Bruce H. Gray

High incidence of restenosis/reocclusion of stents in the percutaneous treatment of long-segment superficial femoral artery disease after suboptimal angioplasty

PURPOSE To evaluate the efficacy of intravascular stents used to treat long-segment stenoses and occlusions of the superficial femoral artery (SFA) after suboptimal angioplasty. METHODS Fifty-eight limbs in 55 patients who underwent stenting of the SFA were identified from a vascular registry. Indications for stent placement after suboptimal PTA included flow-limiting dissection, residual pressure gradient (>15 mm Hg) or stenosis (>30%), or failure to establish initial patency. Lesion length ranged from 6 to 35 cm (mean, 16.5 cm). Endpoints for primary patency were: restenosis of >50%, reocclusion, or diminution of the postprocedure ankle-brachial index greater than 0.15. RESULTS The mean ankle-brachial index improved from 0.48 +/- 0.19 to 0.71 +/- 0.23 (p = 0.001). Primary patency rates by Kaplan-Meier estimates at 1 month, 6 months, and 1 year were 88%, 47%, and 22%, respectively. Secondary patency rates were 94% at 1 month, 59% at 6 months, and 46% at 1 year. The median time to reaching an endpoint of restenosis or reocclusion was 6 months primarily and 9 months secondarily. Clinical improvement at the time of latest follow-up occurred in 56% of patients (mean, 13.8 months). Periprocedural complications occurred in 24.5% of patients with the first intervention. The only factor that favorably influenced outcome was improvement in clinical category after the procedure (p = 0.001). CONCLUSIONS There was a high incidence of restenosis and reocclusion with long-segment SFA disease that required stents to achieve initial success. Despite close surveillance and reintervention, anatomic patency at 1 year was poor. However, clinical benefit was maintained in the majority of patients. The outcome was similar in the claudication population compared with those who had limb-threatening ischemia. Percutaneous revascularization of long-segment SFA disease requiring stents should be reserved for patients with critical limb ischemia for which no reasonable surgical alternative exists.

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 …

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.

One-year outcomes from an international study of the Ovation Abdominal Stent Graft System for endovascular aneurysm repair.

OBJECTIVE This study evaluated 1-year safety and effectiveness outcomes of the United States regulatory trial for the Ovation Abdominal Stent Graft System (TriVascular Inc, Santa Rosa, Calif) for endovascular repair of abdominal aortic aneurysms (AAAs). METHODS This prospective, multicenter, single-arm trial was conducted at 36 sites in the United States, Germany, and Chile to evaluate the safety and effectiveness of the Ovation stent graft. From November 2009 to May 2011, 161 patients (88% males; mean age, 73 ± 8 years) with AAAs (mean diameter, 54 ± 9 mm) were treated with the Ovation stent graft. The main body is a modular two-docking limb device with a 14F outer diameter delivery system, active suprarenal fixation, and polymer-filled proximal rings that accommodate the aortic neck for seal. Main inclusion criteria included proximal aortic neck length ≥ 7 mm, inner neck diameter between 16 and 30 mm, distal iliac landing zones length ≥ 10 mm, and diameter between 8 and 20 mm. Patients were treated under a common protocol, including clinical and imaging follow-up at discharge, 30 days, 6 months, and annually through 5 years. A Clinical Events Committee adjudicated adverse events, an independent imaging core laboratory analyzed imaging, and a Data Safety and Monitoring Board provided study oversight. Complete 1-year follow-up data were available for this report. RESULTS The Ovation stent graft was implanted successfully in 161 patients (100%), including 69 (42.9%) by percutaneous access. General anesthesia was used in 106 patients (65.8%). Technical success was 100%, and mean procedure time was 110 minutes. Median procedural blood loss was 150 mL, and median hospital stay was 1 day. The 30-day major adverse event rate was 2.5%. At 1 year, AAA-related and all-cause mortality were 0.6% and 2.5%, respectively. Major adverse event and serious adverse event rates through 1 year were 6.2% and 38.5%, respectively. The 1-year treatment success rate was 99.3%. The imaging core laboratory reported no stent graft migration or type I, III, or IV endoleaks. At 1 year, type II endoleaks were identified in 34% of patients, and AAA enlargement was identified in one patient (0.7%). No AAA rupture or conversion to open surgery was reported. AAA-related secondary procedures were performed in 10 patients (6.2%) for 12 findings, including endoleak (six), aortic main body stenosis (three), and iliac limb stenosis or occlusion (three). CONCLUSIONS The 1-year results of the Ovation Abdominal Stent Graft System demonstrate excellent safety and effectiveness in treatment of patients with AAAs, particularly in patients with challenging anatomic characteristics, including short aortic necks and narrow iliac arteries. Longer-term follow-up is needed.

The nutcracker syndrome

Left renal vein (LRV) compression, commonly referred to as the nutcracker syndrome or renal vein entrapment syndrome, is a rare and often overlooked condition. Anatomically, the LRV traverses the space between the superior mesenteric artery and the aorta in close proximity to the origin of the artery. In affected individuals, the LRV is subjected to compression between these two structures, resulting in renal venous hypertension. A review of published data on this condition reveals either case reports or small case series. The classic symptoms of nutcracker syndrome include left flank pain with gross or microscopic hematuria. Patients are often children or young adults, with a slight predisposition for women who may also present with pelvic congestion symptoms such as pelvic pain and dyspareunia. Most patients have disease symptoms for many years and nondiagnostic investigations before proper diagnosis can be made. Appropriate diagnostic work-up and treatment may help alleviate patient morbidity from this chronic condition. Although surgical repair has been the standard of care, more recently endovascular intervention has become the first line of therapy. This tabular review compiles published cases in the adult population during the period between 1980 and 2009.

Comparison of Interventional Outcomes According to Preoperative Indication: A Single Center Analysis of 2,240 Limb Revascularizations

BACKGROUND Outcomes after lower extremity revascularization are usually reported according to the level of peripheral arterial disease (PAD, aortoiliac or infrainguinal) or the method of treatment (open or endovascular surgery). Outcomes stratified by indication, ie, claudication or critical limb ischemia (rest pain and tissue loss), have not been well studied. The purpose of this study was to compare postoperative outcomes according to the preoperative indications. STUDY DESIGN Outcomes of 2,240 consecutive limb revascularizations in 1,732 patients from January 1998 through December 2005 were stratified and examined according to preoperative indication: claudication (n=999 limbs), ischemic rest pain (n=464 limbs), or tissue loss (n=777 limbs). End points measured included primary and secondary interventional or operative patency, limb salvage, survival, amputation-free survival, maintenance of ambulation, maintenance of independence, and resolution of presenting symptoms. RESULTS The proportion of medical comorbidities and the severity of disease increased significantly by cohort from claudication to rest pain to tissue loss. With a mean followup of 1,089 days (range 0 to 3,689 days), overall outcomes performance declined consistently according to indication for all end points measured at 5 years (claudication, rest pain, tissue loss, p value): secondary reconstruction patency (93%, 80%, 66%, respectively; p < 0.001), limb salvage (99%, 81%, 68%, respectively; p < 0.001), survival (78%, 46%, 30%, respectively; p < 0.001), amputation-free survival (78%, 42%, 25%, respectively; p < 0.001), maintenance of ambulation (96%, 78%, 68%, respectively; p < 0.001), maintenance of independence (98%, 85%, 75%, respectively; p < 0.001), and resolution of presenting symptoms (79%, 61%, 42%, respectively; p < 0.001). CONCLUSIONS There is a declining spectrum of outcomes performance from claudication to rest pain to tissue loss. These findings question the accuracy of all previously published data for critical limb ischemia, for which rest pain and tissue loss are usually blended and reported as a single outcomes value.

Can the Perclose suture-mediated closure system be used safely in patients undergoing diagnostic and therapeutic angiography to treat chronic lower extremity ischemia?

PURPOSE Mechanical closure devices for arterial hemostasis after angiography, such as the Perclose suture-mediated closure system, are designed to decrease time to ambulation and improve patient comfort. Although these devices are safe and efficacious, to date there has been little reported about use of the Perclose device in a cohort consisting exclusively of patients with lower extremity peripheral vascular disease. The purpose of this study was to determine the safety and efficacy of routine use of the Perclose system in patients with documented peripheral vascular disease undergoing angiography to treat chronic lower extremity ischemia. METHODS The Perclose device was placed for arterial closure after femoral artery access in 500 consecutive patients with documented peripheral vascular disease (ankle-brachial index, <0.8) who underwent diagnostic angiography or percutaneous intervention because of chronic lower extremity ischemia. These 500 patients composed 91% of all patients who underwent angiography because of chronic lower extremity ischemia between January 1, 2001, and April 1, 2002. All complications associated with the Perclose device were identified and reviewed. RESULTS Of the 500 arteries, 54% were accessed for diagnostic angiography and 46% for intervention. Perclose device placement was successful in 475 attempts (95%). Overall major complication rate was 1.4% (7 of 500 arteries). Complications included one death from retroperitoneal hemorrhage; three episodes of limb ischemia, two requiring operation and one requiring lytic therapy; two pseudoaneurysms; and one hematoma, which prolonged hospitalization. The hematoma was the only complication in the 25 patients with failed Perclose device placement. There were no infections requiring admission or operation. CONCLUSION The Perclose suture-mediated closure device is efficacious and can be used safely in selected patients with documented peripheral vascular disease. Complications associated with this device tend to be more severe than those historically reported for manual compression. Substantial experience with use of this device is required to achieve excellent results in patients with difficult anatomy.

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.