Clinical implications of differences between real world and clinical trial usage of left ventricular assist devices for end stage heart failure.
Catherine MezzacappaNeal G RavindraCesar CaraballoFouad ChouairiP Elliott MillerJohn-Ross David ClarkeJadry GruenMakoto MoriMegan McCulloughClancy MullanArnar GeirssonJoseph G RogersMohammad AnwerNihar DesaiTariq AhmadPublished in: PloS one (2020)
Most exclusion criteria used in LVAD clinical trials did not afford a substantially greater risk to patients in the real-world setting. In the relatively infrequent cases of end stage renal disease, thrombocytopenia, respiratory failure, and need for ECMO, the risks and benefits of LVAD therapy need careful weighting and further study.
Keyphrases
- end stage renal disease
- chronic kidney disease
- clinical trial
- peritoneal dialysis
- respiratory failure
- heart failure
- left ventricular
- extracorporeal membrane oxygenation
- acute respiratory distress syndrome
- newly diagnosed
- ejection fraction
- mechanical ventilation
- randomized controlled trial
- hypertrophic cardiomyopathy
- atrial fibrillation
- human health
- phase iii
- study protocol
- prognostic factors
- intensive care unit
- left ventricular assist device
- double blind
- mitral valve
- risk assessment
- coronary artery disease
- mesenchymal stem cells
- climate change