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The Austrian transcatheter aortic valve implantation (TAVI) Registry — 3 years' data
International Journal of Cardiology 177 (2014) 114–116
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
The Austrian transcatheter aortic valve implantation (TAVI) Registry — 3 years' data David Zweiker f,⁎, Robert Maier f, Gudrun Lamm e, Edwin Maurer g, Matthias Heigert c, Thomas Neunteufl h, Eduard Zeindlhofer k, Michael Grund b, Josef Aichinger a, Kurt Huber d, Jens Schneider j, Johann Pollak i, Olev Luha f, Robert Zweiker f, On behalf of the Austrian Society of Cardiology, Committee on Interventional Cardiology a
Department of Cardiology, Hospital Elisabethinen, Linz, Austria Department of Internal Medicine I, Linz General Hospital, Linz, Austria c Department of Internal Medicine II, University Hospital Salzburg, Salzburg, Austria d Department of Internal Medicine III, Wilhelminenspital, Vienna, Austria e Department of Internal Medicine III, Landesklinikum St. Pölten, St. Pölten, Austria f Division of Cardiology, Department of Internal Medicine, Medical University Graz, Graz, Austria g Department of Internal Medicine II, Klinikum Wels-Grieskirchen, Wels, Austria h Division of Cardiology, Medical University Vienna, Vienna, Austria i Herzzentrum Hietzing, Vienna, Austria j Department of Heart Surgery, University Hospital Salzburg, Salzburg, Austria k Department of Internal Medicine, Hospital Barmherzige Schwestern, Linz, Austria b
a r t i c l e
i n f o
Article history: Received 3 September 2014 Accepted 20 September 2014 Available online xxxx Keywords: TAVI Aortic valve disease Valvular heart disease Registry
Aortic valve stenosis leads to dyspnoea, syncope, heart failure and limited life expectancy, 5-year survival is only 15–50% [1]. For highrisk patients, transcatheter aortic valve implantation (TAVI) has been introduced and is recommended by guidelines [2,3]. The nationwide Austrian TAVI Registry started to monitor TAVI procedures on 1 January 2011. The registry is accessible on the Internet and allows an easy assessment of patient data and procedures. All patients gave written informed consent. The Institutional Review Board of the Medical University Graz approved the registry. This report included all patients with a procedure date from 2011 to 2013. The collected data comprised the demography, baseline ⁎ Corresponding author at: Medical University Graz, Department of Internal Medicine, Division of Cardiology, Auenbruggerplatz 15, 8036 Graz, Austria. Tel.: + 43 664 8650460; fax: +43 316 385 13733. E-mail address: [email protected] (D. Zweiker).
http://dx.doi.org/10.1016/j.ijcard.2014.09.096 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
characteristics including comorbidities, Society of Thoracic Surgeons (STS) Score [4,5], Logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) [6], and quality of life (QoL, measured by the Karnofsky Performance Status Scale [7]). Procedural outcome and events were recorded according to the standardized endpoint definitions from the Valve Academic Research Consortium [8]. Follow-up data included echocardiography and a mobility questionnaire before discharge and after 1, 3, 6, 12, 24 and 36 months. In the assessment period, 959 patients (82 ± 5 years) underwent the procedure in 11 centres for interventional cardiology (representing 100% of Austrian institutions offering TAVI by vascular access sites). Please refer to Table 1 for baseline characteristics. STS Score predicted a 30-day-mortality of 15.4 ± 11.0% and Logistic EuroSCORE was 21.4 ± 13.2%. The registry monitored the implantation of 703 CoreValve valves and 256 Sapien valves. Access sites were the femoral (92%), apex (4%), subclavian artery (2%) and transaortic (2%). The procedure itself lasted 78 ± 42 min. Device implantation success rate was 94%. Intrahospital complications occurred in 24% of cases. Most common were pacemaker implantation (15%), unplanned vascular surgery (4%) and major bleeding (3%). Median follow-up duration was 182 days (0 to 1095 days). Followup data showed a significant reduction of gradients and peak velocity, as well as a substantial improvement of valve area, LV-EF and quality of life (Table 2). Mobility improved in 48% of patients. During the first year after TAVI, 12% of patients required hospitalization, most commonly for cardiac complications and cerebrovascular disease. A number of patients (0.7–2%) suffered from severe aortic regurgitation. Cumulative 1-year event-free survival was 71.7%. Thirtyday survival was 94.9%. Cumulative 1-year mortality was 12.6% (Fig. 1).
D. Zweiker et al. / International Journal of Cardiology 177 (2014) 114–116 Table 1 Baseline patient characteristics.
survival curve censored
956 583 373 959 926 367 709
82 ± 5 83 ± 5 81 ± 6 586 (61) 26 ± 5 15.4 ± 11.0 21.4 ± 13.2
758 739 610 758 769 709 697 709 769 758 709 696 696 709
355 (47) 216 (29) 156 (26) 197 (26) 97 (9) 66 (9) 45 (7) 52 (7) 66 (9) 42 (6) 12 (2) 10 (1) 12 (2) 2 (2)
594
60 ± 10
612 731 479 603 594 689 748 753 418
23 ± 2 4.5 ± 0.7 50 ± 19 0.6 ± 0.2 0.4 ± 0.1 5 (0.7) 19 (3) 79 (10) 48 ± 16
cumulative survival (%)
100 Data of n patients
Clinical Age, years, mean ± SD Age of female patients, years, mean ± SD Age of male patients, years, mean ± SD Gender (female), n (%) Body Mass Index, kg/m2, mean ± SD STS Score, %, mean ± SD Logistic EuroSCORE, %, mean ± SD Coronary artery disease, n (%) Pulmonary hypertension, n (%) Extracardial artery disease, n (%) Previous percutaneous coronary intervention, n (%) Previous pericardiotomy ICU treatment before intervention, n (%) Porcelain aorta, n (%) Neurological disease, n (%) Renal failure, n (%) COPD IV, n (%), Myocardial infarction b 30 days, n (%) Liver cirrhosis, n (%) Previous thoracic radiation, n (%) Unstable angina pectoris, n (%) Quality of life Karnofsky Performance Status Scale, %, mean ± SD Echocardiographic Aortic annulus, mm, mean ± SD vmax, m/s, mean ± SD Mean gradient, mm Hg, mean ± SD Valve opening, cm2, mean ± SD Indexed valve opening, cm2, mean ± SD Aortic regurgitation N II+, n (%) Mitral regurgitation N II+, n (%) LVEF b 30%, n (%) SPAP, mm Hg, mean ± SD
115
95
90
85
80 0
100
200
300
days since procedure Fig. 1. Kaplan–Meier curve showing the 1-year survival after procedure.
The data prove that risk scores based on surgical aortic valve implantation (i.e. Logistic EuroSCORE and STS Risk Score) overestimate the risk of TAVI. As derivative, in 2012 the revised EuroSCORE II was published [9]. It seems to estimate the mortality in patients receiving TAVI more appropriately than current scores [10,11]. The German Aortic Valve Score [12], calculated by patient data of both TAVI and surgical AVR, has also the potential to replace the STS Score and Logistic EuroSCORE for patients with severe aortic stenosis. However, validation by other multicentre registries is missing. Both new scores cannot be applied to data of the Austrian TAVI Registry due to missing variables. Besides reduction of mortality, one main goal of TAVI is the improvement of quality of life. This report shows that after TAVI QoL improves significantly. Additionally, in 96% of cases mobility of surviving patients is as good as or better than before the procedure (Table 2).
Table 2 Follow-up data (*p b 0.05 to baseline). Baseline
Pre-discharge
F/U 3 months
F/U 1 year
Clinical data Better mobility than before procedure, n (%)
–
Poorer mobility than before procedure, n (%)
–
Subjective good state of health, n (%)
–
279 (48) n = 585 25 (4) n = 585 –
NYHA I II III IV Karnofsky Performance Status Scale, %, mean ± SD
–
143 (49) n = 294 11 (4) n = 294 294 (96) n = 306 n = 270 158 (59) 98 (36) 14 (5) 0 (0) –
80 (43) n = 188 7 (4) n = 188 194 (98) n = 197 n = 175 114 (65) 57 (33) 4 (2) 0 (0) –
1.9 ± 0.4* n = 240 1.8 ± 0.3* n = 67 9 ± 8* n = 237 42 ± 17* n = 138 2 (0.8) n = 247 7 (3) n = 244 7 (3)* n = 252
2.0 ± 0.4* n = 176 1.7 ± 0.4* n = 31 10 ± 5* n = 177 44 ± 16 n = 83 1 (0.5) n = 186 3 (2) n = 189 3 (2)* n = 152
Echocardiographical data vmax, m/s, mean ± SD Valve area, cm2, mean ± SD Mean gradient, mm Hg, mean ± SD Systolic pulmonary arterial pressure, mm Hg, mean ± SD Aortic regurgitation N II+, n (%) Mitral regurgitation N II+, n (%) LVEF b 30%, n (%)
60 ± 10 n = 594
n = 551 304 (55) 224 (41) 21 (4) 2 (0.3) 80 ± 20* n = 446
4.5 ± 0.7 n = 731 0.6 ± 0.2 n = 603 51 ± 16 n = 741 48 ± 16 n = 418 5 (0.7) n = 689 19 (3) n = 748 79 (10) n = 753
1.9 ± 0.5* n = 575 1.9 ± 0.4* n = 138 9 ± 4* n = 569 45 ± 15* n = 285 10 (2) n = 602 16 (3) n = 598 16 (3)* n = 597
116
D. Zweiker et al. / International Journal of Cardiology 177 (2014) 114–116
Many countries have introduced TAVI registries [13–20] that include data of 328 [13] to 3933 [19] patients. The average Logistic EuroSCORE is comparable between all registries (17–28%) [13–15,17–20] except for the Italian Observant Registry [16] with a lower EuroSCORE. 30-day mortality in Austria (5.1%) goes in line with other registries. However, 1-year mortality (12.6%) is slightly lower than in other registries that include 1-year follow-up data. The German Aortic Valve Registry (GARY) comprises data of 55% of patients who have undergone either surgical or transcatheter aortic valve implantation in 2011 in Germany [14]. For TAVI, intrahospital mortality was 5.1% [14], cerebrovascular events occurred in 1.7%. One-year mortality is 21.6% with followup data of 98.1% of patients (F.W. Mohr, et al. at the ACC Annual Scientific Session 2013, March 9-11, 2013, San Francisco, United States (Oral presentation) [21]). The European Sentinel Registry was developed to evaluate the outcome of TAVI in more detail than national registries. It reports a mean in-hospital mortality of 7.4% based on data of 4,571 patients from 10 pilot countries [20]. The major limitation of this study is the fact that a number of TAVI cases in Austria implanted by surgical centres are not included in the study. This explains the relatively high number of transfemoral accesses. The strengths of this study include the long followup interval and the fact that all Austrian interventional centres participated in the study. In conclusion, the Austrian TAVI Registry proves that results of clinical studies transfer reliably into medical routine. The registry provides a useful tool to monitor procedures, characteristics and longterm follow-up of TAVI patients. Conflict of interest The authors report no relationships that could be construed as a conflict of interest. Acknowledgments We appreciate gratefully the helpful assistance of Mrs Eugenia Lamont, Mrs Karin Berney and Mr Stefan Zweiker in the preparation of the manuscript. References [1] Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology, European Association for Cardio-Thoracic Surgery, Vahanian A, Alfieri O, Andreotti F, Antunes MJ, et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 2012;33:2451–96. [2] Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin 3rd JP, Guyton RA. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014;129:e521–643.
[3] O'Brien SM, Shahian DM, Filardo G, Ferraris VA, Haan CK, Rich JB, et al. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 2—isolated valve surgery. Ann Thorac Surg 2009;88:S23–42. [4] Shahian DM, Edwards FH. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: introduction. Ann Thorac Surg 2009;88:S1. [5] Roques F, Michel P, Goldstone AR, Nashef SA. The logistic EuroSCORE. Eur Heart J 2003;24:881–2. [6] Karnofsky DA, Burchenal JH. The clinical evaluation of chemotherapeutic agents in cancer. Evaluation of chemotherapeutic agents. Columbia: Columbia Univ. Press; 1949. [7] Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, et al. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium. Eur Heart J 2011;32:205–17. [8] Nashef SA, Roques F, Sharples LD, Nilsson J, Smith C, Goldstone AR, et al. EuroSCORE II. Eur J Cardiothorac Surg 2012;41:734–44 discussion 44–5. [9] Sedaghat A, Sinning JM, Vasa-Nicotera M, Ghanem A, Hammerstingl C, Grube E, et al. The revised EuroSCORE II for the prediction of mortality in patients undergoing transcatheter aortic valve implantation. Clin Res Cardiol 2013;102:821–9. [10] Stahli BE, Tasnady H, Luscher TF, Gebhard C, Mikulicic F, Erhart L, et al. Early and late mortality in patients undergoing transcatheter aortic valve implantation: comparison of the novel EuroScore II with established risk scores. Cardiology 2013;126: 15–23. [11] Kotting J, Schiller W, Beckmann A, Schafer E, Dobler K, Hamm C, et al. German Aortic Valve Score: a new scoring system for prediction of mortality related to aortic valve procedures in adults. Eur J Cardiothorac Surg 2013;43:971–7. [12] Bosmans JM, Kefer J, De Bruyne B, Herijgers P, Dubois C, Legrand V, et al. Procedural, 30-day and one year outcome following CoreValve or Edwards transcatheter aortic valve implantation: results of the Belgian national registry. Interact Cardiovasc Thorac Surg 2011;12:762–7. [13] Hamm CW, Mollmann H, Holzhey D, Beckmann A, Veit C, Figulla HR. The German Aortic Valve Registry (GARY): in-hospital outcome. Eur Heart J 2013;35:1588–98. [14] Munoz-Garcia AJ, Del Valle R, Trillo-Nouche R, Elizaga J, Gimeno F, HernandezAntolin R, et al. The Ibero-American transcatheter aortic valve implantation registry with the CoreValve prosthesis. Early and long-term results. Int J Cardiol 2013;169: 359–65. [15] Onorati F, D'Errigo P, Barbanti M, Rosato S, Covello RD, Maraschini A, et al. Different impact of sex on baseline characteristics and major periprocedural outcomes of transcatheter and surgical aortic valve interventions: results of the multicenter Italian OBSERVANT Registry. J Thorac Cardiovasc Surg 2013;147:1529–39. [16] Sabate M, Canovas S, Garcia E, Hernandez Antolin R, Maroto L, Hernandez JM, et al. In-hospital and mid-term predictors of mortality after transcatheter aortic valve implantation: data from the TAVI National Registry 2010–2011. Rev Esp Cardiol 2013;66:949–58. [17] Blackman DJ, Baxter PD, Gale CP, Moat NE, Maccarthy PA, Hildick-Smith D, et al. Do outcomes from transcatheter aortic valve implantation vary according to access route and valve type? The UK TAVI Registry. J Interv Cardiol 2014;27:86–95. [18] Chopard R, Meneveau N, Chocron S, Gilard M, Laskar M, Eltchaninoff H, et al. Impact of chronic obstructive pulmonary disease on valve academic research consortiumdefined outcomes after transcatheter aortic valve implantation (from the FRANCE 2 Registry). Am J Cardiol 2014;113:1543–9. [19] Wenaweser P, Stortecky S, Heg D, Tueller D, Nietlispach F, Falk V, et al. Short-term clinical outcomes among patients undergoing transcatheter aortic valve implantation in Switzerland: the Swiss TAVI registry. EuroIntervention 2014 (in press). [20] Di Mario C, Eltchaninoff H, Moat N, Goicolea J, Ussia GP, Kala P, et al. The 2011–12 pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: inhospital results in 4,571 patients. EuroIntervention 2013;8:1362–71. [21] Mohr FW, Hamm C, Möllmann H, Holzhey D, Beckmann A, et al. One year results of more than 14,000 patients from the German Aortic Valve Registry. ACC Annual Scientific Session 2013. San Francisco, United States: Oral presentation; 10 March 2013.
Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Letter to the Editor
The Austrian transcatheter aortic valve implantation (TAVI) Registry — 3 years' data David Zweiker f,⁎, Robert Maier f, Gudrun Lamm e, Edwin Maurer g, Matthias Heigert c, Thomas Neunteufl h, Eduard Zeindlhofer k, Michael Grund b, Josef Aichinger a, Kurt Huber d, Jens Schneider j, Johann Pollak i, Olev Luha f, Robert Zweiker f, On behalf of the Austrian Society of Cardiology, Committee on Interventional Cardiology a
Department of Cardiology, Hospital Elisabethinen, Linz, Austria Department of Internal Medicine I, Linz General Hospital, Linz, Austria c Department of Internal Medicine II, University Hospital Salzburg, Salzburg, Austria d Department of Internal Medicine III, Wilhelminenspital, Vienna, Austria e Department of Internal Medicine III, Landesklinikum St. Pölten, St. Pölten, Austria f Division of Cardiology, Department of Internal Medicine, Medical University Graz, Graz, Austria g Department of Internal Medicine II, Klinikum Wels-Grieskirchen, Wels, Austria h Division of Cardiology, Medical University Vienna, Vienna, Austria i Herzzentrum Hietzing, Vienna, Austria j Department of Heart Surgery, University Hospital Salzburg, Salzburg, Austria k Department of Internal Medicine, Hospital Barmherzige Schwestern, Linz, Austria b
a r t i c l e
i n f o
Article history: Received 3 September 2014 Accepted 20 September 2014 Available online xxxx Keywords: TAVI Aortic valve disease Valvular heart disease Registry
Aortic valve stenosis leads to dyspnoea, syncope, heart failure and limited life expectancy, 5-year survival is only 15–50% [1]. For highrisk patients, transcatheter aortic valve implantation (TAVI) has been introduced and is recommended by guidelines [2,3]. The nationwide Austrian TAVI Registry started to monitor TAVI procedures on 1 January 2011. The registry is accessible on the Internet and allows an easy assessment of patient data and procedures. All patients gave written informed consent. The Institutional Review Board of the Medical University Graz approved the registry. This report included all patients with a procedure date from 2011 to 2013. The collected data comprised the demography, baseline ⁎ Corresponding author at: Medical University Graz, Department of Internal Medicine, Division of Cardiology, Auenbruggerplatz 15, 8036 Graz, Austria. Tel.: + 43 664 8650460; fax: +43 316 385 13733. E-mail address: [email protected] (D. Zweiker).
http://dx.doi.org/10.1016/j.ijcard.2014.09.096 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
characteristics including comorbidities, Society of Thoracic Surgeons (STS) Score [4,5], Logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) [6], and quality of life (QoL, measured by the Karnofsky Performance Status Scale [7]). Procedural outcome and events were recorded according to the standardized endpoint definitions from the Valve Academic Research Consortium [8]. Follow-up data included echocardiography and a mobility questionnaire before discharge and after 1, 3, 6, 12, 24 and 36 months. In the assessment period, 959 patients (82 ± 5 years) underwent the procedure in 11 centres for interventional cardiology (representing 100% of Austrian institutions offering TAVI by vascular access sites). Please refer to Table 1 for baseline characteristics. STS Score predicted a 30-day-mortality of 15.4 ± 11.0% and Logistic EuroSCORE was 21.4 ± 13.2%. The registry monitored the implantation of 703 CoreValve valves and 256 Sapien valves. Access sites were the femoral (92%), apex (4%), subclavian artery (2%) and transaortic (2%). The procedure itself lasted 78 ± 42 min. Device implantation success rate was 94%. Intrahospital complications occurred in 24% of cases. Most common were pacemaker implantation (15%), unplanned vascular surgery (4%) and major bleeding (3%). Median follow-up duration was 182 days (0 to 1095 days). Followup data showed a significant reduction of gradients and peak velocity, as well as a substantial improvement of valve area, LV-EF and quality of life (Table 2). Mobility improved in 48% of patients. During the first year after TAVI, 12% of patients required hospitalization, most commonly for cardiac complications and cerebrovascular disease. A number of patients (0.7–2%) suffered from severe aortic regurgitation. Cumulative 1-year event-free survival was 71.7%. Thirtyday survival was 94.9%. Cumulative 1-year mortality was 12.6% (Fig. 1).
D. Zweiker et al. / International Journal of Cardiology 177 (2014) 114–116 Table 1 Baseline patient characteristics.
survival curve censored
956 583 373 959 926 367 709
82 ± 5 83 ± 5 81 ± 6 586 (61) 26 ± 5 15.4 ± 11.0 21.4 ± 13.2
758 739 610 758 769 709 697 709 769 758 709 696 696 709
355 (47) 216 (29) 156 (26) 197 (26) 97 (9) 66 (9) 45 (7) 52 (7) 66 (9) 42 (6) 12 (2) 10 (1) 12 (2) 2 (2)
594
60 ± 10
612 731 479 603 594 689 748 753 418
23 ± 2 4.5 ± 0.7 50 ± 19 0.6 ± 0.2 0.4 ± 0.1 5 (0.7) 19 (3) 79 (10) 48 ± 16
cumulative survival (%)
100 Data of n patients
Clinical Age, years, mean ± SD Age of female patients, years, mean ± SD Age of male patients, years, mean ± SD Gender (female), n (%) Body Mass Index, kg/m2, mean ± SD STS Score, %, mean ± SD Logistic EuroSCORE, %, mean ± SD Coronary artery disease, n (%) Pulmonary hypertension, n (%) Extracardial artery disease, n (%) Previous percutaneous coronary intervention, n (%) Previous pericardiotomy ICU treatment before intervention, n (%) Porcelain aorta, n (%) Neurological disease, n (%) Renal failure, n (%) COPD IV, n (%), Myocardial infarction b 30 days, n (%) Liver cirrhosis, n (%) Previous thoracic radiation, n (%) Unstable angina pectoris, n (%) Quality of life Karnofsky Performance Status Scale, %, mean ± SD Echocardiographic Aortic annulus, mm, mean ± SD vmax, m/s, mean ± SD Mean gradient, mm Hg, mean ± SD Valve opening, cm2, mean ± SD Indexed valve opening, cm2, mean ± SD Aortic regurgitation N II+, n (%) Mitral regurgitation N II+, n (%) LVEF b 30%, n (%) SPAP, mm Hg, mean ± SD
115
95
90
85
80 0
100
200
300
days since procedure Fig. 1. Kaplan–Meier curve showing the 1-year survival after procedure.
The data prove that risk scores based on surgical aortic valve implantation (i.e. Logistic EuroSCORE and STS Risk Score) overestimate the risk of TAVI. As derivative, in 2012 the revised EuroSCORE II was published [9]. It seems to estimate the mortality in patients receiving TAVI more appropriately than current scores [10,11]. The German Aortic Valve Score [12], calculated by patient data of both TAVI and surgical AVR, has also the potential to replace the STS Score and Logistic EuroSCORE for patients with severe aortic stenosis. However, validation by other multicentre registries is missing. Both new scores cannot be applied to data of the Austrian TAVI Registry due to missing variables. Besides reduction of mortality, one main goal of TAVI is the improvement of quality of life. This report shows that after TAVI QoL improves significantly. Additionally, in 96% of cases mobility of surviving patients is as good as or better than before the procedure (Table 2).
Table 2 Follow-up data (*p b 0.05 to baseline). Baseline
Pre-discharge
F/U 3 months
F/U 1 year
Clinical data Better mobility than before procedure, n (%)
–
Poorer mobility than before procedure, n (%)
–
Subjective good state of health, n (%)
–
279 (48) n = 585 25 (4) n = 585 –
NYHA I II III IV Karnofsky Performance Status Scale, %, mean ± SD
–
143 (49) n = 294 11 (4) n = 294 294 (96) n = 306 n = 270 158 (59) 98 (36) 14 (5) 0 (0) –
80 (43) n = 188 7 (4) n = 188 194 (98) n = 197 n = 175 114 (65) 57 (33) 4 (2) 0 (0) –
1.9 ± 0.4* n = 240 1.8 ± 0.3* n = 67 9 ± 8* n = 237 42 ± 17* n = 138 2 (0.8) n = 247 7 (3) n = 244 7 (3)* n = 252
2.0 ± 0.4* n = 176 1.7 ± 0.4* n = 31 10 ± 5* n = 177 44 ± 16 n = 83 1 (0.5) n = 186 3 (2) n = 189 3 (2)* n = 152
Echocardiographical data vmax, m/s, mean ± SD Valve area, cm2, mean ± SD Mean gradient, mm Hg, mean ± SD Systolic pulmonary arterial pressure, mm Hg, mean ± SD Aortic regurgitation N II+, n (%) Mitral regurgitation N II+, n (%) LVEF b 30%, n (%)
60 ± 10 n = 594
n = 551 304 (55) 224 (41) 21 (4) 2 (0.3) 80 ± 20* n = 446
4.5 ± 0.7 n = 731 0.6 ± 0.2 n = 603 51 ± 16 n = 741 48 ± 16 n = 418 5 (0.7) n = 689 19 (3) n = 748 79 (10) n = 753
1.9 ± 0.5* n = 575 1.9 ± 0.4* n = 138 9 ± 4* n = 569 45 ± 15* n = 285 10 (2) n = 602 16 (3) n = 598 16 (3)* n = 597
116
D. Zweiker et al. / International Journal of Cardiology 177 (2014) 114–116
Many countries have introduced TAVI registries [13–20] that include data of 328 [13] to 3933 [19] patients. The average Logistic EuroSCORE is comparable between all registries (17–28%) [13–15,17–20] except for the Italian Observant Registry [16] with a lower EuroSCORE. 30-day mortality in Austria (5.1%) goes in line with other registries. However, 1-year mortality (12.6%) is slightly lower than in other registries that include 1-year follow-up data. The German Aortic Valve Registry (GARY) comprises data of 55% of patients who have undergone either surgical or transcatheter aortic valve implantation in 2011 in Germany [14]. For TAVI, intrahospital mortality was 5.1% [14], cerebrovascular events occurred in 1.7%. One-year mortality is 21.6% with followup data of 98.1% of patients (F.W. Mohr, et al. at the ACC Annual Scientific Session 2013, March 9-11, 2013, San Francisco, United States (Oral presentation) [21]). The European Sentinel Registry was developed to evaluate the outcome of TAVI in more detail than national registries. It reports a mean in-hospital mortality of 7.4% based on data of 4,571 patients from 10 pilot countries [20]. The major limitation of this study is the fact that a number of TAVI cases in Austria implanted by surgical centres are not included in the study. This explains the relatively high number of transfemoral accesses. The strengths of this study include the long followup interval and the fact that all Austrian interventional centres participated in the study. In conclusion, the Austrian TAVI Registry proves that results of clinical studies transfer reliably into medical routine. The registry provides a useful tool to monitor procedures, characteristics and longterm follow-up of TAVI patients. Conflict of interest The authors report no relationships that could be construed as a conflict of interest. Acknowledgments We appreciate gratefully the helpful assistance of Mrs Eugenia Lamont, Mrs Karin Berney and Mr Stefan Zweiker in the preparation of the manuscript. References [1] Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology, European Association for Cardio-Thoracic Surgery, Vahanian A, Alfieri O, Andreotti F, Antunes MJ, et al. Guidelines on the management of valvular heart disease (version 2012). Eur Heart J 2012;33:2451–96. [2] Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin 3rd JP, Guyton RA. 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014;129:e521–643.
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