TY - JOUR
T1 - Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist device
T2 - The LATERAL clinical trial
AU - McGee, Edwin
AU - Danter, Matthew
AU - Strueber, Martin
AU - Mahr, Claudius
AU - Mokadam, Nahush A.
AU - Wieselthaler, Georg
AU - Klein, Liviu
AU - Lee, Sangjin
AU - Boeve, Theodore
AU - Maltais, Simon
AU - Pretorius, G. Victor
AU - Adler, Eric
AU - Vassiliades, Thomas
AU - Cheung, Anson
N1 - Funding Information:
This study was supported by Medtronic (formerly HeartWare , Inc.) and registered at www.clinicaltrials.gov (NCT02268942).
Funding Information:
This study was supported by Medtronic (formerly HeartWare, Inc.) and registered at www.clinicaltrials.gov (NCT02268942).
Funding Information:
The LATERAL study was a prospective, single arm, multi-center clinical trial in collaboration with the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) to evaluate the thoracotomy implant technique of the HVAD system in patients with advanced heart failure. This study was conducted as an Investigational Device Exemption study (IDE No. G130279) and following Good Clinical Practices (GCP) to evaluate the safety and effectiveness of implanting the HVAD system via a thoracotomy in patients at risk of death from refractory end-stage left ventricular heart failure, who received the device intended as a bridge to cardiac transplantation. The study was sponsored by Medtronic (formerly HeartWare, Inc.). A total of 158 patients were enrolled between January 15, 2015 and April 26, 2016 at 26 investigational sites, of whom 144 were included in the study population. All subjects in the LATERAL study had to meet INTERMACS eligibility criteria. All enrolled INTERMACS sites had institutional review board/clinical research ethics board (IRB/CREB) approval as required by INTERMACS procedures, as well as IRB/CREB approval of the HeartWare IDE protocol and informed consent documentation. All subjects were consented using the INTERMACS informed consent and health privacy documents according to INTERMACS procedures and local IRB/CREB policy and procedures. In addition, all subjects signed a HeartWare informed consent form and health privacy document before thoracotomy implantation of the HVAD.
Publisher Copyright:
© 2019
PY - 2019/4
Y1 - 2019/4
N2 - BACKGROUND: The HeartWare centrifugal-flow ventricular assist device system (HVAD) is a viable option for treatment of advanced heart failure. There is a growing trend toward the use of less invasive techniques in cardiac surgery, and the thoracotomy technique for HVAD implantation may provide benefits not available with conventional approaches. METHODS: The LATERAL trial is a multicenter, prospective, non-randomized, single-arm trial that utilized data from 144 patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database at 26 centers in the United States and Canada. The primary composite end-point was success at 180 days defined as alive on the originally implanted device and free from disabling stroke (modified Rankin Scale score >3), transplanted or explanted for recovery. The key secondary end-point was mean length of initial hospital stay. RESULTS: The primary end-point was successfully achieved in 88.1% of patients and was significantly greater than the pre-defined performance goal of 77.5% set from historical sternotomy data (p = 0.0012). The key secondary end-point—mean length of initial hospital stay —was 18 days and was significantly shorter than the pre-defined performance goal of 26.1 days obtained from historical sternotomy data (p < 0.0001). The adverse event profile further demonstrated the safety of the thoracotomy approach. The overall patient survival was good, and bleeding requiring reoperation was significantly less frequent than that observed in previous studies using the sternotomy approach. CONCLUSIONS: This prospective clinical trial provides validation that implantation of the HVAD system via the thoracotomy approach used in the LATERAL study represents a safe and effective alternative to median sternotomy in selected patients intended for a bridge-to-transplant indication.
AB - BACKGROUND: The HeartWare centrifugal-flow ventricular assist device system (HVAD) is a viable option for treatment of advanced heart failure. There is a growing trend toward the use of less invasive techniques in cardiac surgery, and the thoracotomy technique for HVAD implantation may provide benefits not available with conventional approaches. METHODS: The LATERAL trial is a multicenter, prospective, non-randomized, single-arm trial that utilized data from 144 patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database at 26 centers in the United States and Canada. The primary composite end-point was success at 180 days defined as alive on the originally implanted device and free from disabling stroke (modified Rankin Scale score >3), transplanted or explanted for recovery. The key secondary end-point was mean length of initial hospital stay. RESULTS: The primary end-point was successfully achieved in 88.1% of patients and was significantly greater than the pre-defined performance goal of 77.5% set from historical sternotomy data (p = 0.0012). The key secondary end-point—mean length of initial hospital stay —was 18 days and was significantly shorter than the pre-defined performance goal of 26.1 days obtained from historical sternotomy data (p < 0.0001). The adverse event profile further demonstrated the safety of the thoracotomy approach. The overall patient survival was good, and bleeding requiring reoperation was significantly less frequent than that observed in previous studies using the sternotomy approach. CONCLUSIONS: This prospective clinical trial provides validation that implantation of the HVAD system via the thoracotomy approach used in the LATERAL study represents a safe and effective alternative to median sternotomy in selected patients intended for a bridge-to-transplant indication.
KW - bridge to transplant
KW - congestive heart failure
KW - left ventricular assist device
KW - mechanical circulatory support
KW - minimally invasive
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U2 - 10.1016/j.healun.2019.02.002
DO - 10.1016/j.healun.2019.02.002
M3 - Article
C2 - 30945636
AN - SCOPUS:85062438554
VL - 38
SP - 344
EP - 351
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
SN - 1053-2498
IS - 4
ER -