Initial experience with the Freedom Solo® stentless aortic valve in a low volume centre.

OBJECTIVES: Freedom Solo is a stentless biological aortic valve which is implanted supra-annularly with a single suture line. An increased risk of postoperative thrombocytopenia in the early postoperative period has been reported in recent studies. In our study we evaluated postoperative haemodynamic performance and thrombocyte-levels. DESIGN: Thirty seven patients who underwent valve implantation of the Sorin Freedom Solo stentless valve were included. The haemodynamic performance of the valve was evaluated by transthoracic echocardiography postoperatively at the fourth day (mean) and after a median of 4.2 months. RESULTS: The mean gradient (mmHg) of Freedom Solo was 7.5 at four days and 8.6 at 4.2 months. Postoperatively no patient had more than grade 1 leakage. Seven percent of the patients had a reduction of thrombocytes to less than 20% of the preoperative level. Seventy six percent had a minimum postoperative thrombocyte level less than 100*10(9)/L. The 30 days mortality in our patient material was zero. CONCLUSIONS: Implantation of the Freedom Solo valve was uncomplicated in our experience. Favourable transvalvular gradients and no significant leaks were found. In accordance with the literature, we found a high percentage of patients having a postoperative level of thrombocytes less than 100*10(9)/L after implantation of Freedom Solo.

Clinical Efficacy of Combined Surgical Patient Safety System and the World Health Organization's Checklists in Surgery: A Nonrandomized Clinical Trial.

Importance: Checklists have been shown to improve patient outcomes in surgery. The intraoperatively used World Health Organization surgical safety checklist (WHO SSC) is now mandatory in many countries. The only evidenced checklist to address preoperative and postoperative care is the Surgical Patient Safety System (SURPASS), which has been found to be effective in improving patient outcomes. To date, the WHO SSC and SURPASS have not been studied jointly within the perioperative pathway. Objective: To investigate the association of combined use of the preoperative and postoperative SURPASS and the WHO SSC in perioperative care with morbidity, mortality, and length of hospital stay. Design, Setting, and Participants: In a stepped-wedge cluster nonrandomized clinical trial, the preoperative and postoperative SURPASS checklists were implemented in 3 surgical departments (neurosurgery, orthopedics, and gynecology) in a Norwegian tertiary hospital, serving as their own controls. Three surgical units offered additional parallel controls. Data were collected from November 1, 2012, to March 31, 2015, including surgical procedures without any restrictions to patient age. Data were analyzed from September 25, 2018, to March 29, 2019. Interventions: Individualized preoperative and postoperative SURPASS checklists were added to the intraoperative WHO SSC. Main Outcomes and Measures: Primary outcomes were in-hospital complications, emergency reoperations, unplanned 30-day readmissions, and 30-day mortality. The secondary outcome was length of hospital stay (LOS). Results: In total, 9009 procedures (5601 women [62.2%]; mean [SD] patient age, 51.7 [22.2] years) were included, with 5117 intervention procedures (mean [SD] patient age, 51.8 [22.4] years; 2913 women [56.9%]) compared with 3892 controls (mean [SD] patient age, 51.5 [21.8] years; 2688 women [69.1%]). Parallel control units included 9678 procedures (mean [SD] patient age, 57.4 [22.2] years; 4124 women [42.6%]). In addition to the WHO SSC, adjusted analyses showed that adherence to the preoperative SURPASS checklists was associated with reduced complications (odds ratio [OR], 0.70; 95% CI, 0.50-0.98; P = .04) and reoperations (OR, 0.42; 95% CI, 0.23-0.76; P = .004). Adherence to the postoperative SURPASS checklists was associated with decreased readmissions (OR, 0.32; 95% CI, 0.16-0.64; P = .001). No changes were observed in mortality or LOS. In parallel control units, complications increased (OR, 1.09; 95% CI, 1.01-1.17; P = .04), whereas reoperations, readmissions, and mortality remained unchanged. Conclusions and Relevance: In this nonrandomized clinical trial, adding preoperative and postoperative SURPASS to the WHO SSC was associated with a reduction in the rate of complications, reoperations, and readmissions. Trial Registration: ClinicalTrials.gov Identifier: NCT01872195.

A dose-response study of levosimendan in a porcine model of acute ischaemic heart failure.

OBJECTIVES: Levosimendan is a novel inotropic agent claimed to improve myocardial contractility by a calcium-sensitizing effect. Our aim was to evaluate dose-dependent effects of levosimendan on left ventricular (LV) contractility and energetic properties in an acute, ischaemic heart failure porcine model. METHODS: Six pigs were used in an anaesthetized in vivo open-chest model. The time points of measurements were: baseline, after heart failure induction and after dose 1-4 (D1-D4). Heart failure was induced by microembolization of the left coronary artery before infusion of four different doses (D1: 2.5 µg/kg, D2: 10 µg/kg, D3: 40 µg/kg, D4: 80 µg/kg) of levosimendan. Haemodynamics were assessed by the pressure-conductance catheter technique. LV oxygen consumption was calculated from coronary flow measurements and coronary sinus blood gases. Mitochondrial respiration was studied in biopsies of the LV. RESULTS: Levosimendan had no significant, load-independent effect on contractile force (slope of preload recruitable stroke work was 34 mmHg immediately following failure and 39 (P = 0.406), 42 (P = 0.219), 46 (P = 0.067) and 41 (P = 0.267) at D1-D4), although the more load-dependent contractility indicator of dP/dt(max) was slightly increased at dose 4 (P < 0.05). LV energy conversion efficiency (PVA-MVO2 relationship) remained unaltered at all doses. Maximal mitochondrial respiration decreased after induction of failure and remained at an unaltered low level during levosimendan infusion. CONCLUSIONS: Surprisingly, levosimendan had no significant effect on contractility, energy efficiency and mitochondrial respiration of the LV, in a porcine model of acute heart failure. At high doses, levosimendan induced vasodilatation and increased heart rate and cardiac output.

Prophylactic treatment with levosimendan: a retrospective matched-control study of patients with reduced left ventricular function.

OBJECTIVE: Levosimendan is a calcium-sensitising inotropic agent and a vasodilator used in the treatment of heart failure. Post-cardiotomy cardiac failure is more common in patients with a low preoperative left ventricular ejection fraction (LVEF). We aim at investigating how prophylactic treatment with levosimendan before weaning from cardiopulmonary bypass (CPB) affects postoperative haemodynamics and outcome in patients with low preoperative LVEF. METHODS: Patients with a preoperative LVEF < or =30% treated with levosimendan before weaning from CPB were included in the study. Each patient was matched to a control patient with respect to the following criteria: surgical procedure, EuroSCORE, age, gender and the use of intra-aortic balloon pump. We investigated postoperative haemodynamics in the intensive care unit (ICU) at time points: 1, arrival; 2, approximately 7h after arrival; and 3, the first postoperative morning. In addition, mortality was evaluated. RESULTS: Thirty patients treated with levosimendan and 30 matched controls were enrolled in the study. No statistically significant differences in cardiac index (CI) (l min(-1)m(-2)), stroke volume index (SVI) (mlm(-2)), mixed venous O(2)-saturation (SvO(2)) (%) or heart rate (HR) (beats per minute) between the two groups measured at the three time points 1-3 were registered. Mean arterial blood pressure (MAP) (mmHg) was lower in the levosimendan group both at time points 2 (68, range: 65-71 vs 75, range: 72-78; p=0.009) and 3 (72, range: 69-74 vs 78, range: 74-82; p=0.01), despite a higher dose of norepinephrine in the treatment group (p=0.021). A significantly higher number of control patients were treated with classic adrenergic inotropes both in the operating room (p=0.013) and in the ICU (p<0.001). Thirty days mortality was the same in both groups (7%). CONCLUSIONS: Prophylactic infusion of levosimendan initiated before weaning from CPB did not lead to superior haemodynamic parameters (CI, SVI, SvO(2)) compared to controls. Levosimendan reduced MAP and increased the need for norepinephrine postoperatively.