TAVR vs SAVR
Aortic Stenosis Microchapters |
Diagnosis |
---|
Treatment |
Percutaneous Aortic Balloon Valvotomy (PABV) or Aortic Valvuloplasty |
Transcatheter Aortic Valve Replacement (TAVR) |
Case Studies |
TAVR vs SAVR On the Web |
American Roentgen Ray Society Images of TAVR vs SAVR |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1],Associate Editor(s)-in-Chief: Seyedmahdi Pahlavani, M.D. [2],Tarek Nafee, M.D. [3],Sabawoon Mirwais, M.B.B.S, M.D.[4]
Overview
Until recently, aortic valve replacement (AVR) was the only effective treatment for severe symptomatic aortic stenosis. Global aging has raised concerns about safety and possibility of surgical procedure in old patients with associated comorbidities.[1] Transcatheter aortic valve replacement (TAVR) created a new era of safety for this population and enabled physicians to replace the stenotic valve with more certainty. In TAVR, also known as Percutaneous Aortic Valve Replacement (PAVR), a synthetic valve is advanced to the heart through a small hole made in groin. This procedure is similar in its mechanism to the insertion of a stent, or performing balloon angioplasty albeit with much larger equipment. Traditional aortic valve replacement is an invasive surgical procedure, with considerable mortality and morbidity, especially in more fragile patients. In the newly developed TAVR procedure, the dysfunctional aortic valve is replaced percutaneously, which obviates the need for open heart surgery.[2]
Patient selection, selecting the appropriate imaging modality, preprocedure evaluation, selecting the appropriate valve type and valve size, post procedure complications and long term follow-up are the main areas of focused importance.
Comparing TAVR and SAVR
- Surgical Aortic Valve Repair (SAVR) is the traditional way of treating a stenotic aortic valve.
- In the last decade, TAVR has emerged as a viable option for patients at high surgical risk or at high risk for post-surgical complications.
Evidence
Systematic reviews have addressed this comparison in patients deemed to be low-risk (Society of Thoracic Surgery (STS) risk score uropean System for Cardiac Operative Risk Evaluation (EuroSCORE) II less than 4%.)[3][4]:
- "In patients with severe aortic stenosis and coronary artery disease, TAVR + PCI was associated with greater all-cause mortality at follow-up compared with SAVR + CABG."[3]
- "Among older low-risk patients with severe aortic stenosis, TAVR is associated with a lower rate of death or disabling stroke compared with SAVR"[4]
The Cochrane Collaboration reviewed the following trials of low-risk patients in 2019[5]:
- Popma (Evolut) [6] 1468 patients
- Thyregod (NOTION)[7] 280 patients
- Mack (PARTNER 3)[8]. 1000 patients
After the Cochrane review, a systematic review by Kheiri in 2020 of low risk patients[4] included the same three trials and added:
- Nielsen (STACCATO), 2012[9] The Cochrane had handled this trial separately due to the trial having "utilised the less contemporary transapical TAVI and was prematurely terminated due to an excess of adverse events in the TAVI group." The Cochrane had excluded this trial because "all study participants were deemed intermediate risk according to the study investigators."
- Serruys (SURTAVI) 2018[10]
Other randomized controlled trials with increased surgical risk:
Non-randomized studies:
- Thourani (SAPIEN 3)
2014 AHA/ACC Guidelines for the Management of Patients With Valvular Heart Disease Recommend the Following:[2]
Class of Recommendation | Recommendation | Evidence Level |
---|---|---|
Class I | "SAVR is recommended in patients who meet an indication for AVR with low or intermediate surgical risk" | A |
Class I | "For patients in whom TAVR or high-risk SAVR is being considered, members of a Heart Valve Team should collaborate to provide optimal patient care" | C |
Class I | "TAVR is recommended in patients who meet an indication for AVR for AS who have a prohibitive surgical risk and a predicted post-TAVR survival >12 months" | B |
Class IIa | "TAVR is a reasonable alternative to SAVR in patients who meet an indication for AVR and who have high surgical risk" | B |
Class IIb | "Percutaneous aortic balloon dilation may be considered as a bridge to SAVR or TAVR in severely symptomatic patients with severe AS" | C |
Class III: No Benefit | "TAVR is not recommended in patients in whom existing comorbidities would preclude the expected benefit from correction of AS" | B |
- In the recent years, terminology has arose to define patients who qualify for TAVR as "inoperable patients" who are at > 50% risk of mortality at 30 days after a potential SAVR procedure.
- There is much debate regarding the subjective nature of defining a patient as "inoperable"; however, the heart valve team should collaborate to determine the optimal procedure for the patient.
- TAVR has demonstrated up to a 20% risk reduction in all-cause-mortality at 12 months which is sustained for up to 5 years post-procedure, when compared to SAVR.
- In high risk patients such as the elderly and those with a NYHA III or IV functional status, TAVR has shown non-inferiority to the traditional SAVR procedure and regardless of the procedure undertaken, patients maintained a NYHA I or II functionality for up to 5 years post-procedure.
- It is noteworthy to say that TAVR is associated with a significant and sustained reduction in risk of ischemic stroke for 30 days and up to 2 years after the procedure compared to surgery.
- Nevertheless, SAVR continues to play a role in patients who require an aortic valve replacement with lower surgical risk.
2017 ESC/EACTS Guidelines for the Management of Patients With Valvular Heart Disease Recommend the Following:
TAVR | SAVR | |
---|---|---|
Clinical Characteristics | ||
STS/EuroSCORE II < 4%
(logistic EuroSCORE I < 10%) |
+ | |
STS/EuroSCORE II ≥ 4%
(logistic EuroSCORE I ≥ 10%) |
+ | |
Presence of severe comorbidity
(not adequately reflected by scores) |
+ | |
Age < 75 years | + | |
Age ≥ 75 years | + | |
Previous cardiac surgery | + | |
Frailty | + | |
Restricted mobility and conditions that may affect
the rehabilitation process after the procedure |
+ | |
Suspicion of endocarditis | + | |
Anatomical and Technical Aspects | ||
Favorable access for transfemoral TAVR | + | |
Unfavorable access (any) for TAVR | + | |
Sequelae of chest radiation | + | |
Porcelain aorta | + | |
Presence of intact coronary bypass grafts at risk
when sternotomy is performed |
+ | |
Expected patient - prosthesis mismatch | + | |
Severe chest deformation of scoliosis | + | |
Short distance between coronary ostia and aortic
valve annulus |
+ | |
Size of aortic valve annulus out of range for TAVR | + | |
Aortic root morphology unfavorable for TAVR | + | |
Valve morphology (bicuspid, degree of calcification,
and calcification patter) unfavorable for TAVR |
+ | |
Presence of thrombi in aorta or left ventricle | + | |
Cardiac Conditions in Addition to Aortic Stenosis that Require
Consideration for Concomitant Intervention | ||
Severe CAD requiring revascularization by CABG | + | |
Severe primary mitral valve disease, which could
be treated surgically |
+ | |
Severe tricuspid valve disease | + | |
Aneurysm of the ascending aorta | + | |
Septal hypertrophy requiring myectomy | + | |
|
Future Perspectives
- TAVR has transformed the treatment and the way of dealing with symptomatic patients suffering from aortic stenosis, particularly in those who are at high risk or inoperable for surgical aortic valve replacement (SAVR).[13]
- When it successfully performed, TAVR returns the patient to a good prognosis and favorable life style.
- It is estimated that 25,000 TAVR procedures were done in the U.S in 2015 and an increase in this number is anticipated because of increase in the number of the elderly population.
- In the United States, the elderly population will reach 50 million by 2019 [14]and this old population is highly vulnerable to degenerative valve disease.
- The future of TAVR will be focusing on more technical aspects; trying to reduce the device profile, enhancing it's positioning, retrievability and promoting valve durability with anticalcification treatments.
- In the last decade, clinicians remained focused on demonstrating efficacy and safety of the procedure. In latter years, the minimalist approach to the deployment of the valves has become the mainstay of advancements in the TAVR procedure.
- Examples include the avoidance of general anesthesia and the utilization of conscious sedation whenever possible, the reduction of reliance or use of transesophageal echocardiography (TEE), the reduction or elimination of balloon pre-dilatation of the stenosed valve, as well as early discharge programs.
- With ongoing clinical trials and further advancements in valve technology, TAVR will establish an expanded indication in patients with moderate to severe aortic stenosis.
References
- ↑ Grube E, Laborde JC, Gerckens U, Felderhoff T, Sauren B, Buellesfeld L, Mueller R, Menichelli M, Schmidt T, Zickmann B, Iversen S, Stone GW (2006). "Percutaneous implantation of the CoreValve self-expanding valve prosthesis in high-risk patients with aortic valve disease: the Siegburg first-in-man study". Circulation. 114 (15): 1616–24. doi:10.1161/CIRCULATIONAHA.106.639450. PMID 17015786. Retrieved 2011-03-17. Unknown parameter
|month=
ignored (help) - ↑ 2.0 2.1 Vahl TP, Kodali SK, Leon MB (2016). "Transcatheter Aortic Valve Replacement 2016: A Modern-Day "Through the Looking-Glass" Adventure". J Am Coll Cardiol. 67 (12): 1472–87. doi:10.1016/j.jacc.2015.12.059. PMID 27012409.
- ↑ 3.0 3.1 Sakurai Y, Yokoyama Y, Fukuhara S, Takagi H, Kuno T (2022). "Complete transcatheter versus surgical approach to aortic stenosis with coronary artery disease: A systematic review and meta-analysis". J Thorac Cardiovasc Surg. doi:10.1016/j.jtcvs.2022.08.006. PMID 36150940 Check
|pmid=
value (help). - ↑ 4.0 4.1 4.2 Kheiri B, Osman M, Bakhit A, Radaideh Q, Barbarawi M, Zayed Y; et al. (2020). "Meta-Analysis of Transcatheter Aortic Valve Replacement in Low-Risk Patients". Am J Med. 133 (2): e38–e41. doi:10.1016/j.amjmed.2019.06.020. PMID 31295442.
- ↑ Kolkailah AA, Doukky R, Pelletier MP, Volgman AS, Kaneko T, Nabhan AF (2019). "Transcatheter aortic valve implantation versus surgical aortic valve replacement for severe aortic stenosis in people with low surgical risk". Cochrane Database Syst Rev. 12 (12): CD013319. doi:10.1002/14651858.CD013319.pub2. PMC 6984621 Check
|pmc=
value (help). PMID 31860123. - ↑ Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D; et al. (2019). "Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients". N Engl J Med. 380 (18): 1706–1715. doi:10.1056/NEJMoa1816885. PMID 30883053.
- ↑ Thyregod HGH, Ihlemann N, Jørgensen TH, Nissen H, Kjeldsen BJ, Petursson P; et al. (2019). "Five-Year Clinical and Echocardiographic Outcomes from the Nordic Aortic Valve Intervention (NOTION) Randomized Clinical Trial in Lower Surgical Risk Patients". Circulation. doi:10.1161/CIRCULATIONAHA.118.036606. PMID 30704298.
- ↑ Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M; et al. (2019). "Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients". N Engl J Med. 380 (18): 1695–1705. doi:10.1056/NEJMoa1814052. PMID 30883058.
- ↑ Nielsen HH, Klaaborg KE, Nissen H, Terp K, Mortensen PE, Kjeldsen BJ; et al. (2012). "A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial". EuroIntervention. 8 (3): 383–9. doi:10.4244/EIJV8I3A58. PMID 22581299.
- ↑ Serruys PW, Modolo R, Reardon M, Miyazaki Y, Windecker S, Popma J; et al. (2018). "One-year outcomes of patients with severe aortic stenosis and an STS PROM of less than three percent in the SURTAVI trial". EuroIntervention. 14 (8): 877–883. doi:10.4244/EIJ-D-18-00460. PMID 29992904.
- ↑ Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK; et al. (2016). "Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients". N Engl J Med. 374 (17): 1609–20. doi:10.1056/NEJMoa1514616. PMID 27040324. Review in: Evid Based Med. 2016 Oct;21(5):173 Review in: Ann Intern Med. 2016 Aug 16;165(4):JC21
- ↑ Adams DH, Popma JJ, Reardon MJ, Yakubov SJ, Coselli JS, Deeb GM; et al. (2014). "Transcatheter aortic-valve replacement with a self-expanding prosthesis". N Engl J Med. 370 (19): 1790–8. doi:10.1056/NEJMoa1400590. PMID 24678937.
- ↑ CARDIAC INTERVENTIONS TODAY,TAVI using the CoreValve revalving system,July.August 2010
- ↑ "www.census.gov" (PDF).