Theodosios Bisdas

Early Outcomes for Fenestrated and Chimney Endografts in the Treatment of Pararenal Aortic Pathologies Are Not Significantly Different: A Systematic Review With Pooled Data Analysis

Purpose To compare short-term outcomes between fenestrated and chimney endografts for pararenal aortic pathologies. Methods An English-language literature search up to January 2012 found 129 articles evaluating the immediate outcomes of endovascular repair of degenerative juxta-/suprarenal aortic aneurysms, type I endoleaks, and para-anastomotic aneurysms using the chimney technique or fenestrated endografts. Data concerning thoracoabdominal aortic aneurysms, ruptured aneurysms, and reports with <5 cases were excluded (n=84). An additional 28 articles were excluded for insufficient data, leaving 17 articles for review: 5 dealing with chimney grafts in 123 patients with pararenal aortic pathologies and 12 presenting data on 631 patients undergoing fenestrated stent-grafting. The composite endpoints were 30-day mortality, deterioration of renal function, new postoperative dialysis dependence, and endoleak rate. Results Cumulative 30-day procedure-related mortality was 0.58% (95% CI 0.0% to 2.93%) for the chimney group (n=3) and 1.17% (95% CI 0.26% to 2.09%, p=0.645) for the f-EVAR group (n=9). In the f-EVAR group, 86 (9.67%;95% CI 4.77% to 14.57%) patients suffered from postoperative renal impairment vs. 16 (12.43%) patients in the chimney group (95% CI 2.39% to 22.48%, p=0.628). In the chimney group, 4 (0.57%;95% CI 0.0% to 2.94%) patients required persistent postoperative dialysis in contrast to the 1.33% (95% CI 0.29% to 2.37%, p=0.567) rate (n=9) in patients undergoing f-EVAR. There were also no significant differences recorded in the endoleak rate: 1.93% (95% CI 0.0% to 4.82%) of the chimney patients had a persistent type Ia endoleak vs. 2.06% (95% CI 0.69% to 3.43%) for the f-EVAR group (p=0.939). For type II endoleaks, the rates were 2.16% (95% CI 0.0% to 10.77%) for the chimney group vs. 6.88% (95% CI 1.92% to 11.83%) for the f-EVAR group (p=0.352). No patient in the chimney group had a type III endoleak, and the rate was low in the f-EVAR group (0.32%,95% CI 0.0% to 0.91%, p=0.079). Conclusion No statistically significant differences were found between the two endovascular approaches for pararenal aortic pathologies in terms of 30-day mortality, renal impairment, or endoleak. These findings support the assumption that chimney grafts may be a reliable alternative in the treatment of pararenal aortic pathologies.

CT angiography at 24 months demonstrates durability of EVAR with the use of chimney grafts for pararenal aortic pathologies.

Purpose To present the 24-month radiological follow-up data for patients with pararenal aortic pathologies treated with chimney and periscope grafts during endovascular repair. Methods Between January 2008 and December 2011, 124 high-risk patients with complex pararenal aortic pathologies were treated using the chimney technique at 2 European vascular and cardiovascular centers with advanced experience of the described technique. In particular, 50 patients were treated at Site 1 and 74 at Site 2. Forty (32.2%) patients (32 men; mean age 79.2±4.9 years) completed computed tomographic angiography follow-up at 24 months postoperatively. Results The overall technical success was 100%, and the early- and midterm procedure-related mortality was 0%. Three (2.4%) patients had a perioperative type Ia endoleak that persisted; two were treated by transbrachial perigraft embolization and cuff implantation. The last patient is under radiological surveillance due to a “low-flow” type Ia endoleak and stable sac size. A type II endoleak was detected in 7 (5.6%) patients. During the 2-year follow-up, significant shrinkage (>5 mm; n=22) or stable aneurysm diameter (n=14) was seen in 36 (90%) of the cases. Overall, mean aneurysm sac shrinkage was 12% (p=0.002) and 10% (p=0.014) for the 2 centers, respectively (overall p=0.008). The causes for sac progression in the 4 (10%) patients were a type Ia endoleak, 2 type II endoleaks, and endotension. Conclusion The present study demonstrates that the use of chimney and/or periscope endografts for pararenal aortic pathologies achieves and maintains successful exclusion of the aneurysm in 90% of the cases at 24 months of radiological follow-up. In centers experienced with this approach, the chimney technique may represent a reliable therapeutic modality in selected patients.

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

OBJECTIVEnThe 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.nnnMETHODSnBetween 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.nnnRESULTSnA 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%.nnnCONCLUSIONSnStandard 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.

Risk factors for spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms

OBJECTIVEnThe introduction of fenestrated and multibranched endografting transformed the treatment paradigm of patients with thoracoabdominal aortic aneurysms (TAAAs). However, despite the minimally invasive character of the procedure, spinal cord ischemia (SCI) remains a devastating complication. The aim of this study was to address the SCI rates after endovascular TAAA repair and to analyze potential risk factors leading to this complication.nnnMETHODSnA consecutive cohort of patients with nonruptured TAAAs treated by means of fenestrated and multibranched endografting between January 2010 and September 2014 was analyzed. Neurologic examination was routinely performed by an independent neurologist before operation and at discharge. The main outcome measure was the onset of SCI (paraplegia or paraparesis). Secondary outcomes were neurologic complications associated with cerebrospinal fluid drainage (CSFD) and 30-day mortality. Finally, a multivariate regression analysis identified risk factors for SCI.nnnRESULTSnA consecutive 142 patients with TAAAs (Crawford type II, n = 54 [38%]; type III, n = 76 [54%]; type IV, n = 12 [8%]) were included in this study. The majority of patients (n = 129 [91%]) were treated for an atherosclerotic aneurysm, whereas 13 patients (9%) were treated for a postdissection aneurysm. The mean maximal aortic diameter was 65 ± 13 mm. SCI developed in 23 patients (16%; paraplegia in 12 [8%] and paraparesis in 11 [8%]). Of these 23 patients, 10 patients (43%) showed the neurologic deficit directly after the procedure, 11 patients (48%) in the first 24 hours, and 2 patients (9%) after 24 hours. There was an improvement of the neurologic status in the majority of patients, with only three patients (2%) showing irreversible paraplegia at discharge. There was no difference in the 30-day mortality between patients with and without SCI (no SCI, n = 3 [3%] vs SCI, n = 1 [4%]; P = .511). Prophylactic use of CSFD before the procedure was performed in 64 patients (45%), and among them, 4 patients (6%) developed a CSFD-associated complication. No clinical benefit for patients receiving prophylactic placement of CSFD was found (P = .498). The multivariate analysis revealed the percentage of thoracic aortic coverage as the only significant risk factor for SCI (odds ratio, 1.03; 95% confidence interval, 1.01-1.05; P = .001).nnnCONCLUSIONSnThe SCI rate after endovascular repair of TAAA was 16%, with 8% of those patients suffering from paraplegia. Prophylactic use of CSFD could not reduce the SCI rate and was associated with 6% adverse events. The percentage of thoracic aortic coverage was the most powerful determinant of SCI in these series.

Outcomes of a novel technique of endovascular repair of aneurysmal internal iliac arteries using iliac branch devices

OBJECTIVEnTo present midterm outcomes of a novel technique of endovascular repair of aneurysmal internal iliac arteries (AIIAs) using iliac branch devices (IBDs).nnnMETHODSnBetween January 2005 and August 2012, 129 patients with aneurysms involving the iliac bifurcation underwent placement of IBDs. In particular, between April 2010 and August 2012, 16 consecutive patients with aortoiliac or solitary iliac aneurysms and coexisting AIIAs were treated with the novel suggested strategy. The follow-up included physical examination and computed tomography (CT) angiography postoperatively, duplex scan at 3 months, CT scan at 6 months, and then CT scan annually.nnnRESULTSnThe technical success rate was 100%. The primary patency rate for the overall 21 internal iliac branches (five patients with bilateral aneurysms) was 95.3%. The overall assisted patency was 100%. No patient had evidence of type I/III endoleak during the follow-up of 2 years. Two patients showed type II endoleaks originating from the abdominal aneurysm sac and are under radiological surveillance.nnnCONCLUSIONSnOur 2-year experience with the described novel approach showed its safety and feasibility, expanding the applicability of IBDs also in case of coexisting AIIAs. Long-term results and an increased number of treated patients with this technique are needed.

Chimney Endografting for Pararenal Aortic Pathologies Using Transfemoral Access and the Lift Technique

Purpose To present a technique for transfemoral implantation of parallel grafts into the renal arteries in patients with anatomy or morphology that blocks standard antegrade chimney graft delivery. Technique In a totally percutaneous approach, a 5-F pigtail angiographic catheter is passed into the aorta above the renal arteries via a 0.035-inch hydrophilic guidewire, followed by an 8-F sheath. The target vessel is cannulated with the hydrophilic wire followed by a 5-F reverse curve catheter; the wire is changed for a Rosen wire. The main stent-graft body is delivered and parked at the level of the aortic bifurcation. The Viabahn chimney endograft is advanced ∼1 to 2 cm into the target renal artery and deployed such that its proximal end faces downward; its distal end is fixed in place with an inflated angioplasty balloon. A stiff guidewire is inserted coaxially through the 8-F sheath, the Rosen guidewire is removed, and the 8-F sheath is carefully pushed over the stiff guidewire, lifting the sheath and chimney endograft upward. With the chimney reoriented cranially, the aortic stent-graft is deployed immediately. The abdominal stent-graft and the chimney graft(s) are molded synchronously using kissing balloons. Conclusion Transfemoral placement of chimney covered stents by the lift technique in cases of unsuccessful or hazardous catheterization of the target vessels via the upper extremity is safe and feasible in centers experienced with the standard chimney technique.

Validation of the Wound, Ischemia, foot Infection (WIfI) classification system in nondiabetic patients treated by endovascular means for critical limb ischemia

BACKGROUNDnThe Society for Vascular Surgery Lower Extremity Guidelines Committee developed the Wound, Ischemia, foot Infection (WIfI) a classification system to predict the amputation risk in patients with critical limb ischemia (CLI). A number of published studies have already evaluated its prognostic value. However, most of the included patients were diabetic, and the validation was done independent of the revascularization procedure. This single-center study evaluated the prognostic value of WIfI stages in nondiabetic patients treated by endovascular means.nnnMETHODSnA retrospective analysis was performed of prospectively collected data of nondiabetic patients treated by endovascular means between January 2013 and September 2014. All patients were classified according to their wound status, ischemia index, and extent of foot infection to four classes: very low risk, low risk, moderate risk, and high risk. Comorbidities and vascular lesions for each group were analyzed. The prognostic value of WIfI was analyzed based on the amputation-free survival, overall survival rate, and freedom from amputation at 12xa0months.nnnRESULTSnData from 302 CLI patients treated in the study period were reviewed. A total of 219 patients (73%) underwent an endovascular intervention, and among them, 126 nondiabetic patients (58%) were enrolled in this study. Most patients were classified as low risk (33%), and the prevalence of very low-risk, moderate-risk, and very high-risk patients was 23%, 23%, and 21%, respectively. The modified Edifoligide for the Prevention of Infrainguinal Vein Graft Failure (PREVENT III) scorexa0was statistically significantly higher in the high-risk group (5.2xa0± 2.4) than in the very low-risk, low-risk, and moderate-risk groups (4.3xa0± 2.5, 3.5xa0± 2.3, 4.5xa0± 2.2, respectively; Pxa0= .048). One major amputation (1%) was performed during the hospital stay in a high-risk patient. Mean follow-up was 14xa0± 8xa0months. The amputation-free survival at 12xa0months was 87%, 81%, 81%, and 62%, in the very low-risk, low-risk, moderate risk, and very high-risk groups, respectively (Pxa0= .106). The difference was statistically significant between the very low-risk and high-risk groups (hazard ratio, 3.4; 95% confidence interval, 1.1-10.3; Pxa0= .029). A similar trend was also observed for 1-year survival between the very low-risk and the high-risk groups (87%, 84%, 81%, 65%; Pxa0= .166). The amputation rate during the follow-up time was 0%, 2% (nxa0= 6), 3% (nxa0= 5), and 12% (nxa0= 9) for the very low-risk, low-risk, moderate-risk, and very high-risk groups, respectively (Pxa0= .033).nnnCONCLUSIONSnThe WIfI classification system predicted the amputation risk and survival in this highly selected group of nondiabetic CLI patients treated by endovascular means, with a statistically significant difference between very low-risk and high-risk patients already at 1xa0year.

Combined Directional Atherectomy and Drug-Eluting Balloon Angioplasty for Isolated Popliteal Artery Lesions in Patients With Peripheral Artery Disease.

Purpose: To evaluate the midterm results of combined directional atherectomy (DA) and drug-eluting balloon (DEB) angioplasty for atherosclerotic lesions of the popliteal artery. Methods: In a single-arm, prospective study, 21 patients (mean age 63±16 years; 16 men) with isolated popliteal artery lesions were enrolled and underwent treatment with combined DA and DEB angioplasty under filter protection between October 2009 and February 2014. The majority (18, 86%) presented with lifestyle-limiting intermittent claudication and 3 with critical limb ischemia. Fifteen (71%) target sites were de novo lesions; 4 were occlusions. The main outcome was primary patency; secondary outcomes were technical success, secondary patency, and early and midterm morbidity and mortality. Results: The TurboHawk atherectomy device was used in 15 (71%) patients and the SilverHawk peripheral plaque excision system in the remaining 6 patients. The In.Pact Admiral/Pacific DEB was used in the majority of cases (15, 71%). The technical success rate was 90% (n=19). One flow-limiting dissection was treated with bailout stenting. Complications included a perforation of the popliteal artery and 2 puncture site hematomas; there was no distal embolic event. The mean follow-up was 18±12 months. Two restenoses were retreated successfully. Kaplan-Meier estimates of primary patency at 12 and 18 months were 95% and 90%, respectively; the secondary patency was 100%. One (5%) patient died in follow-up. None of the patients had an amputation. Conclusion: In this prospective single-arm study, the combined therapy of DA and DEB angioplasty for popliteal artery lesions showed promising midterm performance. The combination of DA and DEB may, in highly selected patients, overcome the challenges presented by the mobility of the knee joint.

Technical Considerations and Performance of Bridging Stent-Grafts for Iliac Side Branched Devices Based on a Pooled Analysis of Single-Center Experiences

Purpose To report a pooled analysis of single-center experiences designed to determine the performance of self-expanding vs. balloon-expandable bridging stent-grafts used in iliac branch devices (IBDs) for the repair of iliac artery aneurysms. Methods The English-language literature in the MEDLINE and EMBASE databases was searched for articles published between 2006 and 1 March 2012 on the performance of bridging stent-grafts in the internal iliac artery. Studies were eligible for the analysis if they contained the type of bridging stent-grafts used and the time and cause of any occlusion of the bridging devices. Eight of the 13 studies published between 2006 and 2011 fulfilled the eligibility criteria. The outcome measure was the patency of bridging stent-grafts defined as absence of occlusion of the side branch in the internal iliac artery. Additionally, the performance of the self-expanding stent-grafts vs. balloon-expandable stent-grafts used in conjunction with the IBDs was compared. Results In the 8 studies, 100 (42%) self-expanding stent-grafts and 136 (58%) balloon-expandable stent-grafts were placed in 185 patients. Of these 236 bridging stent-grafts, 15 (6%) occluded in 13 (7%) patients: 10 within 30 days after the intervention [2 (1.5%) balloon-expandable and 8 (8%) self-expanding stent-grafts] and 5 beyond 30 days [2 (1.5%) balloon-expandable and 3 (3%) self-expanding stent-grafts]. Symptomatic presentation (hip and/or buttock claudication) of the occluded iliac branch was recorded in 7 of the 13 patients. Conclusion The current literature does not support robust conclusions about the performance of bridging endografts of IBDs due to the heterogeneity of the studies. However, the occlusion rate of the bridging stent-grafts was low, especially for balloon-expandable stent-grafts compared to self-expanding devices.

Efficacy and Safety of Transbrachial Access for Iliac Endovascular Interventions.

Purpose: To evaluate the use of a brachial artery access for endovascular treatment of iliac artery disease. Methods: A retrospective review was conducted of 201 patients (mean age 73 years; 147 men) treated via a brachial artery access for iliac artery stenosis. The majority (n=141, 70%) presented with lifestyle-limiting claudication (Rutherford category 3), whereas the incidence of critical limb ischemia (Rutherford categories 4–6) was 30% (n=70). Diagnostic angiography revealed a TransAtlantic Inter-Society Consensus II (TASC) C/D lesion in 114 (57%) patients. The primary outcome was technical success achieved exclusively with a brachial artery access. Secondary outcomes were secondary technical success (adjunctive transfemoral access), access site complications, and stroke/transient ischemic attack (TIA). Results: In 17 (8%) patients, lesion crossing was unsuccessful, while an adjunctive transfemoral approach was necessary to restore iliac vessel patency in 23 (11%) cases. Thus, the primary and secondary technical success rates were 81% and 92%, respectively. Local hematomas (9, 4%) dominated the access site complications, followed by pseudoaneurysms (8, 4%), late brachial artery bleeding (4, 2%), brachial artery occlusion (2, 1%), and puncture site infection (2, 1%). No transient or permanent median nerve dysfunction was observed. The stroke/TIA rate was 2% (n=4). A single patient died due to acute coronary syndrome (0.5% mortality). TASC II class (p=0.58), sex (p=0.66), and target vessel (p>0.3 for all locations) had no effect on technical success. Female gender unfavorably influenced the incidence of access site complications (hazard ratio 6.7, 95% confidence interval 2.7 to 15, p<0.001), but sheath size did not (p=0.22). Conclusion: Brachial artery access enables endovascular treatment of iliac artery disease in the majority of patients, although an adjunctive transfemoral access may be required. However, the high incidences of access site complications and cerebral events remain a significant limitation of the transbrachial approach.