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Embedded structural outcome monitoring in TAVR patients provides insight in areas for improvement
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An outcome-based quality improvement strategy can result in lower procedural, 30-day, and 1‑year all-cause mortality in TAVR patients
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There is a positive temporal trend in the procedural, 30-day, and 1‑year all-cause mortality of TAVR patients in the Netherlands
Introduction
Methods
Quality improvement strategy
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Pre-procedural patient assessment in a dedicated TAVR outpatient clinic for all patients [12];
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Geriatric screening based on age (>80 years) or high frailty score: items from the comprehensive geriatric assessment [13] have been associated with mortality and major adverse cardiac events (MACE) after the procedure [14, 15] and geriatricians are advised to be involved in heart team decisions concerning aortic valve disease management [16];
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Two operators instead of one in case of high risk or complex cases;
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Monthly multidisciplinary evaluation of procedural and clinical TAVR pathway: implemented in compliance with increased awareness of quality assessment in health care.
Inclusion criteria
Definitions and outcomes
Statistical analysis
Results
Patient characteristics
Variablea | Cohort A N = 274 | Cohort B N = 532 | P-value |
---|---|---|---|
Male | 133 (48.7) | 293 (55.0) | 0.12 |
Age, years | 80.1 ± 6.3 | 80.8 ± 6.1 | 0.14 |
BMI, kg/m2 | 26.9 ± 4.6 | 27.0 ± 4.4 | 0.56 |
NYHA class | 0.023 | ||
I–II | 162 (61.8) | 280 (52.8) | |
III–IV | 100 (38.2) | 250 (47.2) | |
LVEF, % | 55 (14–70) | 55 (19–84) | 0.53 |
<30% | 24 (8.8) | 37 (7.3) | <0.01 |
Logistic EuroSCORE I | 17.9 ± 13.4 | 17.9 ± 11.6 | 0.21 |
>10 | 187 (68.2) | 404 (75.9) | 0.018 |
Creatinine, µmol/l | 107.7 ± 57.4 | 109.3 ± 61.7 | 0.33 |
Dialysis | 3 (1.1) | 4 (0.8) | 0.24 |
Diabetes mellitus | 72 (26.6) | 134 (25.3) | 0.73 |
Chronic pulmonary disease | 51 (18.8) | 93 (17.5) | 0.70 |
Peripheral arterial disease | 72 (26.6) | 171 (32.3) | 0.089 |
Previous stroke | 36 (13.3) | 40 (7.5) | 0.011 |
Previous cardiac surgery | 67 (24.6) | 154 (29.1) | 0.18 |
Previous aortic valve surgery | 20 (7.5) | 29 (5.5) | 0.28 |
Myocardial infarction lasts 90 days | 2 (0.7) | 15 (2.8) | 0.068 |
Urgency of procedure | <0.01 | ||
Elective | 251 (92.3) | 435 (82.2) | |
Urgent | 21 (7.7) | 88 (16.6) | |
Emergent | 0 (0.0) | 6 (1.1) | |
Type of implanted valve | <0.01 | ||
Self-expandable | 165 (60.2) | 238 (44.7) | |
Balloon-expandable | 85 (31.0) | 293 (55.1) | |
Direct flow medical | 24 (8.8) | 1 (0.2) | |
Mortality | |||
Procedural | 12 (4.4) | 7 (1.3) | <0.01 |
30-day | 23 (8.4) | 14 (2.7) | <0.01 |
1‑year | 45 (16.4) | 45 (8.5)b | <0.01 |
Outcome
Procedural | 30-day | 1‑year | |||||||
---|---|---|---|---|---|---|---|---|---|
OR | 95% CI | P-value | OR | 95% CI | P-value | OR | 95% CI | P-value | |
Quality improvement strategy | 0.29 | (0.11–0.75) | 0.011a | 0.29 | (0.15–0.58) | <0.01a | 0.47 | (0.31–0.74) | <0.01a |
Age (years) | 1.05 | (0.97–1.14) | 0.22 | 1.05 | (0.99–1.12) | 0.100 | 1.01 | (0.98–1.05) | 0.532 |
Male sex | 0.94 | (0.38–2.35) | 0.89 | 0.79 | (0.40–1.54) | 0.484 | 0.58 | (0.37–0.92) | 0.021 |
LVEF <30% | NA | 0.32 | (0.04–2.39) | 0.266 | 0.83 | (0.34–1.99) | 0.668 | ||
Creatinine (µmol/l) | 0.99 | (0.98–1.01) | 0.37 | 0.99 | (0.99–1.01) | 0.575 | 1.00 | (0.99–1.00) | 0.265 |
BMI (kg/m2) | 0.92 | (0.81–1.05) | 0.20 | 0.91 | (0.84–0.99) | 0.045 | 0.96 | (0.91–1.02) | 0.174 |
Diabetes mellitus | 1.37 | (0.51–3.68) | 0.53 | 1.45 | (0.71–2.95) | 0.312 | 0.87 | (0.52–1.47) | 0.606 |
NYHA III–IV | 1.28 | (0.46–3.62) | 0.63 | 1.56 | (0.77–3.17) | 0.219 | 1.02 | (0.65–1.61) | 0.936 |
Chronic pulmonary disease | 1.49 | (0.47–4.75) | 0.49 | 1.65 | (0.75–3.67) | 0.214 | 2.00 | (1.20–3.34) | <0.01 |
Previous stroke | NA | 0.46 | (0.11–1.99) | 0.302 | 0.59 | (0.25–1.42) | 0.239 | ||
Urgent vs elective | 2.18 | (0.59–8.09) | 0.24 | 2.89 | (1.22–6.82) | 0.016 | 2.33 | (1.31–4.13) | <0.01 |
Balloon vs self-expandable valve | 1.78 | (0.68–4.70) | 0.24 | 1.25 | (0.63–2.05) | 0.524 | 0.81 | (0.51–1.29) | 0.371 |
30-day | 1‑year | |||||
---|---|---|---|---|---|---|
OR | 95% CI | P-value | OR | 95% CI | P-value | |
Quality improvement strategy | 0.19 | (0.09–0.42) | <0.01 | 0.38 | (0.24–0.61) | <0.01 |
Age, years | 1.04 | (0.98–1.11) | 0.157 | |||
Male sex | 0.59 | (0.37–0.96) | 0.032 | |||
BMI, kg/m2 | 0.92 | (0.84–1.01) | 0.078 | |||
Chronic pulmonary disease | 3.29 | (1.16–3.29) | 0.011 | |||
Urgent vs elective | 2.92 | (1.22–6.97) | 0.016 | 2.33 | (1.30–4.17) | <0.01 |