Destination Therapy
Indications for advanced heart failure therapy LVAD
Left ventricular assist devices (LVADs) represent a promising option as a "destination therapy" for advanced-stage heart failure patients who do not respond to conventional therapy.
The following list of risk factors offers a quick reference to help the cardiologist easily identify patients who should be considered for LVAD advanced heart failure therapy.
Patients with severely reduced LVEF ( < 30%) and
- Inability to walk one block without shortness of breath despite optimal medical therapy (OMM = ACE inhibitor, ARB or beta blocker)
- Two hospitalizations in past 6 months despite OMM
- Inability to tolerate (OMM) due to hypotension
- Slowly declining kidney function (i.e serum creatinine rise > 1.8 mg/dl)
Importantly, symptoms should be due to CHF and end organ damage such as renal dysfunction, liver dysfunction, and lung dysfunction should not be severe and irreversible.
Therefore, in example, patients with liver cirrhosis and/or severe COPD, and/or endstage renal disease requiring dialysis are unlikely to benefit from LVAD therapy.
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Select left ventricular assist devices (LVADs) have recently been approved for use as a destination, or permanent, therapy.
This approach is used for end-stage heart failure who are ineligible for a transplant due to age, additional health problems, or other complications.
Most recently, the HeartMate II LVAD® received FDA approval in January, 2010.
This small, quiet, implantable device is suitable for a wide range of patients, including those of smaller stature. The device is designed to last 10 years.
Development of LVAD as Destination Therapy
The landmark REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) trial published as early as November 2001 in the New England Journal of Medicine found that end stage heart failure patients who received an LVAD device (Thoratec HeartMate XVEŽ) had a 52.1% chance of surviving one year, compared with a 24.7% survival rate for patients who took drugs and were medically monitored.
At two years, the likelihood of survival was 22.9%for the LVAD patients versus 8.1% for those receiving medical therapies. However, because of this relatively poor 2 year survival despite LVAD therapy, use of destination therapy has remained rare and efforts were directed at improving pump technology.
In January of 2010 the HeartMate II, a second generation, smaller and inaudible device was approved by the FDA for destination therapy.
In a head to head comparison with the first generation Heartmate I device, two year survival rate were 58 % (HM II) versus 23% (HM I).
In addition, patients reported significant improvements in their quality of life.
At present, modern device therapy in appropriately selected patients therefore offers a likelihood of surviving two years, whereas survival on currently available medical therapy remains below 10%.
We are actively working on further improvement of this already impressive statistic and are employing several third generation devices in clinical trials.
In March 2005, the NIH awarded Columbia University College of Physicians & Surgeons a $17 million SCCOR grant to investigate improving outcomes for end-stage heart failure patients with implanted mechanical devices. Yoshifumi Naka , MD, director, mechanical circulatory support programs is the principal investigator for the grant.
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