Heartware ventricular assist device versus HeartMate II versus HeartMate III in advanced heart failure patients: A systematic review and meta-analysis

Abstract

Objective:

Ventricular assist device is one of the treatment options for heart failure patients. Therefore, the purpose of this review is to aid in clinical decision-making of exchanging previous older ventricular assist device models to the newest one, HM3.

Methods:

The search was conducted across several databases until February 25, 2023, and was registered with the ID of CRD42023405367. Risk of bias was performed using Cochrane Risk of Bias 2.0 and the Newcastle Ottawa Scale. In order to rank and evaluate the pooled odds ratios and mean differences with 95% confidence intervals, we employed conventional and Bayesian network meta-analysis converted to surface under the cumulative ranking.

Results:

A total of 49 studies with 31,105 patients were included in this review. HM3 is the best device exchange choice that causes the lowest risk of mortality (HM3 (99.98) > HM2 (32.43) > HVAD (17.58)), cerebrovascular accidents (HM3 (99.99) > HM2 (42.41) > HVAD (7.60)), other neurologic events beside cerebrovascular accident (HM3 (91.45) > HM2 (54.16) > HVAD (4.39)), pump thrombosis (HM3 (100.00) > HM2 (39.20) > HVAD (10.80)), and bleeding (HM3 (97.12) > HM2 (47.60) > HVAD (5.28)). HM3 is also better than HM2 in hospital admissions (OR: 1.90 (95% CI: 1.15–3.12)). When complications were present, HM2 or Heartware ventricular assist devices exchange to HM3 lowered the mortality rate compared to exchanging it to the same device type.

Conclusion:

HM3 is the best device for all six outcomes. Exchange from Heartware ventricular assist devices or HM2 to HM3 rather than the same ventricular assist device type is recommended only if a complication is present.

Keywords

Heart failure ventricle assist device device exchange

Background

Out of all ventricular assist devices (VADs), HeartMate 3 (HM3), which belongs to the newest generation of VADs and has received Food and Drug Administration (FDA) approval, is the most widely used and the only available VAD in the market today. Many trials and observational studies claimed that HM3 is associated with lower complication risks.^1–12 Despite HM3’s superiority and sole availability, a large number of patients ultimately used HeartMate 2 (HM2) or Heartware ventricular assist devices (HVAD) since HM3 had not been widely distributed previously and was still in trials. What is even more concerning for these patients is that the FDA has instructed HVAD distribution to stop as of 2021.¹³ In such cases, the issue becomes, “Is device exchange to HM3 beneficial?” Hence, our study will evaluate three types of VADs using a large sample pool in order to provide greater significance to investigate the need for device exchange.

Method

Materials and Methods

Our review was conducted following the guidelines outlined in the Cochrane Handbook for Systematic Reviews of Interventions (6.2). Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) were used to report our results. In addition, we ensured compliance with international research ethics regulations by registering this study in the international prospective register of systematic reviews (PROSPERO) under the distinct identification number CRD42023405367.

Search strategy

Until February 25, 2023, four independent reviewers reviewed multiple databases, including Wiley, EBSCOHost, Scopus, PubMed, and ProQuest. Four independent reviewers searched multiple electronic databases, such as Wiley, EBSCOHost, Scopus, PubMed, and ProQuest, up to February 25, 2023. HeartMate 2, axial flow pump, HeartMate 3, centrifugal flow pump, HeartWare VAD, and exchange were the keywords utilized for the research process. Advanced search methods to refine the search were used whenever applicable and accessible.

Study eligibility criteria

The inclusion and exclusion criteria were utilized to screen the studies. Inclusion criteria: (1) an observational study or randomized control trial; (2) comparison between HM2 versus HM3 versus HVAD or comparing HM2 or HVAD exchange to HM3 or the same type of VAD; (3) heart failure patients, but without any coexisting conditions that can influence survival rate; and (4) qualitative and quantitative outcomes. Exclusion criteria: (1) unsuitable study design, including reviews, commentaries, letters to the editor, or preclinical studies; (2) studies with qualitative outcome data only. All steps are visually depicted in Figure 1.

Figure 1.

PRISMA flowchart.

Data extraction

Our extraction data consist of (1) study ID; (2) study attributes, including the method and place of study; (3) samples, including the size, age, and device types; and (4) study outcomes. Study results are divided into two main sections: hospital stay and admissions, as well as postimplantation outcomes for the first implantation and after the exchange. The hospital stay and admissions section consists of first hospital admissions, length of stay (LOS) in the intensive care unit (ICU), and total LOS. Meanwhile, the postimplantation outcomes include infection related to VAD, sepsis, cerebrovascular accidents (CVAs), other neurologic events, device malfunction and/or replacement, right ventricular failure, pump thrombosis, bleeding, cardiac arrhythmias, respiratory failure, renal dysfunction, hepatic dysfunction, reoperation due to any complications, and all-cause mortality. During the process of data extraction, all authors obtained and recorded both qualitative and quantitative characteristics. The accuracy of the extracted data was then further verified during the statistical analysis phase.

Risk of bias in assessment

For observational studies, a thorough appraisal of the included studies’ bias was performed using the Newcastle–Ottawa quality assessment scale.¹⁴ The obtained scores were subsequently converted to the Agency for Healthcare Research and Quality (AHRQ) standards, where scores above 6 were classified as good, scores ranging from 4 to 6 were deemed fair, and scores below 4 were categorized as poor.¹⁵ On the other hand, the randomized control trials were evaluated using the Cochrane Risk of Bias 2.0 (Cochrane Methods, 2021), which evaluates five domains of possible bias sources which are randomization bias, bias due to deviations from intended interventions, missing outcome data, outcome measurement, and bias in reporting results. The first domain, the randomization bias, is further divided into the randomization process and participant selection.¹⁶ The results will be compacted and illustrated with the RobVis tool. Three reviewers independently conducted the quality assessment without knowledge of each other’s scores. Subsequently, they engaged in discussions until a consensus was achieved.

Statistical analysis

Review Manager ver. 5.4 (The Nordic Cochrane Center, The Cochrane Collaboration, Copenhagen) was used to perform statistical analysis. The odds ratio was obtained from studies, and then the pooled effects were interpreted. The DerSimonian–Laird random effects model provided by Riley et al. was applied due to the possibility of indecipherable heterogeneity from studies. Heterogeneity was then calculated using estimated effect (I²) statistics based on the Cochrane threshold (heterogeneity cut-off limits: 0% as insignificant, 25% as low, 50% as moderate, and 75% as high).¹⁷

We carried out a Bayesian network meta-analysis using MetaInsight V4.0.1 Beta for outcome(s) with more than two groups that yielded a p-value <0.05 in the conventional meta-analysis. Forest plots of pooled effect compared each treatment and ranking panel that is included in this study using surface under the cumulative ranking (SUCRA) that was used for the intervention measures, with higher values indicating lower complications. However, the inconsistency assessment of the network cannot be performed due to the open loop of the network. Consequentially, the heterogeneity was reported by means of direct assessment from the forest plot random effects model.¹⁸

Results

Study selection and characteristics

Initially, a total of 18,272 studies were discovered through 6 database searches (specific details can be found in Supplemental Appendix A.1). After removing duplicate and irrelevant studies, 63 records were evaluated based on the eligibility criteria. Ultimately, 49 studies were deemed suitable for both qualitative and quantitative analysis, as depicted in Figure 1. The characteristics of these included studies can be found in Supplemental Appendix B.1 (pertaining to the first implantation) and Supplemental Appendix B.4 (concerning device exchange after the initial implantation). Additionally, Supplemental Appendix B.1 also provides information on the patients’ INTERMACS scores, which is a scoring system utilized for evaluating clinical profiles and predicting unfavorable outcomes following VAD implantation.^{1–12,19–52}

This systematic review encompassed a total of 31,105 patients across all included studies. The majority of these studies were conducted in the United States or Europe. VAD is a commonly employed treatment for patients with advanced heart failure, serving as either a definitive therapy or a bridge to transplant. The study considered three types of VADs: HM2, HM3, and HVAD. Out of the 49 studies, only 5 directly compared these 3 intervention techniques. Specifically, 11 studies compared HM2 with HM3, 16 studies compared HM2 with HVAD, 13 studies compared HM3 with HVAD, and 4 studies focused on outcomes related to VAD exchange to HM3.

Quality assessment

All randomized controlled trials (RCTs) included in this study have a low risk of bias based on Cochrane risk of bias 2.0 (Figure 2 and Supplemental Appendix C.1). The observational study included in our study was assessed in terms of selection, comparability, and outcome using the Newcastle–Ottawa Scale (Supplemental Appendix C.2–C.7). Overall, these observational studies were rated to be of high quality with a low risk of bias. According to the AHRQ, only six studies were deemed to be of “poor quality” (Supplemental Appendix C.5).^{1–12,19–52}

Figure 2.

Visualization of risk of bias 2.0.

Postimplantation outcomes

Fourteen aspects of postoperative outcomes were assessed, such as infection, neurological adverse events, postoperative bleeding, mortality (Supplemental Appendix B.2).^{1–12,19–52} The device showed the highest score in the SUCRA that indicates the lowest risk of adverse events is HM3. This VAD is correlated with a significantly lower risk of complications which is overall mortality (HM3 (99.98) > HM2 (32.43) > HVAD (17.58)), CVA (HM3 (99.99) > HM2 (42.41) > HVAD (7.60)), other neurologic events beside CVA (HM3 (91.45) > HM2 (54.16) > HVAD (4.39)), pump thrombosis (HM3 (100.00) > HM2 (39.20) > HVAD (10.80)), and bleeding (HM3 (97.12) > HM2 (47.60) > HVAD (5.28)). An exception was found in terms of bleeding that showed HM3 did not differ significantly from HVAD. All of these results presented a heterogeneity ranging from insignificant to high. Meanwhile, for other outcomes such as infection, cardiac arrhythmia, and reoperation, as well as right ventricular, respiratory, and renal failure, these three types of VADs have similar results (Supplemental Figure 1).

Hospital admissions and stay

Five included studies that reported patients’ first hospital admissions after VAD implantation (Supplemental Appendix B.3).^{4,5,10,11,25,38,45,48} HM3 is proven to be superior to HM2 with lower hospital admissions (OR: 1.90 (95% CI: 1.15–3.12)) with range of admission timing from 1 until 2 years. However, comparison between HM3 and HVAD could not be made because only one study reported this outcome and within a short follow-up term (1-month) (Supplemental Figure 2). While another included studies that reported ICU, and overall, LOS were unable to be analyzed because of different outcome measurements.

VAD exchanges

Device exchange in most included studies is usually performed when device malfunction is present due to pump thrombosis, other mechanical problems, or other VAD-related problems such as infection. An exchange that was performed due to complications showed that the mortality rate is lower if the HM2 or HVAD is replaced with HM3 rather than replacing it with the same device type. However, if the exchange is performed electively (early exchange to prevent complication risks), HVAD exchange to HM3 showed a higher mortality rate compared to continuing HVAD support (Supplemental Appendix B.4).^53–56

Discussion

VADs are technological supports used as a lifesaving treatment option for patients with severe decompensated HF and an ejection fraction lower than 25%. These devices, which are implanted into the left chambers of the heart, provide an alternative pathway for oxygenated blood flow toward the aorta.^1,3 The evolution of VADs has marked significant technological advancements, particularly in the transition from second- to third-generation pumps. Second-generation VADs, exemplified by the HeartMate II (Abbott Laboratories, Illinois, USA) and Jarvik 2000, are characterized by axial flow, directing blood flow parallel to the axis of rotation. These devices employ mechanical or contactless bearings to support the impeller.⁵⁷

In contrast, third-generation VADs, such as the HVAD and HM3, utilize centrifugal flow, where blood flow is directed perpendicular to the axis of rotation. The HVAD incorporates hybrid magnetic/hydrodynamic impeller suspension technology, while the HM3 features fully magnetic levitation. This innovation in the HM3 significantly reduces heat generation, friction, and shear stress, which in turn minimizes the risk of thrombus formation within the pump.⁵⁷

The HM3 received approval for commercialization in Europe in October 2015 and in the United States in August 2017. The HVAD, initially approved in Europe in 2009 and in the United States in 2012 as a bridge to transplantation, faced discontinuation in June 2021 due to technical issues and the superior clinical outcomes demonstrated by the HM3. The HM3’s design has shown a marked reduction in thrombotic events and ischemic stroke rates compared to its predecessors, solidifying its status as the only third-generation VAD currently approved by the FDA.^58–60

Despite showing development compared to its prior generations, implantation of the VAD has not been completely free from adverse events. Moreover, reviews that discuss postimplantation outcomes are still severely limited, and none address VAD-related hospital stays or admissions.⁵⁶ Our systematic review and meta-analysis included 31,105 patients across 6 RCTs and 43 observational studies. All outcomes were categorized into two big sections: postimplantation outcomes as well as hospital admissions and stay.

For postoperative outcomes, our study reported that HM3 is the best device with the lowest mortality rate (HM3 (99.98) > HM2 (32.43) > HVAD (17.58)). However, a meta-analysis by Cavarretta et al.⁶¹ that compared several devices across different VAD generations with a total of 1,141 patients stated that HM2 is the best device, whilethe HM3 and HVAD have similar overall mortality rates and do not show any statistically significant differences in mortality. A meta-analysis by Kerdany et al.⁶² showed there is no discernible difference between HM2 and HM3 in terms of mortality. The results of both of these meta-analyses are in contrast with our study. However, our results are proven to be more valid because other meta-analyses that only include limited amount of samples, and their included studies are dominated with indirect comparison with single-arm trial studies, further decreasing the significance of the results.

HM3 also causes the lowest risk of other adverse events such as CVA (HM3 (99.99) > HM2 (42.41) > HVAD (7.60)), other neurologic events besides CVA (HM3 (91.45) > HM2 (54.16) > HVAD (4.39)), pump thrombosis (HM3 (100.00) > HM2 (39.20) > HVAD (10.80)). A network meta-analysis by Cavarette et al.⁶¹ reported that HM3 is the best device that has a lower risk of device thrombosis, and stroke, thus strengthening our study results. Mehra et al.’s¹ study also strengthens our finding with their statement that showed HM3 might become an answer to survival free of disabling stroke or reoperation (HM2 (21.2%) versus HM3 (10.7%); OR: 0.368 (0.273–0.497)). Furthermore, as aforementioned, the HM3 lower flow disruptions, leading to a lower number of pump thrombosis (HM2 (89 (17.6) versus HM3 (11 (2.1)); 0.090 (0.049–0.163)). Therefore, supported by a study by Heathley et al.,⁶³ lower pump thrombosis correlates with lower reoperation. The free-from-reoperation rate of HM3 at 6 months reaches 87% due to fewer pump replacements in case of thrombus and drive-line problems, and at 24 months, the success rate becomes 55%. With optimized fluid dynamics and wider blood-flow passages, HM3 is surely a choice for lowering both neurological problems and pump thrombosis events.^1,61,62

Further discussing the comparison with HVAD, the VAD that is also in the newest generation group as HM3 was discontinued due to pump thrombosis and malfunction, as it was also proven by our study’s results. These adverse events were caused by different rotors because as previously stated HM3 utilized magnetically levitated ones, while HVAD used hydrodynamic bearings, which, while reducing frictions, still involve some degree of mechanical contact. This led to higher wear and tear over time, thus contributing to pump thrombosis and malfunctions that became the basis of our study’s results. Furthermore, HVAD also caused higher CVAs, and this is mainly proposed due to lower effectivity of mimicking heart pulsality, which potentially led to higher shear stress on blood component, increasing risk of clot formation and CVAs. HM3 is designed to create a more physiologic pulsatile flow despite being a continuous flow-device, which can improve hemocompability, reducing the risk of clot and CVAs, as opposite to HVAD mechanism. Future VADs are suggested to have a rotor with low even nonexistent flow disruption as well as effective pulsatile flow to prevent major complications such as CVA, pump thrombosis, and malfunction, these major complications are the one that causes HVAD, as part of the new generation to be discontinued.^1,24,61

In terms of other adverse events, network meta-analysis by Cavaretta et al. also reported that HM3 is the best device that has a lower risk of bleeding, thus strengthening our study results. However, in contrast to Cavaretta et al., our study showed that bleeding in HM3 (OR: 1.35 (95% CI: 0.92–2.03)) did not differ significantly from HVAD. In addition, the Cavaretta et al.’s study also stated that HVAD is better than HM2 in terms of bleeding and device thrombosis outcomes, while our study stated otherwise (HM3 (97.49) > HM2 (42.02) > HVAD (10.49)).⁵⁷ Nevertheless, another meta-analysis by Kerdany et al. stated that bleeding and pump thrombosis between HM2 and HM3 have no significant differences, which contradict ours and Caveretta’s study results. This is mainly due to more indirect comparison with single-arm trial studies included in Kerdany et al.’s and Cavaretta et al.’s study.^61,62

According to Cavaretta et al.’s study⁶¹ HM2 is also claimed to be the best device for driveline infection, neurologic, and renal dysfunctions, as well as respiratory and right ventricular failures. These results align with a meta-analysis by Kerdany et al.⁶² that stated VAD infection is lower in HM2 compared to HVAD, although there is no direct comparison between these three devices. Our study, on the other hand, reported that there is no significant difference of infection, renal, and right ventricular failure between the three devices in all of these outcomes. This is mainly due to more indirect comparative studies included in Kerdany et al.’ and Cavaretta et al.’s studies. Hence, showing more reliability in our study results provided a more direct comparison if compared to the previous two studies.

Regarding the infection that become the major concern for VAD-supported patients, our study as previously stated showed comparable results. This is mainly because these VADs utilized similar percutaneous drivelines that cause similar infection rates. Regarding the percutaneous placement, Wert el al.’s study⁶⁴ stated that double tunneling or placement through rectus muscle, then to subcutaneous led to significantly lower infection rates. Based on this, placement in other layers such as muscles will lower infection rates. Besides the placement method, future VADs could develop drivelines with antimicrobial coatings or materials in the driveline to reduce the risk of bacterial adherence.⁶⁵ Aside from the antimicrobial materials, the diameter size and stiffness of the driveline also matter; Imamura et al.’s study⁶⁶ stated that VAD with larger outer diameter and higher stiffness might lower infection rate as proposed in the comparison between HM2, EVAHeart, and DuraHeart. In addition, wireless power transmission for VADs aims to eliminate the need for percutaneous drivelines, eliminating driveline-related infection risks. Campi et al.’s study demonstrated the potential of near-field wireless power transfer systems using magnetic resonant coupling, capable of efficiently powering implanted devices like VADs.⁶⁷

For the hospital admissions, our study showed there are lower hospital admissions in HM3 compared to HM2 (OR: 1.90 (95% CI: 1.15–3.12)). Our study results are also strengthened by Pagani et al., that stated HM3 patients have overall lower readmissions events.⁴ Patients with VAD are usually rehospitalized due to a few common reasons, including bleeding, pump thrombosis, and neurologic events.²¹ In our analysis, HM3 was also found to cause the lowest risk for CVA (HM3 (99.99) > HM2 (42.41) > HVAD (7.60)), other neurologic events besides CVA (HM3 (91.45) > HM2 (54.16) > HVAD (4.39)), pump thrombosis (HM3 (100.00) > HM2 (39.20) > HVAD (10.80)), and bleeding (HM3 (97.12) > HM2 (47.60) > HVAD (5.28)). Lower adverse events in all of these outcomes that become common reasons for patients to be hospitalized could cause lower admissions in HM3 patients compared to HM2.¹¹ Meanwhile, hospital admissions for HM2 and HVAD did not differ significantly due to lots of similarities in most complications’ risks between these two devices.⁶¹

Few studies have reported on the ICU stay and overall LOS after VAD implantation, but no explanations are given about these results. In our study regarding this group, we were unable to perform statistical analysis due to incomparable measurement parameters. All of our included studies have shown that there are a high number of variations in the length of ICU and LOS. Therefore, there is no definite conclusion about which device is best for lowering ICU stay and LOS. Still, further studies with the same measurement parameters are needed to make a definitive conclusion about the overall hospital and ICU stay.^68,69

VADs exchange

In line with the findings of our study that proved HM3 as the newest and best VAD in regards to postimplantation outcomes (specifically in six outcomes), an exchange to HM3 is considered. Our study results showed that HM2 or HVAD exchange to HM3 caused a lower mortality rate than exchange to the same device type as the previous one. The exchange that was performed due to device problems, such as pump thrombosis and other VAD-related problems shows greater benefits for the patients rather than staying on support with the same device type. For elective exchange, a study by Cogswell et al. stated that HVAD to HM3 exchange was associated with a higher mortality rate (26.7%) compared to continuation of HVAD support (21%). Coyle et al. also stated that HVAD exchange to HM3 is correlated with higher mortality and complications rates compared to HM2 exchange to HM3 (29%–43% versus 0%). Furthermore, it is also correlated with higher postoperative complications including right ventricular failure requiring right VAD support (71% versus 0%), prolonged ventilator support days (1 versus 11), and increased need for reoperation (14% versus 100%). This leads to a suggestion that HM2 to HM3 exchange is more recommended than HVAD to HM3, although if there is a life-threatening complication, exchanging to HM3 is preferred over exchanging with the same VAD type. Furthermore, from these studies, there are no enough evidences that support elective exchange of HM2 or HVAD to HM3.^53–56

Strength and limitations

Some of our study outcomes differed from those of the previous studies, but to be noted is the fact that huge limitations existed in other studies which might affect the results. In the meta-analysis performed by Cavaretta et al., most of the p-values are above 0.05, proving their results are insignificant.⁵⁸ Besides, a meta-analysis by Kerdany et al. that compared HM2, HM3, and HVAD only provided limited direct network comparison between the three devices and a limited amount of samples.⁵⁹ Superior to all these studies is the fact that our study provided significant results in six outcomes than other studies that provided direct comparisons. Furthermore, we also included newer and more studies with larger patient populations for VAD outcomes. We also provided outcomes about VADs exchange.

Despite the previously demonstrated superiority, this study acknowledges several limitations. These limitations encompass the heterogeneity of the data, which may stem from variations in outcome parameters, sample sizes, and study designs (including both RCTs and observational studies). We still decided to include both study designs because the RCTs performed gave various outcomes which differ between studies. Furthermore, the incomparability of study periods and timeframes could potentially result in the omission of specific study developments, and studies primarily focused on the USA or Europe might have been inadvertently overlooked. Additionally, the meta-analysis results concerning device exchange outcomes are constrained by the limited number of studies available, but more likely in the current evidence trend, device exchange to HM3 is only suggested if there are life-threatening complications.

Conclusion

HM3 has proven to be better than its previous generation, HM2, and another third generation, HVAD as initial VAD choice. HM3 provides better outcomes by lowering overall mortality, neurological problems (CVA and others), pump thrombosis, bleeding, and hospital admissions, but it did not differ significantly from HVAD in terms of bleeding and hospitalization. In addition, HM2 has been proven to be superior to HVAD in terms of bleeding and CVA. Other than the aforementioned, all three devices have similar outcomes. Postimplantation device exchange from HM2 or HVAD to HM3 rather than the same VAD type is recommended only if a life-threatening complication is present. Future suggestion about the VAD technological and material advancement as well as surgical technique will contribute to lowering all adverse events aforementioned.

Supplemental Material

sj-doc-6-smo-10.1177_20503121241278226 – Supplemental material for Heartware ventricular assist device versus HeartMate II versus HeartMate III in advanced heart failure patients: A systematic review and meta-analysis

Supplemental material, sj-doc-6-smo-10.1177_20503121241278226 for Heartware ventricular assist device versus HeartMate II versus HeartMate III in advanced heart failure patients: A systematic review and meta-analysis by Dudy Arman Hanafy, Theresia Feline Husen, Ruth Angelica, Ilona Nathania, Widya Trianita Suwatri, Pasati Lintangella, Wahyu Prima Erdianto and Prisillia Prasetyo in SAGE Open Medicine

Supplemental Material

sj-docx-1-smo-10.1177_20503121241278226 – Supplemental material for Heartware ventricular assist device versus HeartMate II versus HeartMate III in advanced heart failure patients: A systematic review and meta-analysis

Supplemental material, sj-docx-1-smo-10.1177_20503121241278226 for Heartware ventricular assist device versus HeartMate II versus HeartMate III in advanced heart failure patients: A systematic review and meta-analysis by Dudy Arman Hanafy, Theresia Feline Husen, Ruth Angelica, Ilona Nathania, Widya Trianita Suwatri, Pasati Lintangella, Wahyu Prima Erdianto and Prisillia Prasetyo in SAGE Open Medicine

Supplemental Material

sj-docx-2-smo-10.1177_20503121241278226 – Supplemental material for Heartware ventricular assist device versus HeartMate II versus HeartMate III in advanced heart failure patients: A systematic review and meta-analysis

Supplemental material, sj-docx-2-smo-10.1177_20503121241278226 for Heartware ventricular assist device versus HeartMate II versus HeartMate III in advanced heart failure patients: A systematic review and meta-analysis by Dudy Arman Hanafy, Theresia Feline Husen, Ruth Angelica, Ilona Nathania, Widya Trianita Suwatri, Pasati Lintangella, Wahyu Prima Erdianto and Prisillia Prasetyo in SAGE Open Medicine

Supplemental Material

sj-docx-3-smo-10.1177_20503121241278226 – Supplemental material for Heartware ventricular assist device versus HeartMate II versus HeartMate III in advanced heart failure patients: A systematic review and meta-analysis

Supplemental material, sj-docx-3-smo-10.1177_20503121241278226 for Heartware ventricular assist device versus HeartMate II versus HeartMate III in advanced heart failure patients: A systematic review and meta-analysis by Dudy Arman Hanafy, Theresia Feline Husen, Ruth Angelica, Ilona Nathania, Widya Trianita Suwatri, Pasati Lintangella, Wahyu Prima Erdianto and Prisillia Prasetyo in SAGE Open Medicine

Supplemental Material

sj-docx-4-smo-10.1177_20503121241278226 – Supplemental material for Heartware ventricular assist device versus HeartMate II versus HeartMate III in advanced heart failure patients: A systematic review and meta-analysis

Supplemental material, sj-docx-4-smo-10.1177_20503121241278226 for Heartware ventricular assist device versus HeartMate II versus HeartMate III in advanced heart failure patients: A systematic review and meta-analysis by Dudy Arman Hanafy, Theresia Feline Husen, Ruth Angelica, Ilona Nathania, Widya Trianita Suwatri, Pasati Lintangella, Wahyu Prima Erdianto and Prisillia Prasetyo in SAGE Open Medicine

Supplemental Material

sj-docx-5-smo-10.1177_20503121241278226 – Supplemental material for Heartware ventricular assist device versus HeartMate II versus HeartMate III in advanced heart failure patients: A systematic review and meta-analysis

Supplemental material, sj-docx-5-smo-10.1177_20503121241278226 for Heartware ventricular assist device versus HeartMate II versus HeartMate III in advanced heart failure patients: A systematic review and meta-analysis by Dudy Arman Hanafy, Theresia Feline Husen, Ruth Angelica, Ilona Nathania, Widya Trianita Suwatri, Pasati Lintangella, Wahyu Prima Erdianto and Prisillia Prasetyo in SAGE Open Medicine

Footnotes

Acknowledgements

All authors have nothing to declare.

Author Contributions

Conceptualization, Dudy Arman Hanafy and Theresia Feline Husen; methodology, Theresia Feline Husen; software, Theresia Feline Husen, Ilona Nathania, and Ruth Angelica,; validation, Dudy Arman Hanafy and Widya Trianita Suwatri, formal analysis, Theresia Feline Husen, Wahyu Prima Erdianto, Ilona Nathania, Ruth Angelica; investigation, Dudy Arman Hanafy and Theresia Feline Husen; resources, Dudy Arman Hanafy, Wahyu Prima Erdianto, Theresia Feline Husen, Ilona Nathania,Ruth Angelica, Widya Trianita Suwatri, Pasati Lintangella, and Priscillia Prasetyo; Data curation: Dudy Arman Hanafy, Theresia Feline Husen; writing—original draft preparation, Dudy Arman Hanafy, Theresia Feline Husen, Ilona Nathania, and Ruth Angelica; writing—review and editing, Dudy Arman Hanafy, Theresia Feline Husen, Ilona Nathania,Ruth Angelica, and Wahyu Prima Erdianto; visualization, Theresia Feline Husen, Ilona Nathania, and Ruth Angelica; supervision, Dudy Arman Hanafy and Widya Trianita Suwatri; project administration, Theresia Feline Husen; funding acquisition, Dudy Arman Hanafy. All authors have read and agreed to the published version of the manuscript.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Ethics approval

Not applicable.

Informed consent

Not applicable.

ORCID iD

Dudy Arman Hanafy

Supplemental material

Supplemental material for this article is available online.

References

Mehra

Golstein

Cleveland

JC.

Five-year outcomes in patients with fully magnetically levitated vs axial-flow left ventricular assist devices in the MOMENTUM 3 randomized trial. JAMA Netw 2022; 328: 1233–1242.*

Heiden

Cornelis

Zijderhand

, et al. Mechanical device malfunction of the HeartMate II Versus the HeartMate 3 left ventricular assist device: the Rotterdam Experience. ASAIO J 2023; 69: 80–85.

Goldstein

Mehra

MR.

Clinical outcomes by intended goal of therapy in the MOMENTUM 3 clinical trial: final analysis of the 1028 patient full cohort. J Heart Lung Transplant 2019; 38: 11.*

Pagani

Mehra

Cowger

, et al. Clinical outcomes and healthcare expenditures in the real world with left ventricular assist devices—the CLEAR-LVAD study. J Heart Lung Transplant 2021; 40: 323–323.

Shih

Ning

Kurlansky

, et al. Causes and temporal patterns of hospital readmissions after implantation of the HeartMate 3 left ventricular assist device: a comparison with HeartMate II. J Heart Lung Transplant 2021; 40: 395–396.

Stawiarski

Ramakrishna

Five-year outcomes for the HeartMate3 left ventricular assist device. J Cardiothorac Vasc Anesth 2022; 37: 342–343.

Uriel

Colombo

Cleveland

, et al. Hemocompatibility-related outcomes in the MOMENTUM 3 trial at 6 months. Circ J 2017; 135: 2003–2012.

Mutsuga

Okumura

Morimoto

, et al. Impact of an improved driveline management for HeartMate II and HeartMate 3 left ventricular assist devices. Artif Organs 2023; 47: 387–395.

Malkoun

Hoffman

Feldman

, et al. Incidence of driveline infections in Heartmate 3 compared to Heartmate 2. 2021, https://asaio.org/conference/program/2021/EPCardiac36.cgi (accessed 26 March 2023).

10.

Inoue

Fujita

Yoshioka

, et al. Short-term outcomes of magnetically levitated left ventricular assist device in advanced heart failure. Circ J 2022; 86: 1961–1967.

11.

Vidula

Takeda

Estep

, et al. Hospitalization patterns and impact of a magnetically-levitated left ventricular assist device in the MOMENTUM 3 trial. JACC Heart Fail 2022; 10: 470–481.

12.

Merzah

Hanke

, et al. Outcomes of modular cable exchange in HeartMate 3 patients versus conventional driveline repair in HeartMate II patients. Artif Organs 2022; 47: 380–386.

13.

FDA. Medtronic HeartWare Ventricular Assist Device (HVAD) system. FDA. 2023, https://www.fda.gov/medical-devices/cardiovascular-devices/medtronic-heartware-ventricular-assist-device-hvad-system (accessed 23 March 2023).

14.

Wells

Shea

O’Connell

, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. 2013, http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp (accessed 24 March 2023).

15.

Viswanathan

Ansari

Berkman

, et al. AHRQ Assessing the risk of bias of individual studies in systematic reviews of health care intervention. 2021, https://effectivehealthcare.ahrq.gov/products/methods-guidance-bias-individual-studies/methods (accessed 23 March 2023).

16.

Higgins

JPT

Savović

Page

, et al. Chapter 8: assessing risk of bias in a randomized trial. 2022, https://training.cochrane.org/handbook/current/chapter-08 (accessed 26 March 2023).

17.

Riley

Moons

KGM

Snell

KIE

, et al. A guide to systematic review and meta-analysis of prognostic factor studies. BMJ. Epub ahead of print 30 January 2019. DOI:10.1136/bmj.k4597.

18.

Owen

Bradbury

Xin

, et al. MetaInsight: an interactive web-based tool for analyzing, interrogating, and visualizing network meta-analyses using R-shiny and netmeta. Res Synth Methods 2019; 10: 569–581.

19.

Schlöglhofer

Michalovics

Riebandt

, et al. Left ventricular assist device driveline infections in three contemporary devices. Artif Organs 2020; 45: 464–472.

20.

Hanke

Dogan

Mariani

, et al. Effect of artificial pulse and pulsatility on gastrointestinal bleeding rates after left ventricular assist device implantation. Thorac Cardiovasc Surg 2020; 68: 1–72.

21.

Zhigalov

Mashhour

Szczechowicz

, et al. Clinical outcome and comparison of three different left ventricular assist devices in a high-risk cohort. Artif Organs 2018; 42: 1–8.

22.

Lalonde

Alba

Rigobon

, et al. Clinical differences between continuous flow ventricular assist devices: A comparison between HeartMate II and HeartWare HVAD. J Cardiac Surg 2013; 28: 604–610.

23.

Magruder

Grimm

Crawford

, et al. Survival after orthotopic heart transplantation in patients undergoing bridge to transplantation with the HeartWare HVAD versus the Heartmate II. Ann Thorac Surg 2017; 103: 1505–1511.

24.

Rogers

Pagani

Tatooles

, et al. Intrapericardial left ventricular assist device for advanced heart failure. N Engl J Med 2017; 376: 451–460.

25.

Majure

Sheikh

Hofmeyer

, et al. Comparison of hospitalization rates with the HeartWare HVAD and HeartMate II left ventricular assist devices. J Heart Lung Transplant 2015; 34: 198.

26.

Milano

Rogers

Tatooles

, et al. HVAD: the endurance supplemental trial. JACC Heart Fail 2018; 6: 792–802.

27.

Gaffey

Chen

Chung

, et al. Is there a difference in bleeding after left ventricular assist device implant: centrifugal versus axial? J Cardiothorac Surg 2018; 13: 1–6.

28.

Kawabori

Conyer

Kurihara

, et al. Fatal neurologic dysfunction during continuous-flow left ventricular assist device support. Ann Thorac Surg 2019; 107: 1132–1138.

29.

Stulak

Davis

Haglund

, et al. Adverse events in contemporary continuous-flow left ventricular assist devices: a multi-institutional comparison shows significant differences. J Thorac Cardiovasc Surg 2016; 151: 177–189.

30.

Coffin

Haglund

Davis

, et al. Adverse neurologic events in patients bridged with long-term mechanical circulatory support: a device-specific comparative analysis. J Heart Lung Transplant 2015; 34: 1578–1585.

31.

Frontera

Starling

Sung-Min

, et al. Risk factors, mortality, and timing of ischemic and hemorrhagic stroke with left ventricular assist devices. J Heart Lung Transplant 2016; 36: 673–683.

32.

Parameshwar

Hogg

Rushton

, et al. Patient survival and therapeutic outcome in the UK bridge to transplant left ventricular assist device population. Heart 2019; 105: 291–296.

33.

Sabashnikov

Mohite

Weymann

, et al. Outcomes after implantation of 139 full-support continuous-flow left ventricular assist devices as a bridge to transplantation. Eur J CardioThoracic Surg 2014; 46: 59–66.

34.

Anjum

Kurihara

Critsinelis

, et al. Acute kidney injury after implantation of a left ventricular assist device: a comparison of axial-flow (HeartMate II) and centrifugal-flow (HeartWare HVAD) devices. J Artif Organs 2018; 21: 285–292.

35.

Morris

Pekarek

Wittersheim

, et al. Gender differences in the risk of stroke during support with continuous flow left ventricular assist device. J Heart Lung Transplant 2015; 34: 1570–1577.

36.

Meyer

Malehsa

Budde

, et al. Acquired von willebrand syndrome in patients with a centrifugal or axial continuous flow left ventricular assist device. JACC Heart Fail 2014; 2: 141–155.

37.

Birschmann

Dittrich

Eller

, et al. Ambient hemolysis and activation of coagulation is different between HeartMate II and HeartWare left ventricular assist devices. J Heart Lung Transplant 2014; 33: 80–87.

38.

Coyle

Gallaghe

Kukla

, et al. Two-year outcomes in Hearmate 3 versus Heartware HVAD patients implanted as destination therapy. J Heart Lung Transplant 2020; 39: 411.

39.

Goyal

Chandler

Dalia

, et al. Outcomes in Heartmate 3 (HM3) vs Heartware (HVAD) patients: a single center experience. J Cardiac Fail 2022; 28: 73.

40.

Cho

Mehaffey

Meyers

, et al. Cerebrovascular events in patients with centrifugal-flow left ventricular assist devices: propensity score–matched analysis from the intermacs registry. Circ J 2021; 144: 763–772.

41.

Schramm

Zittermann

Morshuis

, et al. Comparing short-term outcome after implantation of the HeartWare HVAD and the Abbott HeartMate 3. ESC Heart Fail 2020; 7: 908–914.

42.

Chiang

Cox

Schroder

, et al. Stroke risk following implantation of current generation centrifugal flow left ventricular assist devices. J Cardiac Surg 2019; 35: 383–389.

43.

Tops

Coats

Gal

TB.

The ever-changing field of mechanical circulatory support: new challenges at the advent of the ‘single device era’. Eur J Heart Fail 2021; 23: 1428–1432.

44.

Hassett

Cho

Fan

, et al. Stroke rates in centrifugal flow left ventricular assist devices: a device-specific comparative analysis (5163). Neurology 2020; 94: 15.

45.

Mihalj

Heinisch

Schober

, et al. Third-generation continuous-flow left ventricular assist devices: a comparative outcome analysis by device type. ESC Heart Fail 2022; 9: 3469–3482.

46.

Inamullah

Chiang

Bishawi

, et al. Characteristics of strokes associated with centrifugal flow left ventricular assist devices. Sci Rep 2021; 11: 1645.

47.

Zadok

Ben-Avraham

Shaul

, et al. An 18-month comparison of clinical outcomes between continuous-flow left ventricular assist devices. Eur J Cardiothorac Surg 2019; 56: 1054–1061

48.

Ozturk

Demir

Sahutoglu

, et al. Heartmate 3 versus Heartmate 2: is new always better? J Heart Lung Transplant 2018; 37: 272–273.

49.

Alwair

Whitehouse

Slaughter

, et al. A tale of two centrifugal-flow ventricular assist devices as bridge to heart transplant. Ann Thorac Surg 2022; 113: 757–762.

50.

Berg

Shah

Guglin

, et al. Stroke and survival outcomes in left ventricular device patients. J Heart Lung Transplant 2023; 42: 334–335.

51.

Wasilewski

Kedziora

Wisniowska-Smialek

, et al. Outcomes in patients with HeartMate3 versus HeartWare ventricular assist device implanted as destination therapy. Transplant Proc 2022; 54: 1049–1053.

52.

Suarez-Pierre

Lui

Zhou

, et al. Early outcomes after heart transplantation in recipients bridged with a HeartMate 3 device. Ann Thorac Surg 2019; 108: 467–473.

53.

Hanke

Rojas

Dogan

, et al. First series of left ventricular assist device exchanges to HeartMate 3. Eur J Cardiothorac Surg 2017; 51: 887–892.

54.

Coyle

Chau

Gallagher

, et al. CARC9: outcomes of HeartMate 2 and HVAD exchange to HeartMate 3 left ventricular assist device. ASAIO J 2022; 68: 34.

55.

Barac

Wojnarski

Junpaparp

, et al. Early outcomes with durable left ventricular assist device replacement using the HeartMate 3. J Thorac Cardiovasc Surg 2020; 160: 132–139.

56.

Cogswell

Cantor

Vorovich

, et al. HVAD to Heartmate 3 device exchange: a society of thoracic surgeons intermacs analysis. Ann Thorac Surg 2022; 114: 1672–1678.

57.

Mancini

Colombo

PC.

Left ventricular assist devices: a rapidly evolving alternative to transplant. J Am Coll Cardiol 2015; 65(23): 2542–2555.

58.

Symalla

Jeevanandam

Choosing the appropriate left ventricular assist device for your patient. Indian J Thorac Cardiovasc Surg 2020; 36(Suppl 2): 256–264.

59.

Stehlik

Kirklin

JK.

The long and winding road to an effective left ventricular assist device: the Demise of Medtronic’s HVAD. Circulation 2021; 144(7): 509–511.

60.

ABBOTT introduces Heartmate 3 left ventricular assist system—the latest milestone in therapy for advanced heart failure patients. 2017, https://abbott.mediaroom.com/2017-08-28-Abbott-Introduces-HeartMate-3-Left-Ventricular-Assist-System-the-Latest-Milestone-In-Therapy-For-Advanced-Heart-Failure-Patients (accessed 28 March 2023).

61.

Cavarretta

Marullo

Sciarretta

, et al. A network meta-analysis of randomized trials and observational studies on left ventricular assist devices in adult patients with end-stage heart failure. Eur J Cardiothorac Surg 2019; 55: 461–467.

62.

Kerdany

Metwally

Khorshid

, et al. Left ventricular assist device therapy in heart failure: a meta-analysis. Ain Shams Med J 2021; 72: 105–118.

63.

Heatley

Sood

Goldstein

, et al. Clinical trial design and rationale of the multicenter study of MagLev technology in patients undergoing mechanical circulatory support therapy with HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol. J Heart Lung Transplant 2016; 35: 528–536.

64.

Wert

Hanke

Dogan

, et al. Reduction of driveline infections through doubled driveline tunneling of left ventricular assist devices-5-year follow-up. J Thorac Dis 2018; 10(Suppl 15): S1703–S1710.

65.

Peleg

McGiffin

Ventricular assist device-specific infections. J Clin Med 2021; 10(3): 453.

66.

Imamura

Murasawa

Kawasaki

, et al. Correlation between driveline features and driveline infection in left ventricular assist device selection. J Artif Organs 2017; 20(1): 34–41.

67.

Campi

Cruciani

Maradei

, et al. Coil design of a wireless power-transfer receiver integrated into a left ventricular assist device. J Clin Med 2021; 10(8): 874.

68.

Haglund

Davis

Tricarico

, et al. Readmissions after continuous flow left ventricular assist device implantation: differences observed between two contemporary device types. ASAIO J 2015; 61: 410–416.

69.

Hui

Mauermann

Stulak

, et al. Intensive care unit readmission after left ventricular assist device implantation: causes, associated factors, and association with patient mortality. Anesth Analg 2019; 128: 1168–1174.

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