Patients implanted with VAD via thoracotomy may have improved outcomes

Patients with end-stage HF who have had a ventricular assist device implanted by a thoracotomy procedure had similar survival and adverse event profiles compared with historical data of patients who had the device implanted by a standard sternotomy approach, according to results from the HVAD LATERAL study presented at the International Society for Heart and Lung Transplantation Scientific Meeting.

Researchers analyzed the effectiveness of a thoracotomy procedure for the implantation of the HVAD System (Medtronic) in the prospective, single-arm, multicenter study. The trial included 145 patients (mean age, 54 years; 77% men) from 30 centers in the United States and Canada with end-stage HF who did not respond to medical management and qualified for heart transplantation.

The primary endpoint was noninferiority compared with a performance goal based on historical outcomes of similar patients having the device implanted by sternotomy. That endpoint was survival with the original device, free from disabling stroke at 6 months, or having undergone a heart transplant or explant due to recovery.

At 30 days, no patients experienced MI, but events such as bleeding that required transfusion (9%), device malfunction or failure (6.2%) and right HF (22.1%) did occur, although bleeding requiring reoperation appeared low, Simon Maltais, MD, PhD, chair of clinical practice, department of cardiovascular surgery, Mayo Clinic, said during the presentation.

Researchers did not note any adverse safety signals compared with typical adverse events observed when the device is implanted via a sternotomy approach.

At 6-month follow-up, 87.6% of patients (n = 127) achieved the primary endpoint (lower bound of 95% CI, 0.822; P vs. performance goal of 77.5% = .002). The 1-year survival rate for patients was 88.6%.

Quality of life improved from baseline to 6 months, according to the Kansas City Cardiomyopathy Questionnaire and EuroQol 5D. Functional capacity, including the 6-minute walk test and NYHA classification, also improved at 6 months.

“While we only have an early snapshot of adverse event rates at 30 days, we are encouraged by the preliminary data,” Edwin McGee Jr., MD, professor and director of the heart transplant and VAD program at Loyola University Medical Center in Maywood, Illinois, said in a press release. “We look forward to reviewing longer-term patient data, as well as getting a more complete picture of the average length of hospital stay, another meaningful measure for VAD patients.”

The device is approved in the United States for conventional implantation but not for implantation via thoracotomy, according to the release. – by Darlene Dobkowski

Reference:

Danter MR, et al. Contemporary LVAD trials — Same old song or new tune? Presented at: International Society for Heart and Lung Transplantation Scientific Meeting; April 5-8, 2017; San Diego.

Disclosure: The trial was sponsored by Medtronic, formerly HeartWare Inc. Maltais reports consulting for Abbott/Thoratec/St. Jude Medical and Medtronic/HeartWare.

The device is approved in the United States for conventional implantation but not for implantation via thoracotomy, according to the release. – by Darlene Dobkowski

Reference:

Danter MR, et al. Contemporary LVAD trials — Same old song or new tune? Presented at: International Society for Heart and Lung Transplantation Scientific Meeting; April 5-8, 2017; San Diego.

Disclosure: The trial was sponsored by Medtronic, formerly HeartWare Inc. Maltais reports consulting for Abbott/Thoratec/St. Jude Medical and Medtronic/HeartWare.