Transcatheter aortic valve replacement

Transcatheter aortic valve replacement
Transcatheter aortic valve replacement
	Interventional Cardiologist positioning a TAVI device in patient.
Other names	Transcatheter aortic valve implantation, TAVI
Specialty	Interventional cardiology
Complications	Stroke risk is 4-5% higher in the high-risk patients compared to SAVR
Outcomes	Successful rate: 92%.
	[edit on Wikidata]

Transcatheter aortic valve replacement (TAVR) is the implantation of the aortic valve of the heart through the blood vessels without actual removal of the native valve (as opposed to the aortic valve replacement by open heart surgery, surgical aortic valve replacement, AVR). The first TAVI was performed on 16 April 2002 by Alain Cribier, which became a new alternative in the management of high-risk patients with severe aortic stenosis.^[2]^[3] The implantated valve is delivered via one of several access methods: transfemoral (in the upper leg), transapical (through the wall of the heart), subclavian (beneath the collar bone), direct aortic (through a minimally invasive surgical incision into the aorta), and transcaval (from a temporary hole in the aorta near the navel through a vein in the upper leg), among others.

Severe symptomatic aortic stenosis carries a poor prognosis. At present, there is no treatment via medication, making the timing of aortic valve replacement the most important decision to make for these patients.^[4] Until recently, surgical aortic valve replacement was the standard treatment for adults with severe symptomatic aortic stenosis. However, the risks associated with surgical aortic valve replacement are increased in elderly patients and those with concomitant severe systolic heart failure or coronary artery disease, as well as in people with comorbidities such as cerebrovascular and peripheral arterial disease, chronic kidney disease, and chronic respiratory dysfunction.

Overview

Patients with symptomatic severe aortic stenosis have a mortality rate of approximately 50% at 2 years without intervention.^[5] In patients who are deemed too high risk for open heart surgery, TAVI significantly reduces the rates of death and cardiac symptoms.^[6] Until about 2017 TAVI was not routinely recommended for low-risk patients in favor of aortic valve replacement, however it is increasingly being offered to intermediate risk patients, based on studies finding that it is not inferior to surgical aortic valve replacement.^[7]

Transapical TAVI is reserved for patients for whom other approaches are not feasible: an evidence-based BMJ Rapid Recommendation made a strong recommendation against transapical TAVI in people who are also candidates for either transfemoral TAVI or surgery.^[8] People who have the option of either transfemoral TAVI or surgical replacement are likely to choose surgery if they are younger than 75 and transfemoral TAVI if they are older than 75.^[8] The rationale for age-based recommendations is that surgical aortic valve replacements are known to be durable long-term (average of durability of 20 years), so people with longer life expectancy would be at higher risk if TAVI durability is worse than surgery.^[9]

Devices

Medtronic's CoreValve Transcatheter Aortic Valve is constructed of a self-expanding Nitinol (nickel titanium) frame and delivered through the femoral artery. This device received FDA approval in January 2014.^[10]^[11]^[12]

Boston Scientific's Lotus Valve system was awarded CE approval in October 2013. It allows the final position to be assessed and evaluated before release and has been designed to minimise regurgitation.^[12] Boston Scientific has since retired the device as of January 11, 2021.^[13] This was primarily due to difficulty regarding the ability to reposition and recapture the valve.

St Jude Medical's Portico Transcatheter aortic valve received European CE mark approval in December 2013. The valve is repositionable before release to ensure accurate placement helping to improve patient outcomes.^[12]

Edwards' Sapien aortic valve is made from bovine pericardial tissue and is implanted via a catheter-based delivery system. It is approved by the FDA for use in the US.^[10]^[11]^[12]

Implantation

The devices are implanted without open heart surgery. The valve delivery system is inserted in the body, the valve is positioned and then implanted inside the diseased aortic valve, and then the delivery system is removed. The catheter-based delivery system can be inserted into the body from one of several sites.^[14] Pre-procedural planning includes aortic valve annulus measurements and possible procedural complication likelihood. The standard for preoperative plans is to perform a multi-detector computed angiotomography (MDCT), which delivers the information required. Magnetic resonance imaging (MRI) and 3D echocardiography is an alternative.^[15]

Transfemoral approach

The transfemoral approach requires the catheter and valve to be inserted via the femoral artery. Similar to coronary artery stenting procedures, this is accessed via a small incision in the groin, through which the delivery system is slowly fed along the artery to the correct position at the aortic valve. A larger incision in the groin may be required in some circumstances.^[14] The femoral artery (via transfemoral approach) is the traditional access for percutaneous aortic valve implantation.^[16]

Transapical approach

The transapical approach sees the catheter and valve inserted through the tip of the heart and into the left ventricle. Under general anesthesia, a small surgical incision is made between the ribs, followed by a small puncture of the heart. The delivery system is then fed slowly to the correct position at the aortic valve. The puncture in the heart is then sutured shut.^[14]

Transaortic approach

The transaortic approach sees the catheter and valve inserted through the top of the right chest. Under general anesthesia, a small surgical incision is made alongside the right upper breastbone, followed by a small puncture of the aorta. The delivery system is then fed slowly to the correct position at the aortic valve. The hole in the aorta is then sutured shut.^[14]

Transcaval approach

The transcaval approach has been applied to a smaller number of patients who are not eligible for transfemoral, transapical, or transaortic approaches. In the transcaval approach a tube is inserted via the femoral vein instead of the femoral artery, and a small wire is used to cross from the inferior vena cava into the adjacent abdominal aorta. Once the wire is across, a large tube is used to place the transcatheter heart valve through the femoral vein and inferior vena cava into the aorta and from there the heart. This otherwise resembles the transfemoral approach. Afterwards, the hole in the aorta is closed with a self-collapsing nitinol device designed to close holes in the heart.^[17]^[18]

Subclavian approach

In the subclavian approach, an incision is made under the collarbone under general anesthesia, and the delivery system is advanced into the correct position in the aortic valve. The delivery system is then removed and the incision is sutured closed.^{[citation needed]}

After-care

Regular medical checkups and imaging tests are required after TAVI.^[19]

The Mayo Clinic says that blood thinners (anticoagulants) are prescribed to prevent blood clots after TAVI. Artificial heart valves are susceptible to bacterial infection; most bacteria that cause heart valve infections come from the mouth, so that good dental hygiene and routine dental cleaning are recommended. Antibiotics are prescribed for use before certain dental procedures.^[19]

New or worse post-procedure symptoms that require attention include dizziness or light-headedness, swelling of the ankles, sudden weight gain, extreme fatigue with activity, and signs of infection. Emergency attention is required for chest pain, pressure or tightness, severe, sudden shortness of breath, or fainting.^[19]

Complications

When PAVR surgery is performed an important and difficult aspect that affects the patient is the orientation, uniformity and depth at which the valve is inserted. When the valve is not inserted correctly, when there is incomplete sealing between the native heart valve and the stented valve, paravalvular leak (PVL) can occur. Key properties associated with paravalvular leak are the regurgitation volume, the PVL orifice location (anterior or posterior) and the associated fluid dynamic effects that occur from the interactions between the regurgitated flow and the normal transmitral flow.^{[citation needed]}

Morisawa et al.^[20]^{[unreliable medical source?]} carried out quantitative research to determine how the PVL flow effected normal transmitral flow based on three different in-vitro situations: no PVL, anterior orifice PVL and posterior orifice PVL. The results showed that while the two PVL cases worsened the fluid dynamics of the normal transmitral flow seen without leakage, the posterior orifice PVL was worse, leading to a higher circulation and kinetic energy, requiring the heart to work harder and consume more energy to maintain normal bodily functions.

Additionally, the "Big 5 of TAVI complications" include paravalvular leakage (PVL), major bleeding or vascular complications, acute kidney injury (AKI), stroke, and conduction abnormalities, such as high-degree AV-block with need for permanent pacemaker implantation must be monitored to ensure successful procedural outcomes such as low mortality and morbidity.^[21]

There is a ~3% risk of stroke associated with TAVI due to embolism or altered hemodynamics during or after the procedure.^[22] Approximately 70% of patients undergoing TAVI show signs of clinically silent brain infarcts on neuroimaging afterwards.^[23]^[22] Further, levels of the neuroaxonal damage biomarker neurofilament light chain are elevated in blood plasma after TAVI.^[24] Whereas clinical stroke is associated with reduced quality of life and cognitive impairment, the significance of silent brain infarcts and elevated levels of neurofilament light is presently unclear.

Prognosis

Recovery

Within 24 hours post-operation, patients are encouraged to be walking. It is common for patients to have an overnight hospital stay post operatively. Follow-up examinations (Chest X-ray, EKG, and Cardiac US) ensure heart functioning. Incision sites are monitored closely. Pts. are encouraged not to drive for 72 hours post operatively, and to avoid physical activity for up to 10 days. Most patients resume activity within 2 weeks.^[25]

A 2018 study that interviewed nineteen elderly patients six months after a transapical TAVI procedure found that participants felt weak and tired at first after TAVI, some more than before the procedure. Some reported a later "surprisingly simple rehabilitation" with rapid recovery, while others had a "demanding rehabilitation", with slow recovery, fatigue, and weakness.^[26]

Durability

The durability of transcatheter prostheses, in terms of all-cause mortality and the need of re-intervention, was not reliably known as of 2021^[update] due to the lack of long-term follow-up data. A narrative review published in 2021 reported that a 2015 study involving simulation on first-generation prostheses suggested a TAVI durability limited to 7–8 years. Later prostheses have improved durability.^[27]

Bioprosthetic valve disfunction (BVD) has historically been divided into SVD (structural valve deterioration, including irreversible intrinsic changes of the prosthetic valve structure), NSVD (non-structural valve deterioration, including irreversible intra- or para-prosthetic regurgitation, prosthesis malposition, and patient-prosthesis mismatch), valve thrombosis, and endocarditis (which can be potentially reversible). Durability seems to be similar between TAVI and surgical implantation (SAVR), but there is a lack of long-term data, with only computed simulation models available. In many respects TAVI and SAVR are comparable, but TAVI still has a higher rate of NSVD. In elderly patients the prostheses should outlive the patient. The 2021 review suggested that in younger patients (with longer average life expectancy) choosing TAVI might still be premature, due to the increased likelihood of the need for future re-operation with worse prognostic impact.^[27]

History

The catheter procedure was invented and developed in Aarhus University Hospital Denmark in 1989 by Henning Rud Andersen,^[28] who performed the first animal implantations that year.^[29] The first implantation in a human was performed on 16 April 2002 by Alain Cribier in Hopital Charles Nicolle, at the University of Rouen, France.^[30] Technology experts Stan Rowe and Stan Rabinowitz partnered with physicians Alain Cribier and Martin Leon of NewYork–Presbyterian Hospital and others to create the company Percutaneous Valve Technologies (PVT) in 2002. The company was purchased by Edwards Lifesciences in 2004; its valve became the Sapien valve.^[31]^[32] It was the first aortic valve device to receive FDA approval, in November 2011 for use in inoperable patients and in October 2012 for use in patients at high surgical risk.^[33] The device is effective in improving functioning in patients with severe aortic stenosis. It is now approved in more than 50 countries.^{[citation needed]}

Internationally famous pop singer Mick Jagger had the procedure in March 2019 at NewYork–Presbyterian,^[34] which was said to have raised public awareness.^[35]

References

^ ^a ^b Rajput, FA; Zeltser, R (2020), "article-31500", Aortic Valve Replacement, Treasure Island (FL): StatPearls Publishing, PMID 30725821, retrieved 29 March 2020
^ Cribier, A; Eltchaninoff, H; Bash, A; Borenstein, N; Tron, C; Bauer, F; Derumeaux, G; Anselme, F; Laborde, F; Leon, MB (10 December 2002). "Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description". Circulation. 106 (24): 3006–8. doi:10.1161/01.cir.0000047200.36165.b8. PMID 12473543.
^ Figulla, HR; Franz, M; Lauten, A (March 2020). "The History of Transcatheter Aortic Valve Implantation (TAVI)-A Personal View Over 25 Years of development". Cardiovascular Revascularization Medicine: Including Molecular Interventions. 21 (3): 398–403. doi:10.1016/j.carrev.2019.05.024. PMID 31383557.
^ Otto, Catherine M.; Prendergast, Bernard (21 August 2014). "Aortic-Valve Stenosis — From Patients at Risk to Severe Valve Obstruction". New England Journal of Medicine. 371 (8): 744–756. doi:10.1056/NEJMra1313875. PMID 25140960.
^ Ross, John; Braunwald, Eugene (1968). "Aortic Stenosis". Circulation. 38 (1s5): 61–7. doi:10.1161/01.cir.38.1s5.v-61. ISSN 0009-7322. PMID 4894151.
^ Leon, Martin B.; Smith, Craig R.; Mack, Michael; Miller, D. Craig; Moses, Jeffrey W.; Svensson, Lars G.; Tuzcu, E. Murat; Webb, John G.; Fontana, Gregory P.; Makkar, Raj R.; Brown, David L.; Block, Peter C.; Guyton, Robert A.; Pichard, Augusto D.; Bavaria, Joseph E.; Herrmann, Howard C.; Douglas, Pamela S.; Petersen, John L.; Akin, Jodi J.; Anderson, William N.; Wang, Duolao; Pocock, Stuart (21 October 2010). "Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery" (PDF). New England Journal of Medicine. 363 (17). Massachusetts Medical Society: 1597–1607. doi:10.1056/nejmoa1008232. ISSN 0028-4793. PMID 20961243. S2CID 25572326.
^ Reardon, Michael J.; Van Mieghem, Nicolas M.; Popma, Jeffrey J.; Kleiman, Neal S.; Søndergaard, Lars; Mumtaz, Mubashir; Adams, David H.; Deeb, G. Michael; Maini, Brijeshwar; Gada, Hemal; Chetcuti, Stanley; Gleason, Thomas; Heiser, John; Lange, Rüdiger; Merhi, William; Oh, Jae K.; Olsen, Peter S.; Piazza, Nicolo; Williams, Mathew; Windecker, Stephan; Yakubov, Steven J.; Grube, Eberhard; Makkar, Raj; Lee, Joon S.; Conte, John; Vang, Eric; Nguyen, Hang; Chang, Yanping; Mugglin, Andrew S.; Serruys, Patrick W.J.C.; Kappetein, Arie P. (6 April 2017). "Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients" (PDF). New England Journal of Medicine. 376 (14). Massachusetts Medical Society: 1321–1331. doi:10.1056/nejmoa1700456. ISSN 0028-4793. PMID 28304219. S2CID 205101696.
^ ^a ^b Vandvik, Per O; Otto, Catherine M; Siemieniuk, Reed A; Bagur, Rodrigo; Guyatt, Gordon H; Lytvyn, Lyubov; Whitlock, Richard; Vartdal, Trond; Brieger, David; Aertgeerts, Bert; Price, Susanna; Foroutan, Farid; Shapiro, Michael; Mertz, Ray; Spencer, Frederick A. (28 September 2016). "Transcatheter or surgical aortic valve replacement for patients with severe, symptomatic, aortic stenosis at low to intermediate surgical risk: a clinical practice guideline". BMJ. 354 (i5085): i5085. doi:10.1136/bmj.i5085. ISSN 1756-1833. PMID 27680583. Current as of October 2022. Has links to relevant BMJ papers.
^ Foroutan F, Guyatt GH, O'Brien K, et al. (2016). "Prognosis after surgical replacement with a bioprosthetic aortic valve in patients with severe symptomatic aortic stenosis: systematic review of observational studies". BMJ. 354: i5065. doi:10.1136/bmj.i5065. PMC 5040922. PMID 27683072.
^ ^a ^b Medscape. "Transcatheter Aortic Valve Replacement Devices". Retrieved December 2013.
^ ^a ^b Agarwal S, et al. (February 2015). "Transcatheter aortic valve replacement: current perspectives and future implications". Heart. 101 (3): 169–77. doi:10.1136/heartjnl-2014-306254. PMID 25410500. S2CID 21098757.
^ ^a ^b ^c ^d Abdel-Wahab M, et al. (February 2015). "Update on transcatheter aortic valve replacement". Trends Cardiovasc. Med. 25 (2): 154–161. doi:10.1016/j.tcm.2014.10.001. PMID 25453986.
^ Health, Center for Devices and Radiological (27 January 2022). "Boston Scientific Announces LOTUS Edge™ Aortic Valve System Voluntary Recall and Product Discontinuation". www.fda.gov. Retrieved 16 August 2023.
^ ^a ^b ^c ^d Ruparelia, Neil; Prendergast, Bernard David (8 May 2016). "Technical aspects of transcatheter aortic valve implantation (TAVI)". e-Journal of Cardiology Practice. 22 (5).
^ Saadi, R. P.; Tagliari, A. P.; Saadi, E. K.; Miglioranza, M. H.; Polanczyck, C. A. (2022). "Preoperative TAVR Planning". Journal of Clinical Medicine. 11 (9): 2582. doi:10.3390/jcm11092582. PMC 9101424. PMID 35566708.
^ "Taking Alternate Routes for TAVR". Froedtert & the Medical College of Wisconsin. Retrieved 19 August 2023.
^ Steinberger, JD; McWilliams JP; Moriarty JM (10 April 2015). "Alternative Aortic Access: Translumbar, Transapical, Subclavian, Conduit, and Transvenous Access to the Aorta". Tech Vasc Interv Radiol. 18 (2): 93–99. doi:10.1053/j.tvir.2015.04.007. PMID 26070621.
^ Greenbaum, AB; ONeill WW; Paone G; Guerrero M; Wyman JF; Cooper RL; Lederman RJ (1 July 2014). "Caval-aortic access to allow transcatheter aortic valve replacement in otherwise ineligible patients. Initial human experience". J Am Coll Cardiol. 63 (25 Pt A): 2795–2804. doi:10.1016/j.jacc.2014.04.015. PMC 4105161. PMID 24814495.
^ ^a ^b ^c "Transcatheter aortic valve replacement (TAVR)". Mayo Clinic. 13 October 2021.
^ Morisawa, Daisuke; Falahatpisheh, Ahmad; Avenatti, Eleonora; Little, Stephen H.; Kheradvar, Arash (23 October 2018). "Intraventricular Vortex Interaction between Transmitral Flow and Paravalvular Leak". Scientific Reports. 8 (1): 15657. Bibcode:2018NatSR...815657M. doi:10.1038/s41598-018-33648-9. ISSN 2045-2322. PMC 6199255. PMID 30353062.
^ Grube, Eberhard; Sinning, Jan-Malte (February 2019). "The "Big Five" Complications After Transcatheter Aortic Valve Replacement". JACC: Cardiovascular Interventions. 12 (4): 370–372. doi:10.1016/j.jcin.2018.12.019. PMID 30784642.
^ ^a ^b Woldendorp, Kei; Indja, Ben; Bannon, Paul G; Fanning, Jonathon P; Plunkett, Brian T; Grieve, Stuart M (7 March 2021). "Silent brain infarcts and early cognitive outcomes after transcatheter aortic valve implantation: a systematic review and meta-analysis". European Heart Journal. 42 (10): 1004–1015. doi:10.1093/eurheartj/ehab002. ISSN 0195-668X. PMID 33517376.
^ Kahlert, Philipp; Knipp, Stephan C.; Schlamann, Marc; Thielmann, Matthias; Al-Rashid, Fadi; Weber, Marcel; Johansson, Uwe; Wendt, Daniel; Jakob, Heinz G.; Forsting, Michael; Sack, Stefan; Erbel, Raimund; Eggebrecht, Holger (23 February 2010). "Silent and Apparent Cerebral Ischemia After Percutaneous Transfemoral Aortic Valve Implantation: A Diffusion-Weighted Magnetic Resonance Imaging Study". Circulation. 121 (7): 870–878. doi:10.1161/CIRCULATIONAHA.109.855866. ISSN 0009-7322. PMID 20177005.
^ Sjölin, Karl; Christersson, Christina; James, Stefan; Lindbäck, Johan; Åsberg, Signild; Burman, Joachim (28 July 2023). "Plasma Neurofilament Light Chain Is Elevated after Transcatheter Aortic Valve Implantation". Cardiology. 148 (5): 478–484. doi:10.1159/000532041. ISSN 0008-6312. PMID 37517390.
^ "Transcatheter Aortic Valve Replacement (TAVR)". ucsfhealth.org. Retrieved 19 August 2023.
^ Olsson, Karin; Näslund, Ulf; Nilsson, Johan; Hörnsten, Åsa (4 February 2018). "Patients' experiences of the transcatheter aortic valve implantation trajectory: A grounded theory study". Nursing Open. 5 (2): 149–157. doi:10.1002/nop2.124. ISSN 2054-1058. PMC 5867280. PMID 29599990.
^ ^a ^b Marengo, Giorgio; Elia, Edoardo; Bruno, Francesco; Franchin, Luca; Piroli, Francesco; De Filippo, Ovidio; Conrotto, Federico; De Ferrari, Gaetano Maria; D’Ascenzo, Fabrizio (12 March 2021). "Durability of transcatheter aortic valves, current evidence and future prospective". Vessel Plus. 2021. doi:10.20517/2574-1209.2020.58. ISSN 2574-1209.
^ Grigorios T, Stefanos D, Athanasios M, Ioanna K, Stylianos A, Periklis D, George H (January 2018). "Transcatheter versus surgical aortic valve replacement in severe, symptomatic aortic stenosis". J Geriatr Cardiol. 15 (1): 76–85. doi:10.11909/j.issn.1671-5411.2018.01.002 (inactive 2 November 2024). PMC 5803541. PMID 29434629.{{cite journal}}: CS1 maint: DOI inactive as of November 2024 (link)
^ Andersen HR, Knudsen LL, Hasenkam JM (May 1992). "Transluminal implantation of artificial heart valves. Description of a new expandable aortic valve and initial results with implantation by catheter technique in closed chest pigs". Eur. Heart J. 13 (5): 704–8. doi:10.1093/oxfordjournals.eurheartj.a060238. PMID 1618213.
^ Cribier, A; Eltchaninoff H; Bash A; Borenstein N; Tron C; Bauer F; Derumeaux G; Anselme F; Laborde F; Leon MB (10 December 2002). "Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis. First human case description". Circulation. 106 (24): 3006–3008. doi:10.1161/01.cir.0000047200.36165.b8. PMID 12473543.
^ Buntz, Brian (29 June 2012). "TAVR: Still the Next Big Thing in Cardiology?". MDDI.
^ Husten, Larry (2 November 2011). "Sapien Transcatheter Aortic Heart Valve Gains FDA Approval". CardioBrief.
^ "FDA approves first artificial aortic heart valve placed without open-heart surgery". www.fda.gov. Archived from the original on 3 November 2011.
^ "Mick Jagger makes first public appearance since undergoing heart surgery". NME. 24 April 2019.
^ "TAVR Puts the Swagger Back in Mick Jagger". MDI online. 10 April 2019. Retrieved 12 April 2019.