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Journal and News Scan
The Jos University Teaching Hospital in Nigeria has received a donation of surgical equipment for cardiothoracic surgery from Project CURE, which will allow the hospital to offer more surgical services to patients.
Italy’s former president, Giorgio Napolitano, underwent emergency surgery for a ruptured aorta.
A former goalkeeper for the national Pakistani field hockey team is in need of a heart transplant and has appealed to the Indian government for a medical visa.
Drugs and Devices
The CoAp Pro device from HeartStitch, designed to provide a percutaneous suture-based approach for mitral valve remodeling and repair, has received CE Mark approval in the European Union.
The US Food and Drug Administration has expanded approved use of osimertinib from AstraZeneca to include first-line treatment for metastatic non-small cell lung cancer with epidermal growth factor receptor mutations.
A planned firmware upgrade for certain implantable cardiac devices from Abbott includes a cybersecurity update.
Research, Trials, and Funding
The VEST US trial has enrolled the first 20 patients. The trial will evaluate the safety and effectiveness of a device for treating saphenous vein graft disease after coronary artery bypass grafting.
The authors retrospectively evaluated the long-term fate of the aortic arch in 168 patients with bicuspid aortic valves who had undergone either ascending aortic (24%) or aortic root (76%) replacement. At a median follow-up of 5.9 years, the mean aortic arch diameter went from 2.9 cm preoperatively to 3.0 cm at follow-up (p=ns). The authors conclude that prophylactic arch replacement in this population is not indicated, and perhaps neither is long-term aortic surveillance.
Rizwan and colleagues retrospectively reviewed data from the United Network for Organ Sharing database for pediatric donor hearts and transplants from 2000 to 2015. The authors focused on two cohorts: recipients who accepted a heart with three or fewer prior refusals due to donor quality (RDQ), and recipient accepting hearts with more than three RDQs. Recipients who were adolescents, on extracorporeal support, or in need of a retransplant were more likely to accept a donor heart with a high number of RDQs. Despite this, the rates of posttransplant stroke, dialysis, acute rejection, and rejection within one year were not different between the two groups. Additionally, accepting a heart with more than three prior RDQs did not predict one-year or overall mortality (p = 0.427 and p = 0.626, respectively).
The authors report on a randomized, multicenter, open-label, clinical trial involving 500 patients with 1460 saphenous vein grafts (SVG) who were assigned to three groups: (1) ticagrelor + asprin (ASA), (2) ticagrelor alone, or (3) ASA alone. Neither patients nor physicians were blinded to the allocation. The primary outcome was SVG patency at one year, assessed by either coronary angiography or CT angiography.
Results: The SVG patency rates for groups 1,2, and 3 were 88.7%, 82.8%, and 76.5%. The differences between group 1 and group 3 were significant at p<0.001. The differences between the remaining groups were not significant.
Conclusion: Among patients undergoing elective coronary artery bypass grafting, the combination of ASA and ticagrelor resulted in higher SVG patency at one year over ASA alone. Five major bleeding episdoes occurred during one year of follow-up, all in either group 1 or 2.
Stiles and colleagues retrospectively analyzed prospectively-collected data on approximately 3,200 surgical lung cancer patients, finding that more than one fifth of these patients are never-smokers. Compared to patients with a history of smoking, never-smokers were more likely to be younger, female, and to suffer from adenocarcinoma. Despite these demographic and disease differences, these patients had similar survival and risk for recurrence as smokers.
The Chinese Red Cross has announced that 25 Afghan children with congenital heart disease will receive free medical treatment in China.
The National Health System England has chosen HeartFlow™ FFRct Analysis to be funded through the Innovation and Technology Payment program, which may allow more patients with coronary artery disease to avoid angioplasty.
The Children’s Heart Foundation and the Adult Congenital Heart Association will host a number of Congenital Heart Walks around the US in 2018 to promote disease awareness and to raise funding for research and educational programs.
Drugs and Devices
In the latest development in a patent spat over transcatheter heart valve technologies, the European Patent Office has revoked a patent owned by Edwards Lifesciences in favor of Boston Scientific. In March, however, the US Patent and Trademark Office ruled in favor of Edwards Lifesciences that claims made by Boston Scientific were invalid.
Research, Trials, and Funding
Researchers report that 45% of patients with non-small cell lung cancer who received nivolumab prior to surgery showed a major pathologic response in the resected tumor, presenting their findings at the recent annual meeting of the American Association for Cancer Research.
Cardiome Pharma has completed enrollment for the Phase 4 SPECTRUM study in the EU evaluating vernakalant hydrochloride for recent onset atrial fibrillation.
A recent study of Swedish adults found that nut consumption was inversely associated with one’s risk for atrial fibrillation and for heart failure.
The authors present the 5-year follow-up results of the HYBRID trial, wherein 200 patients with multivessel disease requiring revascularization were randomized to either conventional coronary artery bypass grafting (CABG) or hybrid coronary revascularization (HCR). Notably, the patients undergoing HCR had a LIMA to LAD via a minimally invasive approach combined with percutaneous coronary intervention (PCI) of the remaining vessels.
The following table summarizes the results from this trial:
Outcome CABG HCR p-value
All-cause mortality 9.2% 6.4% 0.69
Myocardial infarction 7.2% 3.4% 0.30
Repeat revascularization 45.4% 37.2% 0.38
Stroke 4.1% 2.1% 0.35
MACCE 53.4% 45.2% 0.39
The authors conclude that there were no differences in outcomes between the two types of revascularization.
Comment: Although none of the differences achieved statistical significance, there does appear to be a trend for better outcomes with HCR. The lack of significance may be related to inadequate power of the study to detect a difference.
Question: Is it not time to rethink our approach to HCR? Most centers are approaching the procedure with a minimally invasive approach using a single mammary artery. If our main concern is outcomes—as it should be—is it not time to reassess HCR as a conventional or minimally invasive procedure utilizing both LIMA and RIMA for appropriate targets, and PCI for the rest? This would seem to be the optimal approach, so that the patient gets the true benefit of both worlds: the superiority of bilateral mammary revascularization over any alternative conduits, and the superiority of PCI over SVG. What do you think?
Coronary artery bypass grafting (CABG), the second most common cardiac procedure in the US, was added to the US Hospital Readmissions Reduction Program in 2015. Given the relatively high rate of readmission after CABG, Zywot and colleagues sought to develop a scale for predicting readmission risk. Using the State Inpatient Database discharge records of 126,519 patients from New York and California, the authors found that comorbidities such as renal failure (OR, 1.56) and congestive heart failure (OR, 2.82) were strongly predictive of readmission. Older age, female gender, African American ethnicity, and not having private insurance also predicted a higher readmission rate. Factors that were predictive of and associated with readmission were used to develop a scale of readmission risk, which was shown to be a good predictor of readmission in a validation cohort.
In this systematic review, Drury and colleagues evaluated 333 randomized trials in pediatric cardiac surgery that comprised approximately 24,000 children. Most of the trials were early phase trials and recruited relatively few patients. The authors found that less than one third of the trials met basic quality requirements. They emphasize the need for high-quality multicenter clinical trials to achieve reliable evidence for contemporary pediatric heart surgery.
The authors present their experience in treating 39 patients with thoracic aortic endovascular repair of the ascending aorta who were determined to be very high risk for open surgical repair from 2006 to 2016. Treated pathologies included acute type A dissection in 31%, intramural hematoma in 5%, pseudoaneurysm in 56%, and chronic dissection suture line entry tear in 8%. Ascending TEVAR was performed in 36 pateints, and occluder devices were deployed in three patients with pseudoaneurysm. Operative mortality was 13% in this high risk group of patients, with complications including stroke in 10% and myocardial infarction in 5%. The authors propose a zone zero classification system for describing the location of pathology by segmental proximity to the aortic annulus and for assessing prognosis.