Transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) is increasingly performed in nonagenarians. There is scarce evidence on the feasibility and safety of balloon-expandable TAVI in this patient population. A total of 734 patients who underwent balloon-expandable TAVI at our institute were included in the study. We compared 136 patients who were aged at least 90 years at the time of TAVI (mean age 92.4 ± 2.4 years) with the remaining 598 younger patients (mean age 79.7 ± 7.8 years). Valve Academic Research Consortium 2 end points were compared between the 2 groups. Diabetes mellitus, coronary artery disease (CAD), peripheral artery disease (PAD), and chronic lung disease were significantly less prevalent in patients aged ≥90 years. In contrast, the prevalence of frailty, chronic renal failure, and atrial fibrillation was significantly higher in these patients. Device success was 96% in both groups. All-cause mortality at 30 days and 1 year was 2.9% and 12.5% versus 2.8% and 12.3% in patients aged ≥90 and <90, respectively (p = 0.95 for both). All major complication rates were similar between groups. Nonagenarians had higher rates of minor vascular complications (13.2% vs 7.7%; p = 0.04). In conclusion, performing balloon-expandable TAVI in carefully selected group of nonagenarians is feasible and offers clinical benefit comparable to patients aged <90 years. Advanced age, in the absence of significant co-morbidities, should not deter clinicians from evaluating patients for TAVI for severe AS.
Aortic stenosis (AS) is the most common form of valve disease in the Western world and represents a major healthcare burden. The number of elderly patients with severe symptomatic AS who require aortic valve replacement has been significantly increasing in recent years. However, a decade ago, 1/3 of patients were not referred to surgery, in particular because of advanced age, left ventricular dysfunction, and/or significant multiple co-morbidities. Transcatheter aortic valve implantation (TAVI) has emerged as a treatment option for elderly inoperable or high-risk surgical patients with severe AS. The mean age of patients in the previously reported randomized trials and large TAVI registries was from 81.4 to 83.6 years, but only small minority of these patients were nonagenarians (age ≥90 years). Relatively few studies have examined the outcomes of this procedure in very old patients. The purpose of this study was to assess the feasibility and safety of performing balloon-expandable TAVI in nonagenarians compared to patients aged <90 years.
Methods
We examined consecutive high-risk patients with severe symptomatic AS who underwent balloon-expandable TAVI during a 3-year period at our institute. All patients had congestive heart failure with New York Heart Association (NYHA) class II to IV symptoms. All underwent preprocedural coronary angiography to assess the need of revascularization. Aortic valve disease was assessed initially with transthoracic echocardiography followed by an electrocardiographic-gated, multislice CT angiography study. Decision for TAVI sizing was made by the Heart Team using data from all available imaging modalities at the time of the procedure including immediate preprocedural 3-dimensional transesophageal echocardiography (TEE). Leaflet calcium was quantified by a standard Agatston method for all available noncontrast computed tomographic (CT) scans, with a threshold for calcium detection set at 130 Hounsfield units. TAVI was performed under general anesthesia in all cases. All patients were worked up for “transfemoral first” approach, and alternate access was used in patients ineligible for transfemoral approach. The study was approved by the Institutional Review Board at Cedars-Sinai Medical Center.
Baseline clinical, echocardiographic, and procedural details for TAVI were recorded for all patients including 1-month clinical and echocardiographic assessments during a follow-up visit. Nonagenarians (patients aged ≥90 years at the time of TAVI) were compared to younger patients. TAVI end points, device success, and adverse events were considered according to the Valve Academic Research Consortium (VARC) 2 definitions.
All data were summarized and displayed as mean ± standard deviation (SD) for continuous variables and as number (percentage) of patients in each group for categorical variables. The Student t test and the Pearson chi-square tests were used to evaluate statistical significance between continuous and categorical variables, respectively. Kaplan–Meier survival plot significance was estimated using the log-rank test. Cox multivariate regression analysis was performed to identify independent correlates for overall mortality. The multivariate model was built by selecting baseline and procedural variables that satisfied the entry criterion of p <0.05 in a univariate analysis: patient age, body mass index (BMI), diabetes mellitus, coronary artery disease (CAD), previous coronary artery bypass grafting (CABG) or valve surgery, peripheral artery disease (PAD), chronic lung disease, chronic renal failure (glomerular filtration rate <30 ml/min/m 2 ), previous pacemaker, frailty (assessed based on serum albumin, gait speed, grip strength, and number of independent activities of daily leaving), atrial fibrillation, Society of Thoracic Surgeons (STS) score, implanted valve type, and vascular access approach. All the analyses were considered significant at a 2-tailed p value of <0.05. The SPSS statistical package version 20.0 was used to perform all statistical evaluation (SSPS Inc. Chicago, Illinois).
Results
From April 2012 to December 2014, 734 patients underwent balloon-expandable TAVI (Edwards Lifesciences, Irvine, California), at our institute. From this cohort, 136 patients were aged at least 90 years at the time of TAVI (mean age 92.4 ± 2.4 years). The remaining 598 younger patients had a mean age of 79.7 ± 7.8 years. Transfemoral approach was used in 85.3% of the cases, transapical approach in 5.6%, transaortic approach in 8.3%, and subclavian approach in 0.8%. The baseline clinical, echocardiographic, and CT characteristics of the study population are provided in Table 1 . Several baseline characteristics were not similar between groups. BMI was lower in patients aged ≥90 years. Diabetes mellitus, CAD, previous CABG or valve surgery, PAD, and chronic lung disease were significantly less prevalent in patients aged ≥90 years. In contrast, the prevalence of frailty, chronic renal failure, atrial fibrillation, and baseline permanent pacemaker implantation was significantly higher in these patients ( Table 1 ).
| Variable | Age (years) | p-value | |
|---|---|---|---|
| <90 (n = 598) | ≥90 (n=136) | ||
| Age (years) | 79.7 ± 7.8 | 92.4 ± 2.4 | <0.001 |
| Men | 366 (61.2%) | 78 (57.4%) | 0.41 |
| Body mass index (kg/m 2 ) | 27.4 ± 6.0 | 25.0 ± 5.5 | <0.001 |
| Hypertension | 547 (91.5%) | 122 (89.7%) | 0.51 |
| Diabetes mellitus | 199 (33.3%) | 28 (20.6%) | 0.004 |
| Coronary artery disease | 410 (68.6%) | 69 (50.7%) | <0.001 |
| Previous coronary artery bypass graft | 178 (29.8%) | 20 (14.7%) | <0.001 |
| Previous valve surgery | 56 (9.4%) | 5 (3.7%) | 0.03 |
| Peripheral artery disease | 234 (39.1%) | 36 (26.5%) | 0.01 |
| Previous Stroke | 81 (13.5%) | 12 (8.8%) | 0.14 |
| Chronic lung disease | 246 (41.1%) | 33 (24.3%) | <0.001 |
| Renal insufficiency (glomerular filtration rate <30 mL/min/m 2 ) | 74 (12.4%) | 53 (39%) | <0.001 |
| Previous pacemaker | 105 (17.6%) | 43 (31.6%) | <0.001 |
| Atrial fibrillation | 187 (31.3%) | 61 (44.9%) | <0.001 |
| Frailty | 182 (30.4%) | 81 (59.6%) | <0.001 |
| Society of Thoracic Surgeons score, (%) | 7.2 ± 4.3 | 11.0 ± 6.0 | <0.001 |
| EuroScore II (%) | 10.0 ± 7.1 | 11.8 ± 7.7 | 0.06 |
| Ejection fraction (%) | 57.1 ± 14.1 | 58 ± 14.8 | 0.58 |
| Aortic valve area (cm 2 ) | 0.64 ± 0.16 | 0.60 ± 0.15 | 0.07 |
| Aortic valve mean gradient (mm Hg) | 45.7 ± 13.4 | 46.1 ± 13.8 | 0.77 |
| Aortic valve maximal gradient (mm Hg) | 76.6 ± 21.0 | 76.9 ± 22.4 | 0.88 |
| CT mean annulus diameter (mm) | 24.3 ± 2.7 | 24.2 ± 2.5 | 0.64 |
| CT mean aortic valve Agatston calcification score (Agatston units) ∗ | 3557 ± 2128 | 3927 ± 2199 | 0.11 |
Procedural details are reported in Table 2 . Patients aged ≥90 years had higher rates of the first-generation Sapien valve implanted and were more likely to undergo transfemoral TAVI. Device success was similar between the 2 age groups (96% for both). Postprocedural TEE perivalvular leak (PVL) grades and postprocedural mean aortic valve gradients were not different between the 2 groups. Mean duration of hospitalization was 5.3 ± 5.0 in patients aged ≥90 years versus 5.1 ± 5.4 in younger patients (p = 0.67). The mean NYHA functional capacity class at 30 days was similar between groups (1.84 vs 1.71; p = 0.11).
| Variable | Age (years) | p-value | |
|---|---|---|---|
| <90 (n = 598) | ≥90 (n=136) | ||
| Implanted valve type: | |||
| Edwards-SAPIEN | 154 (25.8%) | 52 (38.2%) | 0.01 |
| Sapien-XT | 289 (48.3%) | 60 (44.1%) | |
| Sapien 3 | 155 (25.9%) | 24 (17.6%) | |
| Implanted valve size (mm): | |||
| 23 | 179 (29.9%) | 47 (34.5%) | 0.11 |
| 26 | 278 (46.5%) | 64 (47.1%) | |
| 29 | 141 (23.6%) | 25 (18.4%) | |
| Vascular access: | |||
| Transfemoral | 499 (83.4%) | 127 (93.4%) | 0.01 |
| Transapical | 38 (6.4%) | 3 (2.2%) | |
| Transaortic | 57 (9.5%) | 4 (2.9%) | |
| Subclavian | 4 (0.7%) | 2 (1.5%) | |
| Device success | 575 (96.2%) | 131 (96.3%) | 0.93 |
| 2 nd valve | 17 (2.8%) | 5 (3.7%) | 0.61 |
| Postdilatation | 50 (8.4%) | 13 (9.6%) | 0.65 |
| Valve embolization | 4 (0.7%) | 0 | 0.34 |
| Fluoroscopy time (minutes) | 15.8 ± 7.6 | 17.0 ± 8.5 | 0.12 |
| Total contrast used (ml) | 83.4 ± 39.9 | 82.5 ± 43.8 | 0.81 |
| TEE postprocedural PVL: | |||
| None/Trace | 461 (77.1%) | 91 (66.9%) | 0.15 |
| Mild | 121 (20.2%) | 38 (27.9%) | |
| Moderate | 15 (2.5%) | 7 (5.1%) | |
| Severe | 1 (0.2%) | 0 | |
| Mean postprocedural aortic valve gradient (mm Hg) | 5.7 ± 5.2 | 5.0 ± 4.5 | 0.10 |
All-cause mortality at 30 days was 2.9% versus 2.8% in patients aged ≥90 and <90 years, respectively (p = 0.95). One-year mortality was 12.5% for nonagenarians versus 12.3% for younger patients (p = 0.75). Overall, there was no significant difference in survival rates between both groups (p = 0.07, log-rank test; Figure 1 ). Thirty-day VARC-2 end points are summarized in Table 3 . Except for higher rates of minor vascular complications (13.2% vs 7.7%; p = 0.04) in nonagenarians, there was no difference in VARC-2–defined end points between the 2 groups. In the multivariate model, age ≥90 years was not found to be significantly associated with all-cause mortality (hazard ratio 0.93, 95% confidence interval 0.56 to 1.56). Diabetes mellitus, chronic renal failure, atrial fibrillation, frailty, and alternative access were found to be independently associated with mortality in this present cohort ( Table 4 ).
| Overall (n = 734) | Age (years) | p-value | ||
|---|---|---|---|---|
| <90 (n = 598) | ≥90 (n=136) | |||
| Mortality | 21 (2.9%) | 17 (2.8%) | 4 (2.9%) | 0.95 |
| Cerebrovascular accident or transient ischemic attack | 20 (2.7%) | 16 (2.7%) | 4 (2.9%) | 0.86 |
| Myocardial infarction | 4 (0.7%) | 4 (0.7%) | 0 | 0.44 |
| Respiratory failure | 22 (3%) | 20 (3.3%) | 2 (1.5%) | 0.40 |
| Cardiogenic shock | 14 (1.9%) | 13 (2.2%) | 1 (0.7%) | 0.49 |
| Cardiac tamponade | 4 (0.5%) | 3 (0.5%) | 1 (0.7%) | 0.56 |
| Major bleeding | 30 (4.1%) | 22 (3.7%) | 8 (5.9%) | 0.24 |
| Major vascular complications | 23 (3.1%) | 17 (2.8%) | 6 (4.4%) | 0.34 |
| Minor vascular complications | 64 (8.7%) | 46 (7.7%) | 18 (13.2%) | 0.04 |
| New permanent pacemaker implantation | 57 (9.6%) | 53 (10.6%) | 4 (4.3%) | 0.08 |
| Acute kidney injury stage 3 | 11 (1.3%) | 8 (1.3%) | 3 (2.2%) | 0.44 |
| Variable | Univariate analysis | Multivariate analysis | ||||
|---|---|---|---|---|---|---|
| Hazard Ratio | Confidence Interval | p-value | Hazard Ratio | Confidence Interval | p-value | |
| Age ≥ 90 years | 1.51 | 0.97-2.36 | 0.07 | 0.93 | 0.56-1.56 | 0.80 |
| Age ∗ (years) | 1.03 | 1.00-1.06 | 0.01 | 1.02 | 0.99-1.06 | 0.21 |
| Body mass index (kg/m 2 ) | 0.96 | 0.92-99 | 0.03 | 0.99 | 0.96-1.04 | 0.82 |
| Diabetes mellitus | 1.38 | 0.93-2.05 | 0.11 | 1.59 | 1.06-2.41 | 0.03 |
| Coronary artery disease | 1.06 | 0.71-1.60 | 0.77 | 0.92 | 0.58-1.47 | 0.74 |
| Previous coronary artery bypass graft or valve surgery | 1.19 | 0.79-1.78 | 0.41 | 1.21 | 0.75-1.96 | 0.43 |
| Peripheral artery disease | 1.73 | 1.18-2.54 | 0.006 | 1.47 | 0.98-2.21 | 0.07 |
| Chronic lung disease | 1.39 | 0.95-2.05 | 0.10 | 1.41 | 0.92-2.17 | 0.12 |
| Chronic renal failure (glomerular filtration rate <30 mL/min/m 2 ) | 3.61 | 2.44-5.36 | <0.001 | 2.58 | 1.54-4.31 | <0.001 |
| Previous pacemaker | 1.63 | 1.07-2.49 | 0.02 | 1.20 | 0.76-1.89 | 0.44 |
| Atrial fibrillation | 1.49 | 1.01-2.19 | 0.05 | 1.53 | 1.01-2.34 | 0.047 |
| Frailty | 2.71 | 1.83-4.00 | <0.001 | 2.07 | 1.34-3.20 | 0.001 |
| Society of Thoracic Surgeons score, (%) | 1.09 | 1.07-1.12 | <0.001 | 1.03 | 0.99-1.07 | 0.10 |
| Sapien valve | 1.62 | 1.09-2.41 | 0.02 | 1.05 | 0.69-1.60 | 0.84 |
| Alternative access (transapical/ transaortic /subclavian) | 2.50 | 1.63-3.85 | <0.001 | 1.84 | 1.14-2.96 | 0.01 |
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