PVL is decreasing with improving sizing and devices in TAVR. I definitively have this impression from my practice. Or is it really? 1/11
2/ @VictorDayan1 showed in October that the criteria for PVL weren’t the same between PARTNER2 and PARTNER3
3/ VARC-II criteria define mild PVL as circumferential extent <10% and regurgitant volume of <30%.
academic.oup.com/ejcts/article/…
academic.oup.com/ejcts/article/…
4/ So how is this defined in PARTNER2? Well you have to work for it: not much in definitions in the supplement
5/ The P2 protocol gives us more details: mild PVL <10% circumferential extent and I don't see any regurgitant volume or fraction


6/ So how is this defined in P3? It claimed VARC-II criteria, but used the following values in the protocol:
This ins’t consistent with VARC-II:
- <10% circumferential extent
- <30% regurgitant fraction
So a moderate PVL under VARC-II would qualify as mild under P3 protocole definitions
- <10% circumferential extent
- <30% regurgitant fraction
So a moderate PVL under VARC-II would qualify as mild under P3 protocole definitions
7/ This was tweeted by @VictorDayan1 months ago. @PPibarot reassured us that this was an old version of the definitions, and that it would be quickly corrected
8/ Months later, it’s still uncorrected. @NEJM, what’s up?
9/ To compound the difficulties, the P3 appendix states another set of criteria, that still aren’t VARC-II
(had to splice these 2 together, as they were on bottom of p. 29 and top of p.30)
The regurg volume and fraction are VARC-II, but circumferential extent is <20%, not <10%.
(had to splice these 2 together, as they were on bottom of p. 29 and top of p.30)
The regurg volume and fraction are VARC-II, but circumferential extent is <20%, not <10%.
10/ So this begs the question: how was PVL actually defined in these studies?!? The definitions seem to be all over the place, and trusting the authors to have it corrected (and reflected in the record as such) hasn’t worked since October 2019
