Are Sutureless and Rapid-Deployment Aortic Valves a Serious Alternative to TA-TAVI? A Matched-Pairs Analysis
Abstract
:1. Introduction
2. Methods
2.1. Study Population
2.2. Surgical Procedures
2.3. Matching
2.4. Statistics
3. Results
3.1. Preoperative Data
3.2. Operative Data
3.3. Postoperative Data
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
- Mack, M.J.; Leon, M.B.; Thourani, V.H.; Makkar, R.; Kodali, S.K.; Russo, M.; Kapadia, S.R.; Malaisrie, S.C.; Cohen, D.J.; Pibarot, P.; et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N. Engl. J. Med. 2019, 380, 1695–1705. [Google Scholar] [CrossRef]
- Baumgartner, H.; Falk, V.; Bax, J.J.; De Bonis, M.; Hamm, C.; Holm, P.J.; Iung, B.; Lancellotti, P.; Lansac, E.; Muñoz, D.R.; et al. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur. Heart J. 2017, 38, 2739–2791. [Google Scholar] [CrossRef]
- Leon, M.B.; Smith, C.R.; Mack, M.J.; Miller, D.C.; Moses, J.W.; Svensson, L.G.; Tuzcu, E.M.; Webb, J.G.; Fontana, G.P.; Makkar, R.; et al. Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery. N. Engl. J. Med. 2010, 363, 1597–1607. [Google Scholar] [CrossRef] [Green Version]
- Smith, C.R.; Leon, M.B.; Mack, M.J.; Miller, D.C.; Moses, J.W.; Svensson, L.G.; Tuzcu, E.M.; Webb, J.G.; Fontana, G.P.; Makkar, R.R.; et al. Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients. N. Engl. J. Med. 2011, 364, 2187–2198. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Adams, D.H.; Popma, J.J.; Reardon, M.J.; Yakubov, S.J.; Coselli, J.S.; Deeb, G.M.; Gleason, T.G.; Buchbinder, M.; Hermiller, J.; Kleiman, N.S.; et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Prosthesis. N. Engl. J. Med. 2014, 370, 1790–1798. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Mack, M.J.; Leon, M.B.; Smith, C.R.; Miller, D.C.; Moses, J.W.; Tuzcu, E.M.; Webb, J.G.; Douglas, P.S.; Anderson, W.N.; Blackstone, E.H.; et al. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): A randomised controlled trial. Lancet 2015, 385, 2477–2484. [Google Scholar] [CrossRef]
- Thyregod, H.G.H.; Steinbrüchel, D.A.; Ihlemann, N.; Nissen, H.; Kjeldsen, B.J.; Petursson, P.; Chang, Y.; Franzen, O.W.; Engstrøm, T.; Clemmensen, P.; et al. Transcatheter Versus Surgical Aortic Valve Replacement in Patients with Severe Aortic Valve Stenosis: 1-Year Results from the All-Comers NOTION Randomized Clinical Trial. J. Am. Coll. Cardiol. 2015, 65, 2184–2194. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Deeb, G.M.; Reardon, M.J.; Chetcuti, S.; Patel, H.J.; Grossman, P.M.; Yakubov, S.J.; Kleiman, N.S.; Coselli, J.S.; Gleason, T.G.; Lee, J.S.; et al. 3-Year Outcomes in High-Risk Patients Who Underwent Surgical or Transcatheter Aortic Valve Replacement. J. Am. Coll. Cardiol. 2016, 67, 2565–2574. [Google Scholar] [CrossRef] [PubMed]
- Leon, M.B.; Smith, C.R.; Mack, M.J.; Makkar, R.R.; Svensson, L.G.; Kodali, S.K.; Thourani, V.H.; Tuzcu, E.M.; Miller, D.C.; Herrmann, H.C.; et al. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N. Engl. J. Med. 2016, 374, 1609–1620. [Google Scholar] [CrossRef]
- Thourani, V.H.; Kodali, S.; Makkar, R.R.; Herrmann, H.C.; Williams, M.; Babaliaros, V.; Smalling, R.; Lim, S.; Malaisrie, S.C.; Kapadia, S.; et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: A propensity score analysis. Lancet 2016, 387, 2218–2225. [Google Scholar] [CrossRef]
- Siontis, G.C.; Praz, F.; Pilgrim, T.; Mavridis, D.; Verma, S.; Salanti, G.; Søndergaard, L.; Jüni, P.; Windecker, S. Transcatheter aortic valve implantation vs. surgical aortic valve replacement for treatment of severe aortic stenosis: A meta-analysis of randomized trials. Eur. Heart J. 2016, 37, 3503–3512. [Google Scholar] [CrossRef] [Green Version]
- Reardon, M.J.; Van Mieghem, N.M.; Popma, J.J.; Kleiman, N.S.; Søndergaard, L.; Mumtaz, M.; Adams, D.H.; Deeb, G.M.; Maini, B.; Gada, H.; et al. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N. Engl. J. Med. 2017, 376, 1321–1331. [Google Scholar] [CrossRef] [PubMed]
- D’Onofrio, A.; Messina, A.; Lorusso, R.; Alfieri, O.R.; Fusari, M.; Rubino, P.; Rinaldi, M.; Di Bartolomeo, R.; Glauber, M.; Troise, G.; et al. Sutureless aortic valve replacement as an alternative treatment for patients belonging to the “gray zone” between transcatheter aortic valve implantation and conventional surgery: A propensity-matched, multicenter analysis. J. Thorac. Cardiovasc. Surg. 2012, 144, 1010–1018. [Google Scholar] [CrossRef] [Green Version]
- Santarpino, G.; Pollari, F.; Fischlein, T. Sutureless versus transcatheter aortic valve implantation: An unresolved dilemma. J. Thorac. Cardiovasc. Surg. 2014, 148, 364–365. [Google Scholar] [CrossRef] [Green Version]
- Santarpino, G.; Pfeiffer, S.; Jessl, J.; Dell’Aquila, A.M.; Pollari, F.; Pauschinger, M.; Fischlein, T. Sutureless replacement versus transcatheter valve implantation in aortic valve stenosis: A propensity-matched analysis of 2 strategies in high-risk patients. J. Thorac. Cardiovasc. Surg. 2014, 147, 561–567. [Google Scholar] [CrossRef] [Green Version]
- Santarpino, G.; Pfeiffer, S.; Jessl, J.; Dell’Aquila, A.; Vogt, F.; Von Wardenburg, C.; Schwab, J.; Sirch, J.; Pauschinger, M.; Fischlein, T. Clinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation with Propensity Score Matching Analysis. Am. J. Cardiol. 2015, 116, 1737–1743. [Google Scholar] [CrossRef]
- Kamperidis, V.; van Rosendael, P.J.; de Weger, A.; Katsanos, S.; Regeer, M.; van der Kley, F.; Mertens, B.; Sianos, G.; Marsan, N.A.; Bax, J.J.; et al. Surgical sutureless and transcatheter aortic valves: Hemodynamic performance and clinical outcomes in propensity score-matched high-risk populations with severe aortic stenosis. JACC Cardiovasc. Interv. 2015, 8, 670–677. [Google Scholar] [CrossRef] [Green Version]
- Muneretto, C.; Bisleri, G.; Moggi, A.; di Bacco, L.; Tespili, M.; Repossini, A.; Rambaldini, M. Treating the patients in the ’grey-zone’ with aortic valve disease: A comparison among conventional surgery, sutureless valves and transcatheter aortic valve replacement. Interact. Cardiovasc. Thorac. Surg. 2015, 20, 90–95. [Google Scholar] [CrossRef] [Green Version]
- Miceli, A.; Gilmanov, D.; Murzi, M.; Marchi, F.; Ferrarini, M.; Cerillo, A.G.; Quaini, E.; Solinas, M.; Berti, S.; Glauber, M. Minimally invasive aortic valve replacement with a sutureless valve through a right anterior mini-thoracotomy versus transcatheter aortic valve implantation in high-risk patients. Eur. J. Cardio Thorac. Surg. 2015, 49, 960–965. [Google Scholar] [CrossRef] [Green Version]
- Takagi, H.; Umemoto, T. Sutureless aortic valve replacement may improve early mortality compared with transcatheter aortic valve implantation: A meta-analysis of comparative studies. J. Cardiol. 2016, 67, 504–512. [Google Scholar] [CrossRef] [Green Version]
- Repossini, A.; Fischlein, T.; Solinas, M.; Di Bacco, L.; Passaretti, B.; Grubitzsch, H.; Folliguet, T.; Santarpino, G.; Di Bartolomeo, R.; Laborde, F.; et al. Stentless sutureless and transcatheter valves: A comparison of the hemodynamic performance of different prostheses concept. Minerva Cardioangiol. 2017, 66, 180–190. [Google Scholar] [CrossRef]
- Santarpino, G.; Gregorini, R.; Specchia, L.; Albano, A.; Nicoletti, A.; Fischlein, T. Sutureless aortic valve replacement vs. transcatheter aortic valve implantation: A review of a single center experience. Minerva Cardioangiol. 2017, 66, 160–162. [Google Scholar]
- Ferrari, E.; Eeckhout, E.; Keller, S.; Muller, O.; Tozzi, P.; Berdajs, D.; Von Segesser, L.K. Transfemoral versus transapical approach for transcatheter aortic valve implantation: Hospital outcome and risk factor analysis. J. Cardiothorac. Surg. 2017, 12, 78. [Google Scholar] [CrossRef] [Green Version]
- Imnadze, G.; Hofmann, S.; Billion, M.; Ferdosi, A.; Kowalski, M.; Smith, K.; Deutsch, C.; Bramlage, P.; Warnecke, H.; Franz, N. Transapical transcatheter aortic valve implantation in patients with a low ejection fraction. Interact. Cardiovasc. Thorac. Surg. 2017, 26, 224–229. [Google Scholar] [CrossRef]
- di Eusanio, M.; Phan, K.; Berretta, P.; Carrel, T.P.; Andreas, M.; Santarpino, G.; di Bartolomeo, R.; Folliguet, T.; Meuris, B.; Mignosa, C.; et al. Sutureless and Rapid-Deployment Aortic Valve Replacement International Registry (SURD-IR): Early results from 3343 patients. Eur. J. Cardiothorac. Surg. 2018. [Google Scholar] [CrossRef]
- Kapadia, S.; Agarwal, S.; Miller, D.C.; Webb, J.G.; Mack, M.; Ellis, S.; Herrmann, H.C.; Pichard, A.D.; Tuzcu, E.M.; Svensson, L.G.; et al. Insights into Timing, Risk Factors, and Outcomes of Stroke and Transient Ischemic Attack After Transcatheter Aortic Valve Replacement in the PARTNER Trial (Placement of Aortic Transcatheter Valves). Circ. Cardiovasc. Interv. 2016, 9, e002981. [Google Scholar] [CrossRef] [Green Version]
- Kumar, N.; Khera, R.; Fonarow, G.C.; Bhatt, D.L. Comparison of Outcomes of Transfemoral Versus Transapical Approach for Transcatheter Aortic Valve Implantation. Am. J. Cardiol. 2018, 122, 1520–1526. [Google Scholar] [CrossRef] [PubMed]
- Nazif, T.M.; Dizon, J.; Hahn, R.T.; Xu, K.; Babaliaros, V.; Douglas, P.S.; El-Chami, M.F.; Herrmann, H.C.; Mack, M.; Makkar, R.R.; et al. Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: The PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry. JACC Cardiovasc. Interv. 2015, 8, 60–69. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Becker, M.; Blangy, H.; Folliguet, T.; Villemin, T.; Freysz, L.; Luc, A.; Maureira, P.; Popovic, B.; Olivier, A.; Sadoul, N. Incidence, indications and predicting factors of permanent pacemaker implantation after transcatheter aortic valve implantation: A retrospective study. Arch. Cardiovasc. Dis. 2017, 110, 508–516. [Google Scholar] [CrossRef] [PubMed]
- Meco, M.; Miceli, A.; Montisci, A.; Donatelli, F.; Cirri, S.; Ferrarini, M.; Lio, A.; Glauber, M. Sutureless aortic valve replacement versus transcatheter aortic valve implantation: A meta-analysis of comparative matched studies using propensity score matching. Interact. Cardiovasc. Thorac. Surg. 2017, 26, 202–209. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Bjursten, H.; Al-Rashidi, F.; Dardashti, A.; Brondén, B.; Algotsson, L.; Ederoth, P. Risks Associated with the Transfusion of Various Blood Products in Aortic Valve Replacement. Ann. Thorac. Surg. 2013, 96, 494–499. [Google Scholar] [CrossRef] [Green Version]
n = 52 Each Group | TAVI (n and Perc. or Mean ± SDM) | SURD-AVR (n and Perc. or Mean ± SDM) | p Value |
---|---|---|---|
female | 32 (62%) | 32 (62%) | |
age, year | 77 ± 4.3 | 75 ± 4.0 | 0.051 |
log. EuroScore I | 19 ± 12 | 17 ± 10 | 0.257 |
STS Score | 4.48 ± 2.76 | 3.93 ± 2.59 | 0.339 |
art. hypertension | 45 (87%) | 45 (87%) | |
hyperlipidemia | 28 (54%) | 28 (54%) | |
impaired LVF | 7 (13%) | 2 (4%) | 0.160 |
renal insufficiency | 16 (31%) | 9 (17%) | 0.117 |
previous MI | 8 (15%) | 5 (9.6%) | 0.371 |
COPD | 18 (35%) | 15 (29%) | 0.527 |
PAD | 15 (29%) | 8 (15%) | 0.98 |
NYHA I-IV | 2.87 ± 0.44 | 2.67 ± 0.59 | 0.062 |
emergency indication | 0 (0%) | 0 (0%) | |
creatinine (mg/dL) | 1.29 ± 0.73 | 0.92 ± 0.40 | 0.002 |
bilirubin (mg/dL) | 0.56 ± 0.35 | 0.62 ± 0.28 | 0.416 |
BMI | 27.3 ± 5 | 28 ± 5 | 0.440 |
diabetes | 21 (40%) | 22 (42%) | 0.971 |
dialysis | 0 (0%) | 0 (0%) |
n = 52 Each Group | TAVI (n and Perc. or Mean ± SDM) | SURD-AVR (n and Perc. or Mean ± SDM) | p Value |
---|---|---|---|
blood transfusion (U) | 0.72 | 1.46 | 0.014 |
CV accident/stroke | 0 (0%) | 1 (1.9%) | 0.315 |
max. bilirubin (mg/dl) | 0.85 ± 0.5 | 0.5 ± 0.7 | 0.115 |
complete AV block | 1 (1.9%) | 4 (7.7%) | 0.169 |
RF requiring dialysis | 4 (7.7%) | 1 (1.9%) | 0.169 |
ventilation time (h) | 26 ± 66 | 25 ± 21 | 0.914 |
re-intubation | 4 (7.7%) | 1 (1.9%) | 0.169 |
postoperative blood transfusion | 2.02 ± 3.84 | 1.14 ± 2.14 | 0.151 |
low-output syndrome | 3 (5.8%) | 3 (5.8%) | 1 |
AR at discharge | |||
-trace to mild | 13 (25%) | 3 (5.8%) | |
-moderate | 1 (1.9%) | 0 (0%) | 0.013 |
re-thoracotomy | 1 (1.9%) | 0 (0%) | 0.315 |
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Al-Maisary, S.; Farag, M.; Te Gussinklo, W.H.; Kremer, J.; Pleger, S.T.; Leuschner, F.; Karck, M.; Szabo, G.; Arif, R. Are Sutureless and Rapid-Deployment Aortic Valves a Serious Alternative to TA-TAVI? A Matched-Pairs Analysis. J. Clin. Med. 2021, 10, 3072. https://doi.org/10.3390/jcm10143072
Al-Maisary S, Farag M, Te Gussinklo WH, Kremer J, Pleger ST, Leuschner F, Karck M, Szabo G, Arif R. Are Sutureless and Rapid-Deployment Aortic Valves a Serious Alternative to TA-TAVI? A Matched-Pairs Analysis. Journal of Clinical Medicine. 2021; 10(14):3072. https://doi.org/10.3390/jcm10143072
Chicago/Turabian StyleAl-Maisary, Sameer, Mina Farag, Willem Hendrik Te Gussinklo, Jamila Kremer, Sven T. Pleger, Florian Leuschner, Matthias Karck, Gabor Szabo, and Rawa Arif. 2021. "Are Sutureless and Rapid-Deployment Aortic Valves a Serious Alternative to TA-TAVI? A Matched-Pairs Analysis" Journal of Clinical Medicine 10, no. 14: 3072. https://doi.org/10.3390/jcm10143072
APA StyleAl-Maisary, S., Farag, M., Te Gussinklo, W. H., Kremer, J., Pleger, S. T., Leuschner, F., Karck, M., Szabo, G., & Arif, R. (2021). Are Sutureless and Rapid-Deployment Aortic Valves a Serious Alternative to TA-TAVI? A Matched-Pairs Analysis. Journal of Clinical Medicine, 10(14), 3072. https://doi.org/10.3390/jcm10143072