Combining Surgical Heart Valve Replacement and Pacemakers May Put Patients’ Hearts at Risk: Study

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Patients receiving permanent pacemaker implants after an aortic valve replacement surgery may face increased risks of heart failure and death, when compared to those using alternative post-operative treatments.

In a new study published this week in the The Journal of the American Medical Association (JAMA), researchers warn healthcare professionals to monitor patients who receive pacemakers within 30 days of undergoing aortic valve replacement surgery.

Aortic valve replacement is a type of open heart procedure in which a surgeon replaces the failing aortic valve of a patientโ€™s heart with either a biological or mechanical heart valve. Patients undergoing these types of procedures commonly require pacemakers, which are small electronic implants used to regulate heart rhythm.

Spinal-Cord-Stimulation-Lawsuit
Spinal-Cord-Stimulation-Lawsuit

As part of this new study, Swedish researchers reviewed 24,983 records of patients who underwent surgical aortic valve replacement (AVR) from 1997 to 2018, in which 849 patients underwent permanent pacemaker implantation within 30 days after surgical treatment. The remaining 24,134 patients did not.

According to the findings, the survival rate for those who underwent valve replacement was 52.8% after 10 years. That compares to a 57.5% survival rate among those without pacemakers. After 20 years, 18% of pacemaker recipients survived, compared to 19.6% survival among those not given pacemakers.

The study found all-cause mortality rates among those receiving pacemakers was statistically significantly higher in the pacemaker group, assigning a hazard ratio of 1.14 to the pacemaker group compared to 1.01 for the non-pacemaker group.

Additionally, researchers determined patients receiving pacemakers after AVR had a higher rate of heart failure which resulted in hospitalization.

The findings add to previous research that highlighted a series of risks associated with AVR and transcatheter aortic valve replacement (TAVR) procedures in a study published in The Journal of the American Medical Association (JAMA) in May, which raised concerns some patients undergoing TAVR procedures face a higher risk of complications and mortality within 30 days post-surgery.

In April, a TAVR mortality study presented at the virtual meeting of the Society for Cardiovascular Angiography and Interventions (SCAI) indicated that even low-risk patients who underwent transcatheter aortic valve replacement may face an increased risk of death from inflammation developing in the heartโ€™s inner lining.

TAVR is a type of heart procedure which allows the surgeon to replace the heart valve by threading it through an artery in the leg instead of via open chest surgery. It places the valve over the damaged aortic valve in a less invasive procedure.

Initially, TAVR was approved only among high risk patients who were frail or could not undergo open heart surgery. The durability of the heart valves was also untested for use among younger patients who may outlive the devices, which were originally designed to last 10 years, not 30 or more years.

Russell Maas
Written by: Russell Maas

Managing Editor & Senior Legal Journalist

Russell Maas is a paralegal and the Managing Editor of AboutLawsuits.com, where he has reported on mass tort litigation, medical recalls, and consumer safety issues since 2010. He brings legal experience from one of the nationโ€™s leading personal injury law firms and oversees the siteโ€™s editorial strategy, including SEO and content development.

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