Spiridon Botsios

First Experience With Drug-Eluting Balloons in Infrapopliteal Arteries: Restenosis Rate and Clinical Outcome

OBJECTIVES The purpose of this study was to investigate the efficacy of drug-eluting balloons (DEBs) in the treatment of long infrapopliteal lesions with regard to the short-term restenosis rate and midterm clinical result. BACKGROUND Restenosis rates of long-segment tibial artery disease are very high. Recently, a restenosis rate of 69% at 3 months after standard balloon angioplasty was demonstrated. METHODS Infrapopliteal angioplasty was performed with a paclitaxel-eluting balloon (In.Pact Amphirion, Medtronic, Minneapolis, Minnesota). Clinical and angiographic follow-up was performed at 3 months to detect binary restenosis, and further clinical assessment was performed over a 12-month period thereafter. RESULTS In 104 patients, 109 limbs were treated for critical limb ischemia (82.6%) or severe claudication (17.4%). Mean lesion length of the arteries treated was 176 ± 88 mm. Angiography studied in 84 treated arteries at 3 months showed a restenosis in 27.4% (19.1% had restenosis of more than 50%, and 8.3% were totally occluded) and usually occurred focally. Only in 9.5% of all angiographically followed up arteries was the entire treated segment restenosed or reoccluded. During a follow-up period of 378 ± 65 days, 1 patient was lost and 17 died. Of the 91 limbs remaining in the analysis, clinical improvement was present in 83 (91.2%). Complete wound healing occurred in 74.2%, whereas major amputation occurred in 4 patients, resulting in limb salvage of 95.6% for patients with critical limb ischemia. CONCLUSIONS The early restenosis rate of long-segment infrapopliteal disease is significantly lower after treatment with DEBs compared with historical data using uncoated balloons. Randomized trials are required to show whether this difference will lead to improvement in clinical outcomes.

Retrograde Approach for Complex Popliteal and Tibioperoneal Occlusions

Purpose: To describe the technical aspects of the retrograde approach for endovascular treatment of complex popliteal and/or tibioperoneal occlusions and determine its efficacy in minimizing failure rates. Methods: An observational registry of retrograde revascularizations was maintained at our institution over 14 months (September 2006 to December 2007). During this time frame, antegrade revascularization failed in 62 (17.8%) of 343 limbs with complex total occlusions of the popliteal and/or infrapopliteal vascular territory. Of these antegrade failures, 51 (82.2%) limbs in 51 patients (32 men; mean age 72±8 years) were suitable for a retrograde attempt. From this subgroup, 45 (88.2%) were treated via a percutaneous transpedal access site and 6 (11.8%) via a transcollateral intra-arterial technique. Results: The overall success rate was 86.3% (44/51); adjunctive stenting was needed in 21 (41.1%) to optimize results. Only 1 (1.9%) major complication (a pedal access site occlusion) and 4 (7.8%) minor sequelae (arterial perforation in 3 and a pedal hematoma without consequence) were documented. Conclusion: In complex popliteal to infrapopliteal occlusions, an antegrade recanalization attempt can fail in up to 20% of the cases. The additional use of a retrograde approach seems feasible and safe and can favorably modify this failure rate. This technique could be valuable for patients with critical limb ischemia due to popliteal and infrapopliteal occlusions once larger studies with follow-up confirm safety, efficacy, and clinical benefit.

Angiographic patency and clinical outcome after balloon‐angioplasty for extensive infrapopliteal arterial disease

Background and objective: Restenosis‐rate after balloon‐angioplasty of long segment tibial arterial disease is largely unknown. We investigated the restenosis‐rates angiographically in patients with critical limb ischemia (CLI) due to extensive infrapopliteal lesions. Methods: Angioplasty for infrapopliteal lesions exclusively ≥80 mm in length was performed using dedicated 80–120 mm long low‐profile balloons. Follow‐up included angiography at 3 months and clinical assessment at 3 and 15 months. Results: Angioplasty was performed in 77 infrapopliteal arteries of 62 limbs of 58 CLI patients with a Rutherford class 4 in 16 (25.8%) limbs and Rutherford class 5 in 46 limbs (74.2%). Average lesion length was 18.4 cm. Treated arteries were stenosed in 35.1% and occluded in 64.9%. After 3 months, a clinical improvement (marked reduction of ulcer‐size or restpain) was seen in 47 (75.8%) limbs, 14 (22.6%) limbs were clinically unchanged and 1 (1.6%) limb showed a clinical deterioration. Angiography at 3 months showed no significant restenosis in 24 of 77 (31.2%) treated arteries, a restenosis ≥50% in 24 (31.2%) arteries and a reocclusion in 29 of 77 (37.6%). At 15 months death rate was 10.5%. After repeat angioplasty in case of restenosis cumulative clinical results at 15 months were minor amputations in 8.1%, no major amputations resulting in a limb‐salvage rate of 100% with no patient requiring bypass surgery. Conclusions: Restenosis‐rate after angioplasty of extensive infrapopliteal arterial disease is high and occurs early after treatment. Despite this the clinical results are excellent, especially given the length of the arterial segments diseased.

Retrograde recanalization technique for use after failed antegrade angioplasty in chronic femoral artery occlusions.

Purpose To describe a technique to approach chronic total occlusions (CTOs) of the superficial femoral artery (SFA) after failed antegrade recanalization as an alternative to a conventional transpopliteal approach. Methods A retrospective analysis was undertaken of 50 patients (37 men; mean age 71 years) who underwent retrograde recanalization via a distal SFA access after failed antegrade recanalization of SFA CTOs that were not beyond the adductor canal. Antegrade recanalization failed due to flush SFA occlusion, occluded stents, wire perforation, and re-entry failure. Retrograde SFA access required introduction of a 7- to 15-cm, 21-G needle distal to the occlusion. A 0.018-inch guidewire was inserted through the needle followed by a 4- or 6-F, 10-cm sheath or dedicated support catheter only. All retrograde SFA punctures were performed with the patient in the supine position. Once retrograde passage of the occlusion was successful, oftentimes requiring a “double-balloon” technique to disrupt the dissection membrane with abutting balloons delivered from both access sites, balloon angioplasty and/or stenting could be performed from either direction. Results Retrograde puncture of the distal SFA was successful in all cases. Retrograde recanalization involved insertion of a 6-F sheath in 3 (6%) cases, a 4-F sheath in 32 (64%), and a sheathless approach in 15 (30%). The “double-balloon” technique was necessary to achieve guidewire passage in 12 cases. Recanalization was successful in 48 (96%) cases. Hemostasis time at the distal puncture site was 9.2 minutes (range 3–30). Perioperative complications included 4 pseudoaneurysms (2 groins, 2 distal), 1 peripheral embolization, and 1 small arteriovenous fistula at the distal puncture site. Conclusion For failure of antegrade recanalization of SFA occlusions, the retrograde SFA puncture distal to the adductor canal with the patient remaining supine is a safe and successful technique that represents a convenient alternative to the conventional transpopliteal approach.

Outback catheter for femoropopliteal occlusions: immediate and long-term results.

Purpose: To report a retrospective, single-center study that evaluates technical and clinical outcomes from subintimal recanalization of femoropopliteal chronic total occlusions (CTO) facilitated by the Outback re-entry catheter. Methods: The Outback catheter was required to complete recanalization of femoropopliteal CTOs (mean lesion length 195±91 mm) in 118 limbs of 113 patients (77 men; mean age 70±10 years). In 80/118 (67.8%) limbs, treatment was performed for claudication and in the remaining 38 (32.2%) for critical limb ischemia (CLI). Technical and procedural success, clinical outcome, and cumulative patency rates in follow-up were evaluated. Results: Re-entry was accomplished in 108/118 limbs (91.5%) with recanalization completed in 107/118 (90.7%). Of these, only 61/107 (57%) arteries were left with a residual stenosis <30%. Complications included minor bleeding of the target vessel (5/118, 4.2%) and minor hematoma/pseudoaneurysm at the access site (6/118, 5.1%). Acute reocclusion developed in 2/118 cases (1.7%) without major complication. After 12 months, primary patency was 56.7%, assisted primary patency 83.1%, and secondary patency 89.1%. Primary patency was significantly reduced in limbs with residual stenosis. Over a median 15-month follow-up (range 2–32), 4 major and 2 minor amputations were performed in patients with CLI. Conclusion: The Outback catheter is a reliable tool to recanalize challenging chronic femoropopliteal occlusions after failed guidewire re-entry. Restenosis rates are high, which may be due to the severity and extent of disease in these patients, who are particularly challenging.

Drug-Eluting Stents for the Treatment of Vertebral Artery Origin Stenosis

Purpose: To present our experience with the use of drug-eluting stents (DES) in patients with symptomatic vertebral artery ostium stenosis (VAOS). Methods: Between 2003 and 2008, 28 consecutive patients (17 men; mean age 66 years) with symptomatic extracranial vertebral artery stenosis were treated with a paclitaxel-eluting stent. All patients were prospectively scheduled for serial clinical, duplex, and angiographic follow-up to identify restenosis. Results: After stent implantation, the mean stenosis was reduced from 68% to 9%. There were no periprocedural neurological complications. After a mean follow-up of 16 months (range 5–41), no strokes, worsening of symptoms, or deaths occurred. Angiographic restenosis >50% was seen in 6 (21.4%) patients. Restenosis occurred significantly more often in patients with an ipsilateral subclavian artery stenosis (p=0.01). Radiography during follow-up angiography revealed stent fracture in 1 patient and stent compression/kinking in 11 (39%) of the patients. Stent compression and recoil, not intimal hyperplasia, were the major contributing factors to restenosis. Conclusion: Compared to the restenosis rate of bare metal stents reported in the literature, DES seems to be superior for the treatment of VAOS. However, stent compression and recoil are relevant problems contributing to restenosis. Further improvement of the materials for the interventional treatment of VAOS seems necessary.

Anatomic variables contributing to a higher periprocedural incidence of stroke and TIA in carotid artery stenting: single center experience of 833 consecutive cases.

This study was conducted to identify patient‐related variables that are associated with a higher rate of neurological adverse events during carotid artery stenting (CAS).

Sirolimus-Eluting Stents for the Treatment of Infrapopliteal Arteries in Chronic Limb Ischemia: Long-term Clinical and Angiographic Follow-up:

Purpose To present the 5-year angiographic and clinical results of a retrospective registry assessing the performance of sirolimus-eluting stents (SES) in the treatment of infrapopliteal atherosclerotic disease. Methods From 2004 to 2009, 158 patients (95 men; mean age 71.9 years) with chronic lower limb ischemia (Rutherford categories 3–6) underwent primary SES placement in focal infrapopliteal lesions. The angiographic endpoint was patency, defined as freedom from in-stent stenosis (ISS) >50%. Clinical endpoints were death, amputation, and bypass surgery. Results were correlated with patient and lesion characteristics and cumulative outcomes were assessed with Kaplan-Meier analysis. Results Technical success was achieved in all cases. The primary patency rates were 97.0% after 6 months, 87.0% after 12 months, and 83.8% at 60 months. In-stent stenosis was predominantly observed in the first year after stent placement. Female gender was associated with a higher rate of ISS. During clinical follow-up of 144 (91%) patients over a mean 31.1±20.3 months, there were 27 (18.8%) deaths, 4 (2.8%) amputations, and no bypass surgery. Clinical status improved in 92% of the patients with critical limb ischemia (CLI) and 77% of the patients suffering from claudication (p=0.022). Conclusion Treatment of focal infrapopliteal lesions with SES showed encouraging long-term angiographic results in this registry. Clinical improvement was evident, but more pronounced in CLI patients than in patients suffering from claudication. Further studies are needed to evaluate the potential clinical benefit of SES as compared to balloon angioplasty or bare metal stents in the treatment of infrapopliteal lesions.

Late open conversion after endovascular aneurysm repair

OBJECTIVES Endovascular treatment of the infrarenal abdominal aorta (endovascular repair, EVAR) has emerged as an alternative to open surgery. However, a small subset of patients exists who undergo conversion either in the first 30 postoperative days or later during the course of postoperative surveillance. In the present study, we review our experience with late conversion operations. METHODS Between December 2004 and August 2012, 411 EVARs were performed. During the same time interval, nine patients (males) with a mean age of 71 years (range, 59-79 years) required late open conversion. The median interval between EVAR and the conversion operation was 34 months (range 14-60 months). RESULTS The indications for late conversion included persistent proximal type I endoleak (n = 2), type II endoleak with sac enlargement (n = 1), aneurysm rupture (n = 1), endotension (n = 2), stent-graft thrombosis (n = 1) and stent-graft infection (n = 2). Complete stent-graft explantation was performed in five patients. Eight patients underwent elective conversion. One patient presenting with rupture had an emergency operation. The 30-day mortality rate was 0%. CONCLUSIONS Late open conversion after EVAR can be performed safely and successfully. Complete stent-graft explantation may be our preferred treatment option, but it is not always necessary, except in cases presenting with graft infection.

Postinterventional microembolism signals detected by transcranial Doppler ultrasound after carotid artery stenting

BACKGROUND The occurrence of early post-procedural complications after carotid artery stenting (CAS) can be attributed to embolization of thrombus or plaque particles released from the stented segment. Vascular emboli can be non-invasively detected by transcranial Doppler ultrasound as microembolic signals (MES). We performed this study to discover factors predicting MES detected by transcranial Doppler (TCD)-monitoring within the early post-interventional phase. PATIENTS AND METHODS In 134 consecutive patients undergoing CAS, transcranial Doppler monitoring of the ipsilateral middle cerebral artery was performed for MES detection during the first post-interventional hour. To identify clinical, morphologic, and procedure-related parameters likely to predict the occurrence of post-interventional MES a logistic regression analysis was performed. RESULTS In 134 patients (111 male, mean age 69.7 years) relevant MES were detected in 51 patients (38 %) with a median of 4 MES/h and a maximum of 62 MES/h. Three factors were observed to be associated with increased post-interventional MES-counts. These included symptomatic lesion (p < 0.05), elevated total cholesterol (p < 0.05), and aspirin monotherapy (p < 0.0005). In a binary logistic regression model, dual antiplatelet therapy (OR 5.6, p < 0.0005) and asymptomatic lesions (OR 2.6, p < 0.05) were revealed as independent predictors for the absence of post-interventional MES. CONCLUSIONS Post-interventional MES were most likely in symptomatic lesions and patients with elevated cholesterol. The absence of an effective dual antiplatelet therapy and symptomatic lesions were revealed as independent predictors for post-interventional MES. An effective pre-interventional dual antiplatelet and lipid lowering therapy might improve the safety of CAS.