Updates 22 Mar 2016
FDA Issues Class I Recall for MitraClip Delivery System
The FDA has issued a recall notice for Abbot Vascular MitraClip delivery System. Abbott Vascular has received reports of cases where the Clip Delivery System could not be detached from the Clip due to a malfunction of the device. These cases resulted in open-heart surgery to retrieve the delivery system. Abbott Vascular is therefore recalling the MitraClip Delivery System to provide updated instructions and training for health care providers who use the device. There have been nine reports of this malfunction and there has been 1 death.
Sudden Cardiac Death After Non ST segment Elevation Acute Coronary Syndrome
A review of 37,555 patients enrolled in clinical trials after suffering non-ST segment elevation ACS found that 513/1640 cardiovascular deaths were sudden death (SCD). At 6, 18, and 30 months, the cumulative incidence estimates of SCD were 0.79%, 1.65%, and 2.37%, respectively. In a multivariable model that included time-dependent clinical events occurring after the index hospitalization for ACS, SCD was associated with recurrent myocardial infarction (hazard ratio [HR], 2.95; 95% CI, 2.29-3.80; P < .001) and any hospitalization (HR, 2.45; 95% CI, 1.98-3.03; P < .001), whereas coronary revascularization had a negative relationship with SCD (HR, 0.75; 95% CI, 0.58-0.98; P = .03).
The Role of Warfarin in Dialysis Patients with Atrial Fibrillation
Patients with end-stage renal failure on dialysis have a 10-20% prevalence of AF, yet questions remain about safety and efficacy of anticoagulation in this group. A retrospective study of 141 such patients by Wang et al is published in this month’s Heart Lung and Circulation. There were 59 (42%) patients on warfarin. The incidence of all embolic events , ischemic stroke, all bleeding and intracranial bleed were 4.1, 3.1, 9.6 and 0.82 / 100 person years. Anticoagulation with warfarin did not reduce risk of embolism or mortality but was associated with increased risk of intracranial bleeding. The authors conclude that larger randomized trials specifically designed for these patient are required to address the safety and efficacy of anticoagulation for dialysis patients.
Bentalls Procedure vs Valve Sparing Root Replacement in Marfan Syndrome
Aortic root replacement for aneurysms in Marfan syndrome can save lives. The original operation was mechanical valve and composite aortic conduit implant (Bentalls) whilst in recent years valve-sparing aortic root replacement (VSRR) has been employed by many. Outcomes at a single centre were compared for 165 patients undergoing Bentalls or VSRR. There were 0 hospital deaths and 9 late deaths in 17 years follow up. The 10-year survival was 90.5% for Bentalls and 96.3% for VSRR. Although VSRR was associated with fewer thromboembolic or hemorrhagic events (p=0.03) there were no differences in survival, freedom from reoperation or endocarditis between Bentalls and VSRR.