Outcomes with post-dilation following transcatheter aortic valve replacement: the PARTNER I trial (placement of aortic transcatheter valve)
Selected in JACC: Cardiovascular Interventions by A. Al-Riyami
R.T. Hahn, P. Pibarot, J. Webb, J. Rodes-Cabau, H. C. Herrmann, M.Williams, R. Makkar, W. Y. Szeto, M. L. Main, V. H. Thourani, E. Murat Tuzcu, S. Kapadia, J. Akin, T. McAndrew, K. Xu, M. B. Leon, S. K. Kodali
J Am Coll Cardiol Intv. 2014;7(7):781-789
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What we know
Several studies have showed an association between post-procedural paravalvular regurgitation (PVR) in Transcatheter Aortic Valve Implantation (TAVI) and increased late mortality. Post-Dilatation (PD) of the implanted valve can reduce the incidence of PVR, and is practiced by many operators. PD, however, has its own set of risks and complications. Whether PD of implanted valves with PVR is beneficial or harmful is not clear.
- PARTNER I trial patients of Cohort A (High risk, n=304) and cohort B (Inoperable, n=194), and nonrandomized continued access TAVI (n=1,637) were evaluated
- PD was performed at the discretion of the operator when PVR was deemed qualitatively more than mild immediately after TAVI, using either the same volume or with an additional 0.5 to 2mL in the inflation syringe.
- PD was performed in 12% of the patients (261 of 2,123); 15% in Cohort A, 7.6% in Cohort B and 12.4% in the nonrandomized continued access patients.
- More PD patients were male, smokers, with CAD, post-CABG, had pulmonary HTN and major arrhythmias compared with those not undergoing PD (NoPD).
- On echo, PD patients had larger LV dimensions and volumes, greater LV mass, worse LV function, larger annular diameters, and larger aortic root diameters.
- Following the procedure the ejection fraction was not significantly different at 1 year (56.7 vs. 55.9, p=0.28) and 2 years (56.0 vs 55.8, p=0.90).
- The PD group had larger effective orifice area (EOA) than did the NoPD group (p<0.001)
- PVR at discharge or 7 days was more in the PD group (p<0.0001): none/trace, 38.7% versus 54.9%; mild, 49.2% versus 36.8%; moderate/severe, 12.1% versus 8.2%.
- There was no difference in in-hospital death between the two groups.
- There was a trend towards higher in-hospital stroke in the PD group (4.9% vs 2.9%, p=0.08).
- There was no difference in the 30-day and 6 months rates of death, CV death, stroke or repeat hospitalization between the two groups.
- At 1 year, there was a trend towards higher rates of death in the PD group compared with the NoPD group (25.4% vs 20.3%, p=0.054)
It is very difficult to derive any hard conclusions from this study. The two populations at baseline are somewhat heterogeneous, although there was no difference in the STS or EuroScores between the two groups. The PD procedure might have reduced paravalvular regurgitation (PVR) but did not abolish it completely. The presence of PVR in the PD group resulted in higher overall death at 1 year, which is inline with previously published data. Whether the outcome would have been worse if PD was not performed cannot be answered by this study. It is clear, however, that PD resulted in acute cerebral events (<7 days) but did not contribute to stroke or death at 30-days or at 1 year.
The results of this study are somewhat comforting in that PD is reasonably safe and might help to reduce long-term mortality from residual PVR in TAVI patients.