Medication Summary

The objectives of pharmacotherapy are to prepare the patient for the procedure, to prevent complications, and reduce morbidity.

Class Summary

It inhibits prostaglandin synthesis, which prevents the formation of platelet-aggregating thromboxane A2.

Clopidogrel (Plavix)

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Clopidogrel selectively inhibits adenosine diphosphate (ADP) binding to platelet receptors and subsequent ADP-mediated activation of the glycoprotein (GP) IIb/IIIa complex, thereby inhibiting platelet aggregation. Antiplatelet therapy with aspirin (162-325 mg) and clopidogrel (300 mg) is started at least 24 hours prior to transcatheter aortic valve implantation.

Aspirin (Bayer Aspirin, Ascriptin Maximum Strength, Ecotrin, Bufferin)

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Patients are pretreated with aspirin (81-325 mg) daily and clopidogrel 300-mg loading dose at least one hour prior to the procedure and continued at 81-mg oral daily dose. Antiplatelet therapy with aspirin (162-325 mg) and clopidogrel (300 mg) is started at least 24 hours prior to transcatheter aortic valve implantation.

Class Summary

Prophylactic intravenous antibiotic therapy at least 1 hour before the procedure is also recommended.

Cefuroxime (Ceftin, Zinacef)

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Cefuroxime is a second-generation cephalosporin that maintains the gram-positive activity of first-generation cephalosporins; it adds activity against Proteus mirabilis, Haemophilus influenzae, E coli, Klebsiella pneumoniae, and Moraxella catarrhalis.

The dose is repeated 6 and 12 hours after the procedure. In patients who are allergic to penicillin (or cephalosporins), vancomycin may be considered.

Vancomycin

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This is a potent antibiotic that is directed against gram-positive organisms and is active against enterococcal species. Vancomycin is used in conjunction with for prophylaxis in penicillin-allergic patients. Dose adjustment may be necessary in patients with renal impairment.

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Media Gallery

Transcatheter Aortic Valve Replacement (TAVR). Medtronic CoreValve.
Transcatheter Aortic Valve Replacement (TAVR). Edwards SAPIEN valve.
Transcatheter Aortic Valve Replacement (TAVR). Sizes and heights of available Edwards SAPIEN valve systems.
Transcatheter Aortic Valve Replacement (TAVR). Edwards SAPIEN valve: transfemoral and transapical approaches.
Transcatheter Aortic Valve Replacement (TAVR). Simultaneous left ventricular (LV) and ascending aortic pressure tracings before and after TAVR. LVEDP = LV end diastolic pressure; MG = mean gradient.
Transcatheter Aortic Valve Replacement (TAVR). Echocardiographic two-dimensional image of the Medtronic CoreValve in the parasternal long-axis view with color Doppler ultrasonography.
Transcatheter Aortic Valve Replacement (TAVR). Echocardiographic two-dimensional image of the Medtronic CoreValve in the parasternal short-axis view, with and without color Doppler ultrasonography.

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Table 1. Evolut Platform Clinical Trial Results

Study	N	Age (y)	STS Score	30-Day Mortality	1-Year Mortality	30-Day All Stroke	1-Year All Stroke
CoreValve US Pivotal Extreme-Risk Trial	483	83.2 ± 8.7	10.3 ± 5.5	8.4%	24.3%	4.0%	7.0%
Corevalve US Pivotal High-Risk Trial	390	83.1 ± 7.1	7.3 ± 3.0	3.3%	14.2%	4.9%	8.8%
Evolut R US Pivotal Trial	241	83.3 ± 7.2	7.4 ± 3.4	2.5%	8.6%	5.0%	7.7%
Evolut Forward Study	1040	81.8 ± 6.2	5.5 ± 4.5	1.9%	8.9%	2.8%	3.4%
SURTAVI Clinical Trial	864	79.9 ± 6.2	4.4 ± 1.5	2.0%	7.0%	2.6%	5.5%
SURTAVI Continued Access Study	274	79.0 ± 6.1	4.1 ± 4.5	0.0%	3.5%	1.8%	4.5%
Evolut PRO Trial	60	83.3 ± 7.2	6.4 ± 3.9	1.7%	11.8%	1.7%	NA
TVT-Registry- Evolut PRO	2065	81.3 ± 7.7	6.7 ± 4.4	1.4%	NA	2.6%	NA
Evolut Low Risk Trial	725	74.1 ± 5.8	1.9 ± 0.7	0.5%	2.4%	3.4%	4.1%
STS = Society of Thoracic Surgeons.

Table 2. Evolut TAVR Profile Sizing Information

	Medtronic Evolut R TAV 23/26/29	Medtronic Evolut PRO TAV 23/26/29 Evolut R TAV 34
Minimum Vessel Indication	≥ 5.0 mm	≥ 5.5 mm
System Classification	14Fr Equivalent	16Fr Equivalent
Delivered Size	6.0 mm	6.7 mm
Fully Expanded	6.0 mm	6.7 mm
TAV = transcatheter aortic valve.

Table 3: Sapien TAVR Profile Sizing Information

	Edwards *Sapien^ 3 20/23 TAVs**	Edwards Sapien 329 TAV
Minimum Vessel Indication	≥5.5 mm	≥6.0 mm
System Classification	14Fr e-sheath	16Fr e-sheath
Delivered Size	5.8 mm	6.5 mm
Fully Expanded	7.6 mm*^†	8.2 mm*^†
* = . ^† = . TAV = transcatheter aortic valve.

Table 4. Sapien Platform Clinical Trial Results

Study	N	Age (y)	STS Score	30-Day Mortality	1-Year Mortality	30-Day All Stroke	1-Year All Stroke
PARTNER IA	348	83.6 ± 6.8	11.8 ± 3.3	3.4%	24.2%	4.7%	6.0%
PARTNER IB	179	83.1 ± 8.6	11.2 ± 5.8	5.0%	30.7%	6.7%	10.0%
PARTNER IIA	1011	81.5 ± 6.7	5.8 ± 2.1	3.9%	12.3%	5.5%	8.0%
PARTNER IIB Sapien	276	84.6 ± 8.6	11.0 ± 5.71	5.1%	23.3%	4.8%	6.6%
PARTNER IIB Sapien XT	284	84.1 ± 8.7	10.29 ± 5.38	3.5%	22.3%	4.3%	6.7%
PARTNER S3 High/Inoperable	583	82.7 ± 8.1	8.7 ± 3.7	2.2%	14.4%	1.4%	4.3%
PARTNER S3i	1078	81.9 ± 6.6	5.3+ 1.3	1.1%	7.4%	2.7%	4.6%
Source 3 TF	1694	81.7 ± 6.7	NA	1.9%	11.8%	1.2%	2.7%
TVT-Registry-Sapien 3	2691	73 ± 11	5.1 ± 4.2	2.5%	14.4%	1.6%	3.7%
PARTNER 3	496	73.3 ± 5.8	1.9 ± 0.7	0.4%	1.0%	0.6%	1.2%
NA = not available; STS = Society of Thoracic Surgeons.

Table 5. Lotus Platform Clinical Trial Results

Study	N	Age (y)	STS Score	30-Day Mortality	1-Year Mortality	30-Day All Stroke	1-Year All Stroke
Reprise II CE	120	84.4 ± 5.3	7.1 ± 4.6	4.2%	10.9%	5.9%	9.2%
Reprise II Extended	250	84.0 ± 5.2	6.5 ± 4.2	4.0%	11.6%	6.8%	8.4%
Reprise III - Lotus	607	82.8	6.7	2.5%	11.9%	4.8%	7.0%
RESPOND Study	1014	80.8 ± 6.5	6.0 ± 6.9	2.6%	12.0%	3.0%	4.9%
STS = Society of Thoracic Surgeons.

Table 2. Minimum Required Arterial Access Diameter for Transcatheter Aortic Valve Replacement (TAVR)

Valve Size	Sheath Size	Minimal Arterial Diameter, mm
CoreValve
23 mm	18F	6
26 mm	18F	6
29 mm	18F	6
31 mm	18F	6
Edwards SAPIEN
23 mm	22F	7
26 mm	24F	8
Edwards-SAPEIN XT
23 mm	18F	6
26 mm	19F	6.5

Table 3. Summary of Approved Sizes for CoreValve

Valve Size, mm	Aortic Annulus Diameter, mm	*Ascending Aorta Diameter, mm**	Sinus of Valsalva Diameter, mm	Native Leaflet to Sinotubular Junction Length, mm
23	18-20	≤34	≥25	≥15
26	20-23	≤40	≥27	≥15
29	23-27	≤43	≥29	≥15
31	26-29	≤43	≥29	≥15
*Ascending aorta measurements are taken at 30 mm from the aortic annulus for the 23-mm device and at 40 mm from the aortic annulus for the 26-, 29-, and 31-mm devices.