Giovanni Torsello

Rupture of abdominal aortic aneurysm previously treated by endovascular stentgraft

We describe a case of abdominal aortic aneurysm (AAA) with rupture 16 months after treatment by an endograft. A 76-year-old patient on Coumadin after aortic valve replacement had initially successful exclusion by stentgraft. There was no evidence of an endoleak seven months after stentgraft repair, although a computed tomography scan detected an enlargement of the aneurysm sac. Sixteen months after initial endograft surgery, rupture of the aneurysm occurred and we performed open emergency surgery. We treated the aneurysm by conventional technique, and the patient survived the rupture. This case emphasized the fact that patients after endograft AAA repair require a close follow-up. An expansion of the aneurysm sac after the procedure should signal failed exclusion, even if a computed tomography scan does not demonstrate an endoleak. Anticoagulation can be an important factor in failure after endoluminal graft treatment. Supravisceral aortic cross clamping is helpful in dealing with a stented aorta.

Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study.

Purpose: To evaluate the long-term efficacy and integrity of the PROTÉGÉ EverFlex stent in superficial femoral artery (SFA) lesions in symptomatic patients with peripheral artery disease (PAD). Methods: A prospective, multicenter, nonrandomized study enrolled 151 subjects (111 men; mean age 67.8 years, range 42–93) undergoing percutaneous treatment of de novo, restenotic, or reoccluded SFA lesions between August 11, 2006, and June 26, 2007. Subjects were scheduled to receive a single stent and be evaluated through 12 months following the implant procedure. Occlusions were present in 40% of the patients. Mean lesion length was 96.4 mm (range 10–150). Results: A total of 161 stents (158 EverFlex) were implanted in the 151 patients: single stents in 93.4% (141/151) and a second stent in 6.6% (10/151). One-year follow-up information was available for 88.7% (134/151) of the study participants; of the remaining 17 subjects, 6 subjects withdrew from the study, 2 were lost to follow-up, and 9 died. Freedom from restenosis data were available for 99.3% (133/134) of the subjects who completed a 12-month follow-up visit. The mean Rutherford classification fell from 2.8±0.8 (range 1–5) at baseline to 0.6±1.1 (range 0–5) at 12 months. The mean ankle-brachial index rose from 0.6±0.2 (range 0–1.4) at baseline to 0.9±0.2 (range 0–1.2) at 12 months. The rates for freedom from >50% restenosis at 6 and 12 months were 91.3% (95% CI 84.9% to 95.2%) and 72.2% (95% CI 63.8% to 79.6%), respectively. The freedom from target lesion revascularization rate at 12 months was 79.1% (95% CI 71.2% to 85.6%). The 1-year stent fracture rate was 8.1% (95% CI 4.0% to 14.4%). Conclusion: The high freedom from >50% restenosis and low fracture rate at 12 months suggests that the PROTÉGÉ EverFlex stent offers a safe and acceptably efficacious means of treating SFA lesions in symptomatic subjects with PAD.

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.

Use of covered chimney stents for pararenal aortic pathologies is safe and feasible with excellent patency and low incidence of endoleaks.

BACKGROUND To present the clinical experience of consecutive series with use of balloon-expandable and self-expanding chimney endografts (balloon-expandable covered stent group [BECS] vs self-expanding covered stent group [SECS]) in the endovascular treatment of challenging aortic pathologies requiring renal and/or visceral revascularization. METHODS Between January 2009 and May 2011, data for 37 high-risk patients from one center and 35 patients from another institution, with pararenal aortic pathologies treated by the chimney endovascular technique, were prospectively collected. The chimney-graft technique is based on the deployment of a covered or bare-metal stent parallel to the aortic endograft, thereby creating a conduit that runs outside the aortic main endograft, and has been proposed to ensure secure proximal fixation extending the sealing zones. RESULTS Forty-six consecutive target vessels (43 renal arteries and 3 superior mesenteric arteries) were revascularized by the Advanta (Atrium, Hudson, NH) BECS (1.2 chimneys/patient); in contrast, 81 consecutive target vessels (64 renal arteries, 11 superior mesenteric arteries, and 6 celiac trunks) were revascularized by the Viabahn (Gore, Flagstaff, Ariz) SECS (2.3 chimneys/patient). The success rate for target vessel preservation was 97.8% for the BECS group and 100% for the SECS group in the entire follow up. There was one symptomatic left renal artery occlusion of the BECS group treated by open thrombectomy of the left renal artery and placement of 8-mm Dacron (BBraun, Aesculap AG, Tuttlingen, Germany) iliorenal bypass. Additionally, one patient underwent repeat balloon angioplasty with a 5-mm balloon due to high-grade in-stent stenosis of a 6 × 59 Advanta stent graft 12 months postoperatively. Overall, one perioperative (and not present in the computed tomography angiography at discharge) type Ia endoleak was detected in the BECS group. In contrast, five perioperative type Ia endoleaks were present in the SECS group; however, only one of them was persistent in the radiological imaging and was treated by proximal extension of a 5-mm cuff, 1 year postoperatively, due to continuous aneurismal sac increase. No patient of any subgroup developed postoperative persistent renal insufficiency with need of hemodialysis. Thirty-day and during the follow-up procedure-related mortality was 0% for both BECS and SECS groups. CONCLUSIONS In summary, midterm results of use of covered chimney stents for pararenal aortic pathologies show safety and feasibility with excellent patency and low incidence of endoleaks.

Percutaneous endovascular aortic aneurysm repair: a prospective evaluation of safety, efficiency, and risk factors.

Purpose: To evaluate the efficiency of totally percutaneous endovascular aortic aneurysm repair in a large cohort of patients and to define risk factors for failure with a 10-F vascular closure system. Methods: A prospective study examined the feasibility and safety of percutaneous femoral artery closure with a single Prostar XL 10-F vascular closure device applied in conjunction with the preclose technique. Between January 2004 and December 2005, 535 consecutive patients were treated for aortic aneurysmal disease. Thirty-five patients were excluded, leaving 500 patients (417 men; mean age 72±6.6 years) treated for aortic aneurysms using the Talent or Zenith stent-graft delivered through sheaths measuring 14-F (191, 21.2%), 16-F (33, 3.7%), 18-F (179, 19.8%), 20-F (2, 0.2%), 22-F (228, 25.2%), and 24-F (271, 29.9%). Primary clinical success was defined as the freedom from additional early or late procedures to treat any complication at the access site. Data were analyzed to reveal any correlation of access site complications or early/late repairs to operator experience or risk factors (obesity, extensive femoral artery calcification, and previous interventions/scars in the groin). Results: Primary success was achieved in 96.1% of all percutaneous approaches. Twenty-three patients developed early (n=16) or late (n=7) complications at the access vessel; in 12 cases, hemostasis was achieved using pledgets with the Prostar sutures. No wound complications were recorded. The need for early conversion to an open access correlated with CFA calcification (OR 74.5, 95% CI 17.8 to 310.7; p<0.001) and operator experience (OR 43.2, 95% CI 9.8 to 189.0; p<0.001). The risk of late access site repairs was significantly higher in the presence of a groin scar (OR 48.8, 95% CI 9.2 to 259.0; p<0.001). Correlation of sheath size with early conversion to open access was weaker compared to all the other factors (OR 1.2, CI 95% 1.0 to 1.4; p<0.05). Obesity was not a risk factor for any complication. Conclusion: Percutaneous EVAR using the Prostar XL is safe, with minimal early and late complications. Operator experience is one of the most significant predictors of success. Anterior wall calcification and severe fibrosis of the access vessel are also predictors of primary failure, whereas obesity and sheath size are not.

Use of Abdominal Chimney Grafts is Feasible and Safe: Short-term Results

Purpose: To present our initial experience with the use of chimney grafts in endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs) with challenging anatomy. Methods: Among 390 EVAR cases performed at our institution between November 2008 and February 2010, 15 patients (all men; mean age 81.8 years) underwent EVAR with synchronous placement of chimney grafts. The chimney technique involved placing covered stents parallel to the main aortic stent-graft to preserve or rescue flow to aortic branch vessels while extending the proximal fixation zone. All patients presented with pararenal aortic aneurysms with short necks (between 0 and 10 mm long) that required either suprarenal clamping to tailor a proximal anastomosis in open repair or suprarenal fixation to anchor an endoprosthesis. Chimney grafts were implanted into 10 left renal and 5 right renal arteries. Results: The immediate technical success was 100%. One early type II endoleak due to retrograde flow from the inferior mesenteric artery was detected and is under surveillance. Mean follow-up was 6.8 months (range 1–13). One chimney graft occluded 45 days postoperatively; the patient underwent open thrombectomy of the left renal artery and iliorenal bypass. The creatinine value at discharge was 1.6 mg/dL, and resting renal scintigraphy showed 36% perfusion for the left kidney and 64% for the right kidney. During follow-up, no patient required hemodialysis; no aneurysm-related deaths were noted. Conclusion: This limited experience demonstrates that the use of abdominal chimney grafts is feasible and safe. Long-term results in larger patient cohorts are needed evaluate the utility of this alternative endovascular technique.

Evaluation of the Endurant stent graft under instructions for use vs off-label conditions for endovascular aortic aneurysm repair

BACKGROUND This study evaluated the early and intermediate results of endovascular aortic aneurysm repair (EVAR) using the Endurant stent graft (Medtronic Cardiovascular, Santa Rosa, Calif) in patients treated according to device-specific instructions for use (IFU) for the proximal aortic neck compared with those obtained in patients treated in an off-label (OL) situation. METHODS Between November 2007 and March 2010, 177 consecutive patients with abdominal aortic aneurysms (AAAs) were treated with the Endurant stent graft at our centers. The IFU for the Endurant stent graft included a proximal neck of 15 mm in length and <75° of angulation or 10 mm of neck length and <60° of angulation. The 121 patients (68.4%) operated on according to IFU were compared with 56 (31.6%) who underwent EVAR in OL circumstances to evaluate significant differences in demographics, intraoperative technical factors, and early (30 days) and intermediate outcomes (1 year). RESULTS Significantly more patients were aged >80 years in the OL group (37.5% vs 19%, P = .008), and they also had larger aneurysms (59 ± 10.6 vs 55.9 ± 10.8 mm, P = .05) and required a longer procedure time (69.3 ± 27.2 vs 60.8 ± 20.4 minutes, P = .02). At 30 days, the risk of type I endoleak was higher in the OL group (2 patients, 3.6% vs 0 in IFU), but this did not reach statistical significance (P = .09). The two groups were similar in rates of perioperative mortality, major morbidity, technical success, clinical success, complications, and reinterventions. At 1 year, there were no differences between the two groups in survival, freedom from any device-related reinterventions, and freedom from graft thrombosis. Estimated 1-year freedom from type I endoleak was 100% in the IFU group vs 93.3% in the OL group (P = .01). CONCLUSIONS In patients with both normal and complex anatomy of the proximal aortic neck, the Endurant stent graft obtained acceptable results, with no difference in survival, morbidity, or reinterventions. However, there was a greater risk of type I endoleak when OL indications were applied. Longer term follow-up is required to evaluate the effectiveness of this endograft in preventing late aneurysm-related complications.

In situ replacement of infected vascular prostheses with rifampin-soaked vascular grafts: Early results

Based on the excellent results of experimental studies with antibiotic-bonded vascular prostheses for prevention of graft infection, gelatin-sealed grafts soaked with rifampin were implanted in situ in five patients with vascular infection. All patients were at risk for limb loss or death and could not be treated by standard techniques such as graft excision and extra-anatomic bypass. In one patient an infected aortic stump aneurysm with involvement of both renal and visceral arteries was found. He was treated by implantation of a bifurcation rifampin-soaked graft between the subdiaphragmal aorta and both renal arteries and reimplantation of celiac and superior mesenteric artery into the graft. In four patients with in-flow or runoff problems on angiography, an antibiotic-soaked graft was used for replacement of a partially or totally infected graft. Cultures were positive for Staphylococcus aureus in three and coagulase-negative staphylococci in two patients. Wound healing was uncomplicated; there was no need for amputation. After a follow-up of at least 6 months, all grafts were patent without any evidence of reinfection on computed tomographic scan. We conclude that infected vascular prostheses can be replaced in situ by rifampin-soaked grafts in patients at high risk for death or major amputation.

Carotid artery stenting versus surgery: adequate comparisons?

A moratorium on carotid artery stenting (CAS) has been recently proposed. Current randomised evidence supports the notion that carotid endarterectomy (CEA) is better than CAS. A meta-analysis of the randomised trials compared the two strategies and included data from the recent International Carotid Stenting Study (ICSS). This meta-analysis indicated that patients who received CAS had a signifi cant increased risk of 30-day death or stroke compared with patients who received CEA (odds ratio 1·60; 95% CI 1·26–2·02). As randomised clinical trials are the gold standard of clinical investigation, it seems unwise to challenge them. However, for the comparison of CAS versus CEA, most of the randomised trials should be considered not only scientifi cally but also ethically questionable because the endovascular experience required for interventionalists to be eligible for the studies was minimal (table). As a consequence, patients allocated to CAS might have been exposed to unnecessary risk and the assessment of safety and effi cacy of the endovascular approach confounded. In the French Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) study, a lifetime experience of at least 12 CAS interventions was required. Alternatively, a minimum of fi ve CAS procedures was deemed to be suffi cient if the interventionalist had a lifetime experience of at least 30 stenting procedures in supraaortic vessels. The rationale for this adjustment is diffi cult to understand given that subclavian and carotid interventions diff er substantially. For investigators who did not comply with these minimum requirements, the EVA-3S protocol allowed the procedure “under the supervision of an experienced tutor”, defi ned in the protocol as “a clinician who qualifi ed to perform stenting in this study”. In later correspondence, the investigators acknowledged that only 16% of the 265 patients treated with stenting were managed by operators who had done more than 50 CAS procedures in their lifetime and that 39% of patients were treated by physicians in training. Although such a track record can hardly be defi ned as good clinical practice or trial conduct, the information was not thought to be suffi ciently relevant to be reported in any of the EVA-3S publications. Concerns about CAS safety in the EVA-3S trial were raised after the enrolment of 80 patients in the endovascular arm. The safety committee recommended stopping the performance of CAS without the use of embolic protection devices, because the 30-day rate of stroke among patients undergoing un protected CAS was 26·7%, which was 3·9 times higher than that of patients treated with embolic protection (8·6%). However, in the clinical alert published by the EVA-3S investigators, the experience of the interventionalists was not questioned because “a learning eff ect is also unlikely to explain the diff erent complications rates, since protected CAS is a more complex technique than unprotected CAS”. This quote reveals a fundamental gap in understanding of the CAS procedure. In real-life practice, the use of embolic protection devices is widely embraced by experienced CAS interventionalists, whereas those with less expertise might be reluctant to use these devices. Additional evidence of the little endovascular experience among the investigators of EVA-3S is derived from the high rate of emergent conversion from CAS to CEA (5%). The fact that CAS was never reimbursed in France did not help the investigators to gain exposure to the procedure. According to the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) study, a minimum of 25 successful consecutive CAS procedures was needed to participate as an investigator. However, a subsequent report revealed that, during the course of the trial, the protocol was amended to allow for tutoring of physicians who had only undertaken ten CAS procedures. Finally, in ICSS, a minimum of 50 total stenting procedures was required as long as at least ten of these involved the carotid artery. Tutor-assisted procedures were allowed for investigators with insuffi cient experience, again raising the concern of adequacy of training. The inexperience of the EVA-3S, SPACE, and ICSS investigators might have exposed the endovascular patients to an increased risk, not only because of insuffi cient operator skills, but also (and equally important) owing to inappropriate selection of patients. Interventions in patients with complex anatomy at the level of the aortic arch and supra-aortic vessels require more catheter manipulation than in patients with less tortuous or diseased vessels and place patients at increased risk of periprocedural stroke.