Linda Travels to Germany for New JenaValve TAVR
Written By: Adam Pick, Patient Advocate, Author & Website Founder
Published: March 27, 2025
Truly amazing. I just heard another extraordinary patient success story from our community.
As many of you know, transcatheter aortic valve replacement (TAVR) is often referred to as one of the greatest “medical breakthroughs” in valvular therapy. Using this minimally-invasive approach, cardiac surgeons and interventional cardiologists can replace a stenotic aortic valve without breaking the patient’s sternum or ribs. However, the use of TAVR has been limited to the treatment of aortic stenosis, a narrow valve. The utility of TAVR for aortic regurgitation (a leaky valve) has not received FDA-approval for the treatment of aortic regurgitation here in the United States.
Given the limited access to TAVR devices for aortic regurgitation, Linda Nolan, a patient with severe aortic regurgitation, had options. Linda could get open heart surgery here in the US. Or, Linda could transform into medical tourist and go abroad for a new type of TAVR called the JenaValve.
Linda’s Story In Her Words…
I could ramble on about Linda’s amazing story. Instead, I thought you might want to her directly from Linda. Here is what Linda wrote to me:
I wanted to take this opportunity to express my appreciation for all the information regarding heart and valve surgery on your website. It was a great comfort to find a resource which contained comprehensive information and contacts for newly diagnosed patients with valvular disorders. Your information enabled me to contact cardiac surgeons, research treatments and understand procedures to correct valvular problems with TAVR and SAVR.
After contacting various cardiac specialists across the United States, a SAVR procedure with the implantation of a prosthetic valve was recommended for me over other surgical techniques such as valve repair or the Ross procedure. My options for SAVR included full sternotomy or more minimally invasive techniques including robotic surgery. However, all surgical procedures required the use of cardiopulmonary bypass and had expected recovery times ranging from several weeks to several months. Surgical procedures also carried an overall 1-2% mortality risk. As I had been diagnosed with aortic regurgitation, TAVR, which has recently gained widespread adoption for aortic stenosis because of its less invasive approach and morbidity and mortality benefit, was unavailable outside limited clinical trials which I did not meet the criteria to enroll (i.e. I was not considered a high-risk candidate for surgery).
With the assistance of a family member who is also in the medical profession, we began to further investigate the research being conducted on newer generation TAVR valves and aortic regurgitation. Our findings led us to the JG|U University Medical Center Mainz in Germany and Dr. Ralph-Stephan von Bardeleben, who is the current Chief of Interventional Structural and Valvular Cardiology, Institut de Cardiologie de Montreal (ICM), Montreal Heart Institute, and Dr. Martin Geyer. Both Dr. von Bardeleben and Dr. Geyer have extensive research and interventional experience associated with transcatheter valve procedures and were included among the investigators for the recently completed ALIGN-AR study using the JenaValve Triology TAVR device.
JenaValve Trilogy is a newly developed, next-generation prosthetic valve which was designed for use in patients with severe aortic regurgitation. As opposed to the United States where this device is only accessible through clinical trials for surgically ineligible patients, in Germany the device is CE Mark approved and has become an available option for eligible patients as part of the treatment for severe aortic regurgitation. Few interventionalists globally have as much experience with implanting the valve as Dr. v.Bardeleben and Dr. Geyer.
Encouraged by these developments, I contacted Dr. v.Bardalaben and Dr. Geyer to discuss my diagnosis and potential eligibility to receive the JenaValve in Germany. After a review of my medical records by both physicians, the cardiovascular team at Mainz and JenaValve, it was determined that I would be an eligible candidate for the procedure. This then began a several months’ long conversation in which the risks of the procedure were reviewed and analyzed (particularly with respect to the more elevated risk of pacemaker implantation vs. SAVR) as were the technicalities of being an international patient in Germany. Communication with Drs. V.Bardeleben and Geyer were exemplary as each took considerable time to answer my questions and to provide a wealth of research that enabled me to make an informed decision about moving forward with the procedure.
In September 2024, my family and I traveled to Germany where the TAVR procedure was performed using the femoral artery for access under conscious sedation. Implantation of the device was on the order of fifteen minutes and the entire procedure lasted approximately one hour. Recovery was short and relatively uneventful. I returned home from Germany a week after the procedure. Follow-up care was advised with either my personal cardiologist or cardiologists with whom Drs. v.Bardeleben and Geyer had as professional contacts at major university medical centers and who were familiar with the JenaValve Trilogy.
and Dr. Bardeleben (middle); Photo Credit: Peter Pulkowski
As previously noted, the JenaValve Triology is not currently available in the United States for patients with severe aortic regurgitation outside of clinical trials. Research is still ongoing, but the experience of interventions in Germany with the use of this device are supportive of this procedure, its effectiveness and its safety. As a nurse practitioner and research consultant, I am asking that you include this information on your website as an additional choice for patients to consider. My hope is that the JenaValve Trilogy will soon become approved for aortic regurgitation and available in the United States as ubiquitously as TAVR is now used for aortic stenosis.
I also wish to highlight the exceptional professionalism and competency of the entire cardiology team at JG|U University Medical Center Mainz and their experience in implanting JenaValve in patients like myself, Drs. v.Bardeleben and Geyer in particular. Lastly, I note that Dr. v.Bardeleben has recently accepted a position at as Head of the Center of Structural Heart and Valvular Interventions and the Heart Valve Center at McGill University in Montreal. Beginning in 2025 he will be spending several weeks a quarter helping to create a team who can perform the procedure with the JenaValve Trilogy in patients like myself.
Related Patient Success Stories:
- 123 Days After Heart Valve Surgery, Justin Runs A Marathon
- After Lifelong Broken Heart, Kevin’s Mojo Returns
- Suzi Goes from Asymptomatic Nerves to a Dr. Gillinov Success Story
Sincerely,
Linda Nolan
Written by Adam Pick
- Patient & Website Founder
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