Postoperative quality of life and pain after upper hemisternotomy and conventional median sternotomy for aortic valve replacement: results of a randomized clinical trial.

OBJECTIVES: Surgical aortic valve replacement through conventional sternotomy yields excellent results. Minimally invasive techniques are deemed equally safe and serve as a viable and less traumatic alternative. However, it is unclear how both surgical techniques affect patient-reported outcomes. The objective of this trial is to compare postoperative cardiac-related quality of life and postoperative pain after upper hemisternotomy and conventional surgical aortic valve replacement. METHODS: In this single-centre, open-label, investigator-initiated randomized clinical trial, patients were randomized to upper hemisternotomy or conventional full median sternotomy. Patients unable to undergo randomization were monitored prospectively (registry group). Primary outcome was cardiac-specific quality of life, measured with the Kansas City Cardiomyopathy Questionnaire up to 1 year postoperatively. RESULTS: Patients undergoing upper hemisternotomy had a significantly higher physical limitation domain score across all postoperative time points than patients undergoing conventional surgical aortic valve replacement (estimated mean difference 2.12 points; P = 0.014). Patients undergoing upper hemisternotomy were more likely to have a pain score <30 the first 2 days postoperatively than patients undergoing conventional surgical aortic valve replacement (odds ratio 2.63; P = 0.007). This was associated with reduced opioid analgesic intake. Postoperative surgical outcome did not differ between both groups. CONCLUSIONS: Surgical aortic valve replacement through both conventional sternotomy and upper hemisternotomy resulted in clinically similar and important improvements in quality of life, with a small advantage for upper hemisternotomy, while there was no compromise in safety.

Comparative Analysis of Therapeutic Strategies in Post-Cardiotomy Cardiogenic Shock: Insight into a High-Volume Cardiac Surgery Center.

Background: Post-cardiotomy cardiogenic shock (PCCS), which is defined as severe low cardiac output syndrome after cardiac surgery, has a mortality rate of up to 90%. No study has yet been performed to compare patients with PCCS treated by conservative means to patients receiving additional mechanical circulatory support with veno-arterial extracorporeal membrane oxygenation (ECMO). Methods: A single-center retrospective analysis from January 2018 to June 2022 was performed. Results: Out of 7028 patients who underwent cardiac surgery during this time period, 220 patients (3%) developed PCCS. The patients were stratified according to their severity of shock based on the Stage Classification Expert Consensus (SCAI) group. Known risk factors for shock-related mortality, including the vasoactive-inotropic score (VIS) and plasma lactate levels, were assessed at structured intervals. In patients treated additionally with ECMO (n = 73), the in-hospital mortality rate was 60%, compared to an in-hospital mortality rate of 85% in patients treated by conservative means (non-ECMO; n = 52). In 18/73 (25%) ECMO patients, the plasma lactate level normalized within 48 h, compared to 2/52 (4%) in non-ECMO patients. The morbidity of non-ECMO patients compared to ECMO patients included a need for dialysis (42% vs. 60%), myocardial infarction (19% vs. 27%), and cerebrovascular accident (17% vs. 12%). Conclusions: In conclusion, the additional use of ECMO in PCCS holds promise for enhancing outcomes in these critically ill patients, more rapid improvement of end-organ perfusion, and the normalization of plasma lactate levels.

Preoperative computed tomography-imaging with patient-specific computer simulation in transcatheter aortic valve implantation: Design and rationale of the GUIDE-TAVI trial.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe aortic valve stenosis, but is still associated with relatively high rates of pacemaker implantation and paravalvular regurgitation. Routine preoperative computed tomography (CT) combined with patient-specific computer modelling can predict the interaction between the TAVI device and the patient's unique anatomy, allowing physicians to assess the risk for paravalvular regurgitation and conduction disorders in advance to the procedure. The aim of this trial is to assess potential improvement in the procedural outcome of TAVI by applying CT-based patient-specific computer simulations in patients with suitable anatomy for TAVI. METHODS: The GUIDE-TAVI trial is an international multicenter randomized controlled trial including patients accepted for TAVI by the Heart Team. Patients enrolled in the study will be randomized into 2 arms of each 227 patients. In patients randomized to the use of FEops HEARTGuide (FHG), patient-specific computer simulation with FHG is performed in addition to routine preoperative CT imaging and results of the FHG are available to the operator(s) prior to the scheduled intervention. In patients randomized to no use of FHG, only routine preoperative CT imaging is performed. The primary objective is to evaluate whether the use of FHG will reduce the incidence of mild to severe PVR, according to the Valve Academic Research Consortium 3. Secondary endpoints include the incidence of new conduction disorders requiring permanent pacemaker implantation, the difference between preoperative and final selected valve size, the difference between target and final implantation depth, change of preoperative decision, failure to implant valve, early safety composite endpoint and quality of life. CONCLUSIONS: The GUIDE-TAVI trial is the first multicenter randomized controlled trial to evaluate the value of 3-dimensional computer simulations in addition to standard preprocedural planning in TAVI procedures.

Renal and Multiorgan Safety of 177Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer in the VISION Dosimetry Substudy.

In the VISION trial, [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) plus protocol-permitted standard of care significantly improved overall survival and radiographic progression-free survival compared with standard of care alone in patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. This VISION dosimetry substudy quantified absorbed doses of 177Lu-PSMA-617 in the kidneys and other organs. Methods: Participants were a separate cohort of 30 nonrandomized patients receiving standard of care plus 177Lu-PSMA-617 at 7.4 GBq per cycle for up to 6 cycles. Blood samples, whole-body conjugate planar image scintigraphy, and abdominal SPECT/CT images were collected. SPECT/CT images were collected at 2, 24, 48, and 168 h after administration in cycle 1 and at a single time point 48 h after administration in cycles 2-6. Outcomes were absorbed dose per unit activity per cycle and cumulative absorbed dose over all cycles. Cumulative absorbed doses were predicted by extrapolation from cycle 1, and calculation of observed values was based on measurements of cycle 1 and cycles 2-6. Safety was also assessed. Results: Mean (±SD) absorbed doses per cycle in the kidneys were 0.43 ± 0.16 Gy/GBq in cycle 1 and 0.44 ± 0.21 Gy/GBq in cycles 2-6. The observed and predicted 6-cycle cumulative absorbed doses in the kidneys were 15 ± 6 and 19 ± 7 Gy, respectively. Observed and predicted cumulative absorbed doses were similar in other at-risk organs. Safety findings were consistent with those in the VISION study; no patients experienced renal treatment-emergent adverse events of a grade higher than 3. Conclusion: The renal cumulative absorbed 177Lu-PSMA-617 dose was below the established limit. 177Lu-PSMA-617 had a good overall safety profile, and low renal radiotoxicity was not a safety concern. Cumulative absorbed doses in at-risk organs over multiple cycles can be predicted by extrapolation from cycle 1 data in patients with metastatic castration-resistant prostate cancer receiving 177Lu-PSMA-617.

Adding Surgical Edge-to-Edge Mitral Valve Repair to Myectomy in Hypertrophic Obstructive Cardiomyopathy: Long-Term Functional and Echocardiographic Outcome.

This study evaluates the early and long-term clinical and echocardiographic outcome of edge-to-edge (E2E) mitral valve repair (MVr) concomitant to septal myectomy (SM) in patients with symptomatic hypertrophic obstructive cardiomyopathy (HOCM). A retrospective single-center analysis was performed of patients who underwent isolated SM or SM with E2E MVr from 2011 to 2022. Exclusion criteria were primary mitral valve (MV) disease or concomitant valve surgery. Early and long-term safety, functional and echocardiographic outcomes were compared between groups. Between January 2011 and April 2022, 76 consecutive patients underwent SM for HOCM: 42 patients (55%) underwent SM without additional E2E MVr (Group 1) and 34 patients (45%) underwent SM with additional E2E MVr (Group 2). At latest follow-up, 87% of patients were in New York Heart Association (NYHA) class I-II with no significant differences in NYHA class between groups. Incidence of safety events was comparable between groups. Echocardiographic relief of left ventricular outflow tract (LVOT) obstruction was comparable at early follow-up (P = 0.68), with a significant but small difference in maximum LVOT pressure gradient at latest follow-up in favor of E2E MVr (P = 0.04). Furthermore, patients who underwent SM with E2E MVr showed less residual systolic anterior motion at early and latest follow-up (P = 0.020; P = 0.178). Reintervention on the MV was absent in both groups at 1 year and equally low at follow-up (P = 0.27). This study demonstrates that adding E2E MVr to septal myectomy is as safe as isolated myectomy for the treatment of HOCM. Moreover, the addition of E2E MVr is associated with similar excellent functional improvement and freedom from MV reintervention.

Reference Values for Inward Displacement in the Normal Left Ventricle: A Novel Method of Regional Left Ventricular Function Assessment.

BACKGROUND: Regional functional left ventricular (LV) assessment using current imaging techniques remains limited. Inward displacement (InD) has been developed as a novel technique to assess regional LV function via measurement of the regional displacement of the LV endocardial border across each of the 17 LV segments. Currently, normal ranges for InD are not available for clinical use. The aim of this study was to validate the normal reference limits of InD in healthy adults across all LV segments. METHODS: InD was analyzed in 120 healthy subjects with a normal LV ejection fraction, using the three standard long-axis views obtained during cardiac MRI that quantified the degree of inward endocardial wall motion towards the true LV center of contraction. For all LV segments, InD was measured in mm and expressed as a percentage of the theoretical degree of maximal segment contraction towards the true LV centerline. The arithmetic average InD was obtained for each of the 17 segments. The LV was divided into three regions, obtaining average InD at the LV base (segments 1-6), mid-cavity (segments 7-12) and apex (segments 13-17). RESULTS: Average InD was 33.4 ± 4.3%. InD was higher in basal and mid-cavity LV segments (32.8 ± 4.1% and 38.1 ± 5.8%) compared to apical LV segments (28.6 ± 7.7%). Interobserver variability correlations for InD were strong (R = 0.80, p < 0.0001). CONCLUSIONS: We provide clinically meaningful reference ranges for InD in subjects with normal LV function, which will emerge as an important screening and assessment imaging tool for a range of HFrEF therapies.

Transcatheter closure of postsurgical aortic pseudoaneurysms guided by three-dimensional image reconstruction: a single-centre experience.

BACKGROUND: Postsurgical thoracic aortic pseudoaneurysms (PTAPs) are a potentially lethal complication after cardiac or aortic surgery. Surgical management can pose a challenge with high in-hospital mortality rates. Transcatheter closure is a less-invasive alternative treatment option for selected patients, although current experience is limited. AIMS: We aimed to evaluate procedural and imaging outcomes of our first 11 cases of transcatheter PTAP closure with the use of closure devices. METHODS: Patients with a high operative risk who underwent transcatheter PTAP closure at our centre from 2019 to 2021 were retrospectively included. Suitability was evaluated on preprocedural computed tomography (CT) scans and three-dimensional (3D) reconstructions. All procedures were performed in the catheterisation laboratory. Intraprocedural aortography and postprocedural CT scans with 3D reconstructions were used to evaluate PTAP occlusion. RESULTS: Eleven consecutive patients with a high operative risk and a history of cardiac/aortic surgery who underwent transcatheter PTAP closure were included. PTAPs were predominantly located at the proximal or distal anastomosis of a supracoronary ascending aortic vascular graft or Bentall prosthesis (82%). Implanted closure devices included Amplatzer Valvular Plug III (82%), Amplatzer septal occluder (9%) and Occlutech atrial septal defect occluder (9%). No periprocedural complications occurred. After device deployment, residual flow was absent on aortography in 64% and minimal residual flow was present in 36% of patients. Subtotal or total occlusion of the PTAP on follow-up CT ranged between 45% and 73%. CONCLUSIONS: Although subtotal or total occlusion of the PTAP was found at follow-up in only 45-73% of cases, transcatheter PTAP closure guided by preprocedural 3D reconstructions can offer a valuable minimally invasive primary treatment option for patients who otherwise would face a high-risk reoperation.

Inward Displacement: A Novel Method of Regional Left Ventricular Functional Assessment for Left Ventriculoplasty Interventions in Heart Failure with Reduced Ejection Fraction (HFrEF).

BACKGROUND: Hybrid minimally invasive left ventricular reconstruction is used to treat patients with ischemic heart failure with reduced ejection fraction (HFrEF) and antero-apical scar. Pre- and post-procedural regional functional left ventricular assessment with current imaging techniques remains limited. We evaluated 'inward displacement' as a novel technique of assessing regional left ventricular function in an ischemic HFrEF population who underwent left ventricular reconstruction with the Revivent System. METHODS: Inward displacement adopts three standard long-axis views obtained during cardiac MRI or CT and assesses the degree of inward endocardial wall motion towards the true left ventricular center of contraction. For each of the standard 17 left ventricular segments, regional inward displacement is measured in mm and expressed as a percentage of the maximal theoretical distance each segment can contract towards the centerline. The left ventricle was divided into three regions, obtaining the arithmetic average of inward displacement or speckle tracking echocardiographic strain at the left ventricular base (segments 1-6), mid-cavity (segments 7-12) and apex (segments 13-17). Inward displacement was measured using computed tomography or cardiac magnetic resonance imaging and compared pre- and post-procedurally in ischemic HFrEF patients who underwent left ventricular reconstruction with the Revivent System (n = 36). In a subset of patients who underwent baseline speckle tracking echocardiography, pre-procedural inward displacement was compared with left ventricular regional echocardiographic strain (n = 15). RESULTS: Inward displacement of basal and mid-cavity left ventricular segments increased by 27% (p < 0.001) and 37% (p < 0.001), respectively, following left ventricular reconstruction. A significant overall decrease in both the left ventricular end systolic volume index and end diastolic volume index of 31% (p < 0.001) and 26% (p < 0.001), respectively, was detected, along with a 20% increase in left ventricular ejection fraction (p = 0.005). A significant correlation between inward displacement and speckle tracking echocardiographic strain was noted within the basal (R = -0.77, p < 0.001) and mid-cavity left ventricular segments (R = -0.65, p = 0.004), respectively. Inward displacement resulted in relatively larger measurement values compared to speckle tracking echocardiography, with a mean difference of absolute values of -3.33 and -7.41 for the left ventricular base and mid-cavity, respectively. CONCLUSIONS: Obviating the limitations of echocardiography, inward displacement was found to highly correlate with speckle tracking echocardiographic strain to evaluate regional segmental left ventricular function. Significant improvements in basal and mid-cavity left ventricular contractility were demonstrated in ischemic HFrEF patients following left ventricular reconstruction of large antero-apical scars, consistent with the concept of reverse left ventricular remodeling at a distance. Inward displacement holds significant promise in the HFrEF population being evaluated pre- and post-left ventriculoplasty procedures.

Circularly Polarized Light Probes Excited-State Delocalization in Rectangular Ladder-type Pentaphenyl Helices.

Ladder-type pentaphenyl chromophores have a rigid, planar π-system and show bright fluorescence featuring pronounced vibrational structure. Such moieties are ideal for studying interchromophoric interactions and delocalization of electronic excitations. We report the synthesis of helical polymers with a rigid square structure based on spiro-linked ladder-type pentaphenyl units. The variation of circular dichroism with increasing chain length provides direct evidence for delocalization of electronic excitations over at least 10 monomeric units. The change in the degree of circular polarization of the fluorescence across the vibronic side bands shows that vibrational motion can localize the excitation dynamically to almost one single unit through breakdown of the Born-Oppenheimer approximation. The dynamic conversion between delocalized and localized excited states provides a new paradigm for interpreting circular dichroism in helical polymers such as proteins and polynucleic acids.

State-of-the-Art Review: Technical and Imaging Considerations in Hybrid Transcatheter and Minimally Invasive Left Ventricular Reconstruction for Ischemic Heart Failure.

Negative left ventricular (LV) remodeling consequent to acute myocardial infarction (AMI) is characterized by an increase in LV volumes in the presence of a depressed LVEF. In order to restore the shape, size, and function of the LV, operative treatment options to achieve volume reduction and shape reconstruction should be considered. In the past decade, conventional surgical LV reconstruction through a full median sternotomy has evolved towards a hybrid transcatheter and less invasive LV reconstruction. In order to perform a safe and effective hybrid LV reconstruction, thorough knowledge of the technical considerations and adequate use of multimodality imaging both pre- and intraoperatively are fundamental. In addition, a comprehensive understanding of the individual procedural steps from both a cardiological and surgical point of view is required.

State-of-the-Art Review: Technical and Imaging Considerations in Novel Transapical and Port-Access Mitral Valve Chordal Repair for Degenerative Mitral Regurgitation.

Degenerative mitral regurgitation (DMR) based on posterior leaflet prolapse is the most frequent type of organic mitral valve disease and has proven to be durably repairable in most cases by chordal repair techniques either by conventional median sternotomy or by less invasive approaches both utilizing extracorporeal circulation and cardioplegic myocardial arrest. Recently, several novel transapical chordal repair techniques specifically targeting the posterior leaflet have been developed as a far less invasive and beating heart (off-pump) alternative to port-access mitral repair. In order to perform a safe and effective minimally invasive mitral chordal repair, thorough knowledge of the anatomy of the mitral valve apparatus and adequate use of multimodality imaging both pre- and intraoperatively are fundamental. In addition, comprehensive understanding of the available novel devices, their delivery systems and the individual procedural steps are required.

Enhancing Electrochemical Transistors Based on Polymer-Wrapped (6,5) Carbon Nanotube Networks with Ethylene Glycol Side Chains.

Organic electrochemical transistors (ECTs) are an important building block for bioelectronics. To promote the required ion transport through the active layer, state-of-the-art semiconducting polymers feature hydrophilic ethylene glycol side chains that increase the volumetric capacitance and transconductance of the devices. Here, we apply this concept to polymer-wrapped single-walled carbon nanotubes (SWCNTs) as a high-mobility semiconducting material. We replace the polyfluorene copolymer (PFO-BPy), which is used for selectively dispersing semiconducting (6,5) SWCNTs and contains octyl side chains, by an equivalent polymer with tetraethylene glycol side chains. Aerosol-jet printed networks of these SWCNTs are applied as the active layer in water-gated ECTs. These show high hole mobilities (3-15 cm2·V-1·s-1), significantly improved volumetric capacitances and larger transconductances. Thin networks of SWCNTs reach (219 ± 16) F·cm-1·V-1·s-1 as the product of mobility and volumetric capacitance. In situ photoluminescence measurements show more efficient quenching of the near-infrared fluorescence for nanotube networks with hydrophilic glycol side chains compared to those with hydrophobic alkyl side chains, thus corroborating more complete charging under bias. Overall, networks of semiconducting SWCNTs with such tailored wrapping polymers provide excellent device performance. Combined with their inherent mechanical flexibility and durability, they constitute a competitive material for bioelectronics.

Midterm Outcome of Hybrid Transcatheter and Minimally Invasive Left Ventricular Reconstruction for the Treatment of Ischemic Heart Failure.

Background: Left ventricular (LV) remodeling after anterior myocardial infarction (AMI) can cause a pathological increase in LV volume, reduction in LV ejection fraction (EF), and symptomatic heart failure (HF). This study evaluates the midterm results of a hybrid transcatheter and minimally invasive surgical technique to reconstruct the negatively remodeled LV by myocardial scar plication and exclusion with microanchoring technology. Methods: Retrospective single-center analysis of patients who underwent hybrid LV reconstruction (LVR) with the Revivent TransCatheter System. Patients were accepted for the procedure when they presented with symptomatic HF (New York Heart Association class ≥ II, EF < 40%) after AMI, in the presence of a dilated LV with either akinetic or dyskinetic scar in the anteroseptal wall and/or apex of ≥50% transmurality. Results: Between October 2016 and November 2021, 30 consecutive patients were operated. Procedural success was 100%. Comparing echocardiographic data preoperatively and directly postoperatively, LVEF increased from 33 ± 8% to 44 ± 10% (p < 0.0001). LV end-systolic volume index decreased from 58 ± 24 mL/m2 to 34 ± 19 mL/m2 (p < 0.0001) and LV end-diastolic volume index decreased from 84 ± 32 mL/m2 to 58 ± 25 mL/m2 (p < 0.0001). Hospital mortality was 0%. After a mean follow-up of 3.4 ± 1.3 years, there was a significant improvement of New York Heart Association class (p = 0.001) with 76% of surviving patients in class I-II. Conclusions: Hybrid LVR for symptomatic HF after AMI is safe and results in significant improvement in EF, reduction in LV volumes, and sustained improvement in symptoms.

Targeting folate receptor beta on monocytes/macrophages renders rapid inflammation resolution independent of root causes.

Provoked by sterile/nonsterile insults, prolonged monocyte mobilization and uncontrolled monocyte/macrophage activation can pose imminent or impending harm to the affected organs. Curiously, folate receptor beta (FRß), with subnanomolar affinity for the vitamin folic acid (FA), is upregulated during immune activation in hematopoietic cells of the myeloid lineage. This phenomenon has inspired a strong interest in exploring FRß-directed diagnostics/therapeutics. Previously, we have reported that FA-targeted aminopterin (AMT) therapy can modulate macrophage function and effectively treat animal models of inflammation. Our current investigation of a lead compound (EC2319) leads to discovery of a highly FR-specific mechanism of action independent of the root causes against inflammatory monocytes. We further show that EC2319 suppresses interleukin-6/interleukin-1ß release by FRß+ monocytes in a triple co-culture leukemic model of cytokine release syndrome with anti-CD19 chimeric antigen receptor T cells. Because of its chemical stability and metabolically activated linker, EC2319 demonstrates favorable pharmacokinetic characteristics and cross-species translatability to support future pre-clinical and clinical development.

Patient selection for LIVE therapy: From clinical indications to multimodality imaging individual case planning.

BACKGROUND: Less Invasive Ventricular Enhancement (LIVE) with Revivent TC is an innovative therapy for symptomatic ischemic heart failure (HF). It is designed to reconstruct a negatively remodeled left ventricle (LV) after an anterior myocardial infarction (MI) by plication of the scar tissue. Its indications are specific, and as with any other structural heart intervention, the success of the procedure starts with appropriate patient selection. We aim to present the indications of the technique, crucial aspects in patient selection, and individual case planning approach. METHODS AND RESULTS: After clinical evaluation, transthoracic echocardiography is the first imaging modality to be performed in a potential candidate for the therapy. However, definitive indication and detailed case planning rely on late gadolinium-enhanced cardiac magnetic resonance imaging or multiphasic contrast-enhanced cardiac computed tomography. These imaging modalities also assist with relative or absolute contra-indications for the procedure. Individual assessment is done to tailor the procedure to the specifics of the LV anatomy and location of the myocardial scar. CONCLUSION: LIVE procedure is a unique intervention to treat symptomatic HF and ischemic cardiomyopathy after anterior MI. It is a highly customizable intervention that allows a patient-tailored approach, based on multimodality imaging assessment and planification.

Comparing quality of life and postoperative pain after limited access and conventional aortic valve replacement: Design and rationale of the LImited access aortic valve replacement (LIAR) trial.

BACKGROUND: Surgical aortic valve replacement (SAVR) via limited access approaches ('mini-AVR') have proven to be safe alternative for the surgical treatment of aortic valve disease. However, it remains unclear whether these less invasive approaches are associated with improved quality of life and/or reduced postoperative pain when compared to conventional SAVR via full median sternotomy (FMS). STUDY DESIGN: The LImited access Aortic valve Replacement (LIAR) trial is a single-center, single blind randomized controlled clinical trial comparing 2 arms of 80 patients undergoing limited access SAVR via J-shaped upper hemi-sternotomy (UHS) or conventional SAVR through FMS. In all randomized patients, the diseased native aortic valve is planned to be replaced with a rapid deployment stented bioprosthesis. Patients unwilling or unable to participate in the randomized trial will be treated conventionally via SAVR via FMS and with implantation of a sutured valve prosthesis. These patients will participate in a prospective registry. STUDY METHODS: Primary outcome is improvement in cardiac-specific quality of life, measured by two domains of the Kansas City Cardiomyopathy Questionnaire up to one year after surgery. Secondary outcomes include, but are not limited to: generic quality of life measured with the Short Form-36, postoperative pain, perioperative (technical success rate, operating time) and postoperative outcomes (30-day and one-year mortality), complication rate and hospital length of stay. CONCLUSION: The LIAR trial is designed to determine whether a limited access approach for SAVR ('mini-AVR') is associated with improved quality of life and/or reduced postoperative pain compared with conventional SAVR through FMS.The study is registered at ClinicalTrials.gov, number NCT04012060.

Blood loss after coronary artery bypass by aspirin responsiveness assessed with preoperative VerifyNow aspirin testing.

BACKGROUND: Aspirin is important for preventing thrombotic events but also increases bleeding complications. Minimizing bleeding while preventing thrombotic events remains challenging in patients undergoing coronary artery bypass grafting (CABG). Establishing the patient's preoperative aspirin response could distinguish patients at risk for perioperative blood loss. OBJECTIVE: Aim was to compare 12-h blood loss after CABG between aspirin-sensitive and aspirin-resistant patients. PATIENTS/METHODS: The primary analysis of this substudy of the POPular CABG trial (NCT02352402) included patients that used aspirin monotherapy preoperatively. A preoperative platelet function test by the VerifyNow aspirin assay was performed before CABG and patients were classified as aspirin-sensitive or aspirin-resistant based on an aspirin reaction units cutoff value of 550. The primary end point was 12-hour blood loss after CABG. The secondary end point was, among others, clinical bleeding events after CABG. RESULTS: A total of 128 patients were included in the primary analysis. Of these, 116 patients were aspirin sensitive and 12 were aspirin resistant. Mean blood loss 12 hours after CABG was 555 ± 278 mL in aspirin-sensitive patients and 406±110 mL in aspirin-resistant patients (P = .04). All bleeding events (n = 15; 11.7%) occurred in aspirin-sensitive patients. CONCLUSIONS: In patients who are on aspirin preoperatively, aspirin sensitivity was associated with 12-hour blood loss after CABG, suggesting that preoperative VerifyNow aspirin testing could identify patients undergoing CABG at high risk for perioperative bleeding.

Validation of motion tracking as tool for observational toothbrushing studies.

Video observation (VO) is an established tool for observing toothbrushing behaviour, however, it is a subjective method requiring thorough calibration and training, and the toothbrush position is not always clearly visible. As automated tracking of motions may overcome these disadvantages, the study aimed to compare observational data of habitual toothbrushing as well as of post-instruction toothbrushing obtained from motion tracking (MT) to observational data obtained from VO. One-hundred-three subjects (37.4±14.7 years) were included and brushed their teeth with a manual (MB; n = 51) or a powered toothbrush (PB; n = 52) while being simultaneously video-filmed and tracked. Forty-six subjects were then instructed how to brush their teeth systematically and were filmed/tracked for a second time. Videos were analysed with INTERACT (Mangold, Germany); parameters of interest were toothbrush position, brushing time, changes between areas (events) and the Toothbrushing Systematic Index (TSI). Overall, the median proportion (min; max) of identically classified toothbrush positions (both sextant/surface correct) in a brushing session was 87.8% (50.0; 96.9), which was slightly higher for MB compared to PB (90.3 (50.0; 96.9) vs 86.5 (63.7; 96.5) resp.; p = 0.005). The number of events obtained from MT was higher than from VO (p < 0.001) with a moderate to high correlation between them (MB: ρ = 0.52, p < 0.001; PB: ρ = 0.87; p < 0.001). After instruction, both methods revealed a significant increase of the TSI regardless of the toothbrush type (p < 0.001 each). Motion tracking is a suitable tool for observing toothbrushing behaviour, is able to measure improvements after instruction, and can be used with both manual and powered toothbrushes.

Effect of Adding Ticagrelor to Standard Aspirin on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting (POPular CABG): A Randomized, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: Approximately 15% of saphenous vein grafts (SVGs) occlude during the first year after coronary artery bypass graft surgery (CABG) despite aspirin use. The POPular CABG trial (The Effect of Ticagrelor on Saphenous Vein Graft Patency in Patients Undergoing Coronary Artery Bypass Grafting Surgery) investigated whether ticagrelor added to standard aspirin improves SVG patency at 1 year after CABG. METHODS: In this investigator-initiated, randomized, double-blind, placebo-controlled, multicenter trial, patients with ≥1 SVGs were randomly assigned (1:1) after CABG to ticagrelor or placebo added to standard aspirin (80 mg or 100 mg). The primary outcome was SVG occlusion at 1 year, assessed with coronary computed tomography angiography, in all patients that had primary outcome imaging available. A generalized estimating equation model was used to perform the primary analysis per SVG. The secondary outcome was 1-year SVG failure, which was a composite of SVG occlusion, SVG revascularization, myocardial infarction in myocardial territory supplied by a SVG, or sudden death. RESULTS: Among 499 randomly assigned patients, the mean age was 67.9±8.3 years, 87.1% were male, the indication for CABG was acute coronary syndrome in 31.3%, and 95.2% of procedures used cardiopulmonary bypass. Primary outcome imaging was available in 220 patients in the ticagrelor group and 223 patients in the placebo group. The SVG occlusion rate in the ticagrelor group was 10.5% (51 of 484 SVGs) versus 9.1% in the placebo group (43 of 470 SVGs), odds ratio, 1.29 [95% CI, 0.73-2.30]; P=0.38. SVG failure occurred in 35 (14.2%) patients in the ticagrelor group versus 29 (11.6%) patients in the placebo group (odds ratio, 1.22 [95% CI, 0.72-2.05]). CONCLUSIONS: In this randomized, placebo-controlled trial, the addition of ticagrelor to standard aspirin did not reduce SVG occlusion at 1 year after CABG. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02352402.

Short-term outcome of the intuity rapid deployment prosthesis: a systematic review and meta-analysis.

OBJECTIVES: Limited access aortic valve replacement is an alternative approach for the treatment of calcified aortic valve disease. To facilitate limited access aortic valve replacement, rapid deployment valve prostheses have been developed aiming to reduce surgical impact. This systematic review gives an overview of current literature regarding the INTUITY or INTUITY Elite rapid deployment biological valve prosthesis. METHODS: Cochrane, Embase and MEDLINE were searched to identify relevant studies. All studies reporting on patients who underwent isolated or combined surgical aortic valve replacement with the INTUITY or INTUITY Elite valve prosthesis were considered eligible. Primary end points were technical success rate, 30-day mortality, cerebrovascular accident, paravalvular leak and permanent pacemaker implantation. Secondary end points included procedural data such as aortic cross-clamping time, cardiopulmonary bypass time and procedural approach. RESULTS: A total of 16 articles fulfilled the inclusion and exclusion criteria and comprised 4.184 patients. Thirty-day mortality was 2.7% (1.9-3.7%), cerebrovascular accident 2.6% (1.4-4.7%), permanent pacemaker implantation 7.9% (6.6-9.5%) and severe postoperative paravalvular leak requiring a reintervention 3.3% (1.7-6.1%). Technical success rate varied between 93.9% and 100%. Conventional median sternotomy was most commonly performed, ranging from 21.7% to 89.6%. Upper hemi-sternotomy was performed more often than anterior right thoracotomy, ranging from 10.4% to 63.3% and 2.2% to 26.1%. The mean transvalvular pressure gradient ranged between 9.0 and 10.3 mmHg at 1 year postoperatively. CONCLUSIONS: This review demonstrates that the technical success rate of the INTUITY or INTUITY Elite rapid deployment valve system is high, also in limited access aortic valve replacement. Mortality and cerebrovascular accident rates are low, but the need for postoperative permanent pacemaker implantation and reintervention rate for paravalvular leakage is increased.