From the Guidelines
In a patient with an ejection fraction (EF) of 15% and severe COPD who has experienced multiple hospitalizations, sacubitril-valsartan should generally be tried before considering a left ventricular assist device (LVAD). This recommendation is based on the most recent and highest quality evidence, which suggests that sacubitril-valsartan reduces the risk of heart failure hospitalization and death in ambulatory patients with heart failure with reduced ejection fraction (HFrEF) who remain symptomatic despite optimal treatment with an ACE inhibitor, a beta-blocker, and a mineralocorticoid receptor antagonist (MRA) 1, 2.
Key Considerations
- Sacubitril-valsartan is a first-line therapy for HFrEF and has shown significant benefits in reducing hospitalizations and mortality 2.
- The recommended starting dose is 24/26 mg twice daily, with titration to 97/103 mg twice daily as tolerated.
- Before initiating this medication, ACE inhibitors should be discontinued for at least 36 hours to avoid angioedema risk.
- Severe COPD is not a contraindication to sacubitril-valsartan, though careful monitoring for hypotension is necessary.
- A comprehensive heart failure regimen should also include beta-blockers, mineralocorticoid receptor antagonists, and possibly SGLT2 inhibitors, along with management of the patient's COPD.
Rationale for Sacubitril-valsartan
- The 2020 ACC/AHA clinical performance and quality measures for adults with heart failure support the use of sacubitril-valsartan in replacement of ACE inhibitor or ARB therapy to reduce mortality and morbidity 2.
- The 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure recommend sacubitril/valsartan as a replacement for an ACE-I to further reduce the risk of HF hospitalization and death in ambulatory patients with HFrEF who remain symptomatic despite optimal treatment with an ACE-I, a beta-blocker, and an MRA 1.
Comparison with LVAD
- LVADs are typically reserved for end-stage heart failure when optimal medical therapy has failed, as they carry significant risks including bleeding, infection, and stroke.
- Sacubitril-valsartan is a less invasive treatment option that can be tried before considering LVAD, especially in patients with severe COPD who may be at higher risk for complications from LVAD implantation.
From the FDA Drug Label
1. 1 Adult Heart Failure Sacubitril and valsartan tablets are indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal LVEF is a variable measure, so use clinical judgment in deciding whom to treat[see Clinical Studies (14.1)].
The patient with EF 15% and severe COPD may benefit from sacubitril-valsartan as it is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure, particularly those with left ventricular ejection fraction (LVEF) below normal.
- Key considerations:
- The patient's severe COPD should be taken into account when making treatment decisions.
- The patient's history of multiple hospitalizations suggests a need for careful consideration of treatment options.
- Sacubitril-valsartan may be tried before left ventricular assist device, but this decision should be made on a case-by-case basis, considering the individual patient's needs and circumstances 3. However, the FDA label does not directly address the specific question of whether sacubitril-valsartan should be tried before left ventricular assist device in a patient with EF 15% and severe COPD after multiple hospitalizations.
From the Research
Patient Profile
- The patient has a severely reduced ejection fraction (EF) of 15% and severe chronic obstructive pulmonary disease (COPD).
- The patient has been hospitalized multiple times, indicating a high risk of morbidity and mortality.
Treatment Options
- Sacubitril-valsartan is a potential treatment option for patients with heart failure and reduced ejection fraction (HFrEF) 4, 5.
- The use of sacubitril-valsartan in patients with HFrEF and COPD has not been specifically studied, but its benefits in reducing mortality and hospitalization rates have been demonstrated in patients with HFrEF 4, 5.
- The presence of COPD is associated with a higher risk of cardiovascular death and hospitalization in patients with heart failure, regardless of EF 6.
Considerations for Treatment
- The patient's severe COPD and multiple hospitalizations suggest a high risk of morbidity and mortality, and sacubitril-valsartan may be considered as a treatment option to reduce this risk 4, 5.
- However, the patient's EF is severely reduced, and the treatment benefit of sacubitril-valsartan may be diminished at lower ejection fractions 5.
- Left ventricular assist device (LVAD) implantation is a potential treatment option for patients with advanced heart failure, but its use is typically considered after other treatment options have been exhausted.
Decision Making
- The decision to try sacubitril-valsartan before LVAD implantation should be made on a case-by-case basis, taking into account the patient's individual profile and medical history 4, 5.
- The potential benefits and risks of sacubitril-valsartan should be carefully considered, including its effects on mortality, hospitalization rates, and quality of life 4, 7, 5, 8.