Local Anesthesia versus Conscious Sedation among Patients Undergoing Transcatheter Aortic Valve Implantation—A Propensity Score Analysis
Abstract
:1. Introduction
2. Methods
2.1. Study Groups and Definitions
2.2. Statistical Analysis
3. Results
Procedural and Peri-Procedural Outcome
4. Discussion
4.1. Conscious Sedation vs. General Anesthesia
4.2. Local Anesthesia in Non-Cardiology Procedures
5. Limitations
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
- Mayr, N.P.; Michel, J.; Bleiziffer, S.; Tassani, P.; Martin, K. Sedation or general anesthesia for transcatheter aortic valve implantation (TAVI). J. Thorac. Dis. 2015, 7, 1518–1526. [Google Scholar] [PubMed]
- Hyman, M.C.; Vemulapalli, S.; Szeto, W.Y.; Stebbins, A.; Patel, P.A.; Matsouaka, R.A.; Herrmann, H.C.; Anwaruddin, S.; Kobayashi, T.; Desai, N.D.; et al. Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement:Insights from the National Cardiovascular Data Registry Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Circulation 2017, 136, 2132–2140. [Google Scholar] [CrossRef] [PubMed]
- Harjai, K.J.; Bules, T.; Berger, A.; Young, B.; Singh, D.; Carter, R.; Agarwal, S.; Crockett, S.; Mascarenhas, V.; Nawaz, Y.; et al. Efficiency, Safety, and Quality of Life After Transcatheter Aortic Valve Implantation Performed With Moderate Sedation Versus General Anesthesia. Am. J. Cardiol. 2020, 125, 1088–1095. [Google Scholar] [CrossRef] [PubMed]
- Tchetche, D.; De Biase, C. Local Anesthesia-Conscious Sedation: The Contemporary Gold Standard for Transcatheter Aortic Valve Replacement. JACC Cardiovasc. Interv. 2018, 11, 579–580. [Google Scholar] [CrossRef] [PubMed]
- Saia, F.; Palmerini, T.; Marcelli, C.; Chiarabelli, M.; Taglieri, N.; Ghetti, G.; Negrello, F.; Moretti, C.; Bruno, A.G.; Compagnone, M.; et al. Routine minimalist transcatheter aortic valve implantation with local anesthesia only. J. Cardiovasc. Med. 2020, 21, 805–811. [Google Scholar] [CrossRef] [PubMed]
- Piayda, K.D.; Gafoor, S.; Bertog, S.; Doss, M.; Vaskelyte, L.; Matic, P.; Franke, J.; Hofmann, I.; Staiger, N.; Reinartz, M.; et al. True First-Line Local-Anesthesia Only Protocol for Transfemoral TAVI. J. Invasive Cardiol. 2015, 27, 501–508. [Google Scholar] [PubMed]
- Kappetein, A.P.; Head, S.J.; Généreux, P.; Piazza, N.; van Mieghem, N.M.; Blackstone, E.H.; Brott, T.G.; Cohen, D.J.; Cutlip, D.E.; van Es, G.-A.; et al. Updated standardized endpoint definitions for transcatheter aortic valve implantation: The Valve Academic Research Consortium-2 consensus document†. Eur. Heart J. 2012, 33, 2403–2418. [Google Scholar] [CrossRef] [PubMed]
- Herrmann, H.C.; Cohen, D.J.; Hahn, R.T.; Babaliaros, V.C.; Yu, X.; Makkar, R.; McCabe, J.; Szerlip, M.; Kapadia, S.; Russo, M.; et al. Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement. Circ. Cardiovasc. Interv. 2020, 14, 10310. [Google Scholar] [CrossRef] [PubMed]
- Husser, O.; Fujita, B.; Hengstenberg, C.; Frerker, C.; Beckmann, A.; Möllmann, H.; Walther, T.; Bekeredjian, R.; Böhm, M.; Pellegrini, C.; et al. Conscious Sedation Versus General Anesthesia in Transcatheter Aortic Valve Replacement: The German Aortic Valve Registry. JACC Cardiovasc. Interv. 2018, 11, 567–578. [Google Scholar] [CrossRef] [PubMed]
- Mosleh, W.; Mather, J.F.; Amer, M.R.; Hiendlmayr, B.; Kiernan, F.J.; McKay, R.G. Propensity Matched Analysis Comparing Conscious Sedation Versus General Anesthesia in Transcatheter Aortic Valve Implantation. Am. J. Cardiol. 2019, 124, 70–77. [Google Scholar] [CrossRef] [PubMed]
- Thiele, H.; Kurz, T.; Feistritzer, H.J.; Stachel, G.; Hartung, P.; Lurz, P.; Eitel, I.; Marquetand, C.; Nef, H.; Doerr, O.; et al. General Versus Local Anesthesia with Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial. Circulation 2020, 142, 1437–1447. [Google Scholar] [CrossRef] [PubMed]
- Yamamoto, M.; Meguro, K.; Mouillet, G.; Bergoend, E.; Monin, J.L.; Lim, P.; Dubois-Rande, J.L.; Teiger, E. Effect of local anesthetic management with conscious sedation in patients undergoing transcatheter aortic valve implantation. Am. J. Cardiol. 2013, 111, 94–99. [Google Scholar] [CrossRef] [PubMed]
- Maas, E.H.; Pieters, B.M.A.; Van de Velde, M.; Rex, S. General or Local Anesthesia for TAVI? A Systematic Review of the Literature and Meta-Analysis. Curr. Pharm. Des. 2016, 22, 1868–1878. [Google Scholar] [CrossRef] [PubMed]
- Ehret, C.; Rossaint, R.; Foldenauer, A.C.; Stoppe, C.; Stevanovic, A.; Dohms, K.; Hein, M.; Schälte, G. Is local anaesthesia a favourable approach for transcatheter aortic valve implantation? A systematic review and meta-analysis comparing local and general anaesthesia. BMJ Open 2017, 7, e016321. [Google Scholar] [CrossRef] [PubMed]
- Van de Graaf, R.A.; Samuels, N.; Mulder, M.J.H.L.; Eralp, I.; van Es, A.C.G.M.; Dippel, D.W.J.; van der Lugt, A.; Emmer, B.J. Conscious sedation or local anesthesia during endovascular treatment for acute ischemic stroke. Neurology 2018, 91, e19–e25. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Treurniet, K.M.; Berkhemer, O.A.; Immink, R.V.; Lingsma, H.F.; Ward-Van Der Stam, V.M.C.; Hollmann, M.W.; Vuyk, J.; Van Zwam, W.H.; Van Der Lugt, A.; Van Oostenbrugge, R.J.; et al. A decrease in blood pressure is associated with unfavorable outcome in patients undergoing thrombectomy under general anesthesia. J. Neurointerv. Surg. 2018, 10, 107–111. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Whalin, M.K.; Halenda, K.M.; Haussen, D.C.; Rebello, L.C.; Frankel, M.R.; Gershon, R.Y.; Nogueira, R.G. Even small decreases in blood pressure during conscious sedation affect clinical outcome after stroke thrombectomy: An analysis of hemodynamic thresholds. Am. J. Neuroradiol. 2017, 38, 294–298. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Ristikankare, M.; Julkunen, R.; Mattila, M.; Laitinen, T.; Wang, S.X.; Heikkinen, M.; Janatuinen, E.; Hartikainen, J. Conscious sedation and cardiorespiratory safety during colonoscopy. Gastrointest. Endosc. 2000, 52, 48–54. [Google Scholar] [CrossRef] [PubMed]
- Lin, O.S. Performing colonoscopy in elderly and very elderly patients: Risks, costs and benefits. World J. Gastrointest. Endosc. 2014, 6, 220. [Google Scholar] [CrossRef] [PubMed]
- Arbel, Y.; Zivkovic, N.; Mehta, D.; Radhakrishnan, S.; Fremes, S.E.; Rezaei, E.; Cheema, A.N.; Al-Nasser, S.; Finkelstein, A.; Wijeysundera, H.C. Factors associated with length of stay following trans-catheter aortic valve replacement—A multicenter study. BMC Cardiovasc. Disord. 2017, 17, 137. [Google Scholar] [CrossRef] [PubMed] [Green Version]
Entire Cohort | Propensity-Score Matching Cohort | |||||
---|---|---|---|---|---|---|
Local Sedation (N = 425) | Conscious Sedation (N = 2827) | p-Value | Local Sedation (N = 274) | Conscious Sedation (N = 822) | p-Value | |
Age, mean ± SD | 81 ± 8 | 82 ± 7 | <0.001 | 81 ± 7 | 81 ± 7 | NS |
Male, N (%) | 220 (52) | 1349 (48) | 0.09 | 114 (42) | 344 (42) | NS |
Coronary artery disease, N (%) | 181 (43) | 1293 (47) | NS | 174 (63) | 533 (65) | NS |
Prior myocardial infarction N (%) | 30 (11) | 436 (17) | 0.004 | 30 (11) | 431 (17) | NS |
s/p CABG N (%) | 75 (26) | 474 (19) | 0.002 | 70 (25) | 206 (25) | NS |
Past CVA/TIA, N (%) | 54 (13) | 401 (14) | NS | 16 (13) | 130 (16) | NS |
Diabetes mellitus, N (%) | 167 (41) | 1077 (39) | NS | 122 (44) | 356 (43) | NS |
Hypertension, N (%) | 354 (87) | 2353 (85) | NS | 250 (91) | 756 (92) | NS |
Chronic kidney disease, N (%) | 214 (50) | 1091 (39) | <0.001 | 135 (49) | 407 (49) | NS |
Euroscore2, mean ± SD | 4.2 ± 4.1 | 4.8 ± 9 | 0.024 | 4.7 ± 4.5 | 4.6 ± 4.5 | NS |
STS score, mean ± SD | 4.1 ± 2.9 | 4.5 ± 3.4 | 0.01 | 4.4 ± 3.1 | 4.0 ± 2.5 | NS |
Body mass index, mean ± SD | 27.8 ± 4.7 | 27.7 ± 5.0 | NS | 27.8 ± 4.6 | 28.1 ± 8.5 | NS |
Local Sedation (N = 274) | Conscious Sedation (N = 822) | p-Value | |
---|---|---|---|
Simpson EF (%) | 52 ± 11 | 56 ± 11 | 0.037 |
LA Area (cm2) | 25.1 ± 6.7 | 24.8 ± 6 | NS |
Aortic valve Peak Pressure(mmHg) | 70 ± 24 | 71 ± 24 | NS |
Aortic valve Mean Pressure(mmHg) | 44 ± 16 | 44 ± 16 | NS |
Aortic valve area (cm) | 0.7 ± 0.2 | 0.7 ± 0.2 | NS |
Systolic pulmonary artery pressure (mmHg) | 34 ± 21 | 39 ± 17 | 0.001 |
Local Sedation (N = 274) | Conscious Sedation (N = 822) | p-Value | |
---|---|---|---|
Vascular access (Femoral artery) | 272 (99%) | 813 (99%) | NS |
Valve type | |||
Self-expandable | 130 (58%) | 479 (60%) | 0.07 |
Balloon-expandable | 94 (42%) | 306 (38%) | |
Mechanically expandable | 0 (0%) | 16 (2%) | |
Valve size | |||
23 mm | 32 (12%) | 123 (15%) | NS |
26 mm | 100 (36%) | 300 (36%) | |
29 mm | 89 (32%) | 32 (39%) | |
34 mm | 3 (1%) | 28 (3%) | |
Balloon pre-dilatation | 218 (81%) | 489 (61%) | <0.001 |
Balloon post-dilatation | 193 (72%) | 629 (78%) | 0.027 |
Device success | 260 (95%) | 749 (96%) | NS |
Hazard Ratio | 95% Confidence Interval | p-Value | |
---|---|---|---|
Conscious sedation vs. local anesthesia | 2.18 | 1.09–4.36 | 0.028 |
Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. |
© 2022 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
Share and Cite
Berkovitch, A.; Finkelstein, A.; Barbash, I.M.; Kornowski, R.; Fefer, P.; Steinvil, A.; Vaknin Assa, H.; Danenberg, H.; Maor, E.; Guetta, V.; et al. Local Anesthesia versus Conscious Sedation among Patients Undergoing Transcatheter Aortic Valve Implantation—A Propensity Score Analysis. J. Clin. Med. 2022, 11, 3134. https://doi.org/10.3390/jcm11113134
Berkovitch A, Finkelstein A, Barbash IM, Kornowski R, Fefer P, Steinvil A, Vaknin Assa H, Danenberg H, Maor E, Guetta V, et al. Local Anesthesia versus Conscious Sedation among Patients Undergoing Transcatheter Aortic Valve Implantation—A Propensity Score Analysis. Journal of Clinical Medicine. 2022; 11(11):3134. https://doi.org/10.3390/jcm11113134
Chicago/Turabian StyleBerkovitch, Anat, Ariel Finkelstein, Israel M. Barbash, Ran Kornowski, Paul Fefer, Arie Steinvil, Hana Vaknin Assa, Haim Danenberg, Elad Maor, Victor Guetta, and et al. 2022. "Local Anesthesia versus Conscious Sedation among Patients Undergoing Transcatheter Aortic Valve Implantation—A Propensity Score Analysis" Journal of Clinical Medicine 11, no. 11: 3134. https://doi.org/10.3390/jcm11113134