Staley, Linda L.

International normalized ratio (INR) measurements manage risks of bleeding and clotting sequelae in the population with left ventricular assist device (LVAD). Studies suggest that point-of-care (POC) INR does not significantly differ from plasma INR (P-INR) values in other patient populations, although this has not been validated in a multicenter LVAD study. We sought to determine whether POC-INR and P-INR values differ significantly in the LVAD population and reviewed patients with permanent LVAD implantation at seven institutions internationally. Our cohort comprised of 279 paired POC-INR and P-INR checks in patients supported on average 630 ± 598 days postimplant with predominately HeartWare, HeartMate II, and HeartMate III devices. The population averaged 57.9 years of age, and there were 86.7% male. We found no statistically significant difference between POC-INR and P-INR values. International normalized ratio accuracy correlated weakly with the time between INR measurements (p < 0.001). When the time difference was less than 4 hours, the difference between INR pairs was significantly lower than measurements greater than 8 hours (p = 0.006). There was no statistically significant difference when comparing paired INR values and time after implant to INR check (p = 0.43), age (p = 0.12), known coagulopathy (p = 0.12), bleeding history (p = 0.22), or thrombosis history (p = 0.34). This is the first large multicenter international study comparing POC-INR and P-INR measurements in patients with LVAD and found no statistically significant difference between either methods, particularly when measured within less than 4 hours of each other.

Transcatheter pulmonary valve placement is emerging as a standard therapy for dysfunctional right ventricular outflow tract conduits. The Melody transcatheter pulmonary valve is indicated for use in the management of pediatric and adult patients with right ventricular outflow tract conduits measuring at least 16 mm in diameter. This is the first reported case of placement in a patient with a left ventricular assist device. We outline the preprocedural evaluation process, the procedural methods, and the outcomes of a successful implantation in a complex patient. With a team-based approach including thoughtful preprocedural evaluation, and close monitoring, successful deployment of a transcatheter pulmonary valve is possible in complex patients in the setting of mechanical circulatory support.

Objective Patients in acute cardiogenic shock are the most challenging patients to manage. Unless a mechanical circulatory assist device is placed, maintaining end-organ function can be difficult. Transporting cardiogenic shock patients to tertiary care centers for higher level care also is difficult. The Mayo Clinic Arizona uses a SWAT team approach to deploy a specialized medical or surgical multidisciplinary team to implant mechanical circulatory assist devices at referring hospitals and transport patients back to Mayo Clinic Arizona. Results The cardiac transport team at Mayo Clinic Arizona got 23 referrals from 15 local community hospitals from February 2006 to September 2009. The medical team deployed for transfers of 6 patients, 3 of whom survived to hospital discharge. The surgical transport team deployed for transfers of 17 patients (6 with left ventricular assist devices, 2 with right ventricular assist devices, 5 with biventricular assist devices, and 4 with extracorporeal membrane oxygenation), of whom 8 survived to hospital discharge. Ten of the 17 referrals (59%) required a surgeon to place a mechanical circulatory assist device at the referring hospital. Conclusion The SWAT team approach allows cardiogenic shock patients to be stabilized at the referring hospital by heart failure and cardiac surgical specialists. If necessary, a surgeon from Mayo Clinic Arizona places a mechanical circulatory assist device at the referring hospital to stabilize the patient. Doing so allows safe transport back to the tertiary care center for higher level care and possible transplant evaluation with placement of a long-term durable device.

Objectives. Increasing number of mechanical circulatory assist devices (MCADs) are being placed in heart failure patients. Morbidity from device placement is high and the outcome of patients who require noncardiac surgery after, is unclear. As laparoscopic interventions are associated with decreased morbidity, we examined the impact of such procedures in these patients. Methods. A retrospective review was conducted on 302 patients who underwent MCAD placement from 2005 to 2012. All laparoscopic abdominal surgeries were included and impact on postoperative morbidity and mortality studied. Results. Ten out of 16 procedures were laparoscopic with 1 conversion to open. Seven patients had a HeartMate II, 2 had Total Artificial Hearts, and 1 had CentriMag. Four patients had devices for ischemic cardiomyopathy and 6 cases were emergent. Surgeries included 6 laparoscopic cholecystectomies, 2 exploratory laparoscopies, 1 laparoscopic colostomy takedown, and 1 laparoscopic ventral hernia repair with mesh. Median age of the patients was 63 years (range, 29-79 years). Median operative time was 123 minutes (range, 30-380 minutes). Five of 10 patients were on preoperative anticoagulation with average intraoperative blood loss of 150 mL (range, 20-700 mL). There were 3 postoperative complications; acute respiratory failure, acute kidney injury and multisystem organ failure resulting in death not related to the surgical procedure. Conclusion. The need for noncardiac surgery in post-MCAD patients is increasing due to limited donors and due to more durable and longer support from newer generation assist devices. While surgery should be approached with caution in this high-risk group, laparoscopic surgery appears to be a safe and successful treatment option.

Objective The portable Freedom Drive (SynCardia Inc, Tucson, AZ USA) for total artificial heart (TAH-t) support was approved for an investigational device exemption study in March 2010. We review our center's experience with the portable driver. Methods A retrospective review was conducted of patients who underwent TAH-t implantation and transfer to portable driver from September 2008 to June 2012, with follow-up through December 2012. Results A total of 30 patients underwent TAH-t implantation during this time period, with 11 patients successfully transferred to the Freedom Driver. Transfer to Freedom Driver after TAH-t implant was a median of 46 days (range, 225–86 days). Ninety-one percent (10) of 11 patients transferred to Freedom Driver were bridged to transplantation. One patient died on support. Five (45.5%) of 11 patients were discharged home and 5 (45.5%) remained in-patient on the portable driver before transplantation. Four patients (80%) successfully discharged home required at least 1 hospital readmission (range, 1–5 admissions per patient). Six patients (55%) transferred to the portable driver required a return to a main driver console. Two patients were temporarily maintained on the main driver then returned to the Freedom Driver for bridge to transplantation. Conclusions Patients with TAH-t can be considered for transfer to the portable Freedom Driver while awaiting transplantation. Issues that complicated this patient population included inadequate social support, hemodynamic instability, and concurrent morbidities. The potential benefits of the portable driver are currently undergoing assessment. These may include increased mobility and improved quality of life, opportunity for discharge home, and decreased overall medical costs.