Validation of Anchoring Devices

Left ventricular assist devices (LVAD) for patients with terminal heart failure (HF) have become a standard treatment option for patients, however, driveline (DL)-associated infections seriously contribute to morbidity and mortality in this patient cohort and fully implantable system are not available so far.1,2 Up to 20% of LVAD patients developed driveline infection (DLI) within 1 year after implantation.3 The MOMENTUM 3 trial revealed an increased mortality rate in the infection group. The authors state the importance of the link between infection-related complications and postoperative outcome.4 In a study by Kranzl et al.,5 as stated in this current article by Schachl et al.,6 the authors examined the mechanical DL features of the HeartMate3 (HM3) (Abbott Laboratories, North Chicago, IL) and its impact on DLI. They found that the HM3 has unfavorable mechanical DL characteristics, with a large diameter, higher stiffness, and lower flexibility. These features may cause more trauma to the abdominal wall at the driveline exit site (DLES).5

The HM3 is currently the only commercially available LVAD with its documented unfavorable DL features. For surgeons, LVAD coordinators and care takers the question on how to best address the crucial issue of DLI is often answered by center-specific experience. Currently, there is no consensus on best practice in how to treat DLI and in how to best prevent DLI and trauma. These questions were addressed by Schachl et al.6 in their study and they provide a scientific approach in analyzing mechanical features of different DL anchoring systems.6 So far, the anchoring devices were often chosen due to recommendations from companies.

Schachl et al.’s6 approach was first to identify different systems through a literature review by contacting international VAD implanting centers and by providing the readers with a vast overview and in vitro data. In this study, eight different fixation systems were tested for tensile strength in an in vitro study. Of these, four anchoring devices withstood a higher tensile force. The central finding in this analysis is that the selection of an appropriate LVAD anchoring device plays a critical role in reducing the risk of DLIs.6

Regardless of the anchoring device used, fixation at 90° provided less tensile forces on the DLES compared with a fixation at 0°. Even the low performing anchoring devices showed less tensile forces at 90° compared with the high performers at 0° fixation angle. This finding emphasizes the importance of surgical position of the DLES and the abdominal positioning of the anchoring device.6

However, it is also important to verify a correlation of these experimental findings in a clinical setting in LVAD patients with DLI. Because an abdominal model with a silicone surface was used, the influence of skin moisture, oiliness, and skin tolerance could not be tested. Other mechanical issues to focus on in future research are the rigidity of the DL and the avoidance of adhesive residue on the smooth surface of the DL which can cause hygiene problems. The size of the adhesive plate plays a role in very small patients, so it would also be interesting to see what force/cm2 is possible with these plates. Another criterion for selection of an anchoring device are ingredients that can trigger allergies, as well as easy handling by the patients, as well as their availability in different countries.

At present, the HM3 is the only permanent LVAD option and devices without a DL for power source connection are still solutions of the future. In the meantime, prevention of DLI to reduce the risk of mortality and morbidity is an effective and vital strategy to reduce adverse events such as systemic infections with serious consequences. Schachl et al.6 offer a valuable solution for the time being in the prevention of DLES trauma and provide the impetus for more studies in fixation systems. They offer evidence of benefits in the right selection of anchoring devices and additional insight into the causes and prevention of dreaded LVAD-related complications such as DLI.

1. de By TM, Mohacsi P, Gummert J, et al.; EUROMACS members: The European Registry for Patients with Mechanical Circulatory Support (EUROMACS): First annual report. Eur J Cardiothorac Surg. 47: 770–776; discussion 776, 2015. 2. Kremer J, Meinert E, Farag M, et al.: New wound management of driveline infections with cold atmospheric plasma. J Cardiovasc Dev Dis. 9: 405, 2022. 3. Goldstein DJ, Naftel D, Holman W, et al.: Continuous-flow devices and percutaneous site infections: Clinical outcomes. J Heart Lung Transplant. 31: 1151–1157, 2012. 4. Patel CB, Blue L, Cagliostro B, et al.: Left ventricular assist systems and infection-related outcomes: A comprehensive analysis of the MOMENTUM 3 trial. J Heart Lung Transplant. 39: 774–781, 2020. 5. Kranzl M, Stoiber M, Schaefer AK, et al.: Driveline features as risk factor for infection in left ventricular assist devices: Meta-analysis and experimental tests. Front Cardiovasc Med. 8: 784208, 2021. 6. Schachl J, Stoiber M, Socha M, et al.: Mechanical characterization of anchoring devices for the prevention of driveline infection in left ventricular assist device patients. ASAIO J, 70: 3249–256, 2024.

留言 (0)

沒有登入
gif