Randomised open-label trial comparing intravenous iron and an erythropoiesis-stimulating agent versus oral iron to treat preoperative anaemia in cardiac surgery (INITIATE trial).

BACKGROUND: Preoperative anaemia is a risk factor for adverse postoperative outcomes after cardiac surgery. Iron deficiency is a frequent cause of low preoperative haemoglobin. An effective treatment for preoperative anaemia associated with iron deficiency has not been determined. METHODS: We conducted a single-centre, open-label, pragmatic randomised trial, enrolling 156 elective cardiac surgery patients who had low preoperative haemoglobin (100-130 g L-1) with iron deficiency (serum ferritin <100 µg L-1 or transferrin saturation <30%) to compare intravenous ferric derisomaltose 1000 mg and darbepoetin 200 µg subcutaneously (intervention group) with oral ferrous sulphate 600 mg daily (control group). The primary outcome was transfusion of at least one unit of allogeneic red cells during surgery and within the following 5 days. Secondary outcomes included the change in haemoglobin concentration between randomisation and surgery, red cell transfusion volume, postoperative blood loss, pre-specified postoperative complications, length of hospital stay, and in-hospital death. RESULTS: The odds of red cell transfusion were lower in the intervention group compared with the control group (adjusted odds ratio=0.33; 95% confidence interval [CI], 0.15-0.75; P=0.008). Of the secondary outcomes, the only significant difference was the increase in haemoglobin between randomisation and surgery, intervention vs control 9.5 g L-1 (95% CI, 6.8-12.2; P<0.001). CONCLUSIONS: In patients with a low preoperative haemoglobin and iron deficiency, preoperative treatment with a single dose of ferric derisomaltose and darbepoetin decreased the proportion of participants who received a perioperative blood transfusion as a consequence of a greater increase in haemoglobin compared with treatment with oral ferrous sulphate. CLINICAL TRIAL REGISTRATION: ISRCTN Number: 41421863; EUDRACT number: 2011-003695-36.

Hyper- and hypocoagulability in COVID-19 as assessed by thromboelastometry -two case reports.

BACKGROUND: Coronavirus disease (COVID-19)-associated coagulopathy is most often characterized by elevated D-dimer, interleukin-6, and plasma fibrinogen concentrations as well as hypercoagulability in thromboelastometry with increased clot firmness in the EXTEM, INTEM, and FIBTEM assays. Clinically, it manifests with a very high incidence of thrombosis, particularly in the pulmonary system, whereas bleeding complications are infrequent. CASE: Here, we describe two critically ill patients with COVID-19 admitted to our intensive care unit demonstrating different thromboelastometry and biomarker patterns. One patient presented with hypercoagulability and the other patient with hypocoagulability and fibrinolysis shutdown in thromboelastometry. The pathophysiology and the potential impact on treatment options are discussed. CONCLUSIONS: A combination of biomarkers and thromboelastometry results can be helpful in the future to decide which therapeutic strategy might be most appropriate for critically ill patients with COVID-19. This would be an important step to establish precision medicine in this high-risk patient population.

Identification of clinical factors predicting warfarin sensitivity after cardiac surgery.

BACKGROUND: Warfarin is commonly initiated post-cardiac surgery to reduce the risk of intracardiac thrombus formation. Studies have found that sensitivity is increased after cardiac surgery and anticoagulation is subsequently difficult to manage. This study set out to identify clinical markers of increased warfarin sensitivity in patients after cardiac surgery, and build a model that can predict warfarin sensitivity, and improve safety in this setting. METHODS: The study was an observational, retrospective cohort design. Clinical parameters including left ventricular ejection fraction (LVEF), cross-clamp time, age, serum albumin and C-reactive protein concentrations were collected from consenting patients who had undergone cardiac surgery and were prescribed postoperative warfarin. The warfarin dose index (WDI) was calculated for each patient from their international normalized ratio (INR) and warfarin dose, as a measure of sensitivity. RESULTS: A total of 41 patients were recruited to the study. Logarithmically transformed WDI (log WDI) significantly correlated with LVEF, cardiopulmonary bypass (CPB) time, cross-clamp time, baseline INR and co-administration of amiodarone (p < 0.05). When added to a linear regression model, LVEF and cross-clamp time produced a model that accounted for 41% of the variance in log WDI (R2 = 0.41), p = 0.0002). Applying a log WDI cutoff value of -0.349 discriminated between patients who develop an INR > 4 and those who do not, with a sensitivity of 75% and a specificity of 70%. CONCLUSIONS: This single-centre study has highlighted two risk factors for increased warfarin sensitivity post-cardiac surgery. Further research is needed to confirm these findings in a wider, more diverse population, and to validate this model.

Transcatheter aortic valve-in-valve treatment of degenerative stentless supra-annular Freedom Solo valves: A single centre experience.

BACKGROUND: Redo surgery for degenerative bioprosthetic aortic valves is associated with significant morbidity and mortality. Report results of valve-in-valve therapy (ViV-TAVI) in failed supra-annular stentless Freedom Solo (FS) bioprostheses, which are the highest risk for coronary occlusion. METHODS: Six patients with FS valves (mean age 78.5 years, 50% males). Five had valvular restenosis (peak gradient 87.2 mm Hg, valve area 0.63 cm2 ), one had severe regurgitation (AR). Median time to failure was 7 years. RESULTS: Patients were high risk (mean STS/Logistic EuroScore 10.6 15.8, respectively). FS valves ranged from 21 to 25 mm. Successful ViV-TAVI was achieved in 4/6 patients (67%). Of the unsuccessful cases, (patient 1 and 2 of series) patient 1 underwent BAV with simultaneous aortography which revealed left main stem occlusion. The procedure was stopped and the patient went forward for repeat surgery. Patient 2 underwent successful ViV-TAVI with a 26-mm CoreValve with a guide catheter in the left main, but on removal coronary obstruction occurred, necessitating valve snaring into the aorta. Among the successful cases, (patients 3, 4, 5, 6) the TAVIs used were CoreValve Evolut R 23 mm (n = 3), and Lotus 23 mm (n = 1). In the successful cases the peak gradient fell from 83.0 to 38.3 mm Hg. No patient was left with >1+ AR. One patient had a stroke on Day 2, with full neurological recovery. Two patients underwent semi-elective pacing for LBBB and PR >280 ms. CONCLUSIONS: ViV-TAVI in stentless Freedom Solo valves is high risk. The risk of coronary occlusion is high. The smallest possible prosthesis (1:1 sizing) should be used, and strategies to protect the coronary vessels must be considered. © 2016 Wiley Periodicals, Inc.

Poor mobility predicts adverse outcome better than other frailty indices in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Surgical risk scoring systems are poor at predicting outcome in patients undergoing transcatheter aortic valve implantation (TAVI). Frailty indices might more accurately predict outcome. AIMS: To examine multiple frailty indices as markers of performance to see whether they predict outcomes both in the shorter (30 days) and longer terms (5 years) in patients who have undergone TAVI. METHODS: Frailty indices (Mobility; Brighton Mobility Index, New York Heart Association (NYHA), Karnofsky Performance Index, Canadian Study Health Association (CSHA) clinical frailty scale, and Katz Index of Dependence) were assessed in 312 consecutive TAVI patients. Mortality tracking was obtained from the Office of National Statistics as of May 2014. RESULTS: Mean age was 81.2 ± 7.0 years; 53.2% were male. Mean Logistic EuroSCORE and STS were 17.4 ± 9.4 and 4.6 ± 2.8, respectively. Mean peak aortic valve gradient and aortic valve area were 79.1 ± 28.0 mm Hg and 0.72 ± 0.25 cm(2) , respectively. 30-day mortality was 4.8%; long-term mortality (maximum 5.8 years, mean 2.2 ± 1.5 years) was 25.3%. Both univariate and multivariate analyses confirmed poor mobility (defined as severe impairment of mobility secondary to musculoskeletal or neurological dysfunction (Euroscore II risk)), as the best predictor of adverse outcome over both the short-term (OR 4.03, 95% CI (1.36-11.96), P = 0.012 (30 days)) and longer term (OR 2.15, 95% CI (1.33-3.48), P = 0.002, (2.2 ± 1.5 years.)). CONCLUSION: Poor mobility predicts worse survival among patients undergoing TAVI, both in the shorter and longer terms. Our data suggest that mobility impairment, of either neurological or musculoskeletal etiology, is an appropriate screening measure when considering patients for TAVI.

Transradial Secondary Arterial Access for Transcatheter Aortic Valve Implantation: Experience and Limitations.

OBJECTIVES: The transradial approach limits vascular complications in coronary interventions. The same may be true for transcatheter aortic valve implantation (TAVI). We present our experience using secondary transradial arterial access. METHODS: Secondary transradial arterial access has been our default strategy for TAVI since 2007. Procedural data is collected prospectively. We assessed procedural success and complications. RESULTS: Data from 282 patients aged 81±5.2 yrs was examined. Secondary arterial access was transradial (74%), femoral (24%) and none (2%). Secondary femoral access was reserved for failed radial access (3%), anatomical anomalies (4%), operator preference (7%), trial requirements (6%) or proctor preference (4%). The principal pathology was aortic stenosis (90.8%), aortic regurgitation (6.7%) or a combination (2.5%). CoreValve (91.4%), Edwards (7%) or Lotus valves (1.7%) were delivered via transfemoral (88.6%), direct aortic (5.3%), subclavian (3.9%) or transapical approaches (1.8%). Significant vascular complications occurred in 25 cases (9.4%), including surgical repair of a failed percutaneous closure device (n=16), ilio-femoral dissection (n=3), iliac perforations (n=3), plaque disruption (n=1) and false aneurysm (n=2), one of which was from the secondary femoral access site. There was no local vascular complication from the secondary radial site. CONCLUSIONS: The transradial secondary access route for TAVI is safe and effective. The transradial route may limit vascular access complications from secondary transfemoral access.

Local versus general anesthesia for transcatheter aortic valve implantation (TAVR)--systematic review and meta-analysis.

BACKGROUND: The hypothesis of this study was that local anesthesia with monitored anesthesia care (MAC) is not harmful in comparison to general anesthesia (GA) for patients undergoing Transcatheter Aortic Valve Implantation (TAVR).TAVR is a rapidly spreading treatment option for severe aortic valve stenosis. Traditionally, in most centers, this procedure is done under GA, but more recently procedures with MAC have been reported. METHODS: This is a systematic review and meta-analysis comparing MAC versus GA in patients undergoing transfemoral TAVR. Trials were identified through a literature search covering publications from 1 January 2005 through 31 January 2013. The main outcomes of interest of this literature meta-analysis were 30-day overall mortality, cardiac-/procedure-related mortality, stroke, myocardial infarction, sepsis, acute kidney injury, procedure time and duration of hospital stay. A random effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals. RESULTS: Seven observational studies and a total of 1,542 patients were included in this analysis. None of the studies were randomized. Compared to GA, MAC was associated with a shorter hospital stay (-3.0 days (-5.0 to -1.0); P = 0.004) and a shorter procedure time (MD -36.3 minutes (-58.0 to -15.0 minutes); P <0.001). Overall 30-day mortality was not significantly different between MAC and GA (RR 0.77 (0.38 to 1.56); P = 0.460), also cardiac- and procedure-related mortality was similar between both groups (RR 0.90 (0.34 to 2.39); P = 0.830). CONCLUSION: These data did not show a significant difference in short-term outcomes for MAC or GA in TAVR. MAC may be associated with reduced procedural time and shorter hospital stay. Now randomized trials are needed for further evaluation of MAC in the setting of TAVR.

Large calibre arterial access device closure for percutaneous aortic valve interventions: use of the Prostar system in 118 cases.

BACKGROUND: Percutaneous aortic valve treatments, balloon aortic valvuloplasty (BAV) and transcatheter aortic valve implantation (TAVI), are effective ways to treat patients with symptomatic aortic stenosis when open surgical repair is not feasible or considered too high risk. Large bore vascular access is required, and successful management of this arterial access is key to overall procedural success. We report outcomes and complications using the Prostar vascular closure device following BAV and TAVI. METHODS: During the period under consideration, 54 patients underwent BAV and 64 patients underwent TAVI (n = 118). Procedural data and outcomes were collected prospectively on a dedicated database. RESULTS: Patients were aged 80 ± 6.9 years (BAV) and 80.8 ± 6.1 years (TAVI) and 46.2% (BAV) and 46.8% (TAVI) were male, respectively. Primary success (hemostasis achieved immediately after deployment of the Prostar system on the table and persisting for a minimum of 24 hr in the absence of major or minor bleeding complications) was achieved in 94.4% (n = 54) of the patients undergoing BAV and 92.2% (n = 64) of the patients undergoing TAVI, respectively. The combined success rate was 93.3%. Major bleeding (see definitions section) was seen in 1.9% of cases in the BAV group and 4.7% of cases in the TAVI group. Minor bleeding (see definitions section) was seen in 3.7% of cases in the BAV group and 3.1% of cases in the TAVI group. CONCLUSIONS: Use of the Prostar vascular closure system to achieve hemostasis following percutaneous aortic valve interventions is associated with a high primary success rate and acceptable level of bleeding complications.

Complications of transcatheter aortic valve implantation: avoidance and management.

Transcatheter aortic valve implantation (TAVI) has taken the world of cardiovascular therapies by storm. The possibility of implanting aortic valves without recourse to sternotomy or cardiopulmonary bypass has been embraced by cardiologists, surgeons and patients alike as a revolution in management. First performed in 2002 by Alain Cribier, the technique has exploded into common use during the last three years, such that over 20,000 implants have now been undertaken worldwide. This article discusses complications of TAVI, their avoidance and management.

Predictors for permanent pacing after transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a new treatment strategy for patients with symptomatic aortic stenosis who are high risk for traditional surgical aortic valve replacement. The incidence of conduction system abnormalities after the procedure is significant. We examine our experience with CoreValve TAVI focusing on electrocardiographic changes found pre-, peri-, and postintervention. METHODS: During 2007-08 we undertook 33 cases utilizing the CoreValve revalving system (CoreValve, Paris, France). Assessment of ECGs, with particular reference to the PR and QRS duration, was made daily during each patient's hospital stay. RESULTS: Patients were aged 81.7 ± 6.7 years and the majority were male (57%). Baseline cardiac rhythm was sinus (n = 28, 80%); atrial fibrillation (n = 6, 18%) or ventricular paced (n = 1, 3%). Following CoreValve implantation, prolongation of both the PR interval and QRS duration was seen. Preprocedural PR interval was 193.5 ± 38.7 ms and QRS interval preprocedure was 115.3 ± 24.8 ms. PR interval increased after the procedure by 23.5 ± 23.9 ms and peaked at day 4 with a mean increase of 66.1 ± 72.7 ms. QRS duration increased by a mean of 30.6 ± 26.1 ms postprocedure and remained stable thereafter during the remaining hospital stay. The need for PPM insertion was partially predicted by pre-procedural QRS morphology: patients with pre-existing right bundle branch block had an 83% chance of requiring a permanent pacemaker (P < 0.01 OR 28 95%CI 2.4-326.7); those with LBBB had a 33% chance of requiring a pacemaker (P = ns OR 2.3 95%CI 0.2-34.9). Patients undergoing the procedure later in our experience showed a decreased incidence of pacing (P = 0.046 OR 0.36 95% CI 0.07-1.82). Pre-procedural annulus measurements also predicted the requirement for pacing with larger annulus sizes more likely to require a pacemaker (P = 0.044 OR 3.3 95% CI 0.63-17.6). The requirement for pacing was not predicted by age, baseline PR interval or gender. Requirement for pacing overall was 32% with an additional 13% having had a pacemaker inserted prior to the TAVI. CONCLUSION: CoreValve insertion was associated with an increase in PR interval and QRS duration. PR interval continued to rise during admission, peaking on Day 4 post procedure, making a prolonged period of monitoring highly desirable. There was a significant requirement for permanent pacing, which was predicted by pre-procedural QRS morphology, annulus measurement, and the learning curve. © 2010 Wiley-Liss, Inc.

Coronary artery bypass grafting in idiopathic thrombocytopenia: use of thromboelastometry without platelet transfusion.

Patients with idiopathic thrombocytopenic purpura have safely undergone cardiac surgical procedures; however, platelets were transfused in 20 of 24 reported instances, and no point-of-care testing of coagulation status was performed. Herein, we report the case of a patient with idiopathic thrombocytopenic purpura who required urgent coronary artery bypass grafting and intra-aortic balloon pump support. Rotational thromboelastometry was used as a point-of-care test of the patient's coagulation status. No preoperative prophylactic transfusion of allogeneic platelets was necessary, and in fact the patient required no allogeneic blood products during his hospitalization. We believe that point-of-care coagulation tests such as thromboelastometry warrant further evaluation regarding their usefulness in the clinical decision of whether to transfuse platelets and other blood products.

Prognostic benefit of transcatheter aortic valve implantation compared with medical therapy in patients with inoperable aortic stenosis.

OBJECTIVES: To compare survival in patients with inoperable aortic stenosis who undergo transcatheter aortic valve implantation against those managed medically. BACKGROUND: Without surgical correction, survival of patients with severe symptomatic aortic stenosis is poor. It is unknown whether patients undergoing transcatheter aortic valve implantation (TAVI) have a better prognosis than similar patients who are treated with medical management. METHODS: Survival rates were compared in consecutive patients with severe symptomatic aortic stenosis who either underwent TAVI or continued on medical management following multidisciplinary team assessment. All patients had been turned down, or considered at unacceptably high risk, for conventional aortic valve surgery. Patients were reviewed in clinic or by telephone six monthly. Mortality data was obtained from the United Kingdom Office of National Statistics. RESULTS: The study group included 85 patients aged 81 +/- 7 years (range 62-94), of whom 48 were male. Thirty eight patients underwent TAVI while 47 patients were deemed unsuitable based on echocardiographic, angiographic, or clinical criteria and remained on medical therapy. The calculated EuroSCORE for the TAVI group was 11 +/- 2 and for the medical group 9 +/- 2 (P < 0.001). TAVI-related procedural mortality was 2.6%, and 30-day mortality was 5.2%. Among the medically-treated patients, 14 (30%) underwent palliative balloon aortic valvuloplasty, with a trend toward improved survival (P = 0.06). During overall follow-up of 215 +/- 115 days there were a total of 18 deaths; TAVI N = 5 (13%); Medical N = 13 (28%) (P = 0.04). CONCLUSIONS: Patients with severe aortic valve disease who are not suitable for surgical aortic valve replacement have an improved prognosis if treated with transcatheter aortic valve implantation rather than continuing on medical management alone.

Percutaneous aortic valve implants under sedation: our initial experience.

OBJECTIVES: We have developed an approach where percutaneous aortic valve (PAVI) procedures are done under remifentanil-based sedation administered by an anesthetist. We report here our initial experience. BACKGROUND: Percutaneous aortic valve implantation is proving to be an effective treatment for aortic stenosis in patients with significant comorbidity precluding surgical aortic valve replacement. Most PAVIs have been done under general anesthetic with transoesophageal echocardiography (TOE). General anesthesia in this patient group is hazardous and associated with significant complications. METHODS AND RESULTS: CoreValve implantation was performed via the retrograde approach in 12 patients at our cardiothoracic center between December 2007 and May 2008. Three had the procedure under general anesthetic and nine under sedation. There were no differences between the groups in terms of comorbidities and clinical characteristics. The procedure was visualized using fluoroscopic aortic calcification coupled with multiple small volume aortograms. One patient converted from sedation to general anesthetic during the procedure. One patient in the general anesthetic group died from respiratory complications. There were no significant differences in procedural success, procedure time, or hospital stay between the two groups. CONCLUSION: Percutaneous aortic valve implantation can, in the majority of cases, be performed under remifentanil-based sedation. Our initial experience suggests that this should result in a shorter implant procedure time, reduced stay in high dependency areas, and shorter time to hospital discharge.