European Journal of Heart Failure (2025) RESEARCH ARTICLE

doi:10.1002/ejhf.3623

Malnutrition and outcomes in patients with

tricuspid regurgitation undergoing
transcatheter tricuspid valve repair
Matteo Pagnesi1†, Marianna Adamo1*†, Lukas Stolz2,3, Edoardo Pancaldi1,
Karl-Patrik Kresoja4, Jennifer von Stein5, Vera Fortmeier6, Benedikt Koell7,8,
Wolfgang Rottbauer9, Mohammad Kassar10, Bjoern Goebel11, Paolo Denti12,
Paul Achouh13, Tienush Rassaf14, Manuel Barreiro-Perez15, Peter Boekstegers16,
Andreas Rück17, Monika Zdanyte18, Flavien Vincent19, Philipp Schlegel20,
Ralph-Stephan von Bardeleben4, Mirjam G. Wild21, Christian Besler21,
Stephanie Brunner22, Stefan Toggweiler22, Julia Grapsa23, Tiffany Patterson23,
Holger Thiele24, Tobias Kister24, Giuseppe Tarantini25, Giulia Masiero25,
Marco De Carlo26, Alessandro Sticchi26, Mathias H. Konstandin20, Eric Van Belle19,
Tobias Geisler18, Rodrigo Estévez-Loureiro15, Peter Luedike14, Nicole Karam13,
Francesco Maisano12, Philipp Lauten11, Fabien Praz10, Mirjam Kessler9,
Daniel Kalbacher7,8, Volker Rudolph6, Christos Iliadis5, Philipp Lurz4,
Jörg Hausleiter2,3‡, and Marco Metra1‡, on behalf of the EuroTR Investigators
1 ASST Spedali Civili di Brescia and Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy; 2 Medizinische
Klinik und Poliklinik I, LMU Klinikum, LMU München, Munich, Germany; 3 German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Munich,
Germany; 4 Department of Cardiology, Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany; 5 Department of Cardiology, Heart
Center, University of Cologne, Cologne, Germany; 6 Department of General and Interventional Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University
Bochum, Bad Oeynhausen, Germany; 7 Department of Cardiology, University Heart & Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg,
Germany; 8 German Center of Cardiovascular Research (DZHK), Partner Site, Hamburg, Germany; 9 Department of Cardiology, University Heart Center Ulm, Ulm, Germany;
10 Department of Cardiology, Inselspital Bern, Bern University Hospital, Bern, Switzerland; 11 Department of Cardiology, Heart Center, Zentralklinik Bad Berka, Bad Berka,

Germany; 12 Heart Valve Center, Cardio-Thoracic-Vascular Department, IRCCS San Raffaele Hospital, Milan, Italy; 13 Cardiology Department, European Hospital Georges
Pompidou, Université Cité, Paris, France; 14 University Hospital Essen, University Duisburg-Essen, West German Heart and Vascular Center, Department of Cardiology and
Vascular Medicine, Essen, Germany; 15 Hospital Álvaro Cunqueiro, Vigo, Spain; 16 Department of Cardiology, Helios Klinikum Siegburg, Siegburg, Germany; 17 Department of
Cardiology, Karolinska University Hospital, Stockholm, Sweden; 18 Medical Clinic III, University Hospital Tübingen, Tübingen, Germany ; 19 Cardiology Department, Centre
Hospitalier Universitaire De Lille, Lille, France; 20 Division of Cardiology, Department of Internal Medicine III, University Hospital Heidelberg, Ruprecht-Karl University
Heidelberg, Heidelberg, Germany; 21 University Heart Center Freiburg/Bad Krozingen, Bad Krozingen, Germany; 22 Heart Center Lucerne, Luzerner Kantonsspital, Lucerne,
Switzerland; 23 Department of Cardiology, Guys and St Thomas NHS Trust, London, UK; 24 Department of Cardiology, Heart Center Leipzig, University of Leipzig, Leipzig,
Germany; 25 Department of Cardiac Thoracic Vascular Sciences and Public Health, University of Padua, Padua, Italy; and 26 Cardiothoracic and Vascular Department, Azienda
Ospedaliero-Universitaria Pisana, Pisa, Italy;

Received 2 October 2024; revised 16 December 2024; accepted 28 January 2025

*Corresponding author. Institute of Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Piazzale Spedali
Civili 1, 25123 Brescia, Italy, Tel: +39 389 7834503, Email: [email protected]

† Contributed equally as co-first authors.

‡ Contributed equally as co-last authors.

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2 M. Pagnesi et al.

Aims The impact of malnutrition in patients with tricuspid regurgitation (TR) undergoing tricuspid transcatheter
edge-to-edge repair (T-TEER) is not well established. We evaluated the impact of malnutrition among patients with
symptomatic TR undergoing T-TEER.
.....................................................................................................................................................................
Methods Baseline nutritional status was evaluated using the geriatric nutritional risk index (GNRI), based on serum albumin
and results concentrations and body weight to ideal body weight ratio, among patients with symptomatic TR undergoing T-TEER,
enrolled in the multicentre EuroTR registry between March 2016 and February 2024. Malnutrition was defined
as GNRI ≤98. The primary outcome of interest was all-cause mortality. A total of 1034 patients were included
(mean age 78.4 ± 7.3 years, 47.7% male). Among them, GNRI ≤98 (i.e. malnutrition) was observed in 211 patients
(20.4%). Estimated rates of all-cause death at 2 years were 45.9% and 28.2% in patients with and without malnutrition,
respectively (log-rank p < 0.001). After multivariable adjustment, malnutrition was independently associated with an
increased risk of mortality (adjusted hazard ratio 1.53, 95% confidence interval 1.11–2.10, p = 0.009), also confirmed
at inverse probability of treatment weighting-adjusted analysis. As compared to post-procedural residual TR ≥3+,
residual TR ≤2+ was associated with a similar lower risk of mortality in patients with and without malnutrition
(interaction p = 0.947).
.....................................................................................................................................................................
Conclusion In the large, real-world, multicentre EuroTR registry, malnutrition was present in one out of five patients with
symptomatic TR undergoing T-TEER and was independently associated with increased mortality. The prognostic
benefit of successful T-TEER in reducing mortality was consistently observed in patients with and without
..........................................................................................................
malnutrition.

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Malnutrition and T-TEER outcomes 3

Graphical Abstract

Malnutrion and outcomes aer T-TEER

An analysis on 1,034 paents from EuroTR

Prevalence of malnutrion (GNRI ≤98) Impact of malnutrion on all-cause mortality

20.4% GNRI ≤98

GNRI >98
80.6%

Adjusted HR 1.53 (95% CI 1.11-2.10)

IPTW-adjusted HR 1.46 (95% CI 1.05-2.03)

Associaon of successful T-TEER with lower mortality in paents with and without malnutrion

No interacon between residual TR and malnutrion

(pinteracon = 0.947)

Malnutrition and outcomes after tricuspid transcatheter edge-to-edge repair (T-TEER). CI, confidence interval; GNRI, geriatric nutritional risk index;
HR, hazard ratio; IPTW, inverse probability of treatment weighting; TR, tricuspid regurgitation.

..........................................................................................................
Keywords Tricuspid regurgitation • Tricuspid transcatheter edge-to-edge repair • Heart failure •
Malnutrition • Clinical outcomes • Geriatric nutritional risk index

Introduction Tricuspid transcatheter edge-to-edge repair (T-TEER) has emerged

..............................................

as a safe option to reduce TR and improve health status.11–13 A

Malnutrition is common in patients with heart failure (HF) and has previous small single-centre study demonstrated that malnutrition,
been associated with adverse outcomes in different settings, includ- assessed by the Mini Nutritional Assessment tool, is common in
ing severe HF and secondary mitral regurgitation (MR).1–4 Despite elderly patients undergoing T-TEER, is associated with a higher
their importance, nutritional disorders are often underrecognized risk of death or HF rehospitalization, and frequently improves
in patients with HF, also due to lack of standardized definitions after T-TEER along with improvements in quality of life, central
and some challenges in their assessment.1 Although malnutrition venous pressure and hepato-renal function.14 However, the impact
was associated with poor prognosis after mitral transcatheter of T-TEER in patients with or without malnutrition has never been
edge-to-edge repair (M-TEER),5,6 a recent analysis of the Car- reported.
diovascular Outcomes Assessment of the MitraClip Percutaneous Among the different nutritional indexes that have been pro-
Therapy for Heart Failure Patients with Functional Mitral Regurgi- posed, the geriatric nutritional risk index (GNRI) allows a simple
tation (COAPT) trial showed that the clinical benefits of M-TEER but comprehensive assessment of the nutritional status and has
are maintained in both patients with or without malnutrition.3 been evaluated in patients with HF and MR.2–4,15 The assessment
Tricuspid regurgitation (TR) and right HF are burdened by of malnutrition through the GNRI might have an impact among
poor quality of life and an increased risk of clinical events.7–10 patients with TR undergoing T-TEER.

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4 M. Pagnesi et al.

The aim of the present study was to evaluate the impact York Heart Association (NYHA) class III–IV, EuroSCORE II, diabetes

........................................................................................................................................................................
of malnutrition, assessed by the GNRI, in a large, contempo- mellitus, right ventricular (RV) fractional area change (FAC), estimated
rary, real-word, multicentre cohort of patients with symptomatic glomerular filtration rate (eGFR), N-terminal pro-B-type natriuretic
TR who underwent T-TEER. Also, we explored the association peptide (NT-proBNP), concomitant M-TEER and post-procedural
residual TR severity ≤2+. Results of the Cox regression analyses are
between procedural success and mortality according to malnutri-
reported as unadjusted or adjusted hazard ratio (HR) with 95% confi-
tion status and compared the prognostic value of GNRI with the
dence interval (CI). The continuous association between the risk of
simpler and more commonly used body mass index (BMI).
the primary outcome and GNRI as a continuous variable was also
assessed by restricted cubic splines with three knots, and the HR
for the impact of increasing values of GNRI on the primary outcome
Methods was plotted. Propensity score methodology with inverse probability
Study design of treatment weighting (IPTW) was also performed to account for
bias between patients with versus without malnutrition.20,21 Propensity
The multicentre, real-world, observational, retrospective European scores predicting each patient’s probability of having GNRI ≤98 were
Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR estimated with multivariable logistic regression including the following
registry) included patients who underwent T-TEER for symptomatic variables: age, sex, NYHA class III–IV, EuroSCORE II, diabetes mel-
TR from March 2016 to February 2024 at 24 centers.16 Indication to litus, RV FAC, eGFR, NT-proBNP, concomitant M-TEER and residual
T-TEER was based on multidisciplinary heart team discussion at each TR severity ≤2+. Stabilized weights were computed from propensity
participating centre. As previously described,17 T-TEER was performed scores by means of IPTW. The weight for GNRI ≤98 was the inverse of
using either the MitraClip/TriClip system (Abbott, Santa Clara, CA, the respective propensity score, whereas the weight for GNRI >98 was
USA) or the PASCAL device (Edwards Lifesciences, Irvine, CA, USA). the inverse of 1 – propensity score. Cox regression models evaluating
Anonymized patient data on demographics, medical history, clinical the impact of GNRI ≤98 vs. GNRI >98 on outcomes were weighted
presentation, echocardiography and laboratory findings, procedural using IPTW. Doubly robust IPTW adjustment was also performed,
data and clinical outcomes were collected, as previously reported.16 augmenting the Cox regression models with additional covariates of
This study adheres to the principles outlined in the Declaration of interest, that were added separately to the IPTW-adjusted models in
Helsinki and received proper ethical oversight (NCT06307262). order to avoid overfitting.22
Malnutrition was assessed using the GNRI and patients with miss- In a sub-analysis, the prognostic impact of BMI on all-cause mor-
ing GNRI were excluded from this analysis. The GNRI was calculated tality was evaluated using the same multivariable model, and Harrell’s
as follows: 1.489 × serum albumin concentration (g/L) + 41.7 × (body C-indexes were derived as a measure of the accuracy of BMI and
weight [kg]/ideal body weight).3,4,18 The ideal body weight was cal- GNRI in predicting mortality. In another sub-analysis, clinical outcomes
culated as follows: 22 × square of height (meters).3,4,19 According to were also stratified in four groups based on malnutrition (GNRI >98
previous studies, patients were stratified in those with evidence of mal- vs. ≤98) and post-procedural residual TR severity (≤2+ vs. ≥3+),
nutrition (i.e. GNRI ≤98) versus those with no evidence of malnutrition and interaction between these two variables was tested to evaluate
(i.e. GNRI >98).3,4,18 whether malnutrition modified the association between successful
T-TEER and outcomes.
All reported p-values are two-sided, and a p-value <0.05 was
Endpoints considered statistically significant. Statistical analyses were performed
The primary outcome of interest of this study was all-cause mortality. with STATA version 16.0 (STATA Corp., College Station, TX, USA).
The composite of all-cause mortality or hospitalization for HF was also
evaluated as additional outcomes of interest.
Results
Statistical analysis Among the 2322 patients enrolled in the EuroTR registry, a
Continuous variables are presented as mean ± standard deviation or total of 1034 patients (44.5%) with available data on GNRI at
median (interquartile range [IQR]), as appropriate, and were com- inclusion were included in the present analysis. The main reason
pared with the unpaired Student’s t-test or the Mann–Whitney U for exclusion was the lack of data on albumin concentration, which
test, respectively. Categorical variables are presented as number and was not available in 1285 out of 1288 excluded patients (99.8%).
percentages and were compared with the 𝜒 2 test. Baseline character- Baseline characteristics in included versus excluded patients are
istics, procedural data and clinical outcomes were compared between reported in online supplementary Table S1.
patients with GNRI >98 versus GNRI ≤98. Patient characteristics were
Among the included patients, 823 (79.6%) had GNRI >98 and
also compared between included patients (i.e. with a known GNRI)
211 (20.4%) had GNRI ≤98. Overall, median GNRI at baseline
versus excluded patients (i.e. with missing GNRI).
was 108 (IQR 100–116), mean age was 78.4 ± 7.3 years, 493
Kaplan–Meier curves and log-rank test were used to evaluate the
first occurrence of clinical outcomes up to 2 years in patients with patients (47.7%) were male, median BMI was 25.2 kg/m2 (IQR
GNRI >98 versus GNRI ≤98. The smoothed hazard estimates of clin- 22.8–28.8 kg/m2 ), and NYHA class III or IV was observed in 890
ical outcomes during follow-up were also plotted. Cox proportional patients (86.5%).
hazards regression analysis was also performed to assess the impact
of GNRI on outcomes. The impact of GNRI ≤98 (i.e. malnutrition)
and the impact of GNRI as a continuous variable were evaluated by
Baseline characteristics
means of univariable and multivariable analyses. The following relevant Baseline characteristics are reported in Table 1. Age, sex and
covariates were included in the multivariable models: age, sex, New NYHA class III or IV were similar between patients with and

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Malnutrition and T-TEER outcomes 5

Table 1 Baseline characteristics

Overall (n = 1034) Patients without Patients with p-value

malnutrition malnutrition
(GNRI >98) (n = 823) (GNRI ≤98) (n = 211)
...........................................................................................................................................
Age (years) 78.4 ± 7.3 78.3 ± 7.0 79.0 ± 8.5 0.183
Male sex 493 (47.7) 398 (48.4) 95 (45.0) 0.387
BMI (kg/m2 ) 25.2 (22.8–28.8) 26.2 (23.7–29.8) 22.2 (19.9–24.2) <0.001
Body weight (kg) 73 (63–84) 75 (66–85) 62 (56–70) <0.001
Ideal body weight (kg) 62 (57–67) 62 (57–67) 63 (58–68) 0.368
EuroSCORE II (%) 6.6 ± 5.9 6.4 ± 5.3 7.6 ± 7.6 0.011
Comorbidities
Hypertension 878 (85.0) 700 (85.2) 178 (84.4) 0.772
Diabetes mellitus 276 (26.7) 234 (28.4) 42 (19.9) 0.012
Atrial fibrillation or flutter 933 (90.2) 744 (90.4) 189 (89.6) 0.718
CAD 463 (44.8) 361 (43.9) 102 (48.3) 0.243
Prior myocardial infarction 109 (10.5) 75 (9.1) 34 (16.1) 0.003
Prior cardiac surgery 300 (29.1) 248 (30.1) 52 (24.6) 0.117
RV lead 308 (29.8) 251 (30.5) 57 (27.0) 0.324
COPD 206 (19.9) 166 (20.2) 40 (19.0) 0.694
Dialysis 49 (4.8) 32 (3.9) 17 (8.1) 0.011
Clinical presentation
NYHA class III–IV 890 (86.5) 701 (85.6) 189 (90.0) 0.095
Any sign of right HF 761 (74.0) 588 (71.8) 173 (82.4) 0.002
Peripheral oedema 660 (63.8) 519 (63.1) 141 (66.8) 0.310
Ascites 153 (14.8) 106 (12.9) 47 (22.3) 0.001
Pleural effusion 241 (24.0) 158 (19.8) 83 (40.1) <0.001
Echocardiographic data
TR severity 0.704
2+ 18 (1.7) 16 (2.0) 2 (1.0)
3+ 552 (53.5) 443 (53.9) 109 (51.9)
4+ 274 (26.6) 215 (26.2) 59 (28.1)
5+ 188 (18.2) 148 (18.0) 40 (19.1)
TR aetiology <0.001
Primary 33 (3.2) 16 (2.0) 17 (8.2)
Secondary 915 (90.0) 745 (92.1) 170 (81.7)
Mixed 69 (6.8) 48 (5.9) 21 (10.1)
TV annular diameter (mm) 44 (39–49) 44 (39–49) 44 (39–48) 0.211
TR EROA (cm2 ) 0.54 (0.40–0.77) 0.54 (0.40–0.77) 0.54 (0.40–0.79) 0.762
TR regurgitant volume (mL) 46 (36–60) 47 (37–60) 45 (33–61) 0.404
TR vena contracta (mm) 10 (8–13) 10 (8–13) 10 (8–13) 0.744
RV mid-ventricular diameter (mm) 40 (34–45) 40 (34–46) 39 (33–45) 0.104
RV FAC (%) 39.5 (31.0–47.3) 40.0 (31.7–47.9) 37.0 (28.0–44.0) 0.001
TAPSE (mm) 17 (14–20) 17 (14–20) 16 (13–19) 0.012
TR max gradient (mmHg) 33 (25–43) 32 (24–43) 34 (25–44) 0.557
sPAP (mmHg) 43 (33–53) 43 (33–53) 42 (33–52) 0.690
LVEF (%) 55 (47–60) 55 (47–60) 55 (45–61) 0.414
LVEDD (mm) 49 (44–54) 49 (44–54) 48 (43–54) 0.162
MR severity 3+ or 4+ 105 (10.3) 61 (7.5) 44 (21.4) <0.001
Laboratory findings
eGFR (ml/min) 45 (31–60) 46 (32–60) 40 (26–57) 0.010
NT-proBNP (pg/ml) 2584 (1396–5002) 2364 (1337–4434) 4054 (1957–7527) <0.001
AST (U/L) 28 (23–35) 27 (23–34) 30 (23–40) 0.013
ALT (U/L) 19 (14–25) 18 (14–25) 19 (14–26) 0.390
GGT (U/L) 94 (50–179) 94 (51–178) 98 (46–202) 0.978
Haemoglobin (g/dl) 11.8 (10.4–13.1) 11.9 (10.5–13.2) 11.1 (9.5–12.5) <0.001
Albumin (g/L) 40 (36–43) 41 (38–44) 33 (29–36) <0.001

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6 M. Pagnesi et al.

Table 1 (Continued)

Overall (n = 1034) Patients without Patients with p-value

malnutrition malnutrition
(GNRI >98) (n = 823) (GNRI ≤98) (n = 211)
...........................................................................................................................................
Medical therapy
MRA 436 (42.3) 345 (42.0) 91 (43.1) 0.772
Loop diuretic 965 (93.6) 772 (94.0) 193 (91.9) 0.261
Beta-blocker 897 (86.8) 713 (86.6) 184 (87.2) 0.828
RASi 429 (58.2) 335 (60.1) 94 (52.2) 0.061

Data are presented as n (%), mean ± standard deviation, or median (Q25–Q75).

ALT, alanine transaminase; AST, aspartate transaminase; BMI, body mass index; CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; eGFR, estimated
glomerular filtration rate; EROA, effective regurgitant orifice area; FAC, fractional area change; GNRI, geriatric nutritional risk index; HF, heart failure; LVEDD, left ventricular
end-diastolic diameter; LVEF, left ventricular ejection fraction; GGT, gamma-glutamyl transferase; MR, mitral regurgitation; MRA, mineralocorticoid receptor antagonist;
NT-proBNP, N-terminal pro-B-type natriuretic peptide; NYHA, New York Heart Association; RASi, renin–angiotensin system inhibitor; RV, right ventricular; sPAP, systolic
pulmonary artery pressure; TAPSE, tricuspid annular plane systolic excursion; TR, tricuspid regurgitation; TV, tricuspid valve.

Table 2 Procedural data

Overall (n = 1034) Patients without Patients with p-value

malnutrition malnutrition
(GNRI >98) (n = 823) (GNRI ≤98) (n = 211)
...........................................................................................................................................
Type of T-TEER device 0.660
TriClip/MitraClip system 645 (63.1) 511 (62.8) 303 (37.2)
PASCAL device 377 (36.9) 134 (64.4) 74 (35.6)
Residual TR severity 0.339
0+ 37 (3.6) 27 (3.3) 10 (4.8)
1+ 429 (41.7) 345 (42.1) 84 (40.0)
2+ 375 (36.4) 303 (37.0) 72 (34.3)
3+ 160 (15.5) 120 (14.6) 40 (19.1)
4+ 21 (2.0) 17 (2.1) 4 (1.9)
5+ 8 (0.8) 8 (1.0) 0 (0.0)
Post-procedural TR ≤2+ 841 (81.7) 675 (82.3) 166 (79.1) 0.275
Concomitant M-TEER 110 (10.6) 64 (7.8) 46 (21.8) <0.001

Data are presented as n (%).

GNRI, geriatric nutritional risk index; M-TEER, mitral transcatheter edge-to-edge repair; T-TEER, tricuspid transcatheter edge-to-edge repair; TR, tricuspid regurgitation.

without malnutrition. As compared to those without malnutrition, of type of T-TEER device implanted (TriClip/MitraClip system or
....................................................

patients with malnutrition had lower body weight and BMI, higher PASCAL device) and in terms of residual TR severity after T-TEER.
EuroSCORE II, were less likely to have diabetes mellitus, and Overall, 81.7% of patients had post-procedural TR ≤2+ (79.1% in
were more likely to have prior myocardial infarction and dialysis. the GNRI ≤98 group vs. 82.3% in the GNRI >98 group, p = 0.275).
Patients with malnutrition were also more likely to have any Concomitant M-TEER was performed more frequently in patients
sign of right HF, ascites and pleural effusion. Primary TR and with malnutrition (21.8%) as compared to those without malnutri-
mixed TR were more common among patients with malnutrition, tion (7.8%, p < 0.001).
whereas secondary TR was more common among those without
malnutrition. Patients with malnutrition had lower tricuspid annular
Impact of malnutrition on clinical
plane systolic excursion and RV FAC, and were more likely to have
concomitant MR 3+ or 4+. Regarding laboratory findings, eGFR outcomes
was lower and NT-proBNP and aspartate aminotransferase were After a median follow-up of 449 (IQR 214–813) days, a total of
higher in patients with malnutrition. 326 patients (31.5%) died and a composite event of all-cause death
or HF hospitalization occurred in 427 patients (41.3%).
The 2-year estimated rate of all-cause death was 45.9% in
Procedural data patients with malnutrition and 28.2% in those without malnutrition
Regarding procedural data (Table 2), there were no significant dif- (log-rank p < 0.001; Figure 1). Time-dependent analysis showed a
ferences between patients with and without malnutrition in terms higher risk of mortality in patients with versus without malnutrition

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Malnutrition and T-TEER outcomes 7

........................................................................................................
All-cause death All-cause death

60
1.0
p-value (log-rank) < 0.001 0.9
50
0.8
Event rate (%)

40

0.7
30

Hazard ratio
0.6
20

0.5

0.4
10

0.3
overall p-value < 0.001
0 6 12 18 24 0.2 p-value for non-linearity = 0.490
Months
0.1
Number at risk
No malnutrition 823 670 529 364 254 0.0
Malnutrition 211 146 109 78 62
90 95 100 105 110 115 120 125
No malnutrition Malnutrition GNRI

Figure 1 Cumulative incidence of 2-year all-cause death in Figure 2 Impact of increasing values of geriatric nutritional risk
patients with or without malnutrition. Kaplan–Meier curves for index (GNRI) on all-cause death. The figure shows the hazard
all-cause death at 2 years in patients with geriatric nutritional risk ratio for the impact of increasing values of GNRI on all-cause
index ≤98 (i.e. malnutrition) versus >98 (i.e. no malnutrition). death, relative to a minimum GNRI value of 90. Hazard ratio is
shown on the y-axis and plotted with 95% confidence interval,
whereas GNRI as a continuous variable is shown on the x-axis.

through the entire 2-year follow-up, with the highest risk observed
during the first 6 months (online supplementary Figure S1). As p < 0.001) and multivariable analysis (adjusted HR for 5-unit GNRI
shown in Table 3, the unadjusted risk of all-cause death was higher increase 0.90, 95% CI 0.85–0.96, p = 0.001). A linear association
in patients with GNRI ≤98 as compared to those with GNRI between all-cause death and GNRI was observed (p-value for
>98 (crude HR 1.87, 95% CI 1.47–2.37, p < 0.001). After mul- non-linearity = 0.490; Figure 2), with a progressively lower risk of
tivariable adjustment, malnutrition remained independently asso- mortality observed at increasing GNRI values.
ciated with an increased risk of all-cause mortality (adjusted HR The 2-year estimated rate of the composite of all-cause death
1.53, 95% CI 1.11–2.10, p = 0.009). This association was con- or HF hospitalization was 59.3% in patients with malnutrition
firmed also after IPTW adjustment (IPTW-adjusted HR 1.46, 95% and 39.1% in patients without malnutrition (log-rank p < 0.001;
CI 1.05–2.03, p = 0.023), including doubly robust IPTW-adjusted Figure 3). At time-dependent analysis, a higher risk of the com-
analyses (online supplementary Table S2). When evaluating GNRI posite endpoint was observed in patients with versus without
as a continuous variable, a lower risk of all-cause mortality was malnutrition through the entire 2-year follow-up, with the highest
observed at increasing GNRI values at both univariable analysis risk during the first 6 months (online supplementary Figure S2).
(crude HR for 5-unit GNRI increase 0.88, 95% CI 0.85–0.92, Malnutrition was associated with an increased risk of the composite

Table 3 Impact of malnutrition on clinical outcomes

Univariable analysisMultivariable analysis IPTW-adjusted analysis

...............................
............................... ................................
Unadjusted p-value Adjusted p-value IPTW-adjusted p-value
HR (95% CI) HR (95% CI) HR (95% CI)
...........................................................................................................................................
All-cause death
GNRI ≤98 (malnutrition) 1.87 (1.47–2.37) <0.001 1.53 (1.11–2.10) 0.009 1.46 (1.05–2.03) 0.023
GNRI as continuous variable 0.88 (0.85–0.92) <0.001 0.90 (0.85–0.96) 0.001 – –
(per 5-unit increase)
All-cause death or HF
hospitalization
GNRI ≤98 (malnutrition) 1.85 (1.50–2.29) <0.001 1.52 (1.15–2.00) 0.003 1.48 (1.12–1.95) 0.005
GNRI as continuous variable 0.89 (0.86–0.92) <0.001 0.91 (0.86–0.96) <0.001 – –
(per 5-unit increase)

BMI, body mass index; CI, confidence interval; eGFR, estimated glomerular filtration rate; FAC, fractional area change; GNRI, geriatric nutritional risk index; HF, heart failure;
HR, hazard ratio; IPTW, inverse probability of treatment weighting; M-TEER, mitral transcatheter edge-to-edge repair; NT-proBNP, N-terminal pro-B-type natriuretic peptide;
NYHA, New York Heart Association; RV, right ventricular; TR, tricuspid regurgitation.
At multivariable analyses, HRs were adjusted for age, sex, NYHA class III–IV, EuroSCORE II, diabetes mellitus, RV FAC, eGFR, NT-proBNP, concomitant M-TEER and
post-procedural residual TR severity ≤2+.

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8 M. Pagnesi et al.

GNRI to the multivariable model including 10 covariates (age,

........................................................................................................................................................................
All-cause death or HF hospitalization sex, NYHA class III–IV, EuroSCORE II, diabetes, FAC, eGFR,
NT-proBNP, concomitant M-TEER, and residual TR ≤2+) slightly
100
80 p-value (log-rank) < 0.001 increased its predictive accuracy (C-index increase from 0.68 to
0.70, p = 0.115). In contrast, the addition of BMI did not increase
Event rate (%)

60

the predictive value of this multivariable model (p = 0.227).

40

Residual tricuspid regurgitation

20

and malnutrition
0 6 12
Months
18 24
Overall, post-procedural residual TR ≤2+ and ≥3+ were observed
Number at risk
No malnutrition 823 625 478 318 214
in 841 (81.7%) and 189 (18.3%) patients, respectively. Median
Malnutrition 211 130 89 58 45 GNRI was 108 (IQR 100–116) and 107 (IQR 99–115) in patients
No malnutrition Malnutrition with residual TR ≤2+ and ≥3+, respectively (p = 0.164). As already
mentioned, the proportion of patients with residual TR ≤2+ was
Figure 3 Cumulative incidence of 2-year all-cause death or similar between patients with and without malnutrition.
heart failure (HF) hospitalization in patients with or without As compared to post-procedural residual TR ≥3+, residual
malnutrition. Kaplan–Meier curves for the composite of all-cause
TR ≤2+ was associated with a lower risk of all-cause mortality
death or hospitalization for HF at 2 years in patients with geriatric
in both patients with malnutrition (2-year estimated rate 40.7%
nutritional risk index ≤98 (i.e. malnutrition) versus >98 (i.e. no
malnutrition). vs. 67.9%; crude HR 0.50, 95% CI 0.31–0.79, p = 0.003) and
without malnutrition (2-year estimated rate 24.5% vs. 44.5%; crude
HR 0.50, 95% CI 0.37–0.63, p < 0.001; Figure 4). No significant
interaction was observed between residual TR (≥3+ vs. ≤2+)
outcome both at univariable and multivariable analyses (adjusted
and malnutrition (GNRI >98 vs. ≤98) with respect to all-cause
HR 1.52, 95% CI 1.15–2.00, p = 0.003; Table 3). This association
mortality (interaction p-value = 0.947).
was confirmed also after IPTW adjustment (IPTW-adjusted HR
Similarly, no significant interaction was observed between the
1.48, 95% CI 1.12–1.95, p = 0.005), including doubly robust
impact of residual TR on outcomes and malnutrition with respect
IPTW-adjusted analyses (online supplementary Table S2). Similarly,
to the composite of all-cause death or HF hospitalization (inter-
when evaluating GNRI as a continuous variable, increasing GNRI
action p = 0.404). Patients with residual TR ≤2+ and ≥3+ had
values were independently associated with a lower risk of the
2-year estimated rates of the composite outcome of 57.5% and
composite outcome (adjusted HR for 5-unit GNRI increase 0.91,
67.4%, respectively, in the GNRI ≤98 group (crude HR 0.70, 95%
95% CI 0.86–0.96, p < 0.001).
CI 0.46–1.08, p = 0.106) and of 35.7% and 54.0%, respectively, in
the GNRI >98 group (crude HR 0.57, 95% CI 0.44–0.74, p < 0.001;
Prognostic value of body mass index online supplementary Figure S4).

and comparison with the geriatric

nutritional risk index Discussion
As compared to patients with BMI ≤ median value (25.2 kg/m ), 2
Our analysis of the large, multicentre, contemporary EuroTR
those with BMI > median value had a similar risk of all-cause registry demonstrates a prevalence of malnutrition, defined as
mortality at both univariable analysis (crude HR 0.83, 95% GNRI ≤98, of 20.4% among the 1034 included patients with
CI 0.67–1.03, p = 0.093) and multivariable analysis (adjusted symptomatic TR undergoing T-TEER and with available serum
HR 0.78, 95% CI 0.58–1.05, p = 0.101) (online supplementary albumin concentration. Malnutrition was associated with a worse
Figure S3). This was confirmed also when comparing patients with clinical profile and poorer outcomes, with a 2-year estimated rate
BMI <22 kg/m2 , 22–27 kg/m2 and >27 kg/m2 (adjusted HR for of all-cause death of 45.9% in patients with versus 28.2% in patients
BMI 22–27 vs. <22 kg/m2 1.02, 95% CI 0.70–1.50, p = 0.907; and without malnutrition. The prognostic value of malnutrition was
adjusted HR for BMI >27 vs. <22 kg/m2 0.80, 95% CI 0.52–1.22, independent of other variables of known prognostic significance
p = 0.296). Similarly, when evaluating BMI as a continuous variable, and larger than BMI alone. Malnutrition did not impact the efficacy
its association with all-cause mortality was not significant at both of T-TEER, and post-procedural TR ≤2+ was associated with lower
univariable analysis (crude HR for 5-point BMI increase 0.94, 95% mortality independent of malnutrition (Graphical Abstract).
CI 0.84–1.05, p = 0.295) and multivariable analysis (adjusted HR Malnutrition is common in HF and has been associated with
for 5-point BMI increase 0.88, 95% CI 0.75–1.04, p = 0.130). The adverse outcomes in different HF settings, including severe HF and
accuracy of GNRI in predicting all-cause mortality (C-index 0.60, secondary MR1–4 Of note, in a previous single-centre study includ-
standard error [SE] 0.02) was higher than the accuracy of BMI ing 86 patients with TR undergoing T-TEER, 15% of patients were
(C-index 0.53, SE 0.02; p < 0.001). Consistently, the addition of malnourished and 79% of patients were at risk for malnutrition
GNRI to BMI significantly increased its accuracy in predicting according to the Mini Nutritional Assessment scores.14 By apply-
all-cause mortality (p = 0.001). Furthermore, the addition of ing a different malnutrition score, i.e. the GNRI, in a much larger

© 2025 European Society of Cardiology.

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Malnutrition and T-TEER outcomes 9

All-cause death

80 100
p-value (log-rank) < 0.001

Event rate (%)

60
40
20
0 6 12 18 24
Months
Number at risk
No malnutrition - TR 2+ 675 562 446 309 215
No malnutrition - TR 3+ 145 107 82 55 39
Malnutrition - TR 2+ 166 118 91 65 55
Malnutrition - TR 3+ 44 27 17 12 6

No malnutrition - TR 2+ No malnutrition - TR 3+
Malnutrition - TR 2+ Malnutrition - TR 3+

Figure 4 Cumulative incidence of 2-year all-cause death according to malnutrition and residual tricuspid regurgitation (TR). Kaplan–Meier
curves for all-cause death at 2 years in four groups of patients based on geriatric nutritional risk index ≤98 (i.e. malnutrition) versus >98 (i.e.
no malnutrition) and on post-procedural residual TR ≤2+ versus ≥3+ after transcatheter tricuspid valve repair.

cohort, the prevalence of malnutrition in our study was quite simi- severe HF,4 GNRI had a higher accuracy than BMI in predicting mor-
...............................................................................................

lar (20%). Interestingly, this prevalence was similar to that observed tality, thus further highlighting that malnutrition scores are more
in recent studies using the same definition (i.e. GNRI ≤98) predictive of outcome than BMI.4,15
among patients with secondary MR and among HF outpatients Interestingly, in our study the benefits of effective T-TEER (i.e.
(16–17%),3,15 but was lower than that observed in other studies with residual TR ≤2+) were consistently observed in patients
enrolling patients with severe HF or HF with preserved ejection with and without malnutrition. This result is novel since never
fraction (35–36%).2,4 The GNRI is a comprehensive tool including investigated before in the T-TEER setting and in line with a
both anthropometric variables (i.e. body weight/ideal body weight) recent analysis of the COAPT trial demonstrating that M-TEER
and laboratory parameters (i.e. serum albumin), thus allowing a plus medical therapy improved long-term clinical outcomes, as
multi-dimensional assessment of the nutritional status.1,18 Of note, compared to medical therapy alone, in patients with HF and
the measurement of serum albumin concentration is particularly severe secondary MR independent of baseline malnutrition status.3
important in patients with TR, since it was recently identified as Considering the clinical benefits of successful T-TEER,11,12,16 our
one of the strongest independent predictors of mortality in a large study suggests that malnutrition cannot be considered as a single
cohort of patients with isolated TR and was consequently included reason to exclude patients with symptomatic TR from T-TEER.
in a novel dedicated risk score.23 Moreover, gastrointestinal and A comprehensive, multidisciplinary assessment taking into account
liver congestion may reduce appetite and favour abdominal dis- not only the nutritional status, but also the whole clinical profile,
comfort and intestinal malabsorption in patients with TR, thus the TR phenotype, the predicted risks and benefits, and the
increasing the risk of malnutrition.14,24 Measurement of albumin feasibility of a safe and effective procedure, seems a more judicious
levels seems therefore advised in these patients to help in identify- approach to evaluate candidacy to T-TEER.7,17,25
ing malnutrition and also for its prognostic significance per se.
Similarly to other studies enrolling patients with HF and/or sec-
ondary MR2–4,15 malnutrition was associated with worse clinical Study limitations
outcomes in our cohort of patients with TR undergoing T-TEER. In Our study has a retrospective nature, thus carrying all the usual
our study, GNRI ≤98 was independently associated with all-cause limitations associated with this design. All data were reported by
mortality and a linear relationship between GRNI and the risk of local investigators and there was not central adjudication of clinical
mortality was identified, with a progressively lower risk observed events. Moreover, a non-negligible proportion of the EuroTR
at increasing GNRI values. Rates of all-cause death at 2 years cohort was not analysed (1288 out of 2322 patients, 55.5%)
were 45.9% and 28.2% in patients with and without malnutrition, due to missing data on GNRI, mainly because of lack of data
respectively. These findings confirm the prognostic role of malnu- on albumin concentration (1285 out of 1288 excluded patients).
trition and, particularly, its assessment by the GNRI,1–4,15 also in Although the characteristics of included versus excluded patients
this particular subset of patients with symptomatic TR undergo- were compared, a certain impact of selection bias on the study
ing T-TEER. Of note, as previously demonstrated in patients with findings cannot be ruled out, including the observed prevalence of

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10 M. Pagnesi et al.

malnutrition. The underrepresentation of some TR phenotypes in NVT, Terumo, Venus, and consulting fees, personal and institutional hon-

........................................................................................................................................................................
the analysed cohort, such as patients with primary TR (accounting oraria from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardio-
for only 3.2% of included patients), might also have influenced valve, Occlufit, Simulands, Mtex, Venus, Squadra, Valgen Royalty Income/IP
the study findings. Finally, alternative definitions of malnutrition Rights Edwards Lifesciences, and is shareholder (including share options)
of Magenta, Transseptalsolutions, 4Tech. F.P. received travel expenses
were not tested in our study, since details on body type or body
from Edwards Lifesciences, Abbott Vascular, Polares Medical, Medira, and
composition and other tools to assess nutritional status were not
Siemens Healthineers. M.K. received speaker honoraria from Edwards and
available in our dataset. Abbott. D.K. received personal fees from Abbott Medical, Edwards Life-
sciences, Pi-Cardia Ltd and Medtronic Inc. V.R. received research grants
from Abbott Medical, Boston Scientific, and Edwards Lifesciences. C.I.
Conclusions received consultant fees and travel expenses from Abbott Medical and
Edwards Lifesciences. P.L. received institutional grants from Edwards Life-
In a large, real-world, multicentre, contemporary cohort of
sciences and honoraria from Innoventrics. J.H. reports research grant sup-
patients with symptomatic TR undergoing T-TEER, malnutrition,
port and speaker honoraria from Edwards Lifesciences. M.M. received con-
defined as GNRI ≤98, was observed in 20.4% of patients and sulting fees in the last 3 years from Abbott Structural Heart, AstraZeneca,
was independently associated with an increased risk of all-cause Bayer, Boehringer Ingelheim, Edwards Lifesciences, Roche Diagnostics. All
mortality. Residual TR was similar in patients with and without other authors have nothing to disclose.
malnutrition, and the association of successful T-TEER with lower
mortality was independent of malnutrition status. Future dedicated
studies are needed to further evaluate the impact of nutritional
Appendix
status in patients with significant TR and its evolution after TR
interventions. EuroTR Investigators
Thomas J. Stocker2 ; Philipp M. Doldi2 ; Roman Pfister5 ; Stephan
Baldus5 ; Muhammed Gerçek6 ; Felix Rudolph6 ; Sebastian Ludwig7,8 ;
Supplementary Information Christoph Pauschinger7,8 ; Leonhard-Moritz Schneider9 ; Dominik
Additional supporting information may be found online in the Felbel9 ; Carsten Salomon11 ; Harald Lapp11 ; Tania Puscas13 ; Alain
Supporting Information section at the end of the article. Berrebi13 ; Amir Abbas Mahabadi14 ; Florian Schindhelm14 ; Berenice
Caneiro-Queija15 ; Julio C. Echarte15 ; Jürgen Schreieck18 ; Andreas
Conflict of interest: M.P. received personal fees from Abbott Laborato- Goldschmied18 ; Natacha Rousse19 ; Samy Aghezzaf19 ; Norbert
ries, AstraZeneca, Boehringer Ingelheim, Novartis, Roche Diagnostics and Frey20 ; Martin Kraus20 ; Dirk Westermann21 ; Leonie Ziegler21 ;
Vifor Pharma. M.A. received consulting fees in the last 3 years from Abbott Sebastian Rosch24 ; Federico Arturi25 ; Andrea Panza25 ; Matteo
Structural Heart and Edwards Lifesciences. L.S. received speaker honoraria
Mazzola26 ; Cristina Giannini26 .
from Edwards Lifesciences. K.P.K. reports travel expenses from Edwards
Lifesciences. J.v.S. received lecture honoraria from Edwards Lifesciences.
W.R. received speaker honoraria from Edwards and Abbott. P.D. served References
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