First-in-men experience with a novel frozen elephant trunk prosthesis featuring an endovascular side branch for left subclavian artery connection.

OBJECTIVES: The objective of this study was to enhance the efficiency of aortic arch replacement through the development of a novel frozen elephant trunk (FET) prosthesis with an endovascular side branch for left subclavian artery (LSA) connection. After successful pre-clinical testing, the feasibility and safety of implementing this innovative prosthesis in human subjects were investigated. METHODS: Between September 2020 and September 2021, 4 patients (mean age 67) with conditions such as penetrating ulcer, non A-non B aortic dissection and chronic arch aneurysm underwent surgery utilizing the customized device. Surgeries were performed under high moderate hypothermia (27°C), employing bilateral selective antegrade cerebral perfusion (SACP) and distal aortic perfusion. Anastomosis of the FET prosthesis with the aortic arch occurred in zone 1, followed by separate reimplantation of the left common carotid artery and the brachiocephalic artery. RESULTS: All patients were discharged in good clinical condition. The mean aortic cross-clamp, antegrade selective cerebral perfusion and distal aortic perfusion times were 111, 71 and 31 min, respectively. Endovascular extension of the side branch for the LSA was required in all cases to prevent endoleak formation. One patient received a stent graft extension at the end of the operation, while 2 others underwent the procedure during their hospital stay. One patient was diagnosed with an endoleak at the first follow-up after 3 months, and endoleak sealing was achieved via the brachial artery with an extension stent graft. CONCLUSIONS: Preliminary clinical outcomes suggest that the newly designed FET prosthesis shows promise in simplifying total arch replacement. These initial findings provide a foundation for planned clinical studies to further assess the effectiveness of this modified surgical hybrid graft, with particular attention to the length and diameter of the LSA sidearm.

Long-Term Results with 187 Frozen Elephant Trunk Procedures.

The frozen elephant trunk (FET) technique is an established therapeutic option in the treatment of complex aortic diseases. We report our long-term clinical outcomes after FET repair. A total of 187 consecutive patients underwent FET repair at our department between 8/2005 and 3/2023. Indications included acute and chronic aortic dissections and thoracic aneurysms. Endpoints included operative morbidity and mortality, long-term survival, and the need for reinterventions. Operative mortality, spinal cord injury and permanent stroke rates were: 9.6%, 2.7% and 10.2%, respectively. At five years, overall survival was 69.9 ± 3.9% and freedom from aortic-related death was 82.5 ± 3.0%, whereas at ten years, overall survival was 53.0 ± 5.5% and freedom from aortic-related death was 75.8 ± 4.8%. Sixty-one reinterventions on the thoracic aorta were necessary. Freedom from secondary interventions at ten years was 44.7 ± 6.4% overall (63.1 ± 10.0% for acute dissections, 40.8 ± 10.3% for chronic dissections and 28.9 ± 13.1% for aneurysms, respectively). The high reintervention rate for chronic dissections and for aneurysms is related to the pre-existing aortic pathology. Late aortic growth of untreated segments with potentially fatal outcome occurs even after ten years, so careful annual follow-up is mandatory in this patient cohort.

Taking the frozen elephant trunk technique to the next level by a stented side branch for a left subclavian artery connection: a feasibility study.

OBJECTIVES: Our goal was to develop a modified frozen elephant trunk (FET) prosthesis with a stented left subclavian artery (LSA) side branch for LSA connection and to perform preclinical testing in a human cadaver model. METHODS: We measured aortic diameters, distance between and diameters of supra-aortic vessels and the distance from the LSA offspring to the level of the left vertebral artery offspring in 70 patients. Based on these measurements, a novel FET prosthesis was developed (Cryolife/Jotec, Hechingen, Germany) featuring a stented side branch for an intrathoracic LSA connection. The feasibility and ease of implantation were tested in 2 human cadaver models at the Anatomical Institute of the Medical University Graz. A covered stent graft (Advanta V12™ by Atrium Medical Corp., Hudson, NH, USA) was used for an LSA extension. RESULTS: Accurate deployment of the novel FET prosthesis with anatomical orientation of the stented side branch towards the LSA ostium followed by consecutive stent graft deployment was feasible in both cases. Proximalizing the distal anastomosis level from zone 3 to zone 1 not only diminished the complexity of the procedure but substantially facilitated the completion of the distal anastomosis. A 2.5-cm long extension stent graft was sufficient to seal to the LSA and to maintain left vertebral artery patency in both cases. CONCLUSIONS: This initial study in human anatomical bodies could demonstrate the feasibility of implanting a newly designed FET prosthesis. This evolution of the FET technique has the potential to substantially ease total aortic arch replacement by proximalization of the distal anastomosis into zone 1 and by shortening spinal and lower body hypothermic circulatory arrest times via a stented side branch to the LSA. This direct connection enables early restoration of systemic perfusion.

Transcatheter Aortic Valve Implantation in Morphologically Complex Root Aneurysms.

Performing transcatheter aortic valve implantation in the presence of aneurysmatic aortopathy is widely contraindicated but needs to be taken into account as a bailout strategy in selected patients. Deliberate preoperative assessment of measurements becomes the crucial key element in this context. After meticulous valve selection, retrograde access is obtained through the right subclavian artery additionally serving as a backup arterial cannulation site in case of conversion. Transcatheter aortic valve implantation is then performed through the transapical route. Transcatheter aortic valve implantation in complex aneurysmatic aortic morphology is feasible in highly selected patients after comprehensive preoperative evaluation. The present article describes our initial experience, safeguards, and technical details.

Quality-of-life in octogenarians one year after aortic valve replacement with or without coronary artery bypass surgery.

The increasing number of interventions for percutaneous aortic valve replacement (AVR) justify a renewed evaluation of one-year survival rates after open AVR with and without coronary artery bypass in octogenarians. Risk factors influencing mortality are compared, and the patients' quality-of-life (QoL) after one year is assessed. One hundred and fifty-four patients (102 females, 52 males) aged on average 82.9±2.5 years, who had undergone open bioprosthetic AVR with (n=80) and without (n=74) coronary artery bypass grafting (CABG) between January 2005 and December 2007 were reviewed retrospectively. Risk factors for mortality were analyzed. The patient's QoL after one year was evaluated by administering the Seattle Angina Questionnaire on the telephone. The mean in-hospital mortality rate was 7.8%. The 12-month survival rate was 81.8%. Preoperative risk factors revealed no difference between survivors and non-survivors: renal insufficiency, chronic obstructive pulmonary disease (COPD), diabetes, cerebrovascular disease (CVD), peripheral vascular disease, logistic EuroSCORE and concomitant CABG. Assessment of QoL revealed a substantial improvement of physical fitness in all 126 patients. Surgery in the aortic valve without CABG is associated with a good outcome. The improvement in QoL after one year supports the decision to operate on patients older than 80 years of age.

Aortic arch surgery using bilateral antegrade selective cerebral perfusion in combination with near-infrared spectroscopy.

OBJECTIVE: Near-infrared spectroscopy (NIRS) complements online monitoring of cerebral oxygenation during aortic arch surgery. Its addition targets at an increase of safety of a complex procedure employing bilateral antegrade cerebral perfusion (BACP) and circulatory arrest under tepid blood temperatures. We report the outcome of NIRS-guided aortic arch surgery using BACP with moderate hypothermic circulatory arrest (MHCA). METHODS: Between December 2006 and December 2008, NIRS was used in 13 patients (mean age: 67.5 ± 11.3 years) undergoing aortic arch repair using BACP combined with MHCA. The diagnosis was atherosclerotic thoracic aneurysms in eight and acute aortic dissection in five patients. Seven patients had a hemi-arch replacement, six underwent frozen stent-graft arch replacement and four patients had concomitant procedures such as coronary artery bypass grafting (CABG) or aortic valve surgery. Our regimen of employing an algorithm for adaptation of perfusion modalities included the threshold of the drop in regional cerebral oxygen saturation <55% and/or a drop in the total oxygen index (TOI) of 15-20% assessed by the means of NIRS. RESULTS: The mean MHCA was 35 ± 16min and lowest bladder temperature was 26 ± 1.2°C. The mean TOI pre-MHCA was 66 ± 6.5%. Twelve out of 13 patients underwent bilateral perfusion because of unilateral drops below the threshold level of TOI (mean: 44±7.9%). In three patients, an organic psychosyndrome was observed. No patient developed permanent neurological dysfunction. CONCLUSION: NIRS-guided BACP during MHCA allows a safe approach to complex aortic arch surgery. The drop of brain oxygenation values in the contralateral hemisphere during unilateral ACP strongly suggests the routine use of BACP, when circulatory arrest under tepid temperatures is used.

A prospective, open-label trial of 6-thioguanine in patients with ulcerative or indeterminate colitis.

OBJECTIVE: 6-thioguanine (6-TG) has emerged as a promising therapeutic alternative in patients with Crohn's disease intolerant or resistant to azathioprine (AZA) and/or 6-mercaptopurine (6-MP). The aim of the present study was to evaluate the safety and efficacy of 6-TG in patients with ulcerative colitis (UC) or indeterminate colitis (IC) intolerant or resistant to AZA/6-MP. MATERIAL AND METHODS: Twenty patients with an acute flare, steroid-dependent or steroid-refractory disease attending our outpatient department were included in the study. Measurement of 6-TG nucleotide levels was done to check compliance. Complete, partial and non-response were defined by means of the clinical activity index and the daily steroid demand. Secondary outcome parameters included changes in cumulative steroid doses, C-reactive protein (CRP) levels, and an endoscopic score. RESULTS: Out of 20 patients 4 were excluded owing to noncompliance; 2/16 compliant patients (13%) had to be prematurely withdrawn because of adverse events, which ceased upon drug discontinuation. By per-protocol analysis, 5/14 patients (36%) were complete, 6/14 (43%) partial and 3/14 (21%) non-responders. In addition to the reduction of the cumulative steroid dose over 3 months, CRP decreased in the study population and the endoscopic score decreased in treatment responders. CONCLUSIONS: Treatment with 6-TG was effective in patients with UC or IC previously intolerant or resistant to AZA/6-MP. Future work is needed to define a subpopulation of patients at low risk for its potential hepatotoxicity, which we assume will benefit from 6-TG.

Do high serum levels of anti-Saccharomyces cerevisiae antibodies result from a leakiness of the gut barrier in Crohn's disease?

OBJECTIVES: To examine the relationship between serum levels of anti-Saccharomyces cerevisiae antibodies (ASCAs) and intestinal permeability at a given time (hypothesis 1) and the probability of increased ASCA serum levels with increased intestinal permeability (hypothesis 2) in patients with Crohn's disease. METHODS: Each hypothesis was tested retrospectively with its own study population: group A for hypothesis 1 and group B for hypothesis 2. Intestinal permeability was measured by lactulose/mannitol test and ASCAs were quantified by using ELISA. Patients received either no treatment or 5-aminosalicylates. The lactulose/mannitol test and sampling of sera for ASCA assessment had to be performed within 1 month in group A. In group B the highest intestinal permeability value obtained from among at least three measurements made during different stages of disease activity was chosen for evaluation. RESULTS: Both study populations consisted of 140 patients with Crohn's disease. Elevated IgG ASCAs were detected in 64% (90/140) in group A compared with 65% (91/140) in group B. In group A, 64% (90/140) and in group B 66% (92/140) were IgA ASCA positive. Correlation analysis showed a tendency for a positive relationship between IgG ASCAs and intestinal permeability in group A (tau = 0.16, P = 0.07) and in group B (tau = 0.16, P = 0.06). A positive trend was seen for the combination of high intestinal permeability and high IgG ASCAs in group B (chi-squared test, P = 0.07). CONCLUSION: Elevated serum levels of anti-S. cerevisiae antibodies do not seem to result primarily from a defect of the gut barrier. This observation points to an intrinsic pathomechanism in the development of increased ASCA serum levels.