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CTA-determined tricuspid annular dilatation is associated with persistence of tricuspid regurgitation after transcatheter aortic valve replacement

CTA-determined tricuspid annular dilatation is associated with persistence of tricuspid... Aim The aim of this study was to analyse the predictive value of CTA-determined tricuspid annular dilatation (TAD) on the persistence of tricuspid regurgitation (TR) in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) and concomitant at least moderate TR. Methods and results 288 consecutive patients treated with TAVR due to severe AS and concomitant at least moderate TR at baseline were included in the analysis. As cutoff for TAD, the median value of the CTA-determined, to the body surface area-normalized tricuspid annulus diameter (25.2 mm/m ) was used. TAD had no impact on procedural characteristics or outcomes, including procedural death and technical or device failure according to the Valve Academic Research Consortium 3 criteria. However, the primary outcome of the study—TR persistence after TAVR was significantly more frequent in patients with compared to patients without TAD (odds ratio 2.60, 95% confidence interval 1.33–5.16, p < 0.01). Multivariable logis- tic regression analysis, adjusting for clinical and echocardiographic baseline characteristics, which are known to influence aetiology or severity of TR, confirmed TAD as an independent predictor of TR persistence after TAVR (adjusted odds ratio 2.30, 95% confidence interval 1.20–4.46, p = 0.01). Moreover, 2 year all-cause mortality was significantly higher in patients with persistence or without change of TR compared to patients with TR improvement (log-rank p < 0.01). Conclusion In patients undergoing TAVR for severe AS and concomitant at least moderate TR at baseline, TAD is a predic- tor of TR persistence, which is associated with increased 2-year all-cause mortality. Daniel Braun and Simon Deseive contributed equally to this work. * Simon Deseive Simon.deseive@med.uni-muenchen.de Medizinische Klinik und Poliklinik I, LMU-Klinikum, Marchioninistr. 15, 81377 Munich, Germany Center for Cardiovascular Diseases (DZHK), Munich Heart Alliance, Partner Site German Munich, Munich, Germany Herzchirurgische Klinik und Poliklinik, Klinikum der Universität München, Munich, Germany Vol.:(0123456789) 1 3 Clinical Research in Cardiology Graphical abstract Keywords Tricuspid annular dilatation · Tricuspid regurgitation · Transcatheter aortic valve replacement 1 3 Clinical Research in Cardiology Abbreviations Munich University Hospital from April 2013 to December AS Aortic stenosis 2019 were included in this study. Patients with a history BARC Bleeding academic research consortium of previous tricuspid valve intervention or surgery and BSA Body surface area patients treated with TAVR for severe aortic regurgitation CTA Computed tomography angiography were excluded. Moreover, external preprocedural CTA was EROA Effective regurgitant orifice area a criterion for exclusion to ensure a standardized imaging NYHA New York Heart Association protocol. RA Right atrium Before TAVR, all patients were assessed by the local RV Right ventricle heart team, consisting of cardiac surgeons and interven- TAD Tricuspid annular dilatation tional cardiologists. Data were collected in the context of TAPSE Tricuspid annular plane systolic excursion the EVERY-Valve registry, which was approved by the local TAVR Transcatheter aortic valve replacement ethics committee of the University of Munich (project num- TR Tricuspid regurgitation ber 19-840). Tricuspid annular dilatation Introduction Preprocedural multidetector computed tomography angi- Moderate or severe tricuspid regurgitation (TR) is observed ography was performed as part of the standard of care in in more than 25% of patients with severe aortic stenosis all patients. To identify patients with TAD, the maximum (AS). Most frequently, TR is of secondary aetiology and septolateral diameter of the tricuspid annulus was measured therefore often caused by left-sided heart disease [1, 2]. In and normalized to the body surface area (BSA) as described patients with severe AS and high surgical risk due to age previously [8]. As cutoff for TAD, the median value of the or comorbidities, transcatheter aortic valve replacement CTA-determined BSA normalized tricuspid annulus diam- (TAVR) is the preferred treatment option, and concomitant eter of all included patients was used. TR is common in these patients [3, 4]. While guidelines recommend concomitant tricuspid valve surgery in patients Echocardiographic analysis undergoing left-sided heart surgery and at least moderate TR in the context of tricuspid annular dilatation, the best Transthoracic echocardiography was performed before and approach for treatment of TR in TAVR patients remains after TAVR in accordance with the European and Ameri- unknown [5]. Besides, an improvement of TR can be can guidelines [9, 10]. Moreover, a central in-house core achieved after TAVR due to reduction of pressure overload laboratory analysis was carried out to assess echocardio- in more than 50% of cases [6]. However, the persistence graphic parameters. Severity of AS was determined using of TR after the procedure is associated with increased all- the continuity equation method. To quantify TR, an inte- cause mortality [6, 7]. Therefore, it is of importance to iden- grated approach taking into account visual appearance, tify determinants of TR persistence in patients undergoing biplane vena contracta width, effective regurgitant orifice TAVR. area (EROA) and regurgitant volume was used whenever Recently, computed tomography angiography (CTA)- possible. For TR grading, a five-grade scheme (mild, moder - determined tricuspid annular dilatation (TAD) proved to be ate, severe, massive, torrential) as proposed by Hahn et al. an independent predictor of 2-year all-cause mortality in was applied [11]. TR aggravation was defined as an increase patients with severe AS undergoing TAVR [8]. The objec- in TR severity and TR persistence as lack of TR improve- tive of this study was to investigate if CTA-determined TAD ment of at least one grade in the follow-up compared to the among TAVR patients who had at least moderate TR at base- preprocedural echocardiography. Right ventricular function line is associated with the persistence of TR after the pro- was assessed using tricuspid annular plane systolic excursion cedure. Moreover, the predictive value of TR persistence on (TAPSE) and fractional area change. the composite of 2-year all-cause mortality in these patients was analysed. TAVR procedure Methods For all TAVR procedures, local anaesthetics were admin- Study design and population istered and a femoral access for TAVR implantation was used. Type and size of the prosthesis were selected con- Consecutive patients with severe AS and at least moder- sidering patients’ characteristics and measurements of the ate concomitant TR at baseline who underwent TAVR at aortic valve in preprocedural CTA by the interventional 1 3 Clinical Research in Cardiology cardiologist. Pre- and/or post-dilatation was performed and device failure at 30 days (technical failure, 30-day mor- according to the operator’s discretion [8]. tality, elevated mean pressure gradient, paravalvular regur- gitation, vascular surgery/intervention) as well as early pace- Study endpoints maker implantation, stroke, bleeding and acute kidney injury according to the Valve Academic Research Consortium 3 The primary endpoint of this study was persistence of TR were recorded [12]. after TAVR and was analysed in patients with available echocardiographic follow-up ≥ 30 days after the procedure. As secondary endpoints, 2-year all-cause mortality, tricuspid Statistical analysis valve intervention, changes of echocardiographic parameters as well as functional status after TAVR using the New York Continuous data are presented as median with interquartile Heart Association (NYHA) functional class were recorded. range and categorical variables are expressed as frequencies Moreover, procedural outcomes of all patients with at and percentages. Differences between groups were tested least moderate TR, such as the composite endpoints techni- for significance using the Fisher exact test, the Wilcoxon cal failure (procedural death, cardiac structural complica- rank sum test or the Wilcoxon signed rank test as appro- tions, conversion to open surgery, prosthesis dislocation, 2nd priate. 2-year all-cause mortality was evaluated using the valve prosthesis, immediate vascular surgery/intervention) Kaplan–Meier method and log-rank test. A two-sided p Table 1 Procedural All TAD − TAD + p-value characteristics and outcomes (n = 288) (n = 144) (n = 144) Procedural characteristics Prosthesis type p = 0.57  Sapien 209 (72.6) 104 (72.2) 105 (72.9)  CoreValve 35 (12.2) 16 (11.1) 19 (13.2)  Accurate Neo 14 (4.9) 10 (6.9) 4 (2.8)  Lotus 21 (7.3) 10 (6.9) 11 (7.6)  Other 9 (3.1) 4 (2.8) 5 (3.5) Prosthesis size p = 0.53   < 25 mm 99 (34.4) 54 (37.5) 45 (31.3)  25–28 mm 110 (38.2) 54 (37.5) 56 (38.9)   > 28 mm 78 (27.1) 36 (25.0) 42 (29.2) Pre-dilatation performed 201 (69.8) 104 (72.2) 97 (67.4) p = 0.37 Post-dilatation performed 16 (5.6) 8 (5.6) 8 (5.6) p = 0.79 Procedural outcomes Technical failure 18 (6.3) 10 (6.9) 8 (5.6) p = 0.81  Procedural death 2 (0.69) 0 (0.00) 1 (1.4) p = 0.50  Cardiac structural complication 5 (1.7) 3 (2.1) 2 (1.4) p = 1.00  Conversion to open surgery 2 (0.7) 0 (0.0) 2 (1.4) p = 0.50  Prosthesis dislocation 4 (1.4) 3 (2.1) 1 (0.7) p = 0.62  2nd valve prosthesis 0 (0.0) 0 (0.0) 0 (0.0) p = 1.00  Immediate vascular surgery/intervention 10 (3.5) 5 (3.5) 5 (3.5) p = 1.00 Device failure at 30 days 46 (16.0) 25 (17.4) 21 (14.6) p = 0.63  30 day mortality 22 (7.6) 11 (7.6) 11 (7.6) p = 1.00  Aortic regurgitation > 1 + 10 (3.5) 6 (4.2) 4 (2.8) p = 0.75  Elevated PG mean > 20 mmHg 4 (1.4) 3 (2.1) 1 (0.7) p = 0.62  Vascular intervention/surgery 11 (3.8) 5 (3.5) 6 (4.2) p = 1.00 Early pacemaker implantation 48 (16.7) 30 (20.8) 18 (12.5) p = 0.08 Stroke 7 (2.4) 5 (3.5) 2 (1.4) p = 0.45 Bleeding BARC type 3 or 4 38 (13.2) 22 (15.3) 16 (11.1) p = 0.38 Acute kidney injury stage 3 or 4 10 (3.5) 8 (5.6) 2 (1.4) p = 0.10 PG pressure gradient, BARC bleeding academic research consortium 1 3 Clinical Research in Cardiology value < 0.05 was considered to indicate statistical signifi- TAD + , p = 0.50), technical failure (6.9% TAD  − vs. cance. All statistical analyses were conducted using R ver- 5.6% TAD + , p = 0.81), device failure at 30 days (17.4% sion 4.0.2 (The R Foundation for Statistical Computing, TAD  − vs. 14.6% TAD + , p = 0.63), s tr ok e (3.5% Vienna, Austria). TAD − vs. 1.4% TAD + , p = 0.45) and bleeding BARC type 3 or 4 (15.3% TAD − vs. 11.1% TAD + , p = 0.38). Procedural characteristics and outcomes stratified by TAD are depicted in Table 1. In addition, all-cause mor- Results tality at 30 days was similar in both groups (p = 1.00), Study population Clinical and echocardiographic baseline characteristics 306 patients with severe AS and at least moderate concomi- tant TR, underwent TAVR procedure at Munich Univer- Out of 266 patients, who had survived at least 30 days after sity Hospital between April 2013 and December 2019. 17 TAVR, echocardiographic follow-up ≥ 30 days after the pro- patients were excluded due to externally acquired prepro- cedure was available for 165 patients (62.0%) (median echo- cedural CTA, and one patient due to history of tricuspid cardiography follow-up time 101 days [interquartile range valve surgery. The median value of the CTA-determined 52–342 days]). Comparing baseline characteristics between BSA normalized tricuspid annulus diameter of the remain- patients with and without available echocardiographic fol- ing 288 patients was 25.2 mm/m and was used as cutoff low-up, patients without follow-up were older (82.2 years to stratify patients into patients with (TAD +) and without [IQR 77.5–86.0] patients with follow-up vs. 84.2 years [IQR TAD (TAD-). 80.2–87.7] patients without follow-up, p < 0.01), but had a similar prevalence of comorbidities, including renal impair- Procedural characteristics and outcomes ment, atrial fibrillation or coronary artery disease. Moreover, there was no difference regarding TR severity at baseline Regarding procedural characteristics, no differences (TR grade ≥ 3: 30.3% in patients with vs. 29.3% in patients could be observed between patients with and without without follow-up, p = 0.90). Clinical and echocardiographic TAD. Moreover, TAD had no impact on procedural out- baseline characteristics comparing patients with and without comes, including procedural death (0.0% TAD − vs. 1.4% follow-up are shown in Supplemental Table 1. Table 2 Clinical baseline All TAD − TAD + p-value characteristics (n = 165) (n = 80) (n = 85) Clinical characteristics Male gender 76 (46.1) 36 (45.0) 40 (47.1) p = 0.88 Age (years) 82.2 (77.5; 86.0) 81.2 (76.2; 84.5) 83.2 (79.6; 86.2) p = 0.03 BMI (kg/m ) 24.7 (22.5; 27.7) 26.6 (24.2; 28.8) 22.9 (21.5; 24.9) p < 0.01 STS score 4.8 (3.1; 7.8) 4.0 (3.0; 7.3) 5.0 (3.7; 8.5) p = 0.08 NYHA functional class ≥ III 153 (93.3) 76 (95.0) 77 (91.7) p = 0.54 Coronary artery disease 91 (57.6) 46 (59.7) 45 (55.6) p = 0.63 Prior myocardial infarction 19 (11.7) 9 (11.3) 10 (12.0) p = 1.00 Prior PCI 42 (25.6) 19 (23.8) 23 (27.4) p = 0.72 Prior CABG 17 (10.4) 10 (12.5) 7 (8.3) p = 0.45 Pacemaker or ICD 28 (17.0) 17 (21.3) 11 (12.9) p = 0.21 Atrial fibrillation 89 (53.4) 36 (45.0) 53 (62.4) p = 0.03 Renal impairment 98 (59.4) 38 (47.5) 60 (70.6) p < 0.01 Diabetes 54 (32.7) 26 (32.5) 28 (32.9) p = 1.00 Hypertension 144 (87.3) 73 (91.3) 71 (83.5) p = 0.16 Smoking 30 (18.9) 12 (15.6) 18 (22.0) p = 0.32 Hypercholesteremia 71 (44.4) 33 (42.9) 38 (45.8) p = 0.75 NT-proBNP (pg/ml) 4040 (2179; 9736) 2911 (1518; 6265) 4324 (3234; 10034) p = 0.09 BMI body mass index, STS score society of thoracic surgeons score, NYHA New York Heart Association, PCI percutaneous coronary intervention, CABG coronary artery bypass graft, ICD implantable cardioverter defibrillator, NT-proBNP N-terminal pro b-type natriuretic peptide 1 3 Clinical Research in Cardiology Table 3 Echocardiographic baseline characteristics All TAD − TAD + p-value (n = 165) (n = 80) (n = 85) Echocardiographic parameters LVEF (%) 53.2 (41.2; 58.6) 53.1 (40.7; 57.1) 53.6 (41.6; 59.5) p = 0.45 PG max aortic valve (mmHg) 49.8 (38.0; 64.1) 48.4 (36.3; 62.1) 49.9 (38.1; 68.10) p = 0.96 PG mean aortic valve (mmHg) 29.3 (22.0; 40.2) 28.6 (21.0; 39.5) 30.3 (23.0; 40.3) p = 0.92 V max aortic valve (cm/s) 348.6 (300.9; 396.8) 341.0 (300.1; 391.5) 352.9 (308.5; 404.1) p = 0.81 Stroke volume index (ml/m ) 29.9 (24.4;36.9) 30.2 (24.7; 35.3) 29.6 (23.9;38.2) p = 0.79 Aortic valve orifice area (cm ) 0.7 (0.6; 0.9) 0.7 (0.6; 0.9) 0.7 (0.6; 0.8) p = 0.26 Aortic regurgitation, n (%) p = 0.33  Grade 0 24 (14.5) 15 (18.8) 9 (10.6)  Grade 1 107 (64.8) 49 (61.3) 58 (68.2)  Grade 2 34 (20.6) 16 (20.0) 18 (21.2) RV area change (%) 35.3 (30.0; 40.8) 36.3 (29.0; 40.7) 35.2 (30.0; 39.9) p = 0.86 RV diameter at mid/BSA (mm/m ) 21.1 (18.7; 23.0) 19.9 (17.7; 22.4) 21.6 (19.9; 24.3) p < 0.01 RV diameter at base/BSA (mm/m ) 27.7 (25.5; 31.3) 26.1 (24.4; 28.5) 29.6 (27.1; 32.6) p < 0.01 Tricuspid annulus diameter/BSA (mm/m ) 22.0 (19.6; 24.6) 20.5 (18.5; 22.5) 23.7 (21.7; 25.6) p < 0.01 2 2 Right atrium/BSA (cm /m ) 15.1 (12.6; 19.0) 13.2 (11.1; 15.5) 17.2 (14.3; 20.4) p < 0.01 TAPSE (mm) 17.0 (13.3; 19.8) 17.0 (14.0; 19.0) 17.0 (13.0; 20.0) p = 0.69 TR vena contracta (mm) 6.2 (4.9; 8.3) 5.8 (4.7; 6.7) 6.5 (5.2; 10.0) p = 0.01 TR EROA (mm ) 28.0 (21.0; 43.3) 26.0 (20.0; 32.0) 32.0 (21.5; 43.0) p = 0.08 TR regurgitant volume (ml) 27.0 (21.0; 37.0) 25.0 (22.0;31.0) 29.0 (21.0; 43.0) p = 0.15 dPmean TV inflow (mmHg) 1.0 (0.8; 1.4) 1.0 (0.8; 1.6) 1.0 (0.8; 1.2) p = 0.17 RV/RA gradient (mmHg) 39.5 (28.9; 49.4) 43.4 (30.0; 49.9) 36.6 (28.0; 48.3) p = 0.08 TR severity p < 0.01  2 115 (69.7) 64 (80.0) 51 (60.0)  3 39 (23.6) 15 (18.8) 24 (28.2)  4 9 (5.5) 1 (1.3) 8 (9.4)  5 2 (1.2) 0 (0.0) 2 (2.4) MR severity ≥ 2 88 (53.3) 40 (50.0) 48 (56.5) p = 0.44 Vena cava inferior (mm) 22.0 (17.0; 25.0) 21.0 (17.0; 24.0) 22.0 (18.8; 25.0) p = 0.12 Respiratory variance VCI 25 (33.8) 16 (51.6) 9 (20.9) p = 0.01 LVEF left ventricular ejection fraction, PG pressure gradient, V max maximum velocity, TV tricuspid valve, VCI vena cava inferior Fig. 1 TR at baseline and follow-up according to TAD 1 3 Clinical Research in Cardiology Fig. 2 A Percentage of patients with TR improvement of at least one grade following TAVR stratified for TAD B Tricuspid annulus dimensions according to TR grade change In patients with available echocardiographic follow-up, performed a multivariable logistic regression analysis with the BSA normalized tricuspid annulus diameter was above adjustment for clinical and echocardiographic parameters, the threshold of 25.2 mm/m in 85 patients (TAD + group). that are known to influence aetiology or severity of TR, Concerning clinical baseline characteristics, patients in including atrial fibrillation, renal impairment, right ven- the TAD + group were older (81.2 years [IQR 76.2–84.5] tricular lead, mitral regurgitation, baseline TR severity, RV/ TAD − vs. 83.2 years [IQR 79.6–86.2] TAD + , p = 0.03) RA gradient and right ventricular function using TAPSE. and suffered more often from atrial fibrillation (45.0% Thus, the predictive value of TAD for TR persistence after TAD − vs. 62.4% TAD + , p = 0.03) and renal impairment TAVR (adjusted odds ratio 2.30, 95% confidence interval (47.5% TAD − vs. 70.6% TAD + , p < 0.01). Clinical base- 1.20–4.46, p = 0.01) could be confirmed. Consistently, tri - line characteristics are presented in Table 2. Regarding echo- cuspid valve intervention after TAVR was conducted in 11 cardiographic parameters, severe AS with a median aortic patients, all of them in the TAD + group (12.9%). valve orifice area of 0.7  cm was present in both groups. Concerning echocardiographic parameters, we observed a Dimensions of the right ventricle (RV) and right atrium similar decline of the aortic pressure gradient after TAVR in (RA) were larger, and baseline TR was more pronounced both groups. Consistent with TR improvement, the reduction in the TAD + group (TR grade ≥ 3: 20.0% TAD − vs. 40.0% of vena contracta width was significantly higher in patients TAD + , p = 0.05). Echocardiographic baseline characteris- without TAD compared to patients with TAD (− 2.0 mm tics are summarized in Table 3. [IQR − 3.9 to − 0.3] TAD − vs. 0.0 mm [IQR − 2.2–2.0] TAD + , p < 0.01). Moreover, we noted an increase in left Impact of tricuspid annular dilatation on tricuspid ventricular ejection fraction at follow-up compared to base- regurgitation line in patients in the TAD  − group. Echocardiographic parameters at baseline and follow-up as well as delta values Improvement of TR after TAVR was observed in both are presented in Table 4A–C. groups, with a higher number of patients with TR grade 1 at follow-up in the TAD − group (TR grade 1 at follow-up: Impact of TR development on survival 50.0% TAD − vs. 23.5% TAD + , p < 0.01) (Fig. 1). Consist- and functional status ently, improvement of TR of at least one grade was signifi- cantly more frequent in patients in the TAD− group (57.0% Two-year follow-up information was available in 81.8% TAD − vs. 34.1% TAD + , corresponding odds ratio for per- of patients. All-cause mortality was significantly lower in sistence of TR: 2.60, 95% confidence interval 1.33–5.16, patients with improvement of TR compared to patients with- p < 0.01) (Fig.  2A). The median value of the CTA-deter- out change or aggravation of TR (log-rank p < 0.01). The mined BSA normalized tricuspid annulus diameter was corresponding hazard ratio for 2-year all-cause mortality in higher in patients with an aggravation or persistence of TR patients with TR improvement vs. no change of TR and vs. compared to patients with an improvement of TR of one aggravation was 0.47 (95% confidence interval 0.24 to 0.94) or two grades (26.4 mm/m [IQR 23.6–28.7] vs. 23.7 mm/ and 0.24 (95% confidence interval 0.11 to 0.54), respec- m [IQR 22.1–26.9], p < 0.001) (Fig.  2B). Moreover, we tively. Kaplan–Meier curves are shown in Fig. 3. Concerning 1 3 Clinical Research in Cardiology Table 4 A–C Echocardiographic parameters at baseline and follow-up, (A) TAD −, (B) TAD + , (C) delta values A TAD- Baseline FU p-value LVEF (%) 50.7 (35.5; 56.2) 54.5 (41.1; 58.7) p = 0.03 PG max aortic valve (mmHg) 45.5 (31.4; 60.9) 13.9 (10.9; 19.2) p < 0.01 PG mean aortic valve (mmHg) 27.0 (18.6; 39.2) 7.6 (6.0; 10.7) p < 0.01 RV area change (%) 35.0 (28.9; 40.2) 37.8 (28.3; 44.5) p = 0.20 RV diameter at mid/BSA (mm/m ) 19.7 (17.7; 22.4) 19.3 (16.2; 21.0) p = 0.12 RV diameter at base/BSA (mm/m ) 26.0 (24.5; 28.1) 25.8 (24.3; 28.6) p = 0.88 Tricuspid annulus diameter/BSA (mm/m ) 21.2 (18.6; 22.5) 19.9 (17.9; 21.7) p = 0.25 2 2 Right atrium/BSA (cm /m ) 13.1 (11.1; 15.7) 13.2 (11.4; 15.6) p = 0.97 TAPSE (mm) 15.0 (13.0; 17.5) 16.0 (13.0; 20.0) p = 0.19 TR vena contracta (mm) 6.1 (4.7; 8.1) 3.8 (2.5; 6.1) p < 0.01 TR EROA (mm ) 31.0 (26.0; 33.0) 23.0 (20.0; 32.0) p = 0.19 TR regurgitant volume (ml) 27.0 (25.0; 27.0) 21.5 (17.0; 26.3) p = 0.20 dPmean TV inflow (mmHg) 1.2 (0.9; 1.8) 1.1 (0.9; 1.3) p = 0.25 RV/RA gradient (mmHg) 40.6 (29.4; 47.7) 36.5 (28.3; 50.8) p = 0.76 Vena cava inferior (mm) 22.0 (17.0; 24.0) 17.0 (16.0; 24.0) p = 0.11 B TAD + Baseline FU p-value LVEF (%) 51.9 (37.1; 58.4) 51.5 (43.2; 57.9) p = 0.40 PG max aortic valve (mmHg) 47.7 (33.8; 58.1) 14.8 (10.1; 18.2) p < 0.01 PG mean aortic valve (mmHg) 29.8 (20.9; 36.7) 7.9 (5.4; 9.9) p < 0.01 RV area change (%) 35.2 (30.4; 37.5) 37.0 (31.0; 43.0) p = 0.17 RV diameter at mid/BSA (mm/m ) 22.0 (20.1; 24.8) 20.7 (18.8; 23.7) p = 0.32 RV diameter at base/BSA (mm/m ) 30.7 )27.2; 32.8] 28.8 )26.4; 32.7] p = 0.15 Tricuspid annulus diameter/BSA (mm/m ) 24.3 (23.0; 26.2) 22.5 (20.9; 25.1) p = 0.01 2 2 Right atrium/BSA (cm /m ) 17.2 )14.5; 20.3] 17.1 )13.8; 20.3] p = 0.11 TAPSE (mm) 15.0 (12.3; 19.8) 16.0 (13.0; 19.0) p = 0.51 TR vena contracta (mm) 6.3 (5.0; 9.2) 6.3 )4.4; 10.0] p = 0.77 TR EROA (mm ) 31.0 (23.5; 50.0) 30.0 (21.0; 49.3) p = 0.56 TR regurgitant volume (ml) 29.0 (21.0;45.0) 31.5 (21.3; 40.8) p = 0.83 dPmean TV inflow (mmHg) 1.0 (0.7; 1.2) 1.0 (0.8; 1.4) p = 0.41 RV/RA gradient (mmHg) 35.3 (25.5; 45.5) 32.7 (27.8; 41.6) p = 0.42 Vena cava inferior (mm) 21.0 (17.0; 25.0) 21.0 (18.0; 26.0) p = 0.93 C TAD − TAD + p value Δ LVEF (%) 3.6 (− 1.4; 5.7) − 0.3 (− 4.8; 6.7) p = 0.34 Δ PG max aortic valve (mmHg) − 29.0 (− 42.7; − 20.8) − 34.2 (− 44.8; − 16.9) p = 0.93 Δ PG mean aortic valve (mmHg) − 18.0 (− 31.2; − 10.4) − 21.5 (− 29.6; − 11.4) p = 0.59 Δ RV area change (%) 3.1 (− 3.2; 5.5) 3.2 (− 7.0; 7.6) p = 0.74 Δ RV diameter at mid (mm/ m ) − 0.6 (− 3.6; 1.5) − 1.2 (− 3.4; 2.3) p = 0.63 Δ RV diameter at base (mm/ m ) 0.0 (− 2.4; 3.2) − 0.7 (− 3.5; 2.0) p = 0.32 Δ Tricuspid annulus diameter/BSA (mm/m ) − 0.3 (− 1.9; 1.0) − 1.2 (− 3.3; 1.1) p = 0.30 2 2 Δ Right atrium (cm /m ) 0.5 (− 2.0; 1.4) − 0.5 (− 3.2; 1.3) p = 0.29 Δ TAPSE (mm) 1.0 (− 1.0; 3.0) − 1.0 (− 3.0; 2.0) p = 0.13 Δ TR vena contracta (mm) − 2.0 (− 3.9; − 0.3) 0.0 (− 2.2; 2.0) p < 0.01 Δ TR EROA (mm ) − 7.0 [− 13.0; − 4.0] − 2.5 (− 11.3; 6.8) p = 0.28 Δ TR regurgitant volume (ml) − 8.0 (− 9.8; 1.3) − 2.0 (− 8.8; 8.8) p = 0.70 Δ dPmean TV inflow (mmHg) − 0.2 (− 0.5; 0.3) 0.0 (− 0.3; 0.3) p = 0.12 Δ RV/RA gradient (mmHg) 0.0 (− 12.1; 8.5) 0.9 (− 9.8; 7.2]) p = 0.91 Δ Vena cava inferior (mm) − 2.0 (− 6.0; 2.0) 0.0 (− 4.0; 3.0) p = 0.31 LVEF left ventricular ejection fraction, PG pressure gradient, TV tricuspid valve 1 3 Clinical Research in Cardiology TAD required tricuspid valve treatment within the 2 year follow-up period. Besides, TR persistence is associated with increased 2 year all-cause mortality. While former studies stated an association between sig- nificant TR at baseline and all-cause mortality in patients with AS undergoing TAVR, recent analyses demonstrated that TR persistence after the procedure is associated with increased mortality and might therefore be prognostically more relevant than TR severity at baseline [6, 7, 13, 14]. In this study, we could confirm that in TAVR patients with con- comitant at least moderate TR at baseline, TR persistence is associated with increased all-cause mortality after 2 years. In addition, improvement of NYHA functional class of at least two grades was observed less often in patients with per- sistence of TR. A multivariable logistic regression analysis with adjustment for atrial fibrillation, renal impairment, right Fig. 3 Survival stratified for development of TR after TAVR ventricular lead, mitral regurgitation, baseline TR severity, RV/RA gradient and right ventricular function confirmed functional status, improvement of NYHA functional class that TAD is an independent predictor of TR persistence. of at least two grades after the procedure was observed less Moreover, no difference regarding procedural characteristics often in patients with persistence of TR compared to patients and outcomes, including procedural mortality, technical or with TR improvement (24.4 vs. 46.5%, p = 0.04) (Fig. 4). device failure was found between patients with and without TAD. Hence, an impact of procedural factors on the differ - ences in outcomes seems unlikely. Discussion As the preprocedural CTA is part of the standard of care to evaluate vascular access routes and to enable accurate Our analysis demonstrates that in patients undergoing TAVR prosthesis selection, the tricuspid annulus diameter can be for severe AS and at least moderate concomitant TR at base- obtained easily without further diagnostic effort. In addition, line, CTA-derived TAD is associated with the persistence the measurement is less error-prone and with a lower degree of TR after the procedure. Consistently, no patient without of interobserver variability compared to echocardiographic Fig. 4 NYHA functional status at baseline and follow-up according to TR improvement 1 3 Clinical Research in Cardiology assessment. In transthoracic echocardiography, an optimal echocardiographic images and especially 3D volumetric data acoustic window of the RV in the RV-focused apical four- were not routinely recorded. chamber view is necessary to obtain the dimensions of the tricuspid valve. Therefore, and due to the complex oval and saddle-shaped anatomy of the valve, its maximal diameter Conclusions is often underestimated in echocardiography. On the con- trary, datasets of CT-scans can be angulated precisely in In patients undergoing TAVR for severe AS with at least the tricuspid annulus for exact assessment of its dimensions moderate concomitant TR, TAD identifies patients with per - as described previously [8]. Hence, CTA-determined BSA sistence of TR after the procedure, which is associated with normalized tricuspid annulus diameter can serve as a reliable increased 2-year all-cause mortality. and easily accessible parameter to predict persistence of TR Supplementary Information The online version contains supplemen- in patients with severe AS treated with TAVR. tary material available at https://doi. or g/10. 1007/ s00392- 023- 02152-0 . Although concomitant tricuspid valve surgery is recom- mended in patients undergoing left-sided heart surgery and Funding Open Access funding enabled and organized by Projekt DEAL. at least moderate TR in the context of tricuspid annular dila- tation, optimal management of TR in TAVR patients remains Declarations unknown [5]. Considering the fact that moderate or severe TR can be observed in more than 25% of patients with severe Conflict of interest Simon Deseive and Julius Steffen received AS and that the number of TAVR procedures will increase speaker honoraria from AstraZeneca. Daniel Braun and Christian Hagl received speaker honoraria from Abbott Vascular and Edwards due to favorable outcomes in recent studies for asympto- Lifesciences. Martin Orban received speaker honoraria from Abbott matic or low-risk patients, this question might be even of Medical, AstraZeneca, Abiomed, Bayer vital, BIOTRONIK, Bristol- higher relevance in the future [4, 15–17]. Myers Squibb, CytoSorbents, Daiichi Sankyo Deutschland, Edwards While sufficient literature regarding tricuspid valve inter - Lifesciences Services, and Sedana Medical. Jörg Hausleiter received research support and speaker honoraria from Abbott Vascular and Ed- vention for persistent TR after TAVR is scarce, a recently wards Lifesciences. The other authors have no conflicts of interest to published propensity-matched case–control study could declare. demonstrate a benefit for patients without AS and at least moderate TR. Patients treated with transcatheter tricuspid Open Access This article is licensed under a Creative Commons Attri- bution 4.0 International License, which permits use, sharing, adapta- valve intervention had significantly lower rates of mortal - tion, distribution and reproduction in any medium or format, as long ity and rehospitalization compared to medically managed as you give appropriate credit to the original author(s) and the source, patients [18]. Besides, the less invasive nature of transcath- provide a link to the Creative Commons licence, and indicate if changes eter valve repair and replacement procedures compared to were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated open-heart surgery could facilitate a watch-and-wait strat- otherwise in a credit line to the material. If material is not included in egy. Therefore, TAD could serve not only as a predictor of the article's Creative Commons licence and your intended use is not TR persistence after TAVR, but also as a tool to identify permitted by statutory regulation or exceeds the permitted use, you will patients in need for intensified post-TAVR echocardio- need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://cr eativ ecommons. or g/licen ses/ b y/4.0/ . graphic and clinical surveillance. In case of TR persistence and lack of symptomatic improvement, these patients might be candidates for transcatheter tricuspid valve interventions. 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Khan F, Okuno T, Malebranche D et al (2020) Transcatheter aortic The retrospective nature and the incomplete echocardio- valve replacement in patients with multivalvular heart disease. graphic follow-up are major limitations of this study, as it  JACC: Cardiovasc Interv 13:1503–1514. https://doi .or g/1 0.1 016/j. poses a selection bias. Furthermore, we performed a central jcin. 2020. 03. 052 core laboratory analysis for the assessment of echocardio- 5. Otto CM, Nishimura RA, Bonow RO et al (2020) ACC/AHA guideline for the management of patients with valvular heart dis- graphic parameters, but analysis was limited by the available ease: a report of the American college of cardiology/American 1 3 Clinical Research in Cardiology heart association joint committee on clinical practice guidelines. 12. Généreux P, Piazza N, Alu MC et  al (2021) Valve academic Circulation 2021:143. https:// doi. org/ 10. 1161/ CIR. 00000 00000 research consortium 3: updated endpoint definitions for aortic 000923 valve clinical research. J Am Coll Cardiol 77:2717–2746. https:// 6. Tomii D, Okuno T, Praz F et al (2021) Potential candidates for doi. org/ 10. 1016/j. jacc. 2021. 02. 038 transcatheter tricuspid valve intervention after transcatheter aor- 13. Takagi H, Hari Y, Kawai N et al (2019) Impact of concurrent tri- tic valve replacement. JACC: Cardiovasc Interv 14:2246–2256. cuspid regurgitation on mortality after transcatheter aortic-valve https:// doi. org/ 10. 1016/j. jcin. 2021. 07. 030 implantation. Catheter Cardiovasc Interv 93:946–953. https://doi. 7. Yoshida J, Ikenaga H, Hayashi A et  al (2019) Predictors and org/ 10. 1002/ ccd. 27948 outcomes of persistent tricuspid regurgitation after transcatheter 14. 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CTA-determined tricuspid annular dilatation is associated with persistence of tricuspid regurgitation after transcatheter aortic valve replacement

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10.1007/s00392-023-02152-0
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Abstract

Aim The aim of this study was to analyse the predictive value of CTA-determined tricuspid annular dilatation (TAD) on the persistence of tricuspid regurgitation (TR) in patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) and concomitant at least moderate TR. Methods and results 288 consecutive patients treated with TAVR due to severe AS and concomitant at least moderate TR at baseline were included in the analysis. As cutoff for TAD, the median value of the CTA-determined, to the body surface area-normalized tricuspid annulus diameter (25.2 mm/m ) was used. TAD had no impact on procedural characteristics or outcomes, including procedural death and technical or device failure according to the Valve Academic Research Consortium 3 criteria. However, the primary outcome of the study—TR persistence after TAVR was significantly more frequent in patients with compared to patients without TAD (odds ratio 2.60, 95% confidence interval 1.33–5.16, p < 0.01). Multivariable logis- tic regression analysis, adjusting for clinical and echocardiographic baseline characteristics, which are known to influence aetiology or severity of TR, confirmed TAD as an independent predictor of TR persistence after TAVR (adjusted odds ratio 2.30, 95% confidence interval 1.20–4.46, p = 0.01). Moreover, 2 year all-cause mortality was significantly higher in patients with persistence or without change of TR compared to patients with TR improvement (log-rank p < 0.01). Conclusion In patients undergoing TAVR for severe AS and concomitant at least moderate TR at baseline, TAD is a predic- tor of TR persistence, which is associated with increased 2-year all-cause mortality. Daniel Braun and Simon Deseive contributed equally to this work. * Simon Deseive Simon.deseive@med.uni-muenchen.de Medizinische Klinik und Poliklinik I, LMU-Klinikum, Marchioninistr. 15, 81377 Munich, Germany Center for Cardiovascular Diseases (DZHK), Munich Heart Alliance, Partner Site German Munich, Munich, Germany Herzchirurgische Klinik und Poliklinik, Klinikum der Universität München, Munich, Germany Vol.:(0123456789) 1 3 Clinical Research in Cardiology Graphical abstract Keywords Tricuspid annular dilatation · Tricuspid regurgitation · Transcatheter aortic valve replacement 1 3 Clinical Research in Cardiology Abbreviations Munich University Hospital from April 2013 to December AS Aortic stenosis 2019 were included in this study. Patients with a history BARC Bleeding academic research consortium of previous tricuspid valve intervention or surgery and BSA Body surface area patients treated with TAVR for severe aortic regurgitation CTA Computed tomography angiography were excluded. Moreover, external preprocedural CTA was EROA Effective regurgitant orifice area a criterion for exclusion to ensure a standardized imaging NYHA New York Heart Association protocol. RA Right atrium Before TAVR, all patients were assessed by the local RV Right ventricle heart team, consisting of cardiac surgeons and interven- TAD Tricuspid annular dilatation tional cardiologists. Data were collected in the context of TAPSE Tricuspid annular plane systolic excursion the EVERY-Valve registry, which was approved by the local TAVR Transcatheter aortic valve replacement ethics committee of the University of Munich (project num- TR Tricuspid regurgitation ber 19-840). Tricuspid annular dilatation Introduction Preprocedural multidetector computed tomography angi- Moderate or severe tricuspid regurgitation (TR) is observed ography was performed as part of the standard of care in in more than 25% of patients with severe aortic stenosis all patients. To identify patients with TAD, the maximum (AS). Most frequently, TR is of secondary aetiology and septolateral diameter of the tricuspid annulus was measured therefore often caused by left-sided heart disease [1, 2]. In and normalized to the body surface area (BSA) as described patients with severe AS and high surgical risk due to age previously [8]. As cutoff for TAD, the median value of the or comorbidities, transcatheter aortic valve replacement CTA-determined BSA normalized tricuspid annulus diam- (TAVR) is the preferred treatment option, and concomitant eter of all included patients was used. TR is common in these patients [3, 4]. While guidelines recommend concomitant tricuspid valve surgery in patients Echocardiographic analysis undergoing left-sided heart surgery and at least moderate TR in the context of tricuspid annular dilatation, the best Transthoracic echocardiography was performed before and approach for treatment of TR in TAVR patients remains after TAVR in accordance with the European and Ameri- unknown [5]. Besides, an improvement of TR can be can guidelines [9, 10]. Moreover, a central in-house core achieved after TAVR due to reduction of pressure overload laboratory analysis was carried out to assess echocardio- in more than 50% of cases [6]. However, the persistence graphic parameters. Severity of AS was determined using of TR after the procedure is associated with increased all- the continuity equation method. To quantify TR, an inte- cause mortality [6, 7]. Therefore, it is of importance to iden- grated approach taking into account visual appearance, tify determinants of TR persistence in patients undergoing biplane vena contracta width, effective regurgitant orifice TAVR. area (EROA) and regurgitant volume was used whenever Recently, computed tomography angiography (CTA)- possible. For TR grading, a five-grade scheme (mild, moder - determined tricuspid annular dilatation (TAD) proved to be ate, severe, massive, torrential) as proposed by Hahn et al. an independent predictor of 2-year all-cause mortality in was applied [11]. TR aggravation was defined as an increase patients with severe AS undergoing TAVR [8]. The objec- in TR severity and TR persistence as lack of TR improve- tive of this study was to investigate if CTA-determined TAD ment of at least one grade in the follow-up compared to the among TAVR patients who had at least moderate TR at base- preprocedural echocardiography. Right ventricular function line is associated with the persistence of TR after the pro- was assessed using tricuspid annular plane systolic excursion cedure. Moreover, the predictive value of TR persistence on (TAPSE) and fractional area change. the composite of 2-year all-cause mortality in these patients was analysed. TAVR procedure Methods For all TAVR procedures, local anaesthetics were admin- Study design and population istered and a femoral access for TAVR implantation was used. Type and size of the prosthesis were selected con- Consecutive patients with severe AS and at least moder- sidering patients’ characteristics and measurements of the ate concomitant TR at baseline who underwent TAVR at aortic valve in preprocedural CTA by the interventional 1 3 Clinical Research in Cardiology cardiologist. Pre- and/or post-dilatation was performed and device failure at 30 days (technical failure, 30-day mor- according to the operator’s discretion [8]. tality, elevated mean pressure gradient, paravalvular regur- gitation, vascular surgery/intervention) as well as early pace- Study endpoints maker implantation, stroke, bleeding and acute kidney injury according to the Valve Academic Research Consortium 3 The primary endpoint of this study was persistence of TR were recorded [12]. after TAVR and was analysed in patients with available echocardiographic follow-up ≥ 30 days after the procedure. As secondary endpoints, 2-year all-cause mortality, tricuspid Statistical analysis valve intervention, changes of echocardiographic parameters as well as functional status after TAVR using the New York Continuous data are presented as median with interquartile Heart Association (NYHA) functional class were recorded. range and categorical variables are expressed as frequencies Moreover, procedural outcomes of all patients with at and percentages. Differences between groups were tested least moderate TR, such as the composite endpoints techni- for significance using the Fisher exact test, the Wilcoxon cal failure (procedural death, cardiac structural complica- rank sum test or the Wilcoxon signed rank test as appro- tions, conversion to open surgery, prosthesis dislocation, 2nd priate. 2-year all-cause mortality was evaluated using the valve prosthesis, immediate vascular surgery/intervention) Kaplan–Meier method and log-rank test. A two-sided p Table 1 Procedural All TAD − TAD + p-value characteristics and outcomes (n = 288) (n = 144) (n = 144) Procedural characteristics Prosthesis type p = 0.57  Sapien 209 (72.6) 104 (72.2) 105 (72.9)  CoreValve 35 (12.2) 16 (11.1) 19 (13.2)  Accurate Neo 14 (4.9) 10 (6.9) 4 (2.8)  Lotus 21 (7.3) 10 (6.9) 11 (7.6)  Other 9 (3.1) 4 (2.8) 5 (3.5) Prosthesis size p = 0.53   < 25 mm 99 (34.4) 54 (37.5) 45 (31.3)  25–28 mm 110 (38.2) 54 (37.5) 56 (38.9)   > 28 mm 78 (27.1) 36 (25.0) 42 (29.2) Pre-dilatation performed 201 (69.8) 104 (72.2) 97 (67.4) p = 0.37 Post-dilatation performed 16 (5.6) 8 (5.6) 8 (5.6) p = 0.79 Procedural outcomes Technical failure 18 (6.3) 10 (6.9) 8 (5.6) p = 0.81  Procedural death 2 (0.69) 0 (0.00) 1 (1.4) p = 0.50  Cardiac structural complication 5 (1.7) 3 (2.1) 2 (1.4) p = 1.00  Conversion to open surgery 2 (0.7) 0 (0.0) 2 (1.4) p = 0.50  Prosthesis dislocation 4 (1.4) 3 (2.1) 1 (0.7) p = 0.62  2nd valve prosthesis 0 (0.0) 0 (0.0) 0 (0.0) p = 1.00  Immediate vascular surgery/intervention 10 (3.5) 5 (3.5) 5 (3.5) p = 1.00 Device failure at 30 days 46 (16.0) 25 (17.4) 21 (14.6) p = 0.63  30 day mortality 22 (7.6) 11 (7.6) 11 (7.6) p = 1.00  Aortic regurgitation > 1 + 10 (3.5) 6 (4.2) 4 (2.8) p = 0.75  Elevated PG mean > 20 mmHg 4 (1.4) 3 (2.1) 1 (0.7) p = 0.62  Vascular intervention/surgery 11 (3.8) 5 (3.5) 6 (4.2) p = 1.00 Early pacemaker implantation 48 (16.7) 30 (20.8) 18 (12.5) p = 0.08 Stroke 7 (2.4) 5 (3.5) 2 (1.4) p = 0.45 Bleeding BARC type 3 or 4 38 (13.2) 22 (15.3) 16 (11.1) p = 0.38 Acute kidney injury stage 3 or 4 10 (3.5) 8 (5.6) 2 (1.4) p = 0.10 PG pressure gradient, BARC bleeding academic research consortium 1 3 Clinical Research in Cardiology value < 0.05 was considered to indicate statistical signifi- TAD + , p = 0.50), technical failure (6.9% TAD  − vs. cance. All statistical analyses were conducted using R ver- 5.6% TAD + , p = 0.81), device failure at 30 days (17.4% sion 4.0.2 (The R Foundation for Statistical Computing, TAD  − vs. 14.6% TAD + , p = 0.63), s tr ok e (3.5% Vienna, Austria). TAD − vs. 1.4% TAD + , p = 0.45) and bleeding BARC type 3 or 4 (15.3% TAD − vs. 11.1% TAD + , p = 0.38). Procedural characteristics and outcomes stratified by TAD are depicted in Table 1. In addition, all-cause mor- Results tality at 30 days was similar in both groups (p = 1.00), Study population Clinical and echocardiographic baseline characteristics 306 patients with severe AS and at least moderate concomi- tant TR, underwent TAVR procedure at Munich Univer- Out of 266 patients, who had survived at least 30 days after sity Hospital between April 2013 and December 2019. 17 TAVR, echocardiographic follow-up ≥ 30 days after the pro- patients were excluded due to externally acquired prepro- cedure was available for 165 patients (62.0%) (median echo- cedural CTA, and one patient due to history of tricuspid cardiography follow-up time 101 days [interquartile range valve surgery. The median value of the CTA-determined 52–342 days]). Comparing baseline characteristics between BSA normalized tricuspid annulus diameter of the remain- patients with and without available echocardiographic fol- ing 288 patients was 25.2 mm/m and was used as cutoff low-up, patients without follow-up were older (82.2 years to stratify patients into patients with (TAD +) and without [IQR 77.5–86.0] patients with follow-up vs. 84.2 years [IQR TAD (TAD-). 80.2–87.7] patients without follow-up, p < 0.01), but had a similar prevalence of comorbidities, including renal impair- Procedural characteristics and outcomes ment, atrial fibrillation or coronary artery disease. Moreover, there was no difference regarding TR severity at baseline Regarding procedural characteristics, no differences (TR grade ≥ 3: 30.3% in patients with vs. 29.3% in patients could be observed between patients with and without without follow-up, p = 0.90). Clinical and echocardiographic TAD. Moreover, TAD had no impact on procedural out- baseline characteristics comparing patients with and without comes, including procedural death (0.0% TAD − vs. 1.4% follow-up are shown in Supplemental Table 1. Table 2 Clinical baseline All TAD − TAD + p-value characteristics (n = 165) (n = 80) (n = 85) Clinical characteristics Male gender 76 (46.1) 36 (45.0) 40 (47.1) p = 0.88 Age (years) 82.2 (77.5; 86.0) 81.2 (76.2; 84.5) 83.2 (79.6; 86.2) p = 0.03 BMI (kg/m ) 24.7 (22.5; 27.7) 26.6 (24.2; 28.8) 22.9 (21.5; 24.9) p < 0.01 STS score 4.8 (3.1; 7.8) 4.0 (3.0; 7.3) 5.0 (3.7; 8.5) p = 0.08 NYHA functional class ≥ III 153 (93.3) 76 (95.0) 77 (91.7) p = 0.54 Coronary artery disease 91 (57.6) 46 (59.7) 45 (55.6) p = 0.63 Prior myocardial infarction 19 (11.7) 9 (11.3) 10 (12.0) p = 1.00 Prior PCI 42 (25.6) 19 (23.8) 23 (27.4) p = 0.72 Prior CABG 17 (10.4) 10 (12.5) 7 (8.3) p = 0.45 Pacemaker or ICD 28 (17.0) 17 (21.3) 11 (12.9) p = 0.21 Atrial fibrillation 89 (53.4) 36 (45.0) 53 (62.4) p = 0.03 Renal impairment 98 (59.4) 38 (47.5) 60 (70.6) p < 0.01 Diabetes 54 (32.7) 26 (32.5) 28 (32.9) p = 1.00 Hypertension 144 (87.3) 73 (91.3) 71 (83.5) p = 0.16 Smoking 30 (18.9) 12 (15.6) 18 (22.0) p = 0.32 Hypercholesteremia 71 (44.4) 33 (42.9) 38 (45.8) p = 0.75 NT-proBNP (pg/ml) 4040 (2179; 9736) 2911 (1518; 6265) 4324 (3234; 10034) p = 0.09 BMI body mass index, STS score society of thoracic surgeons score, NYHA New York Heart Association, PCI percutaneous coronary intervention, CABG coronary artery bypass graft, ICD implantable cardioverter defibrillator, NT-proBNP N-terminal pro b-type natriuretic peptide 1 3 Clinical Research in Cardiology Table 3 Echocardiographic baseline characteristics All TAD − TAD + p-value (n = 165) (n = 80) (n = 85) Echocardiographic parameters LVEF (%) 53.2 (41.2; 58.6) 53.1 (40.7; 57.1) 53.6 (41.6; 59.5) p = 0.45 PG max aortic valve (mmHg) 49.8 (38.0; 64.1) 48.4 (36.3; 62.1) 49.9 (38.1; 68.10) p = 0.96 PG mean aortic valve (mmHg) 29.3 (22.0; 40.2) 28.6 (21.0; 39.5) 30.3 (23.0; 40.3) p = 0.92 V max aortic valve (cm/s) 348.6 (300.9; 396.8) 341.0 (300.1; 391.5) 352.9 (308.5; 404.1) p = 0.81 Stroke volume index (ml/m ) 29.9 (24.4;36.9) 30.2 (24.7; 35.3) 29.6 (23.9;38.2) p = 0.79 Aortic valve orifice area (cm ) 0.7 (0.6; 0.9) 0.7 (0.6; 0.9) 0.7 (0.6; 0.8) p = 0.26 Aortic regurgitation, n (%) p = 0.33  Grade 0 24 (14.5) 15 (18.8) 9 (10.6)  Grade 1 107 (64.8) 49 (61.3) 58 (68.2)  Grade 2 34 (20.6) 16 (20.0) 18 (21.2) RV area change (%) 35.3 (30.0; 40.8) 36.3 (29.0; 40.7) 35.2 (30.0; 39.9) p = 0.86 RV diameter at mid/BSA (mm/m ) 21.1 (18.7; 23.0) 19.9 (17.7; 22.4) 21.6 (19.9; 24.3) p < 0.01 RV diameter at base/BSA (mm/m ) 27.7 (25.5; 31.3) 26.1 (24.4; 28.5) 29.6 (27.1; 32.6) p < 0.01 Tricuspid annulus diameter/BSA (mm/m ) 22.0 (19.6; 24.6) 20.5 (18.5; 22.5) 23.7 (21.7; 25.6) p < 0.01 2 2 Right atrium/BSA (cm /m ) 15.1 (12.6; 19.0) 13.2 (11.1; 15.5) 17.2 (14.3; 20.4) p < 0.01 TAPSE (mm) 17.0 (13.3; 19.8) 17.0 (14.0; 19.0) 17.0 (13.0; 20.0) p = 0.69 TR vena contracta (mm) 6.2 (4.9; 8.3) 5.8 (4.7; 6.7) 6.5 (5.2; 10.0) p = 0.01 TR EROA (mm ) 28.0 (21.0; 43.3) 26.0 (20.0; 32.0) 32.0 (21.5; 43.0) p = 0.08 TR regurgitant volume (ml) 27.0 (21.0; 37.0) 25.0 (22.0;31.0) 29.0 (21.0; 43.0) p = 0.15 dPmean TV inflow (mmHg) 1.0 (0.8; 1.4) 1.0 (0.8; 1.6) 1.0 (0.8; 1.2) p = 0.17 RV/RA gradient (mmHg) 39.5 (28.9; 49.4) 43.4 (30.0; 49.9) 36.6 (28.0; 48.3) p = 0.08 TR severity p < 0.01  2 115 (69.7) 64 (80.0) 51 (60.0)  3 39 (23.6) 15 (18.8) 24 (28.2)  4 9 (5.5) 1 (1.3) 8 (9.4)  5 2 (1.2) 0 (0.0) 2 (2.4) MR severity ≥ 2 88 (53.3) 40 (50.0) 48 (56.5) p = 0.44 Vena cava inferior (mm) 22.0 (17.0; 25.0) 21.0 (17.0; 24.0) 22.0 (18.8; 25.0) p = 0.12 Respiratory variance VCI 25 (33.8) 16 (51.6) 9 (20.9) p = 0.01 LVEF left ventricular ejection fraction, PG pressure gradient, V max maximum velocity, TV tricuspid valve, VCI vena cava inferior Fig. 1 TR at baseline and follow-up according to TAD 1 3 Clinical Research in Cardiology Fig. 2 A Percentage of patients with TR improvement of at least one grade following TAVR stratified for TAD B Tricuspid annulus dimensions according to TR grade change In patients with available echocardiographic follow-up, performed a multivariable logistic regression analysis with the BSA normalized tricuspid annulus diameter was above adjustment for clinical and echocardiographic parameters, the threshold of 25.2 mm/m in 85 patients (TAD + group). that are known to influence aetiology or severity of TR, Concerning clinical baseline characteristics, patients in including atrial fibrillation, renal impairment, right ven- the TAD + group were older (81.2 years [IQR 76.2–84.5] tricular lead, mitral regurgitation, baseline TR severity, RV/ TAD − vs. 83.2 years [IQR 79.6–86.2] TAD + , p = 0.03) RA gradient and right ventricular function using TAPSE. and suffered more often from atrial fibrillation (45.0% Thus, the predictive value of TAD for TR persistence after TAD − vs. 62.4% TAD + , p = 0.03) and renal impairment TAVR (adjusted odds ratio 2.30, 95% confidence interval (47.5% TAD − vs. 70.6% TAD + , p < 0.01). Clinical base- 1.20–4.46, p = 0.01) could be confirmed. Consistently, tri - line characteristics are presented in Table 2. Regarding echo- cuspid valve intervention after TAVR was conducted in 11 cardiographic parameters, severe AS with a median aortic patients, all of them in the TAD + group (12.9%). valve orifice area of 0.7  cm was present in both groups. Concerning echocardiographic parameters, we observed a Dimensions of the right ventricle (RV) and right atrium similar decline of the aortic pressure gradient after TAVR in (RA) were larger, and baseline TR was more pronounced both groups. Consistent with TR improvement, the reduction in the TAD + group (TR grade ≥ 3: 20.0% TAD − vs. 40.0% of vena contracta width was significantly higher in patients TAD + , p = 0.05). Echocardiographic baseline characteris- without TAD compared to patients with TAD (− 2.0 mm tics are summarized in Table 3. [IQR − 3.9 to − 0.3] TAD − vs. 0.0 mm [IQR − 2.2–2.0] TAD + , p < 0.01). Moreover, we noted an increase in left Impact of tricuspid annular dilatation on tricuspid ventricular ejection fraction at follow-up compared to base- regurgitation line in patients in the TAD  − group. Echocardiographic parameters at baseline and follow-up as well as delta values Improvement of TR after TAVR was observed in both are presented in Table 4A–C. groups, with a higher number of patients with TR grade 1 at follow-up in the TAD − group (TR grade 1 at follow-up: Impact of TR development on survival 50.0% TAD − vs. 23.5% TAD + , p < 0.01) (Fig. 1). Consist- and functional status ently, improvement of TR of at least one grade was signifi- cantly more frequent in patients in the TAD− group (57.0% Two-year follow-up information was available in 81.8% TAD − vs. 34.1% TAD + , corresponding odds ratio for per- of patients. All-cause mortality was significantly lower in sistence of TR: 2.60, 95% confidence interval 1.33–5.16, patients with improvement of TR compared to patients with- p < 0.01) (Fig.  2A). The median value of the CTA-deter- out change or aggravation of TR (log-rank p < 0.01). The mined BSA normalized tricuspid annulus diameter was corresponding hazard ratio for 2-year all-cause mortality in higher in patients with an aggravation or persistence of TR patients with TR improvement vs. no change of TR and vs. compared to patients with an improvement of TR of one aggravation was 0.47 (95% confidence interval 0.24 to 0.94) or two grades (26.4 mm/m [IQR 23.6–28.7] vs. 23.7 mm/ and 0.24 (95% confidence interval 0.11 to 0.54), respec- m [IQR 22.1–26.9], p < 0.001) (Fig.  2B). Moreover, we tively. Kaplan–Meier curves are shown in Fig. 3. Concerning 1 3 Clinical Research in Cardiology Table 4 A–C Echocardiographic parameters at baseline and follow-up, (A) TAD −, (B) TAD + , (C) delta values A TAD- Baseline FU p-value LVEF (%) 50.7 (35.5; 56.2) 54.5 (41.1; 58.7) p = 0.03 PG max aortic valve (mmHg) 45.5 (31.4; 60.9) 13.9 (10.9; 19.2) p < 0.01 PG mean aortic valve (mmHg) 27.0 (18.6; 39.2) 7.6 (6.0; 10.7) p < 0.01 RV area change (%) 35.0 (28.9; 40.2) 37.8 (28.3; 44.5) p = 0.20 RV diameter at mid/BSA (mm/m ) 19.7 (17.7; 22.4) 19.3 (16.2; 21.0) p = 0.12 RV diameter at base/BSA (mm/m ) 26.0 (24.5; 28.1) 25.8 (24.3; 28.6) p = 0.88 Tricuspid annulus diameter/BSA (mm/m ) 21.2 (18.6; 22.5) 19.9 (17.9; 21.7) p = 0.25 2 2 Right atrium/BSA (cm /m ) 13.1 (11.1; 15.7) 13.2 (11.4; 15.6) p = 0.97 TAPSE (mm) 15.0 (13.0; 17.5) 16.0 (13.0; 20.0) p = 0.19 TR vena contracta (mm) 6.1 (4.7; 8.1) 3.8 (2.5; 6.1) p < 0.01 TR EROA (mm ) 31.0 (26.0; 33.0) 23.0 (20.0; 32.0) p = 0.19 TR regurgitant volume (ml) 27.0 (25.0; 27.0) 21.5 (17.0; 26.3) p = 0.20 dPmean TV inflow (mmHg) 1.2 (0.9; 1.8) 1.1 (0.9; 1.3) p = 0.25 RV/RA gradient (mmHg) 40.6 (29.4; 47.7) 36.5 (28.3; 50.8) p = 0.76 Vena cava inferior (mm) 22.0 (17.0; 24.0) 17.0 (16.0; 24.0) p = 0.11 B TAD + Baseline FU p-value LVEF (%) 51.9 (37.1; 58.4) 51.5 (43.2; 57.9) p = 0.40 PG max aortic valve (mmHg) 47.7 (33.8; 58.1) 14.8 (10.1; 18.2) p < 0.01 PG mean aortic valve (mmHg) 29.8 (20.9; 36.7) 7.9 (5.4; 9.9) p < 0.01 RV area change (%) 35.2 (30.4; 37.5) 37.0 (31.0; 43.0) p = 0.17 RV diameter at mid/BSA (mm/m ) 22.0 (20.1; 24.8) 20.7 (18.8; 23.7) p = 0.32 RV diameter at base/BSA (mm/m ) 30.7 )27.2; 32.8] 28.8 )26.4; 32.7] p = 0.15 Tricuspid annulus diameter/BSA (mm/m ) 24.3 (23.0; 26.2) 22.5 (20.9; 25.1) p = 0.01 2 2 Right atrium/BSA (cm /m ) 17.2 )14.5; 20.3] 17.1 )13.8; 20.3] p = 0.11 TAPSE (mm) 15.0 (12.3; 19.8) 16.0 (13.0; 19.0) p = 0.51 TR vena contracta (mm) 6.3 (5.0; 9.2) 6.3 )4.4; 10.0] p = 0.77 TR EROA (mm ) 31.0 (23.5; 50.0) 30.0 (21.0; 49.3) p = 0.56 TR regurgitant volume (ml) 29.0 (21.0;45.0) 31.5 (21.3; 40.8) p = 0.83 dPmean TV inflow (mmHg) 1.0 (0.7; 1.2) 1.0 (0.8; 1.4) p = 0.41 RV/RA gradient (mmHg) 35.3 (25.5; 45.5) 32.7 (27.8; 41.6) p = 0.42 Vena cava inferior (mm) 21.0 (17.0; 25.0) 21.0 (18.0; 26.0) p = 0.93 C TAD − TAD + p value Δ LVEF (%) 3.6 (− 1.4; 5.7) − 0.3 (− 4.8; 6.7) p = 0.34 Δ PG max aortic valve (mmHg) − 29.0 (− 42.7; − 20.8) − 34.2 (− 44.8; − 16.9) p = 0.93 Δ PG mean aortic valve (mmHg) − 18.0 (− 31.2; − 10.4) − 21.5 (− 29.6; − 11.4) p = 0.59 Δ RV area change (%) 3.1 (− 3.2; 5.5) 3.2 (− 7.0; 7.6) p = 0.74 Δ RV diameter at mid (mm/ m ) − 0.6 (− 3.6; 1.5) − 1.2 (− 3.4; 2.3) p = 0.63 Δ RV diameter at base (mm/ m ) 0.0 (− 2.4; 3.2) − 0.7 (− 3.5; 2.0) p = 0.32 Δ Tricuspid annulus diameter/BSA (mm/m ) − 0.3 (− 1.9; 1.0) − 1.2 (− 3.3; 1.1) p = 0.30 2 2 Δ Right atrium (cm /m ) 0.5 (− 2.0; 1.4) − 0.5 (− 3.2; 1.3) p = 0.29 Δ TAPSE (mm) 1.0 (− 1.0; 3.0) − 1.0 (− 3.0; 2.0) p = 0.13 Δ TR vena contracta (mm) − 2.0 (− 3.9; − 0.3) 0.0 (− 2.2; 2.0) p < 0.01 Δ TR EROA (mm ) − 7.0 [− 13.0; − 4.0] − 2.5 (− 11.3; 6.8) p = 0.28 Δ TR regurgitant volume (ml) − 8.0 (− 9.8; 1.3) − 2.0 (− 8.8; 8.8) p = 0.70 Δ dPmean TV inflow (mmHg) − 0.2 (− 0.5; 0.3) 0.0 (− 0.3; 0.3) p = 0.12 Δ RV/RA gradient (mmHg) 0.0 (− 12.1; 8.5) 0.9 (− 9.8; 7.2]) p = 0.91 Δ Vena cava inferior (mm) − 2.0 (− 6.0; 2.0) 0.0 (− 4.0; 3.0) p = 0.31 LVEF left ventricular ejection fraction, PG pressure gradient, TV tricuspid valve 1 3 Clinical Research in Cardiology TAD required tricuspid valve treatment within the 2 year follow-up period. Besides, TR persistence is associated with increased 2 year all-cause mortality. While former studies stated an association between sig- nificant TR at baseline and all-cause mortality in patients with AS undergoing TAVR, recent analyses demonstrated that TR persistence after the procedure is associated with increased mortality and might therefore be prognostically more relevant than TR severity at baseline [6, 7, 13, 14]. In this study, we could confirm that in TAVR patients with con- comitant at least moderate TR at baseline, TR persistence is associated with increased all-cause mortality after 2 years. In addition, improvement of NYHA functional class of at least two grades was observed less often in patients with per- sistence of TR. A multivariable logistic regression analysis with adjustment for atrial fibrillation, renal impairment, right Fig. 3 Survival stratified for development of TR after TAVR ventricular lead, mitral regurgitation, baseline TR severity, RV/RA gradient and right ventricular function confirmed functional status, improvement of NYHA functional class that TAD is an independent predictor of TR persistence. of at least two grades after the procedure was observed less Moreover, no difference regarding procedural characteristics often in patients with persistence of TR compared to patients and outcomes, including procedural mortality, technical or with TR improvement (24.4 vs. 46.5%, p = 0.04) (Fig. 4). device failure was found between patients with and without TAD. Hence, an impact of procedural factors on the differ - ences in outcomes seems unlikely. Discussion As the preprocedural CTA is part of the standard of care to evaluate vascular access routes and to enable accurate Our analysis demonstrates that in patients undergoing TAVR prosthesis selection, the tricuspid annulus diameter can be for severe AS and at least moderate concomitant TR at base- obtained easily without further diagnostic effort. In addition, line, CTA-derived TAD is associated with the persistence the measurement is less error-prone and with a lower degree of TR after the procedure. Consistently, no patient without of interobserver variability compared to echocardiographic Fig. 4 NYHA functional status at baseline and follow-up according to TR improvement 1 3 Clinical Research in Cardiology assessment. In transthoracic echocardiography, an optimal echocardiographic images and especially 3D volumetric data acoustic window of the RV in the RV-focused apical four- were not routinely recorded. chamber view is necessary to obtain the dimensions of the tricuspid valve. Therefore, and due to the complex oval and saddle-shaped anatomy of the valve, its maximal diameter Conclusions is often underestimated in echocardiography. On the con- trary, datasets of CT-scans can be angulated precisely in In patients undergoing TAVR for severe AS with at least the tricuspid annulus for exact assessment of its dimensions moderate concomitant TR, TAD identifies patients with per - as described previously [8]. Hence, CTA-determined BSA sistence of TR after the procedure, which is associated with normalized tricuspid annulus diameter can serve as a reliable increased 2-year all-cause mortality. and easily accessible parameter to predict persistence of TR Supplementary Information The online version contains supplemen- in patients with severe AS treated with TAVR. tary material available at https://doi. or g/10. 1007/ s00392- 023- 02152-0 . Although concomitant tricuspid valve surgery is recom- mended in patients undergoing left-sided heart surgery and Funding Open Access funding enabled and organized by Projekt DEAL. at least moderate TR in the context of tricuspid annular dila- tation, optimal management of TR in TAVR patients remains Declarations unknown [5]. Considering the fact that moderate or severe TR can be observed in more than 25% of patients with severe Conflict of interest Simon Deseive and Julius Steffen received AS and that the number of TAVR procedures will increase speaker honoraria from AstraZeneca. Daniel Braun and Christian Hagl received speaker honoraria from Abbott Vascular and Edwards due to favorable outcomes in recent studies for asympto- Lifesciences. Martin Orban received speaker honoraria from Abbott matic or low-risk patients, this question might be even of Medical, AstraZeneca, Abiomed, Bayer vital, BIOTRONIK, Bristol- higher relevance in the future [4, 15–17]. Myers Squibb, CytoSorbents, Daiichi Sankyo Deutschland, Edwards While sufficient literature regarding tricuspid valve inter - Lifesciences Services, and Sedana Medical. Jörg Hausleiter received research support and speaker honoraria from Abbott Vascular and Ed- vention for persistent TR after TAVR is scarce, a recently wards Lifesciences. The other authors have no conflicts of interest to published propensity-matched case–control study could declare. demonstrate a benefit for patients without AS and at least moderate TR. Patients treated with transcatheter tricuspid Open Access This article is licensed under a Creative Commons Attri- bution 4.0 International License, which permits use, sharing, adapta- valve intervention had significantly lower rates of mortal - tion, distribution and reproduction in any medium or format, as long ity and rehospitalization compared to medically managed as you give appropriate credit to the original author(s) and the source, patients [18]. Besides, the less invasive nature of transcath- provide a link to the Creative Commons licence, and indicate if changes eter valve repair and replacement procedures compared to were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated open-heart surgery could facilitate a watch-and-wait strat- otherwise in a credit line to the material. If material is not included in egy. Therefore, TAD could serve not only as a predictor of the article's Creative Commons licence and your intended use is not TR persistence after TAVR, but also as a tool to identify permitted by statutory regulation or exceeds the permitted use, you will patients in need for intensified post-TAVR echocardio- need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://cr eativ ecommons. or g/licen ses/ b y/4.0/ . graphic and clinical surveillance. In case of TR persistence and lack of symptomatic improvement, these patients might be candidates for transcatheter tricuspid valve interventions. 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Journal

Clinical Research in CardiologySpringer Journals

Published: May 1, 2023

Keywords: Tricuspid annular dilatation; Tricuspid regurgitation; Transcatheter aortic valve replacement

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