Diagnostic accuracy of coronary computed tomography angiography-derived fractional flow reserve (CT-FFR) in patients before liver transplantation using CT-FFR machine learning algorithm.

OBJECTIVES: Liver transplantation (LT) is associated with high stress on the cardiovascular system. Ruling out coronary artery disease (CAD) is an important part of evaluation for LT. The aim of our study was to assess whether CT-derived fractional flow reserve (CT-FFR) allows for differentiation of hemodynamically significant and non-significant coronary stenosis in patients evaluated for LT. METHODS: In total, 201 patients undergoing LT evaluation were included in the study. The patients received coronary computed tomography angiography (CCTA) to rule out CAD and invasive coronary angiography (ICA) to further evaluate coronary lesions found in CCTA if a significant (≥ 50 % on CCTA) stenosis was suspected. CT-FFR was computed from CCTA datasets using a machine learning-based algorithm and compared to ICA as a standard of reference. Coronary lesions with CT-FFR ≤ 0.80 were defined as hemodynamically significant. RESULTS: In 127 of 201 patients (63%), an obstructive CAD was ruled out by CCTA. In the remaining 74 patients (37%), at least one significant stenosis was suspected in CCTA. Compared to ICA, sensitivity, specificity, PPV, and NPV of the CT-FFR measurements were 71% (49-92%), 90% (82-98%), 67% (45-88%), and 91% (84-99%), respectively. The diagnostic accuracy was 85% (85-86%). In 69% of cases (52 of 75 lesions), additional analysis by CT-FFR correctly excluded the hemodynamic significance of the stenosis. CONCLUSIONS: Machine learning-based CT-FFR seems to be a very promising noninvasive approach for exclusion of hemodynamic significant coronary stenoses in patients undergoing evaluation for LT and could help to reduce the rate of invasive coronary angiography in this high-risk population. KEY POINTS: • Machine learning-based computed tomography-derived fractional flow reserve (CT-FFR) seems to be a very promising noninvasive approach for exclusion of hemodynamic significance of coronary stenoses in patients undergoing evaluation for liver transplantation and could help to reduce the rate of invasive coronary angiography in this high-risk population.

Defining the optimal revascularization strategy during protected high-risk procedures with Impella.

Complete revascularization (CR) in patients with multi-vessel disease improves outcomes. The use of percutaneous left-ventricular assist devices, such as the Impella heart pump, is useful to minimize the risk of haemodynamic compromise in complex higher risk and clinically indicated patients. The recently published data from the PROTECT III trial suggest more CR during Impella-protected percutaneous coronary intervention with more extensive lesion preparation and treatment, resulting in the reduced need for repeat revascularization. To achieve CR and improve survival, procedural guidance by intravascular imaging, extensive lesion preparation, debulking with atherectomy devices, advanced chronic total occlusion revascularization techniques, and post-interventional treatment with modern anti-platelet medication are essential.

Standardized pre-procedural clinical workup for protected percutaneous coronary intervention.

In addition to appropriate patient screening, pre-procedural preparation is essential to optimize both technical success and patient outcome for protected percutaneous coronary intervention (PCI). A critical component of optimization is the identification and preparation of a suitable femoral access site. Here, we describe several options for both imaging and image-guided access to optimize the approach.

What is known in pre-, peri-, and post-procedural anticoagulation in micro-axial flow pump protected percutaneous coronary intervention?

Interest in the use of percutaneous left ventricular assist devices (p-LVADs) for patients undergoing high-risk percutaneous coronary intervention (PCI) is growing rapidly. The Impella™ (Abiomed Inc.) is a catheter-based continuous micro-axial flow pump that preserves haemodynamic support during high-risk PCI. Anticoagulation is required to counteract the activation of the coagulation system by the patient's procoagulant state and the foreign-body surface of the pump. Excessive anticoagulation and the effect of dual antiplatelet therapy (DAPT) increase the risk of bleeding. Inadequate anticoagulation leads to thrombus formation and device dysfunction. The precarious balance between bleeding and thrombosis in patients with p-LVAD support is often the primary reason that patients' outcomes are jeopardized. In this chapter, we will discuss anticoagulation strategies and anticoagulant management in the setting of protected PCI. This includes anticoagulant therapy with unfractionated heparin, direct thrombin inhibitors, DAPT, purge blockage prevention by bicarbonate-based purge solution, and monitoring by activated clotting time, partial thromboplastin time, as well as anti-factor Xa levels. Here, we provide a standardized approach to the management of peri-interventional anticoagulation in patients undergoing protected PCI.

Epicardial adipose tissue differentiates in patients with and without coronary microvascular dysfunction.

BACKGROUND/OBJECTIVES: Coronary microvascular dysfunction (CMD) is a common disorder, leading to symptoms similar to obstructive coronary artery disease and bears important prognostic implications. Local inflammation is suggested to promote development of CMD. Epicardial adipose tissue (EAT) is a local visceral fat depot surrounding the heart and the coronary arteries, modifying the inflammatory environment of the heart. We compared EAT in patients with and without CMD. METHODS: We retrospectively included consecutive patients undergoing diagnostic coronary angiography as well as transthoracic echocardiography between March and October 2016. EAT thickness was defined as space between the epicardial wall of the myocardium and the visceral layer of the pericardium and EAT index was calculated as EAT thickness/body surface area. Logistic regression analysis was used to determine the association of EAT index with the presence of CMD. RESULTS: Overall, 399 patients (mean age 60.2 ± 14.0 years, 46% male) were included. EAT thickness was significantly higher in patients with CMD compared to patients without CMD (EAT thickness 4.4 ± 1.8 vs. 4.9 ± 2.4 mm, p = 0,048 for patients without and with CMD, respectively). In univariate regression analysis, EAT index was associated with a 30% higher frequency of CMD (odds ratio [95% confidence interval]: 1.30 [1.001-1.69], p = 0.049). Effect sizes remained stable upon adjustment for body mass index (BMI, 1.30 [1.003-1.70], p = 0.048), but were attenuated when ancillary adjusting for age and gender (1.17 [0.90-1.54, p = 0.25). The effect was more pronounced in patients >65 years of age and independent of BMI and sex (1.85 [1.14-3.00], p = 0.013). CONCLUSION: EAT thickness is independently associated with CMD and can differentiate between patients with and without CMD especially in older age groups. Our results support the hypothesis that modulation of local inflammation by epicardial fat is involved in the development of CMD.

Global longitudinal strain is associated with better outcomes in transcatheter aortic valve replacement.

BACKGROUND: Parameters that mark the timing of left ventricular (LV) reverse remodeling following transcatheter aortic valve replacement (TAVR) are incompletely defined. This study aims to identify the dynamics of LV strain derived from speckle tracking echocardiography in a cohort of patients with severe aortic stenosis (AS) who underwent TAVR and its correlation with postprocedural outcomes. METHODS: We selected 150 consecutive patients (82 ± 4 years old, STS score 6.4 ± 6.2) who underwent transfemoral TAVR between 07/2016 and 12/2017 at our tertiary care center. All patients were evaluated at baseline, 1 week after TAVR, and 3 months following TAVR. RESULTS: The global longitudinal strain (GLS) 1 week following TAVR was comparable to that at baseline (- 15,9 ± 4.3 vs - 16.8 ± 4.1; p = NS) but significantly improved at 3 months following TAVR (- 15.9 ± 4.3% vs. -19.5 ± 3.5%; p < 0.001). No significant changes in global circumferential strain (GCS) and global radial strain (GRS) were detectable. The ejection fraction was significantly improved 1 week after the TAVR procedure. The baseline GLS correlated directly with the complication rate (R = 0.36, p = 0.005). The linear regression analysis showed that the main predictors of the improvement in the GLS at 3 months in our cohort were baseline GRS and GCS. CONCLUSION: GLS improves at 3 months after TAVR, while LV ejection fraction does not show a substantial change, signaling an early recovery of LV longitudinal function after the intervention. Additionally, GLS has a direct correlation with the postprocedural outcomes. GLS improvement might emerge as a valuable parameter for a tailored follow-up in TAVR patients.

Impact of baseline left ventricular ejection fraction on outcome after transfemoral transcatheter aortic valve implantation in patients with and without low-gradient aortic stenosis.

OBJECTIVES: To evaluate the impact of baseline left ventricular ejection fraction (LVEF) and its interaction with low-gradient aortic stenosis (LGAS) on all-cause mortality after transfemoral aortic valve implantation (TF-TAVI). METHODS: We reviewed mortality data of 624 consecutive single center TF-TAVI patients and categorized LVEF according to current ASE/EACVI recommendations (normal, mildly-, moderately-, and severely abnormal). RESULTS: Baseline LVEF was normal in 336 (53.8%), mildly abnormal in 160 (25.6%), moderately abnormal in 91 (14.6%), and severely abnormal in 37 (5.9%) patients, and 1-year mortality was 19%, 17%, 23%, and 43% (P = 0.002), respectively. Patients with LGAS had a similar 1-year mortality compared to those without LGAS in groups with normal (19% vs 19%, P = 0.899) and mildly abnormal LVEF (16% vs 17%, P = 0.898). One-year mortality of patients with LGAS was significantly greater than in those without LGAS in presence of moderately abnormal LVEF (31% vs 11%, P = 0.022), and it was numerically greater than in those without LGAS in presence of severely abnormal LVEF (48% vs 25%, P = 0.219). In multivariate analysis, only the combination of moderately/severely abnormal LVEF and LGAS predicted increased 1-year mortality (HR: 2.12, 95% CI: 1.4-3.2, P < 0.001). Other variables, including EuroSCORE I did not affect this result. CONCLUSIONS: Moderately/severely abnormal LVEF (≤40%) at baseline is associated with increased mortality after TF-TAVI, especially when the mean transvalvular aortic gradient is <40 mm Hg (LGAS), while outcomes in patients with normal and mildly abnormal LVEF are comparable regardless of the pressure gradient across the native aortic valve. (DRKS00013729).

Thoracic aortic aneurysm expansion due to late distal stent graft-induced new entry.

OBJECTIVES: This study analyzed the mechanism and risk factors of thoracic aortic aneurysm expansion due to late distal stent graft-induced new entry (dSINE). BACKGROUND: This late complication of thoracic endovascular aneurysm repair (TEVAR) for aortic dissection is under-recognized but potentially life-threatening. METHODS: In 142 patients who underwent TEVAR with endovascular entry sealing for acute and chronic aortic type B dissection, using commercially available straight (nontapered) stent-grafts, we examined the oversizing rate, the aortic taper ratio, and the need for reintervention. RESULTS: Nine of 142 patients developed thoracic aortic aneurysm expansion due to dSINE after TEVAR. The median follow-up was 47.5 ± 37.4 months. There was a significant difference in the distal stent-aorta angle between the patients with and without dSINE (149.08 ± 15.09° vs. 166.72 ± 12.47°, P < 0.005). Patients with dSINE showed a significantly higher taper ratio of the true lumen of the aorta (40.9 ± 14.13% vs. 25.36 ± 20.2%, P < 0.05). There was also a significant difference in the oversizing of the stent-graft in the distal landing zone (95.88 ± 49.3% vs. 55.94 ± 36.23%, P < 0.01). All patients with dSINE underwent a secondary endograft procedure without any complications or deaths. In 7 cases we used a custom-made, highly tapered stent-graft. CONCLUSIONS: Lifelong follow-up of patients is mandatory after TEVAR. A stent-graft with a tapered design should be used in aortic dissection to avoid oversizing and devastating late complications.

Outcome in TAVI patients with symptomatic aortic stenosis not fulfilling PARTNER study inclusion criteria.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has rapidly evolved to the standard-of-care for inoperable patients with severe, symptomatic aortic valve stenosis, and to an alternative treatment option for high-risk patients. However, the randomized PARTNER trial excluded patients with conditions frequently encountered in daily clinical practice. METHODS: From 2006 to 2011, 467 high-risk patients, who underwent transfemoral TAVI (Edwards Sapien n = 166; Medtronic CoreValve n = 301) at two German centers were divided into a "PARTNER-like" (n = 227) and a "Real-World" cohort (n = 240), based on the original PARTNER trial in- and exclusion criteria. Differences in 30-day and 2-year mortality and morbidity were assessed. RESULTS: Mean age of patients was 80 ± 8 years with a logistic EuroSCORE of 22 ± 16%. The most frequent exclusion criteria were previous PCI (15.4%), prior valve surgery (13.7%), chronic renal failure (12.0%), and severe mitral regurgitation (10.8%). Despite significant differences in baseline data, estimated perioperative mortality in terms of STS and logistic EuroScore was identical between both groups. However, patients in the "Real-World" cohort had a non-significant trend towards a higher 30-day mortality (10.0% vs. 6.7%, P = 0.088) and a significantly higher 2-year mortality (23.3% vs. 14.5%, P = 0.016) compared with patients of the "PARTNER-like" cohort. CONCLUSION: Patients meeting PARTNER study exclusion criteria had an acceptable outcome at 30 days and 2 years, however, with significant differences to "PARTNER-like" patients. Still, our results indicate that also real-life patients with relevant comorbidities, who would have been excluded from the randomized PARTNER trials, benefit from TAVI with acceptable short- and long-term outcome.

Regional wall motion abnormalities on focused transthoracic echocardiography in patients presenting with acute chest pain: a predefined post hoc analysis of the prospective single-centre observational EPIC-ACS study.

OBJECTIVES: We evaluated the ability of the assessment of regional wall motion abnormalities (RWMA) detected via transthoracic echocardiography to predict the presence of obstructive coronary artery disease (CAD) in patients presenting with acute chest pain to the emergency department. DESIGN: Prospective single-centre observational study. SETTING: Tertiary care university hospital emergency unit. PARTICIPANTS: Patients presenting to the emergency department with acute chest pain suggestive of obstructive CAD. PRIMARY OUTCOME MEASURE: The primary endpoint was defined as the presence of obstructive CAD, requiring revascularisation therapy. RESULTS: Overall, 657 patients (age 58.1±18.0 years, 53% men) were included in our study. RWMA were detected in 76 patients (11.6%). RWMA were significantly more frequent in patients reaching the primary endpoint (26.2% vs 7.6%, p<0.001). In multivariable regression analysis, the presence of RWMA was associated with threefold increased odds of the presence of obstructive CAD (3.41 (95% CI 1.99 to 5.86), p<0.001). Adding RWMA to a multivariable model of the Thrombolysis in Myocardial Infarction (TIMI) risk score, cardiac biomarkers and traditional risk factors significantly improved the area under the curve for prediction of obstructive CAD (95% CI 0.777 to 0.804, p=0.0092). CONCLUSION: RWMA strongly and independently predicts the presence of obstructive CAD in patients presenting with acute chest pain to the emergency department. TRIAL REGISTRATION: The study has been registered online (NCT03787797).

Acute coronary occlusion with vs. without ST elevation: impact on procedural outcomes and long-term all-cause mortality.

BACKGROUND: Acute total occlusion (ATO) is diagnosed in a substantial proportion of patients with non-ST-elevation myocardial infarction (NSTEMI). We compared procedural outcomes and long-term mortality in patients with STEMI with NSTEMI with vs. without ATO. METHODS AND RESULTS: We included patients with acute myocardial infarction (AMI) undergoing invasive coronary angiography between 2004 and 2019 at our centre. Acute total occlusion was defined as thrombolysis in myocardial infarction (TIMI) 0-1 flow in the infarct-related artery or TIMI 2-3 flow with highly elevated peak troponin (>100-folds the upper reference limit). Association between presentation and long-term mortality was evaluated using multivariable adjusted Cox regression analysis. From 2269 AMI patients (mean age 66 ± 13.2 years, 74% male), 664 patients with STEMI and 1605 patients with NSTEMI (471 [29.3%] with ATO) were included. ATO(+)NSTEMI patients had a higher frequency of cardiogenic shock and no reflow than ATO(-)NSTEMI with similar rates compared with STEMI patients (cardiogenic shock: 2.76 vs. 0.27 vs. 2.86%, P < 0.0001, P = 1; no reflow: 4.03 vs. 0.18 vs. 3.17%, P < 0.0001, P = 0.54). ATO(+)NSTEMI and STEMI were associated with 60 and 55% increased incident mortality, respectively, as compared with ATO(-)NSTEMI (ATO(+)NSTEMI: 1.60 [1.27-2.02], P < 0.0001, STEMI: 1.55 [1.24-1.94], P < 0.0001). Likewise, left ventricular ejection fraction (48.5 ± 12.7 vs. 49.1±11 vs. 50.6 ± 11.8%, P = 0.5, P = 0.018) and global longitudinal strain (-15.2 ± -5.74 vs. -15.5 ± -4.84 vs. -16.3 ± -5.30%, P = 0.48, P = 0.016) in ATO(+)NSTEMI were comparable to STEMI but significantly worse than in ATO(-)NSTEMI. CONCLUSION: Non-ST-elevation myocardial infarction patients with ATO have unfavourable procedural outcomes, resulting in increased long-term mortality, resembling STEMI. Our findings suggest that the occlusion perspective provides a more appropriate classification of AMI than differentiation into STEMI vs. NSTEMI.

Implanted Carbon Nanotubes Harvest Electrical Energy from Heartbeat for Medical Implants.

Reliability of power supply for current implantable electronic devices is a critical issue for longevity and for reducing the risk of device failure. Energy harvesting is an emerging technology, representing a strategy for establishing autonomous power supply by utilizing biomechanical movements in human body. Here, a novel "Twistron energy cell harvester" (TECH), consisting of coiled carbon nanotube yarn that converts mechanical energy of the beating heart into electrical energy, is presented. The performance of TECH is evaluated in an in vitro artificial heartbeat system which simulates the deformation pattern of the cardiac surface, reaching a maximum peak power of 1.42 W kg-1 and average power of 0.39 W kg-1 at 60 beats per minute. In vivo implantation of TECH onto the left ventricular surface in a porcine model continuously generates electrical energy from cardiac contraction. The generated electrical energy is used for direct pacing of the heart as documented by extensive electrophysiology mapping. Implanted modified carbon nanotubes are applicable as a source for harvesting biomechanical energy from cardiac motion for power supply or cardiac pacing.

Cerebral embolization during transcatheter aortic valve implantation: a transcranial Doppler study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is associated with a higher risk of neurological events for both the transfemoral and transapical approach than surgical valve replacement. Cerebral magnetic resonance imaging has revealed more new, albeit clinically silent lesions from procedural embolization, yet the main source and predominant procedural step of emboli remain unclear. METHODS AND RESULTS: Eighty-three patients underwent transfemoral (Medtronic CoreValve [MCV(TF)], n=32; Edwards Sapien [ES(TF)], n=26) and transapical (ES(TA): n=25) TAVI. Serial transcranial Doppler examinations before, during, and 3 months after TAVI were used to identify high-intensity transient signals (HITS) as a surrogate for microembolization. Procedural HITS were detected in all patients, predominantly during manipulation of the calcified aortic valve while stent valves were being positioned and implanted. The balloon-expandable ES prosthesis caused significantly more HITS (mean [95% CI]) during positioning (ES(TF), 259.9 [184.8-334.9]; ES(TA), 206.1[162.5-249.7]; MCV(TF), 78.5 [25.3-131.6]; P<0.001) and the self-expandable MCV prosthesis during implantation (MCV(TF), 397.1 [302.1-492.2]; ES(TF), 88.2 [70.2-106.3]; ES(TA), 110.7 [82.0-139.3]; P<0.001). Overall, there were no significant differences between transfemoral and transapical TAVI or between the MCV and ES prostheses. No HITS were detected at baseline or 3-month follow-up. There was 1 major procedural stroke that resulted in death and 1 minor procedural stroke with full recovery at 3-month follow-up in the MCV group. CONCLUSIONS: Procedural HITS were detected by transcranial Doppler in all patients. Although no difference was observed between the transfemoral and the transapical approach with the balloon-expandable ES stent valve, transfemoral TAVI with the self-expandable MCV prosthesis resulted in the greatest number of HITS, predominantly during implantation.

Hemodynamic assessment of paravalvular aortic regurgitation after TAVI: estimated myocardial supply-demand ratio and cardiovascular mortality.

A relevant (at least moderate) paravalvular regurgitation (PAR) after transcatheter aortic valve implantation (TAVI) is found in up to 20% of cases and associated with increased mortality. The ratio of the diastolic over the systolic pressure time integral (DPTI:SPTI) has been proposed to reflect an estimate of myocardial oxygen supply versus demand and the propensity for myocardial ischemia. We have now evaluated the potential of this ratio to predict PAR-associated cardiovascular mortality after TAVI, retrospectively analyzing data from 167 consecutive TAVI patients. PAR was graded angiographically, and the myocardial supply-demand ratio was estimated from the planimetric integration of the diastolic and systolic pressure-time area (DPTI and SPTI), respectively. PAR was observed in 113 patients (67%) and angiographically graded as mild in 89 (78.8%), moderate in 21 (18.6%) or moderate to severe in 3 (2.7%) cases. The DPTI:SPTI ratio decreased with increasing Sellers grade of PAR (P < 0.001). A DPTI:SPTI of ≤0.7 predicted cardiovascular mortality (area under the curve = 0.96). Cardiovascular mortality at 30 days and 1 yr was increased in patients with DPTI:SPTI ≤ 0.7 over those with DPTI:SPTI > 0.7 (42 vs. 2% and 63 vs. 3%, respectively; P < 0.001). In conclusion, DPTI:SPTI provides an excellent cutoff value of ≤0.7 for the prediction of PAR-associated mortality.

Suture-mediated arterial access site closure after transfemoral aortic valve implantation.

OBJECTIVES: To evaluate feasibility, safety and efficacy of percutaneous arterial access site closure after transfemoral, transcatheter aortic valve implantation (TF-TAVI) using a single, commercially available six French monofilament suture-mediated vascular closure device (VCD) in "preclosure" technique. BACKGROUND: Currently, TF-TAVI is evolving into a completely percutaneous procedure. However, percutaneous access site closure still remains a major technical challenge with room for improvement. METHODS: 94 of 144 consecutive patients underwent completely percutaneous TF-TAVI using following technique for access site closure: After puncture of the common femoral artery using fluoroscopy and contralateral angiography for guidance, the VCD was deployed prior further predilatation of the vessel and insertion of the large-bore introducer sheath. At the end of the procedure, the preloaded sutures were tied for final hemostasis and crossover angiography was used for postprocedural evaluation of the access vessel. RESULTS: Application of the VCD was technically successful in all cases, resulting in an efficient hemostasis with cessation of any bleeding within 10 min of final knot-tying in 83 of the 94 patients, and there was only one closure-failure with continuous bleeding despite prolonged manual compression requiring endovascular treatment. In addition, we observed four closure-related access vessel stenoses of hemodynamic relevance requiring endovascular treatment in three and surgical repair in one patient. However, interventional and surgical repair was not associated with death or irreversible end-organ damage and all patients recovered without sequelae. CONCLUSION: "Preclosure" of the arterial access site with a single six French suture-mediated VCD is relatively easy, safe and efficient method for access site closure after TF-TAVI which, along with ongoing profile reductions of TAVI devices, should further simplify and broaden the way toward a routine, completely percutaneous procedure.

Incidence, predictors, origin and prevention of early and late neurological events after transcatheter aortic valve implantation (TAVI): a comprehensive review of current data.

Transcatheter aortic valve implantation (TAVI) is a novel treatment option for patients with severe, symptomatic aortic valve stenosis considered inoperable or at high risk for surgical aortic valve replacement. Despite rapid adoption of this technology into clinical application, however, recent randomized controlled clinical trials have raised safety concerns regarding an increased risk of neurological events with TAVI compared to both medical treatment and conventional, surgical aortic valve replacement. Moreover, neuro-imaging studies have revealed an even higher incidence of new, albeit clinically silent cerebral lesions as a surrogate for procedural embolization. In this article, we review currently available data on the incidence, timing, predictors, prognostic implications and potential mechanisms of neurological events after TAVI.

A new self-expandable transcatheter aortic valve for transapical implantation: feasibility in acute and chronic animal experiments.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is currently expanding worldwide, however all available prostheses share some fundamental design drawbacks. We investigated the feasibility, safety and hemodynamic performance of the innovative transapical Acurate TA™ self-expandable device, which has the unique advantage of offering anatomically correct self-alignment within the aortic root. DESIGN: Transapical TAVI was performed in six acute swine and six chronic sheep procedures, with follow-up of 7, 14, 21, 28, 60 and 90 days. TAVI was performed under TEE and angiographic guidance without rapid pacing. RESULTS: A partial sternotomy approach was used to access the LV-apex. All valve implantations were performed as planned and all animals survived the implantation procedure. After deployment, no migration, embolization or coronary obstruction was observed during the observation period. Intraoperative TEE examination identified no signs of intravalvular leakage or valve dysfunction. Transvalvular mean pressure gradients were 5.4 ± 2.2 mmHg decreasing during follow-up (1.6 ± 0.8 mmHg, 1.8 ± 0.8 mmHg, 1.3 ± 0.2, 1.8 ± 0.7 mmHg, 1.6 ± 0.8 mmHg), with a slight increase atday 90 (4.0 ± 2.4 mmHg, P < 0.05). Macroscopic examination at necropsy showed correct anatomical positioning of the valve stent without any signs of structural valve deterioration. CONCLUSIONS: These first results of the innovative self-expandable transapical ACURATE TA™ device explore the feasibility and safety of anatomically correct off-pump implantation with optimal hemodynamic results.

Central extracorporeal circulatory life support (cECLS) in selected patients with critical cardiogenic shock.

Background: Percutaneous extracorporeal life support (pECLS) is increasingly applied in cardiogenic shock (CS) despite a lack of evidence from randomized trials. The in-hospital mortality rate of pECLS still reaches up to 60%, while vascular access site complications remain a shortcoming. Surgical approaches with central cannulation for ECLS (cELCS) have emerged as a bail-out option. To date, no systematic approach exists that allows a definition of inclusion or exclusion criteria for cECLS. Methods and results: This single-center, retrospective, case-control study includes all patients fulfilling criteria for CS at the West German Heart and Vascular Center Essen/Germany between 2015 and 2020 who underwent cECLS (n = 58), excluding post-cardiotomy patients. Seventeen patients received cECLS (29.3%) as a first-line treatment strategy and 41 patients as a second-line strategy (70.7%). The main complications leading to the use of cECLS as a second-line strategy were limb ischemia (32.8%) and ongoing insufficient hemodynamic support (27.6%). The first-line cECLS cohort showed a 30-day mortality rate of 53.3% that was constant during follow-up. The 30-day mortality rate of secondary cECLS candidates was 69.8% and the rate at 3 and 6 months was 79.1%. Younger patients (<55 years) were more likely to exhibit survival benefit with cECLS (p = 0.043). Conclusion: Surgical cECLS in CS is a feasible therapy for highly selected patients with hemodynamic instability, vascular complications, or peripheral access site limitations as complementary strategy in experienced centers.

Epicardial adipose tissue and obstructive coronary artery disease in acute chest pain: the EPIC-ACS study.

Aims: We tested the hypothesis that epicardial adipose tissue (EAT) quantification improves the prediction of the presence of obstructive coronary artery disease (CAD) in patients presenting with acute chest pain to the emergency department. Methods and results: Within this prospective observational cohort study, we included 657 consecutive patients (mean age 58.06 ± 18.04 years, 53% male) presenting to the emergency department with acute chest pain suggestive of acute coronary syndrome between December 2018 and August 2020. Patients with ST-elevation myocardial infarction, haemodynamic instability, or known CAD were excluded. As part of the initial workup, we performed bedside echocardiography for quantification of EAT thickness by a dedicated study physician, blinded to all patient characteristics. Treating physicians remained unaware of the results of the EAT assessment. The primary endpoint was defined as the presence of obstructive CAD, as detected in subsequent invasive coronary angiography. Patients reaching the primary endpoint had significantly more EAT than patients without obstructive CAD (7.90 ± 2.56 mm vs. 3.96 ± 1.91 mm, P < 0.0001). In a multivariable regression analysis, a 1 mm increase in EAT thickness was associated with a nearby two-fold increased odds of the presence of obstructive CAD [1.87 (1.64-2.12), P < 0.0001]. Adding EAT to a multivariable model of the GRACE score, cardiac biomarkers and traditional risk factors significantly improved the area under the receiver operating characteristic curve (0.759-0.901, P < 0.0001). Conclusion: Epicardial adipose tissue strongly and independently predicts the presence of obstructive CAD in patients presenting with acute chest pain to the emergency department. Our results suggest that the assessment of EAT may improve diagnostic algorithms of patients with acute chest pain.

BNP and NT-proBNP Thresholds for the Assessment of Prognosis in Patients Without Heart Failure.

Background: Brain natriuretic peptide (BNP)/N-terminal-pro hormone brain natriuretic peptides (NT-proBNP) enable risk stratification, diagnosing, and monitoring of heart failure patients. An additional prognostic value for BNP/NT-proBNP in nonheart failure patients and general population cohorts is described in the literature, but specific cut-off levels are only described for heart failure patients. Objectives: This study aimed to determine thresholds for risk stratification in nonheart failure patients. Methods: Based on the Essen Coronary Artery Disease registry we excluded patients with known heart failure or elevated BNP/NT-pro BNP levels. The resulting cohort was divided into a derivation and validation cohort using random sampling. The prognostic value of BNP/NT-proBNP of incident mortality was evaluated in the derivation cohort using univariate and multivariable cox regression analysis. In receiver operating characteristic analysis and corresponding area under the curve the optimal threshold was determined using Youdens J index. The findings were verified in the validation cohort. Results: A total of 3,690 patients (age 62.9 ± 12.5 years, 71% male, 68% patients with coronary artery disease) were included. During a mean follow-up of 2.6 ± 3.4 years (median 1.2 [IQR: 0.4-2.88]), 169 deaths of any cause occurred. Based on Youden's J index, BNP-thresholds of 9.6 and 29pg/ml and NT-proBNP thresholds of 65 and 77pg/ml for men and women, respectively, were determined. BNP/NT-proBNP levels above these thresholds were associated with increased mortality in the derivation cohort (HR: 2.44 [95% CI: 1.32-4.53], P = 0.005). The predictive value was confirmed in the validation cohort (HR: 2.78 [95% CI: 1.26-6.14], P = 0.01). Conclusions: We here describe sex-specific BNP/NT-proBNP thresholds that allow prediction of impaired survival in patients without heart failure, independent of traditional cardiovascular risk factors.