Food and Drug Administration Malfunction Recalls of Left Ventricular Assist Devices.

Left ventricular assist devices (LVADs) are being increasingly implanted given the increasing prevalence of patients with advanced heart failure stages. However, they are not exempt from device malfunctions. A PubMed search for the key words (left ventricular assist device malfunction) (ventricular assist system malfunction) was performed. We identified 28 publications in the US Food and Drug Administration (FDA) website database that addressed LVAD malfunction. Twenty-nine FDA recalls were identified regarding LVAD malfunctions: 17 regarding HeartWare ventricular assist device, six for HeartMate II, three for HeartMate 3, and three for total artificial heart. Mechanisms involved in LVAD malfunction include battery malfunction, loose driveline connector, malfunction of the system controller, loose power supply connector ports, malfunction of the driveline splice kit, problems with the percutaneous lead connection, disconnection of the bend relief and outflow graft and outflow graft occlusion among others. Multiple mechanisms could be linked to LVAD malfunction. However, multiple device modifications have been developed over the past decade to avoid recurrent malfunctions. Constant improvements and research in biotechnology are needed to prevent these complications. It remains to be seen if newer generation devices will lead to improved patient outcomes over the long term.

Network Analysis of Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement for Stenotic Bicuspid Aortic Valves According to Valve Type.

BACKGROUND: It is currently unknown if outcomes after transcatheter aortic valve replacement (TAVR) differ according to the prosthetic valve deployed in patients with bicuspid aortic valves (BAV). OBJECTIVES: This study evaluated valve-specific outcomes post-TAVR in patients with BAV. METHODS: Literature search was performed using the Cochrane databases, PubMed, ClinicalTrials, SCOPUS and EMBASE databases from inception until July 2018. We computed risk ratios and their 95% confidence intervals for all outcomes of interest. For each outcome, the data were pooled using a multivariate random-effects meta-analysis including multiple treatment as well as direct and indirect comparisons. RESULTS: Ten studies enrolling a total of 1547 BAV patients undergoing TAVR using 6 different prosthetic valve types were analyzed. There were no significant differences in 30-day all-cause mortality, life-threatening bleeding and device success among the diverse prosthetic valve types implanted. However, 2nd generation balloon-expandable valves had consistently lower risk of moderate-to-severe prosthetic valve regurgitation. CONCLUSION: In patients with BAV, there were no significant differences in 30-day all-cause mortality after TAVR among the various prosthetic valve types.

Perioperative management of patients with antiphospholipid syndrome: a single-center experience.

The objective was to describe the management and risk factors for complications of antiphospholipid syndrome (APS) patients who underwent a surgical procedure in a single center. We reviewed medical records of all patients with primary or secondary APS who underwent an elective surgery during a 6-year period. Demographical data, management of anticoagulation and complications were recorded. We identified 43 patients, mean age 37.9 ± 8.9 years, who underwent a total of 48 elective surgeries. All patients had history of at least one thrombotic event and were under vitamin K antagonists. Before surgery, all patients received bridging therapy with intravenous infusion of heparin or low molecular weight heparin (LMWH). Among the LMWH group, 36 had a full anticoagulation regimen and nine prophylactic doses. In 62% of the surgeries, we identified an optimal management of periprocedural anticoagulation according to guidelines. Overall six patients had severe bleeding and three thrombotic complications (full anticoagulation regimen n = 2 and prophylactic dose group n = 1). Patients with optimal management of anticoagulation experienced less thrombotic and hemorrhagic complications (7 vs. 33%; OR 0.14, 95% CI 0.02-0.81; p = 0.040) and patients with INR ≤1.5 at surgery had fewer episodes of major bleeding (6 vs. 29%; OR 0.19, 95% CI 0.02-0.98; p = 0.050). All three thrombotic events occurred in patients with INR ≤1.5. Proper management of anticoagulation based on guidelines is associated with less complications in patients with APS. Notwithstanding the proper use of bridging therapy, some patients may develop thrombotic complications.