The impact of age on baseline characteristics and outcomes in patients with severe aortic stenosis who undergo transcatheter aortic valve implantation (TAVI) has not been thoroughly investigated. To describe the baseline clinical profile of TAVI patients aged >85 and ≤85 years and to evaluate the influence of age differences on outcomes, we evaluated a consecutive cohort of 293 patients who underwent transfemoral TAVI at the Tel Aviv Medical Center. The cohort was divided into 2 groups: patients aged >85 years (n = 93) and patients aged ≤85 years (n = 200). Mean age was 83 ± 5.3 years (range 63 to 98) for the entire cohort. Women comprised 70% of the older group and 57.5% of the younger age group (p = 0.043). Baseline clinical profile, including EuroSCORE index and preprocedural aortic valve area were similar in both age groups. Thirty-day mortality, major vascular complications, need for permanent pacemaker implantation, length of hospital stay, and improvement in functional class after the procedure showed no differences between the 2 groups. Adjustment for baseline clinical differences between groups did not change the results. In conclusion, among patients who underwent transfemoral TAVI, older patients (>85 years) experience similar benefits and outcomes regarding functional status, complication rates, and 30-day mortality.
Aged individuals represent a growing portion of the population in the developed world, and it is predicted that in the next 30 years, the percentage of people aged >75 will double in Western countries. In the field of cardiology, advanced age is considered the most powerful risk factor for the development cardiovascular disease and for cardiovascular-related mortality. In this study we compare the baseline clinical profile of transcatheter aortic valve implantation (TAVI) in patients aged >85 and ≤85 years and evaluate the influence of older age on outcome after adjusting for baseline characteristics.
Methods
Consecutive, high-risk patients who underwent TAVI via the transfemoral approach between March 2009 and September 2012 at the Tel-Aviv Medical Center (Tel-Aviv, Israel) were prospectively included in the Tel Aviv Prospective Angio Survey (TAPAS) database. All had severe symptomatic aortic stenosis, and all were considered high risk for valve surgery by the institutional heart team.
Routine right and left cardiac catheterization with full hemodynamic evaluation was performed before TAVI. During the catheterization, ascending aortography and bilateral iliofemoral arteriography were performed. All patients underwent pre- and post-TAVI transthoracic or transesophageal echocardiograms. All TAVI procedures were performed using either the CoreValve device (Medtronic, Minneapolis, Minnesota) or the Edwards Sapiens or Sapiens XT heart valve system (Edwards Lifesciences, Irvine, California). A temporary pacemaker was placed in the right ventricular apex, and balloon valvuloplasty was performed under rapid ventricular pacing followed by implantation of the valve (26, 29, or 31 mm for CoreValve, and 23 or 26 mm for Edwards Sapiens XT valve). Intravenous heparin was administered targeting an activated clotting time of 250 to 300 seconds. All patients were treated with aspirin and clopidogrel according to guidelines.
All patients were monitored in the intensive care unit for at least 24 hour postprocedurally, after which they were transferred to the cardiology ward for further assessment including daily electrocardiogram recordings and a cardiac echocardiogram before discharge.
After discharge, all patients were assessed by a cardiologist in the hospital’s outpatient cardiology clinic at 1, 6, and 12 months postprocedurally and annually thereafter. Medical interview, physical examination, electrocardiogram recordings, and cardiac echocardiograms were performed at each visit.
The primary end points were 30-day all-cause mortality, survival as measured by Cox regression model, combined 30-day complication rate, and procedural success as defined by the Valve Academic Research Consortium.
For statistical analysis purposes, a cutoff value of 85 years of age was defined, with patients aged ≤85 years considered “the younger age group” and patients ages >85 considered “the older age group.” All data were summarized and displayed as mean (SD) for continuous variables and as number (percentage) of patients in each group for categorical variables. Student’s t and chi-square tests were used to evaluate statistical significance between continuous and categorical variables, respectively. Survival was estimated with Cox regression models using the enter mode. The dependent variable was defined as all-cause mortality and was adjusted for patients and procedural characteristics. All baseline variables presented in Table 1 were available for selection in the model. All analyses were considered significant at a 2-tailed p value of <0.05. The SPSS statistical package was used to perform all statistical evaluation (SSPS, Chicago, Illinois).
| Characteristic | Age (yrs) | p Value | |
|---|---|---|---|
| ≤85 (n = 200) | >85 (n = 93) | ||
| Mean age, yrs | 80.5 ± 4 | 88.8 ± 2.5 | <0.001 |
| Women | 57.5% | 70% | 0.043 |
| Norton score | 6 ± 1.3 | 6.4 ± 1.8 | 0.06 |
| Charlson score | 14.3 ± 8 | 14.2 ± 8 | 1 |
| Preprocedural aortic valve area, cm 2 | 0.71 ± 0.17 | 0.67 ± 0.21 | 0.09 |
| Aortic valve area index, cm 2 /m 2 | 0.392 | 0.398 | 0.7 |
| Hypertension | 84.5% | 90.3% | 0.22 |
| Diabetes mellitus | 36.5% | 24.7% | 0.046 |
| Creatinine clearance test, ml/min | 48.5 | 33.5 | <0.001 |
| Hyperlipidemia | 79.5% | 72% | 0.17 |
| Peripheral vascular disease | 9% | 8.5% | 0.9 |
| Heart failure | 27% | 38.7% | 0.043 |
| Mean ejection fraction | 56% | 56% | 1 |
| Coronary heart disease | 55% | 61.3% | 0.31 |
| Previous myocardial infarction | 11% | 27% | 0.001 |
| Previous percutaneous coronary intervention | 45% | 44% | 0.93 |
| Previous coronary artery bypass graft | 22.5% | 7.5% | 0.002 |
| Previous pacemaker | 8% | 9.7% | 0.68 |
| Cerebrovascular disease | 8% | 7.5% | 0.84 |
| Atrial fibrillation | 16.5% | 18.3% | 0.62 |
| Chronic obstructive pulmonary disease | 21% | 23.7% | 0.61 |
| Pulmonary hypertension | 58.5% | 62.4% | 0.48 |
| EuroSCORE | 26.3 ± 13 | 24 ± 14.5 | 0.3 |
| New York Heart Association functional class | 3.2 | 3.4 | 0.001 |
Results
The study cohort consisted of 293 consecutive patients treated with transfemoral TAVI. Median follow-up was 480 days, with an interquartile range of 330 to 730 days. A Medtronic CoreValve bioprosthesis was used in 84% (n = 246) of patients and Edwards Sapien valve in 16% (n = 47). Median follow-up was 480 days, with an interquartile range of 330 to 730 days. The cohort was divided to 2 groups, 200 patients were aged ≤85 years and 93 patients were >85 years. Mean age for the entire cohort was 83 ± 5.3 years (range 63 to 98) and 80.5 ± 4 years and 88.8 ± 2.5 years for the younger and older groups, respectively (p <0.001). Baseline clinical and demographic profile demonstrated overall similar characteristics between the 2 age groups as presented in Table 1 . The older group of patients had poorer functional capacity as reflected by their higher New York Heart Association functional class (p = 0.001). EuroSCORE index and preprocedural aortic valve area showed no statistically significant differences between the 2 age groups. Both groups had a low Admission Norton Scale Scores and no difference was shown in Charlson Comorbidity Index.
TAVI procedure was successfully completed in all patients. Three patients in the younger age group and 1 patient in the older age group had a moderate angiographic aortic regurgitation at the end of the procedure, without further escalation during follow-up. Two patients in each group had a valve migration, necessitating an implantation of a second valve.
Overall complication rates (Valve Academic Research Consortium definitions) were similar between the 2 age groups, with the exception of respiratory failure events and minor vascular complications, which were more prevalent in older patients (p = 0.034 and p = 0.037, respectively; Table 2 ). Importantly, length of hospital stay and the improvement in functional capacity after TAVI showed no difference between groups.
