Abstract:Background The prevalence of heart failure (HF) is increasing substantially and, despite improvements in medical therapy, HF still carries a poor prognosis. Mechanical circulatory support (MCS) by a continuousflow left ventricular assist device (cf-LVAD) improves survival and quality of life in selected patients. This holds especially for the short-term outcome, but experience regarding long-term outcome is growing as the waiting time for heart transplantation is increasing due to the shortage of donor hearts.… Show more
“…1 Because of a shortage of donor hearts, long-term left ventricular assist devices (LVADs) have become an established therapeutic option for these patients, with a 1 year survival of~80%. 2,3 Even though the use of mechanically circulatory support (MCS) results in improved survival rates, patients often suffer from major complications. Only 20% of the patients are not readmitted to the hospital within the first year after primary implantation.…”
Section: Introductionmentioning
confidence: 99%
“…Heart transplantation (HTx) is the gold standard for patients with end‐stage heart failure 1 . Because of a shortage of donor hearts, long‐term left ventricular assist devices (LVADs) have become an established therapeutic option for these patients, with a 1 year survival of ~80% 2,3 . Even though the use of mechanically circulatory support (MCS) results in improved survival rates, patients often suffer from major complications.…”
Aims Left ventricular assist device therapy has become the cornerstone in the treatment of end-stage heart failure and is increasingly used as destination therapy next to bridge to transplant or recovery. HeartMate 3 (HM3) and HeartWare (HVAD) are centrifugal continuous flow devices implanted intrapericardially and most commonly used worldwide. No randomized controlled trials have been performed yet. Analysis based on large registries may be considered as the best alternative but has the disadvantage of different standard of care between centres and missing data. Bias is introduced, because the decision which device to use was not random, even more so because many centres use only one type of left ventricular assist device. Therefore, we performed a propensity score (PS)-based analysis of long-term clinical outcome of patients that received HM3 or HVAD in a single centre. Methods and results Between December 2010 and December 2019, 100 patients received HVAD and 81 patients HM3 as primary implantation at the University Medical Centre Utrecht. We performed PS matching with an extensive set of covariates, resulting in 112 matched patients with a median follow-up of 28 months. After PS matching, survival was not significantly different (P = 0.21) but was better for HM3. The cumulative incidences for haemorrhagic stroke (P = 0.01) and pump thrombosis (P = 0.02) were significantly higher for HVAD patients. The cumulative incidences for major bleeding, ischaemic stroke, right heart failure, and driveline infection were not different between the groups. We found no interaction between the surgeon who performed the implantation and survival (P = 0.59, P = 0.78, and P = 0.89). Sensitivity analysis was performed, by PS matching without patients on preoperative temporary support resulting in 74 matched patients. This also resulted in a non-significant difference in survival (P = 0.07). The PS-adjusted Cox regression showed a worse but non-significant (P = 0.10) survival for HVAD patients with hazard ratio 1.71 (95% confidence interval 0.91-3.24). Conclusions Survival was not significantly different between both groups after PS matching, but was better for HM3, with a significantly lower incidence of haemorrhagic stroke and pump thrombosis for HM3. These results need to be interpreted carefully, because matching may have introduced greater imbalance on unmeasured covariates. A multicentre approach of carefully selected centres is recommended to enlarge the number of matched patients.
“…1 Because of a shortage of donor hearts, long-term left ventricular assist devices (LVADs) have become an established therapeutic option for these patients, with a 1 year survival of~80%. 2,3 Even though the use of mechanically circulatory support (MCS) results in improved survival rates, patients often suffer from major complications. Only 20% of the patients are not readmitted to the hospital within the first year after primary implantation.…”
Section: Introductionmentioning
confidence: 99%
“…Heart transplantation (HTx) is the gold standard for patients with end‐stage heart failure 1 . Because of a shortage of donor hearts, long‐term left ventricular assist devices (LVADs) have become an established therapeutic option for these patients, with a 1 year survival of ~80% 2,3 . Even though the use of mechanically circulatory support (MCS) results in improved survival rates, patients often suffer from major complications.…”
Aims Left ventricular assist device therapy has become the cornerstone in the treatment of end-stage heart failure and is increasingly used as destination therapy next to bridge to transplant or recovery. HeartMate 3 (HM3) and HeartWare (HVAD) are centrifugal continuous flow devices implanted intrapericardially and most commonly used worldwide. No randomized controlled trials have been performed yet. Analysis based on large registries may be considered as the best alternative but has the disadvantage of different standard of care between centres and missing data. Bias is introduced, because the decision which device to use was not random, even more so because many centres use only one type of left ventricular assist device. Therefore, we performed a propensity score (PS)-based analysis of long-term clinical outcome of patients that received HM3 or HVAD in a single centre. Methods and results Between December 2010 and December 2019, 100 patients received HVAD and 81 patients HM3 as primary implantation at the University Medical Centre Utrecht. We performed PS matching with an extensive set of covariates, resulting in 112 matched patients with a median follow-up of 28 months. After PS matching, survival was not significantly different (P = 0.21) but was better for HM3. The cumulative incidences for haemorrhagic stroke (P = 0.01) and pump thrombosis (P = 0.02) were significantly higher for HVAD patients. The cumulative incidences for major bleeding, ischaemic stroke, right heart failure, and driveline infection were not different between the groups. We found no interaction between the surgeon who performed the implantation and survival (P = 0.59, P = 0.78, and P = 0.89). Sensitivity analysis was performed, by PS matching without patients on preoperative temporary support resulting in 74 matched patients. This also resulted in a non-significant difference in survival (P = 0.07). The PS-adjusted Cox regression showed a worse but non-significant (P = 0.10) survival for HVAD patients with hazard ratio 1.71 (95% confidence interval 0.91-3.24). Conclusions Survival was not significantly different between both groups after PS matching, but was better for HM3, with a significantly lower incidence of haemorrhagic stroke and pump thrombosis for HM3. These results need to be interpreted carefully, because matching may have introduced greater imbalance on unmeasured covariates. A multicentre approach of carefully selected centres is recommended to enlarge the number of matched patients.
“…Already 50-70% of the patients receiving heart transplants have had an LVAD implanted first and the expectation is that this percentage will grow even further. If the number of available donor hearts does not increase substantially, given the current promising short-and medium-term outcome after LVAD implantation, the surgical treatment of advanced heart failure will change considerably in the coming years [5].…”
Section: Mcs and Heart Transplantationmentioning
confidence: 99%
“…MCS is becoming more and more important in the treatment of advanced heart failure and the mid-term outcome with regard to survival and functional recovery is approaching that of heart transplantation [5][6][7][8], although it is a very laborious and expensive therapy [9,10]. In the near future MCS will be used more and more as an alternative to transplantation, and this will certainly have a huge impact on the selection of transplant candidates.…”
The updated listing criteria for heart transplantation are presented on behalf of the three heart transplant centres in the Netherlands. Given the shortage of donor hearts, selection of those patients who may expect to have the greatest benefit from a scarce societal resource in terms of life expectancy and quality of life is inevitable. The indication for heart transplantation includes end-stage heart disease not remediable by more conservative measures, accompanied by severe physical limitation while on optimal medical therapy, including ICD/CRT‑D. Assessment of this condition requires cardiopulmonary stress testing, prognostic stratification and invasive haemodynamic measurements. Timely referral to a tertiary centre is essential for an optimal outcome. Chronic mechanical circulatory support is being used more and more as an alternative to heart transplantation and to bridge the progressively longer waiting time for heart transplantation and, thus, has become an important treatment option for patients with advanced heart failure.
“…Following LVAD implantation, not only survival, but also quality of life and exercise capacity improves impressively, allowing a return to a normal life, including sports activities and even resumption of work [ 18 – 20 ]. Despite this promising survival, morbidity after LVAD implantation remains substantial, as was confirmed in a recent publication showing major bleeding and ventricular tachycardia as the most commonly encountered adverse events [ 21 ]. Fig.…”
In patients with end-stage heart failure, advanced therapies such as heart transplantation and long-term mechanical circulatory support (MCS) with a left ventricular assist device (LVAD) have to be considered. LVADs can be implanted as a bridge to transplantation or as an alternative to heart transplantation: destination therapy. In the Netherlands, longterm LVAD therapy is gaining importance as a result of increased prevalence of heart failure together with a low number of heart transplantations due to shortage of donor hearts. As a result, the difference between bridge to transplantation and destination therapy is becoming more artificial since, at present, most patients initially implanted as bridge to transplantation end up receiving extended LVAD therapy. Following LVAD implantation, survival after 1, 2 and 3 years is 83%, 76% and 70%, respectively. Quality of life improves substantially despite important adverse events such as device-related infection, stroke, major bleeding and right heart failure. Early referral of potential candidates for long-term MCS is of utmost importance and positively influences outcome. In this
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