TCT 2024 Preview: Elevating Patient Care with Innovation and Expertise

As we look forward to October, the spotlight turns to one of the most anticipated events in cardiovascular innovation: Transcatheter Cardiovascular Therapeutics (TCT) 2024. This year’s agenda promises to deliver ground-breaking insights and advancements across the spectrum of cardiovascular care. With just a month to go, it's the perfect time to explore what’s on the horizon at TCT and the key themes that will shape the conversation.

From MedTech innovation and artificial intelligence to precision medicine and personalized care, this year’s TCT is a powerhouse of cutting-edge technologies. Highlights will include sessions exploring the CathLab of the Future, the growing role of noninvasive imaging, and the impact of big data on clinical decision-making. In particular, we’re excited about the focus on AI-driven solutions for optimizing care and improving procedural outcomes.

On the interventional front, coronary interventions take center stage, with deep dives into complex PCI cases, the latest on drug-coated balloons, and innovations in lipid management and coronary imaging to prevent future events. Expect to see key discussions on precision stenting and advanced therapies tailored to complex coronary artery disease.

For those focused on structural heart interventions, there’s a wealth of content covering the latest in TAVR, mitral valve interventions, and left atrial appendage occlusion (LAAO). These sessions will showcase evolving techniques and next-generation technologies, ensuring that clinicians are equipped to handle both routine and highly complex structural cases.

A major theme of TCT 2024 will also be mechanical circulatory support and cutting-edge approaches to heart failure management, including new device-based treatments for HFrEF. If you’re interested in renal denervation (RDN) for hypertension management, you won’t want to miss the sessions diving into these evolving therapies, as well as broader discussions around multiorgan denervation for more comprehensive cardiovascular care.

The focus on managing procedural complications is another key highlight, with case-based sessions exploring real-time problem-solving for issues such as vessel perforation and hemodynamic collapse. Coupled with deep dives into cardiogenic shock management, these topics will address the most critical, high-risk scenarios that interventionalists face today.

Regulatory insights will also play a prominent role through FDA University sessions, offering a behind-the-scenes look at the processes guiding device approval and innovation.

And, as always, TCT’s commitment to patient-centric approaches will shine through, with sessions aimed at integrating patient perspectives into clinical care and exploring the latest outcomes from global cardiovascular research.

This issue of Pulse on Devices is dedicated to previewing these key themes heading into TCT 2024, spotlighting the powerful ecosystem of people, technology, and companies driving advancements in coronary, heart failure, hypertension, structural heart, and endovascular therapies. Included in this issue is an exclusive Q&A with Nuwellis CEO Nestor Jaramillo Jr., where we discuss their latest innovations and the future of patient care.

Charting New Waters in Healthcare: A Q&A with Nestor Jaramillo Jr., CEO of Nuwellis

In the rapidly evolving landscape of healthcare, managing complex conditions like fluid overload requires not just innovative technology but visionary leadership. At the helm of Nuwellis, Inc., a pioneering medical device company, stands Nestor Jaramillo Jr., whose stewardship is guiding the firm into new frontiers of patient care. Nuwellis, renowned for its Aquadex system, has carved a niche in addressing the critical and often overlooked condition of fluid overload, which affects patients with heart failure, kidney disease, and other critical conditions. This technology stands out for its precision, safety, and adaptability to the unique needs of each patient, marking a significant advancement in medical treatment options.

Jaramillo, with his extensive background in the medical device and healthcare sectors, has been instrumental in driving Nuwellis’s mission forward. Under his leadership, the company has not only enhanced its flagship product but also expanded its reach to address the needs of pediatric patients and those requiring specialized care. His strategic vision encompasses a broad spectrum of healthcare needs, focusing on improving outcomes, reducing hospital stays, and, ultimately, lowering the costs associated with complex medical conditions.

As Nuwellis continues to innovate and expand its portfolio, the healthcare community watches closely. Jaramillo's approach to leadership—balancing innovation with practical application—serves as a beacon for the industry, highlighting how technology and compassion can come together to improve patient lives.

In this exclusive Q&A, Nestor Jaramillo Jr. discusses Nuwellis, the impact of its technologies on healthcare, and what the future holds for the company and the patients it serves. Join us as we delve into the insights of a leader who is not just shaping a company but also influencing the broader landscape of healthcare innovation.

What are the most common underlying health conditions that lead to fluid overload in patients?

When addressing common underlying health conditions and treatments, it's important to consider the wide range of challenges patients and healthcare providers face. For example, decompensated heart failure significantly affects a patient's health by causing the body to retain fluid, a situation often exacerbated by conditions like cardio renal syndrome. Initially, diuretics are the go-to treatment, but over time, their effectiveness can diminish, necessitating alternative methods for fluid removal. This condition is chronic and progressive, and without proper management, volume overload can accelerate disease progression.

Similarly, patients undergoing cardiac, trauma, or transplant surgery often receive substantial amounts of fluid during the procedure, which must then be carefully removed to prevent complications. The Aquadex system offers a tailored, gentle, and safe solution for fluid removal, addressing the needs of these patients effectively.

Transplant patients, particularly, face additional challenges with fluid retention due to the medications used to prevent organ rejection. Likewise, individuals with acute kidney injury (AKI), chronic kidney disease (CKD), including pediatric patients, and those with advanced liver disease often struggle with fluid removal. These groups may become resistant to diuretics, making traditional treatment methods less effective.

For those with advanced liver disease, a notable segment of the U.S. adult population, the situation is particularly pressing. Recent insights from a case series at Mt. Sinai in New York City have highlighted a promising application of aquapheresis within existing guidelines that doesn't require further FDA approval. This treatment has shown to significantly improve mobility and ICU recovery times without the complications often associated with other methods.

In summary, fluid management in patients with these conditions presents a complex challenge that requires innovative solutions like Aquadex. This approach not only offers a safe and gentle option for fluid removal but also has the potential to significantly improve the quality of life and outcomes for patients facing these serious health issues.

How does Nuwellis' technology specifically help patients with such underlying health conditions?

Aquadex SmartFlow Ultrafiltration is a cutting-edge treatment that empowers both physicians and clinicians to tailor the process of excess fluid removal to the specific needs of the patient. This personalized approach is not only gentle and safe but also critically attentive to the complexity of the patient's health condition. By customizing fluid removal, we can avoid sudden hemodynamic shifts—those changes that might adversely affect blood pressure. Moreover, it supports the kidneys' vital role in filtering and removing fluid from the body, an essential function for maintaining health.

Fluid retention occurs in three main areas of the body: the intravascular space (within the blood vessels), the interstitial space (between cells), and the intracellular space (inside the cells). The Aquadex system is designed to efficiently remove fluid from the intravascular space, which in turn allows fluid from the other two spaces to naturally migrate back into the intravascular space for removal. This process ensures a balanced and effective approach to fluid management.

Key to this system is our innovative sensor technology, notably the Hematocrit Sensor. This tool enables clinicians to accurately monitor the rate at which plasma refills in the blood vessels. By doing so, it ensures that only the appropriate amount of fluid is removed during each therapeutic session. This precision not only maximizes the effectiveness of the treatment but also upholds the highest standards of patient safety and comfort.

What are the benefits of using Nuwellis' Aquedex SmartFlow technology over traditional fluid management methods?

Aquadex therapy represents a highly personalized and precise method for fluid removal, functioning similarly to an advanced mechanical diuretic. This innovative approach allows for the gentle and safe extraction of excess fluid, tailored to the unique needs of each patient. Unlike traditional medication, which requires time to administer and observe its effects, Aquadex therapy offers immediate start and stop capabilities. This instant adaptability means clinicians can observe fluid removal in real-time, just seconds after the therapy begins, contrasting significantly with the hours or even days it can take to assess the effectiveness of medication.

One of the standout features of Aquadex is its ability to be finely adjusted on the fly, aligning perfectly with the patient's fluid removal goals related to both volume and weight. This level of precision is challenging to achieve with conventional medications. The system operates with two pumps: one to circulate the blood through the device and another to extract fluid from the blood. Remarkably, the ultrafiltrate pump, responsible for fluid removal, can be deactivated while the blood continues to circulate, ensuring the integrity of the circuit is maintained without interruption.

Aquadex distinguishes itself from more aggressive fluid removal methods, such as Continuous Renal Replacement Therapy (CRRT), by having less blood within the circuit and employing only two adjustable pumps. This setup allows the system to operate at a slower, more controlled pace, which significantly reduces inflammation of blood cells. Inflammation is a critical factor that can prompt the body to retain fluid, counteracting the objective of fluid removal technologies. By minimizing this response, Aquadex not only effectively removes excess fluid but also supports the overall well-being of the patient, making it a compassionate choice in fluid management.

Can you elaborate on how Nuwellis' technology integrates into a patient’s overall treatment plan?

Incorporating technology into a patient's comprehensive treatment plan can markedly enhance outcomes, particularly when it comes to managing fluid overload. Evidence has shown that utilizing Aquadex technology early in the treatment process, especially for those patients who are resistant to diuretics, can lead to significant improvements. These include shorter hospital stays and a decrease in both readmissions and rehospitalizations, ultimately contributing to better patient outcomes and reduced healthcare costs.

For patients dealing with chronic volume overload, the stakes are particularly high. Each subsequent hospitalization can significantly increase their risk of mortality. By integrating Aquadex into their treatment regimen, healthcare providers can offer a more proactive approach to managing this condition. This not only helps in mitigating the immediate health risks associated with volume overload but also plays a crucial role in improving the long-term survival prospects of these patients. Through such strategic integration, Aquadex stands out as a valuable tool in the ongoing effort to deliver high-quality, cost-effective healthcare.

What are the future developments Nuwellis is working on to enhance care for patients with fluid overload?

Looking ahead in the realm of fluid overload management, innovation remains a key driver in enhancing patient care, particularly through advanced sensor technology. At the forefront of this innovation is our Hematocrit sensor, a pioneering feature that's integrated directly into the Aquadex system's console pump. This unique design allows clinicians to monitor and assess a patient's condition in real-time during ultrafiltration therapy, a capability that sets Aquadex apart from CRRT (Continuous Renal Replacement Therapy) machines, which require an external sensor for similar assessments. Additionally, Aquadex stands out by measuring SV02 levels, offering an innovative feature not standard in other systems, thereby providing a more comprehensive view of the patient's status.

Nuwellis is not only focused on sensor technology but also on improving venous access. We are thrilled to share that we've received FDA clearance for our new, shorter version delc catheter. This advancement offers additional options for clinicians, ensuring more comfortable and tailored access to the patient's bloodstream across various body types, enhancing the overall treatment experience.

Furthermore, Nuwellis is at the forefront of developing a state-of-the-art pediatric CRRT machine. This groundbreaking device is designed to offer physicians a superior option for managing fluid removal and dialysis in the pediatric population, especially for those young patients who are born with absent or underdeveloped kidneys. Our aim is to provide a lifeline for these children, sustaining them until a transplant becomes available or other surgical interventions can be pursued. Through these innovations, Nuwellis is dedicated to expanding treatment possibilities and improving the lives of patients across all ages with fluid management needs.

Learn more about Nuwellis:

TCT 2024 Preview

As we gear up for TCT 2024, the stage is set for an exciting lineup of sessions focused on the latest advancements in cardiovascular care. This year’s event will spotlight a wide range of innovative topics and groundbreaking research aimed at enhancing patient outcomes through cutting-edge technology and therapeutic interventions. From the evolution of MedTech innovation to the integration of artificial intelligence and precision medicine into clinical practice, TCT promises to be a showcase of the future of cardiovascular treatment.

Here are the key themes and areas of focus for this upcoming event:

1. MedTech Innovation and Technology Integration:

• CathLab of the Future: Sessions explore innovations creating seamless, technology-driven environments for improved care, focusing on integration in cath labs.
• Noninvasive Imaging: Emphasis on the growing role of noninvasive imaging modalities and point-of-care diagnostics.
• AI and Big Data: There are multiple sessions examining the role of artificial intelligence (AI) and big data in clinical decision-making, research, and improving outcomes in interventional cardiology.
• Precision Medicine: Highlighted sessions cover the advancements in personalized care, particularly focusing on coronary and peripheral interventions tailored to patient-specific factors.

2. Coronary Interventions:

• PCI and Complex Coronary Artery Disease: There is significant focus on percutaneous coronary interventions (PCI), including addressing complex cases and complications, like managing diffuse disease and small vessel interventions.
• Lipid Management and Coronary Imaging: Several discussions look at evolving approaches to lipid management, plaque composition changes, and coronary imaging in preventing future cardiovascular events.
• Drug-Coated Balloons and Drug-Eluting Stents: Ongoing trials and discussions on advanced techniques for drug delivery and healing-targeted therapies are central to the PCI-focused sessions.

3. Structural Heart Interventions:

• TAVR and Valve Interventions: There are multiple sessions devoted to advancements in transcatheter aortic valve replacement (TAVR) and strategies to manage valve failure, redo TAVR, and aortic regurgitation.
• Edge-to-Edge Repair Techniques: Focus on mitral and tricuspid valve repairs using transcatheter techniques like TEER (transcatheter edge-to-edge repair).
• Left Atrial Appendage Occlusion (LAAO): Comprehensive sessions explore procedural complexities, new technologies, and post-procedural care in LAAO.

4. Mechanical Circulatory Support and Heart Failure:

• Heart Failure Management: Innovations in managing heart failure, including discussions on GDMT (guideline-directed medical therapy) and new device-based treatments for heart failure with reduced ejection fraction (HFrEF).
• Mechanical Circulatory Support: Latest research on mechanical circulatory support (MCS) devices, with clinical trials like the DanGer Shock trial, emphasizing their use in high-risk PCI and cardiogenic shock.

5. Interventional Hypertension Management:

• Renal Denervation (RDN): Several sessions are dedicated to renal denervation for the management of uncontrolled hypertension, covering safety, effectiveness, and future technologies like ultrasound-based RDN systems.
• Multiorgan Denervation: An expanding area in hypertension management, discussing interventions that go beyond renal to other organs like hepatic denervation.

6. Emerging Challenges and Complications:

• Handling Procedural Complications: Multiple case-based sessions address managing acute and unexpected complications during coronary and structural interventions, including vessel perforation, hemodynamic collapse, and other high-risk scenarios.
• Cardiogenic Shock: In-depth discussions on advancing the understanding and treatment of cardiogenic shock, focusing on registries, trials, and real-time clinical decision-making.

7. FDA Involvement and Regulatory Insights:

• FDA University: There are ongoing sessions focused on regulatory processes, FDA involvement in approving devices and therapies, and the evolving role of innovation in these regulatory frameworks.

8. Patient-Centric Approaches and Outcomes:

• Patient Perspective in Clinical Care: Sessions aimed at integrating patient perspectives into treatment plans, particularly around cardiovascular diseases and interventions.
• Clinical Trials and Evidence-Based Practices: The agenda includes several "Late-Breaking Clinical Trials" sessions, bringing forward the latest research and data from ongoing global cardiovascular studies, including the results of major trials in TAVR, PCI, and drug-eluting technologies.

9. Global Research and Innovation:

• Global Research Forums: Best practices and latest research from around the world, particularly focused on innovations in coronary imaging, aortic valve replacement, mitral and tricuspid valve interventions, and mechanical circulatory support.

Technology Spotlight: Startups Driving New Innovation

As we gear up for TCT 2024, it's not just the main sessions that are buzzing with excitement. Behind the scenes and on the exhibit floor, a hotbed of activity is unfolding, driven by the brave and pioneering startup teams pushing the limits of cardiovascular innovation. These emerging companies are working tirelessly to bring new technologies and solutions that could reshape the future of patient care.

Here’s a spotlight on five startups making waves in the broader ecosystem supported by TCT, each with a distinct focus on advancing critical areas of coronary, structural heart, hypertension, and endovascular therapies.

Conformal Medical: Next-Generation LAAC Device

Conformal Medical is pioneering a novel Left Atrial Appendage Closure (LAAC) device that promises to simplify the procedure while maintaining a high level of safety. Their device is designed to conform to a wide range of anatomies, providing a custom fit without the need for advanced imaging or complex manipulation. By reducing procedure times and minimizing complications, Conformal Medical is addressing the growing need for simpler, more effective options for stroke prevention in patients with atrial fibrillation. As LAAC continues to evolve, this startup is one to watch closely.

4C Medical Technologies: Innovating Mitral Valve Replacement

4C Medical Technologies is making significant strides in the field of transcatheter mitral valve replacement (TMVR). Their flagship product, the AltaValve, offers a novel supra-annular design that sits above the native mitral annulus, reducing the risk of complications involving the left ventricle. This innovative approach could revolutionize the treatment of mitral regurgitation by providing a safer, more efficient transcatheter option. As TMVR technologies advance, 4C Medical’s unique solution could play a pivotal role in reshaping how mitral valve disease is treated.

Sonivie: Ultrasound-Based Renal Denervation for Hypertension

In the growing field of renal denervation (RDN) for hypertension, Sonivie stands out with its TIVUS? System, which utilizes high-intensity ultrasound for renal nerve modulation. Unlike traditional ablation methods, Sonivie’s approach is non-ablative, potentially offering a safer and more effective way to reduce blood pressure in patients with resistant hypertension. With a growing body of evidence supporting the use of RDN, Sonivie’s technology could be a major player as more interventionalists look for advanced options in managing hypertension.

Endologix: Leading Innovation in Endovascular Therapy

Endologix is at the forefront of innovation in endovascular therapy, focusing primarily on treating abdominal aortic aneurysms (AAA) and other complex vascular diseases. Their suite of products includes advanced endografts and minimally invasive technologies that offer safer, more effective alternatives to traditional open surgery. With a commitment to improving procedural outcomes and reducing recovery times, Endologix is paving the way for the next generation of endovascular interventions. Their work in endovascular aneurysm repair (EVAR) continues to set new standards in vascular health, making them a key player in the ongoing transformation of peripheral vascular therapy.

Elixir Medical: Advancing Coronary Interventions with Bioresorbable Scaffolds

Elixir Medical, based in California, is leading the charge in coronary interventions with its innovative bioresorbable scaffold technology. Their flagship product, the DynamX Coronary Bioadaptor System, is designed to support the artery during healing while restoring its natural movement over time, unlike traditional drug-eluting stents that leave permanent implants. Elixir Medical’s bioadaptive technology represents a significant advancement in coronary care, aiming to reduce long-term complications such as restenosis and improve overall patient outcomes.

As we look ahead to another exciting TCT, these startups are contributing to the vibrant and evolving cardiovascular ecosystem. From advancing structural heart therapies to pioneering new techniques in hypertension management and coronary interventions, these companies are committed to improving patient care with innovative technologies. Keep an eye on these bold innovators as they further their cause, ensuring that the future of cardiovascular care continues to advance at the speed of innovation.

Advances in Renal Denervation: From Concept to Reality in the U.S. – The 2023 Edition Update

The 2023 edition of "Renal Denervation: Treatment and Device-Based Neuromodulation" is a excellent update in the field of hypertension treatment. Eight years since the first edition's publication, this new edition delivers in insight into critical advancements in renal denervation. It covers the significant progress made, that is well timed with the breakthrough regulatory approvals that have recently made this innovative therapy a viable option in the United States. This edition offers an in-depth exploration of the evolving landscape of renal denervation, reflecting the latest developments and clinical insights that have emerged since 2015.

Benjamin Franklin’s Medical Invention You Didn’t Know

Known for his contributions to science and politics, Benjamin Franklin also made an early mark on medical innovation. In 1752, he invented the first flexible catheter to ease the suffering of his brother, who endured painful bladder stones and urinary retention. At a time when catheters were rigid and uncomfortable, Franklin designed a flexible metal catheter that was far easier to use and less painful.

Driven by compassion and ingenuity, Franklin’s simple yet groundbreaking invention paved the way for the modern catheters used in medical care today. A true polymath, Franklin’s work extended far beyond electricity—he also helped improve patient care with this enduring innovation.

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