Infrapopliteal drug-eluting stents for chronic limb ischemia.

OBJECTIVE: We report our experience with the elective placement of below-knee, drug-eluting stents in patients with chronic limb ischemia. BACKGROUND: Infrapopliteal percutaneous transluminal angioplasty has been associated with a lower rate of procedural success and high rate of restenosis because of the small size of the tibial vessels and the prevalence of calcified and diffuse atherosclerotic disease. Prior published data reports 3-year patency rates below 25%. Bare metal stents have been reported in bailout situations. Drug-eluting stents have markedly reduced restenosis compared to bare metal stents in the coronary vasculature, but there is little data supporting the use of these devices below the knee. METHODS: Elective placement of drug-eluting stents in infrapopliteal lesions was performed on 10 patients with severe (> or =Fontaine Stage IIb) claudication (n = 1) or limb-threatening ischemia (n = 9) (rest pain, nonhealing ulcers and gangrene). RESULTS: A total of 17 drug-eluting stents were electively placed in 12 below-knee arteries in 10 patients, resulting in an average of 1.7 +/- 0.7 stents per patient. The mean lesion length was 24.8 +/- 10.9 mm, the mean total stent length was 38.3 +/- 19.1 mm, and the mean nominal stent diameter was 2.8 +/- 0.3 mm. One patient required target vessel revascularization (TVR) at 3 weeks because of stent thrombosis. TVR was 10% at 12.4 +/- 6.5 months of follow-up. Clinically driven angiography in three different patients was performed at 4, 15, and 16 months and confirmed drug-eluting stent patency in each case. CONCLUSIONS: The use of below-knee drug-eluting stents is feasible and appears to be safe in our small series of complex infrapopliteal lesions causing chronic limb ischemia. The occurrence of a single case of stent thrombosis warrants continued observation in this cohort. Prospective clinical trials will be necessary to confirm the benefits and justify the costs of this strategy for treating patients with infrapopliteal culprit lesions and chronic limb ischemia.

Therapy of postoperative stroke: report of intra-arterial thrombolysis of a hyperacute embolic stroke 5 days following CABG.

Intra-arterial (IA) recombinant tissue plasminogen activator (rt-PA) is an investigational treatment for acute stroke. We report a case of IA thrombolysis of a hyperacute middle cerebral artery stroke 5 days after coronary artery bypass graft surgery. Despite a serious extracranial bleeding complication (hemothorax), immediate thrombolysis with IA rt-PA led to near complete resolution of the neurological deficit and a favorable outcome.

Vertebral artery stenting.

The safety and efficacy of endoluminal stenting in treating atherosclerotic vertebral artery disease was evaluated in 38 vessels in 32 patients. Indications for revascularization included diplopia (n = 4), blurred vision (n = 4), dizziness (n = 23), transient ischemic attacks (n = 4), drop attack (n = 1), gait disturbance (n = 1), headache (n = 2), and asymptomatic critical stenosis (n = 1). Success (< 20% residual diameter stenosis, without stroke or death) was achieved in all 32 patients (100%). One patient experienced a transient ischemic attack (TIA) 1 hr after the procedure. At follow-up (mean, 10.6 months), all patients (100%) were alive and 31/32 (97%) were asymptomatic. One patient (3%) had in-stent restenosis at 3.5 months and underwent successful balloon angioplasty. Endoluminal stenting of vertebral artery lesions is safe, effective, and durable as evidenced by the low recurrence rate. Primary stent placement is an attractive option for atherosclerotic vertebral artery stenotic lesions. Cathet Cardiovasc Intervent 2001;54:1-5.

Treatment of femoral artery pseudoaneurysm with percutaneous thrombin injection.

Pseudoaneurysm formation of the femoral artery is a well-known complication following catheter-based vascular procedures. Ultrasound-guided compression or surgical correction are commonly used for its repair. We describe a new method of treatment for femoral pseudoaneurysm. The pseudoaneurysm is visualized by contralateral angiography and thrombosed with a percutaneous thrombin injection while the distal vessel is isolated with a brief balloon inflation. Fluoroscopically guided percutaneous thrombin injection is a promising, minimally invasive technique for the treatment of iatrogenic pseudoaneurysm, especially in patients with compromised distal circulation.

Provisional stenting for symptomatic intracranial stenosis using a multidisciplinary approach: acute results, unexpected benefit, and one-year outcome.

Percutaneous techniques have dramatically changed our approach to coronary and peripheral revascularization. Intracranial atherosclerosis is a highly morbid disease; however, techniques for revascularization are still in evolution. The authors comprise a multidisciplinary team of neurologists, neuroradiologists, and interventional cardiologists who have collaborated in treating fifteen patients with symptomatic intracranial stenosis who have failed medical therapy. The acute success rate (100%) and one-year freedom from death and stroke (93.4%) using balloon angioplasty and provisional stenting are encouraging. A surprising observation in this patient cohort was that 53% of patients had improvement or resolution of a deficit that was chronic and presumed to be permanent and irreversible. This type of chronic but reversible deficit is termed "brain angina". The background, rationale for a multidisciplinary team, techniques, and preliminary results of intracranial angioplasty with provisional stenting are presented.

Results of the study to determine rotablator and transluminal angioplasty strategy (STRATAS).

Rotational atherectomy is used to debulk calcified or complex coronary stenoses. Whether aggressive burr sizing with minimal balloon dilation (<1 atm) to limit deep wall arterial injury improves results is unknown. Patients being considered for elective rotational atherectomy were randomized to either an "aggressive" strategy (n = 249) (maximum burr/artery >0.70 alone, or with adjunctive balloon inflation < or = 1 atm), or a "routine" strategy (n = 248) (maximum burr/artery < or =0.70 and routine balloon inflation > or =4 atm). Patient age was 62 +/- 11 years. Fifty-nine percent routine and 60% aggressive strategy patients had class III to IV angina. Fifteen percent routine and 16% aggressive strategy patients had a restenotic lesion treated; lesion length was 13.6 versus 13.7 mm. Reference vessel diameter was 2.64 mm. Maximum burr size (1.8 vs 2.1 mm), burr/artery ratio (0.71 vs 0.82), and number of burrs used (1.9 vs 2.7) were greater for the aggressive strategy, p <0.0001. Final minimum lumen diameter and residual stenosis were 1.97 mm and 26% for the routine strategy versus 1.95 mm and 27% for the aggressive strategy. Clinical success was 93.5% for the routine strategy and 93.9% for the aggressive strategy. Creatine kinase-myocardial band (CK-MB) was >5 times normal in 7% of the routine versus 11% of the aggressive group. CK-MB elevation was associated with a decrease in rpm of >5,000 from baseline for a cumulative time >5 seconds, p = 0.002. At 6 months, 22% of the routine patients versus 31% of the aggressive strategy patients had target lesion revascularization. Angiographic follow-up (77%) showed minimum lumen diameter to be 1.26 mm in the routine group versus 1.16 mm in the aggressive group, and the loss index 0.54 versus 0.62. Dichotomous restenosis was 52% for the routine strategy versus 58% for the aggressive strategy. Multivariable analysis indicated that left anterior descending location (odds ratio 1.67, p = 0.02) and operator-reported excessive speed decrease >5,000 rpm (odds ratio 1.74, p = 0.01) were significantly associated with restenosis. Thus, the aggressive rotational atherectomy strategy offers no advantage over more routine burr sizing plus routine angioplasty. Operator technique reflected by an rpm decrease of >5,000 from baseline is associated with CK-MB elevation and restenosis.

Rheolytic thrombectomy during percutaneous revascularization for acute myocardial infarction: experience with the AngioJet catheter.

BACKGROUND: Although balloon angioplasty and stenting are effective in the treatment of acute myocardial infarction (MI), reduced coronary flow and distal embolization frequently complicate interventions when thrombus is present. Adjunctive treatment with mechanical thrombectomy devices may reduce these complications. METHODS AND RESULTS: We evaluated the angiographic and clinical outcomes of 70 patients with acute MI (16% with cardiogenic shock) and with angiographically evident thrombus who were treated with AngioJet rheolytic thrombectomy followed by immediate definitive treatment. Procedure success (residual diameter stenosis <50% and Thrombolysis in Myocardial Infarction [TIMI] flow > or =2 after final treatment) was achieved in 93.8%. Clinical success (procedure success without major in-hospital cardiac events) was achieved in 87.5%, with an in-hospital mortality rate of 7.1%. Final TIMI 3 flow was achieved in 87.7%. AngioJet treatment resulted in a mean thrombus area reduction from 73.2 +/- 64.6 mm(2) at baseline to 15.5 +/- 30.1 post-thrombectomy (P <.001). Subsequent definitive treatment included stenting in 67% and balloon angioplasty alone in 26% of patients. Procedural complications included distal embolization in six patients and perforation in two patients. There were no further major adverse events during 30-day follow-up. CONCLUSION: Rheolytic thrombectomy can be performed safely and effectively in patients with acute MI, allowing for immediate definitive treatment in thrombus-containing lesions.

Percutaneous profundaplasty in the treatment of lower extremity ischemia: results of long-term surveillance.

PURPOSE: To assess the procedural and long-term clinical outcomes of balloon angioplasty of the profunda femoris artery in patients with severe limb ischemia. METHODS: Thirty-one consecutive patients were evaluated for severe ischemia in 32 limbs: 13 (41%) were categorized Fontaine class 2B, and 19 (59%) were class 3 or 4. The superficial femoral artery was occluded in 20 (62%) limbs; an additional vessel was treated in 22 (69%) limbs. RESULTS: Procedural success was achieved in 91% (31/32) of limbs. The ankle-brachial index increased from 0.5 +/- 0.2 at baseline to 0.7 +/- 0.2 after intervention (p < 0.01). In-hospital limb salvage was 94% (30/32), and in-hospital event-free survival was 90% (28/31). At a mean follow-up of 34 +/- 20 months, no additional amputations were necessary; 3 patients required repeat revascularization, and 5 patients died. Freedom from revascularization was 88% in the 25 survivors. At follow-up, 88% of the patients had Fontaine class 1 or 2A symptoms, and only 12% had Fontaine class 2B or higher (p < 0.001 compared with baseline). CONCLUSIONS: These data suggest that percutaneous profundaplasty is safe, effective, and may be considered as an alternative to surgical therapy in patients with anatomically suitable lesions.

Reduction in QT dispersion with rheolytic thrombectomy in acute myocardial infarction: evidence of electrial stability with reperfusion therapy.

An increase in QT dispersion (QTd) is associated with myocardial ischemia and may serve as a marker of ischemia and ventricular arrhythmia. We studied the effect of early reperfusion with rheolytic thrombectomy using an angiojet catheter (Possis, Minneapolis, MN) on QTd in 12 patients who presented with acute myocardial infarction. QTd and QT dispersion, rate-corrected for RR interval, were significantly reduced from 57 +/- 16 and 68 +/- 13 msec before reperfusion to 34 +/- 16 and 44 +/- 19 msec after reperfusion respectively (mean +/- SD; P < 0.002 and P < 0.0008, respectively). Successful reperfusion with rheolytic thrombectomy reduces QTd and may confer electrical stability to vulnerable myocardium. Reduction in indexes of repolarization inhomogeneity with reperfusion may serve as a noninvasive marker of coronary patency.

Global revascularization.

Percutaneous endovascular intervention has revolutionized the treatment of peripheral vascular disease by allowing successful treatment of patients who are not good surgical candidates. Cardiologists with peripheral vascular training are more readily able to identify patients with concomitant peripheral arterial disease. It has been our experience that the technical skills necessary to perform coronary angioplasty are transferable to the peripheral vasculature. However, an understanding of the natural history of peripheral disease and of patient and lesion selection criteria, and the knowledge of other treatment alternatives are essential elements required to perform these procedures safely and effectively. There are inherent advantages for patients when the interventionalist performing the procedure is also the clinician responsible for the pre- and post-procedure care, analogous to the vascular surgeon who cares for patients before and after surgical procedures. In view of the increased incidence of coronary artery disease in patients with atherosclerotic peripheral vascular disease, the participation of a cardiologist in their care seems appropriate.

Percutaneous transmyocardial laser revascularisation for severe angina: the PACIFIC randomised trial. Potential Class Improvement From Intramyocardial Channels.

BACKGROUND: Percutaneous transmyocardial laser revascularisation (PTMR) is a proposed catheter-based therapy for refractory angina pectoris when bypass surgery or angioplasty is not possible. We undertook a randomised trial to assess the safety and efficacy of this technique. METHODS: 221 patients with reversible ischaemia of Canadian Cardiovascular Society angina class III (61%) or IV (39%) and incomplete response to other therapies were recruited from 13 centres. Patients were randomly assigned PTMR with a holmium:YAG laser plus continued medical treatment (n=110) or continued medical treatment only (n=111). The primary endpoint was the exercise tolerance at 12 months. Analyses were by intention to treat. FINDINGS: 11 patients died and 19 withdrew; 92 PTMR-group and 99 medical-treatment-group patients completed the study. Exercise tolerance at 12 months had increased by a median of 89.0 s (IQR -15 to 183) with PTMR compared with 12.5 s (-67 to 125) with medical treatment only (p=0.008). On masked assessment, angina class was II or lower in 34.1% of PTMR patients compared with 13.0% of those medically treated. All indices of the Seattle angina questionnaire improved more with PTMR than with medical care only. By 12 months there had been eight deaths in the PTMR group and three in the medical treatment group, with similar survival in the two groups. INTERPRETATION: PTMR was associated with increased exercise tolerance time, low morbidity, lower angina scores assessed by masked reviewers, and improved quality of life. Although there is controversy about the mechanism of action, and the contribution of the placebo effect cannot be quantified, this unmasked study suggests that this palliative procedure provides some clinical benefits in the defined population of patients.

Safety, efficacy, and durability of carotid artery stenting for restenosis following carotid endarterectomy: a multicenter study.

PURPOSE: To present the results of a multicenter registry established to collect data on carotid stent procedures in patients with restenosis following carotid endarterectomy. METHODS: The procedural details, outcomes, and late follow-up results were collected from 14 centers in the United States. Thirty-day and late stroke and death rates were analyzed. RESULTS: Three hundred and thirty-eight patients (201 men; 71 +/- 8 years) underwent carotid stenting in 358 arteries. The average duration from carotid endarterectomy was 5.5 +/- 7.3 years. Sixty-one percent of the patients were asymptomatic. The overall 30-day stroke and death rate was 3.7%. The minor stroke rate was 1.7% (6/358), and the major nonfatal stroke rate was 0.8% (3/358). The fatal stroke rate was 0.3% (1/358), and the nonstroke-related death rate was 0.9% (3/338). There was 1 (0.3%) fatal and 1 (0.3%) nonfatal stroke during the follow-up period. The overall 3-year rate of freedom from all fatal and nonfatal strokes was 96% +/- 1% (+/- SE). CONCLUSIONS: Carotid artery stenting can be performed in patients with restenosis following carotid endarterectomy with 30-day complication rates comparable to those of most published studies on repeat carotid endarterectomy. Results of late follow-up suggest that this technique is durable and efficacious.

Acute renal failure after redo thoracoabdominal aortic aneurysm repair in a patient with a solitary kidney: successful percutaneous treatment.

PURPOSE: To report the successful percutaneous treatment of renal artery stenosis that precipitated renal failure following surgical repair of a thoracoabdominal aortic aneurysm (TAAA). METHODS AND RESULTS: A 70-year-old woman with a solitary kidney became anuric 2 hours after urgent repair of a symptomatic true aneurysm of the Carrel patch from an 8-year-old TAAA repair. After medical treatment failed, aortography was performed, identifying complete occlusion of the solitary renal artery. Balloon dilation and implantation of a Palmaz stent restored renal perfusion and improved function. At 6-month follow-up, she was normotensive and her creatinine within normal limits. CONCLUSIONS: Renal artery stenosis or occlusion is a treatable cause of acute renal failure after TAAA repair. Percutaneous treatment options are likely to be better tolerated than surgical revascularization in this patient population.

The emergence of mechanical thrombectomy; a clot burden reduction approach.

Intracoronary thrombi are harbingers for increased procedural complications after percutaneous revascularization techniques. Current approaches to treat coronary thrombus prior to plaque intervention are pharmacologic and mechanical. Whereas the use of coronary thrombolysis prior to or during percutaneous coronary intervention have yielded mixed results, the group of the platelet IIb/IIIa inhibitors have uniformly been shown to decrease the procedural complications and the 30 day rate of major cardiovascular events. Mechanical approaches to managing thrombus include: compression with balloon angioplasty or stenting, removal with atherectomy devices, thromboaspiration with the Possis AngioJet and hydrolyser, and vibration disintegration with the ultrasound thrombolysis device. Recent clinical trials have shown that the Possis AngioJet and the ultrasound thrombolysis device are highly effective and safe for removing coronary thrombi prior to coronary intervention.

Endovascular treatment of multiple visceral artery paradoxical emboli with mechanical and pharmacological thrombolysis.

PURPOSE: To report a case of paradoxical emboli to multiple visceral vessels treated with both mechanical (AngioJet device) and pharmacological (urokinase) thrombolysis. METHODS AND RESULTS: A 72-year-old man presented with a 48-hour history of symptomatic right renal ischemia, which was treated with heparinization. Five days later, an abrupt creatinine elevation prompted arteriography, which demonstrated thromboembolism of the superior mesenteric artery (SMA) and both renal arteries. The AngioJet aspiration device was employed to successfully remove the clot from the SMA; urokinase infusion restored flow to the left kidney. At the 16-month follow-up evaluation, the patient was normotensive without medication and had a stable creatinine (1.4 mg/dL). CONCLUSIONS: Because of its speed and minimal morbidity, the AngioJet device may be an attractive alternative to surgical embolectomy or pharmacological thrombolysis in highly selected cases of acute visceral artery thromboembolism.

Intra-arterial thrombolysis in a patient presenting with an ischemic stroke due to spontaneous internal carotid artery dissection.

We describe a case of a 38-year-old male who presented with acute onset of right-sided hemiplegia and aphasia, who was transferred for emergent percutaneous intervention. Angiography revealed a dissection with total occlusion of the left internal carotid artery (ICA) with propagation of thrombus in the distribution of the middle cerebral artery (MCA). Therapy was directed at the MCA and not the ICA. Intra-arterial thrombolysis was performed on the M1 and M2 branches of the left middle cerebral artery, resulting in almost complete resolution of symptoms during the angiography procedure. Heparin was continued postprocedure, and the patient was discharged home on warfarin and aspirin with minimal residual symptoms.

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.

Predictors of stent thrombosis after primary stenting for acute myocardial infarction.

The aim of the study was to determine if a hypercoagulable state that may persist for several months after an acute myocardial infarction may contribute to an increased incidence of stent thrombosis. Primary stenting was performed in 104 consecutive patients with acute myocardial infarction using 147 coronary stents. Twenty-eight patients (27%) were diabetic and 55 patients (53%) were smokers. A single stent was placed in 63%, two stents in 33%, and more than two stents in 4% of the patients. Procedural success was obtained in 97% of the patients. All stents were deployed using high-pressure balloon inflation. The reference vessel diameter and minimal lumen diameter after stent deployment were 3.30 +/- 0.42 and 3.23 +/- 0.42 mm, respectively. Six patients (5.7%) developed stent thrombosis within 1 month after the procedure complicated by reinfarction in five of the six patients. At 1-month follow-up, all patients remained alive. On multivariate analysis, independent predictors of stent thrombosis were diabetes mellitus (relative risk [RR] 5.2; 95% confidence interval [CI] 1.8, 25.1), tobacco use (RR 4.5; 95% CI 1.3, 24.5), number of stents: 1 vs. > 1 (RR 3.7; 95% CI 1.1, 15.9), minimal lumen diameter poststent placement (RR 0.03; 95% CI 0.0002, 0.74), and duration of chest pain before intervention (RR 1.1; 95% CI 1.01, 1.25). Stent thrombosis had not been associated with diabetes mellitus and tobacco use previously but is in agreement with the enhanced platelet aggregability, coagulation factor abnormalities, and impaired fibrinolysis characteristic of these patients.

An embolization containment device.

A coaxial catheter system for containment of distal embolization is described. Utilizing a novel 0.014" hypotube with a distal elastomeric occlusion balloon, the PercuSurge GuardWire functions as a guidewire while trapping distal embolization resulting from more proximal intervention. The particulate debris is evacuated with a single operator exchange aspiration catheter (Export catheter) prior to deflation of the distal occlusion balloon. This animal study confirmed the feasibility of concept. The system was easily delivered through tortuous coronary anatomy. The GuardWire served as an adequate rail for delivery of dilatation balloons and a multitude of stents. There was no evidence of deep wall damage from low-pressure inflation and apposition of the distal occlusion balloon.