Embolic Protection with the TriGuard 3 System in Nonagenarian Patients Undergoing Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis
Abstract
:1. Introduction
2. Materials and Methods
2.1. Patient Population
2.2. TriGuard 3TM Device
2.3. TAVR Procedure and Operative Technique
2.4. Study Definitions
2.5. Statistical Analysis
3. Results
4. Discussion
Study Limitations
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
- Nkomo, V.T.; Gardin, J.M.; Skelton, T.N.; Gottdiener, J.S.; Scott, C.G.; Enriquez-Sarano, M. Burden of valvular heart diseases: A population-based study. Lancet 2006, 368, 1005–1011. [Google Scholar] [CrossRef]
- 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]
- 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]
- Latif, A.; Ahsan, M.J.; Lateef, N.; Kapoor, V.; Mirza, M.M.; Anwer, F.; Del Core, M.; Kanmantha Reddy, A. Outcomes of surgical versus transcatheter aortic valve replacement in nonagenarians—A systematic review and meta-analysis. J. Community Hosp. Intern. Med. Perspect. 2021, 11, 128–134. [Google Scholar] [CrossRef]
- Gasior, T.; Mangner, N.; Bijoch, J.; Wojakowski, W. Cerebral embolic protection systems for transcatheter aortic valve replacement. J. Interv. Cardiol. 2018, 31, 891–898. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Habertheuer, A.; Aranda-Michel, E.; Schindler, J.; Gleason, T.G.; Kilic, A.; Kliner, D.; Bianco, V.; Toma, C.; Sultan, I. Longitudinal Outcomes of Nonagenarians Undergoing Transcatheter Aortic Valve Replacement. Ann. Thorac. Surg. 2021, 111, 1520–1528. [Google Scholar] [CrossRef] [PubMed]
- Zadrozny, M.; Hainzer, N.; Mehilli, J.; Jochheim, D.; Gschwendtner, S.; Steffen, J.; Theiss, H.; Braun, D.; Hagl, C.; Sadoni, S.; et al. TAVR in nonagenarians: An analysis investigating safety, efficacy, symptomatic improvement, and long-term survival. J. Cardiol. 2021, 78, 44–50. [Google Scholar] [CrossRef]
- Vlastra, W.; Chandrasekhar, J.; Vendrik, J.; Gutierrez-Ibanes, E.; Tchétché, D.; De Brito, F.S.; Barbanti, M.; Kornowski, R.; Latib, A.; D’Onofrio, A.; et al. Transfemoral TAVR in Nonagenarians. JACC Cardiovasc. Interv. 2019, 12, 911–920. [Google Scholar] [CrossRef]
- De Wit, L.; Theuns, P.; Dejaeger, E.; Devos, S.; Gantenbein, A.R.; Kerckhofs, E.; Schuback, B.; Schupp, W.; Putman, K. Long-term impact of stroke on patients’ health-related quality of life. Disabil. Rehabil. 2017, 39, 1435–1440. [Google Scholar] [CrossRef]
- Eggebrecht, H.; Schmermund, A.; Voigtländer, T.; Kahlert, P.; Erbel, R.; Mehta, R.H. Risk of stroke after transcatheter aortic valve implantation (TAVI): A meta-analysis of 10,037 published patients. EuroIntervention 2012, 8, 129–138. [Google Scholar] [CrossRef]
- Lindley, R.I. Stroke Prevention in the Very Elderly. Stroke 2018, 49, 796–802. [Google Scholar] [CrossRef] [PubMed]
- Seeger, J.; Kapadia, S.R.; Kodali, S.; Linke, A.; Wöhrle, J.; Haussig, S.; Makkar, R.; Mehran, R.; Rottbauer, W.; Leon, M. Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: A patient-level propensity-matched analysis. Eur. Heart J. 2019, 40, 1334–1340. [Google Scholar] [CrossRef] [PubMed]
- Frerker, C.; Schlüter, M.; Sanchez, O.D.; Reith, S.; Romero, M.E.; Ladich, E.; Schröder, J.; Schmidt, T.; Kreidel, F.; Joner, M.; et al. Cerebral Protection During MitraClip Implantation: Initial Experience at 2 Centers. JACC Cardiovasc. Interv. 2016, 9, 171–179. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Van Mieghem, N.M.; van Gils, L.; Ahmad, H.; van Kesteren, F.; van der Werf, H.W.; Brueren, G.; Storm, M.; Lenzen, M.; Daemen, J.; van den Heuvel, A.F.; et al. Filter-based cerebral embolic protection with transcatheter aortic valve implantation: The randomised MISTRAL-C trial. EuroIntervention 2016, 12, 499–507. [Google Scholar] [CrossRef]
- Haussig, S.; Mangner, N.; Dwyer, M.G.; Lehmkuhl, L.; Lücke, C.; Woitek, F.; Holzhey, D.M.; Mohr, F.W.; Gutberlet, M.; Zivadinov, R.; et al. Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial. JAMA 2016, 316, 592–601. [Google Scholar] [CrossRef]
- Mohananey, D.; Sankaramangalam, K.; Kumar, A.; Jobanputra, Y.; Villablanca, P.; Krishnaswamy, A.; Mick, S.; Svensson, L.G.; Tuzcu, E.M.; Kapadia, S.R. Safety and efficacy of cerebral protection devices in transcatheter aortic valve replacement: A clinical end-points meta-analysis. Cardiovasc. Revasc. Med. 2018, 19, 785–791. [Google Scholar] [CrossRef]
- Shimamura, J.; Kuno, T.; Malik, A.; Yokoyama, Y.; Gupta, R.; Ahmad, H.; Briasoulis, A. Safety and efficacy of cerebral embolic protection devices in patients undergoing transcatheter aortic valve replacement: A meta-analysis of in-hospital outcomes. Cardiovasc. Interv. 2021. [Google Scholar] [CrossRef]
- Zulman, D.M.; Sussman, J.B.; Chen, X.; Cigolle, C.T.; Blaum, C.S.; Hayward, R.A. Examining the evidence: A systematic review of the inclusion and analysis of older adults in randomized controlled trials. J. Gen. Intern. Med. 2011, 26, 783–790. [Google Scholar] [CrossRef] [Green Version]
- Rassaf, T.; Heusch, G. The West German Heart and Vascular Center at University Medicine Essen. Eur. Heart J. 2021, 42, 963–964. [Google Scholar] [CrossRef]
- Baumgartner, H.C.; Hung, J.C.-C.; Bermejo, J.; Chambers, J.B.; Edvardsen, T.; Goldstein, S.; Lancellotti, P.; LeFevre, M.; Miller, F., Jr.; Otto, C.M. Recommendations on the echocardiographic assessment of aortic valve stenosis: A focused update from the European Association of Cardiovascular Imaging and the American Society of Echocardiography. Eur. Heart J. Cardiovasc. Imaging 2017, 18, 254–275. [Google Scholar] [CrossRef] [Green Version]
- Pedro, G.M.; Nynke, H.M.K.; Geert, E.H.L.; Pauliina, M.M.; Alexandra, J.L.; Adriaan, O.K.; Michiel, V.; Pieter, R.S. A pilot study with the TriGUARD 3 cerebral embolic protection device. EuroIntervention 2020, 16, e507–e509. [Google Scholar]
- Nazif, T.M.; Moses, J.; Sharma, R.; Dhoble, A.; Rovin, J.; Brown, D.; Horwitz, P.; Makkar, R.; Stoler, R.; Forrest, J.; et al. Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection after Transcatheter Aortic Valve Replacement: REFLECT II. JACC Cardiovasc. Interv. 2021, 14, 515–527. [Google Scholar] [CrossRef] [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]
- Marco, B.; Martijn van, M.; Mark, S.S.; Fortunato, I.; Gian Luca, M.; Douglas, F.M.; Francesco, S.; Alessandro Santo, B.; Cameron, G.D.; Frank van der, K.; et al. Optimising patient discharge management after transfemoral transcatheter aortic valve implantation: The multicentre European FAST-TAVI trial. EuroIntervention 2019, 15, 147–154. [Google Scholar]
- Wood, D.A.; Lauck, S.B.; Cairns, J.A.; Humphries, K.H.; Cook, R.; Welsh, R.; Leipsic, J.; Genereux, P.; Moss, R.; Jue, J.; et al. The Vancouver 3M (Multidisciplinary, Multimodality, but Minimalist) Clinical Pathway Facilitates Safe Next-Day Discharge Home at Low-, Medium-, and High-Volume Transfemoral Transcatheter Aortic Valve Replacement Centers. JACC Cardiovasc. Interv. 2019, 12, 459–469. [Google Scholar] [CrossRef]
- Généreux, P.; Piazza, N.; Alu, M.C.; Nazif, T.; Hahn, R.T.; Pibarot, P.; Bax, J.J.; Leipsic, J.A.; Blanke, P.; Blackstone, E.H.; et al. Valve Academic Research Consortium 3: Updated endpoint definitions for aortic valve clinical research. Eur. Heart J. 2021, 42, 1825–1857. [Google Scholar] [CrossRef]
- Mehran, R.; Rao, S.V.; Bhatt, D.L.; Gibson, C.M.; Caixeta, A.; Eikelboom, J.; Kaul, S.; Wiviott, S.D.; Menon, V.; Nikolsky, E.; et al. Standardized Bleeding Definitions for Cardiovascular Clinical Trials. Circulation 2011, 123, 2736–2747. [Google Scholar] [CrossRef] [Green Version]
- Ahmed, N.; Audebert, H.; Turc, G.; Cordonnier, C.; Christensen, H.; Sacco, S.; Sandset, E.C.; Ntaios, G.; Charidimou, A.; Toni, D.; et al. Consensus statements and recommendations from the ESO-Karolinska Stroke Update Conference, Stockholm, Sweden, 11–13 November 2018. Eur. Stroke J. 2019, 4, 307–317. [Google Scholar] [CrossRef] [Green Version]
- Ahmad, Y.; Nijjer, S.; Cook, C.M.; El-Harasis, M.; Graby, J.; Petraco, R.; Kotecha, T.; Baker, C.S.; Malik, I.S.; Bellamy, M.F.; et al. A new method of applying randomised control study data to the individual patient: A novel quantitative patient-centred approach to interpreting composite end points. Int. J. Cardiol. 2015, 195, 216–224. [Google Scholar] [CrossRef]
- Aggarwal, S.K.; Delahunty RN, N.; Menezes, L.J.; Perry, R.; Wong, B.; Reinthaler, M.; Ozkor, M.; Mullen, M.J. Patterns of solid particle embolization during transcatheter aortic valve implantation and correlation with aortic valve calcification. J. Interv. Cardiol. 2018, 31, 648–654. [Google Scholar] [CrossRef]
- Kahlert, P.; Al-Rashid, F.; Döttger, P.; Mori, K.; Plicht, B.; Wendt, D.; Bergmann, L.; Kottenberg, E.; Schlamann, M.; Mummel, P.; et al. Cerebral embolization during transcatheter aortic valve implantation: A transcranial Doppler study. Circulation 2012, 126, 1245–1255. [Google Scholar] [CrossRef] [PubMed] [Green Version]
- Ahmad, Y.; Howard, J.P. Meta-Analysis of Usefulness of Cerebral Embolic Protection during Transcatheter Aortic Valve Implantation. Am. J. Cardiol. 2021, 146, 69–73. [Google Scholar] [CrossRef] [PubMed]
- Cohen, D.J. Cerebral embolic protection and TAVR outcomes: Results from the TVT Registry. In Proceedings of the Transcatheter Cardiovascular Therapeutics Conference (TCT), Virtual Conference, 14–18 October 2020. [Google Scholar]
- Giustino, G.; Mehran, R.; Veltkamp, R.; Faggioni, M.; Baber, U.; Dangas, G.D. Neurological Outcomes With Embolic Protection Devices in Patients Undergoing Transcatheter Aortic Valve Replacement. JACC Cardiovasc. Interv. 2016, 9, 2124–2133. [Google Scholar] [CrossRef] [PubMed]
- Stachon, P.; Kaier, K.; Heidt, T.; Wolf, D.; Duerschmied, D.; Staudacher, D.; Zehender, M.; Bode, C.; von zur Mühlen, C. The Use and Outcomes of Cerebral Protection Devices for Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement in Clinical Practice. JACC Cardiovasc. Interv. 2021, 14, 161–168. [Google Scholar] [CrossRef]
- Popma, J.J.; Deeb, G.M.; Yakubov, S.J.; Mumtaz, M.; Gada, H.; O’Hair, D.; Bajwa, T.; Heiser, J.C.; Merhi, W.; Kleiman, N.S.; et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N. Engl. J. Med. 2019, 380, 1706–1715. [Google Scholar] [CrossRef]
- 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]
- Stachon, P.; Kaier, K.; Zirlik, A.; Bothe, W.; Heidt, T.; Zehender, M.; Bode, C.; von Zur Mühlen, C. Risk-Adjusted Comparison of In-Hospital Outcomes of Transcatheter and Surgical Aortic Valve Replacement. J. Am. Heart Assoc. 2019, 8, e011504. [Google Scholar] [CrossRef] [Green Version]
- Abdel-Wahab, M.; Thiele, H. Cerebral embolic protection during TAVI: Prevent the unpreventable? Eur. Heart J. 2019, 40, 1340–1341. [Google Scholar] [CrossRef]
- Seeger, J.; Gonska, B.; Otto, M.; Rottbauer, W.; Wöhrle, J. Cerebral Embolic Protection during Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared with Unprotected Procedures. JACC Cardiovasc. Interv. 2017, 10, 2297–2303. [Google Scholar] [CrossRef]
- Doshi, R.; Patel, V.; Shah, P. Comparison of in-hospital outcomes between octogenarians and nonagenarians undergoing transcatheter aortic valve replacement: A propensity matched analysis. J. Geriatr. Cardiol. 2018, 15, 123–130. [Google Scholar] [CrossRef]
- Arsalan, M.; Szerlip, M.; Vemulapalli, S.; Holper, E.M.; Arnold, S.V.; Li, Z.; Dimaio, M.J.; Rumsfeld, J.S.; Brown, D.L.; Mack, M.J. Should Transcatheter Aortic Valve Replacement Be Performed in Nonagenarians? J. Am. Coll. Cardiol. 2016, 67, 1387–1395. [Google Scholar] [CrossRef] [PubMed]
- Baumbach, A.; Mullen, M.; Brickman, A.M.; Aggarwal, S.K.; Pietras, C.G.; Forrest, J.K.; Hildick-Smith, D.; Meller, S.M.; Gambone, L.; den Heijer, P.; et al. Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: Results from the DEFLECT I study. EuroIntervention 2015, 11, 75–84. [Google Scholar] [CrossRef] [PubMed]
- Lansky, A.J.; Schofer, J.; Tchetche, D.; Stella, P.; Pietras, C.G.; Parise, H.; Abrams, K.; Forrest, J.K.; Cleman, M.; Reinöhl, J.; et al. A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: Results from the DEFLECT III trial. Eur. Heart J. 2015, 36, 2070–2078. [Google Scholar] [CrossRef] [PubMed]
- Yamamoto, M.; Mouillet, G.; Meguro, K.; Gilard, M.; Laskar, M.; Eltchaninoff, H.; Fajadet, J.; Iung, B.; Donzeau-Gouge, P.; Leprince, P.; et al. Clinical Results of Transcatheter Aortic Valve Implantation in Octogenarians and Nonagenarians: Insights from the FRANCE-2 Registry. Ann. Thorac. Surg. 2014, 97, 29–36. [Google Scholar] [CrossRef]
- Cubero-Gallego, H.; Pascual, I.; Rozado, J.; Ayesta, A.; Hernandez-Vaquero, D.; Diaz, R.; Alperi, A.; Avanzas, P.; Moris, C. Cerebral protection devices for transcatheter aortic valve replacement. Ann. Transl. Med. 2019, 7, 584. [Google Scholar] [CrossRef]
- Samim, M.; Van Der Worp, B.; Agostoni, P.; Hendrikse, J.; Budde, R.P.J.; Nijhoff, F.; Ramjankhan, F.; Doevendans, P.A.; Stella, P.R. TriGuard™HDH embolic deflection device for cerebral protection during transcatheter aortic valve replacement. Catheter. Cardiovasc. Interv. 2017, 89, 470–477. [Google Scholar] [CrossRef]
- Arnold, M.; Schulz-Heise, S.; Achenbach, S.; Ott, S.; Dörfler, A.; Ropers, D.; Feyrer, R.; Einhaus, F.; Loders, S.; Mahmoud, F.; et al. Embolic cerebral insults after transapical aortic valve implantation detected by magnetic resonance imaging. JACC Cardiovasc. Interv. 2010, 3, 1126–1132. [Google Scholar] [CrossRef] [Green Version]
- Samim, M.; Hendrikse, J.; van der Worp, H.B.; Agostoni, P.; Nijhoff, F.; Doevendans, P.A.; Stella, P.R. Silent ischemic brain lesions after transcatheter aortic valve replacement: Lesion distribution and predictors. Clin. Res. Cardiol. 2015, 104, 430–438. [Google Scholar] [CrossRef] [Green Version]
- Leon, M.B.; Mack, M.J.; Hahn, R.T.; Thourani, V.H.; Makkar, R.; Kodali, S.K.; Alu, M.C.; Madhavan, M.V.; Chau, K.H.; Russo, M.; et al. Outcomes 2 Years after Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk. J. Am. Coll. Cardiol. 2021, 77, 1149–1161. [Google Scholar] [CrossRef]
- Kapadia, S.R.; Kodali, S.; Makkar, R.; Mehran, R.; Lazar, R.M.; Zivadinov, R.; Dwyer, M.G.; Jilaihawi, H.; Virmani, R.; Anwaruddin, S.; et al. Protection Against Cerebral Embolism during Transcatheter Aortic Valve Replacement. J. Am. Coll. Cardiol. 2017, 69, 367–377. [Google Scholar] [CrossRef]
Variables | Overall (n = 51) | Unprotected Group (BEV) (n = 14) | Unprotected Group (SEV) (n = 19) | Cerebral Protection Group (CPG) (n = 18) | p-Value |
---|---|---|---|---|---|
Age (years) | 91.9 ± 1.9 | 92.4 ± 2.1 | 91.6 ± 1.6 | 91.7 ± 2.1 | 0.52 |
Male patients | 22 (43.1) | 8 (57.1) | 6 (31.6) | 8 (44.4) | 0.34 |
Body mass index (kg/m2) | 24.8 ± 3.3 | 25.4 ± 3.5 | 24.6 ± 3.8 | 24.6 ± 2.9 | 0.76 |
NYHA III/IV | 36 (70.6) | 10 (71.4) | 13 (68.4) | 13 (72.2) | 0.97 |
Coronary artery disease | 37 (72.5) | 13 (92.9) | 14 (73.7) | 10 (55.6) | 0.06 |
Prior percutaneous coronary intervention | 26 (51) | 7 (50) | 12 (63.2) | 7 (38.9) | 0.34 |
Atrial fibrillation | 31 (60.8) | 10 (71.4) | 10 (52.6) | 11 (61.1) | 0.55 |
Prior pacemaker | 6 (11.8) | 2 (14.3) | 1 (5.3) | 3 (16.7) | 0.53 |
Previous cerebrovascular event | 13 (25.5) | 1 (7.1) | 4 (21.1) | 8 (44.4) | 0.05 |
Peripheral vascular disease | 14 (27.5) | 3 (21.4) | 8 (42.1) | 3 (16.7) | 0.19 |
Cerebral vascular disease | 13 (25.5) | 1 (7.1) | 4 (21.1) | 8 (44.4) | 0.05 |
Diabetes mellitus | 11 (21.6) | 5 (35.7) | 3 (15.8) | 3 (16.7) | 0.32 |
Renal insufficiency (GFR < 60 mL/min/m2) | 32 (62.7) | 9 (64.3) | 13 (68.4) | 10 (55.6) | 0.71 |
GFR (mL/min/2) | 50.3 ± 16.1 | 47.8 ± 16.2 | 52.0 ± 17.9 | 50.4 ± 14.6 | 0.74 |
Logistic EuroScore (%) | 23.7 ± 13.8 | 27.1 ± 14.4 | 25.9 ± 13.6 | 20.4 ± 13.7 | 0.48 |
EuroScore II (%) | 8.2 ± 8.8 | 5.2 ± 3.0 | 7.2 ± 7.8 | 10.4 ± 11.1 | 0.33 |
Echocardiographic variables | |||||
Left ventricular ejection fraction (%) | 48.7 ± 12.0 | 43.7 ± 13.9 | 51.0 ± 11.7 | 50.1 ± 10.0 | 0.19 |
Aortic Valve Area (cm2) | 0.62 ± 0.15 | 0.59 ± 0.14 | 0.65 ± 0.14 | 0.63 ± 0.18 | 0.49 |
Mean Aortic Pressure Gradient (mmHg) | 44.6 ± 16.8 | 43.4 ± 15.2 | 47.2 ± 19.3 | 42.8 ± 15.9 | 0.74 |
Variables | Overall (n = 51) | Unprotected Group (BEV) (n = 14) | Unprotected Group (SEV) (n = 19) | Cerebral Protection Group (CPG) (n = 18) | p-Value |
---|---|---|---|---|---|
Procedural success | 51 (100) | 14 (100) | 19 (100) | 18 (100) | |
Procedure Time (min) | 63.6 ± 25.7 | 58.9 ± 24.4 | 72.2 ± 30.8 | 58.1 ± 18.8 | 0.26 |
Fluoroscopy time (min:sec) | 10:04 ± 3:50 | 9:17 ± 3:14 | 9:49 ± 4:38 | 10:55 ± 3:20 | 0.48 |
Contrast agent (mL) | 180.7 ± 45.8 | 167.9 ± 47.5 | 187.1 ± 48.6 | 183.9 ± 41.9 | 0.46 |
Area dosage (cGy × cm2) | 3023.1 ± 2370.8 | 2239.4 ± 1698.4 | 4096.6 ± 3010.7 | 2499.6 ± 1626.1 | 0.06 |
Mean Aortic Pressure Gradient Post-TAVR (mmHg) | 9.5 ± 5.0 | 8.4 ± 3.0 | 8.5 ± 4.6 | 11.4 ± 6.3 | 0.19 |
Length of stay (days) | |||||
Length of stay pre-interventional (days) | 6.1 ± 3.6 | 8.4 ± 4.7 a | 5.1 ± 3.1 b | 5.4 ± 2.2 b | 0.02 |
Length of stay postinterventional (days) | 7.5 ± 5.6 | 7.4 ± 3.3 | 7.9 ± 5.0 | 7.0 ± 7.6 | 0.88 |
Length of stay in IMC/ICU (days) | 2.9 ± 3.0 | 3.9 ± 4.1 | 3.5 ± 3.1 | 1.6 ± 1.0 | 0.06 |
Total hospital stay (days) | 13.5 ± 6.5 | 15.7 ± 5.0 | 13.0 ± 6.2 | 12.4 ± 7.7 | 0.32 |
Conscious sedation | 50 (98.0) | 14 (100) | 18 (94.7) | 18 (100) | 0.42 |
Prior Valvuloplasty | 25 (49.0) | 9 (64.3) a | 12 (63.2) b | 4 (22.2) a | 0.02 |
Valve Size Edwards Sapien 3 Ultra | |||||
20 mm | 3 (5.9) | 0 | 0 | 3 (16.7) | |
23 mm | 15 (29.4) | 8 (57.1) | 0 | 7 (38.9) | |
26 mm | 13 (25.5) | 6 (42.9) | 0 | 7 (38.9) | |
29 mm | 1 (2.0) | 0 | 0 | 1 (5.6) | |
Valve Size Medtronic Evolut Pro | |||||
26 mm | 8 (15.7) | 0 | 8 (42.1) | 0 | |
29 mm | 10 (19.6) | 0 | 10 (52.6) | 0 | |
34 mm | 1 (2.0) | 0 | 1 (5.3) | 0 | |
Mean Aortic Pressure Gradient post TAVR (mmHg) | 9.5 ± 5.0 | 8.43 ± 3.00 | 8.5 ± 4.6 | 11.4 ± 6.3 | 0.13 |
Variables | Overall (n = 51) | Unprotected Group (BEV) (n = 14) | Unprotected Group (SEV) (n = 19) | Cerebral Protection Group (CPG) (n = 18) | p-Value |
---|---|---|---|---|---|
New permanent pacemaker | 8 (11.5) | 3 (21.4) | 3 (15.8) | 2 (11.1) | 0.73 |
Acute kidney injury | |||||
Stage 1 | 11 (21.6) | 4 (28.6) | 2 (10.5) | 5 (27.8) | 0.34 |
Stage 2 | 2 (3.9) | 0 | 0 | 2 (11.1) | 0.15 |
Stage 3 | 1 (2.0) | 0 | 1 (5.3) | 0 | 0.42 |
Annular Rupture | 0 | 0 | 0 | 0 | |
Coronary Obstruction | 0 | 0 | 0 | 0 | |
Conversion to open surgery | 0 | 0 | 0 | 0 | |
VARC-3—Bleeding complications | |||||
Type 1—minor bleeding (BARC Type 2) | 16 (31.4) | 3 (21.4) | 8 (42.1) | 5 (27.8) | 0.41 |
Type 2—major bleeding (BARC Type 3a) | 8 (15.7) | 1 (7.1) | 5 (26.3) | 2 (11.1) | 0.26 |
VARC-3—Access site complications | |||||
Minor | 2 (3.9) | 0 | 1 (5.3) | 1 (5.6) | 0.67 |
Major | 0 | 0 | 0 | 0 | |
Death < 30 days | 4 (7.8) | 2 (14.3) | 2 (10.5) | 0 | 0.28 |
Variables | Overall (n = 51) | Unprotected Group (BEV) (n = 14) | Unprotected Group (SEV) (n = 19) | Cerebral Protection Group (CPG) (n = 18) | p-Value |
---|---|---|---|---|---|
Neurological complications | |||||
Postinterventional delirium | 9 (17.6) | 3 (21.4) | 4 (21.1) | 2 (11.1) | 0.66 |
Periprocedural minor non-disabling stroke, delirium | 10 (19.6) | 4 (28.6) | 4 (21.1) | 2 (11.1) | 0.46 |
Periprocedural major disabling stroke | 2 (3.9) | 2 (14.3) | 0 | 0 | 0.06 |
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
Lind, A.; Jánosi, R.A.; Totzeck, M.; Ruhparwar, A.; Rassaf, T.; Al-Rashid, F. Embolic Protection with the TriGuard 3 System in Nonagenarian Patients Undergoing Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis. J. Clin. Med. 2022, 11, 2003. https://doi.org/10.3390/jcm11072003
Lind A, Jánosi RA, Totzeck M, Ruhparwar A, Rassaf T, Al-Rashid F. Embolic Protection with the TriGuard 3 System in Nonagenarian Patients Undergoing Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis. Journal of Clinical Medicine. 2022; 11(7):2003. https://doi.org/10.3390/jcm11072003
Chicago/Turabian StyleLind, Alexander, Rolf Alexander Jánosi, Matthias Totzeck, Arjang Ruhparwar, Tienush Rassaf, and Fadi Al-Rashid. 2022. "Embolic Protection with the TriGuard 3 System in Nonagenarian Patients Undergoing Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis" Journal of Clinical Medicine 11, no. 7: 2003. https://doi.org/10.3390/jcm11072003
APA StyleLind, A., Jánosi, R. A., Totzeck, M., Ruhparwar, A., Rassaf, T., & Al-Rashid, F. (2022). Embolic Protection with the TriGuard 3 System in Nonagenarian Patients Undergoing Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis. Journal of Clinical Medicine, 11(7), 2003. https://doi.org/10.3390/jcm11072003