Giovanni F. Torsello

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.

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.

The PROTAGORAS study to evaluate the performance of the Endurant stent graft for patients with pararenal pathologic processes treated by the chimney/snorkel endovascular technique

OBJECTIVE The chimney/snorkel endovascular aortic repair (ch-EVAR) is gaining ever-greater acceptance in the treatment of pararenal pathologic processes. However, the published experience includes mainly short-term clinical results with combinations of several abdominal devices and types of chimney grafts. The aim of this study was the midterm evaluation of the Endurant stent graft (Medtronic, Santa Rosa, Calif) as a standard abdominal device for ch-EVAR. METHODS Between January 2009 and January 2013, prospectively collected data of high-risk patients with pararenal pathologic processes who underwent ch-EVAR with placement of the Endurant abdominal device were analyzed. The chimney graft intended for use was a balloon-expandable covered stent. Main outcome measures were aneurysm sac regression and chimney graft patency. RESULTS A total of 187 snorkel/chimney grafts were successfully placed in 128 patients (mean age, 76.6 years). The technical success was 100%. The mean preoperative proximal neck length and aneurysm size were 4.7 mm and 64.8 mm (range, 48-135 mm), respectively. The postoperative new neck length after use of chimney grafts was 18.7 ± 6.3 mm. The mean aneurysm sac decreased significantly (60.8 mm; 95% confidence interval, 2.036-7.084; P = .001) after a mean radiologic follow up of 24.6 ± 17.4 months. Thirty-day mortality and midterm mortality were 0.8% and 17.2%, respectively. Two patients (1.6%) with single chimneys presented with late new onset of type Ia endoleak and underwent additional tube and multiple chimney placement. Primary chimney graft patency was 95.7%. Freedom from chimney graft-related reinterventions was 93.1%. CONCLUSIONS Standard use of the Endurant abdominal device for ch-EVAR in >120 patients is associated with high technical success, significant aneurysm sac regression, and low incidence of secondary procedures after 2-year radiologic follow-up. These results will give significant impetus to device selection, facilitating the standardization of technique.

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.

Midterm results from the TRAVIATA registry: treatment of thoracic aortic disease with the valiant stent graft.

Purpose: To assess early and midterm outcomes after thoracic endovascular aortic repair (TEVAR) with the Valiant Thoracic Stent Graft. Methods: Data were reviewed retrospectively for 92 patients (69 men; mean age 65±14.5 years) who underwent TEVAR in 52.2% elective and 47.8% urgent/emergent procedures for treatment of 56 degenerative aneurysms, 32 aortic dissections, and 4 traumatic injuries at 4 German centers between June 2005 and March 2008. Results: The technical success rate was 86.9%. Through 30 days, there were 3 (3.3%) deaths. Periprocedural complications included endoleak (n=6), systemic complications (n = 6), arterial rupture or dissection (n = 6), device-related complications (n = 5), retrograde aortic dissection (n = 1), aortic rupture (n = 1), spinal cord ischemia (n = 1), and stroke (n = 1). Cumulative survival was 95.5% at 1 year, 87.4% at 2 years, and 76.4% at 3 years. The rate of aneurysm-related mortality was 2.2% (n=2). For aneurysm and dissection patients, respectively, the rates of major complications were 9.3% and 15.6%, and secondary procedures were required in 7.4% and 12.5%. Type I endoleaks were detected in 4 aneurysm and 2 dissection patients, and graft migration occurred in 1 patient each from the aneurysm and dissection groups. No patients were converted to open surgery during follow-up. Aortic diameter reduction >5 mm was confirmed for 58.4% of patients overall. Conclusion: The high technical and clinical success, the low all-cause and aneurysm-related mortality, the negligible rates of neurological complications and spinal cord ischemia, and the low incidence of endoleak support the safety and effectiveness of TEVAR with the Valiant Thoracic Stent Graft. However, some deployment-related complications could be avoided by enhancements of the deployment mechanism.

Performance of Bridging Stent-grafts in Fenestrated and Branched Aortic Endografting

OBJECTIVE/BACKGROUND Bridging stent grafts (BSGs) are used to connect the target vessel with the main body during fenestrated or branched aortic endografting (f/bEVAR). No dedicated devices are available for BSG. The aims of this study were to assess the performance of BSGs. METHODS Between January 2004 and May 2014 the data of patients treated with f/bEVAR were prospectively collected. Only patients treated after January 2010 were included. The main measurement outcome was any BSG related complications. A logistic regression analysis, including target vessel type, type of joint (fenestration or cuff), and type of BSG identified potential risk factors. RESULTS One hundred and fifty consecutive patients underwent f/bEVAR, and 523 target vessels were involved. These included 104 celiac, 140 superior mesenteric, 275 renal, and four other arteries. The technical success rate was 99% (520/523 target vessels). Balloon expandable BSGs were mainly used (n = 494; 95%), and in 336 (65%) relining stents were combined. The primary reasons for technical failure were the dislocation of the main body (n = 1) and unsuccessful cannulation (n = 2). One was revascularized by means of the periscope technique. Four target vessel injuries were recorded and four renal arteries occluded peri-operatively. After a median follow up of 14 months (interquartile range 5.5-23.0), 13 (2%) BSGs occluded and 19 (4%) required re-interventions. Two SMA occlusions occurred, leading to death in both patients. The patency and freedom from re-intervention rates at 3 years amounted to 85% and 91%, respectively. Use of a branched main body was the only independent risk factor for re-intervention and for the composite event (hazard ratio [HR] 3.5, 95% confidence interval [CI] 1.3-9.9 [p = .02]; and HR 2.8, 95% CI 1.2-7.0 [p < .01], respectively). Of note, the use of relining stents seemed not to prevent BSG related complications. CONCLUSION The currently used BSGs had low occlusion and re-intervention rates. Modifications of the branched design or dedicated BSG devices may improve outcome, especially after bEVAR.

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.

Tortuosity is the Significant Predictive Factor for Renal Branch Occlusion after Branched Endovascular Aortic Aneurysm Repair.

OBJECTIVE After multi-branched endovascular aneurysm repair (mbEVAR), renal branch occlusion is the most frequent form of branch failure. Pre-operative renal angulation and post-operative morphology of the renal branch were quantified and their impact on occlusion was analyzed. METHODS Patients who underwent mbEVAR between January 2010 and December 2013 were reviewed retrospectively. Only renal branches constructed with caudally directed cuffs were included. Patients without post-operative computed (CT) angiography were excluded. The main outcome was the primary patency of the renal branches. The renal angulation and the morphology of renal branch (bridging length, renal coverage length, tortuosity index, and angulation of distal renal artery) were quantified using CT. The impacts of morphology, implanted stents, and patient characteristics were investigated by time to event analyses. RESULTS Ninety renal arteries in 49 patients were enrolled. Median follow up was 12 months (IQR 6-20 months). Balloon expandable stent grafts were used in 93% (84/90) of renal branches. Self expandable stent grafts were used in 12. Ninety-one percent (82/90) were lined with self expandable bare stents. Ten branches occluded after 8 months (median; IQR 1-14 months). Four of them underwent re-interventions, achieving secondary patency. The median renal angulation was -10° (IQR -40 to 0). The median bridging length was 42 mm (IQR 39-46 mm) and renal coverage 17 mm (IQR 12-22 mm). Median tortuosity index was 1.11 (IQR 1.04-1.19). The angulation of the distal renal artery was 140.7 ± 20.5°. In multivariate analysis, a tortuosity index > 1.11 was identified as the only significant predictor for occlusion (hazard ratio: 4.94; 95% CI: 1.01-24.30, p = .04). CONCLUSIONS High tortuosity was a significant predictor for the occlusion of renal branches, but renal angulation, bridging length, and the extent of renal coverage were not. By avoiding highly tortuous renal branch paths, good outcomes are expected even in upwardly directed renal arteries. Longer paths are acceptable.

Durability of a low-profile stent graft for thoracic endovascular aneurysm repair

Objective: The introduction of lower profile endografts expanded the application of aortic endovascular repair. However, evidence about their durability is still scarce. The objective of this study was to assess longer term durability of the Zenith Alpha Thoracic Stent Graft (Cook Inc, Bloomington, Ind) after thoracic endovascular aortic repair. Methods: Prospectively collected data of all patients treated for thoracic aortic aneurysms or penetrating aortic ulcers and having computed tomography angiography‐based follow‐up of ≥12 months were retrospectively analyzed. The primary end point was ongoing clinical success. Among the secondary end points, stent graft migration and fracture were analyzed. Results: Between August 2010 and October 2015, 70 consecutive patients were treated in a single center with the Zenith Alpha stent graft. With computed tomography angiography‐based follow‐up of 22.3 ± 15.9 months, ongoing clinical success was 87.1%. There were three cases of type IA endoleak (4.3%), two cases of type IB endoleak (2.9%), and one case of aneurysm sac enlargement (1.4%). Five patients died postoperatively (7.1%). No type III or type IV endoleak was detected; there was one case of distal stent graft migration and no stent fracture. Reintervention was necessary in one case (1.4%) of a combined type IA and type II endoleak. There were no conversions to open repair and no ruptures or intraoperative deaths. All‐cause mortality was 17.1% at 76 months. Conclusions: The Zenith Alpha Thoracic Stent Graft appears to maintain favorable results in a longer time frame with a low incidence of aneurysm sac growth and migration. Results from multicenter prospective trials are needed to validate these data.

Initial clinical experience with the Zenith alpha stent-graft.

Purpose: To assess safety and short-term efficacy of endovascular repair of the thoracic aorta with the new Zenith Alpha stent-graft. Methods: Between August 2010 and May 2014, 33 patients (21 men; mean age 73.2±9.0 years) were treated Zenith Alpha stent-graft (group ZA). Outcomes of this group were compared with those of 34 patients (25 men; mean age 70.3±8.5 years) treated contemporaneously with the Zenith TX-2 for the same pathologies (group TX). The primary outcome measure was technical success. Data on iliac tortuosity, minimum access vessel diameter, and previous unsuccessful treatment with other endografts was also recorded. Results: Technical success was 93.9% in group ZA and 91.2% in group TX (p=0.67). There was no case of surgical death or conversion to open repair in either group. Two (6%) type I endoleaks occurred in group ZA and 3 (9%) in group TX (p=0.67). Three patients died within 30 days in group ZA vs. none in group TX (p=0.07). Mean minimum access vessel diameter was significantly smaller (5.07 vs. 6.65 mm, p=0.002) and iliac tortuosity indices significantly higher in group ZA (1.34 vs. 1.25, p=0.02). Access vessel complications occurred in 1 (3%) patient in group ZA and 4 (12%) patients in group TX (p=0.17). Significantly more patients in group ZA (6, 18%) were unsuccessfully treated previously with other endografts vs. none in group TX (p=0.01). Conclusion: The new Zenith Alpha appears to be equally as safe and efficacious as the Zenith TX-2 while being used in patients with demanding access vessel morphology.