Abstract
Objectives
Methods
Results
Conclusions
Key Words
Abbreviations and Acronyms:
BAV (bicuspid aortic valve), CABG (coronary artery bypass grafting), CI (confidence interval), HR (hazard ratio), NIS (National Inpatient Sample), NRD (Nationwide Readmission Database), PVL (paravalvular leak), RCT (randomized controlled trial), RR (risk ratio), SAVR (surgical aortic valve replacement), TAVR (transcatheter aortic valve replacement)
- Thourani V.H.
- Edelman J.J.
- Holmes S.D.
- Nguyen T.C.
- Carroll J.
- Mack M.J.
- et al.
Materials and Methods
- Liberati A.
- Altman D.G.
- Tetzlaff J.
- Mulrow C.
- Gøtzsche P.C.
- Ioannidis J.P.A.
- et al.
Search Strategy and Eligibility
Study Selection and Data Collection
Summary Measures
Meta-Analysis
Results
Study Selection

Study Characteristics
Author | Publication year | Study period | Dataset | Adjustment | Patient number (n) | Age | Female (%) | Hypertension (%) | Diabetes mellitus (%) | Smoke (%) | COPD (%) | Chronic kidney disease (%) | Left ventricular ejection fraction <30% (%) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Total | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | |||||
Elbadawi | 2019 | 2012-2016 | National Inpatient Sample | PSM | 1950 | 975 | 975 | 65.7 | 65.2 | 40 | 36.4 | 64.6 | 64.6 | 29.7 | 30.8 | 20.5 | 20 | 32.3 | 25.6 | 19.5 | 24.1 | NA | NA |
Mentias | 2020 | 2015-2017 | Medicare | PSM | 1398 | 699 | 699 | 72.2 | 72.8 | 40 | 40 | 88 | 88 | 36 | 37 | 17 | 16 | 38 | 38 | 27 | 28 | NA | NA |
Husso | 2021 | 2008-2017 | Finn Valve Registry | PSM | 150 | 75 | 75 | 75.8 | 75.7 | 44 | 45.3 | NA | NA | 21.3 | 14.7 | NA | NA | NA | NA | NA | NA | 4.1 | 4 |
Majmunder | 2022 | 2016-2018 | Nationwide Readmission Database | PSM | 2786 | 1393 | 1393 | 68.3 | 68.1 | 37.8 | 38.4 | 78.8 | 75.6 | 28 | 29.4 | 36.8 | 34.3 | 31.3 | 28.7 | 23.8 | 23.8 | NA | NA |
Stroke/TIA (%) | Peripheral artery disease (%) | Prior CABG (%) | Prior PCI (%) | euroSCORE II | STS PROM | Bicuspid aortic valve type | TAVR access | TAVR valve used | Concomitant procedure with SAVR | ||||||||||||||
TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR/SAVR | TAVR | TAVR | SAVR | ||||||||
9.2 | 11.3 | 27.7 | 30.3 | 10.3 | 8.7 | 8.7 | 7.2 | NA | NA | NA | NA | NA | Transapical 10.8% (n = 105) | NA | NA | ||||||||
13 | 12 | 37 | 35 | NA | NA | 13 | 16 | NA | NA | NA | NA | NA | NA | NA | CABG 24% Ascending aorta surgery 11% | ||||||||
8 | 9.3 | 9.3 | 10.7 | 5.3 | 8 | 16 | 8 | 4.0 | 3.8 | 2.9 ± 1.7 | 3.1 ± 3.2 | Type 0; 16.5% Type 1; 81.6% Type 2; 1.9% | Transapical 6.7% (n = 5) | New Generation 81.6% (Sapien, Edwards Lifesciences, 3 (n = 63), Evolut R/CoreValve, Medtronic, (n = 8), Lotus, Boston Scientific, (n = 11), Accurate Neo, Boston Scientific, (n = 2)) Old Generation 18.4% (Medtronic CoreValve (n = 2), Edwards Sapient XT (n = 17)) | CABG 25.3% | ||||||||
6.8 | 6.8 | 26.4 | 25.5 | 5.8 | 6.7 | 10.2 | 9.7 | NA | NA | NA | NA | NA | NA | NA | NA |
In-Hospital Outcomes



All-Cause Mortality During Follow-up

Leave-One-Out Analysis and Meta-Regression
Discussion

Percy ED, Harloff M, Hirji S, Tartarini RJ, McGurk S, Cherkasky O, et al. Outcomes of procedural complications in transfemoral transcatheter aortic valve replacement. J Thorac Cardiovasc Surg. May 4, 2021 [Epub ahead of print]. https://doi.org/10.1016/j.jtcvs.2021.04.082.
- Haunschild J.
- Misfeld M.
- Schroeter T.
- Lindemann F.
- Davierwala P.
- von Aspern K.
- et al.
Study Limitations
Conclusions
Conflict of Interest Statement
Appendix E1




Author | Year | Stroke | Paravalvular leak | Blood transfusion | Vascular complications | Acute kidney injury | Permanent pacemaker placement |
---|---|---|---|---|---|---|---|
Elbadawi | 2019 | ICD-9 or ICD-10 codes as follows CCS-109 | NA | ICD-9 or ICD-10 codes as follows 99.01-99.09 30243N0 30243N1 30243P0 30243P1 30243H0 30243H1 30240N0 30240N1 30240P0 30240P1 30240H0 30240H1 30230H0 30230H1 30230N0 30230N1 30230P0 30230P1 30233N0 30233N1 30233P0 30233P1 | ICD-9 or ICD-10 codes as follows 39.31, 39.41, 39.49, 39.52, 39.53, 39.56, 39.57, 39.58, 39.59, 39.79 04QY0ZZ 04QY3ZZ 04QY4ZZ 04QC0ZZ 04QC3ZZ 04QC4ZZ 04QD0ZZ 04QD3ZZ 04QD4ZZ 03QY0ZZ 03QY3ZZ 03QY4ZZ 03Q30ZZ 04LE4DZ 04LF0DZ 04LF3DZ 04LF3ZZ 04LF4DZ 04LH0DZ 04LH3DZ 04LH3ZZ 04LH4DZ 04LJ0DZ 04LJ3DZ 04LJ3ZZ 04LJ4DZ 04LK0DZ 04LK3DZ 04LK3ZZ 04LK4DZ 04LL0DZ 04LL3DZ 04LL3ZZ 04LL4DZ03Q33ZZ 03Q34ZZ 03Q40ZZ 03Q43ZZ 03Q44ZZ 0GQ60ZZ 0GQ63ZZ 0GQ64ZZ 0GQ70ZZ 0GQ73ZZ 0GQ74ZZ 03L23ZZ 03L33ZZ 03L43ZZ 03L50DZ 03L53DZ 03L53ZZ 03L54DZ 03L60DZ03L63DZ 03L63ZZ | ICD-9 or ICD-10 codes as follows 584 N17 N19 N990 R34 R944 | ICD-9 or ICD-10 codes as follows 37.80, 37.83, 02HK3JZ 02H63JZ 02HN0JZ 02H60JZ 02H60NZ 02H63JZ 02H63NZ 02H64JZ 02H64NZ 02HK0JZ 02HK0NZ 02HK3JZ 02HK3NZ 02HK4JZ 02HK4NZ 02HN4JZ 0JH604Z 0JH634Z 0JH605Z 0JH607Z 0JH635Z 0JH606Z 0JH634Z 0JH635Z 0JH636Z 0JH637Z |
Mentias | 2020 | NA | NA | NA | NA | NA | NA |
Husso | 2021 | VARC-2 | Transthoracic echocardiogram before discharge | Bleeding requiring any blood transfusion | VARC-2 | KDIGO criteria postoperative increase of creatinine ≥ 1.5 times, increase of creatinine ≥ 26.5 mmol/L, or need for renal replacement therapy | NA |
Majmunder | 2022 | ICD-9 or ICD-10 codes as follows I60, I61, I62, I690, I691, I692, I63, G46, I61, I629, I97810, I97811, I97820, I97821 | ICD-9 or ICD-10 codes as follows T8203, T82223 | Bleeding requiring any blood transfusion | NA | ICD-9 or ICD-10 codes as follows N170, N171, N172, N178, N179, N19, N990, R34 | NA |
Author | Year | Period | Exclusion criteria |
---|---|---|---|
Elbadawi | 2019 | 2012-2016 | Age <18 y, concomitant aortic root repair, CABG, other valvular heart surgeries or atrial or ventricular septal defect repair, isolated aortic regurgitation |
Mentias | 2020 | 2015-2017 | Concomitant mitral valve surgery |
Husso | 2021 | 2008-2017 | Age < 18 y, previous surgical or transcatheter intervention on the aortic valve, acute endocarditis, isolated aortic valve regurgitation, or major concomitant other valve or thoracic aortic procedures |
Majumdar | 2022 | 2016-2018 | Age < 18 y, concomitant CABG, mitral, pulmonary, and tricuspid valve surgeries atrial or ventricular sepal defect repair, and aortic root surgery |
Author | Publication year | Study period | Dataset | Adjustment | Patient number (n) | Age | Female (%) | Hypertension (%) | Diabetes mellitus (%) | Smoke (%) | COPD (%) | Chronic kidney disease (%) | Left ventricular ejection fraction <30% (%) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Total | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | |||||
Elbadawi | 2019 | 2012-2016 | National Inpatient Sample | PSM | 35,956 | 1055 | 30,840 | 66.2 | 56.9 | 38.9 | 30 | 65.4 | 61.9 | 31.3 | 16.5 | 21.8 | 17 | 32.2 | 16 | 20.9 | 6.1 | NA | NA |
Mentias | 2020 | 2015-2017 | Medicare | PSM | 4061 | 1054 | 3007 | 74.7 | 69.9 | 42.1 | 35 | 90.4 | 80.3 | 41.2 | 26.2 | 20.5 | 9 | 44.3 | 23.9 | 37 | 13.6 | NA | NA |
Husso | 2021 | 2008-2017 | Finn Valve Registry | PSM | 1023 | 103 | 920 | 77.1 | 70.9 | 41.7 | 42 | NA | NA | 27.2 | 19.2 | NA | NA | 25.2 | 13.7 | NA | NA | 4.9 | 3.7 |
Majmunder | 2022 | 2016-2018 | Nationwide Readmission Database | PSM | 17,068 | 1629 | 15,439 | 69.6 | 58.5 | 36.3 | 31.2 | 80.2 | 68.1 | 30.4 | 25.2 | 37.3 | 30.8 | 32.5 | 17.3 | 27.9 | 8.1 | NA | NA |
Stroke/TIA (%) | Peripheral artery disease (%) | Prior CABG (%) | Prior PCI (%) | euroSCORE II | STS-PROM | Bicuspid aortic valve type | TAVR access | TAVR valve used | Concomitant procedure with SAVR | ||||||||||||||
TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR | SAVR | TAVR/SAVR | TAVR | TAVR | SAVR | ||||||||
9 | 4.1 | 27.5 | 30.5 | 13.7 | 1.2 | 10 | 3.3 | NA | NA | NA | NA | NA | Transapical 10.4% (n = 110) | NA | NA | ||||||||
14.4 | 8.2 | 37.7 | 38 | NA | NA | 22.2 | 5.3 | NA | NA | NA | NA | NA | NA | NA | CABG 24% Ascending aorta surgery 11% | ||||||||
9.7 | 4.7 | 9.7 | 7.4 | 13.6 | 1.3 | 18.4 | 6.6 | 4.8 | 3 | 3.4 | 2.2 | NA | NA | New Generation 81.6% (Sapien, Edwards Lifesciences, 3 (n = 63), Evolut R/CoreValve, Medtronic, (n = 8), Lotus, Boston Scientific, (n = 11), Accurate Neo, Boston Scientific, (n = 2)) Old Generation 18.4% (Medtronic CoreValve (n = 2), Edwards Sapient XT (n = 17)) | CABG 25.3% | ||||||||
7.9 | 4.2 | 27.2 | 25.2 | 9.6 | 1.4 | 12.6 | 3.8 | NA | NA | NA | NA | Type 0; 16.5% Type 1; 81.6%, Type 2; 1.9% | Transapical 6.7% (n = 5) | NA | NA |
Author | Year | Period | Variables |
---|---|---|---|
Elbadawi | 2019 | 2012-2016 | Age, sex, race, diabetes mellitus, hypertension, obesity (defined as body mass index >30 kg/m2), history of heart failure, chronic lung disease, peripheral artery disease, pulmonary circulation disorders, chronic liver disease, chronic kidney disease, chronic anemia, fluid or electrolyte disturbance, coagulopathy, hypothyroidism, smoking, implantable cardioverter-defibrillator, history of cardiac pacemaker, carotid artery disease, prior stroke, prior percutaneous coronary intervention, prior CABG, hospital bed size, hospital region, and hospital teaching status. |
Mentias | 2020 | 2015-2017 | Age, sex, race, hypertension, diabetes, heart failure, coronary artery, lung, kidney, liver, and peripheral arterial disease, atrial fibrillation, stroke, pulmonary hypertension, coronary revascularization, coagulopathy, anemia, weight loss, obesity, electrolyte abnormalities, psychosis, depression, drug and alcohol abuse, connective tissue disease, hypothyroidism, lymphoma, prior bleeding, gastrointestinal bleed, prior implantable cardioverter-defibrillator or pacemaker, sleep apnea, smoking, ascending aortic aneurysm, and frailty. |
Husso | 2021 | 2008-2017 | Age, sex, body mass index, hemoglobin, estimated glomerular filtration rate according to the Chronic Kidney Disease Epidemiology Collaboration equation, diabetes, stroke, pulmonary disease, atrial fibrillation, extracardiac arteriopathy, New York Heart Association class IV, Geriatric Frailty Status Scale 2-3, urgent/emergency procedure, prior pacemaker, acute heart failure within 60 d from the index procedure, prior cardiac surgery, prior percutaneous coronary intervention, left ventricular ejection fraction ≤ 50%, number of diseased vessels and STS score. |
Majumdar | 2022 | 2016-2018 | Age, sex, hypertension, diabetes, hyperlipidemia, peripheral vascular disease, stroke/TIA, chronic heart failure, atrial fibrillation, prior PCI, prior CABG, obesity, chronic pulmonary disease, chronic renal failure, chronic liver disease, smoking, carotid artery disease, pulmonary circulation disorder, history of pacemaker/defibrillator, hospital bed side, teaching status, hospital region, hospital procedure volume, type of admission. |
Author | Year | Confounding | Selection of participants | Classification of interventions | Deviations from intended intervention | Missing data | Measurement of outcomes | Selection of the reported results | Overall quality |
---|---|---|---|---|---|---|---|---|---|
Elbadawi | 2019 | Moderate | Low | Low | Low | Moderate | Low | Low | Moderate |
Mentias | 2020 | Moderate | Low | Low | Low | Moderate | Low | Low | Moderate |
Husso | 2021 | Moderate | Low | Low | Low | Low | Low | Low | Moderate |
Majmunder | 2022 | Moderate | Low | Low | Low | Moderate | Low | Low | Moderate |
References
- Bicuspid aortic valve disease.J Am Coll Cardiol. 2010; 55: 2789-2800https://doi.org/10.1016/j.jacc.2009.12.068
- Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients.N Engl J Med. 2019; 380: 1695-1705https://doi.org/10.1056/nejmoa1814052
- Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients.N Engl J Med. 2019; 380: 1706-1715https://doi.org/10.1056/nejmoa1816885
- The International Society for Minimally Invasive Cardiothoracic Surgery Expert Consensus Statement on transcatheter and surgical aortic valve replacement in low- and intermediate-risk patients: a meta-analysis of randomized and propensity-matched studies.Innov Technol Tech Cardiothorac Vasc Surg. 2021; 16: 3-16https://doi.org/10.1177/1556984520978316
- Temporal trends and outcomes of transcatheter versus surgical aortic valve replacement for bicuspid aortic valve stenosis.JACC Cardiovasc Interv. 2019; 12: 1811-1822https://doi.org/10.1016/j.jcin.2019.06.037
- Meta-analysis of effectiveness and safety of transcatheter aortic valve implantation versus surgical aortic valve replacement in low-to-intermediate surgical risk cohort.Am J Cardiol. 2019; 124: 580-585https://doi.org/10.1016/j.amjcard.2019.05.017
- Outcomes in transcatheter aortic valve replacement for bicuspid versus tricuspid aortic valve stenosis.J Am Coll Cardiol. 2017; 69: 2579-2589https://doi.org/10.1016/j.jacc.2017.03.017
- Outcomes after transcatheter aortic valve replacement in bicuspid versus tricuspid anatomy: a systematic review and meta-analysis.JACC Cardiovasc Interv. 2021; 14: 2144-2155https://doi.org/10.1016/j.jcin.2021.07.052
- The PARTNER 3 Bicuspid Registry for transcatheter aortic valve replacement in low-surgical-risk patients.JACC Cardiovasc Interv. 2022; 15: 523-532https://doi.org/10.1016/j.jcin.2022.01.279
- Propensity-matched 1-year outcomes following transcatheter aortic valve replacement in low-risk bicuspid and tricuspid patients.JACC Cardiovasc Interv. 2022; 15: 511-522https://doi.org/10.1016/j.jcin.2021.10.027
- Meta-analysis of transcatheter aortic valve implantation for bicuspid versus tricuspid aortic valves.J Cardiol. 2019; 74: 40-48https://doi.org/10.1016/j.jjcc.2019.03.018
- The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration.PLoS Med. 2009; 6e1000100https://doi.org/10.1371/journal.pmed.1000100
- ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions.BMJ. 2016; 355: 4-10https://doi.org/10.1136/bmj.i4919
- The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials.BMJ. 2011; 343: 1-9https://doi.org/10.1136/bmj.d5928
- What's the relative risk? A method of correcting the odds ratio in cohort studies of common outcomes.J Am Med Assoc. 1998; 280: 1690-1691https://doi.org/10.1001/jama.280.19.1690
- Practical methods for incorporating summary time-to-event data into meta-analysis.Trials. 2007; 8: 1-16https://doi.org/10.1186/1745-6215-8-16
- Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints.Stat Med. 1998; 17: 2815-2834
- Aggregate data meta-analysis with time-to-event outcomes.Stat Med. 2002; 21: 3337-3351https://doi.org/10.1002/sim.1303
- Outlier and influence diagnostics for meta-analysis.Res Synth Methods. 2010; 1: 112-115https://doi.org/10.1002/jrsm.11
- Transcatheter versus surgical aortic valve replacement in patients with bicuspid aortic valve stenosis.J Am Coll Cardiol. 2020; 75: 2518-2519https://doi.org/10.1016/j.jacc.2020.02.069
- Transcatheter and surgical aortic valve replacement in patients with bicuspid aortic valve.Clin Res Cardiol. 2021; 110: 429-439https://doi.org/10.1007/s00392-020-01761-3
- Early outcomes of transcatheter versus surgical aortic valve implantation in patients with bicuspid aortic valve stenosis.EuroIntervention. 2022; 18: 23-32https://doi.org/10.4244/EIJ-D-21-00757
- Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 Consensus Document.J Am Coll Cardiol. 2012; 60: 1438-1454https://doi.org/10.1016/j.jacc.2012.09.001
Percy ED, Harloff M, Hirji S, Tartarini RJ, McGurk S, Cherkasky O, et al. Outcomes of procedural complications in transfemoral transcatheter aortic valve replacement. J Thorac Cardiovasc Surg. May 4, 2021 [Epub ahead of print]. https://doi.org/10.1016/j.jtcvs.2021.04.082.
- Prognostic significance of mild aortic regurgitation in predicting mortality after transcatheter aortic valve replacement.J Thorac Cardiovasc Surg. 2016; 152: 783-790https://doi.org/10.1016/j.jtcvs.2016.05.023
- Brain injury after transcatheter replacement of bicuspid versus tricuspid aortic valves.J Am Coll Cardiol. 2020; 76: 2579-2590https://doi.org/10.1016/j.jacc.2020.09.605
- Validation of the VARC-3 technical success definition in patients undergoing TAVR.JACC Cardiovasc Interv. 2022; 15: 353-364https://doi.org/10.1016/j.jcin.2021.11.013
- Valve academic research consortium 3: updated endpoint definitions for aortic valve clinical research.J Am Coll Cardiol. 2021; 77: 2717-2746https://doi.org/10.1016/j.jacc.2021.02.038
- Prevalence of permanent pacemaker implantation after conventional aortic valve replacement-a propensity-matched analysis in patients with a bicuspid or tricuspid aortic valve: a benchmark for transcatheter aortic valve replacement.Eur J Cardiothorac Surg. 2020; 58: 130-137https://doi.org/10.1093/ejcts/ezaa053
- Characteristics and long-term outcomes of contemporary patients with bicuspid aortic valves.J Thorac Cardiovasc Surg. 2016; 151: 1650-1659.e1https://doi.org/10.1016/j.jtcvs.2015.12.019
- Long-term fate of dilated ascending aorta after aortic valve replacement for bicuspid versus tricuspid aortic valve disease.Am J Cardiol. 2020; 129: 53-59https://doi.org/10.1016/j.amjcard.2020.05.026
- Prevalence and prognostic impact of ascending aortic dilatation in patients undergoing TAVR.JACC Cardiovasc Imaging. 2020; 13: 175-177https://doi.org/10.1016/j.jcmg.2019.07.025
- Bicuspid aortic valve morphology and outcomes after transcatheter aortic valve replacement.J Am Coll Cardiol. 2020; 76: 1018-1030https://doi.org/10.1016/j.jacc.2020.07.005
- Effect of aortic aneurysm replacement on outcomes after bicuspid aortic valve surgery: validation of contemporary guidelines.J Thorac Cardiovasc Surg. 2014; 148: 2060-2069https://doi.org/10.1016/j.jtcvs.2014.03.027
- A bicuspid aortic valve imaging classification for the TAVR era.JACC Cardiovasc Imaging. 2016; 9: 1145-1158https://doi.org/10.1016/j.jcmg.2015.12.022
- Life expectancy after surgical aortic valve replacement.J Am Coll Cardiol. 2021; 78: 2147-2157https://doi.org/10.1016/j.jacc.2021.09.861
- Clinical impact of conduction disturbances in transcatheter aortic valve replacement recipients: a systematic review and meta-analysis.Eur Heart J. 2020; 41: 2771-2781https://doi.org/10.1093/eurheartj/ehz924
- Regulatory approval and practice guidelines involving cardiovascular valve devices: determining the right evidentiary bar.J Am Coll Cardiol. 2020; 76: 992-995https://doi.org/10.1016/j.jacc.2020.06.057
- TAVR for low-risk bicuspid aortic stenosis: when in doubt, randomize.JACC Cardiovasc Interv. 2022; 15: 533-535https://doi.org/10.1016/j.jcin.2022.01.291
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Drs Kuno and Kaneko contributed equally as co-senior authors to this article.
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