OBJECTIVES Decellularized pulmonary homografts (DPH) have shown excellent results for pulmonary valve replacement. However, controlled multicentre studies are lacking to date. METHODS Prospective European multicentre trial evaluating DPH for pulmonary valve replacement. Matched comparison of DPH to bovine jugular vein (BJV) conduits and cryopreserved homografts (CH) considering patient age, type of heart defect and previous procedures. RESULTS In total, 121 patients (59 female) were prospectively enrolled (August 2014–December 2016), age 21.3 ± 14.4 years, DPH diameter 24.4 ± 2.8 mm. No adverse events occurred with respect to surgical handling; there were 2 early deaths (30 + 59 years) due to myocardial failure after multi-valve procedures and no late mortality (1.7% mortality). After a mean follow-up of 2.2 ± 0.6 years, the primary efficacy end points mean peak gradient (16.1 ± 12.1 mmHg) and regurgitation (mean 0.25 ± 0.48, grade 0–3) were excellent. One reoperation was required for recurrent subvalvular stenosis caused by a pericardial patch and 1 balloon dilatation was performed on a previously stented LPA. 100% follow-up for DPH patients operated before or outside the trial (n = 114) included in the ESPOIR Registry, age 16.6 ± 10.4 years, diameter 24.1 ± 4.2 mm, follow-up 5.1 ± 3.0 years. The combined DPH cohort, n = 235, comprising both Trial and Registry data showed significantly better freedom from explantation (DPH 96.7 ± 2.1%, CH 84.4 ± 3.2%, P = 0.029 and BJV 82.7 ± 3.2%, P = 0.012) and less structural valve degeneration at 10 years when matched to CH, n = 235 and BJV, n = 235 (DPH 61.4 ± 6.6%, CH 39.9 ± 4.4%, n.s., BJV 47.5 ± 4.5%, P = 0.029). CONCLUSIONS: Initial results of the prospective multicentre ESPOIR Trial showed DPH to be safe and efficient. Current DPH results including Registry data were superior to BJV and CH. Trial registration clinicaltrials.gov identifier: NCT 02035540.

OBJECTIVES Decellularized aortic homografts (DAH) may provide an additional aortic valve replacement option for young patients due to their potential to overcome the high early failure rate of conventional allogenic and xenogenic aortic valve prostheses. METHODS A prospective, European Union-funded, single-arm, multicentre, safety study was conducted in 8 centres evaluating non-cryopreserved DAH for aortic valve replacement. RESULTS One hundred and forty-four patients (99 male) were prospectively enrolled between October 2015 and October 2018, mean age 33.6 ± 20.8 years; 45% had undergone previous cardiac operations. Mean implanted DAH diameter 22.6 ± 2.4 mm and mean durations for the operation, cardiopulmonary bypass and cross-clamp were 341 ± 140, 174 ± 80 and 126 ± 43 min, respectively. There were 2 early deaths (1 LCA thrombus on day 3 and 1 ventricular arrhythmia 5 h postop) and 1 late death due to endocarditis 4 months postoperatively, resulting in a total mortality of 2.08%. One pacemaker implantation was necessary and 1 DAH was successfully repaired after 6 weeks for early regurgitation following subcoronary implantation. All other DAH were implanted as a free-standing root. After a mean follow-up of 1.54 ± 0.81 years, the primary efficacy end points peak gradient (mean 11.8 ± 7.5 mmHg) and regurgitation (mean 0.42 ± 0.49, grade 0–3) were excellent. At 2.5 years, freedom from explantation/endocarditis/bleeding/stroke was 98.4 ± 1.1%/99.4 ± 0.6%/99.1 ± 0.9%/99.2 ± 0.8%, respectively, with results almost identical to those in an age-matched Ross operation cohort of 212 patients (mean age 34 years) despite DAH patients having undergone >2× more previous procedures. CONCLUSIONS The initial results of the prospective multicentre ARISE trial show DAH to be safe for aortic valve replacement with excellent haemodynamics in the short follow-up period.

Background The current coronavirus disease 2019 (COVID‐19) pandemic has a huge impact on society and the economy and represents one of the biggest challenges for healthcare systems all over the world. Reports from healthcare institutions in different countries show a variety of crisis exit strategies. Methods The following is a review and update of the situation and crisis management in Zürich and Switzerland with a special focus on the impact on the cardiac surgery program and extracorporeal membrane oxygenation (ECMO)‐therapy in COVID‐19. Results Regional and national measures had avoided the collapse of the health system in Switzerland. There was a reduction of over 50% of the surgical and transcatheter caseload during the first wave of the pandemic. Twenty‐three ECMO devices, 150 oxygenators, and more than 300 different cannulas were at our disposal. Between March and May 2020, nine COVID‐19 patients were treated by us with ECMO‐therapy. Three patients were transported by us from distant institutions. Median age at ECMO implantation was 59 years. Two patients died on support. Conclusions Measures to prevent a collapse of the healthcare system were effective. Our local ECMO‐Program on the ongoing COVID‐19 pandemic has proven to be a useful tool to control mortality and organ failure in critically ill patients.

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Our results suggest a mixed immunological response of remodeling and inflammation following the implantation. The expected process of seeding/migration and remodeling of the bioscaffold into the typical 3-layered architecture were not observed in our explanted specimens.

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Background: Cerebral embolic protection devices (CEPDs) have emerged as a mechanical barrier to prevent debris from reaching the cerebral vasculature, potentially reducing stroke incidence. Bovine aortic arch (BAA) is the most common arch variant and represents challenge anatomy for CEPD insertion during transcatheter aortic valve replacement (TAVR). Methods: Cohort study reporting the SentinelTM Cerebral Protection System insertion’s feasibility and safety in 165 adult patients submitted to a transfemoral TAVR procedure from April 2019 to April 2020. Patients were divided into 2 groups: (1) BAA; (2) non-BAA. Results: Median age, EuroScore II, and STS score were 79 years (74–84), 2.9% (1.7–6.2), and 2.2% (1.6–3.2), respectively. BAA was present in 12% of cases. Successful two-filter insertion was 86.6% (89% non-BAA vs. 65% BAA; p = 0.002), and debris was captured in 95% (94% non-BAA vs. 95% BAA; p = 0.594). No procedural or vascular complications associated with Sentinel insertion and no intraprocedural strokes were reported. There were two postprocedural non-disabling strokes, both in non-BAA. Conclusion: This study demonstrated Sentinel insertion feasibility and safety in BAA. No procedural and access complications related to Sentinel deployment were reported. Being aware of the bovine arch prevalence and having the techniques to navigate through it allows operators to successfully use CEPDs in this anatomy.

OBJECTIVES Options for paediatric aortic valve replacement (AVR) are limited if valve repair is not feasible. Results of paediatric Ross procedures are inferior to adult Ross results, and mechanical AVR imposes constant anticoagulation with the inherent risks. METHODS The study design was a prospective, multicentre follow-up of all paediatric patients receiving decellularized aortic homografts (DAHs) for AVR in 8 European centres. RESULTS A total of 106 children (77 boys) were operated (mean age 10.1 ± 4.8 years, DAH diameter 20.5 ± 3.8 mm). A total of 60 (57%) had undergone previous surgical interventions: 34 with 1, 15 with 2 and 11 with ≥3. There was one early death in a 12-year-old girl, who underwent her fourth aortic valve operation, due to intracerebral haemorrhage on extracorporeal membrane oxygenation after coronary reimplantation problems following 3-sinus reconstruction 1 year earlier. One 2-year-old patient died due to sepsis 2 months postoperatively with no evidence for endocarditis. In addition, a single pacemaker implantation was necessary and a 2.5-year-old girl underwent successful HTx due to chronic myocardial failure despite an intact DAH. After a mean follow-up of 3.30 ± 2.45 years, primary efficacy end points mean peak gradient (18.1 ± 20.9 mmHg) and regurgitation (mean 0.61 ± 0.63, grade 0–3) were very good. Freedom from death/explantation/endocarditis/bleeding/stroke at 5 years was 97.8 ± 1.6/85.0 ± 7.4/100/100/100% respectively. Calculated expected adverse events were lower for DAH compared to cryopreserved homograft patients (mean age 8.9 years), lower than in Ross patients (9.4 years) and in the same range as mechanical AVR (12.8 years). CONCLUSIONS Even though the overall number of paediatric DAH patients and the follow-up time span are still limited, our data suggest that DAHs may present a promising additional option for paediatric AVR.