J. Stephen Jenkins

Management of Massive and Submassive Pulmonary Embolism, Iliofemoral Deep Vein Thrombosis, and Chronic Thromboembolic Pulmonary Hypertension A Scientific Statement From the American Heart Association

Venous thromboembolism (VTE) is responsible for the hospitalization of >250 000 Americans annually and represents a significant risk for morbidity and mortality. Despite the publication of evidence-based clinical practice guidelines to aid in the management of VTE in its acute and chronic forms, the clinician is frequently confronted with manifestations of VTE for which data are sparse and optimal management is unclear. In particular, the optimal use of advanced therapies for acute VTE, including thrombolysis and catheter-based therapies, remains uncertain. This report addresses the management of massive and submassive pulmonary embolism (PE), iliofemoral deep vein thrombosis (IFDVT),and chronic thromboembolic pulmonary hypertension (CTEPH). The goal is to provide practical advice to enable the busy clinician to optimize the management of patients with these severe manifestations of VTE. Although this document makes recommendations for management, optimal medical decisions must incorporate other factors, including patient wishes, quality of life, and life expectancy based on age and comorbidities. The appropriateness of these recommendations for a specific patient may vary depending on these factors and will be best judged by the bedside clinician.

Induction of mild systemic hypothermia with endovascular cooling during primary percutaneous coronary intervention for acute myocardial infarction

OBJECTIVES The purpose of this study was to evaluate the safety and feasibility of endovascular cooling during primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). BACKGROUND In experimental models of AMI, mild systemic hypothermia has been shown to reduce metabolic demand and limit infarct size. METHODS In a multi-center study, 42 patients with AMI (<6 h from symptom onset) were randomized to primary PCI with or without endovascular cooling (target core temperature 33 degrees C). Cooling was maintained for 3 h after reperfusion. Skin warming, oral buspirone, and intravenous meperidine were used to reduce the shivering threshold. The primary end point was major adverse cardiac events at 30 days. Infarct size at 30 days was measured using (99m)Tc-sestamibi SPECT imaging. RESULTS Endovascular cooling was performed successfully in 20 patients (95%). All achieved a core temperature below 34 degrees C (mean target temperature 33.2 +/- 0.9 degrees C). The mean temperature at reperfusion was 34.7 +/- 0.9 degrees C. Cooling was well tolerated, with no hemodynamic instability or increase in arrhythmia. Nine patients experienced mild episodic shivering. Major adverse cardiac events occurred in 0% vs. 10% (p = NS) of treated versus control patients. The median infarct size was non-significantly smaller in patients who received cooling compared with the control group (2% vs. 8% of the left ventricle, p = 0.80). CONCLUSIONS Endovascular cooling can be performed safely as an adjunct to primary PCI for AMI. Further clinical trials are required to determine whether induction of mild systemic hypothermia with endovascular cooling will limit infarct size in patients undergoing reperfusion therapy.

Renal Artery Stent Placement: Utility in Lesions Difficult to Treat With Balloon Angioplasty

OBJECTIVES We assessed the safety and efficacy of stent placement in patients with poorly controlled hypertension and renal artery stenoses, which are difficult to treat with balloon angioplasty alone. BACKGROUND Preliminary experience with stent placement suggests improved results over balloon angioplasty alone in patients with atherosclerotic renal artery stenosis. METHODS Balloon-expandable stents were placed in 100 consecutive patients (133 renal arteries) with hypertension and renal artery stenosis. Sixty-seven of the patients had unilateral renal artery stenosis treated and 33 had bilateral renal artery stenoses treated with stents placed in both renal arteries. RESULTS Angiographic success, as determined by quantitative angiography, was obtained in 132 (99%) of 133 lesions. Early clinical success was achieved in 76% of the patients. Six months after stent placement, the systolic blood pressure was reduced from 173 +/- 25 to 147 +/- 23 mm Hg (p < 0.001); the diastolic pressure from 88 +/- 17 to 76 +/- 12 mm Hg (p < 0.001); and the mean number of antihypertensive medications per patient from 2.6 +/- 1 to 2.0 +/- 0.9 (p < 0.001). Angiographic follow-up at a mean of 8.7 +/- 5.0 months in 67 patients revealed restenosis (>50% diameter narrowing) in 15 (19%) of 80 stented vessels. CONCLUSIONS Renal artery stenting is an effective treatment for renovascular hypertension, with a low angiographic restenosis rate. Stent placement appears to be a very attractive therapy in patients with lesions difficult to treat with balloon angioplasty such as renal aorto-ostial lesions and restenotic lesions, as well as after a suboptimal balloon angioplasty result.

Elevated brain natriuretic peptide predicts blood pressure response after stent revascularization in patients with renal artery stenosis.

Background—A significant number (20% to 40%) of hypertensive patients with renal artery stenosis will not have blood pressure improvement after successful percutaneous revascularization. Identifying a group of patients with refractory hypertension and renal artery stenosis who are likely to respond to renal stent placement would be beneficial. Methods and Results—Brain natriuretic peptide (BNP) was measured in 27 patients with refractory hypertension and significant renal artery stenosis before and after successful renal artery stent placement. This neuropeptide was elevated (median, 187 pg/mL; 25th to 75th percentiles, 89 to 306 pg/mL) before stent placement and fell within 24 hours of the successful stent procedure (96 pg/mL; 25th to 75th percentiles, 61 to 182 pg/mL; P=0.002), remaining low (85 pg/mL; 25th to 75th percentiles, 43 to 171 pg/mL) at follow-up. Clinical improvement in hypertension was observed in the patients with a baseline BNP >80 pg/mL (n=22) in 17 patients (77%) compared with 0% of the patients with a baseline BNP ≤80 pg/mL (n=5) (P=0.001). After correction for glomerular filtration rate, BNP was strongly correlated with improvement in hypertension. Conclusions—BNP is increased in patients with severe renal artery stenosis and decreases after successful stent revascularization. In addition, an elevated baseline BNP level of >80 pg/mL appears to be a good predictor of a blood pressure response after successful stent revascularization.

Effects of Renal Artery Stent Implantation in Patients With Renovascular Hypertension Presenting With Unstable Angina or Congestive Heart Failure

This study evaluates the effect of renal artery stent implantation in patients with renovascular hypertension presenting with unstable angina (n = 20) or congestive heart failure (n = 28). There was a significant improvement in the Canadian Cardiovascular Society angina class and the New York Heart Association functional class, and at 8.4 +/- 6.4 month follow-up.

Rheolytic thrombectomy in the treatment of acute limb-threatening ischemia: Immediate results and six-month follow-up of the multicenter AngioJet® registry

We tested the efficacy of rheolytic thrombectomy in treating 21 patients (mean age 68+/-12 years; 66% male) and 22 vessels (limbs) who presented to the hospital within 2 weeks of the development of limb-threatening ischemia. Fifty-two percent had contraindications to use thrombolytics, and 57% had severe comorbidities. All of the vessels were occluded with thrombus on the initial angiogram. Procedural success was achieved in 20 limbs (91%). Three patients expired in the hospital, and one expired at follow-up due to nonvascular causes. Acute limb salvage was achieved in 18 of 19 limbs (95%) in the 18 survivors, and 6-month limb salvage was achieved in 16 of 18 limbs (89%) in the 17 survivors. Rheolytic thrombectomy is effective in restoring immediate blood flow in acute limb-threatening ischemia, especially in high-risk surgical patients or patients with contraindications to thrombolytic therapy.

Catheter-based treatment of the subclavian and innominate arteries

Objectives: We report outcomes in patients undergoing catheter‐based intervention for symptomatic subclavian and innominate artery (S/IA) atherosclerosis. Background: Symptomatic S/IA obstructive lesions have traditionally been treated with open surgical revascularization. Catheter‐based endovascular therapies reduce the morbidity and mortality associated with surgery in many vascular beds. Methods: Between December 1993 and May 2006, 170 patients underwent primary stent placement in 177 S/IA arteries. Indications for revascularization included arm ischemia (57%), subclavian steal syndrome (37%), coronary‐subclavian steal syndrome (21%), and planned coronary bypass surgery with the involved internal mammary artery (8%). Results: Technical success was achieved in 98.3% (174/177) arteries, including 99.4% for stenotic lesions (155/156) and 90.5% for occlusions (19/21). There were no procedure‐related deaths and one stroke (0.6%, 1/170). Follow‐up was obtained in 151 (89%) patients at 35.2 ± 30.8 months, with a target vessel revascularization rate of 14.6% (23/157). At last follow‐up, 82% (124/151) of all treated patients remained asymptomatic with a primary patency of 83% and a secondary patency of 96%. Conclusions: Catheter‐based revascularization with stents for symptomatic S/IA lesions is safe and effective with excellent patency rates and sustained symptom resolution in the majority (>80%) of patients over 3 years of follow‐up. Percutaneous primary stent therapy is the preferred method of revascularization in patients with suitable anatomy.

Rheolytic Thrombectomy in the Management of Limb Ischemia: 30-Day Results from a Multicenter Registry

Purpose: To evaluate the use of rheolytic thrombectomy (RT) with the AngioJet catheter for treatment of lower extremity ischemia due to arterial/graft thrombotic occlusion. Methods: A retrospective multicenter review was performed of 99 consecutive patients (52 men; mean age 67 ± 13 years, range 30–90) who underwent RT for thrombotic occlusions in native arteries (n=80) or bypass grafts (n=19). Pre- and postprocedural limb ischemia and in-hospital events were evaluated. Amputation and mortality rates at 30 days were determined. Results: The majority of patients (78.8%) presented within 14 days of symptom onset. RT resulted in substantial to complete thrombus removal in 70 (70.7%) patients and partial in 22 (22.2%); there was no angiographic change in 7 (7.1%). Adjunctive post RT thrombolysis was used in 37 patients. Underlying stenoses found in 81 limbs were treated with one or more of the following procedures: balloon angioplasty (n=62), stenting (n=35), or non-emergent surgical revision (n=5). In-hospital complications included 2 major amputations, 5 cases of minor tissue loss, 7 rethromboses, and 3 cases of transient renal insufficiency. Four (4.0% patients died in-hospital; the 95 surviving patients all had viable limbs at discharge. Mortality and amputation rates at 30 days were 7.1% and 4.0%, respectively. Conclusions: Percutaneous treatment of thrombotic occlusions with RT, followed by definitive treatment of the underlying stenosis, is a promising therapeutic option for patients with limb-threatening ischemia.

Primary stenting in acute myocardial infarction: influence of diabetes mellitus in angiographic results and clinical outcome.

BACKGROUND The outcome of patients with diabetes after myocardial infarction (MI) has traditionally been worse than in their nondiabetic counterparts before and during the thrombolytic therapy era. Whether the fate of patients with diabetes might improve with mechanical intervention, particularly with primary stenting, has not previously been studied. METHODS We compared the angiographic and clinical outcome of 76 nondiabetic patients (aged 61 +/- 14 years; 66% male) and 28 patients with diabetes (aged 65 +/- 12 years; 64% male) consecutively treated with primary stenting for acute MI. Coronary Thrombolysis In Myocardial Infarction grade 3 flow was restored in 96% of diabetic and 97% of nondiabetic patients. RESULTS Angiographic results after stent deployment were similar in the 2 groups. At 1-month follow-up, all patients in both groups were alive. Patients with diabetes had a much higher incidence of stent thrombosis (18% vs 1%; P =.003), which accounted for the majority of the major cardiac events at 1 month (21% vs 4%; P =.009). At a mean follow-up of 315 +/- 13 days, 99% of nondiabetic and 89% of patients with diabetes were alive (P =.04). Overall freedom from a major cardiac event (death, MI, target vessel revascularization) at 315 +/- 13 day follow-up was 88% for nondiabetics and 54% for patients with diabetes (P =.0003). By multivariate analysis, diabetes mellitus was the most important predictor for development of 1-month (RR 9.89; 95% confidence interval, 1.6-30) and late major cardiovascular events (RR 8.39; 95% confidence interval, 2.93-24). CONCLUSIONS Primary stenting in acute MI is highly effective in restoring immediate TIMI 3 coronary flow in nondiabetic patients and patients with diabetes. This procedure may improve benefit in terms of mortality rate to both groups, particularly in patients with diabetes, compared with previous reports with thrombolytic therapy. Nevertheless, stent thrombosis and major cardiovascular events at 1 month and late follow-up are more frequent in patients with diabetes.

Endovascular stenting for vertebral artery stenosis.

OBJECTIVES The aim of this study was to demonstrate the safety and long-term durability of catheter-based therapy for symptomatic vertebral artery stenosis (VAS). BACKGROUND Symptomatic VAS carries with it a 5-year 30% to 35% risk of stroke. The 2-year mortality approaches 30% for medically managed strokes involving the posterior circulation. Surgical bypass is rarely performed, due to high morbidity and mortality. Endovascular revascularization with primary stenting offers an attractive treatment option for these patients. METHODS One-hundred five consecutive symptomatic patients (112 arteries, 71% male) underwent stent placement for extracranial (91%) and intracranial (9%) VAS from 1995 to 2006. Fifty-seven patients (54%) had bilateral VAS, 71 patients (68%) had concomitant carotid disease, and 43 patients (41%) had a prior stroke. RESULTS Procedural and clinical success was achieved in 105 (100%) and 95 (90.5%) patients, respectively. One-year follow-up was obtained in 87 (82.9%) patients, of which 69 patients (79.3%) remained symptom-free. At 1 year, 6 patients (5.7%) had died and 5 patients (5%) had a posterior circulation stroke. Target vessel revascularization occurred in 7.4% at 1 year. At a median follow-up of 29.1 months (interquartile range 12.8 to 50.9 months), 13.1% underwent target vessel revascularization, 71.4% were alive, and 70.5% remained symptom-free. CONCLUSIONS In experienced hands, stenting for symptomatic VAS can be accomplished with a very high success rate (100%), with few periprocedural complications, and is associated with durable symptom resolution in the majority (approximately 80%) of patients. We conclude that endovascular stenting of vertebral artery atherosclerotic disease is safe and effective compared with surgical controls and should be considered first-line therapy for this disease.