Early outcomes associated with use of the Zenith TX2 Dissection Endovascular Graft for the treatment of Stanford type B aortic dissection.

OBJECTIVE: To evaluate short term outcomes related to the use of the Zenith TX2 Dissection Endovascular Graft (ZDEG) and the Zenith Dissection Bare stent (ZDES) for the treatment of Stanford type B aortic dissections. METHODS: This retrospective multicenter case cohort study collated data from 10 European institutions for patients with both complicated and uncomplicated type B aortic dissection treated with ZDEG and ZDES between 2011 and 2018. The primary end point was mortality at 30 and 90 days. Secondary end points included complications related to TEVAR, such as, type Ia endoleak, stroke, paraparesis, paraplegia, and retrograde type A dissection (RTAD). Statistical analysis was carried out using the t test, or one-way analysis of variance and the χ2 or Fisher exact tests. RESULTS: We treated 120 patients (87 male; mean age, 62.7 ± 12.2years) either in the acute 76 (63.3%), subacute 16 (13.3%), or chronic 28 (23.3%) phase. Seven patients (5.8%) died within 30 days after the index procedure and two (1.7%) between 30 and 90 days. There was one instance of postoperative RTAD in a patient treated for rupture. Stroke and paraplegia occurred in three (2.5%) and five (4.2%), patients, respectively. Eight patients (6.7%) had a type Ia endoleak in the perioperative period. There were no instances of paraplegia, no permanent dialysis, and no requirement for adjunctive superior mesenteric or celiac artery stenting in the 33 patients (27.5%) who were treated by concurrent placement of ZDES distal to the ZDEG. The length and distal oversizing of ZDEG components used was less in this group. CONCLUSIONS: The present series demonstrates a low (<1%) RTAD rate and favorable morbidity and mortality. The lower rate of paraplegia, dialysis, and visceral artery stenting in the cohort that had adjunctive use of ZDES is compelling and merits further assessment.

Dual- vs single-layer stents for endovascular treatment of symptomatic and asymptomatic internal carotid artery stenosis.

BACKGROUNDS: Plaque protrusion is a common event among carotid artery stenting (CAS) patients and increases ischemic complication risk. Dual-layer stents (DLS) with micromesh technology may offer greater plaque protection compared to single-layer stents (SLS), but few data are available. The aim of the study is to compare clinical outcomes at 12 months for asymptomatic and symptomatic patients treated for primary CAS with DLS or SLS in a high-volume center. METHODS: A retrospective analysis of consecutive symptomatic and asymptomatic patients treated with primary CAS for internal carotid artery (ICA) stenosis, with either DLS or SLS between 2015 and 2019, was performed. Primary endpoints included rates of ipsilateral transient ischemic attacks (TIA)/stroke and death within 1-year from CAS. Secondary endpoints included patency rates and survival according to stent type. RESULTS: Of the 301 patients who met inclusion criteria (74.8 % male; 73.6 mean age ± 8.7 years), most patients were asymptomatic (77.4 %). Among all patients DLS was most frequently deployed (66 %); also, among asymptomatic (62 %) and symptomatic patients (81 %), p < 0.01. Symptomatic patients had less comorbidities and severe disease than asymptomatic patients. Six peri-operative strokes were recorded and, within 1 year, 2 additional strokes were registered among symptomatic patients treated with SLS. No post-operative strokes were encountered in the DLS group (p = 0.04) among symptomatic patients. Higher rates of TIA were observed among asymptomatic patients treated with DLS compared to SLS while rates of TIA were reduced among symptomatic patients treated with DLS. There were no differences in patency rates for DLS and SLS in symptomatic and asymptomatic patients. Primary patency was similar among DLS stent types but differed among SLS stent types (p = 0.01). At a mean follow-up of 27 months ±17.6, survival was comparable between DLS and SLS groups (p = 0.98). CONCLUSION: CAS with DLS seems to reduce the risk of post-procedural stroke for symptomatic patients compared to SLS whilst the choice of stent did not influence ipsilateral TIA, survival or patency rates. These data require confirmation from larger, randomized, prospective studies.

A multicenter comparison between autologous saphenous vein and heparin-bonded expanded polytetrafluoroethylene (ePTFE) graft in the treatment of critical limb ischemia in diabetics.

OBJECTIVES: The aim of this study was to evaluate early and follow-up results of below-knee bypasses performed using a bioactive heparin-treated expanded polytetrafluoroethylene (ePTFE) graft in diabetic patients with critical limb ischemia (CLI) in a multicenter retrospective registry involving seven Italian vascular centers and to compare them with those obtained in patients operated on with autologous saphenous vein (ASV) in the same centers in the same period of time. METHODS: Over an 8-year period, ending in 2009, a heparin-bonded prosthetic graft (Propaten Gore-Tex; W. L. Gore & Associates Inc, Flagstaff, Ariz) was implanted in 180 diabetic patients undergoing below-knee revascularization for CLI in seven Italian hospitals (group 1). In the same period in these seven centers, 133 below-knee bypasses with ipsilateral ASV in diabetics with CLI were performed (group 2). Data concerning these interventions were retrospectively collected in a multicenter registry with a dedicated database. Early (<30 days) results were analyzed in terms of graft patency, major amputation rates, and mortality. Follow-up results were analyzed in terms of primary and secondary graft patency, limb salvage, and survival. RESULTS: The interventions consisted of below-knee bypasses in 132 cases in group 1 (73%) and in 45 cases in group 2 (33%; P < .001); 48 patients in group 1 (27%) and 88 patients in group 2 (67%; P < .001) had distal tibial anastomosis. Patients in group 1 had more frequently adjunctive procedures performed at distal anastomotic sites to improve run-off status. Postoperative and long-term medical treatment consisted of single antiplatelet therapy in 93 cases (52%) in group 1 and in 64 cases (48%, P = ns) in group 2, of double antiplatelet therapy in 18 cases (10%) in group 1 and in four cases (3%; P = .05) in group 2 and of oral anticoagulants in 69 patients in group 1 (38%) and in 65 (49%; P = .02) in group 2. Mean duration of follow-up was 28.3 ± 21.4 months; 308 patients (98%) had at least one postoperative clinical and ultrasonographic examination and 228 (72%) reached at least a 1-year follow-up. Estimated 48-month survival rates were 76.6% in group 1 and 72.7% in group 2 (P = > .9, log-rank 0.08). Primary patency rate at 48 months was significantly better in group 2 (63.5%) than in group 1 (46.3%; P = .03, log-rank 4.1). Assisted primary patency rates at 48 months were 47.3% (SE 0.05) in group 1 and 69% (SE 0.05) in group 2 (P = .01, log-rank 6.3). The rates of secondary patency at 48 months were 57.5% in group 1 and 69.6% in group 2 (P = .1, log-rank 2.3); the corresponding values in terms of limb salvage and amputation free-survival rates were 75.4% and 82.4% (P = .3, log-rank 1), and 59.9% and 64.4% (P = .3, log-rank 0.9), respectively. CONCLUSIONS: Data from this large, retrospective registry confirmed that the indexed heparin-bonded ePTFE graft provides satisfactory early and midterm results in diabetic patients undergoing surgical treatment of CLI. While autologous saphenous vein maintains its superiority in terms of primary patency, secondary patency rates are not statistically different, even in the presence of a trend for improved secondary patency with vein graft; and also limb salvage rates are comparable.

Midterm results from a multicenter registry on the treatment of infrainguinal critical limb ischemia using a heparin-bonded ePTFE graft.

OBJECTIVES: To report midterm results of infrainguinal bypasses performed with a heparin-bonded expanded polytetrafluoroethylene (ePTFE) graft in patients presenting with critical limb ischemia. METHODS: Over a 7-year period ending in 2008, 425 patients presenting with critical limb ischemia underwent infrainguinal revascularization using a heparin-bonded ePTFE graft in seven Italian vascular centers. Preoperative, intraoperative, and follow-up data were collected in a multicenter registry. Patients were predominantly male (79%) with a mean age of 73.5 years. Mean preoperative ankle brachial index (ABI) was 0.35 and 192 of the patients (45%) were diabetic. Intervention consisted of a femoral to below-knee bypass in 324 patients (76%), whereas the remaining 101 patients had a femoral to above-knee bypass. In patients with below-knee bypass, distal target vessels were the popliteal artery in 238 cases, the tibioperoneal trunk in 38 cases, and a tibial vessel in the remaining 48 cases (anterior tibial artery in 20 cases, posterior tibial artery in 23 cases, and peroneal artery in 5). Follow-up consisted of clinical and duplex scanning examinations within 3 months from the intervention and yearly thereafter. Early (<30 day) results were analyzed in terms of deaths, graft thromboses, and amputations with univariate and multivariate (stepwise logistic regression) analysis. Follow-up results were evaluated in terms of primary and secondary graft patency, limb salvage, and survival rate with univariate and multivariate (Cox regression) analysis. RESULTS: Thirteen perioperative deaths occurred (3.1%). Thirty-day primary graft patency was 92.5% and limb salvage was 95.8%. Follow-up was available in 98% of patients with a median duration of 25.5 months (SD, 17.6; range, 1-72). Cumulative estimated 36-month primary and secondary patency, limb salvage, and survival rates were 61%, 70%, 83%, and 83%, respectively. At univariate analysis, the factors associated with poorer limb salvage rates during follow-up were the presence of ischemic ulcers or gangrene (log-rank, 8.4; P = .004; 95% confidence interval [CI] 1.2-3.5; odds ratio [OR], 2.1), the presence of only one patent tibial vessel (log-rank, 41.3; P < .001; 95% CI, 3.1-10.8, OR, 5.8), redo surgery (log-rank, 12.4; P < .001; 95% CI, 1.4-4; OR, 2.4) and the postoperative treatment with antiplatelet therapy in comparison to oral anticoagulants (log-rank, 5.1; P = .02; 95% CI, 1.0-3.4; OR, 1.8). At multivariate analysis redo surgery (P = .02; 95% CI, 1.1-3.1; OR, 1.8), poor runoff score (P < .001; 95% CI, 2.5-9.1; OR, 4.7) and preoperative clinical status (P = .02; 95% CI, 1.1-3.1; OR, 1.8) were independently associated with decreased limb salvage rates. CONCLUSION: The use of a heparin-bonded ePTFE graft provides good early and midterm results, with low rates of late amputations. Primary and secondary patency made this graft an excellent alternative to autologous saphenous vein when it is absent, unsuitable, or of poor quality.

The 'docking maneuver' for Gore Excluder positioning in the treatment of abdominal aortic aneurysms with an ectatic neck.

The aim was to present a technical modification to the 'funnel technique' that allows endovascular repair of infrarenal abdominal aortic aneurysms with an ectatic neck. The body of the Excluder endograft is opened inside the aneurysm, using the slow deployment technique, stopping as soon as the contralateral limb is open. The gate is cannulated in the usual fashion. A percutaneous transluminal angioplasty (PTA) balloon is introduced in the contralateral limb and inflated to nominal pressure. By pulling the introducer of the Excluder delivery system on one side and the PTA balloon on the other, the graft is positioned on the bifurcation with the contralateral leg inside the common iliac artery. At this point, the ipsilateral iliac leg is deployed and the thoracic endograft can be positioned through the abdominal component. Finally, the contralateral iliac leg is deployed. The technique described offers a simple method to treat aortic abdominal aneurysms with an ectatic neck by positioning a bifurcated abdominal graft in such a way that subsequent insertion of the thoracic component is facilitated.