Team based collaborative care model, facilitated by mHealth enabled and trained nurses, for management of heart failure with reduced ejection fraction in India (TIME-HF): design and rationale of a parallel group, open label, multi-centric cluster randomised controlled trial.

Background: Heart failure (HF) is a debilitating condition associated with enormous public health burden. Management of HF is complex as it requires care-coordination with different cadres of health care providers. We propose to develop a team based collaborative care model (CCM), facilitated by trained nurses, for management of HF with the support of mHealth and evaluate its acceptability and effectiveness in Indian setting. Methods: The proposed study will use mixed-methods research. Formative qualitative research will identify barriers and facilitators for implementing CCM for the management of HF. Subsequently, a cluster randomised controlled trial (RCT) involving 22 centres (tertiary-care hospitals) and more than 1500 HF patients will be conducted to assess the efficacy of the CCM in improving the overall survival as well as days alive and out of hospital (DAOH) at two-years (CTRI/2021/11/037797). The DAOH will be calculated by subtracting days in hospital and days from death until end of study follow-up from the total follow-up time. Poisson regression with a robust variance estimate and an offset term to account for clustering will be employed in the analyses of DAOH. A rate ratio and its 95% confidence interval (CI) will be estimated. The scalability of the proposed intervention model will be assessed through economic analyses (cost-effectiveness) and the acceptability of the intervention at both the provider and patient level will be understood through both qualitative and quantitative process evaluation methods. Potential Impact: The TIME-HF trial will provide evidence on whether a CCM with mHealth support is effective in improving the clinical outcomes of HF with reduced ejection fraction in India. The findings may change the practice of management of HF in low and middle-income countries.

Hemodynamic and Clinical Performance of Hearts Donated After Circulatory Death.

BACKGROUND: Donor organ demand continues to outpace supply in heart transplantation. Utilization of donation after circulatory death (DCD) hearts could significantly increase heart donor availability for patients with advanced heart failure. OBJECTIVES: The purpose of this study was to describe hemodynamic and clinical profiles of DCD hearts in comparison to standard of care (SOC) hearts donated after brain death (DBD). METHODS: This single-center retrospective cohort study of consecutive heart transplant recipients analyzed right heart catheterization measurements, inotrope scores, echocardiograms, and clinical outcomes between DCD and DBD heart recipients. RESULTS: Between April 2016 and February 2022, 47 DCD and 166 SOC hearts were transplanted. Median time from DCD consent to transplant was significantly shorter compared with SOC waiting list time (17 days [6-28 days] vs 70 days [23-240 days]; P < 0.001). Right heart function was significantly impaired in DCD recipients compared with SOC recipients 1 week post-transplant (higher median right atrial pressure (10 mm Hg [8-13 mm Hg] vs 7 mm Hg [5-11 mm Hg]; P < 0.001), higher right atrial pressure to pulmonary capillary wedge pressure ratio (0.64 [0.54-0.82] vs 0.57 [0.43-0.73]; P = 0.016), and lower pulmonary arterial pulsatility index (1.66 [1.27-2.50] vs 2.52 [1.63-3.82]; P < 0.001), but was similar between groups by 3 weeks post-transplant. DCD and SOC recipient mortality was similar at 30 days (DCD 0 vs SOC 2%; P = 0.29) and 1 year post-transplant (DCD 3% vs SOC 8%; P = 0.16). CONCLUSIONS: DCD heart utilization is associated with transient post-transplant right heart dysfunction and short-term clinical outcomes otherwise similar to transplantation using DBD hearts.

UNOS policy change benefits high-priority patients without harming those at low priority.

The heart transplantation policy change (PC) has improved outcomes in high-acuity (Old 1A, New 1-3) patients, but the effect on low-priority (Old 1B/2, New 4-6) patients is unknown. We sought to determine if low-priority patient outcomes were compromised by benefits to high-priority patients by evaluating for interaction between PC and priority status (PS). We included adult first-time heart transplant candidates and recipients from the UNOS registry during a 19-month period before and after the PC. We compared clinical characteristics and performed competing risks and survival analyses stratified by PC and PS. There was a dependence of PC and PS on waitlist death/deterioration with an interaction sub-distribution hazard ratio (adjusted sdHR) of 0.59 (0.45-0.78), p-value < .001. There was a trend toward a benefit of PC on waitlist death/deterioration (adjusted sdHR: 0.86 [0.73-1.01]; p = .07) and an increase in heart transplantation (adjusted sdHR: 1.08 [1.02-1.14], p = .007) for low-priority patients. There was no difference in 1-year post-transplant survival (log-rank p = .22) when stratifying by PC and PS. PC did not negatively affect waitlisted or transplanted low-priority patients. High-priority, post-PC patients had a targeted reduction in waitlist death/deterioration and did not come at the expense of worse post-transplant survival.

Infertility - an unfinished reproductive rights agenda in India.

Twenty-five years after the International Conference on Population and Development (ICPD) mandate in 1994, India has fallen far short of providing universal access to preventive and treatment services for infertility. This mandate was a call to "prioritize the reproductive health and rights of all people" (1), and reproductive health was defined as.

Dispelling hope and leaving couples in a state of "inbetweenness": Moral dilemmas in infertility research.

Infertility is a condition that has an inherent cultural significance. In India, married couples with infertility face the brunt of speculations and certain demeaning identities are assigned to the women. Care-seeking options for infertility are deeply gendered. The availability of technologically advanced treatments for infertility provides "hope" to couples, especially women, to resolve the demeaning identities assigned to them, related to infertility. The paper focuses on the moral dilemma faced by a medically trained public health professional while collecting data from women in Kerala who were unable to continue the suggested biomedical treatment. Infertility treatment is an entropic cycle of success and failure; thus, the women studied moved from one stage to another hoping for a resolution to their problem. They were also undergoing alternative treatments that were unlikely to succeed. The paper discusses the moral dilemma of choosing between explaining the poor likelihood of success and leaving them with "hope".

Extracorporeal cardiopulmonary resuscitation (ECPR) survival: A quaternary center analysis.

BACKGROUND: Extracorporeal cardiopulmonary resuscitation (ECPR) has emerged as a rescue strategy for nonresponders to conventional CPR (CCPR) in cardiac arrest. Definitive guidelines for ECPR deployment do not exist. Prior studies suggest that arrest rhythm and cardiac origin of arrest may be variables used to assess candidacy for ECPR. AIM: To describe a single-center experience with ECPR and to assess associations between survival and physician-adjudicated origin of arrest and arrest rhythm. METHODS: A retrospective review of all patients who underwent ECPR at a quaternary care center over a 7-year period was performed. Demographic and clinical characteristics were extracted from the medical record and used to adjudicate the origin of cardiac arrest, etiology, rhythm, survival, and outcomes. Univariate analysis was performed to determine the association of patient and arrest characteristics with survival. RESULTS: Between 2010 and 2017, 47 cardiac arrest patients were initiated on extracorporeal membrane oxygenation (ECMO) at the time of active CPR. ECPR patient survival to hospital discharge was 25.5% (n = 12). Twenty-six patients died on ECMO (55.3%) while nine patients (19.1%) survived decannulation but died before discharge. Neither physician-adjudicated arrest rhythm nor underlying origin were significantly associated with survival to discharge, either alone or in combination. Younger age was significantly associated with survival. Nearly all survivors experienced myocardial recovery and left the hospital with a good neurological status. CONCLUSIONS: Arrest rhythm and etiology may be insufficient predictors of survival in ECPR utilization. Further multiinstitutional studies are needed to determine evidenced-based criteria for ECPR deployment.

Beyond the stethoscope: managing ambulatory heart failure during the COVID-19 pandemic.

There have been nearly 70 million cases of COVID-19 worldwide, with over 1.5 million deaths at the time of this publication. This global pandemic has mandated dramatic changes in healthcare delivery with a particular focus on social distancing in order to reduce viral transmission. Heart failure patients are among the highest utilizers of health care and are at increased risk for COVID-related vulnerabilities. Effectively managing this complex and resource-intensive patient population from a distance presents new and unique challenges. Here, we review relevant data on telemedicine and remote monitoring strategies for heart failure patients and provide a framework to help providers treat this population during the COVID-19 pandemic. This includes (i) dedicated pre-visit contact and planning (i.e. confirm clinical appropriateness, presence of compatible technology, and patient comfort); (ii) utilization of virtual clinic visits (use of telehealth platforms, a video-assisted exam, self-reported vital signs, and weights); and (iii) use of existing remote heart failure monitoring sensors when applicable (CardioMEMS, Optivol, and HeartLogic). While telemedicine and remote monitoring strategies are not new, these technologies are emerging as an important tool for the effective management of heart failure patients during the COVID-19 pandemic. In general, these strategies appear to be safe; however, additional data will be needed to determine their effectiveness with respect to both process and outcomes measures.

Maintaining confidentiality while gaining access to the community.

Qualitative research is used to enhance the understanding of many issues but this method poses certain unique difficulties and ethical dilemmas for the researcher. These tend to be magnified when researching sensitive topics.

Management of Heart Failure and Cardiogenic Shock in Pregnancy.

PURPOSE OF REVIEW: While the prognosis of peripartum cardiomyopathy (PPCM) is generally more favorable than other cardiomyopathies, PPCM can be associated with cardiogenic shock and significant maternal morbidity in young women. The management of a pregnant woman in cardiogenic shock necessitates consideration of harm to the fetus. This review focuses on the management of these women. RECENT FINDINGS: A number of advances have increased the repertoire of therapies available to manage PPCM. Increased understanding of PPCM pathophysiology has led to a number of new and experimental medications. In the current era, mechanical circulatory support has been gaining a stronger presence in critical care and can be used in cardiogenic shock of the pregnant patient refractory to medical therapy. We discuss medical therapies, mechanical circulatory support, arrhythmia management, and a delivery plan in the setting of cardiogenic shock secondary to PPCM.

Pre-emptive pangenotypic direct acting antiviral therapy in donor HCV-positive to recipient HCV-negative heart transplantation: an open-label study.

BACKGROUND: Low donor heart availability underscores the need to identify all potentially transplantable organs. We sought to determine whether pre-emptive administration of pangenotypic direct-acting antiviral therapy can safely prevent the development of chronic hepatitis C virus (HCV) infection in uninfected recipients of HCV-infected donor hearts. METHODS: Patients were recruited for this an open-label, single-centre, proof-of-concept study from Nov 1, 2017, to Nov 30, 2018. Following enrolment, the recipient's status on the heart transplantation waiting list was updated to reflect a willingness to accept either an HCV-positive or HCV-negative heart donor. Patients who underwent transplantation with a viraemic donor heart, as determined by nucleic acid testing (NAT), received pre-emptive oral glecaprevir-pibrentasvir before transport to the operating room followed by an 8-week course of glecaprevir-pibrentasvir after transplantation. Patients receiving HCV antibody-positive donor hearts without detectable circulating HCV RNA were followed using a reactive approach and started glecaprevir-pibrentasvir only if they developed viraemia. The primary outcome was achievement of sustained virological response 12 weeks after completion of glecaprevir-pibrentasvir therapy (SVR12). Patients were followed from study enrolment to 1 year after transplantation. This is an interim analysis, initiated after all enrolled patients reached the primary outcome. Results reflect data from Nov 1, 2017, to May 30, 2019. This trial is registered with ClinicalTrials.gov, number NCT03208244. FINDINGS: 55 patients were assessed for eligibility and 52 consented to enrolment. 25 patients underwent heart transplantation with HCV-positive donor hearts (20 NAT-positive, five NAT-negative), three of whom underwent simultaneous heart-kidney transplantation. All 20 recipients of NAT-positive hearts tolerated glecaprevir-pibrentasvir and showed rapid viral suppression (median time to clearance 3·5 days, IQR 0·0-8·3), with the subsequent achievement of SVR12 by all 20. The five recipients of NAT-negative grafts did not become viraemic. Median pre-transplant waiting time for patients following enrolment in the HCV protocol was 20 days (IQR 8-57). Patient and allograft survival were 100% at a median follow-up of 10·7 months (range 6·5-18·0). INTERPRETATION: Pre-emptive administration of glecaprevir-pibrentasvir therapy results in expedited organ transplantation, rapid HCV suppression, prevention of chronic HCV infection, and excellent early allograft function in patients receiving HCV-infected donor hearts. Long-term outcomes are not yet known. FUNDING: American Association for the Study of Liver Diseases, National Institutes of Health, and the Massachusetts General Hospital.

Impella Placement Guided by Echocardiography Can Be Used as a Strategy to Unload the Left Ventricle During Peripheral Venoarterial Extracorporeal Membrane Oxygenation.

OBJECTIVE: At the authors' institution, before 2015, patients cannulated for peripheral venoarterial extracorporeal membrane oxygenation (VA-ECMO) did not undergo left ventricular (LV) decompression with the use of an LV vent. After 2015, the authors' institution began using the Impella device to vent the left ventricle in patients on VA-ECMO. The authors hypothesized that survival outcomes would improve in patients on VA-ECMO with the use of an Impella for LV venting. DESIGN: Retrospective, chart based review study. SETTING: Single center, university-based hospital. PARTICIPANTS: All adult patients at the authors' institution who required VA-ECMO between January 2015 and May 2017. INTERVENTION: An Impella (Abiomed, Danvers, MA) device was placed percutaneously in patients cannulated for VA-ECMO as a mechanism to provide LV venting and decompression, therefore unloading the heart. MEASUREMENTS AND MAIN RESULTS: Manual chart review was conducted, and a survival analysis was performed. It was observed that patients on VA-ECMO in whom an Impella was implanted had improved survival and an improvement in LV function as demonstrated by echocardiography compared with patients maintained on VA-ECMO alone. CONCLUSIONS: Patients on VA-ECMO plus Impella implantation demonstrated improved survival compared with patients treated with VA-ECMO alone. Key echocardiographic characteristics such as improved LV function after Impella placement and LV cavity size reduction during therapy may help predict those patients who may benefit most from this cannulation strategy.