Left Subclavian Artery Patency Research Articles

In Situ Fenestration and Carotid-Subclavian Bypass for Left Subclavian Artery Revascularization During Thoracic Endovascular Aortic Repair

PurposeTo evaluate the safety and feasibility of left subclavian artery (LSA) revascularization techniques during thoracic endovascular aortic repair (TEVAR)—the in situ needle fenestration (ISNF) technique and the carotid-subclavian bypass (CS-Bp)—for complicated aortic pathologies.MethodsA retrospective single-center observational study was conducted to identify all patients with thoracic aortic pathologies who underwent TEVAR with LSA revascularization using either CS-Bp or ISNFs from January 2014 to December 2020.ResultsOne hundred and twelve consecutive patients who received TEVAR with LSA revascularization were included. Among them, 69 received CS-Bp and 43 received ISNF (29 using the Futhrough adjustable puncture needles, 14 using the binding stent-graft puncture systems). Technical success, defined as achieving aortic arch pathology exclusion and LSA preservation, was attained in 99.1% patients. Early mortality was 0.9%. Major adverse events within 30 days, including one cerebral hemorrhage, one cervical incision hemorrhage, one stroke and two paraplegia, were exclusively observed in the CS-Bp group. Immediate type I, II and III endoleaks occurred in 0%, 4.7% and 2.3% in the ISNF group, respectively, compared to 0%, 2.9% and 0% in the CS-Bp group.One hundred and eight (97.2%) patients were available for follow-up at a median 50 (maiximum of 103) months, revealing a LSA patency rates of 99.1%. Six patients died during follow-ups—five in the CS-Bp group and one in the ISNF group. Cause of death include one aortic-related stent-graft infection, three non-related and two with unknow causes. The survival exhibited no significantly different between the ISNF (97.7%) and CS-Bp (89.9%) groups (p = 0.22).ConclusionsBoth CS-Bp and ISNF are feasible techniques for LSA reconstruction in TEVAR. ISNF, whether using Futhrough or BPS, seems to be competitive with CS-Bp.Graphical

Homemade fenestration and chimney techniques for the left subclavian artery revascularization during zone 2 thoracic endovascular aortic repair.

To investigate the safety and efficacy of homemade fenestration and chimney techniques for the left subclavian artery (LSA) revascularization during zone 2 thoracic endovascular aortic repair (TEVAR). From February 2017 to February 2021, 41 patients undergoing fenestration technique (group A) and 42 patients undergoing chimney technique (group B) to preserve the LSA during zone 2 TEVAR were enrolled in the present study. The procedure was indicated for dissections with unsuitable proximal landing zone with refractory pain and hypertension, rupture and malperfusion, and high-risk radiographic features. The baseline characteristics, peri-procedure, and follow-up clinical and radiographic data were recorded and analyzed. The primary endpoint was clinical success, and the secondary endpoints were rupture-free survival, LSA patency, and complications. Aortic remodeling, defined as patency, partial and complete thrombosis of the false lumen, was also analyzed. Technical success was achieved in 38 and 41 patients in groups A and B, respectively. Four intervention-related deaths were confirmed, two in each group. Immediate post-procedural endoleaks were detected in two and three patients in group A and B, respectively. No other major complications were found in either group, except for one retrograde type A dissection in group A. During follow-up, the initial clinical success rates were 90.24% and 92.86% in groups A and B, respectively. The primary and secondary mid-term clinical success rates were 87.5% and 90% in group A, and both of them were 92.68% in group B. Rupture-free survival and LSA patency were not significantly different between the two groups. The incidence of complete thrombosis in the aorta distal to the stent graft was 67.65% and 61.11% in groups A and B, respectively. Apart from the lower clinical success rate of fenestration technique, both physician-modified techniques are available for LSA revascularization during zone 2 TEVAR and significantly promote favorable aortic remodeling.

Mid-term outcomes of left subclavian artery revascularization with Castor stent graft in treatment of type B aortic dissection in left subclavian artery

BackgroundHere we analyzed mid-term data of thoracic endovascular aneurysm repair (TEVAR) surgery with Castor single-branched stent graft placement for the management of Stanford type B aortic dissection (STBAD) involving the left subclavian artery (LSA). MethodsBetween April 2014 and February 2019, 32 patients with STBAD involving a Castor single-branched stent graft were included. We analyzed their outcomes, including technical success rate (TSR), surgical duration (SD), presence of ischemia, perioperative complications, LSA patency, and survival rate (SR), using computed tomography angiography and clinical evaluation during mid-term follow-up. ResultsThe mean patient age was 54.63 ​± ​12.37 years (range, 36–83 years). The TSR was 96.88% (n ​= ​31/32). The mean SD was 87.44 ​± ​10.89 with a mean contrast volume of 125.31 ​± ​19.30 ​mL. No neurological complications or deaths occurred during the study period. The patients had a mean hospital stay of 7.84 ​± ​3.20 days. At a mean follow-up of 68.78 ​± ​11.26 months, four non-aortic deaths (12.5%) were observed. The LSA patency rate was 100% (n ​= ​28/28). There was only one case of type I endoleak immediately after surgery (3.12%) (type I from LSA). However, none of the patients experienced type II endoleaks, and there were no cases of retrograde type A aortic dissection or stent graft-driven new distal entry. Finally, all patients exhibited good LSA patency. ConclusionTEVAR using a Castor single-branched stent graft may be a highly feasible and efficient procedure for the management of STBAD involving the LSA.

Physician-Modified Endovascular Grafts for Zone-2 Thoracic Endovascular Aortic Repair.

Objective This study aims to describe our technique and early experience with physician-modified endovascular grafts (PMEGs) for aortic arch diseases in zone 2. We used a total endovascular technique based on a single fenestrated endograft to preserve left subclavian artery (LSA) patency. Methods From December 2019 to August 2020, six consecutive patients with a variety of thoracic aortic diseases were treated with handmade fenestrated thoracic aortic grafts: four aortic dissections, one penetrating aortic ulcer, and one intramural hematoma. The planning, endograft modification, surgical technique, and follow-up of the patients were described. We evaluated immediate technical success and after 30 days, the LSA patency, Type-1 endoleak, and postoperative complications. Results Thoracic endovascular aortic repair (TEVAR) was performed for zone 2 in all cases. Immediate technical success, defined as successful alignment of the LSA with a covered stent and no Type-1 endoleak, was achieved in all cases. Patients had a 30-day follow-up computed tomography, which demonstrated LSA patency and no Type-I endoleaks. To date, no strokes, left arm ischemia, paraplegia, or conversions to open surgery have been reported; one patient operated for acute Type B dissection died during the early follow-up. Conclusion TEVAR for zone 2 with a PMEG to maintain LSA patency achieved technical success and early durability. It is expected that with longer follow-up and a larger number of cases, these results will be confirmed.

Identifying risk factors for early neurological outcomes following thoracic endovascular aortic repair using the SUMMIT database.

The aim of this study was to assess risk factors for early neurological complications following thoracic endovascular aortic repair (TEVAR) for multiple thoracic aortic diseases using an aggregated dataset. The Study to Assess Outcomes After Endovascular Repair for Multiple Throacic Aortic Disease dataset included data from 6 studies evaluating Zenith thoracic endografts. Post hoc analysis identified early (30-day) neurological complications by TEVAR indication and corresponding risk factors. The study included 594 TEVAR patients (67% male; mean age 66 ± 15 years) with thoracic aortic aneurysm (n = 329), ulcer (n = 56), acute (n = 126) or non-acute (n = 33) type B aortic dissection (TBAD) or blunt injury (n = 50). Overall early stroke rate was 3.5% (n = 21). Overall early paraplegia and paraparesis rates were 1.3% (n = 8) and 2.5% (n = 15), respectively. Multivariable analysis identified acute TBAD [versus others, odds ratio (OR) = 3.47, 95% confidence internal (CI): 1.41-8.52) and longer procedural time (OR = 1.33, CI: 1.02-1.73) as early stroke risk factors. Risk factors for paraplegia or paraparesis included more endografts deployed (OR = 2.43, CI: 1.30-4.55), older age (OR = 1.05, CI: 1.01-1.10) and higher preoperative serum creatinine (OR = 1.31, CI: 1.05-1.64). Endografts landing proximal to the left subclavian artery (LSA) increased stroke rate (versus distal to the LSA; 6.8% vs 2.3%, P = 0.014). Intraoperative LSA revascularization was performed in 20.9% of patients with endografts proximal to the LSA; revascularization did not significantly alter stroke rate (8.1% with revascularization vs 6.4% without, P = 0.72). Acute TBAD and prolonged procedure time increased early stroke risk, while more endografts placed, age and preoperative renal impairment increased early paraplegia or paraparesis risk. For acute TBAD, endograft placement proximal to the LSA, but not LSA patency, increased stroke risk.

Endovascular Repair for Acute Type B Aortic Dissection With Unfavorable Proximal Landing Zone

BackgroundThe study aimed to compare the safety and effectiveness between fenestrated technique with or without chimney stent and single-branched stent graft for isolated left subclavian artery revascularization during endovascular repair of acute type B aortic dissection with unfavorable proximal landing zone. MethodsFrom January 2016 to December 2019, 65 acute type B aortic dissection patients with unfavorable proximal landing zone were treated with either the fenestrated technique (n = 34, group A) or single-branched stent graft (n = 31, group B). Type I endoleak, retrograde type A dissection, stroke, left subclavian artery patency, 30-day mortality, and aortic remodeling were systematically recorded and retrospectively analyzed. ResultsTechnical success rates for groups A and group B were 94.12% and 100%, respectively. Left subclavian artery primary patency was achieved for all enrolled patients. The incidence of type I endoleak, retrograde type A dissection, stroke, and 30-day mortality was 5.9%, 5.9%, 2.9%, and 2.9% in group A, respectively, but none were encountered in group B. Left subclavian artery occlusion was observed in 3 patients in group A and 2 patients in group B during a mean follow-up of 16.18 ± 2.08 months and 15.19 ± 2.68 months, respectively. After the procedure, significant aortic remodeling was detected in both groups during follow-up. ConclusionsBoth techniques are feasible and safe for isolated left subclavian artery revascularization during endovascular repair for acute type B aortic dissection. Apart from the associated perioperative risks of complications and mortality for the fenestrated technique, both procedures contributed to favorable aortic remodeling.

Management of the Left Subclavian Artery in TEVAR for Chronic Type B Dissection

A retrospective review was performed of the Vascular Quality Initiative registry from July 2010 to July 2016. In 131 patients with chronic type B aortic dissection who had undergone thoracic endovascular aortic repair (TEVAR), the left subclavian artery (LSA) remained patent or had undergone revascularization in 106 patients (81%), and 25 patients (19%) had had occlusion of the LSA without revascularization. Maintaining LSA patency did not significantly affect the in-hospital stroke, spinal cord ischemia, or death rate. Also, no difference was found in the endoleak rate. Maintaining LSA patency during TEVAR for chronic type B dissection offers no advantage in terms of perioperative morbidity or endoleak. Occlusion of the LSA can be performed safely in this cohort, with revascularization reserved for those with anatomy that compromises perfusion to critical organs.

Management of the Left Subclavian Artery in TEVAR for Chronic Type B Aortic Dissection.

Left subclavian artery (LSA) revascularization in thoracic endovascular aortic repair (TEVAR) remains controversial. Left subclavian artery coverage without revascularization can cause stroke and death. TEVAR has gained popularity for the treatment of chronic type B aortic dissection (cTBD). Using the Vascular Quality Initiative (VQI) database, we reviewed outcomes of LSA revascularization in TEVAR for cTBD. The VQI registry identified 5683 patients treated with TEVAR from July 2010 to July 2016, including 208 repairs for cTBD. We analyzed outcomes per the Society for Vascular Surgery reporting standards. Of the 208 patients, 150 (72.1%) were male with a median age of 65.0 years (interquartile range [IQR], 55.0-72.0). Median aneurysm diameter was 5.7 cm (IQR, 5.0-6.5 cm). Data on the patency of the LSA was available in 131 (63.0%) patients. Twenty-five (19.1%) had occlusion of the LSA without revascularization, while 106 (80.9%) maintained patency or had revascularization. Successful device delivery occurred in all 131 (100%) patients. Maintaining LSA patency did not affect the rate of cerebrovascular accident (P = .16), spinal cord ischemia (P = 1.00), or death (P = 1.00). This was also nonsignificant when analyzing the subgroup of 98 elective cases. There was no difference in the rates of endoleak. Any intervention for the LSA (revascularization or occlusion) led to a longer procedure time (203.6 minutes vs 163.7 minutes, P = .04). Maintaining LSA patency during TEVAR for cTBD offers no advantage in perioperative morbidity or endoleak. Occlusion of LSA may be performed safely in this cohort and revascularization reserved for those who have anatomy that compromises perfusion to critical organs.

In Situ Laser Stent Graft Fenestration of the Left Subclavian Artery during Thoracic Endovascular Repair of Type B Aortic Dissection with Limited Proximal Landing Zones: 5-Year Outcomes

PurposeTo assess safety and feasibility of in situ laser stent graft fenestration to revascularize the left subclavian artery (LSA) during thoracic endovascular repair (TEVAR) of type B aortic dissection (TBAD) with limited proximal landing zones with 5 years of follow-up. Materials and MethodsIn a single-center retrospective study, 130 patients with TBAD with limited proximal landing zones (≤ 1.5 cm) underwent in situ laser stent graft fenestration revascularizing the LSA during TEVAR from April 2014 to April 2019. Outcomes were assessed by CT angiography and clinic visits, including technical success rate, operative time, LSA patency, ischemic events, and late aorta-related complications during follow-up. ResultsMean age of patients was 53 y (range, 33–73 y). Primary technical success rate was 96.9% (126/130). Three chimney stents were placed instead of fenestration, and 1 LSA fenestration was combined with a left common carotid artery (LCCA) chimney stent. Mean operative time was 53 min ± 28 with fluoroscopy time of 40 min ± 15. There were no neurologic complications and no deaths, with a mean duration of hospital stay of 9 d (range, 5–21 d). At a mean follow-up of 42 mo (range, 5–60 mo), there was a 97% primary LSA patency. Four patients had a type I endoleak, which disappeared during follow-up. One LCCA became occluded after 6 months. No type II or III endoleaks were found. Retrograde type A aortic dissection and stent graft–induced new distal entry were not found during follow-up. ConclusionsIn situ laser fenestration to revascularize the LSA during TEVAR of TBAD with limited proximal landing zones was efficient, safe, and feasible based on 5-year follow-up.

Periscope sandwich stenting as an alternative to open cervical revascularization of left subclavian artery during zone 2 thoracic endovascular aortic repair

ObjectiveRevascularization of the left subclavian artery (LSA) during zone 2 thoracic endovascular aortic repair (TEVAR) maintains collateral circulation to decrease ischemic complications, including stroke, spinal cord ischemia, and upper extremity ischemia. Both open surgical and endovascular LSA revascularization techniques have been described, each with unique risks and benefits. We describe our “periscope sandwich” technique for the LSA during zone 2 TEVAR, which maintains antegrade access to the distal abdominal aorta if subsequent interventions are necessary. Technical results and short-term outcomes are compared with LSA open surgical debranching. MethodsA single-institution retrospective review was performed for patients requiring zone 2 TEVAR with LSA revascularization by periscope sandwich technique or open surgical debranching with subclavian to carotid transposition (SCT) or carotid-subclavian bypass (CSB). The presenting aortic disease and perioperative details were recorded. Intraoperative angiography and postoperative computed tomography images were reviewed for occurrence of endoleak and branch patency. ResultsBetween January 2013 and December 2018, the LSA was revascularized by periscope sandwich in 18 patients, SCT in 22 patients, and CSB in 13 patients. Compared with open surgical debranching, periscope sandwich had a lower median estimated blood loss (100 mL vs 200 mL for pooled SCT and CSB; P = .03) and lower median case duration (133.5 minutes vs 226 minutes; P < .001). Contrast material volume (120 mL vs 120 mL; P = .98) and fluoroscopy time (13.1 minutes vs 13.3 minutes; P = .92) did not differ significantly between the groups. There was no difference in aorta-related mortality (P = .14), and LSA patency was 100%. Median follow-up for the periscope sandwich group was 11 months, with an overall estimated 91% freedom from gutter leak at 6 months. ConclusionsLSA periscope sandwich technique provides safe and effective LSA revascularization during zone 2 TEVAR. LSA periscope sandwich can be used emergently with off-the-shelf endovascular components and facilitates future branched-fenestrated endovascular repair of thoracoabdominal aortic diseases.

IF10. In Situ Laser Stent Graft Fenestration of the Left Subclavian Artery for Thoracic Endovascular Repair of Type B Aortic Dissection

Aim to assess the security and feasibility of in situ laser stent graft fenestration to reserve left subclavian artery (LSA) for thoracic endovascular repair (TEVAR) of type B aortic dissection (TBAD) with limited proximal landing regions. From April 2014 to July 2018, 130 successive patients under in situ laser stent graft fenestration constructing LSA during TEVAR of TBAD with limited proximal landing regions were analyzed by means of retrospective analysis. Preoperative, together with intraoperative and postoperative medical data were recorded. The mean age of patients was 53 years old (range, 33-73 years), and 76 of 130 patients (58.5%) were male. Single LSA fenestration was formed in 126 patients; thus, the first technological achievement rate was nearly 96.9% (126 of 130 patients). In addition, one LSA fenestration was united with left common carotid artery chimney stent and the other three chimney stents were placed instead of laser fenestration owing to LSA tortuosity. The average operation time was 53 ± 28 minutes and the fluoroscopy duration was 40 ± 15 minutes. Importantly, there were no complexities concerning the preoperative neurologic state and no in-clinic deaths. Additionally, 9 days was the average duration of stay (range, 5-21 days). Patients stayed alive at average 12 months follow-up (range, 3-20 months) with computed tomography angiography showing 97% initial LSA patency. Four patients had type I endoleaks and no fenestration associated with type II or III endoleaks were found. In situ laser fenestration to restore the LSA in TEVAR of TBAD with limited proximal landing regions was efficient, secure, and feasible.

Comparison of Two Different Techniques for Isolated Left Subclavian Artery Revascularization During Thoracic Endovascular Aortic Repair in Zone 2

Purpose: To analyze the results of isolated left subclavian artery (LSA) revascularization during thoracic endovascular aortic repair (TEVAR) using carotid-subclavian bypass (CSbp) or chimney grafts (CGs). Methods: A retrospective multicenter, observational study identified 73 patients (mean age 68±13 years, range 22–87; 56 men) with acute or chronic thoracic aortic lesions who underwent TEVAR with isolated LSA revascularization using either CSbp (n=42) or CGs (n=31) from January 2010 and February 2017. Primary endpoints were TEVAR-related mortality, postoperative stroke, freedom from type Ia endoleak, and LSA patency. Results: Primary technical success was achieved in all cases. Early TEVAR-related mortality was 4.2% (CSbp 2% vs CG 6%, p=0.571). Two (3%) patients had major ischemic strokes (one in each group). Mean follow-up was 24±21 months (range 1–72; median 15). Estimated freedom from TEVAR-related mortality was 93%±3% (95% CI 84.3% to 97.0%) at 12 and 36 months, with no significant difference between CSbp and CG (p=0.258). Aortic reintervention did not differ between the groups (CSbp 5% vs CG 6%, p=0.356); nor did freedom from type Ia endoleak (CSbp 98% vs CG 87%, p=0.134). Gutter-related endoleaks occurred in 4 (13%) CG patients, but none of the patients experienced sac enlargement or the need for reintervention and none died. Primary patency of the LSA was 100% for the entire group during the observation period. Conclusion: In our experience, LSA revascularization proved most satisfactory and equally effective with both the CSbp and CG techniques, without discernible differences at midterm follow-up.

Invited commentary

The accompanying study by Roselli et al1Roselli E.E. Arko 3rd, F.R. Thompson M.M. Valiant Mona LSA Trial InvestigatorsResults of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms.J Vasc Surg. 2015; 62: 1465-1472Abstract Full Text Full Text PDF PubMed Scopus (70) Google Scholar is noteworthy for a couple of reasons: this first-in-man study of “safety and efficacy” was performed (mainly) in the United States through participation in the United States Food and Drug Administration's newly developed Innovation Pathway, and the study device provides a much needed all-endovascular option for the treatment of aneurysms involving the proximal descending thoracic aorta. As described in Roselli et al, the cuff-based side branch of the Valiant Mona LSA stent graft (Medtronic, Minneapolis, Minn) preserves flow to the subclavian artery in an attempt to minimize the risk of stroke, paraplegia, and left hand ischemia. The results of this study confirm the feasibility of the approach. All of the stent grafts and their branches were implanted as intended. The case for safety, efficacy, and durability is less clear. As reported in Table III, six patients (67%) sustained “procedure-related” serious adverse events, and strokes occurred in three (33%), all of which were symptomatic and visible on computed tomography. The high stroke rate is reminiscent of early experience with a two-branch system of arch repair (Cook Medical, Bloomington, Ind). As evidenced by later results with the Cook device, increasing familiarity with key parts of the procedure, decreasing instrumentation of the ascending aorta and arch, and the development of a lower-profile device all help to reduce the stroke rate in procedures of this type.2Haulon S. Greenberg R.K. Spear R. Eagleton M. Abraham C. Lioupis C. et al.Global experience with an inner branched arch endograft.J Thorac Cardiovasc Surg. 2014; 148: 1709-1716Abstract Full Text Full Text PDF PubMed Scopus (200) Google Scholar Five patients (56%) in the current study had an endoleak at some point. The authors suggest that “new endoleaks developed” in the postoperative period. I hope not, because a loss of aneurysm exclusion (new endoleak) would call into question the stability of the device and the durability of the repair. More likely, the endoleaks were present from the time of stent graft implantation. After all, intraoperative angiography is not the most sensitive method of endoleak detection. The current short-term data give little indication of long-term device performance. Nevertheless, I expect that long-term follow-up will confirm the durability of the repair, partly because most of the components of the Valiant Mona LSA device have withstood long-term clinical use in other Medtronic products and partly because the combination of a self-expanding branch with a cuff-bearing stent graft has worked well in the thoracoabdominal aorta3Reilly L.M. Rapp J.H. Grenon S.M. Hiramoto J.H. Sobel J. Chuter T.A. Efficacy and durability of endovascular thoracoabdominal aortic aneurysm repair using the caudally directed cuff technique.J Vasc Surg. 2012; 56: 53-64Abstract Full Text Full Text PDF PubMed Scopus (88) Google Scholar and the aortic arch.2Haulon S. Greenberg R.K. Spear R. Eagleton M. Abraham C. Lioupis C. et al.Global experience with an inner branched arch endograft.J Thorac Cardiovasc Surg. 2014; 148: 1709-1716Abstract Full Text Full Text PDF PubMed Scopus (200) Google Scholar If the device proves to be as durable as I predict, and increasing operator experience achieves the hoped for reduction in stroke rate, the Valiant Mona LSA stent graft has a promising future. It might play a role not only in the repair of aneurysms involving the distal aortic arch and descending thoracic aorta but also in type B dissections and aneurysms of the proximal aortic arch. Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysmsJournal of Vascular SurgeryVol. 62Issue 6PreviewStent graft coverage of the left subclavian artery (LSA) may be required to achieve an adequate landing zone in up to 40% of descending thoracic aneurysms (DTAs). The Valiant Mona LSA Thoracic Stent Graft System (Medtronic, Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency while diverting circulation through the encroaching aneurysm. Participating in the United States Food and Drug Administration's new Innovation Pathway, this first-in-human, early feasibility study evaluates early clinical experience of the Valiant Mona LSA Stent Graft System in patients with DTAs where the proximal landing zone necessitates LSA coverage. Full-Text PDF Open Archive

Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms

Stent graft coverage of the left subclavian artery (LSA) may be required to achieve an adequate landing zone in up to 40% of descending thoracic aneurysms (DTAs). The Valiant Mona LSA Thoracic Stent Graft System (Medtronic, Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency while diverting circulation through the encroaching aneurysm. Participating in the United States Food and Drug Administration's new Innovation Pathway, this first-in-human, early feasibility study evaluates early clinical experience of the Valiant Mona LSA Stent Graft System in patients with DTAs where the proximal landing zone necessitates LSA coverage. This premarket, nonrandomized, single-arm prospective study recruited nine patients (age 72.9 ± 7.6 years). Primary end points were aneurysm-related mortality, stroke, paraplegia, left arm/hand ischemia, and treatment success. Neurologic events were assessed by imaging and by independent neurologists. Inclusion criteria required patients with a DTA or penetrating aortic ulcer to have a distance of ≥10 mm between the left common carotid artery and the LSA. Mean aneurysm diameter was 53.7 ± 10.0 mm. The indication for repair was for saccular DTA in five patients or fusiform DTA in four. Seven patients were at American Society of Anesthesiologists Physical Status Classification III/IV. All nine patients received one main stent graft (diameter 28 to 42 mm) and one branch stent graft (diameter 10 to 14 mm). To extend device coverage distally, a commercial Valiant Captivia device was implanted in seven patients. No uncorrected endoleaks were observed at the end of the implant procedure. Four endoleaks developed before discharge in four of eight evaluable patients. Two were identified as type II and two were of undetermined type. No endoleak resulted in a secondary intervention. Technical success, defined by the clinical investigational plan, was achieved in all nine patients intraoperatively, and treatment success was achieved in all eight evaluable patients at 1 month. There were no major, disabling strokes. Four minor nondisabling strokes were reported in three patients ≤30 days (days 1, 1, 5, and 24). To date, there have been no reports of death, left arm ischemia, paraplegia, rupture, conversion to open surgery, or secondary endovascular procedure. No patients required surgical LSA revascularization. The Valiant Mona LSA system demonstrates technical and treatment success, relative safety, and early durability in its initial use in DTA patients. Midterm results are expected as patients are monitored at regular intervals to 5 years.

Total endovascular repair of aberrant left subclavian artery with Kommerell's diverticulum using a customized branched device

We describe a case of Kommerell's diverticulum involving the distal portion of a right-sided aortic arch and the origin of an aberrant left subclavian artery (LSA). The patient underwent a total endovascular repair with the use of a modified Valiant endograft (Medtronic, Minneapolis, Minn) to which a branch was attached to keep LSA patency. Postoperative computed tomography showed complete exclusion of the lesion, without endoleaks. The use of "customized off-label" devices to treat special conditions was feasible in this case, keeping patency of the LSA without risk of arm claudication or the requirement for a complementary surgical bypass.

Endovascular aneurysm repair using the periscope graft technique for thoracic aortic anastomotic pseudoaneurysm

Replacement of an artificial graft in a redo lateral thoracotomy is extremely difficult with a high risk of lung injury. Endovascular intervention may be an ideal option in such conditions, as in the following case. A 75-year old man with a history of coronary artery bypass graft surgery developed a proximal anastomotic pseudoaneurysm 1 year after undergoing artificial proximal descending aorta replacement surgery. Thoracic endovascular aneurysm repair was performed successfully using the periscope graft technique to preserve the flow into the left subclavian artery from the distal side of the aortic stent graft. Since the patient had coronary artery bypass grafting, debranching of the left subclavian artery was considered too risky. Using the periscope graft technique, the pseudoaneurysm was successfully repaired preserving the left subclavian artery patency, thus obviating a side-to-side subclavian artery crossover bypass.

Simplified surgical procedure of stented elephant trunk fenestration in acute Stanford type A aortic dissection

To study the technical feasibility of simplified total arch replacement via stented elephant trunk fenestration in the treatment of acute Stanford type A aortic dissection. A total of 42 consecutive patients with acute type A aortic dissection underwent total aortic arch replacement plus fenestrate stented elephant trunk implantation under hypothermic cardiopulmonary bypass and bilateral antegrade cerebral perfusion between August 2008 to February 2011. The aortic arch was accessed longitudinally. Transection of aortic arch was performed between left common carotid artery and left subclavian artery. A stented elephant trunk was inserted in descending aorta. Then the reconstruction of left subclavian artery was made by fenestration in stented elephant trunk. Finally 3-branched graft was used to complete the reconstruction of aortic arch. Operations were performed successfully. The mean cardiopulmonary bypass (CPB) time was (156 ± 42) min, mean aortic cross-clamp time (91 ± 18) min, mean circulatory arrest time (20 ± 5) min and mean antegrade cerebral perfusion (ACP) time (33 ± 7) min. No postoperative death occurred. The incidence of temporary neurological dysfunction was 4.8% (2/42). They underwent neither re-exploration for postoperative hemorrhage nor hoarseness due to recurrent nerve palsy. Left radial arterial pulses were palpable in all of them. None had sensory deficit and dyskinesia of left arm. All their angiographic findings showed complete patency of left subclavian artery. There was neither space nor blood flow around the stented elephant trunk. The false lumen of descending aorta around elephant trunk closed and obliterated in all cases. The above-mentioned technique of modified total aortic arch replacement provides a distinct operative field and may achieve simple but reliable anastomosis with less bleeding. Thus aortic arch replacement becomes easier and more effective.

First in the US: can early cardiovascular device evaluation be revived in the US?

Stent graft coverage of the left subclavian artery (LSA) may be required to achieve an adequate landing zone in up to 40% of descending thoracic aneurysms (DTAs). The Valiant Mona LSA Thoracic Stent Graft System (Medtronic, Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency while diverting circulation through the encroaching aneurysm. Participating in the United States Food and Drug Administration's new Innovation Pathway, this first-in-human, early feasibility study evaluates early clinical experience of the Valiant Mona LSA Stent Graft System in patients with DTAs where the proximal landing zone necessitates LSA coverage.This premarket, nonrandomized, single-arm prospective study recruited nine patients (age 72.9 ± 7.6 years). Primary end points were aneurysm-related mortality, stroke, paraplegia, left arm/hand ischemia, and treatment success. Neurologic events were assessed by imaging and by independent neurologists. Inclusion criteria required patients with a DTA or penetrating aortic ulcer to have a distance of ≥10 mm between the left common carotid artery and the LSA. Mean aneurysm diameter was 53.7 ± 10.0 mm. The indication for repair was for saccular DTA in five patients or fusiform DTA in four. Seven patients were at American Society of Anesthesiologists Physical Status Classification III/IV.All nine patients received one main stent graft (diameter 28 to 42 mm) and one branch stent graft (diameter 10 to 14 mm). To extend device coverage distally, a commercial Valiant Captivia device was implanted in seven patients. No uncorrected endoleaks were observed at the end of the implant procedure. Four endoleaks developed before discharge in four of eight evaluable patients. Two were identified as type II and two were of undetermined type. No endoleak resulted in a secondary intervention. Technical success, defined by the clinical investigational plan, was achieved in all nine patients intraoperatively, and treatment success was achieved in all eight evaluable patients at 1 month. There were no major, disabling strokes. Four minor nondisabling strokes were reported in three patients ≤30 days (days 1, 1, 5, and 24). To date, there have been no reports of death, left arm ischemia, paraplegia, rupture, conversion to open surgery, or secondary endovascular procedure. No patients required surgical LSA revascularization.The Valiant Mona LSA system demonstrates technical and treatment success, relative safety, and early durability in its initial use in DTA patients. Midterm results are expected as patients are monitored at regular intervals to 5 years.

Management of Left Subclavian Artery in Endovascular Stent-Grafting for Distal Aortic Arch Disease

Although the left subclavian artery (LSA) is simply covered to exclude distal aortic arch aneurysm during endovascular stent-grafting, this technique is potentially harmful. Between January 2001 and April 2005, 40 cases of stent-grafting were performed for distal aortic arch diseases. For all 31 elective cases, the LSA occlusion test using a balloon catheter was preoperatively performed to predict critical complications secondary to LSA coverage by a stent graft and this revealed 2 cases in which the LSA was crucial for brain circulation (6.5%). The LSA was saved by using a hand-made fenestrated stent graft without bypass-grafting to the LSA in 22 cases. Bypass-grafting to LSA was performed in 5 cases. The LSA was simply occluded in 13 cases. Hospital mortality rates for the elective and emergency cases were 3.2% and 30.0%, respectively. One elective patient had a cerebral infarction (2.5%). LSA patency was successfully maintained in all 22 cases using a fenestrated stent graft. The LSA plays an important role in brain circulation in some patients and so a preoperative LSA occlusion test is helpful when aortic stent-grafting is proposed. Fenestrated stent graft saved the LSA in more than 50% of the present cases.