Ramon L. Varcoe

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.

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.

Diverticulectomy is inadequate treatment for short Meckel's diverticulum with heterotopic mucosa.

Background:  Meckels diverticulum is a vestigial remnant of the vitellointestinal duct that may occasionally contain heterotopic gastric mucosa thought to arise from residual yolk sac cells. This may cause significant rectal bleeding, the source of which may be difficult to identify. The present paper addresses the question of whether the choice of resection technique should depend on the macroscopic appearance of the Meckels diverticulum.

Drug-Coated Balloons for Complex Femoropopliteal Lesions: 2-Year Results of a Real-World Registry

OBJECTIVES The authors sought to investigate the efficacy of a drug-coated balloon (DCB) for treatment of complex femoropopliteal lesions. BACKGROUND Superiority of DCBs compared with uncoated balloon angioplasty for femoropopliteal interventions has been demonstrated in randomized trials for short lesions. Their performance in complex lesions with higher restenosis rates is unclear. METHODS Patency, target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints of femoropopliteal lesions in 288 limbs (n = 260) treated with the In.Pact Pacific or Admiral DCB (Medtronic, Minneapolis, Minnesota) were retrospectively analyzed for up to 2 years of follow-up. Predictors of restenosis were identified by logistic regression. RESULTS Lesions were de novo in 51.7%, restenosis in 11.1%, and in-stent restenosis in 37.2%. Mean lesion length was 24.0 ± 10.2 cm, and 65.3% were occluded. Stent implantation was performed in 23.3%. Kaplan Meier estimates of primary patency were 79.2% and 53.7% for all lesions at 1 and 2 years, respectively, whereas freedom from TLR was 85.4% and 68.6%. Primary patency for in-stent restenosis treatment was 76.6% and 48.6%, and freedom from TLR was 83.0% and 58.7% at 1 and 2 years, respectively. Rutherford category improved from a median 3.3 to 1.2 at 1 year, and to 1.1 at 2 years. Major amputation rate was 2.1% at 2 years. No adverse events were thought to be attributable to the coating of the balloon. CONCLUSIONS These results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract. Further studies are recommended to confirm these results.

Initial Experience With the Absorb Bioresorbable Vascular Scaffold Below the Knee: Six-Month Clinical and Imaging Outcomes

Purpose: To investigate a new bioresorbable vascular scaffold for the treatment of focal tibial and distal popliteal lesions. Methods: Tibial and distal popliteal angioplasty was performed in 15 limbs of 14 patients (9 men; median age 82 years) with critical limb ischemia (CLI, n=7) or severe claudication. The 18 lesions (mean length 22.2±14.0 mm) were implanted with 22 everolimus-eluting bioresorbable scaffolds (Absorb). Clinical and ultrasound follow-up was performed at 1, 3, 6, and 12 months to detect restenosis and evaluate safety, midterm restenosis rate, and clinical improvement. Results: Immediate technical success was 100%, although a single limb suffered 2 scaffold thromboses on the first day; it was salvaged with repeat endovascular intervention. All patients were available for surveillance examinations during a follow-up of 6.1±3.9 months; no patient died. Of the 15 limbs in the analysis, clinical improvement was present in 12 (4 of 7 CLI patients); there was no amputation, bypass surgery, or evidence of binary restenosis on follow-up sonographic examination. Conclusion: Midterm follow-up for this small pilot sample demonstrates acceptable safety and patency results, together with freedom from all major adverse limb events, using the Absorb bioresorbable vascular scaffold below the knee.

An Endovascular-First Approach to the Treatment of Critical Limb Ischemia Results in Superior Limb Salvage Rates:

Purpose: To evaluate the effect of a shift to a primary endovascular revascularization (ER) strategy for patients presenting with critical limb ischemia (CLI) after a change in staff at our center in 2008 altered our revascularization strategy. Methods: Between 2004 and 2012, 344 critically ischemic limbs were treated in 279 patients (mean age 74.0±11.4 years; 179 men) during 546 separate hospital admissions. Limbs were analyzed according to (1) their principal revascularization strategy and (2) their date of presentation [early (2004–2008) or late (2008–2012)]. Results: Compared with the open revascularization (OR) and no revascularization (NR) groups, the ER group had an increased freedom from major amputation (92.3% vs 80.0% OR vs 69.3% NR, p<0.001), reduced hospital stay (15.2 vs OR 31.6 vs NR 25.9 days, p<0.001), intensive care unit (ICU) stay (2.3 vs OR 23.7 vs NR 7.2 hours, p=0.033), and operating time for ER vs OR (157.9 vs 316.8 minutes, respectively; p<0.0001). There was also a significant decrease in limbs requiring minor amputations (23.2% vs OR 29.3% vs NR 37.6%, p=0.041) and mean number of admissions/limb compared to OR (1.5 vs OR 1.9 vs NR 1.5, p=0.007). The late era saw the treatment of a larger number of limbs (223 vs 121) compared with the earlier time period. This institutional shift resulted in increased freedom from major amputation (87.4% vs 74.4%, p<0.01), reduced ICU stay (3.45 vs 16.98 hours, p<0.01), and shorter length of stay (20.9 vs 31.5 days, p<0.01) between the 2 eras, respectively. Conclusion: A shift to an endovascular-first treatment strategy is associated with fewer major amputations and shorter length of stay.

Endovascular Reconstruction of the Occluded Aortoiliac Segment using “Double-Barrel” Self-Expanding Stents and Selective Use of the Outback LTD Catheter

Purpose: To present the early and midterm results of endovascular stent reconstruction of the occluded aortoiliac segment with selective use of the Outback LTD re-entry catheter. Methods: Between April 2004 and February 2010, 8 patients (5 women; mean age 58.4 years, range 47–68) with occlusion of the infrarenal aorta extending to the common or external iliac arteries underwent endovascular reconstruction with double-barrel self-expanding stents. Indications for treatment were severe claudication in 6 and ulceration in 2 patients. Results: The technical success rate was 100%, facilitated by the use of the Outback LTD catheter for accurate wire re-entry in 3 cases. There was no in-hospital mortality. One patient had a major complication (femoral artery dissection, brachial artery thrombosis, and retroperitoneal hematoma) unrelated to the re-entry device. Mean operating time was 137 minutes (range 70–253) and length of stay was 1.5 days (range 1–2). During a mean follow-up of 12.5 months (range 6–29), primary patency was 100% with no secondary interventions. Conclusion: Total endovascular reconstruction of the occluded infrarenal aorta that extends into the iliac arteries is durable at midterm follow-up. Adjunctive use of the Outback LTD re-entry catheter can facilitate technical success.

Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Arteries Below the Knee: 12-Month Clinical and Imaging Outcomes.

OBJECTIVES The aim of this study was to investigate the midterm performance of an everolimus-eluting, bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, California) for the treatment of focal tibial and distal popliteal lesions. BACKGROUND Drug-eluting stents are used below the knee to improve technical success and durability, but the ongoing presence of a permanent metal scaffold may have deleterious effects on the local vessel. METHODS Tibial and distal popliteal angioplasty with scaffold placement was performed using an everolimus-eluting, bioresorbable scaffold (Absorb). Clinical and ultrasound follow-up was performed at 1, 3, 6, 12, and 24 months to detect binary restenosis and evaluate safety, restenosis, and clinical improvement. RESULTS Thirty-eight limbs in 33 patients were treated for critical limb ischemia (68.4%) or severe claudication (31.6%). Fifty scaffolds were used to treat a total of 43 lesions, with a mean length of 19.2 ± 11.6 mm. During a mean follow-up period of 12.0 ± 3.9 months, 5 patients died, and all others were available for follow-up. Among the 38 treated limbs, clinical improvement was present in 30 (79%). Binary restenosis was detected in 3 of 50 scaffolds (6%). Using the Kaplan-Meier method, rates of primary patency were 96% and 84.6% at 12 and 24 months, respectively, and rates of freedom from clinically driven target lesion revascularization were 96% and 96% at 12 and 24 months, respectively. Complete wound healing occurred in 64% of those treated for tissue loss, with no major amputation and a limb-salvage rate of 100%. CONCLUSIONS Twelve-month follow-up demonstrated excellent safety, patency, and freedom from target lesion revascularization using the Absorb bioresorbable vascular scaffold below the knee.