Comparison of Clinical Outcomes after Isolated Rapid Deployment Aortic Valve Replacement in the Real-World: Full Sternotomy vs. Upper Hemisternotomy vs. Right Anterior Thoracotomy
Gunther Laufer1, Alfred Kocher1, Mattia Glauber2, Rainald Seitelberger3, Kim Terp4, Olivier Bouchot5, Francis Duhay6, Christopher Young7.
1Klinisshe Abteiluing Für Herz-thoraxchirurgie, Vienna, Austria, 2G. Pasquinucci Heart Hospital, Massa, Italy, 3Salzburger Universitätsklinikum, Salzburg, Austria, 4Aarhus University Hospital, Skejby, Denmark, 5CHU de Dijon, Dijon, France, 6Edwards Lifesciences, LLC, Irvine, CA, USA, 7St. Thomas' Hospital, London, United Kingdom.
OBJECTIVE: Aortic valve replacement (AVR) through a minimally invasive approach is associated with favorable clinical outcomes. This study compares clinical outcomes after isolated AVR through either a full sternotomy (FS), upper hemi-sternotomy (UHS) or right anterior thoracotomy (RAT) in patients enrolled in FOUNDATION study.
METHODS: FOUNDATION was a prospective, multi-center, single-arm, study that evaluated the safety and performance of rapid deployment aortic valve replacement (RDAVR) using a stented trileaflet bovine pericardial bioprosthesis with a cloth-covered balloon-expandable frame in patients with aortic stenosis. Five hundred and twelve patients were implanted with the study valve. Patients were assessed peri-operatively for procedural times, technical and procedural success rates; and, at discharge, 30 days, 3 months, and 1 year for valve hemodynamic performance, safety, and improvement in NYHA.
RESULTS: Three-hundred and forty eight patients underwent isolated AVR with the study valve through a FS (n=176), UHS (n=135), or RAT (n=37). Mean age, 75.8±6.4 years. Logistic EuroSCORE, % 6.7 ± 3.7 (n=171) for UHS/RAT, and % 7.2 ± 3.8 (n=176) for FS. Mean cross-clamp/CPB times (min) were significantly different among FS, UHS, and RAT, 47.5±15.4/67.8±20.0, 51.5±15.4/79.1±22.1, and 73.4±17.7/104.6±19.6, respectively (p<0.0001). FS showed a trend toward higher rates of acute renal failure and major bleeding events compared to combined UHS and RAT (FS vs. UHS/RAT; renal failure, 4.5% vs. 1.2%, p=0.059; major bleeding, 8.0% vs. 4.1%, p=0.128). (Table 1). Hospital and ICU length of stay (days) were not different among FS, UHS, and RAT, 12.1±29.5/2.5±3.4, 10.8±9.0/2.7±4.1, and 8.8±4.5/3.0±6.4, respectively.
CONCLUSIONS: These data suggest that RDAVR using a subannular balloon-expandable stent frame can mitigate the clinical differences in cross-clamp and CPB times between FS and UHS and may facilitate minimally invasive AVR. FS was associated with a trend toward higher rates of postoperative acute renal failure and major bleeding events. Positive tendencies of MIS may be more evident in a higher risk population.
|Event||FS||UHS||RAT||MIS (UHS +RAT)||p-value FS vs. UHS vs.RAT||p-value FS vs. MIS|
|All-cause mortality||2.8% (5/176)||3.0% (4/135)||0.0% (0/37)||2.3% (4/172)||0.576||0.762|
|Study valve related mortality||1.7% (3/176)||1.5% (2/135)||0.0% (0/37)||1.2% (2/172)||0.730||0.671|
|Renal failure/dysfunction||4.5% (8/176)||0.7% (1/135)||2.7% (1/37)||1.2% (2/172)||0.138||0.059|
|Thromboembolic events||3.4% (6/176)||3.0% (4/135)||0.0% (0/37)||2.3% (4/172)||0.527||0.545|
|Sternal wound infection||0.6% (1/176)||1.5% (2/135)||0.0% (0/37)||1.2% (2/172)||0.575||0.549|
|Major bleeding event||8.0% (14/176)||4.4% (6/135)||2.7% (1/37)||4.1% (7/172)||0.291||0.128|
|Explant||0.6% (1/176)||0.7% (1/135)||2.7% (1/37)||1.2% (2/172)||0.434||0.549|
|PVL requiring surgical intervention||1.1% (2/176)||1.5% (2/135)||2.7% (1/37)||1.7% (3/172)||0.766||0.634|
|Valve related pacemaker implants||4.2% (7/165)||5.3% (7/131)||5.6% (2/36)||5.4% (9/167)||0.887||0.626|
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