DWG-01-023 Rev. C - ©2021
5
11. Directions for Use
11.1. Sizing
The HAART 200 Aortic Annuloplasty Device size should be selected
based on the free-edge length of the non-fused valve leaflet. The free-
edge length is determined using the Sizers provided in the HAART 201
Instrument Set. Sizers are provided in 19, 21, 23, and 25 mm diame-
ters to correspond to the four HAART 200 Aortic Annuloplasty Device
sizes.
Correct annuloplasty device sizing is an important element of suc-
cessful valve repair. The appropriate HAART 200 Aortic Annuloplasty
Device size is selected by threading each individual Sizer onto the
Handle and inserting it behind the non-fused valve leaflet such that the
leaflet free-edge length between commissural insertions lies smoothly
along the circumference of the Sizer. The appropriate Sizer for a given
leaflet has been selected when the distance from one stippled area to
the other matches the leaflet free-edge length from one commissure
to the other (Figure 4). If the leaflet free-edge length is between two
sizes, choose the smaller of the two size options. The size number on
the corresponding Sizer indicates the appropriate Device size based
on the leaflet measured.
Figure 4. Proper sizing of leaflet free-edge length using the sizer
To confirm the device size selected with the Sizer, the distance between
the valve commisures can be measured using a valve sizer such as
a Hegar dilator. The objective of this measurement is to ensure the
diameter of the device chosen using the HAART 201 Sizers will not
cause excessive reduction of the intercommisural distance.
11.2. Handling and Preparation Instructions
Each Device is supplied mounted on a Holder and is packaged in nested,
sealed trays to ease transfer of the Device into the sterile field. Pledgets
are packaged within nested pouches. The inner pouches and sealed
trays should be inspected for damage prior to opening. Do not use the
Device if the sterile packaging has been compromised.
The Holder should be attached to the Handle contained within the
HAART 201 Instrument Set to facilitate removal of the Device from the
packaging and placement of the Device within the aortic root.
11.3. Device Implantation
Post Sutures
Insertion is begun by suturing the two posts of the Device to the two
subcommissural areas using “Cabrol-like” configurations with gener-
ous bites taken in the aortic wall, using 4-0 polypropylene horizontal
mattress sutures supported by Pledgets above the annulus (Figure 5).
Polypropylene suture is recommended for suturing the posts to facil-
itate easy tightening of the sutures and passage of the Device below
the valve.
Figure 5. Suturing technique for the
HAART 200 Aortic Annuloplasty Device Posts
2mm
Figure 6. Placing the post sutures
The post sutures are placed with the HAART 200 Aortic Annuloplasty
Device on the Holder above the valve (Figure 6). The post sutures
should be placed so that the tip of the device post will be positioned at
least 2mm below the top of the subcommissural space.
The HAART 200 Aortic Annuloplasty Device is covered with polyes-
ter fabric, which allows endothelialization. Horizontal mattress post
sutures are used primarily to correctly position the Device prior to
placement of additional looping sutures around the leaflet sections
of the Device. Only the horizontal mattress post sutures should catch
the fabric and then only just on the inside of the posts (Figure 5).
Extra fabric has been added in those areas to allow needle passage,
but only very superficial bites are required.
After the two post sutures are placed, the Device is lowered below the
native valve, and the suture attaching the Device to the Holder is cut.
The HAART 200 Aortic Annuloplasty Device must be removed gently
from the Holder, primarily by pushing the Device off the Holder near the
