Why Boston Scientific’s TAVR Technology Deserves to Play On

Technology

Boston Scientific’s ACURATE trial may have missed its primary endpoint, but the company’s Acurate neo2 valve isn’t just another player in the TAVR market.As a self-expanding device with unique design features, the Acurate neo2 combines the strengths of the market-leading TAVR valves, promising ease of use, great coronary access, and low pacemaker rates. So, a setback for this valve is more than just a strikeout for Boston Scientific—it’s a missed opportunity for the patients and physicians who stand to benefit.After speaking with Michael Reardon, MD, a co-investigator on the trial, I’m convinced that this miss deserves a closer look, and the Acurate neo2 valve deserves another chance at the plate.The investigational device exemption (IDE) trial evaluated the Acurate neo2 valve in the treatment of patients with severe, symptomatic aortic stenosis at low, intermediate, high, and extreme risk of open-heart surgery. The valve is CE marked in Europe but is not approved in the United States. The randomized IDE trial pitted Acurate neo2 against a pre-defined control valve, either Edwards Lifesciences’ Sapien valve or Medtronic’s Evolut TAVR system, selected at the discretion of the implanting physician.Image of the Acurate Neo2, courtesy of Boston ScientificRight off the bat, the investigational device was at a disadvantage in this trial.”Here you have this brand-new valve that nobody in the U.S. is using, it’s just as we start with the first wave of COVID, it takes us four years to finish this, the average time between implants is three months, and there are only three sites that did more than one a month,” said Reardon, a professor of cardiothoracic surgery at Houston Methodist DeBakey Heart & Vascular Center.Not only did the pandemic present staffing challenges, making it tough for the investigators to get the research personnel they needed, and patient recruitment challenges, but the global supply chain crisis made it tough to get the balloons needed for the procedure. So, even though TAVR cases were still being performed commercially every week with Sapien or Evolut, the research cases with Acurate were fewer and farther between.“So, to compare a valve that is brand new to you every couple of months to one you’re doing every week, multiple times, that built in a bias,” Reardon told me.To add insult to injury, this is the first time in TAVR that an IDE trial has done an all-risk analysis right off the bat. When Edwards and Medtronic were going through their TAVR trials, they started with patients who were at extreme and high risk for open surgery before studying the valves in the lower risk populations.”If you look at the original trials, we started with high and extreme risk, we learned about the valve, we iterated the valve, and then we applied it to intermediate risk, and then we learned about the valve, we iterated the valve, and we applied it to the low risk [patients],” Reardon said. “Well, here we’re asked to do all-risk analysis with no chance to learn or to iterate.”Unlike previous times in medical device history when a high-profile IDE trial failed to meet its primary endpoint, the investigators already know what the problem was. A post-hoc analysis identified and evaluated expanded and under-expanded Acurate neo2 valve frames within the trial. The company reviewed key procedural factors, including pre- and post-dilation, which helps to prepare for, enable, and confirm proper valve expansion during the procedure. It turns out that about 20% of the Acurate neo2 valves were under-expanded.“Under expansion means I didn’t expand the valve out as far as it was supposed to go. So, if it doesn’t expand out as far as it’s supposed to go, it’s not going to work normally,” Reardon told MD+DI. “And we know that in the world of endovascular stuff, under expansion is a bad thing.”Fortunately, there is technology available to help implanting physicians know how to spot under expansion, and it’s easy to fix at the time of the procedure if they know to look for it.With limited trial familiarity among U.S. physicians and an all-risk analysis setup, Boston Scientific’s Acurate neo2 was almost starting with two strikes in the ACURATE trial.Reardon said if the trial had been done similarly to the original TAVR trials the investigating physicians would have learned how to look for and treat under expansion by the time the new valve was being implanted into lower-risk patients.U.S. TAVR physicians and their patients deserve to have another choice on the market. Especially because, as Reardon told me, this wouldn’t be just another valve on the shelf.”It is a self-expanding valve that is short – it’s very hard to have a short self-expanding valve, all the other ones are tall,” he said. “And the reason you can do that is to have these stabilizing arms that come out distally and lock the valve into place and then let the self-expanding valve go out. And that’s quick, easy, and reproducible; and you have huge coronary access, and you have low pacemaker rates.”If you look at Edwards’ Sapien balloon-expanding valve, what physicians love about it, Reardon said, is that it’s quick and easy, offers coronary access, and has low pacemaker rates.”If you look at self-expanding valves, what people love about it is they have superior hemodynamics and commissural alignment, which I can now do with Acurate too,” Reardon said. “So, I get kind of a little bit of both in this particular valve.”Boston Scientific noted that there are conversations going on with FDA regarding next steps for the Acurate neo 2 valve, and Reardon says he is hoping for a reasonable path forward.”I think not having this valve available for consideration for our patients would be very unfortunate,” he said.With the right training and adjustments, the Acurate neo2 valve could step up to the plate and knock it out of the park for U.S. physicians and patients.

Herbalist’s Primer weaves science and fantasy into something more

Science and Health

One day, Anna Urbanek’s mother sat her on her lap and laid out three different items on the table in front of her: a small glass of vodka, a few scraps of money, and a tiny leather-bound book. It was her first birthday, and as is the tradition in Poland, it was time for her to make a choice. Which item would she be most attracted to? “My mom specifically took a black book, so it doesn’t skew the results,” Urbanek recalled. “Obviously a child [would reach] for something that’s colorful. So she took her black leather-bound mushroom guide, and of course that’s what I picked. That’s why we are here, I guess.”Over the last several years, the Polish-born author and artist has carved out a niche for herself with a unique series of books — Herbalist’s Primer, Geologist’s Primer, and the soon-to-be-released Mycologist’s Primer (currently on Kickstarter, with help from Hunter’s Entertainment). Together with her partner Jakub Wisz, the pair have created a series of reference materials: illustrative pseudo-textbooks that draw from real biology and the natural sciences, but also from pagan traditions and the occult. The result is a hybrid kind of document, one that looks back on the real world with love and understanding, but through the lens of fantastical fictions — artifacts that can serve as inspiration for tabletop role-play.To Urbanek, the desire to create these artifacts all comes back to her first and deepest passion, which is her love of books.Image: Double Proficiency“I suppose the only true answer to that is that I’m a librarian,” Urbanek told Polygon in a recent interview. The book-loving toddler grew up to receive a master’s degree in library sciences, and while that’s not her day job anymore, it still influences her work.“I care about people reaching for books regardless of their background and their interests,” Urbanek said. “I’m just trying to reach as many people as possible with the cool facts and potentially interesting tidbits of lore that I personally was — and still am — absolutely fascinated by. […] I just want to info-dump everything that I’ve been obsessing about […] in this wonderful world of folklore and natural sciences and how they come together on this very weird intersection that I landed on.”Other book lovers tend to be drawn first to Urbanek’s illustrations. She says they draw inspiration from classic 19th-century field guides, like those from John James Audubon as well as other British, French, and German naturalists. But the really good stuff is just a little bit older than that.Image: Double Proficiency“When it comes to the contents, […] I was definitely much more inspired by the books that were written pre-Enlightenment era,” Urbanek said, referring to books that were written and published prior to the 17th century. “Before that, whenever you had a book on natural sciences, they also included things that weren’t particularly scientific. […] We lost this. There was this giant tradition, in European literature at least, to include not only the science when we’re talking about natural sciences, but also include how it’s represented in the literature or in art in general, and any potential folklore that’s also pertinent to the subject, and I miss that.”Through Urbanek’s recasting and remixing of these both ancient and modern texts, fans of TTRPGs get lots of valuable inspiration for their games. Allspice, in addition to being a potent part of fall feasting, also has “limited control over probability [and] games of chance”; primrose is a flowering perennial, and may also be a sign that a portal to the fey realms is nearby; and wormwood, long considered the “patron plant of herbalists,” is also a votive offering that allows communication with the dead.“When writing Herbalist’s Primer, I was definitely inspired by the classic Green Witchcraft by Ann Moura,” Urbanek said, “which is obviously maybe not something that a standard Dungeons & Dragons player would have fallen into. You have to be interested in the occult in the first place probably to discover some of those books, but they are such an inspiration and such a wonderful source of fascinating stories that you can just pull from and introduce into the worlds you are creating. “I feel like it’s my obligation as a librarian to introduce people to books that they wouldn’t normally find on their own,” she added. “Maybe that’s why I always put a bibliography in those books so people can find whatever I think is interesting.”Image: Double ProficiencyNow that the books are out in the world — both through DriveThruRPG and via Urbanek’s publishing and distribution partner, Renegade Entertainment — information is starting to flow back to her about how people are using her system-agnostic books in their own home games. There are plenty of folks using it to add color to their games of D&D, of course, but also Pathfinder, Blades in the Dark, and more. Soon, it may even become an integral part of even larger projects.“We have released the contents of Herbalist’s Primer, and generally all those books, [and] we are allowing people to use it under the fair use practices,” Urbanek said. “Because I don’t own biology, and I don’t own the folklore that I use to create all of those books. We thought it’s only fair to release it into the wild and allow people to create their projects — as long as they just attribute us somewhere in the credits.”Now that Mycologist’s Primer has reached its goal — and then some, with less than two weeks to go in its campaign — Urbanek says that she Wisz have something even more ambitious in store.“We already have a lineup of several other primers just getting ready in the background,” Urbanek said. “But […] we are working on a really cool sci-fi system called Aphelion. […] We haven’t shared a lot of details yet, but we are definitely working on something that will allow you to ride a garbage truck in space. […] It’s going to be this really cool adventure through the solar system on ships powered by solar sails and solar roadways.”And don’t worry: Urbanek said she’s found plenty of ways to fold her passion for plants, gems, and mushrooms into that project as well.“I don’t know if you know,” Urbanek said, conspiratorially, “but for example, there are fungi and lichens that can feed on solar radiation and actually insulate spaceships from irradiation and protect the people inside. So we are definitely planning something interesting.”The campaign for Mycologist’s Primer ends on Nov. 15. You can find more from Urbanek and Wisz on their website.

The science of Taylor Swift: Purdue event promotes STEM to Swifties

Science and Health

Music blasted from the speakers inside Circle Centre Mall as 10-year-old Leighton Lanpher and her mom, Ashley Lanpher, made Taylor Swift-themed friendship bracelets. Cards on the table walked them through how to use the beads to make letters in binary code.
The two drove from St. Louis for the final three U.S. dates of Swift’s Eras Tour at Lucas Oil Stadium.

They decided to visit Purdue University’s “STEM-era” event where people were able to learn about science, technology, engineering and math through short activities related to the “Anti-Hero” singer.

“It’s a blast,” Lanpher said. “I love this place!”

Activities included making hand lotion, building paper rockets to launch through hoops, and learning about the science in makeup at the e.l.f. Cosmetics glow up station.

“I really like the e.l.f. glow up, and I really liked the pictures, and I liked making that little galaxy,” Lanpher said. 

Another Swiftie, Marissa Gainer, 13, showed off her sparkly galaxy-in-a-bottle key chain.

“I put glitter in it, and then I put some glycerin in it, and then I gave it to the lady, and she put a cap on it,” Gainer said.

The friendship bracelets, makeup and galaxy-in-a-bottle activities represent ways Purdue University is trying to connect women and girls with STEM fields.

“It’s well known there’s a large deficit and the number of women in STEM careers, and something that Purdue has been trying to overcome for a really long time,” said Kelly Hiller, Purdue University Vice President of Marketing.

Aerospace engineering junior Alayna Miller is part of the roughly 15 percent of women in her field. She said the weekend event complements Swift’s symbol of female empowerment.

“Getting to see a woman role model in industry, like Taylor, I think, is an incredible opportunity that you can do whatever you put your mind to,” Miller said.

Chloe Grandusky, a mechanical engineering major, said STEM events for women are usually attended by people who are already interested in the field.

“So it’s really cool to see that gateway and bridge we’re building from Taylor Swift into STEM that girls are like, ‘Oh, actually, wait, this is something I could do and I’m interested in,'” Grandusky said.

Purdue officials said roughly 10,000 people attended the event.

Contact WFYI All Things Considered newscaster and reporter Samantha Horton at [email protected].

MLB’s “Magic Mud” Exposed: The Science Behind Baseball’s Secret Weapon

Science and Health

The magic mud is applied to every ball used in Major League Baseball, including in this year’s World Series. Credit: Mark Griffey
Scientists unveil the long-mysterious qualities of baseball’s “magic” mud, which every MLB team uses on game balls.
The unique properties of baseball’s famed “magic” mud have never been scientifically quantified — until now.
In a new paper published today (November 4) in Proceedings of the National Academy of Sciences (PNAS), researchers from the University of Pennsylvania’s School of Engineering and Applied Science (Penn Engineering) and School of Arts & Sciences (SAS) reveal what gives baseball’s “magic mud” its unique properties.
“It spreads like a skin cream and grips like sandpaper,” explains Shravan Pradeep, the study’s lead author and a postdoctoral researcher in the labs of Douglas J. Jerolmack, Professor in Earth and Environmental Science (EES) within SAS and in Mechanical Engineering and Applied Mechanics (MEAM) within Penn Engineering, and Paulo Arratia, Eduardo D. Glandt Distinguished Scholar and Professor in MEAM and in Chemical and Biomolecular Engineering (CBE).
The Fascination With Magic Mud in Major League Baseball
In 2019, at the request of sportswriter Matthew Gutierrez, the team first analyzed the composition and behavior of the mud, which has been collected for decades by the Bintliff family at a secret location in South Jersey. This mud is applied by each MLB team’s equipment manager to every game ball, including those used in playoffs. “We provided a quick analysis,” says Jerolmack, “but not anything that rose to the level of scientific proof.”
Despite numerous articles and TV segments describing the mud that cite everyone from MLB players to the Bintliffs about the mud’s effects, the researchers could not find any scientific evidence that the mud actually makes balls perform better, as players claim. “I was very interested in whether the use of this mud was based in superstition,” says Jerolmack.
To test the properties of the magic mud, the group developed custom equipment. Credit: Mark Griffey
Scientific Experiments on Spreadability, Stickiness, and Friction
Two years later, when Pradeep joined the labs, he took the lead in devising three sets of experiments to determine if the mud actually works: one to measure its spreadability, one to measure its stickiness and one to measure its effect on baseballs’ friction against the fingertips.
The first two qualities could be measured using existing equipment — a rheometer and atomic force microscopy, respectively — but to measure the mud’s frictional effects, the researchers had to build a new experimental setup, one that mimicked the properties of human fingers. “The question is, how do you quantify the friction between the ball, your finger and the little oils between those two?” says Arratia.
To solve the problem, the researchers created a rubber-like material with the same elasticity as human skin, and covered it with oil similar to that secreted by human skin, then carefully and systematically rubbed the oiled material against strips of baseballs that had been mudded in the manner specified by MLB.
Xiangyu Chen, a MEAM senior and coauthor of the paper, played a key role in devising the artificial finger apparatus. “We needed to have a consistent finger-like material,” says Chen. ”If we just held our fingers to it, it wouldn’t produce very consistent results.”
Shravan Pradeep, Doug Jerolmack, Paulo Arratia and Xiangyu Chen (from left). Credit: Felipe Macera
Findings: Magic Mud’s Performance Benefits Confirmed
The researchers say their work confirms what MLB players have long professed: that the magic mud works, and is not simply a superstition like playoff beards and rally caps. “It has the right mixture to make those three things happen,” says Jerolmack. “Spreading, gripping and stickiness.”
MLB has explored replacing the magic mud with synthetic lubricants, but so far failed to replicate the mud’s properties. The researchers suggest sticking with the original. “This family is doing something that is green and sustainable, and actually is producing an effect that is hard to replicate,” says Jerolmack.
Beyond baseball, the researchers hope their work — and the mud’s star status — will spark more interest in the use of natural materials as lubricants. “This is just a venue for us to show how geomaterials are already being used in a sustainable way,” says Arratia, “and how they can give us some exquisite properties that might be hard to produce from the ground up.”
Reference: “Soft matter mechanics of baseball’s Rubbing Mud” 4 November 2024, Proceedings of the National Academy of Sciences.
This study was conducted at the University of Pennsylvania School of Engineering and Applied Science and School of Arts & Sciences and supported in part by the National Science Foundation (NSF) Major Research Instrumentation Award (NSF-MRI-1920156), NSF Penn MRSEC (NSF-DMR-1720530), NSF Engineering Research Center for the Internet of Things for Precision Agriculture (NSF-EEC-1941529), NASA Planetary Science and Technology Through Analog Research Program (PSTAR Grant 80NSSC22K1313), Army Research Office (ARO Grant W911NF2010113), Penn Center for Soft and Living Matter Postdoctoral Fellowship, and the University of Pennsylvania’s Singh Center for Nanotechnology, a National Nanotechnology Coordinated Infrastructure (NNCI) member supported by NSF Grant ECCS-1542153.
Additional co-authors include Ali Seiphoori of the University of Pennsylvania and the Norwegian Geotechnical Institute, and David Vann of the University of Pennsylvania.

Dallas school receives book vending machine

Arts & Culture, Books

Nov. 4, 2024Jack Lowe Sr. Elementary School has become the latest Dallas Independent School District school to receive a book vending machine, according to a Dallas ISD News report. The book vending machine is the product of a partnership between the Dallas Education Foundation, the Rotary Club of Park Cities and Atmos Energy.The machine, filled with brand new books, aims to foster a love of reading among students. “Education is one of the many initiatives in Rotary and you can’t find a better population to support than elementary school children,” Philip Bankhead from Park Cities Rotary told the news outlet. “By encouraging students to read and help them fall in love with books, they will become good citizens and good students.”The Dallas Education Foundation hopes to install book vending machines in every elementary school in the district, promoting home libraries and a lifelong love of reading.

Oregon City Brewing Company Opens a Book-Themed Beer Destination in Canby

Arts & Culture, Books

Bookworms and beer-lovers can now congregate at Oregon City Brewing’s second location, the Canby Beer Library, which opened in the former Canby Municipal Library building in late October. The taproom pours 51 taps, 45 of which are Oregon City Brewing’s beers and sodas.
The beer library’s adjacent food cart pod has heated seating and houses seven food carts: Adelina’s Mexican Food, Alani Mediterranean, Zula’s Tea & Coffee, Blessing Bites Fish & Chips, Church of Smoke BBQ, Poundtown Smashburgers, and Esan Thai. As a tribute to the building’s former tenants, patrons can purchase books from the Friends of the Canby Library at the taproom, which also features book-themed beer display boards and taster trays. Oregon City Brewing Company opened its original location in 2014. The Canby Beer Library is open at 292 N Holly Street.
Neighborhood bakery Tabor Bread now serves dinner
Whole-grain bakery Tabor Bread — which moved into a new location on Southeast Belmont Street earlier this year — introduced dinner service in mid-October. Chef José Sabas’ current menu includes dishes such as einkorn cavatelli with chanterelle mushrooms, English bangers served with cannellini beans and bay shrimp, and chicken-and-mushroom pie. Tabor Bread serves dinner from 4 p.m. to 10 p.m., Friday to Sunday.
Portland restaurants serve vegan specials for World Vegan Month
World Vegan Month, an initiative by event producer Veganizer, is back for its second annual event. This year, 33 Portland restaurants are serving specials for the entirety of November with a portion of sales going to a nonprofit of the restaurant’s choice. Participating restaurants include Lilla, Mirisata, Orange & Blossom, and Rad Magic Subs. Diners can collect stamps to complete a dining passport for the chance to win restaurant gift cards.

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Paul Walker ‘didn’t like the movie business’

Arts & Culture, Film & TV

Paul Walker “didn’t like” the movie industry.The actor died in a car accident in November 2013, aged 40, and Paul’s younger brother, Cody Walker, has now revealed that the Hollywood star felt frustrated that the movie industry stopped him from spending more time with his daughter, Meadow.Speaking to E! News, Cody explained: “That was his pride and joy, his baby girl. He loved her to death, he only wanted what’s best for her.”According to Cody, Paul felt guilty that he wasn’t able to spend more time with his daughter, because he was busy filming movies.Cody shared: “He loved being a dad. He had a lot of guilt for not being able to always be there. That’s why Paul didn’t like the industry.”Last year, Meadow claimed that she still receives signs from her dad.The 26-year-old model – who starred in ‘Fast X’, the latest movie in the ‘Fast and Furious’ franchise – believes that she still has a connection with the movie star.Meadow told E! News: “For me, it’s numbers, four and seven are my dad’s favourite numbers. And I swear whenever I’m doubting anything or whenever I’m in an argument with someone or anything, I start seeing four and seven everywhere. So I always know that it’s him.”Even yesterday, I was having a moment and then the clock bells started ringing. And I was like, ‘OK, it’s all good, it’s gonna be OK.'”Paul played the part of Brian O’Conner in the hit film franchise, and Meadow was thrilled to have played a part in ‘Fast X’.She shared: “For me this is super exciting and he would be amazed that this is happening.”