Aortic Arch Debranching and Thoracic Endovascular Aortic Repair (TEVAR) for Type B Aortic Dissection.

BACKGROUND: Since its introduction, thoracic endovascular aortic repair (TEVAR) has revolutionized the treatment of type B aortic dissections (TBADs). However, the proximal aspect of the aortic pathology treated may infringe on the origin of the left subclavian artery or even more proximally. Hence, to ensure durable outcomes, the origin of these vessels needs to be covered, but an extra-anatomical bypass is required to perfuse vital branches, known as aortic arch debranching. This series aims to describe and delineate the disparities of aortic arch debranching during TEVAR for TBAD. METHODS: A retrospective review and analysis of a multicenter international database was conducted to identify patients with TBAD treated with TEVAR between 2005 and 2021. Data analyzed included patient demographics, disease characteristics, operative characteristics, and postoperative outcomes with follow-up on mortality and reintervention. All statistical analyses were carried out using IBM SPSS 26. Patient survival was calculated using a Kaplan-Meier survival analysis, and a P value of less than 0.05 was considered statistically significant. RESULTS: A total of 58 patients were included in the analysis, of which 27 (46.6%) presented with complicated disease and 31 were uncomplicated, of which 10 (17.2%) were classed as high risk and 21 (36.2%) low risk. Zone 2 was the most common proximal landing zone for the stent graft. Left subclavian artery bypass was performed selectively (26%), with 1 stroke occurring, likely due to embolic reasons. A further 6 underwent more proximal aortic debranching before TEVAR (10%) and was a significant risk factor for mortality and the number of stents deployed. The overall rates of reintervention and mortality were 17.2% (n = 10) and 29.3% (n = 17). CONCLUSIONS: Aortic arch debranching and TEVAR for TBAD is associated with significant mortality. Future developments to treat aortic arch pathology could incorporate branched graft devices, eliminating the need for debranching, improving stroke rates, and reducing future reinterventions.

Long-Term Survival and Reintervention Following Thoracic Endovascular Aortic Repair in Blunt Traumatic Thoracic Aortic Injury: A Systematic Review and Meta-Analysis.

BACKGROUND: Blunt thoracic aortic injury (BTAI) represents one of the most devastating scenarios of vascular trauma. Different management strategies are available with varying clinical outcomes. However, thoracic endovascular aortic repair (TEVAR) has become the first-line option for most BTAI patients, mainly owing to its minimally invasive nature, yielding improved immediate results. This meta-analysis aims to investigate mortality, long-term survival, and reintervention following TEVAR in BTAI. MATERIAL AND METHODS: A systematic review conducted a comprehensive literature search on multiple electronic databases using strict search terms. Twenty-seven studies met the set inclusion/exclusion criteria. A proportional meta-analysis of extracted data was conducted using the Comprehensive Meta-Analysis Software, v.4. RESULTS: 1498 BTAI patients who underwent TEVAR were included. Using the SVS grading system, 2.6% of the population had Grade 1 injuries, 13.6% Grade 2, 62.2% Grade 3, 19.6% Grade 4, and 1.9% unspecific. All-cause mortality did not exceed 20% in all studies except one outlier with a 37% mortality rate. Using the random effects model, the pooled estimate of overall mortality was 12% (95% confidence interval [CI], 5.35-8.55%; I2 = 70.6%). This was 91% (95% CI, 88.6-93.2; I2 = 30.2%) at 6 months, 90.1% (95% CI, 86.7-92.3; I2 = 53.6%) at 1 year, 89.2% (95% CI, 85.2-91.8; I2 = 62.3%) at 2 years, and 88.1% (95% CI, 83.3-90.9; I2 = 69.6%) at 5 years. Moreover, the pooled estimate of reintervention was 6.4% (95% CI, 0.1-0.49%; I2 = 81.7%). CONCLUSIONS: Despite the high morbidity and mortality associated with BTAI, TEVAR has proven to be a safe and effective management strategy with favorable long-term survival and minimal need for reintervention. Nevertheless, diagnosis of BTAI requires a high index of suspicion with appropriate grading and prompt transfer to trauma centers with appropriate TEVAR facilities.

Driving Technology for Thoracic Endovascular Aortic Repair: An International Analysis of Single-versus Double-Branch RELAY Outcomes.

BACKGROUND: The introduction of endovascular aortic arch repair (EAR) represents a paradigm shift in the management of complex arch pathologies usually treated with open surgical repair (OSR). This shift in treatment of aortic arch disease has also been accompanied with a rise in commercial interest in EAR resulting in the development of several endografts. However, the RELAY™ Branched by Terumo Aortic can be considered the prime endograft choice. In this international original study, a retrospective comparative analysis of international prospective outcomes data on the single- and double-branch RELAY stent grafts is provided. METHODS: International data on EAR procedures carried out from January 2019 to January 2022 using the single- and double-branch RELAY endograft configurations were collected prospectively. Follow-up data were collected at 30 days, 6 months, 12 months, and 24 months postoperatively. Retrospective descriptive analysis, logistic regression, and Kaplan-Meier analysis were performed. RESULTS: A total of 125 patients were included, out of which 17 (13.6%) received the single-branch RELAY and 108 the double-branch device. In the single-branch group, no mortalities, strokes, or reinterventions were recoded over 24 months of follow-up. The rates of these outcomes were higher in the other group; however, the differences did not reach significance. Target vessel patency was maintained at 100% throughout the study period with the single-branched RELAY. Overall, our Kaplan-Meier analyses proved that both configurations of RELAY Branched yield excellent short- and mid-term survival and freedom from reintervention. CONCLUSIONS: Our series has clearly demonstrated that EAR using RELAY Branched is a highly efficacious strategy that yields very favorable results which can be considered superior to other EAR devices as well as OSR. Nevertheless, it seems that clinical outcomes with the single-branch RELAY are more optimal than with the double-branch device.

From the RELAY Family-A Story of Single-Branched International Outcomes.

BACKGROUND: Advances in surgery over the last few decades has led to the development and widespread utilization of thoracic endovascular aortic repair (TEVAR). TEVAR, due to its minimally invasive nature and potential superior outcomes, is now becoming a key focus of interest in treating pathologies of the aortic arch, which has traditionally been treated with open surgical repair. We present our findings of our international multicentre dataset documenting the efficacy of the single-branched RELAY™ endograft in terms of technical success, postoperative outcomes, and reintervention rates. METHODS: Prospective data were collected and retrospectively analyzed with descriptive and distributive analysis between January 2019 and January 2022 from 17 patients treated with RELAY single-branched endoprostheses from centers across Europe. Follow-up data from 30 days and 6 months, 12 months, and 24 months postoperatively was included. Patient follow-up was evaluated in terms of postoperative outcomes, target vessel patency, and reintervention rates. RESULTS: Technical success was achieved in all 17 patients (100%) and there were no postoperative disabling or nondisabling strokes in our single-branched RELAY cohort. The target vessel patency remained 100% during the first 30 days postoperatively; however, by the end of the follow-up period (24 months), target vessel patency was achieved in 93.7% of the patients. There were no reinterventions or deaths during the full study duration using the single-branched RELAY stent-graft. CONCLUSIONS: These results with the single-branched RELAY stent graft demonstrate favorable outcomes in comparison to the literature and demonstrate the feasibility of treatment of aortic pathology with this single-branched graft in the future. Further studies with larger patient cohorts will help us to accumulate evidence for the feasibility of the single-branched RELAY stent graft for aortic arch surgery in the future.

Patient longevity and survival with custom-made endovascular solutions: The Fenestrated AnacondaTM approach.

BACKGROUND: Endovascular aortic repair (EVAR) has become the mainstay treatment for abdominal aortic aneurysms and is associated with excellent clinical outcomes. However, there remains a risk of complications requiring reintervention. Several EVAR devices exist commercially, yet, the Terumo Aortic Fenestrated Anaconda™ has demonstrated outstanding results. The main scope of this study is to evaluate survival/longevity, target vessel patency (TVP), endograft migration and reintervention following Fenestrated Anaconda™ implantation and discuss relevant literature. METHODS: The current study represents a 9-year cross-sectional international analysis of custom-made Fenestrated Anaconda™ device. For the statistical analysis, SPSS 28 for Windows and R was utilised. Pearson Chi-Square analysis was used to assess differences in cumulative distribution frequencies between variables. Statistical significance for all two-tailed tests was set at p < 0.05. RESULTS: A total of 5058 patients received the Fenestrated Anaconda™ endograft. The Fenestrated Anaconda™ was indicated either due to complex anatomy for competitor devices (n = 3891, 76.9%) or based on surgeon preference (n = 1167, 23.1%). Both survival and TVP were 100% during the first 6 postoperative years but dropped to 77.1% and 81% thereafter. In the complex anatomy indication group, cumulative survival and TVP were both 100% until year 7 post-EVAR when they decreased to 82.8% and 75.7%. In the other indication group, survival and TVP were also 100% during the first 6 years but plateaued at 58.1% and 98.8% in years 7-9 of follow-up. No cases of endograft migration and reintervention were recorded. CONCLUSION: The Fenestrated Anaconda™ has been proven across the literature to be a highly effective EVAR endograft, as it has demonstrated excellent survival/longevity and TVP as well as minimal endograft migration and reintervention.

Correlative effect between sac regression and patient longevity following endovascular solution for abdominal aortic aneurysms: an international analysis.

INTRODUCTION: Since the introduction of endovascular aortic repair (EVAR) it has become the mainstay treatment for abdominal aortic aneurysms. Several EVAR devices exist commercially, yet, the Terumo Aortic Fenestrated Anaconda™ endograft has demonstrated outstanding results. Evidence in the literature suggests that sac regression could be linked to patient survival and longevity. The main scope of this study is to evaluate sac regression and survival achieved using the Fenestrated Anaconda™ endograft and to discuss relevant literature. MATERIALS AND METHODS: The current study represents a nine-year cross-sectional international analysis of custom-made Fenestrated Anaconda™ device. For the statistical analysis, SPSS 28 for Windows and R were utilised. Pearson chi-square analysis was used to assess differences in cumulative distribution frequencies between select variables. Statistical significance for all two-tailed tests was set at p < 0.05. RESULTS: A total of 5,058 patients received the Fenestrated Anaconda™ in this study, either due to unsuitable/complex anatomy for competitor devices (n = 3,891) or based on surgeon preference (n = 1,167). A sac regression of 0-30% was observed in 4,772 (94.3%) over the first four years post-EVAR. Here, 99.6% of patients receiving the Fenestrated Anaconda™ due to unsuitable/complex anatomy for competitor devices and 76.8% based on surgeon preference had 0-30% sac regression. During years 5-9 of follow-up, all patients had 20-45% sac regression. Patient survival during the first six years post-EVAR was 100% but dropped to 77.1% in years 7-9. Survival differed between categorical patient subsets based on the indication. DISCUSSION: The Fenestrated Anaconda™ has been proven to be a highly effective EVAR endograft. Evidence in the literature clearly demonstrates that sac regression is an accurate prognostic factor for patient survival and longevity.

Impact of patient demographics and intraoperative characteristics on abdominal aortic aneurysm sac following endovascular repair.

BACKGROUND: Endovascular aortic repair (EVAR) has become the preferred treatment for abdominal aortic aneurysm (AAA). Its main aim is to seal the perfusion of the aneurysmal sac and, thus, induce sac regression and subsequent aortic remodelling. Aneurysmal sac regression has been linked to the short- and long-term clinical outcomes post-EVAR. It has also been shown to be influenced by endograft device choice, with several of these available commercially. This review summarises and discusses current evidence on the influence of pre- and intraoperative factors on sac regression. Additionally, this review aims to highlight the device-specific variations in sac regression to provide an overall holistic approach to treating AAAs with EVAR. METHODS: A comprehensive literature search was conducted using multiple electronic databases to identify and extract relevant data. RESULTS: Female sex, >70 mm original sac diameters, higher pre-procedural fibrinogen levels, smoking and low intra-aneurysmal pressure were found to positively impact sac regression. Whereas renal impairment, ischemic heart disease, high intra-aneurysmal pressure and aneurysm neck thrombus negatively influenced sac regression. Patent lumbar arteries, age, statins and hypercholesterolaemia displayed conflicting evidence regarding sac regression. Regarding the EVAR endografts compared, newer generation devices such as the Anaconda mainly showed the most optimal results. CONCLUSION: Sac regression following EVAR in AAA is an important prognostic factor for morbidity and mortality. Nevertheless, several pre- and intraoperative factors can have an influence on sac regression. Therefore, it is necessary to take them into account when assessing AAA patients for EVAR to optimise outcomes. The choice of EVAR stent-graft can also affect sac regression, with evidence suggesting that the Fenestrated Anaconda is associated with the most favourable results.

Can the Fenestrated Anaconda™ salvage failed competitor endografts? An international frame of reference.

INTRODUCTION: An abdominal aortic aneurysm (AAA) is a life-threatening abnormal dilation of the abdominal aorta that can be repaired either endovascularly or with open surgery. However, endovascular aortic repair (EVAR) has become the main treatment modality for AAA due to its more optimal results. EVAR devices can either be standard, fenestrated, or branched, with fenestrated EVAR (FEVAR) seemingly achieving superior prospects. Although EVAR is associated with excellent outcomes, it still carries a risk of certain complications requiring reintervention or 'rescue'. Several commercial EVAR devices are available on the global market, nevertheless, the Fenestrated Anaconda developed by Terumo Aortic can be considered the superior device due to the wide range of endovascular solutions that it offers along with its unique custom-made approach, excellent results and its highly promising potential to be used as a 'rescue' device for failed competitor endografts. MATERIALS AND METHODS: The current study represents a 9-year cross-sectional international analysis of a custom-made Fenestrated Anaconda™ device. For the statistical analysis, SPSS 28 for Windows and R were utilised. Pearson Chi-square analysis was used to assess differences in cumulative distribution frequencies between select variables. Statistical significance for all two-tailed tests was set at p < 0.05. RESULTS: Out of 5058 EVARs performed using the Fenestrated Anaconda, 2987 (59%) were 'rescue' procedures for migrated Gore (n = 252) and Medtronic (n = 2735) devices. The Fenestrated Anaconda™ was indicated as the reintervention device either due to unsuitable/complex anatomy for the competitor (n = 2411) or based on surgeon preference (n = 576). Overall, the Fenestrated Anaconda was utilised to rescue 3466 (68.5%) failed previous EVARs using competitor devices. Yet, the primary endovascular solution offered by the Fenestrated Anaconda was FEVAR (91.3%), with 112 (2.2%) devices using custom-made iliac stents. DISCUSSION: The use of the Fenestrated Anaconda endograft as a 'rescue' device to salvage failed competitor devices is well-established in the literature with excellent clinical outcomes achieved. The evidence in the literature also highlights the distinctive custom-made approach that the Fenestrated Anaconda offers which enables it to treat extremely complex aortic anatomy.