Konstantinos Stavroulakis

Current practice of first-line treatment strategies in patients with critical limb ischemia.

OBJECTIVE Critical limb ischemia (CLI) is growing in global prevalence and is associated with high rates of limb loss and mortality. However, a relevant gap of evidence about the most optimal treatment strategy still exists. The aim of this study of the prospective, multicenter First-Line Treatments in Patients With Critical Limb Ischemia (CRITISCH) registry was to assess the current practice of all first-line treatments strategies in CLI patients in German vascular centers. METHODS Between January 2013 and September 2014, five first-line treatment strategies-endovascular revascularization (ER), bypass surgery (BS), femoral/profundal artery patchplasty (FAP), conservative treatment, and primary amputation-were determined among CLI patients in 27 vascular tertiary centers. The main composite end point was major amputation or death, or both, during the hospital stay. Secondary outcomes were hemodynamic failure, major adverse cardiovascular and cerebral events, and reintervention. Univariate logistic models were additionally built to preselect possible risk factors for either event, which were then used as candidates for a multivariate logistic model. RESULTS The study included 1200 consecutive patients. First-line treatment of choice was ER in 642 patients (53.4%), BS in 284 (23.7%), FAP in 126 (10.5%), conservative treatment in 118 (9.8%), and primary amputation in 30 (2.5%). The composite end point was met in 24 patients (4%) after ER, in 17 (6%) after BS, in 8 (6%) after FAP, and in 9 (8%) after conservative treatment (P = .172). The highest rate of in-hospital death was observed after primary amputation (10%) and of hemodynamic failure after conservative treatment (91%). Major adverse cardiovascular and cerebral events developed in 4% of patients after ER, in 5% after BS, in 6% after FAP, in 5% after conservative treatment, and in 13% after primary amputation. The reintervention rate was 8%, 14%, 6%, 5%, and 3% in each group, respectively. In the multivariate regression model, coronary artery disease (odds ratio [OR], 2.96; 95% confidence interval [CI], 1.42-6.17) and previous myocardial infarction (PMI) <6 months (OR, 3.67, 95% CI, 1.51-8.88) were identified as risk factors for the composite end point. Risk factors for amputation were dialysis (OR, 3.31, 95% CI, 1.44-7.58) and PMI (OR, 3.26, 95% CI, 1.23-8.36) and for death, BS compared with ER (OR, 3.32; 95% CI, 1.10-10.0), renal insufficiency without dialysis (OR, 6.34; 95% CI, 1.71-23.5), and PMI (OR, 7.41; 95% CI, 2.11-26.0). CONCLUSIONS The CRITISCH registry revealed ER as the most common first-line approach in CLI patients. Coronary artery disease and PMI <6 months were independent risk factors for the composite end point. Special attention should be also paid to CLI patients with renal insufficiency, with or without dialysis, and those undergoing BS.

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.

Endovascular Treatment of Isolated Abdominal Aortic Dissections: Long-term Results

Purpose To examine long-term survival and freedom from reintervention after endovascular treatment of patients with isolated abdominal aortic dissections (IAAD). Methods A retrospective review was conducted of 21 patients (18 men; mean age 72±18 years, range 34–90) with an IAAD who underwent endovascular treatment between January 2000 and December 2012. Fourteen patients had spontaneous abdominal dissections, while 7 dissections were iatrogenic in origin. Thirteen patients with symptomatic acute (n=9) or subacute (n=4) lesions underwent analgesic therapy and medical management of systolic blood pressure for at least 5 days; persistent pain was an indication for endovascular treatment. Eight patients with chronic dissections were treated by endovascular means for co-existent (1) abdominal aortic aneurysm (AAA) that was >5 cm in diameter or had expanded >5 mm in 6 months (n=6) or (2) rupture-threatening penetrating aortic ulcer (PAU, n=2) even with a diameter <5 cm. Mean dissection length was 45±12 mm (range 18–98). Ten patients received tube stent-grafts, 9 had bifurcated endografts, one had an aortouni-iliac (AUI) endoprosthesis, and one patient was treated with a bare metal stent. Follow-up included computed tomographic angiography within 1 month postoperatively, duplex ultrasound at 3 and 6 months, CTA at 12 months, and then annual duplex scans. Results Early (30-day) mortality was 0%; no major adverse events occurred during hospitalization. Patients with co-existent AAA/PAU had complete exclusion of the aneurysm sac. The patient with an AUI graft suffered from an early stent-graft thrombosis in the abdominal aorta; flow was restored after transfemoral thrombectomy and balloon angioplasty of the common iliac artery. During a mean 73±22-month follow-up (range 19–144), 3 patients died due to unrelated causes (95% survival at a median 67 months estimated by Kaplan-Meier analysis). All patients showed full aortic remodeling over a period of 12 years. One patient with AAA underwent surgical conversion due to persistent type II endoleak (95% freedom from reintervention at a median 67 months). Conclusion In this series, long-term evaluation of endovascular IAAD treatment found no mortality, few complications, and rare need for secondary interventions.

Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Isolated Popliteal Artery Lesions

Purpose: To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery. Methods: Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR). Results: The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99). Conclusion: In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively.

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.

Gender-related long-term outcome of primary femoropopliteal stent placement for peripheral artery disease.

Purpose: To evaluate gender-related long-term outcomes in patients undergoing stent treatment of femoropopliteal peripheral artery disease. Methods: Between September 2006 and August 2010, all 517 patients (333 men and 184 women; mean age 70.6 years) undergoing primary stent placement in femoropopliteal atherosclerotic lesions at 2 European vascular centers were prospectively enrolled in the study. The main study outcome was primary stent patency. Secondary outcomes included secondary patency, limb salvage, and all-cause mortality. Results: Women had a higher incidence of critical limb ischemia (32.1% vs. 16.9%, p<0.001). Lesion characteristics according to the TransAtlantic Inter-Society Consensus (TASC) classification were comparable in both genders (p=0.52), although total occlusions and popliteal involvement were observed more frequently in female patients (p=0.043 and p=0.001, respectively). Both genders showed similar 5-year primary patency rates (64.3% men vs. 58.1% women, p=0.11). A statistically significant difference was observed concerning the secondary patency rates in favor of men (71.9% vs. 66.8% at 5 years, p=0.005). Limb salvage rates did not vary between the groups (p=0.83). Survival rates were comparable at 5 years (83.3% and 82.6% for men and women, respectively; p=0.63), although female patients were older at their presentation (68.5 vs. 74.3 years, p<0.001). Female gender was an independent risk factor for restenosis for TASC C/D lesions (primary patency rate 39.8% in women vs. 62.0% in men; p=0.002). Finally, critical limb ischemia was an independent risk factor for restenosis in women (odds ratio 1.5). Conclusion: Female gender was associated with a higher prevalence of critical limb ischemia, poorer secondary patency, and more frequent restenosis in TASC C/D lesions. Endovascular treatment of femoropopliteal lesions provides equal results between genders in terms of primary stent patency in the long term.

Novel indication for chimney graft placement in the inferior mesenteric artery in AAA patients with coexistent bilateral internal iliac artery occlusion.

Purpose: To report a novel indication for the use of chimney grafts to preserve flow to the inferior mesenteric artery (IMA) in patients undergoing endovascular aneurysm repair (EVAR) for aortobi-iliac aneurysms with coexistent bilateral occlusion of the internal iliac arteries (IIA). Technique: Via a cutdown over the left axillary artery, a 5-F vertebral catheter was delivered over a conventional 0.035-inch hydrophilic guidewire to selectively catheterize the IMA via a 7-F shuttle sheath, which was then advanced at least 2 cm into the target vessel. The first chimney graft was advanced into the sheath, and a standard EVAR procedure followed. The chimney graft was deployed at least 2 cm in the IMA; a second chimney graft was advanced and deployed with at least 2 cm overlapping with the first chimney stent parallel and outside of the main abdominal endograft and below the lowest renal artery. The chimney grafts were lined with additional bare nitinol stents. The technique is demonstrated in two male patients who suffered from symptomatic aortobi-iliac aneurysm with patent IMAs and bilateral IIA occlusion. The procedure was completed successfully in both cases without bowel ischemia. At 12 and 6 months, respectively, the chimney grafts remained patent without endoleak. The patients are asymptomatic. Conclusion: The IMA chimney endovascular technique can be considered in EVAR cases with coexistent bilateral IIA occlusion to minimize the risk for bowel ischemia.

Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Common Femoral Artery Atherosclerotic Disease:

Purpose: To report an experience using directional atherectomy (DA) with antirestenotic therapy (DAART) in the form of drug-coated balloon (DCB) angioplasty vs DCB angioplasty alone in common femoral artery (CFA) occlusive lesions. Methods: A retrospective review was conducted of 47 consecutive patients (mean age 71 years; 26 men) treated between October 2011 and July 2016 using either DCB angioplasty alone (n=26) or DAART (n=21) for CFA lesions. The majority of patients had lifestyle-limiting claudication (14 DCB and 15 DAART). Mean lesion length (39±14 mm DCB and 34±16 mm DAART) and vessel calcification (17/26 DCB and 11/21 DAART) were comparable between the groups. There were 4 chronic total occlusions, all in the DAART group. The main outcome measure was primary patency. Key secondary outcomes were technical success, secondary patency, and freedom from clinically-driven target lesion revascularization (TLR). Results: Technical success rates were 89% following DCB angioplasty and 95% for DAART (p=0.41). The 88% 12-month primary patency and 89% freedom from TLR for DAART were higher than the 68% and 75% estimates following DCB angioplasty alone, but neither difference was statistically significant. However, the secondary patency estimate at 12 months was significantly higher in the DAART group (100% vs 81% for DCB, p=0.03). Bailout stenting (1 DCB vs 1 DAART), vessel perforation (1 DCB vs 0 DAART), access site complications (4 DCB vs 3 DAART), and distal embolization (0 DCB vs 1 DAART) were comparable, whereas DCB angioplasty had more non-flow-limiting dissections (8 vs 1 for DAART, p=0.02). Conclusion: Preparation of the atherosclerotic CFA with directional atherectomy was not associated with statistically significantly higher primary patency or freedom from TLR compared to DCB angioplasty alone at 12 months. Nonetheless, both modalities had promising outcomes in a primarily surgically treated vascular territory.

Preservation of Clinically Relevant Accessory Renal Arteries in Infrarenal AAA Patients With Adequate Proximal Landing Zones Undergoing EVAR.

Purpose: To report techniques to preserve the flow to relevant accessory renal arteries (ARA) in patients undergoing infrarenal endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) with adequate landing zones. Methods: ARAs that originate inferior to the lowest ipsilateral main renal artery, supply one-third of the renal parenchyma, and having a diameter >4 mm have significant clinical importance. Between May 2012 and January 2015, among 389 high-risk patients with infrarenal AAAs who underwent standard EVAR, 9 (2.3%) patients each presented with a coexistent clinically relevant ARA. Their perfusion was secured by placing covered stents in the target ARA, parallel and outside of the main abdominal, as chimney grafts. Evaluation of acute and chronic renal decline was based on the consensus definition of RIFLE criteria (risk, injury, failure, loss, and end-stage) and chronic kidney disease (CKD) staging system, respectively. Results: The procedure was completed successfully in all cases. In the immediate postoperative period, no acute kidney injury was observed based on the RIFLE criteria. Eight of the 9 covered stents remained patent during a mean follow-up of 13.8±6.2 months. A single covered stent occlusion was observed 30 days postoperatively with infarction of the caudal pole of the kidney. This patient developed renal function impairment based on the CKD staging system 12 months after the initial procedure. For the remaining 8 patients, improvement of one CKD stage (n=1) or no change (n=7) in the CKD stage was observed. Conclusion: In AAA patients unfit for surgical revascularization, EVAR is associated with a significant decline in renal function. For this reason, preservation of relevant coexistent ARAs using the chimney technique should be considered as an option.

Endovascular treatment of occluded and stenotic visceral vessels in patients with chronic mesenteric ischemia

Objective Current evidence in the literature about endovascular treatment (ET) of visceral vessels in patients with chronic mesenterial ischemia (CMI) based on morphological characteristics is limited. The aim of this study was the evaluation of ET in occluded and stenotic visceral vessels. Methods Patients undergoing ET for CMI between November 2000 and November 2012 were included in this retrospective study. Primary measure outcome was the symptom-free survival (SFS). Secondary outcomes were primary (PPR), secondary patency (SPR) rates and technical success rate (TSR). A Cox-regression analysis identified risk factors for the primary and secondary measure outcomes. Results Forty patients were included in the present study (men: 21, mean age: 68). The overall number of vessels with intention-to-treat was 62. Fifty-two visceral arteries (18 occlusions and 34 stenoses) were successfully treated by endovascular means. The overall TSR was 84%. Visceral vessel occlusions and atherosclerotic disease of the superior mesenteric artery (SMA) were identified as independent risk factors for poorer TSR (p < 0.05). The 12-month SFS was 60%. The overall 12-month PPR and SPR were 71% and 94%, respectively. No significant differences were observed between occluded and stenotic vessels (p > 0.05) concerning the PPR. On the other hand, the subgroup analysis revealed higher SPR among occluded visceral vessels (p < 0.001) and coeliac axis lesions (p < 0.001). Conclusions ET was associated with high incidence of symptoms recurrence despite the satisfying patency rates in both occluded and stenotic vessels. Additionally, visceral vessel occlusion and presence of atherosclerotic lesions in the SMA were associated with poorer TSR.