Transcatheter Aortic Valve Replacement: Efficiency And Safety Improvements With Progressive Experience
Seyed Hossein Aalaei Andabili1, R. David Anderson2, Anthony Bavry2, Teng Lee1, Siddharth Wayangankar2, Charles Klodell1, Thomas Beaver1.
1Division of Thoracic and Cardiovascular Surgery, Gainesville, FL, USA, 2Division of Cardiology, Department of Medicine, University of Florida, Gainesville, FL, USA.
Introduction: Transcatheter aortic valve replacement (TAVR) has emerged for high-risk patients with severe aortic stenosis (AS). In this study, we investigated change in the safety and efficiency of the TAVR procedure and patients’ outcomes by comparison of the first 100, second 100, and the last 100 patients.
Methods: From March-2012 to June-2016, 600 patients underwent TAVR at our center. Three hundred patients were selected for this study and were categorized in three groups; group-A: first to 100th patient, group-B: 101st-200th patient, and group-C: 501st-600th patient.
Results: 300 patients with mean age of 79.10±8.93 years were included. Fluoroscopy time and dose were significantly lower in group-B comparing group-A, 12.19±6.39 minutes versus 18.6±10.59 minutes (p<0.001) and 568.27±425.68 mGy versus 2082.42±1943.61 mGy (p<0.001), respectively. Mean of contrast volume was 106.06±47.61ml in group-A and 76.50±27.39ml in group-B (p<0.001). Fluoroscopy dose and contrast volume were significantly lower in group-C than group-B (285.4±276.20 mGy versus 568.27±425.68 mGy, p<0.001 and 56.85±37.72ml versus 76.50±27.39ml, p<0.001, respectively). Operation and incision times were also significantly lower in group-B than group-A, 136.61±32.13 versus 156.84±54.30, p<0.001 and 98.90±28.26 versus 122.58±52.93, p<0.001. The operation and incision times were even lower in group-C comparing group-B, 106.81±35.10 versus 136.61±32.13 and 54.89±23.87 versus 98.90±28.26, (both p-values<0.001). Acute kidney injury rate was 26% (n=26) in group-A versus 23% (n=23) in group-B (p=0.743), and 1% (n=1) in group-C (p<0.001). Five (5%) strokes in group-A and 2 (2%) strokes in group-B were detected (p=0.44), but no patient in group-C had stroke (p=0.059). In-hospital mortality was 5% (n=5) in group-A, 4% (n=4) in group-B, and 1% (n=1) in group-C (p=0.21).
Conclusion: Increased experience with TAVR procedures increases the operators’ expertise, making the TAVR both more efficient and perhaps safer. The trend in patients’ outcome improvement would likely be significant with comparison of larger group of patients in a longer period of time.
Table-1. Comparison of preoperative and post-operative characteristics
Variable name | Group A | Group B | P-value (A vs. B) | Group C | P-value (B vs. C) |
Male, N (%) | 50 (50) | 54 (54) | 0.67 | 58 (58) | 0.66 |
Age, year, mean±SD | 80.64±8.13 | 78.78±8.12 | 0.10 | 77.85±10.25 | 0.48 |
Diabetes, N (%) | 31 (31) | 37 (37) | 0.45 | 36 (36) | 1.0 |
Peripheral artery disease, N (%) | 14 (14) | 21 (21) | 0.26 | 29 (29) | 0.25 |
Hypertension, N (%) | 71 (71) | 88 (88) | 0.005 | 91 (91) | 0.64 |
Heart failure, N (%) | 35 (35) | 59 (59) | 0.001 | 25 (25) | <0.001 |
Preoperative aortic valve gradient, mmHg, mean±SD | 46.53±18.6 | 42.72±17.17 | 0.14 | 38.98±14.24 | 0.103 |
Preoperative aortic valve area, cm2, mean±SD | 0.61±0.28 | 0.70±0.20 | 0.02 | 0.66±0.26 | 0.301 |
Ejection fraction, %, mean±SD | 51.43±15.75 | 52.36±14.05 | 0.66 | 50.12±14.62 | 0.271 |
Creatinine, mg/dl, mean±SD | 1.18±1.07 | 1.28±1.11 | 0.51 | 1.30±1.01 | 0.87 |
Operation time (minutes), mean±SD | 156.84±54.30 | 136.61±32.13 | <0.001 | 106.81±35.10 | <0.001 |
Incision time (minutes), mean±SD | 122.58±52.93 | 98.90±28.26 | <0.001 | 54.89±23.78 | <0.001 |
Length of ICU admission (hours), mean±SD | 94.46±88.53 | 93.58±110.18 | 0.95 | 56.14±81.80 | 0.007 |
Length of hospital stay (day), mean±SD | 7.92±6.25 | 6.72±4.94 | 0.14 | 2.57±2.49 | <0.001 |
Post-operative acute kidney injury, N (%) | 26 (26) | 23 (23) | 0.74 | 1 (1) | <0.001 |
Post-operative stroke/TIA, N (%) | 5 (5) | 2 (2) | 0.44 | 0 (0) | 0.49 |
ICU readmission, N (%) | 2 (2) | 4 (4) | 0.68 | 0 (0) | 0.12 |
Re-intubation, N (%) | 6 (6) | 7 (7) | 0.78 | 0 (0) | 0.014 |
In-hospital death, N (%) | 5 (5%) | 4 (4%) | 1.0 | 1 (1) | 0.36 |
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