Perforation of the Heart During Elective Removal of an Inferior Vena Cava Filter.

ABSTRACT: A common treatment for venous thromboembolic disease in patients with contraindications to anticoagulation includes placement of an inferior vena cava (IVC) filter. Temporary filters are available to avoid the risk of long-term permanent placement. A woman in her 60s with a history of uterine serous carcinoma presented to the emergency department with cardiac arrest following elective attempted IVC filter removal. Three months prior, a temporary filter was placed because anticoagulation medication was stopped in preparation for a hysterectomy. During the IVC retrieval procedure, which was performed using an intravascular approach from the right jugular vein, the filter was tilted, requiring the use of a different retrieval sheath. During catheter reentry, the patient complained of discomfort in the chest and neck, after which she became hypotensive, lost consciousness, and died. Autopsy revealed 2 cardiac perforations, one in each ventricle. Approximately 600 mL of liquid and clotted blood was within the tense pericardial sac. An IVC filter was found in place, with no adjacent hemorrhage.To our knowledge, this is the first reported fatality due to cardiac perforation by an access sheath during intravascular removal of an IVC filter. This instance also documents the time course of the cardiac perforations to the resultant loss of consciousness.

Discovery of RXFP2 genetic association in resistant hypertensive men and RXFP2 antagonists for the treatment of resistant hypertension.

Hypertension remains a leading cause of cardiovascular and kidney diseases. Failure to control blood pressure with ≥ 3 medications or control requiring ≥ 4 medications is classified as resistant hypertension (rHTN) and new therapies are needed to reduce the resulting increased risk of morbidity and mortality. Here, we report genetic evidence that relaxin family peptide receptor 2 (RXFP2) is associated with rHTN in men, but not in women. This study shows that adrenal gland gene expression of RXFP2 is increased in men with hypertension and the RXFP2 natural ligand, INSL3, increases adrenal steroidogenesis and corticosteroid secretion in human adrenal cells. To address the hypothesis that RXFP2 activation is an important mechanism in rHTN, we discovered and characterized small molecule and monoclonal antibody (mAb) blockers of RXFP2. The novel chemical entities and mAbs show potent, selective inhibition of RXFP2 and reduce aldosterone and cortisol synthesis and release. The RXFP2 mAbs have suitable rat pharmacokinetic profiles to evaluate the role of RXFP2 in the development and maintenance of rHTN. Overall, we identified RXFP2 activity as a potential new mechanism in rHTN and discovered RXFP2 antagonists for the future interrogation of RXFP2 in cardiovascular and renal diseases.

Prevalence of long COVID symptoms in Haryana, India: a cross-sectional follow-up study.

Background: Emerging research indicates growing concern over long COVID globally, although there have been limited studies that estimate population burden. We aimed to estimate the burden of long COVID in three districts of Haryana, India, using an opportunity to link a seroprevalence study to follow-up survey of symptoms associated with long COVID. Methods: We used a population-based seroprevalence survey for COVID-19 conducted in September 2021 across Haryana, India. Adults from three purposively selected districts (Rohtak, Gurugram, and Jhajjar) were eligible to participate; 2205 of 3213 consented to participate in a survey on health status. Trained investigators administered a structured questionnaire that included demographic characteristics, self-reported symptoms of illness in the last six months before the survey, mental health, and history of COVID-19. Findings: Unadjusted regression estimates indicated positive correlations between symptomatic complaints and COVID-19 exposure, suggesting lingering effects of COVID-19 in this population. The overall physical morbidity index was higher among those who tested positive for COVID-19, as was the incidence of new cases. However, both morbidity and incidence became statistically insignificant after adjustment for multiple comparisons. Cough emerged as the only statistically significant individual persistent symptom. Sex-stratified analyses indicated significant estimates only for physical morbidity in women. Interpretation: This study is one of the first from India that uses a large population-based sample to examine longer term repercussions of COVID infections. The burden of long COVID should primarily be addressed in clinical settings, where specialised treatment for individual cases continues to evolve. Our analyses also provide insight into the size and nature of studies required to assess the population-level burden of long COVID. Funding: This paper was produced under the auspices of the Lancet COVID 19 Commission India Task Force, which was supported financially by the Reliance Foundation. The Lancet COVID 19 Commission was set up in July 2020 and submitted its final report by October 2022. This report by the India Task Force was prepared during the same period.

Outcomes of Patients With Left Ventricular Assist Devices Requiring Intermittent Hemodialysis: Single-Center Cohort, Systematic Review, and Individual-Participant Data Meta-Analysis.

Patients with left ventricular assist devices (LVADs) who require intermittent hemodialysis (iHD) are considered to have a poor prognosis despite a paucity of supportive evidence, mostly from small single-center cohorts and extrapolations from studies of patients who received continuous renal replacement therapy but no iHD. We conducted a systematic review and individual-participant-data meta-analysis of the literature including our single-center cohort to examine the outcomes of patients initiated on iHD following LVAD implantation. Sixty-four patients from 5 cohorts met selection criteria (age 57.5 [46-64.5] years, 87% HeartMate II, mostly bridge to transplantation). Follow-up after iHD initiation was 87.5 (38.5-269.5) days, although it was considerably longer in our center than in other cohorts (601.5 [93-1559] days vs 65 [26-180] days, P = 0.0007). The estimated median survival was 308 (76-912.5) days and varied significantly among cohorts, ranging from 60 (57-65) to 838 (103-1872) days (P = 0.0096). Twelve (18.8%) patients achieved either heart transplantation (HT) or remission during follow-up. Patients who received HT had an 8-fold longer estimated median survival (1972 [799-1972] days vs 244 [64-838] days, P = 0.0112). Being from a more recent cohort was associated with better 1-year survival. Renal recovery occurred in eight patients (13.1%) at 30 days and its cumulative incidence increased to 73% (27/37 patients with available data) at 1 year. Most patients initiated on iHD after LVAD experienced renal recovery within the first year after implantation. Improved survival was observed for patients who received HT and in those from more recent cohorts. Some patients were able to survive on LVAD and iHD support for several years.

Women's groups, covariate shocks, and resilience: An evidence synthesis of past shocks to inform a response to COVID-19.

Background: Interventions with women's groups are increasingly seen as an important strategy for advancing women's empowerment, health, and economic outcomes in low- and middle-income countries, with the potential to increase the resiliency of members and their communities during widespread covariate shocks, such as coronavirus disease 2019 (COVID-19). Methods: This evidence synthesis compiles evidence from past shocks on women's group activities and the extent to which women's groups mitigate the effects of shocks on members and communities. We reviewed 90 documents from academic databases, organizational reports, and additional gray literature, and included literature diverse in geography, type of women's group, and shock. Results: The literature suggests that covariate shocks tend to disrupt group activities and reduce group resources, but linkages to formal institutions can mitigate this impact by extending credit beyond the shock-affected resource pool. Evidence was largely supportive of women's groups providing resilience to members and communities, though findings varied according to shock severity, group purpose and structure, and outcome measures. Further, actions to support individual resilience during a shock, such as increased payment flexibility, may run counter to group resilience. The findings of the evidence synthesis are largely consistent with emerging evidence about women's groups and COVID-19 in South Asia and sub-Saharan Africa. Conclusions: We finalize the paper with a discussion on policy implications, including the importance of sustainable access to financial resources for women's group members; equity considerations surrounding the distribution of group benefits and burdens; and the potential for meaningful partnerships between women's groups and local governments and/or non-governmental organizations (NGOs) to enhance community response amidst crises.

Effect of Early Amiodarone Use on Warfarin Sensitivity, Blood Product Use, and Bleeding in Patients With a Left Ventricular Assist Device.

Data are scarce on the effect of amiodarone on warfarin sensitivity and related outcomes after placement of a left ventricular assist device (VAD). This retrospective study compared 30-day outcomes between patients on amiodarone vs no amiodarone after VAD implant. After exclusions, 220 patients received amiodarone and 136 patients did not. Compared to the no amiodarone group, the amiodarone group had a higher warfarin dosing index (0.53 [0.39, 0.79] vs 0.46 [0.34, 0.63]; P = 0.003), incidence of INR ≥ 4 (40.5 vs 23.5%; P = 0.001), incidence of bleeding (24.1 vs 14%; P = 0.021), and use of INR reversal agents (14.5 vs 2.9%, P ≤ 0.001). Amiodarone was associated with bleeding (OR, 1.95; 95% CI, 1.10-3.47; P = 0.022), but not after adjusting for age, estimated glomerular filtration rate, and platelet count (OR, 1.67; 95% CI, 0.92-3.03; P = 0.089). After VAD implant, amiodarone was associated with increased warfarin sensitivity and administration of INR reversal agents.

Hysterectomy and women's health in India: evidence from a nationally representative, cross-sectional survey of older women.

BACKGROUND: Hysterectomy, particularly when conducted in women younger than 45 years, has been associated with increased risk of non-communicable diseases. In India, research indicates that hysterectomy is a common procedure for women, but there have been no studies on its long-term effects. We examined patterns of hysterectomy amongst women in India and associations with their health and well-being in later life. METHODS: This analysis utilised the first wave of the Longitudinal Study on Aging in India, a nationally representative study of adults that included a module on health and well-being. We analysed data on 35,083 women ≥45 years in India. We estimated prevalence of hysterectomy and performed multivariable logistic regression to identify associated risk factors and to examine the association between hysterectomy status and eight self-reported chronic conditions, hospitalisation and mobility. RESULTS: The prevalence of hysterectomy among women >=45 years was 11.4 (95% CI: 10.3, 12.6), with higher odds among urban women (aOR: 1.39; 1.17,1.64) and higher economic status (highest compared to lowest quintile: aOR: 1.95; 1.44, 2.63). Hysterectomy history was associated with four chronic conditions: hypertension (aOR: 1.51; 95% CI: 1.28, 1.79), high cholesterol (aOR: 1.43; 1.04, 1.97), diabetes (aOR: 1.69; 1.28, 2.24), and bone/joint disease (aOR: 1.54; 1.20, 1.97) and higher odds of any hospitalisation in the past year (aOR: 1.69; 1.36, 2.09). CONCLUSIONS: In India, evidence suggests that hysterectomy is associated with major chronic conditions. The assessment for hysterectomy as a treatment option for gynaecological morbidity should consider potential health consequences in later life.

Preimplant Hyponatremia Does Not Predict Adverse Outcomes in Patients With Left Ventricular Assist Devices.

Hyponatremia is a well-established marker of adverse outcomes in chronic heart failure (HF) but not well studied in patients with left ventricular assist device (LVAD). This is a retrospective study, single center study of HM3 [Abbott, USA] LVAD implants. We divided our population based on their sodium prior to LVAD implantation - hyponatremia if <135 mEq/L and normal sodium if 135-145 mEq/L. We compared postoperative and long-term outcomes. A total of 195 patients were included, preimplant hyponatremia was present in 40% with a sodium of 132.1 ± 2.1 vs 137.8 ± 1.9 mEq/L in the normal sodium group. No differences were observed in the postoperative or long-term outcomes. Preimplant hyponatremia was not associated with mortality or HF admissions, likely due to adequate left ventricular unloading and resolution of the mechanisms that lead to hyponatremia. These results suggest that optimization of mild hyponatremia may not be critical and should not delay LVAD placement.

Therapeutic Dilemmas in Mixed Septic-Cardiogenic Shock.

Sepsis is an increasing cause of decompensation in patients with chronic heart failure with reduced or preserved ejection fraction. Sepsis and decompensated heart failure results in a mixed septic-cardiogenic shock that poses several therapeutic dilemmas: Rapid fluid resuscitation is the cornerstone of sepsis management, while loop diuretics are the main stay of decompensated heart failure treatment. Whether inotropic therapy with dobutamine or inodilators improves microvascular alterations remains unsettled in sepsis. When to resume loop diuretic therapy in patients with sepsis and decompensated heart failure is unclear. In the absence of relevant guidelines, we review vasopressor therapy, the timing and volume of fluid resuscitation, and the need for inotropic therapy in patients who, with sepsis and decompensated heart failure, present with a mixed septic-cardiogenic shock.

Prediction of Survival After Implantation of a Fully Magnetically Levitated Left Ventricular Assist Device.

BACKGROUND: Clinical trials inform on average efficacy, but individualized risk assessments for outcome prediction are important in guiding treatment implementation. OBJECTIVES: The authors developed and validated a patient-specific risk score to predict survival at 1 and 2 years after HeartMate 3 (HM3) left ventricular assist device (LVAD) implantation. METHODS: The MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) trial includes 2,200 HM3 LVAD patients in the pivotal trial and Continued Access Protocol study (2014-2018). The authors randomly assigned all patients to a derivation cohort (n = 1,540) or validation cohort (n = 660). Univariate mortality predictors were screened for potential model inclusion, stepwise selection was used to build the multivariable Cox proportional hazards regression model, and performance (discrimination and calibration) was evaluated. RESULTS: Age, prior cardiac surgery (coronary artery bypass grafting [CABG] or valve procedure), lower serum sodium, higher blood urea nitrogen (BUN), small left ventricular size, and right atrial pressure-to-pulmonary capillary wedge pressure (RAP/PCWP) ratio >0.6 were significant risk factors for mortality. Receiver-operating characteristic (ROC) analysis in the validation cohort demonstrated an area under the curve (AUC) of 0.76 (95% CI: 0.70-0.81) at 1 year and 0.71 (95% CI: 0.66-0.77) at 2 years. Calibration between predicted and observed survival of the risk quintiles was high, with Pearson correlation coefficients of 0.986 and 0.994 at 1 and 2 years, respectively. Patients were successfully stratified into tertiles with higher-than-average, average, and lower-than-average survival, and observed mortality risk increased by 2-fold from one tertile to the next. CONCLUSIONS: A practical, easy-to-use HM3 Survival Risk Score with 6 components was developed to accurately predict 1- and 2-year survival after HM3 LVAD implantation. The survival risk score can be used to provide individual survival estimates to facilitate shared decision making when considering HM3 LVAD therapy. (MOMENTUM 3 Trial Portfolio; NCT02224755, NCT02892955).

'We are the bridge': an implementation research study of SEWA Shakti Kendras to improve community engagement in publicly funded health insurance in Gujarat, India.

INTRODUCTION: India's efforts towards universal health coverage include a national health insurance scheme that aims to protect the most vulnerable from catastrophic health expenditure. However, emerging evidence on publicly funded health insurance, as well as experience from community-based schemes, indicates that women face specific barriers to access and utilisation. Community engagement interventions have been shown to improve equitable utilisation of public health services, but there is limited research specific to health insurance. We examined how existing community-based resource centres implemented by a women's organisation could improve women's access to, and utilisation of, health insurance. METHODS: We conducted an implementation research study in Gujarat, India to examine how SEWA Shakti Kendras, established by the Self-Employed Women's Association, worked to improve community engagement in health insurance. SEWA organises women in the informal sector and provides social protection through health, insurance and childcare services. We examined administrative data, programme reports and conducted 30 in-depth qualitative interviews with users and staff. Data were analysed thematically to examine intervention content, context, and implementation processes and to identify enablers and barriers to improving women's access to health insurance through SEWA's community engagement approach. RESULTS: The centres worked through multiple channels-doorstep services, centre-based support and health system navigation-to strengthen women's capability to access health insurance. Each centre's approach varied by contextual factors, such as women's digital literacy levels and rural-urban settings. Effective community engagement required local leadership, strong government partnerships and the flexibility to address a range of public services, with implementation by trusted local health workers. CONCLUSION: SEWA Shakti Kendras demonstrate how a local, flexible and community-based model can serve as a bridge to improve utilisation of health insurance, by engaging women and their households through multiple channels. Scaling up this approach will require investing in partnerships with community-based organisations as part of strategies towards universal health coverage.

Women's groups and COVID-19: An evidence review on savings groups in Africa.

The coronavirus disease 2019 (COVID-19) pandemic and some of the associated policy responses have resulted in significant gendered impacts that may reverse recent progress in gender equality, including in sub-Saharan Africa. This paper presents emerging evidence from studies in diverse contexts in sub-Saharan Africa -with a deep dive into Nigeria and Uganda-on how COVID-19 has affected women's groups, especially savings groups, and how these groups have helped mitigate the gendered effects of the pandemic's and the associated policy responses' consequences up until April 2021. The synthesis presents evidence that savings groups found ways to continue operating, provided leadership opportunities for women during the pandemic, and mitigated some of the negative economic consequences of COVID-19 on individual savings group members. Savings, credit, and group support from other members all likely contributed to the ability of groups to positively affect the resilience of women's group member during COVID-19. Households with a female member in a savings group in Nigeria and Uganda have coped with the crisis better than those not in savings groups. While savings groups have shown the potential for resilience during the pandemic, they often faced financial challenges because of decreased savings, which sometimes resulted in the depletion of group assets. Savings groups also contributed to community responses and provided women a platform for leadership. These findings are consistent with a recent evidence synthesis on how past covariate shocks affected women's groups and their members. We conclude the paper by presenting various policy recommendations to enable savings groups to achieve improvements in women's empowerment and economic outcomes, and research recommendations to address some of the current evidence gaps on how COVID-19 is affecting women's groups and their members.

Women are underrepresented in cardiac resynchronization therapy trials.

INTRODUCTION: Current guidelines for cardiac resynchronization therapy (CRT) device implant are the same across both sexes however women have been traditionally underrepresented in randomized controlled trials (RCTs). We aimed to identify if the number of women included in CRT trials is representative of the real-world burden of heart failure (HF) in women. METHODS: RCTs evaluating the benefit of CRT in HF patients referenced in the 2012 EHRA/HRS expert consensus statement on CRT in HF were included. Studies were evaluated for gender representation, baseline variables, and gender-based analysis of outcomes. RESULTS: A total of 10 CRT trials including 8107 patients were studied. Of the total patient population in these RCTs, only 23% were women. Analysis of outcomes based on sex was reported only in 5 out of 10 trials. Of these five trials reporting sex-based outcomes, multicenter automatic defibrillator implantation trial with cardiac resynchronization therapy (MADIT-CRT) and resynchronization-defibrillation for ambulatory heart failure trial (RAFT) showed a greater benefit in women compared to men. Both MADIT and RAFT trials had a lower ejection fraction (EF) cut-off in the inclusion criteria (EF ≤ 30%) compared to the studies that did not find gender-based differences in the outcome (inclusion criteria: EF ≤ 35% or 40%). Additionally, women had less ischemic cardiomyopathy and more left bundle branch block (LBBB) compared to men in these two trials. CONCLUSION: Women are underrepresented in CRT trials; however, they have been shown to derive a greater benefit from CRT compared to men. Appropriate measures should be taken in future studies to enhance the participation of women in clinical trials for more generalizable evidence.

People's care seeking journey for a chronic illness in rural India: Implications for policy and practice.

Drawing on interviews conducted in 2019-2020, across twenty villages in India, this paper unpacks how people with chronic illness navigate complex care-seeking terrain. We show how the act of seeking care involves navigating through personal, family, social, economic, cultural, and most importantly, difficult health systems spaces-and entails making difficult social, moral, and financial choices. We show how the absence of reliable and accessible points of first contact for primary care results in people running from pillar to post, taking wrong turns, and becoming disappointed, frustrated, and, sometimes, impoverished. We reveal the complex individual and social dynamics of hope and misplaced and misguided expectations, as well as social obligations and their performance that animate the act of navigating care in rural India. We shine light on how a health system with weak primary care and poor regulation amplifies the medical, social, and financial consequences of an otherwise manageable chronic illness, and how these consequences are the worst for those with the least social, network and economic capital. Crucially we highlight the problematic normalisation of the absence of reliable primary care services for chronic illness in India, in rural India specifically. We signpost implications for research, and for policy and practice in India and similar health system contexts, i.e. those with weak primary care and poor regulation of the private sector. We argue that in India, having in place accessible, good quality, and trustworthy sources of advice and care for chronic illness at the first point of call, for all, is critical. We contend that this first point of call should be quality, public primary care services. We conclude that if such arrangements are in place in public services, people will use them.

Cerebral protection during percutaneous intervention for left ventricular assist device outflow graft obstruction.

BACKGROUND: Left ventricular assist devices (LVAD) outflow graft obstruction is an uncommon complication but carries significant morbidity and mortality. Here we provide a case series of patients with LVAD intrinsic outflow graft obstruction who are deemed to be a high surgical risk for pump exchange and, therefore, underwent percutaneous intervention with the concomitant use of neuroprotective device-Sentinel cerebral protection system (CPS) (Boston Scientific) to prevent embolic stroke. METHODS: We retrospectively analyzed patients who underwent LVAD placement in our institution and developed LVAD outflow graft obstruction. The diagnosis of LVAD outflow graft obstruction was confirmed by utilizing various cardiac imaging modalities such as echocardiography and/or computed tomography angiography. All patients were treated with percutaneous intervention and a catheter-based CPS. RESULTS: From a total of 501 LVAD implants in our institute, 6 (1.2%) patients with LVAD outflow graft obstruction who underwent percutaneous treatment were included; 4 patients with HeartMate-III LVAD, 1 patient with HeartMate-II LVAD, and 1 patient with HeartWare (HVAD). The median age of patients was 56.5 years at the time of LVAD implantation. The median time from the LVAD implantation to the episode of LVAD outflow obstruction was 1343 days. Utilization of Sentinel CPS resulted in the capture and removal of thrombus/debris in all patients. CONCLUSIONS: Percutaneous intervention of LVAD outflow graft obstruction is less invasive than surgical pump exchange and an acceptable alternative in properly selected patients. In our experience, utilization of a catheter-based CPS can help in reducing the incidence of periprocedural embolic events.

BREEZE: Open-label clinical study to evaluate the safety and tolerability of treprostinil inhalation powder as Tyvaso DPI™ in patients with pulmonary arterial hypertension.

Inhaled treprostinil is an approved therapy for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease in the United States. Studies have confirmed the robust benefits and safety of nebulized inhaled treprostinil, but it requires a time investment for nebulizer preparation, maintenance, and treatment. A small, portable treprostinil dry powder inhaler has been developed for the treatment of PAH. The primary objective of this study was to evaluate the safety and tolerability of treprostinil inhalation powder (TreT) in patients currently treated with treprostinil inhalation solution. Fifty-one patients on a stable dose of treprostinil inhalation solution enrolled and transitioned to TreT at a corresponding dose. Six-minute walk distance (6MWD), device preference and satisfaction (Preference Questionnaire for Inhaled Treprostinil Devices [PQ-ITD]), PAH Symptoms and Impact (PAH-SYMPACT®) questionnaire, and systemic exposure and pharmacokinetics for up to 5 h were assessed at baseline for treprostinil inhalation solution and at Week 3 for TreT. Adverse events (AEs) were consistent with studies of inhaled treprostinil in patients with PAH, and there were no study drug-related serious AEs. Statistically significant improvements occurred in 6MWD, PQ-ITD, and PAH-SYMPACT. Forty-nine patients completed the 3-week treatment phase and all elected to participate in an optional extension phase. These results demonstrate that, in patients with PAH, transition from treprostinil inhalation solution to TreT is safe, well-tolerated, and accompanied by statistically significant improvements in key clinical assessments and patient-reported outcomes with comparable systemic exposure between the two formulations at evaluated doses (trial registration: clinicaltrials.gov identifier: NCT03950739).

Matching Intent With Intensity: Implementation Research on the Intensity of Health and Nutrition Programs With Women's Self-Help Groups in India.

INTRODUCTION: In India, a large network of self-help groups (SHGs) implements interventions to improve women's and children's health and nutrition. There is growing evidence on the effectiveness of women's group interventions to improve health but limited information on implementation intensity, including how often groups meet, for how long, and with whom, despite this often being cited as a key factor for success. We aimed to assess the implementation intensity of large SHG-based health and nutrition interventions with rural, low-income women, to inform program design, delivery, and measurement. METHODS: We synthesized process data from surveys, meeting observations, and process evaluations across 8 maternal and child health and nutrition interventions in India. We examined the implementation intensity of 3 common intervention delivery channels: group meetings, home visits, and community-level activities. RESULTS: SHG members spent approximately 30 minutes in monthly meetings discussing health or nutrition. SHG dissolution or limited participation in meetings was a common challenge. Beyond group meetings, home visits reached approximately 1 in 3 households with an SHG member. Pregnant and breastfeeding women's participation in community events varied across interventions. DISCUSSION: Interventions that aim to capitalize on existing networks of financial women's groups not specifically formed for health and nutrition objectives, such as SHGs, will need to have an implementation intensity that matches the ambition of their health objectives: substantial changes in behavioral or mortality outcomes are unlikely to be achieved with relatively light intensity. Interventions that require sustained interactions with members to achieve health outcomes need to ensure adequate community and individual outreach to supplement group meetings, as well as improved participation through more intensive community mobilization approaches. Evaluations of group-based interventions should report on implementation intensity to support the interpretation of evaluation evidence and to inform further scale-up.

Six-month outcomes in postapproval HeartMate3 patients: A single-center US experience.

BACKGROUND: The European CE Mark approval study and the MOMENTUM 3 trial demonstrated safety and a reduction in hemocompatibility-related adverse events with the use of HeartMate 3 (HM3) device. This single-center study investigated the real-world experience in HM3 patients since FDA approval. METHODS: This retrospective, observational study included patients implanted with the HM3 LVAD as a primary implant between October 2017 and March 2020. Patients were divided into trial group and postapproval group. The primary endpoint was survival at 6 months. Secondary endpoints were adverse events including pump thrombosis (requiring pump exchange), stroke, renal failure, acute limb ischemia, re-exploratory for bleeding, gastrointestinal bleeding, right ventricular failure, and driveline infection. RESULTS: A total of 189 patients were implanted with HM3 device during the study period. 174 patients met the inclusion criteria: 82 patients in the trial group and 92 patients in the postapproval group. The postapproval group had younger patients, higher preoperative mean international normalized ratio, and greater numbers of patients with bridge to transplant (BTT) indications, IINTERMACS profile 1, and use of mechanical assist devices (other than IABP) than the trial group. Other characteristics between the two groups were comparable. Overall survival at 6 months in the postapproval group was 93.3% versus 93.8% (p = .88). The postapproval group demonstrated a statistically significant lower incidence of re-explorative surgery for bleeding (10.9% vs. 46.3, p = .01) than the trial group. CONCLUSION: In this single-center study, the real-world 6-month survival in the postapproval group was comparable to the trial results. Further studies are needed to monitor long-term outcomes.

Triple Antithrombotic Therapy in Patients With Left Ventricular Assist Devices.

Data on the efficacy and safety of the combination of warfarin and dual-antiplatelet therapy compared with warfarin and mono-antiplatelet therapy (MAPT) in patients with left ventricular assist devices (LVAD) remains scarce. Single-center study of 130 consecutive patients with durable LVAD. Baseline demographics, antithrombotic and antiplatelet regimen, and outcomes were compared between patients receiving warfarin plus dual-antiplatelet therapy (Group 1) and warfarin plus MAPT (Group 2). Antiplatelet therapy was assessed at hospital discharge post-LVAD implant and included aspirin, clopidogrel and dipyridamole. Outcomes at 1-year were assessed in each group. All patients were on aspirin and warfarin. No significant differences with regards to age, gender or ethnicity were noted at baseline between the two groups. Group 1 was more likely to have higher lactate dehydrogenase LDH levels at discharge and a history of stroke. No significant differences in international normalized ratio INR, hemoglobin or hematocrit were noted at discharge. During the study period, 48 patients had gastrointestinal bleeding events: 28 of 68 (41.2%) in Group 1 vs 20 of 62 (32.2%) in Group 2 (P = 0.293). At 1year, no statistically significant differences were noted in gastrointestinal bleeding (Group 1=27.90% vs Group 2 = 25.80, P = 0.784), ischemic stroke (Group 1 = 8.8% vs group 2 = 6.5%, P = 0.612), hemorrhagic stroke (Group 1 = 4.4% vs group 2 = 3.2%, P = 0.725) or mortality (Group 1 = 5.9% vs Group 2 = 1.6%, P = 0.206). Rates of pump thrombosis however were lower in Group 1 (Group 1 = 0% vs Group 2 = 6.5%, P = 0.033). Our study showed a high prevalence of triple-therapy antithrombotic use in LVAD patients with no significant differences in bleeding, stroke or survival. However, the risk for pump thrombosis was lower at 1-year when compared to patient receiving MAPT.