Overview Percutaneous Paravalvular Leak Closure When it works and - - PDF document

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Overview Percutaneous Paravalvular Leak Closure When it works and - - PDF document

10/1/16 Overview Percutaneous Paravalvular Leak Closure When it works and when it doesnt Disclosures: Nothing to disclose. Off label use of devices. Christian Spies, MD Interventional Cardiologist The Queens Center for


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Percutaneous Paravalvular Leak Closure

When it works and when it doesn’t

Christian Spies, MD

Interventional Cardiologist The Queen’s Center for Valve and Structural Heart Disease Associate Professor of Medicine University of Hawaii Honolulu, HI Center for Valve and Structural Heart Disease

Overview

Center for Valve and Structural Heart Disease

  • Disclosures:
  • Nothing to disclose.
  • Off label use of devices.

Overview

Center for Valve and Structural Heart Disease

  • Paravalvular Leaks following Surgical Mitral and Aortic

Valve Replacement

  • Paravalvular Leaks following Transcatheter Aortic Valve

Replacement

Overview

Center for Valve and Structural Heart Disease

  • Why and when
  • Incidence
  • Indications to consider closure
  • Problems with surgery
  • How
  • Basic technique
  • Devices
  • Pitfalls
  • Examples
  • Literature
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Overview

Center for Valve and Structural Heart Disease

  • Why and when
  • Incidence
  • Indications to consider closure
  • Problems with surgery
  • How
  • Basic technique
  • Devices
  • Pitfalls
  • Examples
  • Literature

Paravalvular Leaks

Center for Valve and Structural Heart Disease

  • 210,000 surgical valve replacements worldwide
  • Incidence of paravalvular leaks:
  • 2-10% aortic valve replacement surgery
  • 7-17% mitral valve replacement surgery
  • 1-3% of paravalvular leaks require reoperation

because of symptoms

  • Symptoms of paravalvular leaks:
  • Heart failure
  • Hemolysis
  • Combination, may be sequential

Spiliopoulos et al. Interact Cardiovasc Thorac Surg 2009;8:252 Hammermeister et al. JACC 2000;36:1152 Genomi et al. Eur J Cardiothoracic Surg 2000;17:14 Miller et al. J Heart Valve Dis 1995;4:160

Paravalvular Leaks

Center for Valve and Structural Heart Disease

  • Risk factors:
  • Extensive calcifications of annulus
  • Presence of endocarditis at time of surgery
  • Large atria
  • Renal insufficiency
  • Older age
  • Malnutrition
  • ?? Type of valve
  • ??? surgeon

L Latson. Expert Rev Cardiovasc Ther 2009;7:507

Center for Valve and Structural Heart Disease

  • Concerns with surgery:
  • Mortality: 13%+
  • Morbidity: considerable
  • 20% recurrence rate
  • First percutaneous paravalvular leak closure in 1992

with double umbrella device

Paravalvular Leaks

Exposito et al. Rev Esp Cardiol 2009;62:929 Echevarria et al. Eur J Cardiothoracic Surg 1991;5:523 Genomi et al. Eur J Cardiothoracic Surg 2000;17:14 Hourihan et al. JACC1992;20:1371

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Center for Valve and Structural Heart Disease

Guidelines

Nishimura et al. JACC 2014: 63 (22): e57-185

CLASS I

  • 1. Surgery is recommended for operable patients with mechanical

heart valves with intractable hemolysis or HF due to severe prosthetic or paraprosthetic regurgitation (617,618). (Level of Evidence: B)

CLASS IIa

  • 2. Percutaneous repair of paravalvular regurgitation is reasonable

in patients with prosthetic heart valves and intractable hemo- lysis or NYHA class III/IV HF who are at high risk for surgery and have anatomic features suitable for catheter-based therapy when performed in centers with expertise in the procedure (620–622). (Level of Evidence B)

Surgery is a viable therapeutic option in many patients

PRACTICE GUIDELINE

2014 AHA/ACC Guideline for the Management

  • f Patients With Valvular Heart Disease

A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines

Overview

Center for Valve and Structural Heart Disease

  • Why and when
  • Incidence
  • Indications to consider closure
  • Problems with surgery
  • How
  • Basic technique
  • Devices
  • Pitfalls
  • Examples
  • Literature

Overview

Center for Valve and Structural Heart Disease

  • Why and when
  • Incidence
  • Indications to consider closure
  • Problems with surgery
  • How
  • Basic technique
  • Devices
  • Pitfalls
  • Examples
  • Literature

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Pre-procedural Evaluation

  • 3D-TEE is key
  • Shape (oval, crescentic)
  • Track (straight, serpiginous)
  • Aortic valve: ? proximity to coronary ostia
  • Mitral valve: location is key
  • ? 1/3 of circumference
  • ? Rocking motion of valve

Suspicion is key for diagnosis !!!

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Pre-procedural Evaluation

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Pre-procedural Evaluation

Mahjoub et al. JACC Interv 2011;4:107

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Setup

  • General anesthesia (usually)
  • Intraprocedural 3D-TEE
  • Biplane imaging (tangential and en face view)
  • Use of low frame rate

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Devices

  • Small delivery sheath
  • Thinner nitinol
  • More flexible
  • No protruding discs
  • Small delivery

sheath

  • More rigid
  • Single

retention disc

  • Unilateral
  • rientation
  • Larger delivery

sheath

  • Thick nitinol
  • Rigid
  • Protruding

discs

AVP II ADO VSD AVP II

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Aortic Valve Approach

  • General anesthesia +/-
  • Retrograde/Transaortic
  • Cross leak with Glidewire
  • Rail-wire +/-
  • TEE/TTE
  • Exchange for
  • MP Guider 6Fr.
  • Shuttle sheath (90cm)
  • AVP II or ADO

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Approach

  • Retrograde
  • Antegrade
  • Trans-apical
  • Leak location
  • Mechanical AV
  • Interatrial septum
  • Device deliverability
  • AV loop
  • Single device
  • Rail wire
  • Double device

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Antegrade Mitral Valve Approach

  • Triple telescope technique
  • 8.5Fr. Transseptal (67 cm)
  • 6Fr. JR4 guider (100 cm)
  • 4Fr. Berenstein (110 cm)
  • Agilis sheath
  • AV loop if tight turns
  • Alternative to AV loop:

Amplatz ES or SS with short tip

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Antegrade Mitral Valve Approach

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Antegrade Mitral Valve Approach

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Antegrade Mitral Valve Approach

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Published Case Series

Long-Term Follow-Up of Percutaneous Repair

  • f Paravalvular Prosthetic Regurgitation

Paul Sorajja, MD,* Allison K. Cabalka, MD,† Donald J. Hagler, MD,† Charanjit S. Rihal, MD* Rochester, Minnesota

  • Largest single center

experience (n=126)

  • Report only outcome of

successful closures

  • Average age 67
  • 55% ≥ 2 prior stenotomies
  • Average STS score 6.7
  • 78.5% mitral PVL
  • 38.9% bioprosthesis
  • 30 day mortality 2.4%
  • Of those with CHF 72% had

improvement

Sorajja et al. JACC 2011;58(21):2218

Percutaneous PVL Closure

Published Case Series

Clinical Outcomes in Patients Undergoing Percutaneous Closure of Periprosthetic Paravalvular Leaks

Carlos E. Ruiz, MD, PHD, Vladimir Jelnin, MD, Itzhak Kronzon, MD, Yuriy Dudiy, MD, Raquel Del Valle-Fernandez, MD, Bryce N. Einhorn, Paul T. L. Chiam, MD, Claudia Martinez, MD, Rocio Eiros, MS, Gary Roubin, MD, PHD, Howard A. Cohen, MD New York, New York

  • 43 patients/57 procedures
  • Average age 69
  • Average thoracotomies 1.8
  • 78% mitral PVL
  • 65% bioprosthesis
  • Indication CHF 16%
  • Indication hemolysis 14%
  • Indication both 70%

Ruiz et al. JACC 2011;58(21):2210

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Percutaneous PVL Closure

Published Case Series

Clinical Outcomes in Patients Undergoing Percutaneous Closure of Periprosthetic Paravalvular Leaks

Carlos E. Ruiz, MD, PHD, Vladimir Jelnin, MD, Itzhak Kronzon, MD, Yuriy Dudiy, MD, Raquel Del Valle-Fernandez, MD, Bryce N. Einhorn, Paul T. L. Chiam, MD, Claudia Martinez, MD, Rocio Eiros, MS, Gary Roubin, MD, PHD, Howard A. Cohen, MD New York, New York Center for Valve and Structural Heart Disease

Fluoroscopy time 39 min. Eventual technical success 86% Procedural failures N=12 (21%) Inability to cross defect N=8 (14%) Interference with valve N=3 (5%) Wire entrapment N=1 (2%) Complications N=7 (12%) Acute embolization N=2 (4%) Wire entrapment N=1 (2%) Cardiac perforation N=2 (4%) Iliac artery perforation N=1 (2%) Death N=1 (2%)

Ruiz et al. JACC 2011;58(21):2210

Percutaneous PVL Closure

Published Case Series

Center for Valve and Structural Heart Disease

Of successfully closed 37 patients, 13 (35%) had worsening or new hemolysis post-procedurally.

Ruiz et al. JACC 2011;58(21):2210

Clinical Outcomes in Patients Undergoing Percutaneous Closure of Periprosthetic Paravalvular Leaks

Carlos E. Ruiz, MD, PHD, Vladimir Jelnin, MD, Itzhak Kronzon, MD, Yuriy Dudiy, MD, Raquel Del Valle-Fernandez, MD, Bryce N. Einhorn, Paul T. L. Chiam, MD, Claudia Martinez, MD, Rocio Eiros, MS, Gary Roubin, MD, PHD, Howard A. Cohen, MD New York, New York Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Most Contemporary Series

  • 308 procedures in 259

patients

  • 20 centers over 11 years
  • 44% mitral, 48% aortic PVL
  • Technical success 91%
  • NYHA class improved from

2.7 to 1.6

  • Hospital mortality was 2.9%

in elective cases

  • Factors associated with poor
  • utcome were persistent leak

and renal function

Calvert PA et al., Circulation 2016: 10.1161/CIRCULATIONAHA.116.022684

Percutaneous Device Closure of Paravalvular Leak: Combined Experience from the United Kingdom and Ireland

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  • Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Most Contemporary Series

  • Between 2008-2014: 51 percutaneous closures, 36 surgical

closure

  • Propensity score match in-hospital mortality: 9.8%

percutanous vs. 30.% surgical; OR 6, p=0.01

  • Clinical improvement was higher in percutaneous group

(71.4% vs. 36.4%; p=0.002)

Angulo-Llanos R et ak. CCI 2016: DOI: 10.1002/ccd.26459

Two-Year Follow Up After Surgical Versus Percutaneous Paravalvular Leak Closure: A Non-Randomized Analysis

TABLE VII. Short-Term Outcomes: Mitral and Aortic Patients Percutaneous mitral (41) Surgical mitral (26) P Percutaneous aortic (10) Surgical aortic (10) P Length of stay after procedure 11.6 20.1 d 34.5 29.1 d <0.001 4 3.7 d 26.44 17.1 d 0.008 In-Hospital mortality 12.2% (5) 30.8% (8) 0.06 30% (3) 0.105 Complications Cerebrovascular accident 20% (2) 0.24 Renal insufficiency 9.7% ( 4) 57.7% (15) <0.001 50% (5) 0.016 Vascular complications 19.6 % ( 10) 11.5% (3) 0.37 20% (2) 10% (1) 0.5 Values are presented as mean 6 SD, count or % (n).

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Queen’s Experience

  • First case done in 2009
  • 41% mitral paravalvular leaks
  • 37 cases
  • 42 leaks
  • Peri-procedural mortality 0%
  • Peri- procedural stroke 0%
  • One embolized device

Percutaneous Paravalvular Leak Closure

When it works and when it doesn’t

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Aortic Valve Example

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Aortic Valve Example

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Aortic Valve Example

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Aortic Valve Example

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Aortic Valve Example

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Aortic Valve Example

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Antegrade–

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Antegrade–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Antegrade–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example 2–Antegrade–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Antegrade–

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Antegrade–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Large Isolated –

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Large Isolated–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Large Isolated–

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Large Isolated–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Large Isolated–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Large Isolated–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Aortic Valve Example –Severe & Multiple–

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Aortic Valve Example –Severe & Multiple–

1 2 3 4 5

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Aortic Valve Example –Severe & Multiple–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Summary

  • Finally made it into the guidelines and is a class 2a

recommendation

  • Safe procedure and valid alternative to re-do

sternotomy

  • Reasonably effective
  • Aortic PVL closure simpler than mitral PVL closure
  • Complex procedure should only be done by

experienced operators

  • Multimodality imaging is key
  • Almost always “worth a try” prior to committing

patients to repeat open heart surgery, except in focal VERY large defects

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Meta-Analysis

Mookadam et al. J Heart Valve Disease 2012;21:208

  • Meta-analysis of mitral paravalvular leak closure
  • 8 case series included
  • Includes 100 patients
  • Majority used ADO (62%)
  • 79% mechanical valves
  • 63% antegrade approach

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Meta-Analysis

Mookadam et al. J Heart Valve Disease 2012;21:208

  • Procedural failure due to:
  • Inability to cross the leak – 18%
  • Significant residual leak or hemolysis – 31%
  • Major peri-procedural adverse events – 16%
  • 1-year all cause mortality 24%

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Antegrade Mitral Valve Approach (2)

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Antegrade Mitral Valve Approach (2)

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Antegrade Mitral Valve Approach (2)

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Retrograde Mitral Valve Approach

  • Less commonly used now
  • Medical leaks (1-5
  • ’clock)
  • Modified JL3.5
  • Modified pigtail
  • Long glidewire (450 cm)

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Retrograde Mitral Valve Approach

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Retrograde Mitral Valve Approach

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Retrograde Mitral Valve Approach

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Retrograde Mitral Valve Approach

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Transapical Mitral Valve Approach

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Retrograde–

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Retrograde–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Retrograde–

RA LA Ao Pseudo aneurysm

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Retrograde–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Retrograde–

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Retrograde–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Retrograde–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Retrograde–

Antero- lateral leak Postero- medial leak

Percutaneous PVL Closure

Mitral Valve Example –Multiple–

Center for Valve and Structural Heart Disease

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Percutaneous PVL Closure

Mitral Valve Example –Multiple–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Multiple–

Center for Valve and Structural Heart Disease Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Multiple–

Additional plug

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Multiple–

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Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Multiple–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Adverse Event–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Adverse Event–

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Mitral Valve Example –Adverse Event–

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Percutaneous PVL Closure

Words of Caution

Prosthetic Valve Malfunction After Amplatzer Closure of Paravalvular Leak

Mohammad Hossein Mandegar, MD, and Farideh Roshanali, MD

Shariati General Hospital, Tehran University of Medical Science, Tehran, Iran large paravalvular leak for which he had undergone Fig 2.

Mitral Stenosis Caused by an Amplatzer Occluder Device Used to Treat a Paravalvular Leak

Jamie L.W. Kennedy, MD, Carlos M. Mery, MD, MPH, John A. Kern, MD, and James D. Bergin, MD

Divisions of Cardiology and Thoracic and Cardiovascular Surgery, University of Virginia Health System, Charlottesville, Virginia

Repair of paravalvular prosthetic mitral valve leaks with septal

  • ccluder devices in severely high-risk patients: a word of caution

Craig R. Smith*, Sotiris C. Stamou, William M. Merhi and Robert L. Hooker

Department of Thoracic and Cardiovascular Surgery, Spectrum Health, Frederik Meijer Heart & Vascular Institute, Grand Rapids, MI, USA * Corresponding author. Michigan State University, College of Human Medicine, 15 Michigan St. NE, Grand Rapids, MI 49503, USA. Tel: +1-906-8697955; fax: +1-616-2342638; e-mail: smit1628@msu.edu (C.R. Smith). Received 16 March 2012; received in revised form 11 April 2012; accepted 14 April 2012 Interactive CardioVascular and Thoracic Surgery 15 (2012) 544–546

CASE REPORT - ADULT CARDIAC

doi:10.1093/icvts/ivs210 Advance Access publication 28 May 2012

Bioprosthetic Leaflet Erosion After Percutaneous Mitral Paravalvular Leak Closure

Jason H. Rogers, MD,* Allen S. Morris, MD,† Patricia A. Takeda, MD,* Reginald I. Low, MD* Sacramento, California

Center for Valve and Structural Heart Disease

Percutaneous PVL Closure

Pre-procedural Evaluation

Ao

9 3 12 6

IAS