Background The role of right-ventricular (RV) function in patients with tricuspid regurgitation (TR) undergoing transcatheter tricuspid valve interventions (TTVI) is poorly understood. Although cardiac computed tomography (CCT) provides elaborate three-dimensional (3D) visualization of the entire anatomy of the RV and theoretically allows to assess the global RV systolic function. Nevertheless, the utility of the functional assessments of the RV using CCT remains unclear in patients undergoing TTVI. Purpose This study investigated the association of right-ventricular ejection fraction (RVEF) assessed by CCT with clinical outcome in patients undergoing TTVI. Methods We retrospectively assessed 3D-RVEF by using pre-procedural CCT images in patients undergoing TTVI with either edge-to-edge repair or annuloplasty device. RV dysfunction (RVD) was defined as a CT-RVEF <45%. The primary outcome was a composite outcome, consisting of all-cause mortality and hospitalization due to heart failure, within one year after TTVI. Results Of 157 patients, 58 (36.9%) presented with CT-RVEF <45%. Patients with CT-RVEF <45% were more likely to be male, to have a previous history of coronary artery disease, and had higher EuroSCORE II and a lower LVEF compared to those with CT-RVEF ≥45%, while the severity of TR was comparable between the groups. Among the patients with CT-RVEF <45%, acute procedural success was achieved in 93.1%, and in-hospital mortality was 1.7%, which were comparable to those with CT-RVEF ≥45%. Patients with CT-RVEF <45% had an improvement in New York Heart Association functional class at follow-up compared to baseline; however, CT-RVEF <45% was associated with a higher risk of the composite outcome (adjusted hazard ratio: 3.23; 95% confidence interval: 1.52–6.88; p=0.002) (Figure 1). Furthermore, CT-RVEF had an additional value to stratify the risk of the composite outcome beyond two-dimensional transthoracic echocardiographic (TTE) assessments (Figure 2). In addition, patients with CT-RVEF <45% exhibited an attenuated association between a reduction in TR to <3+ and a lower incidence of the composite outcome after TTVI compared to those with CT-RVEF ≥45%. Conclusions TTVI is safe and feasible regardless of baseline RV function, while RVD, defined as 3D-RVEF <45%, is associated with a higher risk of the composite outcomes within one year after TTVI. Furthermore, our findings suggest that the prognostic benefits of TR reduction might be attenuated in patients with RVD. Given the additional prognostic value of CT-RVEF to the conventional echocardiographic assessments, the assessments of 3D-RVEF with CCT may refine the patient selection for TTVI. Funding Acknowledgement Type of funding sources: None.

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Background Despite major advances, transcatheter aortic valve replacement (TAVR) is associated with procedure-related vascular and bleeding complications, that have a significant impact on mortality. A recently published study has shown that heparin antagonization using protamine resulted in significantly lower rates of serious bleeding events in patients undergoing TAVR as compared to those without heparin reversal. However, the optimal protamine-to-heparin dosing ratio to prevent bleeding complications without increasing ischemic complications in patients undergoing TAVR is unknown. Accordingly, daily clinical practice varies between selective to routine administration of protamine in different dosing ratios. Purpose The aim of this observational multicentre study was to compare the safety and efficacy of two different protamine-to-heparin dosing ratios for the prevention of bleeding complications after TAVR. Methods The study included 1446 patients undergoing TAVR, of whom 623 (43.1%) received partial and 823 (56.9%) full heparin antagonization (0.4–0.6 mg versus 0.9–1.0 mg protamine/100 units of heparin). The indication for partial or full heparin antagonization was left to the discretion of the operator, who made the decision according to the patient's individual thrombotic and bleeding risk. The primary endpoint was a composite of 30-day mortality, life-threatening and major bleeding. Safety endpoints included stroke and myocardial infarction at 30 days. Results The overall study population had a mean age of 81.1±6.0 years; 47.9% were of female gender. The baseline characteristics were well balanced between the two groups. Full antagonization of heparin resulted in significantly lower rates of the primary endpoint as compared to partial heparin reversal (5.6 vs. 10.4%, p<0.01), mainly driven by lower rates of life-threatening (0.5 vs 1.6%, p=0.05) and major bleeding (3.2 vs 7.5%, p<0.01). The incidence of major vascular complications was significantly lower in patients with full heparin reversal (3.5 vs 7.5%, p<0.01), as presented in Figure 1. Accordingly, the post-interventional drop in hemoglobin level and the need for red-blood-cell transfusion was lower in patients receiving full as compared to partial heparin reversal (1.5±1.2 vs 1.7±1.2 g/dl, p<0.01; 10.4 vs 15.9%, p<0.01, respectively). Regarding safety endpoints, no differences were observed in the incidence of stroke and myocardial infarction between the groups (2.2 vs 2.6%, p=0.73 and 0.2 vs 0.4%, p=0.64, respectively). Multivariate regression analyses revealed that full antagonization of heparin (OR: 0.43 [95% CI: 0.24–0.81], p<0.01) was independently associated with the primary end point Conclusion Full heparin antagonization resulted in significantly lower rates of life-threatening and major bleeding after TAVR as compared to partial heparin reversal. The occurrence of stroke and myocardial infarction was low and comparable between both groups. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation).

Background Secondary mitral regurgitation (SMR) is associated with adverse outcomes and the optimal treatment modality remains challenging due to extensive variety in the pathology of SMR. Percutaneous direct annuloplasty using the Cardioband system emerged as a promising treatment in selected patients. However, success predictors of this intervention and their association with prognosis remain unclear. Purpose To investigate the role of echocardiographic and computed tomography (CT) data in patients with SMR undergoing percutaneous direct annuloplasty. Methods We retrospectively analyzed patients who underwent catheter-based direct annuloplasty with the Cardioband system for SMR at five tertiary centres in Germany and Switzerland between 2013 and 2020. Patients with procedural success (defined as postprocedural MR grade ≤2+) were compared to those with MR >2+ with respect to baseline echocardiographic data and outcome. Results We included 130 patients (median age 75.5 [71–79], 37% female). Most patients were severely symptomatic (NYHA class III/IV 86.9%), had a median EF of 39 (29–52) with an ischaemic etiology in 39%. Procedural success was achieved in 68%. Procedural time was 178.5 (147.5–214.5) minutes. Patients with and without procedural success differed significantly in measures of MR severity (defined as postprocedural SMR severity (grade, vena contracta (VC), effective regurgitation orifice area and regurgitation volume), annular dilatation (leaflet length, LA sphericity index at end-systole and CT-derived intercommissural distance) and leaflet tethering (tenting area, regurgitation jet direction). In multivariable analysis of echocardiographic parameters including significant measures of annular dilatation and leaflet tethering, predictors of procedural treatment success were tenting area (OR 0.54; 95% CI 0.33–0.98 per mm2, p=0.016) and central regurgitation jet direction (OR 2.96; 95% CI 1.06–8.25, p=0.038). After adding CT data in the multivariable model, intercommissural distance proved to be the most significant predictor (OR 0.96; 0.92–0.99, p=0.009), whereas VC was the only echo predictor (OR 0.84; 0.73–0.98, p=0.03). NYHA class III/IV at last follow up was significantly different between groups, with 34.1% vs. 55.2% of patients with vs. without procedural success, respectively (p=0.04). The combined endpoint of mortality or reintervention at 1 year was significantly lower in patients with procedural success (27% vs. 63%, p=0.002), whereas the association of procedural success with 1-year mortality was of borderline significance (13% vs. 32%, p=0.05). Conclusion Two thirds of patients undergoing transcatheter direct annuloplasty for SMR had procedural success. Careful patient selection by assessment of mitral valve anatomy is helpful to predict procedural success, which translates into less symptom burden and better clinical outcome. Funding Acknowledgement Type of funding sources: None.

Background A considerable risk of acute kidney injury (AKI) following transcatheter interventions without iodinated contrast agents has also been recognized; however, little is known about the incidence and clinical relevance of post-procedural AKI in patients undergoing transcatheter edge-to-edge repair (TEER) for tricuspid regurgitation (TR). Purpose This study aimed to investigate the prognostic impact and predictors of post-procedural AKI following TEER for TR. Methods We retrospectively analyzed 218 consecutive patients who underwent TEER for TR. Post-procedural AKI was defined as an increase in serum creatinine of ≥0.3 mg/dl within 48 hours or of ≥50% within seven days after the procedure, compared to baseline. Procedural success was defined as at least one grade reduction in TR severity upon discharge. We determined the association between post-procedural AKI and the composite outcome consisting of all-cause mortality and re-hospitalization due to heart failure within one year after the procedure. Results Overall, the mean age of the patients was 79±7 years, and 46.3% of the patients were male. Post-procedural AKI occurred in 32 patients (14.7%) (Figure 1). Among baseline characteristics, male sex and an estimated glomerular filtration rate of <60 ml/min/m2 were associated with the occurrence of AKI. In addition, patients without procedural success had a higher incidence of post-procedural AKI (30.4% vs. 1.8%; p=0.024). Patients with AKI had a higher incidence of in-hospital mortality compared to those without AKI (12.5% vs. 1.1%; p=0.005). Moreover, AKI was associated with the incidence of the composite outcome within one year after TEER for TR (adjusted hazard ratio: 2.06; 95% confidence interval: 1.11–3.84; p=0.023). In addition, our restricted cubic spline curve showed that a post-procedural increase in the creatinine level within seven days after the procedure was associated with a linear trend of the risk of the composite outcome after TEER (Figure 2). Conclusions Post-procedural AKI occurred in 14.7% of patients undergoing TEER for TR, despite the absence of iodinated contrast agents, which was associated with worse clinical outcomes. Male sex and CKD at baseline were related to the occurrence of AKI, and the procedural success of TEER was associated with a lower incidence of AKI. Our findings highlight the clinical impact of AKI following TEER for TR and should help with identifying patients at high risk of AKI. Funding Acknowledgement Type of funding sources: None.