Elsevier

American Heart Journal

Volume 202, August 2018, Pages 33-38
American Heart Journal

Clinical Investigation
Analysis of outcomes for 15,259 US patients with acute myocardial infarction cardiogenic shock (AMICS) supported with the Impella device

https://doi.org/10.1016/j.ahj.2018.03.024Get rights and content

Abstract

Background

The Impella percutaneous ventricular assist device (PVAD) rapidly deploys mechanical circulatory support (MCS) in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS). We present findings from a quality improvement (IQ) registry for US patients with AMICS who received Impella devices.

Methods and Results

From January 2009 to December 2016, 46,949 patients from 1010 US hospitals were entered into the IQ registry; of these, 15,259 had AMICS. Limited de-identified patient information, product performance, and survival to explantation were recorded. Of those with AMICS, 51% survived to explantation of PVAD. There was a significant difference between survival at explantation with quintile volume at hospitals (range: 0–100%; 30% survival rate in lowest quintile vs. 76% in top quintile; P < .0001). Use of the Impella device as first-line treatment pre-PCI was associated with a 59% survival rate, compared with 52% when used as a salvage strategy (P < .001). The survival rate among those who received hemodynamic monitoring with pulmonary artery catheters was 63% as compared with 49% in those who did not (P < .0001). Overall institutional Impella volume was related to survival (56% survival at sites with >7/year vs. 51% at sites with ≤1; P < .001).

Conclusions

In this early clinical experience with Impella support for AMICS, wide variation in outcomes existed across centers. Survival was higher when Impella was used as first support strategy, when invasive hemodynamic monitoring was used, and at centers with higher Impella implantation volume.

Section snippets

Methods

In 2009, the manufacturer of the Impella PVAD (Abiomed) initiated a quality improvement (IQ) registry to collect and collate clinical and technical data from patients in the US treated with an Impella (2.5, CP or 5.0) device. The manufacturer provided technical support to clinicians using a team of trained clinical specialists who were present at device implantation and followed the patient throughout their hospital course until device explantation. From January 2009 to December 2016, a total

Results

From January 2009 to December 2016, 15,259 patients with AMICS from 1010 US hospitals received Impella devices and were entered into the IQ registry. Of these, 479 patients were also entered into the cVAD registry and were available for analysis. Baseline characteristics for the 2 groups are shown in Table I. There were similarities between the 2 patient cohorts, but the variables in the IQ registry are limited. The type of Impella device used in each registry is also shown in Table I.

Discussion

The IQ registry collected limited data among patients with AMICS who received an Impella device at 1010 US hospitals between 2009 and 2016. Using data from this registry, we identified wide variation in outcomes when an Impella device was used. Our findings further suggest that high-volume hospitals have a better survival to device explantation as compared with low-volume hospitals. While this registry cannot fully explore the reason for this volume–outcome relationship, this is consistent with

Conclusion

This analysis of Impella PVAD use for the treatment of patients with AMICS at 1010 US hospitals between 2009–2016 represents the initial learning curve experience for US physicians and hospitals. Wide variation in survival exists between US hospitals. Practice patterns that consist of early initiation of MCS, before PCI, use of right heart monitoring, and greater institutional experience are associated with improved survival. These practices are being prospectively studied in the National

Acknowledgments

We are grateful for editorial assistance by Elizabeth Cook and Betty Summers.

Funding Source

The IQ database and cVAD registry are supported by Abiomed.

Disclosures

O'Neill: Consultant: MDT, Edwards Lifesciences, BSCI and Abiomed.

Grines: Speaker honorarium: Abiomed.

Schreiber: None.

Moses: None.

Maini: Speaker's bureau, Advisory board and contracted research: Abiomed, Siemens, Medtronic, Abbott Vascular, Boston Scientific.

Dixon: None.

Ohman: Consultant: Abiomed, Biotie, Boehringer Ingelheim, Chiesi, Faculty Connection, Gilead Sciences, and Medscape. Research grant: Gilead Sciences.

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