J. Michael Bacharach

2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients With Extracranial Carotid and Vertebral Artery Disease

Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .491 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .493 2. Recommendations for Duplex Ultrasonography to Evaluate Asymptomatic Patients With Known or Suspected Carotid Stenosis . . . . . . . . . . . . . . . . .494 3. Recommendations for Diagnostic Testing in Patients With Symptoms or Signs of Extracranial Carotid Artery Disease . . . . . . . . . . . . .495 4. Recommendations for the Treatment of Hypertension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .495 5. Recommendation for Cessation of Tobacco Smoking. . . . . . . . . . . . . . . . . . . . . . . . . . .495 6. Recommendations for Control of Hyperlipidemia. . . . . . . . . . . . . . . . . . . . . . . . . . . . .496 7. Recommendations for Management of Diabetes Mellitus in Patients With Atherosclerosis of the Extracranial Carotid or Vertebral Arteries. . . . . . . . . . . . …

Angioplasty and primary stenting of the subclavian, innominate, and common carotid arteries in 83 patients

PURPOSE The initial and long-term results of angioplasty and primary stenting for the treatment of occlusive lesions involving the supra-aortic trunks were studied. METHODS All patients in whom angioplasty and stenting of the supra-aortic trunks was attempted were included in a prospective registry. Results are, therefore, reported on an intent-to-treat basis. The preprocedural and postprocedural clinical records, arteriograms, and noninvasive vascular laboratory examinations of 83 patients (41 men [49.4%] and 42 women [50.6%]; mean age at intervention, 63 years) in whom endovascular repair of the subclavian (66, 75.9%), left common carotid (14, 16.1%), and innominate (7, 8.0%) arteries was attempted were retrospectively reviewed. RESULTS Initial technical success was achieved in 82 of 87 procedures (94.3%). The inability to cross 4 complete subclavian occlusions and the iatrogenic dissection of 1 common carotid artery lesion accounted for the 5 initial failures. Complications occurred in 17.8% of 73 subclavian and innominate procedures, including access-site bleeding in 6 and distal embolization in 2. Ischemic strokes occurred in 2 of 14 common carotid interventions (14.3%), both of which were performed in conjunction with ipsilateral carotid bifurcation endarterectomy. The 30-day mortality rate was 4.8% for the entire group. By means of life-table analysis, 84% of the subclavian and innominate interventions, including initial failures, remain patent by objective means at 35 months. No patients have required reintervention or surgical conversion for recurrence of symptoms. Of the 11 patients available for follow-up study who underwent common carotid interventions, 10 remain stroke-free at a mean of 14.3 months. CONCLUSION Angioplasty and primary stenting of the subclavian and innominate arteries can be performed with relative safety and expectations of satisfactory midterm success. Endovascular repair of common carotid artery lesions can be performed with a high degree of technical success, but should be approached with caution when performed in conjunction with ipsilateral bifurcation endarterectomy.

Clinical benefit of renal artery angioplasty with stenting for the control of recurrent and refractory congestive heart failure

Renal artery stenosis (RAS) may cause hypertension, azotemia, episodes of flash pulmonary edema and congestive heart failure. Renal artery angioplasty and stenting was performed in 207 patients from 1991 to 1997. Thirty-nine of these patients (19%) underwent renal artery stenting for the control of recurrent episodes of congestive heart failure and flash pulmonary edema. All patients had angiographic evidence of severe (>70%) bilateral RAS (n = 18) or severe RAS to a solitary functioning kidney (n = 21). Sixteen patients (41%) were male and 23 (59%) were female, mean age 69.9 years (range 50- 85 years). Of the 18 patients with bilateral RAS, 12 (66.6%) underwent bilateral stenting. Mean blood pressure decreased from 174/85 6 32/23 mmHg to 148/72 6 24/14 mmHg (p < 0.001). Mean number of blood pressure medications decreased from 3 6 1 to 2.5 6 1 (p = 0.006). Twenty-eight patients (71.8%) had improvement in blood pressure control. The mean serum creatinine decreased from 3.16 6 1.61 to 2.65 6 1.87 (p = 0.06). Six of 39 patients (15.4%) used angiotensin converting enzyme (ACE) inhibitors prior to stenting whereas 19 of 39 patients (48.7%) used ACE inhibitors poststenting (p = 0.004). Twenty of 39 patients (51.4%) demonstrated improvement in serum creatinine, 10 of 39 patients (25.6%) had stabilization of serum creatinine and nine of 39 patients (23%) demonstrated worsening. The number of hospitalizations due to congestive heart failure in the year preceding renal artery stenting was 2.4 6 1.4 and poststenting was 0.3 6 0.7 (p < 0.001). The New York Heart Association Functional Class decreased from 2.9 6 0.9 prestenting to 1.6 6 0.9 poststenting (p < 0.001). Thirty of 39 patients (77%) had no hospitalizations for congestive heart failure during a mean follow-up period of 21.3 months. Nine patients expired during the course of follow up; eight of the nine patients died within the first year after renal artery stenting. Renal artery stenting decreased the frequency of congestive heart failure, flash pulmonary edema, and the need for hospitalization in most patients. Blood pressure was markedly improved in the majority of patients with improved or stabilized renal function. Evaluation for RAS is important in hypertensive patients who present with recurrent congestive heart failure or flash pulmonary edema.

Fibromuscular Dysplasia: State of the Science and Critical Unanswered Questions A Scientific Statement From the American Heart Association

Fibromuscular dysplasia (FMD) is nonatherosclerotic, noninflammatory vascular disease that may result in arterial stenosis, occlusion, aneurysm, or dissection.1–3 The cause of FMD and its prevalence in the general population are not known.4 FMD has been reported in virtually every arterial bed but most commonly affects the renal and extracranial carotid and vertebral arteries (in ≈65% of cases).5 The clinical manifestations of FMD are determined primarily by the vessels that are involved. When the renal artery is involved, the most frequent finding is hypertension, whereas carotid or vertebral artery FMD may lead to dizziness, pulsatile tinnitus, transient ischemic attack (TIA), or stroke. There is an average delay from the time of the first symptom or sign to diagnosis of FMD of 4 to 9 years.5,6 This is likely because of a multitude of factors: the perception that this is a rare disease and thus FMD is not considered in the differential diagnosis, the reality that FMD is poorly understood by many healthcare providers, and the fact that many of the signs and symptoms of FMD are nonspecific, thus leading the clinician down the wrong diagnostic pathway. A delay in diagnosis can lead to impaired quality of life and poor outcomes such as poorly controlled hypertension and its sequelae, TIA, stroke, dissection, or aneurysm rupture. It should also be noted that FMD may be discovered incidentally while imaging is performed for other reasons or when a bruit is heard in the neck or abdomen in an asymptomatic patient without the classic risk factors for atherosclerosis. The first description of FMD is attributed to Leadbetter and Burkland7 in a 5½-year-old boy with severe hypertension and a renal artery partially occluded by an intra-arterial mass of smooth muscle. He underwent a unilateral nephrectomy of an …

Safety and effectiveness of the INVATEC MO.MA® proximal cerebral protection device during carotid artery stenting: Results from the ARMOUR pivotal trial

Objective: The multicenter ARMOUR (ProximAl PRotection with the MO.MA Device DUring CaRotid Stenting) trial evaluated the 30‐day safety and effectiveness of the MO.MA® Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS). Background: Distal embolic protection devices (EPD) have been traditionally utilized during CAS. The MO.MA device acts as a balloon occlusion “endovascular clamping” system to achieve cerebral protection prior to crossing the carotid stenosis. Methods: This prospective registry enrolled 262 subjects, 37 roll‐in and 225 pivotal subjects evaluated with intention to treat (ITT) from September 2007 to February 2009. Subjects underwent CAS using the MO.MA device. The primary endpoint, myocardial infarction, stroke, or death through 30 days (30‐day major adverse cardiac and cerebrovascular events [MACCE]) was compared to a performance goal of 13% derived from trials utilizing distal EPD. Results: For the ITT population, the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians. Device success was 98.2% and procedural success was 93.2%. The 30‐day MACCE rate was 2.7% [95% CI (1.0–5.8%)] with a 30‐day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during this trial. Conclusions: The ARMOUR trial demonstrated that the MO.MA® Proximal Cerebral Protection Device is safe and effective for high surgical risk patients undergoing CAS. The absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multicenter registry trial to date.

Percutaneous transluminal angioplasty and primary stenting of the iliac arteries in 288 patients

PURPOSE This study reports the initial and late results of percutaneous transluminal angioplasty (PTA) and intravascular stenting for atherosclerotic occlusive disease of the iliac arteries. METHODS The preprocedural and postprocedural clinical records, arteriograms, segmental limb pressure measurements (ankle-brachial [ABI] and thigh-brachial [TBI] indexes), and pulse volume recordings of 288 patients who underwent PTA and primary stenting of the common iliac (354, 69.4%) and external iliac (156, 30.6%) arteries were reviewed. Initial and late clinical, hemodynamic, and angiographic success were assessed by objective criteria. Data on patients who underwent unsuccessful attempts at iliac stent placement are unavailable; results are not reported on an intent-to-treat basis. RESULTS Clinical follow-up data (mean, 11.9 months) are available for 268 of 288 patients (93.1%) and for 394 of 424 limbs (92.9%). The initial success rates, as determined by TBI, ABI, and clinical limb status, were 90.2%, 87.8%, and 74.6%, respectively. The Kaplan-Meier estimates of angiographic patency (101 arteries) were 96%, 81%, and 73% at 6, 12, and 24 months. Cumulative patency rates were 84%, 76%, and 57% on the basis of TBI, ABI, and clinical limb status at 24 months. Factors associated with initial success included the need for multiple stents (p = 0.0001), a higher degree of initial stenosis (p = 0.0001), lower severity of baseline ischemia (p = 0.007), younger age (p = 0.0015), and the preprocedural patency of the ipsilateral superficial femoral artery (p = 0.002). A higher degree of initial stenosis (p < 0.001) and superficial femoral artery patency (p = 0.004) were also associated with late success. CONCLUSIONS PTA and stenting of the iliac arteries is associated with reasonable angiographic, hemodynamic, and clinical success. The outcome is favorably affected by higher initial severity of stenosis and greater extent of disease, lower severity of baseline ischemia, younger age, and by patency of the ipsilateral superficial femoral artery.

2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: Executive summary: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses

Preamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .e422 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .e424 2. Recommendations for Duplex Ultrasonography to Evaluate Asymptomatic Patients With Known or Suspected Carotid Stenosis . . . . . . . . . . . . . . . . .e425 3. Recommendations for Diagnostic Testing in Patients With Symptoms or Signs of Extracranial Carotid Artery Disease . . . . . . . . . . . . .e426 4. Recommendations for the Treatment of Hypertension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .e426 5. Recommendation for Cessation of Tobacco Smoking. . . . . . . . . . . . . . . . . . . . . . . . . . .e426 6. Recommendations for Control of Hyperlipidemia. . . . . . . . . . . . . . . . . . . . . . . . . . . . .e427 7. Recommendations for Management of Diabetes Mellitus in Patients With Atherosclerosis of the Extracranial Carotid or Vertebral Arteries. . . . . . . . . . . . …

Claudication secondary to Perclose use after percutaneous procedures

The use of suture‐mediated arterial closure devices has dramatically increased with the increased number of percutaneous procedures being performed. Complications from suture‐mediated closure devices have been underreported. Specifically, arterial stenosis resulting in claudication has not been previously described in detail. We present nine patients who presented with various leg symptoms after Perclose was used to achieve arterial hemostasis following percutaneous procedures. All cases were found to have significant arterial stenoses from the Perclose sutures. Once diagnosis was correctly made, the patients either underwent surgical repair or percutaneous balloon angioplasty and in all cases the symptoms abated.

Carotid stenting with a new system for distal embolic protection and stenting in high-risk patients: the carotid revascularization with ev3 arterial technology evolution (CREATE) feasibility trial.

The purpose of this study was to evaluate the feasibility of carotid artery revascularization using a new system for carotid stenting and distal embolic protection in 30 patients with severe carotid stenosis and high risk for carotid endarterectomy (Carotid Revascularization With ev3 Arterial Technology Evolution, or CREATE). Previous studies suggest that patients with carotid stenosis and serious comorbid cardiopulmonary and anatomic conditions are at high risk for carotid endarterectomy. All patients underwent percutaneous revascularization using the Protégé GPS self‐expanding nitinol stent (ev3, Plymouth, MN) and the Spider distal embolic protection system (ev3). In‐hospital and 30‐day outcomes were analyzed. High‐risk features included age > 75 years (63%), left ventricular ejection fraction < 35% (20%), and restenosis after prior carotid endarterectomy (53%). Procedural success was 100%. In‐hospital complications included severe vasovagal reactions in six patients (20%) and a popliteal embolus in one patient (3.3%), treated by successful embolectomy. During 30 days of follow‐up, two patients (6.6%) experienced minor neurological deficits, including transient expressive aphasia that resolved without therapy in one patient and homonymous hemianopsia due to contralateral posterior circulation stroke in one patient. This study supports the feasibility of percutaneous carotid artery revascularization with the Protégé GPS self‐expanding stent and Spider distal embolic protection system, which will be evaluated in a large multicenter pivotal trial (CREATE Pivotal Trial). Catheter Cardiovasc Interv 2004;63:1–6.

2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/ SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients With Extracranial Carotid and Vertebral Artery Disease: Executive Summary

A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery