Transcatheter Aortic Valve Implantation (TAVI) for Native Aortic Valve Regurgitation　― A Systematic Review ―

Abstract

Background: Transcatheter aortic valve implantation (TAVI) has become the standard of care for management of high-risk patients with aortic stenosis. Limited data is available regarding the performance of TAVI in patients with native aortic valve regurgitation (NAVR). Methods and Results:We performed a systematic review from 2002 to 2016. The primary outcome was device success as per VARC-2 criteria. Secondary endpoints included procedural complications, and 30-day and 1-year mortality rates. A total of 175 patients were included from 31 studies. Device success was reported in 86.3% of patients -with device failure driven by moderate aortic regurgitation (AR ≥3+) and/or need for a second device. Procedural complications were rare, with no procedural deaths, myocardial infarctions or annular ruptures reported. Procedural safety was acceptable with a low 30-day incidence of stroke (1.5%). The 30-day and 1-year overall mortality rates were 9.6% and 20.0% (cardiovascular death, 3.8% and 10.1%, respectively). Patients receiving 2nd-generation valves demonstrated similar safety profiles with greater device success compared with 1st-generation valves (96.2% vs. 78.4%). This was driven by the higher incidence of second-valve implantation (23.4% vs. 1.7%) and significant paravalvular leak (8.3% vs. 0.0%).Conclusions: TAVI demonstrates acceptable safety and efficacy in high-risk patients with severe NAVR. Second-generation valves may afford a similar safety profile with improved device success. Dedicated studies are needed to definitively establish the efficacy of TAVI in this population.

Nationwide outcomes of aortic valve replacement for pure aortic regurgitation in Germany 2008–2015

“…Previous smaller case series assume improved outcomes of TAVR with second generation valve systems in patients with pure AR . The device success was between 74 and100%, with a 30‐days all‐cause mortality of 7%, which is in the range of the mortality in our study .…”

“…Previous smaller case series assume improved outcomes of TAVR with second generation valve systems in patients with pure AR. 16 The device success was between 74 and100%, with a 30-days all-cause mortality of 7%, which is in the range of the mortality in our study. 17 Since 2015, second-generation valve systems were widely used, which could explain the better outcomes over the recent years 32 besides improved patient selection and learning curves.…”

“…Therefore, only case series with high‐risk patients and smaller retrospective studies describing the use of TAVR in AR exist, but randomized controlled trials are still missing . Those small studies reported a device success of nearly 90% with a 1‐year mortality of 20%, a value comparable to the 1‐year mortality rate in the high risk collective of the PARTNER I trial …”

Transcatheter Aortic Valve Implantation Current Indications and Future Directions

“…However, in selected patients with AR, TAVR provides an effective treatment option. According to a systemic review encompassing 175 high-risk patients with native AR, TAVR particularly using second-generation devices, was associated with excellent clinical outcomes and device success (36). Furthermore, the STS/ACC TVT Registry suggests that highly selected patients with AR considered inappropriate candidates for surgery, do benefit from a TAVR procedure with second generation devices (37).…”

Exercise Training for Patients With Severe Aortic Stenosis in a Convalescent Rehabilitation Ward ― A Retrospective Cohort Study ―

“…1 There have been considerable advances in treatments for AS, including transcatheter aortic valve implantation (TAVI), which was recently introduced for patients who cannot undergo surgical aortic valve replacement (SAVR). 2 With regard to mortality, SAVR and TAVI result in good outcomes among older patients. 3 In contrast, some patients with AS are inoperable because of their clinical status or comorbidities, 1 and up to 40% of patients with severe AS still do not undergo SAVR or TAVI.…”