TRACER: 6-Month Outcomes of ePTFE Cordal Repair for Severe Primary - - PowerPoint PPT Presentation

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TRACER: 6-Month Outcomes of ePTFE Cordal Repair for Severe Primary - - PowerPoint PPT Presentation

Apr 27, 2023 430 likes •774 views

TRACER: 6-Month Outcomes of ePTFE Cordal Repair for Severe Primary Mitral Regurgitation Dr. Alison Duncan, MBBS, PhD 6 James S. Gammie, MD 1 Ms. Rashmi Yadev, MBBS, PhD, FRCS (CTh) 6 Andrzej Gackowski, MD, PhD 2 Augusto DOnofrio, MD 7 Judy Hung,

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SLIDE 1

TRACER: 6-Month Outcomes of ePTFE Cordal Repair for Severe Primary Mitral Regurgitation

James S. Gammie, MD1 Andrzej Gackowski, MD, PhD2 Judy Hung, MD5 Michael N. D’Ambra, MD4 Piotr Kolsut, MD3 Piotr Szymanski, MD, PhD3 Boguslaw Kapelak, MD, PhD2 Agata Bilewska, MD, PhD3 Mariusz Kusmierczyk, MD, PhD3

  • Mr. Neil Moat, MBBS, FRCS6
  • Dr. Alison Duncan, MBBS, PhD6
  • Ms. Rashmi Yadev, MBBS, PhD, FRCS (CTh)6

Augusto D’Onofrio, MD7 Gino Gerosa, MD, PhD7

  • Mr. Steve Livesey, FRCS8
  • Dr. Paul Diprose, FRCA8

Paolo Denti, MD9 Giovanni La Canna, MD9 Ottavio Alfieri, MD, PhD9 Michele De Bonis, MD9 Krzysztof Bartus, MD, PhD2

TCT First Report Investigation Nov 1, 2017 Denver, CO, USA

1 University of Maryland School of Medicine, Baltimore, MD, USA 2 Jagellonian University John Paul II Hospital, Krakow Poland 3 Institute of Cardiology, Warsaw Poland 4 Brigham and Women’s Hospital , Boston, MA, USA 5 Massachusetts General Hospital, Boston, MA, USA 6 The Royal Brompton & Harefield NHS Foundation Trust, London UK 7 Padova University Hospital, Padova Italy 8 University Hospital Southampton NHS Foundation Trust UK 9 Ospedale San Raffaele, Milan Italy

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SLIDE 2

Disclosure Statement of Financial Interest

  • Consulting Fees/Honoraria
  • Major Stock Shareholder/Equity
  • Edwards Lifesciences
  • Harpoon Medical

Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the

  • rganization(s) listed below.

Affiliation/Financial Relationship Company

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SLIDE 3

Background

  • Mitral regurgitation (MR) most common valve disease
  • Affects 4 million people in USA; 1 in 10 adults > 65 years
  • 2/3rds mitral operations for degenerative MR (DMR)
  • Superior outcomes for repair vs. replacement
  • Conventional surgery successful BUT:

Sternotomy/thoracotomy, CPB, XC: disability, morbidity Results unpredictable: global 20 – 40 % replacement rate Repair quality and durability uneven

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SLIDE 4

Harpoon mitral valve repair system (H-MVRS)

Beating-heart image-guided cordal mitral valve repair

Goal:

▪Replicate ePTFE Non-Resectional MV Repair ▪Transventricular, Beating-Heart

Courtesy A. M. Gillinov, MD

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SLIDE 5

Harpoon Enabling Technology:

Beating-Heart Mitral Valve Repair

Real-time adjustment of cords to maximize coaptation

3

Simplified off-pump repair of degenerative MR

1

Image guided placement & anchoring of ePTFE cords

2

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SLIDE 6

Harpoon: Technology

21-gauge needle with pre-wound ePTFE suture in preformed knot configuration Hemostatic introducer to reduce blood loss Delivered to the valve via a low profile 3mm delivery system Double helix anchor with ePTFE suture as the only implant

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SLIDE 7

Harpoon Procedure

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SLIDE 8

Harpoon Procedure

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SLIDE 9

Harpoon: Real-Time Titration of ePTFE Cordal Length

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SLIDE 10

Movie here

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SLIDE 11

Background: Harpoon Mitral Valve Repair

Early Feasibility Study

First 11 Patients

  • Safe
  • Effective MR Reduction

(follow-up ongoing)

  • Circulation. 2016;134:189–197
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SLIDE 12

TRACER (Mitral TransApical Cordal Echo-Guided Repair) Trial

Prospective, multicenter Study Safety and performance of Harpoon Mitral Valve Repair System Methods: 6 European Sites 30 Patients (March – December 2016) Scheduled F/U at 30 days, 6, 12, 24 Months Echocardiography Core Lab: Massachusetts General Hospital (J. Hung, MD)

ASE Grading of MR: None/Trace Mild Moderate Severe

TRACER CE Study Design: Harpoon MVRS

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SLIDE 13

Primary Endpoints:

  • Performance: successful implantation of 1 or more ePTFE Cords with MR

reduction to </= Moderate MR at 30 days

  • Safety: Rate of Serious Adverse Events (SAEs) through 30 days

Inclusion Criteria:

  • Severe degenerative Mitral Regurgitation
  • Isolated posterior leaflet prolapse
  • Good predicted surface of coaptation

Harpoon Mitral Valve Repair – TRACER

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SLIDE 14

Characteristic

  • No. (%), or Mean

Age (years) 61 ± 13 Male gender 23 (77%) BMI (Kg/m2) 26.2 ± 3.7 NYHA Class – no. (%) I II III 15 (50 %) 10 (33 %) 5 (17 %) STS PROM (%) 0.69 ± 0.72 Atrial fibrillation 9 (30 %) Hypertension 22 (73 %) GFR 79 ± 15 mL/min/m2

Cardiac Structure/Function

LV Ejection Fraction, mean, % 69 ± 7 LA Diameter, mm 46 ± 7 LV end-diastolic diameter, mm 53 ± 6 LV end-systolic diameter, mm 32 +/- 6 sPAP (mm Hg) 42 ± 13

TRACER Study Results: Patient Characteristics N = 30

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SLIDE 15

Characteristic

  • No. (%), or Mean

Age (years) 61 ± 13 Male gender 23 (77%) BMI (Kg/m2) 26.2 ± 3.7 NYHA Class – no. (%) I II III 15 (50 %) 10 (33 %) 5 (17 %) STS PROM (%) 0.69 ± 0.72 Atrial fibrillation 9 (30 %) Hypertension 22 (73 %) GFR 79 ± 15 mL/min/m2

Cardiac Structure/Function

LV Ejection Fraction, mean, % 69 ± 7 LA Diameter, mm 46 ± 7 LV end-diastolic diameter, mm 53 ± 6 LV end-systolic diameter, mm 32 +/- 6 sPAP (mm Hg) 42 ± 13

TRACER Study Results: Patient Characteristics N = 30

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SLIDE 16

Characteristic

  • No. (%), or Mean

Age (years) 61 ± 13 Male gender 23 (77%) BMI (Kg/m2) 26.2 ± 3.7 NYHA Class – no. (%) I II III 15 (50 %) 10 (33 %) 5 (17 %) STS PROM (%) 0.69 ± 0.72 Atrial fibrillation 9 (30 %) Hypertension 22 (73 %) GFR 79 ± 15 mL/min/m2

Cardiac Structure/Function

LV Ejection Fraction, mean, % 69 ± 7 LA Diameter, mm 46 ± 7 LV end-diastolic diameter, mm 53 ± 6 LV end-systolic diameter, mm 32 +/- 6 sPAP (mm Hg) 42 ± 13

TRACER Study Results: Patient Characteristics N = 30

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SLIDE 17

Technical success rate: 93 % (28/30)

4.1 (1-5) ePTFE cordal pairs inserted Procedural time = 125 ± 43 min Blood loss 275 cc

Two intraoperative conversions to conventional surgery

  • Patient #1 Imaging equipment dysfunction, insufficient MR reduction
  • Patient #10 Imaging equipment dysfunction, access site bleeding

Both received MV repair with ePTFE cords, No MR at D/C

MR reduced to: None/Trace in 24/28 (86 %); Mild in 4/28 (14%) TRACER Study Results: Performance Endpoint

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SLIDE 18

Technical success rate: 93 % (28/30)

4.1 (1-5) ePTFE cordal pairs inserted Procedural Time = 125 ± 43 min

Two intraoperative conversions to conventional surgery

  • Patient #1 Imaging equipment dysfunction, insufficient MR reduction
  • Patient #10

Imaging equipment dysfunction, access site bleeding Both received MV repair with ePTFE cords, No MR at D/C

MR reduced to: None/Trace in 24/28 (86 %); Mild in 4/28 (14%) TRACER Study Results: Performance Endpoint

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SLIDE 19

Primary Endpoint at 30 days: 90% (27/30)

One repaired valve MSSA infective endocarditis POD #27 Preop elevated WBC, dental disease unrecognized: successful MV replacement

MR reduced to: </= Mild in 24/27 (89 %); Moderate in 3/27 (11%) TRACER Results: Performance Endpoint

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SLIDE 20

Harpoon TRACER Results: Safety

Outcome N (%)

Mortality Stroke Renal Failure Blood Transfusion 1 (3 %) (intraoperative conversion) Permanent Pacemaker Intraoperative Inotrope Myocardial Infarction New Postoperative AF 2/21 (10 %)

Serious Adverse Events: 8:

2 Operative Conversions Repaired Valve IE (POD 27) 2 Pleural Effusions (POD 8, 9) Chronic Cholecystitis (POD 36) Chest Pain (POD 5) Atrial Flutter (POD 38)

No Late stroke, Reoperation, Thromboembolism or Death

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SLIDE 21

Harpoon TRACER Results: Safety

Outcome N (%)

Mortality Stroke Renal Failure Blood Transfusion 1 (3 %) (intraoperative conversion) Permanent Pacemaker Intraoperative Inotrope Myocardial Infarction New Postoperative AF 2/21 (10 %)

Serious Adverse Events: 8:

2 Operative Conversions Repaired Valve IE (POD 27) 2 Pleural Effusions (POD 8, 9) Chronic Cholecystitis (POD 36) Chest Pain (POD 5) Atrial Flutter (POD 38)

No Late stroke, Reoperation, Thromboembolism or Death

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SLIDE 22

Harpoon TRACER Results: Safety

Outcome N (%)

Mortality Stroke Renal Failure Blood Transfusion 1 (3 %) (intraoperative conversion) Permanent Pacemaker Intraoperative Inotrope Myocardial Infarction New Postoperative AF 2/21 (10 %)

Serious Adverse Events: 8:

2 Operative Conversions Repaired Valve IE (POD 27) 2 Pleural Effusions (POD 8, 9) Chronic Cholecystitis (POD 36) Chest Pain (POD 5) Atrial Flutter (POD 38)

No Late stroke, Reoperation, Thromboembolism or Death

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SLIDE 23

Harpoon TRACER Results: Safety

Outcome N (%)

Mortality Stroke Renal Failure Blood Transfusion 1 (3 %) (intraoperative conversion) Permanent Pacemaker Intraoperative Inotrope Myocardial Infarction New Postoperative AF 2/21 (10 %)

Serious Adverse Events: 8:

2 Operative Conversions Repaired Valve IE (POD 27) 2 Pleural Effusions (POD 8, 9) Chronic Cholecystitis (POD 36) Chest Pain (POD 5) Atrial Flutter (POD 38)

No Late stroke, Reoperation, Thromboembolism or Death

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SLIDE 24

Harpoon Mitral Valve Repair: MR Grades 6 Months

100% 100% 89% 85% 11% 8% 100% 8%

0% 20% 40% 60% 80% 100% Baseline Procedure Discharge 30-Day 6-Month (30) (28) (25) (27) (26)

Severe Moderate Mild or Less *Excludes 3 conversions prior to 30 days

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SLIDE 25

Harpoon Mitral Valve Repair: MR Grades 6 Months

100% 100% 89% 85% 11% 8% 100% 8%

0% 20% 40% 60% 80% 100% Baseline Procedure Discharge 30-Day 6-Month (30) (28) (25) (27) (26)

Severe Moderate Mild or Less *Excludes 3 conversions prior to 30 days

85 % None/Trace or Mild MR at 6 Months

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SLIDE 26

Harpoon Mitral Valve Repair: Functional Status

30 Days: 93 % NYHA Class I 6 Months: 100 % NYHA Class I

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SLIDE 27

Harpoon Mitral Valve Repair: One-Year Echo

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SLIDE 28

Harpoon Mitral Valve Repair: Remodeling

Preoperative 6 Month p value

LVEDD (mm) 53 ± 6 48 ± 6 <0.001 LV EDV (ml) 161 ± 36 122 ± 30 <0.001 LA volume (ml) 106 ± 36 69 ± 24 <0.001 LVEF (%) 69 ± 7 66 ± 7 <0.05 Annular Diameter (mm) 34.7 ± 6 28.2 ± 5 <0.001 Mitral annular area (cm2) 10.0 ± 2.7 6.9 ± 2.0 <0.001 Gradient (mean) mmHg N/A 1.5 ± 0.6

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SLIDE 29

Harpoon Mitral Valve Repair: Remodeling

Preoperative 6 Month p value

LVEDD (mm) 53 ± 6 48 ± 6 <0.001 LV EDV (ml) 161 ± 36 122 ± 30 <0.001 LA volume (ml) 106 ± 36 69 ± 24 <0.001 LVEF (%) 69 ± 7 66 ± 7 <0.05 Annular Diameter (mm) 34.7 ± 6 28.2 ± 5 <0.001 Mitral annular area (cm2) 10.0 ± 2.7 6.9 ± 2.0 <0.001 Gradient (mean) mmHg N/A 1.5 ± 0.6

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SLIDE 30

Harpoon Mitral Valve Repair: Remodeling

Preoperative 6 Month p value

LVEDD (mm) 53 ± 6 48 ± 6 <0.001 LV EDV (ml) 161 ± 36 122 ± 30 <0.001 LA volume (ml) 106 ± 36 69 ± 24 <0.001 LVEF (%) 69 ± 7 66 ± 7 <0.05 Annular Diameter (mm) 34.7 ± 6 28.2 ± 5 <0.001 Mitral annular area (cm2) 10.0 ± 2.7 6.9 ± 2.0 <0.001 Gradient (mean) mmHg N/A 1.5 ± 0.6

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SLIDE 31

Harpoon Mitral Valve Repair: Remodeling

Preoperative 6 Month p value

LVEDD (mm) 53 ± 6 48 ± 6 <0.001 LV EDV (ml) 161 ± 36 122 ± 30 <0.001 LA volume (ml) 106 ± 36 69 ± 24 <0.001 LVEF (%) 69 ± 7 66 ± 7 <0.05 Annular Diameter (mm) 34.7 ± 6 28.2 ± 5 <0.001 Mitral annular area (cm2) 10.0 ± 2.7 6.9 ± 2.0 <0.001 Gradient (mean) mmHg N/A 1.5 ± 0.6

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SLIDE 32

Harpoon Annuloplasty Effect

P2

Pre Post

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SLIDE 33
  • Harpoon MVRS successfully enables anchoring of ePTFE artificial cords
  • Safe, minimally-invasive
  • Stable, predictable and durable reduction of MR
  • Harpoon repair associated with favorable remodeling
  • Harpoon ePTFE vectors result in a broad annuloplasty effect
  • Harpoon knots do not damage the leaflet: option for open repair preserved
  • Titration of cordal length on loaded heart optimizes coaptation and repair

quality

  • Future directions: device/procedural/selection refinement

direct comparison to conventional mitral valve surgery

Harpoon Transapical Mitral Valve Repair: CONCLUSIONS