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Procyrion Aortix’s CRS Impact | RV’s Week in the Spotlight March 30, 2023
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Together with
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“The underdog, the often bypassed ventricle, underappreciated like the grant-less master clinicians in academia. Viva right ventricle!”
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Penn Medicine’s Saurabh Jha, MBBS, celebrating RV’s long-awaited week in the spotlight.
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Surgeries & Interventions
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Data presented at THT 2023 showed that Procyrion’s Aortix pump leads to rapid decongestion and improved kidney function in hospitalized patients with cardiorenal syndrome (CRS), representing a key milestone for Procyrion and potentially for CRS treatment.
CRS is a hard-to-treat condition defined by acute decompensated heart failure and worsening renal failure. CRS impacts 40% of patients with ADHF, many of whom are still congested after four days of therapy (up to 90%) and following hospital discharge (up to 60%).
The Aortix pump is designed to treat those unresponsive CRS patients. It’s placed in the descending thoracic aorta via a percutaneous catheter procedure (~45min), and is used to simultaneously unload and rest the heart and increase kidney perfusion.
The 10-center pilot study treated 18 CRS patients with the Aortix pump for an average of 4.6 days, after they didn’t respond to standard treatments for an average of 9 days. Following the Aortix pump treatments, the patients achieved:
- Rapid decongestion – shed an average of 10.7 liters of excess fluid
- Decreased filling pressure – CVP and PCWP dropped by over 33%
- Improved kidney function – eGFR increased by a median of 29% at 30 days
- Improved cardiac function – NT-proBNP decreased by a median of 34% at 30 days
- Reduced shortness of breath – symptoms reduced by 46% at 30 days
Roughly half of the patients experienced serious adverse events, although none involved death, device failure, thromboembolic events, or limb ischemia. All of the events were procedure-related, indicating a need to refine training materials and anticoagulation requirements.
This study didn’t generate much social buzz, and heart failure physicians will want to see how Aortix’s performance holds up in a RCT. However, most would likely agree that CRS therapy remains a large clinical problem, especially among unresponsive patients like those in this study.
More importantly than social buzz, the pilot study did seem to generate enough evidence to support Procyrion’s upcoming DRAIN-HF pivotal trial, which would put Aortix on track for FDA approval within three or four years if everything goes well.
The Takeaway
Procyrion still has plenty to prove, but these initial clinical results certainly show the Aortix pump’s potential to improve unresponsive CRS patients’ treatments and outcomes. That could be a big deal given the high-and-growing prevalence of CRS and the poor prognosis that unresponsive CRS patients face.
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Automating Echo Strain Analysis
Check out our Q&A with Us2.ai president and co-founder, Yoran Hummel, discussing how his career as a sonographer led him to echo AI, and how Us2.ai’s upcoming automated strain analysis feature brings the company even closer to democratizing echo.
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Evolving Coronary Disease Imaging Pathways
HeartFlow’s PRECISE trial showed that their precision approach for evaluating stable chest pain avoids unnecessary testing and improves care – without risking missed heart disease diagnoses. In this Cardiac Wire Show, HeartFlow’s Chief Medical Officer Dr. Campbell Rogers dives into the PRECISE trial results and its implications for clinical practice.
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Accurately Measuring Heart Rate Variability
Heart rate variability measurement and analysis involves two critical elements – the ability to accurately discern the R wave in noisy environments, and using the correct analysis method for a given application. Check out how Monebo’s Kinetic HRV ECG Algorithm excels at both of these essential tasks.
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- A Very Special RV Review: The right ventricle doesn’t always get the attention it deserves, but it currently has the focus of many in cardiology after NEJM published an extremely popular review on RV failure. NEJM describes the paper as a discussion of “the mechanisms, clinical presentation, and evaluation of right ventricular failure, as well as its management,” which is a bit drier than reviews seen on Cardiology Twitter calling it “the best ever,” “a joy to read,” “beautiful,” and “blisteringly good.”
- Is CCTA Set for AS Screening? A new study out of Denmark supports coronary CTA’s potential for population-based atherosclerosis screening. The researchers performed CCTAs on 9,533 asymptomatic individuals (all over 40yrs), finding evidence of subclinical coronary atherosclerosis in 46% of subjects. Moreover, participants with extensive atherosclerosis, obstructive atherosclerosis, or both extensive and obstructive disease had extremely high risks of myocardial events over a median follow-up of 3.5 years (8x, 9x, and 12x higher risk).
- Mitochondria Transplants’ Cardiac Potential: Northwell Health researchers added more evidence that mitochondria transplants might help heal hearts and other organs damaged during cardiac arrest. The researchers resuscitated 33 rats after 10 minutes in cardiac arrest, and then injected them with either fresh mitochondria, damaged frozen-thawed mitochondria, or a solution without mitochondria. After three days, rats that received fresh mitochondria had far higher survival rates (91% vs. 55%), and showed greater improvements in biomarkers associated with tissue and neurological recovery.
- Medinbox & Abbott’s EP Alliance: Medinbox announced an electrophysiology alliance with Abbott, integrating Medinbox’s smart video collaboration solution with the Abbott EnSite X EP cardiac mapping platform, and making Abbott its exclusive global distributor for electrophysiology. The new EnSite Connected Care solution combines Abbott’s EnSite Connect Remote Support tool with the Medinbox solution, allowing EP labs to record and share live case streams, and access remote support for complex ablation procedures.
- No Obesity Paradox: A new European Heart Journal study contends that there’s no ‘obesity-survival paradox,’ debunking a longstanding theory that obese individuals with heart failure have better outcomes than normal-weight individuals with HF (based on BMI). The researchers analyzed data from 8,399 people with HFrEF, comparing outcomes across various obesity metrics. After adjusting for other risk factors (e.g. natriuretic peptide levels) and changing their obesity metric from BMI to waist-to-height ratio, overweight patients actually had higher risks of HF hospitalization and death.
- Milestone’s Strategic Financing: Milestone Pharmaceuticals followed up on its etripamil PSVT treatment’s successful Phase 3 results by adding $125M in strategic financing to fund its FDA approval and commercialization processes through mid-2025. Etripamil is a calcium channel blocker nasal spray that allows patients to treat their PSVT attacks outside the ED, which could prove to be a valuable self-management option given that these patients often experience unexpected cardiac arrhythmia episodes.
- Remote Monitoring Improves HF Risks: A meta-analysis of three trials (CHAMPION, GUIDE-HF, and LAPTOP-HF) found that remote hemodynamic monitoring could reduce HF hospitalizations and all-cause mortality in patients with HFrEF. The monitored patients had a mortality rate up to 25% lower than the controls at two years, highlighting RM’s potential to help doctors proactively adjust treatment plans before the disease worsens, potentially saving lives. The CHAMPION and GUIDE-HF trials both used Abbott’s CardioMEMS system, while the LAPTOP-HF trial used Abbott’s Left Atrial Pressure Monitoring System.
- Service Tech Shortage: You’ve experienced the ongoing staffing shortages within cardiology’s clinical teams, but there’s also a looming shortage of biomedical equipment techs who service their devices. Becker’s Hospital Review reports that many technicians are getting close to retirement age, and there’s not enough new biomedical techs entering the workforce due to a decline in training programs. In just the last few years, 25 biomed training programs were shut down, leaving 17 states with no programs at all.
- Early Rhythm Control’s Cost Effectiveness: Early rhythm control can be cost effective, in addition to clinically effective. That’s from analysis of 1,664 German patients over six years (832 w/ ERC) that found ERC added €1,924 in annual costs per patient, or €10,638 per additional year without a primary outcome (CV death, stroke, or related hospitalization) and €22,536 per life year gained. At a willingness-to-pay value of ≥€55k, ERC would be more cost effective for ≥95% of patients per year without a primary outcome and for ≥80% of patients per life year gained.
- AHA/ACC’s HFpEF Exercise Therapy Statement: A new AHA/ACC Scientific Statement strongly supports supervised exercise training for patients with HFpEF, highlighting exercise’s broad range of benefits and proven safety. They also called for the creation of reimbursements for clinicians who supervise HFpEF patients’ exercise, noting that exercise reimbursements are available with HFrEF patients (who seem to have fewer benefits) and suggesting that exercise is more economical than drug treatments.
- Social Media’s Physician Influence: More than half (57%) of physicians in the US alter their view of a medication or treatment based on social media content, and 41% have changed their prescribing practices due to information on social media. That’s from a recent survey (200+ physicians, 50+ pharma marketers) conducted by a physician engagement platform company and a social media solutions firm. Unsurprisingly, 90% of the surveyed pharma marketers are leveraging social media and 50% anticipate a greater portion of their budget will go toward social ads in the coming year.
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PIA Medical Processes It All
Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.
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Preparing for the Future of Cardiovascular Data and Analytics
There’s plenty of short term benefits to cardiology data analytics, but it’s just as important for providers to make sure they’re ready for the future of cardiology analytics. This Change Healthcare article with Dr. Jennifer Hall, chief of data science at the American Heart Association, examines what technology leaders can do today to facilitate their future advancements in cardiovascular data and analytics.
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Personalized Care Pathway for Heart Attack Prevention
More than 50% of patients who suffer a heart attack are considered “low risk” based on symptoms, but in fact do have plaque build up. Cleerly tackles the matter head-on in their 5-step care pathway for early diagnosis, informed decision making, and personalized treatment.
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