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Use of a Percutaneous Ventricular Assist Device/Left Atrium to Femoral Artery Bypass System for Cardiogenic Shock
Published on: August 16, 2021
Contemporary outcomes of continuous-flow left ventricular assist devices-a systematic review
Nicholas McNamara1,2,3, Harry Narroway4, Michael Williams1,2
1Cardiothoracic Surgical Department, Royal Prince Alfred Hospital, Sydney, Australia.
Insights
Continuous-flow left ventricular assist devices (cf-LVADs) offer excellent survival and improved quality of life for end-stage heart failure patients. However, adverse events like bleeding and infection impact long-term outcomes, necessitating further research.
Area of Science:
- Cardiovascular Medicine
- Medical Devices
- Surgical Technology
Background:
- End-stage heart failure presents a growing challenge due to increasing prevalence and limited donor hearts for transplantation.
- Left ventricular assist devices (LVADs) have emerged as critical therapeutic options, serving as bridge-to-transplant or destination therapy.
- Continuous-flow LVADs (cf-LVADs) represent advancements in mechanical circulatory support, aiming to improve patient outcomes.
Purpose of the Study:
- To systematically review and quantify survival rates following cf-LVAD implantation.
- To determine the incidence and frequency of major adverse events associated with cf-LVADs.
- To evaluate the impact of cf-LVADs on long-term quality of life and functional status.
Main Methods:
- Systematic literature review encompassing 63 studies with 9,280 patients.
- Primary outcome analysis focused on survival and adverse event rates (bleeding, infection, thrombosis, stroke, right ventricular failure).
- Secondary outcome assessment included quality of life (Kansas City Cardiomyopathy Questionnaire) and functional status (6-minute walk test).
Main Results:
- Overall survival varied, with industry-funded trials reporting better outcomes than case series; 48-month survival reached 57% in a large registry.
- Gastrointestinal bleeding (up to 35%), device-related infection (up to 55%), and right heart failure (up to 40%) were the most frequent complications.
- Significant improvements in quality of life and functional status were observed post-implantation, sustained up to two years.
Conclusions:
- cf-LVADs provide excellent short-term survival comparable to heart transplantation, but long-term survival is constrained by post-implantation adverse events.
- Despite complications, cf-LVAD therapy significantly enhances long-term quality of life and functional capacity.
- Adverse events remain a critical area for improvement to reduce morbidity and mortality in cf-LVAD patients.
Background:
End stage heart failure is a major cause of morbidity and mortality, and its prevalence is expected to rise with the ageing population. For suitable patients, orthotopic heart transplantation remains the gold standard therapy, however, a paucity of donor organs has led to the development of left ventricular assist devices (LVAD). These devices can be utilized as either a bridge-to-transplant (BTT) or as an alternative to heart transplantation. While these devices can prolong life and improve quality of life, they are associated with a significant number of adverse events. We aim to systematically review the literature to quantify survival and the incidence of adverse events following implantation of continuous-flow LVADs (cf-LVAD).
Methods:
A systematic review was performed to determine outcomes following implantation of a cf-LVAD. Primary outcomes were survival and frequency of adverse events (such as bleeding, infection, thrombosis, stroke and right ventricular failure). Secondary outcomes included quality of life and assessment of functional status.
Results:
Sixty-three studies reported clinical outcomes of 9,280 patients. Survival after cf-LVAD varied between studies. Industry-funded trials generally reported better overall survival than the single- and multi-center case series, which showed significant variation. The largest registry report documented twelve, twenty-four and forty-eight-month survival rates of 82%, 72% and 57% respectively. The most commonly reported adverse events were gastrointestinal bleeding (GIB), device-related infection, neurological events and right heart failure (RHF). Bleeding, RHF and infection were the most frequent complications experienced by those supported with cf-LVAD, occurring in up to 35%, 40% and 55% of patients, respectively. Quality of life as measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and functional status as measured with the 6-minute walk test (6MWT) improved after cf-LVAD implantation with no decline evident two years after implantation.
Conclusions:
The paucity of donor hearts has led to the development of left-ventricular assist devices as a BTT or as a destination therapy (DT). Outcomes after cf-LVAD implantation are excellent, with short-term survival comparable to heart transplantation, but long-term survival remains limited due to the incidence of post-implantation adverse events. Despite these complications, quality of life and functional status improve significantly post-implantation and remain improved over the long-term. This study demonstrates the potential benefits of cf-LVAD therapy whilst also identifying adverse events as an area of increased morbidity and mortality.
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