Reinterventions After TAVR or SAVR for Severe Aortic Stenosis

Quick Takes

  • Reinterventions through 5 years after TAVR or SAVR were uncommon in the randomized controlled trial patients included in this analysis and while reintervention after TAVR typically occurred within the first year, reintervention after SAVR was delayed.
  • Paravalvular regurgitation was the most common indication for reintervention after TAVR and commonly treated percutaneously, whereas endocarditis was the most common indication after SAVR and often required a redo SAVR.
  • These low reintervention rates through 5 years after TAVR or SAVR will help physicians making lifetime management decisions for patients with aortic valve disease.

Study Questions:

What is the 5-year incidence of valve reintervention after self-expanding CoreValve/Evolut transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR)?

Methods:

The investigators pooled data from CoreValve and Evolut R/PRO (Medtronic) randomized trials and single-arm studies encompassed 5,925 TAVR (4,478 CoreValve and 1,447 Evolut R/PRO) and 1,832 SAVR patients. Reinterventions were categorized by indication, timing, and treatment. The cumulative incidence of reintervention was compared between TAVR versus SAVR, Evolut versus CoreValve, and Evolut versus SAVR. The cumulative incidence of reintervention with competing risk of death was reported using Fine-Gray subdistribution hazard models. Reintervention timing, indication, and resolution across all studies were summarized using descriptive characteristics (frequency and percentage).

Results:

There were 99 reinterventions (80 TAVR and 19 SAVR). The cumulative incidence of reintervention through 5 years was higher with TAVR versus SAVR (2.2% vs. 1.5%; p = 0.017), with differences observed early (≤1 year; adjusted subdistribution hazard ratio [HR], 3.50; 95% confidence interval [CI], 1.53-8.02) but not from >1 to 5 years (adjusted subdistribution HR, 1.05; 95% CI, 0.48-2.28). The most common reason for reintervention was paravalvular regurgitation after TAVR and endocarditis after SAVR. Evolut had a significantly lower incidence of reintervention than CoreValve (0.9% vs. 1.6%; p = 0.006) at 5 years with differences observed early (adjusted subdistribution HR, 0.30; 95% CI, 0.12-0.73) but not from >1 to 5 years (adjusted subdistribution HR, 0.61; 95% CI, 0.21-1.74). The 5-year incidence of reintervention was similar for Evolut versus SAVR (0.9% vs. 1.5%; p = 0.41).

Conclusions:

The authors report that a low incidence of reintervention was observed for CoreValve/Evolut R/PRO and SAVR through 5 years.

Perspective:

This pooled study reports that reinterventions through 5 years after TAVR or SAVR were uncommon in the randomized controlled trial patients included in this analysis and while reintervention after TAVR typically occurred within the first year, reintervention after SAVR was delayed. Furthermore, paravalvular regurgitation was the most common indication for reintervention after TAVR and commonly treated percutaneously, whereas endocarditis was the most common indication after SAVR and often required a redo SAVR. Of note, there were no mortalities in patients who required a surgical reintervention after index TAVR. Additional longer-term follow-up is needed to better understand reintervention after TAVR and SAVR but these low reintervention rates through 5 years after TAVR or SAVR will help physicians making lifetime management decisions for patients with aortic valve disease.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and VHD

Keywords: Cardiac Surgical Procedures, Transcatheter Aortic Valve Replacement


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