Transcatheter Edge-to-Edge Mitral Valve Repair versus Minimally Invasive Mitral Valve Surgery: An Observational Study.

Background: Minimally invasive mitral valve surgery (MIC-MVS) has been established as preferred treatment of mitral regurgitation (MR), but mitral transcatheter edge-to-edge valve repair (M-TEER) is routinely performed in patients at high surgical risk and is increasingly performed in intermediate risk patients. Methods: From 2010 to 2021, we performed 723 M-TEER and 123 isolated MIC-MVS procedures. We applied a sensitivity analysis by matching age, left ventricular ejection fraction (LVEF), EuroSCORE II and etiology of MR. Results: Baseline characteristics showed significant differences in the overall cohort (p < 0.01): age 78.3 years vs. 61.5 years, EuroSCORE II 5.5% vs. 1.3% and LVEF 48.4% vs. 60.4% in M-TEER vs. MIC-MVS patients. Grade of MR at discharge was moderate/severe in 24.5% (171/697) in M-TEER vs. 6.5% (8/123) in MIC-MVS (p < 0.01). One-year survival was 91.5% (552/723) in M-TEER vs. 97.6% (95/123) in MIC-MVS (p = 0.04). A matching with 49 pairs (n = 98) showed comparable survival during follow-up, but a numerically higher mean mitral valve gradient of 4.1 mmHg (95% CI: 3.6-4.6) vs. 3.4 mmHg (95% CI: 3.0-3.8) in M-TEER (p = 0.04). Conclusions: Patients undergoing M-TEER had lower one-year survival than MIC-MVS, but differences disappeared after matching. Reduction in MR was less effective in M-TEER patients and postprocedural mitral valve gradients were higher.

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.

Outcomes of transcatheter edge-to-edge repair for atrial functional mitral regurgitation.

BACKGROUND: The prognostic benefits of transcatheter edge-to-edge repair (TEER) remain unclear in patients with atrial functional mitral regurgitation (AFMR). AIMS: We aimed to investigate the clinical outcomes of TEER for patients with AFMR. METHODS: We retrospectively classified functional mitral regurgitation (FMR) patients undergoing TEER into those with AFMR or ventricular FMR (VFMR). A residual MR ≤1+ at discharge was considered optimal mitral regurgitation (MR) reduction, and an elevated mean mitral valve pressure gradient (MPG) was defined as an MPG ≥5 mmHg at discharge. The primary outcome was a composite of all-cause mortality and hospitalisation due to heart failure within one year. RESULTS: Of 441 FMR patients, 125 patients were considered as having AFMR. Residual MR ≤1+ was associated with a lower risk of the composite outcome in both AFMR and VFMR patients, while an MPG ≥5 mmHg was associated with a higher risk of the composite outcome in patients with AFMR but not with VFMR. AFMR patients with residual MR ≤1+ and an MPG ≥5 mmHg, as well as those with residual MR >1+, had a higher incidence of the composite outcome than those with residual MR ≤1+ and an MPG <5 mmHg (50.7%, 41.8%, and 14.3%, respectively; p<0.001). This association was consistent after adjustment for clinical and echocardiographic characteristics. CONCLUSIONS: An MR reduction to ≤1+ following TEER was associated with a lower risk of clinical outcomes in patients with AFMR, while an MPG ≥5 mmHg was related to a higher risk of clinical outcomes. Optimal MR reduction by TEER may have potential benefits on the prognosis of patients with AFMR, although the prognostic benefit may be attenuated by an elevated MPG.

Characteristics and outcomes of patients undergoing transcatheter mitral valve replacement with the Tendyne system.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) has emerged as alternative to transcatheter edge-to-edge repair (TEER) for treatment of mitral regurgitation (MR); however, the role of TMVR with the Tendyne system among established treatments of MR is not well defined. We assessed characteristics and outcomes of patients treated with the Tendyne system in the current clinical practice. METHODS: We reviewed patients who underwent cardiac computed tomography and were judged eligible for the Tendyne system. RESULTS: A total of 63 patients were eligible for TMVR with the Tendyne system. Of these, 17 patients underwent TMVR, and 46 were treated by TEER. Patients treated with the Tendyne system were more likely to have a high transmitral pressure gradient and unsuitable mitral valve morphology for TEER than those treated with TEER. TMVR with the Tendyne system reduced the severity of MR to less than 1 + in 94.1% of the patients at discharge and achieved a greater reduction in left ventricular (LV) end-diastolic volume at the 30-day follow-up compared with TEER. In contrast, patients treated with the Tendyne system had a higher 30-day mortality than those treated with TEER, while the mortality between 30 days and one year was comparable between Tendyne and TEER. CONCLUSIONS: Among patients eligible for the Tendyne system, approximately a quarter of the patients underwent TMVR with the Tendyne system, which led substantial reduction of MR and LV reverse remodeling than TEER. In contrast, the 30-day mortality rate was higher after TMVR with the Tendyne compared to TEER.

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.

Cardiac computed tomography-based assessment of mitral annular calcification in patients undergoing mitral transcatheter edge-to-edge repair.

BACKGROUND: The role of assessment of mitral annular calcification (MAC) using cardiac computed tomography (CCT) in mitral transcatheter edge-to-edge repair (TEER) remains unclear. The aim of this study was to investigate the association of MAC assessed by CCT with procedural and clinical outcomes in patients undergoing TEER. METHODS: We retrospectively analyzed 275 patients who underwent pre-procedural CCT prior TEER. Mitral calcium volume (MCV) and MAC score were measured by CCT. Functional procedural success was defined as residual mitral regurgitation of ≤2+ with mean transmitral gradient of <5 â€‹mmHg at discharge. All-cause mortality within two years after TEER was collected. RESULTS: MAC was present in 115 of 275 patients (41.8 %). The median MCV was 198 â€‹mm3 (interquartile range [IQR]: 84 to 863 â€‹mm3), and the median MAC score was 3 (IQR: 2 to 4). Higher MCV and MAC score were inversely related to the rate of functional procedural success, independently of anatomical features of mitral valve. Patients with moderate/severe MAC, defined as MAC score of ≥4, had a lower rate of functional procedural success than those without MAC (56.1 â€‹% vs. 81.3 â€‹%; p â€‹= â€‹0.002). Moreover, higher MCV and MAC score were associated with a higher risk of all-cause mortality within two years, irrespective of baseline characteristics and functional procedural success. CONCLUSIONS: The presence and burden of MAC assessed by CCT were associated with procedural and clinical outcomes in patients undergoing TEER. The CCT-based assessment of MAC may improve patient selection for TEER.

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.

Contemporary Treatment and Outcomes of High Surgical Risk Mitral Regurgitation.

Before the development of transcatheter interventions, patients with mitral regurgitation (MR) and high surgical risk were often conservatively treated and subject to poor prognoses. We aimed to assess the therapeutic approaches and outcomes in the contemporary era. The study participants were consecutive high-risk MR patients from April 2019 to October 2021. Among the 305 patients analyzed, 274 (89.8%) underwent mitral valve interventions, whereas 31 (10.2%) received medical therapy alone. Of the interventions, transcatheter edge-to-edge mitral repair (TEER) was the most frequent (82.0% of overall), followed by transcatheter mitral valve replacement (TMVR) (4.6%). In patients treated with medical therapy alone, non-optimal morphologies for TEER and TMVR were shown in 87.1% and 65.0%, respectively. Patients undergoing mitral valve interventions experienced less frequent heart failure (HF) rehospitalization compared to those with medical therapy alone (18.2% vs. 42.0%, p < 0.01). Mitral valve intervention was associated with a lower risk of HF rehospitalization (HR 0.36 [0.18-0.74]) and an improved New York Heart Association class (p < 0.01). Most high-risk MR patients can be treated with mitral valve interventions. However, approximately 10% remained on medical therapy alone and were considered as unsuitable for current transcatheter technologies. Mitral valve intervention was associated with a lower risk of HF rehospitalization and improved functional status.

Cusp overlap versus standard three-cusp technique for self-expanding Evolut transcatheter aortic valves.

BACKGROUND: Reducing rates of permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) is important for achieving the best procedural outcomes. The cusp overlap technique (COT) implements procedural steps including an overlap angulation of the right and left coronary cusp to mitigate this complication. AIMS: We investigated the incidence of PPI and complication rates following the COT compared to the standard three-cusp implantation technique (3CT) in an all-comers cohort. METHODS: A total of 2,209 patients underwent TAVI with the self-expanding Evolut platform from January 2016 to April 2022 at five sites. Baseline, procedural and in-hospital outcome characteristics were compared for both techniques before and after one-to-one propensity score matching. RESULTS: A total of 1,151 patients were implanted using the 3CT and 1,058 using the COT. At discharge, the rates of PPI (17.0 vs 12.3%; p=0.002) and moderate/severe paravalvular regurgitation (4.6% vs 2.4%; p=0.006) were significantly reduced with the COT compared with 3CT within the unmatched cohort. Overall procedural success and complication rates were similar; major bleeding was less common in the COT group (7.0% vs 4.6%; p=0.020). These results remained consistent after propensity score matching. In multivariable logistic regression analysis, right bundle branch block (odds ratio [OR] 7.19, 95% confidence interval [CI]: 5.18-10.0; p<0.001) and diabetes mellitus (OR 1.38, 95% CI: 1.05-1.80; p=0.021) emerged as predictors of PPI, whereas the COT (OR 0.63, 95% CI: 0.49-0.82; p<0.001) was protective. CONCLUSIONS: The introduction of the COT was associated with a significant and relevant reduction of PPI and paravalvular regurgitation rates without an increase in complication rates.

Left ventricular reverse remodeling after transcatheter aortic valve implantation in patients with low-flow low-gradient aortic stenosis.

OBJECTIVES: Left ventricular reverse remodeling (LVRR) is associated with improved outcome in patients with heart failure. Factors associated with and predictive of LVRR in patients with low-flow low-gradient aortic stenosis (LFLG AS) after transcatheter aortic valve implantation (TAVI) and its impact on outcome were assessed. METHODS: Pre- and postprocedural left ventricular (LV) function and volume were investigated in 219 patients with LFLG. LVRR was defined as an absolute increase of ≥10% in LV ejection fraction (LVEF) and reduction of ≥15% in LV end-systolic volume (LVESV). The primary endpoint was the combination of all-cause mortality and rehospitalization for heart failure. RESULTS: The mean LVEF was 35.0 ± 10.0%, with a stroke volume index (SVI) of 25.9 ± 6.0 mL/m2 and LVESV of 94.04 ± 46.0 mL. At a median of 5.2 months (interquartile range, 2.7-8.1 months), 77.2% (n = 169) of the patients showed echocardiographic evidence of LVRR. A multivariate model revealed three independent factors for LVRR after TAVI: SVI of <25 mL/m2 (hazard ratio [HR], 2.31; 95% confidence interval [CI], 1.08-3.58; p < 0.01), LVEF of <30% (HR, 2.76; 95% CI, 1.53-2.91; p < 0.01), and valvulo-arterial impedance (Zva) of <5 mmHg/mL/m2 (HR, 5.36; 95% CI, 1.80-15.98; p < 0.01). Patients without evidence of LVRR showed a significantly higher incidence of the 1-year combined endpoint (32 [64.0%] vs. 75 [44.4%], p < 0.01). CONCLUSIONS: The majority of patients with LFLG AS show LVRR after TAVI, which is associated with favorable outcomes. An SVI of <25 mL/m2, LVEF of <30%, and Zva < 5mmHg/mL/m2 represent predictors of LVRR.

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.

Transcatheter aortic valve implantation with different self-expanding devices-a propensity score-matched multicenter comparison.

OBJECTIVE: Several supra-annular self-expanding transcatheter systems are commercially available for transcatheter aortic valve implantation (TAVI). Comparative data in large-scale multicenter studies are scant. METHODS: This study included a total of 5175 patients with severe aortic stenosis undergoing TAVI with the ACURATE neo (n = 1095), Evolut R (n = 3365), or Evolut PRO (n = 715) by a transfemoral approach at five high-volume centers. Propensity score matching resulted in 654 triplets. Outcomes are reported according to the Valve Academic Research Consortium-3 (VARC-3) consensus. RESULTS: Moderate or severe paravalvular regurgitation (PVR) occurred significantly more often in the ACURATE neo group (5.2%) than in the Evolut R (1.8%) and Evolut PRO (3.3%) groups (p = 0.003). The rates of major vascular-/access-related complications (4.6%, 3.8%, and 5.0%; p = 0.56), type 3 or 4 bleeding (3.2%, 2.1%, and 4.1%; p = 0.12), and 30-day mortality (2.4%, 2.6%, and 3.7%; p = 0.40) were comparable. The rate of new permanent pacemaker implantation (PPI) was significantly lower in the ACURATE neo group (9.5%, 17.6%, and 16.8%; p < 0.001). Independent predictors for 2-year survival were a Society of Thoracic Surgeons (STS) risk score ≥5%, diabetes mellitus, a glomerular filtration rate <30 ml/min, baseline mean transvalvular gradient ≤ 30 mm Hg, treating center, and relevant PVR. CONCLUSION: In this multicenter study, TAVI with the ACURATE neo, Evolut R, or Evolut PRO was feasible and safe. The rate of relevant PVR was more frequent after the ACURATE neo implantation, with, however, lower rates of PPI. Two-year survival was mainly driven by baseline comorbidities.

Transcatheter Edge-to-Edge Repair for Atrial Secondary Mitral Regurgitation.

BACKGROUND: Atrial secondary mitral regurgitation (ASMR) is a subtype of SMR that has a poor prognosis, and thus far, evidence of the therapeutic options for the management of ASMR is limited. OBJECTIVES: This study aimed to investigate the effectiveness of transcatheter edge-to-edge repair (TEER) for ASMR. METHODS: The study retrospectively analyzed consecutive patients who underwent MitraClip at the Heart Center Bonn. ASMR was defined as cases that met all of the following criteria: 1) normal mitral leaflets without organic disorder; 2) left ventricular ejection fraction >50%; and 3) absence of LV enlargement and segmental abnormality. The primary outcome measure was MR reduction to ≤1+, and its predictors were explored in a logistic regression analysis. RESULTS: Among 415 patients with SMR, 118 patients met the criteria for ASMR (mean age 80 ± 8 years, 39.8% male). The technical success rate was 94.1%, and MR reduction to ≤1+ after TEER was achieved in 94 (79.7%) patients with ASMR. The in-hospital mortality rate was 2.5%. In multivariable logistic analysis, a large left atrial volume index and low leaflet-to-annulus index were associated with a lower incidence of MR reduction to ≤1+ after TEER for ASMR. In addition, the use of a newer generation of the MitraClip systems (NTR/XTR or G4 systems) was associated with a higher incidence of MR reduction to ≤1+. CONCLUSIONS: TEER is a safe and feasible therapeutic option for patients with ASMR. Assessments of left atrial volume index and leaflet-to-annulus index may assist with patient selection for TEER in patients with ASMR.

Predictive value of the Fibrosis-4 index in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

BACKGROUND: Liver dysfunction is associated with an increased risk of mortality after cardiac interventions. The Fibrosis-4 (FIB-4 index), a marker of hepatic fibrosis, has been associated with a worse prognosis in heart failure. The prognostic relevance of the index in patients undergoing transcatheter aortic valve replacement (TAVR) is unknown. The aim of this study was to evaluate the clinical implications associated with the FIB-4 index in patients undergoing TAVR. METHODS: Between May 2012 and June 2019, 941 patients undergoing TAVR were stratified into a low or high FIB-4 index group, based on a cutoff value that was determined according to a receiver operating characteristic curve predicting 1-year all-cause mortality. RESULTS: Patients with a high FIB-4 index (n = 480), based on the cutoff value of 1.82, showed higher rates of pulmonary hypertension (43.8% vs. 31.8%, p < 0.01), right-ventricular systolic dysfunction (29.5% vs. 19.2%, p < 0.01) and larger inferior vena cava diameter (1.6 ± 0.6 cm vs. 1.3 ± 0.6 cm, p < 0.01) than patients with a low FIB-4 index (n = 461). Furthermore, a high FIB-4 index was associated with a significantly higher cumulative 1-year all-cause mortality (17.5% vs. 10.2%, p < 0.01) and non-cardiovascular mortality (12.1% vs. 2.5%, p < 0.01), compared to a low FIB-4 index. Multivariable analysis revealed that a high FIB-4 index was independently associated with all-cause mortality (HR: 1.75 [95% CI: 1.18-2.59], p < 0.01). CONCLUSIONS: A high FIB-4 index is associated with right-sided heart overload and an increased risk of mortality in patients undergoing TAVR. The FIB-4 index may be useful as an additional predictor of outcomes in these patients.

Percutaneous trans-axilla transcatheter aortic valve replacement.

The left axillary artery is an attractive alternative access route for transcatheter aortic valve replacement (TAVR) and may provide better outcomes compared to other alternatives. Nevertheless, there remain concerns about vascular complications, lack of compressibility, and thorax-related complications. Between March 2019 and March 2021, 13 patients underwent transaxillary TAVR for severe aortic stenosis at the University Hospital Bonn. The puncture was performed with a puncture at the distal segment of the axillary artery through the axilla, with additional femoral access for applying a safety wire inside the axillary artery. Device success was defined according to the VARC 2 criteria. The study participants were advanced in age (77 ± 9 years old), and 54% were female, with an intermediate risk for surgery (STS risk score 4.7 ± 2.0%). The average diameter of the distal segment of the axillary artery was 5.8 ± 1.0 mm (i.e., the puncture site) and 7.6 ± 0.9 mm for the proximal axillary artery. Device success was achieved in all patients. 30-day major adverse cardiac and cerebrovascular events were 0%. With complete percutaneous management, stent-graft implantation was performed at the puncture site in 38.5% of patients. Minor bleeding was successfully managed with manual compression. Moreover, no thorax-related complications, hematomas, or nerve injuries were observed. Percutaneous trans-axilla TAVR was found to be feasible and safe. This modified approach may mitigate the risk of bleeding and serious complications in the thorax and be less invasive than surgical alternatives.

Left atrial function index (LAFI) and outcome in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: Clinical data regarding the association between the left atrial function index (LAFI) and outcome in patients undergoing transcatheter aortic valve replacement (TAVR) are limited. OBJECTIVES: We aimed to investigate the association between the left atrial function index (LAFI) and outcome in patients undergoing TAVR. METHODS: In this retrospective multicenter study, we assessed baseline LAFI in 733 patients undergoing TAVR for severe aortic stenosis in two German high-volume centers between 2008 and 2019. Based on receiver operating characteristic curves, patients were stratified according to their baseline LAFI into two groups (LAFI ≤ 13.5 vs. LAFI > 13.5) and assessed for post-procedural outcome. The primary endpoint of our study was the 1-year all-cause mortality. RESULTS: Patients with a LAFI ≤ 13.5 had significantly more often atrial fibrillation (p < 0.001), lower LVEF (p < 0.001) and higher levels of NT-proBNP (p < 0.001). After TAVR, a significant improvement in the LAFI as compared to baseline was observed at 12 months after the procedure (28.4 vs. 32.9; p = 0.001). Compared to patients with a LAFI > 13.5, those with a LAFI ≤ 13.5 showed significantly higher rate of 1-year mortality (7.9% vs. 4.0%; p = 0.03). A lower LAFI has been identified as independent predictor of mortality in multivariate analysis (HR (95% CI) 2.0 (1.1-3.9); p = 0.03). CONCLUSION: A reduced LAFI is associated with adverse outcome and an independent predictor of mortality in TAVR patients. TAVR improves LAFI within 12 months after the procedure. Left Atrial Function Index (LAFI) in Patients undergoing Transcatheter Aortic Valve Implantation. A Kaplan-Meier survival analysis of 1-year all-cause mortality in patients with LAFI ≤ 13.5 compared with patients with LAFI > 13.5. Comparing rates of 1-year all-cause mortality between the different LAFI groups, we found a significant association between left atrial function and mortality. LAFI Left atrial function index. B Comparison of the mean LAFI before and after TAVR. After long-term follow-up the LAFI improved significantly. LAFI Left atrial function index; FU follow-up. C Assessment of the left atrial function index using the pre-procedural transthoracic echocardiography. A Measurement of the minimal left atrial volume (LAEDV). B Assessment of the maximal left atrial volume (LAESV).

Haemodynamic differences between two generations of a balloon-expandable transcatheter heart valve.

OBJECTIVES: This study aimed to investigate early haemodynamic and clinical performance of the SAPIEN 3 Ultra (S3 Ultra) transcatheter heart valve (THV) system in comparison to its precursor, the SAPIEN 3 (S3). Previous studies have indicated potential haemodynamic differences between the S3 Ultra and S3. Such differences may impact clinical outcome after transcatheter aortic valve implantation (TAVI). METHODS: Postprocedural haemodynamic performance and 30-day clinical outcome were compared in patients who underwent TAVI receiving either the S3 or the new S3 Ultra prostheses. Multivariable analysis and propensity score matching (PSM) were used to identify factors associated with higher mean transvalvular gradients. RESULTS: We included 697 patients (S3 Ultra: n=314, S3: n=383) from the multicentre RhineHeart TAVI Registry. Patients receiving the S3 Ultra prosthesis showed significantly higher postprocedural mean transvalvular gradients (14.2±4.8 vs 10.2±4.4 mm Hg; p<0.01). Multivariable logistic regression analyses and additional PSM revealed the use of the S3 Ultra to be associated with higher postprocedural mean transvalvular gradients (p<0.01). 30-day clinical outcomes, such as mortality, myocardial infarction, permanent pacemaker implantation and vascular complications were comparable between the groups. CONCLUSIONS: The new S3 Ultra THV was associated with a higher postprocedural mean transvalvular gradient compared with the S3 system, while there was no difference in mortality or adverse clinical outcomes at 30 days. These echocardiographic differences will require long-term studies to assess the clinical relevance of this finding.

Baseline PA/BSA ratio in patients undergoing transcatheter aortic valve replacement - A novel CT-based marker for the prediction of pulmonary hypertension and outcome.

BACKGROUND: Pulmonary hypertension (pH) has a prognostic impact on patients undergoing transcatheter aortic valve replacement (TAVR). Pulmonary artery (PA) dilatation assessed by multidetector computed tomography (MDCT) has the potential to predict PH. The aim of the study was to evaluate the clinical parameters associated with PA dilatation and to investigate its prognostic relevance in patients undergoing TAVR. METHODS: In 770 patients undergoing TAVR between February 2016 and July 2019, PA diameter was measured by MDCT before TAVR. Additionally, PA diameter divided by ascending aorta diameter or body surface area (BSA) was calculated. RESULTS: Of all the CT-derived parameters compared with a receiver operating characteristic curve, the value for PA/BSA with a median of 1.68 (IQR 1.47, 1.91) cm/m2 showed the greatest area-under-the-curve (0.75) for predicting PH at baseline. Based on this median, patients were assigned to a small PA/BSA (n = 386) or a large PA/BSA (n = 384) group. Hereby, a large PA/BSA was independently associated with PH at baseline (OR:8.39 [5.36-13.14], p < 0.001) and after TAVR (OR:1.73 [1.18-2.53], p = 0.005). A large PA/BSA was associated with a significantly higher cumulative two-year all-cause mortality compared to small PA/BSA (30.0% vs. 13.7%, p < 0.001), which was supported in the multivariable model (HR:1.87; 95%CI, 1.12-3.04; p = 0.017). CONCLUSION: Patients with a large PA/BSA on MDCT are more likely to have PH at baseline and after TAVR. Large PA/BSA is associated with an increased risk of mortality and could provide additional information for risk stratification in patients undergoing TAVR.