Category Archives: Cardiology

Cardiology

Tri-City Cardiology’s Ambulatory Surgical Center (ASC) Leads the Way in Revolutionizing Heart Failure Management – PR Newswire

MESA, Ariz., April 12, 2024 /PRNewswire/ --In the ongoing battle against heart failure, continuous monitoring stands as a beacon of hope. Among the array of innovative solutions, the CardioMEMS HF System shines brightly, offering a groundbreaking approach to managing this debilitating condition. Imagine a world where patients can receive crucial heart failure management in the comfort of an outpatient setting, such as an Ambulatory Surgical Center (ASC). This vision is now a reality, with Tri-City Cardiology's ASC at the forefront of this medical revolution. Access to cutting-edge technology is key in reshaping the landscape of heart failure management. The CardioMEMS HF System embodies this shift, offering a minimally invasive procedure that provides real-time monitoring of pulmonary artery pressurea vital metric in tracking heart failure progression.

Notably, while this technology has been available in hospital settings, the Centers for Medicare & Medicaid Services (CMS) recognition to perform these procedures at our ASC marks a significant advancement in accessibility and convenience for patients.At Tri-City Cardiology's ASC, patients can now undergo this procedure with ease, thanks to its streamlined approach and expertise in outpatient care. Being one of the first ASCs selected to perform this procedure, Tri-City Cardiology demonstrates its commitment to innovation and patient-centered care. Once implanted, the CardioMEMS sensor seamlessly transmits data to healthcare providers, empowering them to monitor patients remotely and make timely interventions. This proactive monitoring enables early detection of changes in pulmonary artery pressure, allowing for personalized treatment plans tailored to each patient's needs. The benefits of CardioMEMS extend beyond early detection; they encompass a clinically proven improvement in quality of life. By preventing heart failure exacerbations and reducing hospitalizations, patients can experience fewer symptoms and regain a sense of independence and mobility. Moreover, the integration of CardioMEMS into mainstream healthcare practices holds the promise of significant cost savings by minimizing the need for emergency interventions and hospitalizations.

Tri-City Cardiology's ASC serves as a pioneer in advancing cardiac care, integrating innovative technologies like CardioMEMS into outpatient settings. As technology continues to advance, such initiatives herald a brighter and healthier future for individuals battling heart failure. In the journey towards better heart failure management, the CardioMEMS HF System represents not just a milestone, but a paradigm shift. With Tri-City Cardiology, patients can rest assured knowing that they are receiving the most advanced and personalized care available, right in their own community.

About Tri-City Surgical Centers and Tri-City Cardiology

In 2022, the Ambulatory Surgical Center (ASC) opened, offering a wide range of services, including the latest innovations in heart failure management. Tri-City Surgical Centers is a modern, free-standing, state-of-the-art ambulatory surgical center designed to help patients receive quality care outside of the traditional hospital setting, allowing Tri-City Cardiologists to complete the continuum of care for our patients while offering a multitude of additional benefits.

Tri-City Surgical Centers allows patients to be seen quicker with a more predictable schedule and in some cases lower cost. The center offers many out-patient surgical procedures including pacemaker and defibrillator insertion, replacement, loop recorder insertion, heart catheterizations, cardiac angioplasty, cardiac stenting, and peripheral angiograms and interventions.

Established in 1979, Tri-City Cardiology is widely known for its progressive and innovative approach to heart and vascular services. Tri-City Cardiology consists of 27 board-certified physicians coming from some of the top medical universities and fellowship programs in the country. We provide comprehensive services, including medical cardiology, diagnostic testing, interventional cardiology, electrophysiology, peripheral vascular testing, medical imaging, vein center, and disease management clinics (heart failure, anticoagulation, and device). Tri-City Cardiology has multiple office locations in the Phoenix Metropolitan area and has affiliations with both Banner and Dignity Hospital Facilities for inpatient services.

For more information, visit: Tri-City Surgical Centers - Tri City Cardiology Consultants Heart & Vascular Care in Phoenix, AZ | Tri City Cardiology CardioMEMS HF System Procedure Overview | Abbott (cardiovascular.abbott) CardioMEMS HF System Animated Implant Procedure Overview (youtube.com)

Contact: Mark Chkeiban Phone: 480-505-5279 [emailprotected]

SOURCE Tri-City Cardiology

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Tri-City Cardiology's Ambulatory Surgical Center (ASC) Leads the Way in Revolutionizing Heart Failure Management - PR Newswire

Cardiology

Watchdog group calls out risks associated with private equity in cardiology, other specialties – Cardiovascular Business

Lets call out private equitys abuse for what it is: legal looting, she said. The Private Equity Stakeholder Projects new state risk index is a razor-sharp tool in the fight to hold private equity accountable. Together, were taking on this trillion-dollar, behemoth industry thats hurting working people and sucking money out of the rest of the economy.

By providing transparent data on the risks associated with private equity investments, we empower communities, working families, and policymakers to advocate for change and protect their states from the threats posed by unchecked private equity firms, added Chris Noble, PESP policy director. This is an important step toward mitigating the risk and tangible harms wrought by private equity across the county.

The rise of PE continues to be one of the biggest trends in all of healthcare, and its presence in cardiology seems to be growing by the day. Cardiovascular Associates of America, Cardiovascular Logistics and other PE-backed cardiology management groups are acquiring more and more practices, and the trend has shown no signs of slowing down.

A recent survey found that a majority of physicians have a negative opinion about the rise of PE in cardiology, radiology and other healthcare specialties. Just last month, thousands of U.S. physicians united to launch a new Coalition for Patient-Centered Care.

In addition, the increasing influence of PE was one of the biggest topics at ACC.24, the annual meeting of the American College of Cardiology (ACC). ACC.24 focused on the business of cardiology much more than previous ACC meetings, in part as a response to ongoing trends cardiologists are witnessing throughout the country.

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Watchdog group calls out risks associated with private equity in cardiology, other specialties - Cardiovascular Business

Cardiology

Heart health: Cardiologist shares impact of advanced wearable technology on patient monitoring – News9 LIVE

Women are more damaged mentally and should be targeted for more assistance. (Photo credit: Pexels)

New Delhi: Cardiovascular diseases (CVD) are the leading cause of death in India. Heart disease remains a significant health burden across the globe. The risk factors of heart disease include poor lifestyle habits, smoking, alcohol consumption and more. The rising incidences in cases have led to the development and advancement of technology for cardiac treatments. Among these is the advanced wearable technology for patient monitoring but do they really create an impact?

Dr Keshava R, Senior Director, Interventional Cardiology, Fortis Hospital, Cunningham Road, Bengaluru told News9, In recent years, the integration of cutting-edge wearable technology into the field of cardiology has ushered in a new era of patient monitoring and care. Among the array of innovative devices, a groundbreaking wearable medical device has emerged as a beacon of progress, offering continuous, non-invasive monitoring of heart arrhythmias.

Continuous Monitoring of Heart Arrhythmias

Equipped with state-of-the-art sensors and sophisticated algorithms, the wearable medical device excels in detecting various heart arrhythmias, including atrial fibrillation (AF), bradycardia, tachycardia, premature ventricular contractions (PVCs), pause, and long QT syndrome. Dr R said, Unlike conventional ECG devices, this device provides continuous monitoring, enabling the timely identification and intervention of potentially life-threatening arrhythmias. Clinical studies highlight its exceptional sensitivity and specificity in detecting AF, outperforming traditional ECG methods.

Comprehensive Health Monitoring

The watch goes beyond arrhythmia detection, offering a comprehensive suite of features catering to diverse cardiology patient needs. It continuously monitors heart rate, respiratory rate, oxygen saturation, and core temperature, providing valuable insights into overall health and well-being. This holistic approach allows healthcare providers to obtain a more nuanced understanding of patients cardiovascular health.

User-Friendly Interface and Data Integration

According to Dr R, The user-friendly interface of the wearable medical device, coupled with seamless data integration with healthcare providers, empowers patients to actively participate in managing their cardiovascular health. Real-time and historical data are easily accessible, enabling patients to identify patterns, monitor trends, and share progress with their healthcare team. This collaborative approach fosters a more engaged and informed patient population.

Future Prospects and Ongoing Research

As technology evolves, the potential of this groundbreaking wearable medical device is set to expand further. Ongoing research and development may lead to the incorporation of advanced features such as blood pressure monitoring, sleep apnea detection, and stress assessment. The device has the potential to transform into a comprehensive cardiovascular health monitoring system, providing a holistic view of an individuals well-being.

Various devices like wearable watches and other devices are available with different sensitivity and specificity for various arrhythmias. The devices are improving in leaps and bounds with the use of artificial intelligence and machine learning every year.

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Heart health: Cardiologist shares impact of advanced wearable technology on patient monitoring - News9 LIVE

Cardiology

TAVR Found Non-Inferior to SAVR for Low-Risk Patients – Diagnostic and Interventional Cardiology

April 11, 2024 Transcatheter aortic valve replacement (TAVR) was found to bring no increased risks and was associated with substantial decreased rates of death or stroke at one year in lowrisk patients, compared with surgical aortic valve replacement (SAVR), according to findings presented at the American College of Cardiologys Annual Scientific Session.

TAVR and SAVR are procedures to replace a damaged aortic valve that is not functioning properly. U.S. guidelines recommend TAVR, a catheter-based approach in which the new valve is threaded to the heart through a blood vessel in the groin or chest, over open-heart SAVR for older patients and those with high cardiovascular risk. However, previous studies and different countries guidelines have varied when it comes to determining the optimal approach for younger and lower-risk patients.

We can now provide strong data that in this low-risk patient population, you could very safely offer TAVR vs. SAVR, said Moritz Seiffert, MD, professor of cardiology at BG University Hospital Bergmannsheil, Ruhr University Bochum in Bochum, Germany, and one of the study authors. TAVR is less invasive; its usually performed under local anesthesia, lasting 30-60 minutes, and the convalescence is shorter than with open chest surgery. [These findings offer] a strong argument toward catheter-based treatment, at least for the one-year timeframe of this study, in these patients.

The DEDICATE-DZHK6 trial compared TAVR vs. SAVR in 1,414 patients who underwent valve replacement procedures at 38 centers in Germany.

All patients enrolled in the trial were eligible for either TAVR or SAVR and had similar characteristics in terms of the severity of aortic stenosis (narrowing of the valve which makes it harder for blood to flow efficiently) and a similar balance of risks and benefits expected with either type of procedure. Patients with bicuspid valves, previous heart surgery or additional coronary or valvular diseases requiring further treatment were excluded. The average age of participants was 74 years and 43% were women.

Researchers randomly assigned half of the participants to undergo TAVR and the other half to SAVR. Since the trial was intended to mirror real-world conditions, many decisions were left to the local heart teams at each study site, rather than strict predetermined study protocols. Local interdisciplinary heart teams determined which patients were eligible to participate in the study based on broad inclusion criteria. Operators selected which replacement valve to use and followed their own centers standard practices for performing the procedures.

The co-primary safety endpoint was designed to assess whether TAVR was non-inferior to SAVR as indicated by an absolute increase of no more than 1% in the composite rate of death or stroke at one year. The trial met this endpoint, showing that people who underwent TAVR were 47% less likely than those undergoing SAVR to experience death or stroke at one year. Event rates for several secondary endpoints, including all-cause death or disabling stroke, were also significantly lower in patients undergoing TAVR compared with those undergoing SAVR at one year.

Although we primarily tested for non-inferiority, the magnitude of the difference surprised us, Seiffert said. Valve prosthesis selection based on individual patients anatomical and medical considerations may have played a role. In addition, the COVID-19 pandemic might have amplified the surgical risk. In fact, the relative difference was comparable to previous studies, but the overall higher event rates and larger patient population may have led to these significant results.

Researchers plan to further investigate some factors that set the trial apart from previous studies and may have contributed to the substantially reduced risk in the TAVR group, including the relatively high proportion of females in the study group. The data were consistent among the subgroups tested so far.

Overall, researchers said that the findings are likely generalizable to patient populations and health care environments across many developed countries.

What it really adds to previous trials is that it mirrors clinical routine, Seiffert said. Its completely industry independent, not focused on one particular device but comparing a catheter-based strategy to a surgical strategy overall. That makes it more applicable and aligned with the types of decisions physicians are making in their daily medical work.

The researchers will continue to track outcomes for at least five years. Future analyses will include additional metrics for assessing clinical superiority as well as quality of life outcomes. In addition, researchers plan to examine whether certain subgroups appear to derive specific risks or benefits from one approach or the other.

The study was funded by German Center for Cardiovascular Research with financial support by the German Heart Foundation. This study was simultaneously published online in the New England Journal of Medicine at the time of presentation.

For more information:www.acc.org

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TAVR Found Non-Inferior to SAVR for Low-Risk Patients - Diagnostic and Interventional Cardiology

Cardiology

Telemedicine Strategy After MI Scores a Win in TELE-ACS – TCTMD

ATLANTA, GAA telemedicine-based approach to care after acute coronary syndromes can reduce readmissions to the hospital, visits to the emergency department (ED), and the rates of stroke and MI, according to results from the randomized TELE-ACS trial. Notably, use of the management strategy also was linked a reduction in patient-reported symptoms.

MI remains one of the leading causes of mortality in the UK despite cutting-edge medical and interventional therapies, said Nasser S. Alshahrani, MSc (Imperial College London, England, and King Khalid University, Abha, Saudi Arabia), presenting the data at the recent American College of Cardiology (ACC) 2024 Scientific Session. Moreover, around 10% of patients return to the hospital within 30 days of their event.

TELE-ACS, said Alshahrani, was designed to see if a novel telemonitoring system-based algorithm would reduce hospital readmissions for patients post-ACS by using well-validated technologies coupled with an urgent remote consultation with a cardiologist.

One question at the outset was whether the remote monitoring would provide enough information to guarantee clinicians could effectively assess patients without necessitating a face-to-face encounter, he said. The results, simultaneously published in the Journal of the American College of Cardiology, suggest the answer to that is yes.

ACC President Cathleen Biga, MSN, RN (Cardiovascular Management of Illinois, Woodridge), said she was struck by this trial and others at the meeting that focused on transformation of care delivery. So much of medicine has evolved, yet our quality hasnt gotten better, Biga commented. We have got to figure out a different way of caring for our patients because our MI readmission rate, our 30-day mortality after an acute coronary syndrome, the needle isnt moving. So what are we going to do differently to help move that needle?

Biga said the TELE-ACS trial speaks to the possibilities that a remote approach could continue to offer MI patients in todays practice.

The COVID-19 pandemic abruptly upended care back in 2020, Biga pointed out. We went completely telehealth in 12 hours, . . . before we opened our office that Monday. We changed in a nanosecond. Then, as the world grew more used to the virus, we went right back to packed waiting rooms [and] in-person visits, she noted.

Telemedicine vs Usual Care

Alshahrani and colleagues analyzed data for 337 patients (mean age 58.1 years; 86% male; 46% white) with at least one cardiovascular risk factor who had been hospitalized with ACS between January 2022 and April 2023. Three-quarters had hypercholesterolemia, nearly 60% were smokers or had a history of smoking, around half had hypertension, four in 10 had a family history of CAD, and a little more than a quarter had diabetes.

Prior to discharge, the patients were randomized to receive either telemedicine-based or standard care; to participate, they had to have access to a smartphone or other smart device.

In the intervention group, patients received a telemonitoring package consisting of a 12-lead ECG belt (SHL SmartHeart; SHL Telemedicine), an automated blood-pressure monitor (Omron Basic M2; Omron Corporation), and a pulse oximeter (Kinetik Wellbeing), as well as training in how to use the devices. They also received follow-up phone calls for training at 2, 4, and 8 weeks.

When these patients felt symptoms they thought were potentially cardiac, they used their telemonitoring tools, with the details transmitted to a cardiologist. The cardiologist performed remote clinical assessment and then triaged patients to receive either reassurance with clinical follow-up as previously planned or advice to contact their general practitioner, go to the ED for further testing, or call emergency services. Cardiologists based their decision-making on an algorithm that categorized symptoms and clinical parameters. Remote consultations were available from 7 AM to 11 PM on weekdays; outside of these time frames, or if they didnt hear from a cardiologist within 15 minutes of reporting their symptoms, patients were meant to seek medical advice through the usual clinical pathways.

In the control arm, patients sought medical advice through the usual pathways and received standard routine clinical care, with remote, phone-based follow-up at 3, 6, and 9 months.

We have got to figure out a different way of caring for our patients, because . . . the needle isnt moving. Cathleen Biga

Study participants made a total of 169 calls, 64% of them during the active hours on weekdays. Reported symptoms were most often chest pain/discomfort, followed by palpitations and general weakness.

Of the 108 calls during the active hours, 54.6% resulted in patients receiving reassurance. Another 26.9% were advised to visit their general practitioner, 13.9% told to visit the ED, and 4.62% recommended to call emergency services.

By 6-month follow-up, there were 20 readmissions with telemedicine and 50 with standard care. Thus, the time to readmission (primary endpoint) was reduced with the remote strategy, as were visits to the ED and MIs. Stroke trended lower, though the rate of all-cause death was identical in the two groups.

Six-Month Outcomes in ACS Patients

Telemedicine

Control

HR (95% CI)

Readmission

8%

29%

0.24 (0.13-0.44)

ED Visit

24%

37%

0.59 (0.40-0.89)

MI

7%

22%

0.27 (0.14-0.53)

Stroke

2%

5%

0.38 (0.10-1.42)

All-Cause Death

1.2%

1.2%

1.03 (0.15-7.31)

Moreover, patients in the telemedicine group had fewer unplanned coronary revascularizations than did controls (3% vs 9%) and were less likely to report chest pain (9% vs 24%), breathlessness (21% vs 39%), and dizziness (6% vs 18%).

Telemonitoring in the active study arm ceased at 6 months. Notably, though, the initial effect between 0 to 6 [months] was large enough to leave a legacy effect up to 9 months, Alshahrani said.

At 9-month follow-up, hospital readmissions still were less common with the intervention than with usual care (HR 0.35; 95% CI 0.21-0.59). So, too, were visits to the emergency department (HR 0.66; 95% CI 0.46-0.94) and the rate of invasive coronary angiography and/or angioplasty (4% vs 10%; P= 0.03). However, there was no longer a difference in symptoms between the two groups.

Alshahrani, in his presentation, cited several limitations to their study. Among them were its predominately male population, the potential for recall bias due to retrospective collection of symptom data, and the fact that participants were required to have access to a smartphone.

Additionally, the high level of support for the telemedicine group, with prompt cardiology responses, may be challenging to replicate outside a trial setting, requiring significant investment and training, he continued, while technological barriers and infrastructure requirements may pose some obstacles to implementation. . . . Further studies need to establish the feasibility of implementation in different healthcare systems.

We were surprised by the large effect. Nasser S. Alshahrani

Malissa Wood, MD (Lee Health Heart Institute, Fort Myers, FL), discussant for the TELE-ACS results, highlighted the decrease in MI with monitoring. Do you think the intervention was related to that, as far as the patients knowing that they were being monitored or that they could reach out to someone? Did you look at any psychosocial variables to see if that reduced stress, anxiety, or depression in that population that may have been related to that reduction in myocardial infarction?

We were surprised by the large effect, and it could be because of the high level of support that we delivered and also the patient education on symptoms at the point of contact and then at regular intervals thereafter, Alshahrani explained. It could be the Hawthorne effect: when the patient is monitored, they tend to change their behavior.

For ease of use, Wood suggested that going forward it would be good to have a device that incorporates all three measurementsoxygen saturation, blood pressure, and ECG readingsso you dont have the patient having to [use] all these different devices to transmit data.

Biga, speaking with TCTMD, said that much of the positive impact in TELE-ACS may come from the fact that telemedicine offered a way to connect regularly with a human touch, albeit remote, that was reassuring but also offered practical advice and constant education. This can be valuable for patients feeling overwhelmed by the intricacies of their care after discharge, she said.

As Biga noted, the challenge lies in how to implement the strategy. Patients may prefer to call their own doctors office over a less-familiar hotline, and any added personnel or other resources to handle these calls must be paid for. The most convenient, cost-effective option going forward might be third-party companies to streamline remote monitoring, she added, so the practices dont carry the burden, because the payment from [Medicare for] remote patient monitoring isnt going to begin to cover the cost of that: you have the equipment and the intellectual property.

Scaling up is tricky, especially with the tsunami of data, Biga stressed. In just one of her practices, Biga said, 900 patients are seen a daymore than five times the number of participants in the intervention arm of TELE-ACS. The real-world math is daunting, she pointed out. How many MIs do I have a month? Can I get them all hooked up and compliant and have the staff to analyze that data?

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Cardiology

Global Interventional Cardiology Devices Market Projected to Reach $21.9 Billion by 2030 – GlobeNewswire

Dublin, April 08, 2024 (GLOBE NEWSWIRE) -- The "Global Interventional Cardiology Devices Market Size, Share & Industry Trends Analysis Report By End-use (Hospitals & Clinics, Ambulatory Surgical Centers & Others), By Product, By Regional Outlook and Forecast, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.

Market Dynamics and Growth Factors

The global interventional cardiology devices market is expected to achieve significant growth, with projections estimating a reach of $21.9 billion by 2030. This growth is anticipated to occur at a CAGR of 7.4% during the forecast period. Technology advancements, strategic collaborations, and an increasing burden of cardiovascular diseases serve as major catalysts for this expansion.

Unified by the common objective to combat cardiovascular diseases (CVDs) and improve patient outcomes, industry leaders are reinforcing their market positions through strategic partnerships and collaborations. The integration of cutting-edge technologies in the treatment of heart conditions is a key component driving the global market forward.

Product Innovations and Strategic Alliances

Pioneering products such as drug-eluting stents (DES) are playing a crucial role in shaping the future of cardiovascular care, offering new avenues for treatment with lower restenosis rates. Additionally, the ability of DES to reduce the risk of stent thrombosis marks a significant technological milestone. Furthermore, notable collaborations among top industry players are set to enhance the range of cardiovascular devices available, thereby augmenting the scope of patient care.

COVID-19 Impact and Resilience

The onset of the COVID-19 pandemic initially disrupted the interventional cardiology devices sector due to postponed elective procedures and a shift in healthcare priorities. Despite this, the market demonstrated resilience with the continued necessity for acute cardiovascular interventions and adoption of remote monitoring practices. The market is now recovering and showing a return to pre-pandemic activity levels.

Market Outlook by End-use and Product

The hospitals & clinics segment continues to lead the interventional cardiology devices market, given their comprehensive cardiac care offerings. Nevertheless, ambulatory surgical centers are steadily gaining ground, proving themselves as efficient venues for interventional cardiology procedures. The product landscape remains diverse, with coronary stents, PTCA balloon catheters, and accessory devices shaping the interventional approach to cardiovascular care.

Regional Market Insights

From a regional perspective, the Asia Pacific market is displaying robust growth, underpinned by an increasing prevalence of cardiovascular diseases and rising healthcare investments. This mirrors the global concern for advanced solutions to address the surging incidence of heart-related ailments, reinforcing the need for sophisticated interventional cardiology devices across diverse healthcare settings.

The report provides an in-depth analysis of market dynamics, product segments, and regional trends that are influencing the growth trajectory of the interventional cardiology devices industry. The insights are dedicated to fostering a comprehensive understanding of market forces and strategic imperatives in the healthcare sector.

Future Outlook

Looking ahead, the interventional cardiology devices market is poised for sustained growth, drawing from an expanding patient pool and continuous innovation in medical technologies. The focus on improving cardiovascular treatments and mitigating disease impact stands as a testament to the healthcare industry's commitment to enhancing the quality of life for patients globally.

Companies Featured

For more information about this report visit https://www.researchandmarkets.com/r/sdy5ts

About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Global Interventional Cardiology Devices Market Projected to Reach $21.9 Billion by 2030 - GlobeNewswire

Cardiology

Impact of Interatrial Shunt May Vary by Heart Failure Type – Diagnostic and Interventional Cardiology

April 6, 2024 Patients with heart failure who had a small shunt inserted between the hearts left and right atria did not see any significant benefits overall compared with those who received a placebo procedure after a median of 22 months follow-up, in a study presented at the American College of Cardiologys Annual Scientific Session.

The trial, called RELIEVE-HF, is the first randomized placebo-procedure controlled trial of interatrial shunting that included patients with both major types of heart failure: heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). While the trial did not meet its primary endpoint, it moves the field forward by offering signals that the benefits and risks of interatrial shunts may vary by heart failure type, according to researchers.

Gregg Stone, MD

When you examine the outcomes in patients with heart failure across a broad range of left ventricular ejection fraction, the Ventura interatrial shunt was extremely safe but did not improve outcomes compared with no treatment. However, in a prespecified analysis, data suggest that the shunt may be beneficial in patients with HFrEF and worsen outcomes in patients with HFpEF, said Gregg Stone, MD, professor of cardiology and population health sciences at Icahn School of Medicine at Mount Sinai in New York and the studys first author. We believe further studies are warranted to confirm the benefits we observed in patients with reduced ejection fraction.

Heart failure is a condition in which the heart becomes too weak or stiff to effectively pump blood, leading to fatigue, organ damage, shortness of breath and an increased risk of life-threatening cardiovascular events. In HFrEF, the heart muscle becomes weak and does not squeeze as hard as it should. In HFpEF, the left ventricle becomes stiff and does not properly fill with blood.

The Ventura shunt is one of several interatrial devices being tested to aid in the treatment of heart failure. It is designed to form a small connection or passage between the left and right atria to allow blood to leave the left atriumespecially as left atrial pressure risesthus reducing the pressure in the left atrium and the lungs. High left atrial pressure is a primary cause of shortness of breath and hospitalizations related to heart failure.

The trial randomized 508 patients at 94 sites in North America, Europe, Israel, Australia and New Zealand. All participants had symptomatic heart failure despite taking medications at maximally tolerated doses. About 40% of participants had HFrEF and 60% had HFpEF.

Participants were randomly assigned to undergo a procedure to insert the Ventura shunt or a placebo procedure in which a script was followed with all the same protocols to mask patients as to whether the shunt was inserted. Operators were aware of which procedure each patient received but patients, their families and the rest of the medical teams taking care of the patient after the procedure were not. Researchers tracked outcomes in each participant for at least one year and up to two years.

The results showed no significant difference between groups in terms of the trials primary endpoint, a hierarchical composite ranking of death from any cause; heart transplant or left ventricular assist device; heart failure hospitalizations; worsening of outpatient heart failure events; and change in quality of life, as measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ). This hierarchical composite approach for assessing efficacy allows diverse types of outcomes to be incorporated in ranked fashion into an overall win ratio reflecting the overall outcome of a drug or device.

In a pre-planned analysis focused on heart failure type, patients with HFrEF who received the shunt were found to have improvements across all outcomes assessed (especially fewer hospitalizations for heart failure), while those with HFpEF who received the shunt were found to have increased rates of death and heart failure hospitalizations. This difference could be attributed to the greater compliance or flexibility of the heart muscle with HFrEF, potentially allowing it to more easily accommodate the extra blood flowing into the right atrium, Stone said.

There were no device-related or procedure-related major adverse cardiovascular or neurologic events in either group during the duration of the trial.

Surprisingly, a marked improvement in quality of life as measured with KCCQ was observed across all groupsincluding those who received a placebo procedure, both with HFrEF and HFpEFsuggesting that the metric may not be a reliable indicator for quality-of-life outcomes in this context, Stone said.

There was a tremendous placebo effect, he said. These observations, especially the fact that quality of life improved in HFpEF patients who were more likely to be hospitalized for heart failure and had reduced survival after shunt treatment, raise questions about the interpretation of this quality-of-life measure in these kinds of trials.

Although the observed differences in outcomes among people with different types of heart failure may inform future research and development for interatrial devices, the researchers said that the trial was not powered to show differences in the two types of heart failure. As such, these results should be considered exploratory. They also said that the results may not be applicable to other interatrial shunts beyond the Ventura shunt.

The study was funded by V-Wave Medical.

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Impact of Interatrial Shunt May Vary by Heart Failure Type - Diagnostic and Interventional Cardiology

Cardiology

SGLT-2 Inhibitors Show Mixed Results After Heart Attack – Diagnostic and Interventional Cardiology

April 6, 2024 Use of the sodium glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin following a heart attack did not show a significant benefit in reducing overall heart failure hospitalizations or death from any cause, according to a study presented at the American College of Cardiologys Annual Scientific Session. However, researchers said the drug may be helpful in reducing heart failure risks, including hospitalization, following a heart attack.

Javed Butler, MD

Despite falling short of its primary endpoint, results from the EMPACT-MI trial found that people who took empagliflozin had a significantly lower risk of certain outcomes directly related to heart failure, including first hospitalization for heart failure, total hospitalization for heart failure and a composite of heart failure hospitalization and death from heart failure, without any increased risk of adverse events.

We found that empagliflozin did not reduce mortality after a heart attack but did reduce the risk of heart failure after heart attack, said Javed Butler, MD, president of the Baylor Scott and White Research Institute in Dallas, distinguished professor of medicine at the University of Mississippi in Jackson, Mississippi, and the studys lead author. To have a 25% to 30% reduction in heart failure hospitalizations is pretty clinically meaningful, but if you put it together with all-cause mortality, it was not a positive study for our primary endpoint.

SGLT-2 inhibitors were initially approved to treat Type 2 diabetes by lowering blood sugar. As evidence has mounted pointing to their benefits in reducing heart failure and other forms of heart disease, researchers have sought to determine whether these drugs could help to prevent heart failure even in people without diabetes or chronic kidney disease.

A heart attack can damage the heart muscle in ways that sometimes lead to heart failure, a condition in which the heart becomes too weak or too stiff to effectively pump blood throughout the body. The EMPACT-MI trial was designed to determine whether SGLT-2 inhibitors could safely help to prevent heart failure and reduce mortality in people with a high risk of heart failure following a heart attack.

The study enrolled 6,522 people treated for acute myocardial infarction at 451 centers in 22 countries. Participants had no history of heart failure but had at least one heart failure risk factor in addition to signs of potential heart dysfunction as indicated by a newly lowered left ventricle ejection fraction to below45% and/or signs or symptoms of congestion requiring treatment. About 32% had Type 2 diabetes. On average, participants were 64 years old and approximately 25% were women and 84% were White. Within 14 days of being admitted to the hospital for a heart attack, half of the participants were randomly assigned to receive empagliflozin at a dose of 10 mg daily, while the other half received a placebo. Researchers tracked outcomes for a median of just under 18 months.

The studys primary composite endpoint occurred in 8.2% of those who received empagliflozin and 9.1% of those receiving a placebo, a difference that was not statistically significant. There was also no difference in the rate of death from any cause, which occurred in 5.2% of those receiving empagliflozin and 5.5% of the control group.

All secondary endpoints related specifically to heart failure outcomes were significantly reduced among patients who received empagliflozin. For example, those receiving empagliflozin were 23% less likely to experience a first heart failure hospitalization and 33% less likely to experience any heart failure hospitalizationincluding recurrent hospitalizationscompared with those taking a placebo. The composite rate of total heart failure hospitalizations and death from heart failure was also 31% lower among those receiving empagliflozin.

Among patients who were not taking common heart failure therapies such as diuretics, angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor/neprilysin inhibitor (ARNI) at the time of their initial hospital discharge, those taking empagliflozin were significantly less likely to start such therapies within six months compared with those taking a placebo.

In terms of heart failure outcomes, the data is not only strong, but its consistent with what weve found over the past 10 years in yet another population, Butler said. This finding is completely consistent in both direction and magnitude with other studies of SGLT-2 inhibitors in populations with diabetes and chronic kidney disease.

While as a pragmatic trial design to simplify trial procedures and make it easier on both the participants and the sites, the study had limitations that may have influenced the findings, researchers said. For example, because outcomes were not adjudicated by independent reviewers, outpatient heart failure events were not formally captured as part of the primary endpoint. However, researchers said data on outpatient heart failure visits were collected as part of the study protocols for assessing adverse events. An analysis of these events showed outpatient visits for heart failure were substantially lower in participants who received empagliflozin compared with placebo.

Another limitation was the use of all-cause mortality as part of the primary endpoint, which meant that deaths unrelated to heart failure were included in the endpoint even though the study drug was unlikely to influence them. There were also some unusual circumstances that may have influenced rates of both hospitalization and death, including the COVID-19 pandemic and conflicts involving Russia, Ukraine and Israel, all countries that participated in the trial.

Finally, researchers said that the follow-up period may have been too short to fully capture any difference in mortality related to heart failure. Since people who developed heart failure following their heart attack typically did not begin to show heart failure symptoms until a few months later, any reductions in mortality would not be expected to emerge until after that.

We just did not have long enough follow-up to see whether that heart failure prevention would lead to a benefit in mortality, but its a reasonable clinical thing to say that if youre preventing heart failure, its a good thing, Butler said.

The study was funded by Boehringer Ingelheim and Eli Lilly.

This study was simultaneously published online in the New England Journal of Medicine at the time of presentation.

Butler presented the study, Empagliflozin After Acute Myocardial Infarction: Results of the EMPACTMI Trial, on day one of the 3-day ACC.24 conference.

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SGLT-2 Inhibitors Show Mixed Results After Heart Attack - Diagnostic and Interventional Cardiology

Cardiology

No Reduction in 90-Day Deaths, Heart Attacks With Human Apo/A1, A Building Block of HDL Cholesterol – Diagnostic and Interventional Cardiology

April 6, 2024 The first trial of a novel strategy for removing cholesterol from patients arteries did not reduce the risk of death, heart attack or stroke within three months of a prior heart attack, according to research presented at the American College of Cardiologys Annual Scientific Session. However, the findings suggest that the strategy may be beneficial with longer follow-up.

C. Michael Gibson, MD

We did not see a statistically significant reduction in the primary endpoint of risk for death, a heart attack or a stroke at 90 days, or a reduction in risk for stroke at any time, said C. Michael Gibson, MD, a professor of medicine at Harvard Medical School and the studys lead author. However, in an exploratory analysis of outcomes, treated patients had fewer heart attacks and heart-attack deaths than patients in the control group at six months, he said.

Although we missed our primary endpoint, our data support the hypothesis that HDL cholesterol plays a role in reducing subsequent coronary plaque disruption events like heart attack via enhanced cholesterol efflux attacks, Gibson said.

People who have had a heart attack are at high risk for another one, especially during the next 90 days, Gibson said. This study was the first in which patients received an infusion of ApoA-I, a component of HDL (good) cholesterol, shortly after a heart attack, with the aim of stabilizing coronary plaque and reducing adverse cardiovascular events. The investigational drug CSL112 used in the study is a form of ApoA-I thats extracted from human plasma, the liquid component of blood.

High levels of LDL cholesterol create a build-up of plaque in the arteries that carry blood to the heart, increasing risk for an arterial blockage that causes a heart attack. HDL cholesterol removes cholesterol from the arteries and carries it to the liver, which then excretes it. ApoA-I, the main component of HDL cholesterol, helps initiate the process of removing cholesterol from the body. A previous study showed that a single infusion of CSL112 reduced the amount of LDL cholesterol in arterial plaque by as much as 50%.

Other studies have shown that high levels of HDL cholesterol are associated with reduced heart attack risk. Recent research, however, suggests that the level of HDL cholesterol number may be less important for reducing heart attack risk than how well it performs at removing cholesterol, Gibson said.

We know that in the setting of a heart attack, when the HDL cholesterol is good at getting a lot of cholesterol out of the arteries, that results in better outcomes for patients, he said.

Gibson and his colleagues hypothesized that infusions of CSL112 given shortly after a heart attack mightby boosting the bodys ability to dispose of cholesterolreduce patients risk for a repeat heart attack during the next crucial 90 days. The international AEGIS-II trial, conducted in 49 countries, was designed to test this hypothesis.

The study enrolled 18,219 patients (median age 65.5 years, 74% men and 84.5% White) who had been hospitalized for a heart attack and had multiple blockages in arteries carrying blood to the heart that elevated their risk for another heart attack. They also had other risk factors, including having had a previous heart attack, receiving drug treatment for diabetes or being 65 or older. Patients were randomly assigned to receive infusions of either CSL112 or a placebo for four weeks, with the first infusion given within five days of hospitalization.

The studys primary endpoint was the time to the first occurrence of a major adverse cardiovascular event (MACE; i.e., heart attack, stroke or death due to heart disease or a stroke) at 90 days. Secondary endpoints included the time to the first occurrence of a MACE within six months and one year and of each specific event within 90 days, six months and one year.

At 90 days, patients treated with CSL112 had a 4.8% reduction in risk for death, heart attack or stroke compared with 5.2% for those treated with a placebo, a difference that was not statistically significant. In an exploratory analysis, however, patients treated with CSL112 were 14% less likely to have or die from a heart attack at 180 days. In addition, patients treated with CSL112 were 32% less likely to have a heart attack caused by a blood clot in a stent (a tiny mesh tube inserted into an artery to prevent it from becoming blocked) at 90 days and 29% less likely at 180 days.

Another potentially important finding, Gibson said, is that patients whose LDL cholesterol level was 100 mg/dL or higher at study entry experienced a 30% decrease in the primary endpoint, a statistically significant finding, whereas patients whose LDL cholesterol at study entry was less than 100 mg/dL saw no decrease in the primary endpoint.

Baseline LDL modulated the treatment effect, Gibson said.

Overall, our findings are consistent with ApoA-I having a role in stabilizing heart blockages and reducing the risk of a blockage that ruptures and causing a heart attack further out than 90 days, Gibson said. Its plausible that by giving ApoA-1 to clear the cholesterol out of the body and then treating the patient with cholesterol-lowering medications to keep LDL cholesterol levels low, we could see reductions in deaths and heart attacks that continue over time.

Future research will focus on identifying high-risk patients who might benefit from this approach, he said. An antiplatelet effect of CSL112 or a reduction of cholesterol in the arteries resulting from treatment with CSL112 could also explain the significant reduction in the number of heart attacks caused by a blood clot in a stent, he said. The reason strokes were not reduced may be that strokes can be caused by mechanisms other than the rupture of arterial blockages, he said.

A limitation of the study is that women, Black people and people of Asian heritage were underrepresented, which could reduce the findings generalizability, Gibson said.

The study was funded by CSL Behring, the manufacturer of CSL112

This study was simultaneously published online in the New England Journal of Medicine at the time of presentation. The findings of the exploratory analysis were/will be published in the Journal of the American College of Cardiology, JACC.

Gibson presented the study, Patients With Acute Myocardial Infarction (ApoA-I Event Reducing In Ischemic Syndromes II (AEGIS-II) Trial): Primary Trial Results, on Saturday, April 6, the first day of the ACC Scientific Session being held thru April 8 in Atlanta, GA.

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No Reduction in 90-Day Deaths, Heart Attacks With Human Apo/A1, A Building Block of HDL Cholesterol - Diagnostic and Interventional Cardiology

Cardiology

Association of Black Cardiologists’ "We Are The Faces" Campaign Unveils New Videos for Black Maternal Health Week – PR Newswire

WASHINGTON, April 6, 2024 /PRNewswire/ -- In celebration of Black Maternal Health Week (April 11-17, 2024) and April's Minority Health Month, the Association of Black Cardiologists (ABC) is proud to unveil a new slate of videos as part of its third year of the "We Are The Faces of Black Maternal Health" awareness and advocacy campaign.

This new collection of videos features excerpts from powerful patient narratives interwoven with insights from leading ABC member clinicians across diverse specialties. This series amplifies the intergenerational impact of the Black maternal health crisis and underscores the critical role of healthcare professionals in addressing racial disparities in maternal health outcomes.

Recent findings continue to show that Black women are disproportionately impacted by maternal morbidity and mortality. These disparities extend to other women of color as well, highlighting the need for comprehensive action to ensure equitable access to quality care for all.

"Decades of headlines emphasize the urgent need for a multi-faceted approach that addresses the systemic and institutional factors exacerbating the disparity gap in Black maternal and cardiovascular health," states ABC President Dr. Anekwe Onwuanyi. "ABC remains committed to raising awareness, fostering collaboration and finding solutions to advance the health and wellbeing of Black women and their families."

ABC members are uniquely positioned to address the maternal health crisis, given the intersection of maternal health and cardiovascular well-being. Standing at the "crossroads" of being patients, relatives of patients, healthcare professionals treating these patients, or all of the aforementioned, gives them a distinct perspective and opportunity to drive meaningful change on this issue.

"It is so important to recognize that we all have a role to play in mitigating this epidemic that negatively affects the Black family," said Rachel M. Bond, MD, Co-chair of the Cardiovascular Disease in Women and Children Committee for ABC. "An essential aspect of the campaign draws attention to the vital role Black men play - whether as spouses or relatives - in their support of Black women by advocating to ensure the mother's concerns are heard and addressed, but this support also includes prioritizing their own cardiovascular health before, during, and after the pregnancy."

"As a pediatric cardiologist, I recognize the profound impact of maternal health on the well-being of families, especially Black families" states Annette K. Ansong, MD, Co-Chair of the Cardiovascular Disease in Women and Children Committee for ABC. "We must work collaboratively with our colleagues in primary care, obstetrics, and cardiology to advocate for integrated strategies that prioritize the health of mothers and babies. After all, Black women are first Black girlsTM, and by promoting heart-healthy habits from childhood, we can help pave the way for healthier pregnancies."

Individuals are invited to visit WeAreTheFaces.ABCardio.org to watch the videos, download patient and clinician infographic resources, share their stories, and learn more about maternal health disparities. Together, we can effect tangible change and rewrite the narrative on Black maternal health.

About ABC

Founded in 1974, the Association of Black Cardiologists, Inc. (ABC) is a nonprofit with a global membership exceeding 2,000 individuals, including health professionals, community health advocates, and corporate and institutional members. The ABC remains dedicated to its mission of promoting heart health and wellness in minority communities. Today, by fostering public and private partnerships and advocating for equitable access to care, ABC continues to make strides in improving cardiovascular outcomes for all. Connect with us atwww.abcardio.org and join our efforts on Twitter,Facebook,Instagram, andLinkedIn.

SOURCE Association of Black Cardiologists, Inc.

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Association of Black Cardiologists' "We Are The Faces" Campaign Unveils New Videos for Black Maternal Health Week - PR Newswire