Minimalist Transcatheter Aortic Valve Replacement (MA-TAVR)

Transcription

1 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

2 Disclosures Dr. Jensen: None Dr. Thourani: Research/Consultant: Edwards Lifesciences

3 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

4 Background

5 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

6 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)

7 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

8 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

9 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

10 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) STS PROM % 10 (7-13) 9 (8-14) 9 (6-13) Severe COPD 8 (16) 9 (18) 9 (18) Diabetes 22 (44) 28 (48) 17 (32) BMI 25 (23-30) 27 (24-31) 27 (23-29) Cerebrovascular disease 18 (36) 13 (26) 13 (26) Previous AVR 2 (4) 5 (10) 8 (16) Data presented as Median (IQR) for continuous variables and n (%) for categorical variables

11 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) O:E ratio N/A Major stroke 5 (3.3) 1 (2) 3 (6) 1 (2) Major vascular complication 4 (2.6) 1 (2) 1 (2) 2 (4) New pacemaker 12 (7.9) 2 (4) 6 (12) 4 (8) 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) >Mild PVL 10 (7) 4 (8) 4 (8) 2 (4) Data presented as Median (IQR) for continuous variables and n (%) for categorical variables

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

13 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

14 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

15 Thank you

16 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) nd Valve Implanted 5 (10) 6 (12) 5 (10) Postoperative BAV 15 (30) 19 (38) 12 (24) IABP 1 (2) 1 (2) 2 (4) Operation time 87 (75-120) 95 (79-113) 92 (80-102) Data presented as Median (IQR) for continuous variables and n (%) for categorical variables

17 Length of hospital stay

18 Early discharge Within 48h (n=65) After 48h (n=82) P value Age 84 (80-88) 84 (79-88) STS PROM 8.3 ( ) 10.3 ( ) Severe COPD 15 (18) 10 (15) Diabetes 20 (31) 40 (49) Operation time 93 (79-107) 98 (80-123) Major stroke 0 (0) 5 (6.1) Major vasc comp 0 (0) 2 (2.4) New pacemaker 1 (1.5) 11 (13.4) Readmission 1 (1.5) 11 (13) Data presented as Median (IQR) for continuous variables and n (%) for categorical variables

19 When to ICU after MA-TAVR? Ongoing vasopressor requirement / other hemodynamic instability Issues with vascular closure Potential need for a pacemaker

20 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

21 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 = Copyright The American College of Cardiology. All rights reserved.

22 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.

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24 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

25 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

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