Long-term durability of bioprosthetic valves is predominantly limited by structural valve deterioration. RESILIA^™ tissue has exhibited reduced calcification in pre-clinical and early clinical studies. This study evaluated the 5-year clinical and haemodynamic outcomes of an aortic valve with this tissue. This was a prospective, non-randomized, single-arm study of 133 patients implanted with a RESILIA aortic bioprosthesis between July 2011 and February 2013 at 2 sites in Poland. Clinical outcomes and haemodynamic performance were assessed annually for 5 years post-implant. Safety events were adjudicated by a Clinical Events Committee and echocardiographic data were assessed by an independent core laboratory. Mean patient age was 65.3 ± 13.5 years, with 34 patients (25.6%) ≤60. The mean follow-up was 4.2 ± 1.5 years. Early (≤30 days) and late (>30 days) all-cause mortality were 2.3% (N = 3) and 3.2%/late patients-years (N = 18) respectively. Early events included thromboembolism in 3 patients (2.3%). Late valve-related events included endocarditis in 1 patient, which led to explant, and valve thrombosis in another patient. There were no events of structural valve deterioration throughout the study. At 5 years, mean gradient was 14.8 ± 7.6 mmHg and effective orifice area was 1.4 ± 0.5 cm², a marked improvement over baseline values. All New York Heart Association class III patients and most class II patients at baseline had improved classifications at 5 years. The bioprosthesis with RESILIA tissue demonstrated a good safety profile with excellent haemodynamic performance over 5 years of follow-up. These encouraging outcomes warrant additional investigation of this novel tissue. NCT01651052

Altered fibrin clot structure has been reported both in patients with coronary artery disease (CAD) and those with type 2 diabetes mellitus (DM2). The aim of the present study was to evaluate plasma fibrin clot permeability and susceptibility to lysis in patients with DM2 and CAD. We studied 132 consecutive CAD patients, including 67 subjects with DM2, scheduled for elective coronary artery bypass grafting surgery. Ex vivo plasma fibrin clot permeability (K_s) and lysis time (t_50%) induced by 1 μg/mL recombinant tissue plasminogen activator (tPA), along with plasma levels of plasminogen activator inhibitor-1 (PAI-1), thrombin activatable fibrinolysis inhibitor (TAFI), tPA, von Willebrand factor (vWF), P-selectin, soluble CD40 ligand (sCD40L), were measured. Diabetic and non-diabetic patients did not differ in regard to demographics and remaining cardiovascular risk factors. Concomitant DM2 was associated with higher glucose (+24.3 %, p < 0.001), fibrinogen (+9.0 %, p = 0.037), PAI-1 (+58.7 %, p < 0.001), tPA (+24.0 %, p < 0.001) and P-selectin (+12.2 %, p < 0.001). Compared with the non-diabetic group, the CAD patients with DM2 had lower K_s (-6.1 %, p = 0.02) and prolonged t_50% (+5.1 %, p = 0.04). Multiple regression analysis of the whole study group showed that vWF, PAI-1, fibrinogen and DM2 were the independent predictors of t_50% (R ² = 0.58, p < 0.001), while only vWF was an independent predictor of K_s (R ² = 0.22, p < 0.001). This study indicates that DM2 is potent enough to unfavorably affect plasma fibrin clot characteristics despite abnormal clot phenotype typically observed in CAD. Of note, platelet and endothelial markers appear to contribute to fibrin clot properties in CAD concomitant with DM2.

The durability of bioprosthetic heart valves is limited by structural valve deterioration (SVD) due to long-term calcification. A novel bioprosthetic tissue (RESILIATM) has been developed which, in preclinical studies, has shown reduced calcification. The purpose of this study was to evaluate the intermediate-term clinical outcomes and hemodynamic performance of this tissue. A prospective, single-arm, observational trial was conducted in patients who required surgical aortic valve replacement (AVR). Between July 2011 and February 2013, 133 patients were implanted at two sites in Poland. Hemodynamic performance and clinical outcomes were assessed annually through 4 years of follow-up. All safety events were adjudicated by an independent Clinical Events Committee, and echocardiographic data were evaluated by a core laboratory. Patients were 65.3±13.5 years old and 26% were ≤60 years old. The average follow-up was 3.8±1.1 (median: 4.1; IQR, 4.0-4.3) years. Early (≤30 day) and late (>30 day) all-cause mortality rates were 2.3% (n=3) and 3.2% late patient-years (n=16), respectively. There were no cases of early or late SVD. There was one early case of major paravalvular leak (0.8%), and no late cases. At 4 years, the mean gradient was 14.5±7.4 mmHg and the effective orifice area was 1.6±0.4 cm2, both markedly improved from baseline. At 4 years, the New York Heart Association functional class had improved from baseline in 54.5% of patients. The aortic bioprosthesis with novel RESILIATM tissue demonstrated excellent hemodynamic performance and safety outcomes over 4 years. Longer follow-up will be important to confirm the durability of this bioprosthesis.

The primary cause of long-term failure of bioprosthetic valves is structural valve deterioration due to tissue calcification. A novel anti-calcification technology platform was developed that may irreversibly block calcium binding sites in bioprosthetic valves. Twenty patients with severe aortic stenosis underwent isolated aortic valve replacement using a bioprosthetic valve treated with the novel anti-calcification technology. Mean patient age and body mass index was 73.7 ± 4.8 years and 30.1 ± 5.8 kg/m², respectively. Females comprised 65% of the patient population, and 30% of the population was in New York Heart Association class III/IV. Other baseline characteristics included hypertension (90%), hyperlipidaemia (75%), diabetes (35%), renal failure (25%), pulmonary disease (10%), and myocardial infarction (10%). Patients were followed-up for up to one year. Haemodynamic performance was evaluated by echocardiography. All complications were recorded. There was one early death on postoperative day five. No other complications were noted up to discharge. Follow-up at 3-6 months and at one year were both 100%. At one year, no valve-related mortality, structural valve deterioration, major paravalvular leak (> 2+), thromboembolic events, major bleeding, prosthetic valve endocarditis, or reoperation were observed. Mean effective orifice area increased from 1.0 ± 0.5 cm² at baseline to 1.8 ± 0.5 cm² at one year. Mean gradient decreased from 54.8 ± 21.2 mm Hg at baseline to 11.3 ± 3.4 mm Hg at one year. This early clinical experience using an aortic bioprosthetic valve treated with a novel anti-calcification tissue processing technology demonstrated excellent valve performance, durability, and safety. No valve-related complications were noted. Longer-term follow-up is needed to verify these promising results.

OBJECTIVES: On-pump coronary artery bypass grafting (CABG) is associated with elevated bleeding risk. Our aim was to evaluate the role of surgical experience in postoperative blood loss. METHODS: A propensity score-matched analysis was employed to compare on-pump CABG patients operated on by residents and specialists. End points included drainage volume and bleeding severity, as assessed by the Universal Definition of Perioperative Bleeding in cardiac surgery and E-CABG scale. RESULTS: A total of 212 matched pairs (c-statistics 0.693) were selected from patients operated on by residents (n = 294) and specialists (n = 4394) between October 2012 and May 2018. Patients did not differ in bleeding risk. There were no statistically significant differences in postoperative 6-, 12- and 24-h drainages between subjects operated on by residents and specialists, and there was no between-group difference in rethoracotomy or transfusion rate. There were no differences in Universal Definition of Perioperative Bleeding or E-CABG grades. In June 2018, after a median follow-up of 2.8 years (range 0.1–5.7 years), the overall survival was 94%, with no differences between the patients operated on by residents (95%) and specialists (92%) (P = 0.27). CONCLUSIONS: Patients undergoing on-pump CABG, when operated on by a resident, are not exposed to an elevated bleeding risk, as compared with patients operated on by experienced surgeons.

Background/Objectives: Multi-organ failure (MOF) often complicates advanced heart failure (HF), contributing to a poor prognosis. The Model of End-Stage Liver Disease 3.0 (MELD-3.0) scale incorporates liver and kidney function parameters. This study aims to evaluate the prognostic significance of the MELD-3.0 score in patients with advanced HF who have undergone heart transplantation (HTx). Methods: The MELD-3.0 score was computed using the average values of the international normalized ratio and bilirubin, creatinine, sodium, and albumin levels during a hospital stay following HTx. The average MELD-3.0 scores from the period of 1 month preceding HTx and 1 week after HTx were analyzed. The primary endpoint of the study was the 6-month total mortality, and the secondary endpoint was ICU hospitalization time after HTx. Results: The analysis included 106 patients undergoing HTx, with a median age of 53 years (44–63), 81% of whom were male. Within 6 months post-HTx, 17 patients (16%) died; those patients had a higher 1-week post-HTx MELD-3.0 score of 18.3 (14.5–22.7) in comparison to survivors, whose average score was 13.9 (9.5–16.4), p < 0.01. There was no difference in MELD 3.0 score in the pre-HTx period: 16.6 (11.4–17.8) vs. 12.3 (8.6–17.1), p = 0.36. The post-HTx MELD-3.0 score independently predicted death: RR 1.17 (95% CI 1.05–1.30), p < 0.01. A Receiver Operating Characteristic (ROC) determined the cut-off value of the MELD-3.0 score as 17.3 (AUC = 0.83; sensitivity—67%; specificity—86%). Survivors with scores above this value had a longer ICU hospitalization time: 7 (5.0–11.0) vs. 12 (8–20) days (p = 0.01). Conclusions: The post-HTx MELD-3.0 score serves as an independent predictor of an unfavorable prognosis in patients with advanced HF undergoing HTx. The evaluation of MELD-3.0 scores provides additional prognostic information in this population.