Objective performance goals of safety and blood pressure efficacy for clinical trials of renal artery bare metal stents in hypertensive patients with atherosclerotic renal artery stenosis

Objective : To provide safety and performance goals for prospective single‐arm trials of bare metal renal artery stenting in patients with resistant hypertension associated with high grade atherosclerotic renal artery stenosis. Background : To date, there have been no US Pre‐Market Approval (PMA) bare metal renal stent device trials which have focused on improvement of blood pressure control as a primary effectiveness endpoint. Methods : Analysis of subject‐level data from three large industry sponsored pre‐market approval (PMA) trials was performed. Hypertensive patients (≥155 mmHg) with a ≥50% atherosclerotic renal artery stenosis were included. Thirty day and 9‐month systolic and diastolic blood pressure measurements, renal function and 9‐month duplex ultrasound assessment of renal artery patency were analyzed. Results : Initial data analysis of 600 patients from the 3 PMA trials identified 286 patients who met inclusion criteria. The mean baseline systolic blood pressure was 177.8 ± 19.3 mmHg with a mean 68.1% diameter renal artery stenosis. Nine months after successful stenting, the mean SBP was 156.7 ± 24.1 mmHg; the 9 month restenosis rate was 14.4%. Conclusion : Based on the statistical modeling of these data and a priori established performance criteria, the co‐primary endpoints of 9 month reduction in blood pressure and in‐stent restenosis are proposed. The reduction in blood pressure will be analyzed as a continuous variable and will be compared to this performance goal. © 2011 Wiley‐Liss, Inc.     

Primary cardiac hydatid cyst presenting as noncompaction cardiomyopathy

We report a case of cyst was initially labeled as left ventricular noncompaction cardiomyopathy. An accurate diagnosis is essential to establish the most effective treatment strategy. In particular, echocardiographic examination assists in identifying the correct diagnosis. In this case, two‐dimensional and three‐dimensional echocardiography and computed tomography were used for definitive diagnosis of cardiac hydatid cyst.     

Post-traumatic pseudoaneurysm of the brachial artery and its surgical treatment

The frequency of peripheral artery aneurysms in the upper extremities is much less than in the lower extremities. Diagnosis and surgical treatment are important because upper extremity aneurysms can cause severe decreases in function and lead to the loss of an arm or of fingers. We performed aneurysmal resection together with saphenous vein graft interpositioning in 9 patients with a diagnosis of post-traumatic brachial pseudoaneurysm from January 1995 through February 2003. Of these patients, 7 were men (77%). The mean age was 38.2 years (range, 26-46 years. Four patients had gunshot wounds (44%) and 5 had stab wounds (56%). The mean duration from injury to hospital admission was 26.7 months (range, 17 months-7 years). All patients underwent color-flow arterial Doppler ultrasonography and selective upper extremity digital subtraction angiography. In all patients, we performed aneurysmal resection and saphenous vein graft interpositioning. There was no instance of death or ischemic extremity loss. Patients were discharged from the hospital a mean of 3.2 days after surgery (range, 2-6 days). Early and late graft patency rates were 100%. We followed the patients' cases for a mean of 3.4 years (range, 1 month-7 years). Very rarely, post-traumatic upper extremity pseudoaneurysms show symptoms after a long period of time. Diagnosis is very easy with a review of the patient's history and a physical examination; surgical reconstruction is the preferred treatment for such patients.