Neil E. Strickman

Long-Term Results of Carotid Stenting versus Endarterectomy in High-Risk Patients

BACKGROUND We previously reported that, in a randomized trial, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy for the treatment of carotid artery disease at 30 days and at 1 year. We now report the 3-year results. METHODS The trial evaluated carotid artery stenting with the use of an emboli-protection device as compared with endarterectomy in 334 patients at increased risk for complications from endarterectomy who had either a symptomatic carotid artery stenosis of at least 50% of the luminal diameter or an asymptomatic stenosis of at least 80%. The prespecified major secondary end point at 3 years was a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke between 31 days and 1080 days (3 years). RESULTS At 3 years, data were available for 260 patients (77.8%), including 85.6% of patients in the stenting group and 70.1% of those in the endarterectomy group. The prespecified major secondary end point occurred in 41 patients in the stenting group (cumulative incidence, 24.6%; Kaplan-Meier estimate, 26.2%) and 45 patients in the endarterectomy group (cumulative incidence, 26.9%; Kaplan-Meier estimate, 30.3%) (absolute difference in cumulative incidence for the stenting group, -2.3%; 95% confidence interval, -11.8 to 7.0). There were 15 strokes in each of the two groups, of which 11 in the stenting group and 9 in the endarterectomy group were ipsilateral. CONCLUSIONS In our trial of patients with severe carotid artery stenosis and increased surgical risk, no significant difference could be shown in long-term outcomes between patients who underwent carotid artery stenting with an emboli-protection device and those who underwent endarterectomy. (ClinicalTrials.gov number, NCT00231270 [ClinicalTrials.gov].).

Pivotal Trial to Evaluate the Safety and Efficacy of the Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II)

OBJECTIVES The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial evaluated the safety and efficacy of the coronary Orbital Atherectomy System (OAS) to prepare de novo, severely calcified coronary lesions for stent placement. BACKGROUND Despite advances in interventional techniques, treatment of calcified coronary lesions remains a challenge. Stent placement in these lesions may result in stent underexpansion, malapposition, and procedural complications. METHODS ORBIT II is a prospective, multicenter, nonblinded clinical trial that enrolled 443 consecutive patients with severely calcified coronary lesions at 49 U.S. sites from May 25, 2010, to November 26, 2012. Investigators used the centrifugal action of the OAS diamond-coated crown to modify calcified lesions prior to stent placement. RESULTS The pre-procedure mean minimal lumen diameter of 0.5 mm increased to 2.9 mm after the procedure. The primary safety endpoint was 89.6% freedom from 30-day major adverse cardiac events compared with the performance goal of 83%. The primary efficacy endpoint (residual stenosis <50% post-stent without in-hospital major adverse cardiac events) was 88.9% compared with the performance goal of 82%. Stent delivery occurred successfully in 97.7% of cases with <50% stenosis in 98.6% of subjects. Low rates of in-hospital Q-wave myocardial infarction (0.7%), cardiac death (0.2%), and target vessel revascularization (0.7%) were reported. CONCLUSIONS The ORBIT II coronary OAS trial met both the primary safety and efficacy endpoints by significant margins. Preparation of severely calcified plaque with the OAS not only helped facilitate stent delivery, but improved both acute and 30-day clinical outcomes compared with the outcomes of historic control subjects in this difficult-to-treat patient population. (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions [ORBIT II]; NCT01092416).

Percutaneous Repair of Abdominal Aortic Aneurysms Using the AneuRx Stent Graft and the Percutaneous Vascular Surgery Device

Endovascular exclusion of abdominal aortic aneurysms (AAAs) was developed in an effort to treat patients who were at high risk for complications following standard surgical repair. Stent grafts used for endovascular repair of AAAs require the use of large‐bore sheaths and surgical exposure of the common femoral arteries (CFAs). To decrease the invasiveness of AAA repair, we attempted to perform the procedure percutaneously utilizing the Prostar XL Percutaneous Vascular Surgery Device and the preclose technique. Thirty patients underwent an attempted percutaneous AAA repair. These patients were followed prospectively to assess the success of the procedure. Twenty‐eight patients (93%) had successful percutaneous repair of both CFA access sites. One patient had inadequate hemostasis of the 22 Fr CFA entry site and one patient had inadequate hemostasis of the 16 Fr CFA entry site. Both of these CFA sites underwent open surgical repair. The rate of successful repair of the 22 Fr CFA access site was 29 of 30 (96%); for the 16 Fr CFA access site, 29 of 30 (96%). No in‐hospital groin complications were seen. The procedure time was 105 ± 21 min. The estimated blood loss was 90.6 ± 50 cc. The hemoglobin loss was 1.54 ± 0.89 mg/dL and the hematocrit loss was 5.04% ± 2.8%. Complete percutaneous endoluminal AAA repair is feasible using the preclose technique. CFAs with sheaths up to 22 Fr can be safely and successfully accessed and repaired percutaneously using this technique. This method provides secure hemostasis and reduces the invasiveness of procedures requiring large‐bore sheaths. Cathet Cardiovasc Intervent 2002;55:281–287.

Predictors of carotid stent restenosis

Objectives: We sought to determine the predictors of restenosis after carotid artery stenting and report alternatives for its management. Background: Carotid artery stenting has been increasingly accepted as an alternative to carotid endarterectomy (CEA). Predictors of carotid stent restenosis have not been firmly established, and management of restenotic lesions can be challenging. Methods: A retrospective, single‐center review was conducted of 399 carotid stent procedures in 363 patients over 9 years, with a mean follow‐up of 24 months (range 6–99 months). Clinical variables included age, gender, symptoms, hypertension, diabetes, tobacco use, renal insufficiency, coronary artery disease, hyperlipidemia, peripheral vascular disease, history of CEA, and history of neck radiation (XRT). Angiographic variables included reference vessel diameter, lesion length, poststenting residual stenosis, stent diameter, type of stent, and number of stents. Results: Overall, restenosis occurred in 15 patients (3.8%). However, the restenosis occurred in 7 of 35 (20%) patients who had previous XRT, 6 of 57 (10.5%) patients who had previous CEA, and 2 of 9 (22%) patients who previously had both CEA and XRT. The only analyzed variables that were significantly associated with an increased risk of restenosis were previous CEA (OR 4.28, P = 0.008) or XRT (OR 11.3, P ≤≤ 0.0001). Restenosis was most often asymptomatic and detected at routine ultrasound follow‐up. Restenotic lesions were successfully treated in 11/11 cases with angioplasty (27%) or stenting (73%). Four patients that are asymptomatic are being monitored closely with ultrasound. No patients required surgical therapy for restenosis. Conclusions: Restenosis after carotid stenting is uncommon; however, patients with previous CEA or XRT are at increased risk. Restenotic lesions may be safely treated with further percutaneous interventions.

Endovascular Exclusion of Popliteal Artery Aneurysms with Stent-Grafts: A Prospective Single-Center Experience

Purpose: To determine the safety and efficacy of percutaneous treatment for popliteal artery aneurysms (PAA) using self-expanding stent-grafts. Methods: From October 2000 through September 2007, 29 patients (27 men; mean age 68±6 years, range 54–88) underwent endovascular exclusion of 33 PAAs. All had symptoms of claudication, and all were atherosclerotic in origin. Four patients presented with popliteal venous thrombosis. Twenty-eight of the treated PAAs had associated mural thrombus. The mean aneurysm diameter was 34.3± 13.3 mm and the mean lesion length was 98.6±102.1 mm. Results: All PAAs were successfully excluded from the arterial circulation using 59 stent-grafts (15 Wallgraft and 44 Viabahn). The average number of stent-grafts implanted was 1.9±0.4 (range 1–3); the mean length of covered vessel (per lesion) was 198.6±105.3 mm. There were no device-associated complications or deaths. Over an average follow-up of 35.4±32.1 months (range 6–120), the primary and secondary patency rates, respectively, were 93.9% and 100% at 6 months, 93.9% and 96.9% at 1 year, and 87.5% and 96.8% at 2 years. At 4.5 years, primary and secondary patency rates were 84.8% and 96.8%, respectively. No endoleaks, aneurysm rupture, thromboembolism, or limb loss occurred at follow-up. Conclusion: Stent-graft exclusion of PAAs is safe and effective, yielding primary and secondary patency rates comparable to surgical repair. In spite of encouraging results in this study, further larger studies are warranted to reconfirm our observations.

Preliminary results of endovascular abdominal aortic aneurysm exclusion with the AneuRx stent-graft.

OBJECTIVES This study evaluated the clinical effectiveness of the Medtronic AneuRx stent-graft in patients with infrarenal abdominal aortic aneurysms (AAAs) who were treated in an endovascular suite. BACKGROUND The use of endovascular stent-graft prosthesis for the treatment of AAAs is receiving increasing attention as an alternative to standard surgical repair. Endovascular treatment of AAAs offers the potential to avoid the significant morbidity and mortality associated with surgical repair. METHODS In this series, 215 patients have undergone AAA exclusion with the AneuRx stent-graft. Six-month follow-up is available in 132 patients; one-year follow-up is available in 84 and two-year follow-up in 22. RESULTS Of the patients, one hundred ninety-two (89%) were male; 87% had hypertension, and 58.6% were American Society of Anesthesiologists grade IV or higher. The procedural success was 99.5%; we were unable to place the device in one patient. There was no procedural or one-month mortality. There were no acute conversions to surgical repair. One patient had a non-Q-wave myocardial infarction 24 h after the procedure. Endoleaks were present in 82 patients (42%) at discharge, 15 patients (11.3%) at six months and 10 patients (11.9%) at one year. Twenty-two patients had a secondary procedure for endoleak repair of which three were conversions to surgical repair. Twelve late deaths have occurred, none due to device failure or AAA rupture. Mean hospital stay was 1.9 days. CONCLUSIONS These results reveal that infrarenal AAAs can be safely and successfully treated in an endovascular suite with the AneuRx stent-graft. Further follow-up is needed to determine the long-term efficacy of endoluminal treatment to prevent rupture and death due to AAAs.

Successful treatment of aortic endograft thrombosis with rheolytic thrombectomy.

Purpose: To report the benefits of rheolytic thrombectomy for treating aortic endograft thrombosis. Methods: Of 40 patients who received the Ancure bifurcated endograft to treat abdominal aortic aneurysm (AAA) during a 9-month period, 6 (15%) patients (6 men; mean age 62.6 years, range 53–77) developed thrombosis of the endograft at an average of 9 weeks (range 1–20 months). Five patients were taking aspirin, and 3 were on warfarin therapy for atrial fibrillation. Immediately after angiography, rheolytic thrombectomy was used to remove the thrombus, followed by adjunctive procedures to treat the underlying pathology. Results: Causes were kinking or extrinsic compression of the graft limb in 5 cases and thrombosis of the surgical closure site in a common femoral artery. Mechanical thrombectomy was successful in restoring circulation in all cases; thrombolysis was used in 1. All 6 patients had additional stents placed in the graft limbs, re-establishing patency. There was no mortality or recurrent thrombosis in a follow-up that has extended to 26 months, but 1 patient required additional stenting for subsequent focal kinking of a graft limb above the previously implanted stent. Conclusions: Rheolytic thrombectomy can safely and effectively treat endograft thrombosis after endovascular AAA repair. Additional thrombolytic agents, angioplasty, and stenting may be needed to correct the underlying causes of the thrombosis. Prophylactic stenting of iliac limbs at the time of implantation in patients with complex anatomy may prevent thrombosis of unsupported bifurcated endografts.

Carotid artery stenting with emboli protection surveillance study: outcomes at 1 year.

OBJECTIVES The CASES-PMS (Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study) multicenter, prospective, single-arm, surveillance study was designed to assess the safety and efficacy of carotid artery stenting (CAS) when performed by physicians with varied experience in CAS utilizing a formal training program. Whether the excellent results achieved at 30 days would be sustained to 1 year was the subject of the current investigation. BACKGROUND Previously, the pivotal SAPPHIRE (Stenting and Angioplasty with Protection of Patients with High Risk for Endarterectomy) trial demonstrated that CAS was not inferior to carotid endarterectomy (CEA) when performed by physicians experienced in carotid stenting. METHODS High surgical-risk patients with de novo atherosclerotic or post-endarterectomy restenotic lesions in native carotid arteries were enrolled at participating centers. Inclusion and exclusion criteria matched those of the SAPPHIRE trial. The primary end point was a composite of 30-day major adverse events (MAE) including death, any stroke, or myocardial infarction. RESULTS A total of 1,492 patients were enrolled at 73 sites. The primary end point of 30-day MAE was 5.0%, meeting criteria for noninferiority to the prespecified objective performance criteria (OPC) established by the SAPPHIRE trial. The 1-year cumulative percentage of MAE was 12.5% by Kaplan-Meier analysis. All strokes to 30 days plus ipsilateral stroke between 31 and 360 days with CASES-PMS (5.4%) was similar to the rate seen with the SAPPHIRE trial stent cohort (4.9%). There were no significant differences in outcomes at 1 year by symptom status and high-risk status. CONCLUSIONS With the formalized training program utilized in this study, physicians with varied experience in carotid stenting can achieve similar short- and longer-term results to the highly experienced SAPPHIRE Investigators. (Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study [CASES-PMS]; NCT00231231).

Cardiac Kaposi's sarcoma following heart transplantation.

Kaposis sarcoma (KS) is a tumor seen with increased frequency in organ transplant recipients. We present a case of disseminated KS in a heart transplant recipient of Mediterranean origin in whom myocardial involvement was suspected on the basis of coronary angiographic and magnetic resonance imaging (MRI) findings. KS in the transplant population and cardiac KS are reviewed. Cathet. Cardiovasc. Intervent. 49:208–212, 2000.

Hemodynamic compromise (tricuspid stenosis and insufficiency) caused by an unruptured aneurysm of the sinus of Valsalva

A patient is described with an unruptured aneurysm of the noncoronary sinus of Valsalva that occupied the right ventricular inflow tract and caused dynamic tricuspid stenosis and insufficiency. Results of two-dimensional echocardiography delineated the anatomy of the aneurysm and pulsed Doppler examination provided evidence that the aneurysm was unruptured. The unruptured aneurysm was resected successfully.