Dr. Andrew Sharp on the challenges with assessing Abiomed’s Impella pump.

Surgeries & Interventions

How to Assess the Abiomed Impella Pump

Abiomed’s Impella pump is being used across America to support patients with acute myocardial infarction with cardiogenic shock (AMICS) – but do we know it’s safe and effective? 

The FDA teamed up with Boston-based researchers to tackle this question in response to previous studies suggesting that Impella is associated with worse outcomes.

• However, their results led to even more questions and prompted new debates about how we can properly assess devices used to treat sudden, life-threatening complications.

Using data from 23,478 Medicare patients with AMICS who underwent PCI, they found that, on the same day as the PCI procedures:

• 17.3% were supported with the Impella percutaneous microaxial LVAD 
• 29.7% were supported with an intra-aortic balloon pump (IABP)
• 53% didn’t receive support from a mechanical circulatory device 

The Impella patients were younger, more likely to be male, and more likely to have severe cases or CVD histories.

To overcome challenges associated with observational studies, the researchers used a range of advanced statistical techniques, finding that Impella patients had higher 30-day mortality rates based on:

• Inverse probability analysis (risk difference: 14.9%, 95% CI, 12.9%-17.0%)
• Grace period analysis w/ support within 48 hours of PCI (risk difference: 18.4%; 95% CI, 12.1%-24.7%)
• Instrumental variable analysis (risk difference: 13.5%; 95% CI 3.9%-23.2%)

However, when they compared hospitals with different levels of Impella adoption, they found such wide variations that they concluded that these outcomes were influenced by confounding factors (Impella patients are often sicker, usage/results vary by institution, and Medicare severity data is lacking). That also prompted the researchers to believe that observational data might not ever allow accurate comparisons.

The Takeaway

The study and editorial authors (and folks on CardioTwitter) all seemed to agree that this largely proves that physicians are more likely to use the Impella pump with more severe AMICS patients, and that it will take a RCT to know for sure how the Impella pump compares to alternatives.

The good news is two Impella RCTs are on the way, but the bad news is the Impella pump has been in use for years without RCT confirmation of its safety, efficacy, or most appropriate patients. The risk of patient recruitment bias with cardiogenic shock also has some doubting whether these future RCTs can be trusted when they do come out.

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The Wire

• The ICs Are Not Alright: A new JACC survey revealed widespread dissatisfaction among the world’s interventional cardiologists. Lowlights from the survey (1,159 attendings, 192 fellows, 50% US based), revealed that the majority of ICs felt impacted by burnout (69%), believed they are working too hard (78%), and are frustrated by their work (58%), prompting 41% to consider quitting in the last year. The main burnout drivers were excessive documentation, lack of administrative support, bureaucracy, and insufficient income (excluding US attendings).

• Etripamil Safe and Effective for PSVT: A new Lancet study (N=692) found that Milestone Pharmaceuticals’ etripamil self-administered nasal spray is safe and effective for converting paroxysmal supraventricular tachycardia to normal sinus rhythm. Etripamil converted patients to sinus rhythm faster than placebo (median: 17.2 vs. 53.5 min) and didn’t lead to serious adverse events, although it did have more adverse events (50% vs. 11%). With etripamil’s clinical evidence mounting (here’s its previous trial), Milestone is actively ramping up its regulatory and commercialization processes.

• CVAUSA Acquires in Tampa Bay: Cardiovascular Associates of America (CVAUSA) kept its cardiology practice acquisition spree going, partnering with Tampa, Florida-area practice Bay Area Cardiology and Vascular Associates (15 physicians, 4 locations). The partnership comes less than two weeks after CVAUSA acquired New Jersey-based practice Shore Heart Group, and marks CVAUSA’s seventh new practice partnership in 2023 (14th since 2021).

• Photon-Counting Cardiac CT: Photon-counting CT is widely viewed as the next big thing for the CT modality, and a new study showed one way it might impact cardiac imaging. Researchers scanned 68 patients with severe aortic valve stenosis who were scheduled for TAVR, finding that Photon-counting CCTA rivaled invasive coronary angiography for detecting coronary artery disease (AUCs: 0.93 per participant; 0.92 per segment) and was good enough to be used in high-risk TAVR candidates who previously weren’t suitable for CT workup.

• Surmodics’ DCB FDA: Surmodics announced the FDA approval of its SurVeil drug-coated balloon (DCB) for percutaneous angioplasty treatment of peripheral artery disease, coming almost exactly three years after its European CE Mark Certification. SurVeil DCB will be exclusively distributed by Abbott, which will give Surmodics a $27M milestone payment for the approval, plus a cut of its future SurVeil DCB sales.

• Philips Unveils 5500CV Echo: Philips’ debuted its new cardiology-focused Ultrasound Compact 5500CV system at ASE 2023, bringing the image quality, workflows, and transducers found in Philips’ cart-based EPIQ CVx and Affiniti CVx echo systems into a wireless and portable setup. To support its mobile use, the Ultrasound Compact 5500CV also features an optional 2.5hr battery and supports remote collaboration via Philips’ Collaboration Live solution.

• Underprescribed Hospitalized HFrEF Patients: A new report from the AHA found that patients hospitalized for HFrEF are often prescribed only a portion of the medications they could benefit from. Between 2017 and 2020, over 50k patients were eligible for an average of four evidence-based medications, but were only prescribed an average of three at discharge. While the number of patients receiving all indicated medications nearly doubled from admission (14.9%) to discharge (32.8%), there are still missed opportunities for medication initiation. 

• Qardio Launches Livestream ECG: Virtual patient monitoring startup Qardio unveiled its Livestream ECG solution suite, which provides remote care clinicians and their patients real-time continuous ECG and blood pressure monitoring along with a broad range of other metrics (pulse oximetry, body temp, weight, and body positioning). Qardio specifically highlighted how its real-time ECG readings extend beyond 30 seconds and how its QardioCore technology allows patients to take ECG readings without shaving or adhesive patches.

• Evinacumab Extends Life in HoFH Patients: New mathematical models suggest that Regeneron’s evinacumab paired with standard lipid-lowering therapies (LLTs) may dramatically extend survival in patients with two copies of the familial hypercholesterolemia gene. The authors used efficacy data from the ELIPSE HoFH trial to generate their models, which predicted how lipid lowering therapies influenced life expectancy. The most robust model predicted that patients already taking PCSK9i, ezetimibe, and a high-intensity statin could live 12 additional years if they added evinacumab to their regimen. 

• Docs Harassed on Social Media: There’s a downside to doctors using social media for public health advocacy. A study in JAMA Network Open found that 66% of physicians have been attacked on social media, with high levels of gender- and race-based harassment (45% and 27%). Harassment usually follows physicians weighing in on topics like vaccinations, abortion, or firearms, and has unsurprisingly gotten significantly worse during the pandemic.

• Cardio Flow Design’s 4D Flow FDA: The 4D Flow MRI segment just added another competitor, following the FDA clearance of Japan-based Cardio Flow Design’s iTFlow solution. Like other 4D Flow products, iTFlow uses CMRI data to support blood flow analysis and evaluation, while providing users with fluid dynamics visualization of heart and blood vessels in both 2D and 3D.

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