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The learning curve in transcatheter aortic valve implantation clinical studies: A systematic review

Published online by Cambridge University Press:  21 April 2020

Anne-Pauline Thivilliers ,
Rémi Ladarré ,
Océane Merabti ,
Caroline François ,
Sarah Fontenay ,
Hélène van den Brink ,
Judith Pineau ,
Patrice Prognon ,
Isabelle Borget  and
Nicolas Martelli Open the ORCID record for Nicolas Martelli [Opens in a new window]
Anne-Pauline Thivilliers
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France
Rémi Ladarré
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France
Océane Merabti
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France
Caroline François
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France
Sarah Fontenay
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France
Hélène van den Brink
Affiliation:
Faculty of Pharmacy, University Paris-Sud, GRADES, 5 Rue Jean-Baptiste Clément, 92290 Châtenay-Malabry, France
Judith Pineau
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France
Patrice Prognon
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France
Isabelle Borget
Affiliation:
Department of Health Economics, Gustave Roussy Institute, 114, Rue Edouard-Vaillant, 94805Villejuif, France Faculty of Pharmacy, University Paris-Sud, GRADES, 5 Rue Jean-Baptiste Clément, 92290 Châtenay-Malabry, France
Nicolas Martelli
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France Faculty of Pharmacy, University Paris-Sud, GRADES, 5 Rue Jean-Baptiste Clément, 92290 Châtenay-Malabry, France
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Abstract

Background

Transcatheter aortic-valve implantation (TAVI) has become an essential alternative to surgical aortic-valve replacement in the treatment of symptomatic severe aortic stenosis, and this procedure requires technical expertise. The aim of this study was to identify prospective studies on TAVI from the past 10 years, and then to analyze the quality of information reported about the learning curve.

Materials and methods

A systematic review of articles published between 2007 and 2017 was performed using PubMed and the EMBASE database. Prospective studies regarding TAVI were included. The quality of information reported about the learning curve was evaluated using the following criteria: mention of the learning curve, the description of a roll-in phase, the involvement of a proctor, and the number of patients suggested to maintain skills.

Results

A total of sixty-eight studies met the selection criteria and were suitable for analysis. The learning curve was addressed in approximately half of the articles (n = 37, 54 percent). However, the roll-in period was mentioned by only eight studies (12 percent) and with very few details. Furthermore, a proctorship was disclosed in three articles (4 percent) whereas twenty-five studies (37 percent) included authors that were proctors for manufacturers of TAVI.

Conclusion

Many prospective studies on TAVI over the past 10 years mention learning curves as a core component of successful TAVI procedures. However, the quality of information reported about the learning curve is relatively poor, and uniform guidance on how to properly assess the learning curve is still missing.

Keywords

Transcatheter aortic valve implantationPercutaneous valveLearning curveRoll-inSystematic review
Type
Assessment
Information
International Journal of Technology Assessment in Health Care , Volume 36 , Issue 2 , April 2020 , pp. 152 - 161
Copyright
Copyright © Cambridge University Press 2020

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References

Smith, CR, Leon, MB, Mack, MJ, Miller, DC, Moses, JW, Svensson, LG, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011;364:2187–98.10.1056/NEJMoa1103510CrossRefGoogle ScholarPubMed
Vandvik, PO, Otto, CM, Siemieniuk, RA, Bagur, R, Guyatt, GH, Lytvyn, L, et al. Transcatheter or surgical aortic valve replacement for patients with severe, symptomatic, aortic stenosis at low to intermediate surgical risk: A clinical practice guideline. Br Med J. 2016;354:i5085.10.1136/bmj.i5085CrossRefGoogle ScholarPubMed
Mack, MJ, Leon, MB, Smith, CR, Miller, DC, Moses, JW, Tuzcu, EM, 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 (Lond., Engl.) 2015;385:2477–84.10.1016/S0140-6736(15)60308-7CrossRefGoogle ScholarPubMed
Généreux, P, Cohen, DJ, Mack, M, Rodes-Cabau, J, Yadav, M, Xu, K, et al. Incidence, predictors, and prognostic impact of late bleeding complications after transcatheter aortic valve replacement. J Am Coll Cardiol. 2014;64:2605–15.10.1016/j.jacc.2014.08.052CrossRefGoogle ScholarPubMed
Gurvitch, R, Tay, EL, Wijesinghe, N, Ye, J, Nietlispach, F, Wood, DA, et al. Transcatheter aortic valve implantation: Lessons from the learning curve of the first 270 high-risk patients. Catheter Cardiovasc Interv. 2011;78:977–84.10.1002/ccd.22961CrossRefGoogle ScholarPubMed
Alli, OO, Booker, JD, Lennon, RJ, Greason, KL, Rihal, CS, Holmes, DR.Transcatheter aortic valve implantation: Assessing the learning curve. JACC Cardiovasc Interv. 2012;5:72–79.10.1016/j.jcin.2011.09.014CrossRefGoogle ScholarPubMed
Alli, O, Rihal, CS, Suri, RM, Greason, KL, Waksman, R, Minha, S 'ar, et al. Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance. Catheter Cardiovasc Interv. 2016;87:154–62.10.1002/ccd.26120CrossRefGoogle ScholarPubMed
Webb, JG, Altwegg, L, Boone, RH, Cheung, A, Ye, J, Lichtenstein, S, et al. Transcatheter aortic valve implantation: Impact on clinical and valve-related outcomes. Circulation. 2009;119:3009–16.10.1161/CIRCULATIONAHA.108.837807CrossRefGoogle ScholarPubMed
Motte, A-F, Diallo, S, van den Brink, H, Châteauvieux, C, Serrano, C, Naud, C, et al. Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: A systematic review. J Clin Epidemiol. 2017;91:111–20.10.1016/j.jclinepi.2017.07.005CrossRefGoogle Scholar
Gurevich, S, John, R, Kelly, RF, Raveendran, G, Helmer, G, Yannopoulos, D, et al. Avoiding the learning curve for transcatheter aortic valve replacement. Cardiol Res Pract. 2017;2017:7524925.10.1155/2017/7524925CrossRefGoogle ScholarPubMed
Glauber, M, Murzi, M, Cerillo, AG. Is proctoring mandatory when starting a TAVI program? Ann Cardiothorac Surg. 2012;1(2):190–93.Google ScholarPubMed
Medical Device and Health Technology Evaluation Committee (CNEDiMTS). Recommendation, 21st October 2014, Corevalve, Medtronic. Saint-Denis: French National Health Authority (HAS); 2014.Google Scholar
Medical Device and Health Technology Evaluation Committee (CNEDiMTS). Recommendation, 22nd April 2014, Sapien 3, Edwards. Saint-Denis: French National Health Authority (HAS); 2014.Google Scholar
Amoore, JN. A structured approach for investigating the causes of medical device adverse events. J Med Eng. 2014;2014:314138.10.1155/2014/314138CrossRefGoogle ScholarPubMed
Reardon, MJ, Van Mieghem, NM, Popma, JJ, Kleiman, NS, Søndergaard, L, Mumtaz, M, et al. Surgical or transcatheter aortic-valve replacement in intermediate-risk patients. N Engl J Med. 2017;376:1321–31.10.1056/NEJMoa1700456CrossRefGoogle ScholarPubMed
Raman, G, Gaylor, JM, Rao, M, Chan, J, Earley, A, Chang, LKW, et al. Quality of reporting in systematic reviews of implantable medical devices. Rockville, MD: Agency for Healthcare Research and Quality (US); 2012.Google ScholarPubMed
Arai, T, Lefèvre, T, Hovasse, T, Hayashida, K, Watanabe, Y, O'Connor, SA, et al. Evaluation of the learning curve for transcatheter aortic valve implantation via the transfemoral approach. Int J Cardiol. 2016;203:491–97.10.1016/j.ijcard.2015.10.178CrossRefGoogle ScholarPubMed
Webb, JG, Pasupati, S, Humphries, K, Thompson, C, Altwegg, L, Moss, R, et al. Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis. Circulation. 2007;116:755–63.10.1161/CIRCULATIONAHA.107.698258CrossRefGoogle ScholarPubMed
Hernández-Antolín, R.A., García, E., Sandoval, S., Almería, C., Cuadrado, A., Serrano, J., et al. Findings of a mixed transfemoral aortic valve implantation program using Edwards and corevalve devices. Rev Esp Cardiol. 2011;64:35–42.10.1016/j.recesp.2010.07.003CrossRefGoogle ScholarPubMed
Takagi, K, Latib, A, Al-Lamee, R, Mussardo, M, Montorfano, M, Maisano, F, et al. Predictors of moderate-to-severe paravalvular aortic regurgitation immediately after CoreValve implantation and the impact of postdilatation. Catheter Cardiovasc Interv. 2011;78:432–43.Google ScholarPubMed
Leclercq, F, Robert, P, Labour, J, Lattuca, B, Akodad, M, Macia, J-C, et al. Prior balloon valvuloplasty versus DIRECT transcatheter aortic valve implantation (DIRECTAVI): Study protocol for a randomized controlled trial. Trials. 2017;18(1): 303. doi:10.1186/s13063-017-2036-yCrossRefGoogle ScholarPubMed
Deeb, GM, Chetcuti, SJ, Reardon, MJ, Patel, HJ, Grossman, PM, Schreiber, T, et al. 1-year results in patients undergoing transcatheter aortic valve replacement with failed surgical bioprostheses. JACC Cardiovasc Interv. 2017;10:1034–44.10.1016/j.jcin.2017.03.018CrossRefGoogle ScholarPubMed
Musa, TA, Uddin, A, Swoboda, PP, Fairbairn, TA, Dobson, LE, Singh, A, et al. Cardiovascular magnetic resonance evaluation of symptomatic severe aortic stenosis: Association of circumferential myocardial strain and mortality. J Cardiovasc Magn Reson. 2017;19:1–10.CrossRefGoogle ScholarPubMed
Greenbaum, AB, Babaliaros, VC, Chen, MY, Stine, AM, Rogers, T, O'Neill, WW, et al. Transcaval access and closure for transcatheter aortic valve replacement: A prospective investigation. J Am Coll Cardiol. 2017;69:511–21.10.1016/j.jacc.2016.10.024CrossRefGoogle ScholarPubMed
Attizzani, GF, Ohno, Y, Latib, A, Petronio, AS, Giannini, C, Ettori, F, et al. Acute and long-term (2-years) clinical outcomes of the CoreValve 31 mm in large aortic annuli: A multicenter study. Int J Cardiol. 2017;227:543–49.10.1016/j.ijcard.2016.10.104CrossRefGoogle Scholar
Sinning, J-M, Petronio, AS, Van Mieghem, N, Zucchelli, G, Nickenig, G, Bekeredjian, R, et al. Relation between clinical best practices and 6-month outcomes after transcatheter aortic valve implantation with CoreValve (from the ADVANCE II study). Am J Cardiol. 2017;119:84–90.10.1016/j.amjcard.2016.09.016CrossRefGoogle Scholar
D'Ancona, G, Agma, HU, Ince, H, El-Achkar, G, Dißmann, M, Ortak, J, et al. Transcatheter aortic valve implantation with the direct flow medical prosthesis: Impact of native aortic valve calcification degree on outcomes. Catheter Cardiovasc Interv. 2017;89:135–42.10.1002/ccd.26517CrossRefGoogle ScholarPubMed
Conte, L, Fabiani, I, Pugliese, NR, Giannini, C, La Carruba, S, Angelillis, M, et al. Left ventricular stiffness predicts outcome in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation. Echocardiography (Mt Kisco, NY). 2017;34:6–13.10.1111/echo.13402CrossRefGoogle ScholarPubMed
Eidet, J, Dahle, G, Bugge, JF, Bendz, B, Rein, KA, Aaberge, L, et al. Long-term outcomes after transcatheter aortic valve implantation: The impact of intraoperative tissue Doppler echocardiography. Interact Cardiovasc Thorac Surg. 2016;23:403–09.10.1093/icvts/ivw159CrossRefGoogle ScholarPubMed
Ahn, HC, Nielsen, N-E, Baranowski, J. Can predilatation in transcatheter aortic valve implantation be omitted?—A prospective randomized study. J Cardiothorac Surg. 2016;11:124.10.1186/s13019-016-0516-xCrossRefGoogle Scholar
Deeb, GM, Reardon, MJ, Chetcuti, S, Patel, HJ, Grossman, PM, Yakubov, SJ, et al. 3-year Outcomes in high-risk patients who underwent surgical or transcatheter aortic valve replacement. J Am Coll Cardiol. 2016;67:2565–74.10.1016/j.jacc.2016.03.506CrossRefGoogle ScholarPubMed
Thyregod, HGH, Holmberg, F, Gerds, TA, Ihlemann, N, Søndergaard, L, Steinbrüchel, DA, et al. Heart team therapeutic decision-making and treatment in severe aortic valve stenosis. Scand Cardiovasc J. 2016;50:146–53.10.3109/14017431.2016.1148825CrossRefGoogle ScholarPubMed
Barbanti, M, Immè, S, Ohno, Y, Gulino, S, Todaro, D, Sgroi, C, et al. Prosthesis choice for transcatheter aortic valve replacement: Improved outcomes with the adoption of a patient-specific transcatheter heart valve selection algorithm. Int J Cardiol. 2016;203:1009–10.10.1016/j.ijcard.2015.11.105CrossRefGoogle ScholarPubMed
Ribera, A, Slof, J, Andrea, R, Falces, C, Gutiérrez, E, Del Valle-Fernández, R, et al. Transfemoral transcatheter aortic valve replacement compared with surgical replacement in patients with severe aortic stenosis and comparable risk: Cost-utility and its determinants. Int J Cardiol. 2015;182:321–28.10.1016/j.ijcard.2014.12.109CrossRefGoogle ScholarPubMed
Muneretto, C, Bisleri, G, Moggi, A, Di Bacco, L, Tespili, M, Repossini, A, et al. 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.CrossRefGoogle ScholarPubMed
Calleja I, Pascual, Avanzas, P, Munoz Navarro, AJ, Lopez Otero, D, Del Valle, R, Jimenez Navarro, MF, et al. Transcatheter aortic valve implantation in very elderly patients: Immediate results and medium term follow-up. Eur Heart J. 2015;36:895.Google Scholar
Popma, JJ, Adams, DH, Reardon, MJ, Yakubov, SJ, Kleiman, NS, Heimansohn, D, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery. J Am Coll Cardiol. 2014;63:1972–81.CrossRefGoogle ScholarPubMed
Fanning, JP, Wesley, AJ, Platts, DG, Walters, DL, Eeles, EM, Seco, M, et al. The silent and apparent neurological injury in transcatheter aortic valve implantation study (SANITY): Concept, design and rationale. BMC Cardiovasc Disord. 2014;14:45.CrossRefGoogle ScholarPubMed
Schofer, J, Colombo, A, Klugmann, S, Fajadet, J, DeMarco, F, Tchétché, D, et al. Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve. J Am Coll Cardiol. 2014;63:763–68.10.1016/j.jacc.2013.10.013CrossRefGoogle ScholarPubMed
Webb, J, Gerosa, G, Lefèvre, T, Leipsic, J, Spence, M, Thomas, M, et al. Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. J Am Coll Cardiol. 2014;64:2235–43.CrossRefGoogle ScholarPubMed
Wendt, D, Kahlert, P, Pasa, S, El-Chilali, K, Al-Rashid, F, Tsagakis, K, et al. Transapical transcatheter aortic valve for severe aortic regurgitation: Expanding the limits. JACC Cardiovasc Interv. 2014;7:1159–67.CrossRefGoogle ScholarPubMed
Barbanti, M, Petronio, AS, Capodanno, D, Ettori, F, Colombo, A, Bedogni, F, et al. Impact of balloon post-dilation on clinical outcomes after transcatheter aortic valve replacement with the self-expanding CoreValve prosthesis. JACC Cardiovasc Interv. 2014;7:1014–21.10.1016/j.jcin.2014.03.009CrossRefGoogle ScholarPubMed
Kasel, AM, Cassese, S, Ischinger, T, Leber, A, Antoni, D, Riess, G, et al. A prospective, non-randomized comparison of SAPIEN XT and CoreValve implantation in two sequential cohorts of patients with severe aortic stenosis. Am J Cardiovasc Dis. 2014;4:87–99.Google ScholarPubMed
Sawa, Y, Saito, S, Kobayashi, J, Niinami, H, Kuratani, T, Maeda, K, et al. First clinical trial of a self-expandable transcatheter heart valve in Japan in patients with symptomatic severe aortic stenosis. Circ J. 2014;78:1083–90.CrossRefGoogle ScholarPubMed
Hong, S-J, Hong, M-K, Ko, Y-G, Choi, D, Hong, G-R, Shim, J-K, et al. Multidisciplinary team approach for identifying potential candidate for transcatheter aortic valve implantation. Yonsei Med J. 2014;55:1246–52.10.3349/ymj.2014.55.5.1246CrossRefGoogle ScholarPubMed
Fiorina, C, Maffeo, D, Curello, S, Lipartiti, F, Chizzola, G, D'Aloia, A, et al. Direct transcatheter aortic valve implantation with self-expandable bioprosthesis: Feasibility and safety. Cardiovasc Revasc Med. 2014;15:200–03.CrossRefGoogle ScholarPubMed
Reinöhl, J, Gutmann, A, Kollum, M, Von Zur Mühlen, C, Baumbach, H, Avlar, M, et al. Transfemoral aortic valve implantation: Bleeding events, related costs and outcomes. J Thromb Thrombolysis. 2013;35:469–75.CrossRefGoogle ScholarPubMed
Gotzmann, M, Thiessen, A, Lindstaedt, M, Mügge, A, Ewers, A.Left atrial diameter, aortic mean gradient, and hemoglobin for risk stratification in patients undergoing transcatheter aortic valve implantation. Clin Cardiol. 2013;36:228–34.CrossRefGoogle ScholarPubMed
Kempfert, J, Treede, H, Rastan, AJ, Schönburg, M, Thielmann, M, Sorg, S, et al. Transapical aortic valve implantation using a new self-expandable bioprosthesis (ACURATE TA™): 6-month outcomes. Eur J Cardio-Thorac Surg. 2013;43:52–56; discussion 57.CrossRefGoogle ScholarPubMed
Treede, H, Mohr, F-W, Baldus, S, Rastan, A, Ensminger, S, Arnold, M, et al. Transapical transcatheter aortic valve implantation using the JenaValve™ system: Acute and 30-day results of the multicentre CE-mark study. Eur J Cardio-Thorac Surg. 2012;41:e131–8.10.1093/ejcts/ezs129CrossRefGoogle ScholarPubMed
Osnabrugge, RLJ, Head, SJ, Genders, TSS, Van Mieghem, NM, De Jaegere, PPT, van der Boon, RMA, et al. Costs of transcatheter versus surgical aortic valve replacement in intermediate-risk patients. Ann Thorac Surg. 2012;94:1954–60.CrossRefGoogle ScholarPubMed
Jegaden, O, Lapeze, J, Farhart, F, de Gevigney, G. Aortic valve stenosis after previous coronary bypass: Transcatheter valve implantation or aortic valve replacement? J Cardiothorac Surg. 2012;7:47.CrossRefGoogle ScholarPubMed
Yamamoto, M, Meguro, K, Mouillet, G, Bergoend, E, Monin, J-L, Lim, P, et al. Comparison of effectiveness and safety of transcatheter aortic valve implantation in patients aged ≥90 years versus <90 years. Am J Cardiol. 2012;110:1156–63.10.1016/j.amjcard.2012.05.058CrossRefGoogle Scholar
Walther, T, Thielmann, M, Kempfert, J, Schroefel, H, Wimmer-Greinecker, G, Treede, H, et al. PREVAIL TRANSAPICAL: Multicentre trial of transcatheter aortic valve implantation using the newly designed bioprosthesis (SAPIEN-XT) and delivery system (ASCENDRA-II). Eur J Cardio-Thorac Surg. 2012;42:278–83; discussion 283.10.1093/ejcts/ezr325CrossRefGoogle Scholar
Walther, T, Kasimir, M-T, Doss, M, Schuler, G, Simon, P, Schächinger, V, et al. One-year interim follow-up results of the TRAVERCE trial: The initial feasibility study for trans-apical aortic-valve implantation. Eur J Cardiothorac Surg. 2011;39:532–37.CrossRefGoogle ScholarPubMed
Modine, T, Obadia, JF, Choukroun, E, Rioufoul, G, Sudre, A, Laborde, JC, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. 2011;141:487–91, 491.e1.10.1016/j.jtcvs.2010.01.044CrossRefGoogle ScholarPubMed
John, D, Buellesfeld, L, Yuecel, S, Mueller, R, Latsios, G, Beucher, H, et al. Correlation of device landing zone calcification and acute procedural success in patients undergoing transcatheter aortic valve implantations with the self-expanding CoreValve prosthesis. JACC Cardiovasc Interv. 2010;3:233–43.10.1016/j.jcin.2009.11.015CrossRefGoogle ScholarPubMed
Krane, M, Deutsch, M-A, Bleiziffer, S, Schneider, L, Ruge, H, Mazzitelli, D, et al. Quality of life among patients undergoing transcatheter aortic valve implantation. Am Heart J. 2010;160:451–57.CrossRefGoogle ScholarPubMed
Clavel, M-A, Webb, JG, Pibarot, P, Altwegg, L, Dumont, E, Thompson, C, et al. Comparison of the hemodynamic performance of percutaneous and surgical bioprostheses for the treatment of severe aortic stenosis. J Am Coll Cardiol. 2009;53:1883–91.10.1016/j.jacc.2009.01.060CrossRefGoogle ScholarPubMed
Grube, E, Buellesfeld, L, Mueller, R, Sauren, B, Zickmann, B, Nair, D, et al. Progress and current status of percutaneous aortic valve replacement: Results of three device generations of the CoreValve revalving system. Circ Cardiovasc Interv. 2008;1(3):167–75.10.1161/CIRCINTERVENTIONS.108.819839CrossRefGoogle ScholarPubMed
Wöhrle, J, Gonska, B, Rodewald, C, Seeger, J, Scharnbeck, D, Rottbauer, W.Transfemoral aortic valve implantation with the New Edwards Sapien 3 valve for treatment of severe aortic stenosis-impact of valve size in a single center experience. PLoS One. 2016;11:e0151247.CrossRefGoogle ScholarPubMed
Gooley, RP, Talman, AH, Cameron, JD, Lockwood, SM, Meredith, IT.Comparison of self-expanding and mechanically expanded transcatheter aortic valve prostheses. JACC Cardiovasc Interv. 2015;8:962–71.CrossRefGoogle ScholarPubMed
Kapadia, S, Stewart, WJ, Anderson, WN, Babaliaros, V, Feldman, T, Cohen, DJ, et al. Outcomes of inoperable symptomatic aortic stenosis patients not undergoing aortic valve replacement: Insight into the impact of balloon aortic valvuloplasty from the PARTNER trial (Placement of AoRtic TraNscathetER Valve trial). JACC Cardiovasc Interv. 2015;8:324–33.10.1016/j.jcin.2014.08.015CrossRefGoogle Scholar
Reardon, MJ, Adams, DH, Coselli, JS, Deeb, GM, Kleiman, NS, Chetcuti, S, et al. Self-expanding transcatheter aortic valve replacement using alternative access sites in symptomatic patients with severe aortic stenosis deemed extreme risk of surgery. J Thorac Cardiovasc Surg. 2014;148:2869–76.e1–7.10.1016/j.jtcvs.2014.07.020CrossRefGoogle ScholarPubMed
Spethmann, S, Dreger, H, Baldenhofer, G, Pflug, E, Sanad, W, Stangl, V, et al. Long-term Doppler hemodynamics and effective orifice areas of Edwards SAPIEN and Medtronic CoreValve prostheses after TAVI. Echocardiography (Mt Kisco, NY). 2014;31:302–10.CrossRefGoogle ScholarPubMed
Yamamoto, M, Hayashida, K, Mouillet, G, Chevalier, B, Meguro, K, Watanabe, Y, et al. Renal function-based contrast dosing predicts acute kidney injury following transcatheter aortic valve implantation. JACC Cardiovasc Interv. 2013;6:479–86.CrossRefGoogle ScholarPubMed
Wendler, O, Dworakowski, R, Monaghan, M, MacCarthy, PA.. Direct transapical aortic valve implantation: A modified transcatheter approach avoiding balloon predilatation. Eur J Cardio-Thorac Surg. 2012;42:734–36.CrossRefGoogle ScholarPubMed
Yared, K, Garcia-Camarero, T, Fernandez-Friera, L, Llano, M, Durst, R, Reddy, AA, et al. Impact of aortic regurgitation after transcatheter aortic valve implantation: Results from the REVIVAL trial. JACC Cardiovasc Imaging. 2012;5:469–77.CrossRefGoogle ScholarPubMed
Nielsen, HHM, Klaaborg, KE, Nissen, H, Terp, K, Mortensen, PE, Kjeldsen, BJ, et al. 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 J Eur Collab Work Group Interv Cardiol Eur Soc Cardiol. 2012;8:383–89.Google ScholarPubMed
Kempfert, J, Van Linden, A, Kim, W-K, Blumenstein, J, Rolf, A, Möllmann, H, et al. Ventricular function assessed by MRI after transapical aortic valve implantation: Apical trauma or simple and safe access? Innov Technol Tech Cardiothorac Vasc Surg. 2012;7:109.Google Scholar
Modine, T, Sudre, A, Delhaye, C, Fayad, G, Lemesle, G, Collet, F, et al. Transcutaneous aortic valve implantation using the left carotid access: Feasibility and early clinical outcomes. Ann Thorac Surg. 2012;93:1489–94.CrossRefGoogle ScholarPubMed
Ong, SH, Bauernschmitt, R, Schuler, G, Mueller, R. Short- and mid-term safety and effectiveness of transcatheter aortic valve implantation in a failing surgical aortic bioprosthesis. Eur J Cardio-Thorac Surg. 2012;42:268–76; discussion 276.10.1093/ejcts/ezs014CrossRefGoogle Scholar
Modine, T, Sudre, A, Collet, F, Delhaye, C, Lemesles, G, Fayad, G, et al. Transcutaneous aortic valve implantation using the axillary/subclavian access with patent left internal thoracic artery to left anterior descending artery: Feasibility and early clinical outcomes. J Thorac Cardiovasc Surg. 2012;144:1416–20.CrossRefGoogle ScholarPubMed
Grube, E, Naber, C, Abizaid, A, Sousa, E, Mendiz, O, Lemos, P, et al. Feasibility of transcatheter aortic valve implantation without balloon pre-dilation: A pilot study. JACC Cardiovasc Interv. 2011;4:751–57.CrossRefGoogle ScholarPubMed
Lefèvre, T, Kappetein, AP, Wolner, E, Nataf, P, Thomas, M, Schächinger, V, et al. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study. Eur Heart J. 2011;32:148–57.CrossRefGoogle ScholarPubMed
Bruschi, G, De Marco, F, Oreglia, J, Colombo, P, Barosi, A, Botta, L, et al. Transcatheter aortic valve implantation for severe aortic stenosis after mitral valve surgery. G Ital Cardiol. 2012;13:170S.Google Scholar
Eidet, J, Dahle, G, Bugge, JF, Bendz, B, Rein, KA, Fosse, E, et al. Transcatheter aortic valve implantation and intraoperative left ventricular function: A myocardial tissue Doppler imaging study. J Cardiothorac Vasc Anesth. 2015;29:115–20.CrossRefGoogle ScholarPubMed
Adams, DH, Popma, JJ, Reardon, MJ. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014;371:967–68.Google ScholarPubMed
Grube, E, Schuler, G, Buellesfeld, L, Gerckens, U, Linke, A, Wenaweser, P, et al. Percutaneous aortic valve replacement for severe aortic stenosis in high-risk patients using the second- and current third-generation self-expanding CoreValve prosthesis: Device success and 30-day clinical outcome. J Am Coll Cardiol. 2007;50:69–76.CrossRefGoogle ScholarPubMed
Fraccaro, C, Napodano, M, Tarantini, G, Gasparetto, V, Gerosa, G, Bianco, R, et al. Expanding the eligibility for transcatheter aortic valve implantation the trans-subclavian retrograde approach using: The III generation CoreValve revalving system. JACC Cardiovasc Interv. 2009;2:828–33.10.1016/j.jcin.2009.06.016CrossRefGoogle ScholarPubMed
Webb, JG, Chandavimol, M, Thompson, CR, Ricci, DR, Carere, RG, Munt, BI, et al. Percutaneous aortic valve implantation retrograde from the femoral artery. Circulation. 2006;113:842–50.CrossRefGoogle ScholarPubMed
Kempfert, J, Rastan, A, Holzhey, D, Linke, A, Schuler, G, van Linden, A, et al. Transapical aortic valve implantation: Analysis of risk factors and learning experience in 299 patients. Circulation. 2011;124:S124–129.CrossRefGoogle ScholarPubMed
Leon, MB, Smith, CR, Mack, M, Miller, DC, Moses, JW, Svensson, LG, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363:1597–607.CrossRefGoogle ScholarPubMed
Kempfert, J, Rastan, AJ, Beyersdorf, F, Schönburg, M, Schuler, G, Sorg, S, et al. Trans-apical aortic valve implantation using a new self-expandable bioprosthesis: Initial outcomes. Eur J Cardio-Thorac Surg. 2011;40:1114–19.10.1016/j.ejcts.2011.01.078CrossRefGoogle ScholarPubMed
Lunardi, M, Pesarini, G, Zivelonghi, C, Piccoli, A, Geremia, G, Ariotti, S, et al. Clinical outcomes of transcatheter aortic valve implantation: From learning curve to proficiency. Open Heart. 2016;3:e000420.CrossRefGoogle Scholar
Khawaja, MZ, Wang, D, Pocock, S, Redwood, SR, Thomas, MR.The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial: Study protocol for a randomized controlled trial. Trials. 2014;15:300.CrossRefGoogle ScholarPubMed
Vallely, MP, Wilson, MK, Adams, M, Ng, MKC. How to set up a successful TAVI program. Ann Cardiothorac Surg. 2012;1(2):185–89.Google ScholarPubMed
Papanna, R, Biau, DJ, Mann, LK, Johnson, A, Moise, KJ.Use of the learning curve-cumulative summation test for quantitative and individualized assessment of competency of a surgical procedure in obstetrics and gynecology: Fetoscopic laser ablation as a model. Am J Obstet Gynecol. 2011;204:218.e1–9.CrossRefGoogle Scholar
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