Systematic review of multiple versus single device closure of Secundum atrial septal defects in adults.

INTRODUCTION: Multiple device closure (MDC) strategy has been used in treating of complex Atrial septal defects (ASDs) in adults. The safety profile of MDC compared to conventional single device closure (SDC) is unknown in this population. This report represents the first review examining the outcomes of single versus multiple device ASD closure in adults with ostium secundum defects. METHODS: Literature databases and manual search from their inception until June 30th, 2017 followed the Preferred Reporting Items of Systemic Review and Meta-Analysis (PRISMA) guideline. Main outcomes are 1) overall complication incidence, 2) arrhythmia incidence, 3) residual shunt rate. Each outcome profile was pooled by MDC and SDC, respectively and chi-square analysis was applied to examine statistical significance between MDC and SDC strategies (two-sided and p < .050). RESULTS: A total of 1806 + studies were initially screened, and 20 studies were finally selected (MDC group, 147 patients; SDC group, 1706 patients). There was no difference in overall complication incidence (χ2 = 1.269; p = .259) and arrhythmia incidence (χ2 = 0.325; p = .568) between MDC and SDC. There was no difference in residual shunt rate between the SDC (4.10 %; 70/1706) and MDC groups (6.80 %; 10/147; χ2 = 2.387; p = .122). CONCLUSIONS: The outcomes of percutaneous multiple ASD closure (MDC) seem to be safe and effective as compared to conventional single ASD (SDC) closure in terms of device - related complications and technical success of the procedure. Prospective registry data and randomized trials are needed to determine the long-term outcomes of percutaneous ASD closure using MDC.

2022 ACC/AHA guideline for the diagnosis and management of aortic disease: A report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines.

AIM: The "2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease" provides recommendations to guide clinicians in the diagnosis, genetic evaluation and family screening, medical therapy, endovascular and surgical treatment, and long-term surveillance of patients with aortic disease across its multiple clinical presentation subsets (ie, asymptomatic, stable symptomatic, and acute aortic syndromes). METHODS: A comprehensive literature search was conducted from January 2021 to April 2021, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through June 2022 during the guideline writing process, were also considered by the writing committee, where appropriate. STRUCTURE: Recommendations from previously published AHA/ACC guidelines on thoracic aortic disease, peripheral artery disease, and bicuspid aortic valve disease have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with aortic disease have been developed. There is added emphasis on the role of shared decision making, especially in the management of patients with aortic disease both before and during pregnancy. The is also an increased emphasis on the importance of institutional interventional volume and multidisciplinary aortic team expertise in the care of patients with aortic disease.

2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines.

AIM: The "2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease" provides recommendations to guide clinicians in the diagnosis, genetic evaluation and family screening, medical therapy, endovascular and surgical treatment, and long-term surveillance of patients with aortic disease across its multiple clinical presentation subsets (ie, asymptomatic, stable symptomatic, and acute aortic syndromes). METHODS: A comprehensive literature search was conducted from January 2021 to April 2021, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through June 2022 during the guideline writing process, were also considered by the writing committee, where appropriate. Structure: Recommendations from previously published AHA/ACC guidelines on thoracic aortic disease, peripheral artery disease, and bicuspid aortic valve disease have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with aortic disease have been developed. There is added emphasis on the role of shared decision making, especially in the management of patients with aortic disease both before and during pregnancy. The is also an increased emphasis on the importance of institutional interventional volume and multidisciplinary aortic team expertise in the care of patients with aortic disease.

2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines.

AIM: The "2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease" provides recommendations to guide clinicians in the diagnosis, genetic evaluation and family screening, medical therapy, endovascular and surgical treatment, and long-term surveillance of patients with aortic disease across its multiple clinical presentation subsets (ie, asymptomatic, stable symptomatic, and acute aortic syndromes). METHODS: A comprehensive literature search was conducted from January 2021 to April 2021, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through June 2022 during the guideline writing process, were also considered by the writing committee, where appropriate. STRUCTURE: Recommendations from previously published AHA/ACC guidelines on thoracic aortic disease, peripheral artery disease, and bicuspid aortic valve disease have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with aortic disease have been developed. There is added emphasis on the role of shared decision making, especially in the management of patients with aortic disease both before and during pregnancy. The is also an increased emphasis on the importance of institutional interventional volume and multidisciplinary aortic team expertise in the care of patients with aortic disease.

Elective Percutaneous Paravalvular Leak Closure Under Conscious Sedation: Procedural Techniques and Clinical Outcomes.

BACKGROUND: Paravalvular leaks (PVLs) are a well-recognized complication of prosthetic valves that are detected up to 18% of all implanted surgical valves. Perioperative morbidity is thought to be lower in percutaneous compared to surgical PVL repair. However, a direct comparison of PVL closure techniques has never been performed. Our study is the first to demonstrate that elective PVL closure with monitored anesthesia care can be achieved with high success and low complications rates resulting in short hospital stays. METHODS: This is a retrospective cohort of patients admitted electively for catheter-based treatment of symptomatic prosthetic paravalvular regurgitation from Jan 2013 to April 2018. Both mitral and aortic PVLs were included. Patients' demographics, risk factors, procedural outcomes, In-hospital and thirty-day mortality were all reported. We followed the Valve Academic Research Consortium (VARC) criteria to define device and procedural technical success. In-hospital and 30- day outcomes were assessed by retrospective chart review. RESULTS: A total of 54 PVLs in thirty-seven patients were repaired (65% aortic & 35% mitral). The mean-age in the mitral cohort was lower than the aortic cohort (61 vs 72years, P<0.0001) but the two groups shared similar clinical risk factors (P>0.05). Average hospital stay was 1-2days (<1.5days overall cohort) which was significantly lower in the aortic compared to the mitral cohort (P=0.009). All procedures were guided by TEE under conscious sedation with monitored anesthesia care. Procedural technical success defined as any significant residual shunt was 81% in the overall cohort and 88% in the aortic group. No procedural deaths were reported. Short-term mortality during the first 30days was 5.4% (two patients). CONCLUSION: Elective catheter-based repair of symptomatic prosthetic paravalvular regurgitation appears to be safe and effective. The use of conscious sedation with monitored anesthesia care resulted in short hospital stay.

Using the Minimally Invasive Impella 5.0 via the Right Subclavian Artery Cutdown for Acute on Chronic Decompensated Heart Failure as a Bridge to Decision.

BACKGROUND: Outcomes of traditional mechanical support paradigms (extracorporeal membrane oxygenation, intraaortic balloon pump [IABP], and permanent left ventricular assist device [LVAD]) in acute decompensated heart failure have generally been suboptimal. Novel approaches, such as minimally invasive LVAD therapy (Impella 5.0 device), promise less invasive but equivalent hemodynamic support. However, it is yet unknown whether the outcomes with such devices support widespread acceptance of this new technology. We recently started utilizing the right subclavian artery (RSA) for Impella 5.0 implantation and report our early experience and outcomes with this novel approach. METHODS: A single-center retrospective review was performed of 24 patients with acute on chronic decompensated heart failure who received the Impella 5.0 via the RSA from June 2011 to May 2014. The device was implanted via a cutdown through an 8-mm vascular graft sewn to the RSA. The device was positioned with fluoroscopy and transesophageal echocardiography. RESULTS: The mean age of the patients was 51.29 years, and 75% were male. At implantation, all patients were mechanically ventilated on at least 2 inotropes with persistent cardiogenic shock, and 17 (70.8%) were on IABP support. Postimplantation, 21 (87.5%) tolerated extubation, and all 17 of the patients with IABPs tolerated discontinuation of IABP support. The reduction in the Model for End-Stage Liver Disease score preimplantation vs postimplantation was statistically significant (21.17 vs 14.88, P=0.0014), suggesting improvement in end organ function. A significant decrease was also seen in creatinine levels before and after implantation (2.17 mg/dL vs 1.50 mg/dL, P=0.0043). The endpoint of support included recovery in 6 patients (25.0%), permanent LVAD in 9 (37.5%), and heart transplantation in 2 (8.3%). Death occurred in 7 patients (29.2%) as a result of multisystem organ failure, infection, or patient withdrawal of care. CONCLUSION: Minimally invasive LVAD therapy using the Impella 5.0 via the RSA cutdown is an attractive option in acute on chronic decompensated heart failure. Improvement in end organ function allows for transition to recovery or to advanced surgical therapies such as permanent LVAD and heart transplantation. Significant advantages to this approach include improved left ventricular unloading, lower anticoagulation need, and the potential for ambulation and physical therapy.

SCAI/SVM expert consensus statement on carotid stenting: Training and credentialing for carotid stenting.

Carotid artery stenting (CAS) has become an integral part of the therapeutic armamentarium offered by cardiovascular medicine programs for the prevention of stroke. The purpose of this expert consensus statement is to provide physician training and credentialing guidance to facilitate the safe and effective incorporation of CAS into clinical practice within these programs. Since publication of the 2005 Clinical Competence Statement on Carotid Stenting, there has been substantial device innovation, publication of numerous clinical trials and observational studies, accumulation of extensive real-world clinical experience and widespread participation in robust national quality improvement initiatives [5]. Collectively, these advances have led to substantial evolution in the selection of appropriate patients, as well as in the cognitive, technical and clinical skills required to perform safe and effective CAS. Herein, we summarize published guidelines, describe training pathways, outline elements of competency, offer strategies for tracking outcomes, specify facility, equipment and personnel requirements, and propose criteria for maintenance of CAS competency.

Vascular brachytherapy versus drug-eluting stents in the treatment of in-stent restenosis: A meta-analysis of long-term outcomes.

INTRODUCTION: Clinical trials have shown a short-term benefit of drug-eluting stents (DES) compared to vascular brachytherapy (VBT) for treatment of in-stent restenosis (ISR). The long-term benefits of DES vs. VBT are conflicting in the literature. This study aimed to do a meta-analysis of long-term outcomes of DES compared to VBT for treatment of ISR. METHODS: PubMed, EMBASE, Cochrane Central and unpublished data were searched for cohort studies and randomized controlled trials (RCTs) that directly compared VBT to DES for the treatment of ISR. We evaluated the following outcomes at 2-5 years of follow-up: target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), stent thrombosis, cardiovascular (CV) mortality, and overall mortality. Heterogeneity was defined as I(2) values > 25%. Review Manager 5.1 was used for statistical analysis. RESULTS: We included 1,375 patients from five studies, of which three were RCTs. VBT was used to treat ISR in 685 (49.8%) patients. After a 2-5 year follow-up, no significant differences were found between treatment groups regarding MI (P = 0.49), stent thrombosis (P = 0.86), CV mortality (P = 0.35), and overall mortality (P = 0.71). TLR (OR 2.37; CI 1.55-3.63; P < 0.001) and TVR (OR 2.23; CI 1.01-4.94; P = 0.05) were significantly increased in patients who received VBT. CONCLUSION: This study suggests that DES are associated with decreased long-term revascularization procedures when compared to VBT for the treatment of ISR. This benefit does not appear to be associated with a significant reduction in mortality or myocardial infarction.

Comparison of Cutting Balloon Angioplasty and Percutaneous Balloon Angioplasty of Arteriovenous Fistula Stenosis: A Meta-Analysis and Systematic Review of Randomized Clinical Trials.

BACKGROUND: Hemodialysis (HD) access failure is a common cause of increased morbidity and healthcare cost in patients with end stage renal disease (ESRD). Percutaneous balloon angioplasty has been used to treat hemodialysis access stenosis but is complicated by a high rate of restenosis. Percutaneous cutting balloon (PCB) angioplasty is an alternative approach that has shown to reduce restenosis. OBJECTIVES: The aim of the study is to assess the safety and efficacy of PCB angioplasty in comparison with conventional and high-pressure balloon angioplasty in the treatment of hemodialysis access site stenosis. METHODS: We searched PubMed, EMBASE and the Cochrane Central register of controlled trials (CENTRAL) databases through August 2014 and selected studies using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist. We included all randomized clinical trials with a head-to-head comparison between PCB and conventional or high-pressure balloon angioplasty RESULTS: Three studies with 1034 participants (age 60.7 (±12.9) years and 50.1% males) with 525 in PCB and 509 in control arm were included in the analysis. The immediate procedural success rate was not significantly different in the PCB angioplasty and control arm respectively, (87.2% vs. 83.7% RD -0.02; 95%CI -0.06 to 0.01; P = 0.38). The six-month target lesion patency was significantly higher in the PCB angioplasty arm (67.2% vs. 55.6% RD 0.12; 95%CI 0.05-0.19; P < 0.05) with number needed to treat (NNT) of 9. The device related complications were not statistically significant between groups (RD 0.03; 95%CI -0.02 to 0.07; P = 0.26). CONCLUSIONS: PCB angioplasty is effective in treatment of hemodialysis access stenosis, with significantly higher six-month patency compared to balloon angioplasty.

Cilostazol increases patency and reduces adverse outcomes in percutaneous femoropopliteal revascularisation: a meta-analysis of randomised controlled trials.

BACKGROUND: Cilostazol is an oral antiplatelet agent currently indicated for treatment of intermittent claudication. There is evidence that cilostazol may reduce femoropopliteal restenosis after percutaneous endovascular intervention. METHODS: We searched PubMed, Scopus and Cochrane databases from 1966 through September 2013 for randomised controlled trials (RCTs) evaluating the addition of cilostazol to standard care in patients receiving femoropopliteal endovascular treatment. Restenosis, target lesion revascularisation and combined adverse outcomes (death, revascularisation and amputation) within 1-2 years postprocedure were evaluated. RESULTS: Of 205 articles, three RCTs were included in the analysis. The pooled data provided a total of 396 patients, 195 of whom received cilostazol. When compared to standard medical therapy alone, cilostazol significantly reduced the risk of restenosis (risk difference -0.20; 95% CI -0.29 to -0.11; p<0.0001; number needed to treat 5), target lesion revascularisation (risk difference -0.17; 95% CI -0.25 to -0.09; p<0.0001; number needed to treat 6). Death and amputation were not different in between groups. CONCLUSIONS AND LIMITATION: Cilostazol significantly increases femoropopliteal patency and decreases adverse outcomes in percutaneous endovascular intervention. However, further RCTs are needed because of limited sample size; this meta-analysis represents the best current evidence.

Endovascular management of acute limb ischemia.

Acute limb ischemia (ALI) is defined as a sudden decrease (<14 days) in limb perfusion causing a potential threat to limb viability. Endovascular treatment of ALI is an effective and appropriate primary treatment strategy in patients with a viable acutely ischemic limb due to a recent arterial occlusion. We present a case of acute limb ischemia and discuss percutaneous interventional treatment strategies including catheter-directed thrombolysis, rheolytic thrombectomy, and utilization of distal protection devices.

Carotid artery stenting: patient, lesion, and procedural characteristics that increase procedural complications.

From the earliest experiences with carotid artery stenting (CAS) presumptive high risk features have included thrombus-containing lesions, heavily calcified lesions, very tortuous vessels, and near occlusions. In addition patients have been routinely excluded from CAS trials if they have contra-indications to dual antiplatelet therapy (aspirin and thienopyridines), a history of bleeding complications and severe peripheral arterial disease (PAD) making femoral artery vascular access difficult. Variables that increase the risk of CAS complications can be attributed to patient characteristics, anatomic or lesion features, and procedural factors. Clinical features such as older age (≥80 years), decreased cerebral reserve (dementia, multiple prior strokes, or intracranial microangiopathy) and angiographic characteristics such as excessive tortuosity (more than two 90° bends within 5 cm of the target lesion) and heavy calcification (concentric calcification ≥ 3 mm in width) have been associated with increased CAS complications. Other high risk CAS features include those that prolong catheter or guide wire manipulation in the aortic arch, make crossing a carotid stenosis more difficult, decrease the likelihood of successful deployment or retrieval of an embolic protection device (EPD), or make stent delivery or placement more difficult. Procedure volume for the operator and the catheterization laboratory team are critical elements in reducing the risk of the procedure. In this article, we help CAS operators better understand procedure risk to allow more intelligent case selection, further improving the outcomes of this emerging procedure.

Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial.

PURPOSE: To evaluate longer outcomes of primary nitinol stenting for the treatment of femoropopliteal lesions up to 15 cm long after these stents were found to have superior short-term patency vs. balloon angioplasty. METHODS: Two hundred and six patients (143 men; mean age 67 years) with intermittent claudication due to superficial femoral and proximal popliteal artery lesions were randomized (2:1) to treatment with nitinol stents or balloon angioplasty at 24 US and European centers and followed for 3 years. In that time, 15 patients died, 20 withdrew consent, and 10 were lost to follow-up, leaving 161 (78.2%) patients for 36-month assessment. RESULTS: The 12-month freedom from target lesion revascularization (TLR) was 87.3% for the stent group vs. 45.2% for the angioplasty group (p<0.0001). At 3 years, there was no difference in survival (90.0% vs. 91.7%, p=0.71) or major adverse events (75.2% vs. 75.2%, p=0.98) between the stent and angioplasty groups. Duplex ultrasound was not mandated after the first year, so stent patency could not be ascertained beyond 1 year, but freedom from TLR at 3 years was significantly better in the stent group (75.5% vs. 41.8%, p<0.0001), as was clinical success (63.2% vs. 17.9%, p<0.0001). At 18 months, a 4.1% (12/291) stent fracture rate was documented. CONCLUSION: In this multicenter trial, primary implantation of a nitinol stent for moderate-length lesions in the femoropopliteal segment of patients with claudication was associated with better long-term results vs. balloon angioplasty alone.

A randomized trial of intravenous n-acetylcysteine to prevent contrast induced nephropathy in acute coronary syndromes.

BACKGROUND: Pharmacokinetic data suggests that the intravenous form of n-acetylcysteine (NAC) may be more effective than the oral formulation in preventing contrast induced nephropathy (CIN). NAC owing to its anti-oxidant properties might be beneficial for patients with acute coronary syndromes (ACS) who are at increased risk for CIN. The aim of this prospective randomized, single-center, double-blind, placebo controlled trial (NCT00939913) was to assess the effect of high-dose intravenous NAC on CIN in ACS patients undergoing coronary angiography and/or percutaneous coronary intervention (PCI). METHODS: We randomized 398 ACS patients scheduled for diagnostic angiography ± PCI to an intravenous regimen of high-dose NAC (1,200 mg bolus followed by 200 mg/hr for 24 hr; n = 206) or placebo (n = 192). The primary end-point was incidence of CIN defined as an increase in serum creatinine concentration ≥ 25% above the baseline level within 72 hr of the administration of intravenous contrast. RESULTS: There was no difference found for the primary end point with CIN in 16% of the NAC group and in 13% of the placebo group (p = 0.40). Change in serum cystatin-C, a sensitive marker for renal function, was 0.046 ± 0.204 in the NAC group and 0.002 ± 0.260 in the control group (p = 0.07). CONCLUSION: In ACS patients undergoing angiography ± PCI, high-dose intravenous NAC failed to reduce the incidence of CIN.

A simple percutaneous technique for hemostasis and closure after transcatheter aortic valve implantation.

Access closure is a key element to successful retrograde percutaneous transfemoral transcatheter aortic valve implantation. It requires large-bore femoral arterial access (18Fr-28Fr) which most operators manage with surgical access and closure under general anesthesia. We report a case example of how, using our center's peripheral interventional experience, we have developed a simple five step technique to achieve hemostasis percutaneously.

Elective percutaneous intervention for intracranial atherosclerotic stenoses by interventional cardiologists.

BACKGROUND: Current "best" medical therapy with anti-platelet and/or anti-thrombotic agents for symptomatic atherosclerotic intracranial (IC) disease is associated with high recurrence. IC catheter-based therapy (CBT) using balloon angioplasty with or without stent placement is an option for patients who have failed medical therapy. We sought to examine the outcomes of CBT for patients with symptomatic IC arterial disease managed by experienced interventional cardiologists. METHODS: We retrospectively studied 89 consecutive symptomatic patients with 99 significant (≥70% diameter) IC arterial stenoses who underwent CBT. CBT was performed by experienced interventional cardiologists with the consultative support of a neurovascular team. The primary endpoint was stroke and vascular death. RESULTS: Procedure success was achieved in 96/99 (97%) lesions and percent diameter stenosis was reduced from 91% ± 7.5% preprocedure to 19% ± 15% postprocedure (P < 0.001). The rate of in-hospital periprocedural stroke and all death was 3%. The primary endpoint of stroke and vascular death rate at 1 year was 5.7% (5/88) and at 2 years was 13.5% (11/81). The 2-year all-cause mortality was 11.3% (10/88). CONCLUSIONS: For patients with symptomatic IC arterial stenosis who have failed medical therapy or are considered very high risk for stroke, CBT performed by experienced interventional cardiologists is safe and offers both high procedural success rates and excellent clinical outcomes at 1 year. CBT is an attractive option for this high-risk patient population considering the expected 12-15% rate of recurrent stroke at 1 year.

Factors related to a clinically silent peri-procedural drop in hemoglobin with coronary and peripheral vascular interventions.

Clinically evident and subclinical peri-procedural bleeding following interventional therapies are associated with adverse cardiovascular outcomes. The risk factors for clinically evident bleeding have been well described. Despite the well-documented association of adverse outcomes for patients with a subclinical peri-procedural hemoglobin drop, the clinical predictors have not yet been defined. We identified 1176 consecutive patients with a subclinical drop in hemoglobin (fall of ≥ 1 g/dl in patients without clinical bleeding) following percutaneous coronary interventions (PCI) and peripheral vascular interventions (PVI). Multivariate logistic regression analysis was performed. A subclinical peri-procedural hemoglobin drop ≥ 1 g/dl was identified in 41% (400/972) of PCI and in 49% (213/435) of PVI. More than one access site predicted a higher risk of a subclinical drop in hemoglobin in both groups. A body mass index ≥ 30 predicted a lower risk of a subclinical drop in hemoglobin in both groups. For PCI, creatinine clearance < 60 ml/min was associated with a higher risk of a subclinical drop in hemoglobin. In conclusion, clinically silent peri-procedural hemoglobin fall ≥ 1 g/dl is common in patients undergoing both coronary and peripheral percutaneous intervention. Predictors identified in our study will need prospective validation.

Catheter-based therapy of common femoral artery atherosclerotic disease.

The objective of this paper is to describe outcomes of endovascular therapy in patients with symptomatic common femoral artery (CFA) lesions. Symptomatic atherosclerotic disease of the common femoral artery is an uncommon clinical entity, and there is no consensus regarding the suitability of catheter-based therapy. We reviewed the records of 26 consecutive patients treated with catheter-based therapy for symptomatic CFA lesions between 1994 and 2009. Angiographic success and procedure success were obtained in all vessels and in all patients. At 1 year, 100% (16/16) of the claudication patients and 70% (7/10) of the critical limb ischemia (CLI) patients maintained clinical success. The ankle- brachial index (ABI) significantly improved from a baseline of 0.47 ± 0.18 to 0.77 ± 0.18 (p < 0.001) after the procedure. At their most recent clinic visit (31 months ± 14 months), clinical success was maintained in 100% of the claudication patients and in 70% (7/10) of the CLI patients. During the follow-up period, femoral vascular access for an unrelated procedure was obtained through the CFA stent. In conclusion, patients with symptomatic CFA atherosclerotic disease obtained excellent clinical outcomes with angioplasty with stenting. We found that angioplasty with stenting of the CFA did not preclude future CFA vascular access. Our data suggest that catheter-based therapies should be considered as an option to open surgery in selected patients with symptomatic CFA disease.

Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial.

BACKGROUND: Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation. METHODS AND RESULTS: A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of nitinol stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the stent group and 64 mm for the angioplasty group. Acute lesion success (<30%residual stenosis) was superior for the stent group compared with the angioplasty group (95.8% versus 83.9%; P<0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the stent group compared with 45.1% for the angioplasty group (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3% versus 36.7%; P<0.0001). Through 12 months, fractures occurred in 3.1% of stents implanted. No stent fractures resulted in loss of patency or target lesion revascularization. CONCLUSIONS: In this multicenter trial, primary implantation of a self-expanding nitinol stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00673985.