The Frozen Elephant Technique Using a Novel Hybrid Prosthesis for Extensive Aortic Arch Disease: A Multicentre Study.

INTRODUCTION: The frozen elephant trunk technique (FET) has become routine for aortic arch and descending aortic repair. New hybrid prosthesis models are constantly being developed to increase effectiveness and durability of aortic repair. Recently, concerns were raised regarding increased post-operative bleeding using a new-generation hybrid prosthesis (E-vita® OPEN NEO, CryoLife Inc. JOTEC GmbH, Hechingen, Germany). We report the outcomes of a multi-centre experience of using the E-vita OPEN NEO. METHODS: All patients undergoing aortic surgery at five European centres using the E-vita OPEN NEO from 2020 to 2022 were included (n = 22). The primary endpoint was the amount of chest drain fluid after 24 h and re-thoracotomy rate for bleeding. RESULTS: Median patient age was 62.5 ± 12.6 years, 50.0% (11/22 patients) were female and 27.3% (6/22) of procedures were re-operative cardiac surgeries. Aortic dissection was present in 54.5% (12/22). The median cardiopulmonary bypass time was 148 min and ischaemia time was 84 min. Mortality at 30 days was 4.5% (1/22) and the stroke rate was 18.2% (4/22). The rate of re-thoracotomy for bleeding was 4.5% (1/22) with a median amount of chest drain fluid within 24 h of 569 (IQR 338-910) ml. There were no device-associated adverse events. CONCLUSIONS: Use of this new-generation hybrid prosthesis for FET was safe and effective. Patient follow-up was largely uneventful given the extent of the procedures performed. In particular, bleeding events were uncommon in this cohort of patients comprising many aortic dissections and re-operative procedures. No increase in oozing was observed.

Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement - rationale and design of the international IMPACT registry.

BACKGROUND: Degenerative aortic valve disease accounts for 10-20% of all cardiac surgical procedures. The impact of pre-existing comorbidities on the outcome of patients undergoing surgical aortic valve replacement (SAVR) needs further research. METHODS: The IMPACT registry is a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years to assess the impact of pre-existing comorbidities of patients undergoing SAVR with the INSPIRIS RESILIA aortic valve on outcomes. IMPACT will be conducted across 25 sites in Austria, Germany, The Netherlands and Switzerland and intends to enroll approximately 500 patients. Patients will be included if they are at least 18 years of age and are scheduled to undergo SAVR with the INSPIRIS RESILIA Aortic Valve with or without concomitant ascending aortic root replacement and/or coronary bypass surgery. The primary objective is to determine all-cause mortality at 1, 3, and 5 years post SAVR. Secondary objectives include cardiac-related and valve-related mortality and structural valve deterioration including hemodynamics and durability, valve performance and further clinical outcomes in the overall study population and in specific patient subgroups characterized by the presence of chronic kidney disease, hypertension, metabolic syndrome and/or chronic inflammation. DISCUSSION: IMPACT is a prospective, multicenter European registry, which will provide much-needed data on the impact of pre-existing comorbidities on patient outcomes and prosthetic valve performance, and in particular the performance of the INSPIRIS RESILIA, in a real-world setting. The findings of this study may help to support and expand appropriate patient selection for treatment with bioprostheses. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04053088 .

The Ross-Konno procedure in neonates and infants less than 3 months of age.

OBJECTIVES: Patients with severe left ventricular outflow tract obstruction often suffer from impaired left ventricular function, endocardial fibroelastosis and borderline-sized structures. The early Ross-Konno operation can offer complete repair due to outflow tract stenosis and enable the functional recovery and growth of small structures. METHODS: Between 2008 and March 2017, 44 early Ross-Konno procedures were performed at our centre. Thirty-five patients were neonates, and 9 were infants less than 3 months of age. A retrospective single-centre investigation was carried out analysing early and late deaths, postoperative complications and reoperations during the follow-up period. Potential prognostic influence factors as previous fetal intervention, associated lesions as presence of a VSD or hypoplastic aortic arch or severe endocardial fibroelastosis were examined. RESULTS: The in-hospital mortality rate was 7% (3 of 44), and the late mortality rate was 2%. There were no deaths in the group with ventricular septal defects (9 cases), and there was 1 death in the group with critical aortic stenosis without arch repair (1 of 24; 4%). The most deaths occurred in patients with critical aortic stenosis and aortic arch repair (3 of 11; 27%) (P = 0.012). Fifteen patients with foetal intervention had a mid-term survival rate of 87%. Reoperations were necessary in 19 of 40 surviving patients during a mean follow-up period of 5.9 years. CONCLUSIONS: The early Ross-Konno procedure can enable biventricular repair even in borderline left ventricles with good long-term outcome. Thus far, there were no reoperations at the level of the autograft or the left ventricular outflow tract in our cohort. The highest operative risk was observed in patients with critical aortic stenosis and aortic arch hypoplasia.

Double-arterial cannulation during aortic arch reconstruction in pediatric patients.

Aortic arch reconstruction is a highly demanding procedure in congenital heart surgery. The 2 conventional options for cardiopulmonary bypass - deep hypothermic circulatory arrest or antegrade cerebral perfusion - both result in lack of perfusion of the entire or lower body.  In 2003, the Children's Heart Center Linz started to use a double-arterial cannulation technique for aortic arch reconstructions in order to provide whole body perfusion during the entire operation. Our technique, demonstrated in this video tutorial, is as follows: After inserting an arterial cannula into the innominate artery, followed by venous cannulation, the cardiopulmonary bypass is started. The left pleural cavity is opened directly above the diaphragm. The inferior pulmonary ligament is transected and the descending aorta is then visualized and can be cannulated directly. Both arterial cannulas are linked via a Y-connector. The surgeons in our center have used this method in more than 450 uni- and biventricular newborns and children. There has not been a lethal incident associated with this cannulation technique; one intraoperative lesion of the descending aorta was repaired immediately.  Our double-arterial cannulation technique is a simple and safe method for perfusing the brain and the lower parts of the body during aortic arch reconstruction.

Looking for a Learning Curve in EVAR Based on the Zenith Stent Graft.

The purpose of this study was to report the learning curve of endovascular aneurysm repair (EVAR) based on the Zenith stent graft (Cook Medical Inc., Bloomington, IN). In the last 9 years, 101 patients were treated with a Zenith stent graft. To display the learning curve, a cumulative sum (CUSUM) failure analysis curve of the 30-day technical success rate was calculated. For detailed analysis, our EVAR patient cohort was chronologically divided into three groups. Technical and clinical results, basic patient parameters, and procedural data were compared. The CUSUM graph indicated an initial sharp rise within the first 35 cases and a plateau thereafter. The 30-day technical success rate significantly increased from the first to the second group (83 vs. 100%; p = 0.019), as did the primary technical success rate (66 vs. 97%; p = 0.001). EVAR based on the Zenith stent graft required ∼35 cases to reach a stably high rate of short-term technical success.

Self-retaining pledgeted suture as retractor for mitral procedure.

A simple reliable maneuver to optimize exposure of the left atrium for mitral valve operations is described. It offers more space to mobilize the valvular structure, facilitating complicated reconstruction in the posteromedial commisural area.