Reoperative AVR or TAVR Valve in Valve

Vinod H. Thourani, MDProfessor of Surgery

Chair, Department of Cardiac SurgeryMedStar Heart and Vascular Institute

Georgetown UniversityWashington, DC, USA

AATS International Valve Symposium (Brazil)December 8, 2017

Disclosures• Abbott Medical/St. Jude Medical

– Structural Heart Advisory board– Executive Committee: Portico trial

• Boston Scientific– Advisory Board, Executive Committee (Lotus Valve Trial)– National Co-PI, REPRISE IV trial

• Claret Medical– Advisory Board

• Cryolife– Advisor– Executive Committee, PROACT II trial

• Edwards Lifesciences– National Co-PI: PARTNER 2 (SAPIEN 3 Trial)– National Co-PI: ACTIVE Trial– Executive Committee: PARTNER 3 trial– Advisory Board

• Gore Vascular– Advisor

• Jenavalve– National Co-PI TAVR trial

TAVR and SAVR Procedures In the TVT Registry and STS ACSD

Source: STS/ACC TVT Registry Database and STS Database

Chart1

20122012

20132013

20142014

20152015

20162016

TAVRs (TVT Registry)

SAVRs (ACSD)

4612

28778

9175

30665

16382

29810

24861

29462

37113

28037

Sheet1

TAVRs (TVT Registry)SAVRs (ACSD)

20124,61228,778

20139,17530,665

201416,38229,810

201524,86129,462

201637,11328,037

To resize chart data range, drag lower right corner of range.

% of TAVRs -Valve-in-Valve

1.7%

2.5%3.0%

5.9%6.3%

5.8%

0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

2012 2013 2014 2015 2016 2017 Q1

Source: STS/ACC TVT Registry Database.as of Jul 17,2017

Chart1

2012

2013

2014

2015

2016

2017 Q1

0.017

0.025

0.03

0.059

0.063

0.058

Sheet1

20121.7%

20132.5%

20143.0%

20155.9%

20166.3%

2017 Q15.8%

Sheet1

Sheet2

Sheet3

Increased use of bioprosthetic valve in AVR

•

Brown et al. JTCVS 2009

More patients are expected to develop structural valve deterioration and

require reoperative AVR

Bioprosthetic Valves

Dvir D et al: JAMA 312:162-170, 2014

Patient LW83 YO F with severe stenosis of a 21 mm Edwards Perimount bioprosthetic AoV (1999) and NYHA IV heart failure symptoms.

Height 152 cm Weight 60 kg Creatinine 0.77 mg/dL– Ovarian CA on active chemo– Paroxysmal AF on warfarin– Dyslipidemia/HTN– Hypothyroidism– Moderate COPD: FEV1 = 0.95 L (60 %)– LVEF 60 %

STS 15%

Patient LW

LVOT 20.2 mmAVA 0.51 cm2

Patient LWRCALCA

LAO 19, caudal 10

Patient LW

What would you do??

Patient LW

Patient LW

Patient LW

Patient LW

• No ICU stay• No pacemaker• No complications• Discharged on POD #1

ReopAVR following previous AVR (re-AVR)

• Redo sternotomy• Mediastinal dissection• Removal of old prosthesis

• 216 re-AVR vs 2,375 primary AVR– Operative mortality 4.6% vs 2.3% (p=0.10)– Reop not a risk factor in multivariate analysis

Davierwala et al JTCVS 2006

• 162 re-AVR vs 2,290 primary AVR– Operative mortality 4.9% vs 3.1% (p=0.20)– Reop not a risk factor in multivariate analysis

Potter et al JTCVS 2005

Operative mortality of 4-9%Potter et al JTCVS 2005

Davierwala et al JTCVS 2006Chan et al JTCVS 2012

Tang et al ATS 2007Leontyev et al 2011

Contemporary Outcomes of Reoperative AVR:Findings From the

STS Adult Cardiac Surgery Database

T. Kaneko1, C. M. Vassileva2, B. R. Englum3, S. Kim3, P. Saha-Chaudhuri3, M. Yammine1, J. Brennan3, R. M. Suri4, V. H. Thourani5, S. F. Aranki1

1 Brigham and Women’s Hospital, Boston, MA 2 Southern Illinois University, Springfield, IL

3 Duke University, Durham, NC4 Mayo Clinic, Rochester, MN,

5 Emory University, Atlanta, GA

Annals of Thoracic Surgery

Study population

• Study period of July 2011- Sep 2013• 723 STS Adult Cardiac Database participating sites

3,383 Isolated reoperative AVR following previous AVR

3 under age 20

3,380 re-AVR2,544 previous AVR

833 previous AVR+CABG 54,183 primary AVRvs

2,213 Stented bioprostheses explanted

Re-AVR vs Primary AVR

Preoperative dataRe-AVR (N=3,380) Primary AVR (N=54,183) p value

Age (median) 66 56-75 70 61-78

Operative variablesOperative data Re-AVR (N=3,380) Primary AVR (N=54,183) p value

X-clamp time (min, median) 93 73-120 73 58-91

Postoperative outcomesRe-AVR

(N=3,380)

Primary AVR

(N=54,183) p value

Operative mortality 4.6% 2.2%

Valve-in-Valve:a less invasive approach for

failed bioprostheses

TAVR Valve-in-Valve Concerns

• Valve malpositioning• Occlusion of LM or ostial RCA• Resultant high aortic valve gradients

Global Valve in Valve RegistryPatients undergoing V-in-V procedures in sites in Europe, North-America, Australia, New Zealand, South Africa, South America and the Middle-East

Dvir et al.

Treatment of lower risk patients

Mortality after aortic VinV

Dvir D et al. JAMA. 2014;312(2):162-170.

Correlates of survivalafter aortic valve-in-valve

Survival after VinV

Incidence of Coronary Obstruction According to the Type of Surgical Bioprosthesis

Ribeiro HB et al. TCT 2016

Residual stenosis:the “Achilles’ heel” of VinV procedures

Dvir D et al. JAMA. 2014;312(2):162-170.

Incidence of valve thrombosis after VIVVIV-TAVI, N=294

Antiplateletsn = 196

Oral Anticoagulantsn =98

Valve thrombosis, N=22 Valve thrombosis, N=1

Incidence of valve thrombosis on antiplatelets = 11.2%

P = 0.001

Simonato et al. VIVID Registry. CircCVIntervention. 2016

High implantation results larger EOA

Simonato et al. VIVID Registry. EuroIntervention. 2016

Jens Erik Nielsen-Kudsk. et al. Circ Cardiovasc Interv. 2015

When there is no option…break that ring!

Post-TAVR and Post-Dilation

Mean gradient = 44 mmHg AVA 1.0 cm2

Final Appearance (1 week f/u)

BVF: More Photogenic Example

Post- 20 mm Tru Balloon (16 atm)

Mean gradient = 18 mmHg AVA 1.9 cm2

The first surgical bioprosthesis specifically designed to enable optimal valve-in-valve, if needed.

A novel surgical bioprosthesis

new class of bovine pericardial tissue

size identifier

Unique expansion mechanism

Summary - Aortic VinV• Aortic VinV procedures are performed using various THV devices

and are associated with good clinicial outcomes; survival comparable to redo surgery.

• Clinical results are worse in small and stenotic surgical valves.• Cases at risk for coronary obstruction could be identified pre-

procedure. Redo surgery should be reconsidered in these patients.• Severe PPM is the Achiles’ Heel of aortic VinV procedures. Risk

for elevated gradients could be reduced with higher deviceimplantation.

• Clinical thrombosis after VinV is relatively common, especially within specific surgical valves without anticoagulation tx.

Conclusions• The field of valve-in-valve for failed surgically

placed bioprosthesis is expected to increase• The proper configuration for placement of the

TAVR valve is for a high implant• Long-term results for this procedure are not

known• The standard of care remains surgical redo

valve replacement in low-, and medium-risk and some high-risk patients

Thank You

Vinod H. Thourani, MD

vinod.h.thourani@medstar.net

Reoperative AVR or TAVR Valve in ValveSlide Number 2TAVR and SAVR Procedures In the TVT Registry and STS ACSD�% of TAVRs -Valve-in-Valve �Increased use of bioprosthetic valve in AVRSlide Number 6Patient LWPatient LWPatient LWSlide Number 10Slide Number 11Slide Number 12Slide Number 13Slide Number 14Patient LWReopAVR following previous AVR (re-AVR) Contemporary Outcomes of Reoperative AVR:�Findings From the�STS Adult Cardiac Surgery DatabaseStudy populationRe-AVR vs Primary AVRPreoperative dataOperative variablesPostoperative outcomesSlide Number 23TAVR Valve-in-Valve ConcernsSlide Number 25Treatment of lower risk patientsSlide Number 27Correlates of survival�after aortic valve-in-valveSlide Number 29Slide Number 30Residual stenosis:�the “Achilles’ heel” of VinV proceduresIncidence of valve thrombosis after VIVSlide Number 33Slide Number 34When there is no option…break that ring!Post-TAVR and Post-DilationSlide Number 37Post- 20 mm Tru Balloon (16 atm)Slide Number 39Summary - Aortic VinVSlide Number 41Slide Number 42