400pmET Transcatheter Tricuspid Valve Treatment TCT 2019

Transcatheter versus medical treatment of
symptomatic severe tricuspid regurgitation:

a propensity score matched analysis
Maurizio Taramasso MD, PhD

from a TriValve – Mayo Clinic – Leiden University collaboration
University Hospital of Zurich, University of Zurich, Switzerland

Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial
interest/arrangement or affiliation with the organization(s) listed below:
Affiliation/Financial Relationship Company
Consulting Fees/Honoraria Abbott

Boston Scientific
Edwards Lifesciences
4tech
CoreMedic
Background
• High prevalence of TR in the cardiological

population (concomitant left-side heart disease,
chronic atrial fibrillation, or pulmonary
hypertension setting)
• For long considered a benign valve disease,

but highly impact the survival
• Uncertainty in regard to the clinical efficacy of

TR therapies
Benfari G. et al. Circulation. 2019 Jul 16;140(3):196-206
Background
• TR surgical treatment is associated to high
operative mortality, suboptimal long-term
survival, and frequent TR recurrence after
repair.
• Uncertainty in regard to the clinical efficacy

of TR therapies (currently transcatheter
therapies are not included in the guidelines).
• Lacking RCTs
TriValve Registry
• The TriValve International Registry represents so far the largest
multicenter, multi-devices series of patients with symptomatic severe
TR who underwent transcatheter tricuspid valve interventions (TTVI)
Aim
• Comparing outcomes of TTVI in high-risk patients (TriValve registry)

to a control group of similar patients under conservative treatment
with GDMT
Methods
• The control cohort of patients with severe TR was formed by consecutive
patients evaluated at Mayo Clinic, Rochester, Mn, USA and Leiden University
Medical Center, The Netherlands
• Exclusion criteria were previous tricuspid valve surgery or intervention, and

iatrogenic (pacemaker lead related) TR
• Patients in the TTVI cohort (TriValve registry) were matched with controls using
propensity scores (distance ± 0.2 SD). The variable adopted to calculate
propensity score were age, Euroscore II, and pulmonary pressure level
Methods
• Primary endpoint was mortality from any cause or rehospitalization
for heart failure (HF)
• Secondary endpoint was overall mortality. Follow-up data were

collected for patients up to 12 month
• TTVI procedural success was defined as patient alive at the end of

the procedure, with device successfully implanted, delivery system
retrieved and residual TR <3+
Results
Overall population Propensity matched cohort
N=1652 N=536
TTVI Controls P-value TTVI Controls P-value
N=472 N=1179 N=268 N=268
Age, y±SD 77±8 76 ±13 0.07 77±8 76 ±13 0.2
Women, % 55% 63% 0.007 56% 59% 0.4
TR of functional etiology 90% 96% 0.0004 90% 95% 0.1
Left ventricular EF, % 50 ±13 49 ±17 0.2 49±15 50 ±15 0.2
Left ventricular EF <35%, % 18% 26% 0.0006 22% 21% 0.7
Euroscore II, (%) 10.5±11.2 17.9±11.7 <0.0001 12±11 13±9 0.6
Right ventricular dysfunction 34% 20% <0.0001 37% 29% <0.0001
S-PAP, mmHg 40±15 52±15 <0.0001 44±14 43±14 0.3
Pulmonary hypertension, % 27% 50% <0.0001 34% 29% 0.2
NYHA III-IV, % 93% 39% <0.0001 93% 23% <0.0001
Mitral regurgitation > 2+ 33% 18% <0.0001 40% 17% <0.0001
Atrial Fibrillation, % 83% 57% <0.0001 82% 50% <0.0001
Pacemaker or defibrillator, % 26% 5% <0.0001 29% 12% <0.0001
Results: Primary and secondary endpoint
77±3%
68±4%
64±3%
51±3%
Results: Multivariable adjusted models
HR for death or heart
HR for mortality
Model for control group failure hosp P-value P-value
(secondary endpoint)
(primary endpoint)
1) Unadjusted 0.60 (0.46-0.79) 0.003 0.56 (0.39-0.79) 0.001
HR for mortality
Model for control group failure hosp. P-value P-value
(primary endpoint)
1) Unadjusted 0.60 (0.46-0.79) 0.003 0.56 (0.39-0.79) 0.001
2) Adj. for
0.46 (0.31-0.68) 0.0001 0.49 (0.31-0.79) 0.003
sex and NYHA
HR for mortality
(primary endpoint)
1) Unadjusted 0.60 (0.46-0.79) 0.003 0.56 (0.39-0.79) 0.001
2) Adj. for
0.46 (0.31-0.68) 0.0001 0.49 (0.31-0.79) 0.003
sex and NYHA
3) Adj. for
sex and NYHA, Afib, 0.39 (0.26-0.59) <0.0001 0.41 (0.26-0.67) 0.0004
and RV dysf.
HR for mortality
(primary endpoint)
1) Unadjusted 0.60 (0.46-0.79) 0.003 0.56 (0.39-0.79) 0.001
2) Adj. for
0.46 (0.31-0.68) 0.0001 0.49 (0.31-0.79) 0.003
sex and NYHA
3) Adj. for
sex and NYHA, Afib, 0.39 (0.26-0.59) <0.0001 0.41 (0.26-0.67) 0.0004
and RV dysf.
4) Adj for
sex and NYHA, Afib,
0.35 (0.23-0.54) <0.0001 0.38 (0.23-0.63) 0.002
and RV dysf, MR>2+,
PM/ICD
Results: subgroup analysis
Results: TTVI device type
Total matched TTVI: 268
15%
85%
Mitra Clip Others

Results: Procedural success vs. residual TR
Results: impact of concomitant MR
Limitations of the study
• it is not a randomized trial and relevant confounders might not be

represented in the risk-adjustment process
• Absence of Core-Lab
• A minority of patients had concomitant MR treatment
• Medical therapy for severe TR not standardised
• Highly selected patients in TTVI group
Conclusions
• TTVI in high-risk patients with symptomatic severe TR as compared to
medical treatment alone is associated to lower incidence of composite
endpoint as well as lower all-cause mortality, at 1 year follow-up
• A significant difference was observed between patients undergoing TTVI

with procedural success compared to those in whom procedural success
was not achieved
• TTVI patients without a significant reduction in TR presented similar

outcomes vs. control group, confirming the prognostic role of TR
reduction in improving outcomes

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Transcatheter versus medical treatment of

symptomatic severe tricuspid regurgitation:

Maurizio Taramasso MD, PhD

University Hospital of Zurich, University of Zurich, Switzerland

Affiliation/Financial Relationship Company

Consulting Fees/Honoraria Abbott

• High prevalence of TR in the cardiological

• For long considered a benign valve disease,

• Uncertainty in regard to the clinical efficacy of

• Uncertainty in regard to the clinical efficacy

• Comparing outcomes of TTVI in high-risk patients (TriValve registry)

• Exclusion criteria were previous tricuspid valve surgery or intervention, and

• Secondary endpoint was overall mortality. Follow-up data were

• TTVI procedural success was defined as patient alive at the end of

Mitra Clip Others

• it is not a randomized trial and relevant confounders might not be

• A significant difference was observed between patients undergoing TTVI

• TTVI patients without a significant reduction in TR presented similar

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