Transcatheter Aortic Valve Replacement Without Preballoon Aortic Valvuloplasty
John Mayfield1, Seyed Hossein Aalaei Andabili1, Anthony Bavry2, John Petersen2, R David Anderson2, Charles Klodell1, Teng Lee1, Thomas Beaver1.
1Division of Thoracic and Cardiovascular Surgery, Gainesville, FL, USA, 2Division of Cardiology, Department of Medicine, University of Florida, Gainesville, FL, USA.
OBJECTIVE: Balloon Aortic Valvuloplasty (BAVP) facilitates Transcatheter Aortic Valve Replacement (TAVR) but may 1) increase stroke with additional wire manipulation and potential emboli and 2) increase perivalvular leak (PVL) by repeated valve dilation. The latest generation SAPIEN 3 transcatheter valve, TAVR can be placed without BAVP. However, outcomes of patients undergoing TAVR without BAVP has not been defined.
METHODS: Retrospective review at a single university center of TAVR without BAVP using the SAPIEN 3 (S3) valve. Patients’ demographics, operative and post-operative outcomes including stroke, and intraoperative transesophageal echocardiography (TEE) measurements for PVL were reviewed.
RESULTS: From March 2012 through March 2016, 544 patients underwent TAVR, of which 84 patients had TAVR using S3 valve. Procedural success was 98.8%; one patient (1.19%) developed intraoperative device embolization and was converted to open surgery. Finally, n=83 patients (48 (58%) males and 35 (42%) females) with mean±SD age of 77±10 and mean±SD STS risk score of 7.05±3.7 were included. Post-TAVR ICU admission and ventilation hours were 65.53±107.12 and 3.25±1.96, respectively. Length of hospital stay was 2.86±3.06 days. No in-hospital death occurred and 30-day mortality rate was 3.6% (N=3). There were zero (0%) in-hospital procedural strokes, though one patient (1/83, 1.2%) had a stroke outside of the hospital within 30-days of TAVR. Two (2.4%) patients needed permanent pacemaker insertion after TAVR, and 5 (6.02%) other patients developed new left bundle branch block. During 12-months follow-up, no other stroke was detected. There was no other post-operative complication, reoperation, or 30-day readmission (Table-1). On post-TAVR TEE, 95.2% (79/83) patients had zero PVL, 3 (3.6%) patients had trace PLV, and only one (1.2%) patient had mild PVL (Figure-1). Kaplan-Meier survival analysis showed 92% survival rate at 30-days and 90% at 12-months.
CONCLUSIONS: TAVR without Balloon Aortic Valvuloplasty using SAPIEN 3 is safe and effective. Post-operative stroke and peri-valvular leak rates are excellent and should be followed in a larger study.
Table 1. Patients’ pre-operative characteristics and post-operative outcomes
|Age, mean±SD||77.56 ± 10.09|
|STS risk score, mean±SD||7.05±3.7|
|Male, N (%)||49 (59)|
|Diabetes mellitus, N (%)||24 (28.9)|
|Hypertension, N (%)||64 (77.1)|
|Hyperlipidemia, N (%)||50 (60.2)|
|Prior Stroke, N (%)||10 (12.1)|
|Prior TIA, N (%)||4 (4.8)|
|Length of Stay (day), mean±SD||2.86±3.06|
|ICU admission hours, mean±SD||65.53±107.12|
|Ventilation hours, mean±SD||3.25±1.96|
|Post-operative kidney injury, N (%)||0 (0)|
|Re-intubation, N (%)||0 (0)|
|Major vascular complication, N (%)||0 (0)|
|Post-operative infection, N (%)||0 (0)|
|In-hospital stroke, N (%)||0 (0)|
|30-day stroke, N (%)||1 (1.2)|
|In-hospital mortality, N (%)||0 (0)|
|30-mortality, N (%)||3 (3.6)|
|30-day readmission||0 (0)|
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