Day: October 13, 2023

The Food and Drug Administration (FDA) has granted 510(k) clearance for the SpotLight and SpotLight Duo computed tomography (CT) scanners that are specifically geared to cardiovascular assessments. In addition to a 25 cm field of view for dedicated cardiovascular CT scans, key benefits of the SpotLight system include best-in-class specifications for one beat whole heart coverage (14 cm), spatial resolution (0.5 mm detector) and temporal resolution (120 msec), according to Arineta, the developer of the SpotLight and SpotLight Duo scanners. “… The new SpotLight systems continue Arineta’s history of clinical innovation,” said Scott Schubert, the CEO of Arineta. “Our vision is to grow cardiac CT as the front-line non-invasive test for diagnosing, therapy planning and monitoring of cardiovascular disease, the number one cause of death and costs for healthcare worldwide.” Arineta said the SpotLight Duo offers whole organ acquisition with 4D imaging for enhanced visualization of vascular flow and organ motion. The SpotLight Duo also features 45 cm high resolution scans to facilitate full cardiothoracic CT assessments for conditions such as lung cancer, COVID-19 and other pulmonary diseases, according to Arineta.

Fewer patients with CLL experienced cardiac toxicity with Calquence than Imbruvica. Calquence (acalabrutinib) led to fewer treatment-related heart toxicities and an otherwise similar safety profile compared with Imbruvica (ibrutinib) when used to treat patients with chronic lymphocytic leukemia (CLL). These results were seen regardless if patients had cardiovascular disorders at the start of treatment, according to recent research. Data presented at the 2023 International Workshop on CLL demonstrated that the exposure-adjusted incidence rates of cardiac disorder events observed were consistently lower in the Calquence group compared with the comparator arms across the three individual trials regardless of grade. Although no distinct trend was noted among patients who presented with one or more baseline cardiovascular disorders, the number of events in this subgroup was limited. In the pooled comparator group (585 patients), incidence of any grade of cardiac disorder events were approximately twice as high to the pooled Calquence group (599 patients). Analysis of cardiac disorder events in patients who switched from other treatments to Calquence in the phase 3 ELEVATE-TN trial (72 patients) demonstrated a lower incidence of any-grade cardiac disorder events during the post-crossover period with Calquence compared with the pre-crossover period with comparator treatment. “This analysis does not suggest an increased risk of cardiac treatment-emergent adverse effects and outcomes in (Calquence)-treated patients, regardless of the presence of baseline cardiovascular disorders,” Dr. Rupal O’Quinn, of Perelman School of Medicine, and colleagues wrote in a poster presentation on the data. Although the first-generation BTK inhibitor Imbruvica has shown significant efficacy in the treatment of patients with CLL, it is associated with notable cardiac toxicity, including cardiac arrhythmias, cardiac failure and sudden death. In contrast, the next-generation BTK inhibitor Calquence offers a more favorable cardiovascular safety profile with fewer atrial fibrillation events compared with Imbruvica due to its selectivity. Given that the CLL patient population is inherently at higher risk for cardiac events due to factors like advanced age, polypharmacy, substantial comorbidities and pre-existing cardiac conditions, a comprehensive evaluation of cardiac toxicities associated with CLL therapies is imperative. In this longitudinal review, investigators conducted a comprehensive assessment of cardiac outcomes with Calquence compared to active comparator drugs, such as Imbruvica in patients with and without cardiovascular disorders at baseline. The analysis evaluated how CLL therapies affect cardiac health. Safety data were gathered from 3 randomized phase 3 studies: ELEVATE-RR, ELEVATE-TN, and ASCEND. Regarding patients’ treatment regimen, those on ELEVATE-RR received Calquence or Imbruvica, those on ELEVATE-TN were treated with Calquence with or without Gazyva (obinutuzumab) vs Gazyva plus chlorambucil, and patients in ASCEND received Calquence vs Zydelig (idelalisib) plus Rituxan (rituximab) or bendamustine plus Rituxan. A total of 1,362 patients who experienced 3,672 treatment-related side effects were identified from the clinical trial database. Demographic and baseline characteristics were similar between the Calquence and comparator arms in all three trials. Across all trials, 404 patients (29.7%) presented with at least one baseline cardiovascular disorder. The distribution of these baseline cardiovascular disorders was also comparable between the Calquence and comparator arms across the various studies. Specifically, 599 patients received Calquence monotherapy, 178 were treated with Calquence plus Gazyva, and 585 were treated with various comparators, including Imbruvica and other anticancer agents. Within the ELEVATE-TN and ASCEND trials, 72 patients who initially received Gazyva plus chlorambucil and 80 patients who were treated with Zydelig plus Rituxan or bendamustine plus Rituxan later transitioned to Calquence monotherapy. Notably, the median duration of exposure to BTK inhibitors administered continuously exceeded that of the comparator treatments across all studies. Regarding the incidence for baseline cardiac disorder events in patients without any baseline cardiovascular disorders, the results varied by trial. In ELEVATE-RR, the incidence associated with Imbruvica was two-times higher than that observed with Calquence (0.67 vs. 0.34). Meanwhile, the EAIR in ELEVATE-TN was numerically lower for both Calquence plus Gazyva (0.28) and Calquence monotherapy (0.25) vs chlorambucil plus Gazyva (0.59). In the ASCEND trial, Calquence demonstrated a numerically lower incidence (0.28) vs Zydelig plus Rituxan (0.44) and bendamustine plus Rituxan (0.54). These findings suggest a potentially favorable cardiovascular safety profile associated with Calquence. Pooled analysis revealed that the incidence of any-grade cardiac disorder events among patients without any baseline cardiovascular disorders was numerically lower in the pooled Calquence group (0.29) vs the comparator group (0.62). Patients in the pooled Calquence group with a baseline number of one, two or three or more cardiovascular disorders experienced any-grade incidence of 0.16, 0.05 and 0.05, respectively. Corresponding any-grade incidence in the pooled comparator arm were 0.22, 0.07 and 0.04. The most frequently occurring any-grade cardiac disorder in both groups was atrial fibrillation (Calquence group, 0.20; comparator group, 0.41). Other common any-grade PTs included palpitations (0.08; 0.12), cardiac failure (0.04; 0.08), tachycardia (0.04; 0.08), angina pectoris (0.06; 0.05), sinus tachycardia (0.01; 0.05), chronic cardiac failure (0.01; 0.04), myocardial ischemia (0.01; 0.04), acute myocardial infarction (0.01; 0.03), arrythmia (0.02; 0.03) atrial flutter (0.01; 0.03), cardiac arrest (0.00; 0.03), coronary artery disease (0.00; 0.03), mitral valve incompetence (0.00; 0.03), myocardial infarction (0.01; 0.03), pericarditis (0.00; 0.03) and sinus bradycardia (0.03; 0.03) Notably, the incidence of fatal events within the cardiac disorder category was three- to four-times higher in the pooled comparator group vs the pooled Calquence group. However, the incidence of fatal events did significantly increase in patients with one or more baseline cardiovascular disorder compared with those without baseline cardiovascular disorders (0.01 vs 0.06). Within the subgroup of patients without baseline cardiovascular disorders, the incidence of fatal events was three-times higher in the pooled comparator group compared with the pooled Calquence group. The overall incidence of fatal events remained low. In the ELEVATE-TN trial (72 patients), the incidence of grade 3 or greater (moderate to severe) events remained similar pre- and post-crossover, and only one fatal event occurred during the post-crossover period. However, among patients with no cardiovascular disorders at baseline, the incidence were similar pre- and post-crossover (0.44 vs 0.40). Conversely, the incidence among those who had one or more any-grade cardiovascular disorder at baseline was higher pre- vs post-crossover. Those

The changing business landscape of nuclear cardiology Discussions at the ASNC meeting examined several key business-related considerations for nuclear cardiology practices. Topics included how to grow your new nuclear cardiology lab; diversity, equity and inclusion session; and how to get start a positron emission tomography (PET) imaging program. Hendel said PET is the way of the future for nuclear cardiology because it offers better imaging and additional information on microvascular blood flow while it enables imaging for new types of cardiac conditions. He said PET offers advantages well beyond what is possible from single photon emission computed tomography (SPECT), the current workhorse nuclear cardiology technology. “The business aspects included an update on coding and reimbursement issues and how to develop a pro forma and recognize new expenses,” Hendel said. “I think the average nuclear cardiologist, especially those just maybe starting out and growing their laboratory, really haven’t been exposed to that. So this was sort of an introduction to at least give them some background.” While cardiologists are trained to diagnose, treat and care for patients, he said the transformation of the American healthcare system in recent years requires managers of cardiology departments to better understand the business side of operations. This is something most clinicians are not taught at universities. Addressing the squeeze on margins in cardiology One of the key drivers behind the focus on business aspects in nuclear cardiology is the evolving healthcare landscape in the United States. Reimbursements for cardiovascular imaging have been steadily declining, placing a financial squeeze on practices. There also have been major shifts in ownership of cardiology practices in recent years. “We’ve watched it transform from private practice to hospital based and hospital owned. And now we have a lot of private equity firms and venture capital dollars going in, which really transforms the landscape in terms of nuclear cardiology business profiles,” he explained. The pressure to maintain quality patient care while navigating these financial challenges has led to a growing interest in understanding how to maximize resources, optimize laboratory operations and reduce costs. “I think there’s a big squeeze. The margins, especially for cardiovascular imaging, have been drastically reduced. Some would say it’s not really worthwhile anymore. And also the transition from the reimbursement levels that let’s say a private practice got versus a hospital owned practice that’s different. And now with private equity, it’s a whole new ballgame,” Handel said. While patient care is paramount, he said cardiology is also a business, so resources cannot be wasted and departments cannot spend unnecessarily. There are also concerns in nuclear cardiology, where surveys of ASNC members have shown some practices are still using imaging systems and technology from the 1990s. New technology has greatly improved computed tomography (CT), echocardiography and cardiac MRI, but nuclear cardiology is being left behind with poorer imaging quality, less valuable clinical information and high radiation doses. Handel said one standout presentation at ASNC was on the venture capital infusion of dollars and private equity firms because they are willing to make the initial investments to modernize nuclear cardiology departments to keep them competitive. He said these changes taking place in ownership may offer opportunities to improve the imaging technology. “That’s really been a tough point for a lot of small practices and even small hospitals to go out and spend another half a million or a million or more for new equipment. But in terms of being able to afford a capital investments, it certainly does provide opportunities,” Hendel said. Coding and reimbursement challenges in nuclear cardiology One of the areas of concern discussed at the ASNC meeting was coding and reimbursement. While coding in nuclear cardiology has not seen significant changes in recent years, the reimbursement landscape has evolved, where it is expected that the levels of reimbursement between office-based imaging and hospitals will see more equalization. The session also stressed the importance of accurately completing American Medical Association (AMA) Specialty Society Relative Value Scale Update Committee (RUC) surveys they are sent. Hendel said these surveys tend to have very low participation, but are the tool used to determine reimbursement levels for physician relative value units (RVUs). “If people just throw the surveys out and don’t pay attention to them, we’re going to get what you expect, which is very little or it’s going to be negative. So you can’t whine about something if you don’t participate. So if you get a RUC survey, even though it seems pretty straightforward, please go ahead and do it, and do it fairly, so that we can maximize what we think is fair reimbursement,” Handel explained. He said this can include explaining the time to teach techs on how to do a better scan, reviewing the image processing, and watching the quality of your lab by performing cath correlations with nuclear cardiology studies. He said that should all be accounted. Prior authorizations and appropriate use criteria The challenges posed by prior authorizations have been another significant concern for nuclear cardiology practices. While prior authorizations aim to ensure the appropriate use of studies, they also can create administrative burdens. In response to these concerns, some states have implemented “gold carding” programs to exempt high-performing practices from the burdensome prior authorization process. At the federal level, the Prior Authorization and Accountability Act (PAMA) is currently on hold, with uncertainty about its future. This hold is because the Centers of Medicare and Medicaid Services (CMS) found requiring pre-authorization for all imaging exams created more work for doctors and was adding cost and frustration for hospitals. “A number of states have already moved forward with gold carding where if a practice or an individual is doing well and they’re performing at a high level with appropriate use of the studies and the technologies, then they don’t have to go through prior authorization every single time. And that’s what we’ve been advocating for a long time, and we’re seeing that now has traction,” Handel said. When prior authorization requests are denied, there is

Specialists at Cleveland Clinic have treated a hypertrophic cardiomyopathy (HCM) patient with a new gene therapy designed to reverse disease progression. This represents the first patient to receive treatment as part of the MyPeak-1 Phase Ib clinical trial, a first-in-human study sponsored by Tenaya Therapeutics. The trial intends to recruit at least six adult patients diagnosed with MYBPC3-associated nonobstructive HCM. Myosin binding protein C3 (MYBPC3) gene mutations are a common cause of HCM. The group hopes this new-look gene therapy, known as TN-201, can restore the patient’s MYBPC3 levels and eventually lead to disease reversal. The only other HCM treatments at this time are mavacamten, which the U.S. Food and Drug Administration (FDA) approved in 2022, and more invasive procedures such as septal myectomy and alcohol ablation. Cardiologist and cardiac imaging specialist Milind Desai, MD, director of Cleveland Clinic’s Hypertrophic Cardiomyopathy Center and vice chair of its Heart, Vascular and Thoracic Institute, is one of the trial’s primary investigators. Desai has years of experience studying potential HCM treatments and even presented data at ACC.22 on mavacamten’s safety and effectiveness before it had received FDA approval. He is also a paid consultant of Tenaya Therapeutics.

The gold markers, visible on X-ray imaging, have been perhaps the most publicized of the Evolut FX valve’s new features since the device first launched. In one recent study published in Circulation: Cardiovascular Interventions, for instance, researchers wrote that the radiopaque markers were able to help TAVR operators confirm commissural alignment during TAVR.[1] “This exciting milestone helps us continually enhance a trusted platform to better respond to clinicians’ needs making TAVR procedures easier to visualize and more predictable for heart teams,” Jeffrey Popma, MD, vice president and chief medical officer of Medtronic’s structural heart and aortic business, said in a prepared statement. “Receiving CE Mark for the Evolut FX system highlights our commitment to providing minimally invasive treatment options globally for patients experiencing severe aortic stenosis.” “With the latest Evolut FX system, we are elevating the precision, control and predictability of transcatheter aortic valve replacement procedures for patients with severe aortic stenosis,” added Danny Dvir, MD, director of interventional cardiology and cath labs at Shaare Zedek Hospital Canter in Jerusalem, Israel. “The system provides physicians with an innovative solution to meet the needs of a patient population desiring to get back to their active lifestyles sooner.” Now that Medtronic has gained this key approval, the company expects the Evolut FX valve to be commercially available throughout Europe in “the coming weeks.”