Background: There are few randomized trials comparing bioprostheses for transcatheter aortic valve replacement (TAVR), and no trials compared TAVR bioprostheses with supra-annular design. The SCOPE 2 trial was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut valves. Methods: SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years with an indication for transfemoral TAVR as agreed by the Heart Team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary endpoint, powered for non-inferiority of the ACURATE neo valve, was all-cause death or stroke at 1 year. The key secondary endpoint, powered for superiority of the ACURATE neo valve, was new permanent pacemaker implantation at 30 days. Results: Among 796 randomized patients (mean age 83.2±4.3 years; mean STS-PROM score 4.6± 2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary endpoint occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference 1.8%, upper one-sided 95% confidence limit 6.1%, p=0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the ACURATE neo group and 18.0% in the CoreValve Evolut group (absolute risk difference -7.5%, 95% confidence interval -12.4 to -2.60, p=0.0027). No significant differences were observed in the components of the primary endpoint. Cardiac death at 30 days (2.8% vs. 0.8%, p=0.03) and 1 year (8.4% vs. 3.9%, p=0.01), and moderate or severe aortic regurgitation at 30 days (10% vs. 3%, p=0.002) were significantly increased in the ACURATE neo group. Conclusions: Transfemoral TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Clinical Trial Registration: URL: https://clinicaltrials.gov/ Unique Identifier: NCT03192813.

Tac-based immunosuppressive therapy results in a lower rate of acute rejection after pulmonary transplantation, with similar infection rates and a slightly higher incidence of new onset diabetes mellitus compared with CsA-based therapy.

OBJECTIVES Our goal was to present histopathological findings of human explants of a tissue-engineered bovine pericardium CardioCel (Admedus Regen Pty Ltd, Malaga, WA, Australia) used for heart valve repair in patients with congenital and acquired heart valve disease. METHODS Sixty patients underwent heart valve repair from May 2014 to November 2018 using CardioCel as a substitute for valve tissue. We identified 9 cases in which the CardioCel patch was explanted following valve repair and available for histomorphological analyses. CardioCel explants were evaluated histologically using haematoxylin and oeosin, Elastica van Gieson and immunohistochemical stains. RESULTS The indications for explantation were related to the CardioCel patch in 6 patients. Median time between the implantation and explantation was 242 (range 3–1247) days. We demonstrated a characteristic remodelling pattern with superficial coating of the tissue-engineered bovine pericardium by granulation tissue composed of histiocytes, few lymphocytes and fibrin. We had 2 cases with a multifocal nodular disruption, fragmentation and sclerosis of the decellularized collagen matrix with focal calcification after 795 and 1247 days in situ. CONCLUSIONS Our data suggest that the tissue-engineered CardioCel patch is initially tolerated in the valvular position in the majority of patients. However, we also experienced graft failures that showed degeneration with fragmentation of the collagen matrix and even 2 cases with focal calcification evident from the histopathological analysis. Further analyses of mid- and long-term performance are mandatory.

Background: Applying the gender lens to risk factors and outcome after adult cardiac surgery is of major clinical interest, as the inclusion of sex and gender in research design and analysis may guarantee more comprehensive cardiovascular science and may consecutively result in a more effective surgical treatment as well as cost savings in cardiac surgery. Methods: We have reviewed classical cardiovascular risk factors (diabetes, arterial hypertension, hyperlipidemia, smoking) according to a gender-based approach. Furthermore, we have examined comorbidities such as depression, renal insufficiency, and hormonal influences in regard to gender. Gender-sensitive economic aspects have been evaluated, surgical outcome has been analyzed, and cardiovascular research has been considered from a gender perspective. Results: The influence of typical risk factors and outcome after cardiac surgery has been evaluated from a gender perspective, and the gender-specific distribution of these risk factors is reported on. The named comorbidities are listed. Economic aspects demonstrated a gender gap. Outcome after coronary and valvular surgeries as well as after heart transplantation are displayed in this regard. Results after postoperative use of intra-aortic balloon pump are shown. Gender-related aspects of clinical and biomedical cardiosurgical research are reported. Conclusions: Female gender has become an independent risk factor of survival after the majority of cardiosurgical procedures. Severely impaired left ventricular ejection fraction independently predicts survival in men, whereas age does in females.

Decision making in noncompliant drug addicts with recurrent prosthesis infection and in HIV-positive patients leads beyond surgical challenges to ethical and economic considerations.

Regarding operative mortality, EuroSCORE II showed in this study a slightly higher discriminatory accuracy than EuroSCORE I. There were no significant differences in the calibration of the two model versions in "low-" and "moderate-risk" patients regarding early as well as mid-term mortality. Analyses in larger patient populations will contribute to further model improvement.

Bicuspid aortic valve (BAV) anatomy is becoming an increasingly frequently encountered challenge in transcatheter aortic valve implantation (TAVI). Bicommissural non-raphe-type BAV (Sievers and Schmidtke Type 0) is composed morphologically of two aortic cusps with no raphe and is less common than the tricommissural or bicommissural raphe-type configurations. Precise annular sizing is a key step for successful TAVI in BAV. The challenge in bicommissural non-raphe-type BAV is that a three-dimensional structure has to be reconstructed using only two anatomical hinge points. For this reason, available software are limited when it comes to bicommissural non-raphe-type BAV. We propose that manual assessment of the aortic root in bicommissural non-raphe-type BAV using multi-planar reconstruction (MPR) software can be performed successfully by aligning the two available hinge points and measuring the smallest identifiable annular dimensions in the transverse plane (Fig. 1). We identified 12 patients with bicommissural non-raphe-type BAV undergoing TAVI between January 2013 and December 2017 in our high-volume institution. Our novel sizing strategy was employed prospectively in three patients-with good clinical outcomes-and evaluated retrospectively in the remainder (Table 1). No patient suffered a central major vascular complication or required new permanent pacemaker implantation. Device success occurred in all patients except one (post-procedural echocardiographic transvalvular gradient of 23 mmHg). In the retrospectively assessed cases, the novel annulus measure was concordant with the implanted THV size in 7 out of 9 procedures and, importantly, did not overestimate the annulus dimensions in any case. Furthermore, in two balloon-expandable THV cases the new measure may, in retrospect, have prompted consideration of a smaller implant size. To be noted, balloon sizing of the aortic annulus has additional value when selecting the valve size in BAV anatomy. Further prospective validation of this novel MDCT sizing technique is required.

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