OP248 A Minimum Data-Set For Left Ventricular Assist Device On Destination Therapy: Cross-Border Collaboration Pilot On Real World Data

2021 ◽  
Vol 37 (S1) ◽  
pp. 9-9
Author(s):  
Leonor Varela-Lema ◽  
Janet Puñal-Rioboo ◽  
María José Faraldo Vallés
Keyword(s):  
Real World ◽  
Left Ventricular ◽  
Real World Data ◽  
Assist Device ◽  
Data Set ◽  
Ventricular Assist ◽  
World Data ◽  
Cross Border ◽  
Minimum Data ◽  
Left Ventricular Assist

IntroductionThe European Health Technology Assessment Network (EUnetHTA) Work Package 5B1, is focused on testing the levels of cross-border collaboration on real world data for supporting reimbursement/pricing decision-making. Within this Work Package, we are conducting a pilot on Left Ventricular Assist Device on destination therapy in collaboration with the National Institute for Health and Care Excellence (NICE, UK), the Belgian Health Care Knowledge Centre (KCE, Belgium) and the Italian National Agency for Regional Health Services (AGENAS, Italy). This pilot aims to define the minimum data set for gathering and sharing high quality registry data on key uncertainties found at the time of the health technology assessment (HTA). Furthermore, the pilot will assess the feasibility of carrying out a common analysis or reusing this data for National or Joint Reassessments.MethodsEvidence gaps were based on the four national assessments. Collaborating partners were responsible for agreeing on the key outcomes and proposing the minimum dataset to be registered. European clinical experts and patients rated and prioritized the dataset using a two round Delphi technique (not relevant, important but not critical; critical). The dataset will confirm the basis for the Spanish LVAD registry, implemented at the national health service level to inform inclusion into the healthcare portfolio.ResultsThe key outcomes agreed upon by agencies relate to safety, effectiveness, satisfaction and acceptability of the patient and cost-effectiveness, budget impact and organizational impact. Expert cardiologists and cardiac surgeons representing the European and Spanish Society, among others, participated in the prioritization of basic data. The final dataset is expected by December 2020.ConclusionsThe variation in the quality and definition of outcome measures for measuring key evidence gaps reduces the utility of registries for HTA, making it difficult to compare, link, and aggregate data across countries. The EUnetHTA pilot is intended to offer a model for cross-border collaboration on real world data for supporting the decision-making process for pricing and reimbursement.

Machine Learning-Based Prediction of Myocardial Recovery in Patients With Left Ventricular Assist Device Support

2021 ◽  
Author(s):  
Veli K. Topkara ◽  
Pierre Elias ◽  
Rashmi Jain ◽  
Gabriel Sayer ◽  
Daniel Burkhoff ◽  
...  
Keyword(s):  
Left Ventricular ◽  
Receiver Operating Curve ◽  
Myocardial Recovery ◽  
Assist Device ◽  
Validation Data ◽  
Data Set ◽  
Ventricular Assist ◽  
Left Ventricular Assist ◽  
Selection Operator ◽  
Receiver Operating

Background: Prospective studies demonstrate that aggressive pharmacological therapy combined with pump speed optimization may result in myocardial recovery in larger numbers of patients supported with left ventricular assist device (LVAD). This study sought to determine whether the use of machine learning (ML) based models predict LVAD patients with myocardial recovery resulting in pump explant. Methods: A total of 20 270 adult patients with a durable continuous-flow LVAD in the INTERMACS registry (Interagency Registry for Mechanically Assisted Circulatory Support) were included in the study. Ninety-eight raw clinical variables were screened using the least absolute shrinkage and selection operator for selection of features associated with LVAD-induced myocardial recovery. ML models were developed in the training data set (70%) and were assessed in the validation data set (30%) by receiver operating curve and Kaplan-Meier analysis. Results: Least absolute shrinkage and selection operator identified 28 unique clinical features associated with LVAD-induced myocardial recovery, including age, cause of heart failure, psychosocial risk factors, laboratory values, cardiac rate and rhythm, and echocardiographic indices. ML models achieved area under the receiver operating curve of 0.813 to 0.824 in the validation data set outperforming logistic regression-based new INTERMACS recovery risk score (area under the receiver operating curve of 0.796) and previously established LVAD recovery risk scores (INTERMACS Cardiac Recovery Score and INTERMACS Recovery Score by Topkara et al.) with area under the receiver operating curve of 0.744 and 0.748 ( P <0.05). Patients who were predicted to recover by ML models demonstrated a significantly higher incidence of myocardial recovery resulting in LVAD explant in the validation cohort compared with those who were not predicted to recover (18.8% versus 2.6% at 4 years of pump support). Conclusions: ML can be a valuable tool to identify subsets of LVAD patients who may be more likely to respond to myocardial recovery protocols.

scholarly journals Organic Dissemination and Real-World Implementation of Patient Decision Aids for Left Ventricular Assist Device

2018 ◽  
Vol 3 (1) ◽  
pp. 238146831876765 ◽  
Author(s):  
Jocelyn S. Thompson ◽  
Daniel D. Matlock ◽  
Megan A. Morris ◽  
Colleen K. McIlvennan ◽  
Larry A. Allen
Keyword(s):  
Decision Making ◽  
Left Ventricular Assist Device ◽  
Real World ◽  
Decision Aids ◽  
Left Ventricular ◽  
Shared Decision ◽  
Assist Device ◽  
Ventricular Assist ◽  
Patient Decision ◽  
Left Ventricular Assist

Background. Although patient decision aids (PtDAs) have been shown to improve patient knowledge and satisfaction, they are infrequently used in the real world. We aimed to understand how our publicly available PtDAs developed for destination therapy left ventricular assist device (DT LVAD) were implemented in clinical practice and characterize factors influencing adoption. Methods. We contacted 39 people, 31 who had independently emailed inquiring about our DT LVAD PtDAs and 8 identified through snowball sampling. Thirty people from 23 programs participated in semistructured interviews, which were analyzed using normalization process theory. Results. Eleven programs currently use the PtDAs, 5 plan to use them but have not yet, and 7 do not currently use them nor have active plans to use them. Due to major tradeoffs and preference sensitivity of the DT LVAD decision, participants recognized a role for shared decision making and a need for significant information transfer. Due to a relative lack of resources, participants saw the PtDAs as a way to help facilitate a higher quality decision-making process. Limited time, lack of personnel, and perceived burden to implementing system-level change were cited as barriers to use. Initial implementation was accomplished by a champion of the PtDAs. Actual use of the PtDAs most commonly occurred through LVAD coordinators at the start of formal patient teaching sessions, where the PtDAs could be integrated into the existing LVAD consent and education structure. Conclusion. Interest in and implementation of PtDAs occurred independently at several LVAD programs due to a favorable decisional context, including a perceived role for shared decision making in the high-stakes decision around DT LVAD, unmet informational needs, preexisting education sessions, and invested clinical champions.

Ultrastructural observations of the aorta of calves implanted with a mechanical left ventricular assist device

1990 ◽  
Vol 48 (3) ◽  
pp. 834-835
Author(s):  
J P Cassella ◽  
V Salih ◽  
T R Graham
Keyword(s):  
Left Ventricular Assist Device ◽  
Ventricular Assist Device ◽  
Left Ventricular ◽  
Aortic Tissue ◽  
Assist Device ◽  
Ventricular Assist ◽  
Transmission Electron ◽  
Left Ventricular Assist ◽  
Preliminary Study

Left ventricular assist systems are being developed for eventual long term or permanent implantation as an alternative to heart transplantation in patients unsuitable for or denied the transplant option. Evaluation of the effects of these devices upon normal physiology is required. A preliminary study was conducted to evaluate the morphology of aortic tissue from calves implanted with a pneumatic Left Ventricular Assist device-LVAD. Two 3 month old heifer calves (calf 1 and calf 2) were electively explanted after 128 days and 47 days respectively. Descending thoracic aortic tissue from both animals was removed immediately post mortem and placed into karnovsky’s fixative. The tissue was subsequently processed for transmission electron microscopy (TEM). Some aortic tissue was fixed in neutral buffered formalin and processed for routine light microscopy.

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