April 1, 2016
View Full PaperImpact of chronic kidney disease on outcomes after percutaneous mitral valve repair with the MitraClip system: insights from the GRASP registry
Key Result
Baseline chronic kidney disease was associated with lower 12-month freedom from death, MV surgery, or grade ≥3+ MR post-PMVR compared to no-CKD (65.8% vs 84.2%; adjusted HR 2.48, 95% CI 1.29-4.79).
Study Design
Type
Cohort (n=214)
Structured PICO
Does baseline chronic kidney disease worsen clinical outcomes in patients undergoing percutaneous edge-to-edge mitral valve repair?
P
Population
214 consecutive patients undergoing percutaneous edge-to-edge mitral valve repair, followed for up to 12 months.
E
Exposure
Percutaneous edge-to-edge mitral valve repair (PMVR) with the MitraClip system
C
Comparator
Patients without baseline chronic kidney disease (no-CKD)
O
Outcome
Primary safety endpoint: incidence of major adverse events; Primary efficacy endpoint: freedom from death, surgery for MV dysfunction, or grade ≥3+ MR at 12-month follow-upcomposite
Baseline chronic kidney disease is associated with worse safety and efficacy outcomes, including higher rates of death, surgery, or severe MR, at 12 months following percutaneous mitral valve repair.
Main Result
Hazard Ratio: 2.48 (95% CI 1.29–4.79)
Absolute Event Rate: 65.8% vs 84.2%
p-value: p=0.006
Abstract
AIMS: Our aim was to evaluate the impact of baseline chronic kidney disease (CKD) on clinical outcomes after percutaneous edge-to-edge mitral valve repair (PMVR). METHODS AND RESULTS: Two hundred and fourteen consecutive patients dichotomised by the presence of baseline CKD (n=113) or no-CKD (n=101) had their clinical outcomes compared up to 12-month follow-up. The primary safety endpoint was the incidence of major adverse events and the primary efficacy endpoint was freedom from death, surgery for MV dysfunction, or grade ≥3+ MR. The primary safety endpoint was demonstrated in 12.4% vs. 2.0% in CKD and no-CKD patients, respectively (p=0.003). The primary efficacy endpoint at 12 months was significantly lower in CKD patients (65.8% vs. 84.2%, respectively, log-rank p=0.005). While MR reduction and NYHA functional class improvement were mostly sustained and equivalent up to 12 months in no-CKD patients, they were impaired in CKD patients. Baseline CKD was an independent predictor of the primary efficacy endpoint (adjusted HR 2.48, 95% CI: 1.29 to 4.79, p=0.006) and calcified leaflet predicted grade ≥3+ MR at 12 months (adjusted HR 6.56, 95% CI: 2.71 to 15.88, p<0.001). CONCLUSIONS: CKD patients had worse clinical outcomes compared with no-CKD patients post PMVR. CKD was an independent predictor of the primary efficacy endpoint, whereas calcified leaflet was an independent predictor of grade ≥3+ MR at 12 months.