The clinical significance of cervical tears' anatomical location - A retrospective study.

OBJECTIVE: Up to 4.8% of all vaginal deliveries are complicated by significant cervical tears related to maternal compromise, yet the location of the cervical tear and its impact on the attributed risk have not been studied to date. This study aimed to determine the associations between the location and characteristics of cervical tears with short-term maternal complications and outcomes. METHODS: This is a retrospective cohort study. Included were all patients that delivered vaginally at our institute between the years 2009-2020 and were diagnosed with a cervical tear. Maternal complications were compared between cases with posterior cervical tears and cases with anterior or lateral cervical tears. Exclusion criteria included patients who delivered by cesarean delivery and preterm labor below 37.0 weeks of gestation. RESULTS: Overall, 96 patients were diagnosed with posterior cervical tears, while 117 patients were diagnosed with anterior or lateral tears. Maternal demographics and pregnancy characteristics were similar between the groups. There were also no differences in delivery outcomes between the groups. Patients with posterior cervical tears had a higher rate of disseminated intravascular coagulation (DIC) (6.25 % vs. 0.9 %, p = 0.04) and prolonged hospitalization (35.4 % vs. 23.1 %, p = 0.05), as compared to patients with anterior or lateral tears. There were no differences in other maternal complications. CONCLUSIONS: Cases of posterior cervical tears are at higher risk for maternal adverse outcomes (DIC and prolonged hospitalization), as compared to cases of anterior or lateral tears.

The use of virtual reality during extra-amniotic balloon insertion for pain and anxiety relief-a randomized controlled trial.

BACKGROUND: Induction of labor with an extra-amniotic balloon catheter is a procedure commonly associated with maternal discomfort, pain, and anxiety. OBJECTIVE: We aimed to investigate the distractive effect of virtual reality technology on pain and anxiety among pregnant patients who underwent induction of labor with an extra-amniotic balloon catheter. STUDY DESIGN: In this randomized controlled trial, pregnant patients who were undergoing planned induction of labor using an extra-amniotic balloon catheter at term for various obstetrical indications were recruited and randomized in a 1:1 ratio into 2 groups. Patients in the virtual reality group were exposed to a virtual reality technology clip (using SootheVR All-In-One virtual reality care system for pain and anxiety) during the entire extra-amniotic balloon catheter insertion, whereas patients in the control group received the institutional standard care for extra-amniotic balloon catheter insertion. Pain scores, expressed as visual analog scale scores, and maternal hemodynamic parameters were obtained before, during, and after extra-amniotic balloon catheter insertion. Anxiety was evaluated using the validated State-Trait Anxiety Inventory Scale before and after the procedure. Maternal satisfaction with the virtual reality technology was also recorded. The primary outcome was the change in visual analog scale score before and during extra-amniotic balloon catheter insertion. Among the secondary outcomes was the change in anxiety levels before and after extra-amniotic balloon catheter insertion. The study was powered to detect a 25% decrease in the primary outcome. RESULTS: A total of 132 pregnant patients were recruited (66 in each group). There were no differences between groups in terms of age, body mass index, gestational age at enrollment, indication for induction of labor, and preprocedural visual analog scale score and anxiety levels. The change in visual analog scale score (maximal visual analog scale score during the procedure minus the initial visual analog scale score before the procedure, ie, the primary outcome) was significantly lower in the virtual reality group than in the control group (2.78±3.0 vs 4.09±2.99; P=.01). In addition, the virtual reality group experienced a higher rate of anxiety relief, expressed as the difference between the preprocedure and postprocedure State-Trait Anxiety Inventory Scale scores (-6.46±9.6 vs -2.01±9.11; P=.007). Patients in the virtual reality group reported a very high overall (94%) satisfaction score. CONCLUSION: In this randomized controlled trial, we demonstrated that the use of virtual reality technology among patients who underwent induction of labor using an extra-amniotic balloon catheter was associated with lower visual analog scale scores during the procedure and a significant reduction in anxiety than patients who received standard care. There was also a very high satisfaction rate with the use of virtual reality technology.

Procedure-to-delivery interval after late amniocentesis and the need for routine antenatal corticosteroids.

OBJECTIVES: The aim of this study is to assess the procedure-to-delivery interval (PDI), the obstetric complications, and the early neonatal outcome in patients that did or did not receive glucocorticosteroids (GCSs) before third-trimester amniocentesis (TTA). METHODS: A retrospectively analysis of 445 TTA procedures divided into two groups based on the administration (study group = 220 patients) or not (control group = 225 patients) of GCSs before TTA. The PDI was calculated for all patients. Obstetric and neonatal outcomes were compared between the groups. RESULTS: The rate of procedure-associated complications was similar between the groups. The mean PDI was 47.2 ± 16.8 days. The overall incidence of preterm birth was 11.7%; 9% delivered between 34 and 37 weeks and 2.7% between 28 and 34 weeks. Only nine patients (2%) delivered within seven days following TTA. The incidence of respiratory distress syndrome in the study and control groups was 1.8% and 1.3%, p = .71, respectively. There were no significant differences in other neonatal outcomes in term and preterm deliveries between the study and control groups. CONCLUSIONS: In the present study, the administration of glucocorticoids prior to TTA did not reduce the rates of neonatal complications, which was similar in both groups and not higher than the general population.

The effectiveness of McCall culdoplasty following vaginal hysterectomy in advanced stages of uterine prolapse.

INTRODUCTION AND HYPOTHESIS: Following vaginal hysterectomy (VH), fixation of the vaginal vault is needed to prevent post-operative recurrence/exacerbation of vault prolapse. The effectiveness of McCall culdoplasty in cases of advanced prolapse is unclear. We aimed to compare the effectiveness of McCall culdoplasty following VH in patients with mild versus advanced stages of uterine prolapse. METHODS: In this retrospective study, the Pelvic Floor Distress Inventory (PFDI-20) was utilized to compare the subjective results of vaginal hysterectomy plus McCall culdoplasty between women with mild uterine prolapse stage 2 (mild prolapse group) and advanced uterine prolapse stages 3-4 (advanced prolapse group). The primary outcome, the subjective awareness of prolapse, was analyzed as well as all other aspects of PFDI-20. A sample size of 130 was calculated. RESULTS: The mild prolapse group consisted of 26 (19.3%) patients and the advanced prolapse group consisted of 109 (80.7%) patients. There were no differences between the groups in demographic and clinical characteristics. The rates of concomitant prolapse and incontinence surgeries, performed at the time of VH and post-operative complications. were the same between groups. The mean follow-up was more than 5 years in both groups. Awareness of prolapse was similar between the groups (11.5% in the mild prolapse group and 5.5% in the advanced prolapse group, p = 0.374). There was no significant correlation between the stage of apical prolapse before surgery and awareness of prolapse after the surgery (r = 0.0132, p = 0.879). All aspects of the PFDI-20 questionnaire were similar in the two groups. CONCLUSION: McCall culdoplasty was found to have an equal subjective effectiveness following VH in both mild and advanced stages of uterine prolapse.

Management of pregnancies with suspected preeclampsia based on 6-hour vs 24-hour urine protein collection-a randomized double-blind controlled pilot trial.

BACKGROUND: Traditionally, the diagnosis of preeclampsia requires elevated blood pressure measurements and proteinuria demonstrated in a 24-hour urine collection. This prolonged urine collection is associated with patient discomfort, a delay in diagnosis, and in some cases, hospitalization for further management of outcomes. OBJECTIVE: We aimed to assess the feasibility, reliability, and association between maternal and neonatal outcomes of pregnancies managed according to a 6-hour vs 24-hour urine protein collection for suspected preeclampsia. STUDY DESIGN: This was a randomized controlled trial conducted at a tertiary university hospital between January 2019 and January 2021 (ClinicalTrials.gov Identifier: NCT03724786). Patients who were hospitalized for preeclampsia workup were asked to participate and randomized at a 1:1 ratio to 6- and 24-hour urine protein collection groups. Both groups collected urine for 24 hours, during which the collection was also tested after 6-hours. After 24 hours, both results were reviewed by one of the research staff, and either the 6- or 24-hour collection result was reported to the patient's managing physician and was documented in the patient's medical record. Both patient and the managing physician were blinded to group allocation. Unblinding was undertaken in cases of a discrepancy between the results (1 of 2 results of >300 mg protein), and the results were analyzed by intention to treat. The primary study outcome was defined as a composite of adverse maternal outcomes. The sample size was set empirically as per proof on concept design. RESULTS: During the study period, 115 patients participated in the trial, 101 of whom completed the follow-up and were analyzed-51 in the 6-hour group and 50 in the 24-hour group. Patient demographics were similar between the study groups. Unblinding occurred in 7 cases in the 6-hour group, in which the initial 6-hour result ranged from 168 to 475 mg. The rates of composite adverse maternal outcomes were 15.6% and 12.0% in the 6- and 24-hour groups, respectively (P=.59). No significant difference was demonstrated in the rate of adverse neonatal outcomes, cesarean delivery, induction of labor, gestational age at delivery, betamethasone treatment, or neonatal birthweight. CONCLUSION: Managing pregnancies suspected of preeclampsia with a 6-hour urine protein collection is feasible and associated with similar maternal and neonatal outcomes. In cases where the 6-hour result is in the 168 to 475 mg range, we propose completing a 24-hour collection.

The Degree of the Predischarge Pulmonary Congestion in Patients Hospitalized for Worsening Heart Failure Predicts Readmission and Mortality.

BACKGROUND: Prediction of readmission and death after hospitalization for heart failure (HF) is an unmet need. AIM: We evaluated the ability of clinical parameters, NT-proBNP level and noninvasive lung impedance (LI), to predict time to readmission (TTR) and time to death (TTD). METHODS AND RESULTS: The present study is a post hoc analysis of the IMPEDANCE-HF extended trial comprising 290 patients with LVEF ≤45% and New York Heart Association functional class II-IV, randomized 1:1 to LI-guided or conventional therapy. Of all patients, 206 were admitted 766 times for HF during a follow-up of 57 ± 39 months. The normal LI (NLI), representing the "dry" lung status, was calculated for each patient at study entry. The current degree of pulmonary congestion (PC) compared with its dry status was represented by ΔLIR = ([measured LI/NLI] - 1) × 100%. Twenty-six parameters recorded during HF admission were used to predict TTR and TTD. To determine the parameter which mainly impacted TTR and TTD, variables were standardized, and effect size (ES) was calculated. Multivariate analysis by the Andersen-Gill model demonstrated that ΔLIRadmission (ES = 0.72), ΔLIRdischarge (ES = -3.14), group assignment (ES = 0.2), maximal troponin during HF admission (ES = 0.19), LVEF related to admission (ES = -0.22) and arterial hypertension (ES = 0.12) are independent predictors of TTR (p < 0.01, χ2 = 1,206). Analysis of ES showed that residual PC assessed by ∆LIRdischarge was the most prominent predictor of TTR. One percent improvement in predischarge PC, assessed by ∆LIRdischarge, was associated with a likelihood of TTR increase by 14% (hazard ratio [HR] 1.14, 95% confidence interval [CI] 1.13-1.15, p < 0.01) and TTD increase by 8% (HR 1.08, 95% CI 1.07-1.09, p < 0.01). CONCLUSION: The degree of predischarge PC assessed by ∆LIR is the most dominant predictor of TTR and TTD.

Reproductive outcome after early pregnancy loss treated with misoprostol versus surgical aspiration.

RESEARCH QUESTION: Does long-term reproductive outcome after early pregnancy loss (EPL) differ between women who are treated with misoprostol and surgical aspiration. DESIGN: A historic cohort study of all women who were diagnosed with early pregnancy loss (≤12 weeks), in a single medical centre, between September 2016 and August 2017, was conducted. The women were treated with either misoprostol or surgical aspiration according to their own preferences. Women who were lost to follow-up or did not attempt to conceive again were excluded. The primary outcome measure was the cumulative pregnancy rate within 12 months from intervention. RESULTS: Baseline characteristics were comparable between women who received misoprostol (n = 163) and women who underwent surgical aspiration (n = 122). Women who received misoprostol had a higher rate of interventions for retained products of conception (11.0% versus 3.3%, respectively; P = 0.015). The misoprostol and the surgical aspiration groups did not differ in rate of repeated miscarriages (17.8% versus 21.3%, respectively; P = 0.45), or pregnancy rate within 6 months (58.3% versus 50.0%, respectively; P = 0.16), 12 months (78.5% versus 78.7%, respectively; P = 0.97) and 24 months (92.0% versus 91.8%, respectively; P = 0.94). Live birth rate within 24 months was comparable (62.0% versus 58.2%, respectively; P = 0.52), as well as gestational age at birth (38.5 versus 38.6 weeks, respectively; P = 0.81) and birthweight (3295 versus 3161 g, respectively; P = 0.07). CONCLUSIONS: Long-term reproductive outcomes are comparable in women with EPL who are treated with either misoprostol or surgical aspiration. Our findings may help counselling patients facing EPL who have concerns about their future reproduction.

Enhancing patient mobility following cesarean-delivery - the efficacy of an improved postpartum protocol assessed with pedometers.

BACKGROUND: The incidence of thromboembolic complications is highest in the immediate postpartum period, especially following caesarean delivery (CD). Ambulation following CD is important in their prevention. We examined the effect of an educational protocol on patients' mobility following CD, with the use of digital step counters (pedometers). METHODS: Starting February 2018, we implemented an educational protocol at the maternity ward, which included nurses' tutoring and subsequent patients' education, regarding the importance of early ambulation. Following CD, ambulation was initiated 4 h following surgery (as compared to 6 h prior). Scheduled IV acetaminophen was administered at six-hour intervals for 48 h (as compared to only 24 h prior), while additional analgesics were given upon patient request. We compared maternal demographics, delivery and postpartum course between the pre-protocol group (n = 101) and the post-protocol group (n = 100). All patients were asked to wear pedometers for 48 h following the delivery to assess ambulation. RESULTS: Patients' demographics, surgical and post-partum course were non-significant between the groups, except for surgical length (48.5 ± 14.6 vs. 53.5 ± 15.3 min in the pre and post protocol groups, respectively, p = 0.02). The pre-protocol group was treated with more additional analgesics (p = 0.02). A higher number of steps was taken in the post-protocol group as compared to the pre-protocol group (4394 ± 2985 vs.3551 ± 2931, respectively p = 0.04). In a linear regression analysis in which the number of steps served as the dependent variable, this educational protocol was independently associated with a higher number of steps [coefficient 988 steps, 95% CI 137-1838, p = 0.02], as was smoking, after adjustment for surgical length, emergent surgery, maternal age and body mass index. CONCLUSION: An educational protocol which included earlier ambulation and regular interval pain control was associated with improved ambulation following CD.

Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial.

OBJECTIVE: To assess the effect of a personalized repeated feedback approach using digital step counters (pedometers) on mobility after cesarean delivery in high-risk patients. METHODS: This was a randomized controlled trial at a tertiary university hospital. Patients who underwent cesarean delivery and were defined as high risk for thromboembolic events were asked to wear a pedometer around their wrists postpartum for 48 hours. Patients were randomized to the feedback group, which received personalized feedback by the research staff regarding their mobility at three set timepoints, or the control group, which received standard care. The number of steps taken by patients was compared between the groups and served as the primary outcome. Secondary outcomes included patient reported pain, physical and mental recovery, and overall satisfaction. Sample size was predetermined to detect a 25% between-group difference in the primary outcome. RESULTS: From December 2018 to July 2019, 215 patients were recruited, randomized and completed follow-up-108 in the feedback group and 107 in the control group. Patients' demographics and intrapartum course were similar between the groups. The number of steps taken was significantly higher in the feedback group compared with the control group: 5,918±3,116 vs 4,161±2,532 steps, P<.001. Pain scores were similar between the groups, as was analgesic consumption. Patients in the feedback group reported a significantly easier physical and mental postpartum recovery and were significantly more satisfied with their delivery experience. Postpartum complications did not differ between the groups. CONCLUSION: In high-risk patients after cesarean delivery, mobility was improved by using a personalized feedback approach. Enhanced mobility was not associated with a higher rate of complications or pain and was positively associated with patient satisfaction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03724760.

Pregnancy outcomes in association with placental histopathology in pregnancies complicated by macrosomia in diabetic vs. non-diabetic women.

OBJECTIVE: We aimed to compare pregnancy outcomes in association with placental pathology in pregnancies complicated by macrosomia in diabetic vs. non-diabetic women. STUDY DESIGN: Pregnancies complicated by macrosomia (≥4000gr) were included. Pregnancy and delivery characteristics, neonatal outcomes and placental histopathology reports were compared between macrosomia in diabetic [pre-gestational or Gestational Diabetes Mellitus (GDM)] women (diabetic-macrosomia group) vs. non-diabetic women (non-diabetic macrosomia group). Adverse neonatal outcome was defined as ≥1 neonatal complications. Multivariate analysis was used to identify independent associations with adverse neonatal outcome. RESULTS: The diabetic macrosomia group (n = 160) was characterized by higher maternal age (p = 0.002), Body Mass Index (BMI) (p < 0.001), and smoking (p = 0.03), and lower gestational age at delivery (p = 0.001). The diabetic-macrosomia group had higher rates of scheduled Cesarean deliveries (CDs) (58.9 % vs23.7 %,p < 0.001) while the non-diabetic macrosomia group (n = 214) had higher rates of emergent CDs (76.3 % vs.40.7 %,p < 0.001), perineal tears (p = 0.027) and Post Partum Hemorrhage (PPH) (p = 0.006). Placentas from the non-diabetic macrosomia group were characterized by higher rates of maternal and fetal inflammatory response lesions (p < 0.001). Except for higher jaundice rate in the diabetic macrosomia group (p < 0.001), none of the other neonatal outcomes including shoulder dystocia differed between the groups. In multivariate analysis GA < 37 weeks (aOR = 1.4,95 %,CI-1.2-3.9), and emergent CDs (aOR = 1.7,95 %,CI-1.4-4.1) but not diabetes (aOR = 1.1,95 %,CI-0.7-3.9) were associated with adverse neonatal outcome. CONCLUSIONS: Despite major differences in maternal demographics, mode of delivery, maternal morbidity, and placental characteristics- adverse neonatal outcome did not differ between macrosomia in diabetic vs. non-diabetic women and was high in both groups. Clinicians should be aware of the high rate of adverse neonatal outcome in macrosomic fetuses, even in the absence of diabetes mellitus.

Mobility following cesarean delivery: an observational study utilizing pedometers.

Introduction: Thromboembolic events are a leading cause of maternal death, and peak in the postpartum period. We aimed to assess immediate patient mobility following cesarean delivery (CD) with digital step counters (pedometers), and to characterize factors associated with reduced mobility.Materials and methods: This was a prospective observational study at the maternity unit of the Edith Wolfson Medical Center between June 2017 and February 2018. Patients who underwent a cesarean - primary and repeat, and emergent and nonemergent - were asked to wear pedometers for 48 h following cesarean. Comparison of maternal characteristics, surgical, and postpartum course was performed between three groups: high mobility patients (n = 33), intermediate mobility patients (n = 34), and low mobility patients (n = 34), according to the upper third of steps recorded, intermediate third, and the lower third, respectively.Results: The average number of steps taken during the first 48 h following delivery was 6974 ± 2582, 2724 ± 732, and 1056 ± 454 in the high, intermediate, and low mobility groups, respectively, p < .001. Patients' demographics, parity, intrapartum, and postpartum course were not found to be associated with patient mobility. However, smokers were found to walk an additional 1549 steps following CD as compared to nonsmokers.Conclusion: This study failed to identify risk factors for reduced mobility in the immediate postpartum period, but an increased mobility was noted in smokers, most probably related to the need to ambulate outside the maternity ward. The decision to treat patients following a cesarean with thromboprophlaxis will continue to be based on previously identified risk factors.

Pregnancy outcomes in correlation with placental histopathology in subsequent pregnancies complicated by preeclampsia.

OBJECTIVE: In attempt to deepen our understanding of the etiopathogenesis of preeclampsia we aimed to study the placental component and pregnancy outcomes in two consecutive pregnancies complicated by preeclampsia in the same patient. STUDY DESIGN: Pregnancy and placental reports of all pregnancies complicated by preeclampsia between 2008 and 2018 were reviewed. Included were only cases with recurrent preeclampsia in two consecutive pregnancies Neonatal outcomes and placental histopathology were compared between the first preeclampsia delivery (first preeclampsia group) and the subsequent preeclampsia delivery (subsequent preeclampsia group), thus each subject served as her own control in two consecutive pregnancies. Placental lesions were classified according to the current "Amsterdam" criteria. Adverse neonatal outcome was defined as ≥1 early neonatal complication. RESULTS: Included in the study a total of 83 cases with recurrent preeclampsia. The first preeclampsia group delivered at an earlier gestational age (35.7 ±â€¯3.7 vs. 36.8 ±â€¯3.1 weeks, p = 0.03) and had higher rates of severe features (44.6% vs. 25.3%, p = 0.03), placental weight <10th percentile (44.5% vs. 26.5%, p = 0.02), maternal vascular malperfusion (MVM) lesions (84.3% vs. 62.6%, p = 0.002), SGA (44.5% vs. 33.7%, p = 0.03), and adverse neonatal outcome (55.4% vs. 34.9%,p = 0.01), compared to the subsequent preeclampsia group. Using multivariate logistic regression analysis, severe features (aOR = 1.36, 95%CI = 1.12-2.36), MVM lesions (aOR = 1.12, 95%CI = 1.04-1.87) and adverse neonatal outcome (aOR = 1.26 95%CI = 1.14-2.23) were found to be independently associated with the first preeclampsia group. CONCLUSION: The first event of preeclampsia is characterized by an earlier, more severe presentation, as well as a higher rate of MVM lesions, SGA, and adverse neonatal outcome, compared to preeclampsia in a subsequent pregnancy.

Pregnancy outcomes in correlation with placental histopathology in subsequent pregnancies complicated by fetal growth restriction.

OBJECTIVE: In attempt to shed new light on the etiopathogenesis of fetal growth restriction (FGR) we aimed to compare pregnancy outcomes and placental histopathology in cases of first vs. subsequent FGR occurrence. STUDY DESIGN: Pregnancy and placental reports of FGR pregnancies (defined by birth weight <10th percentile), born between 2008 and 2018 were reviewed. Included only cases with recurrent FGR, in two consecutive pregnancies, thus each subject served as her own control in two FGRs consecutive pregnancies. Neonatal outcome and placental histopathology were compared between the first FGR delivery (first FGR group) and the subsequent FGR delivery (subsequent FGR group). Composite adverse neonatal outcome was defined as one or more early neonatal complications. RESULTS: Included in the study a total of 96 cases with recurrence of FGR pregnancies. Placentas from the first FGR group were characterized by higher rate of maternal vascular malperfusion (MVM) lesions as compared with the subsequent FGR group (71.8% versus 55.2%, respectively, p = 0 .02). Adverse neonatal outcome was more prevalent in the first FGR group as compared to the recurrent FGR group (41.6% versus 25%, respectively, p = 0.02). After controlling for confounders, using multivariate regression analysis, placental MVM lesions (aOR = 1.36, 95% CI = 1.12-1.45) and composite adverse neonatal outcome (aOR = 1.18 95% CI = 1.09-1.55) were found to be independently associated with the first FGR group. CONCLUSION: First event of FGR is associated with a higher rate of placental MVM lesions and adverse neonatal outcome as compared to FGR in subsequent pregnancies.

Early versus delayed follow-up after misoprostol treatment for early pregnancy loss.

RESEARCH QUESTION: Does extending the follow-up after misoprostol treatment for early pregnancy loss increase the success rate? DESIGN: Patients who had experienced early pregnancy loss (<12 weeks) and were treated with misoprostol in a single university-affiliated medical centre were prospectively followed before and after the implementation of a new treatment protocol extending the follow-up from 1 to 2 weeks. All patients received misoprostol 800 µg vaginally on day 1 and a second dose, when needed, on day 4 or 8. Patients underwent surgical aspiration after 1 week in the early follow-up group (n = 84) or 2 weeks in the delayed follow-up group (n = 85) if complete expulsion was not achieved (defined as endometrial thickness ≤15 mm and absence of gestational sac on transvaginal sonography). The primary outcome was treatment success, defined as no need for surgical aspiration. RESULTS: Women in the delayed follow-up group had a higher rate of successful treatment compared with women in the early follow-up group (88.2% versus 76.2%, respectively; P = 0.040), and a lower rate of second dose administration (32.9% versus 51.2%, respectively; P = 0.016). The incidence of non-expulsion of the gestational sac was also lower in the delayed follow-up group (1.2% versus 10.7%; P = 0.009). Treatment acceptability did not differ between the study groups. CONCLUSION: In women with early pregnancy loss treated with misoprostol, extending the follow-up protocol from 1 to 2 weeks resulted in an increase in treatment success.

Prediction of readmissions and mortality in patients with heart failure: lessons from the IMPEDANCE-HF extended trial.

AIMS: Readmissions for heart failure (HF) are a major burden. We aimed to assess whether the extent of improvement in pulmonary fluid content (ΔPC) during HF hospitalization evaluated by lung impedance (LI), or indirectly by other clinical and laboratory parameters, predicts readmissions. METHODS AND RESULTS: The present study is based on pre-defined secondary analysis of the IMPEDANCE-HF extended trial comprising 266 HF patients at New York Heart Association Class II-IV and left ventricular ejection fraction ≤ 35% randomized to LI-guided or conventional therapy during long-term follow-up. Lung impedance-guided patients were followed for 58 ± 36 months and the control patients for 46 ± 34 months (P < 0.01) accounting for 253 and 478 HF hospitalizations, respectively (P < 0.01). Lung impedance, N-terminal pro-brain natriuretic peptide, weight, radiological score, New York Heart Association class, lung rales, leg oedema, or jugular venous pressure were measured at admission and discharge on each hospitalization in both groups with the difference defined as ΔPC. Average LI-assessed ΔPC was 12.1% vs. 9.2%, and time to HF readmission was 659 vs. 306 days in the LI-guided and control groups, respectively (P < 0.01). Lung impedance-based ΔPC predicted 30 and 90 day HF readmission better than ΔPC assessed by the other variables (P < 0.01). The readmission rate for HF was lower if ΔPC > median compared with ΔPC ≤ median for all parameters evaluated in both study groups with the most pronounced difference predicted by LI (P < 0.01). Net reclassification improvement analysis showed that adding LI to the traditional clinical and laboratory parameters improved the predictive power significantly. CONCLUSIONS: The extent of ΔPC improvement, primarily the LI based, during HF-hospitalization, and study group allocation strongly predicted readmission and event-free survival time.

Non-Invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic Heart Failure Patients: A Randomized Controlled Trial (IMPEDANCE-HF Trial).

BACKGROUND: Previous investigations have suggested that lung impedance (LI)-guided treatment reduces hospitalizations for acute heart failure (AHF). A single-blind 2-center trial was performed to evaluate this hypothesis (ClinicalTrials.gov-NCT01315223). METHODS: The study population included 256 patients from 2 medical centers with chronic heart failure and left ventricular ejection fraction ≤35% in New York Heart Association class II-IV, who were admitted for AHF within 12 months before recruitment. Patients were randomized to a control group treated by clinical assessment and a monitored group whose therapy was also assisted by LI, and followed for at least 12 months. Noninvasive LI measurements were performed with a new high-sensitivity device. Patients, blinded to their assignment group, were scheduled for monthly visits in the outpatient clinics. The primary efficacy endpoint was AHF hospitalizations; the secondary endpoints were all-cause hospitalizations and mortality. RESULTS: There were 67 vs 158 AHF hospitalizations during the first year (P < .001) and 211 vs 386 AHF hospitalizations (P < .001) during the entire follow-up among the monitored patients (48 ± 32 months) and control patients (39 ± 26 months, P = .01), respectively. During the follow-up, there were 42 and 59 deaths (hazard ratio 0.52, 95% confidence interval 0.35-0.78, P = .002) with 13 and 31 of them resulting from heart failure (hazard ratio 0.30, 95% confidence interval 0.15-0.58 P < .001) in the monitored and control groups, respectively. The incidence of noncardiovascular death was similar. CONCLUSION: Our results seem to validate the concept that LI-guided preemptive treatment of chronic heart failure patients reduces hospitalizations for AHF as well as the incidence of heart failure, cardiovascular, and all-cause mortality.