Transcatheter Aortic Valve Implantation in Low-Risk Tricuspid or Bicuspid Aortic Stenosis: The NOTION-2 Trial.

BACKGROUND AND AIMS: Transcatheter aortic valve implantation (TAVI) has become the first choice to treat older patients with severe symptomatic aortic stenosis (AS). This study aimed to compare TAVI with surgery in low-risk patients ≤ 75 years of age, including both tricuspid and bicuspid AS. METHODS: The NOTION-2 trial enrolled and 1:1 randomized low-risk patients aged ≤ 75 years with severe symptomatic AS to TAVI or surgery. The primary endpoint was a composite of all-cause mortality, stroke or rehospitalization (related to the procedure, valve or heart failure) at 12 months. RESULTS: A total of 370 patients were enrolled with a mean age of 71.1 years and a median Society of Thoracic Surgeons risk score of 1.1%. A total of 100 patients had bicuspid AS. The 1-year incidence of the primary endpoint was 10.2% in the TAVI group and 7.1% in the surgery group (absolute risk difference 3.1%; 95% confidence interval [CI], -2.7% to 8.8%; hazard ratio (HR) 1.4, 95% CI: 0.7 to 2.9; p=0.3). Patients with TAVI, when compared to surgery, had lower risk of major bleeding and new-onset atrial fibrillation and higher risk of non-disabling stroke, permanent pacemaker implantation and moderate-or-greater paravalvular regurgitation. The risk of the primary composite endpoint was 8.7% and 8.3% in patients with tricuspid AS (HR 1.0, 95% CI: 0.5 to 2.3) and 14.3% and 3.9% in patients with bicuspid AS (HR 3.8, 95% CI: 0.8 to 18.5) treated with TAVI or surgery, respectively (P for interaction=0.1). CONCLUSIONS: Among low-risk patients aged ≤ 75 years with severe symptomatic AS, the rate of the composite of death, stroke, or rehospitalization at one year was similar between TAVI and surgery. TAVI outcomes in young bicuspid AS patients warrant caution and should be further investigated. (NOTION-2, ClinicalTrials.gov, NCT02825134).

Randomized comparison of TAVI valves: The Compare-TAVI trial.

INTRODUCTION: Based on technical advancements and clinical evidence, transcatheter aortic valve implantation (TAVI) has been widely adopted. New generation TAVI valve platforms are continually being developed. Ideally, new valves should be superior or at least non-inferior regarding efficacy and safety, when compared to best-in-practice contemporary TAVI valves. METHODS AND ANALYSIS: The Compare-TAVI trial (ClinicalTrials.gov NCT04443023) was launched in 2020, to perform a 1:1 randomized comparison of new vs contemporary TAVI valves, preferably in all comers. Consecutive cohorts will be launched with sample sizes depending on the choice of interim analyses, expected event rates, and chosen superiority or non-inferiority margins. Enrollment has just been finalized in cohort B, comparing the Sapien 3/Sapien 3 Ultra Transcatheter Heart Valve (THV) series (Edwards Lifesciences, Irvine, California, USA) and the Myval/Myval Octacor THV series (Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India) balloon expandable valves. This non-inferiority study was aimed to include 1062 patients. The 1-year composite safety and efficacy endpoint comprises death, stroke, moderate-severe aortic regurgitation, and moderate-severe valve deterioration. Patients will be followed until withdrawal of consent, death, or completion of 10-year follow-up, whichever comes first. Secondary endpoints will be monitored at 30 days, 1, 3, 5, and 10 years. SUMMARY: The Compare-TAVI organization will launch consecutive cohorts wherein patients scheduled for TAVI are randomized to one of two valves. The aim is to ensure that the short- and long-term performance and safety of new valves being introduced is benchmarked against what achieved by best-in-practice contemporary valves.

Bleeding is associated with severely impaired outcomes in surgery for acute type a aortic dissection.

Background. Surgery for acute type A aortic dissection confers a risk for significant bleeding. We analyzed the impact of massive bleeding on complications after surgery for acute type A aortic dissection. Methods. Patients undergoing surgery for acute type A aortic dissection from the retrospective multicenter Nordic Consortium for Acute Type A Aortic Dissection (NORCAAD) database 2005-2014 were eligible. Massive bleeding was defined according to the Universal Definition of Perioperative Bleeding. The primary outcome measure was early mortality and secondary outcome measures were perioperative stroke, mechanical ventilation more than 48 h, new-onset dialysis, and intensive care unit stay. Propensity score matching was performed to adjust for differences in covariates. Results. Nine hundred ninety-seven patients were included, of whom 403 (40.4%) had massive bleeding. In the propensity score-matched cohort (344 pairs), patients with massive bleeding had higher 30-day mortality (17.2 versus 7.6%, p < .001), mechanical ventilation more than 48 h (52.8 versus 22.6%, p < .001), perioperative stroke (24.3 versus 14.8%, p = .002), new-onset dialysis (22.5 versus 4.9%, p < .001), and longer intensive care unit stay (6 versus 3 days, p < .001), compared with patients without massive bleeding. Risk factors for massive bleeding were previous cardiac surgery, preoperative clopidogrel or ticagrelor therapy, DeBakey type I dissection, and localized or generalized malperfusion. Conclusions. Massive bleeding in surgery for acute type A aortic dissection is associated with a markedly increased risk for severe complications as well as early death. Further improvement of surgical technique and pharmacological optimization of coagulation is paramount to possibly improve outcomes in acute type A aortic dissection repair.

Increasing obesity is associated with lower postoperative bleeding in coronary bypass patients.

OBJECTIVE: Despite inherent comorbidities, obese cardiac surgical patients paradoxically had shown lower morbidity and mortality, although the nature of this association is still unclear. Thus, the authors intended in this large registry-based study to investigate the impact of obesity on short- and long-term postoperative outcomes, focusing on bleeding and transfusion requirements. DESIGN: Retrospective registry study. SETTING: Three university hospitals. PARTICIPANTS: A cohort of 12,330 prospectively compiled data from coronary bypass grafting patients undergoing surgery between 2007 to 2020 were retrieved from the Western Denmark Heart Registry. INTERVENTIONS: The parameters were analyzed to assess the association between body mass index (BMI) and the selected outcome parameters. MEASUREMENTS AND MAIN RESULTS: The crude data showed a clear statistically significant association in postoperative drainage from 637 (418-1108) mL in underweight patients with BMI <18.5 kg/m2 to 427 (295-620) mL in severely obese patients with BMI ≥40 kg/m2 (p < 0.0001, Kruskal-Wallis). Further, 50.0% of patients with BMI <18.5 received an average of 451 mL/m2 in red blood cell transfusions, compared to 16.7% of patients with BMI >40 receiving 84 mL/m2. The obese groups were less often submitted to reexploration due to bleeding, and fewer received perioperative hemostatics, inotropes, and vasoconstrictors. The crude data showed increasing 30-day and 6-month mortality with lower BMI, whereas the one-year mortality showed a V-shaped pattern, but BMI had no independent impact on mortality in logistic regression analysis. CONCLUSION: Patients with high BMI may carry protection against postoperative bleeding after cardiac surgery, probably secondary to an inherent hypercoagulable state, whereas underweight patients carry a higher risk of bleeding and worse outcomes.

Platelet function assessed by ROTEM®platelet in patients receiving antiplatelet therapy during cardiac and vascular surgery.

Patients undergoing coronary artery bypass graft (CABG) surgery or carotid endarterectomy (CEA) continue antiplatelet therapy perioperatively, which may increase bleeding risk. We aimed to investigate whether Rotational thromboelastometry (ROTEM®) platelet, a newly marketed platelet function analysis, would detect antiplatelet therapy in CABG and CEA patients; whether detection of reduced platelet function was associated with increased bleeding; and whether ex vivo desmopressin increased platelet function. We included 20 CABG patients continuing aspirin and 20 CEA patients continuing clopidogrel (n = 1) or clopidogrel and aspirin (n = 19). Platelet function was analyzed with ROTEM®platelet and light transmission aggregometry (LTA). According to the lower reference limit, ROTEM®platelet managed to detect aspirin, but clopidogrel detection was inadequate compared to LTA. Using a previously published cut-off for bleeding risk, 6 (30%) patients receiving aspirin and 4 (21%) patients receiving both clopidogrel and aspirin demonstrated platelet function below this cut-off. One of the four CEA patients below the cut-off died from intracerebral hemorrhage postoperatively. CABG patients below (n = 6) and above (n = 14) the cut-off did not differ in chest tube output (median [range]: 373 ml [250-900] vs. 368 ml [195-820]). Ex vivo addition of desmopressin did not increase platelet function. In conclusion, ROTEM®platelet does reveal aspirin treatment whereas clopidogrel treatment is most often overlooked. Due to low bleeding in the study population, it was not possible to conclude on the association with bleeding risk.

Mechanical circulatory support for refractory out-of-hospital cardiac arrest: a Danish nationwide multicenter study.

BACKGROUND: Mechanical circulatory support (MCS) with either extracorporeal membrane oxygenation or Impella has shown potential as a salvage therapy for patients with refractory out-of-hospital cardiac arrest (OHCA). The objective of this study was to describe the gradual implementation, survival and adherence to the national consensus with respect to use of MCS for OHCA in Denmark, and to identify factors associated with outcome. METHODS: This retrospective, observational cohort study included patients receiving MCS for OHCA at all tertiary cardiac arrest centers (n = 4) in Denmark between July 2011 and December 2020. Logistic regression and Kaplan-Meier survival analysis were used to determine association with outcome. Outcome was presented as survival to hospital discharge with good neurological outcome, 30-day survival and predictors of 30-day mortality. RESULTS: A total of 259 patients were included in the study. Thirty-day survival was 26%. Sixty-five (25%) survived to hospital discharge and a good neurological outcome (Glasgow-Pittsburgh Cerebral Performance Categories 1-2) was observed in 94% of these patients. Strict adherence to the national consensus showed a 30-day survival rate of 30% compared with 22% in patients violating one or more criteria. Adding criteria to the national consensus such as signs of life during cardiopulmonary resuscitation (CPR), pre-hospital low-flow < 100 min, pH > 6.8 and lactate < 15 mmol/L increased the survival rate to 48%, but would exclude 58% of the survivors from the current cohort. Logistic regression identified asystole (RR 1.36, 95% CI 1.18-1.57), pulseless electrical activity (RR 1.20, 95% CI 1.03-1.41), initial pH < 6.8 (RR 1.28, 95% CI 1.12-1.46) and lactate levels > 15 mmol/L (RR 1.16, 95% CI 1.16-1.53) as factors associated with increased risk of 30-day mortality. Patients presenting signs of life during CPR had reduced risk of 30-day mortality (RR 0.63, 95% CI 0.52-0.76). CONCLUSIONS: A high survival rate with a good neurological outcome was observed in this Danish population of patients treated with MCS for OHCA. Stringent patient selection for MCS may produce higher survival rates but potentially withholds life-saving treatment in a significant proportion of survivors.

A systematic approach to weaning from extracorporeal membrane oxygenation in patients with refractory cardiac failure.

BACKGROUND: Veno-arterial extracorporeal membrane oxygenation (V-A ECMO) is commonly used to provide haemodynamic support for patients with severe cardiac failure. However, timing ECMO weaning remains challenging. We aimed to examine if an integrative weaning approach based on predefined haemodynamic, respiratory and echocardiographic criteria is associated with successful weaning. METHODS: All patients weaned from ECMO between April 2017 and April 2019 at Aarhus University Hospital, Denmark, were consecutively enrolled. Predefined haemodynamic, respiratory and echocardiographic criteria were assessed before and during ECMO flow reduction. A weaning attempt was commenced in haemodynamic stable patients and patients remaining stable at minimal flow were weaned from ECMO. Comparisons were made between patients who met the criteria for weaning at first attempt and patients who did not meet these criteria. Patients completing a full weaning attempt with no further need for mechanical support within 24 h were defined as successfully weaned. RESULTS: A total of 38 patients were included in the study, of whom 26 (68%) patients met the criteria for weaning. Among these patients, 25 (96%) could be successfully weaned. Successfully weaned patients were younger and had less need for inotropic support and ECMO duration was shorter. Fulfilling the weaning criteria was associated with successful weaning and both favourable 30-d survival and survival to discharge. CONCLUSION: An integrative weaning approach based on haemodynamic, respiratory and echocardiographic criteria may strengthen the clinical decision process in predicting successful weaning in patients receiving ECMO for refractory cardiac failure.

Distribution and prognostic value of left ventricular global longitudinal strain in elderly patients with symptomatic severe aortic stenosis undergoing transcatheter aortic valve replacement.

AIMS: The aim of present study was to examine the preoperative prevalence and distribution of impaired left ventricular global longitudinal strain (LVGLS) in elderly patients with symptomatic aortic stenosis (AS) undergoing transcutaneous aortic valve replacement (TAVR) and to determine the predictive value of LVGLS on survival. METHODS: We included 411 patients with symptomatic severe AS treated with TAVR during a 5-year period, where a baseline echocardiography including LVGLS assessment was available. RESULTS: Mean age was 80.1 ± 7.1 years and aortic valve area (AVA) index 0.4 ± 0.1 cm2. 78 patients died during a median follow-up of 762 days. Mean left ventricular ejection fraction (LVEF) was 50 ± 13% and mean LVGLS was - 14.0%. LVEF was preserved in 60% of patients, while impaired LVGLS > - 18% was seen in 75% of the patients. Previous myocardial infarction, LVEF < 50%, LVGLS > - 14%, low gradient AS (< 4.0 m/s), tricuspid regurgitant gradient > 30 mmHg were identified as significant univariate predictors of all-cause mortality. On multivariate analysis LVGLS > - 14% (HR 1.79 [1.02-3.14], p = 0.04) was identified as the only independent variable associated with all-cause mortality. Reduced survival was observed with an impaired LVGLS > - 14% in the total population (p < 0.002) but also in patients with high AS gradient with preserved LVEF. LVGLS provided incremental prognostic value with respect to clinical characteristics, AVA and LVEF (χ2 19.9, p = 0.006). CONCLUSIONS: In patients with symptomatic AS undergoing TAVR, impaired LVGLS was highly prevalent despite preserved LVEF. LVGLS > - 14% was an independent predictor of all-cause mortality, and survival was reduced if LVGLS > - 14%.

Colloids in Cardiac Surgery-Friend or Foe?

OBJECTIVE: The right choice of fluid replacement still is a matter of debate. Recently, two large-scale studies on the use of hydroxyethyl starches (HES) in the intensive care setting have been published, which have caused a huge shift in the daily practice of volume therapy. These results have been applied to patients outside intensive care. The aim of this study was to evaluate the impact this change has had on the outcomes in a large population of cardiac surgery patients, with a focus on the type of colloid infusion. DESIGN: A prospective, registered, observational study, using propensity score matching. SETTING: Cohort study from 3 university hospitals using a common registry. PARTICIPANTS: The study comprised 17,742 patients who were referred for cardiac surgery from 2007 to 2014. INTERVENTIONS: Patients were divided in groups according to perioperative fluid replacement with either crystalloids or colloids. The colloid group was further divided into HES or human albumin (HA). Analyses were based on the following 3 subsections: HES versus crystalloids, HA versus crystalloids, and HES versus HA, with use of propensity score matching or direct matching of cases. Primary outcome parameters were 30-day and 6-month mortality, new postoperative renal replacement therapy, and new cardiac ischemic events. MEASUREMENTS AND MAIN RESULTS: The groups were fully comparable in individual analyses. The use of HES had no impact on new dialysis and 30-day mortality. A Cox proportional regression analysis showed that HES had no impact on 6-month mortality and new postoperative ischemic events. When comparing HA with crystalloid use, a significantly increased risk in crude analysis was demonstrated on all outcome parameters; and when comparing HA with HES, a significantly higher risk was observed in HA patients in mortality parameters and new postoperative, but after adjustment, only the risk of new postoperative dialysis persisted. CONCLUSION: This study underlined the difficulties in establishing hardcore outcome data, even in large cohort studies. The findings seemed to diminish the magnitude of risk when using HES in cardiac surgery patients and seriously questioned the choice of HA when a plasma expander is needed.

Three-dimensional multidetector computed tomography versus conventional 2-dimensional transesophageal echocardiography for annular sizing in transcatheter aortic valve replacement: Influence on postprocedural paravalvular aortic regurgitation.

OBJECTIVES: In transcatheter aortic valve replacement (TAVR), the influence of aortic annular assessment with either multidetector computed tomography (MDCT) or conventional transesophageal echocardiography (TEE) on the incidence of postprocedural paravalvular aortic regurgitation (PAR) was evaluated. BACKGROUND: PAR remains a major limitation in TAVR. Appropriate selection of transcatheter heart valve (THV) size is crucial to prevent PAR. METHODS: Outcomes following TAVR with a balloon-expandable THV were compared in two retrospective cohorts identified according to whether THV size selection was based on TEE (study group 1, n = 80) or MDCT (study group 2, n = 58). RESULTS: The two study groups were comparable with regard to baseline clinical, risk score, and echocardiographic characteristics. The incidence of moderate/severe PAR was lower in study group 2 than in group 1, 8.6% versus 28.8% (P < 0.01). The difference between the THV nominal diameter and MDCT annular diameter was predictive of moderate/severe PAR (AUC 0.84; 95% CI: 0.72-0.92). Neither age, gender, body mass index, annular eccentricity index, aortic valve calcification nor the difference between the THV diameter and the TEE annular diameter predicted postprocedural PAR. Increased THV oversizing relative to the MDCT mean annular diameter was associated with reduced severity of PAR. No difference in perprocedural complications between two study groups was observed. CONCLUSION: MDCT-based annular sizing in TAVR significantly reduces postprocedural PAR, and THV oversizing appears pivotal in this aspect. Further delineation of the optimal degree of THV oversizing is needed.

Conservative treatment of type A aortic dissection: a case report with 5 years of follow-up.

Background: Acute aortic dissection causes major morbidities and mortalities. The treatment of choice for type A aortic dissection (TAAD) is emergent surgical intervention. However, surgery per se may be associated with significant risk, in part due to the general surgical challenges, and the inherent hemodynamic- and organ malperfusion effects. In particular, surgery correlates with marked perioperative mortality in octo- and nonagenarians and those with severe comorbidities. Conservative medical treatment represents an alternative approach to patients for whom surgery is deemed high-risk, but case literature in this field remains sparse. Case Description: We present a case of an 86-year-old female admitted with TAAD and deemed inoperable by the cardiothoracic surgical team due to excessive risks. The patient was treated conservatively with an extensive and aggressive antihypertensive regimen, leading to an uneventful recovery. Conclusions: Most cases of TAADs require emergent surgery. However, surgery is often contraindicated in comorbid and older patients due to excessive risks. The patient in this report is unique due to the long follow-up after conservative treatment and the close adherence to treatment protocol due to continuous therapeutic monitoring. It is important to consider factors for and against conservative therapeutic strategies, and, importantly, adherence to such should be carefully monitored to optimize patient outcomes.

Long-term survival, functional capacity and quality of life after refractory out-of-hospital cardiac arrest treated with mechanical circulatory support.

Introduction: Studies on long-term outcomes after refractory out-of-hospital cardiac arrest (OHCA) treated with mechanical circulatory support (MCS) are limited. This study aimed to evaluate long-term neurologically intact survival, functional capacity and quality of life after refractory OHCA treated with MCS. Methods: This was a follow-up study of survivors after refractory OHCA treated with MCS. Follow-up examinations comprised clinical assessment with transthoracic echocardiography and cardiopulmonary exercise test (CPX). Neurological and cognitive screening was evaluated with the Cerebral Performance Category (CPC) and Montreal Cognitive Assessment (MoCA test). A good neurological outcome was defined as CPC 1 or CPC 2. Health-related quality of life was measured by questionnaires (Short Form-36 (SF-36)). Results: A total of 101 patients with refractory OHCA were treated with MCS at Aarhus University Hospital between 2015 and 2019. The total low-flow time was median 105 min [IQR, 94-123] minutes. The hospital discharge rate was 27%. At a mean follow-up time of 4.8 years ± 1.6 (range 2.8-6.1 years), 21 patients remained alive of whom 15 consented to participate in the present study. Good neurological outcome with CPC 1-2 was found in 93% (14/15) patients. No severe cognitive function was discovered; mean MoCA score of 26.4 ± 3.1. Functional capacity examined by CPX showed acceptable VO2 max values (23.9 ± 6.3 mL/kg/min). Mean SF-36 scores revealed an overall high level of quality of life in long-term survivors. Conclusions: Long-term survival with a good neurological outcome with functional recovery was high in patients with refractory OHCA treated with MCS. These patients may expect a reasonable quality of life after discharge despite prolonged resuscitation.

Fewer transfusions are still more-red blood cell transfusions affect long-term mortality in cardiac surgery.

OBJECTIVES: Previous studies indicated higher long-term mortality after the transfusion of allogeneic red blood cells (RBC); newer recommendations emphasize lower transfusion rates. The consequences of the transfusion of RBCs in cardiac surgery are unclear because later studies focused on transfusion triggers and short-term outcomes. Reports on long-term complications after cardiac surgery are few. MATERIAL AND METHODS: The mandatory Western Denmark Heart Registry was used to identify all adult cardiac operations performed in 4 centres from 2000 to 2019. Patients with multiple entries or previous cardiac operations, special/complex procedures, dying within 30 days and not eligible for follow-up were excluded. RESULTS: A total of 32,581 adult cardiac operations performed in 4 centres from 2000 to 2019 were included. The Kaplan-Meier survival plot for low-risk patients undergoing simple cardiac operations showed a significantly lower 15-year survival (0.384 vs 0.661) of patients who received perioperative RBC transfusions [odds ratio 2.43 (confidence level 2.23-2.66)]. The risk decreased with increasing comorbidity or age. No difference was found in high-risk patients. The adjusted risk ratio after an RBC transfusion, including age, sex, comorbidity and surgery, was 1.62 (1.48-1.77). CONCLUSIONS: Despite reduced transfusion rates, long-term follow-up on especially low-risk patients undergoing comparable cardiac operations still demonstrates substantially more deaths of patients receiving perioperative RBC transfusions. Even transfusion of 1-2 units is associated with increased long-term mortality.

Selection of patients for mechanical circulatory support for refractory out-of-hospital cardiac arrest.

OBJECTIVE: To describe characteristics of patients admitted with refractory cardiac arrest for possible extracorporeal cardiopulmonary resuscitation (ECPR) and gain insight into the reasons for refraining from treatment in some. METHODS: Nationwide retrospective cohort study involving all tertiary centres providing ECPR in Denmark. Consecutive patients admitted with ongoing chest compression for evaluation for ECPR treatment were enrolled. Presenting characteristics, duration of no-flow and low-flow time, end-tidal carbon dioxide (ETCO2), lactate and pH, and recording of reasons for refraining from ECPR documented by the treating team were recorded. Outcomes were survival to intensive care unit admission and survival to hospital discharge. RESULTS: Of 579 patients admitted with refractory cardiac arrest for possible ECPR, 221 patients (38%) proceeded to ECPR and 358 patients (62%) were not considered candidates. Median prehospital low-flow time was 70 min (IQR 56 to 85) in ECPR patients and 62 min (48 to 81) in no-ECPR patients, p<0.001. Intra-arrest transport was more than 50 km in 92 (42%) ECPR patients and 135 in no-ECPR patients (38%), p=0.25. The leading causes for not initiating ECPR stated by the treating team were duration of low-flow time in 39%, severe metabolic derangement in 35%, and in 31% low ETCO2. The prevailing combination of contributing factors were non-shockable rhythm, low ETCO2, and metabolic derangement or prehospital low-flow time combined with low ETCO2. Survival to discharge was only achieved in six patients (1.7%) in the no-ECPR group. CONCLUSIONS: In this large nationwide study of patients admitted for possible ECPR, two-thirds of patients were not treated with ECPR. The most frequent reasons to abstain from ECPR were long duration of prehospital low-flow time, metabolic derangement and low ETCO2.

Fibrinogen as a hemostatic agent.

Coagulation factor I (fibrinogen) plays an essential role in the hemostatic system by bridging activated platelets and being the key substrate for thrombin in establishing a consolidating fibrin network. Fibrinogen is synthesized in the liver and the plasma concentration is 1 to 5-4.0 g/L. During recent 10 years, fibrinogen has been recognized to play an important role in controlling hemorrhage. Dilutional coagulopathy induced by colloid plasma expanders is characterized by fibrinogen deficiency and dysfunctional fibrin polymerization. Trauma and use of extracorporeal circulation is also known to reduce levels of fibrinogen. A series of laboratory experiments and experimental animal studies have suggested fibrinogen as a potent hemostatic agent. These data are supported by retrospective surveys as well as a series of prospective proof of principal clinical trials. This article provides a description of the biochemistry and mechanisms of fibrinogen as well as the etiology for developing fibrinogen deficiency. Furthermore, it summarizes laboratory and experimental data on the role of fibrinogen in dilutional coagulopathy and addresses laboratory monitoring issues. Finally, it lists retrospective and prospective studies, which have been designed to assess the clinical efficacy and safety of hemostatic intervention with fibrinogen concentrate.

Survival and neurological outcome after out-of-hospital cardiac arrest treated with and without mechanical circulatory support.

Aim: The aim of this study was to describe the survival and neurological outcome in patients with OHCA treated with and without mechanical circulatory support (MCS). Methods: This was a retrospective observational cohort study on patients with OHCA admitted to Aarhus University Hospital, Denmark, between January 2015 and December 2019. Kaplan-Meier estimates were used to evaluate 30-day and 30-180-day survival. Cox regression analysis was used to assess the association between covariates and one-year mortality. Results: Among 1,015 patients admitted, 698 achieved return of spontaneous circulation (ROSC) before admission, 101 patients with refractory OHCA received mechanical circulatory support (MCS) and the remaining 216 patients with refractory OHCA did not receive MCS treatment. Survival to hospital discharge was 47% (478/1015). Good neurological outcome defined as Cerebral Performance Categories 1-2 were seen among 92% (438/478) of the patients discharged from hospital. Median low-flow was 15 [8-22] minutes in the ROSC group and 105 [94-123] minutes in the MCS group. Mortality rates were high within the first 30 days, however; 30-180-day survival in patients discharged remained constant over time in both patients with ROSC on admission and patients admitted with MCS. Advanced age > 70 years (hazard ratio (HR) 1.98, 95% confidence interval (CI) 1.11-3.49), pulseless electrical activity (HR 2.39, 95% CI 1.25-4.60) and asystole HR 2.70, 95% CI 1.25-5.95) as initial rhythms were associated with one-year mortality in patients with ROSC. Conclusions: Short-term survival rates were high among patients with ROSC and patients receiving MCS. Among patients who survived to day 30, landmark analyses showed comparable 180-day survival in the two groups despite long low-flow times in the MCS group. Advanced age and initial non-shockable rhythms were independent predictors of one-year mortality in patients with ROSC on admission.

[Treated prolonged cardiac arrest without severe cognitive impairment].

The cognitive function and quality of life after extracorporeal cardiopulmonary resuscitation (ECPR) remain uncertain. In this case report, a 61-year-old male underwent ECPR for refractory out-of-hospital cardiac arrest after 102 minutes of resuscitation. The cause of cardiac arrest was acute myocardial infarction, and occlusion of the left anterior descending artery was treated with balloon angioplasty. Five years later, the patient had preserved psychical and mental health, cognitive function, and good quality of life despite prolonged cardiopulmonary resuscitation.

Two case reports of transcatheter valve-in-valve implantation of Sapien 3 and MyVal in degenerated biological tricuspid prosthesis valves.

Background: Patients with severe tricuspid valve stenosis or dysfunction following degeneration of biological valve prosthesis in tricuspid position are complex, have substantial comorbidity, and very high surgical risk. Case summary: We report two cases with transcatheter tricuspid valve-in-valve implantation in patients with degenerated tricuspid bioprosthesis with transfemoral and transjugular access with Sapien 3 valve and MyVal, respectively. Discussion: In patients with high surgical risk, transcatheter tricuspid valve implantation is a good alternative. Careful consideration of optimal access site, device size, and delivery system is paramount. This case report demonstrates technically feasible and safe transcatheter valve-in-valve implantantion in tricuspid position and highlights the importance of meticulous procedure planning.

Once after a full moon: acute type A aortic dissection and lunar phases.

OBJECTIVES: Acute type A aortic dissection (ATAAD) is a rare but severe condition, routinely treated with emergent cardiac surgery. Many surgeons have the notion that patients with ATAAD tend to come in clusters, but no studies have examined these observations. This investigation was undertaken to study the potential association between the lunar cycle and the incidence of ATAAD. METHODS: We collected information on 2995 patients who underwent ATAAD surgery at centres from the Nordic Consortium for Acute Type A Aortic Dissection collaboration. We cross-referenced the time of surgery with lunar phase using a case-crossover design with 2 different definitions of full moon (>99% illumination and the 7-day full moon period). RESULTS: The period when the moon was illuminated the most (99% definition) did not show any significant increase in incidence for ATAAD surgery. However, when the full moon period was compared with all other moon phases, it yielded a relative risk of 1.08 [95% confidence interval (CI) 1.00-1.17, P = 0.057] and, compared to waxing moon, only the relative risk was 1.11 (95% CI 1.01-1.23, P = 0.027). The peak incidence came 4-6 days after the moon was fully illuminated. CONCLUSIONS: This study found an overrepresentation of surgery for ATAAD during the full moon phase. The explanation for this is not known, but we speculate that sleep deprivation during full moon leads to a temporary increase in blood pressure, which in turn could trigger rupture of the aortic wall. While this finding is interesting, it needs to be corroborated and the clinical implications are debateable.

Extracorporeal cardiopulmonary resuscitation: a national study on the association between favourable neurological status and biomarkers of hypoperfusion, inflammation, and organ injury.

AIMS: In refractory out-of-hospital cardiac arrest (OHCA) with prolonged whole-body ischaemia, global tissue injury proceeds even after establishment of circulation with extracorporeal cardiopulmonary resuscitation (ECPR). We aimed to investigate the role of biomarkers reflecting hypoperfusion, inflammation, and organ injury in prognostication of patients with refractory OHCA managed with ECPR. METHODS AND RESULTS: This nationwide retrospective study included 226 adults with refractory OHCA managed with ECPR in Denmark (2011-2020). Biomarkers the first days after ECPR-initiation were assessed. Odds ratio of favourable neurological status (Cerebral Performance Category 1-2) at hospital discharge was estimated by logistic regression analyses. Cut-off values were calculated using the Youden's index. Fifty-six patients (25%) survived to hospital discharge, 51 (91%) with a favourable neurological status. Factors independently associated with favourable neurological status were low flow time <81 min, admission leukocytes ≥12.8 × 109/L, admission lactate <13.2 mmol/L, alkaline phosphatase (ALP) < 56 (day1) or <55 U/L (day2), and day 1 creatine kinase MB (CK-MB) < 500 ng/mL. Selected biomarkers (leukocytes, C-reactive protein, and lactate) were significantly better predictors of favourable neurological status than classic OHCA-variables (sex, age, low-flow time, witnessed arrest, shockable rhythm) alone (P = 0.001) after hospital admission. CONCLUSION: Biomarkers of hypoperfusion (lactate), inflammation (leucocytes), and organ injury (ALP and CK-MB) were independently associated with neurological status at hospital discharge. Biomarkers of hypoperfusion and inflammation (at hospital admission) and organ injury (days 1 and 2 after ECPR) may aid in the clinical decision of when to prolong or terminate ECPR in cases of refractory OHCA.