Jörg Tessarek

Endovascular suture versus cutdown for endovascular aneurysm repair: a prospective randomized pilot study

PURPOSE To evaluate safety and cost benefits of the percutaneous technique for treatment of aortic aneurysm, a prospective randomized study was performed that compared the endovascular suture technique with conventional cutdown access and repair. MATERIALS AND METHODS From January 2002 through July 2002, 30 endografts, including 14 Talent stent-grafts (Medtronic, Sunrise, Fla) and 16 Zenith endografts (Cook, Bloomington, Ind) were implanted in 30 patients for endovascular aneurysm treatment. The patients were randomized to either percutaneous technique (group A) or conventional cutdown (group B). Fifty-five femoral arteries were cannulated with large-bore (14F-25F) introducers and were included in the study. Safety and efficiency of both techniques were assessed by recording the complication rates, operation time, discharge, and time to ambulation. Comparison of selected estimated costs included both variable and fixed costs for femoral access and expenses for treatment of complications. RESULTS No operative deaths occurred. The complication rates were similar and included 1 arterial thrombosis in each group, 3 lymphoceles in group B, and 1 conversion to cutdown because of bleeding in group A. Mean surgery time (86.7 +/- 27 minutes vs 107.8 +/- 38.5 minutes; P <.05) and time to ambulation (20.1 +/- 4.3 hours vs 33.1 +/- 18.4 hours; P <.001) were significantly shorter in the group treated percutaneously. Because of the cost of the closure device, total cost of the percutaneous technique averaged 99.2 euro; more than cutdown. CONCLUSIONS The percutaneous technique decreases the invasiveness of endovascular therapy of aortic aneurysm and reduces operative time and time to ambulation. Complications were roughly equivalent in severity. The additional cost for the device appears to justify its use for this form of aneurysm treatment.

Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease.

OBJECTIVE Critical limb ischemia, the most severe form of peripheral arterial disease, results in extremity amputation if left untreated. Endovascular recanalization of stenotic or occluded infrapopliteal arteries has recently emerged as an effective form of therapy, although the duration of patency is typically limited by restenosis. Recently, it has been suggested that drug-eluting stents originally developed for the coronary arteries might also be effective in preventing restenosis in the infrapopliteal arteries. This prospective, randomized, controlled clinical trial tested the hypothesis that treatment of infrapopliteal arterial occlusive lesions with an everolimus-eluting stent (Xience V) would provide superior patency to treatment with a bare-metal stent (Multi-Link Vision). METHODS A sample size of 140 patients was planned to be enrolled at five European investigative sites. The primary end point was arterial patency at 12 months, defined as the absence of ≥50% restenosis based on quantitative analysis of contrast angiography. RESULTS Between March of 2008 and September of 2009, 74 patients were treated with Xience V and 66 patients were treated with Vision. After 12 months, the primary patency rate after treatment with Xience V was 85% compared with 54% after treatment with Vision (P = .0001). Treatment with Xience V significantly reduced mean in-stent diameter stenosis (21% ± 21% vs 47% ± 27%; P < .0001) and mean in-stent late lumen loss (0.78 ± 0.63 vs 1.41 ± 0.89 mm; P = .001). There were no differences in the percentage of patients receiving a designation of Rutherford class 0 or 1 at the 12-month follow-up visit (56% for Vision, vs 60% for Xience V; P = .68). Major extremity amputations were rare in both groups (two for Vision and one for Xience V). The use of the Xience V stent significantly reduced the need for repeat intervention: freedom from target lesion revascularization was 91% for Xience V vs 66% for Vision (P = .001). CONCLUSIONS Treatment of the infrapopliteal occlusive lesions of critical limb ischemia with everolimus-eluting stents reduces restenosis and the need for reintervention compared with bare metal stents.

Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study.

Purpose To report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov ). Methods The Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2–6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6±9.5 years) were enrolled at 30 international sites. Results Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5±82.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. There were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%. The ankle-brachial index, Rutherford score, and walking distance/speed scores significantly improved (p<0.001) from baseline to 12 months. Conclusions These results indicate that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy.

Secondary Procedures After Aortic Aneurysm Repair With Fenestrated and Branched Endografts

Purpose To investigate the secondary procedures in patients with previous endovascular aortic repair by fenestrated or branched stent-grafts for aneurysms involving the renal and visceral vessels. Methods Between January 2001 and May 2010, 107 consecutive high-risk patients (97 men; mean age 73 years, range 50–86) with aortic aneurysms involving the renal and visceral arteries were treated with endovascular techniques. A custom-made Zenith graft was used in all patients. All secondary graft-related procedures performed in the perioperative period and during follow-up were analyzed. Estimates of survival, freedom from migration/type I endoleak, and freedom from any device-related secondary procedures were assessed with Kaplan-Meier analyses. Results The 30-day mortality rate was 1.9%. During follow-up (mean 25 months, range 1–94), 34 secondary procedures were performed in 28 (26.2%) patients for 6 (17.6%) limb graft stenoses/thromboses (5.6% of 107 cases), 8 (23.5%) in-stent visceral vessel stenoses/ occlusions (7.5% of 107 cases), 8 (23.5%) migrations/type I endoleaks with/without visceral stent fractures (7.5% of 107 cases), and 12 (35.3%) type III endoleaks (9.3% of 107 cases). The mean interval between the primary and secondary procedures was 12.9 months (range 1?68). In 26 (76.5%) of 34 cases, a secondary endovascular procedure was performed; in the remaining 8 (23.5%) cases, the complication was treated surgically. The secondary procedure was unsuccessful in 9 cases of visceral vessel compromise (failure to cannulation, stent fracture/migration, in-stent stenosis/occlusion). Estimated 3-year survival was 77%, while the 3-year rate for freedom from any device-related secondary procedure was 75.5%. Conclusion The incidence of early and late complications requiring a secondary procedure after treatment with fenestrated or branched devices was not negligible. Endoleak type III represented the most common cause for reintervention during follow-up. Secondary procedures performed for visceral vessel compromise had high rates of treatment failure. Accurate preoperative planning, the advent of new materials/techniques, and strict follow-up could be the key factors to improving the results of fenestrated or branched stent-graft interventions and to reduce the rate of secondary procedures.

Endovascular Aortic Aneurysm Repair with the Endurant Stent-graft: Early and 1-year Results from a European Multicenter Experience

PURPOSE To assess preliminary results of the Endurant stent-graft, which was developed to treat patients with abdominal aortic aneurysms (AAAs) and challenging aortoiliac anatomy. MATERIALS AND METHODS From November 2007 to October 2008, 45 patients with AAAs were treated with the Endurant stent-graft in three European vascular centers. Thirty-eight of the 45 patients (84%) had a hostile anatomy of the proximal neck. Early (30 days), early midterm (6 months), and late midterm (1 year) results were analyzed in terms of technical success, clinical success, morbidity, and mortality. RESULTS Intraoperative immediate technical and clinical success was achieved in all cases. At completion angiography, a type II endoleak was detected in seven of the 45 patients (16%) and an iliac limb stenosis was diagnosed and successfully treated in five (11%). At discharge, computed tomography demonstrated a type I endoleak in one of the 45 patients (2.2%). At 30 days, a graft limb thrombosis was diagnosed (2.2%) and successfully treated. The 30-day overall technical and clinical success rates were 97.8% (44/45 cases) and 95.6% (43/45 cases), respectively. During follow-up (mean duration, 8 months; range, 5-16 months), the type I endoleak was successfully treated with an aortic extension. Estimated freedom from type I or III endoleak and repeat intervention at 1 year was 97.8% (44/45 cases) and 93.3% (42/45 cases), respectively. CONCLUSIONS The initial experience shows that the Endurant stent-graft appears to be effective in endovascular repair of AAAs in patients with hostile aortoiliac anatomy. This graft permits a broader group of patients to be treated with endovascular aneurysm repair; however, further studies are needed to evaluate the long-term results.

Vascular Endostapling: New Concept for Endovascular Fixation of Aortic Stent-Grafts

Purpose: To evaluate the feasibility of a new vascular endostapling system in treating infrarenal abdominal aortic aneurysms using commercially available endografts. Methods: Eight patients (6 men; mean age 71 years, range 59–82) underwent endovascular aneurysm repair (EVAR) using Talent or Zenith stent-grafts and the Anson Refix clip, which provides transmural aortic fixation of the endoprosthesis with high pullout force proportional to the number of the clips deployed. Results: Twenty (69%) of the 29 endostaples were successfully implanted and secured with the endostaple system; 9 clips that did not fully penetrate the graft and tissue due to severe calcification of the neck were retracted successfully into the delivery device. The delivery time from insertion of the Refix delivery catheter to its withdrawal was a mean 57 minutes (range 20–102) over and above the regular stent-graft procedure. Notably, the delivery time was reduced as the learning curve was passed: mean 89.75 minutes in the first 4 cases versus 27.5 minutes in the last 4. No endostaple migrated or was lost from the intended deployment site based on radiological imaging. No patients had evidence of perioperative endoleak based on computed tomography. No endograft-related complications have been documented during follow-up at 30 days. Conclusion: The initial experience established the safety and feasibility of EVAR using the Anson Refix endostapling system. However, further clinical evaluation is mandatory to draw robust conclusions about the utility of this new concept for fixation of aortic stent-grafts.

Below-knee Bare Nitinol Stent Placement in High-risk Patients with Critical Limb Ischaemia and Unlimited Supragenicular Inflow as Treatment of Choice

PURPOSE To evaluate the effectiveness of nitinol stent placement in long infrapopliteal lesions in patients with critical limb ischaemia. MATERIALS AND METHODS Between January 2005 and January 2008, 34 high-risk patients (18 female; mean age: 73.8+/-6.1 years) with critical limb ischaemia underwent infragenicular stenting. They had serious cardiovascular co-morbidities (>3, such as chronic obstructive pulmonary disease (COPD), congestive heart failure and coronary artery occlusive disease), American Society of Anaesthesiologists score of 3 or more, previous myocardial infarction, coronary stent or bypass. The mean stenosis length was 6.5+/-0.9 cm (range: 2.2-8 cm), and the mean occlusion length was 7.5+/-2.9 cm (range: 3-9.6 cm). Primary stent implantation was performed for long stenosis or occlusion based on the TransAtlantic InterSociety Consensus (TASC) C and D classification, secondary stenting for flow-limiting dissections or elastic recoil after balloon dilatation. All patients who returned to the outpatient clinic were assessed for claudication by clinical examination, ankle-brachial index (ABI) measurements, colour flow and duplex Doppler ultrasound (US). Digital subtraction angiography was performed if restenosis or re-occlusion was identified by Doppler US or transcutaneous measurement of partial oxygen pressure (TcpO(2)) measurements, when appropriate. RESULTS The technical success rate was 97.1% (33 of 34 cases). The crude rate of primary patency rate was 91.1% during a follow-up period of 10.4+/-7.3 months. The mean ankle-brachial index increased significantly following intervention (0.45+/-0.25-0.92+/-0.13, p<0.001). Two patients underwent successful redo angioplasty after tibioperoneal interventions due to in-stent restenosis (>70%) with relevant limitation of pain-free walking distance. In another patient, bypass surgery to the anterior tibial artery 6 months after primary intervention was necessary due to rest pain. Two patients required surgical revision of the femoral artery after antegrade access. No procedure-related death was recorded in the entire follow-up period. CONCLUSIONS The mid-term outcome underscores infrapopliteal stent placement as a reliable treatment option in patients with critical limb ischaemia. In patients at high risk for crural bypass, with no flow-limiting supragenicular lesions, below-knee stent-supported angioplasty should be considered as a first choice of treatment.

Hybrid Thoracoabdominal Aneurysm Repair with Simultaneous Antegrade Visceral Revascularization and Supra-Aortic Debranching from the Ascending Aorta

Purpose: To describe a hybrid technique involving combined antegrade revascularization of both supra-aortic and visceral arteries and complete exclusion of a dissecting thoracoabdominal aortic aneurysm (TAAA). Technique: A 46-year-old man had a dissecting TAAA involving the left subclavian artery (LSA) and the descending thoracic and abdominal aorta down to the left common iliac artery. The ascending aorta was the only feasible source of inflow to the cerebral and visceral vessels. Via a median thoracolaparotomy, the supra-aortic and visceral arteries were dissected, and an octopus graft was implanted using 3 bifurcated Dacron grafts. An 18-×9-mm bifurcated Dacron graft was anastomosed in an end-to-side fashion to the ascending aorta, the brachiocephalic trunk, and the left common carotid artery. A 16-×8-mm bifurcated Dacron graft was sutured end-to-side to the celiac artery and superior mesenteric artery. A third 12-×7-mm bifurcated graft was sutured to both renal arteries. In a second step, 3 tapered custom-made thoracic Zenith T×2 endografts were used to repair the thoracic and the thoracoabdominal aorta. A bifurcated Zenith AAA device was used to treat the aneurysm at the level of the infrarenal aorta and both iliac arteries. Despite covering the LSA and all intercostal and lumbar arteries, the patient developed only a temporary paresis of the left leg. Computed tomography showed complete exclusion of the aneurysm and normal flow to the supra-aortic and visceral arteries. Conclusion: In selected cases, this hybrid approach using the ascending aorta for antegrade revascularization of cerebral and visceral arteries is feasible, with acceptable perioperative morbidity. However, its role for the treatment of complex thoracoabdominal aortic disease must be evaluated further.

Retrograde stenting of a recurrent degenerative aneurysm of the superior mesenteric artery.

Sonneson and colleagues recently described a hybrid technique for recanalizing a superior mesenteric artery (SMA) occlusion. This combined surgical and retrograde interventional approach for chronic SMA occlusion is viable, but we have used the retrograde approach to the SMA in a new way: to exclude an aneurysm. We encountered a 64-year-old man whose symptoms of abdominal pain were due to a recurrent 34-mm SMA aneurysm (Figure, A) that had been treated some years before via a transperitoneal approach at an outside hospital. Computed tomography (CT) showed a proximal neck favorable for stentgraft deployment, but there was a short distal landing zone because the SMA split into 3 major vessels at the distal end of the aneurysm (Figure, B,C). Nevertheless, an interventional attempt was made, but it proved impossible to stabilize any guidewire distal to the aneurysm. The procedure was abandoned. Some days later, under general anesthesia, a median laparotomy was performed via the old scar. The distal aspect of the aneurysm was exposed, and the 3 main draining vessels were identified in the scar tissue (Figure, D). The largest of these was punctured and a 5-F sheath (Terumo Medical Corporation, Tokyo, Japan) inserted. After heparinization (5000 units), a 0.035-inch angled soft guidewire (Terumo) was crossed into the aorta and exchanged to a 0.035-inch Supracore wire (Abbott Laboratories, Abbott Park, IN, USA) over an angiographic catheter. After changing the 5-F to a 10-F sheath, a 13.5-3120-mm Fluency Plus stent-graft (Bard Inc., Murray Hill, NJ, USA) was placed into the SMA, covering the entire distance from the aorta to the short distal landing zone (Figure, E). The graft extended into the aorta for about 10 mm, which was unavoidable due to the length that was selected based on the preoperative CT scan. The sheath was removed, and the puncture site closed with 6-0 Prolene suture. After inspection of the well perfused bowel, the abdomen was closed. The patient was well, with no signs of graft failure at 6 months; the CT scan showed no endoleak (Figure, F). Retrograde access to an SMA aneurysm via a median laparotomy in a previously operated abdomen avoids the major scared areas at the proximal SMA and near the aorta. Even with some scar tissue at the distal end of the aneurysm, the major SMA branches could be isolated and the biggest used as access. We chose a flexible self-expanding stent-graft to allow conformation to the SMA anatomy, although balloon-expandable stent-grafts have been used here. Under fluoroscopy, the distal landing zone was easy to identify through the sheath; proximally, we calculated a liberal overlap into the aorta. Our initial interventional attempt failed because it was not possible to stabilize a wire and a sheath for later stenting. Although a brachial access was considered, we expected it to fail as well. Moreover, a 9-F sheath would have been required for advancing the stentgraft. Had we encountered problems implanting the stent-graft, we could have tried proximal occlusion of the SMA and distal ligation of the aneurysm with an anteor retrograde bypass from the aorta, the hepatic artery, or the iliac artery to the distal SMA. Alternatively, we could have occluded the SMA and resected the non-perfused bowel areas, although this would have been a problem in this case because the main stem of the SMA was affected. In the short term, this combined approach has several advantages, but durability of sucha long stent-graft in thisvessel is notwell known.Type I endoleak,especiallydistal, can occur if thestentgraft retracts into the aneurysm. Stent fractures are possible as well, with or without consequences for graft patency. One could speculate that a chronic occlusion willoccur with sufficient collateralization from the celiac trunk and the inferior mesenteric artery. The worst case scenario would be an acute occlusion requiring 244 J ENDOVASC THER 2008;15:244–247

Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry

Purpose: To evaluate the safety and performance of the Treovance stent-graft. Methods: The global, multicenter RATIONALE registry (ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes. Results: Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related. Conclusion: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting.