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Transcatheter Aortic Valve Replacement (TAVR)

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

Medication

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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Piazza N, Grube E, Gerckens U, et al. Procedural and 30-day outcomes following transcatheter aortic valve implantation using the third generation (18F) CoreValve revalving system: results from the multicentre, expanded evaluation registry 1-year following CE mark approval. EuroIntervention. 2008. 4:242–9. [Medline].
Tamburino C, Capodanno D, Ramondo A, et al. Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis. Circulation. 2011. 123:299 –308. [Medline]. [Full Text].
Eltchaninoff H, Prat A, Gilard M, et al. Transcatheter aortic valve implantation: early results of the FRANCE (French Aortic National CoreValve and Edwards) registry. Eur Heart J. 2011. 32:191–7. [Medline]. [Full Text].
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. [Medline]. [Full Text].
Leon MB, Smith CR, Mack M, et al, for the PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21. 363(17):1597-607. [Medline].
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. [Medline]. [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. [Medline]. [Full Text].
Roques F, Michel P, Goldstone AR, Nashef SA. The logistic EuroSCORE. Eur Heart J. 2003 May. 24(9):882-3. [Medline].
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. [Medline].
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. [Medline].
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. [Medline].
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. [Medline].
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. [Medline].
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. [Medline].
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. [Medline]. [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. [Medline]. [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. [Medline]. [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. [Medline]. [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. [Medline].
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. [Medline].
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. [Medline].
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. [Medline].
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. [Medline].
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. [Medline]. [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. [Medline].
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. [Medline]. [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. [Medline].
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. [Medline].
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. [Medline].
Schoen FJ. Cardiac valve prostheses: pathological and bioengineering considerations. J Card Surg. 1987 Mar. 2 (1):65-108. [Medline].
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. [Medline].
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. [Medline].
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. [Medline].
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. [Medline]. [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. [Medline].
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. [Medline]. [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.

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Author

Deepak R Talreja, MD, FACC, FSCAI Cardiovascular Associates

Deepak R Talreja, MD, FACC, FSCAI is a member of the following medical societies: Alpha Omega Alpha, American College of Cardiology, American College of Physician Executives, American College of Physicians, Phi Beta Kappa, Society for Cardiac Angiography and Interventions

Disclosure: Serve(d) as a speaker or a member of a speakers bureau for: Medtronic, Edwards, BI, Pfizer, Janssen, Lilly.

Chief Editor

Eric H Yang, MD Associate Professor of Medicine, Director of Cardiac Catherization Laboratory and Interventional Cardiology, Mayo Clinic ArizonA

Eric H Yang, MD is a member of the following medical societies: Alpha Omega Alpha

Disclosure: Nothing to disclose.

Additional Contributors

Ramin Assadi, MD Assistant Professor of Medicine, Division of Interventional Cardiology, University of California, Los Angeles, David Geffen School of Medicine

Ramin Assadi, MD is a member of the following medical societies: American College of Cardiology, American College of Physicians, American Medical Association, Society for Cardiovascular Angiography and Interventions

Disclosure: Nothing to disclose.

Prakash Wadhumal Mansukhani, MD, FACC Assistant Director, Regional Department of Cardiac Catheterization, Southern California Permanente Medical Group (SCPMG); Attending Cardiologist, Kaiser Foundation Hospital; Assistant Professor of Medicine, University of California, Los Angeles, David Geffen School of Medicine

Prakash Wadhumal Mansukhani, MD, FACC is a member of the following medical societies: American College of Cardiology, American College of Physicians, American Medical Association, International Society for Heart and Lung Transplantation

Disclosure: Nothing to disclose.

Vicken J Aharonian, MD, FACC, FCCP, FSCAI Director, Regional Department of Cardiac Catheterization, Kaiser Permanente - Southern California Permanente Medical Group (SCPMG)

Vicken J Aharonian, MD, FACC, FCCP, FSCAI is a member of the following medical societies: American College of Cardiology, American College of Chest Physicians, American Heart Association, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography

Disclosure: Nothing to disclose.

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

Transcatheter Aortic Valve Replacement (TAVR) Medication

Medication Summary

Antiplatelet Agents