Thoracotomy Clinical Evidence Medtronic HVAD System

HVAD pump with a graphic of a man depicting entry points for thoracotomy surgery for VAD implantation

The First VAD Approved For the Less-invasive Thoracotomy Approach

The HVAD™ Pump is the world’s smallest commercially available, full-support, centrifugal VAD, enabling unmatched procedural versatility. It is also the only full-support, durable VAD with clinical evidence to prove its safety and effectiveness when used in a less-invasive thoracotomy approach.

Alert Indications, Safety, and Warnings

      

Mounting Clinical Evidence

The latest clinical evidence from the HVAD LATERAL Trial demonstrated a significant improvement in quality of life, including 87% unprecedented survival at two years and 30% reduced length of stay.1

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87%

Unprecedented Survival at 2 Years1

Graph depicting survival rate over time with the HVAD implanted

30%

Reduced Length of Stay1

Graph depicting lateral trial data for HVAD

95%

FREEDOM FROM DISABLING STROKE2 as demonstrated from the latest clinical evidence from the HVAD LATERAL Trial

HVAD System data featuring data involving stroke for HVAD patients

The Trial Also Demonstrated Low Adverse Event Rates Through 2 Years, Including2:

  • EXCHANGE for VAD thrombus was only 2.1% with no new events between 1–2 years.
  • 0.12 EPPY driveline infection rate.
  • 0.10 EPPY stroke rate.

Data submitted for publication.

Low Incidence of Right Heart Failure2:

  • The lowest rate of right heart failure requiring an RVAD reported in a VAD clinical trial.
  • No new severe right heart failure events reported after three months.

Data submitted for publication.

A number of centers are beginning to study the potential impact that implanting the HVAD Pump via a less-invasive thoracotomy approach may have on the incidence of right heart failure.3

"We retrospectively reviewed our cohort of HVAD implantations between 2013 and 2017, and found that the lateral group was associated with less RV dysfunction compared with patients in the conventional sternotomy group."3

Zachary N. Kon, M.D.
New York University, New York, NY, USA

  

Thoracotomy Economic Value

A recent study demonstrated that HVAD implant using the less-invasive thoracotomy approach has a $56,385 reduction in costs compared to HVAD implant using the sternotomy approach.4

  • 30% relative reduction in LOS compared to sternotomy approach1
  • > $50,000 absolute average reduction in cost comparted to sternotomy approach4

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Lateral Versus Medicare Database Comparison

Graph depicting the economic value of thoracotomy versus sternotomy in VAD surgeries

Economic LATERAL Data
(N = 95)

 Medicare Data
(N = 2,831)
HVAD Thoracotomy Population Only Predominantly VAD Sternotomy Population
Both focused exclusively on cost of VAD implant hospitalization 

  

Less-invasive Thoracotomy Procedures Are Trending Up

The percentage of HVADs implanted via the less-invasive thoracotomy approach has continued to rise as the clinical evidence and positive patient outcomes continue to build. Today, an average of 26% of HVAD Pumps are implanted via a thoracotomy approach.5

Thoracotomy in Action

26%

Average percent of HVAD Pumps that are implanted via a thoracotomy approach5

Graph with three blue bars showing an upward trend in thoracotomy for HVAD

Longer-length Coring Tools

Ask your Medtronic sales rep about optimized surgical tools designed specifically for use in thoracotomy procedures.

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Education and Training Resources

Interested in learning more about the HVAD System and the less-invasive thoracotomy approach? Medtronic offers educational programs designed for clinicians interested in expanding their knowledge of VAD therapy and the HVAD System. To learn more about these educational opportunities, please speak with your Medtronic sales representative or register to access Medtronic Academy.

See Education Offerings

References

1

McGee E Jr, Danter M, Strueber M, et al. Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist device: The LATERAL clinical trial. J Heart Lung Transplant. April 2019;38(4):344-351.

2

Wieselthaler G, et al. Temporal Adverse Event Profile following LVAD Implantation via a Thoracotomy Approach: 2 Year Follow-up of the LATERAL Trial. Presented at ASAIO 2019; San Francisco, CA.

3

Pasrija C, Sawan MA, Sorensen E, et al. Less invasive left ventricular assist device implantation may reduce right ventricular failure. Interact Cardiovasc Thorac Surg. October 1, 2019;29(4):592-598.

4

Mokadam NA, McGee E, Wieselthaler G, et al. Cost of Thoracotomy Approach: An Analysis of the LATERAL Trial. Ann Thorac Surg. November 2020;110(5):1512-1519.

5

U.S. source data on file with Medtronic as of October 2019.