OBJECTIVES:Fresh, non-cryopreserved and non-seeded, decellularized pulmonary homografts (DPHs) were translated in 2005 into clinical practice. The aim of this current study is to summarize our 20-year clinical experience with DPH for pulmonary valve replacement (PVR) in congenital heart disease. METHODS:Prospective follow-up of all DPH implanted within 2 institutions. Indication for PVR according to current clinical guidelines was the key inclusion criterion without age limits; patients with active endocarditis were not included. RESULTS:From January 2005 to August 2025, 310 patients (188 male) received DPH for PVR. Median patient age at implantation was 14.8 years, (interquartile range [IQR] 12.7-16.6 years, min. 0.1 years, max.72.8 years), and the median DPH diameter was 22 mm (IQR 19-23 mm, min. 12 mm, max 34 mm). Median follow-up was 8.3 years (IQR 4.5-12.1, max 20.5 years). Seven out of 310 patients died, a freedom from death according Kaplan-Meier of 96.9% (confidence interval [CI] 93.1%-98.6%) at 20 years. Freedom from DPH explantation was 85.2% (CI 75.1%-91.4%), and freedom from endocarditis was 91.0% (CI 77.1%-96.6%) at 20 years. Valve function showed a steady decline over the study period. At 15 years, freedom from stenosis, as defined as a maximum gradient of ≥ 50 mmHg, was 68.3% (CI 52.4%-79.8%) and 0 at 20 years. Freedom from ≥ moderate pulmonary regurgitation was 65.1% (CI 48.1%-77.7%) at 15 years and 0 at 20 years. The number of patients at risk beyond 15 years was limited. CONCLUSIONS:Decellularized pulmonary homografts show good long-term results for PVR with freedom from explantation that appears favourable compared with published long-term series of cryopreserved homografts. However, our data also indicate a decline in valve function over 2 decades. We hypothesize that residual immunogenicity is the underlying cause, suggesting that there is potential for further refinement of decellularization methods.

BACKGROUND Decellularized aortic homografts (DAH) were introduced in 2008 as a further option for paediatric aortic valve replacement. Subcoronary DAH implantation may eliminate the need for aortic root replacement and coronary artery reimplantation in patients with sufficient left ventricular outflow tract dimensions. METHODS Ovine aortic xenografts were harvested from the slaughterhouse and decellularized using an approved detergent-based decellularization protocol. Two cardiac surgeons performed subcoronary implantation in explanted ovine hearts and results were compared regarding procedure time and procedural success. After these ex-vivo experiments four adult black-headed sheep were operated on in acute experiments. RESULTS The two surgeons were able to perform the ex-vivo subcoronary implantation of the decellularized ovine aortic allografts (DOAA) without technical problems within an hour. Mechanical strength of the processed ovine DOAA appeared comparable to that of native aortic tissue. Both surgeons stated that there were no differences with respect to appearance, haptics, trimability, and sewability.The initial two sheep operated on showed significant valvular incompetence. Following modification of the surgical protocol to a single-line suture technique, the next two sheep showed fully competent aortic valves with laminar flow across the subcoronary implanted DOAA. CONCLUSIONS We have developed a technique for subcoronary implantation of decellularized aortic homografts including acute large animal experiments. Long-term animal experiments will provide further insight into durability and recellularization.

Background:Surgical pulmonary valve replacement (PVR) is the most common cardiac operation in adults with congenital heart disease (ACHD). Nearly one-quarter of all cardiac procedures in this population are PVRs, and approximately 96% are redo surgeries. This study aimed to compare operative and early postoperative outcomes in patients undergoing first-, second-, and third-time, or more, PVR. Methods:We retrospectively analyzed 104 consecutive adult patients with repaired congenital heart disease who underwent total valved pulmonary trunk replacement at our institution between January 2014 and March 2022. Results:A total of 53 patients underwent first-time PVR, 31 second-time PVR, and 20 third-time, or more, PVR. All patients had at least one previous sternotomy. In all redo procedures, extended resection of the degenerated pulmonary valve graft was performed. Operative complexity increased with the number of previous PVRs, reflected by significantly longer cardiopulmonary bypass times (134 versus 185 versus 222 minutes) and aortic cross-clamp times (68 versus 91 versus 114 minutes; p < 0.001). Postoperative length of stay was also longer with increasing number of prior PVRs (7 versus 10 versus 8 days; p = 0.012). Despite increased surgical complexity, no significant differences (p > 0.05) were observed in intraoperative or postoperative complications, postoperative peak transvalvular gradients, or relevant valve regurgitation. Overall mortality was low. Three patients died, two of whom had a history of endocarditis. Conclusion:Patients undergoing multiple PVRs demonstrate early clinical outcomes comparable to those undergoing first-time PVR despite increased surgical complexity. Endocarditis remains a major risk factor in redo PVR surgery.

OBJECTIVES:We sought to evaluate compliance and flow of the ascending aorta of patients with decellularized aortic homografts compared to donor age-matched healthy controls. METHODS:Male patients and donor age-matched male healthy controls were included. Cardiac function was evaluated by retrospectively electrocardiography-gated cine balanced steady-state free precession magnetic resonance imaging (MRI). Time-resolved 2- and 3-dimensional phase-contrast sequences were used to determine relative area change and pulse wave velocity as surrogate parameters for vessel compliance as well as maximum blood flow velocity. RESULTS:Thirteen patients were matched according to the age of their homograft donor (median 42 years, interquartile range [IQR] 32-50) to 7 healthy controls (median 40 years, IQR 36-48). Time to post-operative MRI was 3.33 (1.33-4.50) years. Relative area change in the proximal ascending aorta was significantly lower in the homograft group compared to healthy controls (26%, IQR 23-44 vs 38%, IQR 24-44, P < .001), with no significant difference observed in the distal ascending aorta (22%, IQR 22-33 vs 34%, IQR 22-41, P = .438). Maximum blood flow velocity in the proximal ascending aorta was significantly higher in the homograft group compared to healthy controls (168 cm s-1, IQR 148-188 vs 115 cm s-1, IQR 114-120, P = .009). CONCLUSIONS:Decellularized aortic homograft patients seem to have a reduced compliance of the proximal ascending aorta compared to donor age-matched healthy controls. This may be attributable to the in vitro decellularization process or post-operative graft degeneration. These findings highlight the ultimate need for follow-up data to understand the long-term in vivo effects of decellularized human tissue. This study is a follow-up study of the patients included in the ARISE Study registered on ClinicalTrials.gov (NCT02527629). For the purposes of this manuscript, healthy individuals were subsequently recruited to serve as the control group.

Background:Because of the increasing importance of quality assurance and individualised patient treatment, EuroSCOREs were analysed for reliability in predicting 30-day mortality in patients with postinfarction ventricular septal rupture (piVSR). To address the specific conditions of patients with piVSR, the Hannover piVSR Score (HpiVSR) was developed. Methods:Between 2001 and 2019, 45 patients with piVSR underwent surgery. Data were collected as necessary for EuroSCORE calculation. Clinically relevant variables were validated for the HpiVSR Score using a nonparsimonious binary logistic regression model. All models were tested for their significant predictive power for 30-day mortality. Their validity was assessed using Hosmer-Lemeshow test and Nagelkerke R 2. Receiver operating characteristic curve and area under the curve were used to illustrate and quantify score accuracy. Results:The specificity was 77.8% for all EuroSCOREs and 92.6% for the HpiVSR Score, and the sensitivity was in the random range for the EuroSCOREs and 83.3% for the HpiVSR Score. Accordingly, the areas under the curve were 0.676 (95% CI 0.507-0.845) for EuroSCORE II; 0.729 (95% CI 0.581-0.878) and 0.739 (95% CI 0.591-0.886) for the additive and logistic EuroSCORE, respectively; and 0.949 (95% CI 0.891-1.006) for the HpiVSR Score. Conclusion:The HpiVSR Score enables a more reliable and accurate prediction of 30-day mortality than the EuroSCOREs using 7 significant, objective, reliable, and preoperatively determinable variables. Because of the small sample size of the present study and the fact that only internal validation has been performed so far, the weighting of the factors of the HpiVSR Score can be adjusted after studies with larger patient samples.

BACKGROUND:Foreign body (FB) aspiration is a typical emergency experienced by young children and associated with significant morbidity and mortality unless diagnosed early and treated adequately. Data on anesthetic management, applicability, complications and risk factors in the context of foreign body removal (FBR) is scarce, especially for flexible techniques, which are increasingly being used. AIM:Analyzation of the complication rate and risk factors of two different techniques (rigid vs. flexible) as well as the anesthetic management for FBR in children. METHOD:This is a retrospective single center analysis of 160 cases who underwent bronchoscopy for suspected FB aspiration under general anesthesia between January 2014 and January 2022 at a tertiary hospital. RESULTS:An FB was detected in 67 patients (median age 1.8 years). The preferred anesthesia regimes were total intravenous anesthesia (91.9%) and laryngeal mask (95%) for flexible bronchoscopy. Flexible bronchoscopy was used in 52.2%, rigid bronchoscopy in 31.3%, and both techniques were used in 16.4% of cases. The complication rate was 2.19 versus 1.29/patient in rigid versus flexible bronchoscopy, respectively. Independent risk factors for severe complications were rigid bronchoscopy (OR 11.6, p < 0.01) and airway infections (OR 4.1, p < 0.01). We observed flexible bronchoscopy being increasingly used for FBR during the observational period. CONCLUSION:FBR can result in serious complications that require experienced pediatric anesthetic management. In our series, the use of a rigid bronchoscope and pre-existing airway infection were independent risk factors for severe complications. Flexible bronchoscopy was shown to be a safe, fast and successful tool for FBR with secured laryngeal mask airway and total intravenous anesthesia with fewer adverse events compared to rigid bronchoscopy.

BACKGROUND:Consensus regarding on-support evaluation and weaning concepts from Impella 5.5 support is scarce. The derived left ventricular end-diastolic pressure (dLVEDP), estimated by device algorithms, is a rarely reported tool for monitoring the weaning process. Its validation and clinical accuracy have not been studied in patients. We assess dLVEDP's accuracy in predicting pulmonary capillary wedge pressure (PCWP) and propose a corrective equation. METHODS:We included 29 consecutive patients treated with Impella 5.5: 12 in a generation cohort and 17 in a validation cohort. dLVEDP and PCWP were measured 5-fold every 8 hours during support, totaling 698 series with 3490 measurements. Variables such as Impella 5.5 performance level, heart rhythm, pacemaker settings, sex, mechanical ventilation, and body mass index were recorded. Linear regression was used to correct dLVEDP-PCWP discrepancies. Analysis included Bland-Altman plots, linear regression, histograms, and violin plots. RESULTS:The raw dLVEDP and PCWP data did not coincide satisfactorily. The Impella 5.5 dLVEDP overestimation was 3.5±1.5 mm Hg (mean±SD), increasing with higher pressures and unaffected by cardiac rhythm, mechanical ventilation, and performance levels. Statistical correction using the formula modified dLVEDP=-0.457+(1-sex[1=male, 0=female])×0.719-0.0496× body mass index+1.015×body surface area+0.811×dLVEDP significantly reduced the overestimation (P<0.01) to 0.0±1.2 mm Hg. CONCLUSIONS:dLVEDP, calculated by the Impella 5.5 Smart Algorithm, is a feasible and effective tool for continuously monitoring PCWP at performance levels 3 to 9. Correction of dLVEDP by using the described equation further enhances its accuracy. Hence, hemodynamic surveillance via dLVEDP may aid in managing and weaning temporary microaxial support, potentially reducing the need for continuous monitoring with a Swan-Ganz catheter.

OBJECTIVES:Donor-recipient size matching in patients with pulmonary fibrosis may be performed according to the actual total lung capacity (aTLC) as measured by body plethysmography, the corrected total lung capacity (cTLC), and the predicted total lung capacity (pTLC). However, there is still no consensus on the ideal matching total lung capacity. Therefore, we aimed to analyse post-transplant outcomes of patients with pulmonary fibrosis listed according to aTLC, cTLC, or pTLC. METHODS:Patient records were retrospectively reviewed and analysed using Bayesian statistics. Patients with pulmonary fibrosis who underwent double lung transplantation without concomitant lung reduction surgery were included. RESULTS:Between November 2017 and May 2023, among the 521 patients who underwent lung transplantation at our institution, 122 (24%) were included, with 11 (9%) forming the aTLC group, 21 (17%) forming the cTLC group, and 90 (74%) forming the pTLC group. Overall patient and graft mortality was decreased in patients who were listed according to aTLC when compared to cTLC (HR 0.11; 95% CrI 0-0.99). However, Bayesian Cox multivariable analysis revealed that this was due to the higher incidence of associated pulmonary hypertension and chronic renal failure in the cTLC group. No difference was seen in the incidence of biopsy-confirmed rejection and chronic lung allograft dysfunction. CONCLUSIONS:Our study showed that listing patients according to aTLC improved mortality when compared to listing according to cTLC, because patients listed according to cTLC had a higher preoperative morbidity.

Background: Mitral valve infective endocarditis (IE) still has a high mortality. Minimally invasive mitral valve surgery (MIMVS) is technically more challenging, especially in patients with endocarditis. Here, we compare the early postoperative outcome of patients with endocarditis and other indications for MIMVS. Methods: Two groups were formed, one consisting of patients who underwent surgery because of mitral valve endocarditis (IE group: n = 75) and the other group consisting of patients who had another indication for MIMVS (non-IE group: n = 862). Patients were observed for 30 postoperative days. Data were retrospectively reviewed and collected from January 2011 to September 2023. Results: Patients from the IE group were younger (60 vs. 68 years; p < 0.001) and had a higher preoperative history of stroke (26% vs. 6%; p < 0.001) with neurological symptoms (26% vs. 9%; p < 0.001). No difference was seen in overall surgery time (211 vs. 206 min; p = 0.71), time on cardiopulmonary bypass (137 vs. 137 min; p = 0.42) and aortic clamping time (76 vs. 78 min; p = 0.42). Concerning postoperative data, the IE group had a higher requirement of erythrocyte transfusion (2 vs. 0; p = 0.041). But no difference was seen in the need for a mitral valve redo procedure, bleeding, postoperative stroke, cerebral bleeding, new-onset dialysis, overall intubation time, sepsis, pacemaker implantation, wound healing disorders and 30-day mortality. Conclusions: Minimally invasive mitral valve surgery in patients with mitral valve endocarditis is feasible and safe. Infective endocarditis should not be considered as a contraindication for MIMVS.

BACKGROUND:The German guidelines recommend that intravenous fluid therapy should not be mandatorily performed in children with short fasting times undergoing short anesthesia, but there is a lack of clinical studies including a large number of pediatric patients. Therefore, we performed a prospective non-interventional multicenter observational study to evaluate the perioperative hemodynamic and metabolic stability of children undergoing short anesthesia without intravenous fluid therapy.AIMS:The primary aim was to assess the incidence of hypotension and the secondary aim was to assess the real preoperative fasting times, the incidence of hypoglycemia and the impact on ketone bodies and acid-base balance.METHODS:Children aged 1 month-18 years undergoing short anesthesia (<1 h) without intravenous fluid therapy were enrolled. Patient demographics, the surgical or diagnostic procedure performed, anesthesia, hemodynamic, laboratory data, and adverse events were documented using a standardized case report form.RESULTS:Four hundred and twenty seven children that were investigated at three pediatric centers from July 2021 to June 2022 (mean age 83.4 ± 58.9 months, body weight 27.9 ± 19.8 kg) were included in the analysis. The real preoperative fasting times were 14.2 ± 3.6 h for solids, 7.2 ± 3.5 h for milk and 5 ± 4.8 h for clear fluids. During the course of anesthesia, hypotension (<2.5th percentile) was detected in 3 of 427 cases (0.7%), hypoglycemia (glucose <3.0 mmol L-1) in 1 of 355 cases (0.3%), and ketosis (ketone bodies ≥0.6 mmol L-1) in 51 of 233 cases (21.9%). The occurrence of ketosis was associated with lower body weight (p <.001) and longer fasting times for solids or milk (p =.021), but not for clear fluids (p =.69).CONCLUSIONS:Our study supported the German guidelines recommendation that perioperative intravenous fluid therapy is not mandatory in children beyond the neonatal period with short pre- and postoperative fasting times undergoing short anesthesia (<1 h).

Background: Micro-axial pumps are well-established temporary mechanical circulatory support devices (tMCS). Treatment strategies are bridge-to-recovery or bridge-to-decision, as well as high-risk elective cardiac surgeries. A new feature of the device is the capability of deriving the left ventricular end-diastolic pressure from the continuously measured LV-waveform. The objective was to evaluate the precision of this calculated LVEDP (cLVEDP) as compared to invasively measured pulmonary capillary wedge pressure (PCWP) while using Swan-Ganz-Catheters (SGC).

OBJECTIVES:Decellularized aortic homografts (DAH) were introduced in 2008 as a further option for paediatric aortic valve replacement (AVR). METHODS:Prospective, multicentre follow-up of all paediatric patients receiving DAH for AVR in 8 European centres. RESULTS:A total of 143 DAH were implanted between February 2008 and February 2023 in 137 children (106 male, 74%) with a median age of 10.8 years (interquartile range 6.6-14.6). Eighty-four (59%) had undergone previous cardiac operations and 24 (17%) had undergone previous AVR. The median implanted DAH diameter was 21 mm (interquartile range 19-23). The median operation duration was 348 min (227-439) with a median cardiopulmonary bypass time of 212 min (171-257) and a median cross-clamp time of 135 min (113-164). After a median follow-up of 5.3 years (3.3-7.2, max. 15.2 years), the primary efficacy end-points peak gradient (median 14 mmHg, 9-28) and regurgitation (median 0.5, interquartile range 0-1, grade 0-3) showed good results but an increase over time. Freedom from death/explantation/endocarditis/bleeding/thromboembolism at 5 years were 97.8 ± 1.2/88.7 ± 3.3/99.1 ± 0.9/100 and 99.2 ± 0.8%, respectively. Freedom from death/explantation/endocarditis/bleeding/thromboembolism at 10 years were 96.3 ± 1.9/67.1 ± 8.0/93.6 ± 3.9/98.6 ± 1.4 and 86.9 ± 11.6%, respectively. In total, 21 DAH were explanted. Seven were replaced by a mechanical AVR, 1 Ross operation was performed and a re-do DAH was implanted in 13 patients with no redo mortality. The calculated expected adverse events were lower for DAH compared to cryopreserved homograft patients (mean age 8.4 years), and in the same range as for Ross patients (9.2 years) and mechanical AVR (13.0 years). CONCLUSIONS:This large-scale prospective analysis demonstrates excellent mid-term survival using DAH with adverse event rates comparable to paediatric Ross procedures.

Purpose: Lung transplantation represents the only curative treatment for patients with end-stage pulmonary fibrosis. Organ allocation typically considers various factors, including recipient lung capacity measurements. While actual total lung capacity (aTLC) is provided by direct measurements, predicted total lung capacity (pTLC), calculated by age, body-height and sex according to the Global Lung Function Initiative, and corrected total lung capacity (cTLC), being the mean of aTLC and pTLC, are estimated.

OBJECTIVES:Decellularized aortic homografts (DAH) were introduced as a new option for aortic valve replacement for young patients. METHODS:A prospective, EU-funded, single-arm, multicentre study in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement. RESULTS:A total of 144 patients (99 male) were prospectively enrolled in the ARISE Trial between October 2015 and October 2018 with a median age of 30.4 years [interquartile range (IQR) 15.9-55.1]; 45% had undergone previous cardiac operations, with 19% having 2 or more previous procedures. The mean implanted DAH diameter was 22.6 mm (standard deviation 2.4). The median operation duration was 312 min (IQR 234-417), the median cardiopulmonary bypass time was 154 min (IQR 118-212) and the median cross-clamp time 121 min (IQR 93-150). No postoperative bypass grafting or renal replacement therapy were required. Two early deaths occurred, 1 due to a LCA thrombus on day 3 and 1 due ventricular arrhythmia 5 h postoperation. There were 3 late deaths, 1 death due to endocarditis 4 months postoperatively and 2 unrelated deaths after 5 and 7 years due to cancer and Morbus Wegener resulting in a total mortality of 3.47%. After a median follow-up of 5.9 years [IQR 5.1-6.4, mean 5.5 years. (standard deviation 1.3) max. 7.6 years], the primary efficacy end-points peak gradient with median 11.0 mmHg (IQR 7.8-17.6) and regurgitation of median 0.5 (IQR 0-0.5) of grade 0-3 were excellent. At 5 years, freedom from death/reoperation/endocarditis/bleeding/thromboembolism were 97.9%/93.5%/96.4%/99.2%/99.3%, respectively. CONCLUSIONS:The 5-year results of the prospective multicentre ARISE trial continue to show DAH to be safe for aortic valve replacement with excellent haemodynamics.