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Use of a Percutaneous Ventricular Assist Device/Left Atrium to Femoral Artery Bypass System for Cardiogenic Shock
Published on: August 16, 2021
Clinical introduction of the Tandemheart, a percutaneous left ventricular assist device, for circulatory support
Pascal Vranckx1, David P Foley, Pim J de Feijter
1Department of Cardiology, Thoraxcenter, Erasmus, Medical Centre, Rotterdam, The Netherlands.
Insights
The Tandem-heart device effectively supports patients during high-risk percutaneous coronary intervention (PCI), maintaining hemodynamic stability and showing promising results for future use in cardiac interventions.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- Percutaneous coronary intervention (PCI) poses hemodynamic risks for patients with poor left ventricular function and complex coronary lesions.
- Prolonged ischemia during PCI can lead to significant adverse hemodynamic consequences.
- The Tandem-heart is a percutaneous left ventricular assist device designed for short-term circulatory support.
Purpose of the Study:
- To evaluate the safety and efficacy of the Tandem-heart device for circulatory support during elective high-risk percutaneous coronary intervention (PCI).
- To assess the device's ability to maintain hemodynamic stability in patients undergoing complex PCI procedures.
Main Methods:
- The Tandem-heart device, featuring specific arterial and transseptal cannulae and a centrifugal blood pump, was electively used in three male patients undergoing high-risk PCI.
- The device withdraws oxygenated blood from the left atrium and delivers it to the arterial circulation.
- Hemodynamic parameters and device performance, including pump flow and duration of support, were monitored.
Main Results:
- Procedural success was 100% in all three patients.
- Systemic hemodynamics significantly improved prior to PCI in two patients.
- Mean pump flow was 3.17 liters/min, with a mean support duration of 33 hours. No significant hemolysis or bleeding occurred. All patients were successfully weaned and remained event-free for up to seven months.
Conclusions:
- The Tandem-heart device demonstrated ease of insertion and effective preservation of hemodynamic stability during high-risk PCI.
- The device's performance was independent of the patients' intrinsic cardiac function.
- This initial clinical experience suggests optimism for broader application of the Tandem-heart in PCI and other indications.
Background:
In patients with poor left ventricular function and high-risk coronary lesions, prolonged ischemia during percutaneous coronary intervention (PCI) may have major hemodynamic consequences. The Tandemheart is a percutaneous left ventricular assist device intended for short-term circulatory support.
Methods And Results:
The Tandem-heart incorporates 9-17 F. arterial cannulae and a unique 21 F. transseptal cannula and centrifugal bloodpump. Operating at 7500 rpm, the pump withdraws oxygenated blood from the left atrium and delivers up to 4 liters/min to the arterial circulation. As of May 2001, the Tandem-heart was electively employed in three male patients (ages 52, 54 and 56) scheduled for high-risk PCI. The mean time to initial circulatory support was less than 30 minutes. Systemic hemodynamics significantly improved prior to PCI in two patients. Pump flow after one hour ranged from 2.43 to 3.8 liters/min (mean 3.17 liters/min) and duration of support from 23 to 49 hours (mean 33 hours). Procedural success was 100%, with no significant hemolysis or bleeding. Successful weaning was completed in all patients, who have remained free of major cardiac events up to seven months post-PCI.
Conclusions:
In this first clinical experience of elective use of Tandem-heart for circulatory support during high-risk PCI, the device was easily inserted and preserved hemodynamic stability, regardless of the intrinsic cardiac function, creating optimism for more widespread use for this and other indications.
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