New Model for the Assessment of Transcatheter Aortic Valve Replacement Devices in Sheep

Figures & data

Table 1. Experimental design and data collection events.

		Study events
Group	N	Surgical procedure	14 days post-MAA	60 days post-MAA	30, 60, 90, 120 days post-TAVR insertion	140 days post-TAVR insertion
Control	7	MAA	TTE	TTE Necropsy	NA	NA
Test	5	MAA	TTE	TTE TAVR insertion	TTE	TTE Necropsy

* MAA = modified aortic annuloplasty, TTE = transthoracic echocardiogram, NA = not applicable.

Figure 1. Photograph of the annuloplasty ring used in the modified aortic annuloplasty procedure.

Figure 2. Figure 2A presents an illustration of how the annuloplasty ring sections are sewn to the aortic annulus. Figure 2B is a photograph of the newly created modified aortic annulus immediately after implant, as viewed from the left ventricle outflow tract.

Table 2. Transthoracic echo data at 14 and 60 days post-MAA collected on Test and Control group animals.

	14 days		60 days
Group	Maximum Systolic LV-Ao Gradient (mmHg)	Mean Systolic LV-Ao Gradient (mmHg)	Maximum Systolic LV-Ao Gradient (mmHg)	Mean Systolic LV-Ao Gradient (mmHg)
Test (n = 5)	23.4 ± 8.6	12.6 ± 3.7	14.1 ± 6.5	7.3 ± 3.3
Control (n = 7)	17.2 ± 7.3	9.2 ± 3.8	13.7 ± 6.5	7.6 ± 3.3
Test vs. Control P Value	0.12	0.08	0.46	0.46

* LV = left ventricle; Ao = aorta.

Figure 3. Photograph of annuloplasty ring segments healed into the aortic annulus in a Control group animal at 60-day gross exam. Note the fibrous appearance of the ring segments and the circumferential scarring of the left ventricle outflow tract and aortic annulus.

Figure 4. Fluoroscopic images obtained during TAVR device deployment. Figure 4A presents an angiogram collected prior to TAVR insertion. Note the modified aortic annulus (white arrow) with aortic insufficiency present (arrow head). Figure 4B presents a post-insertion angiogram with the TAVR device seated within the modified aortic annulus (white arrow). Note that aortic insufficiency is no longer present (arrow head) following TAVR insertion.

Figure 5. Photograph of the TAVR device healed into the modified annulus in a Test group animal at 140 day gross examination.

Data availability statement

The data that support the findings of this study are available from the corresponding author, JPC, upon reasonable request.