Scarce data are available on the impact of age on transcatheter aortic valve implantation (TAVI) outcomes. We therefore, analyzed 1,845 consecutive patients from 9 Italian centers who underwent TAVI with the Corevalve Revalving System from September 2007 to March 2014; patients were dichotomized according to their age in the date of the procedure, as follows: 75 to 85 years old and >85 years old. End points were defined according to Valve Academic Research Consortium definitions. In-hospital, 30-day, and 1-year clinical and echocardiographic data were available for 100% of the patients included. Propensity matching was performed. Procedural success rates were high (>94%) and comparable between groups. Although worse baseline renal function was observed in the older group, the incidence of acute kidney injury after procedure was comparable (17.1% and 17.4%, respectively for the 75- to 85- and >85-year-old group, p = 0.877); importantly, >99% of acute kidney injury episodes in both groups were grades 1 and 2. Procedural complications rates were low without between-group differences. In-hospital death (3.7% and 4.6%, p = 0.379) and stroke/transient ischemic attack (1.9% and 1.9%, respectively, p = 0.960) were comparable. The 1-year death rates were 14.9% and 17.2% (p = 0.197) in the 75- to 85- and >85-year-old group, respectively. Cardiovascular death was observed in 7.8% and 7% (p = 0.542), while stroke/transient ischemic attack was demonstrated in 5.2% and 4.4% (p = 0.496), respectively. Results were sustained after propensity matching. In conclusion, advanced age did not negatively impact the outcomes of TAVI through 1-year after procedure.
Although extensively studied in percutaneous coronary intervention, coronary artery bypass grafting, and surgical aortic valve replacement (SAVR) settings, the investigation of the impact of age in patients undergoing transcatheter aortic valve implantation (TAVI) has been hampered by single-center studies and limited sample sizes. We, therefore, used data from a large prospective, multicenter Italian data repository to assess age-related differences and its potential impact on clinical outcomes at 30-day and 12-month follow-up in consecutive patients undergoing TAVI.
Methods
Starting from June 2007, all consecutive patients with degenerative severe aortic stenosis who underwent TAVI with the third-generation 18Fr Corevalve Revalving System (CRS) device (Medtronic Inc., Minneapolis, Minnesota) in 9 Italian centers were prospectively included in the ClinicalService Project ( http://clinicaltrials.gov/ct2/show/NCT01007474 ). This is a nation-based clinical data repository and medical care project aimed at describing and improving the use of implantable devices in Italian clinical practice. The project was approved by each site’s institutional review board or medical director and conforms to the principles outlined in the Declaration of Helsinki. Each patient signed an informed consent for data collection and analysis. Clinical and echocardiographic follow-up were performed at 30 days, 1 year, and then yearly with visits or telephone contacts according to each center’s clinical practice. All events were site reported. All data provided by each interventional site were anonymized, centrally collected, and assessed for quality. In particular, all outcome data were confirmed by source documentation collected from each participating center. TAVI program in all the participating sites was supported by a local heart team. For the purpose of the present study, patients who underwent TAVI with CRS from September 2007 to March 2014 were dichotomized according to their age in the date of the procedure, as follows: 75 to 85 years old and >85 years old. End points were defined according to Valve Academic Research Consortium definitions.
Design features of the CRS and technical details of the procedures have been previously described. The CRS, available in 26 mm and 29 mm sizes and, starting from September 2011 and August 2012 respectively, even in 31 mm and 23 mm sizes, was implanted using the transfemoral, subclavian, and transaortic approaches with an 18Fr delivery catheter, later improved by an AccuTrak stability layer (Medtronic Inc.). All procedures were performed under local anesthesia (with or without additional sedation and/or analgesia) or general anesthesia and endotracheal intubation (i.e., decided by the heart team during preoperative meetings), under angiography associated with transesophageal echocardiography guidance or exclusive angiography guidance in a standard cardiac catheterization laboratory with surgical backup or in a hybrid operating room. After valve deployment, the angiographic assessment of aortic regurgitation (AR) severity was performed using previously described method. Evaluation was initially performed by 2 treating physicians and discrepancies in the measured degree of post-TAVI AR were resolved by consensus. After the procedure, most patients were managed in an intensive care unit or coronary care unit for at least a day, and a temporary pacemaker was left in place for at least 48 hours. All patients received acetylsalicylic acid (at least 100 mg before the procedure and lifelong) and clopidogrel (300-mg loading dose plus 75 mg daily for 3 to 6 months unless prolonged administration was required for previous coronary intervention with drug-eluting stents). During the intervention, unfractionated heparin 70 to 100 IU/kg was administered to achieve an activated clotting time of 200 to 250 seconds for the duration of the procedure.
Continuous data were summarized as mean and SD or median and 25th to 75th percentiles in case of skewed distributions. Absolute and relative frequencies were reported for categorical variables. Continuous variables were compared using the Mann–Whitney test. Normality of distribution was tested, calculating skewness and kurtosis values. Comparisons of categorical variables were performed by means of the Fisher’s exact test for extreme proportions or, otherwise, chi-square test. Survival analysis was carried out by means of the Kaplan–Meier method. Different curves were compared using the log-rank test. A 2-tailed value of p <0.05 was considered significant. Propensity score matching was performed. Variables used to balance groups were those that were different at baseline.
Results
We included 1,845 consecutive patients who underwent TAVI in 9 Italian centers from June 2007 to June 2012. Although risk scores (i.e., EuroScore and Society of Thoracic Surgeons score) were progressively higher and renal function impairment was more common with increasing age, previous stroke, myocardial infarction, and chronic obstructive pulmonary disease were more frequently observed in younger patients. Atrial fibrillation was more common among older patients, but other conductions disturbances were comparable between groups ( Table 1 ). Baseline echocardiogram data revealed higher rates of concomitant ≥2+ mitral regurgitation and greater systolic pulmonary artery pressures in >85-year-old group ( Table 2 ).
| Patient Characteristics | Total (n=1845) | Age 75-85 y (n=1258) | Age >85 y (n=587) | p-value |
|---|---|---|---|---|
| Age at procedure (years) | 83.3 ± 4.2 | 81.1 ± 2.9 | 88.0 ± 2.1 | <0.001 |
| Male | 43.2%(797/1845) | 46.7%(588/1258) | 35.6%(209/587) | <0.001 |
| Log Euroscore | 1599 (86.7%) | 1091 (86.7%) | 508 (86.5%) | <0.001 |
| 1 – 91 | 1 – 91 | 2 – 85 | ||
| 19.3 (12-29) | 18.1 (11-27) | 21.5 (14-31) | ||
| 22.7 ± 14.9 | 21.6 ± 14.9 | 25.1 ± 14.6 | ||
| Society of Thoracic Surgeons Score | 1334 (72.3%) | 924 (73.4%) | 410 (69.8%) | <0.001 |
| 1 – 77 | 1 – 72 | 2 – 77 | ||
| 6.1 (4-10) | 5.4 (4-9) | 7.5 (6-11) | ||
| 8.8 ± 8.4 | 8.2 ± 8.3 | 10.1 ± 8.6 | ||
| Creatinine (mg/dL) | 1.2 (1-1) | 1.1 (1-1) | 1.2 (1-2) | 0.183 |
| Glomerular filtration rate<30ml/min | 22.9% (397/1733) | 18.8% (224/1191) | 31.9% (173/542) | <0.001 |
| NYHA III-IV | 74.3% (1370/1845) | 74.7% (940/1258) | 73.3% (430/587) | 0.502 |
| Chronic Kidney Disease | 50.1% (883/1762) | 46.8% (565/1207) | 57.3% (318/555) | <0.001 |
| Hemodyalisis | 1.3% (24/1786) | 1.7% (21/1219) | 0.5% (3/567) | 0.046 |
| Hypertension | 82.0% (1509/1841) | 82.2% (1033/1256) | 81.4% (476/585) | 0.648 |
| Dyslipidemia | 47.2% (707/1497) | 50.8% (533/1049) | 38.8% (174/448) | <0.001 |
| Smoking | 8.7% (132/1519) | 9.3% (99/1060) | 7.2% (33/459) | 0.172 |
| Diabetes Mellitus | 28.3% (517/1824) | 31.5% (394/1249) | 21.4% (123/575) | <0.001 |
| Prior ischemic event | 10.4% (191/1845) | 10.9% (137/1258) | 9.2% (54/587) | 0.267 |
| Prior stroke | 6.7% (123/1845) | 7.6% (95/1258) | 4.8% (28/587) | 0.026 |
| Coronary artery disease | 41.9% (766/1826) | 42.6% (531/1246) | 40.5% (235/580) | 0.397 |
| Prior myocardial infarction | 16.9% (310/1832) | 18.1% (227/1252) | 14.3% (83/580) | 0.042 |
| Prior percutaneous coronary intervention | 28.1% (514/1830) | 28.8% (360/1250) | 26.6% (154/580) | 0.319 |
| Peripheral vascular disease | 26.0% (479/1845) | 25.0% (315/1258) | 27.9% (164/587) | 0.186 |
| Chronic obstructive pulmonary disease | 20.8% (383/1845) | 22.3% (281/1258) | 17.4% (102/587) | 0.014 |
| Prior coronary artery bypass grafting | 13.7% (253/1845) | 16.7% (210/1258) | 7.3% (43/587) | <0.001 |
| Atrial fibrillation ECG before procedure | 13.8% (254/1843) | 12.6% (159/1257) | 16.2% (95/586) | 0.039 |
| Chronic atrial fibrillation | 7.3% (134/1843) | 7.7% (97/1257) | 6.3% (37/586) | 0.280 |
| Left bundle branch block | 10.7% (197/1843) | 10.9% (137/1257) | 10.2% (60/586) | 0.669 |
| Right bundle branch block | 6.8% (126/1843) | 6.8% (85/1257) | 7.0% (41/586) | 0.853 |
| Left anterior hemiblock | 9.8% (181/1843) | 9.7% (122/1257) | 10.1% (59/586) | 0.808 |
| Permanent pacemaker | 13.2% (235/1786) | 12.5% (153/1221) | 14.5% (82/565) | 0.249 |
| Patient Characteristics | Total (n=1845) | Age 75-85 y (n=1258) | Age >85 y (n=587) | p-value |
|---|---|---|---|---|
| Mean aortic gradient (mmHg) | 51.4 ± 15.7 | 50.5 ± 15.4 | 53.2 ± 16.0 | 0.004 |
| Aortic regurgitation ≥ 2+ | 31.8% (540/ 1696) | 33.0% (382/ 1159) | 29.4% (158/ 537) | 0.146 |
| Mitral regurgitation ≥ 2+ | 44.0% (753/ 1713) | 41.7% (488/ 1171) | 48.9% (265/ 542) | 0.005 |
| Left ventricle ejection fraction | 51.7 ± 12.2 | 51.7 ± 12.3 | 51.8 ± 11.9 | 0.717 |
| Left ventricle ejection fraction < 35% | 10.5% (189/ 1794) | 11.2% (137/ 1223) | 9.1% (52/ 571) | 0.115 |
| Systolic pulmonary artery pressure > 60 mmHg | 8.2% (151/ 1843) | 6.8% (86/ 1257) | 11.1% (65/ 586) | 0.002 |
Although differences were demonstrated in the type of access and size of valve used, device and procedural success rates were comparable between the groups ( Table 3 ); likewise, the rates of procedural complications and overall in-hospital outcomes were low and comparable ( Tables 4 and 5 ).
| Procedural Characteristics | TOTAL (n=1845) | Age 75-85 y (n=1258) | Age >85 y (n=587) | p-value |
|---|---|---|---|---|
| Access | ||||
| Femoral | 82.9% (1525/ 1840) | 84.2% (1058/ 1256) | 80.0% (467/ 584) | 0.044 |
| Subclavian | 12.3% (226/ 1840) | 11.6% (146/ 1256) | 13.7% (80/ 584) | |
| Aortic | 4.8% (89/ 1840) | 4.1% (52/ 1256) | 6.3% (37/ 584) | |
| General Anesthesia | 26.1% (470/ 1804) | 26.3% (324/ 1234) | 25.6% (146/ 570) | 0.773 |
| Second CoreValve deployed | 4.7% (86/ 1841) | 5.2% (65/ 1255) | 3.6% (21/ 586) | 0.131 |
| Prosthesis Size | ||||
| 23mm | 2.9% (53/ 1839) | 3.2% (40/ 1253) | 2.2% (13/ 586) | <0.001 |
| 26mm | 47.1% (866/ 1839) | 43.6% (546/ 1253) | 54.6% (320/ 586) | |
| 29mm | 42.2% (776/ 1839) | 44.5% (557/ 1253) | 37.4% (219/ 586) | |
| 31mm | 7.8% (144/ 1839) | 8.8% (110/ 1253) | 5.8% (34/ 586) | |
| Paravalvular Leak ≥ moderate | 17.3% (291/ 1685) | 16.7% (193/ 1153) | 18.4% (98/ 532) | 0.396 |
| Post-dilatation | 22.5% (392/ 1739) | 22.5% (268/ 1193) | 22.7% (124/ 546) | 0.909 |
| Device success | 92.7% (1711/ 1845) | 92.4% (1162/ 1258) | 93.5% (549/ 587) | 0.372 |
| Procedural success | 94.5% (1743/ 1845) | 94.4% (1187/ 1258) | 94.7% (556/ 587) | 0.751 |
| Procedural time (min) | 105.0 ( 70- 130) | 105.0 ( 70- 130) | 109.5 ( 70- 129) | 0.292 |
| 109.8 ± 53.2 | 108.3 ± 51.8 | 113.0 ± 56.1 | ||
| Fluoroscopy time (min) | 21.0 ( 15- 28) | 21.0 ( 15- 30) | 21.0 ( 16- 28) | 0.443 |
| 23.8 ± 13.8 | 24.3 ± 14.9 | 22.7 ± 11.0 | ||
| Contrast media (ml) | 170.0 ( 120- 222) | 172.0 ( 120- 230) | 161.0 ( 120- 210) | 0.125 |
| 185.1 ± 102.6 | 189.3 ± 112.7 | 175.9 ± 75.6 | ||
| Complications | Total (n=1845) | Age 75-85 y (n=1258) | Age >85 y (n=587) | p-value |
|---|---|---|---|---|
| Cardiac tamponade | 2.0% (36/ 1819) | 2.1% (26/ 1240) | 1.7% (10/ 579) | 0.598 |
| Conversion to open-chest surgery | 0.3% (6/ 1805) | 0.4% (5/ 1231) | 0.2% (1/ 574) | 0.425 |
| Any major arrhythmia | 39.8% (735/ 1845) | 39.0% (490/ 1258) | 41.7% (245/ 587) | 0.255 |
| Valve in Valve | 3.7% (66/ 1804) | 4.0% (49/ 1229) | 3.0% (17/ 575) | 0.277 |
| Embolization | 0.1% (1/ 1845) | 0.1% (1/ 1258) | 0 | 0.494 |
| Transfusion ≥ 3 units of blood | 5.4% (99/ 1845) | 5.4% (68/ 1258) | 5.3% (31/ 587) | 0.912 |
| Major bleeding | 9.2% (170/ 1845) | 9.0% (113/ 1258) | 9.7% (57/ 587) | 0.615 |
| Life-threating or disabling bleeding | 3.5% (65/ 1845) | 3.4% (43/ 1258) | 3.7% (22/ 587) | 0.720 |
| Stroke/TIA | 2.4% (26/ 1067) | 2.4% (17/ 715) | 2.6% (9/ 352) | 0.858 |
| Vascular Complications | 16.2% (298/ 1845) | 15.6% (196/ 1258) | 17.4% (102/ 587) | 0.329 |
| Outcomes | Total (n=1845) | Age 75-85 y (n=1258) | Age >85 y (n=587) | p-value |
|---|---|---|---|---|
| In-hospital death | 4.0% (74/ 1845) | 3.7% (47/ 1258) | 4.6% (27/ 587) | 0.379 |
| In-hospital cardiovascular death | 2.8% (51/ 1845) | 2.7% (34/ 1258) | 2.9% (17/ 587) | 0.813 |
| In-hospital MI | 1.0% (19/ 1845) | 1.2% (15/ 1258) | 0.7% (4/ 587) | 0.311 |
| In-hospital Stroke/TIA | 1.9% (35/ 1845) | 1.9% (24/ 1258) | 1.9% (11/ 587) | 0.960 |
| Aortic Surgery | 0.3% (5/ 1845) | 0.2% (2/ 1258) | 0.5% (3/ 587) | 0.175 |
| New PM | 25.4% (409/ 1610) | 25.1% (277/ 1105) | 26.1% (132/ 505) | 0.647 |
| AKI | 17.2% (254/ 1479) | 17.1% (170/ 996) | 17.4% (84/ 483) | 0.877 |
| AKI Classes | ||||
| 0 | 82.8% (1225/ 1479) | 82.9% (826/ 996) | 82.6% (399/ 483) | 0.726 |
| 1 | 16.7% (247/ 1479) | 16.7% (166/ 996) | 16.8% (81/ 483) | |
| 2 | 0.4% (6/ 1479) | 0.3% (3/ 996) | 0.6% (3/ 483) | |
| 3 | 0.1% (1/ 1479) | 0.1% (1/ 996) | 0.0% (0/ 483) | |
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