Duplex ultrasound assessment of native stenoses in the superficial femoral and popliteal arteries: a comparative study examining the influence of multisegment lesions.

PURPOSE: To evaluate duplex ultrasonography (DUS) in the assessment of femoropopliteal stenoses comparing a single native stenosis (SNS) to multisegmental native stenoses (MNS). METHODS: Among the 1284 patients treated for atherosclerotic occlusive disease involving the femoropopliteal segment between November 2002 and November 2012, 139 patients (97 men; mean age 68±8 years) with 142 SNS or 143 MNS in 79 and 60 patients, respectively, were eligible for this retrospective analysis. The peak systolic velocity ratios with proximal (PSVRprox) and distal (PSVRdist) reference for the 285 lesions were compared with their respective angiographic stenosis grade as measured by 2 independent readers using quantitative vascular analysis to ensure objectivity. Receiver operating characteristic curve analysis was used to evaluate sensitivity, specificity, and the optimal thresholds of PSV and PSVR for detection of stenoses by grade (>50%, >70%, or >80% diameter stenosis). The area under the curve (AUC) values of dependent and independent receiver operating characteristic curves were compared. RESULTS: For SNS, correlation of PSVRprox to diameter stenosis (R=0.88) was higher (p<0.001) than the correlation for MNS (R=0.78). In the SNS group, the AUC for detecting a >50% (0.99±0.01), >70% (0.98±0.01), and >80% (0.96±0.01) stenosis with PSVRprox was significantly higher than in the MNS group [AUC50% 0.93±0.02 (p=0.01), AUC70% 0.92±0.02 (p=0.02), and AUC80% 0.87±0.03 (p=0.003)]. The optimal thresholds for detecting >50%, >70%, and >80% stenoses for SNS using PSVRprox were 2.6, 3.3, and 3.9, respectively. For MNS, the optimal thresholds of PSVRprox were 2.6, 3.4, and 3.9, respectively, with respective sensitivities of 87%, 81%, and 75%; respective specificities of 93%, 90%, and 82%; negative predictive values of 45%, 64%, and 74%; and positive predictive values of 99%, 95%, and 83%. CONCLUSION: DUS is an optimal tool for quantification of SNS. However, a multisegment setting has a significant negative impact on the quantification of femoropopliteal artery stenosis.

Drug-coated balloons vs. drug-eluting stents for treatment of long femoropopliteal lesions.

PURPOSE: To compare the performance of drug-coated balloons (DCB) and drug-eluting stents (DES) in long femoropopliteal lesions. METHODS: A retrospective dual center study included 228 patients (139 men; median age 69 years) with femoropopliteal lesions ≥10 cm suffering from peripheral artery disease (Rutherford categories 1-5) treated either with DCB or DES. Propensity score stratification was used to minimize bias. The 131 DCB patients (77 men; mean age 68.9±10.5 years) had a mean lesion length of 194.4±86.3 mm (range 100-450), while the 97 DES patients (62 men; mean age 68.2±8.0 years) had lesions averaging 195.0±64.5 mm (range 100-350) in length. Restenotic lesions were treated in 68 (51.9%) DCB patients and 43 (44.3%) DES patients; over half the lesions in both groups were total occlusions [DCB: 69 (52.7%), DES: 61 (62.9%)]. Outcome measures were patency (peak systolic velocity ratio <2.4), clinically driven target lesion revascularization (TLR), event-free survival, and freedom from worsening of Rutherford classification by ≥2 categories. RESULTS: In the DCB cohort, provisional stent placement was performed in 24 (18.3%) lesions for refractory stenosis (5, 3.8%), flow-limiting dissection (13, 9.9%), and other reasons (6, 4.6%). There was no procedure-related mortality in either cohort. The binary restenosis rates were 23.9% (26/109) and 30.4% (24/79, p=0.319) in the DCB and DES cohorts, respectively, and clinically driven TLR rates were 15.6% (17/109) vs. 19.0% (15/79, p=0.543), respectively. Estimates for freedom from clinically driven TLR and event-free survival were not different between the study cohorts nor were outcomes regarding the ankle-brachial index and Rutherford category. CONCLUSION: DCB and DES perform equally well in the endovascular treatment of femoropopliteal lesions ≥10 cm and better than traditional endovascular treatment. In a real world setting of TASC C and D lesions, the provisional stent rate in the DCB cohort is low.

Angioplasty and provisional stent treatment of common femoral artery lesions.

PURPOSE: Isolated atherosclerotic common femoral artery (CFA) disease is a rare cause of symptomatic peripheral arterial disease. Although surgical endarterectomy is considered the therapy of choice, little is known about outcomes of percutaneous treatment. MATERIALS AND METHODS: A prospectively maintained single-center database was retrospectively analyzed for outcomes of consecutive patients undergoing isolated percutaneous revascularization of CFA disease between 1996 and 2007. In all cases, the intended strategy was balloon angioplasty with provisional stent placement in case of poor angioplasty results. Among 516 consecutive procedures involving the CFA, 419 were excluded because of nonatherosclerotic disease (n = 156) or treatment of additional vascular segments during the same procedure (n = 263). Procedural success (ie,<30% residual stenosis), in-hospital vascular complications (major [requiring surgical or percutaneous treatment] or minor [treated conservatively]), and 12-month restenosis and target lesion revascularization (TLR) rates were assessed for the remaining 97 interventions. RESULTS: CFA bifurcation lesions were present in 40 cases (41.2%) and required treatment of the deep femoral artery in 25 (25.8%). Chronic total CFA occlusions accounted for 11 cases (11.3%). Balloon angioplasty was performed in 96 cases (98.9%), and provisional stent placement was necessary in 37 (38.1%). The procedure was successful in 89 cases (91.8%). Minor and major vascular complications at 30 days occurred in three (3.1%) and four (4.1%) cases, respectively. At 12 months, restenosis greater than 50% and TLR were observed in 19.5% and 14.1% of procedures, respectively. CONCLUSIONS: This series shows that isolated CFA lesions may be safely and efficaciously treated with angioplasty and provisional stent placement.

Sirolimus-eluting stents for treatment of infrapopliteal arteries reduce clinical event rate compared to bare-metal stents: long-term results from a randomized trial.

OBJECTIVES: The study investigated the long-term clinical impact of sirolimus-eluting stents (SES) in comparison with bare-metal stents (BMS) in treatment of focal infrapopliteal lesions. BACKGROUND: There is evidence that SES reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. No data from randomized trials are available concerning the clinical impact of this finding during long-term follow-up. METHODS: The study extended the follow-up period of a prospective, randomized, multicenter, double-blind trial comparing polymer-free SES with placebo-coated BMS in the treatment of focal infrapopliteal de novo lesions. The main study endpoint was the event-free survival rate defined as freedom from target limb amputation, target vessel revascularization, myocardial infarction, and death. Secondary endpoints include amputation rates, target vessel revascularization, and changes in Rutherford-Becker class. RESULTS: The trial included 161 patients. The mean target lesion length was 31 ± 9 mm. Thirty-five (23.3%) patients died during a mean follow-up period of 1,016 ± 132 days. The event-free survival rate was 65.8% in the SES group and 44.6% in the BMS group (log-rank p = 0.02). Amputation rates were 2.6% and 12.2% (p = 0.03), and target vessel revascularization rates were 9.2% and 20% (p = 0.06), respectively. The median (interquartile range) improvement in Rutherford-Becker class was -2 (-3 to -1) in the SES group and -1 (-2 to 0) in the BMS group, respectively (p = 0.006). CONCLUSIONS: Long-term event-free survival, amputation rates, and changes in Rutherford-Becker class after treatment of focal infrapopliteal lesions are significantly improved with SES in comparison with BMS. (YUKON-Drug-Eluting Stent Below the Knee-Randomised Double-Blind Study [YUKON-BTX]; NCT00664963).

Endovascular treatment of common femoral artery disease: medium-term outcomes of 360 consecutive procedures.

OBJECTIVES: The purpose of this study was to evaluate the technical feasability, safety, and 1-year efficacy of the endovascular treatment of atherosclerotic common femoral artery (CFA) obstructions. BACKGROUND: Atherosclerotic CFA obstruction is a known cause of symptomatic peripheral arterial disease. Although surgical endarterectomy is considered the therapy of choice for this condition, little is known about the percutaneous options. METHODS: Using a prospectively maintained single-center database, we retrospectively analyzed the outcomes of 360 consecutive percutaneous interventions of the CFA for atherosclerotic disease and assessed procedural success, in-hospital complications, and 1-year patency and target lesion revascularization rates. RESULTS: Ninety-seven procedures (26.9%) were isolated CFA interventions, whereas 157 (43.6%) and 152 (42.2%) also involved inflow and outflow vessels, respectively. Bifurcation lesions were present in 140 cases (38.9%), and concomitant treatment of the profunda femoral artery was performed on 93 occasions (25.8%). Chronic total CFA occlusions were recanalized in 60 cases (16.7%). Balloon angioplasty was performed as the primary intervention in virtually all cases (98.6%), whereas stenting was needed for suboptimal angioplasty results in 133 procedures (36.9%). Failures-defined as a final angiographic result with a >30% residual stenosis-were observed on 26 occasions (7.2%). In-hospital major (i.e., requiring surgery) and minor (i.e., treated percutaneously or conservatively) complications occurred in 5 (1.4%) and 18 (5.0%) procedures, respectively. One-year follow-up data were available for 281 patients (87.5%). Restenosis >50% by duplex scanning and target lesion revascularization were observed in 74 of 268 (27.6%) and 64 of 322 (19.9%) procedures, respectively. CONCLUSIONS: This large series suggests that the percutaneous approach may be a valid alternative to surgery for CFA atherosclerotic obstructions.

One-year outcome after percutaneous rotational and aspiration atherectomy in infrainguinal arteries in patient with and without type 2 diabetes mellitus.

BACKGROUND: To compare the safety and efficacy of a rotational aspiration atherectomy system (Jetstream) for the treatment of infrainguinal arteries in diabetic versus nondiabetic patients. METHODS: A total of 172 patients with Rutherford stage 1-5 lower limb ischemia were treated with rotational aspiration atherectomy between February 2006 and February 2007. Of these, 80 patients with type 2 diabetes mellitus (DM: 46.5%) were compared with 92 nonDM (53.5%) patients. Overall, 210 target lesions (99 DM; 111 nonDM) were treated, located in the superficial femoral (67% DM; 61% nonDM), popliteal (25% DM; 30% nonDM), and tibial (8% DM; 9% nonDM) arteries. Lesion characteristics were comparable in both groups, mean lesion length was 28.5 mm (DM) and 26.2 mm (nonDM); total occlusions were present in 29% (DM) and 32% (nonDM), and 15% (DM) and 14% (nonDM) were restenotic. RESULTS: In the entire cohort, device success was 99% (all but two lesions). The major adverse event (MAE) rate (death, index limb amputation, myocardial infarction, target lesion revascularization [TLR] and target vessel revascularization) in DM at 30 days was 2.5% (n = 2 planned amputations) and 0% in nonDM. At 6 and 12 months, MAE in DM was seen in 13.8% (11/80) and 25% (20/80) compared with 21.7% (20/92) and 31.5% (29/92) in nonDM, respectively. TLR rate through 12 months was 20% (16/80) in DM and 28% in nonDM (26/92). Overall, 1 year restenosis rate was 38.2% based on duplex. The ankle-brachial index, mean Rutherford categories, and walking impairment questionnaire did not differ between groups at baseline and were increased significantly in both study cohorts at 12 months. CONCLUSION: Jetstream-assisted atherectomy in infrainguinal arteries is safe and effective in DM compared with nonDM patients. In this short-lesion cohort, vessel patency in diabetics was as good as for non-DM at 1 year. TLR and MAE were higher by trend in nonDM, although planned amputations were seen only in DM. The clinical benefit was similar in both groups.

The 1-year clinical impact of rotational aspiration atherectomy of infrainguinal lesions.

The present study was carried out to provide information about outcome of the Jetstream atherectomy device for treatment of infrainguinal arteries. From February 2006 to February 2007, 172 patients with Rutherford class 1 to 5 lower limb ischemia were enrolled at 9 study sites. The endpoints were evaluation of quality of life according to the walking impairment questionnaire (WIQ) besides technical parameters. In the total study cohort, the WIQ scale maintained improved up to 12-month follow-up. Furthermore, target lesion revascularization rate was 26% (42/162), ankle-brachial index (ABI) increased from 0.59 ± 0.21 at baseline to 0.82 ± 0.27 (P < 0.05), and mean Rutherford class dropped from 3.0 ± 0.9 at baseline to 1.5 ± 1.3 at 1 year (P < .05). The results of this prospective, multicenter, clinical study demonstrate that the Jetstream atherectomy device is a potential treatment alternative for the endovascular management to improve clinical outcome in patients with peripheral arterial occlusive disease.

Primary use of sirolimus-eluting stents in the infrapopliteal arteries.

PURPOSE: To report 12-month outcomes following application of sirolimus-eluting stents (SES) in infrapopliteal arteries in patients with chronic limb ischemia. METHODS: A prospective single-center study was conducted involving 146 consecutive patients (102 men; mean age 73+/-9 years) with Rutherford-Becker categories 2 to 5 lower limb ischemia who underwent SES placement. The average degree of stenosis at baseline was 86%+/-5%; there were 44 (30%) occlusions. The main study endpoint was the 1-year primary patency rate, defined as freedom from in-stent restenosis (luminal narrowing > or =70%) detected with angiography or, if appropriate, with duplex ultrasound. Secondary endpoints included the 6-month primary patency rate, secondary patency rate, ankle-brachial index (ABI), and changes in the Rutherford-Becker classification. RESULTS: Fifteen (10%) patients were lost to follow-up, and 27 (18%) patients died during the follow-up period, leaving 104 patients undergoing the 6- and 12-month follow-up examinations. After 6 months and 1 year, the primary patency rates were 88.5% and 83.7%, respectively. The mean ABI increased from 0.6+/-0.4 at baseline to 0.8+/-0.2 after 6 months and remained significantly improved during 1-year follow-up (p<0.0001). The mean Rutherford-Becker classification decreased from 3.3+/-0.8 at baseline to 0.9+/-1.1 (p<0.0001) after 1 year. CONCLUSION: Treatment of infrapopliteal arteries with SES yields encouraging long-term results that compare favorably with previously published data on bare metal stents or plain balloon angioplasty.

Debulking procedures: potential device specific indications.

During the past decade, the endovascular treatment of peripheral arterial disease has become more widespread due to the impressive extension of the endovascular toolbox to include different atherectomy technologies. The promise of atherectomy is to avoid the "barotraumas" defined as complications of traditional angioplasty such as dissection, elastic recoil, and disruption of the internal elastic lamina resulting in overwhelming neointima and smooth muscle cell proliferation. The oldest atherectomy technologies are the excimer laser and the Rotablator. The excimer laser technology is based on the principle of photoablation converting occlusive material into microbubbles being immediately dissolved into the blood. The Rotablator and the newer diamondback device are high speed rotational "sanding" devices particularly developed for the treatment of highly calcified plaque particularly in small vessel lesions, such as the popliteal and infrapopliteal segments. The Silverhawk system, currently the most widespread used device, is a directional atherectomy device particularly designed for eccentric and not severely calcified infrainguinal lesions whereas a variation of this device, the Rockhawk, is dedicated for the treatment of calcified plaques. The Jetstream system is the latest approved rotational atherectomy device focusing on native arteries with a reference vessel diameter of 4-6 mm in its current version; uniquely this device also has an aspiration capability making the device not only an atherectomy device but potentially also a thrombectomy device. This article will review the different indications for the use of these atherectomy devices including tips and specific device limitations.

One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial.

PURPOSE: To report a safety and efficacy study of a novel rotational atherectomy system with aspiration capabilities for the treatment of infrainguinal arterial lesions. METHODS: From February 2006 to January 2007, 172 patients (88 women; mean age 72 years, range 51-93; 47% diabetics) with Rutherford class 1-5 lower limb ischemia were enrolled at 9 study sites. Inclusion criteria were atherosclerotic stenoses >70% and up to 10 cm long in the femoropopliteal segment or up to 3 cm long in the infrapopliteal vessels (reference vessel diameter 3.0-5.0 mm). In the study, 210 lesions (mean length 2.7 cm) were treated with the Pathway PV System, including total occlusions (31%), lesions with a moderate to high calcium score (51%), and post-angioplasty (non-stent) restenotic lesions (15%). The primary study endpoint was the 30-day major adverse event (MAE) rate. RESULTS: Device success was 99% (208/210 lesions). MAE at 30 days was 1% (2 preplanned amputations). Clinically driven target lesion revascularization rates at 6 and 12 months were 15% (25/172) and 26% (42/162), respectively. The 1-year restenosis rate was 38.2% based on duplex imaging. The ankle-brachial index increased significantly from 0.59+/-0.21 at baseline to 0.82+/-0.27 (p<0.05) at 12 months. Mean Rutherford class improved from 3.0+/-0.9 at baseline to 1.5+/-1.3 at 1 year (p<0.05). CONCLUSION: The use of the Pathway PV System in atherosclerotic lesions appears to be safe and effective in improving stenosis severity, even in the presence of challenging lesion conditions. Vessel patency following intervention appears to be good up to 12 months, and these results translate into clinical benefit.

Retrograde transpopliteal recanalization of chronic superficial femoral artery occlusion after failed re-entry during antegrade subintimal angioplasty.

PURPOSE: To evaluate the acute success and clinical impact of retrograde transpopliteal access for subintimal recanalization of superficial femoral artery (SFA) and proximal popliteal artery (PA) occlusions after failed attempts to re-enter the true lumen in the antegrade femoral approach. METHODS: From 2002 to 2007, 56 patients (43 men; mean age 68+/-9 years, range 43-87) with stable chronic peripheral artery disease (Rutherford category 2 to 5) were treated with antegrade subintimal angioplasty that could not be completed owing to re-entry failure. Mean occlusion length was 17+/-7 cm (range 4-32), including 13 TASC II A (23.2%), 10 TASC II B (17.8%), 16 TASC II C (28.5%), and 17 TASC II D (30.3%) lesions. After re-entry to the true lumen failed in the antegrade approach, including predilation of the false channel, all patients were turned to a prone position, and a 5-F or 6-F sheath was placed into the mid segment of the PA under fluoroscopic guidance. Retrograde wire passage was attempted with a 0.035-inch hydrophilic guidewire. RESULTS: Fifty-five (98.2%) of 56 procedures were finished successfully with a residual stenosis of <30%; the 1 failure was due stent deformation within the occluded segment that could not be passed from either an antegrade or retrograde access. In all interventions, balloon angioplasty was performed; provisional stenting was done in 40 (71.4%). In 3 (5.3%) lesions, additional excimer laser atherectomy were performed. Six (10.7%) complications occurred, including 1 arteriovenous fistula from the PA to the popliteal vein and 1 sealing device induced PA occlusion. The mean ankle-brachial index increased from 0.44+/-0.26 to 0.86+/-0.23. The restenosis rate after 12 months was 54.9%. CONCLUSION: Failed antegrade attempts to recanalize chronic total occlusions of the SFA and proximal PA can be salvaged using a retrograde popliteal access, with a low complication rate, as an alternative to using a re-entry device. However, durability of the intervention using current interventional tools is limited.

Safety and efficacy of the StarClose vascular closure system using 7-F and 8-F sheath sizes: a consecutive single-center analysis.

PURPOSE: To assess the safety and efficacy of the StarClose device following peripheral vascular interventions employing 7-F and 8-F femoral sheaths. METHODS: From May 2006 to December 2007, 226 consecutive patients (143 men; mean age 69 years, range 36-92) underwent 231 groin punctures (150 with a 7-F sheath and 81 with an 8-F sheath) that were sealed with the StarClose Vascular Closure System. All the patients underwent duplex control of the puncture site 24 hours after deployment of the device to determine the presence of vascular complications (hematoma, pseudoaneurysm, arteriovenous fistula, and arterial/venous thrombosis or stenosis). Endpoints were major vascular complications during the hospital stay, device success (hemostasis using the StarClose device alone or with <5 minutes of adjunctive compression and freedom from major vascular complications), and procedure success (hemostasis established using any method and freedom from major vascular complications). RESULTS: Procedural success was 96.0% (144/150) for the 7-F group and 97.5% (79/81) in the 8-F group. Device success was achieved in 91.3% (137/150) of the 7-F group and 90.1% (73/81) the 8-F group. Major vascular complications occurred in 4.1% (6/150) of the 7-F group: 1 patient developed massive retroperitoneal hematoma that required blood transfusion and surgical evacuation, 2 patients presented new ipsilateral lower extremity ischemia requiring revascularization, and 3 other patients developed pseudoaneurysm treated by ultrasound-guided compression or thrombin injection. In the 8-F group, only 2 (2.5%) patients had a major complication: 1 developed a high-grade stenosis of the punctured femoral artery that required angioplasty and the other developed massive retroperitoneal hematoma followed by blood transfusion and surgical evacuation. Minor complications occurred at a rate of 11.3% (17/150) in the 7-F group and 9.9% (8/81) in the 8-F group. CONCLUSION: Common femoral artery closure with the StarClose device following peripheral vascular procedures utilizing 7-F and 8-F sheath sizes is feasible, with few device-specific complications. A randomized trial of a larger number of patients comparing standard compression methods and StarClose is warranted.

RADAR - A randomised, multi-centre, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with haemodynamically relevant atherosclerotic renal artery stenosis.

BACKGROUND: Prospective, international, multi-centre, randomised (1:1) trial to evaluate the clinical impact of percutaneous transluminal renal artery stenting (PTRAS) on the impaired renal function measured by the estimated glomerular filtration rate (eGFR) in patients with haemodynamically significant atherosclerotic renal artery stenosis. METHODS: Patients will be randomised to receive either PTRAS using the Dynamic Renal Stent system plus best medical treatment or best medical treatment. Renal stenting will be performed under angiographic imaging. For patients randomised to best medical treatment the degree of stenosis measured by renal duplex sonography (RDS) will be confirmed by MR angio or multi-slice CT where possible. Best medical treatment will be initiated at randomisation or post procedure (for PTRAS arm only), and adjusted as needed at all visits. Best medical treatment is defined as optimal drug therapy for control of the major risk factors (blood pressure < or = 125/80 mmHg, LDL cholesterol < or = 100 mg/dL, HbA1c < or = 6.5%). Data recordings include serum creatinine values, eGFR, brain natriuretic peptide, patients' medical history and concomitant medication, clinical events, quality of life questionnaire (SF-12v2), 24 hour ambulatory blood pressure measurement, renal artery duplex ultrasound and echocardiography. Follow-up intervals are at 2, 6, 12 and 36 months following randomisation.The primary endpoint is the difference between treatments in change of eGFR over 12 months. Major secondary endpoints are technical success, change of renal function based on the eGFR slope change between pre-treatment and post-treatment (i.e. improvement, stabilisation, failure), clinical events overall such as renal or cardiac death, stroke, myocardial infarction, hospitalisation for congestive heart failure, progressive renal insufficiency (i.e. need for dialysis), need of target vessel revascularisation or target lesion revascularisation, change in average systolic and diastolic blood pressure, change in left ventricular mass index calculated from echocardiography, difference in the size of kidney (pole to pole length) measured by renal duplex sonography, total number, drug name, drug class, daily dose, regimen and Defined Daily Dose (DDD), of anti-hypertensive drugs, and change in New York Heart Association (NYHA) classification. Approximately 30 centres in Europe and South America will enrol patients. Duration of enrolment is expected to be 12 months resulting in study duration of 48 months. TRIAL REGISTRATION NUMBER: NCT00640406.

Recanalization of chronic occlusions of the superficial femoral artery using the Outback re-entry catheter: a single centre experience.

PURPOSE: To report our experience with a catheter system (The Outback catheter) designed to allow fluoroscopically controlled re-entry after subintimal guide wire passage during recanalization of chronically occluded femoro-popliteal arteries. METHODS: Between March 2007 and August 2008, 65 legs in 61 patients (60% male, mean age 73 (49-98 years) with chronic occlusion of the SFA and proximal popliteal artery were treated. Clinical presentation was severe intermittent claudication (Rutherford category 3, 59%), rest pain (Rutherford category 4, 16%), and minor ulcerations (Rutherford category 5, 25%). In all cases, the true lumen could not be entered by using standard antegrade catheter and guide wire techniques. RESULTS: Median lesion length was 200 +/- 102 mm. Recanalization of the arterial occlusion was successful in 57 of 65 treated lesions (88%). One patient died of myocardial infarction after delayed femoral bleeding possibly due to extensive recanalization attempts. There were no further procedure-related complications. CONCLUSION: Use of the Outback re-entry catheter system is a valuable option for interventional therapy of chronically occluded femoro-popliteal arteries following failed standard antegrade recanalization attempt.

Percutaneous retrieval of intravascular and intracardiac foreign bodies with a dedicated three-dimensional snare: a 3-year single center experience.

INTRODUCTION: The presence of symptomatic or asymptomatic intravascular/intracardiac foreign body (FB) is under-reported in the literature, but it is more commonly encountered in clinical practice. The implantation of long-term venous catheters and the number of technical challenging endovascular procedures are both constantly increasing. Thus, the number of reported FBs will also increase, becoming a serious concern, especially once associated with a cardiovascular complication. MATERIALS AND METHODS: We report the analysis of 22 patients in whom an intravascular/cardiac FBs retrieval was attempted. The details of the procedure have been discussed in depth emphasizing the technical aspects of the utilized dedicated three-dimensional snare device (Entrio snare). The technical feasibility, safety, and efficacy of the retrieval procedure were then analyzed. RESULTS: We divided our patients into two groups. Group 1 included 12 patients in whom the FB had already migrated in the right heart or in the pulmonary circulation. Group 2 included 10 patients with an intravascular FB (intravenous or intraarterial). Technical retrieval success rate was 95.5% (21/22), with a 35-min procedural mean time and no in-hospital procedural-related complications. CONCLUSIONS: Our data confirm that different kinds of FBs lodging in different sites of the cardiovascular system can safely and efficaciously be percutaneously retrieved by utilizing a dedicated three-dimensional snare device. This, therefore, suggests that this minimally invasive intervention should be rapidly attempted, thus anticipating several serious complications.

Critical review of indications for renal artery stenting: do randomized trials give the answer?

Significant renal artery stenosis (RAS) is a well accepted cause of deterioration of arterial hypertension and of renal insufficiency. Just recently, more interest has been focused on the impact of RAS on structural heart disease and patient survival. Technical improvements of diagnostic and interventional endovascular tools have lead to a more widespread use of endoluminal renal artery revascularization and extension of the indications for this type of therapy during the past 2 decades. Since the first renal artery angioplasties performed by Felix Mahler and Andreas Grüntzig, numerous single centre studies have reported the beneficial effect of percutaneous transluminal renal angioplasty, and since the early 1990's stenting of renal artery stenosis caused either by atherosclerosis or fibromuscular dysplasia. However, none of the so far published or presented randomized controlled trials (RCT) could prove a beneficial outcome of RAS revascularization compared with medical management. As a result of these negative trials including the recently presented ASTRAL trial, referrals to endovascular renal artery revascularization went down and moreover, reimbursement of these procedures became a matter of debate. This article summarizes the background and the limitations of the so far published and still ongoing controlled trials. Moreover, we discuss why well-designed registries might give important insight on the impact of endovascular revascularization of hemodynamically relevant atherosclerotic RAS.

Results after balloon angioplasty or stenting of atherosclerotic subclavian artery obstruction.

INTRODUCTION: Endovascular therapy is an accepted treatment strategy in occlusive disease of the subclavian artery. The purpose of this study was to evaluate the technical and clinical long-term outcome following either balloon angioplasty (plain balloon angioplasty (PTA)) or stenting. PATIENTS AND METHODS: The authors retrospectively analyzed 108 interventions of atherosclerotic lesions of subclavian arteries or the brachiocephalic trunk (107 patients; mean age of 66 +/- 9 years; 90% symptomatic) representing 92% of the patients treated with subclavian artery obstructive disease during a 10-year period. Primary endpoint of the study was the 1-year primary patency rate. Follow-up was based on oscillometry, Doppler blood pressure measurements, and duplex ultrasound. RESULTS: The primary success rate was 97% (100% for stenoses (78/78) and 87% for total occlusions (26/30)). Treatment modalities included PTA alone (13%; n = 14) or stenting (87%; n = 90) with balloon-expandable (n = 61), self-expanding (n = 17), or both types of devices (n = 12). The 1-year primary patency rate of the 97 patients eligible for follow-up was 88%, for the subgroups 79% (PTA) and 89% (stenting; P = 0.2). The blood pressure difference between both limbs at baseline was 45 +/- 26 mm Hg and dropped to 10 +/- 14 mm Hg (P < 0.001) after the intervention and 15 +/- 19 mm Hg at 1 year (P < 0.01). CONCLUSION: Endovascular therapy of atherosclerotic subclavian artery obstructions result in excellent acute success rates even in total occlusions. Results evince good durability of endovascular therapy for atherosclerotic occlusive disease of subclavian arteries and with a trend towards better outcome with stenting compared to PTA.

Improved renal function and blood pressure control following renal artery angioplasty: the renal artery angioplasty in patients with renal insufficiency and hypertension using a dedicated renal stent device study (PRECISION).

AIMS: To evaluate the technical performance of a dedicated renal stent device and the clinical outcome. METHODS AND RESULTS: Fifty patients with 55 renal artery stenoses (RAS) >70% (66 +/- 12 years, 58% male) were included in this non-randomised, prospective, multicentre registry. Primary endpoint was the primary patency rate at one year defined as > or =70% as determined by duplex ultrasound. Major secondary endpoints were procedural success, 30 days MACE rate, the impact of the intervention on renal function, blood pressure control, and on B-type natriuretic peptide (BNP) level. Procedural success rate was 100% and 30 days MACE rate was 0%. Restenosis rate (primary endpoint) and target lesion revascularisation rate after 12 months were 3.5% and 1.8%, respectively. After one year estimated glomerular filtration rate increased from 51 +/- 26 ml/min to 61 +/- 28 ml/min (P=0.004). Mean ambulatory blood pressure was reduced from 102 +/- 14 mmHg to 93 +/- 9 mmHg (P=0.001). Mean daily dose of antihypertensive drugs decreased from 3.0 +/- 1.7 to 2.7 +/- 1.4 (P=0.09). Mean BNP decreased from 251 +/- 282 pg/ml to 188 +/- 219 pg/ml (P=0.046) before discharge. CONCLUSIONS: Technical outcome of the tested device is favourable. The impact of the stent revascularisation on renal function and blood pressure control was promising.

Acute and long-term outcome of endovascular therapy for aortoiliac occlusive lesions stratified according to the TASC classification: a single-center experience.

PURPOSE: To compare acute and long-term outcomes of endovascular therapy for TASC (TransAtlantic Inter-Society Consensus) A and B lesions versus TASC C and D lesions. METHODS: Based on a prospectively maintained database, a retrospective analysis was conducted of 375 symptomatic patients (335 men; mean age 63+/-8 years) who underwent 438 interventions for aortoiliac arterial obstructions. Lesions were stratified according to the TASC II classification: 259 (59%) procedures involved TASC A/B lesions, while 113 (26%) were for TASC C and 66 (15%) for TASC D lesions. RESULTS: The baseline characteristics of patients with TASC A/B lesions differed significantly in the ankle-brachial index (ABI), occurrence of renal insufficiency, and lesion characteristics from those with TASC C or D lesions. Acute treatment success, defined as residual stenosis <30%, was 100%, 96%, 93%, and 100% for TASC A, B, C, and D lesions, respectively. The primary 1-year patency rate, which was 86% for the entire study cohort, was similar for all TASC classifications (89%, 86%, 86%, 85% for TASC A to D lesions, respectively). In the TASC A/B cohort, the 5-year event-free survival (70%) was not significantly better than in the C/D cohort (57%, p=0.124). The clinical outcome, as measured by Rutherford stage and ABI, improved significantly in all TASC subgroups after successful intervention and was maintained up to 1 year. Stenting was an independent predictor for lower restenosis rates (HR 0.517, 95% CI 0.317 to 0.842; p=0.008). CONCLUSION: In experienced hands, endovascular therapy of aortoiliac lesions can be successfully performed with sustained long-term outcome independent of the TASC II classification, even in class D lesions.

Arterial puncture closure using a clip device after transpopliteal retrograde approach for recanalization of the superficial femoral artery.

PURPOSE: To report the safety and efficacy of a clip device to close retrograde popliteal artery puncture sites used in recanalization of the superficial femoral artery (SFA). METHODS: From January 2005 to March 2007, 28 patients (20 men; mean age 66+/-10 years) with stable chronic peripheral artery disease were treated for chronic total SFA occlusion. All patients received aspirin and clopidogrel and were heparinized during the procedure. After failed antegrade recanalization, the SFA was revascularized via a retrograde transpopliteal access. The StarClose Vascular System was used to seal the popliteal artery puncture site. RESULTS: All (100%) interventions were finished successfully, and hemostasis was secured with the StarClose device in all cases. There was 1 (3.6%) major complication with the StarClose system: a transient popliteal artery occlusion induced by plaque shift during sheath removal, which was corrected with balloon angioplasty via the femoral access. Three (10.8%) small hematomas (<5 cm) occurred at the puncture site without causing significant patient discomfort. CONCLUSION: In this small experience, the StarClose Vascular Closure System appeared to be an effective and safe sealing device after percutaneous transpopliteal interventions. Plaque shifting leading to stenosis or occlusion at the puncture site can occur.