Impact of paravalvular leak following transcatheter aortic valve replacement on one-year mortality: analysis of the combined PARTNER cohorts
Key result
Moderate/severe PVL post-TAVR linked to ~258% higher one-year mortality versus none or trace.
- HR 3.58
- 95% CI 2.42-5.29
- P<0.0001
- n=2,270
Why the study?
The study was conducted to examine the severity of paravalvular leak and its association with 1-year mortality and other outcomes after TAVR with the Edwards Sapien valve in the combined PARTNER cohorts.
Does mild or moderate/severe paravalvular leak increase one-year mortality in patients undergoing TAVR compared to none/trace leak?
Population
2270 TAVR patients with discharge or 7-day echocardiograms in the PARTNER trial
Comparison
Paravalvular leak graded as none/trace vs mild vs moderate or severe
Design
Cohort analysis of randomized and non-randomized trial cohorts
Follow-up
≥ 1yr
Authors
Discussion
Loading...
Member takes
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
CRCraig R. SmithChief of Surgery, NewYork-Presbyterian/Columbia
“One of the unanswered questions is: How important is that? We know now from this report that in medium-risk patients, at 2 years, there was indeed significantly more paravalvular regurgitation with TAVR valves than surgery, but in only 8% was it moderate or greater. Most was mild or trace. Compared with previous experiences reported with a balloon-expandable valve, this is an improvement in the rate of paravalvular regurgitation. If you are in the 8% that is moderate or severe [paravalvular regurgitation], there is indeed impact on mortality, but in the mild group, it no longer appears to affect mortality, at least in this cohort.”
DKDharam KumbhaniCardiologist, UT Southwestern Medical Center
“When this trial was ongoing, we didn't have an appreciation that leaving these patients with paravalvular leaks, large leaks, was actually going to be bad for them. That's what we've learned actually from the PARTNER trials, that leaving them with a lot of leaks is a bad thing.”
“We have to be vigilant in not having moderate-to-severe PVR and if... for whatever reason we leave moderate-to-severe [PVR], we have to do other adjunctive therapies to decrease that. We've already shown that that'll be beneficial.”
Implication
Mild PVL post-TAVR may warrant closer surveillance; leaves open whether mitigation improves survival in prospective trials.
Key Points
- This research aims to investigate the effect of paravalvular leak (PVL) severity on one-year mortality after TAVR using the Edwards Sapien valve.
- Analyzed 2553 patients from the PARTNER trial, focusing on those with discharge or 7-day echos (N=2270) for PVL grading.
- PVL was graded as none/trace, mild, or moderate/severe based on semi-quantitative criteria; clinical events were adjudicated by CEC.
- Evaluated the impact of PVL on mortality using a Cox proportional hazards model.
- At one year, all-cause mortality was 14.1% (none/trace), 22.1% (mild), and 34.1% (mod/sev), with significant differences (p<0.0001).
- Cardiac mortality followed a similar pattern: 5.1% (none/trace), 7.4% (mild), and 18.2% (mod/sev), also significant (p<0.0001).
- The presence of moderate/severe PVL (HR 3.58, 95% CI [2.42, 5.29], p<0.0001) was linked to increased late mortality.
Study Design
Type
Cohort (n=2,270)
Multicenter
Yes
Structured PICO
Does mild or moderate/severe paravalvular leak increase one-year mortality in patients undergoing TAVR compared to none/trace leak?
P
Population
2,270 patients who underwent TAVR in the PARTNER trial with available discharge or 7-day echocardiograms, followed for at least 1 year.
E
Exposure
Mild or moderate/severe paravalvular leak (PVL) following TAVR
C
Comparator
None/trace paravalvular leak (PVL)
O
Outcome
One-year all-cause mortalityhard clinical
Main Result
Hazard Ratio: 3.58 (95% CI 2.42–5.29)
Absolute Event Rate: 34.1% vs 14.1%
p-value: p=<0.0001
Even mild paravalvular leak following TAVR is associated with a significantly increased risk of one-year all-cause and cardiac mortality.
Cite This Study
Kodali et al. (2013) conducted a cohort in Paravalvular leak following transcatheter aortic valve replacement (n=2,270). Moderate/severe paravalvular leak vs. None/trace paravalvular leak was evaluated on One-year all-cause mortality (HR 3.58, 95% CI 2.42-5.29, p=<0.0001). Following TAVR, moderate/severe (HR 3.58; 95% CI 2.42-5.29) and mild paravalvular leak (HR 1.75; 95% CI 1.28-2.39) were associated with increased one-year all-cause mortality compared to none/trace.