Continuous vs. Pulsatile LVAD implantable devices

By: Laurin Proffitt

Meet My Patient

39 year old Male Single, no children Lives in a 2 story home alone? Lives in a 1 story home with brother? Lives in a 3 story home with sister? Father lives close by Already owns a Rollator and a cane

Medical History

Physical therapy diagnosis: Middle cerebral artery stroke in April

Past Medical History: Emergency LVAD placement in February for non-ischemic cardiomyopathy

Hypertension, obesity, congestive heart failure, renal failure, respiratory failure

Patient History

Before LVAD placement patient ambulating at home independently with a Rollator

Before MCA stroke patient ambulating in parallel bars & transferring with moderate assistance

Examination

Cognition: Impulsive, easily distracted, follows 1 step commands 90% of the time

Sensation: Diminished in Left extremities ROM: Within functional limits Strength: 3-/5 in left extremities Supine to sit Max x 1 Sit to stand Mod x 1 1 step to chair Mod x 1 Left side neglect

Evaluation Findings

Impairments: Decreased strength, endurance, mobility, sensation

Functional limitations: Unable to walk independently, unable to transfer independently, unable to perform ADLs

Disabilities: Unable to return home, unable to work

Prognosis

Fair-good Positive: young age, family support Negative: many co-morbidities, patient

attitude, lack of motivation, limited cognitive functioning

Physical Therapy Goals

By discharge the patient will… Perform supine to sit with mod. assist Perform sit to stand with min. assist Perform bed to chair with min. assist Sit unsupported static with supervision

assist for 5 minutes Ambulate 25 feet with least restrictive

device with mod. assist

Plan of Care

Discharge to inpatient rehab Physical therapy 5x a week Focus on: therapeutic exercise, transfer

training, endurance activities, balance and gait training

Interventions

Transfer training: supine to sit and sit to stand ranged from dependent to minimum assist

Ambulation with ARJO platform walker up to 30 feet.

Interventions

LVAD training: changing device to portable battery pack

Balance training: sitting edge of bed with reaching tasks required moderate assist x1

Did he meet his goals?

Pt. supine to sit with mod. assist ✔ (min. assist)

Pt. sit to stand with min. assist ✖ (mod. assist) Pt. bed to chair with min. assist ✖ (mod.

assist) Pt. sit unsupported static with supervision

assist for 5 minutes ✔ (10 minutes unsupported while changing battery pack)

Pt. will ambulate 25 feet with least restrictive device with mod. assist ✔ (30 ft. with ARJO & mod. assist)

What do I want to know?

Do continuous flow LVAD devices have less incidence of stroke than pulsatile LVAD devices?

Advanced Heart Failure Treated with Continuous-Flow Left Ventricular Assist Device

Mark S. Slaughter, M.D., Joseph G. Rogers, M.D., Carmelo A. Milano, M.D., Stuart D. Russell, M.D., John V. Conte, M.D., David Feldman, M.D., Ph.D., Benjamin Sun, M.D., Antone J. Tatooles, M.D., Reynolds M. Delgado, III, M.D., James W. Long, M.D., Ph.D., Thomas C. Wozniak, M.D., Waqas Ghumman, M.D., David J. Farrar, Ph.D., and O. Howard Frazier, M.D.

2009 Randomized Controlled Trial in the New England Journal of Medicine

Methods

200 patients; 133 received continuous, 59 received pulsatile device

Age range 26-81; mean age of 62 Inclusion factors: Ejection fraction

<25%, ineligible for heart transplant, and NY Heart Association class III or IV symptoms

Exclusion factors: active infection, irreversible renal, pulmonary, or hepatic dysfunction

Results

Positive outcome was considered surviving without having a disabling stroke or device replacement

62 patients (46%) from the continuous flow group achieved this; only 7 patients (11%) of the pulsatile group did

17% from continuous group suffered a disabling stroke; 14% from pulsatile group

Continuous group did have less incidence of infection, renal failure, respiratory failure, cardiac arrhythmia & right heart failure

Conclusion

Overall the continuous flow group did better

Occurrence of stroke was higher in continuous group, but this difference was not statistically significant

Study Restrictions

Large age range; most participants older than my patient

Limited surgeon experience Patients not blinded

Use of a Continuous-Flow Device in Patients Awaiting Heart Transplantation

Leslie W. Miller, M.D., Francis D. Pagani, M.D., Ph.D., Stuart D. Russell, M.D., Ranjit John, M.D., Andrew J. Boyle, M.D., Keith D. Aaronson, M.D., John V. Conte, M.D., Yoshifumi Naka, M.D., Donna Mancini, M.D., Reynolds M. Delgado, M.D., Thomas E. MacGillivray, M.D., David J. Farrar, Ph.D., and O.H. Frazier, M.D.

2007 Observational Clinical Study in the New England Journal of Medicine

Methods

133 patients receiving a continuous flow device

Age range 37-63 ; average age of 50 Inclusion factors: NY Heart Association

class IV symptoms and eligible for a heart transplant

Exclusion factors: active infection, severe renal, pulmonary, or hepatic dysfunction, or the presence of mechanical circulatory support

Results

Positive outcome was considered survival, still eligible for transplant, or already received a transplant at 180 days post-op

100 (75%) patients achieved this 25 patients died; remaining 8 had

severe medical complications making them ineligible for transplant

11(8%) patients suffered strokes

Conclusion

Compared their study to 3 previously written studies regarding pulsatile devices

Both types had the same overall survival rate

Pulsatile had twice the incidence of stroke

Study Restrictions

Study subjects healthier than my patient

Subjects older than my patient Not a direct comparison

Conclusion

The risk for stroke is low, but it does still happen

Important to monitor patients very closely after this surgery

Overall, continuous devices seem to be more beneficial with less adverse events

Would I do anything different?

Questions?