Effect of Availability of Transcatheter Aortic-Valve Replacement on Clinical Practice

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1 The new england journal of medicine Original Article Effect of Availability of Transcatheter Aortic-Valve Replacement on Clinical Practice Jochen Reinöhl, M.D., Klaus Kaier, Ph.D., Holger Reinecke, M.D., Claudia Schmoor, Ph.D., Lutz Frankenstein, M.D., Werner Vach, Ph.D., Alain Cribier, M.D., Friedhelm Beyersdorf, M.D., Christoph Bode, M.D., and Manfred Zehender, M.D., Ph.D. ABSTRACT From the Departments of Cardiology and Angiology I ( J.R., K.K., C.B., M.Z.) and Cardiovascular Surgery (F.B.), Heart Center, and Center for Medical Biometry and Medical Informatics (K.K., W.V.) and Clinical Trials Unit (C.S.), Medical Center, University of Freiburg, Freiburg, Project Group Diagnosis Related Groups, German Cardiac Society, Duesseldorf ( J.R., H.R., L.F.), Department of Cardiovascular Medicine, Division of Vascular Medicine, University Hospital Muenster, Muenster (H.R.), and Department of Cardiology, Angiology, and Pulmonology, University of Heidelberg, Heidelberg (L.F.) all in Germany; and the Department of Cardiology, Rouen University Hospital Charles Nicolle, Rouen, France (A.C.). Address reprint requests to Dr. Reinöhl at the Department of Cardiology and Angiology I, Heart Center, University of Freiburg, Hugstetter Str. 55, 7916 Freiburg, Germany, or at jochen.reinoehl@universitaets-herzzentrum.de. N Engl J Med 215;373: DOI: 1.156/NEJMoa15893 Copyright 215 Massachusetts Medical Society. BACKGROUND Since the adoption of transcatheter aortic-valve replacement (TAVR), questions have been raised about its effect on clinical practice in comparison with the effect of surgical aortic-valve replacement, which is considered the current standard of care. Complete nationwide data are useful in examining how the introduction of a new technique influences previous clinical standards. METHODS We analyzed data on characteristics of patients and in-hospital outcomes for all isolated TAVR and surgical aortic-valve replacement procedures performed in Germany from 27 to 213. RESULTS In total, 32,581 TAVR and 55,992 surgical aortic-valve replacement procedures were performed. The number of TAVR procedures increased from 144 in 27 to 9147 in 213, whereas the number of surgical aortic-valve replacement procedures decreased slightly, from 8622 to 748. Patients undergoing TAVR were older than those undergoing surgical aortic-valve replacement (mean [±SD] age, 81.±6.1 years vs. 7.2±1. years) and at higher preoperative risk (estimated logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation], 22.4% vs. 6.3%, on a scale of to 1%, with higher scores indicating greater risk and a score of more than 2% indicating high surgical risk). In-hospital mortality decreased in both groups between 27 and 213 (from 13.2% to 5.4% with TAVR and from 3.8% to 2.2% with surgical aortic-valve replacement). The incidences of stroke, bleeding, and pacemaker implantation (but not acute kidney injury) also declined. CONCLUSIONS The use of TAVR increased markedly in Germany between 27 and 213; the concomitant reduction in the use of surgical aortic-valve replacement was moderate. Patients undergoing TAVR were older and at higher procedural risk than those undergoing surgical aortic-valve replacement. In-hospital mortality decreased in both groups but to a greater extent among patients undergoing TAVR. (Funded by the Heart Center, Freiburg University.) 2438 n engl j med 373;25 nejm.org December 17, 215

2 Transcatheter Aortic-Valve Replacement in Clinical Practice Surgical aortic-valve replacement was a major clinical advance in the 196s 1 and offered a cure for aortic stenosis, a condition for which no disease-modifying pharmacologic therapy is available. Surgical replacement remained the only treatment option until 27, when devices for transcatheter aortic-valve replacement (TAVR) were approved. 2 Since then, TAVR has become established not only as an effective therapy for patients for whom surgery is not an option 3 but also as an alternative for high-risk patients. 4 The introduction of TAVR has led to questions about the effect of this relatively new approach on current clinical practice and its effect on surgical aortic-valve replacement, which is still considered the standard of care. The currently available guidelines rely almost entirely on numerous noncomparative studies and a small number of randomized, controlled trials. 5,6 However, assessing the effect of TAVR on clinical practice requires data from unselected, population-based cohorts. The aim of our analysis was to evaluate how the treatment of patients for aortic stenosis has evolved in Germany since the introduction of TAVR. Methods Data Source Analyses were performed on our behalf by the Research Data Center of the Federal Bureau of Statistics, in Wiesbaden, Germany, and aggregated statistics were provided on the basis of SAS codes (SAS software, version 9.2; SAS Institute) that we supplied to the Research Data Center. We sought to retrieve in-hospital data on all isolated surgical aortic-valve replacement and TAVR procedures performed throughout Germany between 27 and 213, including cases in which a single patient had multiple admissions for procedures. With respect to procedural characteristics, baseline characteristics of patients, and in-hospital complications and mortality, groups with fewer than three procedures were excluded by the Research Data Center to ensure anonymity. These data were not included in summary statistics. Study Oversight and Support There was no commercial support for the study or the preparation of this report. Because our study did not involve direct access by the investigators to data on individual patients but only access to summary results provided by the Research Data Center, approval by an ethics committee and informed consent were determined not to be required, in accordance with German law. Diagnoses, Procedural Codes, and Definitions Since the introduction of a diagnosis- and procedure-related remuneration system in Germany in 24, known as the German Diagnosis Related Groups (G-DRG) system, it has been mandatory for all hospitals to transfer patient data on diagnoses, coexisting conditions, and procedures to the Institute for the Hospital Remuneration System. Coding guidelines and annual adaptations by the German Institute for Medical Documentation and Information (Cologne, Germany) ensure uniform documentation. Diagnoses are coded according to the International Statistical Classification of Diseases and Related Health Problems, 1th revision, German modification (ICD-1-GM). Similarly, endovascular and surgical procedures must be coded according to the German Procedure Classification (OPS). Therefore, we were able to use the OPS codes for surgical aortic-valve replacement (OPS codes , , , and ) and TAVR (OPS codes 5-35a. in 27 and 5-35a. and 5-35a.1 since 28) to identify all admissions that were relevant for our analysis. Patients with a baseline diagnosis of pure aortic regurgitation and those who underwent aortic-valve replacement not coded with the above-mentioned OPS codes, as well as patients who underwent concomitant cardiac surgery or percutaneous coronary intervention, were not included in this analysis. For details of the selection process, see Table S1 and Fig. S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org. To obtain data on coexisting conditions and complications, we used the available diagnostic and procedural codes for acute and chronic conditions (OPS and ICD-1-GM codes are presented in Table S1 in the Supplementary Appendix). A history of coronary-bypass or valve surgery was recorded as previous cardiac surgery. Bleeding as a complication was defined as bleeding that required transfusion with more than 5 units of red cells during the admission. n engl j med 373;25 nejm.org December 17,

3 The new england journal of medicine Logistic EuroSCORE Characteristics of the patients (age and sex), admission status, and ICD-1-GM codes for coexisting conditions were obtained from the Federal Bureau of Statistics to estimate the procedural risk for patients. We used the available information to calculate an estimated logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) for each patient. (The logistic EuroSCORE, calculated by means of a logisticregression equation, ranges from to 1%, with higher scores indicating greater risk and a score of more than 2% indicating high surgical risk. 7 ) Details of the variables and the formula used to calculate the logistic EuroSCORE are presented in Table S2 and Figure S2, respectively, in the Supplementary Appendix. We were able to populate all fields except for critical preoperative state and left ventricular function. For these missing variables, we assumed a low-risk state (i.e., no critical preoperative state and no left ventricular dysfunction) and thus calculated a best-case scenario for the EuroSCORE values for each patient. Statistical Analysis Differences in baseline characteristics between groups were calculated with the use of the chisquare test for categorical variables and Student s t-test for continuous variables. Trends in in-hospital mortality over time were estimated by means of linear or logistic-regression analyses with time as the sole covariate. The effect of a single complication on in-hospital mortality was determined with the use of logistic-regression analyses comparing mortality among patients with and those without that complication. In addition, these estimates were adjusted for all baseline and procedural characteristics as well as for the effect of all other complications considered in this report. All regression analyses were carried out with the use of Stata software, version 13 (StataCorp). Results Characteristics of the Patients We obtained data on 88,573 admissions to German hospitals for isolated surgical aortic-valve replacement (55,992 procedures) and isolated TAVR (32,581 procedures) in Germany between 27 and 213 (Table 1). Numbers of procedures excluded from the analysis because of the performance of concomitant procedures are shown in Table S3 in the Supplementary Appendix. As would be expected, there were significant differences between the group of patients undergoing surgical aortic-valve replacement and the group undergoing TAVR for all variables (P<.1 for all comparisons) (Table 2). Overall, patients undergoing TAVR were significantly older than those undergoing surgical aortic-valve replacement (81.±6.1 years vs. 7.2±1. years), were more likely to be female, and were more likely to have coexisting conditions and a history of heart disease. Of particular note, previous cardiac surgery was more frequent with TAVR (18.4% of procedures) than with surgical aortic-valve replacement (7.3%). Numbers of Procedures In 27, a total of 8622 surgical aortic-valve replacements were performed, and only 144 TAVR procedures were performed, since the first two Conformité Européenne (CE) marks earned were granted in March and November of 27 (Table 1). Thenceforth, the numbers of surgical aortic-valve replacement procedures declined slightly, to 748 procedures in 213, whereas TAVR procedures increased from year to year, with 9147 procedures performed in 213. Among surgical aortic-valve replacements, there was a decline in the use of mechanical prostheses, whereas the use of bioprosthetic implants remained almost unchanged. When procedure numbers were examined according to age group, there were only minor changes in the numbers of surgical aortic-valve replacements among patients who were less than 8 years of age, with a moderate decline in numbers among those 8 years of age or older (Fig. 1). There was also a decline in the use of mechanical prostheses, from 21.% of all surgical aortic-valve replacements in 27 to 12.% in 213 (Table 1), with mechanical prostheses used almost exclusively in patients who were less than 75 years of age (Fig. 1). Both transfemoral and transapical TAVR increased over time in absolute numbers, but the fraction of transfemoral TAVR increased steadily from 29 to 213, accounting for more than three quarters of all TAVR procedures in 213 (Table 1). The overall increase in the numbers of aortic-valve replacement procedures was largely due to the marked 244 n engl j med 373;25 nejm.org December 17, 215

4 Transcatheter Aortic-Valve Replacement in Clinical Practice increase in TAVR procedures in patients who were 8 years of age or older (Fig. 1). In-Hospital Mortality and Risk Profiles Overall in-hospital mortality was significantly higher with TAVR than with surgical aortic-valve replacement (6.5% vs. 2.8%; odds ratio for death with TAVR, 2.41; P<.1), probably reflecting to some degree the difference in the mean estimated logistic EuroSCORE at baseline (22.4% for TAVR vs. 6.3% for surgical aortic-valve replacement) (Table 3). When adjusted for the EuroSCORE, the odds ratio decreased substantially (1.3, P<.1). There were significant reductions in mortality in both groups between 27 and 213 (Table S4 in the Supplementary Appendix), but these improvements were smaller for surgical aortic-valve replacement (from 3.8% in 27 to 2.2% in 213, P<.1) than for TAVR (from 13.2% to 5.4%, P<.1). Over the same period, the risk scores decreased for patients undergoing surgical aorticvalve replacement (from 6.9% to 5.6%, P<.1) and increased slightly for TAVR (from 21.3% in 27 to 23.3% in 29 to 22.4% in 213, P<.1). These results were generally consistent in all age groups (Fig. 2), although the trend in in-hospital mortality with surgical aortic-valve replacement in patients who were 85 years of age or older was somewhat unstable because of small and decreasing numbers of patients. In 213, in-hospital mortality with TAVR was the same as that with surgical aortic-valve replacement among patients who were 8 to 84 years of age (4.4% in both groups), despite the difference in risk (estimated EuroSCORE, 9.9% for patients undergoing surgical aortic-valve replacement vs. 22.4% for patients undergoing TAVR). Among the youngest patients, surgical aortic-valve replacement remained superior to TAVR in 213 with respect to in-hospital mortality (1.4% vs. 5.5%). However, a reduction in mortality was seen with TAVR over time, especially in the youngest age group (from 9.2% in 29 to 5.5% in 213). Complications Overall, the frequencies of documented complications differed markedly between the two procedures (Table 3). Permanent pacemaker implantation was the most frequently reported complication of TAVR, and it occurred significantly more often than with surgical aortic-valve Table 1. Numbers of Surgical Aortic-Valve Replacement (SAVR) and Transcatheter Aortic-Valve Replacement (TAVR) Procedures, According to Year.* Procedure Total SAVR Total no. (frequency) 8622 (1.5) 863 (1.5) 8259 (1.1) 819 (9.9) 7899 (9.7) 7452 (9.1) 748 (8.7) 55,992 (9.8) Bioprostheses no. (%) 6128 (71.1) 6196 (72.) 6284 (76.1) 6266 (77.3) 6296 (79.7) 65 (81.2) 5838 (82.8) 43,58 (76.9) Mechanical prostheses no. (%) 181 (21.) 173 (19.8) 1333 (16.1) 1228 (15.1) 114 (14.) 113 (13.6) 847 (12.) 9,38 (16.1) Other prostheses no. (%) 689 (8.) 712 (8.3) 645 (7.8) 621 (7.7) 55 (6.4) 391 (5.2) 365 (5.2) 3,928 (7.) TAVR Total no. (frequency) 144 (.2) 1122 (1.4) 2599 (3.2) 486 (5.9) 6523 (8.) 824 (1.1) 9147 (11.3) 32,581 (5.7) Transfemoral no. (%) NA 825 (73.5) 1618 (62.3) 351 (63.5) 4283 (65.7) 5881 (71.4) 6794 (74.3) 22,452 (68.9) Transapical no. (%) NA 32 (26.9) 986 (37.9) 1772 (36.9) 2253 (34.5) 2363 (28.7) 2367 (25.9) 1,43 (3.8) All procedures no ,858 12,915 14,422 15,692 16,195 88,573 * Numbers represent procedures, not individual patients; some patients may have undergone more than one procedure. The number of procedures in the subgroups exceeds the total number of procedures for various reasons (e.g., double coding). Percentages may not sum to 1 because of rounding. NA denotes not available. Frequency (number of procedures per 1, population) is based on population data for Germany from the Organisation for Economic Co-operation and Development ( oecd.org). As shown in Table S1 in the Supplementary Appendix, this category includes allotransplants (German Procedure Classification [OPS] code ) and stentless bioprostheses (OPS code ). n engl j med 373;25 nejm.org December 17,

5 The new england journal of medicine Table 2. Baseline Characteristics of the Patients According to Type of Procedure.* Characteristic SAVR TAVR Total (N = 55,992) Bioprostheses (N = 43,58) Mechanical Prostheses (N = 938) Other Prostheses (N = 3928) Total (N = 32,581) Transfemoral (N = 22,452) Transapical (N = 1,43) Female sex no. (%) 24,162 (43.2) 19,495 (45.3) 2842 (31.4) 1836 (46.7) 18,534 (56.9) 13,63 (58.2) 5424 (54.) Age yr 7.2± ±8. 58.± ±NA 81.± ± ±6.2 Estimated logistic EuroSCORE % 6.3± ± ± ±NA 22.4± ± ±14. Aortic-valve stenosis no. (%) 32,24 (57.5) 25,8 (59.9) 454 (49.8) 1917 (48.8) 22,21 (67.6) 15,283 (68.1) 6659 (66.3) Combined aortic-valve diseases no. (%) 2,316 (36.3) 14,786 (34.3) 3877 (42.9) 1663 (42.3) 8,79 (27.) 5,863 (26.1) 2922 (28.8) Heart failure no. (%) NYHA II 5,56 (9.) 3,771 (8.8) 91 (1.1) 376 (9.6) 2,632 (8.1) 1,949 (8.7) 677 (6.7) NYHA III or IV 12,981 (23.2) 1,271 (23.9) 18 (19.9) 92 (23.) 13,42 (41.2) 8,758 (39.) 431 (4.1) Hypertension no. (%) 36,459 (65.1) 28,61 (66.4) 5178 (57.3) 2695 (68.6) 2,481 (62.9) 13,827 (61.6) 6598 (65.7) CAD no. (%) 9,773 (17.5) 8,18 (18.8) 111 (12.3) 563 (14.3) 15,95 (46.3) 1,134 (45.1) 494 (49.2) Previous myocardial infarction no. (%) 4 mo earlier 274 (.5) 222 (.5) 3 (.3) 22 (.6) 538 (1.7) 339 (1.5) 197 (2.) 5 12 mo earlier 127 (.2) 1 (.2) 19 (.2) 8 (.2) 254 (.8) 172 (.8) 82 (.8) >12 mo earlier 96 (1.7) 751 (1.7) 112 (1.2) 96 (2.4) 1,411 (4.3) 854 (3.8) 556 (5.5) Previous CABG no. (%) 2,27 (3.6) 1,657 (3.8) 229 (2.5) 135 (3.4) 4,194 (12.9) 2,236 (1.) 1947 (19.4) Previous cardiac surgery no. (%) 4,14 (7.3) 3,127 (7.3) 674 (7.5) 34 (7.7) 5,981 (18.4) 3,562 (15.9) 247 (24.) Peripheral vascular disease no. (%) 2,556 (4.6) 2,42 (4.7) 326 (3.6) 188 (4.8) 3,912 (12.) 2,59 (9.2) 1854 (18.5) Carotid disease no. (%) 2,467 (4.4) 2,19 (4.7) 235 (2.6) 216 (5.5) 2,12 (6.2) 1,81 (4.8) 924 (9.2) COPD no. (%) 6,155 (11.) 4,869 (11.3) 785 (8.7) 55 (12.9) 5,8 (15.4) 3,127 (13.9) 187 (18.6) Pulmonary hypertension no. (%) 5,789 (1.3) 4,496 (1.4) 882 (9.8) 412 (1.5) 7,43 (22.7) 5,28 (23.2) 2174 (21.6) Renal disease no. (%) GFR <15% 64 (1.1) 454 (1.1) 144 (1.6) 39 (1.) 984 (3.) 587 (2.6) 396 (3.9) GFR <3% 675 (1.2) 569 (1.3) 57 (.6) 49 (1.2) 1,573 (4.8) 1,25 (4.6) 548 (5.5) Atrial fibrillation no. (%) 23,33 (41.7) 18,879 (43.8) 2684 (29.7) 1782 (45.4) 14,928 (45.8) 9,712 (43.3) 5187 (51.6) Diabetes no. (%) 14,346 (25.6) 11,478 (26.7) 1776 (19.7) 195 (27.9) 1,84 (33.2) 7,352 (32.7) 342 (34.1) * Plus minus values are means ±SD. Numbers represent procedures, not individual patients; some patients may have undergone more than one procedure. The number of procedures in the subgroups does not equal the total number of procedures for various reasons (e.g., double coding). For all variables, P<.1 for the comparison between SAVR and TAVR procedures. CABG denotes coronary-artery bypass grafting, CAD coronary artery disease, COPD chronic obstructive pulmonary disease, GFR glomerular filtration rate, NA not available, and NYHA New York Heart Association. The logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) is calculated by means of a logistic-regression equation; scores range from to 1%, with higher scores indicating greater risk and a score of more than 2% indicating high surgical risk. For calculation of the EuroSCORE, we were able to populate all fields except critical preoperative state and left ventricular function, for which we assumed a low-risk state (i.e., no critical preoperative state and no left ventricular dysfunction) and thus calculated a best-case scenario. This characteristic is the combination of aortic-valve stenosis and aortic-valve regurgitation n engl j med 373;25 nejm.org December 17, 215

6 Transcatheter Aortic-Valve Replacement in Clinical Practice A Patients 85 Yr of Age B Patients 8 84 Yr of Age 6 5 SAVR, bioprostheses SAVR, mechanical prostheses SAVR, others TAVR, TF TAVR, TA 6 5 SAVR, bioprostheses SAVR, mechanical prostheses SAVR, others TAVR, TF TAVR, TA No. of Procedures No. of Procedures C Patients Yr of Age D Patients <75 Yr of Age 6 5 SAVR, bioprostheses SAVR, mechanical prostheses SAVR, others TAVR, TF TAVR, TA 6 5 SAVR, bioprostheses SAVR, mechanical prostheses SAVR, others TAVR, TF TAVR, TA No. of Procedures No. of Procedures Figure 1. Number of Transcatheter Aortic-Valve Replacement (TAVR) and Surgical Aortic-Valve Replacement (SAVR) Procedures Performed, According to Type of Procedure and Age Group, Numbers represent procedures, not individual patients; some patients may have undergone more than one procedure. Groups with fewer than three procedures were excluded for reasons of anonymity. TA denotes transapical, and TF transfemoral. replacement (17.7% vs. 4.%, P<.1). Stroke rates were also higher with TAVR than with surgical aortic-valve replacement (2.5% vs. 1.8%, P<.1), as was the overall rate of acute kidney injury (5.5% vs. 3.%, P<.1). Bleeding complications occurred more frequently with surgical aortic-valve replacement (14.%, vs. 8.2% with TAVR; P<.1). The rates of complications generally tended to decrease with time in both groups (details are given in Table S4 in the Supplementary Appendix). Among the patients undergoing TAVR, there were significant changes in rates of bleeding (from 9.% in 27 to 6.4% in 213, P<.1), and permanent pacemaker implantation (from 22.2% in 27 to 15.6% in 213, P<.1). The rates of stroke and acute kidney injury also declined, but the reductions were not significant (stroke: from 3.5% in 27 to 2.6% in 213, P =.12; acute kidney injury: from 5.6% in 27 to 5.2% in 213, P =.84). Similar trends were seen among patients undergoing surgical aorticvalve replacement, with significant decreases in rates of stroke, bleeding, and permanent pacemaker implantation. However, the rate of acute kidney injury with surgical aortic-valve replacement increased over time (from 2.4% in 27 to 3.8% in 213, P<.1). In-hospital mortality was typically increased among patients with major procedure-related complications (Table 3). Among the patients undergoing TAVR, acute kidney injury was associated with the greatest increase in the risk of death among all the major complications (unadjusted odds ratio for the comparison with patients who did not have acute kidney injury, n engl j med 373;25 nejm.org December 17,

7 The new england journal of medicine Table 3. Complications and In-Hospital Mortality.* Fully Adjusted Odds Ratio (95% CI) P Value Partially Adjusted Odds Ratio (95% CI) P Value Unadjusted Odds Ratio (95% CI) P Value Variable Frequency Mortality percent SAVR (55,992 procedures) 2.8 Stroke ( ) < ( ) < ( ) <.1 Bleeding ( ) < ( ) < ( ) <.1 Acute kidney injury ( ) < ( ) < ( ) <.1 Permanent pacemaker ( ) (.52.91).9.57 (.42.77) <.1 implantation TAVR (32,581 procedures) 6.5 Stroke ( ) < ( ) < ( ) <.1 Bleeding ( ) < ( ) < ( ) <.1 Acute kidney injury ( ) < ( ) < ( ) <.1 Permanent pacemaker (.73.93).2.85 (.75.96).1.79 (.71.87) <.1 implantation * The estimated logistic EuroSCORE was 6.3% for SAVR and 22.4% for TAVR. Bleeding was recorded as a complication if more than 5 units of red cells were transfused. Odds ratios are for the effect of each complication on the risk of death, as compared with the risk in the absence of that complication. Partially adjusted odds ratios were adjusted for all baseline characteristics listed in Table 2 and all procedural characteristics listed in Table 1. Fully adjusted odds ratios were adjusted for all patient and procedural characteristics and all other complications. Both overall mortality and complication-related mortality are shown. 12.6; 95% confidence interval [CI], 1.82 to 13.46; P<.1). This increase in risk remained significant after adjustment for baseline characteristics of the patients, procedural details, and other complications (odds ratio, 7.24; 95% CI, 6.39 to 8.2; P<.1). Both stroke and bleeding also increased the adjusted risk of death; permanent pacemaker implantation did not. Similar findings were noted for patients undergoing surgical aortic-valve replacement. Discussion We report here nationwide and contemporary data on in-hospital outcomes for isolated TAVR (32,581 procedures) and surgical aortic-valve replacement (55,992 procedures) in Germany between 27 and 213. During this period, a marked increase in the number of TAVR procedures occurred contemporaneously with a relatively small decrease in the number of surgical aortic-valve replacement procedures, primarily in the oldest patients and those at highest risk. Moreover, the proportion of TAVR procedures performed in the youngest patients (<75 years of age) remained consistently low, and in all age groups, the estimated logistic EuroSCORE values were significantly higher in patients undergoing TAVR than in those undergoing surgical aorticvalve replacement. The data reveal significant trends toward improvement in outcomes for both TAVR and surgical aortic-valve replacement. The decline in in-hospital mortality in the group undergoing TAVR was probably due to a combination of factors, including a learning curve effect on procedural skills and improvements in patient selection and care, as well as advances in device development. For the group undergoing surgical aortic-valve replacement, the improvement in outcomes was probably due in part to the shift from surgical replacement to TAVR for high-risk patients. The reduction in the rate of permanent pacemaker implantation among patients undergoing TAVR may reflect the more frequent use of balloon-expandable devices than self-expanding devices, but the data we obtained did not identify the type of device that was used in each procedure. Reduced bleeding may be a consequence of lower-profile delivery systems (i.e., those involving smaller sheath sizes) and less frequent use of surgical cutdown for vascular access n engl j med 373;25 nejm.org December 17, 215

8 Transcatheter Aortic-Valve Replacement in Clinical Practice SAVR in-hospital mortality SAVR EuroSCORE TAVR in-hospital mortality TAVR EuroSCORE A Patients 85 Yr of Age B Patients 8 84 Yr of Age Percent 15 Percent C Patients Yr of Age D Patients <75 Yr of Age Percent 15 Percent Figure 2. In-Hospital Mortality and Estimated Logistic EuroSCORE among Patients Undergoing SAVR and Those Undergoing TAVR. For calculation of the logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), we were able to populate all fields except for critical preoperative state and left ventricular function, for which we assumed a low-risk state (i.e., no critical preoperative state and no left ventricular dysfunction) and thus calculated a best-case scenario. Numbers represent procedures, not individual patients; some patients may have undergone more than one procedure. Groups with fewer than three procedures were excluded for reasons of anonymity. On the basis of data from the prospective German Aortic Valve Registry, which included surgical aortic-valve replacement and TAVR procedures performed at 78 sites (13,68 procedures), 8,9 in-hospital mortality was slightly lower for both groups than was in-hospital mortality in our study (2.1% vs. 2.8% for surgical aorticvalve replacement and 5.9% vs. 6.5% for TAVR), as were rates of stroke and permanent pacemaker implantation. These discrepant findings may be due to differences in data-collection methods and definitions, but they may also point to systematic differences in the populations covered. A fairly wide range of in-hospital mortality rates have been reported with TAVR in other published registries and studies (9.7% in the French Aortic National CoreValve and Edwards [FRANCE 2] Registry at 3 days, 1 7.4% in the European Sentinel Registry of Transcatheter Aortic Valve Implantation, % in the U.K. Transcatheter Aortic Valve Implantation Registry, 12 and 5.5% in the Society of Thoracic Surgeons American College of Cardiology Transcatheter Valve Therapy Registry 13 ). On the basis of U.S. data from 211, in-hospital mortality among patients undergoing surgical aortic-valve replacement with or without coronary-artery bypass grafting (CABG) (3.8%), as well as 3-day mortality among patients undergoing surgical aortic-valve replacement without CABG (3.5%), n engl j med 373;25 nejm.org December 17,

9 The new england journal of medicine was slightly higher than in-hospital mortality in our study population. 14 These differences are also likely to be a consequence of differences in both data collection and study populations. Mortality with TAVR was lower in the randomized, controlled Placement of Aortic Transcatheter Valves (PARTNER) trials 3,4 (5.% for inoperable patients and 3.4% for high-risk patients) and the Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve versus Edwards SAPIEN XT (CHOICE) trial (4.6%) 15 than in the registry data. These lower rates are probably a consequence of the highly selected patient population. Our study has several limitations, beyond those normally associated with a retrospective analysis. First, it is based on administrative data. As a consequence, coding errors are inevitable. However, about 2% of all cardiovascular diagnosis related groups are checked by independent physician task forces from health insurers. Second, comparative analyses are difficult to perform because of insufficient clinical detail, but the size and nature of the data set have strengths in terms of completeness and masking of data from clinicians. Third, the lack of risk scores in the data is a drawback, and we did not have all the variables necessary for complete calculation of a logistic EuroSCORE; however, we generated an approximation of the logistic EuroSCORE, which provides a conservative estimate. Several reports have validated the accuracy of the EuroSCORE in predicting the risk of death among patients undergoing CABG, but it appears to overestimate the risk of death among higher-risk patients, especially those undergoing valvular heart surgery or TAVR. 16,17 Finally, our analysis is restricted to data for Germany and therefore may not be applicable to other health care systems. In conclusion, we analyzed all isolated surgical aortic-valve replacement and TAVR procedures performed in Germany between 27 and 213. The use of TAVR increased markedly during this period, with only a moderate concomitant reduction in surgical aortic-valve replacement. Patients undergoing TAVR tended to be older and at higher procedural risk than those undergoing surgical aortic-valve replacement, and the increase in the use of TAVR occurred to a substantial degree among patients who would have been unlikely to undergo surgery owing to their age and risk profile. In-hospital outcomes improved over time for both TAVR and surgical aorticvalve replacement. Supported by internal funding from the Heart Center, Freiburg University. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. References 1. Harken DE, Soroff HS, Taylor WJ, Lefemine AA, Gupta SK, Lunzer S. Partial and complete prostheses in aortic insufficiency. J Thorac Cardiovasc Surg 196; 4: Cribier A. Development of transcatheter aortic valve implantation (TAVI): a 2- year odyssey. Arch Cardiovasc Dis 212; 15: Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 21; 363: Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 211; 364: Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease (version 212). Eur Heart J 212; 33: Nishimura RA, Otto CM, Bonow RO, et al. 214 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. J Thorac Cardiovasc Surg 214; 148(1): e1-e Roques F, Michel P, Goldstone AR, Nashef SA. The logistic EuroSCORE. Eur Heart J 23; 24: Hamm CW, Möllmann H, Holzhey D, et al. The German Aortic Valve Registry (GARY): in-hospital outcome. Eur Heart J 214; 35: Mohr FW, Holzhey D, Möllmann H, et al. The German Aortic Valve Registry: 1-year results from 13,68 patients with aortic valve disease. Eur J Cardiothorac Surg 214; 46: Gilard M, Eltchaninoff H, Iung B, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 212; 366: Di Mario C, Eltchaninoff H, Moat N, et al. The pilot European Sentinel Registry of Transcatheter Aortic Valve Implantation: in-hospital results in 4,571 patients. EuroIntervention 213; 8: Moat NE, Ludman P, de Belder MA, et al. Long-term outcomes after transcatheter aortic valve implantation in highrisk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) Registry. J Am Coll Cardiol 211; 58: Mack MJ, Brennan JM, Brindis R, et al. Outcomes following transcatheter aortic valve replacement in the United States. JAMA 213; 31: Barreto-Filho JA, Wang Y, Dodson JA, et al. Trends in aortic valve replacement for elderly patients in the United States, JAMA 213; 31: Abdel-Wahab M, Mehilli J, Frerker C, et al. Comparison of balloon-expandable 2446 n engl j med 373;25 nejm.org December 17, 215

10 Transcatheter Aortic-Valve Replacement in Clinical Practice vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. JAMA 214; 311: Brown ML, Schaff HV, Sarano ME, et al. Is the European System for Cardiac Operative Risk Evaluation model valid for estimating the operative risk of patients considered for percutaneous aortic valve replacement? J Thorac Cardiovasc Surg 28; 136: Dewey TM, Brown D, Ryan WH, Herbert MA, Prince SL, Mack MJ. Reliability of risk algorithms in predicting early and late operative outcomes in high-risk patients undergoing aortic valve replacement. J Thorac Cardiovasc Surg 28; 135: Copyright 215 Massachusetts Medical Society. n engl j med 373;25 nejm.org December 17,

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