Outcomes of Transcatheter Tricuspid Edge-to-Edge Repair in Patients With Right Ventricular Dysfunction.

BACKGROUND: We assessed the safety profile of tricuspid transcatheter edge-to-edge repair (TEER) in patients with right ventricular (RV) dysfunction. METHODS: We identified patients undergoing TEER to treat tricuspid regurgitation from June 2015 to October 2021 and assessed tricuspid annular plane systolic excursion (TAPSE) and RV fractional area change (RVFAC). RV dysfunction was defined as TAPSE <17 mm and RVFAC <35%. The primary end point was 30-day mortality after TEER. We also investigated the change in the RV function in the early phase and clinical outcomes at 2 years. RESULTS: The study participants (n=262) were at high surgical risk (EuroSCORE II, 6.2% [interquartile range, 4.0%-10.3%]). Among them, 44 patients met the criteria of RV dysfunction. Thirty-day mortality was 3.2% in patients with normal RV function and 2.3% in patients with RV dysfunction (P=0.99). Tricuspid regurgitation reduction to ≤2+ was consistently achieved irrespective of RV dysfunction (76.5% versus 70.5%; P=0.44). TAPSE and RVFAC declined after TEER in patients with normal RV function (TAPSE, 19.0±4.7 to 17.9±4.5 mm; P=0.001; RVFAC, 46.2%±8.1% to 40.3%±9.7%; P<0.001). In contrast, those parameters were unchanged or tended to increase in patients with RV dysfunction (TAPSE, 13.2±2.3 to 15.3±4.7 mm; P=0.011; RVFAC, 29.6%±4.1% to 31.6%±8.3%; P=0.14). Two years after TEER, compared with patients with normal RV function, patients with RV dysfunction had significantly higher mortality (27.0% versus 56.3%; P<0.001). CONCLUSIONS: TEER was safe and feasible to treat tricuspid regurgitation in patients with RV dysfunction. The decline in the RV function was observed in patients with normal RV function but not in patients with RV dysfunction.

Changes in right ventricular function and clinical outcomes following tricuspid transcatheter edge-to-edge repair.

AIMS: Prognostic impact of post-procedural changes in right ventricular (RV) function after tricuspid transcatheter edge-to-edge repair (T-TEER) is still unclear. We investigated association of RV function and its post-procedural changes with clinical outcomes in patients undergoing T-TEER. METHODS AND RESULTS: We retrospectively analysed 204 patients who underwent T-TEER and echocardiographic follow-up at 3 months after T-TEER. RV function was assessed by RV fractional area change (RVFAC), and RV dysfunction was defined as RVFAC <35%. Patients with an increase in RVFAC from baseline to the follow-up were considered as RV responders. Patients were divided into four groups according to baseline RVFAC and the RV responder. The primary outcome was a composite of mortality and hospitalization due to heart failure within 1 year. Forty-five of 204 patients (22.1%) had RVFAC <35% at baseline, and 71 (34.8%) were RV responders. The association between the RV responder and the composite outcome had a significant interaction with RVFAC at baseline. Among patients with baseline RVFAC <35%, RV responders had a lower risk of the composite outcome than RV non-responders, while this association was not significant in those with baseline RVFAC ≥35%. Among patients with baseline RVFAC <35%, a smaller RV diameter and a greater reduction of tricuspid regurgitation were predictors for the RV responder. CONCLUSION: Post-procedural increase in RVFAC after T-TEER is associated with improved outcomes in patients with RV dysfunction. The factors related to the increase in RVFAC may support patient selection for T-TEER in patients with RV dysfunction.

Impact of body mass index in patients with tricuspid regurgitation after transcatheter edge-to-edge repair.

BACKGROUND: Obesity and underweight represent classical risk factors for outcome in patients treated for cardiovascular disease. This study describes the impact of different body mass index (BMI) categories on 1-year clinical outcome in patients with tricuspid regurgitation (TR) undergoing transcatheter-edge-to-edge repair (TEER). METHODS: We analyzed 211 consecutive patients (age 78.3 ± 7.2 years, 55.5% female, median EuroSCORE II 9.6 ± 6.7) with tricuspid regurgitation undergoing TEER from June 2015 until May 2021. Patients were prospectively enrolled in our single center registry and were retrospectively analyzed. Patients were stratified according to body mass index (BMI) into 4 groups: BMI < 20 kg/m2 (underweight), BMI 20.0 to < 25.0 kg/m2 (normal weight), BMI 25.0 to > 30.0 kg/m2 (overweight) and BMI ≥ 30 kg/m2 (obese). RESULTS: Kaplan-Meier survival curves demonstrated inferior survival for underweight and obese patients, but comparable outcomes for normal and overweight patients (global log rank test, p < 0.01). Cardiovascular death was significantly higher in underweight patients compared to the other groups (24.1% vs. 7.0% vs. 6.3% vs. 6.4%; p < 0.01). Over all, there were comparable rates of bleeding, stroke and myocardial infarction. Multivariable Cox regression analysis (adjusted for age, gender, coronary artery disease, chronic obstructive pulmonary disease, tricuspid annular plane systolic excursion, left-ventricular ejection fraction) confirmed underweight (HR 3.88; 95% CI 1.64-7.66; p < 0.01) and obesity (HR 3.24; 95% CI 1.37-9.16; p < 0.01) as independent risk factors for 1-year all-cause mortality. CONCLUSIONS: Compared to normal weight and overweight patients, obesity and underweight patients undergoing TEER display significant higher 1-year all-cause mortality.

Refining accuracy of RV-PA coupling in patients undergoing transcatheter tricuspid valve treatment.

BACKGROUND: Assessing right ventricular (RV) function is paramount for risk stratification, which remains challenging in patients with tricuspid regurgitation (TR). We assessed RV-pulmonary artery (PA) coupling and its predictability of outcomes after transcatheter tricuspid valve repair (TTVR). METHODS: Study participants comprised patients undergoing transcatheter tricuspid valve repair to treat symptomatic TR from June 2015 to July 2021. We calculated an RV-PA coupling ratio using a formula, which is dividing tricuspid annular plane systolic excursion (TAPSE) by echocardiographically estimated (ePASP) or invasively measured PASP (iPASP) at baseline. The primary outcome was all-cause mortality or heart failure rehospitalization within one year. RESULTS: The study participants (n = 206) were at high surgical risk (EuroSCORE II: 7.4 ± 4.8%). The primary outcome occurred in 57 patients within one year. The c-statistics for the outcome were 0.565 (95% CI 0.488-0.643) for TAPSE/ePASP and 0.695 (95% CI 0.631-0.759) for TAPSE/iPASP. The correlation between the ePASP and iPASP was attenuated in patients with massive/torrential TR compared to those with severe TR (interaction p = 0.01). In the multivariable Cox proportional model, TAPSE/iPASP was inversely associated with the risk of the primary outcome (per 0.1-point increase: adjusted-HR 0.67, 95% CI 0.56-0.82, p < 0.001), independent of baseline demographics. According to the TAPSE/iPASP quartiles (i.e., ≤ 0.316; 0.317-0.407; 0.408-0.526; ≥ 0.527), the event-free survival was 43.4%, 48.3%, 77.9%, and 85.4% at one year after TTVR. CONCLUSION: RV-PA coupling predicts one-year mortality and heart failure rehospitalization after TTVR in patients with TR. The predictability is improved if invasively-measured PA pressure is included.

Carotid Stiffness After Transcatheter Aortic Valve Replacement.

The present study aimed to analyze common carotid artery strain properties in patients (n = 59) with severe aortic valve stenosis who underwent transcatheter aortic valve replacement (TAVR). Arterial compliance of the common carotid artery was assessed by ultrasound speckle-tracking before and after TAVR. For sub-analysis the study cohort was divided according to aortic valve area <.75 cm2 (n = 30) vs ≥.75 cm2 (n = 29). Comparison of pre- and post-procedural strain variables showed an improvement in median radial velocity (P < .0001), radial displacement (P = .007), circumferential strain (P = .004), radial strain rate (P = .023), and circumferential strain rate (P < .0001), while the increase of radial strain showed a trend (P = .082). Analysis of aortic valve area revealed an inverse correlation between aortic valve area and the differences (post-procedural-pre-procedural values) for radial strain rate, and circumferential strain. Moreover, sub-analysis revealed that the increase of carotid strain variables before and after TAVR were more pronounced in the sub-group of aortic valve area .75 vs ≥.75 cm2. TAVR led to a reduction of arterial wall stiffness of the common carotid artery assessed by ultrasound speckle-tracking. The decrease of arterial wall stiffness after TAVR was more pronounced in more severe aortic valve stenosis.

Right ventricular ejection fraction assessed by computed tomography in patients undergoing transcatheter tricuspid valve repair.

AIMS: The role of right ventricular function in patients undergoing transcatheter tricuspid valve repair (TTVR) is poorly understood. This study investigated the association of right ventricular ejection fraction (RVEF) assessed by cardiac computed tomography (CCT) with clinical outcomes in patients undergoing TTVR. METHODS AND RESULTS: We retrospectively assessed three-dimensional (3D) RVEF by using pre-procedural CCT images in patients undergoing TTVR. RV dysfunction was defined as a CT-RVEF of <45%. The primary outcome was a composite outcome, consisting of all-cause mortality and hospitalization due to heart failure, within 1 year after TTVR. Of 157 patients, 58 (36.9%) presented with CT-RVEF <45%. Procedural success and in-hospital mortality were comparable between patients with CT-RVEF <45% and ≥45%. However, CT-RVEF of <45% was associated with a higher risk of the composite outcome (hazard ratio: 2.99; 95% confidence interval: 1.65-5.41; P = 0.001), which had an additional value beyond two-dimensional echocardiographic assessments of RV function to stratify the risk of the composite outcome. In addition, patients with CT-RVEF ≥45% exhibited the association of procedural success (i.e. residual tricuspid regurgitation of ≤2+ at discharge) with a decreased risk of the composite outcome, while this association was attenuated in those with CT-RVEF <45% (P for interaction = 0.035). CONCLUSION: CT-RVEF is associated with the risk of the composite outcome after TTVR, and a reduced CT-RVEF might attenuate the prognostic benefit of TR reduction. The assessment of 3D-RVEF by using CCT may refine the patient selection for TTVR.

Tricuspid valve anatomy of massive to torrential tricuspid regurgitation: Computed tomography analysis.

BACKGROUND: We aimed to comprehensively assess tricuspid valve anatomy and to determine factors associated with the more advanced stages beyond severe TR (i.e., massive to torrential). METHODS: We retrospectively analyzed the pre-procedural cardiac CT images in patients with ≥severe TR using 3mensio software. The tricuspid valve annulus size, right-atrial and right-ventricular dimensions, tenting height, and leaflet angles were measured. RESULTS: A total of 103 patients were analyzed. The mean effective regurgitant orifice area was 61.7 â€‹± â€‹31.5 â€‹mm2, vena contracta was 13.1 â€‹± â€‹4.6 â€‹mm, and massive/torrential TR was observed in 62 patients. Compared to patients with severe TR, patients with massive/torrential TR had a larger tricuspid annulus area (18.6 â€‹± â€‹3.4 â€‹cm2 vs. 20.6 â€‹± â€‹5.3 â€‹cm2, p â€‹= â€‹0.037), right atrial short-axis diameter (66.1 â€‹± â€‹9.1 â€‹mm vs. 70.6 â€‹± â€‹9.9 â€‹mm, p â€‹= â€‹0.022), increased tenting height (8.8 â€‹± â€‹3.6 â€‹mm vs. 10.7 â€‹± â€‹3.7 â€‹mm, p â€‹= â€‹0.014), and greater leaflet angles (anterior leaflet: 22 â€‹± â€‹9° vs. 32 â€‹± â€‹13°, p â€‹< â€‹0.001; posterior leaflet: 22 â€‹± â€‹11° vs. 30 â€‹± â€‹11°, p â€‹= â€‹0.003). In the multivariable logistic regression model, the angle of anterior leaflet (OR 1.08, 95%CI 1.03-1.14, p â€‹= â€‹0.004) and posterior leaflet (OR 1.07, 95%CI 1.02-1.13, p â€‹= â€‹0.007) were associated with massive/torrential TR. Additionally, patients with massive/torrential TR more often had TR jets from non-central/non-anteroseptal commissure (34% vs. 76%, p â€‹< â€‹0.001). In the multivariable model, a greater angle of the leaflets and a more elliptical annulus were associated with non-central/non-anteroseptal TR jets. CONCLUSIONS: Anterior and posterior leaflet angles are significant factors associated with massive/torrential TR. Furthermore, leaflet angles and ellipticity of the tricuspid valve are associated with the location of TR jets.

Deep sedation vs. general anesthesia for transcatheter tricuspid valve repair.

Background: Transcatheter tricuspid valve repair (TTVr) is routinely performed under general anesthesia (GA). This study aimed to investigate whether TTVr procedures can be performed effectively and safely without GA but using deep sedation (DS). Methods: We performed a retrospective analysis of 104 patients from three centers who underwent TTVr between 2020 and 2021. The primary performance endpoints were technical success and severity of TR assessed at the time of discharge. The safety outcome was a composite of in-hospital complications, including occurrence of death, conversion to surgery, major adverse cardiac and cerebrovascular events, major vascular complications, or occurrence of pneumonia. Results: Sixty-four procedures were performed in GA and 40 procedures were performed in DS. The groups did not differ in age, EuroScore II, TR severity, ventricular function, or hemodynamic parameters. Technical success was achieved in 92.5% of the patients in the DS group and in 93.6% of the patients in the GA group (p = 0.805). In none of the patients intraprocedural conversion from DS to GA was required. There was no difference in total duration of the procedure, and number of devices implanted. The degree of TR was ≤2+ in 77.5% of the patients in the DS group and in 74.2% of the patients in the GA group (p = 0.705). The composite safety endpoint did not differ between the groups (2.5 vs. 6.3%, p = 0.384). The total duration of hospital stay was shorter in patients who underwent TTVr in DS compared to those who underwent TTVr in GA (6 [5, 9] days vs. 8 [6, 11] days; p = 0.011). Conclusion: Performing TTVr in DS was effective with similar procedural results, and was safe with similar low complication rates compared to GA.

Acute Kidney Injury Following Tricuspid Transcatheter Edge-to-Edge Repair.

BACKGROUND: Little is known about the incidence and clinical relevance of postprocedural acute kidney injury (AKI) in patients undergoing transcatheter edge-to-edge repair (TEER) for tricuspid regurgitation (TR). OBJECTIVES: The aim of this study was to investigate the prognostic impact of postprocedural AKI following TEER for TR. METHODS: Two hundred sixty-eight patients who underwent TEER for TR at 2 centers were retrospectively analyzed. Postprocedural AKI was defined as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or ≥50% within 7 days after the procedure compared with baseline. The association between AKI and the composite outcome, consisting of all-cause mortality and rehospitalization for heart failure within 1 year after the procedure, was determined. RESULTS: The mean age of the patients was 79.0 ± 6.8 years, and 43.3% were men. Postprocedural AKI occurred in 42 patients (15.7%). Age, male sex, an estimated glomerular filtration rate of <60 mL/min/1.73 m2, and absence of procedural success were associated with the occurrence of AKI. Patients with AKI had a higher incidence of in-hospital mortality than those without AKI (9.5% vs 0.9%; P = 0.006). Moreover, AKI was associated with the incidence of the composite outcome within 1 year after TEER for TR (adjusted HR: 2.39; 95% CI: 1.45-3.94; P = 0.001). CONCLUSIONS: Postprocedural AKI occurred in 15.7% of patients undergoing TEER for TR, despite the absence of iodinated contrast agents, which was associated with worse clinical outcomes. These findings highlight the clinical impact of AKI following TEER for TR and should help in identifying patients at high risk for AKI.

Guideline-directed medical therapy after transcatheter edge-to-edge mitral valve repair.

OBJECTIVE: A sizeable proportion of patients with secondary mitral regurgitation (SMR) do not receive guideline-directed medical therapy (GDMT) for heart failure (HF). We investigated the association between the use of GDMT and mortality in patients with SMR who underwent transcatheter edge-to-edge repair (TEER). METHODS: We retrospectively analysed patients with SMR and a left ventricular ejection fraction of <50% who underwent TEER at three centres. According to current HF guidelines, GDMT was defined as triple therapy consisting of beta-blockers, renin-angiotensin system (RAS) inhibitors and mineralocorticoid receptor antagonists (MRAs). Patients were divided into two groups: GDMT and non-GDMT groups. We calculated the propensity scores and carried out inverse probability of treatment weighting (IPTW) analyses to compare 2-year mortality between the two groups. RESULTS: Of 463 patients, 228 (49.2%) were treated with GDMT upon discharge. IPTW-adjusted Kaplan-Meier curve showed patients with GDMT had a lower incidence of mortality than those without GDMT (19.8% vs 31.1%, p=0.011). In IPTW-adjusted Cox proportional hazards analysis, GDMT was associated with a reduced risk of 2-year mortality (HR: 0.58; 95% CI: 0.35 to 0.95; p=0.030), which was consistent among clinical subgroups. Moreover, patients with GDMT had a higher rate of left ventricular reverse remodelling at 1 year after TEER than those without GDMT. CONCLUSION: GDMT, defined as triple therapy consisting of beta-blockers, RAS inhibitors and MRAs, was associated with a reduced risk of 2-year mortality after TEER for SMR. Optimisation of medical therapy is crucial to improve clinical outcomes in patients undergoing TEER for SMR.

Impact of right ventricular-pulmonary arterial coupling on clinical outcomes of tricuspid regurgitation.

BACKGROUND: In terms of pathophysiology, tricuspid regurgitation (TR) and right ventricular (RV) function are linked to each other. AIMS: This study sought to evaluate RV-pulmonary artery (PA) coupling and its impact on clinical outcomes of TR in patients undergoing mitral transcatheter edge-to-edge repair (TEER). METHODS: We calculated RV-PA coupling ratios in patients undergoing mitral TEER from August 2010 to March 2019 by dividing the tricuspid annular plane systolic excursion (TAPSE) by the echocardiographic estimated PA systolic pressure (PASP). TR was graded as none/trace, mild, moderate, or severe. The primary outcome was all-cause mortality or rehospitalisation within 12 months. RESULTS: Among 744 patients analysed, severe TR was documented in 22.3% of patients and the mean TAPSE/PASP was 0.43±0.25. Technical success of TEER was achieved in 97.2% of participants. Severe TR vs TR ≤moderate (adjusted HR 1.92, 95% CI: 1.39-2.66) and TAPSE/PASP (adjusted HR 0.45, 95% CI: 0.22-0.93) were associated with the outcome. Patients were divided according to the TAPSE/PASP tertile. Compared to patients with TR ≤moderate, patients with severe TR had a higher event rate (TAPSE/PASP <0.30: 32.9% vs 45.1%; 0.30≤ TAPSE/PASP <0.44: 27.8% vs 41.8%; TAPSE/PASP ≥0.44: 16.0% vs 40.4%), whereas the prognostic significance of TR was attenuated in patients with reduced TAPSE/PASP (i.e., RV-PA uncoupling; interaction term p=0.03). The trends were consistent in the multivariable regression models, spline curves, and sensitivity analysis using post-interventional parameters. CONCLUSIONS: RV-PA coupling affects the outcome correlation of TR in patients undergoing mitral TEER. The prognostic impact of TR is attenuated in patients with RV-PA uncoupling.

Recurrent Mitral Regurgitation After MitraClip: Predictive Factors, Morphology, and Clinical Implication.

BACKGROUND: Recurrent mitral regurgitation (MR) following MitraClip has not been thoroughly investigated. We aimed to examine the predictive factors, morphology, and long-term outcome of recurrent MR after MitraClip. METHODS: We assessed data from the Heart Failure Network Rhineland registry from August 2010 to October 2018. Competing risk analyses were performed using the Fine and Gray model to assess the risk of recurrent MR. RESULTS: Among 685 MitraClip patients with a reduction in MR to ≤2+, 61 patients developed recurrent MR within the first 12 months. Flail leaflet (hazard ratio, 3.68; P=0.002) and residual MR (MR grade 2+ versus ≤1+: hazard ratio, 2.56; P=0.03) were the predictors of recurrent MR in primary MR patients, while left atrial volume (per 10 mL increase: hazard ratio, 1.11; P<0.001) and residual MR (hazard ratio, 2.45; P=0.01) were independently associated with recurrent MR in secondary MR patients. In primary MR patients, loss of leaflet insertion or leaflet tear were the predominant morphologies with recurrent MR. In secondary MR patients, more than half of the patients with recurrent MR did not show any disorder of the clip or leaflets. Patients with recurrent MR were more likely to experience unplanned heart failure hospitalization or heart failure symptom with New York Heart Association scale III/IV (54.1% versus 37.8%; P=0.018) and undergo a repeat mitral valve intervention (9.8% versus 2.2%; P=0.005) during the follow-up. In the landmark survival analysis, patients with recurrent MR tended to have lower long-term survival (58.7% versus 83.9%; P=0.08) than patients without recurrent MR. CONCLUSIONS: Flail leaflet and residual MR were the predictors of recurrent MR in primary MR patients, while a larger left atrial volume and residual MR were associated with recurrent MR in secondary MR patients, which may be associated with long-term clinical outcomes of patients after MitraClip.

Leaflet-to-annulus index and residual tricuspid regurgitation following tricuspid transcatheter edge-to-edge repair.

BACKGROUND: A mismatch between tricuspid leaflet size and annular dilation is one of the morphological features tied to the development of tricuspid regurgitation (TR). AIMS: We assessed the association of the leaflet-to-annulus index (LAI) with residual TR after transcatheter edge-to-edge repair (TEER). METHODS: Consecutive patients who underwent TEER for TR were enrolled. Significant residual TR was defined as a post-procedural TR ≥3+, and patients were divided into two groups according to the amount of residual TR. The LAI was retrospectively calculated using procedural transoesophageal echocardiography and was defined as follows: (anterior leaflet length+septal leaflet length)/septolateral tricuspid annulus diameter. RESULTS: Of 140 patients, 43 patients had residual TR ≥3+ after TEER. The patients with residual TR ≥3+ had a lower LAI compared to those with residual TR <3+ (1.04±0.10 vs 1.13±0.09; p=0.001). In multivariable analysis, the LAI was associated with residual TR ≥3+ (odds ratio [OR] [per 0.1 increase]: 0.57; 95% confidence interval [95% CI]: 0.35-0.94; p=0.02), independent of baseline TR severity or coaptation gap size. Patients with residual TR ≥3+ had a higher incidence of the composite outcome, consisting of all-cause mortality and heart failure hospitalisation within one year after TEER (47.1% vs 26.6%, p=0.02). Residual TR ≥3+ was an independent predictor of the composite outcome within one year (hazard ratio: 2.04; 95% CI: 1.01-4.11; p=0.04). CONCLUSIONS: The leaflet-to-annulus mismatch (i.e., LAI) is associated with residual TR ≥3+ after TEER for TR. A detailed echocardiographic analysis of the tricuspid valve will be conducive to identifing suitable subjects for TEER.

Early response of right-ventricular function to percutaneous mitral valve repair.

BACKGROUND: The change in right-ventricular function (RVF) after transcatheter mitral valve repair is still poorly understood. We assessed the early response of RVF to the MitraClip procedure and its clinical relevance. METHODS: We analyzed consecutive patients who underwent a MitraClip procedure to treat MR between August 2010 and March 2019 in the Heart Failure Network Rhineland registry. RVF was assessed before and after the procedure. Impaired RVF was defined as an RV fractional area change (RVFAC) < 35% or tricuspid annular plane systolic excursion (TAPSE) < 16 mm. RESULTS: 816 eligible patients (77 ± 9 years, 58.5% male) were included in the analysis. Baseline values of RVF were: RVFAC 38.6 (IQR 29.7-46.7) % and TAPSE 17.0 (IQR 14.0-21.0) mm. At a median time of 3 (IQR 2-5) days after the procedure, the RVF remained normal in 34% (n = 274), normalized in 17% (n = 140), deteriorated in 15% (n = 125), and was persistently impaired in 34% (n = 277) of patients. The RVF response was significantly associated with a composite outcome of all-cause mortality and hospitalization due to heart failure within a 2-year follow-up. Compared to stable/normal RVF, the adjusted hazard ratios for the outcome were 1.78 (95% CI 1.10-2.86) for normalized RVF, 1.89 (95% CI 1.34-3.15) for deteriorated RVF, and 2.25 (95% CI 1.47-3.44) for persistently impaired RVF. Changes in TAPSE and RVFAC as continuous variables were significantly correlated with the outcome. CONCLUSION: An early change in RVF following transcatheter mitral valve repair is predictive of mortality and hospitalization due to heart failure during follow-up. Early response of RVF after MitraClip and its clinical significance. An acute, early change in RVF can be observed following the MitraClip procedure, which is associated with the risk of mortality and hospitalization for HF.

Machine Learning Identifies Clinical Parameters to Predict Mortality in Patients Undergoing Transcatheter Mitral Valve Repair.

OBJECTIVES: The aim of this study was to develop a machine learning (ML)-based risk stratification tool for 1-year mortality in transcatheter mitral valve repair (TMVR) patients incorporating metabolic and hemodynamic parameters. BACKGROUND: The lack of appropriate, well-validated, and specific means to risk-stratify patients with mitral regurgitation complicates the evaluation of prognostic benefits of TMVR in clinical trials and practice. METHODS: A total of 1,009 TMVR patients from 3 university hospitals within the Heart Failure Network Rhineland were included; 1 hospital (n = 317) served as external validation. The primary endpoint was all-cause 1-year mortality. Model performance was assessed using receiver-operating characteristic curve analysis. In the derivation cohort, different ML algorithms were tested using 5-fold cross-validation. The final model, called MITRALITY (transcatheter mitral valve repair mortality prediction system) was tested in the validation cohort with respect to existing clinical scores. RESULTS: Extreme gradient boosting was selected for the MITRALITY score, using only 6 baseline clinical features for prediction (in order of predictive importance): urea, hemoglobin, N-terminal pro-brain natriuretic peptide, mean arterial pressure, body mass index, and creatinine. In the external validation cohort, the MITRALITY score's area under the curve was 0.783 (95% CI: 0.716-0.849), while existing scores yielded areas under the curve of 0.721 (95% CI: 0.63-0.811) and 0.657 (95% CI: 0.536-0.778) at best. CONCLUSIONS: The MITRALITY score is a novel, internally and externally validated ML-based tool for risk stratification of patients prior to TMVR, potentially serving future clinical trials and daily clinical practice.

Periprocedural changes in natriuretic peptide levels and clinical outcome after transcatheter mitral valve repair.

AIMS: This multicentre study investigated the association of periprocedural changes in the levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) with clinical outcomes after transcatheter edge-to-edge mitral valve repair (TMVR). METHODS AND RESULTS: Patients were retrospectively analysed who underwent TMVR with the MitraClip system (Abbott Vascular, Santa Clara, CA, USA) and had available sequential NT-proBNP testing at baseline and 2 months after TMVR. Periprocedural changes in NT-proBNP following TMVR were assessed as the percent change in NT-proBNP between baseline and the 2 month follow-up, and the significant reduction in NT-proBNP was defined as a decrease of >30% in the follow-up NT-proBNP compared with the pre-procedural NT-proBNP level. Primary outcome was defined as a composite outcome consisting of all-cause mortality and hospitalization due to heart failure from 2 months to 2 years after TMVR. Additionally, we identified the cut-off value of pre-procedural NT-proBNP to predict the composite outcome using a receiver operating characteristic analysis (cut-off: 2485 pg/mL). Of 485 patients undergoing TMVR (age: 76.2 ± 9.2 years, female: 42.1%, secondary mitral regurgitation: 67.2%), 150 patients (30.9%) had the significant reduction in NT-proBNP (>30%) following the procedure. Patients with the NT-proBNP reduction had a lower incidence of the composite outcome, compared with those without the reduction in NT-proBNP (31.4% vs. 40.2%; log-rank P = 0.03). The significant reduction in NT-proBNP was also associated with a lower risk of the composite outcome [adjusted hazard ratio (HR): 0.67; 95% confidence interval (CI): 0.45-0.97; P = 0.04], independently of pre-procedural NT-proBNP levels and other clinical parameters. The percent change in NT-proBNP was associated with a linear trend of the incidence of the composite outcome (adjusted HR per 10% decrease: 0.96; 95% CI: 0.94-0.98; P < 0.001). A stratified analysis revealed that the prognostic impact of the significant reduction in NT-proBNP was consistent among clinical subgroups, including aetiology of mitral regurgitation (P for interaction = 0.99). Higher pre-procedural NT-proBNP level (>2485 pg/mL) was associated with the increased risk of the composite outcome (adjusted HR: 1.50; 95% CI: 1.03-2.17; P = 0.03); however, patients with a higher pre-procedural NT-proBNP who achieved the significant reduction in NT-proBNP had a similar risk of the composite outcome to those with a lower pre-procedural NT-proBNP. CONCLUSIONS: Changes in sequential NT-proBNP measurements were associated with clinical outcomes within 2 years after TMVR. The assessment of NT-proBNP dynamics may be valuable to assess the residual risk for patients undergoing TMVR and could assist with post-procedural management after TMVR.