Comparison of Outcomes in Patients With and Without Chronic Kidney Disease Undergoing Transcatheter Tricuspid Valve Replacement

Abstract

Background

Patients with chronic kidney disease (CKD), including end-stage renal disease (ESRD), undergoing transcatheter tricuspid valve replacement (TTVR) may be at increased risk of adverse outcomes. We compared clinical outcomes after TTVR in patients with versus without CKD/ESRD.

Methods

We analyzed 145 patients who underwent TTVR for tricuspid regurgitation (TR). Patients were stratified into 2 cohorts: CKD/ESRD (dialysis dependence and/or estimated glomerular filtration rate <30 mL/min/1.73 m²; n = 24) and no CKD/ESRD (n = 121). Baseline characteristics and clinical outcomes were compared.

Results

Patients with CKD/ESRD were slightly younger (76.3 years [IQR, 69.2-78.6] vs 80.8 years [IQR, 73.4-85.0]; P = .48) and had higher body mass index (29.7 kg/m² [IQR, 24.2-32.2] vs 26.8 kg/m² [IQR, 23.2-31.0]; P = .19), with significantly higher Society of Thoracic Surgeons scores (20.8 vs 12.1; P = .002) and right ventricle systolic pressure (47.5 vs 36.0 mm Hg; P < .001). Baseline New York Heart Association functional class III/IV and TR severity were similar between groups. At 30-day follow-up, all-cause mortality was numerically higher in the CKD/ESRD group (8.3% vs 3.3%; P = .25). Residual TR reduction was achieved in 100% of patients in CKD/ESRD group and 97.6% of patients in the non-CKD/ESRD group (P = .99). Functional outcomes were comparable overall; New York Heart Association functional class III/IV persisted in 25.0% vs 19.3% (P = .73) and median Kansas City Cardiomyopathy Questionnaire-Overall Summary scores were similar (45.8 vs 50.5; P = .57). Major bleeding occurred at similar rates between groups (12.5% vs 12.4%; P = .10), whereas new pacemaker implantation was significantly more common in the CKD/ESRD group (29.2% vs 11.6%; P = .04).

Conclusions

TTVR in patients with CKD/ESRD provides comparable functional improvement to that in patients without CKD. However, the patients with CKD/ESRD group have a significantly higher rate of pacemaker implantation, highlighting the need for individualized risk assessment and careful clinical management in this population.

Introduction

Tricuspid regurgitation (TR) is a common valvular disorder, particularly in older adults, and is associated with increased morbidity and mortality.¹ Historically, treatment options have been limited, especially for patients considered high-risk for surgery. In recent years, transcatheter tricuspid valve replacement (TTVR) has emerged as a promising, minimally invasive alternative, demonstrating improvements in TR severity, symptoms, and quality of life. However, early data also highlight procedural risks, including major bleeding and the need for permanent pacemaker implantation.²

Among patients undergoing transcatheter valve procedures, chronic kidney disease (CKD), including end-stage renal disease (ESRD), is highly prevalent and strongly associated with adverse outcomes.3, 4, 5 CKD and ESRD are linked to higher risks of bleeding, infection, vascular complications, and impaired recovery.^3,6,7 Large-scale analyses of transcatheter aortic valve replacement have demonstrated significantly higher in-hospital mortality, major bleeding, vascular complications, and longer hospital stays in patients with CKD or ESRD.^3,8 Similar findings have been reported in patients undergoing transcatheter edge-to-edge mitral valve repair.^9,10 Limited data in tricuspid interventions suggest higher rates of heart failure, acute kidney injury, hemothorax, and discharge to rehabilitation among patients with CKD.⁵

Despite these findings, there is a marked lack of data specifically evaluating outcomes of TTVR in patients with CKD or ESRD. The TRISCEND II trial demonstrated the safety and efficacy of TTVR in reducing TR severity and improving functional status,² but subgroup analyses by renal function were not reported. As a result, this high-risk population remains underrepresented in clinical trials, and the impact of CKD or ESRD on post-TTVR outcomes is poorly understood.

This study aims to compare the clinical and functional outcomes after TTVR in patients with versus without CKD/ESRD. Understanding these differences is essential for guiding patient selection, risk stratification, and postprocedural management in this complex patient population.

Methods

Study cohort and procedural technique

This study retrospectively analyzed a single-center database of 145 patients who underwent TTVR for symptomatic TR at a single tertiary center between 2024 and 2025. Patient eligibility and treatment decisions were made by a multidisciplinary heart team, considering clinical characteristics, comorbidities, and procedural risk. All patients received optimized medical therapy, including diuretics and heart failure medications, prior to TTVR. Procedural details of TTVR were consistent with previously described techniques.^2,11,12 Briefly, the EVOQUE tricuspid valve replacement system (Edwards Lifesciences) is a transfemoral transcatheter system consisting of a self-expanding nitinol frame, bovine pericardial leaflets, and a fabric skirt to reduce paravalvular leak. It features a unique anchoring mechanism that uses the annulus, leaflets, and subvalvular chords, with 9 ventricular anchors for stable implantation. The 28F outer diameter delivery system allows 3 planes of motion to achieve precise, coaxial alignment with the tricuspid valve, aided by independent depth control. Procedures were performed under general anesthesia with transesophageal echocardiography and fluoroscopic guidance, with selective addition of intracardiac ultrasound when deemed necessary by the operators. Access was gained through the femoral vein, and a preshaped stiff guide wire was advanced into the right ventricle. The system was guided across the tricuspid annulus, aligned, and deployed in stages, ensuring leaflet capture and proper depth before final valve release. Patients received intravenous heparin during the procedure and oral anticoagulation for ≥6 months postoperatively.^11,12 Clinical data were collected at baseline, discharge, and 30-day follow-up.

Data collection and outcomes

Patients were stratified into 2 cohorts based on the presence or absence of CKD requiring dialysis. The CKD/ESRD group (n = 24) included patients who undergoing chronic dialysis, as documented in the medical record, and/or had an estimated glomerular filtration rate <30 mL/min/1.73 m². The non-CKD/ESRD group (n = 121) included all other patients not receiving dialysis therapy. This classification allowed for focused analysis of outcomes in patients with advanced renal dysfunction requiring dialysis.

Baseline demographics, comorbidities, and echocardiographic and procedural data were obtained through medical records. Clinical outcomes assessed at baseline and 30 days after the procedure included all-cause mortality, heart failure symptoms evaluated by the New York Heart Association (NYHA) functional classification, and functional status. Quality of life was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Major bleeding was defined according to the Mitral Valve Academic Research Consortium.¹³ Experienced echocardiographers performed all assessments in alignment with current professional society recommendations. In this study, right ventricular systolic pressure was measured via echocardiography and used as a surrogate for pulmonary artery systolic pressure to evaluate pulmonary hypertension, aligning with current clinical practice.¹⁴

The study protocol was approved by the local ethics committee, and all patient data were collected in accordance with institutional guidelines.

Statistical analysis

Continuous variables were tested for normality using the Shapiro-Wilk test of normality and are reported as mean ± SD or median (IQR) accordingly. Categorical variables are expressed as counts and percentages. Between-group comparisons for continuous variables used t tests or Kruskal-Wallis rank sum tests as appropriate; categorical variables were compared using Fisher exact tests. Changes from baseline to 30 days were assessed using paired tests (eg, Wilcoxon signed-rank test). Statistical significance was defined as P < .05. Statistical analyses were conducted using RStudio version 2024.04.2.

Results

Baseline characteristics

Baseline characteristics are presented in Table 1. A total of 145 patients underwent TTVR, of whom 24 (16.6%) had CKD or ESRD and 121 (83.4%) did not. Patients with CKD/ESRD were younger than those without (median age 76.3 years [IQR, 69.2-78.6] vs 80.8 years [IQR, 73.4-85.0]; P = .48). The proportion of women was slightly lower in the CKD/ESRD group (54.2% vs 65.3%; P = .36). The CKD/ESRD group had a higher mean body mass index (29.7 kg/m² [IQR, 24.2-32.2] vs. 26.8 kg/m² [IQR, 23.2-31.0]; P = .20) and a significantly higher median Society of Thoracic Surgeons score (20.8 [IQR, 14.5-23.9] vs 12.1 [IQR, 7.8-18.5]; P = .01), indicating elevated surgical risk.

Table 1.

Characteristics of the patients at baseline.

Variable	No CKD/ESRD (n = 121)	CKD/ESRD (n = 24)	P
Demographics
Age, y	80.8 (73.4-85.0)	76.3 (69.2-78.6)	.484
Women	79 (65.3)	13 (54.2)	.355
STS score, %	12.1 (7.8-18.5)	20.8 (14.5-23.9)	.002a
Body mass index, kg/m2	26.8 (23.2-31.0)	29.7 (24.2-32.2)	.197
Clinical
NYHA functional class III or IV	91 (75.2)	18 (75.0)	.99
KCCQ-OS score	45.8 (30.2-66.7)	50.5 (38.9-58.6)	.570
Prior heart failure hospitalization in last 12 mo	13 (10.7)	2 (8.3)	.99
Tricuspid regurgitation grade
None/trace	0 (0.0)	0 (0.0)
Mild	0 (0.0)	0 (0.0)
Moderate	9 (7.4)	2 (8.3)
Severe	112 (92.6)	22 (91.7)
LVEF, %	57 (49.5-62.0)	55.5 (43.8-60.0)	.431
Atrial fibrillation	94 (77.7)	19 (79.2)	.99
Pacemaker	34 (28.1)	6 (25.0)	.652
COPD	44 (36.4)	6 (25.0)	.351
RSVP, mm Hg	36 (28.3-42.0)	47.5 (38.3-54.3)	<.001a
Medication
Diuretics	106 (87.6)	12 (50.0)	<.001a
Spironolactone	28 (23.1)	3 (12.5)	.290
β-blocker	91 (75.2)	18 (75.0)	.99
SGLT2 inhibitor	28 (23.3)	4 (16.7)	.596
ACE inhibitor	12 (12.8)	0 (0.0)	.208
Oral anticoagulant	98 (81.0)	16 (66.7)	.169

Data are n (%) or median (IQR). CKD/ESRD group included 24 patients, of whom 14 were on chronic dialysis. P values based on t test, Kruskal-Wallis test, or Fisher exact test as appropriate.

ACE, angiotensin-converting enzyme; COPD, chronic obstructive pulmonary disease; ESRD, end-stage renal disease; KCCQ-OS, Kansas City Cardiomyopathy Questionnaire-Overall Summary; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; RSVP, right ventricle systolic pressure; SGLT2, sodium/glucose cotransporter 2; STS, Society of Thoracic Surgeons.

^aP < .05 was considered statistically significant.

Both groups had similar prevalence of NYHA functional class III or IV symptoms (75.0% vs 75.2%; P = 1.00) and comparable median KCCQ scores (50.5 [IQR, 38.9-58.6] vs 45.8 [IQR, 30.2-66.7]; P = .57). Prior heart failure hospitalization within the past 12 months was also similar (8.3% vs 10.7%; P = 1.00). TR severity was broadly comparable between groups, with most patients having severe or greater TR (CKD/ESRD: 91.7%; No CKD/ESRD: 92.6%). Left ventricular ejection fraction was similar (55.5% [IQR, 43.8-60.0] vs 57% [IQR, 49.5–62.0]; P = .43), as was the prevalence of atrial fibrillation (79.2% vs 77.7%; P = 1.00) and baseline pacemaker presence (25.0% vs 28.1%; P = .65).

Patients with CKD/ESRD had significantly higher right ventricular systolic pressure (47.5 mm Hg [IQR, 38.3-54.3] vs. 36 mm Hg [IQR, 28.3–42.0]; P = .001). The prevalence of chronic obstructive pulmonary disease and medication use was similar across both cohorts. In patients with CKD/ESRD, volume management was frequently achieved through dialysis rather than diuretic therapy. Exploratory analyses demonstrated that baseline diuretic use was not significantly associated with changes in NYHA functional class or KCCQ scores at 30 days, either in univariate analysis or in models incorporating CKD/ESRD status.

Clinical outcomes at 30 days

Clinical outcomes at 30 days are presented in Table 2. At 30-day follow-up, all-cause mortality was low but numerically higher in the CKD/ESRD group (8.3%) than in non-CKD group (3.3%) (P = .25). Reintervention rates were rare at 0.8% in the non-CKD group and 0% in the CKD group (P = 1.00). Functional status improved overall, although a slightly higher proportion of patients with CKD/ESRD remained in NYHA class III or IV at follow-up (25.0% vs 19.3%; P = .31). KCCQ scores at 30 days were similar between groups (69.8 vs 63.5; P = .86). Both groups achieved substantial reductions in TR severity, with residual TR reduction observed in 100% of patients in the CKD/ESRD group and 97.6% of patients in the non-CKD/ESRD group (P = .99).

Table 2.

Clinical outcomes at 30 days follow-up.

Variable	No CKD/ESRD (n = 121)	CKD/ESRD (n = 24)	P
All-cause mortality	4 (3.3)	2 (8.3)	.258
Reintervention	1 (0.8)	0 (0.0)	.99
NYHA functional class III or IV	17 (19.3)	4 (25.0)	.310
Tricuspid regurgitation grade
None/trace	56 (65.9)	7 (50.0)
Mild	22 (25.9)	4 (28.6)
Moderate	6 (7.1)	3 (21.4)
Severe	1 (1.2)	0 (0.0)
TR grade reduction (residual TR)	83 (97.6)	14 (100.0)	.99
KCCQ-OS score	69.8 (43.8-80.2)	63.5 (42.2-70.8)	.864
Major bleeding	15 (12.4)	3 (12.5)	.100
New pacemaker	14 (11.6)	7 (29.2)	.049a
Stroke	1 (0.8)	0 (0.0)	.99
Myocardial infraction	0 (0.0)	0 (0.0)	.99
Device malposition/ migration/ embolization	1 (0.8)	0 (0.0)	.99

Data are n (%) or median (IQR). P values based on t test, Kruskal-Wallis test, or Fisher exact test as appropriate.

KCCQ-OS, Kansas City Cardiomyopathy Questionnaire-Overall Summary; NYHA, New York Heart Association; TR, tricuspid regurgitation.

^aP < .05 was considered statistically significant.

Figure 1 shows the degree of TR severity at baseline and 30 days after TTVR in patients with and without CKD/ESRD. At baseline, the majority of patients in both groups had severe TR, with 92.6% in the non-CKD/ESRD group and 91.7% in the CKD/ESRD group. At 30-day follow-up, both groups demonstrated significant improvements in TR severity (P < .001). In the non-CKD/ESRD group, 65.9% of patients had no or trace TR, 25.9% had mild TR, 7.1% had moderate TR, and 1.2% had severe TR. Similarly, in the CKD/ESRD group, 50.0% had no or trace TR, 28.6% had mild TR, and 21.4% had moderate TR, with no patients in the severe category. This marked reduction in TR severity was observed consistently across both cohorts, indicating that TTVR is effective in significantly reducing TR regardless of renal function status.

Figure 1.

Tricuspid regurgitation severity and clinical improvement at 30 days in patients with or without CKD/ESRD.P value is based on Wilcoxon signed-ranked test. CKD, chronic kidney disease; ESRD, end-stage renal disease.

Adverse events

Adverse events at 30 days are summarized in Figure 2. Among patients with and without CKD/ESRD, most adverse event rates were low and comparable between groups. The most notable difference was a significantly higher rate of permanent pacemaker implantation at discharge/after surgery in the CKD/ESRD group (29.2% vs 11.6%; P < .05). All permanent pacemaker implantations occurring after surgery or within 30 days were observed exclusively in pacemaker-naïve patients, with no cases among patients with a pre-existing pacemaker. Other events, including acute kidney injury, atrial fibrillation, cardiac arrest, death, pulmonary embolism, stroke, and device-related events, occurred infrequently and did not show statistically significant differences between groups (P > .05 for all). No events were reported in either group for annular rupture, coronary artery compression, myocardial infarction, endocarditis, or vascular complications.

Figure 2.

Adverse events in patients with and without CKD/ESRD. CKD, chronic kidney disease; ESRD, end-stage renal disease.

Discussion

To our knowledge, this study is the first dedicated evaluation of TTVR outcomes in patients with advanced CKD. Despite similar technical success and comparable improvements in TR severity and functional status to those of patients without CKD, the CKD/ESRD cohort had higher early mortality and a greater need for new permanent pacemaker implantation. These findings underscore a clinically meaningful trade-off in this vulnerable population: substantial symptomatic benefit accompanied by a higher procedural risk profile (Central Illustration).

Central Illustration.

Clinical outcomes of TTVR in patients with versus without CKD/ESRD, showing similar TR reduction and functional improvement, with a higher rate of pacemaker implantation in patients in the CKD/ESRD group. CKD, chronic kidney disease; ESRD, end-stage renal disease; NYHA, New York Heart Association (functional class); TR, tricuspid regurgitation; TTVR, transcatheter tricuspid valve replacement.

Although the difference in 30-day mortality did not reach statistical significance, the trend toward higher early mortality in patients with CKD/ESRD is clinically relevant. Patients with advanced CKD had substantially higher baseline risk, as assessed by Society of Thoracic Surgeons score, which likely contributed to the observed outcome gap. This is consistent with prior experience in transcatheter aortic valve replacement, in which CKD and ESRD are associated with increased periprocedural mortality and complications.³ Our TTVR data extend this risk paradigm to the area of tricuspid valve disease, emphasizing that advanced kidney disease is a potent marker of frailty and adverse outcomes even with minimally invasive therapy. Importantly, the absolute 30-day mortality in patients with CKD/ESRD remains lower than historical surgical mortality in similar high-risk TR populations.¹⁵

Encouragingly, symptomatic and quality-of-life gains were comparable between groups, indicating that patients with advanced CKD derive the full clinical benefit of TTVR. These data suggest that, even in the context of CKD, TTVR can meaningfully restore functional capacity in advanced TR.

The overall safety profile of TTVR in CKD/ESRD was acceptable; however, certain complications were overrepresented in this cohort and warrant targeted mitigation. Conduction disturbances requiring permanent pacing were significantly more frequent in patients with advanced CKD, affecting roughly one-quarter of the cohort. These observations support anticipatory strategies: thorough preprocedural conduction assessment, early electrophysiology involvement, and planning for pacing support in high-risk cases (eg, consideration of a leadless system). Post-TTVR, operators should maintain a low threshold for early permanent pacemaker implantation when meaningful conduction delay is observed, given the risk of delayed high-grade atrioventricular block.

Bleeding complications were low and comparable between groups. Major bleeding occurred in 12.4% of patients in the non-CKD group and 12.5% of those in the CKD/ESRD, group with no statistically significant difference between them. This similar incidence suggests that, although CKD is a recognized risk factor for bleeding, careful periprocedural management may help mitigate excess risk in patients undergoing TTVR. Reassuringly, other major complications were rare and did not differ between groups.

Our study complements recent investigations of transcatheter tricuspid edge-to-edge repair (T-TEER) in similar populations,¹⁶ which likewise report favorable clinical results. Important distinctions, however, deserve emphasis. TTVR entails greater procedural complexity than T-TEER, and although clip-based repair may avoid certain risks (eg, it confers minimal risk to the conduction system), it can leave residual TR and may be unsuitable in the setting of extreme annular dilation. Rather than positioning replacement and repair as competing strategies, our data support a complementary paradigm: T-TEER may be preferable for carefully selected ESRD patients with favorable anatomy or an absolute contraindication to postprocedural anticoagulation, whereas TTVR can offer more complete, and potentially more durable, TR correction in patients without such contraindications.

Crucially, both approaches demonstrate that renal failure should not automatically exclude patients from transcatheter tricuspid therapies; each modality can deliver meaningful symptomatic relief to a group historically deemed ‘too high-risk’ and often left untreated. Future studies directly comparing TTVR and T-TEER in CKD will help refine patient selection and procedural planning and possibly identify risk factors for poor outcomes in patients with CKD, which can be focused on for mitigation of these outcomes. Our analysis is hypothesis-generating and underscores the need for prospective investigations and larger multicenter registries. Intentional inclusion of patients with CKD/ESRD in forthcoming tricuspid trials is essential to close the current evidence gap and to develop nuanced, renal-specific guidelines. Taken together, our findings suggest that TTVR in CKD/ESRD is feasible and clinically rewarding, yielding symptomatic improvement comparable to that seen in patients without CKD, and contribute to a growing evidence base aimed at optimizing care and achieving equitable outcomes and quality of life in this expanding population.