Minimalist Transcatheter Aortic Valve Replacement (MA-TAVR) 95 th Annual Meeting of the AATS Seattle, WA 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

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 balloon- expandable 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

Group 1 N=50 Group 2 N=50 Group 3 N=51 P value Age83 (77-88)84 (79-87)86 (80-88)0.390 STS PROM %10 (7-13)9 (8-14)9 (6-13)0.857 Severe COPD8 (16)9 (18) Diabetes22 (44)28 (48)17 (32)0.302 BMI25 (23-30)27 (24-31)27 (23-29)0.299 Cerebrovascular disease 18 (36)13 (26) Previous AVR2 (4)5 (10)8 (16)0.146 Data presented as Median (IQR) for continuous variables and n (%) for categorical variables

Results At 30 daysAll 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 N/A Major stroke 5 (3.3)1 (2)3 (6)1 (2)0.430 Major vascular complication 4 (2.6)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) 2 (4)0.429 >Mild PVL 10 (7)4 (8) 2 (4)0.604 Data presented as Median (IQR) for continuous variables and n (%) for categorical variables

Sequence number Events CUSUM of postoperative events (death, stroke, renal failure or PVL > mild) No apparent learning curve

Results

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

Operative characteristicGroup 1Group 2Group 3P value Valve type Sapien47 (94)25 (50)31 (61) >0.01 Sapien XT3 (6)25 (50)20 (39) Valve size 23mm20 (40)25 (50)23 (45) mm29 (58)17 (34)20 (39) 29mm1 (2)8 (16) 2 nd Valve Implanted5 (10)6 (12)5 (10)0.925 Postoperative BAV15 (30)19 (38)12 (24)0.286 IABP1 (2) 2 (4)0.785 Operation time87 (75-120)95 (79-113)92 (80-102)0.049 Data presented as Median (IQR) for continuous variables and n (%) for categorical variables Results

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 ( )10.3 ( )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) 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

Copyright © The American College of Cardiology. All rights reserved. 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): doi: /j.jacc 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 = (B) AR index = ([40 − 20]/130) × 100 = 15.4.

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 TF (procedure of choice) TA TAo TC Small ileofemoral vessel, tortuosity, calcification, severe PVD, redo EF < 15-20%, severe COPD w/ FEV1 < %, primary chest Last option and CCA > 8mm w/o stenosis