Sections

Transcatheter Aortic Valve Replacement (TAVR)

Sections Transcatheter Aortic Valve Replacement (TAVR)
Overview
Periprocedural Care
Technique
Medication
Media Gallery
Tables
References

Periprocedural Care

Patient Education and Consent

For obtaining informed consent, it is critical to appropriately inform patients and their family about the benefits and risks of the procedure so the patient is ultimately able to make a voluntary decision. A central goal in this interaction is the exchange of relevant detailed information about treatment strategies delivered in terminology that is understood by the patient and family. It is important to recognize that risk tolerance and patient expectations vary across many patient populations. Thus, a thorough review of personalized risk/benefit profile is essential for each patient undergoing transcatheter aortic valve replacement (TAVR).

Pre-Procedure Planning

Patients who are considered for TAVR should undergo the preprocedural workup below.

Echocardiography is used to confirm the severity of aortic stenosis, aortic valve anatomy, and extent of calcification and to evaluate the diameter of the aortic annulus, ascending aorta, sinus of Valsalva, the distance of the aortic valve leaflets to sinotubular junction, the presence of concomitant severe other valvular disease, and the LVEF.

CT angiography of the aortic root is used to determine the optimal image orientation for valve positioning.

Left and right cardiac catheterization is used to evaluate for concomitant coronary artery disease or pulmonary hypertension that may require treatment prior to TAVR.

CT angiography of the thoracoabdominal and iliofemoral arteries is used to evaluate the diameter, tortuosity of the vessels, and calcifications and to plan for the access site.^{[9, 27]}

Equipment

The equipment required for TAVR depends on the specific approach to the procedure and the performing center protocols.

CoreValve

The current, third-generation 18F CoreValve System has 3 components, as follows:

A self-expanding nitinol support frame with cells configured in a diamond cell design, which anchors a trileaflet porcine pericardial tissue valve
An 18F delivery catheter
A disposable loading system

Transcatheter Aortic Valve Replacement (TAVR). Medtronic CoreValve.
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Edwards-SAPIEN valve

The Edwards SAPIEN valve is a trileaflet bioprosthesis made of bovine pericardium mounted on a balloon-expandable stainless-steel stent. This system is currently available in two sizes: (1) a 23-mm valve with a stent height of 14.3 mm and (2) a 26-mm valve with a stent height of 16.1 mm.

Transcatheter Aortic Valve Replacement (TAVR). Edwards SAPIEN valve.

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Transcatheter Aortic Valve Replacement (TAVR). Sizes and heights of available Edwards SAPIEN valve systems.

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The second-generation device, Edwards SAPIEN XT, is made of a cobalt-chromium alloy, which provides the same radial strength with a reduced valve profile. This valve is currently commercially available in Europe and is approved for the TF approach. It is under investigation for the TA approach. The system will be available in 21-mm and 29-mm sizes in the future.^[27]

Retroflex balloon catheter

The retroflex balloon catheter is used for valvuloplasty of the stenotic native aortic valve prior to implantation of an Edwards SAPIEN transcatheter heart valve. The device is not intended for postdilation of deployed transcatheter heart valves.

Crimper

The crimper is used in preparing the Edwards SAPIEN transcatheter heart valve for implantation by manually and symmetrically compressing the overall diameter of the bioprosthesis from its expanded size to its minimal delivery profile. The provided cylindrical gauge is used to confirm that the collapsed profile of the valve system will feasibly move through the introducer sheath. A measuring ring is used to calibrate the balloon inflation to its desired size and to determine the amount of saline/contrast mixture in the syringe required for balloon inflation at the time of deployment.

Retroflex guiding catheter

This catheter has a deflectable tip that changes direction when activated by the rotation of an actuator incorporated in the handle. The catheter is then used to direct the valve delivery system through the arterial system, around the aortic arch, and across the aortic valve, providing a less traumatic passage. The retroflex catheter assists in centering and supporting the valve as it crosses the calcified and stenotic native valve.

The Novoflex catheter is a newer-generation catheter that allows loading of the Edwards SAPIEN XT prosthesis onto the balloon while in the body, decreasing the sheath size dramatically.

Ascendra delivery system

This delivery catheter is used for the TA approach. The catheter allows for easy manipulation of the valve to improve orientation of the bioprosthesis.

Delivery sheath

This a 25-cm–long hydrophilic-coated sheath that is advanced into the abdominal aorta to decrease vascular complications, as the bioprosthetic valve and the deflecting guide catheter are introduced into the aorta. The sheaths are equipped with a hemostatic mechanism to decrease blood loss. The TF delivery system requires a 22F and 24F sheath for the 23-mm and 26-mm valves, respectively. See Table 3.

The TA sheath is 26F, is shorter, and has a flexible tip to minimize trauma as it is introduced in to the left ventricle.^{[9, 27, 30]}

Anesthesia

Transcatheter aortic valve implantation can be performed under conscious sedation or general anesthesia. General anesthesia is preferred if TEE echocardiography is performed.

Positioning

The patient remains in the supine position during the procedure.

Testing and medications

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. After the procedure, aspirin (at least 81 mg daily) is continued indefinitely, and clopidogrel 81 mg daily is continued for 1-6 months.

Adjunctive antacids are to be considered.

Routing laboratory tests prior to the procedure include complete blood cell (CBC) count, international normalized ratio (INR), partial thromboplastin time (PTT), albumin and transaminase levels, renal function testing, and 12-lead electrocardiography (ECG). Cardiac biomarker levels (ie, CK and CK-MB) are also tested within 48 hours of the procedure.

To minimize the risk of prosthetic valve infection, prophylactic intravenous antibiotic therapy at least 1 hour before the procedure is also recommended. The authors use cefuroxime 750 mg IV 1 hour preprocedure, and the dose is repeated 6 and 12 hours after the procedure. In patients who are allergic to penicillin (or cephalosporins), vancomycin may be considered.

Monitoring & Follow-up

The patient should be observed with a temporary pacemaker in a cardiovascular ICU for up to 48 hours to monitor for any conduction system abnormalities. If no conduction system disturbances are detected, the patient is monitored for an additional 72 hours and then discharged.

The patient should continue taking aspirin 81-325 mg daily and clopidogrel 75 mg daily for at least 3 months following the procedure.

Both transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) may be used to guide the procedure and evaluate for complications, as needed.

Continuous invasive hemodynamic monitoring should be used throughout the procedure.

Operating Room

The procedure can be performed in the cardiac catheterization laboratory or in a hybrid operating room. A fixed fluoroscopy unit is required and should be capable of providing high-quality images, as well as storing the reference images. Cardiopulmonary bypass equipment should be available easily in case of complications. The room should also be equipped with supplies required to treat vascular and coronary complications.

Technique

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Zahn A, Gerckens U, Grube E, et al. Transcatheter aortic valve implantation: first results from a multicentre real-world registry. Eur Heart J. 2011. 32:198 –204. [QxMD MEDLINE Link]. [Full Text].
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Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011. 364:2187–98. [QxMD MEDLINE Link]. [Full Text].
[Guideline] Holmes DR Jr, Mack MJ, Kaul S, et al. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol. 2012 Mar 27. 59(13):1200-54. [QxMD MEDLINE Link]. [Full Text].
Roques F, Michel P, Goldstone AR, Nashef SA. The logistic EuroSCORE. Eur Heart J. 2003 May. 24(9):882-3. [QxMD MEDLINE Link].
Safety and efficacy study of the Medtronic CoreValve system in the treatment of symptomatic severe aortic stenosis in high risk and very high risk subjects who need aortic valve replacement. ClinicalTrials.gov. Available at http://clinicaltrials.gov/ct2/show/NCT01240902. Accessed: 4/22/14.
Yu PJ, Mattia A, Cassiere HA, et al. Should high risk patients with concomitant severe aortic stenosis and mitral valve disease undergo double valve surgery in the TAVR era?. J Cardiothorac Surg. 2017 Dec 29. 12 (1):123. [QxMD MEDLINE Link].
Leon MB, Piazza N, Nikolsky E, et al. Standardized endpoint definitions for Transcatheter Aortic Valve Implantation clinical trials: a consensus report from the Valve Academic Research Consortium. J Am Coll Cardiol. 2011 Jan 18. 57(3):253-69. [QxMD MEDLINE Link].
Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. May 2012. 366:1686-95. [QxMD MEDLINE Link].
Makkar RR, Fontana GP, Jilaihawi H, et al. Transcatheter aortic-valve replacement for inoperable severe aortic stenosis. N Engl J Med. May 2012. 366:1696-704. [QxMD MEDLINE Link].
Aldalati O, Kaura A, Khan H, et al. Bioprosthetic structural valve deterioration: how do TAVR and SAVR prostheses compare?. Int J Cardiol. 2018 Oct 1. 268:170-5. [QxMD MEDLINE Link].
Danielsen SO, Moons P, Sandven I, et al. Thirty-day readmissions in surgical and transcatheter aortic valve replacement: A systematic review and meta-analysis. Int J Cardiol. 2018 Oct 1. 268:85-91. [QxMD MEDLINE Link].
Rodes-Cabau J, Dumont E, Boone RH, et al. Cerebral embolism following transcatheter aortic valve implantation: comparison of transfemoral and transapical approaches. J Am Coll Cardiol. 2011. 57:18-28. [QxMD MEDLINE Link]. [Full Text].
Kahlert P, Knipp SC, Schlamann M, et al. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation. 2010. 121:870-878. [QxMD MEDLINE Link]. [Full Text].
Arnold M, Schulz-Heise S, Achenbach S, et al. Embolic cerebral insults after transapical aortic valve implantation detected by magnetic resonance imaging. J Am Coll Cardiol Intv. 2010. 3:1126-1132. [QxMD MEDLINE Link]. [Full Text].
Ghanem A, Muller A, Nahle CP, et al. Risk and fate of cerebral embolism after transfemoral aortic valve implantation: a prospective pilot study with diffusion-weighted magnetic resonance imaging. J Am Coll Cardiol. 2010. 55:1427-1432. [QxMD MEDLINE Link]. [Full Text].
Berry C, Cartier R, Bonan R. Fatal ischemic stroke related to nonpermissive peripheral artery access for percutaneous aortic valve replacement. Catheter Cardiovasc Interv. 2007. 69(1):56-63. [QxMD MEDLINE Link].
Koos R, Mahnken AH, Aktug O, et al. Electrocardiographic and imaging predictors for permanent pacemaker requirement after transcatheter aortic valve implantation. J Heart Valve Dis. 2011. 20:83-90. [QxMD MEDLINE Link].
Nuis RJ, Van Mieghem NM, Schultz CJ, et al. Timing and potential mechanisms of new conduction abnormalities during the implantation of the Medtronic CoreValve System in patients with aortic stenosis. Eur Heart J. 2011. 32:2067-2074. [QxMD MEDLINE Link].
Oestreich BA, Mbai M, Gurevich S,et al. Computed tomography (CT) assessment of the membranous septal anatomy prior to transcatheter aortic valve replacement (TAVR) with the balloon-expandable SAPIEN 3 valve. Cardiovasc Revasc Med. 2017 Dec 27. [QxMD MEDLINE Link].
Mangieri A, Lanzillo G, Bertoldi L, et al. Predictors of advanced conduction disturbances requiring a late (≥48 H) permanent pacemaker following transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2018 Aug 13. 11 (15):1519-26. [QxMD MEDLINE Link].
Cribier A, Zajarias A, Eltchaninoff H, et al. Trans-catheter aortic valve interventions: from balloon aortic valvuloplasty to trans-catheter aortic valve implantation. Topol EJ, Teirstein PS, eds. Textbook of Interventional Cardiology. 6th ed. Philadelphia, PA: Elsevier; 2011. 661-82.
Kahlert P, Al-Rashid F, Weber M, et al. Vascular access site complications after percutaneous transfemoral aortic valve implantation. Herz. 2009 Aug. 34(5):398-408. [QxMD MEDLINE Link]. [Full Text].
Hayashida K, Lefevre T, Chevalier B, et al. Transfemoral aortic valve implantation new criteria to predict vascular complications. JACC Cardiovasc Interv. 2011 Aug. 4(8):851-8. [QxMD MEDLINE Link].
Edwards transcatheter heart valves. Edwards.com. Available at https://www.edwards.com/devices/heart-valves/transcatheter. Accessed: August 13, 2018.
Indications, safety and warnings: transcatheter aortic valve replacement. CoreValve Evolut R and CoreValve Evolut Pro. Medtronic.com. Available at http://www.medtronic.com/us-en/healthcare-professionals/products/cardiovascular/heart-valves-transcatheter/indications-safety-warnings.html. Accessed: August 13, 2018.
Baim DS, ed. Grossman's Cardiac Catheterization, Angiography, and Intervention. 7th ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2006.
[Guideline] Goldstein LB, Bushnell CD, Adams RJ, et al. Guidelines for the primary prevention of stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011 Feb. 42 (2):517-84. [QxMD MEDLINE Link]. [Full Text].
Mihara H, Shibayama K, Jilaihawi H, et al. Assessment of post-procedural aortic regurgitation after TAVR: an intraprocedural TEE study. JACC Cardiovasc Imaging. 2015 Sep. 8(9):993-1003. [QxMD MEDLINE Link].
Jensen HA, Condado JF, Devireddy C, et al. Minimalist transcatheter aortic valve replacement: The new standard for surgeons and cardiologists using transfemoral access?. J Thorac Cardiovasc Surg. 2015 Oct. 150(4):833-40. [QxMD MEDLINE Link].
Liebetrau C, Gaede L, Kim WK, et al. Early changes in N-terminal pro-B-type natriuretic peptide levels after transcatheter aortic valve replacement and its impact on long-term mortality. Int J Cardiol. 2018 Aug 15. 265:40-6. [QxMD MEDLINE Link].
Schoen FJ. Cardiac valve prostheses: pathological and bioengineering considerations. J Card Surg. 1987 Mar. 2 (1):65-108. [QxMD MEDLINE Link].
Sun W, Li K, Sirois E. Simulated elliptical bioprosthetic valve deformation: implications for asymmetric transcatheter valve deployment. J Biomech. 2010 Dec 1. 43 (16):3085-90. [QxMD MEDLINE Link].
Borz B, Durand E, Tron C, et al. Expandable sheath for transfemoral transcatheter aortic valve replacement: procedural outcomes and complications. Catheter Cardiovasc Interv. 2014 May 1. 83 (6):E227-32. [QxMD MEDLINE Link].
Popma JJ, Deeb GM, Yakubov SJ, et al, for the Evolut Low Risk Trial Investigators. Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients. N Engl J Med. 2019 May 2. 380 (18):1706-15. [QxMD MEDLINE Link].
Koehler T, Buege M, Schleiting H, Seyfarth M, Tiroch K, Vorpahl M. Changes of the esheath outer dimensions used for transfemoral transcatheter aortic valve replacement. Biomed Res Int. 2015. 2015:572681. [QxMD MEDLINE Link]. [Full Text].
Mack MJ, Leon MB, Thourani VH, et al, PARTNER 3 Investigators. Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients. N Engl J Med. 2019 May 2. 380 (18):1695-705. [QxMD MEDLINE Link].
Gunning PS, Saikrishnan N, Yoganathan AP, McNamara LM. Total ellipse of the heart valve: the impact of eccentric stent distortion on the regional dynamic deformation of pericardial tissue leaflets of a transcatheter aortic valve replacement. J R Soc Interface. 2015 Dec 6. 12 (113):20150737. [QxMD MEDLINE Link]. [Full Text].
US Food and Drug Administration. LOTUS Edge Valve System - P180029 (approved April 23, 2019). Available at https://www.fda.gov/medical-devices/recently-approved-devices/lotus-edgetm-valve-system-p180029. Reviewed: May 23, 2019; Accessed: July 24, 2019.

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.