Dataset Information

Assessment of Mortality Among Durable Left Ventricular Assist Device Recipients Ineligible for Clinical Trials.

ABSTRACT:

Importance

While wide-scale adoption of durable left ventricular assist devices (LVADs) can be attributed to favorable randomized clinical trial outcomes, restrictive selection criteria may be associated with a lack of generalizability to real-world experience.

Objective

To estimate the proportion of LVAD recipients who are eligible for clinical trials and to assess whether an association exists between trial eligibility and mortality.

Design, setting, and participants

This cohort study examined 14 679 patients undergoing primary, intracorporeal continuous-flow LVAD implantation (with or without a right ventricular assist device) in 181 North American centers from January 1, 2012, to June 30, 2017, identified in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). To simulate a trial population, trial criteria from the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Therapy With HeartMate 3 (MOMENTUM 3) were mapped to INTERMACS variables. Patients were categorized as eligible for trial inclusion or ineligible for trial inclusion and by number of ineligibility criteria met. Follow-up in INTERMACS was complete for all patients through October 31, 2017. Data were analyzed from July 2019 through November 2020.

Exposures

Undergoing durable LVAD implantation.

Main outcomes and measures

Trial eligibility and postimplant mortality were analyzed using Kaplan-Meier estimates and Cox proportional hazards models.

Results

Among 14 679 recipients, mean (SD) age was 57 (13) years, 11 503 individuals (78.4%) were men, and 11 406 individuals (77.7%) presented with New York Heart Association class IV heart failure. A total of 6429 recipients (43.8%) were ineligible for trial inclusion, of whom 4226 individuals (65.7%) met 1 ineligibility criterion, 1442 individuals (22.4%) met 2 criteria, and 761 individuals (11.8%) met 3 or more criteria. Estimated mortality for recipients who were trial-ineligible was higher than for recipients who were trial-eligible (1-year mortality: 25.3% [95% CI, 24.2%-26.5%] vs 16.2% [95% CI, 15.4%-17.1%]; 3-year mortality: 42.8% [95% CI, 41.3%-44.4%] vs 36.4% [95% CI, 35.0%-37.8%]; log-rank P < .001 for both). Patients who were trial-ineligible had increased risk of mortality compared with patients who were trial-eligible if they met 1 trial ineligibility criterion (hazard ratio [HR], 1.16 [95% CI, 1.08-1.24]; P < .001), 2 trial ineligibility criteria (HR, 1.51 [95% CI, 1.36-1.67]; P < .001), or 3 or more trial ineligibility criteria (HR, 2.09 [95% CI, 1.84-2.39]; P < .001). Among patients meeting only 1 ineligibility criterion, 4 criteria were independently associated with mortality: prior or ongoing mechanical circulatory support (HR, 1.63 [95% CI, 1.23-2.16]; P = .001), elevated creatinine level (HR, 1.42 [95% CI, 1.17-1.72]; P < .001), elevated bilirubin level (HR, 1.39 [95% CI, 1.17-1.66]; P < .001), and low albumin or prealbumin level (HR, 1.18 [95% CI, 1.05-1.33]; P = .007).

Conclusions and relevance

These findings suggest that while treatment for patients who are ineligible for LVAD trial inclusion should be weighed against medical management, more consideration could be given to designing trials with eligibility criteria that reflect real-world experience.

SUBMITTER: Brescia AA

PROVIDER: S-EPMC7794668 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveAlthough infections are common after left ventricular assist device implantation, the relationship between timing and type of first infection with regard to mortality is less well understood.MethodsThe Society of Thoracic Surgeons Interagency Registry for Mechanically Assisted Circulatory Support patients receiving a primary left ventricular assist device from April 2012 to May 2017 were included. The primary exposure was defined 3 ways: any infection, timing of first infection (early: ≤90 days; intermediate: 91-180 days; late: >180 days), and type (ventricular assist device specific, ventricular assist device related, non-ventricular assist device). The association between first infection and all-cause mortality was estimated using Cox regression.ResultsThe cohort included 12,957 patients at 166 centers (destination therapy: 47.4%, bridge-to-transplant: 41.2%). First infections were most often non-ventricular assist device (54.2%). Rates of first infection were highest in the early interval (10.7/100 person-months). Patients with any infection had a significantly higher adjusted hazard of death (hazard ratio, 2.63; 2.46-2.86). First infection in the intermediate interval was associated with the largest increase in adjusted hazard of death (hazard ratio, 3.26; 2.82-3.78), followed by late (hazard ratio, 3.13; 2.77-3.53) and early intervals (hazard ratio, 2.37; 2.16-2.60). Ventricular assist device-related infections were associated with the largest increase in hazard of death (hazard ratio, 3.02; 2.69-3.40), followed by ventricular assist device specific (hazard ratio, 2.92; 2.57-3.32) and non-ventricular assist device (hazard ratio, 2.42; 2.20-2.65).ConclusionsRelative to those without infection, patients with any postimplantation infection had an increased risk of death. Ventricular assist device-related infections and infections occurring in the intermediate interval were associated with the largest increase in risk of death. After left ventricular assist device implantation, infection prevention strategies should target non-ventricular assist device infections in the first 90 days, then shift to surveillance/prevention of driveline infections after 90 days.

Project description:BackgroundThe HeartMate 3 (HM3) left ventricular assist device (LVAD) (Abbott, Inc, Chicago, Ill) is a fully magnetically levitated centrifugal implantable pump used to treat patients with chronic heart failure. The MOMENTUM (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) trial demonstrated that patients treated with the HM3 experienced reduced need for reoperation for LVAD replacement compared with a control group receiving an axial flow design, Heartmate II (Abbott, Inc). However, there are few reports of using HM3 as the replacement pump in patients who already are supported by a durable LVAD and experience a device-related complication necessitating replacement.MethodsAn institutional LVAD database was used to identify 19 consecutive patients who underwent pump replacement to HM3 (group 1) versus 85 consecutive control patients who underwent pump replacement to either Heartmate II or HeartWare Ventricular Assist Device (Medtronic Inc, Minneapolis, Minn) (group 2), at a single institution from January 2010 to August 2018. Patient baseline characteristic and outcomes were obtained from a prospectively maintained database. The primary endpoint was a composite of freedom from death or need for another replacement surgery.ResultsThere was no difference between the groups in heart failure etiology, indication for replacement, as well as the average days on the previous pump or the type of previous pump. The HM3 group did have a significantly greater body mass index (37 vs 31.6 P = .01), a greater number of previous LVAD implants (36.8% vs 5.9%, had 2 previous LVADs, P < .001), and a greater number of previous sternotomies (31.6% vs 7.1%, had 3 previous sternotomies, P = .001). No difference was found between the groups in terms of postoperative adverse event rates. With regards to the primary endpoint, the patients with HM3 replacements (group 1) versus group 2 experienced significantly greater freedom from either death or need for another replacement during the follow-up period (P = .039). During follow-up, there were no thrombosis events for the patients who received replacement with HM3.ConclusionsLVAD replacement with HM3 can be performed safely and may be considered as the pump of choice in patients requiring LVAD replacement.

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