R. Lookstein

2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines

Jonathan L. Halperin, MD, FACC, FAHA, Chair Glenn N. Levine, MD, FACC, FAHA, Chair-Elect Sana M. Al-Khatib, MD, MHS, FACC, FAHA Kim K. Birtcher, PharmD, MS, AACC Biykem Bozkurt, MD, PhD, FACC, FAHA Ralph G. Brindis, MD, MPH, MACC Joaquin E. Cigarroa, MD, FACC Lesley H. Curtis, PhD, FAHA

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 …

Challenges of endovascular tube graft repair of thoracic aortic aneurysm: midterm follow-up and lessons learned.

OBJECTIVES Endovascular stent-graft repair has great potential in treatment of thoracic aortic aneurysms. This study analyzed a single centers experience with first-generation commercially produced thoracic stent grafts used to treat descending thoracic aortic aneurysms. METHODS Over 58 months 84 patients underwent endovascular stent-graft repair of descending thoracic aortic aneurysms; 22 patients received the Gore TAG stent graft, and 62 patients received the Talent thoracic endovascular stent-graft system. Each patient was enrolled in one of three distinct US Food and Drug Administration trials at Mount Sinai Medical Center in accordance with strict inclusion and exclusion criteria, including suitability for open surgery, aneurysm anatomy, and presence of comorbid medical illness. Mean age of this cohort was 71 +/- 12 years. There were 54 men and 30 women, and 74 (88%) had three or more comorbid illnesses. Primary technical success was achieved in 76 patients (90%). Mean follow-up was 15 months (range, 0-52 months). RESULTS Successful aneurysm exclusion was achieved in 69 patients (82%). Major procedure-related or device-related complications occurred in 32 patients (38%). There were six proximal attachment failures (8%), four distal attachment failures (6%), one intergraft failure (1%), two mechanical device failures (3%), five periprocedural deaths (6%), and five late aneurysm ruptures (6%). At 40 months, overall survival was 67% (+/-10%), and freedom from rupture or from type I or type III endoleak was 74% (+/-10%). CONCLUSION While promising, this midterm experience with commercially available devices highlights the shortcomings of current stent-graft technology. Three significant advancements are required to fulfill the potential of this important treatment method: a stent graft with a durable proximal and distal fixation device, enhanced engineering to accommodate high thoracic aortic fatigue forces, and a mechanism to adapt to aortic arch and visceral segment branches to enable treatment of lesions that extend to or include these vessels.

Arteriotomy Closure Devices for Cardiovascular Procedures A Scientific Statement From the American Heart Association

Arterial puncture and sheath insertion by use of the modified Seldinger technique has become the standard method by which invasive cardiovascular procedures are performed.1 With improvement in techniques and devices, a significant number of patients with atherosclerotic disease are undergoing invasive vascular procedures. Approximately 7 million invasive cardiovascular procedures are performed worldwide each year, and this number is expected to increase with the aging of the population. The vast majority of these procedures are performed with femoral arterial access. Because the number of cardiovascular procedures performed via the femoral artery approach continues to increase, effective arterial hemostasis techniques are essential to high-quality patient care. In fact, vascular access complications, reported to be as high as 6% in some series, remain the leading cause of morbidity after a cardiac catheterization procedure.2 Manual compression has been considered the traditional technique to achieve closure of the arteriotomy site, requiring close observation and immobilization for success. Arteriotomy closure devices (ACDs) were introduced in 1995 to decrease vascular complications and reduce the time to hemostasis and ambulation. Subsequently, several generations of passive and active ACDs have been introduced that incorporate suture, collagen plug, nitinol clip, and other mechanisms to achieve hemostasis. According to a new Life Science Intelligence report entitled “2008 Global Vascular Closure Device Markets: US, Europe, Rest of World,” the global market for vascular closure devices will reach nearly

Inferior Mesenteric Artery Embolization before Endovascular Aneurysm Repair: Technique and Initial Results

1 billion in 2013.3 Despite this widespread use of both passive and active ACDs, there are incomplete data on their safety and efficacy. Additionally, there are few published recommendations regarding the indications for the use of these devices, their comparative effectiveness versus manual compression, and the end points of clinical interest for patients undergoing vascular closure. Therefore, the present scientific statement provides an overview of vascular access and patient risk for …

Endovascular stent graft repair of abdominal and thoracic aortic aneurysms: a ten-year experience with 817 patients.

PURPOSE To report a single centers technique and initial results in the preoperative embolization of the inferior mesenteric artery (IMA) before endovascular aneurysm repair (EVAR). MATERIALS AND METHODS Over a 3-year period, 102 patients at a single clinical site, including 86 men and 16 women aged 54-93 years (mean, 75 years), were found to have a patent IMA on computed tomographic (CT) angiography before EVAR. Coil embolization was performed after subselective catheterization with use of microcoils placed in the IMA proximal to the origin of the left colic artery. All patients in whom the IMA was visualized on flush aortography and successfully accessed underwent embolization. One month and 6 months after surgery, results in this cohort were retrospectively compared with those from a similar group of patients who underwent EVAR during the same period. These patients had patent IMAs on preoperative CT angiography but did not undergo embolization as a result of nonvisualization during flush aortography. All patients underwent EVAR with bifurcated modular devices with proximal transrenal fixation. All patients underwent postoperative follow-up with multiphase CT angiography to detect the presence of endoleak. Six-month follow-up data were available for 18 patients who underwent embolization and 54 patients who did not. Change in sac diameter was compared in these patients. RESULTS Embolization was technically successful in 30 of 32 patients (94%) in whom it was attempted. There were no complications. At 1-month follow-up, five of 30 patients in the embolization group were noted to have a type II endoleak (17%). None of the endoleaks in this group were related to the IMA. The group with patent IMAs who did not undergo preoperative embolization had a 42% incidence of type II endoleak (P < .05). At 6 months after surgery, three of 18 patients who had undergone embolization (17%) had a type II endoleak, compared with 26 of 54 in the other group (48%; P < .05). Among the patients in whom 6-month data were available, mean changes in sac diameter were -5.2 mm (range, -24 to 2 mm) in the embolized group and -2.1 mm (range, -19 to 8 mm) in the nonembolized group. CONCLUSION These initial results demonstrate that embolization of the IMA with subselective microcoils before EVAR is a safe and effective procedure to reduce the incidence of type II endoleaks. The data also suggest that preoperative embolization of the IMA is associated with greater shrinkage of aneurysm sac diameter at 6 months.

Improved outcomes are associated with multilevel endovascular intervention involving the tibial vessels compared with isolated tibial intervention

Objective: On November 23, 1992, the first endovascular stent graft (ESG) repair of an aortic aneurysm was performed in North America. Following the treatment of this patient, we have continued to evaluate ESG over the past 10 years in the treatment of 817 patients. Summary and Background Data: Abdominal (AAA) or thoracic (TAA) aortic aneurysms are a significant health concern traditionally treated by open surgical repair. ESG therapy may offer protection from aneurysm rupture with a reduction in procedure morbidity and mortality. Methods: Over a 10-year period, 817 patients were treated with ESGs for AAA (723) or TAA (94). Patients received 1 of 12 different stent graft devices. Technical and clinical success of ESGs was reviewed, and the incidence of procedure-related complications was analyzed. Results: The mean age was 74.3 years (range, 25–95 years); 678 patients (83%) were men; 86% had 2 or more comorbid medical illnesses, 67% of which included coronary artery disease. Technical success, on an intent-to-treat basis was achieved in 93.8% of patients. Primary clinical success, which included freedom from aneurysm-related death, type I or III endoleak, graft infection or thrombosis, rupture, or conversion to open repair was 65 ± 6% at 8 years. Of great importance, freedom from aneurysm rupture after ESG insertion was 98 ± 1% at 9 years. There was a 2.3% incidence of perioperative mortality. One hundred seventy five patients died of causes not related to their aneurysm during a mean follow-up of 15.4 months. Conclusions: Stent graft therapy for aortic aneurysms is a valuable alternative to open aortic repair, especially in older sicker patients with large aneurysms. Continued device improvements coupled with an enhanced understanding of the important role of aortic pathology in determining therapeutic success will eventually permit ESGs to be a more durable treatment of aortic aneurysms.

Radiologic diagnosis and treatment of gastrointestinal hemorrhage and ischemia

OBJECTIVE Endovascular intervention is increasingly accepted as an alternative to surgery for the treatment of tibial vessel disease. Tibial vessel disease can occur in isolation or in conjunction with disease that involves the proximal lower extremity vasculature (multilevel disease). This study evaluated the overall efficacy of endovascular intervention for tibial vessel disease and whether the requirement for single-level compared with multilevel intervention affected outcomes. METHODS This study evaluated a consecutive unselected group of patients who underwent an infrapopliteal intervention from November 2002 to February 2008. The primary end points evaluated were technical success, limb salvage, primary patency, and secondary patency. The secondary end points evaluated were 30-day access site (ie, hematoma, pseudoaneurysm, and wound infection), intervention site (ie, thrombosis), and systemic (ie, acute renal failure, myocardial infarction, and mortality) complications. Patency and limb salvage were evaluated using Kaplan-Meier life-table analyses and compared using Cox regression analysis. P < .05 was considered statistically significant. RESULTS The study comprised 85 patients, 89 limbs, and 114 procedures. Age was 72.4 +/- 13.1 years, 67% were men, and follow-up was 245.8 +/- 290.8 days. The technical success rate for all procedures was 91%. Limb salvage rates for patients with critical limb ischemia at 6, 12 and 18 months were 85% +/- 0%, 81% +/- 0%, and 69% +/- 0%, respectively. For the complete patient cohort, primary patency rates at 6, 12 and 18 months were 68% +/- 6%, 50% +/- 8%, and 37% +/- 9%, respectively, and secondary patency rates were 81% +/- 5%, 71% +/- 7%, and 63% +/- 8%. Multilevel intervention was associated with significantly improved secondary patency compared with single-level intervention (P = .045). CONCLUSIONS Patency and limb salvage rates for endovascular treatment of tibial vessel disease in this study are comparable with prior reports and with historical surgical controls. Patients who undergo multilevel intervention involving the tibial vessels exhibit improved secondary patency compared with those who undergo intervention for lesions isolated to the tibial vessels. This may reflect increased distal disease burden for patients who undergo isolated tibial intervention. The study data suggest that the presence of multilevel disease should not preclude an attempt at percutaneous revascularization. Further study is required before formulating definitive recommendations for the endovascular treatment of tibial vessel disease.

Preoperative Inferior Mesenteric Artery Embolization before Endovascular Aneurysm Repair: Decreased Incidence of Type II Endoleak and Aneurysm Sac Enlargement with 24-month Follow-up

Major breakthroughs in catheter, guidewire, and other angiographic equipment currently allow interventional radiologists to diagnose massive life-threatening upper and lower GI hemorrhage and to stop the bleeding safely and effectively using superselective catheterization and microcoil embolization. Similarly, the interventional radiologist can treat acute intestinal ischemia safely and effectively with selective catheterization and papaverine administration and treat chronic mesenteric ischemia by percutaneous angioplasty and stent placement. A multidisciplinary approach, including the gastroenterologist, radiologist, and surgeon, is critical in managing GI bleeding and intestinal ischemia, particularly in patients at high risk or presenting as diagnostic dilemmas.

The impact of stent graft evolution on the results of endovascular abdominal aortic aneurysm repair

PURPOSE To review the effect of preoperative embolization of the inferior mesenteric artery (IMA) before endovascular aneurysm repair (EVAR) on subsequent endoleaks and aneurysm growth. MATERIALS AND METHODS Between August 2002 and May 2010, 108 patients underwent IMA embolization before EVAR. Coil embolization was performed in all patients in whom the IMA was successfully visualized and accessed during preoperative conventional angiography. In this cohort, the incidences of type II endoleak, aneurysm sac volume enlargement at 24 months, and repeat intervention were compared with a group of 158 consecutive patients with a patent IMA on preoperative computed tomography angiography but not on conventional angiography, who therefore did not undergo preoperative embolization. RESULTS The incidence of type II endoleak was significantly higher in patients not treated with embolization (49.4% [78 of 158] vs 34.3% [37 of 108]; P = .015). The incidence of secondary intervention for type II endoleak embolization was also significantly higher in those who did not undergo embolization (7.6% [12 of 158] vs 0.9% [one of 108]; P = .013). At 24 months, an increase in aneurysm sac volume was observed in 47% of patients in the nonembolized cohort (21 of 45), compared with 26% of patients in the embolized cohort (13 of 51; P = .03). No aneurysm ruptures or aneurysm-related deaths were observed in either group. One patient in the embolization group developed mesenteric ischemia and ultimately died. CONCLUSIONS Preoperative embolization of the IMA was associated with reduced incidences of type II endoleak, aneurysm sac volume enlargement at 24 months, and secondary intervention.