Meeting News

RESCUE: Thoracic stent graft system safe, effective for blunt aortic injury

Thoracic endovascular aneurysm repair with a thoracic stent graft was safe and effective at 5 years in patients with blunt thoracic aortic injury, according to findings from the RESCUE trial presented at the Society of Thoracic Surgeons Annual Meeting.

The researchers evaluated the performance of the stent graft (Valiant Captivia, Medtronic) in 50 patients treated at 20 sites for blunt thoracic aortic injury between 2010 and 2012.

“These data from the RESCUE trial demonstrate that TEVAR with Valiant Captivia continues to be a valuable, safe and less invasive alternative to open surgery for patients facing life-threatening aortic injury of [blunt thoracic aortic injury], especially in the setting of critical multisystem injuries,” presenter Himanshu J. Patel, MD, from the department of cardiac surgery at the University of Michigan, said in a press release. “This is the first 5-year industry-issued data set ever disseminated. The outcomes demonstrate Valiant Captivia to be a safe and durable therapy for high-risk [blunt thoracic aortic injury] patients.”

The mean age of the patients was 41 years and 70% had an aortic injury grade of III or IV.

Technical success was 100% and mean endograft oversizing was 11.5%, Patel said.

The primary outcome of 30-day mortality occurred in 8% of patients. Patel said three patients (6%) died between 30 days and 5 years — one from respiratory failure, one from bowel ischemia and one from metastatic prostate cancer.

The Kaplan-Meier estimate of survival at 5 years was 85.2%, according to the researchers.

There were no cases of stroke, paraplegia, retrograde dissection or conversion to open surgery, Patel said during the presentation, noting that there were two cases of type II endoleak resolved by 30 days.

There were seven adverse events related to the device, procedure or aorta, of which six occurred in the first 30 days, and the Kaplan-Meier estimate of freedom from such events was 83.1% at 5 years, he said.

Four patients required left subclavian artery bypass, and the Kaplan-Meier estimate of freedom from reintervention at 5 years was 90.6%, according to the researchers.

Limitations include that the study was not randomized, had a small sample size and lost 12 patients to follow-up, Patel said, also noting that anatomic data such as landing zone diameter were not recorded.

Given that the primary long-term issue identified in this blunt thoracic aortic injury dataset was related to left subclavian artery (LSA) coverage without preemptive revascularization, we believe future technological advances should consider branched technology as a way to reduce the relatively infrequent but present risk for LSA bypass,” Patel said. – by Erik Swain

Reference:

Patel HJ, et al. Adult Cardiac: General. Presented at: Society of Thoracic Surgeons Annual Meeting and Exhibition; Jan. 27-29, 2019; San Diego.

Disclosures: The study was funded by Medtronic. Patel reports he received consultant fees from Medtronic, Terumo and W.L. Gore and Associates and is a co-patent holder with W.L. Gore and Associates.

Thoracic endovascular aneurysm repair with a thoracic stent graft was safe and effective at 5 years in patients with blunt thoracic aortic injury, according to findings from the RESCUE trial presented at the Society of Thoracic Surgeons Annual Meeting.

The researchers evaluated the performance of the stent graft (Valiant Captivia, Medtronic) in 50 patients treated at 20 sites for blunt thoracic aortic injury between 2010 and 2012.

“These data from the RESCUE trial demonstrate that TEVAR with Valiant Captivia continues to be a valuable, safe and less invasive alternative to open surgery for patients facing life-threatening aortic injury of [blunt thoracic aortic injury], especially in the setting of critical multisystem injuries,” presenter Himanshu J. Patel, MD, from the department of cardiac surgery at the University of Michigan, said in a press release. “This is the first 5-year industry-issued data set ever disseminated. The outcomes demonstrate Valiant Captivia to be a safe and durable therapy for high-risk [blunt thoracic aortic injury] patients.”

The mean age of the patients was 41 years and 70% had an aortic injury grade of III or IV.

Technical success was 100% and mean endograft oversizing was 11.5%, Patel said.

The primary outcome of 30-day mortality occurred in 8% of patients. Patel said three patients (6%) died between 30 days and 5 years — one from respiratory failure, one from bowel ischemia and one from metastatic prostate cancer.

The Kaplan-Meier estimate of survival at 5 years was 85.2%, according to the researchers.

There were no cases of stroke, paraplegia, retrograde dissection or conversion to open surgery, Patel said during the presentation, noting that there were two cases of type II endoleak resolved by 30 days.

There were seven adverse events related to the device, procedure or aorta, of which six occurred in the first 30 days, and the Kaplan-Meier estimate of freedom from such events was 83.1% at 5 years, he said.

Four patients required left subclavian artery bypass, and the Kaplan-Meier estimate of freedom from reintervention at 5 years was 90.6%, according to the researchers.

Limitations include that the study was not randomized, had a small sample size and lost 12 patients to follow-up, Patel said, also noting that anatomic data such as landing zone diameter were not recorded.

Given that the primary long-term issue identified in this blunt thoracic aortic injury dataset was related to left subclavian artery (LSA) coverage without preemptive revascularization, we believe future technological advances should consider branched technology as a way to reduce the relatively infrequent but present risk for LSA bypass,” Patel said. – by Erik Swain

Reference:

Patel HJ, et al. Adult Cardiac: General. Presented at: Society of Thoracic Surgeons Annual Meeting and Exhibition; Jan. 27-29, 2019; San Diego.

Disclosures: The study was funded by Medtronic. Patel reports he received consultant fees from Medtronic, Terumo and W.L. Gore and Associates and is a co-patent holder with W.L. Gore and Associates.