Transcatheter Aortic Valve Replacement Outcomes in End-Stage Renal Disease Patients on Hemodialysis Requiring Midodrine

Q: What are the key findings of this study?

Midodrine use in dialysis-dependent ESRD patients undergoing TAVR was associated with significantly higher 30-day mortality compared to ESRD patients not on midodrine (20.1% vs 5.6%, p=0.001).

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), stratified by dialysis-dependent end-stage renal disease (ESRD) and midodrine use (n=7159). Intervention: Midodrine use in dialysis-dependent ESRD prior to TAVR (ESRD [+M]) vs. Dialysis-dependent ESRD patients not taking midodrine (ESRD [-M]) and non-ESRD patients. Primary outcome: 30-day mortality (p=0.001).

Q: What does this research mean for the field?

Midodrine use in dialysis-dependent end-stage renal disease (ESRD) patients undergoing transcatheter aortic valve replacement (TAVR) is associated with significantly higher 30-day mortality compared to ESRD patients not on midodrine. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

Ethan C Korngold; Ruyun Jin; Kateri J. Spinelli; Vishesh Kumar; Brydan D. Curtis; Sameer Gafoor; Derek Phan; Daniel B. Spoon; Aidan A. Raney; Lisa A. McCabe; Brandon Jones

doi:10.1016/j.shj.2023.100163

March 3, 2023Structural HeartOpen Access

Transcatheter Aortic Valve Replacement Outcomes in End-Stage Renal Disease Patients on Hemodialysis Requiring Midodrine

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Key result

Midodrine in dialysis patients undergoing TAVR is linked to ~3.6-fold higher 30-day mortality.

P=0.001
n=7,159

Figures

Why the study?

Dialysis-dependent ESRD patients taking midodrine may be at high risk for poor outcomes following TAVR.

Does pre-procedural midodrine use increase 30-day and 1-year mortality in dialysis-dependent end-stage renal disease patients undergoing transcatheter aortic valve replacement?

Key Points

To evaluate procedural and survival outcomes after transcatheter aortic valve replacement (TAVR) in dialysis-dependent end-stage renal disease (ESRD) patients receiving midodrine.
Retrospective analysis of non-clinical trial TAVR patients (N=7159) treated between February 2012 and December 2020 across 11 facilities in a Western US health system.
Patients were stratified into ESRD on midodrine before TAVR (ESRD [+M], n=45), ESRD without midodrine (ESRD [-M], n=216), and non-ESRD (n=6898).
Thirty-day and 1-year mortality endpoints were estimated using Kaplan-Meier survival curves and compared via log-rank tests.
Thirty-day mortality was significantly higher in ESRD (+M) patients (20.1% [95% CI = 11.0%-35.1%]) than in ESRD (-M) patients (5.6% [3.2%-9.6%], p = 0.001) and non-ESRD patients (2.5% [2.2%-2.9%], p < 0.001).
At 1 year, mortality was 41.9% [28.7%-58.1%] for ESRD (+M) versus 29.8% [24.1%-36.5%] for ESRD (-M) (p = 0.070), and was significantly higher than non-ESRD patients (10.7% [10.0%-11.5%], p < 0.001).
ESRD (+M) patients had higher 30-day stroke rates (6.7% vs. 1.4%, p = 0.033) and major vascular complications (6.7% vs. 0.9%, p = 0.011) compared to ESRD (-M) patients.

Study Design

Type

Cohort (n=7,159)

Multicenter

Yes

Structured PICO

Does pre-procedural midodrine use increase 30-day and 1-year mortality in dialysis-dependent end-stage renal disease patients undergoing transcatheter aortic valve replacement?

P

Population

7,159 non-clinical trial TAVR patients (median age 81.7 years, 44.5% female), including 45 dialysis-dependent ESRD patients on midodrine, 216 ESRD patients not on midodrine, and 6,898 non-ESRD patients, followed for up to 1 year across 11 US facilities.

E

Exposure

Pre-procedural oral midodrine therapy in dialysis-dependent ESRD patients undergoing TAVR (ESRD [+M], n=45)

C

Comparator

Dialysis-dependent ESRD patients not taking midodrine (ESRD [-M], n=216) and non-dialysis-dependent patients (non-ESRD, n=6,898) undergoing TAVR

O

Outcome

30-day and 1-year mortality represented by Kaplan-Meier survival estimatorhard clinical

Main Result

Absolute Event Rate: 20.1% vs 5.6%

p-value: p=0.001

Dialysis-dependent ESRD patients requiring midodrine have a 20.1% 30-day and 41.9% 1-year mortality rate following TAVR despite similar STS risk scores to ESRD patients not on midodrine, identifying midodrine requirement as a critical marker of extreme post-TAVR risk.

Limitations

Retrospective design
Small sample size for the ESRD subgroups
Inability to examine risk-adjusted or propensity-matched outcomes due to small sample size and low event rates
Did not stratify non-ESRD patients for midodrine status, so some non-ESRD patients may have been on midodrine
Missing data for 1-year survival status in approximately 12% of patients
Inability to examine risk-adjusted or propensity-matched outcomes for the ESRD groups due to small sample size and low event rates
Did not stratify non-ESRD patients for midodrine status

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Implication

May flag extreme post-TAVR risk in dialysis-dependent ESRD; leaves open whether midodrine drives mortality or marks unmeasured frailty.

Abstract

Background: Patients with dialysis-dependent end-stage renal disease (ESRD) taking midodrine may be at high risk for poor outcomes following transcatheter aortic valve replacement (TAVR). We evaluated dialysis-dependent ESRD patients taking midodrine. Methods: We conducted a retrospective analysis of non-clinical trial TAVR patients from February 2012 to December 2020 from 11 facilities in a Western US health system. Patient groups included ESRD patients on midodrine before TAVR (ESRD [+M]), ESRD patients without midodrine (ESRD [-M]), and non-ESRD patients. The endpoints of 30-day and 1-year mortality were represented by Kaplan-Meier survival estimator and compared by log-rank test. In contrast, ESRD (-M) patients had no significant differences from non-ESRD patients for these outcomes. Conclusions: Our experience suggests ESRD patients on midodrine are a higher acuity population with worse survival after TAVR, compared to ESRD patients not on midodrine. These findings may help with risk stratification for ESRD patients undergoing TAVR.

Discussion

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Cite This Study

Korngold et al. (2023) conducted a cohort in Aortic stenosis undergoing transcatheter aortic valve replacement (TAVR), stratified by dialysis-dependent end-stage renal disease (ESRD) and midodrine use (n=7,159). Midodrine use in dialysis-dependent ESRD prior to TAVR (ESRD [+M]) vs. Dialysis-dependent ESRD patients not taking midodrine (ESRD [-M]) and non-ESRD patients was evaluated on 30-day mortality (p=0.001). Midodrine use in dialysis-dependent ESRD patients undergoing TAVR was associated with significantly higher 30-day mortality compared to ESRD patients not on midodrine (20.1% vs 5.6%, p=0.001).

synapsesocial.com/papers/6a789a720c6965f1a01f52f2 https://doi.org/10.1016/j.shj.2023.100163

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Transcatheter Aortic Valve Replacement Outcomes in End-Stage Renal Disease Patients on Hemodialysis Requiring Midodrine

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Transcatheter Aortic Valve Replacement Outcomes in End-Stage Renal Disease Patients on Hemodialysis Requiring Midodrine

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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