Minimalist Transcatheter Aortic Valve Replacement (MA-TAVR) Jensen HA, Condado JF, Devireddy C, Binongo JN, Leshnower BG, Babaliaros V, Sarin EL, Lerakis S, Guyton RA, Stewart JP, Syed AQ, Mavromatis K, Kaebnick B, Rajei M, Tsai LL, Rahman A, Simone A, Keegan P, Block PV and Thourani VH Emory University School of Medicine Atlanta, Georgia 95 th Annual Meeting of the AATS Seattle, WA
Disclosures Dr. Jensen: None Dr. Thourani: Research/Consultant: Edwards Lifesciences
Background In the US, Transfemoral (TF) TAVR is the preferred technique for the treatment of AS in high- or extreme risk TAVR Minimalist TAVR (MA-TAVR) is the concept of performing TF-TAVR: Percutaneously With IV sedation and local anesthesia Using TTE No swan-ganz or arterial line catheters At Emory, this procedure is performed in the cath lab by a cardiac surgeon and a cardiologist equally as a 1 o operator
Background
Objectives Assess morbidity and mortality in those patients undergoing MA-TAVR Assess our outcomes and learning curve in MA-TAVR over the past 2 years
Methods Retrospective study at Emory University Hospitals from May 2012 to July 2014 Prior to implementation of MA-TAVR, we had performed ~ 300 TAVR 151 MA-TAVR patients Group 1 (n=50, May 2012 Jan 2013) Group 2 (n=50, Feb Aug 2013) Group 3 (n=51, Sep 2013 Jul 2014)
Methods Suitable for MA-TAVR Suitable for transfemoral TAVR Uncomplicated vascular access Weight < 110kg No mental disorders precluding conscious anesthesia Coronary arteries at sufficient height No barriers to emergent intubation if needed
Methods All procedures performed with a balloonexpandable valve Femoral access obtained with micropuncture kit under fluoroscopy Pre-closure with 2 vascular closure devices Roadmap angiogram for placement of delivery sheath Patients observed in the postoperative cath lab unit or regular telemetry floor after the procedure
Results 90% 80% MA-TAVR of all TF-TAVR 85% 77% 70% 66% 60% 50% 40% 30% 20% 10% 0% Group 1 Group 2 Group 3
Results Group 1 N=50 Group 2 N=50 Group 3 N=51 P value Age 83 (77-88) 84 (79-87) 86 (80-88) 0.390 STS PROM % 10 (7-13) 9 (8-14) 9 (6-13) 0.857 Severe COPD 8 (16) 9 (18) 9 (18) 0.356 Diabetes 22 (44) 28 (48) 17 (32) 0.302 BMI 25 (23-30) 27 (24-31) 27 (23-29) 0.299 Cerebrovascular disease 18 (36) 13 (26) 13 (26) 0.426 Previous AVR 2 (4) 5 (10) 8 (16) 0.146 Data presented as Median (IQR) for continuous variables and n (%) for categorical variables
Results At 30 days All N=151 Group 1 N=50 Group 2 N=50 Group 3 N=51 P value Mortality 3 (1.9) 1 (2) 0 (0) 2 (4) 0.369 O:E ratio 0.2 0.2 0.0 0.4 N/A Major stroke 5 (3.3) 1 (2) 3 (6) 1 (2) 0.430 Major vascular complication 4 (2.6) 1 (2) 1 (2) 2 (4) 0.785 New pacemaker 12 (7.9) 2 (4) 6 (12) 4 (8) 0.335 Length of stay 3 (2-4) 3 (2-5) 3 (2-4) 2 (2-3) 0.07 Readmission 12 (8) 5 (10) 5 (10) 2 (4) 0.429 >Mild PVL 10 (7) 4 (8) 4 (8) 2 (4) 0.604 Data presented as Median (IQR) for continuous variables and n (%) for categorical variables
Events CUSUM of postoperative events (death, stroke, renal failure or PVL > mild) 30 25 No apparent learning curve 20 15 10 5 0 1 11 21 31 41 51 61 71 81 91 101 111 121 131 141 151 Sequence number
Results Need for ICU stay after MA-TAVR (p<0.001) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 86% 54% 43% Group 1 Group 2 Group 3
Conclusions MA-TAVR can be performed safely with acceptable morbidity and mortality in a high risk patient population by cardiologists or surgeons Overall mortality was 1.9% at 30 days for all patients In an experienced site, no apparent learning curve for MA-TAVR is noted MA-TAVR can be done with minimal or no ICU support leading to a shorter hospital stay and improved resource utilization There is a potential for significant cost savings utilizing this MA-TAVR
Thank you
Results Operative characteristic Group 1 Group 2 Group 3 P value Valve type Sapien 47 (94) 25 (50) 31 (61) >0.01 Sapien XT 3 (6) 25 (50) 20 (39) Valve size 23mm 20 (40) 25 (50) 23 (45) 26mm 29 (58) 17 (34) 20 (39) 29mm 1 (2) 8 (16) 8 (16) 0.042 2 nd Valve Implanted 5 (10) 6 (12) 5 (10) 0.925 Postoperative BAV 15 (30) 19 (38) 12 (24) 0.286 IABP 1 (2) 1 (2) 2 (4) 0.785 Operation time 87 (75-120) 95 (79-113) 92 (80-102) 0.049 Data presented as Median (IQR) for continuous variables and n (%) for categorical variables
Length of hospital stay
Early discharge Within 48h (n=65) After 48h (n=82) P value Age 84 (80-88) 84 (79-88) 0.882 STS PROM 8.3 (5.9-11.2) 10.3 (7.9-14.2) 0.004 Severe COPD 15 (18) 10 (15) 0.615 Diabetes 20 (31) 40 (49) 0.027 Operation time 93 (79-107) 98 (80-123) 0.137 Major stroke 0 (0) 5 (6.1) 0.067 Major vasc comp 0 (0) 2 (2.4) 0.503 New pacemaker 1 (1.5) 11 (13.4) 0.012 Readmission 1 (1.5) 11 (13) 0.012 Data presented as Median (IQR) for continuous variables and n (%) for categorical variables
When to ICU after MA-TAVR? Ongoing vasopressor requirement / other hemodynamic instability Issues with vascular closure Potential need for a pacemaker
Minimizing PVL after MA-TAVR Pre-operative TTE and CT scans (or 3D TEE if appropriate) for optimal sizing Intraoperative balloon-sizing After valve deployment: long-axis, short-axis and apical views with TTE invasive monitoring to measure an aortic regurgitation index
From: Aortic Regurgitation Index Defines Severity of Peri-Prosthetic Regurgitation and Predicts Outcome in Patients After Transcatheter Aortic Valve Implantation J Am Coll Cardiol. 2012;59(13):1134-1141. doi:10.1016/j.jacc.2011.11.048 Calculation of the AR Index Simultaneous determination of left ventricular end-diastolic pressure (LVEDP) (blue line) and diastolic blood pressure (DBP) in the aorta (red line) (A) a patient without peri-prosthetic aortic regurgitation (periar) (B) a patient with moderate periar calculation of the aortic regurgitation (AR) index: ([DBP LVEDP]/SBP) 100. (A) AR index = ([65 10]/160) 100 = 34.4. (B) AR index = ([40 20]/130) 100 = 15.4. Copyright The American College of Cardiology. All rights reserved.
The AR index varies with the level of the LVEDP that might be elevated due to high systemic blood pressure, concomitant diastolic dysfunction, significant myocardial ischemia during balloon valvuloplasty and valve deployment, or complications related to the TAVI procedure itself (e.g., tearing of the mitral valve with resultant regurgitation). A nonspecific elevation of the LVEDP might lead to a low transvalvular end-diastolic gradient and thus to a false positive AR index in these cases. This underscores the complementary value of the AR index, which should be used in addition to other imaging methods and has its best discriminative ability in patients with borderline periar.
Balloon-sizing Annulus 18-21mm ; 21-22mm balloon ; 23mm THV Annulus 21-24mm ; 24-25mm balloon ; 26mm THV Annulus 24-28mm ; 27-28mm balloon ; 29mm THV
Emory TAVR Access Pathway Pt with severe AS assessed by heart and valve team Small ileofemoral vessel, tortuosity, calcification, severe PVD, redo EF < 15-20%, severe COPD w/ FEV1 < 30-35%, primary chest TF (procedure of choice) TA TAo Last option and CCA > 8mm w/o stenosis TC