Thoraflex Hybrid Graft Research Articles

Five-Year Outcomes of Hybrid Arch Frozen Elephant Trunk Repair With Novel Multibranched Hybrid Graft

BackgroundThe objective of this study was to report the 5-year outcomes of hybrid arch frozen elephant trunk (FET) procedures with a multibranched hybrid graft. MethodsBetween 2014 and 2020, 50 consecutive patients (63 ± 15 years old; 34% women) underwent hybrid arch FET with Thoraflex hybrid graft (Terumo Aortic) at a single center. Indications included aortic aneurysm (n = 48 [96%]), acute aortic dissection (n = 10 [20%]), and chronic dissection (n = 20 [40%]). Follow-up was complete, and mean follow-up was 1455 ± 664 days. ResultsAll 50 patients experienced successful device implantation. The 30-day/in-hospital mortality was 2% (n = 1). Stroke and transient neurologic deficits occurred in 1 patient (2%) and 3 patients (6%). Two patients (4%) and 1 patient (2%) experienced transient and permanent spinal cord ischemia. FET thromboembolic complication was observed in 1 patient (2%). In follow-up, 6 patients died of aortic events, and there were 13 reinterventions in the downstream aorta, of which 46% (6/13) were planned second-stage operations. Survival rate at 1 year, 2 years, and 5 years was 96%, 92%, and 85%, and freedom from unplanned distal reintervention at 1 year, 2 years, and 5 years was 98%, 92%, and 81%. Computed tomography follow-up demonstrated positive distal aortic remodeling with aneurysmal regression and stabilized aortic dimensions in patients with aortic dissection. ConclusionsThe hybrid arch FET procedure with a novel hybrid graft is associated with good early and midterm outcomes. Longer term outcomes merit further investigation.

C40 SYSTEMATIC TOTAL ARCH REPLACEMENT WITH THORAFLEX HYBRID GRAFT IN ACUTE TYPE A AORTIC DISSECTION: A SINGLE CENTRE EXPERIENCE

Abstract Introduction The traditional surgical management for acute Type A aortic dissection focuses on handling emergencies in the aortic root and ascending aorta. The remaining untreated distal portion of the aorta has a potential risk of rupture or causing malperfusion syndrome. Therefore, an aggressive repair approach using total aortic arch replacement combined with the frozen elephant trunk (FET) implantation has been advocated. We describe the early and midterm clinical outcomes of the Thoraflex Hybrid graft for the treatment of emergency type A aortic dissection. Methods Between December 2017 and January 2022, 69 consecutive patients were admitted with acute type A aortic dissection; of those, 66 patients (62.9 ± 10.2 years of age, 81.8% men) underwent emergency hybrid aortic arch and frozen elephant trunk repair with the multibranched Thoraflex hybrid graft and were enrolled in the study. Primary end point were 30 days– and in–hospital mortality. To better clarify the impact of age on surgical outcomes, we have divided the study population into two groups: group A for patients < 70 years of age (47 patients), group B for patients ≥ 70 years (19 patients). Results All 66 device implants were technically successful. Mean follow–up was 19.7 ±17.4 months. 30–days– and in–hospital mortality were 10.6 and 13.6%, respectively. Stroke occurred in 3 (4.5%) patients. Two (3.0%) patients experienced spinal cord ischemia. Renal failure requiring CVVH and respiratory failure requiring tracheostomy were 30.3% and 28.8%, respectively. Overall survival for the entire cohort at 3 months, 6 months, 12 months and 24 months was 85%, 80.3%, 76.5%, 74.4% respectively. We did not find any statistically significant difference among the two groups in terms of main post–operative outcomes. The multivariable Cox proportional hazard model showed left ventricular ejection fraction (HR: 0.83, 95% CI: 0.79–0.92, p <0.01), peripheral vascular disease (HR: 15.8, 95% CI: 3.9–62.9, p < 0.01), coronary malperfusion (HR: 0.10, 95% CI: 0.01–0.77, p =0.03), lower limbs malperfusion (HR: 5.1, 95% CI: 1.10–23.4, p = 0.04) and cardiopulmonary bypass time (HR: 1.02, 95% CI: 1 – 1.04, p = 0.01) as independent predictors of long term mortality. Conclusions Hybrid aortic arch and frozen elephant trunk repair with the Thoraflex Hybrid graft to treat emergency type A aortic dissection appears to be associated with good early and mid–term clinical outcomes even in the elderly.

Systematic total arch replacement with thoraflex hybrid graft in acute type A aortic dissection: A single centre experience.

IntroductionIn the last two decades, a more aggressive approach has been encouraged to treat patients with acute type A aortic dissection (ATAAD), extending the repair to the aortic arch and proximal descending thoracic aorta with the frozen elephant trunk (FET) implantation. Here, we report our single-centre experience with the FET technique for the systematic treatment of emergency type A aortic dissection.Materials and methodsBetween December 2017 and January 2022, 69 consecutive patients were admitted with ATAAD; of those, 66 patients (62.9 ± 10.2 years of age, 81.8% men) underwent emergency hybrid aortic arch and FET repair with the multibranched Thoraflex hybrid graft and were enrolled in the study. Primary endpoints were 30 days- and in-hospital mortality. Secondary endpoints were postoperative morbidity and follow-up survival. To better clarify the impact of age on surgical outcomes, we have divided the study population into two groups: group A for patients <70 years of age (47 patients), and group B for patients ≥70 years (19 patients). Time-to-event analysis has been conducted using the Log-rank test and is displayed with Kaplan-Meier curves. A multiple Cox proportional Hazard model was developed to identify predictors of long-term survival with a stepwise backward/forward selection process.Results30-days- and in-hospital mortality were 10.6 and 13.6%, respectively. Stroke occurred in three (4.5%) patients. Two (3.0%) patients experienced spinal cord ischemia. We did not find any statistically significant difference between the two groups in terms of main post-operative outcomes. The multivariable Cox proportional hazard model showed left ventricular ejection fraction (HR: 0.83, 95% CI: 0.79–0.92, p < 0.01), peripheral vascular disease (HR: 15.8, 95% CI: 3.9–62.9, p < 0.01), coronary malperfusion (HR: 0.10, 95% CI: 0.01–0.77, p =0.03), lower limbs malperfusion (HR: 5.1, 95% CI: 1.10–23.4, p = 0.04), and cardiopulmonary bypass time (HR: 1.02, 95% CI: 1–1.04, p = 0.01) as independent predictors of long term mortality.ConclusionsFrozen elephant trunk repair to treat emergency type A aortic dissection appears to be associated with good early and mid-term clinical outcomes even in the elderly.

Aortic remodelling and false lumen changes after the frozen elephant trunk technique using the thoraflex hybrid stented graft for aortic dissection

BackgroundDespite the marked improvement in the aortic dissection repair techniques, residual dissected aorta with a patent false lumen remains an issue. So, the aim of our study is to observe the effect of inserting the Thoraflex Hybrid Graft on the aortic diameters in patients with type A aortic dissection involving the arch and descending aorta. Patients with type I aortic dissection who had aortic dissection repair using the Thoraflex Hybrid Graft in University Hospitals Birmingham were studied. Radiological assessment with computed tomography of the aorta was done at the level of the diaphragm to measure the true lumen, false lumen and total aortic diameters. Significance of change of diameters at early post-operative as compared to the pre-operative period was analysed.ResultsEight cases were done in the acute setting, while 14 cases were done in the chronic setting. The ratio of true lumen to the total aortic diameter has significantly increased in the follow-up period as compared to the pre-operative period (P = 0.031). Whereas false lumen to total aortic diameter ratio has significantly decreased (P = 0.024). Subgroup analysis revealed that these changes were not significantly altered by whether the dissection was acute or chronic.ConclusionsThe Thoraflex Hybrid Graft will induce positive aortic remodelling with expansion of true lumen and will diminish the false lumen. But we could not find a significant difference between acute or chronic cases due to small sample size.

4D flow MRI after aortic replacement with frozen elephant trunk using thoraflex hybrid graft.

Four-dimensional (4D) flow magnetic resonance imaging (MRI) has not been used to describe flow through a Thoraflex Hybrid graft. We present the first 4D flow MRI depiction of Thoraflex Hybrid graft after use as a frozen elephant trunk to repair a DeBakey Type I aortic dissection.

Thoraflex hybrid as frozen elephant trunk in chronic, residual type A and chronic type B aortic dissection.

The frozen elephant trunk technique is an increasingly common treatment for extensive disease of the thoracic aorta. The objective of the study was to evaluate the outcomes of frozen elephant trunk specifically in chronic (residual) aortic dissections, focusing on downstream aortic remodelling. Between 2013 and 2019, a total of 28 patients were treated using the Vascutek Thoraflex hybrid graft at our institution for chronic dissections/post-dissection aneurysms. Immediate and follow-up outcomes were studied, as well as the changes in total aortic diameter, true lumen and false lumen diameter and the status of the false lumen at 3 different levels of the thoraco-abdominal aorta. No in-hospital or 30-day mortality was observed, temporary paraparesis rate was 7% and disabling stroke incidence was 14.3%. Freedom from all-cause mortality at 2 years was 91.6 ± 5.7%, while freedom from reintervention on the downstream aorta at 2 years was 59.1 ± 10.8%. Positive aortic remodelling was achieved in 50.0%, with an enlargement in the true lumen and a reduction of the false lumen not only at the level of the proximal descending aorta with 73.1% of complete thrombosis but also at the level of the distal descending thoracic aorta, with 41.7% of complete thrombosis. The frozen elephant trunk is a good solution in chronic (residual) downstream aortic dissections inducing positive aortic remodelling and preventing from II stage operations or allowing an endovascular approach.

Open total arch replacement with trifurcated graft and frozen elephant trunk.

The frozen elephant trunk (FET) technique was introduced in Hannover Medical School in 2001 to treat patients with complex aortic arch pathologies. Since 2012, we primarily use the trifurcated Thoraflex Hybrid FET graft. In this article, we report our experience with the trifurcated FET graft. Between November 2012 and September 2018, 211 patients underwent FET implantation with the trifurcated Vascutek Thoraflex Hybrid graft. The indications for surgery were: degenerative aneurysms in 68 patients, acute aortic dissections (AD) in 96 patients, and chronic ADs in 47 patients. And, 18% of cases were sternal re-operations. Mean cardiopulmonary bypass time, aortic cross-clamp time, and myocardial ischemia time were 262±84, 115±71, 50±26 minutes, respectively. Incidence of re-thoracotomy for bleeding, stroke, permanent paraplegia/paraparesis, prolonged ventilatory support (>96 h), and long-term dialysis were 13%, 18%, 2%, 21%, and 5%, respectively. In-hospital mortality was 12%. Follow-up was complete for 100% of patients and comprised a total of 513 patient years. The mean follow-up time was 2.2 [0-6] years. During follow-up, there were 32 aortic re-interventions distal to the FET. The survival rate at 1 and 5 years was 84% and 81%, respectively. Total aortic arch replacements with trifurcated FET can be performed with positive results. The trifurcated graft allows selective anastomosis of the supra-aortic vessels, which might result in improved hemostasis.

VD10 FROZEN ELEPHANT TRUNK AND DAVID PROCEDURE BY USING THORAFLEX AND GORE HYBRID PROSTHESES IN A MARFAN PATIENT WITH ACUTE TYPE A AORTIC DISSECTION

We present the case of a 19-year-old Marfan patient with 53 mm ascending aorta aneurysm complicated by acute type A aortic dissection. Cardiopulmonary bypass was established by cannulation of right femoral artery and right atrium. Moderate (25°C) hypotermic circulatory arrest was used and the aortic root prepared for reimplantation technique. At 25°C, the aortic arch was opened and the antegrade selective cerebral perfusion was established through cannulation of brachiocephalic trunk and left carotid artery. A 22/24 mm Thoraflex hybrid graft was used and distal anstomosis performed in arch zone 2. During the rewarming, the supraaortic vessels were separately reimplanted, using also a Gore 8 mm prosthesis for the left subclavian artery. The aortic valve was reimplanted in a 30 mm Valsalva conduit. The procedure was completed with the suture of the two vascular conduits. Post-operative echocardiogram showed a well-functioning aortic valve and angio CT scan showed a good surgical result.

Early Clinical Outcomes of Hybrid Arch Frozen Elephant Trunk Repair With the Thoraflex Hybrid Graft

Hybrid aortic arch surgery has evolved to include several technical variations, with most including an off-label use of a conventional thoracic endograft. We describe the early clinical outcomes of the Thoraflex Hybrid graft (Vascutek, Glasgow, Scotland) specifically designed for the treatment of complex arch and proximal descending aortic disease. Between January 2014 and April 2017, 40 consecutive patients (66 ± 14 years of age, 45% women) underwent hybrid aortic arch and frozen elephant trunk repair with the multibranched Thoraflex Hybrid graft at 9 Canadian centers. Surgical indications included transverse arch or proximal descending aortic aneurysm in 100%, acute dissection in 10%, chronic dissection in 43%, and acute aortic rupture in 1 patient. Antegrade cerebral perfusion and moderate hypothermia (24.3 ± 1.8°C) were employed in all cases. All 40 device implants were successful. The 30-day or in-hospital mortality was 5%. Stroke and transient neurological deficits occurred in 5% and 3% of patients, respectively. Two (5%) patients experienced transient spinal cord ischemia-there were no instances of permanent paraplegia. Mean follow-up was 550 ± 328 days and late complications included type A aortic dissection in 1 patient, type B dissection in 2 patients, and further distal endografting in 2 patients. Survival at 30 days, 1 year, and 2 years was 95%, 95%, and 90%, respectively. Hybrid aortic arch and frozen elephant trunk repair with the Thoraflex Hybrid graft appearstobe associated with good clinical outcomes, despitebeing early in the learning curve with this graft. Further investigation with this device is warranted toestablish its role within the variations of hybrid archrepair.

Total aortic arch replacement with a novel 4-branched frozen elephant trunk prosthesis: Single-center results of the first 100 patients

ObjectiveCombined disease of the aortic arch and the proximal descending aorta remains a surgical challenge. The Thoraflex Hybrid graft (Vascutek, Inchinnan, United Kingdom) consists of a 4-branched graft with a stent graft at the distal end allowing a total aortic arch replacement, including the origins of the supra-aortic vessels combined with endoluminal treatment of the proximal descending aorta. We present the midterm results of our first 100 patients who were treated with this frozen elephant trunk prosthesis. MethodsFrom April 2010 to October 2014, 100 patients (65 men aged 59 ± 14 years) underwent operation (37 acute dissections, 31 chronic dissections, and 32 aneurysms). Fifty-four percent of patients received concomitant cardiac procedures, and 28% were reoperations. ResultsThe perioperative mortality was 7% (n = 7). Midterm survival after a follow-up of 3.1 ± 1.4 years was 81% (n = 81). Mean cardiopulmonary bypass time was 243 ± 61 minutes, cardiac ischemia time was 101 ± 65 minutes, and circulatory arrest time was 51 ± 20 minutes. Aortic root replacement was performed in 41 patients (n = 41; valve-sparing: 30% [n = 30]). Twenty-two percent of patients underwent secondary aortic reinterventions during follow-up (15% planned second stage operations). Sixty percent of reinterventions were performed via endovascular approach. Acute dissection patients needed significantly fewer reinterventions (n = 3; 8%). ConclusionsThe Thoraflex Hybrid graft adds to the frozen elephant trunk concept for treating aortic arch and descending aortic disease. Implantation of the Thoraflex Hybrid graft resulted in excellent outcomes and beneficial aortic remodeling during follow-up. This graft increases surgeons' armamentarium in the treatment of complex and diverse aortic arch pathology.

Aortic Arch Replacement with Frozen Elephant Technique - A Single Center Experience Evaluating the Neurological Outcome

Introduction: A modern concept for the treatment of extensive aortic disease involving the aortic arch and the proximal descending aorta is the frozen elephant trunk (FET) technique. The perioperative incidence of spinal cord ischemia and stroke is reported to be up to 24% and 16%, respectively. The results on neurological outcome with the FET technique are presented. Methods: Between July 2011 and August 2014, 33 consecutive patients underwent extensive thoracic aorta surgery using the FET technique (n = 11 E-vita hybrid open stent graft, n = 22 Thoraflex hybrid graft). Root replacement was performed in 38.7% (Bentall n = 9, David procedure n = 3) and additional bypass grafting in 6.1% (n = 2). Mean age of these high-risk patients (mean Euroscore II 13.2 ± 15.7) was 63.2 ± 10.7 years (75.8% males). Indications for surgery were as follows: extensive degenerative aneurysm (33.3%, n = 11), acute (36.4%, n = 12), and chronic (30.3%, n = 10) type A dissection. Of these, 3 patients had acute aortic rupture and 3 patients suffered from Marfan syndrome. About one quarter (24.2%, n = 8) were reoperations. Preoperative neurological pathologies were as follows: paraparesis n = 1, monoparesis n = 2, impaired consciousness n = 2. In addition, 4 patients had already been intubated at the referring clinic. For perioperative neurological protection deep hypothermia (< 25°C) and bilateral antegrade perfusion were used and cerebral oxygenation was monitored by NIRS. Results: Cardiopulmonary bypass, aortic clamping, cerebral perfusion, and circulatory arrest times were 262 ± 79, 143 ± 63, 88 ± 31 and 80 ± 28 minute, respectively. The 30-day mortality was 15.2% (n = 5). Of these, 4 patients underwent emergency surgery. Only 1 patient who underwent elective FET died (3%). Permanent and temporary neurological deficit occurred in 6.3% (n = 2) and 15.2% (n = 5), respectively. Paraplegia occurred in 1 patient (3%) who had previous complete thoracoabdominal endovascular stenting. Left recurrent nerve paralysis was observed in 22.6% (n = 7). Conclusion: The above-mentioned regime which involves bilateral antegrade cerebral perfusion in combination with deep hypothermia provides adequate protection for the spinal cord and the brain even during longer periods of circulatory arrest. Due to anatomical reasons, the left recurrent nerve is difficult to protect.

Aortic root and total arch replacement with frozen elephant trunk procedure, using a Thoraflex Hybrid Graft.

Aortic root and total arch replacement with frozen elephant trunk procedure, using a Thoraflex Hybrid Graft.

Frozen elephant trunk surgery using the Vascutek Thora-flex hybrid prosthesis.

The Vascutek Thoraflex hybrid graft (Vascutek, Scotland) is a novel commercially available 4-branched frozen elephant trunk (FET) graft used to treat patients with extensive diseases of the thoracic aorta (1). This hybrid prosthesis is composed of a distal endograft sealed to a proximal 4-branched gelweave graft with an incorporated sewing collar (Figure 1). Figure 1 The Vascutek Thora-flex hybrid prosthesis The text of this manuscript describes our FET technique with the Vascutek Thoraflex hybrid graft in detail (Video 1). Video 1 Frozen elephant trunk surgery using the Vascutek Thora-flex hybrid prosthesis Clinical vignette A 73-year-old man who had undergone a supra-coronary ascending aorta replacement for a DeBakey type 1 acute aortic dissection in a different Institution in 1997 was recently referred to our hospital for a residual chronic post-dissection aneurysm of the thoraco-abdominal aorta. Upon admission, the angio CT scan showed severe dilatation of the thoracic (48 mm) and abdominal (72 mm) aorta. The false lumen of the abdominal aorta was completely thrombosed; all the visceral vessels originated from the true lumen of the dissection with the exception of the left renal artery; large intimal tears were identified at the origin of the innominate artery and at the level of distal descending thoracic aorta. The native aortic root measured 33 mm (Figure 2). A trans-thoracic echocardiogram showed a competent tricuspid aortic valve and a normal left ventricular ejection fraction (62%). The preoperative coronary angiogram revealed severe 3-vessel coronary artery disease with critical stenoses of the left anterior descending, obtuse marginal and right coronary arteries. Figure 2 Angio CT image showing the residual DeBakey type 1 aortic dissection of the thoraco-abdominal aorta The patient was scheduled for a 3-staged hybrid treatment involving complete arch replacement with the FET and myocardial revascularization (stage 1), replacement of the abdominal aorta with visceral vessel de-branching (stage 2), and endovascular stenting of the remaining aortic segments from the FET to the abdominal aortic graft (stage 3). This video focuses on the stage-one procedure.