Transcatheter aortic valve replacement

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Transcatheter aortic valve replacement
TAVRprocedure.jpg
Interventional Cardiologist positioning a TAVI device in patient.
Specialty Interventional cardiology
Complications Stroke risk is 4-5% higher in the high-risk patients compared to SAVR [1]
OutcomesSuccessful rate: 92%. [1]

Transcatheter aortic valve implantation (TAVI) 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.

Contents

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 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]

Related Research Articles

<span class="mw-page-title-main">Aortic stenosis</span> Narrowing of the exit of the hearts left ventricle

Aortic stenosis is the narrowing of the exit of the left ventricle of the heart, such that problems result. It may occur at the aortic valve as well as above and below this level. It typically gets worse over time. Symptoms often come on gradually with a decreased ability to exercise often occurring first. If heart failure, loss of consciousness, or heart related chest pain occur due to AS the outcomes are worse. Loss of consciousness typically occurs with standing or exercising. Signs of heart failure include shortness of breath especially when lying down, at night, or with exercise, and swelling of the legs. Thickening of the valve without causing obstruction is known as aortic sclerosis.

<span class="mw-page-title-main">Aortic valve</span> Valve in the human heart between the left ventricle and the aorta

The aortic valve is a valve in the heart of humans and most other animals, located between the left ventricle and the aorta. It is one of the four valves of the heart and one of the two semilunar valves, the other being the pulmonary valve. The aortic valve normally has three cusps or leaflets, although in 1–2% of the population it is found to congenitally have two leaflets. The aortic valve is the last structure in the heart the blood travels through before stopping the flow through the systemic circulation.

<span class="mw-page-title-main">Interventional cardiology</span> Catheter-based treatment of structural heart diseases

Interventional cardiology is a branch of cardiology that deals specifically with the catheter based treatment of structural heart diseases. Andreas Gruentzig is considered the father of interventional cardiology after the development of angioplasty by interventional radiologist Charles Dotter.

Aortic valve replacement is a procedure whereby the failing aortic valve of a patient's heart is replaced with an artificial heart valve. The aortic valve may need to be replaced because:

<span class="mw-page-title-main">Aortic valvuloplasty</span>

Aortic valvuloplasty, also known as balloon aortic valvuloplasty (BAV), is a procedure used to improve blood flow through the aortic valve in conditions that cause aortic stenosis, or narrowing of the aortic valve. It can be performed in various patient populations including fetuses, newborns, children, adults, and pregnant women. The procedure involves using a balloon catheter to dilate the narrowed aortic valve by inflating the balloon.

<span class="mw-page-title-main">Valve replacement</span> Replacement of one or more of the heart valves

Valve replacement surgery is the replacement of one or more of the heart valves with either an artificial heart valve or a bioprosthesis. It is an alternative to valve repair.

<span class="mw-page-title-main">Carotid stenting</span>

Carotid artery stenting is an endovascular procedure where a stent is deployed within the lumen of the carotid artery to treat narrowing of the carotid artery and decrease the risk of stroke. It is used to treat narrowing of the carotid artery in high-risk patients, when carotid endarterectomy is considered too risky.

Mitral valve replacement is a procedure whereby the diseased mitral valve of a patient's heart is replaced by either a mechanical or tissue (bioprosthetic) valve.

<span class="mw-page-title-main">Endovascular aneurysm repair</span> Surgery used to treat abdominal aortic aneurysm

Endovascular aneurysm repair (EVAR) is a type of minimally-invasive endovascular surgery used to treat pathology of the aorta, most commonly an abdominal aortic aneurysm (AAA). When used to treat thoracic aortic disease, the procedure is then specifically termed TEVAR for "thoracic endovascular aortic/aneurysm repair." EVAR involves the placement of an expandable stent graft within the aorta to treat aortic disease without operating directly on the aorta. In 2003, EVAR surpassed open aortic surgery as the most common technique for repair of AAA, and in 2010, EVAR accounted for 78% of all intact AAA repair in the United States.

A valvulotomy, valvotomy, valvuloplasty, or valvoplasty is a procedure used in heart valve surgery that consists of making one or more incisions at the edges of the commissure formed between the two, or three tricuspid valve leaflets. This relieves the constriction of valvular stenosis.

<span class="mw-page-title-main">Lexington Medical Center</span> Hospital in South Carolina, United States

Lexington Medical Center is a medical complex in Lexington, SC. Lexington Medical Center is owned by Lexington County Health Service District, Inc., a private company. The network includes six community medical centers, an occupational health facility, the largest nursing home in the Carolinas, an Alzheimer's disease care center, and seventy physician practices in a variety of services.

Lars Georg Svensson is a cardiac surgeon and the chairman of the heart and vascular institute at Cleveland Clinic. He is the Director of the Aorta Center, Director of the Marfan Syndrome and Connective Tissue Disorder Clinic, and is a professor of surgery at Cleveland Clinic Lerner College of Medicine and Case Western Reserve University. He is also the Director of Quality Outcomes and Process Improvement for the Department of Thoracic and Cardiovascular Surgery and Affiliate Cardiac Surgery Program at Cleveland Clinic.

<span class="mw-page-title-main">Hybrid cardiac surgery</span>

A hybrid cardiac surgical procedure in a narrow sense is defined as a procedure that combines a conventional, more invasive surgical part with an interventional part, using some sort of catheter-based procedure guided by fluoroscopy imaging in a hybrid operating room (OR) without interruption. The hybrid technique has a reduced risk of surgical complications and has shown decreased recovery time. It can be used to treat numerous heart diseases and conditions and with the increasing complexity of each case, the hybrid surgical technique is becoming more common.

<span class="mw-page-title-main">Apicoaortic conduit</span> Cardiothoracic surgical process

Apicoaortic Conduit (AAC), also known as Aortic Valve Bypass (AVB), is a cardiothoracic surgical procedure that alleviates symptoms caused by blood flow obstruction from the left ventricle of the heart. Left ventricular outflow tract obstruction (LVOTO) is caused by narrowing of the aortic valve (aortic stenosis) and other valve disorders. AAC, or AVB, relieves the obstruction to blood flow by adding a bioprosthetic valve to the circulatory system to decrease the load on the aortic valve. When an apicoaortic conduit is implanted, blood continues to flow from the heart through the aortic valve. In addition, blood flow bypasses the native valve and exits the heart through the implanted valved conduit. The procedure is effective at relieving excessive pressure gradient across the natural valve. High pressure gradient across the aortic valve can be congenital or acquired. A reduction in pressure gradient results in relief of symptoms.

<span class="mw-page-title-main">MitraClip</span>

MitraClip is a medical device used to treat mitral valve regurgitation for individuals who should not have open-heart surgery. It is implanted via a tri-axial transcatheter technique and involves suturing together the anterior and posterior mitral valve leaflets.

Alain Cribier, FACC, FESC was a French interventional cardiologist, Professor of Medicine and Director of Cardiology at the University of Rouen's Charles Nicolle Hospital. Alain Cribier was best known for performing the world's first transcatheter aortic valve implantation in 2002, first transcatheter mitral commissurotomy in 1995, and first balloon aortic valvuloplasty in 1986.

John G. Webb, M.D., FRCPC is a Canadian interventional cardiologist and the McLeod Professor of Heart Valve Intervention at the University of British Columbia. He is most well known for performing the first transfemoral and the first transapical transcatheter aortic valve implantation in the world both in 2005. He completed the first ever transcatheter mitral valve-in-valve replacement in 2009 and the first in-human TMVR to be completed with the Neovasc Tiara device in 2014. In addition, he was an investigator in the PARTNER trial, a randomized clinical trial demonstrating the efficacy of TAVI compared to aortic valve replacement and medical intervention.

<span class="mw-page-title-main">Christoph Huber</span> Swiss cardiac surgeon

Christoph Huber MD, FMH, FECTS is a Swiss cardiac surgeon who is a professor and the head of the Division of Cardiac and Vascular Surgery at the University Hospital Geneva, Switzerland.

Transcatheter pulmonary valve replacement (TPVR), also known as percutaneous pulmonary valve implantation (PPVI), is the replacement of the pulmonary valve via catheterization through a vein. It is a significantly less invasive procedure in comparison to open heart surgery and is commonly used to treat conditions such as pulmonary atresia.

Joseph E. Bavaria, M.D., FACS, FRCS (Edin) ad hom, is an American cardiothoracic surgeon a professor of surgery at the University of Pennsylvania and Director of its Thoracic Aortic Surgery Program. Bavaria is known as a leading figure in clinical trials for catheter-based aortic valve replacement (TAVR), thoracic aortic surgery, and aortic endograft procedures (TEVAR). He wrote more than 600 research papers and founded the Penn Aortic Center. Bavaria served as the 52nd president of the Society of Thoracic Surgeons (STS) from 2016 to 2017, the 3rd President of the Thoracic Surgery Foundation (TSF) (2019-2022), the Chairman of The Society of Thoracic Surgeons/ACC TVT Registry Steering Committee (2017-2020) and an International Councilor of the European Association for Cardio-Thoracic Surgery (EACTS) (2021-2024) Bavaria has performed more than 9,000 surgeries throughout his career as of 2019.

References

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  30. ↑ 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.
  31. ↑ Buntz, Brian (29 June 2012). "TAVR: Still the Next Big Thing in Cardiology?". MDDI.
  32. ↑ Husten, Larry (2 November 2011). "Sapien Transcatheter Aortic Heart Valve Gains FDA Approval". CardioBrief.
  33. ↑ "FDA approves first artificial aortic heart valve placed without open-heart surgery". www.fda.gov. Archived from the original on 3 November 2011.
  34. ↑ "Mick Jagger makes first public appearance since undergoing heart surgery". NME . 24 April 2019.
  35. ↑ "TAVR Puts the Swagger Back in Mick Jagger". MDI online. 10 April 2019. Retrieved 12 April 2019.

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