Improved Outcomes With Transcarotid Stenting vs Femoral Stenting

Target Audience and Goal Statement: Vascular surgeons, neuroradiologists, neurologists, neuropsychologists, cardiologists, hospitalists

The goal of this study was to compare outcomes associated with transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TF-CAS) among patients with carotid artery stenosis.

Question Addressed:

• Was the TCAR procedure associated with a lower risk of stroke and death compared with TF-CAS among patients undergoing treatment for carotid artery stenosis?

Study Synopsis and Perspective:

Every 40 seconds someone in the U.S. has a stroke. Strokes are commonly caused by atherosclerotic lesions of the carotid artery bifurcation. Two prospective randomized trials — the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and the Asymptomatic Carotid Atherosclerosis Study (ACAS) — established carotid endarterectomy as the gold-standard treatment for high-grade symptomatic and asymptomatic carotid artery stenosis, respectively.

Action Points

• Transcarotid artery revascularization (TCAR) was significantly associated with a lower risk of stroke and death compared with transfemoral carotid artery stenting among patients who underwent treatment for carotid artery stenosis.
• Note that researchers did not see statistically significant differences between the two procedures for in-hospital myocardial infarction events.

TF-CAS has been used as an alternative method for patients at high surgical risk with carotid endarterectomy; however, evidence from the literature has shown that TF-CAS is associated with a higher periprocedural stroke risk versus carotid endarterectomy, especially in symptomatic and elderly patients.

Recently, a transcarotid neuroprotection system has been indicated in the U.S. in conjunction with a transcarotid stent system for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet prespecified criteria. The neuroprotection system enables the surgeon to directly access the common carotid artery in the neck and initiate high-rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the stent.

The TCAR Surveillance Project was designed to obtain more data about real-world outcomes of TCAR in comparison with carotid endarterectomy as performed by centers participating in the Vascular Quality Initiative (VQI).

In an updated exploratory analysis in JAMA, Marc Schermerhorn, MD, of Beth Israel Deaconess Medical Center in Boston, and colleagues looked at patients who underwent TCAR or TF-CAS from September 2016 (at the launch of the TCAR Surveillance Project) to April 2019.

Schermerhorn’s group compared 5,251 patients who received TCAR versus 6,640 patients who received TF-CAS; propensity score matching yielded 3,286 matched pairs for comparison (TCAR: mean age 71.7 years, 35.7% women; TF-CAS: mean age 71.6 years, 35.1% women).

TCAR was associated with significantly lower rates of in-hospital stroke and death compared with TF-CAS (1.6% vs 3.1%, relative risk [RR] 0.51, 95% CI 0.37-0.72, P<0.001), as well as the individual rates of stroke (1.3% vs 2.4%, RR 0.54, 95% CI 0.38-0.79, P=0.001) and death (0.4% vs 1.0%, RR 0.44, 95% CI 0.23-0.82, P=0.008). However, researchers did not see statistically significant differences between the two procedures for in-hospital myocardial infarction events (0.2% vs 0.3%, RR 0.70, 95% CI 0.27-1.84, P=0.47).

TF-CAS also led to more radiation (median fluoroscopy time 5 minutes vs 16 minutes, P<0.001) and more contrast used (median 30 mL vs 80 mL, P<0.001). Patients who underwent TCAR were also significantly less likely to fail CMS-recommended discharge criteria (16.4% vs 22.7% for TF-CAS, P<0.001), including length of stay greater than 2 days (13.9% vs 19.0%, P<0.001) and failed discharge home (7.3% vs 12.7%, P<0.001).

Ipsilateral stroke or death at 1 year were lower in patients who underwent TCAR versus TF-CAS (5.1% vs 9.6%, hazard ratio 0.52, 95% CI, 0.41-0.66, P<0.001), based on a separate risk-adjusted analysis looking at patients with 1-year follow-up.

Although there were no statistically significant differences in overall access site bleeding complications, TCAR was associated with higher risks of access site bleeding resulting in interventional treatment (1.3% vs 0.8%, RR 1.63, 95% CI 1.02-2.61, P=0.04).

No causal inferences were possible due to the observational study design. While 95.4% of all transcarotid procedures utilizing flow reversal performed in the U.S. were recorded in this registry, researchers stated that there was the possibility that stroke ascertainment or subject selection could be prone to bias.

In addition, transient ischemic attack was defined in the study as being based on focal neurological symptoms lasting less than 24 hours, rather than the current definition set forth by the American Heart Association and American Stroke Association. Also, 1-year follow-up had not been completed for all patients at the time of publication, but this was accounted for with Kaplan-Meier censoring. Additionally, the study may have been underpowered to detect differences for stroke rates between symptomatic and asymptomatic patients. Unmeasured confounding was also a possibility, the researchers acknowledged.

Source Reference: JAMA 2019; DOI: 10.1001/jama.2019.18441

Study Highlights and Explanation of Findings:

TCAR versus TF-CAS was significantly associated with a lower risk of stroke and death among patients who underwent treatment for carotid artery stenosis.

TCAR was developed to avoid the high-risk maneuvers associated with TF-CAS, especially “manipulation of the aortic arch to cannulate the common carotid artery and crossing the carotid lesion unprotected to deploy the embolic protection filter distally,” the researchers wrote. Following deployment, there was always the possibility that filter devices could allow passage of small emboli through or around the filter if incompletely placed in proximity to the vessel wall. The TCAR procedure bypasses the aortic arch and employs direct common carotid access and flow reversal prior to crossing the lesion. In one study, more than two-thirds (68%) of patients were anatomically eligible for the transcarotid approach, and 79% were eligible for the transfemoral approach.

The multicenter, single-group ROADSTER trial was the first study to confirm the theoretical benefits of TCAR by showing a 30-day stroke rate of 1.4% and a stroke-free survival rate of 95% at 1 year. Compared with the ROADSTER trial, the present study found a similar, but slightly lower, perioperative stroke rate of 1.2% following TCAR.

Notably, researchers did not see statistically significant differences between the two procedures for in-hospital myocardial infarction events.

“Transcarotid artery revascularization, which also uses a less invasive approach than endarterectomy, showed no significant difference in [the] perioperative myocardial infarction profile as compared with transfemoral carotid artery stenting in both asymptomatic and symptomatic patients,” they wrote.

“These benefits were found despite the higher rates of bleeding complications associated with intervention following transcarotid artery revascularization,” they added.

Last Updated January 10, 2020

Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco

Primary Source

JAMA

Source Reference: Schermerhorn ML, et al “Association of transcarotid artery revascularization vs transfemoral carotid artery stenting with stroke or death among patients with carotid artery stenosis” JAMA 2019; DOI: 10.1001/jama.2019.18441.

Secondary Source

MedPage Today

Source Reference: Lou N “Study: Transcarotid Stenting Has a Leg Up Over Femoral Approach” 2019.

https://www.medpagetoday.org/cardiology/pci/84281?_ga=2.236002504.831987228.1578674207-1125047970.1528569052

Bloomberg sees California as model for U.S.

Mike Bloomberg’s plan for California – export it.

The Democratic presidential candidate and former New York City mayor likes a lot of what he sees in the Golden State and thinks its efforts on climate change, gun control and criminal justice reform sets a benchmark for other states to emulate.

“I think that California can serve as a great example for the rest of this country,” Bloomberg told supporters at the opening of his Angeles headquarters.

Yes, there are problems, including homelessness, struggling public schools and scarce, costly housing. But California “is something the rest of the country looks up to,” Bloomberg said. “California has been a leader in an awful lot of things.”

His comments marked a sharp departure from views of President Donald Trump, whose administration has been in a long-running feud with the nation’s most populous state over issues from environmental protection to homelessness. Trump called California “a disgrace” last year shortly after its Democratic-controlled Legislature passed a bill that would have required presidential candidates to release their tax returns to get on the 2020 ballot, a proposal aimed squarely at the president. It was later voided in court.

Bloomberg’s visit came as part of a swing through a state that he sees as central to his hopes of winning the White House. After a late entry into the race, Bloomberg is bypassing the first four primary and caucus states and is anchoring his strategy to California and other Super Tuesday states on March 3.

His TV ads have been appearing routinely on television, attempting to connect with voters who might know little or nothing about the billionaire businessman.

With more delegates than any other state, California “has a lot of power in the nominating process,” Bloomberg noted.

https://www.washingtontimes.com/news/2020/jan/6/michael-bloomberg-sees-california-model-us/

40% of patients would switch physicians for more affordability — survey

If access to more affordable payment options were available, 2 in 5 patients would switch providers, according to a survey published by AccessOne, a patient portal.

That number is on the rise, according to the survey, which includes responses from more than 1,000 consumers. In 2018, 33 percent of individuals said the same. The survey also found 75 percent of consumers are willing to shop care prices, and 38 percent already do.

Across generations, baby boomers are less likely to switch providers if more affordable payment options are provided. Still, 55 percent of baby boomer respondents said they consider transparency on out-of-pocket costs a key part of choosing a provider.

https://www.beckershospitalreview.com/finance/40-of-patients-would-switch-physicians-for-more-affordability-survey-finds.html

How controlling fat ‘doormen’ could lead to new obesity treatments

In healthy people, fat cells take in nutrients and let out energy-supplying lipids in a finely tuned process that prevents the excessive buildup of belly fat. When this process goes wrong, however, obesity can emerge.

Scientists at Yale University have discovered a new regulator of fat transport—an enzyme they believe could be targeted with drugs to help control obesity. They described the discovery in the journal Nature Communications.

The enzyme is called O-GlcNAc transferase (OGT), and its role in maintaining a healthy metabolism has been widely reported. In 2015, for example, a Johns Hopkins University team discovered that high levels of OGT disrupt energy production in a way that leads to high blood sugar.

The new study from Yale focuses on OGT’s impact on “fat droplet sentinels,” which are molecules inside of fat cells that act like “doormen” for nutrients and fat, according to a statement from the university. The researchers discovered mice that lack the enzyme are lean and their cells burn off lipids at a faster rate than they take in carbohydrates. Mice that overexpress OGT, by contrast, take in more carbohydrates, they reported.

“The commander of this doorman makes it easier for nutrients to get in, but harder for lipids to get out,” said senior author Xiaoyong Yang, Ph.D., associate professor of comparative medicine and of cellular and molecular physiology at Yale’s medical school, in a statement.

Yale has undertaken a variety of research efforts aimed at reducing the buildup of unhealthy fat in the body. In 2018, a team at the Yale Cardiovascular Research Center published a mouse study that showed that inhibiting the VEGF-A receptor FLT1 normalized fat transport in the body and prevented weight gain.

As for OGT overexpression, it doesn’t just control the flow of nutrients and fats. It also sends signals to the brain that trigger overeating, Yang’s team previously discovered. “This makes OGT a very attractive target to pharmaceutically treat obesity,” he said.

https://www.fiercebiotech.com/research/how-controlling-fat-doormen-could-lead-to-new-obesity-treatments

U Va. plan to cut hospital readmissions picked for national AI competition

A UVA Health proposal to reduce hospital readmissions was among 25 submissions chosen – from more than 300 applications – for a national competition seeking ideas on how artificial intelligence can improve healthcare.

The UVA Health data science team will compete alongside proposals from organizations that include IBM and Mayo Clinic in the first Centers for Medicare & Medicaid Services Artificial Intelligence Health Outcomes Challenge. UVA’s project seeks to not only predict which patients are at risk for being readmitted to the hospital multiple times, but suggesting a personalized plan to prevent those readmissions.

Artificial Intelligence is a vehicle that can help drive our system to value – proven to reduce out-of-pocket costs and improve quality. It holds the potential to revolutionize healthcare: imagine a doctor being able to predict health outcomes – such as a hospital admission – and to intervene before an illness strikes. The participants in our AI Challenge demonstrate that such possibilities will soon be within reach. We congratulate the 25 innovators who have been selected to continue, and we look forward to seeing what else they have in store.”

Seema Verma, CMS Administrator

Predicting and preventing readmissions

An analysis by the UVA Health data science team developing the proposal found that 3% of patients at UVA account for 30% of readmissions within 30 days of being discharged from the hospital. Most of those return hospital visits occur within 12 months of the first admission, so being able to predict which patients are at risk for multiple readmissions is vital.

One challenge is that not all readmissions can be stopped; published research estimates that less than one-third of readmissions within 30 days of discharge from the hospital are actually preventable. For example, elderly patients are at higher risk for readmissions, but there’s nothing that can be done about a patient getting older.

Based on an analysis of data from insurance claims and electronic medical records – and building on work they have already done to reduce readmissions – the UVA Health team has identified several risk factors that can be addressed.

For example, a patient may not be taking full advantage of preventive care options, may have chronic conditions such as diabetes or may not be able to effectively manage their due to medical illiteracy or other factors. A patient’s risk for readmission may also vary based on why they are coming to the hospital. For instance, a patient with cancer coming to the hospital for a regular chemotherapy session would be at lower risk than if the same patient was admitted to the hospital with a hip fracture.

But the model doesn’t stop with identifying patients at increased risk for multiple readmissions. “The core idea of our proposal is to suggest possible interventions,” said Bommae Kim, PhD, a UVA Health senior data scientist. “For example, a patient may have dementia and can’t take care of themselves. So we may talk with a caregiver about different care options or help find other resources to help the patient.”

Refining their work

The UVA Health team has until February 2020 to submit their updated proposal to CMS. Later next year, they will learn whether they were selected as 1 of 7 finalists to compete for a $1 million grand prize. But the opportunity to build on the team’s efforts over the past five years to incorporate AI into patient care has already proved valuable.

“Just putting together the proposal is helping us accelerate our work to improve care for our patients,” said Jonathan Michel, PhD, UVA Health’s director of data science.

Source:

University of Virginia Health System

https://www.news-medical.net/news/20200111/UVA-Health-proposal-to-reduce-hospital-readmissions-selected-for-national-AI-competition.aspx

How sewage plants can remove pharmaceuticals from wastewater

A study of seven wastewater treatment plants in the Eastern United States reveals a mixed record when it comes to removing medicines such as antibiotics and antidepressants.

The research points to two treatment methods — granular activated carbon and ozonation — as being particularly promising. Each technique reduced the concentration of a number of pharmaceuticals, including certain antidepressants and antibiotics, in water by more than 95%, the scientists’ analysis found.

Activated sludge, a common treatment process that uses microorganisms to break down organic contaminants, serves an important purpose in wastewater treatment but was much less effective at destroying persistent drugs such as antidepressants and antibiotics.

The take-home message here is that we could actually remove most of the pharmaceuticals we studied. That’s the good news. If you really want clean water, there are multiple ways to do it.”

Diana Aga, PhD, Henry M. Woodburn Professor of Chemistry, University at Buffalo College of Arts and Sciences

“However, for plants that rely on activated sludge only, more advanced treatment like granular activated carbon and/or ozonation may be needed,” Aga adds. “Some cities are already doing this, but it can be expensive.”

The findings are important because any drugs discharged from treatment plants can enter the environment, where they may contribute to phenomena such as antibiotic resistance, or be consumed by wildlife.

“Our research adds to a growing body of work showing that advanced treatment methods, including ozonation and activated carbon, can be very effective at removing persistent pharmaceuticals from wastewater,” says Anne McElroy, PhD, Professor and Associate Dean for Research in the Stony Brook University School of Marine and Atmospheric Sciences.

The study — funded by New York Sea Grant — was published in November in the journal Environmental Science: Water Research & Technology.

Aga and McElroy led the project, with UB chemistry PhD student Luisa Angeles as first author. The paper was a partnership between researchers at UB, Stony Brook University, the Hampton Roads Sanitation District and Hazen and Sawyer, a national water engineering firm that designs advanced wastewater treatment systems, including some of the systems studied.

The research analyzed a variety of technologies in use at seven wastewater treatment plants in the Eastern U.S., including six full-scale plants and one large pilot-scale plant. According to the paper, “more precise locations are not provided in order to protect the identity” of the facilities.

Angeles says the study’s findings could guide future decision-making, especially in areas where water is scarce and in cities that may want to recycle wastewater, converting it into drinking water.

The research is also important for environmental conservation. It demonstrated that larval zebrafish did not change their behavior when they were exposed to wastewater discharged from treatment plants. However, much more work is needed to understand how longer-term exposures may impact wildlife, Aga says.

In a separate study in 2017, Aga’s team found high concentrations of antidepressants or the metabolized remnants of those drugs in the brains of numerous fish in the Niagara River, part of the Great Lakes region.

Scientists still don’t fully understand the behavioral and ecological impacts that may occur when chemicals from human medicines build up in wild animals over time, Aga says.

Though wastewater treatment plants were historically designed and operated for purposes such as removing organic matter and nitrogen from used water, the new research and other prior studies demonstrate that these facilities could also be harnessed to remove different classes of medicines.

Source:

University at Buffalo

Journal reference:

Angeles, L. F. et al. (2020) Assessing pharmaceutical removal and reduction in toxicity provided by advanced wastewater treatment systems. Environmental Science: Water Research & Technology. doi.org/10.1039/C9EW00559E.

https://www.news-medical.net/news/20200109/Study-shows-how-sewage-plants-can-remove-pharmaceuticals-from-wastewater.aspx

US IPO Week Ahead

Chinese immunotherapy biotech I-Mab Biopharma (IMAB) plans to raise $100 million at an $876 million market cap. I-Mab would be the first Chinese biotech to IPO in the US in over two years and the second largest Chinese biotech to IPO in the US ever.

Chinese cancer diagnostics provider AnPac Bio-Medical Science (ANPC) plans to raise $22 million at a $150 million market cap.

Lock-up periods will be expiring for nine companies. On Tuesday, January 14: Fulcrum Therapeutics (FULC), Mirum Pharmaceuticals (MIRM), and Phreesia (PHR). On Wednesday, January 15: Innate Pharma (IPHA).

Street research is expected for Monopar Therapeutics (MNPR) on Monday, January 13.

https://www.renaissancecapital.com/IPO-Center/News/66757/US-IPO-Week-Ahead-The-2020-US-IPO-market-debuts-with-a-5-IPO-week