Objective The complex aortic branch anatomy in thoracoabdominal aortic aneurysms (TAAAs) and pararenal aortic aneurysms (PRAAs) presents a challenge for endovascular repair. The multibranched ...endovascular device has durable midterm results with use of a custom branch stent graft (CSG) configuration. The midterm results with use of the standard branch stent graft (SSG) configuration are unknown, but it has the advantage of off-the-shelf technology. The goal of this study was to compare the midterm outcomes of CSG and SSG multibranched endovascular devices. Methods From July 2005 to September 2014, 133 patients underwent elective endovascular repair of TAAA and PRAA in a prospective trial. Beginning in December 2008, SSGs were used in those with suitable anatomy. Results Fifty patients (mean age, 71 ± 7 years; 11 women 22%) were treated using SSGs, and 83 patients (mean age, 74 ± 9 years; 22 women 26.5%) underwent repair using CSGs. The SSG and CSG groups were similar with regard to aneurysm size, aneurysm extent, and medical comorbidities, with the sole exception of lung disease, which was more common in the SSG group. All stent grafts were deployed as intended, with no conversions to open repair. Mean ± standard deviation follow-up (days) was 694 ± 525 for the SSG group and 942 ± 764 for the CSG group ( P = .045). There were no significant differences in aneurysm-related death, renal failure requiring dialysis, stroke, endoleak, visceral or renal branch occlusion, lower extremity weakness, or reintervention ( P > .05 for each). The volume of contrast material was significantly lower in those with SSGs compared with CSGs ( P = .016), but there were no significant differences in operative or fluoroscopy times. Time to treatment (days from consent to surgery) was significantly lower in SSG patients compared with CSG patients ( P = .01). Conclusions For patients with suitable anatomy, the use of SSGs for TAAA and PRAA repair results in significantly shorter wait times to surgery and is as safe, effective, and durable in the midterm compared with CSGs.
Objective This study determined early and intermediate results of multibranched endovascular thoracoabdominal (TAAA) and pararenal aortic aneurysm (PRAA) repair using a uniform operative technique. ...Methods Eighty-one patients (mean age, 73 ± 8 years, 19 23.5% women) underwent endovascular TAAA repair in a prospective trial using self-expanding covered stents connecting axially oriented, caudally directed cuffs to target aortic branches. Mean aneurysm diameter was 67 ± 10 mm. Thirty-nine TAAA (48.1%) were Crawford type II, III, or V; 42 (51.9%) were type IV or pararenal. Thirty-three procedures (40.7%) were staged. The insertion approach was femoral for aortic components and brachial for branch components. Follow-up assessments were performed at 1, 6, and 12 months, and yearly thereafter. Results All devices (n = 81) and branches (n = 306) were successfully inserted and deployed, with no conversions to open repair. Overall mortality was 6.2% (n = 5), including three perioperative (3.7%) and two late treatment-related deaths (2.5%). Permanent paraplegia occurred in three patients (3.7%), and transient paraplegia/paraparesis occurred in 16 (19.8%). Four patients (4.9%) required dialysis postoperatively, three permanently and one transiently. Women accounted for 67% of the paraplegia, 75% of the perioperative dialysis, and 60% of the perioperative or treatment-related deaths. During a mean follow-up of 21.2 months, no aneurysms ruptured, but four (4.9%) enlarged: two were successfully treated, one was unsuccessfully treated, and one was not treated. No late onset spinal cord ischemia symptoms developed. Of the five patients starting dialysis during follow-up, two resulted from renal branch occlusion. Sixteen branches occluded (nine renal, two celiac) or developed stenoses (four renal, one superior mesenteric artery), requiring stenting. Primary patency was 94.8%, and primary-assisted patency was 95.1%. Thirty-two patients (39.5%) underwent 42 reinterventions. Of 25 early reinterventions (≤45 days), 10 were to treat access or insertion complications, and 5 were for endoleak. Of 17 late reinterventions, eight were for endoleak and five were for branch stenosis/occlusion. New endoleaks developed in two patients during follow-up. Overall, 73 of 81 patients (90.1%) were treated without procedure-related death, dialysis, paralysis, aneurysm rupture, or conversion to open repair. Conclusions Total endovascular TAAA/PRAA repair using caudally directed cuffs is safe, effective, and durable in the intermediate term. The most common form of late failure, renal artery occlusion, rarely had a clinically significant consequence (dialysis). The trend toward worse outcome in women needs further study.
Objective Clinical decision making and accurate outcomes comparisons in advanced limb ischemia require improved staging systems. The Society for Vascular Surgery Lower Extremity Threatened Limb ...Classification System (Wound extent, Ischemia, and foot Infection WIfI) was designed to stratify limb outcomes based on three major factors-wound extent, ischemia, and foot infection. The Project or Ex-Vivo vein graft Engineering via Transfection III (PREVENT) III (PIII) risk score was developed to stratify patients by expected amputation-free survival (AFS) after surgical revascularization. This study was designed to prospectively assess limb and patient-based staging for predicting outcomes of hospitalized patients in an amputation prevention program. Methods This study undertook a retrospective analysis of prospectively gathered registry data of consecutive patients with limb-threatening conditions admitted to a fully integrated vascular/podiatry service over a 16-month period. Upon admission, limb risk was stratified using the WIfI system and patient risk was categorized using PIII classification. Patients were assessed for perioperative and postdischarge outcomes, and their relationship to staging at admission was analyzed. Results There were 174 threatened limbs (143 hospitalized patients) stratified by WIfI stage (1%-12%, 2%-28%, 3%-24%, 4%-28%, 5%-3%, unstaged-5%) and PIII risk (34% low, 49% moderate, and 17% high risk). Diabetes and end-stage renal disease were associated with WIfI stage ( P = .006 and P = .018) and PIII risk ( P = .003 and P < .001). Perioperative (30-day) events included 3% mortality, 8% major adverse cardiovascular events and 2.4% major amputation. There were 119 limbs (71%) that underwent revascularization, including 108 infrainguinal reconstructions (endovascular or open revascularization). Rate of revascularization increased with WIfI stage ( P < .001), concomitant with the number of podiatric procedures, minor amputations, and initial hospital duration of stay (all P < .001). Increased WIfI stage was associated with major adverse limb events ( P = .018), reduced limb salvage ( P = .037), and decreased AFS ( P = .048). In contrast, PIII risk category was associated with mortality ( P < .001) and AFS ( P < .001). Among infrainguinal reconstruction procedures, there was a similar distribution of endovascular (46%) and surgical (54%) interventions. Freedom from major adverse limb events was best for autogenous vein bypass ( P = .025), and surgical revascularization was associated with improved limb salvage among the most severely threatened limbs (WIfI stage 4: 95% limb salvage for open bypass vs 68% limb salvage for endovascular; P = .026). Conclusions Among patients hospitalized with limb-threatening conditions and treated by a multidisciplinary amputation prevention team, PIII risk correlates with mortality whereas WIfI stage strongly predicts initial hospital duration of stay, and key mid-term limb outcomes. Surgical revascularization performed best in the limbs at greatest risk (WIfI stage 4), and autogenous vein bypass was the preferred conduit for open bypass. These data support the use of WIfI and PIII as complementary staging tools in the management of chronic limb-threatening ischemia.
The objective of this study was to assess midterm functional status, wound healing, and in-hospital resource use among a prospective cohort of patients treated in a tertiary hospital, ...multidisciplinary Center for Limb Preservation.
Data were prospectively gathered on all consecutive admissions to the Center for Limb Preservation from July 2013 to October 2014 with follow-up data collection through January 2016. Limbs were staged using the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) threatened limb classification scheme at the time of hospital admission. Patients with nonatherosclerotic vascular disorders, acute limb ischemia, and trauma were excluded.
The cohort included 128 patients with 157 threatened limbs; 8 limbs with unstageable disease were excluded. Mean age (±standard deviation SD) was 66 (±13) years, and median follow-up duration (interquartile range) was 395 (80-635) days. Fifty percent (n = 64/128) of patients were readmitted at least once, with a readmission rate of 20% within 30 days of the index admission. Mean total number of admissions per patient (±SD) was 1.9 ± 1.2, with mean (±SD) cumulative length of stay (cLOS) of 17.1 (±17.9) days. During follow-up, 25% of limbs required a vascular reintervention, and 45% developed recurrent wounds. There was no difference in the rate of readmission, vascular reintervention, or wound recurrence by initial WIfI stage (P > .05). At the end of the study period, 23 (26%) were alive and nonambulatory; in 20%, functional status was missing. On both univariate and multivariate analysis, end-stage renal disease and prior functional status predicted ability to ambulate independently (P < .05). WIfI stage was associated with major amputation (P = .01) and cLOS (P = .002) but not with time to wound healing. Direct hospital (inpatient) cost per limb saved was significantly higher in stage 4 patients (P < .05 for all time periods). WIfI stage was associated with cumulative in-hospital costs at 1 year and for the overall follow-up period.
Among a population of patients admitted to a tertiary hospital limb preservation service, WIfI stage was predictive of midterm freedom from amputation, cLOS, and hospital costs but not of ambulatory functional status, time to wound healing, or wound recurrence. Patients presenting with limb-threatening conditions require significant inpatient care, have a high frequency of repeated hospitalizations, and are at significant risk for recurrent wounds and leg symptoms at later times. Stage 4 patients require the most intensive care and have the highest initial and aggregate hospital costs per limb saved. However, limb salvage can be achieved in these patients with a dedicated multidisciplinary team approach.
Background The strength and direction of the associations between inflammation and coagulation biomarkers with kidney disease onset and progression remain unclear, especially in a population-based ...setting. Study Design Prospective observational study. Setting & Participants 4,966 participants from the Multi-Ethnic Study of Atherosclerosis (MESA) with a cystatin C–based estimate of glomerular filtration rate (eGFRcys ) >60 mL/min/1.73 m2 and at least one follow-up measurement of kidney function. All participants were free of cardiovascular disease at entry. Predictor We evaluated the associations of C-reactive protein (CRP), interleukin 6 (IL-6), fibrinogen, factor VIII, and d -dimer levels with kidney function decrease. Outcomes & Measurements Kidney function decrease was assessed primarily by repeated measurements of eGFRcys over 5 years. Rapid decrease in kidney function was defined as eGFR decrease >3 mL/min/1.73 m2 per year. Incident low eGFR was defined as the onset of eGFRcys <60 mL/min/1.73 m2 at any follow-up examination and eGFRcys decrease ≥1 mL/min/1.73 m2 per year. Results Mean age was 60 years, 39% were white, 52% were women, and 11% had diabetes. Mean eGFRcys was 96 mL/min/1.73 m2 and 7% had albuminuria. Median follow-up was 4.77 years. Higher factor VIII levels (per 1 standard deviation SD of biomarker) had the strongest association with kidney function decrease (β = −0.25; 95% CI, −0.38 to −0.12; P < 0.001), followed by IL-6 (β = −0.16; 95% CI, −0.29 to −0.03; P = 0.01), CRP (β = −0.09; 95% CI, −0.22 to 0.03; P = 0.1), and fibrinogen levels (β = −0.09; 95% CI, −0.22 to 0.04; P = 0.2). Each 1-SD higher concentration of IL-6 (OR, 1.15; 95% CI, 1.07-1.23), factor VIII (OR, 1.11; 95% CI, 1.03-1.18), and CRP (OR, 1.09; 95% CI, 1.02-1.16) at baseline was associated significantly with rapid kidney function decrease. Only IL-6 level was associated significantly with incident low eGFR (OR, 1.09; 95% CI, 1.00-1.19). Limitations Observational study design and absence of measured GFR. Conclusions Inflammation and coagulation biomarkers are associated with decreasing kidney function in ambulatory adults without established cardiovascular disease or chronic kidney disease.
Objective The purpose of this study was to compare the branch morphology and short-term outcome of endovascular aneurysm repair using multibranched thoracoabdominal custom-made stent grafts (CSGs) vs ...standard stent grafts (SSGs). Methods Data on patient demographics, aortic morphology, component use, and outcome were collected prospectively. Final branch length (cuff to target artery orifice) and branch angle (cuff orientation to target artery orientation) were determined using 3-D reconstruction of computed tomographic angiograms (CTAs). Results Between January 2008 and March 2010, 28 patients underwent endovascular aneurysm repair using 14 CSGs and 14 SSGs. Two patients were excluded from analysis: one patient in the CSG group had yet to undergo CTA, and one patient in the SSG group had crossed renal branches due to problems traversing a previously reconstructed aortic arch. All the stent grafts were implanted successfully. There were no perioperative deaths. There were no statistically significant differences between the CSG (n = 13) and SSG (n = 13) groups in terms of patient age (74.4 ± 7.9 years vs 73.5 ± 6.0 years), aneurysm diameter (66.1 ± 9.0 mm vs 71.2 ± 9.0 mm), operative time (311 ± 94 minutes vs 286 ± 57 minutes), fluoroscopy time (108 ± 43 minutes vs 101 ± 30 minutes), contrast volume (98 ± 39 minutes vs 91 ± 27 minutes), blood loss (458 ± 205 mL vs 433 ± 193 mL), mean branch angle (22.8 ± 19.0 degrees vs 22.0 ± 17.6 degrees), or branch length (25.3 ± 12.1 mm vs 23.4 ± 10.2 mm). Conclusion The substitution of SSG for CSG had no effect on the complexity of the procedure, the branch morphology, or the perioperative outcome. The availability of an off-the-shelf SSG will broaden the application of endovascular thoracoabdominal aortic aneurysm repair by eliminating manufacturing delays.
Objective This study was conducted to determine the outcome of adjunctive renal artery stenting for renal artery coverage at the time of endovascular abdominal aortic aneurysm repair (EVAR). Methods ...Between August 2000 and August 2008, 29 patients underwent elective EVAR using bifurcated Zenith stent grafts (Cook, Indianapolis, Ind) and simultaneous renal artery stenting. Renal artery stenting during EVAR was performed with endograft “encroachment” on the renal artery ostium (n = 23) or placement of a renal stent parallel to the main body of the endograft (“snorkel,” n = 8). Follow-up included routine contrast-enhanced computed tomography (CT), multiview abdominal radiographs, and serum creatinine measurement at 1, 6, and 12 months, and then yearly thereafter. Results Thirty-one renal arteries were stented successfully in 29 patients. The 18 patients with planned renal artery stent placement had a proximal neck length <15 mm. Mean proximal neck length was shorter in patients who underwent the “snorkel” technique (6.9 ± 3.1 mm) compared with those with planned endograft encroachment (9.9 ± 2.6 mm). None of the patients with unplanned endograft encroachment had neck lengths <15 mm (mean length, 26.3 ± 10.2 mm). Mean proximal neck angulation was 42.8° ± 24.0° and did not differ between the groups. One patient had a type I endoleak on completion angiography, and two additional patients had a type I endoleak on the first postoperative CT scan. All type I endoleaks resolved by the 1-month postoperative CT scan. The primary assisted patency of renal artery stents was 100% at a median follow-up of 12.5 months (range, 2 days-77.4 months). In one patient near occlusion of a renal artery stent was noted on follow-up CT scan at 9 months; patency was restored by placement of an additional stent. One patient required dialysis after sustained hypotension from a right external iliac artery injury that resulted in prolonged postoperative bleeding. Mean serum creatinine was 1.1 ± 0.3 mg/dL at baseline, 1.2 ± 0.5 mg/dL at 1 month of follow-up, and 1.2 ± 0.5 mg/dL at 2 years of follow-up. There were no late type I endoleaks (>1 month postoperatively) or stent graft migrations. Conclusions Adjunctive renal artery stenting during endovascular AAA repair using the “encroachment” and “snorkel” techniques is safe and effective. Short- and medium-term primary patency rates are excellent, but careful follow-up is needed to determine the durability of these techniques.
Abstract Objective In patients lacking autogenous vein suitable for infrainguinal bypass, cryopreserved saphenous vein (CSV) allograft (CryoLife, Inc, Kennesaw, Ga) may be an acceptable alternative. ...The purpose of this study was to examine outcomes of CSV conduit for infrainguinal revascularization. Methods Between February 2008 and August 2015, 70 patients underwent infrainguinal bypass grafts in 73 limbs using CSV. All patients lacked suitable arm or leg vein. Demographic data and patient outcomes were retrospectively collected using electronic medical records. Results The mean age of our cohort was 70 ± 14 years, and 36 (51%) were male; 47 (67%) were white, 39 (56%) had coronary artery disease, 27 (39%) had diabetes, 56 (80%) had hypertension, and 50 (71%) were former or current smokers. Median follow-up was 304 days (interquartile range, 130-991 days). Indications for the index operation included rest pain (27%), tissue loss (55%), and prosthetic graft infection (18%); 62 of 73 (85%) bypasses were performed for critical limb ischemia, and 45 of 73 (62%) were redo operations. Distal targets included superficial femoral artery or popliteal (38%), tibial (55%), and pedal (7%). All grafts had a minimum diameter of 3 mm. At 30 days, 55 of 64 grafts (86%) were patent; 9 were lost to early follow-up. The only significant risk factors associated with 30-day failure were ABO mismatch (43% vs 10%; P = .05) and donor blood type B or AB (40% vs 9%; P = .03). Estimated overall 1-year primary patency was 35%. In a multivariate analysis, nonblack race ( P = .05), donor B or AB blood type ( P = .01), and bypass to a tibial or pedal target ( P = .05) were independently associated with loss of primary patency. There were 20 (27%) major amputations, and all grafts in these limbs had occluded at the time of amputation. Of the 33 limbs with ischemic tissue loss that had long-term follow-up, 17 of 33 (52%) went on to graft occlusion, 10 of 33 (30%) had a major amputation, and 24 of 33 (73%) had complete healing of the index wound. Conclusions In the setting of a multidisciplinary team with aggressive wound care, CSV may be a reasonable choice for infrainguinal revascularization in patients with ischemic tissue loss who lack autogenous conduit. However, poor midterm to long-term patency suggests that optimal selection of patients is needed to derive meaningful clinical benefit.
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