Methods

From December 2007 to June 2011, 137 consecutive patients who were diagnosed with severe symptomatic aortic stenosis (AS) and were at high surgical risk were prospectively enrolled in the present study at the Henri Mondor University Hospital. “Severe AS” was defined as an aortic valve area of <0.8 cm ² , a peak aortic jet velocity of >4.0 m/s, or mean aortic valve gradient >40 mm Hg, as determined by echocardiography. Evaluation of the operative risk was calculated using the logistic European System for Cardiac Operative Risk Evaluation and the Society of Thoracic Surgeons predictive risk of mortality score. A high risk of surgery was defined as a logistic European System for Cardiac Operative Risk Evaluation >20% or Society of Thoracic Surgeons Predictive Risk of Mortality score >10% and was also assessed by the presence of cardiac or noncardiac co-morbidities. From the prescreening results, patients had been determined to be unsuitable for conventional AVR by both a cardiac surgeon and a cardiologist. The decision to use TAVI in these nonagenarians was determined by the usual indicators for TAVI but with additional confirmation that the patients were free from severe dementia, understood this procedure, could receive supportive care in the hospital and from their family, had a life expectancy of >1 year, and were expected to experience improvement in their activities of daily life. One male patient (aged 84 years) was excluded from the initial analysis because TAVI was not performed. The patient had experienced a stroke before implantation of the valve. The remaining 136 patients were divided into 2 groups: those aged <90 years and those aged ≥90 years. All the data to be analyzed were obtained from the patients’ medical records. The data included the baseline clinical findings; patient characteristics; findings from coronary angiography, computed tomography, transthoracic echocardiography, and transesophageal echocardiography; procedural parameters; and the length of intensive care unit and hospital stays. Information regarding patient survival was obtained from the treating hospital or through telephone calls directly to the patients. The status of the clinical symptoms was evaluated using the New York Heart Association (NYHA) classification system for all patients at baseline. The survivors were also evaluated 6 months after TAVI. The medical ethics committee at Henri Mondor University Hospital, Val-de-Marne University approved the study protocol, and all patients provided written informed consent before the TAVI procedure.

The TAVI procedure was previously reported in detail. In brief, the access route was first chosen as the femoral artery; other access sites (the subclavian or carotid artery) were considered when femoral access was not suitable for advancing the large sheath. The femoral artery was punctured percutaneously and closed using a suture device (Proster XL, Abbott, Chicago, Illinois), and the other access sites were managed surgically. We used 2 commercially available systems: a self-expandable prosthesis, the Medtronic CoreValve Revalving System (Medtronic, Minneapolis, Minnesota), and a balloon-expandable prosthesis, the Edwards SAPIEN valve (Edwards Lifesciences, Irvine, California). After the procedure, all patients were evaluated using transthoracic echocardiography and, if required, transesophageal echocardiography. In accordance with the Valve Academic Research Consortium (VARC) criteria, procedural complications, device success, and 30-day combined safety were evaluated. According to the VARC criteria, bleeding complications were classified as “life-threatening,” “major,” or “minor.” Vascular and stroke complications were also classified as major or minor. Acute kidney injury was classified as grade 1 and 2, or 3, with a grade greater than 2 defined as an acute kidney injury complication. The combined safety end point was set as any of the following: all-cause mortality, major stroke, life-threatening bleeding, acute kidney injury stage 3 (including renal replacement therapy), periprocedural myocardial infarction, major vascular complications, or repeat procedure for valve-related dysfunction (surgical or interventional therapy). The degree of pre- and postprocedural aortic regurgitation and mitral regurgitation were measured with color Doppler using transthoracic echocardiography on the basis of the current guidelines and the VARC definition. Semiquantitative analysis was applied to preprocedural aortic regurgitation and pre- and postprocedural mitral regurgitation: grade 0, none; grade 1, trivial; grade 2, mild; grade 3, moderate; and grade 4, severe.

All statistical analyses were performed using the SPSS software, version 19 (SPSS, Chicago, Illinois). Continuous variables are expressed as the mean ± SD or median, depending on the variable distribution. Categorical data are expressed as the percentage of the total. Comparisons between the 2 groups were performed using the chi-square test or the unpaired Student’s t test, as appropriate. The Kaplan-Meier method was used to estimate the cumulative mortality rates in the 2 age groups. Differences in mortality between the 2 groups were compared using the log-rank test. Cox regression analysis was used to detect the predictive values of cumulative survival at follow-up between the 2 groups. All statistical tests were 2-sided, and p <0.05 was considered significant.

Results

The baseline patient characteristics are listed in Table 1 , and the age distribution of all 136 patients is presented in Figure 1 . The echocardiographic findings are listed in Table 2 . The group aged <90 years included 110 patients (81% of the total enrolled), with a mean age of 82.3 ± 8.3 years. The group aged ≥90 years included 26 patients (19%), with a mean age of 91.6 ± 1.9 years. The prevalence of women was lower in the <90-years group than the ≥90-year group (50% vs 81%; p = 0.004). All parameters related to body characteristics showed significant differences between the 2 groups. In the ≥90-year group, the patients had a lower height, lower weight, lower body mass index, and lower body surface area. Smoking was more prevalent, and β blockers were more frequently prescribed for patients aged <90 years than those aged ≥90 years (p = 0.004 and p = 0.046, respectively). Other baseline characteristics did not differ between the 2 groups, nor did the estimated operative mortalities calculated using the logistic European System for Cardiac Operative Risk Evaluation and Society of Thoracic Surgeons Predictive Risk of Mortality score (p = 0.25 and p = 0.55, respectively). The degree of AS was more severe in the patients aged ≥90 years than in those aged <90 years. Differences were present between the 2 groups with respect to the peak aortic valve gradient and mean aortic valve gradient. The prevalence of grade 2 or greater mitral regurgitation was also greater in patients aged ≥90 years (11% vs 35%, p = 0.006). The postprocedural peak aortic valve gradient and the presence of grade 2 aortic regurgitation or greater did not differ between the 2 groups.

Age distribution in study population. Age distribution of all 136 patients presented. The prevalence of nonagenarians was 19% (26 of 110); the remaining 81% (110 of 136) were aged <90 years. Of the 110 patients aged <90 years, 27 (24.5%) were aged <80, 28 (25.5%) were aged 81 to 84 years, and 55 (50.0%) were aged 85 to 89 years.

The procedural characteristics are listed in Table 3 . No significant differences were found in the procedural time, dose of contrast media, valve types, or the approach sites used between the 2 groups. Moreover, the length of hospital and intensive care unit stays in patients aged ≥90 years were equal to those of the patients aged <90 years (p = 0.55 and p = 0.87, respectively). In VARC-defined procedural variables, the procedural success rates were similar (96% vs 100%, p = 0.58). Although the occurrence of most procedural complications did not differ between the 2 groups, the major vascular complications were more prevalent in the group aged ≥90 years (5% vs 19%, p = 0.022). Thus, the 30-day combined safety end point showed a significant difference between the 2 groups (13% vs 31%, p = 0.037). The follow-up rate for both groups was 100%, and all patients were followed up for ≥6 months after TAVI. No statistically significant differences were found between the 2 groups with respect to the 30-day and 6-month mortality rates (6% vs 15%, p = 0.22; and 14% vs 27%, p = 0.14, respectively). However, the mortality of patients aged ≥90 years was double that of patients aged <90 years. We lost 7 patients aged ≥90 years within 6 months after TAVI. The clinical findings of these patients are listed in Table 4 . Most of patients were from the early half experience since introducing TAVI and had NYHA class III or IV at baseline. Of the 4 patients who died within 30 days, 2 had an associated vascular complication. At baseline, no patients were categorized as NYHA class I (0% vs 0%). The prevalence of NYHA class II and III was similar in the 2 groups (40 [36%] of 110 vs 9 [34%] of 26, p = 0.87; and 63 [57%] of 100 vs 11 [42%] of 26, p = 0.17, respectively). The rate of NYHA class IV was greater in patients aged ≥90 years than in those aged <90 years (7 [6%] of 110 vs 6 [23%] of 26, p = 0.014). Of these, 15 patients aged <90 years died (NYHA class II in 7, NYHA class III in 6, NYHA class IV in 2) and 7 patients aged ≥90 years died (NYHA class II in 1, NYHA class III in 3, and NYHA class IV in 3).

Table 3

Periprocedural and postprocedural patient characteristics

Variable	Overall (n = 136)	Age (years)		p Value
		<90 (n = 110)	≥90 (n = 26)
Periprocedural
Procedure time (min)	79.6 ± 27.7	79.7 ± 26.5	79.2 ± 32.8	0.93
Fluoroscopy time (min)	19.8 ± 9.9	20.3 ± 10.3	17.8 ± 8.2	0.27
Contrast medium volume (ml)	184.4 ± 89.9	187.5 ± 94.1	171.4 ± 70.3	0.46
Medotronic CoreValve	130 (95%)	106 (96%)	24 (92%)	0.32
Edwards SAPIEN	6 (5%)	4 (4%)	2 (8%)	0.32
Transfemoral approach	130 (96%)	106 (96%)	24 (92%)	0.32
Subclavian approach	4 (3%)	3 (3%)	1 (4%)	0.58
Carotid approach	2 (2%)	1 (1%)	1 (4%)	0.35
Postprocedural
Length of stay in hospital (days)	9.4 ± 7.7	9.6 ± 8.1	8.6 ± 5.8	0.55
Length of stay in intensive care unit (days)	3.4 ± 1.7	3.4 ± 1.6	3.4 ± 2.2	0.87
30-Day mortality	11 (8%)	7 (6%)	4 (15%)	0.22
6-Month mortality	22 (16%)	15 (14%)	7 (27%)	0.14
Valve Academic Research Consortium
Procedural success	131 (96%)	105 (96%)	26 (100%)	0.58
30-Day combined safety end point	22 (16%)	14 (13%)	8 (31%)	0.037
Myocardial infarction	2 (1%)	1 (1%)	1 (4%)	0.83
Stroke and transient ischemic accident	9 (7%)	5 (5%)	4 (15%)	0.068
Major stroke	3 (2%)	2 (2%)	1 (4%)	0.47
Acute kidney injury grade 2 or greater	24 (18%)	20 (18%)	4 (15%)	>0.99
Vascular complication (major)	10 (7%)	5 (5%)	5 (19%)	0.022
Bleeding (life-threatening)	6 (4%)	5 (5%)	1 (4%)	>0.99
Bleeding (major)	41 (30%)	33 (30%)	8 (31%)	>0.99
Other complications
Two-valve implantation	3 (2%)	3 (3%)	0 (0%)	>0.99
Device migration	6 (4%)	5 (5%)	1 (4%)	>0.99
Surgery for vascular complication	8 (6%)	4 (4%)	4 (15%)	0.043
Red blood cell transfusion	24 (18%)	20 (18%)	4 (15%)	>0.99
Newly implantation of pacemaker	23 (21%)	20 (24%)	3 (12%)	0.39
Cardiogenic shock during procedure	4 (3%)	3 (3%)	1 (4%)	>0.99
Cardiac tamponade during procedure	1 (1%)	1 (1%)	0 (0%)	>0.99
Conversion to aortic valve replacement	1 (1%)	1 (1%)	0 (0%)	>0.99
Ventricular fibrillation	0 (0%)	0 (0%)	0 (0%)	>0.99

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