Hospital administrators should have a strategic plan and invest resources into programs that support complex PCI. Not only do PCI programs meet the needs of several cardiovascular services, but it also serves patients with CAD. CAD patients may present in a variety of states ranging from elective outpatient cases, to emergencies such as myocardial infarctions (heart attacks) or cardiogenic shock (when your heart can’t pump enough blood to your body’s organs). The most effective service lines involve a collaborative “heart team” approach, bringing together the skills of heart failure specialists, critical care intensivists, and interventional cardiologists.

Not having a structured MCS program led equally by administrators and clinicians could impact patient care and lead to missed financial opportunities for hospitals. As a result, patients who could benefit from complex PCI may have this therapy withheld, depending on which physician is on call.

The DanGer trial⁴ focuses on patients with ST-segment elevation myocardial infarction (STEMI) and cardiogenic shock — those whose hearts are no longer able to pump enough blood to their vital organs due to a previous heart attack. It’s also the first study to demonstrate that a physician-led intervention (using the Abiomed Impella CP® heart pump) resulted in better survival for patients who experienced cardiogenic shock due to a heart attack. Specifically, the trial demonstrated a 26% relative risk reduction and 12.7% absolute reduction in mortality (p=0.04, n=355). It found that for every eight patients treated (Number Needed to Treat or NNT), one additional death was prevented. However, the investigators found an even more striking outcome when analyzing patients aged 77 and younger. The NNT dropped to five, corresponding to a 20% absolute reduction and a 35.7% relative reduction in mortality (p=0.001, n=274).⁵

For decades, the go-to treatment opened the blocked artery to address the root cause of the shock. We’ve known for a long time, however, that we need to look at both the blocked artery and the impaired heart — open the blocked artery and stabilize the heart function to improve vital organ perfusion. The traditional approach has been to open the artery first and then stabilize the patient, often using a heart pump or medications to support blood pressure.

The DanGer trial is particularly exciting for reconsidering norms and asking this breakthrough question: What if you stabilize the heart first and then open the artery? This question may sound simple, but many physicians wouldn’t think of leaving an artery blocked while getting a patient onto a heart pump. This concept of “unloading” the heart first has been discussed in smaller studies, but the DanGer trial was the first large, randomized controlled trial to give this different approach the solid statistical backing it needed.

How has the DanGer study changed your hospital’s approach to treating patients?

Tufts Medical Center has been at the forefront of researching the concept of unloading for about 15 years. The DanGer study’s findings not only validate the protocols that we've been implementing for the past five to 10 years but also influence skeptics to revise their clinical practices to align with these strategies. Furthermore, the American College of Cardiology and American Heart Association updated their clinical guidelines to reflect this new level of evidence. As of February 2025, micro axial flow pumps (i.e. Impella) have upgraded to Class 2a for STEMI cardiogenic shock patients based on the DanGer Shock RCT. The next generation of medical professionals will be trained with the understanding that unloading and resting the heart is a priority in the management of heart attacks with cardiogenic shock.

More recent post-study discussions have impacted our approach to avoiding (or managing potential) adverse events. We now emphasize early intervention with a readiness to step up support within the first critical hours, which is becoming a key part of improving patient care. This understanding has lowered our threshold for using the Impella earlier on in the catheterization lab, especially for heart attack patients and those in cardiogenic shock, improving outcomes for these complex and sick patients.

The trial's impact extends to the administrators at our network's spoke hospitals, who are newer to Impella and its protocols. They've seen the value of early mechanical circulatory support, hemodynamic assessments in the catheterization lab, and the importance of timely transfers for escalation of care. This has strengthened patient care in community hospitals where historically, patients with severe conditions and high mortality risk might not have survived or would have been transferred too late to improve survival. Now, these hospitals are equipped to stabilize patients on-site, improving their outcomes before considering a transfer.

Why should hospitals in community-based settings that don’t currently have an established MCS program consider investing in one?

The DanGer trial demonstrated better patient outcomes with physician-led intervention:

• Higher survival rates at six months
• Shorter ICU stays
• Less drug therapy for cardiogenic shock

However, positive patient outcomes like these can greatly depend on quick access to appropriate hemodynamic support to stabilize blood flow and pressure.

Community-based hospitals can benefit from having a robust and balanced MCS program (high risk PCI and cardiogenic shock) for several reasons. First, it fosters operator experience, which is directly linked to improved safety, better patient outcomes, and more accurate patient selection. This expertise is essential, because medical teams well-versed in handling a variety of cases can provide more comprehensive care to their patients, regardless of how or where they enter the healthcare system.

Also, being able to stabilize patients effectively is crucial. Sometimes, patients may need to be transferred to another facility for advanced treatments not available locally. A balanced program ensures there are protocols in place to support patients during their initial care and facilitate a smooth transfer, if needed.

One of the key benefits of having a balanced program with a strategy for both high-risk PCI and cardiogenic shock is the ability to build experience in a controlled setting through complex, elective interventions. This means when emergency cases arise, medical teams aren't learning on the fly — they're prepared and capable. In rural areas, where certain emergencies might be seen more often than in urban settings, it's vital for medical teams to have a reliable platform that can support both the left and right sides of the heart.

Finally, with access to a comprehensive suite of support options like Impella, community-based hospitals can manage a wider range of patient acuity. They can retain more patients and provide escalation of care on-site, reducing the need for transfers. These results align with hospital administrators' goals of expanding service lines to enhance patient care, which ultimately leads to better outcomes.

From a financial perspective, U.S. reimbursement structures can offset the costs associated with establishing and maintaining an MCS service line, making it a financially viable investment.

The Centers for Medicare and Medicaid Services (CMS) have established dedicated Category I CPT codes for procedures involving Impella devices, providing a standardized reimbursement process for physicians.

Additionally, the Diagnosis-Related Group (DRG) system offers reimbursement and removes financial barriers for hospitals looking to establish or maintain a MCS program. For instance, DRG 1, which includes the most complex patients, translates to a CMS national average payment rate of approximately $200,000 for FY2025.⁶

By integrating an MCS service line, hospitals can provide care that improves survival rates for high-risk cardiac patients while benefiting from established reimbursement frameworks, thereby aligning clinical excellence with financial sustainability.

What advice do you have for healthcare leaders starting, or looking to start, a MCS program?

In the medical field, it is rare to have lifesaving technology that both improves patient survival rates and positively impacts a hospital’s financial bottom line. When these things come together, it’s a wonderful thing.

As a physician, it’s important to ask yourself, “Am I doing the right thing for my patients in my current clinical practice?” If your answer is “I'm not sure,” then the next step is to look at the data, specifically the DanGer trial. If you're still not convinced by a statistically significant positive RCT in the New England Journal of Medicine,⁷ then look at your own data. If you’re seeing mortality rates for your AMI shock population in the typical range of 50%, then you must try something different.

All physicians need to reflect on whether we’re doing the right things for our patients and dig into the data to support our approach. Until more data proves other approaches, like ECMO or balloon pumps, are better, we should consider the DanGer trial findings and determine if they're right for our patients. We must let data, not opinions, drive clinical practice forward.

J&J MedTech: Heart Recovery is the maker of the Impella® heart pumps. The Impella heart pumps are the only U.S. Food and Drug Administration-approved percutaneous heart pump technology indicated for patients with severe coronary artery disease or AMI cardiogenic shock due to a heart attack. Impella has the unique ability to enable heart recovery, allowing patients to return home with their native hearts.

Learn more about J&J MedTech: Heart Recovery and the Impella® heart pumps.

This article is sponsored by J&J MedTech: Heart Recovery, an Advisory Board member organization. Representatives of J&J MedTech helped select the topics and issues addressed. Advisory Board experts maintained final editorial approval, and conducted the underlying research independently and objectively. Advisory Board does not endorse any company, organization, product or brand mentioned herein.

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