News | March 25, 2015

New Recommendations Emerge for Minimally Invasive Valve Treatments for Children, Adults

Consensus statement on transcatheter pulmonic valve replacement stresses importance of heart team to collaborate on treatment decisions

congenital heart disease, CHD, tPVR, consensus paper, minimally invasive

March 25, 2015 — A new expert consensus paper released by a coalition of cardiovascular organizations provides guidance on transcatheter pulmonic valve replacement (tPVR) for children and adults who were previously treated for congenital heart disease (CHD). The paper was jointly issued by the Society for Cardiovascular Angiography and Interventions (SCAI), American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC) and The Society of Thoracic Surgeons (STS).

Pulmonary valve replacement may be necessary in patients who have had certain types of CHD repaired with reconstruction of the right ventricular outflow tract (RVOT),  an area of the heart that carries blood out of the right ventricle. As patients with CHD live longer than they did in the past, dysfunction of the repair can occur over time. In the past, these patients would require a repeat open-heart surgery. Today, tPVR offers a less invasive option for many patients.

"Transcatheter valve treatments are allowing us to offer less invasive options to patients who were previously treatable only with open-heart surgery, or may not have been eligible for treatment at all," said Ziyad M. Hijazi, M.D., MPH, FACC, MSCAI, chair of the writing committee, acting chief medical officer and chairman of the Department of Pediatrics at Sidra Medical and Research Center in Doha, Qatar. "These procedures are complementing standard surgical approaches, allowing physicians to provide greater options for our patients."

As treatment advances, cardiologists and surgeons have the opportunity to collaborate in determining the best treatment option for each patient. The consensus paper stresses that tPVR treatment recommendations should be made by a heart team consisting of interventional cardiologists, cardiac surgeons, noninvasive cardiologists, and cardiac anesthesiologists and radiologists.

"There is strong consensus that these new valve therapies should be performed under the guidance of a multidisciplinary heart team, involving both interventional cardiologists and surgeons," said Hijazi. "Increasing evidence shows a team-based approach provides the greatest quality care for patients with complex heart disease, including patients considering tPVR."

The paper further recommends that institutions offering tPVR perform at least 150 congenital/structural catheterization procedures per year, including 100 that are interventional, as well as 100 open-heart congenital surgical procedures. Institutions should have the heart-lung bypass support known as extracorporeal membrane oxygenation (ECMO); echocardiography, cardiac computed tomography (CT) and cardiac magnetic resonance imaging (MRI) imaging capabilities; a cardiovascular cath lab; and hemodynamic evaluation. Additionally, institutions should participate in a national registry. Because tPVR is a new treatment option, the committee stressed the importance of continuing to collect data on the procedure, including total numbers of tPVR in the United States and numbers of procedures by operator and institution.

Physicians performing tPVR should perform at least 100 interventional cases per year, including 50 congenital/structural interventional cases. They should have experience with balloon valvuloplasty as well as stenting within pulmonary arteries and RVOT. The paper also recommends physicians attend peer-to-peer training and a simulated case if available. The first three procedures performed should be under the guidance of an experienced physician.

"As physician experience with tPVR increases over time, complication rates are declining significantly, reflecting the importance of experience in improving patient outcomes," said Hijazi.

A committee of cardiac surgeons and interventional cardiologists developed the recommendations, which were created to help physicians and hospitals offer consistent and appropriate care to tPVR patients. The new paper is the third in a series of expert consensus papers for hospitals and physicians performing transcatheter valve procedures. The first two papers discussed aortic and mitral valve procedures.

The document, titled "Operator & Institutional Requirements for Transcatheter Valve Repair and Replacement, Part III - Pulmonic Valve," will simultaneously e-publish in Catheterization and Cardiovascular Interventions (CCI), Journal of Thoracic and Cardiovascular Surgery (JTCVS), Journal of the American College of Cardiology (JACC) and The Annals of Thoracic Surgery.

For more information: www.scai.org, www.aats.org, www.acc.org, www.sts.org

Related Content

Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
The ChordArt transcatheter mitral valve leaflet chord replacement system on X-ray, showing the anchoring sections of the artificial chord.

The ChordArt transcatheter mitral valve leaflet chord replacement system on X-ray, showing the anchoring sections of the artificial chord.

News | Heart Valve Technology| August 01, 2017
Aug.
Hitachi and West Virginia University Partner to Advance Left Ventricular Mechanical Function Evaluation
News | Cardiovascular Ultrasound| July 21, 2017
Hitachi Healthcare and the West Virginia University Heart and Vascular Institute announced the formation of a new...
AHA and ACC Publish New Data Dictionary for Ambulatory EHRs in Pediatric and Congenital Cardiology
News | Congenital Heart| July 19, 2017
July 19, 2017 — The American Heart Association (AHA) and the American College of Cardiology (ACC) recently published
Edwards Sapien 3 TAVR valve will be implanted in asymptomatic aortic stenosis patients in the EARLY TAVR Trial
Feature | Heart Valve Technology| July 14, 2017
July 14, 2017 — Morristown Medical Center, part of Atlantic Health System, has randomized the first patient in the wo
Ziosoft's PhyZiodynamics 4-D processing showing a replaced aortic valve

An example of Ziosoft's PhyZiodynamics 4-D processing showing a replaced aortic valve.

Technology | Computed Tomography (CT)| July 12, 2017
July 12, 2017 — At the 2017 annual meeting for the Society of Cardiovascular Computed Tomography (SCCT), Ziosoft show
Medtronic's CoreValve Evolut R gained FDA approval for intermediate risk patients

An illustration of the self-expanding CoreValve Evolut R TAVR valve half deployed in the aortic root.

Feature | Heart Valve Technology| July 10, 2017
The U.S. Food and Drug Administration (FDA) has cleared an additional indication to expand the use Medtronic's self-...
HAART 300 Aortic Annuloplasty Device Sees U.S. Pilot Launch, First Commercial Use
News | Annuloplasty Rings| July 05, 2017
July 5, 2017 — BioStable Science & Engineering Inc.
Overlay Init