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Journal and News Scan
Once again, analyses of studies that are ostensibly well-designed randomized controlled trials have limitations that do not answer the question at hand: are two-arterial CABGs better than one? This editorial comments on a publication regarding the EXCEL Study, which showed no differences at 3 years.
Patient Care and General Interest
Surgeons at the Cleveland Clinic Abu Dhabi in the UAE used a metal stent for an emergency repair of a patient’s windpipe, which had been completely severed in a traffic accident.
A report from the UK Lung Cancer Coalition says that geographic variation persists despite improvements in 5-year survival rates for lung cancer in the UK.
Drugs and Devices
Medtronic has received the CE Mark for its Valiant Navion™ thoracic stent graft system, a low-profile thoracic stent for patients with small iliac arteries and other anatomic variations.
Research, Trials, and Funding
Physicians in Ontario, Canada, evaluate in-hospital counseling and surgery for injection drug users with endocarditis, finding that both reduce mortality in these patients.
Researchers at Stanford University in California are matching donor and pediatric recipient heart volumes using CT scans, rather than relying on height and weight to determine if a child could accept a particular donor heart.
At the recent meeting of the American Heart Association, researchers from Germany reported similar rates of major adverse cardiovascular events and major bleeding for patients taking either ticagrelor or aspirin after coronary artery bypass.
Netuka provides several important technical nuances to consider when implanting the HeartMate 3 left heart assist device. He focuses on apical cuff attachment, optimal positioning of the pump in the pericardial cavity, and positioning of the outflow graft. Furthermore, he describes alternative surgical implantation strategies for minimizing invasiveness.
Patent descending aortic false lumen in type A dissection is associated with limited long-term outcomes. Inoue and colleagues aimed to evaluate the efficacy of their group’s strategy for these patients. Among 290 patients with type A aortic dissection and patent false lumen at the descending aorta, 124 underwent ascending aortic replacement and 166 additional total aortic arch replacement. Total aortic arch replacement was associated with better freedom from descending aortic aneurysm. There was no difference in in-hospital mortality between the groups.
Hebeler and colleagues hypothesized that the inclusion of measures of frailty might improve the prediction of mortality one-year after transcatheter aortic valve replacement (TAVR). In 470 patients undergoing TAVR, sarcopenia was measured and frailty was assessed preoperatively by gait speed, hand grip strength, serum albumin, and Katz activities of daily living. The addition of both sarcopenia and frailty measures to the STS Predicted Risk of Mortality improved the predictive capacity of the model (area under the curve of 0.61 versus 0.52), and albumin was the only marker that was significantly associated with an increased one-year mortality risk.
On November 26, 2018, FDA Commissioner Scott Gottlieb, MD, and Director of the Center for Devices and Radiological Health Jeff Shuren, MD, announced proposed changes intended to modernize the 510(k) clearance pathway to keep pace with the increasing complexity of rapidly evolving technology. The FDA is planning to rename this new approach the “Safety and Performance Based Pathway” to reflect its focus on advancing improved safety and performance of new low-risk to moderate-risk products. It is an alternative pathway to substantial equivalence that will provide more direct evidence of the safety and performance of a device and better information for patients and providers to make well-informed health care decisions. This new approach may also drive greater market competition to develop safer devices.
The authors compared the early and long-term survival in 9165 patients undergoing medical therapy (95%), open repair (2%), and thoracic endovascular aortic repair (TEVAR, 2.9%) for uncomplicated acute type B dissection. One- and 5-year survivals were 84% and 60% for medical therapy, 76% and 67% for open repair, and 85% and 76% for TEVAR (log-rank, P < .01). On risk-adjusted multivariable analysis, TEVAR had a significant survival benefit compared to medical therapy (hazard ratio, 0.68; 95% confidence interval, 0.6-0.8; P < .01). This study on survival after acute uncomplicated type B aortic dissection shows a survival advantage for TEVAR over medical therapy. These data add further evidence for a paradigm shift in the management of acute type B dissection in favor of early TEVAR.
Saito and colleagues evaluated the idea that anastomosis assist devices reduced complications for patients undergoing off-pump coronary artery bypass grafting. Their study is a one-to-one propensity scores matched analysis including 7,348 pairs of patients comparing the outcomes of anastomosis assist devices with a side-biting clamp. The authors found no difference in 30-day mortality or stroke. However, transient ischemic attack occurred more frequently in the side-clamp group.
This single institution retrospective study examined the utility of using nonpledgeted sutures for aortic valve replacement. In short-term follow-up, 3.6% of patients had insignificant perivalvular leak and 0.9% had significant perivalvular leak requiring reoperation. This technique has the potential benefits of reduced cross-clamp time, reduced risk of decreasing the effective orifice area, reduced cost, and reduced indwelling foreign body.
Brown and colleagues evaluated levels of six biomarkers to determine if they improved the prediction of readmission after cardiac surgery: ST2, galectin-3, N-terminal pro-brain natriuretic peptide, cystatin C, interleukin-6, and interleukin-10. The addition of these biomarkers to a model based on only clinical risk factors improved the predictive ability of the model in the derivation cohort (area under the receiver-operating characteristics curve (AUROC) of 0.74 versus 0.66), but it did not improve prediction in an external validation cohort (AUROC of 0.52 versus 0.48).