News | Heart Valve Technology | March 25, 2020

First Human Use of Transcatheter Duo Tricuspid Valve Announced in Ireland

The heart team at St. James University Hospital Dublin was the first to perform a human implant of the CroiValve Duo Tricuspid Coaptation Valve technology for tricuspid repair.  

The heart team at St. James University Hospital Dublin was the first to perform a human implant of the CroiValve Duo Tricuspid Coaptation Valve technology for tricuspid repair.  

 

March 25, 2020 — CroiValve announced the successful first human use of its Duo Tricuspid Coaptation Valve technology for tricuspid heart valve repair. The procedure was performed by an experienced Heart Team in St. James University Hospital Dublin, led by Stephen O’Connor, M.D., interventional cardiologist, and Michael Tolan, M.D., cardiac surgeon, assisted by doctors Andrew Maree, Charlie McCreery and Caroline Daly.  

The patient had severe tricuspid regurgitation (TR) with reduced heart function and was at risk of a further deterioration in heart function with treatment of the tricuspid valve. Based on this, the patient had been turned down for open surgical repair. Because the unique, atraumatic approach of the Duo device allows for temporary implantation of the device to restore function without any impact to the native anatomy, the heart team elected to assess the acute effect of tricuspid valve repair on heart function. The procedure was approved by the Irish regulatory body (HPRA) under their compassionate use program.

“The unique capability of the Duo Coaptation Valve, to restore tricuspid valve function atraumatically, while facilitating straightforward percutaneous removal, enabled us to determine a strategy to treat the patient," Tolan said. "Considering this patient has had significant suffering from this disease and had no other options, we are extremely proud the physicians and staff at St James University Hospital found an innovative approach to understanding the right treatment approach for this patient.”

The procedure, delivery and retrieval were completed fully percutaneously, with the device delivered in five minutes without complications. TR was reduced from torrential to mild and the mean right atrial pressure reduced from 26 to 13 mmHg, with an increase in systolic BP, while the device was in situ. No significant change in right ventricular function was noted during the 30 minutes that the device was in place. The patient is recovering well from the intervention and permanent transcatheter repair of her valve is planned due to the positive cardiac response to treatment.

“Early use of the CroíValve system indicates it to be an easy to use, safe and effective intervention for patients with severe tricuspid regurgitation,” O’Connor said.

The Duo Tricuspid Coaptation Valve technology provides a simple and atraumatic approach for addressing severe TR in high risk patients. The device is currently being evaluated in a clinical study in Poland to assess the impact of correction of severe tricuspid regurgitation in patients, prior to surgical intervention. The system is also in development for permanent implantation, with clinical studies planned for early next year.

For more information: http://www.croivalve.com/

Related Content

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
htisham 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...
People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.  In early December 2019, leaders of the European Association for Cardiothoracic Surgery (EACTS) withdrew their support for European practice guidelines that endorse the use of coronary stents in many patients with left main coronary artery disease.

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes.

News | Cath Lab | January 02, 2020 | Dave Fornell, Editor
January 2, 2020 — In early December 2019, leaders of the European As...