Balloon predilation or direct valve implantation in TAVI for women: Insights from the DIRECTAVI study.

BACKGROUND: The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. However, the female population with smaller anatomy may have potential higher risk of residual gradient and/or mismatch. PURPOSE: We assessed the impact of BAV on the procedural success rate and clinical outcomes in the female population of the DIRECTAVI trial. METHODS: Between May 2016 and May 2018, 91 of the 250 patients included in the DIRECTAVI trial were women (38.6%), 45 of them (49.5%) were enrolled in the BAV group and 46 of them (50.5%) in the direct TAVI group. The primary endpoint was procedural success rate in women (Valve Academic Research Consortium-2 criteria). The secondary endpoint included evaluation of PPM and 1-month major adverse events according to the implantation stategy in women and comparison between men and women regarding major endpoints. RESULTS: The primary endpoint occurred in 29 women (64.4%) in the BAV group and in 34 women (73.9%) in the direct TAVI group (mean difference 9.47%; 95% confidence interval: 6.5%-25.4%; p = 0.045 for non-inferiority of the direct strategy). One-month major adverse events were similar between the 2 women groups. Procedural success was lower in women vs men (p = 0.01) due to higher incidence of moderate mismatches in women (p = 0.001) but with no significant difference regarding the implantation strategy (p = 0.4). CONCLUSION: Direct implantation of the balloon-expandable SAPIEN 3 valve was non-inferior to predilatation on procedural success in women. Incidence of moderate mismatch was higher in women but was not related to the implantation strategy.

Ex Vivo Comparison of the Elastic Properties of Vascular Substitutes Used for Pulmonary Artery Replacement.

INTRODUCTION: Study aims were to evaluate the elastic properties of vascular substitutes frequently used for pulmonary artery (PA) replacement, and then to compare their compliance and stiffness indexes to those of human PA. METHODS: A bench-test pulsatile flow experiment was developed to perfuse human cadaveric vascular substitutes (PA, thoracic aorta, human pericardial conduit), bovine pericardial conduit, and prosthetic vascular substitutes (polytetrafluorethylene and Dacron grafts) at a flow and low pulsed pressure mimicking pulmonary circulation. Intraluminal pressure was measured. An ultrasound system with an echo-tracking function was used to monitor vessel wall movements. The diameter, compliance, and stiffness index were calculated for each vascular substitute and compared to the human PA at mean pressures ranging from 10 to 50 mmHg. RESULTS: The compliance of the PA and the thoracic aorta were similar at mean physiological pressures of 10 mmHg and 20 mmHg. The PA was significantly less compliant than the aorta at mean pressures above 30 mmHg (P = 0.017). However, there was no difference in stiffness index between the two substitutes over the entire pressure range. Compared to the PA, human pericardial conduit was less compliant at 10 mmHg (P = 0.033) and stiffer at 10 mmHg (P = 0.00038) and 20 mmHg (P = 0.026). Bovine pericardial conduit and synthetic prostheses were significantly less compliant and stiffer than the PA for mean pressures of 10, 20, and 30 mmHg. There were no differences at 40 and 50 mmHg. CONCLUSIONS: Allogenic arterial grafts appear to be the most suitable vascular substitutes in terms of compliance and stiffness for PA replacement.

Endovascular Recanalization of Aortic Isthmus Atresia with an "Electrified Wire Technique".

PURPOSE: For aortic coarctation in adults endovascular repair is the treatment of choice with an acceptable safety profile. Aortic isthmus atresia is a related condition with a complete occlusion of the aorta not allowing catheterization across the isthmus. This technical note describes a recanalization of an aortic isthmus atresia using radiofrequency with an "electrified wire technique." TECHNIQUE: A guidewire was selectively denuded of PTFE (polytetrafluoroethylene) at the distal end and was placed through a catheter distal to the aortic isthmus atresia. The denuded end of the wire was clamped to an electrosurgery pencil. By pushing the wire toward a tulip-snare, which was placed as a target proximal of the occlusion via left trans-brachial access, and shortly activating of the electrosurgery pencil the electrified wire recanalized the occlusion and was snared and used to guide implantation of a balloon-expandable covered stent. CONCLUSION: The electrified wire puncture technique can be used to recanalize adult aortic isthmus atresia after failed conventional attempts. CLINICAL IMPACT: The electrified wire technique offers an off-the shelf option to modify standard guidewires for the use with radiofrequency to cross a complete aortic isthmus occlusion after failed conventional attempts. This new technique may be applied also in other situations like dissection flap fenestration, transcaval access and similar.

Homemade fenestrated physician-modified stent grafts for arch aortic degenerative aneurysms.

OBJECTIVE: We evaluated the early- and medium-term outcomes of single- and double-fenestrated physician-modified endovascular grafts (PMEGs) for total endovascular degenerative aortic arch aneurysm repair. METHODS: We performed a single-center, retrospective analysis of prospectively collected data from 52 patients from August 2013 through January 2021 who had undergone homemade fenestrated thoracic endovascular aortic repair for degenerative aortic aneurysms. In all cases, a distal smaller fenestration for the left subclavian artery (LSA) was fashioned and was the only one stented. For a double-fenestrated endograft, a proximal larger fenestration that incorporated both the brachiocephalic trunk and the left common carotid artery was added. RESULTS: A total of 52 patients with degenerative aortic arch aneurysms were treated. Of the 52 patients, 36 were men, the mean age was 75 ± 8 years, 31% had received a single LSA fenestration, and 69% had undergone double-fenestrated thoracic endovascular aortic repair. Of the 52 procedures, 5 (10%) were emergent procedures. The technical success was 100%. The median time required for stent graft modification was 22 ± 6 minutes. The 30-day mortality was 2% (n = 1). Five patients (10%) had experienced a cerebrovascular event, including two transient ischemic attacks, one minor stroke with full neurologic recovery, and two with sequelae. Two patients (4%) had experienced perioperative retrograde dissection during follow-up. No patient had developed a type I, II, or III endoleak from the LSA. No patient had required reintervention. All supra-aortic trunks were patent. During a mean follow-up of 18 ± 11 months, no patient had required conversion to open surgical repair, aortic rupture, or paraplegia. CONCLUSIONS: Single or double PMEG is a safe and suitable tool for the treatment of high morbidity pathology such as aortic arch degenerative aneurysm repair. In addition, this device can be used in patients requiring elective or emergency repair.

Transcatheter aortic valve implantation in patients with uninterrupted vitamin K antagonists.

BACKGROUND: Bridging of vitamin K antagonist (VKA) with heparin is usually not promoted during interventional or surgical procedures related to increased risk of bleeding and thrombotic events but this strategy has not been evaluated during transcatheter aortic valve implantation (TAVI). PURPOSE: The aim of this study was to evaluate the rate of major bleeding and vascular complications after TAVI performed in patients with uninterrupted VKA. METHODS: From January 2016 to October 2017, consecutive patients who underwent TAVI with uninterrupted VKA (International Normalized Ratio [INR] between 1.5 and 3.5) were prospectively included in a monocentric registry. TAVI was performed according to current guidelines and a 50 U/kg bolus of heparin was injected at the beginning of the procedure for all patients. Vascular and bleeding complications were assessed using the Valve Academic Research Consortium 3 (VARC3) and the Bleeding Academic Research Consortium (BARC) definitions at a 30-day follow-up. RESULTS: A total of 88 patients were included with a median age of 84 years (81.8-87.0), 42% being female. The median society of thoracic surgeons score was 5.1 (4.1-7.5), the median CHADS2-VASc was 5.5 (5-6) and 60.2% had a chronic kidney failure. Median INR at the time of implantation was 2.1 (1.8-2.6). The main VKA indication was atrial fibrillation. Transfemoral access was used in 88.6% of the patients. Major bleeding (BARC ≥ 3b) occurred in five patients (5.7%) and major vascular complications occurred in seven patients (8.0%). At 1 month follow-up, major bleeding (BARC ≥ 3) or vascular complications occurred in 10 patients (11.4%). In patients with major bleeding peripheral arterial disease (RR = 10.95; 95% confidence interval (CI) 1.63-73.75; p = 0.014) and carotid access (RR = 8.56; 95% CI 1.19-1.51; p = 0.033) were more common. INR > 2.5 was significantly associated with vascular complications (RR = 7.14; 95% CI 1.29-39.63; p = 0.025). At 30 days, mortality and stroke rates were 2.3% and 4.5%, respectively. CONCLUSION: TAVI with uninterrupted VKA treatment seems feasible and safe with a low risk of major bleeding and vascular complications in this first single-center experience. Particular caution is advocated in high body mass index patients and to keep INR < 2.5.

Physician-Modified Endograft With Inner Branches for the Treatment of Complex Aortic Urgencies.

PURPOSE: To describe the use of physician-modified endograft (PMEG) with the exclusive use of inner branches or in combination with fenestrations for the urgent treatment of complex aortic aneurysms. TECHNIQUE: We present two urgent cases. A patient with a 6.8 cm saccular juxtarenal aneurysm and another patient with a contained rupture of the thoracoabdominal aorta right above the celiac trunk (CT). In both cases, a Cook Zenith TX2 thoracic endograft was back-table modified, in the first case by adding three fenestrations and one inner branch for the left renal artery to improve sealing due to its partial involvement in the aneurysm and, in the second case, with the use of two inner branches for the CT and superior mesenteric artery. Both procedures were successful, with uneventful postoperative courses and complete aneurysm exclusion on postoperative CT angiography. CONCLUSION: Use of PMEGs with inner branches is feasible for urgent repair in complex aortic anatomy.

Modular Endo-Bentall Procedure Using a "Rendez-Vous Access".

PURPOSE: The concept of a single endovascular valve-carrying conduit device was designated endo-Bentall, but published experience is limited to a single case. This technical note describes an alternative modular endo-Bentall technique and a novel access technique to implant it. TECHNIQUE: A 82-year-old woman with chest pain referred for a 10 cm symptomatic aneurysm of the distal arch and descending aorta. An ascending aortic aneurysm of 5.5 cm prevented endovascular aortic arch repair due to lack of a proximal landing zone. The technique is a modular approach combining a physician-modified endograft (PMEG) with 3 large fenestrations for coronary artery perfusion and a transcatheter aortic valve implantation (TAVI). A "rendez-vous access" with a transapical and transfemoral through-and-through wire offered rapid sequential deployment in a modular fashion of both components. The PMEG was deployed first, landing 5 mm deep in the left ventricular outflow tract (LVOT) and the transcatheter aortic valve was implanted few millimeters below. The endo-Bentall procedure was combined with endovascular aortic arch repair. CONCLUSION: A modular endo-Bentall procedure combining a PMEG and TAVI is feasible and adaptable to emergent setting using the "rendez-vous access."

Total Arch Thoracic Endovascular Aortic Repair Using Double Fenestrated Physician-Modified Stent-Grafts: 100 Patients.

OBJECTIVE: The aim was to evaluate early and medium-term outcomes of double fenestrated physician-modified endovascular grafts for total endovascular aortic arch repair. METHODS: This single-center retrospective analysis of prospectively-collected data included 100 patients, from January 2017 to December 2021, undergoing thoracic endovascular aortic repair (TEVAR) for zone 0. The fenestrations were a proximal larger fenestration that incorporated the brach2iocephalic trunk and left common carotid artery and a distal smaller fenestration for the left subclavian artery (LSA). Only the LSA fenestration was stented. RESULTS: The median duration for stent-graft modification was 23±6 minutes. Of the 100 patients, 70 were men. The mean patient age was 70±10.5 years. Indications for treatment included degenerative aortic arch aneurysm (n=32), dissecting aortic arch aneurysm after type A dissections (n=23) and (n=19) after type B dissections, acute complicated type B dissection (n=16), and other pathologies (n=10). Technical success rate was 97%. The 30 day mortality was 2% (n=2). Four patients (4%) had minor stroke with full recovery. One patient (1%) had a type IA endoleak, 1 patient (1%) had a type IB endoleak, and 2 patients (2%) have a type II endoleak from the LSA. Eight patients (8%) required reintervention: 1 type IA endoleak, 1 type IB endoleak, 1 retrograde type A dissection, and 5 because of access-related complications. During a mean follow-up of 24±7.2 months, there were no aortic rupture, paraplegia, and all supra-aortic trunks were patent. CONCLUSIONS: Double homemade fenestrated TEVAR is both feasible and effective for total endovascular aortic arch repair avoiding the need for anatomical and extra-anatomical surgical revascularization. The long-term durability will need to be assessed in studies with long-term follow-up. CLINICAL IMPACT: Double homemade fenestrated TEVAR is effective for total endovascular aortic arch repair avoiding the need for anatomical and extra-anatomical surgical revascularization. The standout feature of this double fenestrated device is its simple handling during operation with the proximal fenestrations being directed to the orifices of the BT and LCCA automatically when the LSA fenestration is catheterized and secured by covered stent placement. The deployment algorithm actively steers the operator away from superfluous manipulations of the device within the arch and avoids guidewire manipulation in carotid arteries. The long-term durability will need to be assessed in studies with long-term follow-up.

One-Year Results of ZBIS Iliac Branch Device With an Off-Label Connection Limb.

PURPOSE: The purpose of this article is to study 1-year results of Zenith branch iliac endovascular graft (ZBIS) with the off-label use of a 13 mm spiral Z limb to connect to the aortic main body. MATERIALS AND METHODS: A retrospective review from 2015 to 2019 of all iliac branch devices (IBDs) was performed at 1 institution that were connected to an aortic main body with a 13 mm spiral Z limb and had at least 1-year follow-up with computed tomography (CT). Primary endpoints are freedom from ZBIS separation from the connection limb, endoleak (EL), or reintervention at 1 year. Secondary endpoints are primary and secondary ZBIS patency, presence of any EL, and aortic reinterventions. RESULTS: Of 149 IBDs implanted in this period, 45 ZBIS in 35 patients were connected with a 13 mm limb and had a 1-year CT; 97% of patients had common iliac artery (CIA) aneurysms, 7% of patients had hypogastric artery (HA) aneurysms, and 30% of patients had bilateral ZBIS implantation. Technical success was 98%. In 84% of cases, the Advanta V12 was used as the HA mating stent; 56% of patients had an EL, mostly type II, which resolved spontaneously in 70% at 1 year, and 9% of ZBIS required reinterventions at 1 year (2 for thrombosis, 2 for type Ic EL from HA mating stent). One-year ZBIS primary patency and secondary patency were 96% and 100%, respectively. No EL was noted to be related to the 13 mm connection limb. No migration or separation of the devices occurred. CONCLUSIONS: The use of 13 mm spiral Z limb to connect a ZBIS with the main body in our series yields a high technical success rate and good 12-month outcomes without device separation or migration.

Non-Standard Management of Target Vessels With the Inner Branch Arch Endograft: A Single-Center Retrospective Study.

PURPOSE: The purpose of this study was to evaluate early and mid-term results of non-standard management of the supraaortic target vessels with the use of the inner branch arch endograft in a single high-volume center. MATERIAL AND METHODS: A single-center retrospective study including all patients undergoing implantation of an inner branch arch endograft from December 2012 to March 2021, who presented a non-standard management of the supraaortic target vessels (any bypass other than a left carotid-subclavian or landing in a dissected target vessel). Technical success, mortality, reinterventions, endoleak (EL), and aortic remodeling at follow-up were analyzed. RESULTS: Twenty-four patients were included. In 17 (71%) cases, the non-standard management was related to innominate artery (IA) compromise (12 with IA dissection, 2 with short IA, 2 with short proximal aortic landing zone that required occlusion of IA, 1 with occluded IA after open arch repair). Two (8%) cases were related to an aberrant right subclavian artery (RSA), 1 patient (4%) due to the concomitant presence of a left vertebral artery (LVA) arising from the arch and an occluded left subclavian artery (LSA), and another patient presented with an occluded LSA distal to a dominant vertebral artery. Three (13%) cases were exclusively related to management in patients with genetic aortic syndromes. Twenty (83%) patients had a previous type A aortic dissection. Ten (42%) patients presented a thoracic or thoracoabdominal aortic aneurysm and 8 (33%) patients an arch aneurysm, 6 of them associated to false lumen (FL) perfusion. There were 2 (8%) perioperative minor strokes, and 1 patient with perioperative mortality. Seven patients presented an early type I endoleak, all resolved at follow-up. Seven patients required reinterventions during follow-up (7 reinterventions related to continuous false lumen perfusion, 3 related to Type Ia endoleak, 2 related to surgical bypass). All patients who presented with FL perfusion had complete FL thrombosis at follow-up. No patient presented aneurysm growth at follow-up. CONCLUSIONS: The use of the inner branch arch endograft with a non-standard management of the supraaortic target vessels is a possible option. Despite a high reintervention rate, regression or stability of the aneurysmal diameter was achieved in all the patients with follow-up.

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement: A Propensity-Matched Comparison From the FRANCE-TAVI Registry.

BACKGROUND: No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has been conducted to date. METHODS: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality. RESULTS: In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 [95% CI, 1.46-1.91]; P<0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 [95% CI, 1.63-2.22]; P<0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 [95% CI, 1.07-1.66]; P=0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 [95% CI, 1.06-1.29]; P=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. CONCLUSION: The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV. CLINICAL TRIAL REGISTRATION: https://www.clinicaltrials.gov. Unique identifier: NCT01777828.

Double fenestrated physician-modified stent-grafts for total aortic arch repair in 50 patients.

OBJECTIVE: Our aim was to evaluate the early- and medium-term outcomes of using double fenestrated physician-modified endovascular grafts (PMEGs) for total endovascular aortic arch repair. METHODS: The present single-center retrospective analysis of prospectively collected data included 50 patients from January 2017 through October 2019, who had undergone thoracic endovascular aortic repair (TEVAR). The fenestrations were a proximal larger fenestration that incorporated the brachiocephalic trunk and left common carotid artery and a distal smaller fenestration for the left subclavian artery (LSA). Only the LSA fenestration was stented. RESULTS: The median duration for stent graft modification was 26 ± 6 minutes. Of the 50 patients, 41 were men. The mean patient age was 68 ± 11.5 years. The indications for treatment included degenerative aortic arch aneurysm (n = 17), dissecting aortic arch aneurysm after type A dissection (n = 13), type B dissection (n = 13), aortic ulcer (n = 3), and other pathologies (n = 4). The technical success rate was 94% (47 of 50) overall, and 100% (28 of 28) after a technical modification incorporating a preloaded guide wire for the LSA fenestration (P < .05). The 30-day mortality was 2% (n = 1). Two patients (4%) had a minor stroke with full recovery. One patient (2%) had a type IB and two patients (4%) had a type II endoleak from the LSA. Four patients (8%) required reintervention: one because of a type IB endoleak and three because of access-related complications. All supra-aortic trunks were patent. During a mean follow-up of 16 ± 8.3 months, no conversions to open surgical repair were required and no aortic rupture, paraplegia, or retrograde dissection occurred. CONCLUSIONS: Using double fenestrated PMEGs for TEVAR is both feasible and effective for total endovascular aortic arch repair, avoiding the need for anatomic and extra-anatomic surgical revascularization. The absence of brachiocephalic trunk stenting was not associated with endoleaks or treatment failure and resulted in a lower stroke risk than alternative strategies. The midterm results suggest that stenting of the brachiocephalic trunk and right common carotid artery might not be necessary for a large proportion of patients undergoing total endovascular aortic arch repair. The persistence of the seal and ongoing durability require assessment in studies with long-term follow-up data available.

Transcarotid versus transfemoral access in patients undergoing transcatheter aortic valve replacement with complex aortofemoral anatomy.

AIMS: While major vascular complications (MVC) remains an issue after Transfemoral (TF) transcatheter aortic valve replacement (TAVR), we compared outcomes in TF versus transcarotid (TC) approaches in patients with complex vascular anatomy. METHODS AND RESULTS: Among patients undergoing TAVR in our center between 2015 and 2018, we evaluated patients with complex vascular anatomy defined on CT scan as: (a) iliofemoral diameter between 5.5 and 6 mm or <6.5 mm with severe calcifications or tortuosity AND/OR (b) abdominal aorta pathology. The primary endpoint included access failure, mortality, MVC, major bleeding and stroke at 1-month. Among 483 patients, 131 (31.2%) with complex vascular anatomy underwent TF (n = 51;39.2%) or TC (n = 80;60.8%) TAVR. The mean age was 81.7 ± 6.9. TC group had higher STS score (p = .01), higher incidence of coronary artery disease (p = .04) and lower left ventricular ejection fraction (p < .001). In TC group, primary endpoint occurred twice less without reaching significance compared to TF group (n = 8; 10.0% vs. n = 10; 19.6% respectively; p = .1). Incidence of MVC was higher in TF group (11.8 vs. 1.3% in the TC group; p = .01) with similar incidence of stroke between groups (p = .8). CONCLUSIONS: Despite higher patient risk profile, TC approach in complex aortofemoral anatomy provides similar favorable outcomes with less MVC compared to TF approach.

"Powered Cheese Wire Technique" for Septal Fenestration in Complex Endovascular Repair for Chronic Thoracoabdominal Aortic Dissection.

PURPOSE: Endovascular repair of chronic thoracoabdominal aortic dissection with aneurysmal degeneration presents a therapeutic challenge when one or more visceral branches arise from the false lumen without an adjacent reentry. The chronic dissection flap can be thick and resistant to flap fenestration with standard techniques. TECHNIQUE: The powered cheese wire technique facilitates cutting of a dissection flap using electrical current on a noninsulated through-and-through wire segment. The mid-shaft of the guidewire is denuded and kinked to form the "flying V" configuration. This solution is based on the BASILICA procedure, which uses electrosurgery to split aortic valve tissue lengthwise prior to transcatheter aortic valve replacement to prevent coronary artery obstruction. We demonstrate the technique in a case of branched endovascular aortic repair of a complex thoracoabdominal dissecting aneurysm in which a renal artery from the false lumen was catheterized by creating a powered cheese wire fenestration. CONCLUSION: The powered cheese wire technique is an effective approach to access false lumen originating branches during endovascular aortic repair of chronic aortic dissections.

Midterm Follow-up of Fenestrated and Scalloped Physician-Modified Endovascular Grafts for Zone 2 TEVAR.

Purpose: To investigate the midterm outcomes of scalloped or fenestrated physician-modified endovascular grafts (PMEGs) for zone 2 thoracic endovascular aortic repairs (TEVAR). Materials and Methods: Between November 2013 and May 2019, 54 consecutive patients (mean age 63 years; 41 men) were treated with thoracic PMEGs modified with 7 scallops or 47 fenestrations for the left subclavian artery (LSA). Indications for aortic repair were acute complicated type B aortic dissection (17, 31%), degenerative aneurysm (13, 24%), acute traumatic rupture of the aortic isthmus (9, 16%), post chronic dissection aneurysmal evolution (8, 15%), penetrating aortic ulcer (3, 6%), intramural hematoma (2, 4%), and floating thrombus (2, 4%). Results: Technical success was 94%; 3 (6%) LSAs were unintentionally covered. An intraoperative type Ia endoleak was treated during the index procedure. One (2%) patient suffered spinal cord ischemia, with irreversible bilateral paraplegia. Three (6%) patients experience postoperative minor strokes with full neurological recovery. Four (7%) patients died in the perioperative period; 2 (2%) were due to aneurysm rupture. Mean follow-up was 26±16 months; 15 (28%) patients had at least 3 years of follow-up. Two (4%) type II endoleaks were identified and successfully treated (4% reintervention rate); no other endoleaks were identified. All the LSAs remained clinically and radiologically patent. There were no conversions to open repair, ruptures, retrograde dissection, stent fracture, migrations, or other aortic complications. Conclusion: Scalloped or single-fenestrated PMEGs for the LSA appear to be durable and safe in the midterm. Combined with low periprocedural morbidity and mortality, these results suggest that this approach can be considered as an off-label alternative to extend proximal seal to zone 2 for TEVAR. Further studies with a larger number of patients and long-term outcomes are needed to fully validate this approach.

Aortic Arch Anatomy Pattern in Patients Treated Using Double Homemade Fenestrated Stent-Grafts for Total Endovascular Aortic Arch Repair.

Purpose: To analyze the structural variation of the aortic arch and the supra-aortic arteries and establish an average spatial configuration that would be a pattern for a "universal double fenestration" design for physician-modified endovascular grafts (PMEGs) used in total thoracic endovascular aortic repair (TEVAR). Materials and Methods: Aortic arch morphology was retrospectively analyzed by reviewing the preoperative thoracic computed tomography angiography scans in 33 consecutive patients (mean age 68 years; 27 men) treated between January 2017 and March 2019 using double-fenestrated PMEGs for zone 0 TEVAR. Image analysis was completed according to a standardized technique on a vascular workstation with center lumen line reconstruction for all measurements. Variations in branching pattern of the aortic arch were classified into 8 types. Results: The arch trunk configuration was type I in 26 patients (79%), type II in 5 (15%), type III in 1, and type IV in 1. Mean aortic diameters at the level of mid ascending aorta, innominate artery (IA), left common carotid artery (LCCA), and left subclavian artery (LSA) were 35.7±3.7, 34.2±4.5, 33.3±6.7, and 33.7±4.7 mm, respectively. Mean diameters of the trunk were 12.2±1.7, 7.5±1.4, and 8.0±0.8 mm, respectively. Mean longitudinal center to center lengths were 15.9±2.5 mm between the LSA and LCCA and 12.1±3.0 mm between the LCCA and IA. Mean clock positions using the LSA as reference were 12:50 for the IA and 12:05 for the LCCA. In 32 patients (97%) all the supra-aortic branch vessels fit perfectly inside two delimited areas defined by a proximal common square area of 30×30 mm for the IA and LCCA and a second distal 8-mm-diameter circle for the LSA. Conclusion: Variations of the aortic arch anatomy are numerous and common. A general morphological pattern is described that delimits the aortic area where these variations occur. This information can be utilized for the design of an off-the-shelf double-fenestrated stent-graft for zone 0 TEVAR.

Pulse pressure and end-tidal carbon dioxide for monitoring low native cardiac output during veno-arterial ECLS: a prospective observational study.

BACKGROUND: Veno-arterial extracorporeal life support (VA-ECLS) results in cardiopulmonary shunting with reduced native cardiac output (NCO). Low NCO occurrence is common and associated with risk of thromboembolic and pulmonary complications. Practical tools for monitoring NCO during VA-ECLS would therefore be valuable. Pulse pressure (PP) and end-tidal carbon dioxide (EtCO2) are known to be related to cardiac output. We have designed a study to test whether PP and EtCO2 were efficient for the monitoring of NCO during VA-ECLS. METHODS: In this prospective single-center observational study, patients who underwent a VA-ECLS for cardiogenic shock from January 2016 to October 2017 were included, provided low NCO was suspected by a PP < 20 mmHg. NCO was measured with pulmonary artery catheter or echocardiography and compared to PP and EtCO2. The ability of PP and EtCO2 to predict NCO < 1 L/min was evaluated with receiver operating characteristics (ROC) curves. RESULTS: Among the 106 patients treated with VA-ECLS for cardiogenic shock during the study period, 26 were studied, allowing the collection of 196 study points. PP and EtCO2 relationships with NCO were nonlinear and showed strong correlations for NCO < 2 L/min (r = 0.69 and r = 0.78 respectively). A PP < 15 mmHg and EtCO2 < 14 mmHg had good predictive values for detecting NCO < 1 L/min (area under ROC curve 0.93 [95% CI 0.89-0.96] and 0.97 [95% CI 0.94-0.99] respectively, p = 0.058). CONCLUSIONS: PP and EtCO2 may offer an accurate real-time monitoring of low NCO events during VA-ECLS support. Further studies are needed to show if their utilization may help to implement therapeutic strategies in order to prevent thromboembolic and respiratory complications associated with VA-ECLS, and to improve patients' prognosis. TRIAL REGISTRATION: NCT03323268 , July 12, 2016.

Double homemade fenestrated stent graft for total endovascular aortic arch repair.

OBJECTIVE: The aim of this retrospective analysis was to evaluate the outcomes of physician-modified double fenestrated stent grafts for total endovascular aortic arch repair: one proximal large fenestration for the brachiocephalic trunk and the left common carotid artery and one distal fenestration for the left subclavian artery (LSA). METHODS: From January 2017 through February 2018, 17 patients (88.2% elective) underwent thoracic endovascular aortic repair (TEVAR) with double homemade fenestrated stent graft for total endovascular aortic arch repair to maintain supra-aortic trunk patency. Indications were degenerative aortic arch aneurysm (n = 7), dissecting aortic arch aneurysms subsequent to surgical treatment of acute type A dissections (n = 6), chronic complicated type B aortic dissection (n = 3), and acute complicated type B aortic dissection (n = 1). Routine postoperative follow-up imaging with computed tomography angiography was performed to assess TEVAR and supra-aortic trunks patency and endoleak. RESULTS: The median time for stent graft modification was 19 minutes (range, 16-20 minutes). Endovascular exclusion of the aortic arch was achieved in all the cases. One LSA catheterization failed and LSA revascularization was performed by carotid axillary bypass and coverage of the LSA fenestration by additional stent graft placement. Additional planned endovascular procedures were required in three patients: closure of supra-aortic trunks re-entry tears in two cases of dissecting aortic arch aneurysms and one transcatheter aortic valve replacement for severe native aortic valve regurgitation. One stroke, with no long-term deficit, was observed. No patients died. All left supra-aortic trunks are patent. No type I endoleak was observed. We only observed one patient with a type II endoleak. During a mean follow up of 7 ± 2 months, there were no conversions to open surgical repair, aortic rupture, paraplegia, or retrograde dissection. CONCLUSIONS: Double homemade fenestrated TEVAR is both feasible and effective for maintaining the patency of the supra-aortic trunks and allows total endovascular aortic arch repair. Durability concerns will need to be assessed in additional studies with long-term follow-up.

Risk factors for distal stent graft-induced new entry tear after endovascular repair of thoracic aortic dissection.

OBJECTIVE: A review of the literature was conducted for incidence, outcomes, and risk factors for distal stent graft-induced new entry (SINE) after thoracic endovascular aortic repair (TEVAR) of aortic dissection. METHODS: The review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: Seven articles reporting on 1415 patients with thoracic aortic dissection undergoing TEVAR without supplemental distal bare stenting were included. In this cohort, 86 patients were treated for a residual type A aortic dissection and 1329 for a complicated type B aortic dissection. Distal SINE occurred in 112 patients (7.9%). The mean time to identification of distal SINE was 19 ± 7 months. The incidence of distal SINE after TEVAR for type B aortic dissection differed on the basis of whether it was a chronic or acute dissection repair and was, respectively, 12.9% (43/331) and 4.3% (12/273). Successful secondary interventions were performed in 54% of the patients. All the studies analyzing the relationship between distal stent graft oversizing and incidence of distal SINE reported a significantly higher rate of SINE with oversizing. CONCLUSIONS: The successful management of complicated descending thoracic aortic dissections by TEVAR is well established. Whereas distal SINE is relatively frequent, if it does occur, the complication can generally be treated with additional TEVAR without a poor outcome. The main determinant of SINE seems to be excessive distal oversizing.

Homemade Fenestrated Stent-Grafts for Complete Endovascular Repair of Aortic Arch Dissections.

Purpose: To evaluate outcomes of homemade fenestrated stent-grafts for complete endovascular aortic repair of aortic arch dissections. Materials and Methods: From July 2014 through September 2018, 35 patients (mean age 66±11 years; 25 men) underwent homemade fenestrated stent-graft repair of acute (n=16) or chronic (n=10) complicated type B aortic dissections (n=16) and dissecting aortic arch aneurysms subsequent to surgical treatment of acute type A dissections (n=9). Nineteen (54%) procedures were emergent. Results: Zone 2 single-fenestrated stent-grafts were used in 25 cases; the remaining 10 were double-fenestrated stent-grafts deployed in zone 0. Median time for stent-graft modification was 18 minutes (range 16-20). Technical success was achieved in all cases. An immediate distal type I endoleak was treated intraoperatively. Among the double-fenestrated stent-graft cases, the left subclavian artery fenestration could not be cannulated in 2 patients and revascularization was required. Partial coverage of the left common carotid artery necessitated placement of a covered stent in 3 cases. One (3%) patient had a stroke without permanent sequelae. Two type II endoleaks required additional covered stent placement at 5 and 7 days postoperatively, respectively. The 30-day mortality was 6% (2 patients with ruptured aortic arch aneurysm). During a mean follow-up of 17.6±13 months, there was no aortic rupture or retrograde dissection. One late type I endoleak was treated with additional proximal fenestrated stent-graft placement. One type II endoleak is currently under observation. One additional patient died (unrelated to the aorta); overall mortality was 9%. All supra-aortic trunks were patent. Conclusion: The use of homemade fenestrated stent-grafts for endovascular repair of aortic arch dissections is feasible and effective for total endovascular aortic arch repair. Durability concerns will need to be assessed in additional studies with long-term follow-up.