Comparison of a Pure Plug-Based Versus a Primary Suture-Based Vascular Closure Device Strategy for Transfemoral Transcatheter Aortic Valve Replacement: The CHOICE-CLOSURE Randomized Clinical Trial.

BACKGROUND: Transcatheter aortic valve replacement is an established treatment option for patients with severe symptomatic aortic stenosis and is most commonly performed through the transfemoral access route. Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce. METHODS: The CHOICE-CLOSURE trial (Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure during Transfemoral Transcatheter Aortic Valve Implantation) is an investigator-initiated, multicenter study, in which patients undergoing transfemoral transcatheter aortic valve replacement were randomly assigned to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex) with no additional VCDs or a primary suture-based technique (ProGlide, Abbott Vascular) potentially complemented by a small plug. The primary end point consisted of access site- or access-related major and minor vascular complications during index hospitalization, defined according to the Valve Academic Research Consortium-2 criteria. Secondary end points included the rate of access site- or access-related bleeding, VCD failure, and time to hemostasis. RESULTS: A total of 516 patients were included and randomly assigned. The mean age of the study population was 80.5±6.1 years, 55.4% were male, 7.6% of patients had peripheral vascular disease, and the mean Society of Thoracic Surgeons score was 4.1±2.9%. The primary end point occurred in 19.4% (50/258) of the pure plug-based group and 12.0% (31/258) of the primary suture-based group (relative risk, 1.61 [95% CI, 1.07-2.44], P=0.029). Access site- or access-related bleeding occurred in 11.6% versus 7.4% (relative risk, 1.58 [95%CI: 0.91-2.73], P=0.133) and device failure in 4.7% versus 5.4% (relative risk, 0.86, [95% CI, 0.40-1.82], P=0.841) in the respective groups. Time to hemostasis was significantly shorter in the pure plug-based group (80 [32-180] versus 240 [174-316] seconds, P<0.001). CONCLUSIONS: Among patients treated with transfemoral transcatheter aortic valve replacement, a pure plug-based vascular closure technique using the MANTA VCD is associated with a higher rate of access site- or access-related vascular complications but a shorter time to hemostasis compared with a primary suture-based technique using the ProGlide VCD. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04459208.

Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation: Results From an International, Multicenter Cohort Study.

BACKGROUND: Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is increasingly used to treat cardiogenic shock. However, VA-ECMO might hamper myocardial recovery. The Impella unloads the left ventricle. This study aimed to evaluate whether left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO was associated with lower mortality. METHODS: Data from 686 consecutive patients with cardiogenic shock treated with VA-ECMO with or without left ventricular unloading using an Impella at 16 tertiary care centers in 4 countries were collected. The association between left ventricular unloading and 30-day mortality was assessed by Cox regression models in a 1:1 propensity score-matched cohort. RESULTS: Left ventricular unloading was used in 337 of the 686 patients (49%). After matching, 255 patients with left ventricular unloading were compared with 255 patients without left ventricular unloading. In the matched cohort, left ventricular unloading was associated with lower 30-day mortality (hazard ratio, 0.79 [95% CI, 0.63-0.98]; P=0.03) without differences in various subgroups. Complications occurred more frequently in patients with left ventricular unloading: severe bleeding in 98 (38.4%) versus 45 (17.9%), access site-related ischemia in 55 (21.6%) versus 31 (12.3%), abdominal compartment in 23 (9.4%) versus 9 (3.7%), and renal replacement therapy in 148 (58.5%) versus 99 (39.1%). CONCLUSIONS: In this international, multicenter cohort study, left ventricular unloading was associated with lower mortality in patients with cardiogenic shock treated with VA-ECMO, despite higher complication rates. These findings support use of left ventricular unloading in patients with cardiogenic shock treated with VA-ECMO and call for further validation, ideally in a randomized, controlled trial.

Interventional closure of the left atrial appendage for stroke prevention.

BACKGROUND: Transcatheter left atrial appendage (LAA) closure is an alternative therapy for stroke prevention in atrial fibrillation (AF) patients. However; real-world efficacy, safety and complications have yet to be investigated. We sought to determine the procedural outcomes and potential complications of LAA closure in routine clinical practice at a high-volume center. METHODS AND RESULTS: The study group comprised 179 patients (105 males; 72.7±9.0 years) with AF undergoing LAA closure at a single center in Germany. The rate of successful implantation was 98.9% (2 patients did not undergo implantation) and the overall procedure-related complication rate was 11.2% (major: 3.3%: tamponade 2; possibility of transient ischemic attack (TIA) 1; device dislocation 3; minor: 7.8%: pericardial effusion 2; air embolization with transient ST segment elevation 3; thrombus on device/sheath 3; puncture complications 5). At 45 days; 99.4% showed successful sealing of the LAA and 94.5% discontinued oral anticoagulation (OAC). TIA occurred in 2 patients during 6-month follow-up; but no cases of stroke were reported. There were no hemorrhagic stroke or device-related deaths. Only 1 patient was hospitalized with traumatic subdural hematoma. Minor bleeding was reported in 5 patients. CONCLUSIONS: Transcatheter LAA closure in a high-volume center is safe and feasible. Life-threatening complications are rare. Discontinuation of OAC 45 days after implantation was also safe.

A study of bailout plug-based closure after failed suture-based closure in patients undergoing transfemoral TAVI.

BACKGROUND: Percutaneous suture-based arterial access site closure (ProGlide) is commonly applied in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). However, the failure of a suture-based vascular closure device (VCD) may require additional treatment. AIMS: We aimed to evaluate the efficacy and safety of bailout access site closure using a large-bore plug-based device (MANTA) in patients with failed suture-based closure during transfemoral TAVI. METHODS: Patients undergoing a bailout attempt with the MANTA VCD were identified from a prospectively enrolling, institutional registry. Efficacy was defined as haemostasis at the access site without the need for alternative treatment other than manual compression or endovascular ballooning. Safety was defined as freedom from vascular dissection, stenosis and occlusion requiring intervention. RESULTS: Of 2,505 patients, 66 underwent a bailout attempt with MANTA as a result of ProGlide failure, which occurred before the large-bore sheath insertion in 16.7% of patients and after the sheath removal in 83.3% of patients. Bailout MANTA was deemed effective in 75.8% of patients (50/66), and the technique was considered safe in 86.4% (57/66) of patients. Failure of bailout MANTA occurred because of its superficial application, resulting in persistent bleeding in 18.2% of patients (12/66), and because of its deep application, resulting in stenosis or occlusion in 6.1% of patients (4/66). Operator experience with the technique (odds ratio [OR] 12.29, 95% confidence interval [CI]: 1.99-75.99; p=0.007) and prior use of three ProGlides (OR 0.02, 95% CI: <0.01-0.39; p=0.010) were the only independent predictors of the efficacy endpoint. CONCLUSIONS: Bailout MANTA after ProGlide failure was effective and safe, but operator experience seems to be crucial. Further technological refinements to facilitate accurate placement appear necessary.

Prognostic significance and clinical utility of left atrial reservoir strain in transcatheter aortic valve replacement.

AIMS: Patients with diastolic dysfunction (DD) experience worse outcomes after transcatheter aortic valve replacement (TAVR). We investigated the prognostic value and clinical utility of left atrial reservoir strain (LARS) in patients undergoing TAVR for aortic stenosis (AS). METHODS AND RESULTS: All consecutive patients undergoing TAVR between January 2018 and December 2018 were included if discharge echocardiography and follow-up were available. LARS was derived from 2D-speckle-tracking. Patients were grouped into three tertiles according to LARS. DD was analysed using the ASE/EACVI-algorithm. The primary outcome was a composite of all-cause death and readmission for worsening heart failure 12 months after TAVR. Overall, 606 patients were available [age 80 years, interquartile range (IQR) 77-84], including 53% women. Median LARS was 13.0% (IQR 8.4-18.3). Patients were classified by LARS tertiles [mildly impaired 21.4% (IQR 18.3-24.5), moderately impaired 13.0% (IQR 11.3-14.6), severely impaired 7.1% (IQR 5.4-8.4), P < 0.0001]. The primary outcome occurred more often in patients with impaired LARS (mildly impaired 7.4%, moderately impaired 13.4%, and severely impaired 25.7%, P < 0.0001). On adjusted multivariable Cox regression analysis, LARS tertiles [hazard ratio (HR) 0.62, 95% confidence interval (CI) 0.44-0.86, P = 0.005] and higher degree of tricuspid regurgitation (HR 1.82, 95% CI 1.23-2.98, P = 0.003) were the only significant predictors of the primary endpoint. Importantly, DD was unavailable in 56% of patients, but LARS assessment allowed for reliable prognostication regarding the primary endpoint in subgroups without DD assessment (HR 0.64, 95% CI 0.47-0.87, P = 0.003). CONCLUSION: Impaired LARS is independently associated with worse outcomes in patients undergoing TAVR. LARS allows for risk stratification at discharge even in patients where DD cannot be assessed by conventional echocardiographic means.

Interrater Variability of ML-Based CT-FFR in Patients without Obstructive CAD before TAVR: Influence of Image Quality, Coronary Artery Calcifications, and Location of Measurement.

Objectives: CT-derived fractional flow reserve (CT-FFR) can improve the specificity of coronary CT-angiography (cCTA) for ruling out relevant coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR). However, little is known about the reproducibility of CT-FFR and the influence of diffuse coronary artery calcifications or segment location. The objective was to assess the reliability of machine-learning (ML)-based CT-FFR prior to TAVR in patients without obstructive CAD and to assess the influence of image quality, coronary artery calcium score (CAC), and the location of measurement within the coronary tree. Methods: Patients assessed for TAVR, without obstructive CAD on cCTA were evaluated with ML-based CT-FFR by two observers with differing experience. Differences in absolute values and categorization into hemodynamically relevant CAD (CT-FFR ≤ 0.80) were compared. Results in regard to CAD were also compared against invasive coronary angiography. The influence of segment location, image quality, and CAC was evaluated. Results: Of the screened patients, 109/388 patients did not have obstructive CAD on cCTA and were included. The median (interquartile range) difference of CT-FFR values was -0.005 (-0.09 to 0.04) (p = 0.47). Differences were smaller with high values. Recategorizations were more frequent in distal segments. Diagnostic accuracy of CT-FFR between both observers was comparable (proximal: Δ0.2%; distal: Δ0.5%) but was lower in distal segments (proximal: 98.9%/99.1%; distal: 81.1%/81.6%). Image quality and CAC had no clinically relevant influence on CT-FFR. Conclusions: ML-based CT-FFR evaluation of proximal segments was more reliable. Distal segments with CT-FFR values close to the given threshold were prone to recategorization, even if absolute differences between observers were minimal and independent of image quality or CAC.

Complications in patients with cardiogenic shock on veno-arterial extracorporeal membrane oxygenation therapy: distribution and relevance. Results from an international, multicentre cohort study.

AIMS: Veno-arterial extracorporeal membrane oxygenation therapy (VA-ECMO) restores circulation and tissue oxygenation in cardiogenic shock (CS) patients, but can also lead to complications. This study aimed to quantify VA-ECMO complications and analyse their association with overall survival as well as favourable neurological outcome (cerebral performance categories 1 + 2). METHODS AND RESULTS: All-comer patients with CS treated with VA-ECMO were retrospectively enrolled from 16 centres in four countries (2005-2019). Neurological, bleeding, and ischaemic adverse events (AEs) were considered. From these, typical VA-ECMO complications were identified and analysed separately as device-related complications. n = 501. Overall, 118 were women (24%), median age was 56.0 years, median lactate was 8.1 mmol/L. Acute myocardial infarction caused CS in 289 patients (58%). Thirty-days mortality was 40% (198/501 patients). At least one device-related complication occurred in 252/486 (52%) patients, neurological AEs in 108/469 (23%), bleeding in 192/480 (40%), ischaemic AEs in 123/478 (26%). The 22% of patients with the most AEs accounted for 50% of all AEs. All types of AEs were associated with a worse prognosis. Aside from neurological ones, all AEs and device-related complications were more likely to occur in women; although prediction of AEs outside of neurological AEs was generally poor. CONCLUSION: Therapy and device-related complications occur in half of all patients treated with VA-ECMO and are associated with a worse prognosis. They accumulate in some patients, especially in women. Aside from neurological events, identification of patients at risk is difficult, highlighting the need to establish additional quantitative markers of complication risk to guide VA-ECMO treatment in CS.

Clinical presentation, shock severity and mortality in patients with de novo versus acute-on-chronic heart failure-related cardiogenic shock.

AIMS: Heart failure-related cardiogenic shock (HF-CS) accounts for a significant proportion of CS cases. Whether patients with de novo HF and those with acute-on-chronic HF in CS differ in clinical characteristics and outcome remains unclear. The aim of this study was to evaluate differences in clinical presentation and mortality between patients with de novo and acute-on-chronic HF-CS. METHODS AND RESULTS: In this international observational study, patients with HF-CS from 16 tertiary care centres in five countries were enrolled between 2010 and 2021. To investigate differences in clinical presentation and 30-day mortality, adjusted logistic/Cox regression models were fitted. Patients (n = 1030) with HF-CS were analysed, of whom 486 (47.2%) presented with de novo HF-CS and 544 (52.8%) with acute-on-chronic HF-CS. Traditional markers of CS severity (e.g. blood pressure, heart rate and lactate) as well as use of treatments were comparable between groups. However, patients with acute-on-chronic HF-CS were more likely to have a higher CS severity and also a higher mortality risk, after adjusting for relevant confounders (de novo HF 45.5%, acute-on-chronic HF 55.9%, adjusted hazard ratio 1.38, 95% confidence interval 1.10-1.72, p = 0.005). CONCLUSION: In this large HF-CS cohort, acute-on-chronic HF-CS was associated with more severe CS and higher mortality risk compared to de novo HF-CS, although traditional markers of CS severity and use of treatments were comparable. These findings highlight the vast heterogeneity of patients with HF-CS, emphasize that HF chronicity is a relevant disease modifier in CS, and indicate that future clinical trials should account for this.

Association between left ventricular ejection fraction, mortality and use of mechanical circulatory support in patients with non-ischaemic cardiogenic shock.

BACKGROUND: Currently, use of mechanical circulatory support (MCS) in non-ischaemic cardiogenic shock (CS) is predominantly guided by shock-specific markers, and not by markers of cardiac function. We hypothesise that left ventricular ejection fraction (LVEF) can identify patients with a higher likelihood to benefit from MCS and thus help to optimise their expected benefit. METHODS: Patients with non-ischaemic CS and available data on LVEF from 16 tertiary-care centres in five countries were analysed. Cox regression models were fitted to evaluate the association between LVEF and mortality, as well as the interaction between LVEF, MCS use and mortality. RESULTS: N = 807 patients were analysed: mean age 63 [interquartile range (IQR) 51.5-72.0] years, 601 (74.5%) male, lactate 4.9 (IQR 2.6-8.5) mmol/l, LVEF 20 (IQR 15-30) %. Lower LVEF was more frequent amongst patients with more severe CS, and MCS was more likely used in patients with lower LVEF. There was no association between LVEF and 30-day mortality risk in the overall study cohort. However, there was a significant interaction between MCS use and LVEF, indicating a lower 30-day mortality risk with MCS use in patients with LVEF ≤ 20% (hazard ratio 0.72, 95% confidence interval 0.51-1.02 for LVEF ≤ 20% vs. hazard ratio 1.31, 95% confidence interval 0.85-2.01 for LVEF > 20%, interaction-p = 0.017). CONCLUSION: This retrospective study may indicate a lower mortality risk with MCS use only in patients with severely reduced LVEF. This may propose the inclusion of LVEF as an adjunctive parameter for MCS decision-making in non-ischaemic CS, aiming to optimise the benefit-risk ratio.

Sex-related differences in patients presenting with heart failure-related cardiogenic shock.

BACKGROUND: Heart failure-related cardiogenic shock (HF-CS) accounts for a significant proportion of all CS cases. Nevertheless, there is a lack of evidence on sex-related differences in HF-CS, especially regarding use of treatment and mortality risk in women vs. men. This study aimed to investigate potential differences in clinical presentation, use of treatments, and mortality between women and men with HF-CS. METHODS: In this international observational study, patients with HF-CS (without acute myocardial infarction) from 16 tertiary-care centers in five countries were enrolled between 2010 and 2021. Logistic and Cox regression models were used to assess differences in clinical presentation, use of treatments, and 30-day mortality in women vs. men with HF-CS. RESULTS: N = 1030 patients with HF-CS were analyzed, of whom 290 (28.2%) were women. Compared to men, women were more likely to be older, less likely to have a known history of heart failure or cardiovascular risk factors, and lower rates of highly depressed left ventricular ejection fraction and renal dysfunction. Nevertheless, CS severity as well as use of treatments were comparable, and female sex was not independently associated with 30-day mortality (53.0% vs. 50.8%; adjusted HR 0.94, 95% CI 0.75-1.19). CONCLUSIONS: In this large HF-CS registry, sex disparities in risk factors and clinical presentation were observed. Despite these differences, the use of treatments was comparable, and both sexes exhibited similarly high mortality rates. Further research is necessary to evaluate if sex-tailored treatment, accounting for the differences in cardiovascular risk factors and clinical presentation, might improve outcomes in HF-CS.

Transcatheter closure of multiple interatrial communications.

OBJECTIVES: We sought to examine acute and midterm results of closure of multiple interatrial communications with staged device deployment and to review the relevant literature. BACKGROUND: Information about percutaneous methods of closure for multiple defects is limited. METHODS: We treated 148 patients with multiple defects. Of these, 88 had a relevant left to right shunt ("LRS"), 52 had a presumed paradoxical embolism ("PPE"), five had both (LRS and PPE), and one patient, respectively, had migraine, decompression sickness, and a right to left shunt. After implantation of the first device, closure of additional septal defects was attempted only if indicated clinically. RESULTS: Ninety-four patients received a single device and 53 more than one. In four patients, surgical defect closure followed. At the end of follow-up (FU; mean 4.5 ± 3.4 years), complete closure of all defects occurred in 67.6% (62.1% for LRS, 76.5% for PPE). Clinical success (small or trivial residual shunt) was achieved in 86.9% (83.9% for LRS, 90.2% for PPE). Complications included pericardial effusions in 2.7%, recurrent thromboembolic events in 4.8%, and new onset of atrial fibrillation in 10.1%. In a significant number of patients with multiple defects, after single device implantation, the likelihood of complete closure increased with FU time (26% complete closure at 1 month vs. 78% at 24 months). CONCLUSION: Percutaneous closure of multiple interatrial communications is feasible and safe. Importantly, many residual defects close without further intervention at FU. Therefore, staged device delivery is an alternative to simultaneous device implantation, possibly requiring fewer and smaller second devices.

Recurrent events after percutaneous closure of patent foramen ovale.

OBJECTIVES: To determine the incidence of symptomatic recurrent embolic events after patent foramen ovale (PFO) closure and potential causes for these events. BACKGROUND: It is well-known that cerebral or other embolic events may occur after PFO closure. METHODS: This is a retrospective analysis of consecutive patients who underwent PFO closure for secondary prevention of embolic events at a single institution. RESULTS: 1,930 patients (mean age of 50 ± 13.3 years) underwent transcatheter PFO closure. Complete closure occurred in 92%. The annual recurrence rate of embolic events before PFO closure was 22.4% (785 events in 3,497 patient-years). During follow-up (mean 39 months), 63 recurrent events were documented: 25 strokes, 36 transient ischemic attacks (TIAs), and 2 peripheral embolic events. The overall annual recurrence rate after the procedure was 1% per year (63 events in 6,211 patient-years). The majority of events occurred in patients without residual shunts (54/63). There was no significant association between the presence of a residual shunt and recurrent events [hazard ratio (HR) 1.7; 95% confidence interval (CI) 0.8-3.6, P = 0.16]. The most common cause for recurrent events was atherosclerosis. Nine out of 63 events were considered likely or possible paradoxical embolism due to residual shunt [stroke (2), TIA (5), and peripheral embolism (2)]. After PFO closure, the annual rate of events potentially related to paradoxical embolism was 0.14% (9 events in 6,211 patient-years). CONCLUSION: The incidence of symptomatic embolic events after PFO closure is low. Most recurrent events are related to coexistent conditions associated with thromboembolic risk rather than residual shunts.

Hypertrophic, Dilated, and Arrhythmogenic Cardiomyopathy: Where Are We?

Cardiomyopathies are a heterogeneous group of structural, mechanical, and electrical heart muscle disorders which often correlate with life-threatening arrhythmias and progressive heart failure accounting for significant cardiovascular morbidity and mortality. Currently, cardiomyopathies still represent a leading reason for heart transplantation worldwide. The last years have brought remarkable advances in the field of cardiomyopathies especially in terms of understanding the molecular basis as well as the diagnostic evaluation and management. Although most cardiomyopathy treatments had long focused on symptom management, much of the current research efforts aim to identify and act on the disease-driving mechanisms. Regarding risk assessment and primary prevention of sudden cardiac death, additional data are still pending in order to pave the way for a more refined and early patient selection for defibrillator implantation. This review summarizes the current knowledge of hypertrophic, dilated and arrhythmogenic cardiomyopathy with a particular emphasis on their pathophysiology, clinical features, and diagnostic approach. Furthermore, the relevant ongoing studies investigating novel management approaches and main gaps in knowledge are highlighted.

Comparison of plug-based versus suture-based vascular closure for large-bore arterial access: a collaborative meta-analysis of observational and randomized studies.

BACKGROUND: Large-bore arteriotomies can be percutaneously closed with suture-based or plug-based vascular closure device (VCD) strategies. The efficacy of both techniques remains controversial. AIMS: We conducted a meta-analysis of comparative studies between both VCD strategies, focusing on the most commonly applied VCDs (MANTA and ProGlide). METHODS: We searched MEDLINE, the Cochrane Central Register of Controlled Trials and Google scholar for observational studies (OS) and randomized controlled trials (RCT) comparing vascular closure with the MANTA-based and the ProGlide-based technique. The principal endpoint of this analysis was access-site related vascular complications. Both study types were analyzed separately. RESULTS: Access-site related vascular complications were less frequent after vascular closure with the MANTA technique in the analysis of OS (RR 0.61 [95%CI 0.43-0.89], p = 0.01, I2 = 0%), but more frequent in the analysis of RCT data (RR 1.70 [95%CI 1.16-2.51], p = 0.01, I2 = 0%). Both data sets provided no significant difference between the VCD techniques in terms of overall bleeding events (OS: RR 0.57 [95%CI 0.32-1.02], p = 0.06, I2 = 70%; and RCT: RR 1.37 [95%CI 0.82-2.28], p = 0.23, I2 = 30%). RCT data showed that endovascular stenting or vascular surgery due to VCD failure occurred more often after MANTA application (RR 3.53 [95%CI 1.07-11.33], p = 0.04, I2 = 0%). CONCLUSIONS: While OS point to favorable outcomes for large-bore vascular closure with the MANTA-based technique, RCT data show that this strategy is associated with more access-site related vascular complications as well as endovascular stenting or vascular surgery due to device failure compared with the ProGlide-based technique.

Interrater variability of ML-based CT-FFR during TAVR-planning: influence of image quality and coronary artery calcifications.

Objective: To compare machine learning (ML)-based CT-derived fractional flow reserve (CT-FFR) in patients before transcatheter aortic valve replacement (TAVR) by observers with differing training and to assess influencing factors. Background: Coronary computed tomography angiography (cCTA) can effectively exclude CAD, e.g. prior to TAVR, but remains limited by its specificity. CT-FFR may mitigate this limitation also in patients prior to TAVR. While a high reliability of CT-FFR is presumed, little is known about the reproducibility of ML-based CT-FFR. Methods: Consecutive patients with obstructive CAD on cCTA were evaluated with ML-based CT-FFR by two observers. Categorization into hemodynamically significant CAD was compared against invasive coronary angiography. The influence of image quality and coronary artery calcium score (CAC) was examined. Results: CT-FFR was successfully performed on 214/272 examinations by both observers. The median difference of CT-FFR between both observers was -0.05(-0.12-0.02) (p < 0.001). Differences showed an inverse correlation to the absolute CT-FFR values. Categorization into CAD was different in 37/214 examinations, resulting in net recategorization of Δ13 (13/214) examinations and a difference in accuracy of Δ6.1%. On patient level, correlation of absolute and categorized values was substantial (0.567 and 0.570, p < 0.001). Categorization into CAD showed no correlation to image quality or CAC (p > 0.13). Conclusion: Differences between CT-FFR values increased in values below the cut-off, having little clinical impact. Categorization into CAD differed in several patients, but ultimately only had a moderate influence on diagnostic accuracy. This was independent of image quality or CAC.

Timing of Active Left Ventricular Unloading in Patients on Venoarterial Extracorporeal Membrane Oxygenation Therapy.

BACKGROUND: It is currently unclear if active left ventricular (LV) unloading should be used as a primary treatment strategy or as a bailout in patients with cardiogenic shock (CS) treated with venoarterial extracorporeal membrane oxygenation (VA-ECMO). OBJECTIVES: This study sought to evaluate the association between timing of active LV unloading and implantation of VA-ECMO with outcomes of patients with CS. METHODS: Data from 421 patients with CS treated with VA-ECMO and active LV unloading at 18 tertiary care centers in 4 countries were analyzed. Patients were stratified by timing of device implantation in early vs delayed active LV unloading (defined by implantation before up to 2 hours after VA-ECMO). Adjusted Cox and logistic regression models were fitted to evaluate the association between early active LV unloading and 30-day mortality as well as successful weaning from ventilation. RESULTS: Overall, 310 (73.6%) patients with CS were treated with early active LV unloading. Early active LV unloading was associated with a lower 30-day mortality risk (HR: 0.64; 95% CI: 0.46-0.88) and a higher likelihood of successful weaning from ventilation (OR: 2.17; 95% CI: 1.19-3.93) but not with more complications. Importantly, the relative mortality risk increased and the likelihood of successful weaning from ventilation decreased almost proportionally with the time interval between VA-ECMO implantation and (delayed) initiation of active LV unloading. CONCLUSIONS: This exploratory study lends support to the use of early active LV unloading in CS patients on VA-ECMO, although the findings need to be validated in a randomized controlled trial.

Extracorporeal Membrane Oxygenation in Infarct-Related Cardiogenic Shock.

Mortality in infarct-related cardiogenic shock (CS) remains high, reaching 40-50%. In refractory CS, active mechanical circulatory support devices including veno-arterial extracorporeal membrane oxygenation (VA-ECMO) are rapidly evolving. However, supporting evidence of VA-ECMO therapy in infarct-related CS is low. The current review aims to give an overview on the basics of VA-ECMO therapy, current evidence, ongoing trials, patient selection and potential complications.

Manta versus Perclose ProGlide vascular closure device after transcatheter aortic valve implantation: Initial experience from a large European center.

BACKGROUND: Vascular and bleeding complications are common after transcatheter aortic valve implantation (TAVI) and are associated with worse outcomes. The plug-based Manta (M) vascular closure device (VCD) is a novel option to achieve haemostasis for large-bore arterial access sites. OBJECTIVE: We aimed to compare vascular and bleeding complications between the M-VCD and the established suture-based Perclose ProGlide (P)-VCD. METHODS: From February to September 2019 a total of 578 patients underwent transfemoral TAVI at a single high-volume centre. Access site closure was performed using M-VCD in 195 patients (33.7%) and P-VCD in 383 patients (66.3%). We assessed vascular and access site-related complications as well as bleeding events according to the Valve Academic Research Consortium-2 definition. RESULTS: Overall vascular complications occurred less frequently in the M-VCD group (10.7% vs. 19.0%, p = 0.011) driven by a significantly lower rate of major vascular events (2.0% vs. 6.5%, p = 0.025). Access site-related complications were significantly less frequent in the M-VCD cohort (10.7% vs. 16.6%, p = 0.048). The M-VCD was associated with significantly lower rates of major (0.5% vs. 4.4%, p = 0.009) and life-threatening bleeding (0% vs. 2.3%, p = 0.032). In multivariable analysis, the use of M-VCD was the only independent predictor of vascular complications (odds ratio 0.54, 95% confidence interval 0.32-0.91, p = 0.022). CONCLUSIONS: The M-VCD was associated with a reduction of vascular and access-site complications as well as severe bleeding after transfemoral TAVI compared to the P-VCD in this observational study.

Risk Assessment of Coronary Obstruction During Transcatheter Aortic Valve Replacement: Insights From Post-BASILICA Computed Tomography.

OBJECTIVES: The aim of this study was to examine the predictive value of preprocedural computed tomography (CT)-based risk stratification of coronary obstruction during transcatheter aortic valve replacement (TAVR) on the basis of geometric measurements on postprocedural CT. BACKGROUND: Proper patient selection for additional procedures to prevent coronary obstruction during TAVR has not been adequately evaluated. METHODS: Pre- and postprocedural computed tomographic scans of 28 patients treated using bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) and TAVR were analyzed. Using the postprocedural computed tomographic images, threatened coronary obstruction (TCO) was defined as: 1) ostial obstruction (adherence of the transcatheter heart valve [THV] to the coronary ostium with leaflet extension above the ostium); and/or 2) sinus sequestration (THV adherence to the sinotubular junction [STJ] with leaflet extension above the STJ) and was substratified into complete and incomplete types. RESULTS: A total of 51 leaflets were evaluated (88% surgical tissue valves) after excluding leaflets not visible on CT (n = 5). On postprocedural CT, complete TCO was observed in 25.4% (13 of 51 leaflets). On preprocedural CT, leaflets were at high risk for complete TCO (incidence 53%) if the virtual THV-to-coronary distance (VTC) was <3.0 mm, or if the virtual THV-to-STJ distance (VTSTJ) was <1.0 mm with STJ height - leaflet length <0 mm (leaflet-STJ mismatch). Leaflets were at low risk (incidence 0%) if the VTC was ≥3 mm and VTSTJ was ≥3.0 mm or STJ height - leaflet length was ≥+2.0 mm. Of 28 leaflets treated using BASILICA, complete TCO was seen in 35.7% (n = 10), due to sinus sequestration (100%) with coexisting ostial obstruction (30%). Actual coronary events occurred in 7.1% (n = 2) because of leaflet prolapse, corresponding to an absolute risk reduction by BASILICA of 29% (P = 0.021). CONCLUSIONS: Risk assessment of coronary obstruction after TAVR may improve with a multiparametric approach incorporating VTC, VTSTJ, and leaflet-STJ mismatch. BASILICA appeared to reduce actual coronary events even in leaflets with anticipated coronary obstruction.

Combined cCTA and TAVR Planning for Ruling Out Significant CAD: Added Value of ML-Based CT-FFR.

OBJECTIVES: The purpose of this study was to analyze the ability of machine-learning (ML)-based computed tomography (CT)-derived fractional flow reserve (CT-FFR) to further improve the diagnostic performance of coronary CT angiography (cCTA) for ruling out significant coronary artery disease (CAD) during pre-transcatheter aortic valve replacement (TAVR) evaluation in patients with a high pre-test probability for CAD. BACKGROUND: CAD is a frequent comorbidity in patients undergoing TAVR. Current guidelines recommend its assessment before TAVR. If significant CAD can be excluded on cCTA, invasive coronary angiography (ICA) may be avoided. Although cCTA is a very sensitive test, it is limited by relatively low specificity and positive predictive value, particularly in high-risk patients. METHODS: Overall, 460 patients (age 79.6 ± 7.4 years) undergoing pre-TAVR CT were included and examined with an electrocardiogram-gated CT scan of the heart and high-pitch scan of the vascular access route. Images were evaluated for significant CAD. Patients routinely underwent ICA (388/460), which was omitted at the discretion of the local Heart Team if CAD could be effectively ruled out on cCTA (72/460). CT examinations in which CAD could not be ruled out (CAD+) (n = 272) underwent additional ML-based CT-FFR. RESULTS: ML-based CT-FFR was successfully performed in 79.4% (216/272) of all CAD+ patients and correctly reclassified 17 patients as CAD negative. CT-FFR was not feasible in 20.6% because of reduced image quality (37/56) or anatomic variants (19/56). Sensitivity, specificity, positive predictive value, and negative predictive value were 94.9%, 52.0%, 52.2%, and 94.9%, respectively. The additional evaluation with ML-based CT-FFR increased accuracy by Δ+3.4% (CAD+: Δ+6.0%) and raised the total number of examinations negative for CAD to 43.9% (202/460). CONCLUSIONS: ML-based CT-FFR may further improve the diagnostic performance of cCTA by correctly reclassifying a considerable proportion of patients with morphological signs of obstructive CAD on cCTA during pre-TAVR evaluation. Thereby, CT-FFR has the potential to further reduce the need for ICA in this challenging elderly group of patients before TAVR.