Vascutek Terumo Research Articles

Total Aortic Arch Replacements With a 4 Branched Frozen Elephant Trunk (FET) Graft in Acute Aortic Dissection (DeBakey type I)

Total Aortic Arch Replacements With a 4 Branched Frozen Elephant Trunk (FET) Graft in Acute Aortic Dissection (DeBakey type I)

Total arch replacement and frozen elephant trunk for acute type A aortic dissection

ObjectiveThe present study aimed to evaluate the outcomes of total aortic arch replacement with proximalization of distal anastomosis using the frozen elephant trunk technique with the J Graft FROZENIX (Japan Lifeline, Tokyo, Japan) and Gelweave Lupiae (Vascutek Terumo Inc, Scotland, United Kingdom) graft (distal anastomosis performed in zones 1 and 2) in patients with acute Stanford type A acute aortic dissection. MethodsA total of 50 patients underwent total aortic arch replacement using the frozen elephant trunk technique, deploying the J Graft FROZENIX into zone 1 or 2 (zone 1: n = 17, zone 2: n = 33) in combination with the Gelweave Lupiae graft for acute Stanford type A acute aortic dissection. Patient characteristics, intraoperative data, and early and midterm outcomes were analyzed. ResultsThe overall in-hospital mortality rate was 4% (2 patients). The in-hospital mortality rate in patients with visceral malperfusion was 11% (1/9). There were no patients with paraplegia and stent graft–induced new entry. Resection or closure of the most proximal entry tear was achieved in 100% of 42 patients who had postoperative computed tomography. The overall survival was 87.9%, 84.1%, and 84.1% at 1, 2, and 3 years, respectively. However, 1 patient required endovascular extension for the dilatation of the descending thoracic aorta 4 months after the initial surgery. ConclusionsTotal aortic arch replacement with the frozen elephant trunk technique (zone 1-2) and Gelweave Lupiae graft was safe and effective in simplifying surgery for acute Stanford type A acute aortic dissection.

Intraoperative contrast-enhanced ultrasound examination for endoleak detection after complex and infrarenal endovascular aortic repair

ObjectiveThe aim of this pilot study was to evaluate intraoperative contrast-enhanced ultrasound (iCEUS) examination for endoleak (EL) detection after complex endovascular aortic repairs (EVAR) in comparison with the standard angiographic completion control. MethodsTwenty-one patients (16 male; median age, 73 years [range, 54-81 years]) who underwent single-stage EVARs at our center between October 2016 and October 2018 were included prospectively. The procedures comprised fenestrated and/or branched EVAR (n = 14; 66%), infrarenal EVAR (n = 5; 24%), infrarenal EVAR with bilateral iliac side branch implantation (n = 1; 5%), and infrarenal EVAR with occluder implantation into the internal iliac artery (n = 1; 5%). The used endografts included 14 custom made devices (Cook, Australia Pty Ltd, Brisbane, Australia, n = 6; Vascutek Terumo, Glasgow, Scotland, n = 8) and seven standard infrarenal endografts (Medtronic Inc, Santa Rosa, Calif, n = 5; Vascutek Terumo, Glasgow, Scotland, n = 1; Cook, n = 1). All patients underwent an angiographic completion control for EL detection followed by iCEUS examination. The iCEUS examination was performed by the same examiner who was blinded to the angiography result. In addition to the comparison of the angiographic results to iCEUS examination, iCEUS examination was also compared with the computed tomography angiography (CTA) before discharge (median time to CTA, 5 days [range, 1-7 days]). ResultsAngiography detected eight type II EL, defining the EL origin in four cases. In addition to detecting all of those eight EL, iCEUS examination revealed eight more type II EL not seen on angiography (P = .002) and allowed a definition of the EL origin in all cases. CTA before discharge showed a persistence of only 5 of the 16 type II EL detected by iCEUS examination (31%, P = .002). ConclusionsAn iCEUS examination can be used as another adjunct to decrease exposure to contrast agent and radiation during EVAR, including complex procedures. A replacement of the completion angiography by iCEUS examination is conceivable for infrarenal EVAR, but also for endovascular type IV or type V repairs. Future studies with larger patient numbers will help to further validate iCEUS examination during complex EVAR.

Aortic Replacement After TEVAR-Diameter Correction With Modified Use of the Siena Prosthesis

To report a new technique for diameter correction in patients after thoracic endovascular aortic repair (TEVAR) with large stent-grafts using the Vascutek Siena 4-branch collared prosthesis (Vascutek Terumo, Inchinnan, Scotland, UK) in patients undergoing thoracoabdominal (TA) aortic replacement. Within a 24-month period, 39 patients underwent TA replacement at our center. Of these, 6 patients had undergone previous TEVAR with large stent-grafts (42 to 48 mm diameter). Indications for TEVAR were aneurysm formation in 3 patients and residual type B aortic dissection (status post repair of type A dissection) in 3 patients. In these patients, the Vascutek Siena 4-branch prosthesis was used in a reversed fashion, removing the elephant trunk portion and using the sewing collar for diameter correction at the anastomotic site. No 30-day mortality and no stroke or symptomatic spinal cord ischemia was observed. Median diameter of the TEVAR graft at the anastomotic site was 44 mm. Median size of the Siena graft used was 26 mm. Diameter correction was successfully achieved in all patients by tailoring the sewing collar of the Siena 4-branch prosthesis to the individual need according to the diameter of the distal end of the stent-graft. Using the sewing collar of the Vascutek Siena 4-branch prosthesis for diameter correction in patients undergoing TA replacement after previous TEVAR with large stent-grafts adds a useful adjunct to the armamentarium of options in a growing patient population.

New graft sizing rings for aortic valve reimplantation procedures.

The objective was to design sizing rings that would enable proper sizing of the graft in reimplantation procedures and to perform leaflet repair before graft implantation. The rings were designed in Autodesk Fusion 360 (San Rafael, CA, USA) and 3D printed using a commercial online 3D printing service. We designed incomplete rings with a low profile and complete rings with a high profile. The complete rings are best suited for reimplantation procedures, whereas low profile C rings are intended for isolated aortic valve repair, where the ascending aorta is not transected. The rings come in sizes corresponding to Vascutek Gelweave graft sizes (Vascutek Terumo, Renfrewshire, Scotland). The ring internal diameters are 5% larger than the designated ring sizes and account for the 5% stretch of the grafts when pressurized. Blades of the rings are placed at 20° intervals. The slits between the blades are designed in such a way that the commissural U-sutures, when put in place and under tension, will lock the ring in position. The rings were successfully used in 10 of our latest reimplantation procedures. After dissection of the aortic root, the commissures were suspended with U-stitches and then the ring was seated onto them. Complete leaflet repair with plication to achieve adequate effective height was then performed, followed by graft implantation. No additional leaflet repair was needed. The newly designed sizing rings enable proper sizing of the graft in reimplantation procedures and enable complete leaflet repair before graft implantation.

Multibranched hybrid device for frozen elephant trunk: What does it change?

Multibranched hybrid device for frozen elephant trunk: What does it change?

Impact of intraoperative adverse events during branched and fenestrated aortic stent grafting on postoperative outcome

ObjectiveFenestrated and branched endovascular devices are increasingly used for complex aortic diseases, and despite the challenging nature of these procedures, early experiences from pioneering centers have been encouraging. The objectives of this retrospective study were to report our experience of intraoperative adverse events (IOAEs) during fenestrated and branched stent grafting and to analyze the impact on clinical outcomes.MethodsConsecutive patients treated with fenestrated and branched stent grafting in a tertiary vascular center between February 2006 and October 2013 were evaluated. A prospectively maintained computerized database was scrutinized and updated retrospectively. Intraoperative angiograms were reviewed to identify IOAEs, and adverse events were categorized into three types: target vessel cannulation, positioning of graft components, and intraoperative access. Clinical consequences of IOAEs were analyzed to ascertain whether they were responsible for death or moderate to severe postoperative complications.ResultsDuring the study period, 113 consecutive elective patients underwent fenestrated or branched stent grafting. Indications for treatment were asymptomatic complex abdominal aortic aneurysms (CAAAs, n = 89) and thoracoabdominal aortic aneurysms (TAAAs, n = 24). Stent grafts included fenestrated (n = 79) and branched (n = 17) Cook stent grafts (Cook Medical, Bloomington, Ind), Ventana (Endologix, Irvine, Calif) stent grafts (n = 9), and fenestrated Anaconda (Vascutek Terumo, Scotland, UK) stent grafts (n = 8). In-hospital mortality rates for the CAAA and TAAA groups were 6.7% (6 of 89) and 12.5% (3 of 24), respectively. Twenty-eight moderate to severe complications occurred in 21 patients (18.6%). Spinal cord ischemia was recorded in six patients, three of which resolved completely. A total of 37 IOAEs were recorded in 34 (30.1%) patients (22 CAAAs and 12 TAAAs). Of 37 IOAEs, 15 (40.5%) resulted in no clinical consequence in 15 patients; 17 (45.9%) were responsible for moderate to severe complications in 16 patients, and five (13.5%) led to death in four patients. The composite end point death/nonfatal moderate to severe complication occurred more frequently in patients with IOAEs compared with patients without IOAEs (20 of 34 vs 12 of 79; P < .0001).ConclusionsIn this contemporary series, IOAEs were relatively frequent during branched or fenestrated stenting procedures and were often responsible for significant complications.

HVAD continuous flow assist device for ischemic ventricular septal rupture

HVAD continuous flow assist device for ischemic ventricular septal rupture

Thrombose d’une endoprothèse couverte aorto-bi-iliaque posée en cure d’une fistule artério-veineuse après chirurgie discale lombaire

Major vessel injury is a rare complication of spinal surgery. Iliac artery injury is the most common. Frequently, a chronic arteriovenous fistula develops. We describe the case of a 63-year-old woman who had developed a chronic arteriovenous fistula following lumbar disc hernia surgery. The patient was treated using an Anaconda™ stent graft (Vascutek Terumo). After 2years, the prothesis thrombosed and an aorto-iliac bypass was performed. A gel soft prosthesis 18/9 (Vascutek Terumo) was implanted by laparotomy. The postoperative period was uneventful. A month later, the patient had recovered good lower limb function. The choice between endovascular versus open surgery must take into account the patient's age, the risk of long-term complications, and the need for radiographic surveillance. Curative open surgery remains a valid option for young patients.

Chronic Dissection and Aneurysmal Dilatation of a BioValsalva Conduit

The BioValsalva (Vascutek Terumo, Renfrewshire, Scotland, UK) conduit is the first commercially available prefabricated bioprosthetic aortic valved conduit. We present a case of chronic dissection of a BioValsalva valved conduit presenting as a 7.5-cm aortic root aneurysm 1 year after a Bentall operation. Intraoperatively, the conduit was found to have dissected from the annulus upward, and the coronary buttons were avulsed from the inner layers while remaining attached to the outer layer. Both the outer layer and the coronary buttons were grossly dilatated.

Branched Graft Inversion Technique for Distal Anastomosis in Total Arch Replacement

Distal anastomosis during total arch replacement for thoracic aortic aneurysm is at times difficult, and bleeding from it is a serious problem because of its limited surgical exposure. We have modified a new procedure, the branched graft inversion (BGI) technique. We investigated the effectiveness of our technique by comparing it with the conventional stepwise technique. Between January 2008 and August 2011, 40 patients, divided into two groups of 20 each, underwent elective total arch replacement. One group underwent surgery using BGI; the stepwise technique was performed on the remaining 20 patients. Our modified BGI technique offers easy and secure distal anastomosis under good surgical procedure, resulting in shorter durations of operation, cardiopulmonary bypass, and circulatory arrest (455.1±101.3 min versus 354.7±49.3 min, p<0.001; 248.2±46.6 min versus 199.7±28.2 min, p<0.001; 76.6±27.7 min versus 61.6±10.4 min, p=0.029, respectively). As a result, this technique could be a useful in performing total arch replacement.

SS8. Chimney and Periscope Grafts: Mid-term Results in 77 Consecutive Patients with Complex Aortic Aneurysms

Author Disclosures: N. D. Andersen: Nothing to disclose; G. Hughes: W.L. Gore and Associates,Research Grants W.L. Gore and Associates, Consulting fees or other remuneration (payment) W.L. Gore and Associates, Speaker’s bureauMedtronic Vascular, Consulting fees or other remuneration (payment) Medtronic Vascular, Speaker’s bureauVascutek Terumo, Consulting fees or other remuneration (payment) Vascutek Terumo, Speaker’s bureau; R. L. McCann: Nothing to disclose; A. A. Shah: Nothing to disclose; J. B. Williams: Nothing to disclose.

First 102 Patients With the Biovalsalva Conduit for Aortic Root Replacement

We retrospectively evaluated our results with the BioValsalva Conduit (Vascutek Terumo, Renfrewshire Scotland), a stentless porcine valve incorporated in a 3-layered prosthetic graft. From July 2008 through April 2011, 102 patients with a mean age of 70.9 ± 7.3 years underwent aortic root replacement with a BioValsalva conduit. The indication for surgery was aneurysmal disease of the aorta in 81 patients (79.4%), aortic valve endocarditis in 15 patients (14.7%), acute type A aortic dissection in 4 patients (3.9%), and other causes in 2 patients (2.0%). In 26 patients (25.5%), the intervention was a reoperation. Overall hospital mortality was 4.9% (n = 5; 95% confidence limit [CL], 1.6%-11.1%). Cause of death was cardiac failure in 2 patients, multiple organ or renal failure in 2 patients, and tamponade in 1 patient. Mean follow-up was 8.1 months. During follow-up, 3 deaths occurred (3.1%) because of mediastinitis, cardiac ischemia, and arrhythmia. The overall survival at 3 and 12 months was 95.9% (95% CL, 92.0% -99.9%) and 92.1% (95% CL, 85.7% -98.9%) respectively. Three patients (3.1%) had new-onset endocarditis of the BioValsalva conduit; 2 of these patients required reoperation and 1 patient received antibiotic treatment only. Retrospective analysis of the BioValsalva conduit for aortic root replacement in more than 100 consecutive patients demonstrated satisfactory initial results, with low mortality and acceptable low morbidity rates. Follow-up is mandatory and long-term results are to be awaited.

New Uncoated Vascular Prosthesis Reduces Mediastinal Tube Drainage After Thoracic Aortic Surgery

A new vascular graft (Triplex [Vascutek Terumo, Tokyo, Japan]) has a three-layer structure and no biologic coating material. We assessed inflammatory reaction and mediastinal tube drainage after thoracic aortic surgery using this graft. Between January 2009 and September 2009, 127 patients underwent open ascending aortic or arch repair. Triplex grafts (Vascutek Terumo) were used in 39 patients. After matching surgical procedures, 35 matched pairs (35 with Triplex, group A; 35 with coated graft, group B) were created. We compared postoperative inflammatory markers, amount, and duration of mediastinal drainage between the two groups. There was no difference in postoperative inflammatory marker levels between the two groups. The median total amounts of mediastinal drainage were 690 mL (group A) and 1,500 mL (group B) (p < 0.001). The median durations of drainage were 67 and 128 hours, respectively (p < 0.001). Multivariate linear regression analyses showed that use of the Triplex graft is an independent predictor of the small amount and short duration of mediastinal drainage. Triplex grafts reduce the amount and duration of mediastinal drainage after thoracic aortic surgery, which may promote early ambulation and fast postoperative recovery.

Hybrid Aortic Arch Debranching With Staged Endovascular Completion in DeBakey Type I Aortic Dissection

We assess midterm results of a hybrid approach to DeBakey type I aortic dissection using a new multibranched Dacron graft to create, by relocation of the inflow openings to the arch vessels toward the aortic root, a new aortic arch for an easier and safer second-staged endovascular stent grafting of the distal thoracic aorta. From March 2006 to July 2008 24 patients with DeBakey type I aortic dissection underwent ascending aorta and aortic arch replacement with debranching of epiaortic vessels using a new prosthesis to create an optimal landing zone for possible subsequent endovascular stent grafting of the distal thoracic aorta. Fifteen patients, who postoperatively presented a residual patent distal false lumen, underwent a successful second-stage endovascular stent-graft implantation. One patient died after the surgical stage while there was no death after the endovascular stage with hospital mortality of 4.2%. Follow-up confirmed complete thrombosis of the residual distal false lumen in 95.6% and partial thrombosis in 4.4% of patients with no evidence of endoleaks in the cases that required the endovascular procedure. Overall actuarial survival at 28 months is 92.1% ± 7.9% with 100% freedom from reoperation. Hybrid treatment of DeBakey type I aortic dissection with aortic arch debranching, using a new multibranched prosthesis (Lupiae Graft; Vascutek Terumo Inc, Scotland, United Kingdom) is confirmed to facilitate the subsequent endovascular completion. Midterm results in terms of survival and distal false lumen thrombosis are satisfactory. Further study of this operation is warranted to confirm the effectiveness and the durability of this approach.

Ruptured Thoracic Aneurysms

Recently published long-term outcomes of the UK Endovascular Abdominal Aortic Aneurysm Repair (EVAR) trial investigators and the Dutch Randomized Endovascular Aneurysm Repair group have continued to demonstrate the superiority of EVAR in the perioperative period, but they have failed to establish long-term sustainable durability compared to open repair because of increased graft-related complications and reinterventions.1,2 In 2005, thoracic endovascular aneurysm repair (TEVAR) was approved in the United States for the treatment of descending thoracic aortic aneurysms (DTAAs). This approval, based on the results of a phase II trial3 evaluating the GORE TAG endovascular prosthesis (W.L. Gore and Associates, Newark, Delaware), led to a nationwide explosion in the use of thoracic endovascular techniques for managing DTAAs.4 Physicians had already been performing EVAR for more than a decade. Whereas EVAR was initially used to repair abdominal aneurysms with a favorable anatomy, its use later expanded to include complex cases involving a short aneurysmal neck, a tortuous aorta, and (more recently) aneurysmal rupture. Although TEVAR has only a brief history, a similar trend is obvious: This approach is being used with reasonable success to treat dissections and even ruptured aneurysms5; in addition, various new debranching techniques are allowing TEVAR to be applied to portions of the aorta previously deemed unapproachable. Article see p 2718 Najibi and colleagues6 reported the results of the first study to compare TEVAR with open aortic repair. Their series comprised 18 patients, and the control group included a historic cohort of patients who had undergone open aortic repair during the previous 3 years. Short-term follow-up data showed that the endovascular group had significantly shorter operative times, shorter hospital and intensive-care–unit stays, and less operative blood loss. Subsequently, Bavaria and associates7 reported the results of a phase II multicenter trial that assessed GORE …

Acute dissection of an ascending aorta vascular conduit

Fig. 1. After removal of clots, surgical exploration showed the ruptured third layer of a Triplex (Vascutek Terumo, Renfrewshire, Scotland) prosthesis, owing to an infra-layer haematoma. The rupture was due to bleeding from the proximal anastomosis, between the second and the third layer of the vascular conduit. The second layer was the site of a diffuse oozing, which was stopped by applying Bioglue and Tachosyl. The procedure was uneventful.

Aortic Root Replacement with Re-Implantation Technique in an Infant with Loeys-Dietz Syndrome and a Bicuspid Aortic Valve

We report on an infant with a Loeys-Dietz Syndrome and a bicuspid aortic valve, who presented with rapid dilatation of the aortic root. We performed a valve-sparing aortic root replacement with re-implantation technique using a Dacron graft with pseudo-sinuses (Gelweave Valsalva conduit, Vascutek Terumo, Glasgow, Scotland).

Dissected Biovalsalva Prosthesis

A 75-year-old man underwent a Bentall procedure and hemi-arch replacement with a Biovalsalva conduit (Vascutek Terumo, Renfrewshire, Scotland) and concomitant coronary re-vascularisation. Three days later, the patient underwent an uneventful re-sternotomy due to cardiac tamponade. During the procedure, blood was drained to release the tamponade; however, no primary area for blood loss was found, though the proximal Biovalsalva appeared dissected (Fig. 1). www.elsevier.com/locate/ejcts European Journal of Cardio-thoracic Surgery 36 (2009) 400

Preassembled stentless valved-conduit for the replacement of the ascending aorta and aortic root

Here we report the early clinical results of a new preassembled stentless valved-conduit incorporating artificial sinuses of Valsalva (BioValsalva). This new composite conduit incorporates a stentless porcine aortic valve (Elan, Vascutek Terumo, UK) suspended within a triple-layered vascular conduit (Triplex, Vascutek Terumo, UK) constructed with sinuses of Valsalva. Between December 2006 and January 2008, 17 patients with the mean age of 65 years underwent aortic valve, root and ascending aorta replacement with the BioValsalva valved-conduit. There was no perioperative mortality. There were no myocardial infarctions, cardiac failure or cerebrovascular events. Mean cardiopulmonary bypass time was 156+/-56 min and ischemic time was 112+/-33 min. Eight patients required deep hypothermic circulatory arrest for additional distal ascending aorta replacement. Mean mediastinal drainage was 499+/-262 ml. Postoperative transthoracic echocardiography and CT-scans of the aorta in all patients before discharge demonstrated well-functioning prosthetic aortic valves with small residual mean gradients, no regurgitation, and the presence of sinuses of Valsalva. In conclusion, the novel prefabricated, composite stentless valved-conduit BioValsalva possesses excellent hemodynamic performance and can be implanted with low morbidity. In addition, the conduit material has good hemostatic properties which reduced bleeding, and is easy to implant with a variety of surgical techniques.