News | Structural Heart Occluders | March 27, 2019

SCAI Offers Recommendations for Safe Use of PFO Closure Technologies

Completion of the randomized trials demonstrating the superiority of PFO closure and medical therapy over medical therapy alone 

SCAI Offers Recommendations for Safe Use of PFO Closure Technologies. SCAI said completion of the randomized trials demonstrating the superiority of PFO closure and medical therapy over medical therapy alone

March 27. 2019 — A newly released expert consensus statement provides recommendations for the safe and effective dissemination of newly approved patent foramen ovale (PFO) closure technologies. The document, developed by the Society for Cardiovascular Angiography and Interventions (SCAI) and affirmed by the American Academy of Neurology (AAN), was published online in SCAI’s official journal, Catheterization and Cardiovascular Interventions.

Access the full text of the "SCAI expert consensus statement on operator and institutional requirements for PFO closure for secondary prevention of paradoxical embolic stroke.[1]

Nearly 25 percent of the general population may have a PFO, which is an opening between the top left and right chambers of the heart. Closure of the PFO is one strategy in mitigating the risk of recurrent stroke in PFO patients who have experienced a cryptogenic stroke. Stroke is the fifth most common cause of death and the leading cause of preventable disability in the United States.

“Completion of the randomized trials demonstrating the superiority of PFO closure and medical therapy over medical therapy alone for appropriately selected patients with cryptogenic stroke and a PFO was a landmark achievement that has resolved decades of uncertainty,” said Eric Horlick, M.D., FSCAI, chair of the paper’s writing group and an interventional cardiologist at the Peter Munk Cardiac Centre, University of Toronto.

The writing group makes specific recommendations in the paper for operator competencies and training, facility infrastructure, multidisciplinary collaboration, and quality assessment measures. “The appropriate use of PFO closure has the potential to change the natural history of a potentially devastating disease process. SCAI and AAN representatives collaborated to help cardiologists and neurologists provide the highest standard of care,” Horlick said.

“SCAI can now confidently offer evidenced-based recommendations for the treatment of these patients, who are seeking answers to guide their therapeutic decision making after a potentially catastrophic event. I am very proud of the work produced by our dedicated and highly experienced SCAI writing group, including representatives from the AAN. The resulting document is pragmatic and aims to inform and assist clinicians and institutions in maintaining an evidenced-based, patient-centered approach to the care of this patient population with a focus on quality and safety.,” he continued.

The U.S. Food and Drug Administration (FDA) recently approved two percutaneous PFO occluder devices. Prior to approval, closure devices had only been available off-label through a humanitarian device exemption, and in randomized clinical trials. Now approved, the devices are widely available.

 

Related PFO Closure Content:

VIDEO: How Transcatheter PFO Closure Can Reduce Cryptogenic Stroke — Interview with John Rhodes, M.D.

VIDEO: An Overview of PFO Closure to Treat Cryptogenic Stroke — Interview with Karen Orjuela, M.D.

VIDEO: Transcatheter Closure of Holes in the Heart — Interview with Ziyad Hijazi, M.D.

VIDEO: Demonstration of a Transcatheter PFO Occluder Implantation

VIDEO: Addressing Adult Congenital Heart Referrals — Interview with Ami Bhatt, M.D.

 

Reference:

1. Eric Horlick, Clifford J. Kavinsky, Zahid Amin, et al. SCAI expert consensus statement on operator and institutional requirements for PFO closure for secondary prevention of paradoxical embolic stroke. Catheterization and Cardiovascular Interventions. First published online 21 March 2019. https://doi.org/10.1002/ccd.28111

 

Related Content

News | Cath Lab | July 06, 2020
July 6, 2020 — Black patients who undergo percutaneous coronary intervention (PCI) are at an increased risk for major
TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th
Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.
Videos | Cath Lab | January 09, 2020
Haval Chweich, M.D., medical director of the cardiac critical care unit (CCU) at Tufts Medical Center, and assistant...