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.

Massive air embolism resulting in ischemic stroke after left ventricular assist device implantation.

We present the first case of ischemic stroke secondary to massive air embolus during implantation of a left ventricular assist device (LVAD). The patient experienced a suction event at the time of aortic cannula removal. Despite the use of all standard deairing techniques and flooding the operative field with continuous-flow carbon dioxide, a significant amount of air was delivered into the ascending aorta through the LVAD pump.

Use of the Heartmate 3 for biventricular support as a bridge to heart transplant-first US implant.

Right ventricular failure continues to be the Achilles heel in the management of heart failure patients. Traditionally, either high doses of inotropes and inhaled nitric oxide or jerry-rigged temporary mechanical devices have been used to support failing right ventricles. No durable implantable right ventricular assist device has been developed to address this long-standing concern. Because of this vacuum of innovation, surgeons have started using the third-generation LVADs to support the right ventricle. The HeartMate 3 (Abbott) LVAD is a safe and effective therapy for the management of biventricular failure.

First pediatric HeartMate 3 implantation: US experience.

Children with heart failure have few mechanical circulatory support options and have a high incidence of embolic events. The favorable hemocompatibility and smaller profile of HeartMate 3 may provide more long-term options for the pediatric population.

Posttreatment FDG-PET/CT Hopkins criteria predict locoregional recurrence after definitive radiotherapy for oropharyngeal squamous cell carcinoma.

BACKGROUND: Metabolic response assessment for oropharyngeal squamous cell carcinoma (OPSCC) aids in identifying locoregional persistence/recurrence (LRR). The Hopkins Criteria are a standardized qualitative response assessment system using posttreatment FDG-PET/CT. METHODS: We conducted a retrospective cohort study of patients with node-positive OPSCC treated with definitive (chemo)radiotherapy. We assessed Hopkins Criteria performance for LRR, then developed and validated a competing-risks model. RESULTS: Between 2004 and 2018, 259 patients were included with median follow-up of 43 months. The Hopkins Criteria sensitivity, specificity, negative predictive value, and accuracy were 68%, 88%, 95%, and 85%. The 36-month cumulative incidence of LRR was greater with positive scores (45% vs. 5%, HR 12.60, p < 0.001). PET/CTs performed ≤10 weeks after radiotherapy were associated with a four-fold increase in pathologically negative biopsies/surgeries (36% vs. 9%, p = 0.03). The AUC for LRR was 0.89 using a model integrating the Hopkins score. CONCLUSIONS: The Hopkins Criteria predict LRR with high accuracy for OPSCC response assessment.

An Evaluation of Socio-Demographic and Risk Factor Profile in End-Stage Renal Disease Patients: A Cross-Sectional Assessment.

Background The global incidence and prevalence of chronic kidney disease (CKD) is skyrocketing. In Asia, the prevalence of CKD varies from 10%-18%. However, as Asia is largely populated by developing countries with nascent health care systems, there is a dearth of research and data. It is estimated that a large number of cases go unreported. As a result, the exact disease burden remains unclear. The knowledge about risk factors and their proportionate role in CKD is indispensable in regards to patient management and care.  Objective The early recognition of the most important risk factors for end-stage renal disease (ESRD) is key to early diagnosis, successful treatment, and general heightened awareness regarding CKD. In developing countries, the provision of medical services, in general, and nephrological services, in particular, is wholly inadequate. The insufficiency of solid and regularly updated data compounds the problem. This research study aims to partake in catering to that need. Methodology A structured questionnaire was used to obtain quantitative and categorical data from 119 ESRD patients in the nephrology ward, Allied Hospital, Faisalabad through non-probability sampling. Socio-demographic profile of the patients and information regarding the presence or absence of risk factors were collected. The resulting dataset was analyzed using R version 3.6.3 (R Foundation for Statistical Computing, Vienna, Austria) for data visualization and descriptive analysis. Results The most common age group for ESRD presentation was 46-60 years (52.1%). Among the 119 ESRD patients, the most frequent risk factor was hypertension with 85.7% of the patients presenting with the condition, followed by diabetes mellitus (DM) in 54.6%, renal calculi in 28.6%, glomerulonephritis (GN) in 31.1%, Family history of CKD in 24.4%, and polycystic kidney disease (PKD) in 5% of the patients. Gender-wise distribution of the patients shows that the proportion of patients with hypertension, renal calculi, and family history of CKD varied very little among the two groups. Conclusion In conclusion, our study has reinforced the existing body of knowledge and brought some fresh evidence regarding the prevalence of risk factors in ESRD to light. Hypertension and DM, together, represent the vast majority of cases with ESRD. However, hypertension far outpaces DM as the leading risk factor. Nephrolithiasis was also present in a considerable minority, with a figure much higher than previously reported. Finally, a relatively younger age group (45-60 years) formed the majority of the ESRD patients which is a concerning development. It points to early progression of CKD to ESRD. Long-term adequate control of these risk factors limits disease progression.

Preoperative Vitamin K Reduces Blood Transfusions at Time of Left Ventricular Assist Device Implant.

BACKGROUND: Congestive heart failure patients have hepatic congestion and abnormal coagulation profiles, increasing perioperative bleeding at time of ventricular assist device implantation. This study examined the impact of the preoperative administration of vitamin K on perioperative blood transfusion requirements. METHODS: Retrospectively, 190 patients met inclusion criteria. Patients received no vitamin K (n = 62) or two 10-mg doses of intravenous vitamin K (n = 128) in the 24 hours before assist device implantation. Primary end points included transfusion requirements and reexploration rates for bleeding. Secondary outcomes were pump thrombosis and in-hospital mortality. RESULTS: Baseline characteristics were similar between the 2 groups, with slight differences (not statistically significant) noted in the Interagency Registry for Mechanically Assisted Circulatory Support profile and total bilirubin levels. The only significant difference noted was the year of implantation (P < .001). Blood product usage was significantly lower in the vitamin K group compared to the no vitamin K group (P < .001). Higher rates of reexploration for bleeding (29.7% vs 13.6%, P = .023) and death at hospital discharge (16.2% vs 2.8%, P = .004) were noted for the no vitamin K group compared with the vitamin K group. After adjusting for age, sex, race, body mass index, Interagency Registry for Mechanically Assisted Circulatory Support profile, total bilirubin, surgeon, and year of operation, reexploration rates and death did not achieve statistical significance. No statistically significant difference was observed in stroke and pump thrombosis rates between the 2 groups. CONCLUSIONS: Preoperative vitamin K administration may help reduce blood product use without any increased risk for strokes or pump thrombosis.

Clinical and Etiological Spectrum of Hypokalemic Periodic Paralysis in a Tertiary Care Hospital in Pakistan.

Introduction Hypokalemic periodic paralysis (HPP) is characterized by muscle weakness secondary to low serum potassium levels. It may be primary in origin or there may be secondary causes like thyrotoxic periodic paralysis, renal or suprarenal causes, or non-renal causes like gastroenteritis. Aim To study the etiology, clinical manifestations, and outcome after therapy of patients with hypokalemic paralysis. Methodology The study was conducted from January 2016 to December 2016. Patients fulfilling the diagnostic criteria for hypokalemic paralysis, i.e., flaccid muscle weakness involving two or more limb muscles due to serum potassium < 3.5 mmol/L and with no objective sensory signs were included in the study. Relevant investigations were done. Those with other causes of flaccid weakness or on diuretic therapy were excluded from the study. Data was analyzed using SPSS Version 20.0 (IBM Corp., Armonk, NY). Results In our study, 14 patients out of a total of 18 (14/18, i.e., 77.78%) were male and 4/18 (22.22%) were female [Male: Female ratio: 3.5:1]. The mean age of onset of HPP in males (29.5±10.14 yrs.) was lesser than that of females (41±10.8 yrs.), but this difference was statistically not significant (p<0.066). In the entire sample there were 15/18 cases (83.33%) of primary and 3/18 (16.67%) cases of secondary HPP [2/3 had thyrotoxic periodic paralysis and 1/3 had gastroenteritis]. Furthermore, 12/18 patients (66.66%) had symmetrical weakness (five cases of paraparesis and all were male; seven cases of quadriparesis: six males and one female) and 6/18 (33.33%) had asymmetrical weakness (two paraparesis: one male, one female; four quadriparesis: two males, two females). Statistically, no significant difference (p<0.709) was seen in those with symmetrical versus those with asymmetrical weakness. In this study 7/18 (38.89%) cases had absent, 1/18 (5.55%) had diminished, and 10/18 (55.55%) cases had intact deep tendon reflexes. None of the cases had cranial, bulbar, or respiratory involvement. The mean serum potassium of sample was 3.18±0.5 standard deviation (SD). The reduction in serum potassium was moderate (2.5-3.5 mmol/L) in primary and severe (<2.5 mmol/L) in secondary HPP. Those with quadriparesis had severe hypokalemia with a mean serum potassium of 2.1 mmol/L. Only 3/18 patients had concomitant magnesium deficiency. Patients given intravenous potassium replacement (except one with moderate hypokalemia and given oral replacement) recovered dramatically. The mean recovery time was 38.6±20.3 hours. The recovery time in quadriparesis was about 24 hours and in paraparesis was 12 hours. Only one patient with thyrotoxic periodic paralysis (TPP) and with severe serum potassium deficiency (0.9 meq/L) died due to cardiac arrhythmia. No atypical presentation was seen. Conclusion HPP has male preponderance. The age of onset of HPP is earlier in males than in females. Moreover, males are more prone to have symmetrical weakness. Asymmetrical weakness has almost an equal gender distribution. Primary hypokalemic paralysis is more frequent than secondary. Thyrotoxic periodic paralysis is the commonest cause of secondary periodic paralysis. The recovery time in quadriparesis is almost double the recovery time in paraparesis. Respiratory involvement is rare. HPP is an important differential in the diagnosis of acute flaccid muscle weakness. It should be promptly addressed to prevent recurrence of paralysis.

Right Heart Failure in Different Left Ventricular Assist Devices: Single-Center Experience.

Background: Right heart failure (RHF) following left ventricular assist device (LVAD) implantation increases morbidity and mortality for those who develop this complication. The purpose of this study was to assess the differences in incidence of RHF and outcomes between 2 types of continuous-flow LVADs at a single center. Methods: From January 2012 through June 2016, 184 patients were implanted with a continuous-flow LVAD (161 patients with the HeartMate II and 23 patients with the HeartWare device) either as a bridge to transplant or as destination therapy. Preoperative demographics, medical history, laboratory values, hemodynamics, and device type were analyzed to determine the variables associated with RHF and mortality. Results: Preoperative variables between the 2 groups were homogeneous. Most patients were Interagency Registry for Mechanically Assisted Circulatory Support profile 1 or 2 (92%) and New York Heart Association class IV (81%). More patients in the HeartMate II group had the indication of destination therapy (54% vs 30%), while more patients in the HeartWare group were implanted as bridge to transplant (70% vs 46%). RHF occurred in 57% of HeartWare patients compared to 16% of patients who received the HeartMate II (P=0.0001). After propensity score analysis, patients receiving the HeartWare device had increased odds for RHF (P=0.0013) and renal failure requiring dialysis (P=0.0135). The HeartMate II patient survival rate exceeded the HeartWare patient survival rate at 1 year (82.1% vs 67.2%) and at 2 years (74.6% vs 61.7%), but this difference did not achieve statistical significance (log-rank P=0.087). Conclusion: These results indicate that device type may affect RHF incidence and mortality. Studies at other centers are needed to replicate these findings.

A Public Health Analysis on Gaps in Disease Monitoring and Opportunities for Improved Care for the Management of Hepatitis B and C.

Hepatitis B and Hepatitis C have been major disease-causing agents among humans since they were discovered in the 1960s. Both cause jaundice-like symptoms initially but their prognosis and treatment are somehow different and depend upon many demographic details, such as the age and susceptibility of the patients and any other comorbid conditions. They clinically present primarily with hepatitis and can have many adverse effects or even be life-threatening at times, if not treated properly. However, their epidemiological background and findings in terms of morbidity, mortality, and case fatality rates are different. The disease burden, impact on the healthcare system, and prevention of the two diseases are quite different. The treatment and management options along with the prevention and control measures share unique strategies for handling the two diseases. The purpose of this review is to highlight the gaps in disease monitoring and to find ways and opportunities that can lead to improved care and better management of Hepatitis B and C locally and globally. Online databases were searched and peer-reviewed articles were selected. Key issues identified were lack of education globally in resource-limited settings, leading to a decreased understanding of the potential hazards associated with needle sharing and lack of access to healthcare because of a lack of insurance. The failure of compliance with vaccination leads to an increase in mother-to-child transmission (MTCT)-related infections. Increased global travel demands a systematic program in most immigrant-receiving countries to screen for hepatitis B virus (HBV)/hepatitis c virus (HCV) infections. Delayed U.S. Food and Drug Administration (FDA) licensing for new drugs hampers the treatment of chronic Hepatitis-B (CHB) among children. With the advancement in science, an effective vaccine against HCV will definitely help in eradicating the infection.

Prevention of Congenital Syphilis Through Antenatal Screenings in Lusaka, Zambia: A Systematic Review.

Congenital syphilis is one of the preventable diseases caused by the gram-negative bacteria Treponema pallidum; yet, it imposes a serious global health and economic burden, with more than half of the cases resulting in serious adverse outcomes, including infant mortality. Mother-to-child transmission (MTCT) of syphilis is estimated at 3.6 million adjusted life years (DALYs) and around $309 million in medical costs. In 2006, an estimated 9.7 million children of age less than five years died in developing countries; almost four million were neonatal deaths. There were 3.2 million stillbirths globally, among whom 95% were in the developing countries. In sub-Saharan Africa, there is an estimated 2.7% (0.1%-10.3%) of pregnant women infected with syphilis, representing more than 900,000 pregnancies at risk each year. There were many non-specific and specific diagnostic tests used in the past, which required laboratory equipment and electricity, but there are many newer tests available now that provide rapid results with high sensitivity and specificity, e.g., the immunochromatographic strip (ICS) and rapid syphilis tests (RST). Early syphilis can be completely eliminated with a single injection of penicillin, which is readily available, cheap, and highly effective, and treating pregnant women with penicillin is 98% effective at preventing congenital syphilis. Targeting women at a high risk of having syphilis makes universal screening in antenatal programs the most efficacious way to prevent syphilis-associated morbidity and mortality. The potential for a program to prevent congenital syphilis in the perinatal, neonatal, and postnatal periods is evident. While considering resource allocation to child survival programs in areas where the prevalence of syphilis is high, officials need to include antenatal syphilis screening, using rapid tests and treatment at the first contact of the mother with the health care system. In countries like Zambia and other resource-limited settings, a same-day test and treatment with penicillin should be prioritized to achieve the goal of eliminating congenital syphilis. Eliminating MTCT of syphilis through screening and treatment in antenatal care (ANC) is highly cost-effective in a wide range of settings, especially in countries with a high prevalence.

Safety of Electro-Medical Equipment in Floods in Austere Environment.

Pakistan is prone to floods. In 2010, floods in North-Western Pakistan caused devastation in wide areas. Electro-medical equipment is very expensive and without proper equipment adequate surgery is not possible. We retrospectively analyzed how expensive electro-medical equipment got damaged during floods of 2010 at a district-level hospital in North-Western Pakistan and how we could have saved this equipment or reduced the damage to the minimum. The article provides the lessons learned and recommendations aimed to prevent or minimize damage to the valuable and expensive equipment in the areas prone to floods. (Disaster Med Public Health Preparedness. 2018;12:803-805).

A Meta-analysis of the Association Between Needle Exchange Programs and HIV Seroconversion Among Injection Drug Users.

We assessed the association between different levels of needle exchange program (NEP) use and human immunodeficiency virus (HIV) seroconversion in the injecting drug user (IDU) population using meta-analysis to aggregate risk estimates from any reported cohort studies or randomized controlled trials (RCTs) in the literature. We searched the literature for articles published from January 1990 to August 2014 using Medical Subject Headings and other terms from MEDLINE® (using Ovid), Embase, ProQuest, the International Aids Society Abstract database, and the European AIDS clinical society database, and the European Conferences Abstract Archive. Articles were included if data were reported from an original study; the study was a prospective cohort or RCT design; estimates for seroconversion (hazard ratios [HRs]) for drug-users with different levels of NEP-use, as well as variance data, or the information to calculate these were reported; risk estimates were adjusted for unstable housing, risky sexual behaviors, frequency of injections, cocaine use, and risky needle sharing practices; and the study was published between January 1990 and August 2014. Information abstracted was general study information (i.e., study name, authors, publication year, study site, sample size, length of follow-up, and follow-up intervals, incentives to IDUs for improving compliance/enrollment), outcomes variable measures (seroconversion HR estimates, variance figures, and factors adjusted for), description of the study population (inclusion and exclusion criteria and definitions of comparison groups), type of intervention (NEP program), statistical methods used, and sub-group information. Two prospective cohort studies with a total of 3,172 IDUs were eligible for inclusion. Comparison groups had different levels of NEP-use (e.g., daily use vs. non-daily use and NEP-users vs. non-users) from fixed-site NEPs. Our Q-statistic was insignificant with a p-value of 0.401 while the I2 value was 0.0%. A random-effects model was used to aggregate the estimates, and we found an overall significant positive association between NEP-use and HIV seroconversion with an HR estimate of 1.59 (95% confidence interval [CI]: 1.2 to 2.1). According to our results, higher usage of NEPs is associated with a higher risk of HIV seroconversion in the IDU population. The observed association aligns with previous findings of NEP programs being inadequate for HIV control in IDUs. Further research on the topic needs to be done including studies on different NEP designs and how they can be made more effective by combining with other strategies, including the study of IDU characteristics which make them more likely to use safe syringes when they inject.

The Effect of Thiazide Diuretics on Blood Lipid Profile in Hypertensive Adults: A Meta-analysis of Randomized Controlled Trials.

This study explores the effect of diuretics use on metabolic markers (i.e., the lipid profile) since thiazide diuretics are extensively used to treat cardiac patients with hypertension (HTN) and other comorbidities. The Embase and PubMed databases were searched for relevant English-language peer-reviewed articles. Different search terms and medical subject headings (MesH) terms were used to find the relevant articles. Our study included randomized controlled trials with hypertensive adult patients in the intervention group receiving thiazide diuretics; controls receiving any other diuretic or any other intervention for HTN where an intention to treat analysis was performed. We collected the demographic details, baseline lipid profile values, and end-of-study lipid profile values of all the participants in the studies along with the standard deviation of each value to calculate the net change effect. Five studies were included. We used the Q-test and I2 index for heterogeneity and the inverse variance method for weighting. We used the fixed effects model for total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) because TC and LDL-C had no heterogeneity (I2 was 0%). We used a random-effects model for triglycerides (TG) and high-density lipoprotein cholesterol (HDL-C), which showed moderate heterogeneity (I2 was 57.2% and 59.5%, respectively). We used the Cochrane quality assessment to assess the quality level of the included studies. We used a funnel plot to avoid publication bias. Diuretics have a significant effect on lipid profiles. However, because this conclusion is supported by a low number of studies, further research is needed, and physicians are advised to use their best clinical judgment until the relationship between diuretics and lipid profiles seen in this study can be further supported by additional studies.

Managing Postural Hypotension in Diabetic Autonomic Dysfunction When Adrenergic Drugs are Contraindicated: Case Report and Review of Literature.

Postural hypotension, as a manifestation of autonomic neuropathy is a very sinister long-term debilitating complication of diabetes, is usually irreversible and tough to manage with medications. The treatment of this condition following the standard treatment protocols can be contraindicated in the patients with underlying heart conditions. We report the case of a patient at our hospital who presented with full-blown symptomatic dysautonomia secondary to long-standing diabetes, with bedside testing positive for autonomic dysfunction. Treating this patient with the standard protocol of adrenergic agonist could have worsened his underlying coronary artery disease. So, we moved a step aside to go out of the box and we have a trial of the ß1-selective beta-blocker, with astonishing results and significant improvement in the quality of life and symptoms of postural hypotension. We report here the use of alternative treatment option in managing a patient with severe postural hypotension secondary to diabetes-related autonomic neuropathy when adrenergic drugs are contraindicated.