Journal and News Scan

In the February issue of The Annals, The Society of Thoracic Surgeons published the first annual report after the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) joined the STS National Database in January 2018.  This report summarizes the outcomes in patients (≥19 years of age) undergoing durable MCS implant between June 23, 2006, and December 31, 2017.

Among 25,145 patients, 18,539 (74%) received continuous flow left ventricular assist devices (CF LVADs), 667 (2.6%) had a right ventricular assist device (RVAD) with CF LVAD, 339 (1.3%) received a total artificial heart, and 20 (0.07%) received an isolated RVAD. Of the CF LVADs, mean age was 57 ± 1 years, 26% were listed for transplantation, and 51% were in cardiogenic shock (profile 1 to 2) preoperatively. CF LVADs included 14,527 axial flow (78%) and 4,012 centrifugal flow (22%) devices. Recently (2012-2016), more patients are in Intermacs profile 3, with better renal and hepatic function, and received implants for destination therapy (48%), with a centrifugal flow device (51%).

Mean CF LVAD support duration was 20 months. Survival for isolated CF LVADs was 83% at 1 year and 46% at 5 years. One-year survivals for centrifugal versus axial flow devices were 85% and 84%, respectively. Patients with concomitant RVAD support had 1-year and 5-year survivals of 58% and 28%, respectively. Freedom from all-cause readmission was 70% at 1 month and 20% at 1 year. At 1 year, stroke occurred in 20% with centrifugal flow and 13% with axial flow support (p < 0.001), gastrointestinal bleeding affected 20% with centrifugal flow devices and 25% with axial flow devices (p < 0.001), and pump-related infection occurred in 28% of patients with centrifugal flow devices versus 25% with axial flow devices (p = 0.01). Neurologic dysfunction (19% of deaths) and multisystem organ dysfunction (15%) were the most common causes of death.

On February 4, 2019, Cook Medical announced recent approval from the US Food and Drug Administration for its Zenith Dissection Endovascular System. The system consists of a proximal stent-graft component and a distal bare stent component. It provides a less invasive alternative to open surgery for repair of type B dissections. The device will be available for sale in the United States in the coming months.

In this systemic review and meta-analysis, the authors compared outcomes for patients undergoing aortic root replacement to those undergoing a David operation. Mosbahi and colleagues analyzed 27 studies that included a total of 3058 patients with acute type A aortic dissections. In-hospital mortality and midterm survival both favored aortic valve reimplantation. Freedom from valve-related reintervention was 100% (confidence interval (CI) 93.7 - 100%) in patients who underwent reimplantation compared to 94.6% (CI 86.7 - 99.1%) for a composite valve graft intervention. The authors conclude that in type A dissection the reimplantation procedure (David operation) provided a superior outcome.

In a letter to healthcare providers, the US FDA summarized a recent evaluation of a postapproval study of the Abiomed Impella RP system. In clinical trials, 73% of patients survived 30 days after device explant, hospital discharge, or to definitive intervention. In the postapproval study, just over 17% of patients met this goal. There is some evidence to suggest that patients in the postapproval study were suboptimal candidates for the system.