Clinician perspectives regarding CYP2C19 genotype testing in patients with critical limb ischemia: A Delphi approach.

OBJECTIVES: Antiplatelet therapy is an essential element in the management of patients with arterial vascular disease. In peripheral arterial disease (PAD), dual antiplatelet therapy (DAPT), primarily clopidogrel and aspirin, is routinely prescribed following intervention. There is sparse data regarding the need for DAPT, the appropriate duration, or the heterogeneity of treatment effects for antiplatelet regimens across patients, leading to potential uncertainty and heterogeneity around treatment practices. An example of heterogeneity of treatment effects is a patients' metabolizer status for the use of clopidogrel. The aim of the study was to (1) assess clinicians' knowledge of and attitudes toward managing patients with CYP2C19 mutations, (2) identify barriers to implementation of CYP2C19 testing and management policies, and (3) reach consensus for CYP2C19 testing and management strategies for patients with PAD who undergo peripheral vascular interventions (PVI). METHODS: A modified Delphi method was used to establish consensus amongst PAD interventionalists around CYP2C19 testing. All practicing Yale New Haven Hospital PAD interventionalists with backgrounds in interventional cardiology, vascular surgery, or interventional radiology were approached by email for participation. Round 1 included the collection of baseline demographic questions, knowledge questions, and three statements for consensus. Knowledge questions were rated on a 0-10 Likert scale with the following anchors: 0 ("Not at all"), 5 ("Neutral), and 10 ("Very Much"). Participants were asked to rate the importance of the three consensus statements on a 9-point Likert scale from 1 ("Strongly Disagree") to 10 ("Strongly Agree"). In Round 2, participants were shown the same consensus statements, the median response of the group from the previous round, and their previous answers. Participants were instructed to revise their rating using the results from the previous round. This process was repeated for Round 3. RESULTS: Of the 28 experts invited to participate, 13 agreed (46%). Participants were predominantly male (92.3%) and white (61.5%) with representation from interventional cardiology (46.2%) and vascular surgery (53.8%). Most participants reported more than 10+ years in practice (61.5%). PAD interventionalists felt they would benefit from more education regarding CYP2C19 mutations (median score 8.0, interquartile range 5.0-8.5). They indicated some familiarity with CYP2C19 mutations (7.0, 6.0-9.5) but did not feel strongly that CYP2C19 was important to their practice (6.0, 5.5-7.5). In each round, the median responses for the three consensus statements were 5, 6, and 9, respectively. With each successive round the interquartile range narrowed indicative of evolving consensus but did not reach the prespecified interquartile range for consensus of 1 for any of the statements. CONCLUSIONS: PAD interventionalists practicing at an academic health system recognize the heterogenous response of their patients to clopidogrel therapy but are unsure when to leverage genetic testing to improve outcomes for their patients. Our study identified gaps regarding PAD interventionalists' knowledge, perceived barriers, and attitudes toward CYP2C19 testing in PAD. This information highlights the need for randomized data on genetic testing for clopidogrel responsiveness in peripheral vascular disease following intervention to help guide antiplatelet management.

Comparison of mortality and amputation after lower extremity bypass versus peripheral vascular intervention in patients with chronic limb-threatening ischemia and comorbid chronic kidney disease.

OBJECTIVE: Comorbid chronic kidney disease (CKD) is associated with worse outcomes for patients with chronic limb-threatening ischemia (CLTI). However, comparative effectiveness data are limited for lower extremity bypass (LEB) vs peripheral vascular intervention (PVI) in patients with CLTI and CKD. We aimed to evaluate (1) 30-day all-cause mortality and amputation and (2) 5-year all-cause mortality and amputation for LEB vs PVI in patients with comorbid CKD. METHODS: Individuals who underwent LEB and PVI were queried from the Vascular Quality Initiative with Medicare claims-linked outcomes data. Propensity scores were calculated using 13 variables, and a 1:1 matching method was used. The mortality risk at 30 days and 5 years in LEB vs PVI by CKD was assessed using Kaplan-Meier and Cox proportional hazards models, with interaction terms added for CKD. For amputation, cumulative incidence functions and Fine-Gray models were used to account for the competing risk of death, with interaction terms for CKD added. RESULTS: Of 4084 patients (2042 per group), the mean age was 71.0 ± 10.8 years, and 69.0% were male. Irrespective of CKD status, 30-day mortality (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.63-1.42, P = .78) was similar for LEB vs PVI, but LEB was associated with a lower risk of 30-day amputation (sub-HR [sHR]: 0.66, 95% CI: 0.44-0.97, P = .04). CKD status, however, did not modify these results. Similarly, LEB vs PVI was associated with a lower risk of 5-year mortality (HR: 0.79, 95% CI: 0.71-0.88, P < .001) but no difference in 5-year amputation (sHR: 1.03, 95% CI: 0.89-1.20, P = .67). CKD status did not modify these results. CONCLUSIONS: Regardless of CKD status, patients had a lower risk of 5-year all-cause mortality and 30-day amputation with LEB vs PVI. Results may help inform preference-sensitive treatment decisions on LEB vs PVI for patients with CLTI and CKD, who may commonly be deemed too high risk for surgery.

Sex-specific analysis of intravascular lithotripsy for peripheral artery disease from the Disrupt PAD III observational study.

OBJECTIVE: Endovascular therapy of lower extremity peripheral artery disease (PAD) is associated with higher complication rates and worse outcomes in women vs men. Although intravascular lithotripsy (IVL) has shown similarly favorable outcomes in men and women in calcified coronary arteries, there is no published safety and effectiveness data of peripheral IVL differentiated by sex. This study aims to evaluate sex-specific acute procedural safety and effectiveness following IVL treatment of calcified PAD. METHODS: We performed a secondary analysis of the multicenter Disrupt PAD III Observational Study, which assessed short-term procedural outcomes of patients undergoing treatment of symptomatic calcified lower extremity PAD with the Shockwave peripheral IVL system. Adjudicated acute safety and efficacy outcomes were compared by sex using univariate analysis performed with the χ2 test or Fisher exact test, as appropriate. RESULTS: A total of 1262 patients (29.9% women) were included, with >85% having moderate to severe lesion calcification. Women were older (74 vs 71 years; P < .001), had lower ankle-brachial index (0.7 vs 0.8; P = .003), smaller reference vessel size (5.3 vs 5.6 mm; P = .009), and more severe stenosis at baseline vs men (82.3% vs 79.8%; P = .012). Rates of diabetes, renal insufficiency, chronic limb-threatening ischemia, lesion length, and atherectomy use were similar in both groups. Residual stenosis after IVL alone was significantly reduced in both groups. Final residual stenosis was 21.9% in women and 24.7% in men (P = .001). Serious angiographic complications were infrequent and similar in both groups (1.4% vs 0.6%; P = .21), with no abrupt vessel closure, distal embolization, or thrombotic events during any procedure. CONCLUSIONS: The use of IVL to treat calcified PAD in this observational registry demonstrated favorable acute safety and effectiveness in both women and men.

Wireless pulmonary artery sensor implantation in a unilateral lung transplant recipient.

Patients with lung transplantation can have concomitant left ventricular failure which can either precede the lung transplantation or develop after. Implantable wireless pulmonary artery (PA) pressure monitors to guide hemodynamic management in heart failure such as the CardioMEMS device (Abbott, Sylmar, CA, USA) have been shown to improve outcomes. However, in a lung transplant recipient there are unique physiological and practical considerations when contemplating to implant a PA pressure sensor such as safety of implanting the device, choice of site of implantation, accuracy of wedge tracings to calibrate, and exclusion of vascular stenoses post transplantation. We discuss these considerations in the context of a man in his early 60s with a known left lung transplant two years previously who developed worsening heart failure needing invasive monitoring. Right lung PA sensor placement was considered, but on selective pulmonary angiography the right PA was found to be of small caliber and with significant tortuosity. After careful hemodynamic assessment, the PA sensor was implanted in the PA of the transplanted lung which is the first such case to our knowledge. Learning objective: We report the first documented case of an implantable wireless pulmonary artery pressure monitor (CardioMEMs) into a transplanted lung. Device-related complications, such as pulmonary artery injury, infection, and hemoptysis, must be assessed after placement. Given the changes in pulmonary artery pressures after lung transplantation, recalibration of the CardioMEMs device may need to be considered if placed within first year of transplant.

Community distress and risk of adverse outcomes after peripheral vascular intervention.

INTRODUCTION: Community distress is associated with adverse outcomes in patients with cardiovascular disease; however, its impact on clinical outcomes after peripheral vascular intervention (PVI) is uncertain. The Distressed Communities Index (DCI) is a composite measure of community distress measured at the zip code level. We evaluated the association between community distress, as measured by the DCI, and 24-month mortality and major amputation after PVI. METHODS: We used the Vascular Quality Initiative database, linked with Medicare claims data, to identify patients who underwent initial femoropopliteal PVI between 2017 and 2018. DCI scores were assigned using patient-level zip code data. The primary outcomes were 24-month mortality and major amputation. We used time-dependent receiver operating characteristic curve analysis to determine an optimal DCI value to stratify patients into risk categories for 24-month mortality and major amputation. Mixed Cox regression models were constructed to estimate the association of DCI with 24-month mortality and major amputation. RESULTS: The final cohort consisted of 16,864 patients, of whom 4734 (28.1%) were classified as having high community distress (DCI ≥70). At 24 months, mortality was elevated in patients with high community distress (30.7% vs 29.5%, P = .02), as was major amputation (17.2% vs 13.1%, P <.001). After adjusting for demographic and clinical characteristics, a 10-point higher DCI score was associated with increased risk of mortality (hazard ratio: 1.01; 95% confidence interval: 1.00-1.03) and major amputation (hazard ratio: 1.02; 95% confidence interval: 1.00-1.04). CONCLUSIONS: High community distress is associated with increased risk of mortality and major amputation after PVI.

Real-world VASCADE closure device versus manual compression use and outcomes in patients with severe common femoral artery disease.

BACKGROUND: The VASCADE closure device deploys an extravascular collagen plug. Its use in those with access site disease undergoing peripheral vascular intervention (PVI) is unknown. We aimed to evaluate the efficacy and safety of the VASCADE closure device compared to manual compression (MC) in patients with moderate femoral access site disease. METHODS: We performed a single-center, retrospective review of patients undergoing PVI with at least moderate access site disease. Our institutional database was linked to the Vascular Quality Initiative database, and 200 patients were selected from a 1:1 propensity-matched cohort. Data on procedural metrics and outcomes up to 30-days were abstracted. RESULTS: There were 103 procedures that used VASCADE and 97 used MC. Baseline variables were similar between groups. The mean age was 68.2 ± 11.2 years and 37.6% were women. Closing mean activated clotting time (ACT) was shorter in VASCADE (198 s VASCADE vs. 213 s MC; p = 0.018). There was a nonsignificant decrease in external compression device use with VASCADE (VASCADE 19.0% vs. MC 28.1%; p = 0.15). At 30-days, there was a nonsignificant reduction in hematoma with VASCADE (3.8% vs. 7.8% MC; p = 0.25) and no difference in retroperitoneal bleeding (0.5%). Pseudoaneurysm rate was similar (1.3% VASCADE vs. 1.7% MC; p = 0.79). The 30-day mortality rate was similar between the two groups and not related to the procedure (1.3% VASCADE vs. 0.9% MC; p = 0.79). CONCLUSION: In patients undergoing PVI with at least moderate access site disease, safety and efficacy after using VASCADE was comparable with MC.

Antiplatelet regimens following carotid artery revascularization.

Dual antiplatelet therapy (DAPT) is indicated following carotid artery stenting (CAS) and single antiplatelet therapy (SAPT) following carotid endarterectomy (CEA), but it remains unknown how providers adhere to these guidelines in real-world clinical practice. Using the Vascular Quality Initiative New England data, we found that of 12,257 patients, 82% patients were discharged on DAPT following CAS and 66% were discharged on SAPT following CEA. While a high percentage of patients undergoing CAS appropriately receive DAPT, the use of SAPT following CEA exists with more variability and lower adherence rates.

The shifting care and outcomes for patients with endangered limbs - Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale.

BACKGROUND: Critical limb ischemia (CLI), the most severe form of peripheral artery disease, is associated with pain, poor wound healing, high rates of amputation, and mortality (>20% at 1 year). Little is known about the processes of care, patients' preferences, or outcomes, as seen from patients' perspectives. The SCOPE-CLI study was co-designed with patients to holistically document patient characteristics, treatment preferences, patterns of care, and patient-centered outcomes for CLI. METHODS: This 11-center prospective observational registry will enroll and interview 816 patients from multispecialty, interdisciplinary vascular centers in the United States and Australia. Patients will be followed up at 1, 2, 6, and 12 months regarding their psychosocial factors and health status. Hospitalizations, interventions, and outcomes will be captured for 12 months with vital status extending to 5 years. Pilot data were collected between January and July of 2021 from 3 centers. RESULTS: A total of 70 patients have been enrolled. The mean age was 68.4 ± 11.3 years, 31.4% were female, and 20.0% were African American. CONCLUSIONS: SCOPE-CLI is uniquely co-designed with patients who have CLI to capture the care experiences, treatment preferences, and health status outcomes of this vulnerable population and will provide much needed information to understand and address gaps in the quality of CLI care and outcomes.ClinicalTrials.gov identifier (NCT Number): NCT04710563 https://clinicaltrials.gov/ct2/show/NCT04710563.

Association of sleep apnea with outcomes in peripheral artery disease: Insights from the PORTRAIT study.

BACKGROUND: Sleep apnea is a predictor of adverse cardiovascular outcome in many cardiovascular diseases but whether it is associated with worse health status outcomes or mortality in peripheral artery disease (PAD) is unknown. METHODS: PORTRAIT is an international (US, Netherlands, Australia) prospective PAD registry that consecutively enrolled patients who presented with new-onset or recent exacerbations of PAD symptoms to any of 16 vascular specialty clinics. Health status was assessed upon presentation and at 12 months with the disease-specific Peripheral Artery Questionnaire (PAQ). Higher PAQ scores indicate better health status. A sequentially-adjusted hierarchical linear regression model examined the association between sleep apnea and 1-year PAQ symptoms, quality of life, and summary scores. Five-year survival curves by comorbid sleep apnea status for US patients were compared using the log-rank test. RESULTS: The mean age of the 1204 PORTRAIT participants was 67.6 ± 9.4 years with 37.5% women and 8.3% (n = 100) having sleep apnea. Patients with sleep apnea were more likely to be from the US, more sedentary, and to have diabetes, obesity, coronary disease, more depressive symptoms and a history of prior peripheral interventions. Paradoxically, they also had higher ankle-brachial indices, but lower PAQ Summary scores at presentation and 12 months (41.2 ± 22.0 vs. 49. 9± 21.6 and 58.6 ± 27.9 vs. 71.3 ± 24.9, respectively, p = <0.05). The association between sleep apnea and 1-year health status persisted after multivariable adjustment, but there were no differences in all-cause mortality over 5 years (28.0% vs. 23.4%, p = 0.76). CONCLUSION: In patients presenting with PAD, comorbid sleep apnea is independently associated with worse health status over time. Future studies should test whether better treatment of sleep apnea can improve the health status of patients with PAD. CLINICAL TRIAL REGISTRATION: NCT01419080.

Safety and efficacy outcomes of the Pioneer Plus catheter in endovascular revascularization of lower extremity chronic total occlusions.

OBJECTIVE: Our aim was to evaluate the efficacy and safety outcomes of the Pioneer Plus catheter (Philips, San Diego, Calif) and report the in-hospital and 30-day outcomes of lower extremity chronic total occlusion (CTO) interventions assisted by the Pioneer Plus catheter. In addition, we explored the factors associated with procedural success. METHODS: We conducted a retrospective review of 135 consecutive procedures in 116 patients from July 2011 to September 2018 performed by eight operators with various levels of experience at a high-volume center where the Pioneer Plus catheter was used for lower extremity CTO. The patient demographics, preprocedural symptoms, preprocedural testing results, procedural setting, and angiography findings were abstracted. The outcomes were divided into device-related and procedure-related outcomes. Device-related efficacy outcome included procedural success. Device-related safety outcomes included device-related complications. Procedure-related outcomes included procedure-related complications, 30-day major adverse cardiovascular events, and 30-day major adverse limb events. We conducted univariate comparisons of the provider, patient, and procedural characteristics stratified by procedural success. RESULTS: Procedural success was observed in 118 procedures overall (87.4%), and success rates ≤95.8% were observed for operators with an experience level of >25 devices deployed. No device-related complications, such as pseudoaneurysm formation, vessel perforation, or arteriovenous fistula formation, were observed. The Pioneer Plus catheter was mostly often used for CTO in the superficial femoral and popliteal arteries. Overall, the procedure-related complications included access site hematoma (5.2%), major bleeding (0.7%), pseudoaneurysm formation (0.7%), distal embolization (1.5%), and acute arterial thrombosis (1.5%). The 30-day major adverse limb events included index limb unplanned amputation (0.7%), index limb reintervention (4.4%), and index limb acute limb ischemia (0.7%) and occurred in 5.9% of the procedures. The only factor associated with procedural success was operator experience (P < .0001). CONCLUSIONS: The results from the present study have shown that Pioneer Plus catheter use is safe and effective when used to cross lower extremity CTO. However, further investigation is needed to identify patient- and provider-level factors to optimize patient outcomes.

Systematic review and meta-analysis of outcomes of lower extremity peripheral arterial interventions in patients with and without chronic kidney disease or end-stage renal disease.

OBJECTIVE: Patients with chronic kidney disease (CKD) have a greater risk of peripheral arterial disease (PAD). Although individual studies have documented an association between CKD and/or end-stage renal disease (ESRD) and adverse outcomes in patients undergoing PAD interventions in an era of technological advances in peripheral revascularization, the magnitude of the effect size is unknown. Therefore, we performed a meta-analysis to compare the outcomes of PAD interventions for patients with CKD/ESRD with those patients with normal renal function, stratified by intervention type (endovascular vs surgical), reflecting contemporary practice. METHODS: Five databases were analyzed from January 2000 to June 2019 for studies that had compared the outcomes of lower extremity PAD interventions for patients with CKD/ESRD vs normal renal function. We included both endovascular and open interventions, with an indication of either claudication or critical limb ischemia. We analyzed the pooled odds ratios (ORs) across studies with 95% confidence intervals (CIs) using a random effects model. Funnel plot and exclusion sensitivity analyses were used for bias assessment. RESULTS: Seventeen observational studies with 13,140 patients were included. All included studies, except for two, had accounted for unmeasured confounding using either multivariable regression analysis or case-control matching. The maximum follow-up period was 114 months (range, 0.5-114 months). The incidence of target lesion revascularization (TLR) was greater in those with CKD/ESRD than in those with normal renal function (OR, 1.68; 95% CI, 1.25-2.27; P = .001). The incidence of major amputations (OR, 1.97; 95% CI, 1.37-2.83; P < .001) and long-term mortality (OR, 2.28; 95% CI, 1.45-3.58; P < .001) was greater in those with CKD/ESRD. The greater TLR rates with CKD/ESRD vs normal renal function were only seen with endovascular interventions, with no differences for surgical interventions. The differences in rates of major amputations and long-term mortality between the CKD/ESRD and normal renal function groups were statistically significant, regardless of the intervention type. CONCLUSIONS: Patients with CKD/ESRD who have undergone lower extremity PAD interventions had worse outcomes than those of patients with normal renal function. When stratifying our results by intervention (endovascular vs open surgery), greater rates of TLR for CKD/ESRD were only seen with endovascular and not with open surgical approaches. Major amputations and all-cause mortality were greater in the CKD/ESRD group, irrespective of the indication. Evidence-based strategies to manage this at-risk population who require PAD interventions are essential.

Impact of Kidney Disease on Peripheral Arterial Interventions: A Systematic Review and Meta-Analysis.

BACKGROUND: There are limited data on outcomes of patients undergoing peripheral arterial disease (PAD) interventions who have comorbid CKD/ESRD versus those who do not have such comorbid condition. We performed a systematic review and meta-analysis to analyze outcomes in this patient population. METHODS: Five databases were searched for studies comparing outcomes of lower extremity PAD interventions for claudication and critical limb ischemia (CLI) in patients with CKD/ESRD versus non-CKD/non-ESRD from January 2000 to June 2019. RESULTS: Our study included 16 observational studies with 44,138 patients. Mean follow-up was 48.9 ± 27.4 months. Major amputation was higher with CKD/ESRD compared with non-CKD/non-ESRD (odds ratio [OR 1.97] [95% confidence interval [CI] 1.39-2.80], p = 0.001). Higher major amputations with CKD/ESRD versus non-CKD/non-ESRD were only observed when indication for procedure was CLI (OR 2.27 [95% CI 1.53-3.36], p < 0.0001) but were similar for claudication (OR 1.15 [95% CI 0.53-2.49], p = 0.72). The risk of early mortality was high with CKD/ESRD patients undergoing PAD interventions compared with non-CKD/non-ESRD (OR 2.55 [95% CI 1.65-3.96], p < 0.0001), which when stratified based on indication, remained higher with CLI (OR 3.14 [95% CI 1.80-5.48], p < 0.0001) but was similar with claudication (OR 1.83 [95% CI 0.90-3.72], p = 0.1). Funnel plot of included studies showed moderate bias. CONCLUSIONS: Patients undergoing lower extremity PAD interventions for CLI who also have comorbid CKD/ESRD have an increased risk of experiencing major amputations and early mortality. Randomized trials to understand outcomes of PAD interventions in this at-risk population are essential.

Safety and efficacy of paclitaxel drug-coated balloon in femoropopliteal in-stent restenosis.

INTRODUCTION: The femoropopliteal (FP) segment is a common site of involvement in peripheral arterial disease (PAD) and endovascular therapy has been shown to be safe and effective in the treatment of FP disease. Self-expanding nitinol stents are now frequently used for the treatment of FP disease but in-stent restenosis (ISR) remains a major issue that can lead to recurrence of symptoms requiring repeated revascularizations. Compared to plain old balloon angioplasty (POBA), drug-coated balloons (DCBs) have shown promising results with reduction of ISR rates and target lesion revascularization (TLR). AREAS COVERED: The aim of this review is to describe the mechanisms and classification of ISR and to summarize the available data on outcomes of all DCBs, especially in the treatment of FP ISR. EXPERT OPINION: Currently available data supports the use of DCBs as a first-line therapy in patients with FP ISR, with lower rates of TLR and higher patency rates at 1-year follow-up, when compared to POBA. Further randomized studies are essential to evaluate longer term safety and efficacy of DCBs.

Utility of Intravascular Ultrasound in Peripheral Vascular Interventions: Systematic Review and Meta-Analysis.

OBJECTIVES: We sought to compare outcomes between intravascular ultrasound- (IVUS) versus angiography (AO)-guided peripheral vascular interventions (PVIs). Introduction: Intravascular ultrasound facilitates plaque visualization and angioplasty during PVIs for peripheral arterial disease. It is unclear whether IVUS may improve the durability of PVIs and lead to improved clinical outcomes. METHODS: This is a study-level meta-analysis of observational studies. The primary end points of this study were rates of primary patency and reintervention. Secondary end points included rates of vascular complications, periprocedural adverse events, amputations, technical success, all-cause mortality, and myocardial infarction. RESULTS: Eight observational studies were included in this analysis with 93 551 patients. Mean follow-up was 24.2 ± 15 months. Intravascular ultrasound-guided PVIs had similar patency rates when compared with AO-guided PVIs (relative risk [RR]: 1.30, 95% confidence interval [CI]: 0.99-1.71, P = .062). There was no difference in rates of reintervention in IVUS-guided PVIs when compared to non-IVUS-guided PVIs (RR: 0.41, 95% CI: 0.15-1.13, P = .085). There is a lower risk of periprocedural adverse events (RR: 0.81, 95% CI: 0.70-0.94, P = .006) and vascular complications (RR: 0.81, 95% CI: 0.68-0.96, P = .013) in the IVUS group. All-cause mortality (RR: 0.76, 95% CI: 0.56-1.04, P = .084), amputation rates (RR 0.83, 95% CI: 0.32-2.15, P = .705), myocardial infarctions (RR: 1.19, 95% CI: 0.58-2.41, P = .637), and technical success (RR: 1.01, 95% CI: 0.86-1.19, P = .886) were similar between the groups. Conclusions: Intravascular ultrasound-guided PVIs had similar primary patency and reintervention when compared with AO-guided PVIs with significantly lower rates of periprocedural adverse events and vascular complications in the IVUS-guided group.

Carotid, Vertebral, and Brachiocephalic Interventions.

Carotid atherosclerosis most frequently manifests in the proximal internal carotid artery and the common carotid artery bifurcations. Subclavian artery atherosclerosis affects the proximal segments with a relatively higher incidence on the left and becomes clinically important in the presence of vertebrobasilar insufficiency or coronary steal. Atherosclerosis of the vertebral artery can lead to posterior circulation stroke. The authors review the major trials on carotid carotid, brachiocephalic and vertebral artery stenosis along with the various available diagnostic and interventional techniques.

Carotid revascularization: a systematic review of the evidence.

OBJECTIVE AND BACKGROUND: The aim of this study is to provide an evidence-based review of the periprocedural safety and long-term effectiveness of carotid artery stenting (CAS) compared to carotid endarterectomy (CEA), with particular attention paid to the use of embolic protection devices and patients at high risk for CEA. METHODS: Electronic databases (Ovid Medline, Cochrane central register of controlled trials, Pubmed, and Embase) were searched to identify: (1) randomized controlled trials (RCT) comparing outcomes of CEA and CAS, and (2) prospective clinical trials assessing the safety of CAS in patients at high surgical risk. Pooled incidence rates and one-sided 95% confidence interval for the periprocedural and long-term composite end-point of stroke, myocardial infarction, or death among high surgical risk patients were generated and compared to objective performance criteria (OPC) reported by previous trials. RESULTS: Six RCTs and 14 prospective clinical trials met our search criteria. Selected RCTs showed inconsistency in reported periprocedural and long-term outcome rates. Pooled incidence rates of the periprocedural and long-term composite end-point of stroke, myocardial infarction or death in high surgical risk candidates were 5.59% and 7.92%, respectively. These results were noninferior to selected OPCs (P-value <0.001). CONCLUSIONS: CAS represents a safe and effective stroke prevention strategy in high surgical risk patients when compared with CEA. The inconsistent results from the RCTs and the improved outcomes in the prospective clinical trials are likely related to variability in operator experience, use of embolic protection devices, and patient selection strategies.

Long-term outcomes after percutaneous patent foramen ovale closure.

Percutaneous patent foramen ovale (PFO) closure is a treatment for cryptogenic stroke and migraine headache. The goal of this study was to assess long-term outcomes of patients treated with percutaneous PFO closure. Records of patients with percutaneous PFO closure at Emory University Hospital from February 2002 to July 2009 were reviewed. Follow-up telephone questionnaire and chart review assessed recurrent stroke, migraine, and complications. Data was reviewed on 414 consecutive patients. Long-term follow-up was obtained in 207 of patients, and mean follow up was 4.6 ± 2.0 years. Cryptogenic stroke was the primary indication for intervention in 193 (93%) patients. Thirteen (7%) patients had a recurrent neurologic event post closure. In patients with multiple neurological events at baseline, 17% (n = 11) had a recurrent event, compared with 2% (n = 2) of patients with a single neurological event prior to PFO-closure (P < 0.002). Post closure, migraine frequency and severity declined from 4.5 to 1.1 migraine/month (P < 0.01) and 7.2 to 3.6 out of 10 (P < 0.01) in patients with history of migraine (n = 60). Thirty-day mortality was 1% (n = 2). One patient had device erosion 5 years post-procedure requiring emergent surgery. Atrial fibrillation was newly diagnosed in 8 (4%) patients within 6 months. In conclusion, the long-term rate of recurrent stroke after PFO closure is low in patients with a single neurological event at baseline. Serious long-term complications after PFO closure are rare. PFO closure may decrease the frequency and severity of migraine.

Ventricular noncompaction and associated cardiac anomalies.

An 80-year-old woman was referred for transcatheter aortic valve implantation for correction of aortic stenosis. An echocardiogram at the author's institution revealed severe hypertrophy of the left ventricle with deep recesses into the myocardium and hypokinesis involving the left ventricular apex. In addition, there was subaortic stenosis secondary to a muscular ridge. The aortic valve was only mildly stenotic. In this Cardiology Grand Rounds, the authors present a rare case of ventricular noncompaction and review the literature on this subject and its association with other cardiac abnormalities.