Abstract
Background: Limited data are available for clinical outcomes in patients who underwent urgent or emergency transcatheter aortic valve implantation (TAVI). This study investigated in-hospital and 1-year outcomes and explored prognostic covariates in urgent/emergency TAVI using nationwide registry data.
Methods and Results: Among 26,775 patients who underwent TAVI between August 2013 and December 2019, 25,495 with 1-year follow-up information were analyzed in this study. Baseline and procedural characteristics, as well as clinical adverse events, were compared between the urgent/emergency and elective TAVI groups. The primary outcome was all-cause mortality within 1 year after TAVI. Multivariable Cox regression models were constructed to identify independent predictors after urgent or emergency TAVI. Urgent or emergency TAVI was performed in 578 (2.3%) patients. The Society of Thoracic Surgeons score was significantly higher in the urgent/emergency than elective TAVI group (13.3% vs. 6.0%; P<0.001). Device success rate was comparable between the 2 groups. All-cause death-free survival within 1 year was lower in the urgent/emergency than elective TAVI group (77.2% vs. 92.2%; log rank P<0.001). Malignancy, albumin and creatinine concentrations, ejection fraction, and mean pressure gradient were associated with 1-year mortality in the urgent/emergency TAVI group.
Conclusions: Despite higher surgical risk and more comorbidities, the procedure was successfully performed in patients undergoing urgent/emergency TAVI, although it should be noted that prognosis was worse than for elective TAVI.
The number of patients with aortic stenosis (AS) has increased rapidly due to the incremental increase in the elderly population globally.1,2 It is well known that the prevalence of AS increases with aging, reaching 7–10% among those aged ≥80 years.3,4 Patients with severe AS often experience heart failure, and may rapidly develop severe pulmonary congestion and hypotension, resulting in acute decompensated heart failure (ADHF) and cardiogenic shock. ADHF and cardiogenic shock are reported as important predictors for prognosis in patients with severe AS and are associated with higher long-term mortality rates, even after surgical aortic valve replacement (SAVR).5 Contemporary treatment with transcatheter aortic valve implantation (TAVI) is a far less invasive treatment option and is becoming increasingly widespread as an alternative to SAVR. Thus, patients with severe AS, especially those presenting with ADHF or cardiogenic shock and with serious comorbidities, can benefit from early intervention with TAVI.
Although previous studies reported on the feasibility of urgent/emergency TAVI in selected patients with decompensated AS, it has also been reported that the prognosis of patients requiring urgent/emergency TAVI is significantly worse than for patients undergoing elective TAVI.6,7 Conversely, a previous report from a large-scale registry in experienced centers demonstrated that emergency TAVI was not independently associated with 1-year mortality.8 Given these conflicting reports, further investigation based on results from a national large-scale cohort study is warranted. Thus, the purpose of the present study was to investigate clinical outcomes and explore prognostic factors in patients with severe AS undergoing urgent/emergency TAVI using nationwide registry data in Japan.
Methods
Data Source
This study used the database of the Japan-Transcatheter Valve Therapies (J-TVT) Registry, which is a representative nationwide registry. The J-TVT Registry mandates the registration of all TAVI cases in Japan and comprehensive data entry, including baseline patient characteristics, procedural information, and short- and long-term clinical outcomes.9 In addition, complete follow-up data entry into this registry is one of the requirements for renewal of institutional certification to perform TAVI in Japan. Routine annual onsite audits are conducted (~10 institutions per year) to maintain data accuracy.
This study was approved by the scientific committee of the J-TVT Registry and the institutional review board of Chiba University (ID: 3750). The requirement for informed consent was waived because of the anonymous nature of the data.
Study Population
In this retrospective study, 26,775 patients who underwent initial TAVI procedure between August 2013 and December 2019 were screened. The TAVI procedure became clinically available with insurance reimbursement in October 2013 in Japan. In the J-TVT Registry, 6 patients were included in August and September 2013 who underwent TAVI as an advanced medical therapy approved by the Ministry of Health, Labour and Welfare. Of the 26,775 patients in the registry, patients undergoing TAVI for non-primary AS (n=638), patients without age information (n=84) or follow-up data (n=413), patients on maintenance dialysis (which was off-label use during the study period; n=123), and patients who underwent salvage TAVI (n=22) were excluded. Thus, 25,495 patients were included in the present study.
Patients were divided into 2 groups according to the status of their procedure: elective vs. urgent/emergency TAVI. Procedure status was defined based on the timing of the procedure and the clinical status of the patient prior to the procedure, in compliance with data collection system of the Society of Thoracic Surgeons (STS).6 As similarly described in the 2021 ACC/AHA/SCAI guideline for coronary artery revascularization,10 ‘urgent’ TAVI is defined as a procedure required during the same hospitalization to reduce the likelihood of further clinical deterioration (typically within 24–48 h) in cases such as worsening sudden chest pain, congestive heart failure, acute myocardial infarction (MI), anatomy, the use of an intra-aortic balloon pump, and unstable angina with intravenous nitroglycerin or rest angina, among others. ‘Emergency’ TAVI is defined as a procedure in patients with cardiac compromise, regardless of hemodynamic instability, that is not responsive to any form of therapy except cardiac surgery and is typically performed immediately following admission or a diagnostic procedure.10 Newer-generation valve was defined as SAPIEN3 (Edwards Lifesciences, Irvine, CA, USA) and Evolut PRO (Medtronic, Minneapolis, MN, USA) valves. In the present study, mechanical circulatory support during the procedure included intra-aortic balloon pump, percutaneous ventricular assist device, extracorporeal membrane oxygenation, and cardiopulmonary bypass.
Clinical Outcomes
The primary outcome was all-cause mortality within 1 year after TAVI. Secondary outcomes included device success, conversion to open surgery, second valve at the procedure, mortality, stroke, major bleeding, and annular rupture within 3 days after the procedure, as well as stroke, pacemaker installation, acute kidney injury (AKI) or dialysis, MI, major bleeding, and reintervention within 30 days after the procedure.
Statistical Analysis
Statistical analyses were performed using SAS 9.4 (SAS Institute, Cary, NC, USA). Baseline clinical and procedural characteristics were compared between the elective and urgent/emergency TAVI groups. Categorical variables are presented as percentages, and were compared between groups using the Chi-squared test or Fisher’s exact test. Continuous variables are expressed as the median with interquartile range and were compared between groups using the Wilcoxon rank-sum test. Two-sided P<0.05 was considered statistically significant.
Kaplan-Meier curve analysis was used to estimate the cumulative survival from all-cause death within 1 year after TAVI in each group. In addition, a multivariable Cox proportional hazards model analysis was used in all patients to clarify whether urgent/emergency TAVI was independently associated with all-cause death after adjusting for the baseline covariates. We also constructed a Cox model among patients undergoing urgent/emergency TAVI to investigate independent predictors for all-cause death. For this model, the predictors were preselected to reduce the number of correlated variables in the model and to allow straightforward interpretation of the derived estimates.
Results
Baseline Clinical Characteristics
Of the 25,495 patients enrolled in this study, 578 (2.3%) underwent TAVI as an urgent/emergency procedure (446 [1.7%] urgent, 132 [0.5%] emergency; Figure 1). Baseline clinical characteristics are presented in Table 1. The urgent/emergency TAVI group had a lower body surface area, a greater prevalence of New York Heart Association (NYHA) Class 3 or 4, and higher rates of coronary artery disease, cerebrovascular disease, pulmonary hypertension, porcelain aorta, and bicuspid aortic valve. The STS score was significantly higher in the urgent/emergency than elective TAVI group (median 13.3% vs. 6.0%, respectively; P<0.001).
Table 1. Baseline Clinical Characteristics
| |
Elective TAVI
(n=24,917) |
Urgent/emergency
TAVI (n=578) |
P value |
| Age (years) |
| <65 |
65 (0.3) |
6 (1.0) |
<0.001 |
| 65–74 |
865 (3.5) |
28 (4.8) |
| 75–84 |
10,897 (43.7) |
219 (37.9) |
| 85–89 |
9,438 (37.9) |
207 (35.8) |
| ≥90 |
3,652 (14.7) |
118 (20.4) |
| Male sex |
7,870 (31.6) |
176 (30.4) |
0.56 |
| BSA (m2) |
1.42 [1.31–1.55] |
1.40 [1.29–1.53] |
0.003 |
| STS score (%) |
6.0 [4.2–8.6] |
13.3 [8.2–25.0] |
<0.001 |
| NYHA Class 3 or 4 |
6,151 (24.7) |
429 (74.2) |
<0.001 |
| Hypertension |
19,738 (79.2) |
436 (75.4) |
0.03 |
| Dyslipidemia |
12,140 (48.7) |
264 (45.7) |
0.15 |
| Diabetes |
6,607 (26.5) |
160 (27.7) |
0.53 |
| Chronic respiratory disease |
1,976 (7.9) |
54 (9.3) |
0.22 |
| Coronary artery disease |
7,773 (31.2) |
213 (36.9) |
0.004 |
| Non-cardiac artery disease |
3,095 (12.4) |
81 (14.0) |
0.25 |
| Carotid artery disease |
1,524 (6.1) |
26 (4.5) |
0.11 |
| Prior PCI |
5,750 (23.1) |
148 (25.6) |
0.15 |
| Prior CABG |
1,122 (4.5) |
23 (4.0) |
0.55 |
| Prior cardiac surgery |
1,932 (7.8) |
38 (6.6) |
0.29 |
| Cerebrovascular disease |
2,271 (9.1) |
73 (12.6) |
0.004 |
| Pulmonary hypertension |
3,591 (14.4) |
208 (36.0) |
<0.001 |
| Prior permanent pacemaker |
1,384 (5.6) |
35 (6.1) |
0.60 |
| Porcelain aorta |
2,337 (9.4) |
87 (15.1) |
<0.001 |
| Malignancy |
2,296 (9.2) |
44 (7.6) |
0.18 |
| Bicuspid aortic valve |
628 (2.5) |
25 (4.3) |
0.007 |
| Laboratory data |
| Hemoglobin (g/dL) |
11.3 [10.2–12.5] |
10.7 [9.6–12.0] |
<0.001 |
| Albumin (g/dL) |
3.8 [3.4–4.1] |
3.2 [2.8–3.6] |
<0.001 |
| Creatinine (mg/dL) |
0.9 [0.7–1.2] |
1.0 [0.7–1.4] |
<0.001 |
| Echocardiography |
| Mean PG (mmHg) |
46.1 [38.0–59.4] |
47.3 [36.0–63.0] |
0.58 |
| Aortic valve area (cm2) |
0.6 [0.5–0.8] |
0.5 [0.4–0.7] |
<0.001 |
| LVEF (%) |
64 [57–70] |
48 [34–63] |
<0.001 |
| Aortic insufficiency Grade 3 or 4 |
1,752 (7.0) |
78 (13.5) |
<0.001 |
| Mitral insufficiency Grade 3 or 4 |
1,938 (7.8) |
129 (22.3) |
<0.001 |
Unless indicated otherwise, data are given as the median [interquartile range] or n (%). BSA, body surface area; CABG, coronary artery bypass graft; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; PG, pressure gradient; STS, Society of Thoracic Surgeons; TAVI, transcatheter aortic valve implantation.
In terms of laboratory data, hemoglobin and albumin concentrations were lower and creatinine concentrations were higher in the urgent/emergency TAVI group. Baseline echocardiographic data indicated a smaller aortic valve area, lower left ventricular ejection fraction (LVEF), and a greater prevalence of aortic and mitral insufficiency Grade 3 or 4 in the urgent/emergency compared with elective TAVI group, although mean pressure gradient (PG) was comparable between the 2 groups.
Comparisons between patients undergoing urgent vs. emergency TAVI revealed a greater body surface area, higher STS score, a greater prevalence of NYHA Class 3 or 4, higher creatinine concentrations, and lower LVEF among those undergoing emergency TAVI (Supplementary Table 1).
Procedural Characteristics
Procedural characteristics are presented in Table 2. The anesthetic techniques were similar between the 2 groups. In terms of vascular access site, the rate of transapical access was lower and the rate of transfemoral and trans-subclavian access was higher in the urgent/emergency group. The usage rate of self-expanding valves tended to be higher (P=0.054) and the use of newer-generation valve was significantly more frequent (P<0.001) in the urgent/emergency than elective TAVI group. During the TAVI procedure, the urgent/emergency TAVI group more frequently required mechanical circulatory support than the elective TAVI group (23.9% vs. 2.3%, respectively; P<0.001). The device success rate, the incidence of conversion to open surgery, and a second valve at the procedure were comparable between the 2 groups. The incidence of postoperative aortic insufficiency grade 3 or 4 was significantly higher in the urgent/emergency than elective TAVI group (P<0.001).
Table 2. Procedural Characteristics
| |
Elective TAVI
(n=24,917) |
Urgent/emergency
TAVI (n=578) |
P value |
| Anesthesia |
| Moderate sedation |
5,041 (20.2) |
111 (19.2) |
0.54 |
| General anesthesia |
19,876 (79.8) |
467 (80.8) |
| Access site |
| Femoral |
22,107 (88.7) |
525 (90.8) |
0.001 |
| Transiliac |
354 (1.4) |
5 (0.9) |
| Transaortic |
265 (1.1) |
4 (0.7) |
| Transapical |
1,790 (7.2) |
24 (4.2) |
| Subclavian |
363 (1.5) |
18 (3.1) |
| Other |
38 (0.2) |
2 (0.3) |
| Device used |
| SAPIEN XT |
4,322 (17.3) |
47 (8.2) |
<0.001 |
| SAPIEN3 |
14,390 (57.8) |
368 (63.7) |
| CoreValve |
636 (2.6) |
9 (1.6) |
| Evolut R |
3,470 (13.9) |
87 (15.1) |
| Evolut PRO |
2,049 (8.2) |
67 (11.6) |
| Not used |
50 (0.2) |
0 (0) |
| Self-expanding valve |
6,155 (24.7) |
163 (28.2) |
0.054 |
| Newer-generation valve |
16,439 (66.0) |
435 (75.3) |
<0.001 |
| Valve size |
| SAPIEN series |
| 20 mm |
1,285 (6.9) |
22 (5.3) |
0.65 |
| 23 mm |
10,408 (55.6) |
233 (56.1) |
| 26 mm |
5,875 (31.4) |
135 (32.5) |
| 29 mm |
1,144 (6.1) |
25 (6.0) |
| CoreValve series |
| 23 mm |
605 (9.8) |
27 (16.6) |
0.01 |
| 26 mm |
3,182 (51.7) |
83 (50.9) |
| 29 mm |
2,368 (38.5) |
53 (32.5) |
| Device success |
23,883 (95.9) |
547 (94.6) |
0.15 |
| Conversion to open surgery |
237 (1.0) |
3 (0.5) |
0.29 |
| Mechanical circulatory support |
571 (2.3) |
138 (23.9) |
<0.001 |
| IABP |
135 (0.5) |
66 (11.4) |
<0.001 |
| PVAD |
7 (0.03) |
1 (0.2) |
| ECMO or CPB |
429 (1.7) |
71 (12.3) |
| Second valve |
150 (0.6) |
6 (1.0) |
0.17 |
| Postoperative aortic insufficiency Grade 3 or 4 |
459 (1.8) |
22 (3.8) |
<0.001 |
Unless indicated otherwise, data are given as n (%). CPB, cardiopulmonary bypass; ECMO, extracorporeal membrane oxygenation; IABP, intra-aortic balloon pump; PVAD, percutaneous ventricular assist device; TAVI, transcatheter aortic valve implantation.
Comparisons of the urgent and emergency TAVI groups revealed that self-expanding valves were less frequently selected and that mechanical circulatory support was more frequently used in the emergency TAVI group (Supplementary Table 2).
Clinical Adverse Events
Adverse events within 3 and 30 days after TAVI are presented in Table 3. Within 3 days after the procedure, mortality (1.0% vs. 0.3%; P=0.01) and the rate of major bleeding (2.8% vs. 1.3%; P=0.003) were significantly higher in the urgent/emergency than elective TAVI group, although the incidence of stroke, life-threatening bleeding, and annular rupture was similar between the 2 groups.
Table 3. Adverse Events
| |
Elective TAVI
(n=24,917) |
Urgent/emergency
TAVI (n=578) |
P value |
| Adverse events within 3 days |
| Death |
72 (0.3) |
6 (1.0) |
0.01 |
| Stroke |
121 (0.5) |
1 (0.2) |
0.53 |
| Life-threatening bleeding |
36 (0.1) |
2 (0.3) |
0.21 |
| Major bleeding |
326 (1.3) |
16 (2.8) |
0.003 |
| Annular rupture |
90 (0.4) |
3 (0.5) |
0.47 |
| Adverse events within 30 days |
| Death |
273 (1.1) |
39 (6.7) |
<0.001 |
| Stroke |
339 (1.4) |
7 (1.2) |
1.00 |
| New pacemaker installation |
1,334 (5.4) |
32 (5.5) |
0.85 |
| AKI or dialysis |
106 (0.4) |
15 (2.6) |
<0.001 |
| Myocardial infarction |
27 (0.1) |
4 (0.7) |
0.005 |
| Life-threatening bleeding |
104 (0.4) |
8 (1.4) |
0.004 |
| Major bleeding |
555 (2.2) |
26 (4.5) |
<0.001 |
| Reintervention |
25 (0.1) |
1 (0.2) |
0.45 |
| Major vascular complication |
651 (2.6) |
23 (4.0) |
0.04 |
Unless indicated otherwise, data are given as n (%). AKI, acute kidney injury; TAVI, transcatheter aortic valve implantation.
Within 30 days after TAVI, mortality was significantly higher (6.7% vs. 1.1%; P<0.001), as was the rate of AKI or dialysis, MI, life-threatening bleeding, major bleeding, and major vascular complications, in the urgent/emergency than elective TAVI group. However, the incidence of stroke, new pacemaker installation, and reintervention was similar between the 2 groups. The observed-to-expected ratio of mortality within 30 days was 0.18 (1.1%/6.0%) in the elective TAVI group and 0.50 (6.7%/13.3%) in the urgent/emergency TAVI group.
Comparisons between the urgent and emergency TAVI groups revealed no significant differences in the incidence of adverse events within 3 and 30 days after TAVI (Supplementary Table 3).
Kaplan-Meier curve analysis revealed that all-cause death-free survival within 1 year was significantly lower in the urgent/emergency than elective TAVI group (77.2% vs. 92.2%, respectively; log-rank P<0.001; Figure 2). Kaplan-Meier curve analysis was also conducted for the urgent and emergency TAVI subgroups separately (Supplementary Figure). In this analysis, all-cause death-free survival remained lower in both the urgent and emergency TAVI groups compared with the elective TAVI group (77.8% and 75.1% vs. 92.2%, respectively; log-rank P<0.001). Urgent/emergency status was associated with an increased hazard of mortality within 1 year (hazard ratio [HR] 1.89; 95% confidence interval [CI] 1.53–2.32) after adjusting for baseline factors (Table 4). In the urgent/emergency TAVI group, malignancy, lower albumin concentration, higher creatinine concentration, higher LVEF, and lower mean PG were significantly associated with mortality within 1 year (Table 5).
Table 4. Estimates From a Multivariable Cox Regression Model Assessing the Relative Hazard for 1-Year Death With Urgent or Emergency vs. Elective TAVI
| |
HR |
95% CI |
P value |
| Urgent or emergency procedure |
1.89 |
1.53–2.32 |
<0.001 |
| Age <65 years |
1.37 |
0.65–2.90 |
0.41 |
| Age <75 years |
1.08 |
0.85–1.37 |
0.55 |
| Age <90 years |
1.07 |
0.96–1.19 |
0.24 |
| Age ≥90 years |
1.35 |
1.19–1.54 |
<0.001 |
| Female sex |
0.48 |
0.43–0.55 |
<0.001 |
| BSA |
0.18 |
0.12–0.25 |
<0.001 |
| NYHA Class 3 or 4 |
1.29 |
1.16–1.43 |
<0.001 |
| Hypertension |
0.92 |
0.82–1.02 |
0.12 |
| Dyslipidemia |
0.69 |
0.62–0.76 |
<0.001 |
| Diabetes |
1.24 |
1.11–1.37 |
<0.001 |
| Chronic respiratory disease |
1.50 |
1.30–1.71 |
<0.001 |
| Coronary artery disease |
1.03 |
0.86–1.23 |
0.78 |
| Non-cardiac artery disease |
1.49 |
1.32–1.68 |
<0.001 |
| Prior PCI |
1.01 |
0.84–1.22 |
0.90 |
| Prior CABG |
1.04 |
0.77–1.39 |
0.82 |
| Prior cardiac surgery |
1.25 |
1.01–1.56 |
0.045 |
| Cerebrovascular disease |
1.03 |
0.89–1.19 |
0.70 |
| Pulmonary hypertension |
1.16 |
1.03–1.31 |
0.013 |
| Prior permanent pacemaker |
0.99 |
0.82–1.19 |
0.91 |
| Porcelain aorta |
1.17 |
1.02–1.35 |
0.030 |
| Malignancy |
1.71 |
1.50–1.94 |
<0.001 |
| Bicuspid aortic valve |
1.08 |
0.82–1.19 |
0.57 |
| Hemoglobin |
0.90 |
0.88–0.93 |
<0.001 |
| Albumin |
0.57 |
0.52–0.61 |
<0.001 |
| Creatinine |
1.04 |
1.02–1.06 |
0.001 |
| Mean PG |
0.99 |
0.983–0.989 |
<0.001 |
| Aortic valve area |
0.88 |
0.74–1.04 |
0.14 |
| LVEF |
1.00 |
0.998–1.006 |
0.30 |
| Aortic insufficiency Grade 3 or 4 |
1.01 |
0.85–1.19 |
0.95 |
| Mitral insufficiency Grade 3 or 4 |
0.98 |
0.84–1.15 |
0.82 |
CI, confidence interval; HR, hazard ratio. Other abbreviations as in Table 1.
Table 5. Predictors for 1-Year Mortality in the Urgent/Emergency TAVI Group
| |
HR |
95% CI |
P value |
| Age |
1.02 |
0.99–1.05 |
0.27 |
| Female sex |
0.74 |
0.48–1.13 |
0.16 |
| Diabetes |
0.75 |
0.48–1.17 |
0.20 |
| Coronary artery disease |
1.39 |
0.93–2.08 |
0.11 |
| Cerebrovascular disease |
0.78 |
0.44–1.39 |
0.40 |
| Malignancy |
2.27 |
1.32–3.90 |
0.003 |
| Albumin |
0.47 |
0.33–0.67 |
<0.001 |
| Creatinine |
1.51 |
1.21–1.89 |
<0.001 |
| LVEF (per 1% increase) |
1.01 |
1.00–1.03 |
0.022 |
| Mean PG (per 1-mmHg increase) |
0.98 |
0.97–0.99 |
0.002 |
Abbreviations as in Tables 1,4.
Discussion
The main findings of the present study are as follows. First, only 2.3% of patients in the nationwide J-TVT Registry underwent urgent/emergency TAVI. Second, patients who underwent urgent/emergency TAVI were at higher surgical risk, with worse NYHA class, a higher frequency of comorbidities, worse laboratory data, and more severe echocardiographic parameters than patients undergoing elective TAVI. Third, although the use of mechanical circulatory support was significantly more frequent in the urgent/emergency TAVI group, the success of the procedure was similar to that in the elective TAVI group. Fourth, mortality and major bleeding within 30 days were more frequent in the urgent/emergency TAVI group, although the frequency of stroke and new pacemaker installation was similar between the 2 groups. Finally, mortality within 1 year was significantly higher in the urgent/emergency TAVI group, with independent predictors including malignancy, a lower albumin concentration, a higher creatinine concentration, higher LVEF, and lower mean PG at baseline.
Frequency of Urgent/Emergency TAVI
In this large-scale analysis using the nationwide registry data of Japan, only 2.3% of patients underwent urgent/emergency TAVI. This rate of urgent/emergency TAVI was lower than that of 10–24% reported in Western countries.6,11–13 In many countries, TAVI can be performed in the cardiac catheterization laboratory, as well as in the hybrid operation room, according to guidelines or consensus documents.14 Furthermore, the feasibility and safety of TAVI performed in the cardiac catheterization laboratory have been widely reported.15–17 In the TVT registry in the US, approximately 40% of TAVI procedures were performed in the cardiac catheterization laboratory.17,18 Conversely, in Japan, the TAVI procedure can only be performed in the hybrid operating room, limiting access for urgent/emergency TAVI cases; this possibly accounts for the lower number of urgent/emergency TAVI cases being performed overall as shown in the present study. A previous study from the TVT Registry reported no difference in the observed-to-expected ratio of mortality within 30 days after TAVI between elective and urgent/emergency TAVI groups.6 However, in the present study, this ratio was relatively higher in the urgent/emergency TAVI group compared with the elective TAVI group (0.50 vs. 0.18, respectively). This difference may be due to urgent/emergency TAVI being performed only in more limited and severe cases. As such, allowing TAVI to be performed in the cardiac catheterization laboratory may an important future issue in Japan.
Comparison Between Urgent/Emergency and Elective TAVI
Comparisons of the urgent/emergency with elective TAVI groups revealed that patients in the former group had more comorbidities, with higher surgical risk. However, as reported in previous studies,6–8 there was no difference in procedural success rates between the urgent/emergency and elective procedures. The incidence of postoperative aortic insufficiency Grade 3 or 4 was higher in the urgent/emergency group. When severe AS was improved enough to save lives by urgent/emergency TAVI, a certain degree of paravalvular leakage may be acceptable in those undergoing urgent/emergency TAVI. In terms of the TAVI devices used, self-expanding valves tended to be used more frequently than balloon-expandable valves. It is thought that self-expanding valves, which do not require rapid pacing, were preferred in the urgent/emergency TAVI group because there were more patients with hemodynamic instability in this group. In addition, newer-generation devices were more frequently used in the urgent/emergency TAVI group. Newer, improved devices with fewer complications and gained experience have possibly led to an increase in the number of urgent/emergency TAVI cases.
With regard to performing urgent/emergency TAVI, there are reports of acceptable outcomes being achieved and encouraging its use;8 in contrast, others have reported that urgent/emergency TAVI has a worse prognosis, with more complications than elective TAVI, and should be carefully considered in individual cases.7 The point estimate in the report from the Optimized CathEter vAlvular iNtervention-TAVI (OCEAN-TAVI) Registry8 was similar to that in the present study (adjusted HR 1.63 [95% CI 0.95–2.81; P=0.076] vs. 1.89 [95% CI 1.53–2.32; P<0.001], respectively). The statistical significance may have been influenced by the large number of observations in our study (1,613 vs. 25,495). Another important distinction between the present study and the OCEAN-TAVI Registry is that advanced and experienced institutions primarily participated in latter, which may affect the generalizability of the results of that study. Although it is impractical to properly validate the efficacy of urgent/emergency TAVI due to the difficulty of conducting a randomized trial, there are a substantial number of patients for whom urgent/emergency TAVI may be the only option.
Complications of Urgent/Emergency TAVI
To improve prognosis in patients undergoing urgent/emergency TAVI, efforts should be made to reduce complications. Stroke and new pacemaker installation were infrequent in both 2 groups in the present study, which were similar to the previous studies.19,20 The incidence of major bleeding was increased after urgent/emergency TAVI, and major bleeding was probably associated with a significant increase in subsequent mortality.21 The higher incidence of major bleeding may be explained by the more frequent use of mechanical circulatory support during the procedure. Careful management of patients on mechanical circulatory support is required, and single antiplatelet therapy or oral anticoagulation therapy alone, as indicated, is preferred over dual antiplatelet therapy or combination therapy to prevent major bleeding in such patients.22 Further studies with a longer follow-up are needed to clarify how to reduce bleeding events.23
In the present study, AKI and dialysis were more common after urgent/emergency TAVI, which may impair both early and late survival.24–26 Patients who underwent urgent/emergency TAVI had a higher baseline creatinine concentration and may undergo computed tomography angiography and cardiac catheterization in a short period before the procedure.6 Low contrast medium volume in pre-TAVI computed tomography examinations and a zero-contrast TAVI procedure may be considered to avoid AKI after urgent/emergency TAVI.27,28
MI within 30 days after TAVI was more frequently observed in the urgent/emergency TAVI group. As per the baseline characteristics, the prevalence of coronary artery disease was higher in the urgent/emergency TAVI group, which may affect the higher incidence of MI. Although it is often difficult to precisely evaluate coronary artery disease before urgent/emergency TAVI, it seems important to undertake a risk assessment as much as possible.
Prognostic Factors for Urgent/Emergency TAVI
It is important to clarify what kinds of factors influence prognosis in patients undergoing urgent/emergency TAVI, because this may help us understand how best to manage these patients and possibly improve long-term outcomes. In the urgent/emergency TAVI group, malignancy, lower albumin concentration, higher creatinine concentration, higher LVEF, and lower mean PG were especially associated with all-cause mortality within 1 year. These predictive factors should be considered when deciding to perform urgent/emergency TAVI. The serum albumin concentration is an important component of patient frailty. Previously studies have reported the association between low albumin concentration and poor prognosis.29–32 Similarly in an urgent/emergency situation, highly frail patients with low albumin concentrations may achieve fewer benefits from TAVI, as observed in the present study.
In terms of mean PG at baseline, a lower gradient was significantly associated with a worse clinical prognosis. Low-gradient AS has been reported as one of the important predictors for mortality after TAVI.33,34 In addition, this population may include a substantial proportion of patients with low-flow and low-gradient AS, which was reported to be significantly related to poor clinical outcomes after TAVI.35 These pathophysiologies are reportedly associated with accelerated myocardial fibrosis and abnormal remodeling with reduced compliance of the left ventricle.36,37 Furthermore, it has been reported that a low gradient is a significant predictor of poor recovery of LVEF after TAVI.38 Because the stroke volume index, an important parameter for evaluating transaortic flow state, was not included in the J-TVT Registry database, detailed analysis identifying normal or low-flow AS could not be performed in the present study. Another possible reason for the poor prognosis of low-gradient AS patients may be that AS itself did not critically contribute to their poor condition. Thus, assessment of AS severity and decisions regarding the treatment strategy may need to be carefully discussed in the case of patients with low-gradient AS.
Study Limitations
This study has several limitations. First, this was a retrospective study based on observational registry data, raising the possibility of unmeasured confounding factors that could not be ruled out. Second, the decision to perform urgent/emergency TAVI was made based on discussion by an institutional heart team. Therefore, the indication criteria for urgent/emergency TAVI could vary depending on the facility and heart team. Third, although an audit is performed to ensure accurate recording of the data, it is still possible that the frequency of some clinical events may be under-reported. Fourth, there was no detailed information about the cause of death in the present study. Further investigations are required to better elucidate how patient prognosis can be improved after urgent/emergency TAVI.
Conclusions
Urgent/emergency TAVI was performed in patients with higher surgical risk and more comorbidities, but the device success rate was comparable with that after elective TAVI. Although it should be noted that prognosis of urgent/emergency TAVI was worse than elective TAVI, it may be a feasible treatment option for patients with severe AS if prognostic factors are taken into consideration in the decision-making process.
Acknowledgment
The authors thank Heidi N. Bonneau for her editorial review of the manuscript.
Sources of Funding
This study did not receive any specific funding.
Disclosures
Y.K. is a member of Circulation Journal’s Editorial Team. H. Kumamaru reports receiving consultation fees from Mitsubishi-Tanabe Pharma Corporation and EPS Corporation, as well as speakers fees from Chugai Pharmaceutical Co., Ltd. and Johnson and Johnson K.K. H. Kumamaru and S.K. are affiliated with the Department of Health Quality Assessment at the University of Tokyo, a social collaboration department supported by the National Clinical Database, Johnson & Johnson K.K., Nipro Corporation, and Intuitive Surgical Sàrl. All other authors report no conflicts of interest related to this study.
IRB Information
This study was approved by the institutional review board of Chiba University, Chiba, Japan (ID: 3750).
Data Availability
The deidentified participant data from this study will not be shared.
Supplementary Files
Please find supplementary file(s);
https://doi.org/10.1253/circj.CJ-22-0536
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