CME: Guidance on Transcatheter Pulmonic Valve Replacement

CME: Guidance on Transcatheter Pulmonic Valve Replacement
Author Information (click to view)

Carlos E. Ruiz, MD, PhD

Director, Division of Congenital and Structural Heart Disease
Lenox Hill Heart and Vascular Institute
North Shore/LIJ Health System

Carlos E. Ruiz, MD, PhD, has indicated to Physician’s Weekly that he has or has had no financial interests to report.

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Target Audience (click to view)

This activity is designed to meet the needs of physicians.

Learning Objectives(click to view)

Upon completion of the educational activity, participants should be able to:

 

  • Discuss an expert consensus paper released by the Society for Cardiovascular Angiography and Interventions, American Association for Thoracic Surgery, American College of Cardiology, and Society of Thoracic Surgeons that provides guidance on transcatheter pulmonic valve replacement for children and adults who were previously treated for congenital heart disease.

Method of Participation(click to view)

Statements of credit will be awarded based on the participant reviewing monograph, correctly answer 2 out of 3 questions on the post test, completing and submitting an activity evaluation.  A statement of credit will be available upon completion of an online evaluation/claimed credit form at www.akhcme.com/pwApr6.  You must participate in the entire activity to receive credit.  If you have questions about this CME/CE activity, please contact AKH Inc. at dcotterman@akhcme.com.

Credit Available(click to view)

AKH

CME Credit Provided by AKH Inc., Advancing Knowledge in Healthcare

Physicians
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AKH Inc., Advancing Knowledge in Healthcare and Physician’s Weekly’s.  AKH Inc., Advancing Knowledge in Healthcare is accredited by the ACCME to provide continuing medical education for physicians.

 

AKH Inc., Advancing Knowledge in Healthcare designates this enduring activity for a maximum of 0.5 AMA PRA Category 1 Credit(s)™.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Commercial Support(click to view)

There is no commercial support for this activity.

Disclosures(click to view)

It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The author must disclose to the participants any significant relationships with commercial interests whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflicts of interest are resolved by AKH prior to accreditation of the activity and may include any of or combination of the following: attestation to non-commercial content; notification of independent and certified CME/CE expectations; referral to National Author Initiative training; restriction of topic area or content; restriction to discussion of science only; amendment of content to eliminate discussion of device or technique; use of other author for discussion of recommendations; independent review against criteria ensuring evidence support recommendation; moderator review; and peer review.

Disclosure of Unlabeled Use & Investigational Product(click to view)

This educational activity may include discussion of uses of agents that are investigational and/or unapproved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer(click to view)

This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through participant’s misunderstanding of the content.

Faculty & Credentials(click to view)

FACULTY DISCLOSURES

Keith D’Oria – Editorial Director
Discloses no financial relationships with pharmaceutical or medical product manufacturers.
Carlos E. Ruiz, MD, PhD
Discloses no financial relationships with pharmaceutical or medical product manufacturers:
AKH and PHYSICIAN WEEKLY’S STAFF/REVIEWERS

Dorothy Caputo, MA, BSN, RN- CE Director of Accreditation
Discloses no financial relationships with pharmaceutical or medical product manufacturers.

AKH planners and reviewers have no relevant financial relationships to disclose.


Carlos E. Ruiz, MD, PhD (click to view)

Carlos E. Ruiz, MD, PhD

Director, Division of Congenital and Structural Heart Disease
Lenox Hill Heart and Vascular Institute
North Shore/LIJ Health System

Carlos E. Ruiz, MD, PhD, has indicated to Physician’s Weekly that he has or has had no financial interests to report.

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A position paper from experts in cardiology provides guidance on transcatheter pulmonic valve replacement, or TPVR, for children and adults who were previously treated for congenital heart disease.
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Treatment for congenital heart disease (CHD) has advanced considerably over the years, allowing for more children with CHD to live into adulthood. Despite these advances, CHD patients may require additional treatment over time. Pulmonary valve replacement may be necessary in patients who have had certain types of CHD that was repaired with reconstruction of the right ventricular outflow tract (RVOT). As patients with CHD live longer, dysfunction of the repair can occur. In the past, these patients would require a repeat open-heart surgery. Fortunately, transcatheter pulmonic valve replacement (TPVR) has emerged as a less invasive treatment option for many of these patients.

Transcatheter valve treatments like TPVR are allowing clinicians to offer less invasive options to CHD patients who were previously treatable only with open heart surgery or may not have been eligible for treatment. These procedures are complementing standard surgical approaches, allowing physicians to provide more options for patients. The medical community has recognized the applicability, effectiveness, and practicality of transcatheter valve therapies, which in turn has fueled interest in these treatments.

 

Reaching a Consensus

Recently, an expert consensus paper was released by the Society for Cardiovascular Angiography and Interventions, American Association for Thoracic Surgery, American College of Cardiology, and Society of Thoracic Surgeons to provide guidance on TPVR for children and adults who were previously treated for CHD. The consensus paper was published simultaneously in Catheterization and Cardiovascular Interventions, the Journal of Thoracic and Cardiovascular Surgery, the Journal of the American College of Cardiology, and Annals of Thoracic Surgery. A committee of cardiac surgeons and interventional cardiologists developed the recommendations.

The consensus paper outlines criteria for operator and institutional requirements to help enable institutions and providers to participate responsibly in this new and rapidly developing field (Table 1). “Given the high-risk nature of these interventions and the availability of alternative options with traditional surgical approaches, several considerations are important for institutions and operators planning to implement these new technologies,” says Carlos E. Ruiz, MD, PhD, who was a member of the writing group that developed the consensus paper. “Defining operator and institutional requirements for these novel therapies is an important first step to ensuring that implementation is optimized.”

 

Team-Based Care

The consensus document stresses that TPVR treatment recommendations should be made by a multi-disciplinary Heart Team consisting of interventional cardiologists, cardiac surgeons, noninvasive cardiologists, and cardiac anesthesiologists and radiologists. “This collaboration can increase quality of care for patients with complex heart disease, including those considering TPVR,” Dr. Ruiz says. It can help clinicians determine the best treatment option for each individual patient.

The Heart Team should be actively engaged in the treatment of congenital and/or structural heart disease and should have experience in treating conditions of the pulmonary valve, pulmonary arteries and the RVOT. Each case should be discussed among Heart Team members. Furthermore, the institution should have extracorporeal membrane oxygenation (ECMO) capabilities for the rare patient who may require such support.

 

Cardiac Cases

The consensus paper also recommends that institutions offering TPVR perform at least 150 congenital or structural catheterization procedures per year. Of those, 100 should be interventional in nature, including but not limited to stenting of branch pulmonary arteries and RVOT. Furthermore, the institution should perform a minimum of a 100 open heart surgeries in patients with CHD if it is a children’s hospital or an adult program associated with such a hospital. Adult programs should perform a minimum of 25 adult-congenital surgical cases per year.

Physicians performing TPVR are also recommended to have experience with balloon valvuloplasty and stenting within pulmonary arteries and RVOT. Additionally, the consensus document recommends that physicians attend peer-to-peer training and simulated cases if they are available. The first three procedures performed should be under the guidance of an experienced physician.

 

Imaging Necessities

Institutions are recommended to have echocardiography, cardiac CT, and cardiac MRI imaging capabilities (Table 2) when performing TPVR. A cardiovascular catheterization laboratory is needed and clinicians should evaluate hemodynamic components, such as blood pressure and electrocardiography. “It’s also critical to track outcomes and performance with these procedures,” says Dr. Ruiz. “Institutions should participate in a national registry that collects data on all patients undergoing TPVR. This data can be used to follow patient outcomes and compare them with patients who undergo traditional surgical approaches.”

As experience with TPVR increases over time, complication rates are declining significantly. “This reflects the importance of experience in improving patient outcomes,” Dr. Ruiz says. “The consensus paper on operator and institutional requirements for TPVR can help ensure that these procedures are optimally implemented in hospitals throughout the country.”

Readings & Resources (click to view)

Hijazi ZM, Ruiz CE, Zahn E, et al. SCAI/AATS/ACC/STS operator and institutional requirements for transcatheter valve repair and replacement, part III: pulmonic valve. Catheter Cardiovasc Interv. 2015 Mar 24 [Epub ahead of print]. Available at: http://www.scai.org/Assets/658f68de-6376-4cf4-853e-20640825d4f1/635628726930500000/scai-2015-02-23-tavrrequirements-pdf.

Tommaso CL, Bolman III RM, Feldman T, et al. Multisociety (AATS, ACCF, SCAI, and STS) expert consensus statement: operator and institutional requirements for transcatheter valve repair and replacement, Part 1: Transcatheter aortic valve replacement. J Am Coll Cardiol. 2012;59:2028-2042.

Nishimura RA, Otto CM, Bonow RO, et al. AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63:e57-e185.

Warnes CA, Williams RG, Bashore TM, et al. ACC/AHA 2008 guidelines for the management of adults with congenital heart disease: executive summary: a report of the American College of Cardiology/American Heart Association task force on practice guidelines. Circulation. 2008;118:2395-2451.

Kenny D, Hijazi ZM. Transcatheter pulmonary valve replacement: current status and future potentials. Interv Cardiol Clin. 2013;2:181-193.

2 Comments

  1. Dr. Longabaugh,
    I’ll do my best to get in touch with Dr. Ruiz and see what he has to say regarding your question.

    Reply
  2. I have a patient with significant 4 valve regurgitation some thirty years after Rad Rx for lymphoma. She’s not a traditional surgical candidate. Native valve PI is perhaps the worst of the lesions. Is there an indication for TPVR in native pulmonic valve disease of this sort? Thanks

    Reply

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