Cardiovascular Pharmacist Ricky Turgeon PharmD after Novo Nordisk’s semaglutide was found to improve a range of heart failure QoL metrics, and people actually paid attention.

Surgeries & Interventions

ReCor Medical Takes Renal Denervation Lead Following FDA Panel Review

The renal denervation votes are in, and they’re pointing in very different directions for ReCor Medical and Medtronic’s respective RDN devices. 

The companies argued their premarket approval cases to an FDA expert panel last week, and only ReCor walked away with panel support.

• The panel endorsed the ReCor Paradise System’s hypertension efficacy with a 8-3 margin (one abstained) and a unanimous 12-0 vote supporting its safety, leading to a solid 10-to-2 vote that the Paradise’s benefits outweigh its risks.
  
• The panelists supported the Medtronic Symplicity Spyral’s efficacy with a narrower 7-6 margin, and another unanimous safety vote, but only 6 out of 7 found that the system’s benefits outweigh its risks.

Although the judges still had plenty of concerns about study design and potential use, ReCor’s ultrasound-based RDN device passed with the help of its three sham-controlled RCTs, including two off-medication trials with a -4.5 mmHg average BP reduction.

Medtronic likely expected the panel to be challenging, given that only one of its catheter-based RDN system’s two trials met its primary effectiveness endpoint (for off-medication patients). The panelists did see how the Symplicity Spyral could benefit patients, but concerns about trial results, study design, and a mismatch between the results and the device’s proposed indication led to their decision against its PMA. 

Despite these very different results, both devices might still be on track for FDA approval, noting that the FDA often follows panel advice but isn’t obligated to, and some analysts still believe Medtronic could gain FDA approval. 

• Both devices are also already approved in Europe, and have more ongoing trials to support future regulatory decisions.

The Takeaway

Although the FDA’s actual decision is still pending, it’s hard not to view ReCor Medical as the new renal denervation frontrunner given its stronger study results and advisory panel acceptance. 

More notable from a patient care perspective, it appears that the US is closer than ever to having a FDA-approved renal denervation system available. That addition to clinicians’ hypertension treatment toolbox could be notable, given that millions of people are living with high BP that can’t be controlled with current medications (or with patients’ challenges with medication adherence).

AI Echo Copilot – The Future of Echocardiography

New technology from Us2ai called Us2.connect allows you to add AI automation to any echo device. Any echo machine can now have 100% automated reporting with disease detection and editable measurements – all generated in realtime as you scan.

A CCTA-Based Approach to Heart Attack Prevention

Cardiologists are increasingly relying on cardiac CT angiograms as a heart disease diagnostic tool. See what’s driving this trend in this Cleerly report detailing the key attributes of CCTA exams, evidence of its effectiveness, and CCTA’s medical guideline support.

The Wire

• Semaglutide’s HF Impact: Weeks after Novo Nordisk’s semaglutide (Wegovy / Ozempic) was found to reduce major cardiac event risks by 20%, new data at ESC 2023 reveals that the weight loss drug also improves key heart failure quality of life metrics. Researchers gave 529 obese patients with HFpEF either semaglutide or a placebo, finding that after 52 weeks the semaglutide group had greater average improvements to their KCCQ-CSS scores (+16.6 vs. +8.7 points), 6-minute walk distance (+21.5 m vs. +1.2 m), CRP levels (-43.5% vs. -7.3%), and of course bodyweight (−13.3% vs. −2.6%).

• Viz.ai Licenses UCSF Algorithms: Viz.ai signed an agreement with UCSF to license three ECG AI algorithms for automated detection of cardiac amyloidosis, pulmonary hypertension, and supraventricular tachycardia. Upon regulatory clearance, the new algorithms will join Viz.ai’s existing ECG algorithm for hypertrophic cardiomyopathy detection, along with a portfolio of imaging-focused algorithms in its Viz Cardio Suite.

• Colchicine’s Insignificant Impact: New data presented at ESC 2023 found that colchicine doesn’t significantly reduce perioperative AFib or myocardial injury after non-cardiac surgery (MINS) in patients who underwent major non-cardiac thoracic surgery. In the COP-AF trial, 3,209 patients took either colchicine or a placebo before and for 10-days after major non-cardiac thoracic surgeries, finding statistically similar levels of clinically important AFib (6.4% vs. 7.5%) and MINS (18.3% vs. 20.3%). However, the authors still saw some positive benefits from colchicine’s inflammation reduction.

• Patients Leaving ED Without Care: Rebounding ED volumes and growing wait times have led to a record number of patients leaving the ED without receiving complete care, according to EDBA data from over 1,500 EDs. The percentage of patients who left the ED before completing treatment increased from 2.7% in 2019 to 4.6% in 2022, amounting to roughly 7M patients and $1B in lost revenue. Much of that increase is explained by average boarding times (between patients arriving in the ED and transitioning to a hospital bed), which jumped from 121 minutes to 192 minutes over that same period.

• CCTA Fine-Tuning: A pair of PRECISE trial-based studies in JAMA Cardiology highlighted ways to improve CCTA and angiography exam decision making. In the initial study, 2.1k patients with stable CAD were randomized to receive standard testing (e.g. cardiac SPECT or catheterization) or “precision” testing with CCTA and FFR-CT analysis, finding that the precision pathway was far more efficient and similarly safe. A one year follow-up study on low-risk patients who had all testing delayed found that the delayed testing patients had fewer adverse events and a higher ratio of positive angiography exams.

• CCTA Predicts Plaque Risk: Meanwhile, in Radiology researchers used CCTA to predict which plaques were most likely to result in major adverse cardiac events in patients with non-ST-segment elevation (NSTE) and acute coronary syndrome. In a study of 342 people scheduled for invasive angiography, plaques with lipid core burden greater than 2.8% were far more likely to lead to MACE (HR: 12.6). These findings support use of CCTA for plaque characterization in NSTE patients, even after revascularization. 

• GE CardioVisio AF Launch: GE Healthcare kicked off ESC 2023 with the launch of its new CardioVisio for Atrial Fibrillation solution. The clinical decision support tool analyzes patient-specific longitudinal data (lab, echo, and ECG results, clinical parameters, previous diagnoses and interventions, etc.) and provides guideline-directed insights to support personalized AFib treatment decisions. CardioVisio for Atrial Fibrillation is now available in the U.S. and will expand to other countries in the coming months.

• GE’s Cardiac & Vascular Handheld Ultrasound: One day later, GE HealthCare unveiled its new Vscan Air SL handheld ultrasound scanner, which sports a dual-headed probe with sector and linear arrays, making it ideal for switching between cardiac and vascular assessments at the point of care. GE launched the Vscan line in 2010, although this is the first cardiac and vascular version of the truly-wireless Vscan Air platform that launched in 2021.

• Updated EU HF Guidelines: Europe’s updated heart failure guidelines are out, and they introduce a strong “class IA” endorsement for SGLT2 inhibitors for HFmrEF and HFpEF patients, going a step beyond the US’s “class IIa” recommendations (for now anyway). The new guidelines also emphasize 1) early initiation and titration of oral meds for hospitalized HF patients and proactive medication management after discharge, 2) intravenous iron supplementation in iron-deficient HFrEF and HFmrEF patients, and 3) the preventative use of SGLT2is or finerone in people with chronic kidney disease and type 2 diabetes. 

• Cardiac Images Scare Patients Straight: Showing patients medical images of their own heart structure can inspire some to lead healthier lifestyles. In JACC: Cardiovascular Imaging, researchers analyzed six trials encompassing 7.1k patients with subclinical atherosclerosis who were shown their own CT coronary artery calcium or carotid ultrasound images. Follow-up at 10 years showed a 0.91% improvement in Framingham risk score (P=0.01) as well as statistically significant reductions in LDL, total cholesterol, and systolic blood pressure (P<0.05).

• Missing the Mark on Stroke Guidelines: When someone having a stroke arrives at the ER but needs procedures at another hospital, current guidelines say that no more than 120 minutes should elapse between arrival and departure. New research in JAMA found that nearly 2,000 US hospitals miss that mark by almost an hour, with the median door-in-door-out time clocking in at 174 minutes. Black, Hispanic, female, and over-80 patients all experienced longer times, with COVID also tacking on an extra 16 minutes between 2019 and 2021.

Optimizing Your Post-Processing Workflow

The growth of cardiac CT and CMRI volumes and continued shortages in the imaging technologist workforce can mean big challenges for imaging organizations. Join this Cardiac Wire Show starring Precision Image Analysis’ Jim Canfield and Cleveland Clinic’s Scott D. Flamm, MD, MBA to see how outsourcing cardiac image post-processing can solve this problem, while improving efficiency, accuracy, and standardization.

Upcoming master class: Multimodality imaging for cardiac interventions

Join Dr. Nicolo Piazza for a five-session master class delving into chamber views, projection curves, and advanced imaging. The first session kicks off on September 18 at 7:30 p.m. ET. Don’t miss it!

The Resource Wire

• Looking to optimize your cardiovascular imaging services, but don’t know what to measure? Check out this Change Healthcare report for insights on how to track and evaluate your cardiovascular imaging performance, assess quality, and enhance operational efficiency. Read the full article now and start measuring what matters!

• HeartFlow’s new RoadMap Analysis solution allows CT readers to accurately, efficiently, and consistently identify stenoses in the coronary arteries. See how RoadMap Analysis’ visual and quantitative insights into the narrowing of all major coronary arteries helps readers evaluate coronary CT angiograms before determining the need for an FFRCT.

• The expansion of remote cardiac patient monitoring is creating more care opportunities, but also new operational challenges for cardiology teams. Check out this Cardiac Wire Show, where ARTELLA Solutions’ Jacinta Fitzsimons shares how the right combination of technology and service can help physicians get the most out of their cardiac RPM programs – today and into the future.