Strategies and outcomes of extracorporeal membrane oxygenation use in peripartum patients: a single institution experience.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) use in peripartum patients is rare, and there is a gap in the literature on the outcomes and guidance on using ECMO in peripartum patients. This study describes ECMO strategies our institution uses for peripartum patients and reports outcomes of ECMO use in peripartum patients with respiratory and/or cardiac failure. METHODS: A case series of all peripartum patients, defined as pregnant or up to 6 weeks after delivery of an infant >20 weeks gestation, from 2018 to 2023 from a single center requiring ECMO support. Patients were included if ECMO was initiated in the setting of cardiac, pulmonary, or combined failure. Patient demographics, operative details, ECMO data, and adverse outcomes for maternal, fetus, and neonates were all collected. RESULTS: Eighteen patients met the inclusion criteria. The cohort had a mean maternal age of 30.7 years old and was racially diverse. A majority of this cohort tested positive for COVID-19 (n = 10, 55%). ECMO was a bridge to recovery for all patients, of whom 14 (78%) were discharged out of the hospital alive. No patients received transplantation or a durable mechanical device. The most common complications were infection (25%) and postpartum hemorrhage (22%). CONCLUSIONS: ECMO use in peripartum patients in a single tertiary center was associated with a high survival rate. Furthermore, a strong multidisciplinary team, careful reevaluation of clinical trajectory, and consideration of complications and risks associated with using ECMO in peripartum patients are possible frameworks to use when challenged with critically ill peripartum patients.

Racial Disparities in Breastfeeding Rates in Patients with Heart Disease.

OBJECTIVE: To evaluate racial disparities in breastfeeding rates in patients with heart disease. STUDY DESIGN: Retrospective cohort of pregnant patients with maternal cardiac disease managed by a Cardio-Obstetrics program. Patients self-identifying as Non-Hispanic Black (NHB) and Non-Hispanic White (NHW), who attended ≥ 1 prenatal visit at the Cardio-Obstetrics Program and delivered at the same hospital between March 2015 and June 2019 were included. The primary outcome was breastfeeding rate at discharge from the delivery-associated hospitalization. Secondary outcomes included breastfeeding intent on admission and breastfeeding rates at the postpartum visit among patients who initiated breastfeeding. RESULTS: 138 pregnant patients with cardiac disease were included: 58 (42%) NHB and 80 (58%) NHW patients. Parity, marital status and insurance were statistically different between groups. NHB patients were more likely to have government insurance compared to NHW patients (77.6% vs. 40%; p < 0.001). There was a significant difference in the intent to breastfeed upon admission for the delivery-associated hospitalization (74.2% NHB vs. NHW 91.3%; p = 0.01), but not at hospital discharge (84.5% NHB vs. 93.8% NHW; p = 0.08). However, breastfeeding rates were significantly lower among NHB patients at the postpartum visit among the entire cohort (38.2% in NHB vs. 61.1% in NHW women; p = 0.036) and among those who initiated breastfeeding (35.3% NHB vs. 61.1% NHW, p = 0.018). CONCLUSIONS: Despite similar breastfeeding rates at hospital discharge, NHB patients with maternal cardiac disease were less likely to intend to breastfeed at admission and/or continue breastfeeding by the postpartum visits. Qualitative studies understanding these differences are crucial to improve breastfeeding rates, especially for NHB patients with maternal cardiac disease.

Breastfeeding Practices in Patients with Heart Disease Stratified by Area Deprivation Index.

Objective: We sought to evaluate breastfeeding (BF) practices in patients with maternal cardiac disease (MCD) stratified by area deprivation index (ADI) to identity communities at risk. Study Design: Retrospective cohort of patients managed by the University of Alabama at Birmingham (UAB) Cardio-Obstetrics Program. Patients were included if they had ≥1 prenatal visit with the Cardio-Obstetrics team, delivered at UAB, and had a street address on file. The primary outcome was BF rate at hospital discharge. Secondary outcomes included BF intent on admission and BF at the postpartum (PP) visit. ADI reports socioeconomic disadvantage at the census tract level; 1 = least deprived and 100 = most deprived. Baseline characteristics and BF rates were compared by ADI categories: Low (ADI 1-33), medium (ADI 34-66), and high (ADI 67-100). Results: One hundred and forty-eight patients were included: 14 (10%) low, 42 (28%) medium, and 92 (62%) high ADI. Patients in the high ADI category were younger relative to those in the medium or low ADI (26 versus 28 versus 32 years; p < 0.01) and less likely to be married or living with a partner (30.4% versus 58.5% versus 71.4%; p < 0.01), There was no difference in BF intent between the lowest, medium, and highest ADI categories (85.7% versus 85.4% versus 81.6%; p = 0.38) or BF rates at hospital discharge (100% versus 92.7% versus 85.6%, p = 0.23). However, there was a significant difference in BF rates at the PP visit (90% versus 63.0% versus 38.6%; p < 0.01) even after controlling for differences in baseline characteristics (odds ratio = 0.11 (95% confidence interval [0.01-0.93]), p = 0.043). Conclusions: There was an association between living in a resource-poor community and early cessation of BF in our population of patients with MCD. Community-based interventions targeting mothers with heart disease living in high ADI communities may help these individuals achieve higher BF rates.

Efficacy of Intravenous Iron in Patients with Heart Failure with Reduced Ejection Fraction and Iron Deficiency: A Systematic Review and Meta-Analysis of Randomized Control Trials.

BACKGROUND: The European Society of Cardiology (ESC) provided a focused update to the 2021 Guideline for the Management of Heart Failure, now providing a 1A recommendation for intravenous iron in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency (ID). However, the findings from randomized controlled trials (RCT) are mixed. This systematic review of RCTs aims to provide an update and synthesize the evidence addressing the association of intravenous iron with patient-based outcomes in patients with HFrEF and ID. METHODS: Any RCT evaluating the effect of intravenous iron in patients with HFrEF and ID was eligible for inclusion. A complete search of the EMBASE and PubMed databases was conducted from inception until 15 September 2023. The primary outcome was the composite of the quality of life (QoL) questionnaires, while the secondary outcomes included first heart failure (HF) hospitalizations and all-cause mortality. Data extraction was performed independently by two reviewers. Data were pooled using a random-effects model. RESULTS: Of the 1035 references, 15 RCTs enrolling 6649 patients were included in this study. Intravenous iron was associated with significant improvement in the composite of QoL (standardized mean difference - 1.36, 95% confidence interval [CI] - 2.24 to - 0.48; p = 0.002), a significant reduction in first HF hospitalizations (hazard ratio [HR] 0.73, 95% CI 0.56-0.95; p = 0.02), and with no change in all-cause mortality (HR 0.90, 95% CI 0.79-1.03; p = 0.12). The certainty of the evidence ranged from moderate to very low. CONCLUSION: Intravenous iron is possibly associated with improved QoL and reduced HF hospitalizations, without impacting all-cause mortality. These findings not only support the use of intravenous iron in patients with HFrEF but also emphasize the need for well-designed and executed RCTs with granular outcome reporting and powered sufficiently to address the impact of intravenous iron on mortality in patients with HFrEF and ID. REGISTRATION: PROSPERO identifier number CRD42023389.

Survival analysis from the INCREASE study in PH-ILD: evaluating the impact of treatment crossover on overall mortality.

OBJECTIVE: A post-hoc analysis of the INCREASE trial and its open-label extension (OLE) was performed to evaluate whether inhaled treprostinil has a long-term survival benefit in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). METHODS: Two different models of survival were employed; the inverse probability of censoring weighting (IPCW) and the rank-preserving structural failure time (RPSFT) models both allow construction of a pseudo-placebo group, thereby allowing for long-term survival evaluation of patients with PH-ILD receiving inhaled treprostinil. Time-varying stabilised weights were calculated by fitting Cox proportional hazards models based on the baseline and time-varying prognostic factors to generate weighted Cox regression models with associated adjusted HRs. RESULTS: In the INCREASE trial, there were 10 and 12 deaths in the inhaled treprostinil and placebo arms, respectively, during the 16-week randomised trial. During the OLE, all patients received inhaled treprostinil and there were 29 and 33 deaths in the prior inhaled treprostinil arm and prior placebo arm, respectively. With a conventional analysis, the HR for death was 0.71 (95% CI 0.46 to 1.10; p=0.1227). Both models demonstrated significant reductions in death associated with inhaled treprostinil treatment with HRs of 0.62 (95% CI 0.39 to 0.99; p=0.0483) and 0.26 (95% CI 0.07 to 0.98; p=0.0473) for the IPCW and RPSFT methods, respectively. CONCLUSION: Two independent modelling techniques that have been employed in the oncology literature both suggest a long-term survival benefit associated with inhaled treprostinil treatment in patients with PH-ILD.

Efficacy of Decision Aids in The Use of Left Ventricular Assist Device in Patients With Advanced Heart Failure: A Systematic Review and Meta-Analysis of Randomized Control Trials.

Although left ventricular assist device (LVAD) implantation can improve survival in patients with end-stage heart failure, it is not without risk. Numerous complications are possible, and durable support requires substantial lifestyle changes. The use of various knowledge-assessment tools may allow for more informed patient decisions. To synthesize the totality of the evidence, we conducted a systematic review and meta-analysis to summarize the efficacy of decision aid (DA) use in patients with advanced heart failure who are eligible for LVAD. Any randomized controlled trial (RCT) evaluating the efficacy of DAs in patients considering LVAD was eligible for inclusion. A complete search of EMBASE and PubMed was conducted from the start until June 8, 2023. The primary outcome was patients' LVAD knowledge. Data extraction was performed independently by 2 reviewers. Data were pooled using a random-effects model. Of the 575 references, 2 RCTs randomizing 490 patients were included in this study. DAs were associated with no significant change in LVAD knowledge (standardized mean difference 0.07, 95% confidence interval -0.24 to 0.39, p = 0.64) or decisional conflict (mean difference -1.48, 95% confidence interval -5.28 to 2.32, p = 0.45). The certainty of the evidence ranged from moderate to very low. The use of DAs in LVAD-eligible patients with advanced heart failure resulted in no difference in patients' knowledge of LVAD after LVAD education. The findings from this study will aid in the power analysis of a well-designed RCT to evaluate and encourage further investigation into the efficacy and relevance of DAs in preparing patients for a life with LVAD.

Breastfeeding practices among patients managed by a comprehensive cardio-obstetrics program.

Objective: To evaluate breastfeeding intent, rates at discharge, and continued breastfeeding at follow-up in patients managed in a comprehensive cardio-obstetrics program stratified by severity of maternal cardiac disease.Study Design: Retrospective cohort of patients managed by a comprehensive cardio-obstetrics program at the University of Alabama at Birmingham (UAB). Patients were included if they had ≥1 prenatal visit with the Cardio-Obstetrics team and delivered at UAB. The primary outcome was the breastfeeding rate on discharge from the delivery-associated hospitalization. Secondary outcomes included intent to breastfeed on admission and breastfeeding at the postpartum visit. Baseline characteristics and rates were compared between patients with less severe (mWHO I - II/III) vs. more severe (mWHO III - IV) maternal cardiac disease.Results: 147 patients were included: 85 (57.8%) mWHO class I - II and 62 (42.2%) mWHO class III-IV. Patients with more severe maternal cardiac disease had higher rates of chronic hypertension (22.6% vs. 9.4%; p = 0.027), lower gestational age at delivery (36.4 vs 37.7 weeks; p = 0.008), and higher rates of NICU admission (31.2% vs. 14.1%; p = 0.013). There were no significant differences between mWHO class I-II vs. mWHO class III-IV in intent to breastfeed upon admission to the delivery-associated hospitalization (84.7% vs. 82.3%; p = 0.67), breastfeeding rates upon discharge from the delivery-associated hospitalization (90.6% vs. 87.1%; p = 0.50), or breastfeeding rates at the postpartum visit (54.1% vs. 48.5%; p = 0.60).Conclusions: Despite potential barriers in this high-risk population, over 85% of patients breastfed upon discharge from the delivery-associated hospitalization. However, breastfeeding rates dropped by 40% at the postpartum visit. Strategies to support breastfeeding in the post-partum period in patients with maternal cardiac disease are imperative.

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).

Management of reproductive health after cardiac transplantation.

Pregnancy after cardiac transplantation poses immense challenges. Maternal risks include hypertensive disorders of pregnancy, rejection, and failure of the cardiac allograft that may lead to death. Fetal risks include potential teratogenic effects of immunosuppression and prematurity. Because of the high-risk nature of pregnancy in a heart transplant patient, management of reproductive health after cardiac transplantation should include preconception counseling to all women in the reproductive age group before and after cardiac transplantation. Reliable contraception is vital as nearly half of the pregnancies in this population are unintended. Despite the associated risks, successful pregnancies after cardiac transplantation have been reported. A multidisciplinary approach proposed in this review is essential for successful outcomes. A checklist for providers to guide management is provided.

Management of reproductive health in patients with pulmonary hypertension.

Pulmonary hypertension is characterized by elevated pulmonary artery pressure caused by several clinical conditions that affect pulmonary vasculature. Morbidity and death in this condition are related to the development of right ventricular failure. Normal physiologic changes that occur in pregnancy to support the growing fetus can pose hemodynamic challenges to the pregnant patient with pulmonary hypertension that results in increased morbidity and mortality rates. Current guidelines recommend that patients with known pulmonary hypertension be counseled against pregnancy. This review aims to provide clinicians with guidelines for preconception counseling, medication management, and delivery planning.

Anemia, Mortality, and Hospitalizations in Heart Failure With a Preserved Ejection Fraction (from the TOPCAT Trial).

In this post-hoc analysis of the TOPCAT trial, we evaluated the prognostic role of anemia in adverse cardiovascular (CV) outcomes in heart failure with a preserved ejection fraction (HFpEF). Anemia was defined as hemoglobin of <12 g/dl in females and <13 g/dl in males. The primary outcome was a composite of CV mortality, aborted cardiac arrest (ACA), and heart failure (HF) hospitalization. Secondary outcomes were components of the primary outcome, all-cause, CV and non-CV mortality, cause-specific CV and non-CV mortality, all-cause and HF hospitalization, myocardial infarction, and stroke. Among 1,748 patients from TOPCAT-Americas, patients with anemia had a 52% higher risk of the primary outcome (hazard ratio [HR] 1.52, 95% confidence interval 1.27, 1.83, p<0.05) during a median follow up of 2.4 years. These patients were also at higher risk of all-cause and CV mortality with no difference in non-CV mortality. Among CV causes, patients with anemia had higher risk of sudden cardiac death (SCD)/ACA and presumed CV death with no difference in death due to pump failure. Among non-CV causes, patients with anemia had higher risk of death due to malignancy (HR 2.61, p<0.05). Patients with anemia had higher risk of all-cause and HF hospitalizations (HR 1.26 and 1.56, respectively, p<0.05 for both). There was no difference in the risk of myocardial infarction or stroke. In conclusion, patients with HFpEF and anemia are at higher risk of mortality and hospitalization. Anemia is a significant risk factor for SCD/ACA, death due to presumed CV causes and malignancy in HFpEF.

Performance of Noninvasive Assessment in the Diagnosis of Right Heart Failure After Left Ventricular Assist Device.

Right heart failure (RHF) after left ventricular assist device (LVAD) is associated with poor outcomes. Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) defines RHF as elevated right atrial pressure (RAP) plus venous congestion. The purpose of this study was to examine the diagnostic performance of the noninvasive Intermacs criteria using RAP as the gold standard. We analyzed 108 patients with LVAD who underwent 341 right heart catheterizations (RHC) between January 1, 2006, and December 31, 2013. Physical exam, echocardiography, and laboratory data at the time of RHC were collected. Conventional two-by-two tables were used and missing data were excluded. The noninvasive Intermacs definition of RHF is 32% sensitive (95% cardiac index (CI), 0.21-0.44) and 97% specific (95% CI, 0.95-0.99) for identifying elevated RAP. Clinical assessment failed to identify two-thirds of LVAD patients with RAP > 16 mm Hg. More than half of patients with elevated RAP did not have venous congestion, which may represent a physiologic opportunity to mitigate the progression of disease before end-organ damage occurs. One-quarter of patients who met the noninvasive definition of RHF did not actually have elevated RAP, potentially exposing patients to unnecessary therapies. In practice, if any component of the Intermacs definition is present or equivocal, our data suggest RHC is warranted to establish the diagnosis.

Acute Hemodynamic Effects of Biventricular Pacing After Left Ventricular Assist Device.

BACKGROUND: Despite cardiac resynchronization therapy (CRT), some patients with heart failure progress and undergo left ventricular assist device (LVAD) implantation. Management of CRT after LVAD implantation has not been well studied. The purpose of this study was to determine whether RV pacing or biventricular pacing measurably affects acute hemodynamics in patients with an LVAD and a CRT device. METHODS AND RESULTS: Seven patients with CRT and LVAD underwent right heart catheterization. Pressures and oximetry were measured and LVAD parameters were recorded during 3 different conditions: RV pacing alone, biventricular pacing, and intrinsic atrioventricular conduction. Paired t tests were used to evaluate changes within subjects. There were no significant changes in right atrial pressure, pulmonary arterial pressures, pulmonary capillary wedge pressure, cardiac index, or any LVAD parameter (P > .05). CONCLUSIONS: Our data suggest that CRT probably has no acute hemodynamic effect in patients with LVADs, but further study is needed.

Burden of nursing activities during hemodynamic monitoring of heart failure patients.

BACKGROUND: Concerns remain about the burden of nursing care required to implement pulmonary artery pressure monitoring of heart failure patients. METHODS: We conducted a retrospective analysis of patients (N = 15) with a PAP sensor at our center. We defined three categories of PAP activity and estimated the nursing time spent on PAP monitoring. RESULTS: During the 6 months after implantation, the median patient contact time was 67 (55-75) minutes/patient/month and the median frequency of patient contact was 5.8 (4.6-6.4) contacts/patient/month. The intensity of nurse-patient contact decreased after the first 3 months (81 [52-102] minutes/patient/month vs. 45 [29-61] minutes/patient/month; P = 0.005). CONCLUSIONS: The intensity of nurse-patient contact increased significantly after PAP sensor implantation but declined after the first 3 months with medical stabilization. These data from our center may serve as a benchmark to project the nursing time required to support PAP monitoring in practice.

Sacubitril/Valsartan: From Clinical Trials to Real-world Experience.

PURPOSE OF REVIEW: Compared to enalapril, use of angiotensin-receptor blocker and neprilysin inhibitor sacubitril/valsartan to treat patients with heart failure and reduced ejection fraction (HFrEF) is associated with substantial reductions in both cardiovascular mortality and heart failure progression. The purpose of this review is to discuss the real-world experience of sacubitril/valsartan. RECENT FINDINGS: In the years following the publication of the landmark PARADIGM-HF trial in 2014 and its subsequent FDA approval, a growing evidence base supports the safety and efficacy of sacubitril/valsartan in a broad spectrum of patients with HFrEF. Updated clinical practice guidelines have embraced the use of sacubitril/valsartan in preference to ACE inhibitors or ARBs in selected patients. In this review, we highlight the clinical trials that led to these key updates to clinical guidelines, offer practical strategies for patient selection and utilization in clinical practice, and identify important areas of uncertainty that require future research.

High Right Atrial Pressure and Low Pulse Pressure Predict Gastrointestinal Bleeding in Patients With Left Ventricular Assist Device.

BACKGROUND: Gastrointestinal bleeding (GIB) remains a major morbid event during continuous flow left ventricular assist device (LVAD) support. This study investigated whether a common hemodynamic profile is associated with GIB in patients with LVADs. METHODS AND RESULTS: A single institution analysis reviewed all patients who underwent right heart catheterization (RHC) following LVAD implant between January 1, 2006, and December 31, 2013, with follow-up through June 2015. Kaplan-Meier and multiphase hazard statistical methods were employed. Among 108 patients with 341 RHC, 55 hospitalizations for GIB occurred within 1 year of RHC. Freedom from GIB at 6 months was 92% in patients with pulse pressure ≥35 mmHg, compared with 76% with pulse pressure <35 mmHg. By multivariable analysis, the significant predictors of GIB were: older age at implant, number of prior GIB, lower pulse pressure, lower mean arterial pressure, and higher right atrial pressure (all P < .05). The magnitude of effect is influenced by pulse pressure. CONCLUSIONS: Greater pulsatility and less venous congestion, along with other factors, are associated with a lower risk for GIB. It is reasonable to adjust therapeutic strategies to target this hemodynamic profile in patients with a propensity for GIB.