Jade S. Hiramoto

A Standardized Multi-Branched Thoracoabdominal Stent-Graft for Endovascular Aneurysm Repair

Purpose: To assess the feasibility of endovascular thoracoabdominal aortic aneurysm (TAAA) repair using a standard off-the-shelf multi-branched stent-graft. Methods: The aortic anatomy of 66 patients (45 men; mean age 74 years, range 57–87) referred for endovascular repair of TAAA was measured using 3-dimensional reconstructed images from computed tomographic angiograms. In particular, the orientation and longitudinal position of the orifice of each celiac artery, right renal artery, and left renal artery were measured relative to the location of the superior mesenteric artery (SMA) orifice. Based on prior experience, branch insertion with a standard endograft was considered feasible under the following conditions: (1) no more than 4 indispensable (target) arteries to the abdominal viscera, (2) the celiac artery and SMA were 6 to 10 mm in diameter, (3) the renal arteries were 4 to 8 mm in diameter, (4) all target arteries were accessible from a transbrachial approach, (5) the distance between each cuff and the corresponding arterial orifice was ≤50 mm, and (6) the line between the cuff and the orifice deviated by ≤45° from the long axis of the aorta. Results: Seven (11%) of 66 patients violated conditions 1 through 4: 2 had target arteries that were either too wide or too narrow, 2 had >4 indispensable visceral or renal branches, and 3 patients had inaccessible upward directed renal artery branches. Three of the remaining 59 patients had renal arteries outside the boundaries defined by conditions 5 and 6 when the hypothetical stent-graft was positioned with its SMA cuff 25 mm proximal to the corresponding SMA orifice. However, if the stent-graft were deployed in a more caudal location, only 1 of these 3 renal arteries would have been out of range. Therefore, 58 (88%) of 66 patients met all the eligibility criteria for repair using the off-the-shelf stent-graft. Conclusion: A standardized, off-the-shelf, multi-branched stent-graft is applicable in 88% of cases of TAAA that would otherwise have been treated using customized stent-grafts. The use of a pre-made stent-graft has the potential to eliminate long manufacturing delays and expand the scope of endovascular repair of TAAA.

A Double-Barrel Stent-Graft for Endovascular Repair of the Aortic Arch

Purpose: To extend the role of endovascular aneurysm repair in the presence of angulation and dilatation of the distal arch that compromise the proximal implantation site. Case Report: A 70-year-old man with an asymptomatic 7-cm thoracic aortic aneurysm was treated with a TAG stent-graft. However, attempts to gain secure hemostatic implantation of the endograft resulted in inadvertent coverage of the subclavian and left carotid arteries. Flow to the left carotid artery was re-established by transcarotid insertion of a self-expanding covered stent alongside the primary stent-graft. Conclusion: This technique may have a role as an intended part of endovascular repair when there is no suitable implantation site in the descending thoracic aorta.

Efficacy and durability of endovascular thoracoabdominal aortic aneurysm repair using the caudally directed cuff technique

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.

Double-barrel technique for endovascular exclusion of an aortic arch aneurysm without sternotomy.

Purpose: To report the use of commercially available stents and a stent-graft in coaxial orientation to extend the proximal limits of endografting within the aortic arch. Case Report: A 70-year-old man was found to have an asymptomatic 7-cm saccular aortic arch aneurysm, extending distally from the origin of the left carotid artery and involving the left subclavian artery; there was only 11 mm between the innominate artery orifice and the aneurysm. The patient was deemed to be high risk for open surgical repair due to a history of 2 prior sternotomies and the requirement for hypothermic circulatory arrest. A “double-barrel” stent-graft strategy combining retrograde placement of an innominate stent with thoracic stent-graft implantation into zone 0 was successfully executed. The patient has continued to fare well after 10 months on close follow-up. Conclusion: The “double-barrel” stent technique may extend the limits of thoracic endografting by preserving the aortic arch branches while avoiding the need for sternotomy. Using this technique, proximal fixation can be obtained well into the ascending aorta using commercially available devices.

Double-Barrel Technique for Preservation of Aortic Arch Branches During Thoracic Endovascular Aortic Repair

Thoracic endovascular aortic repair (TEVAR) may involve either planned or inadvertent coverage of aortic branch vessels when stent grafts are implanted into the aortic arch. Vital branch vessels may be preserved by surgical debranching techniques or by placement of additional stents to maintain vessel patency. We report our experience with a double-barrel stent technique used to maintain aortic arch branch vessel patency during TEVAR. Seven patients underwent TEVAR using the double-barrel technique, with placement of branch stents into the innominate (n = 3), left common carotid (n = 3), and left subclavian (n = 1) arteries alongside an aortic stent graft. Gore TAG endografts were used in all cases, and either self-expanding stents (n = 6) or balloon-expandable (n = 1) stents were utilized to maintain patency of the arch branch vessels. In three cases the double-barrel stent technique was used to restore patency of an inadvertently covered left common carotid artery. Four planned cases involved endograft deployment proximally into the ascending aorta with placement of an innominate artery stent (n = 3) and coverage of the left subclavian artery with placement of a subclavian artery stent (n = 1). TEVAR using a double-barrel stent was technically successful with maintenance of branch vessel patency and absence of type I endoleak in all seven cases. One case of zone 0 endograft placement with an innominate stent was complicated by a left hemispheric stroke that was attributed to a technical problem with the carotid-carotid bypass. On follow-up of 2-18 months, all double-barrel branch stents and aortic endografts remained patent without endoleak, migration, or loss of device integrity. The double-barrel stent technique maintains aortic branch patency and provides additional stent-graft fixation length during TEVAR to treat aneurysms involving the aortic arch. Moreover, the technique uses commercially available devices and permits complete aortic arch coverage (zone 0) without a sternotomy. Although initial outcomes are encouraging, long-term durability remains unknown.

Inflammation and Coagulation Markers and Kidney Function Decline: The Multi-Ethnic Study of Atherosclerosis (MESA)

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 (eGFR(cys)) >60 mL/min/1.73 m(2) 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 eGFR(cys) over 5 years. Rapid decrease in kidney function was defined as eGFR decrease >3 mL/min/1.73 m(2) per year. Incident low eGFR was defined as the onset of eGFR(cys) <60 mL/min/1.73 m(2) at any follow-up examination and eGFR(cys) decrease ≥1 mL/min/1.73 m(2) per year. RESULTS Mean age was 60 years, 39% were white, 52% were women, and 11% had diabetes. Mean eGFR(cys) was 96 mL/min/1.73 m(2) 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.

Systemic Inflammation, Coagulopathy, and Acute Renal Insufficiency Following Endovascular Thoracoabdominal Aortic Aneurysm Repair

OBJECTIVE To characterize the inflammatory and coagulopathic response after endovascular thoracoabdominal aortic aneurysm (TAAA) repair and to evaluate the effect of the response on postoperative renal function. METHODS From July 2005 to June 2008, 42 patients underwent elective endovascular repair of a TAAA using custom designed multi-branched stent-grafts at a single academic institution. Four patients were excluded from the analysis. White blood cell count (WBC), platelet count, prothrombin time (PT), and creatinine were measured in all patients. In the last nine patients, interleukin-6 (IL-6), protein C, Factor V, d-dimers, cystatin C, and neutrophil gelatinase-associated lipocalin (NGAL) levels were also measured. Change in lab values were expressed as a percentage of baseline values. RESULTS The 30-day mortality rate was 5% (2/38). All patients (n = 38) had a higher WBC (mean +/- SD: 139 +/- 80%, P < .0001), lower platelet count (56 +/- 15%, P < .0001), and higher PT (median: 17%, Interquartile range (IQR) 12%-22%, P < .0001) after stent-graft insertion. Twelve of 38 patients (32%) developed postoperative acute renal insufficiency (>50% rise in creatinine). Patients with renal insufficiency had significantly larger changes in WBC (178 +/- 100% vs 121 +/- 64%, P = .04) and platelet count (64 +/- 17% vs 52 +/- 12%, P = .02) compared with those without renal insufficiency. All patients (n = 9) had significant increases in NGAL (182 +/- 115%, P = .008) after stent-graft insertion. Six of nine patients (67%) had increased cystatin C (35 +/- 43%, P = .04) after stent-graft insertion, with a greater rise in those with postoperative renal insufficiency (87 +/- 32% vs 8 +/- 13%, P = .02). IL-6 levels were markedly increased in all patients (n = 9) after repair (9840 +/- 6160%, P = .008). Protein C (35 +/- 10%, P = .008) and Factor V levels (28 +/- 20%, P = .008) were uniformly decreased, while d-dimers were elevated after repair in all patients (310 +/- 213%, P = .008). CONCLUSIONS Leukocytosis and thrombocytopenia were uniform following endovascular TAAA repair, and the severity of the response correlated with post-operative renal dysfunction. Elevation of a sensitive marker of renal injury (NGAL) suggests that renal injury may occur in all patients after stent-graft insertion.

Association Between Depression and Peripheral Artery Disease: Insights From the Heart and Soul Study

Background Depression is known to increase the risk of coronary artery disease, but few studies have evaluated the association between depression and peripheral artery disease (PAD). We examined the association of depression with PAD and evaluated potential mediators of this association. Methods and Results We used data from the Heart and Soul Study, a prospective cohort of 1024 men and women with coronary artery disease recruited in 2000–2002 and followed for a mean of 7.2±2.6 years. Depressive symptoms were assessed with the validated 9-item Patient Health Questionnaire. Prevalent PAD at baseline was determined by self-report. Prospective PAD events were adjudicated on the basis of review of medical records. We used logistic regression and Cox proportional-hazards models to estimate the independent associations of depressive symptoms with prevalent PAD and subsequent PAD events. At baseline, 199 patients (19%) had depressive symptoms (Patient Health Questionnaire ≥10). Prevalent PAD was reported by 12% of patients with depression and 7% of those without depression (base model adjusted for age and sex: odds ratio 1.79, 95% confidence interval 1.06–3.04, P=0.03; full model adjusted for comorbidities, medications, PAD risk factors, inflammation, and health behaviors: odds ratio 1.59, 95% confidence interval 0.90–2.83, P=0.11). During follow-up, PAD events occurred in 7% of patients with depression and 5% of those without depression (base model adjusted for age and sex: hazard ratio 2.09, 95% confidence interval 1.09–4.00, P=0.03; full model adjusted for comorbidities, medications, PAD risk factors, inflammation, and health behaviors: hazard ratio 1.33, 95% confidence interval 0.65–2.71, P=0.44). Factors explaining >5% of the association between depression and incident PAD events included race/ethnicity, diabetes, congestive heart failure, high-density lipoprotein, triglyceride levels, serum creatinine, inflammation, smoking, and levels of physical activity. Conclusions Depressive symptoms were associated with a greater risk of PAD. Because the association was explained partly by modifiable risk factors, our findings suggest that more aggressive treatment of these risk factors could reduce the excess risk of PAD associated with depression. (J Am Heart Assoc. 2012;1:e002667 doi: 10.1161/JAHA.112.002667.)

Successful long-term outcomes using pediatric en bloc kidneys for transplantation.

Goal: The objective of our study was to determine whether acceptable long‐term graft survival and function can be achieved using pediatric en bloc renal transplants by employing specific immunologic and selection strategies.

The transition from custom-made to standardized multibranched thoracoabdominal aortic stent grafts

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.