Connect with us


Transcatheter tricuspid valve repair is effective in the real world



Real-life data collected in Europe outside of clinical trials support both the safety and benefits of two edge-to-edge (TEER) transcatheter devices designed specifically for the treatment of tricuspid regurgitation (TR).

For the TriClip system (Abbott), data was obtained from a prospective post-marketing registry, and for the EVOQUE system (Edwards Lifesciences), data was obtained from a charity program.

The TriClip system is approved and available in Europe, but neither system is approved by the US regulators.

Two sets of data, each presented at the annual meeting of the European Association for Transcutaneous Cardiovascular Interventions, are consistent with controlled trials. Each system was associated with high procedural success rates, low rates of adverse events, and sustained improvements in quality of life.

Real backup for TRILUMINATE

Submitted just a few days before the flagship multinational TRILUMINATE study was published in New England Journal of Medicinea post-marketing study with the bRIGHT TriClip device showed a successful procedure and subsequent reduction in TR that was at least as good, but in significantly ill patients.

“To evaluate these results, you have to evaluate the baseline TR level in our population,” said Philipp Lurtz, MD, Leipzig Heart Center, University of Leipzig, Germany. Whereas only 70% of patients randomized to TRILUMINATE had a grade 4 (massive) or 5 (torrential) TR, in bRIGHT this proportion was 90%.

The proportion with TR of moderate or less severity was 77% when assessed after 30 days in bRIGHT compared to 72%, however, when assessed after 1 year in TRILUMINATE. In addition, the success of procedures in both studies was 99%, despite the fact that patients in bRIGHT were on average older and had more comorbidities. At baseline, 80% of patients with bRIGHT were New York Heart Association (NYHA) class III or IV. heart failure compared to 59% in the TRILUMINATE group.

The TRILUMINATE data, presented prior to publication at the American College of Cardiology annual meeting earlier this year, did not link transcatheter TR repair with reduced mortality or reduced hospitalizations for heart failure, which were the first two of three hierarchical outcomes. endpoints, but it did show benefit in a third, namely quality of life. According to the Kansas City Cardiomyopathy Questionnaire (KCCQ), patients in the transcatheter repair group scored 12.3 compared to 0.6 (12).P < 0.001) on drug therapy.

In the bRIGHT registry, patients scored 19 on the KCCQ scale after treatment. By day 30, the proportion of patients with NHYA class III/IV decreased from 80% to 20%. The rate of major adverse events of 2.5% at 30 days was only slightly higher than the rate of 1.7% at 30 days in TRILUMINATE.

“The safety profile remained strong despite the heavier population treated in the registry,” said Lurtz, whose results were simultaneously published in the Journal of the American College of Cardiology (JACC).

The analysis of the bRIGHT registry was based on 511 patients treated in 26 centers in Europe. Lurtz described it as “the first prospective, single-arm, open, multicenter, aftermarket registry to evaluate the safety and efficacy of any transcatheter tricuspid catheter. valve repair system.”

In a panel discussion following the presentation, Nicole Karam, MD, co-head of the heart valve department at the Georges Pompidou Hospital in Paris, praised the field study of the TEER tricuspid valve device, but indicated that the question of who to treat remains unanswered. While symptom relief is important for a condition that can lead to a significant reduction in quality of life, she called for more data to identify optimal candidates, especially if there is consistently no significant impact on hard endpoints.

Lurz agreed. In the bRIGHT study, predictors of moderate or smaller FR at discharge included shorter tether distance, smaller right ventricular diastolic size, smaller right atrial volume, and smaller tricuspid annulus diameter.

Each of these predictors favors earlier treatment, he says, even though later treatment in clinical trials is more likely to eventually show benefits on hard endpoints.

“Remarkable cut”

Evidence from a much smaller compassionate evaluation of the use of the EVOQUE system resulted in similar evidence for safety and benefit, and showed that earlier intervention was more likely to prevent irreversible progression. At a much longer follow-up, a compassionate use analysis, in which patients participated even in a more severe condition than patients included in bRIGHT, showed that these repairs are durable.

In this retrospective analysis of 38 patients treated at eight centers in Europe, the US, and Canada, mortality increased steadily over 2 years of follow-up, reaching 29% at 2 years, despite TR being reduced to <1%. after the procedure and remained long-term suppressed at a median follow-up of 520 days.

Tricuspid valve repair with the EVOQUE system “was associated with a significant reduction in heart failure symptoms and a significant improvement in NYHA functional class up to a maximum of 1074 days post-intervention,” said Lukas Stolz, MD, Interventional Cardiologist at Ludwig Maximilian University, Munich .

In the data he presented at EuroPCR, which were published simultaneously in a letter to JACC, he reported that favorable right ventricular remodeling, which was observed as early as 30 days after the procedure, was maintained at long-term follow-up.

Uncontrolled compassionate data, such as the bRIGHT registry, could not confirm that tricuspid repair alters the trajectory of progressive heart disease, but the positive effects reported by Stoltz on cardiovascular function, not just symptoms, support this idea.

Lurz has financial relationships with Edwards Lifesciences, ReCor and Abbott, which funded the bRIGHT registry. Karam reports financial relationships with Abbott, Edwards Lifesciences and Medtronic. Stoltz reports no potential conflicts of interest, but the other retrospective co-investigators have a financial relationship with Edwards Lifesciences, which is developing the EVOQUE system.

This story originally appeared on MDedge.compart of the Medscape professional network.


More than 1 in 6 adults suffer from depression, according to the survey, as depression reaches an all-time high in the US.




According to new report from Gallup.

About 18% of adults — more than 1 in 6 — say they have depression or are being treated for depression, up 7 percentage points from 2015, when Gallup first began conducting surveys on the topic.

According to the survey, nearly 3 in 10 adults have been clinically diagnosed with depression at some point in their lives, also a record high.

The Covid-19 pandemic has taken an undeniable toll on mental health. Rates of clinical depression have risen steadily in the US but have “rebounded markedly” in recent years, Gallup data shows.

“The fact that Americans are more depressed and struggling after this period of incredible stress and isolation is perhaps not surprising,” the doctor said. Rebecca Brendel, President of the American Psychiatric Association who did not participate in the new study. “There are lingering effects on our health, especially our mental health, over the past three years that have eroded everything we knew.”

But experts say mental health awareness has grown, which could lead to more diagnoses — and that’s a good thing.

“We simplify the conversation about mental health and consider it as part of our overall well-being, just like physical health,” Brendel said. “People are aware of depression and people are seeking help.”

The younger generation is especially willing to talk about mental health issues, she says. But the Covid-19 pandemic has also disrupted key growth periods for young people, which may have made them more susceptible to depression-causing factors.

According to a Gallup poll, young people report higher rates of depression than any other age group and the biggest increase in years. Nearly a quarter of adults under 30 say they are currently depressed.

Lifetime rates of clinical depression are significantly higher among women, with rates rising twice as fast as men. More than a third of women said they had been diagnosed with depression at some point in their lives, compared with a fifth of men, according to the survey.

In addition, for the first time, lifetime rates of clinical depression among blacks and Hispanics equaled or exceeded those among white adults.

“Depression has many different manifestations. Connecting with cultural norms and belief systems is something that the APA and other organizations have been paying much more attention to in recent years,” Brendel said.

Recent updates to the Diagnostic and Statistical Manual of Mental Disorders, the formal guide to the clinical assessment of mental health conditions, have included cultural language interviews to help keep the individual experience at the center of attention.

But as demand for mental health services grows, the US is facing a severe shortage of providers. The US needs more than 8,000 mental health practitioners to fill the gap, according to the Health Resources and Services Administration.

There is a wide range of treatment options available, including support from primary care physicians and workplace benefits.

“Depression is treatable,” Brendel said. “The sooner we ask for help, the more effectively and quickly it will help us get back on track.”

Continue Reading


According to Judge Gorsuch, emergency COVID orders are among the “most serious infringements on civil liberties.”



WASHINGTON– The Supreme Court got rid of the pandemic-related immigration case with one verdict.

Judge Neil Gorsuch had much more to say, sharply criticizing the way governments, from small towns to the nation’s capital, have responded to the biggest public health threat in a century.

The judge, a 55-year-old conservative who was President Donald Trump’s first Supreme Court nominee, called the emergency measures taken during the COVID-19 crisis, which has killed more than 1 million Americans, perhaps “the greatest assault on civil liberties in the history of peace.” time.” this country.”

He pointed to orders to close schools, limit church services, make vaccines mandatory, and ban evictions. His volleys were aimed at local, state and federal officials – even his colleagues.

“Executive officials across the country have issued emergency decrees on a breathtaking scale,” Gorsuch wrote on Thursday in an eight-page statement that accompanied a pending Supreme Court ruling formally closing a case involving the use of Section 42 policy to prevent infiltration of asylum seekers. , to country. United States.

The policy was terminated last week with the expiration of the public health emergency first declared over three years ago due to the coronavirus pandemic.

Since starting his tenure on the Supreme Court in 2017, Gorsuch, a Colorado native who enjoys skiing and cycling, has been more inclined than most justices to part ways with his colleagues, both left and right.

During his six years as a judge, he largely voted with other conservatives, joining the majority that reversed the decision against Roe. Wade and expanded gun rights last year.

But he took a different course on some issues, writing a 2020 court opinion that extended federal protections against discrimination in the workplace to include LGBTQ people. He also joined liberal judges in support of Native American rights.

When the omicron option skyrocketed in late 2021 and early 2022, Gorsuch was the only judge to show up in the courtroom without a mask, even though his neighbor Judge Sonia Sotomayor, who has diabetes, reportedly did not feel safe in close contact with people who were not clothed. masks

So Sotomayor, who continues to wear a mask in public, did not take a seat with the other judges in January 2022. The two judges denied reports that they were at odds on the issue.

The emergency orders that Gorsuch complained about were first announced in the early days of the pandemic when Trump was president and months before the virus was well understood and a vaccine was developed.

The essence of his complaint is not new. He has previously written on individual cases brought to court during the pandemic, sometimes disagreeing with orders that upheld emergency orders.

Judges have intervened in several COVID-related cases.

When Gorsuch and five other conservatives were in the majority, they lifted the moratorium on evictions and blocked the Biden administration’s plan to require employees of large companies to be vaccinated or wear masks and undergo regular tests. After Amy Coney Barrett joined the court, after the death of Ruth Bader Ginsburg they lifted restrictions on religious services in some areas.

By a vote of 5 to 4, disagreed by Gorsuch and three of his conservative colleagues, the court allowed the administration to require many medical workers to be vaccinated.

But on Thursday, Gorsuch collected his complaints in one place, writing about the lessons he hoped to learn from the past three years.

“One lesson might be this: Fear and the desire for security are powerful forces. They can lead to a call to action – almost any action – if someone does something to eliminate the perceived threat. A leader or expert who claims he can fix everything if we only do exactly as he says can be an unstoppable force,” he wrote.

Another possible lesson he wrote: “The concentration of power in the hands of a small number of people can be effective and sometimes popular. But this is not conducive to healthy government.”

He also had strong words for the Republican-led states that were trying to keep the Section 42 policy and the five conservative judges whose votes extended the policy five months after it would have otherwise ended at the end of December.

“At the very least, it is to be hoped that the judiciary will not soon allow itself to become part of the problem again by allowing litigants to manipulate our list of cases to perpetuate a ruling meant for one emergency to solve another,” Gorsuch wrote.

In the last paragraph of his statement, Gorsuch acknowledged, but only reluctantly, that emergency orders are sometimes needed. “Make no mistake—strong executive action is sometimes necessary and appropriate. But if emergency decrees promise to solve some problems, they threaten to create others,” he wrote.

Continue Reading


Jennifer Garner just wore the freshest summer take on a revealing corset dress



Jennifer Garner has just unveiled a casual summer take on one of this year’s sexiest trends: open corset dresses.

On May 18, Garner walked out in a light, off-the-shoulder corset dress at the Charter Oak Hotel in St. Helena, California for the Rockout/Knockout Cancer event hosted by Garner and Elise Walker to raise money for St. Helena Hospital. Foundation and early detection of cancer. Alexander McQueen’s dress, which sells for $3490features a midi skirt, corseted bodice with visible underwire, and perhaps most importantly, pockets!

While the visible corset lends a modern edge to the summer dress, Garner has looked the part for the past three decades in brown platform sandals, gold bangles and hoop earrings. She completed the classic ensemble with light, shimmery makeup and wore a shoulder-length bob in loose waves. Now that’s all how you take a trend and make it last forever.

Kelly Sullivan/Getty Images

Jennifer Garner is currently filming an Apple TV+ miniseries. The last thing he said to menear Game of Thrones actor Nikolai Coster-Waldau. During a recent interview with People, Garner opened up about the prank that Coster-Waldau played on her while filming the emotional drama. “I talked to Josh [Singer], and it seemed to me that the background player came up and sat next to me,” Garner shared. And Josh started to smile. And this person became more and more comfortable around me, and I thought, “I don’t know you.”

It turns out that it was Coster-Waldau in a completely new image. “I immediately was just… I was so shocked. He had a beard,” she explained. “They were checking his appearance for the last scene. And he just totally, totally took me by surprise. And, you know, I cried and yelled at them. And then we moved on.”

Continue Reading


Copyright © 2023 Millennial One Media.