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

Atrial fibrillation (AF), a risk factor for stroke and systemic thromboembolism, is associated with unfavorable fibrin clot properties and increased thrombus formation in peripheral blood. The left atrial appendage (LAA) is known to be the primary site of thrombus formation. We investigated the relative differences in plasma fibrin clot features including plasma fibrin clot permeability (Ks) and clot lysis time (CLT) between the right atrium (RA), right ventricle (RV), left atrium (LA), left ventricle (LV), LAA, and peripheral blood. Sixteen patients with nonvalvular AF who stopped oral anticoagulant therapy at least 2 days before a LARIAT procedure participated in a single-center prospective study. We measured fibrinogen and plasminogen levels along with Ks, CLT, and endogenous thrombin potential (ETP) during the LARIAT procedure in blood obtained from the right femoral vein, RA, RV, LA, LV and LAA. LAA clot porosity was reduced by 16.2% compared to peripheral blood (p = 0.026), also after adjustment for fibrinogen levels (p = 0.038). Ks was similar for the RA, RV, LA, LV, and LAA (all p > 0.05). We found 14.7% prolonged CLT for clots prepared from blood samples obtained from the LAA compared to those prepared from peripheral blood, but no differences between the RA, RV, LA and LV (all p > 0.05) were found. There were no significant differences in other parameters, including ETP, between heart chambers. Patients with AF are characterised by a local prothrombotic state as reflected by formation of compact fibrin clots in the LAA compared to peripheral blood, which may contribute to LAA thrombus formation and device-related thrombi.

Background: Aortic valve replacement (AVR) is one of the most common surgeries performed in cardiac surgery operating rooms. We present actual, real life trends from the last 10 years for AVR interventions based on a multicentre National Registry of Cardiac Surgery Database. Methods: The study population consisted of all 50,846 consecutive adult patients who underwent AVR between January 2006 and August 2016 in all cardiac surgery units in Poland. The main outcome measures were changes in the number of valves, characteristics of valves, operative details, and in-hospital mortality. Analysis consisted of all aortic valve (AV) procedures, including isolated AV surgery, combination procedures and patients who had a prior valve operation. Results: In last 10 years, the number of procedures increased by 46%. Isolated surgical AVR was performed in 61.2%, AVR + coronary artery bypass grafting (CABG) in 23.9%, AVR + mitral valve replacement (MVR) in 7%, and transcatheter aortic valve implantation (TAVI) in 2.3% of patients. The mean patient age increased significantly from 61.4 years in 2006 to 66.1 years in 2016. Aortic stenosis was diagnosed in 73.4%, severe aortic insufficiency in 15.8% of cases. The most common valve pathology was calcification. Congenital valve dysfunction was diagnosed in 3.7% of cases. There was a 33.7% increase of bioprosthesis, and the most common implanted bioprosthesis was the Hancock II. The most common implanted mechanical prosthesis was the St. Jude Medical Mechanical Valve. In-hospital mortality decreased significantly over the 10-year period in all AV procedures from 10.9% in 2006 to 8.3% in 2016. Mean in-hospital mortality was: 4.0% in isolated surgical AVR, 5.4% in TAVI, 6.8% in AVR + CABG, 9.8% in AVR + MVR, 17.2% in AVR + MVR + CABG. Conclusions: In the last ten years, the number of AV procedure has doubled. Mortality was significantly lower with all types of AV procedure despite very rapid aging of AVR patients. TAVI procedure rapidly grew in popularity. There is significant increase in the use of bioprosthesis.

Left atrial appendage closure (LAAC) with LARIAT offers an alternative to oral anticoagulation (OAC) for patients with atrial fibrillation. The aim of this study was to present long-term clinical outcomes of LAAC in these patients (AF). A prospective, single-center study was performed in 139 patients undergoing LAAC with Lariat. Thromboembolic events, severe bleeding and mortality rate were recorded. The reduction in risk of thromboembolism and bleeding after LAAC was calculated. The mean CHADS₂-score was 1.8 ± 1.0, mean CHA₂DS₂-VASc score was 2.9 ± 1.6 and HAS-BLED score was 3.1 ± 1.1. After 428.4 patient-years of follow-up (mean 4.2±1.0 years), the thromboembolism rate was 0.6% with a calculated thromboembolism risk reduction of 81%. The severe bleeding rate was 0.8%; calculated bleeding risk reduction was 78%. The overall mortality rate was 1.6%. Long-term outcomes show that LAAC with Lariat is a safe and effective treatment for stroke prevention and bleeding risk reduction in AF patients with a high level of underlying risk.

The incidence of accidental hypothermia (core temperature ≤35 °C) is difficult to estimate, as the affected population is heterogeneous. Both temperature and clinical presentation should be considered while determining severity, which is difficult in a prehospital setting. Extracorporeal rewarming is advocated for all Swiss Staging System class IV (hypothermic cardiac arrest) and class III (hypothermic cardiac instability) patients. Veno-arterial extracorporeal membrane oxygenation (ECMO) is the method of choice, as it not only allows a gradual, controlled increase of core body temperature, but also provides respiratory and hemodynamic support during the unstable period of rewarming and reperfusion. This poses difficulties with the coordination of patient management, as usually only cardiac referral centers can deliver such advanced treatment. Further special considerations apply to subgroups of patients, including drowning or avalanche victims. The principle of ECMO implantation in severely hypothermic patients is no different from any other indication, although establishing vascular access in a timely manner during ongoing resuscitation and maintaining adequate flow may require modification of the operating technique, as well as aggressive fluid resuscitation. Further studies are needed in order to determine the optimal rewarming rate and flow that would favor brain and lung protection. Recent analysis shows an overall survival rate of 40.3%, while additional prognostic factors are being sought for determining those patients in whom the treatment is futile. New cannulas, along with ready-to-use ECMO sets, are being developed that would enable easy, safe and efficient out-reach ECMO implantation, thus shortening resuscitation times. Moreover, national guidelines for the management of accidental hypothermia are needed in order that all patients that would benefit from extracorporeal rewarming would be provided with such treatment. In this perspective article, we discuss burning problems in ECMO therapy in hypothermic patients, outlining the important research goals to improve the outcomes.