Results Support Therapeutic Intra-vascular Ultrasound (TIVUS) for - Pulmonary Hypertension News
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
- Owlstone, Actelion Team to Develop Breath-based Test for Diagnosing PH - Pulmonary Hypertension News
| Results Support Therapeutic Intra-vascular Ultrasound (TIVUS) for - Pulmonary Hypertension News 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  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. 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.  |
| Owlstone, Actelion Team to Develop Breath-based Test for Diagnosing PH - Pulmonary Hypertension News Posted: 30 May 2019 05:00 AM PDT Owlstone Medical has established a strategic collaboration with Actelion Pharmaceuticals to develop and validate a breath-based diagnostic test for different types of pulmonary hypertension (PH). Actelion Pharmaceuticals will solely fund this discovery and development program. The test will be based on Owlstone's non-invasive method called Breath Biopsy, in which the patient's breath is sampled to identify PH-specific volatile organic compounds (VOC) that can serve as diagnostic markers. "Owlstone Medical was founded with the objective of improving the early diagnosis of disease in order to save lives through the application of Breath Biopsy. This strategic collaboration with Actelion, which is focused on improving the lives of those suffering from PH and PAH [pulmonary arterial hypertension], represents a tremendous opportunity to do just that," Billy Boyle, co-founder, and CEO at Owlstone Medical, said in a press release. "This is particularly true in underdiagnosed areas such as PH, where early diagnosis is difficult and so screening has to be simple, reliable, and cost effective," Boyle added. PH is a progressive condition caused by the narrowing of blood vessels, which restricts blood flow, causing an excessive increase in blood pressure in vessels and added strain on the heart. Routine physical exams do not detect the early signs of PH, and the symptoms of advanced PH are very similar to those of other heart and lung conditions, thereby increasing the chances of misdiagnosis. Also, diagnosing the type of PH is critical because it determines the course of treatment. That is why early screening and proper detection are crucial in the management of PH, emphasizing the need for efficient tests that are simple, specific, reliable, and cost-effective. Of note, VOCs are the result of metabolic processes within the body, meaning that changes in metabolic activity can be associated with particular VOC patterns characteristic of specific diseases. As part of this collaboration, exhaled breath samples containing VOCs will be collected from more than 1,000 patients from the United States, the United Kingdom, and other counties in the European Union. ReCIVA, Owlstone Medical's proprietary VOC sampling device, will be used to collect the samples. The samples then will be analyzed by Owlstone Medical to identify PH-specific signatures that can be developed as biomarkers to help in early PH detection. "We believe Breath Biopsy will deliver a program from discovery through to the launch of a test to the market, and this novel approach will make a real difference for the healthcare of patients suffering from PH," Boyle said.  |
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