollment was restricted to patients with favorable vascular anatomy and lesion characteristics. Many participants entered the trial with opportunities to improve key vascular risk factors. Obesity and overweight were common among the cohort, and although new weight-loss agents may modify cardiovascular risk profiles, their effects on carotid atherosclerosis remain uncertain. With stringent operator credentialing and selective anatomical eligibility, carotid stenting demonstrated improved periprocedural safety relative to earlier multicenter experiences and effective stroke prevention. Carotid endarterectomy continued to show numerically favorable stroke-prevention outcomes compared with intensive medical management alone, although the observed risk reduction at 4 years did not reach statistical significance. Intensive medical management remains the foundational treatment strategy, yet revascularization retains an important role when performed by experienced operators in appropriately selected patients.
Since the first carotid endarterectomy (CEA) in 1953 by Dr. Michael DeBakey, the management of carotid stenosis has evolved tremendously, with the introduction of transfemoral carotid artery stenting (tfCAS) in the 1990s...Since the first carotid endarterectomy (CEA) in 1953 by Dr. Michael DeBakey, the management of carotid stenosis has evolved tremendously, with the introduction of transfemoral carotid artery stenting (tfCAS) in the 1990s and transcarotid artery revascularization (TCAR), introduced by Dr. Juan Parodi in 1998 and available commercially in 2015, as well as improved medical management. Society guidelines endorse revascularization for symptomatic patients with high-grade stenosis and acceptable procedural risk. Introduced as a minimally invasive alternative to CEA, tfCAS has been consistently associated with higher perioperative stroke risk compared with CEA. As such, guidelines recommend CEA for patients older than 70 years, although stenting may be considered for younger patients or those with high surgical risk. TCAR has increased in volume since its introduction in 2015, with continued growth after its coverage expansion in April 2022. Although no trials have directly compared TCAR with the other techniques, registry data have indicated its safety and equivocal outcomes compared with CEA, and guidelines show a preference for TCAR over tfCAS and CEA in patients with high surgical risk. Management of asymptomatic disease remains controversial, with advancements in medical therapy. The recent CREST-2 trial found a lower risk of perioperative stroke or death and ipsilateral stroke within 4 years after tfCAS and intensive medical therapy compared with intensive medical therapy alone; CEA and intensive medical therapy also had a lower risk but the difference did not reach statistical significance. As such, patient selection should continue to be individualized.