Transcatheter Aortic Valve Replacement in Patients With End-Stage Renal Disease
Key result
ESRD in TAVR patients is linked to ~50% higher in-hospital mortality.
- P<0.01
- n=72,631
Why the study?
In patients with ESRD, surgical aortic valve replacement carries higher mortality and adverse outcomes, and there are limited reported outcomes for TAVR as an alternative.
What are the clinical outcomes of TAVR in patients with end-stage renal disease compared to those not on dialysis?
Key Points
- To determine in-hospital and 1-year clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with end-stage renal disease (ESRD) on dialysis compared with nondialysis patients.
- Analyzed data from the STS/ACC TVT registry on 72,631 patients with severe aortic stenosis undergoing TAVR.
- Compared 3,053 patients (4.2%) with ESRD on dialysis against nondialysis patients for baseline risk profiles and clinical outcomes.
- ESRD patients had higher in-hospital mortality (5.1% vs. 3.4%; p < 0.01) and higher rates of major bleeding (1.4% vs. 1.0%; p = 0.03), with similar rates of major vascular complications (4.5% vs. 4.6%; p = 0.86).
- One-year mortality was significantly higher among dialysis-dependent ESRD patients compared to nondialysis patients (36.8% vs. 18.7%; p < 0.01).
Study Design
Type
Observational (n=72,631)
Multicenter
Yes
Structured PICO
What are the clinical outcomes of TAVR in patients with end-stage renal disease compared to those not on dialysis?
P
Population
72,631 patients with severe aortic stenosis treated with TAVR from the STS/ACC TVT registry, comparing 3,053 patients with end-stage renal disease to those not on dialysis.
E
Exposure
Transcatheter aortic valve replacement (TAVR) in patients with end-stage renal disease (ESRD)
C
Comparator
Transcatheter aortic valve replacement (TAVR) in patients not on dialysis
O
Outcome
In-hospital mortality and 1-year mortalityhard clinical
Main Result
Absolute Event Rate: 5.1% vs 3.4%
p-value: p=< 0.01
TAVR in patients with ESRD is associated with high 1-year mortality (36.8%), suggesting the need for careful risk-benefit assessment in this population.
Ask about this paper
Answers are grounded in this paper and cite their sources.
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“When we see dialysis patients, we really take into account why they are on dialysis. The person who has polycystic kidney disease and is on dialysis is very different than the person who has diabetes, peripheral vascular disease, and hypertension. So we really look at the cause of their dialysis and try to assess what the 1- or 2-year mortality is without aortic stenosis.”
“Although there is a subset of patients who survive more than 1 year, careful selection of the ESRD patient is required to focus the therapy on patients who will survive long enough to receive benefit. Careful adjudication of the technology should be done to ensure that TAVR is offered to patients who will benefit the most from it.”
“Although ESRD may not be an absolute contraindication to TAVR, just because we can replace the valve does not mean we should in every dialysis patient with severe AS. More data is needed to identify a probably small subset of ESRD patients with AS who are too sick to undergo surgical repair, yet who would benefit from a TAVR. Even then, those patients and their families need to know that the procedure carries high risk and may, at best, only buy a little more time.”
Implication
TAVR in ESRD links to higher mortality and bleeding; leaves open net benefit versus alternatives in this high-risk group.
Abstract
BACKGROUND In patients with end-stage renal disease (ESRD), surgical aortic valve replacement is associated with higher early and late mortality, and adverse outcomes compared with patients without renal disease. Transcatheter aortic valve replacement (TAVR) offers another alternative, but there are limited reported outcomes. OBJECTIVES The purpose of this study was to determine the outcomes of TAVR in patients with ESRD. METHODS Among the first 72,631 patients with severe aortic stenosis (AS) treated with TAVR enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT (Transcatheter Valve Therapies) registry, 3,053 (4.2%) patients had ESRD and were compared with patients who were not on dialysis for demographics, risk factors, and outcomes. RESULTS Compared with the nondialysis patients, ESRD patients were younger (76 years vs. 83 years; p < 0.01) and had higher rates of comorbidities leading to a higher STS predicted risk of mortality (median 13.5% vs. 6.2%; p < 0.01). ESRD patients had a higher in-hospital mortality (5.1% vs. 3.4%; p < 0.01), although the observed to expected ratio was lower (0.32 vs. 0.44; p < 0.01). ESRD patients also had a similar rate of major vascular complications (4.5% vs. 4.6%; p = 0.86), but a higher rate of major bleeding (1.4% vs. 1.0%; p = 0.03). The 1-year mortality was significantly higher in dialysis patients (36.8% vs. 18.7%; p < 0.01). CONCLUSIONS Patients undergoing TAVR with ESRD are at higher risk and had higher in-hospital mortality and bleeding, but similar vascular complications, when compared with those who are not dialysis dependent. The 1-year survival raises concerns regarding diminished benefit in this population. TAVR should be used judiciously after full discussion of the risk-benefit ratio in patients on dialysis.
Discussion
No takes yet. Share an insight, caveat, or question.
Cite This Study
Szerlip et al. (2019) conducted an observational in Severe aortic stenosis (n=72,631). End-stage renal disease vs. Not on dialysis was evaluated on In-hospital mortality (p=< 0.01). Among patients undergoing TAVR, end-stage renal disease was associated with higher in-hospital mortality and 1-year mortality.