Clinical Conference Proceedings: 15th Biennial International Andreas Gruentzig Society Meeting.

The International Andreas Gruentzig Society is an educational society of physicians and scientists interested in cardiovascular and related fields. Members cooperate in the advancement of knowledge and education through research, publication, study, and teaching in the fields of cardiovascular disease. This summary reflects the proceedings from the recent scientific meeting to assess current clinical problems and propose future directions and possible solutions.

Endovascular Management of Abdominal Aortic Aneurysms: the Year in Review.

OPINION STATEMENT: Endovascular aneurysm repair (EVAR) has become the predominant method of treatment for abdominal aortic aneurysms (AAA). The use of conscious sedation with local anesthesia and percutaneous femoral access has further decreased the morbidity of the procedure. Current devices can more effectively manage increasingly "hostile" aneurysm necks, while chimney grafts or dedicated fenestrated stent-grafts can be used for juxta-renal disease with favorable results. However, endovascular repair does present a new set of challenges, and endoleaks remain an area of concern. While there is general consensus that type I and type III endoleaks require treatment, type II endoleaks are the topic of ongoing research and debate. Development of devices and techniques to prevent and treat endoleak continues to progress. Advances in contrast-enhanced ultrasound are reducing reliance on computed tomography for post-operative monitoring. This is an important step in this population at high risk for the development of kidney failure. Despite these many innovations, further research is needed to optimize the care of patients with AAA.

SCAI expert consensus statement for aorto-iliac arterial intervention appropriate use.

Aorto-iliac arterial occlusive disease is common and may cause a spectrum of chronic symptoms from intermittent claudication to critical limb ischemia. Treatment is indicated for symptoms that have failed lifestyle and medical therapies or occasionally to facilitate other interventional procedures such as TAVR and/or placement of hemodynamic assist devices. It is widely accepted that TASC A, B, and C lesions are best managed with endovascular intervention. In experienced hands, most TASC D lesions may be treated by endovascular methods, and with the development of chronic total occlusion devices, many aorto-iliac occlusions may be recanalized safely by endovascular means. Interventional cardiologists should be well versed in the anatomy, as well as the treatment of aorto-iliac disease, given their need to traverse these vessels during transfemoral procedures. Overall, aorto-iliac occlusive disease is more commonly being treated with an endovascular-first approach, using open surgery as a secondary option. This document was developed to guide physicians in the clinical decision-making related to the contemporary application of endovascular intervention among patients with aorto-iliac arterial disease.

Nine-month results of the REFORM study: a prospective, single-arm, multicenter clinical study of the safety and effectiveness of the Formula™ balloon-expandable stent for treatment of renal artery stenosis.

OBJECTIVES: To evaluate the 9-month safety and effectiveness outcomes of the Formula™ balloon-expandable renal stent (Cook Medical, Bloomington, IN) for the treatment of atherosclerotic renal artery stenosis (RAS) following suboptimal angioplasty. BACKGROUND: Atherosclerotic RAS can cause hypertension and ischemic nephropathy. When clinically indicated, an interventional approach with renal angioplasty and stent implantation is the preferred method for revascularization of atherosclerotic renal artery stenoses. METHODS: The REFORM study is a prospective, multicenter, single-arm study of stent implantation following suboptimal PTRA using the Formula stent. One hundred patients with atherosclerotic ostial renal artery lesions =18 mm in length with a >50% residual stenosis following PTA were enrolled. The primary endpoint was 9-month primary patency. RESULTS: The 9-month primary patency rate was 91.7%. The 9-month major adverse event rate was 2.2%. Mean systolic blood pressure was significantly decreased at follow-up (from 150 ± 21 mm Hg at baseline to 141 ± 21 mm Hg at 9 months; P = 0.003). Mean serum creatinine (SCr) level and mean estimated glomerular filtration rate (eGFR) were not significantly different at 9 months. A clinically meaningful improvement in renal function (i.e., =25% increase in eGFR or =0.5 mg/dl decrease in SCr) was observed in 9% of patients at 1 month and 12% of patients at 9 months. A clinically meaningful decline in renal function (i.e., =25% decrease in eGFR or =0.5 mg/dl increase in SCr) was observed in only 3% of patients at 1 month and 7% of patients at 9 months. CONCLUSIONS: The Formula stent was safe and effective in treating atherosclerotic RAS following suboptimal angioplasty.

A meta-analysis of proximal occlusion device outcomes in carotid artery stenting.

BACKGROUND: The clinical risk predictors for adverse events in carotid stenting using distal embolic protection devices are well established and include patient age and symptomatic status. The risk predictors for adverse events with proximal occlusion devices are not as well established. This study is a meta-analysis of available data on proximal occlusion devices to determine the risk predictors of adverse events in carotid stenting. METHODS: Study-specific results on 2,397 patients from six independent databases of two different proximal occlusion devices were meta-analyzed by an independent statistical analysis organization for predictors of 30-day major adverse clinical events including stroke, myocardial infarction, and death using random effects models. The primary endpoint was the composite of total stroke, myocardial infarction, and death at 30 days. RESULTS: The incidence of stroke was 1.71%. The incidence of myocardial infarction was 0.02%. The incidence of death was 0.40%. The composite primary endpoint at 30 days was 2.25%. Age and diabetic status were found to be the only significant independent risk predictors; however, total stroke rates remained below 2.6% in all subgroups, including symptomatic octogenarians. The other baseline demographic variables including patient gender, symptomatic status, and contralateral carotid occlusion were not found to be independent risk predictors. CONCLUSIONS: A meta-analysis of CAS procedures performed with proximal occlusion devices demonstrated a very low incidence of adverse events at 30 days. The only independent risk predictors were age and diabetes. Patient gender, symptomatic status, and other baseline characteristics were not found to be risk predictors for CAS using proximal occlusion devices.

Carotid artery revascularization in high surgical risk patients with the NexStent and the Filterwire EX/EZ: 1-year results in the CABERNET trial.

OBJECTIVE: The multicenter, single-arm CABERNET trial evaluated outcomes in high-surgical-risk patients with carotid artery stenosis treated with the NexStent plus FilterWire EX/EZ Emboli Protection System. BACKGROUND: For patients at high surgical risk, carotid artery stenting (CAS) offers a less invasive alternative to carotid endarterectomy (CEA). METHODS: The trial enrolled 454 high-surgical-risk patients with carotid stenosis by angiography > or = 50% for symptomatic patients and > or = 60% for asymptomatic patients. The comparator primary endpoint was the 1-year major adverse event (MAE, defined as any death, stroke, or myocardial infarction [MI]) rate. It was compared with a proportionally weighted objective performance criterion (OPC) of 12.1% representative of published CEA results in similar patients plus a prespecified noninferiority margin (delta) of 4%. A second primary endpoint was the composite rate of 30-day MAE plus late (31-365 days) ipsilateral stroke. RESULTS: Symptoms of carotid stenosis were present in 24.2% of patients; 36.6% of patients were considered high-surgical-risk due to comorbid risk factors and 63.4% due to anatomic risk factors. The rate of 30-day MAE plus late ipsilateral stroke was 4.7% (20/438). The comparator primary endpoint of 1-year MAE was 11.6% (51/438) and was noninferior to the OPC of 12.1% (95% upper confidence interval of 14.5% versus OPC plus delta of 16.1%, P = 0.005). Late ipsilateral stroke was 0.7% and target vessel revascularization at 1 year was 2.4%. CONCLUSIONS: The CABERNET trial demonstrates that CAS with NexStent and FilterWire is noninferior to (equivalent or better than) traditional CEA at 1 year in high-surgical-risk patients based on historical controls.

Prevention of contrast-induced nephropathy with sodium bicarbonate: a randomized controlled trial.

CONTEXT: Contrast-induced nephropathy remains a common complication of radiographic procedures. Pretreatment with sodium bicarbonate is more protective than sodium chloride in animal models of acute ischemic renal failure. Acute renal failure from both ischemia and contrast are postulated to occur from free-radical injury. However, no studies in humans or animals have evaluated the efficacy of sodium bicarbonate for prophylaxis against contrast-induced nephropathy. OBJECTIVE: To examine the efficacy of sodium bicarbonate compared with sodium chloride for preventive hydration before and after radiographic contrast. DESIGN, SETTING, AND PATIENTS: A prospective, single-center, randomized trial conducted from September 16, 2002, to June 17, 2003, of 119 patients with stable serum creatinine levels of at least 1.1 mg/dL (> or =97.2 micromol/L) who were randomized to receive a 154-mEq/L infusion of either sodium chloride (n = 59) or sodium bicarbonate (n = 60) before and after iopamidol administration (370 mg iodine/mL). Serum creatinine levels were measured at baseline and 1 and 2 days after contrast. INTERVENTIONS: Patients received 154 mEq/L of either sodium chloride or sodium bicarbonate, as a bolus of 3 mL/kg per hour for 1 hour before iopamidol contrast, followed by an infusion of 1 mL/kg per hour for 6 hours after the procedure. MAIN OUTCOME MEASURE: Contrast-induced nephropathy, defined as an increase of 25% or more in serum creatinine within 2 days of contrast. RESULTS: There were no significant group differences in age, sex, incidence of diabetes mellitus, ethnicity, or contrast volume. Baseline serum creatinine was slightly higher but not statistically different in patients receiving sodium bicarbonate treatment (mean [SD], 1.71 [0.42] mg/dL [151.2 [37.1] micromol/L] for sodium chloride and 1.89 [0.69] mg/dL [167.1 [61.0] micromol/L] for sodium bicarbonate; P =.09). The primary end point of contrast-induced nephropathy occurred in 8 patients (13.6%) infused with sodium chloride but in only 1 (1.7%) of those receiving sodium bicarbonate (mean difference, 11.9%; 95% confidence interval [CI], 2.6%-21.2%; P =.02). A follow-up registry of 191 consecutive patients receiving prophylactic sodium bicarbonate and meeting the same inclusion criteria as the study resulted in 3 cases of contrast-induced nephropathy (1.6%; 95% CI, 0%-3.4%). CONCLUSION: Hydration with sodium bicarbonate before contrast exposure is more effective than hydration with sodium chloride for prophylaxis of contrast-induced renal failure.