Real-world 1-Year Results of Tricuspid Edge-to-Edge Repair from the bRIGHT Study.

BACKGROUND: Severe tricuspid regurgitation (TR) is known to be associated with poor quality of life and increased risk of death when left untreated. OBJECTIVES: To report the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (TEER) with the TriClip system in a contemporary, real-world setting. METHODS: The bRIGHT post-approval study is a prospective, single-arm, open-label, multicenter, post-market registry conducted at 26 sites in Europe with central event adjudication and echocardiographic core-lab assessment. RESULTS: Enrolled subjects were elderly (79±7 years) with significant comorbidities. Eighty-eight percent had baseline massive or torrential TR and 80% percent of subjects were in NYHA class III/ IV. TR was reduced to moderate or less in 81% at 1 year. Significant improvements in NYHA class (21% to 75% I/II, P<0.0001) and KCCQ score (19±26-point improvement, P<0.0001) were observed at 1 year. One-year mortality was significantly lower in subjects who achieved moderate or lower TR at 30 days; however, there was no difference in mortality among subjects that achieved moderate, mild, or trace TR at 30 days. In addition to TR reduction at 30 days, baseline serum creatinine and baseline RV TAPSE were independently associated with mortality at 1 year (OR: 2.169, 95% CI: [1.494, 3.147], P<0.0001; OR: 0.636, 95% CI: [0.415, 0.974], P=0.0375). Mortality was not associated with baseline TR grade, nor with center volume. CONCLUSIONS: Tricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant TR and advanced disease in a diverse, real-world population.

Prediction of diagnosis and diastolic filling pressure by AI-enhanced cardiac MRI: a modelling study of hospital data.

BACKGROUND: With increasing numbers of patients and novel drugs for distinct causes of systolic and diastolic heart failure, automated assessment of cardiac function is important. We aimed to provide a non-invasive method to predict diagnosis of patients undergoing cardiac MRI (cMRI) and to obtain left ventricular end-diastolic pressure (LVEDP). METHODS: For this modelling study, patients who had undergone cardiac catheterisation at University Hospital Heidelberg (Heidelberg, Germany) between July 15, 2004 and March 16, 2023, were identified, as were individual left ventricular pressure measurements. We used existing patient data from routine cardiac diagnostics. From this initial group, we extracted patients who had been diagnosed with ischaemic cardiomyopathy, dilated cardiomyopathy, hypertrophic cardiomyopathy, or amyloidosis, as well as control individuals with no structural phenotype. Data were pseudonymised and only processed within the university hospital's AI infrastructure. We used the data to build different models to predict either demographic (ie, AI-age and AI-sex), diagnostic (ie, AI-coronary artery disease and AI-cardiomyopathy [AI-CMP]), or functional parameters (ie, AI-LVEDP). We randomly divided our datasets via computer into training, validation, and test datasets. AI-CMP was not compared with other models, but was validated in a prospective setting. Benchmarking was also done. FINDINGS: 66 936 patients who had undergone cardiac catheterisation at University Hospital Heidelberg were identified, with more than 183 772 individual left ventricular pressure measurements. We extracted 4390 patients from this initial group, of whom 1131 (25·8%) had been diagnosed with ischaemic cardiomyopathy, 1064 (24·2%) had been diagnosed with dilated cardiomyopathy, 816 (18·6%) had been diagnosed with hypertrophic cardiomyopathy, 202 (4·6%) had been diagnosed with amyloidosis, and 1177 (26·7%) were control individuals with no structural phenotype. The core cohort only included patients with cardiac catherisation and cMRI within 30 days, and emergency cases were excluded. AI-sex was able to predict patient sex with areas under the receiver operating characteristic curves (AUCs) of 0·78 (95% CI 0·77-0·78) and AI-age was able to predict patient age with a mean absolute error of 7·86 years (7·77-7·95), with a Pearson correlation of 0·57 (95% CI 0·56-0·57). The AUCs for the classification tasks ranged between 0·82 (95% CI 0·79-0·84) for ischaemic cardiomyopathy and 0·92 (0·91-0·94) for hypertrophic cardiomyopathy. INTERPRETATION: Our AI models could be easily integrated into clinical practice and provide added value to the information content of cMRI, allowing for disease classification and prediction of diastolic function. FUNDING: Informatics for Life initiative of the Klaus-Tschira Foundation, German Center for Cardiovascular Research, eCardiology section of the German Cardiac Society, and AI Health Innovation Cluster Heidelberg.

Genetic associations of cardiovascular risk genes in European patients with coronary artery spasm.

BACKGROUND: Coronary artery spasm (CAS) is a frequent finding in patients presenting with angina pectoris. Although the pathogenesis of CAS is incompletely understood, previous studies suggested a genetic contribution. Our study aimed to elucidate genetic variants in a cohort of European patients with angina and unobstructed coronary arteries who underwent acetylcholine (ACh) provocation testing. METHODS: A candidate association analysis of 208 genes previously associated with cardiovascular conditions was performed using genotyped and imputed variants in patients grouped in epicardial (focal, diffuse) CAS (n = 119) and microvascular CAS (n = 87). Patients with a negative ACh test result (n = 45) served as controls. RESULTS: We found no association below the genome-wide significance threshold of p < 5 × 10-8, thus not confirming variants in ALDH2, NOS3, and ROCK2 previously reported in CAS patients of Asian ancestry. However, the analysis identified suggestive associations (p < 10-05) for the groups of focal epicardial CAS (CDH13) and diffuse epicardial CAS (HDAC9, EDN1). Downstream analysis of the potential EDN1 risk locus showed that CAS patients have significantly increased plasma endothelin-1 levels (ET-1) compared to controls. An EDN1 haplotype comprising rs9349379 and rs2070698 was significantly associated to ET-1 levels (p = 0.01). CONCLUSIONS: In summary, we suggest EDN1 as potential genetic risk loci for patients with diffuse epicardial CAS, and European ancestry. Plasma ET-1 levels may serve as a potential cardiac marker.

Axillary vs Femoral Arterial Cannulation in Acute Type A Dissection: International Multicenter Data.

BACKGROUND: Cannulation strategy in acute type A dissection (ATAD) varies widely without known gold standards. This study compared ATAD outcomes of axillary vs femoral artery cannulation in a large cohort from the International Registry of Acute Aortic Dissection (IRAD). METHODS: The study retrospectively reviewed 2145 patients from the IRAD Interventional Cohort (1996-2021) who underwent ATAD repair with axillary or femoral cannulation (axillary group: n = 1106 [52%]; femoral group: n = 1039 [48%]). End points included the following: early mortality; neurologic, respiratory, and renal complications; malperfusion; and tamponade. All outcomes are presented as axillary with respect to femoral. RESULTS: The proportion of patients younger than 70 years in both groups was similar (n = 1577 [74%]), as were bicuspid aortic valve, Marfan syndrome, and previous dissection. Patients with femoral cannulation had slightly more aortic insufficiency (408 [55%] vs 429 [60%]; P = .058) and coronary involvement (48 [8%] vs 70 [13%]; P = .022]. Patients with axillary cannulation underwent more total aortic arch (156 [15%] vs 106 [11%]; P = .02) and valve-sparing root replacements (220 [22%] vs 112 [12%]; P < .001). More patients with femoral cannulation underwent commissural resuspension (269 [30.9%] vs 324 [35.3%]; P = .05). Valve replacement rates were not different. The mean duration of cardiopulmonary bypass was longer in the femoral group (190 [149-237] minutes vs 196 [159-247] minutes; P = .037). In-hospital mortality was similar between the axillary (n = 165 [15%]) and femoral (n = 149 [14%]) groups (P = .7). Furthermore, there were no differences in stroke, visceral ischemia, tamponade, respiratory insufficiency, coma, or spinal cord ischemia. CONCLUSIONS: Axillary cannulation is associated with a more stable ATAD presentation, but it is a more extensive intervention compared with femoral cannulation. Both procedures have equivalent early mortality, stroke, tamponade, and malperfusion outcomes after statistical adjustment.

Non-femoral focused transaxillary access in TAVI: GARY data analysis and future trends.

BACKGROUND: In patients not suitable for transfemoral transcatheter aortic valve implantation (TAVI), several access strategies can be chosen. AIM: To evaluate the use and patient outcomes of transaxillary (TAx), transapical (TA), and transaortic (TAo) as alternative access for TAVI in Germany; to further evaluate surgical cutdown vs. percutaneous TAx access. METHODS: All patients entered the German Aortic Valve Registry (GARY) between 2011 and 2019 who underwent non-transfemoral TAVI were included in this analysis. Patients with TA, TAo, or TAx TAVI were compared using a weighted propensity score model. Furthermore, a subgroup analysis was performed for TAx regarding the percutaneous or surgical cutdown approach. RESULTS: Overall, 9686 patients received a non-transfemoral access. A total of 8918 patients (92.1%) underwent TA, 398 (4.1%) TAo, and 370 (3.8%) TAx approaches. Within the TAx subgroup, 141 patients (38.1%) received subclavian cutdown, while 200 (54.1%) underwent a percutaneous approach. The TA patients had a significantly lower 30-day survival than TAx patients (TA 90.92% vs. TAx 95.59%, p = 0.006; TAo 92.22% vs. TAx 95.59%, p = 0.102). Comparing percutaneous and cutdown TAx approaches, no significant differences were seen. However, more vascular complications occurred (TA 1.8%, TAo 2.4%, TAx 12.2%; p < .001), and the hospital length of stay was shorter (TA 12.9 days, TAo 14.1 days, TAx 12 days; p < .001) after TAx access. CONCLUSION: It may be reasonable to consider TAx access first in patients not suitable for TF-TAVI, because the 30-day survival was higher compared with TA access and the 1-year survival was higher compared with TAo access. It remains important for the heart teams to offer alternative access modalities for patients not amenable to the standard TF-TAVI approaches.

Aortic Valve Repair Results in Better 1-Year Survival Than Replacement: Results From German Aortic Valve Registry.

BACKGROUND: Aortic valve (AV) repair is an evolving surgical strategy in the treatment of nonelderly adults with aortic regurgitation. We aimed to determine the 1-year outcome after AV repair vs surgical AV replacement (sAVR) using real-world data from the German Aortic Valve Registry. METHODS: A total of 8076 aortic regurgitation patients (mean age, 59.1 ± 15.0 years; 76% men; mean The Society of Thoracic Surgeons score, 1.3 ± 1.1), who underwent AV surgical procedures between 2011 and 2015, were identified from German Aortic Valve Registry. The AV was repaired in 2327 patients (29%), and the remaining 5749 patients (71%) underwent sAVR. A weighted propensity score model, including the variables of age, sex, and The Society of Thoracic Surgeons score, was used to correct for baseline differences between AV repair and sAVR cohorts. The primary end point was 1-year survival after AV repair vs sAVR. Secondary end points were freedom from cardiac events and AV reinterventions. RESULTS: Survival at 1 year was 97.7% (95% CI, 97.0%-98.5%) in the AV repair cohort vs 96.4% (95% CI, 95.9%-96.9%) in the propensity score-weighted sAVR cohort (log-rank P < .001). Cox regression revealed a significant advantage of AV repair vs sAVR (hazard ratio, 0.68; 95% CI, 0.51-0.90; P < .0001) on 1-year survival, which was independent of age. Cardiac event-free survival at 1 year was 85.7% (95% CI, 483.8%-87.7%) in the AV repair group vs 81.7% (95% CI, 80.7%-82.9%) in the sAVR group (log-rank P < .001). AV reintervention was required in 38 AV repair patients (1.6%) compared with 1.6% in the sAVR cohort (P = .59). CONCLUSIONS: AV repair surgery, whenever intraoperatively feasible, is associated with a significantly better 1-year survival and 1-year cardiac event-free survival compared with sAVR.

Persistent atrial fibrillation without the evidence of low-voltage areas: a prospective randomized trial.

BACKGROUND: An effective therapy of persistent atrial fibrillation beyond pulmonary vein isolation remains unsatisfactory. Targeting endocardial low-voltage areas represents an approach of substrate modification. This prospective, randomized study investigated the efficacy of ablation of low-voltage areas versus PVI and additional linear ablations in patients with persistent atrial fibrillation in terms of single-procedure arrhythmia-free outcome and safety. METHODS AND RESULTS: A total number of 100 patients undergoing de-novo catheter ablation for persistent AF were randomized in a 1:1 ratio into two different treatment arms: group A: pulmonary vein isolation (PVI) and, if low-voltage areas were present, a substrate modification. Group B: PVI and, if atrial fibrillation persisted, additional ablations, such as linear ablation and/or ablation of non-PV triggers. A total of 50 patients were randomized into each group without significant differences in baseline characteristics. During a mean follow-up of 17.64 ± 4.5 months after a single procedure, 34 (68%) patients of group A were free of arrhythmia recurrence versus 28 (56%) patients in group B (p = ns). In group A, 30 (60%) patients did not show endocardial fibrosis and received solely PVI. Both procedures were performed with a low number of complications; no pericardial effusion or stroke were seen in either group. CONCLUSIONS: A significant proportion of patients with persistent atrial fibrillation do not show low-voltage areas. A total of 70% of the patients receiving solely PVI did not show any recurrence of atrial fibrillation, and therefore, extensive additional ablation should be avoided in de-novo patients.

Characterization of Tricuspid Valve Anatomy and Coaptation Gap in Subjects Receiving Tricuspid Transcatheter Edge-To-Edge Repair: Observations From the bRIGHT TriClip Study.

BACKGROUND: Transcatheter edge-to-edge repair (TEER) for the treatment of tricuspid regurgitation (TR) has experienced fast adoption following commercial approval. Defining the appropriate target population for TEER therapy is important to guide patient selection. The aim of this study was to characterize tricuspid valve anatomy and coaptation gap in subjects receiving TEER for the treatment of TR in a contemporary postmarket setting. METHODS: The bRIGHT study is a prospective, multicenter, single-arm, postmarket study evaluating the safety and effectiveness of the TriClip device. Procedural outcomes included implant success, acute procedural success, TR severity, major adverse events, single-leaflet device attachment, and embolization through 30 postprocedure days. Tricuspid valve characteristics, including morphology, annulus size, and leaflet mobility, were assessed via two-dimensional transesophageal echocardiography from the screening visit by an independent echo core lab to characterize subject variability. Coaptation gap measurements were taken in both the transgastric short-axis (TG SAX) and RV inflow/outflow views. RESULTS: The independent echo core lab performed a detailed assessment of the tricuspid valve on 135 consecutive subjects with available TG SAX views from 24 sites. Tricuspid valve morphologies included 2 to 5 leaflets, with a non-trileaflet valve in 28% of subjects and ≥4 leaflets in 21% of subjects. The etiology of TR was functional in 91% (96/105), mixed in 7% (7/105), and lead induced in 2% (2/105) of subjects. Leaflet mobility was mildly restricted in 69% (78/113) and moderately restricted in 7% (8/113) of subjects. Annulus diameter averaged 4.7 ± 0.7 cm with a range of 2.5 to 6.2 cm. From the TG SAX view, the coaptation gap measured 8.1 ± 3.1 and 5.2 ± 2.3 mm in the central and mid regions of the anterior-septal coaptation line and 6.6 ± 3.2 and 3.8 ± 2.1 mm in the central and mid regions of the septal-posterior coaptation line, respectively. From the right ventricular inflow/outflow view, the coaptation gap measured 4.7 ± 2.4, 5.2 ± 2.4, and 4.6 ± 3.0 mm in the anterior, mid, and posterior regions of the tricuspid valve, respectively. Thirty-day TR reduction (by number of grades) was similar among subjects with coaptation gaps of <7 mm, 7 to 10 mm, and >10 mm. CONCLUSION: A broad range of anatomies was observed in this postmarket population. Characterization of the tricuspid valve and coaptation gap will help to better understand and better define the target patient population for tricuspid TEER therapy.

Impact of Access Site on Periprocedural Bleeding and Cerebral and Coronary Events in High-Bleeding-Risk Percutaneous Coronary Intervention: Findings from the RIVA-PCI Trial.

INTRODUCTION: The preference for using transradial access (TRA) over transfemoral access (TFA) in patients requiring percutaneous coronary intervention (PCI) is based on evidence suggesting that TRA is associated with less bleeding and fewer vascular complications, shorter hospital stays, improved quality of life, and a potential beneficial effect on mortality. We have limited study data comparing the two access routes in a patient population with atrial fibrillation (AF) undergoing PCI, who have a particular increased risk of bleeding, while AF itself is associated with an increased risk of thromboembolism. METHODS: Using data from the RIVA-PCI registry, which includes patients with AF undergoing PCI, we analyzed a high-bleeding-risk (HBR) cohort. These patients were predominantly on oral anticoagulants (OAC) for AF, and the PCI was performed via radial or femoral access. Endpoints examined were in-hospital bleeding (BARC 2-5), cerebral events (TIA, hemorrhagic or ischemic stroke) and coronary events (stent thrombosis and myocardial infarction). RESULTS: Out of 1636 patients, 854 (52.2%) underwent TFA, while 782 (47.8%) underwent the procedure via TRA, including nine patients with brachial artery puncture. The mean age was 75.5 years. Groups were similar in terms of age, sex distribution, AF type, cardiovascular history, risk factors, and comorbidities, except for a higher incidence of previous bypass surgeries, heart failure, hyperlipidemia, and chronic kidney disease (CKD) with a glomerular filtration rate (GFR) < 60 ml/min in the TFA group. No clinically relevant differences in antithrombotic therapy and combinations were present at the time of PCI. However, upon discharge, transradial PCI patients had a higher rate of triple therapy, while dual therapy was preferred after transfemoral procedures. Radial access was more frequently chosen for non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris (UAP) cases (NSTEMI 26.6% vs. 17.0%, p < 0.0001; UAP 21.5% vs. 14.5%, p < 0.001), while femoral access was more common for elective PCI (60.3% vs. 44.1%, p < 0.0001). No differences were observed for ST-segment elevation myocardial infarction (STEMI). Both groups had similar rates of cerebral events (TFA 0.2% vs. TRA 0.3%, p = 0.93), but the TFA group had a higher incidence of bleeding (BARC 2-5) (4.2% vs. 1.5%, p < 0.01), mainly driven by BARC 3 bleeding (1.5% vs. 0.4%, p < 0.05). No significant differences were found for stent thrombosis and myocardial infarction (TFA 0.2% vs. TRA 0.3%, p = 0.93; TFA 0.4% vs. TRA 0.1%, p = 0.36). CONCLUSIONS: In HBR patients with AF undergoing PCI for acute or chronic coronary syndrome, the use of TRA might be associated with a decrease in in-hospital bleeding, while not increasing the risk of embolic or ischemic events compared to femoral access. Further studies are required to confirm these preliminary findings.

Deep Learning-Based Automated Labeling of Coronary Segments for Structured Reporting of Coronary Computed Tomography Angiography in Accordance With Society of Cardiovascular Computed Tomography Guidelines.

PURPOSE: To evaluate a novel deep learning (DL)-based automated coronary labeling approach for structured reporting of coronary artery disease according to the guidelines of the Society of Cardiovascular Computed Tomography (CT) on coronary CT angiography (CCTA). PATIENTS AND METHODS: A retrospective cohort of 104 patients (60.3 ± 10.7 y, 61% males) who had undergone prospectively electrocardiogram-synchronized CCTA were included. Coronary centerlines were automatically extracted, labeled, and validated by 2 expert readers according to Society of Cardiovascular CT guidelines. The DL algorithm was trained on 706 radiologist-annotated cases for the task of automatically labeling coronary artery centerlines. The architecture leverages tree-structured long short-term memory recurrent neural networks to capture the full topological information of the coronary trees by using a two-step approach: a bottom-up encoding step, followed by a top-down decoding step. The first module encodes each sub-tree into fixed-sized vector representations. The decoding module then selectively attends to the aggregated global context to perform the local assignation of labels. To assess the performance of the software, percentage overlap was calculated between the labels of the algorithm and the expert readers. RESULTS: A total number of 1491 segments were identified. The artificial intelligence-based software approach yielded an average overlap of 94.4% compared with the expert readers' labels ranging from 87.1% for the posterior descending artery of the right coronary artery to 100% for the proximal segment of the right coronary artery. The average computational time was 0.5 seconds per case. The interreader overlap was 96.6%. CONCLUSIONS: The presented fully automated DL-based coronary artery labeling algorithm provides fast and precise labeling of the coronary artery segments bearing the potential to improve automated structured reporting for CCTA.

Comparison of contemporary transcatheter heart valve prostheses: data from the German Aortic Valve Registry (GARY).

BACKGROUND: Various second-generation transcatheter heart valve (THV) prostheses with high clinical efficacy and safety are available, but there is limited large-scale data available comparing their hemodynamic performance and clinical implications. OBJECTIVE: To compare the hemodynamic performance and short-term clinical outcome of four second-generation THV prostheses. METHODS: 24,124 patients out of the German Aortic Valve Registry who underwent transfemoral transcatheter aortic valve implantation (TAVI) (Evolut™ R n = 7028, Acurate neo™ n = 2922, Portico n = 878 and Sapien 3 n = 13,296) were included in this analysis. Propensity-score weighted analysis was performed to control for differences in age, left ventricular function, STS score and sex. Primary endpoint was survival at one-year, secondary endpoints were 30 days survival, pre-discharge transvalvular gradients, paravalvular leakage and peri-procedural complications. RESULTS: Thirty-day and one-year survival were not significantly different between the four patient groups. Transvalvular gradients in Evolut™ R and Acurate neo™ were significantly lower as compared to Portico and Sapien 3 at hospital discharge. This difference exists across all annulus sizes. Paravalvular leakage ≥ II occurred significantly less often in the Sapien 3 group (1.2%, p < 0.0001). Rate of severe procedural complications was low and comparable in all groups. Permanent pacemaker implantation rate at one year was lowest in the ACUARATE neo group (13.0%) and highest in the Evolut™ R group (21.9%). CONCLUSION: Albeit comparable short-term clinical outcomes there are certain differences regarding hemodynamic performance and permanent pacemaker implantation rate between currently available THV prostheses which should be considered for individual prosthesis selection.

Drug repurposing-a promising approach for patients with angina but non-obstructive coronary artery disease (ANOCA).

In today's era of individualized precision medicine drug repurposing represents a promising approach to offer patients fast access to novel treatments. Apart from drug repurposing in cancer treatments, cardiovascular pharmacology is another attractive field for this approach. Patients with angina pectoris without obstructive coronary artery disease (ANOCA) report refractory angina despite standard medications in up to 40% of cases. Drug repurposing also appears to be an auspicious option for this indication. From a pathophysiological point of view ANOCA patients frequently suffer from vasomotor disorders such as coronary spasm and/or impaired microvascular vasodilatation. Consequently, we carefully screened the literature and identified two potential therapeutic targets: the blockade of the endothelin-1 (ET-1) receptor and the stimulation of soluble guanylate cyclase (sGC). Genetically increased endothelin expression results in elevated levels of ET-1, justifying ET-1 receptor blockers as drug candidates to treat coronary spasm. sGC stimulators may be beneficial as they stimulate the NO-sGC-cGMP pathway leading to GMP-mediated vasodilatation.

Direct oral anticoagulants versus vitamin K antagonist after transcatheter aortic valve implantation.

OBJECTIVE: After transcatheter aortic valve implantation (TAVI), the optimal regimen of anticoagulant therapy in patients with an additional indication for oral anticoagulation remains a matter of debate. This study investigates the efficacy of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in patients after TAVI in a real-world population. METHODS: The German Aortic Valve RegistrY (GARY) is a prospective, multicentre registry enrolling patients undergoing invasive treatment for aortic valve disease. From January 2011 to December 2019, 1 41 790 patients from 92 hospitals in Germany were enrolled. Anticoagulatory treatment regimens were assessed at hospital discharge for patients after TAVI procedures. All-cause mortality and the combined endpoint 'cardiac and cerebrovascular events' containing myocardial infarction, stroke, transient ischaemic attack, aortic prosthesis reintervention and all-cause mortality in the first year after TAVI were examined by treatment regimen. RESULTS: Of 45 598 patients (mean age 80.7±5.7 years, 49.3% males) undergoing TAVI, 16 974 patients (37.2%) received an anticoagulant regimen that included VKA or DOAC. Hereof, the majority of patients were prescribed VKA (n=11 333, 66.8%) compared with DOAC (n=5641, 33.2%) with an increase of DOAC use from 9.4% in 2011 to 69.9% in 2019. During the 1-year follow-up, the absolute event rates per 100 person-years for all-cause mortality and the combined endpoint cardiac and cerebrovascular events were 1.9 and 1.3 for VKA-treated and 1.7 and 1.2 for DOAC-treated patients, respectively. After adjustment for baseline confounders, all-cause mortality (HR 0.95, 95% CI 0.88 to 1.01, p=0.114) and cardiac and cerebrovascular event-free survival (HR 0.93, 95% CI 0.86 to 1.01, p=0.071) did not differ significantly between VKA and DOAC groups. CONCLUSIONS: This study supports evidence of the efficacy of DOAC use after TAVI in patients with an indication for oral anticoagulation.

Development and validation of explainable machine learning models for risk of mortality in transcatheter aortic valve implantation: TAVI risk machine scores.

Aims: Identification of high-risk patients and individualized decision support based on objective criteria for rapid discharge after transcatheter aortic valve implantation (TAVI) are key requirements in the context of contemporary TAVI treatment. This study aimed to predict 30-day mortality following TAVI based on machine learning (ML) using data from the German Aortic Valve Registry. Methods and results: Mortality risk was determined using a random forest ML model that was condensed in the newly developed TAVI Risk Machine (TRIM) scores, designed to represent clinically meaningful risk modelling before (TRIMpre) and in particular after (TRIMpost) TAVI. Algorithm was trained and cross-validated on data of 22 283 patients (729 died within 30 days post-TAVI) and generalisation was examined on data of 5864 patients (146 died). TRIMpost demonstrated significantly better performance than traditional scores [C-statistics value, 0.79; 95% confidence interval (CI)] [0.74; 0.83] compared to Society of Thoracic Surgeons (STS) with C-statistics value 0.69; 95%-CI [0.65; 0.74]). An abridged (aTRIMpost) score comprising 25 features (calculated using a web interface) exhibited significantly higher performance than traditional scores (C-statistics value, 0.74; 95%-CI [0.70; 0.78]). Validation on external data of 6693 patients (205 died within 30 days post-TAVI) of the Swiss TAVI Registry confirmed significantly better performance for the TRIMpost (C-statistics value 0.75, 95%-CI [0.72; 0.79]) compared to STS (C-statistics value 0.67, CI [0.63; 0.70]). Conclusion: TRIM scores demonstrate good performance for risk estimation before and after TAVI. Together with clinical judgement, they may support standardised and objective decision-making before and after TAVI.

Short-Term Outcomes of Tricuspid Edge-to-Edge Repair in Clinical Practice.

BACKGROUND: Severe tricuspid regurgitation (TR) is known to be associated with substantial morbidity and mortality. OBJECTIVES: The authors sought to study the acute outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair with the TriClip system (Abbott) in a contemporary, real-world setting. METHODS: The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device) postapproval study is a prospective, single-arm, open-label, multicenter, postmarket registry conducted at 26 sites in Europe. Echocardiographic assessment was performed at a core laboratory. RESULTS: Enrolled subjects were elderly (79 ± 7 years of age) with significant comorbidities. Eighty-eight percent had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III or IV. Successful device implantation occurred in 99% of subjects, and TR was reduced to ≤moderate at 30 days in 77%. Associated significant improvements in NYHA functional class (I/II, 20% to 79%; P < 0.0001) and Kansas City Cardiomyopathy Questionnaire score (19 ± 23 points improvement; P < 0.0001) were observed at 30 days. With baseline TR grade removed as a variable, smaller right atrial volume and smaller tethering distance at baseline were independent predictors of TR reduction to ≤moderate at discharge (OR: 0.679; 95% CI: 0.537-0.858; P = 0.0012; OR: 0.722; 95% CI: 0.564-0.924; P = 0.0097). Fourteen subjects (2.5%) experienced a major adverse event at 30 days. CONCLUSIONS: Transcatheter tricuspid valve repair was found to be safe and effective in treating significant TR in a diverse, real-world population. (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device [bRIGHT]; NCT04483089).

Editor's Choice - Trends in Management and Outcomes of Type B Aortic Dissection: A Report From the International Registry of Aortic Dissection.

OBJECTIVE: To describe the trends in management and outcomes of patients with acute type B aortic dissection in the International Registry of Acute Aortic Dissection. METHODS: From 1996 - 2022, 3 908 patients were divided into similar sized quartiles (T1, T2, T3, and T4). In hospital outcomes were analysed for each quartile. Survival rates following admission were compared using Kaplan-Meier analyses with Mantel-Cox Log rank tests. RESULTS: Endovascular treatment increased from 19.1% in T1 to 37.2% in T4 (ptrend < .001). Correspondingly, medical therapy decreased from 65.7% in T1 to 54.0% in T4 (ptrend < .001), and open surgery from 14.8% in T1 to 7.0% in T4 (ptrend < .001). In hospital mortality decreased in the overall cohort from 10.7% in T1 to 6.1% in T4 (ptrend < .001), as well as in medically, endovascularly and surgically treated patients (ptrend = .017, .033, and .011, respectively). Overall post-admission survival at three years increased (T1: 74.8% vs. T4: 77.3%; p = .006). CONCLUSION: Considerable changes in the management of acute type B aortic dissection were observed over time, with a significant increase in the use of endovascular treatment and a corresponding reduction in open surgery and medical management. These changes were associated with a decreased overall in hospital and three year post-admission mortality rate among quartiles.

Characterization and implications of intracoronary hemodynamic assessment during coronary spasm provocation testing.

BACKGROUND: Current diagnostic criteria for coronary spasm are based on patient's symptoms, ECG shifts and epicardial vasoconstriction during acetylcholine (ACh) spasm testing. AIMS: To assess the feasibility and diagnostic value of coronary blood flow (CBF) and resistance (CR) assessment as objective parameters during ACh testing. METHODS: Eighty-nine patients who underwent intracoronary reactivity testing including ACh testing with synchronous Doppler wire-based measurements of CBF and CR were included. Coronary microvascular and epicardial spasm, respectively, were diagnosed based on COVADIS criteria. RESULTS: Patients were 63 ± 13 years old, predominantly female (69%) and had preserved LV ejection fraction (64 ± 8%). Overall, assessment of CBF and CR during ACh testing revealed a decrease in CBF of 0.62 (0.17-1.53)-fold and an increase of CR of 1.45 [0.67-4.02]-fold in spasm patients compared to 2.08 (1.73-4.76) for CBF and 0.45 (0.44-0.63) for CR in patients without coronary spasm (both p < 0.01). Receiver operating characteristic revealed a high diagnostic ability of CBF and CR (AUC 0.86, p < 0.001, respectively) in identifying patients with coronary spasm. However, in 21% of patients with epicardial spasm and 42% of patients with microvascular spasm a paradoxical response was observed. CONCLUSIONS: This study demonstrates feasibility and potential diagnostic value of intracoronary physiology assessments during ACh testing. We observed opposite responses of CBF and CR to ACh in patients with positive vs. negative spasm test. While a decrease in CBF and an increase in CR during ACh seem pathognomonic for spasm, some patients with coronary spasm demonstrate paradoxical ACh response demanding further scientific investigations.