PARTNER Exclusion #23 – Bulky calcified aortic valve leaflets in close proximity to coronary ostia

In prior posts I have argued in support of the clinical need for the AVBG procedure because transcatheter heart valves, even if proven safe and effective, will have significant limitations with regard to broad clinical use.  The recently published Partner Study evaluating the Sapien transcatheter valve in non-operable patients seems to support my argument.  The study lists 23 exclusion criteria limiting the use of the Sapien valve.  In  past posts I have discussed in some detail two of the major exclusion criteria.

Exclusion Criterion # 2 – Aortic valve was a congenital unicuspid or congenital bicuspid valve, or was non-calcified.

(I posted that bicuspid valves are present in 40% of surgical valve patients over the age of 70)

Exclusion Criterion # 7 – Untreated clinically significant coronary artery disease requiring revascularization

(I posted  that CAD is present in 65% of surgical valve patients over the age of 70)

After the PARTNER study was published, I reviewed the entire list of exclusion criteria published in the paper supplement.   I noticed an additional exclusion criterion was added that was not included in the original protocol :

Exclusion Criterion #23 – Bulky calcified aortic valve leaflets in close proximity to coronary ostia.

Bulky Leaflet

I did a little research on “bulky leaflets” and found a good paper by Dr. Masson and colleagues describing a transcatheter patient who had this type of calcific leaflet.   The authors report that when the Sapien valve was expanded into place the “bulky leaflet” was pushed up and positioned in front of the entrance to the coronary artery causing a deadly limitation in the amount of blood flowing to the heart muscle.

It is unclear how many potential transcatheter patients present with a bulky calcified leaflet.  There is no data in the PARTNER study results stating how many patients were excluded for this or any other condition.  All we know is that in aggregate, only 35 % of the patients that cardiologists and surgeons nominated  (1,079 of 3,105) were included in the study.

My point is, with 23 exclusion criteria it is not unreasonable to expect that the majority of  patients presenting with severe aortic stenosis needing an off pump/beating heart procedure will not qualify for a transcatheter implant.   For these patients, an alternative less “excluding” less invasive procedure will be needed.

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