Aortic stenosis (AS) is the most frequent heart valve disease. Surgical aortic valve replacement (SAVR) is the reference treatment. Transcatheter aortic valve implantation (TAVI) has emerged as an alternative treatment. New strategies for treating the AS are upcoming. The aim of the study was to assess if the clinical profile of octogenarian patients treated surgically before and after the TAVI program initiation has changed. We retrospectively included consecutive octogenarian patients, who underwent isolated SAVR, from January 2006 to December 2011 in a single high-volume center. We compared preoperative and postoperative characteristics before and after the initiation of TAVI (February 2009). Five hundred seventeen patients were included: 229 in the “pre-TAVI” group (2006 to 2008), 288 in the “post-TAVI” group (2009 to 2011). The mean age was 83.2 ± 2.0 in the “pre-TAVI” group, 83.5 ± 2.1 in the “post-TAVI” group (p = 0.106). There were no significant differences in preoperative characteristics: New York Heart Association class (p = 0.374), history of heart failure (p = 0.680), left ventricular ejection fraction (59.8 ± 12.2% in the “pre-TAVI” group, 59.9 ± 11.3% in the “post-TAVI” group, p = 0.922), coronary artery disease (p = 0.431), chronic pulmonary disease (p = 0.363), and previous cardiac surgery (p = 0.085). The logistic EuroSCORE was 7.78 ± 4.60% in the “pre-TAVI” group and 7.33 ± 3.96% in the “post-TAVI” group (p = 0.236). The operative mortality (30-day) was comparable: 5.2% in the “pre-TAVI” group, 6.9% in the “post-TAVI” group (p = 0.424). Thus, with the emergence of TAVI, the number of octogenarian patients operated on, their preoperative characteristics, and the operative mortality remained comparable.
Aortic stenosis (AS) is the most frequently treated heart valve disease. The prevalence of AS increases with age, and it affects around 10% of octogenarians. Surgical aortic valve replacement (SAVR) is the standard treatment with good long-term outcomes. An alternative treatment appeared in 2002 with the first transcatheter aortic valve implantation (TAVI). TAVI is indicated in patients with severe and symptomatic AS who are not suitable for SAVR as assessed by a “heart team” and should be considered in patients with high surgical risk who may still be suitable for surgery. Little is known about the impact of TAVI on the indications to SAVR in the elderly and whether it has prompted an evolution in the characteristics of elderly patients who actually receive SAVR. In this study, we compared the preoperative features, perioperative characteristics, and 30-day postoperative outcomes of octogenarian patients who underwent isolated SAVR before and after the initiation of the TAVI program in a single tertiary center.
Methods
We analyzed data from consecutive patients aged >80 years, who underwent isolated SAVR (i.e., without concomitant coronary artery bypass or other cardiac procedure), from January 1, 2006, to December 31, 2014. All patients were enrolled within a single tertiary center where the TAVI program started in February 2009.
We distinguished 3 groups: the pre-TAVI group (patients operated from January 1, 2006, to December 31, 2008), the post-TAVI 1 group (patients operated from January 1, 2009, to December 31, 2011), and the post-TAVI 2 group (patients operated from January 1, 2012, to December 31, 2014).
Treatment strategies for individual patients were decided during weekly meetings of a multidisciplinary “heart valve team” including physicians (cardiologists, anesthesiologists, geriatricians, and so forth) and surgeons working in the same heart valve clinic. The decision to perform SAVR or TAVI was based on the clinical evaluation by cardiologists, surgeons, and geriatricians in charge of the patient and the Logistic EuroSCORE I in accordance with the national recommendations. These conform the latest European and American guidelines.
The preoperative characteristics, perioperative data, and postoperative mortality and morbidity were collected prospectively at the time of hospital discharge and entered in a computerized database.
The following preoperative characteristics were compared between the pre-TAVI group and each post-TAVI group: mean age, proportion of very elderly patients (aged >85 years), gender, New York Heart Association (NYHA) class, history of acute heart failure, history of atrial fibrillation, history of previous pacemaker implantation, and echocardiographic data (left ventricular ejection fraction, mean aortic valve gradient, aortic valve area). Data about baseline co-morbidities were also analyzed including coronary artery disease (all patients had a coronary angiography before surgery), cerebrovascular disease, peripheral vascular disease, chronic renal failure (defined as a creatinine clearance <60 ml/min according to the Cockcroft–Gault equation), chronic pulmonary disease (defined as abnormal pulmonary function tests or chronic use of bronchodilators or inhaled steroids), hypertension, diabetes mellitus, obesity (defined as a body mass index >30 kg/m 2 ). We used Logistic EuroSCORE I to calculate the estimated operative risk of mortality.
We assessed for the 3 groups the perioperative data, including operative priority (salvage for surgery performed immediately, emergency for surgery within 24 hours, urgent for surgery within a few days and elective for planned surgery), the cardiopulmonary bypass and cross-clamp time, and the type of prosthesis used.
We compared the operative mortality (defined as death within 30 days of surgery) and the incidence of inhospital postoperative complications (reoperation for bleeding, tamponade, prolonged ventilatory support, renal failure, stroke, blood transfusion, atrial fibrillation, and pacemaker implantation) between the pre-TAVI and each post-TAVI groups.
Continuous variables were expressed as mean ± standard deviation and were compared using the Student t test. Normality of continuous variables was checked through the Kolmogorov–Smirnov test. Categorical variables were expressed as a percentage and were compared using either the chi-square test or Fisher’s exact test. All reported p values were 2 sided. A p value <0.05 was considered significant. Statistical analyses were performed using SAS version 9.3 (SAS Institute Inc, Cary, NC).
Results
During the study period, 845 consecutive patients were included, 229 were in the pre-TAVI group, 288 in the post-TAVI 1 group, and 328 in the post-TAVI 2 group ( Figure 1 ). Over time, there was a trend toward an increase in the yearly rate of SAVR performed ( Figure 1 ). Similarly, there was an increase in the number of TAVI procedures among octogenarians, 72 cases from 2009 to 2011, and 202 cases from 2012 to 2014.
Preoperative characteristics were comparable between the pre-TAVI group and the post-TAVI 1 group ( Table 1 ). Nonetheless, the post-TAVI 2 group was characterized by less women; lower prevalence of heart failure, coronary artery disease, severe left ventricular systolic dysfunction; and greater prevalence of hypertension and obesity than the pre-TAVI group ( Table 1 ). Moreover, there was a trend toward less chronic pulmonary disease in the post-TAVI 2 group ( Table 1 ). The Logistic EuroSCORE I trended to decrease in the post-TAVI group 2 ( Table 1 ). The aortic valve area was larger in the 2 post-TAVI groups compared with the pre-TAVI group ( Table 1 ).
Variables | Pre-TAVI (n = 229) | Post-TAVI 1 (n = 288) | p Value ∗ | Post-TAVI 2 (n = 328) | p Value † |
---|---|---|---|---|---|
Age (years) | 83.2 ± 2.0 | 83.5 ± 2.1 | 0.11 | 83.5 ± 2.1 | 0.09 |
Age ≥ 85 years | 49 (21%) | 76 (26%) | 0.19 | 92 (28%) | 0.08 |
Female | 123 (54%) | 152 (53%) | 0.83 | 149 (45%) | 0.05 |
NYHA class | 0.37 | 0.37 | |||
I or II | 133 (58%) | 156 (54%) | 203 (62%) | ||
III or IV | 96 (42%) | 132 (46%) | 125 (38%) | ||
Logistic EuroSCORE I (%) | 12.4 ± 5.9 (10.4%) | 12.7 ± 6.2 (10.7%) | 0.68 | 11.6 ± 5.1 (10.1%) | 0.06 |
History of congestive heart failure | 56 (25%) | 75 (26%) | 0.68 | 37 (11%) | < 0.001 |
Atrial fibrillation | 34 (15%) | 58 (20%) | 0.15 | 59 (18%) | 0.35 |
Permanent pacemaker | 16 (7%) | 13 (5%) | 0.22 | 17 (5%) | 0.37 |
Coronary artery disease | 51 (22%) | 56 (19%) | 0.43 | 33 (10%) | < 0.001 |
Cerebrovascular disease | 12 (5%) | 15 (5%) | 0.99 | 16 (5%) | 0.85 |
Peripheral vascular disease | 49 (21%) | 67 (23%) | 0.61 | 60 (18%) | 0.36 |
Chronic renal failure | 11 (5%) | 20 (7%) | 0.31 | 24 (7%) | 0.23 |
Chronic pulmonary disease | 28 (12%) | 28 (10%) | 0.36 | 25 (8%) | 0.07 |
Previous cardiac surgery | 7 (3%) | 2 (1%) | 0.08 | 6 (2%) | 0.35 |
Hypertension | 135 (59%) | 189 (66%) | 0.12 | 227 (69%) | 0.01 |
Diabetes mellitus | 19 (8%) | 20 (7%) | 0.56 | 27 (8%) | 0.98 |
Obesity ‡ | 40 (18%) | 70 (24%) | 0.06 | 80 (24%) | 0.05 |
LVEF (%) | 60 ± 12 | 60 ± 11 | 0.92 | 61 ± 10 | 0.32 |
LVEF < 50% | 36 (17%) | 43 (16%) | 0.81 | 33 (10%) | 0.02 |
Mean aortic valve gradient (mmHg) | 51 ± 15 | 51 ± 17 | 0.70 | 52 ± 15 | 0.40 |
Aortic valve area (cm 2 ) | 0.6 ± 0.1 | 0.7 ± 0.2 | 0.007 | 0.7 ± 0.2 | < 0.001 |
∗ p Value between pre-TAVI and post-TAVI 1.
† p Value between pre-TAVI and post-TAVI 2.
Concerning perioperative data, there were significantly more urgent surgeries and lower decrease of the cardiopulmonary bypass and cross-clamp time in the post-TAVI 1 group ( Table 2 ). They were similar between the pre-TAVI group and the post-TAVI 2 group ( Table 2 ). The operative mortality was comparable (5.2% in the pre-TAVI group, 6.9% in the post-TAVI 1 group, 4.3% in the post-TAVI 2 group). Concerning the incidence of early postoperative complications, there were statistically more cases of renal failure in the post-TAVI 1 group ( Table 3 ).
Variables | Pre-TAVI (n = 229) | Post-TAVI 1 (n = 288) | p Value ∗ | Post-TAVI 2 (n = 328) | p Value † |
---|---|---|---|---|---|
Operation status | 0.03 | 0.32 | |||
Elective | 227 (99%) | 277 (96%) | 321 (98%) | ||
Urgent | 2 (1%) | 11 (4%) | 7 (2%) | ||
Cardiopulmonary bypass time (min) | 57 ± 19 | 54 ± 14 | 0.01 | 57 ± 19 | 0.98 |
Cross-clamp time (min) | 44 ± 15 | 42 ± 11 | 0.02 | 45 ± 16 | 0.45 |
Bioprosthetic valves | 229 (100%) | 288 (100%) | 1.00 | 328 (100%) | 1.00 |