Results Support Therapeutic Intra-vascular Ultrasound (TIVUS) for - Pulmonary Hypertension News

Results Support Therapeutic Intra-vascular Ultrasound (TIVUS) for - Pulmonary Hypertension News
The Significance of Databases for PAH - MD Magazine
Grant Will Award Up to $1 Million in Pulmonary Hypertension Research - The Cardiology Advisor
Bayer Grant Will Award Up to $1 Million in PAH, CTEPH Research - Pulmonology Advisor

Posted: 31 May 2019 06:00 AM PDT

New data support the safety and effectiveness of TIVUS (therapeutic intra-vascular ultrasound) for patients with pulmonary arterial hypertension (PAH) on a stable treatment regimen.

The data were recently presented at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EuroPCR), in Paris.

In PAH, small arteries inside the lungs become constricted. This creates resistance, making it harder for the heart to pump blood from the right ventricle to the lungs, resulting in high blood pressure (hypertension) in the pulmonary arteries.

Combination therapy with two oral medications to reduce pulmonary vascular resistance is now regarded as the standard of care in PAH. However, many patients continue to have symptoms.

The autonomic nervous system, which is responsible for controlling vital functions such as breathing and heart rate, plays an essential role in constricting or dilating blood vessels. The sympathetic system constricts vessels and the parasympathetic system dilates them.

Scientists believe vascular constriction in PAH may be a sign of a sympathetic system on overdrive.

"A growing body of data suggests that the sympathetic nervous system may play an important role in the pathogenesis of PAH. Decreasing sympathetic activity may help to reduce symptoms and slow disease progression," Alex Rothman, MD, PhD, who presented the TIVUS results at EuroPCR, said in a press release.

The TIVUS system is a therapeutic catheter developed by SoniVie (formerly known as Cardiosonic) that is introduced into the pulmonary artery during a right heart catheterization procedure. The catheter produces ultrasound, which selectively ablates the sympathetic nerves that constrict the pulmonary arteries without damaging the vessel walls or adjacent tissues.

Rothman presented results on the safety, performance, and initial effectiveness of the TIVUS System at EuroPCR in an oral session, "Percutaneous therapeutic intravascular ultrasound pulmonary artery denervation for the treatment of pulmonary arterial hypertension (TROPHY1): a multicenter, international, open-label trial."

TROPHY1 (Treatment Of Pulmonary Hypertension 1; NCT02835950 and NCT02516722) was conducted at eight clinical sites in Europe, Israel, and the United States. It involved 23 Functional Class III PAH patients who were on an established regimen of dual-oral medical therapy. Functional Class III means that patients showed symptoms and marked limitation of activity.

TROPHY1 data showed that there were no serious adverse events related to the TIVUS device or procedure. Five months after the procedure, pulmonary vascular resistance decreased by a mean of 17.8% in patients, and the six-minute walk distance increased by 42 meters (the 6-minute walk test measures aerobic capacity and endurance). Daily activity increased with respect to baseline values.

A reduction in baseline pulmonary vascular resistance of more than 10% was observed in 70% of the patients, and 40% had a reduction of more than 20%. Improvements in mean pulmonary artery pressure and right atrial pressure were also observed.

However, at five-month follow-up, no significant changes were identified in quality of life or in N-terminal pro b-type natriuretic peptide levels (a hormone produced in the heart in response to heart failure or cardiac dysfunction).

"The favorable safety and initial efficacy results observed to date in TROPHY1 suggest that TIVUS improves cardiopulmonary function and daily activity in PAH patients. Additional studies of this innovative approach to PAH therapy are warranted, as many patients continue to have symptoms on current treatment options," Rothman said.

Chuck Carignan, MD, chief executive officer at SoniVie, said: "The completion of TROPHY1 is an important milestone for the company, and the results provide a solid foundation on which to advance the clinical and regulatory development of the TIVUS System. We expect to initiate a pivotal trial in 2020."

The Significance of Databases for PAH - MD Magazine

Posted: 30 May 2019 05:30 AM PDT

Patients who present with symptoms of pulmonary arterial hypertension could land on any spot of a spectrum which indicates minimal to significant risk of comorbidities, and even mortality. The uncommon, burdensome condition often requires that patients are receiving optimized therapy early and aggressively following diagnosis.

That puts pressure on investigators to broaden their access to clinical data. In an interview with MD Magazine®, Rich Channick, MD, director of the Acute and Thromboembolic Disease Program at the UCLA Medical Center, and Prof. Sean Gaine, director of the National Pulmonary Hypertension Unit in Ireland, explained the utility of national, international registries of PAH patients, and how it influences their ability to identify low- and high-risk patients.

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MD Mag: How critical are broad database in assessing care of patients with a rare, chronic condition such as PAH?

Channick: Yeah, I mean there's a lot of creative ways to get data. A lot of people are using claims data, insurance claims, instead of getting a big data. You can find a lot of patience. And now with coding, diagnostic codes, you look at pulmonary hypertension as a code for an insurance claim.

Obviously, there's a lot of different insurance companies. It's different in other countries, but you can really then look at different testing that has been done, what drugs are getting used, and patterns of use. You often can't get very granular, as we say, a higher view. But you can look at it a lot of patients.

Gaine: Yeah, in fact, we saw it at our session today, that we were presenting the GRIPHON data from the VA (Veterans Affairs). So the VA is an enormous database, and patients who attend VA have pulmonary hypertension—some of them—and you can gather data from there. So there are those are national registries that we pour through, not just registries from drug trials and seeing how patients are using them, but the national registries. And we learn a lot from them.

We've learned in the last few years that PAH as a disease seems to be sort of shifting—or at least what we're seeing is older patients that we wouldn't have seen previously. So we have to reset where to look for the disease. We used to say, "Oh, this is a disease of idiopathaty from the arterial hypertension." Formerly, primary pulmonary hypertension was a disease in young women in their mid-30s. So you knew where to look, in the sense of when a young woman arrived in breathless. You thought, this is unusual, maybe it's primary pulmonary hypertension, maybe it's idiopathic pulmonary hypertension.

Now we've learned from these registries that it's not necessarily always the case. You may have a 55 year old person who comes in says, "I'm breathless." You're thinking, well you're not doing any exercise, that's why you're breathless. But, in fact—normal pulmonary function, normal chest, X-ray, ECG. They need to go for an echo, and the echo is the number 1 screening tool to see if a person has problems with the right ventricle. So again, in primary care, someone comes in and it just doesn't fit, think of an echo as a really valuable screening tool.

Channick: Yeah, the last thing I'd say about registries—especially all the registries in Europe and elsewhere—is they have allowed us to start to look at things like risk stratification. One of the big mantras in pulmonary hypertension is determining what risk category are patients in, based on composite parameters—coming up with scores where we can actually profile a patient.

And when you treat a patient with these therapies, they determine whether they are into what we call the low-risk category, meaning they'll have a good prognosis. We quantify that. So, these registries have really allowed us both to develop some of these scores, and then validate them to show that it actually are predictive.

And that's really how we're treating. We have the GRIPHON subgroup to really look at the ability of the agent to lower risk, to put people into a low-risk category—that's really important in our treatment.

Grant Will Award Up to $1 Million in Pulmonary Hypertension Research - The Cardiology Advisor

Posted: 30 May 2019 10:00 PM PDT

Pulmonary Hypertension Accelerated Bayer Awards, a new program launched by Bayer US, will award up to $1 million in grants to support clinical research in pulmonary hypertension, with a focus in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

Grant applications will be open to physician practitioners and nonphysicians in the United States starting May 28 through June 30, 2019. Applicants will be expected to submit letters of intent with a short proposal that will be reviewed by an independent Grants Review Committee of 6 to 8 leading medical experts. After the initial evaluation, applicants will be invited to submit a full proposal by August 31, 2019.

The applications can be submitted within 4 categories of clinical research:

Level 1 is appropriate for investigators wishing to conduct a single center or restricted multicenter clinical trial in <5 sites in the United States. The award value is worth up to $200,000 total, the duration is for 2 years, and the maximum number of new awards per year is 2.

Level 2 is appropriate for early to midcareer professionals working pulmonary hypertension. The award value is worth up to $150,000 total, the duration is for 2 years, and the maximum number of new awards per year is 2.

Level 3 is appropriate for fellows and will be supporting research completed within the first 2 years of the applicant's first faculty position. The award value is worth up to $100,000 total, the duration of the award is for 2 years, and the maximum number of new awards per year is 2.

Level 4 is appropriate for allied health professionals working in pulmonary hypertension, including nurses, nurse practitioners, physiotherapists, pharmacists, and psychologists. The award value is worth up to $50,000 total, the duration of the award is for 1 to 2 years, and the maximum number of new awards per year is 2.

"The Pulmonary Hypertension Accelerated Bayer Awards is a reflection of our commitment to ensuring continued advancement in pulmonary hypertension science and care, and to the continued growth of young scientists, clinicians, and allied healthcare professionals involved in pulmonary hypertension research and education," said Aleksandra Vlajnic, MD, Vice President of Medical Affairs at Bayer in a press release.

The deadline for the letter of intent submissions is 12:00 AM PST, June 30, 2019. The entries will be evaluated on "significance, investigators, innovation, approach, and environment."

Reference

Bayer launches Pulmonary Hypertension Accelerated Bayer (PHAB) Awards to help propel clinical advancements forward with up to 1 million dollars in grants [news release]. Whippany, NJ: Bayer; May 20, 2019.

This article originally appeared on Pulmonology Advisor

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Bayer Grant Will Award Up to $1 Million in PAH, CTEPH Research - Pulmonology Advisor

Posted: 24 May 2019 12:00 AM PDT

The applications can be submitted within 4 categories of clinical research:

The deadline for the letter of intent submissions is 12:00 AM PST, June 30, 2019. The entries will be evaluated on "significance, investigators, innovation, approach, and environment."

Reference

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PAH Pulmonary Hypertension

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