News | EP Lab | November 09, 2016

Getting a Pacemaker Soon After Heart Valve Replacement Linked with Worse Outcomes

Study shows risks are both short- and long-term

transcatheter aortic valve replacement, pacemakers, implantation, post-TAVR implantation, worse outcomes, study

November 9, 2016 — Patients who undergo minimally invasive heart valve replacement, known as transcatheter aortic valve replacement (TAVR), sometimes develop heart rhythm problems that necessitate placement of a permanent pacemaker. However, when a pacemaker is needed soon after TAVR, patients often have worse outcomes than those who did not need a pacemaker, according to a study published recently in JACC: Cardiovascular Interventions. The study shows that the risks are both short- and long-term and include lengthier hospital and intensive care unit stays as well as a greater risk of death.

“While pacemakers can and do help save lives, what our study shows is that when they are placed within a month post-TAVR, they may be associated with worsened outcomes as compared to those who did not need pacemakers,” said the study’s lead researcher, Opeyemi Fadahunsi, MBBS, MPH, a cardiology fellow at Dalhousie University in Halifax, Nova Scotia. At the time the study was conducted, Fadahunsi served at Reading Health System in West Reading, Pa. 

TAVR is a relatively new, minimally invasive surgical procedure that repairs the aortic heart valve without needing to remove the old valve. Often a patient spends less time recovering and avoids some of the risks associated with open-heart valve replacement. It is typically recommended for patients who are not able to undergo a traditional open-heart procedure — many times, these are people in their 80s or 90s who have other medical conditions that make an open-heart surgery a less preferred option.

Using data from the STS/ACC TVT Registry, researchers analyzed patients undergoing TAVR in the United States at 229 sites between November 2011 and September 2014 to see how permanent pacemaker implantation after having TAVR affected them.

Of the 9,785 study participants, 651 needed a permanent pacemaker within 30 days of the TAVR procedure. Those who needed a permanent pacemaker had a slightly longer hospital stay as well as longer reported hours in the intensive care unit. They also had an increased risk of death from any cause at one year. In addition, they found that the combination of death from any cause or heart failure hospitalizations was increased at one year.

“While TAVR is a great advance in medical care, cardiologists need to better understand both how to prevent patients from developing heart rhythm problems and why patients who need pacemakers in the setting of recent TAVR have worsened outcomes,” Fadahunsi said. “We found in our study that the need for a pacemaker was more common in certain valve types and larger-sized valves, in those undergoing the procedure at an older age, and those who were sicker.”

In an accompanying editorial, Marina Urena, M.D., Ph.D., and Josep Rodés-Cabau, M.D., said the findings provide new insight into the conundrum of conduction abnormalities in TAVR. If confirmed, these results urge engineers, device manufacturers and physicians to work even harder to find ways to reduce the rate of permanent pacemaker placement after TAVR.

For more information: www.jacc.org

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init