Percutaneous Mechanical Circulatory Support Devices for High-Risk Percutaneous Coronary Intervention

Purpose of Review

Percutaneous mechanical circulatory support devices (PMCSD) consist of the intra-aortic balloon pump (IABP), Impella (Abiomed Inc., Danvers, Massachusetts), Tandem Heart (Cardiac Assist, Inc., Pittsburgh, Pennsylvania), or extracorporeal membranous oxygenation (ECMO). They augment cardiac output, cardiac index, and cardiac power which allow the operator to mitigate hemodynamic perturbations during high-risk percutaneous coronary intervention (HR-PCI). This review discusses PMCSD and their contemporary literature.

Recent Findings

Recent literature has substantiated the hemodynamic benefits of PMCSD in HR-PCI and cardiogenic shock, but no mortality benefit was found.

Summary

As stent technology improves, PCI is expanding into high-risk cases in which PMCSD provide hemodynamic support allowing safe and complete revascularization.

     

The Role of Impella for Hemodynamic Support in Patients With Aortic Stenosis

Purpose of review

The goal of this review is to discuss the effects of Impella (Abiomed, Danvers, MA), to support in the hemodynamics of patients with severe aortic stenosis, and to explore the clinical scenarios in which the use of Impella may be beneficial in this setting.

Recent findings

The management of patients with severe aortic stenosis who go on to develop left ventricular failure and cardiogenic shock remains an important clinical challenge associated with increased morbidity and mortality.

Summary

Once considered a relative contraindication, the use of Impella in severe aortic stenosis has now been proven feasible and demonstrated promising results in selected high-risk patients. The use of Impella to provide hemodynamic support maybe considered in patients with aortic stenosis in cardiogenic shock or those with severe left ventricular dysfunction and CAD who require high-risk PCI and or balloon aortic valvuloplasty. Impella is also an attractive option in selected cases of hemodynamic collapse during TAVR.

     

Extrakorporale Membranoxygenierung beim akuten Lungenversagen

Background

Extracorporeal membrane oxygenation (ECMO) is a life-saving technique for patients with acute lung failure when the maximum use of conventional therapy is no longer sufficient.

Objectives

This article deals with the selection criteria, management and complications of ECMO therapy in acute lung failure. Special emphasis is placed on the causes of lung failure and their prognostic value. The characteristic features of the different age groups from newborns to adults are compared and discussed.

Results

Besides acquired respiratory diseases as the classical ECMO indications, there is a shift towards congenital diaphragmatic hernia in newborns needing ECMO. In this aspect newborns therefore differ from all other age groups. In older children and adults, the causes leading to ECMO are similar with pneumonia as the main cause. Survival rates are still best in newborns and infants. Important negative prognostic factors are severe hypoxia prior to ECMO, long-lasting traumatic ventilation before ECMO and the presence of comorbidities. The most important complications mainly lead to neurological and respiratory disorders and special attention must be paid to these aspects in follow-up treatment.

Conclusion

The ECMO treatment is an established salvage therapy in acute lung injury in all age groups. Success rates vary depending on the age of patients and the causes of lung failure. Survival rates and quality are particularly dependent on the experience of the ECMO center. A close cooperation of the on-site medical team with the ECMO center is recommended in follow-up treatment.

     

Risk factors and predictors of mortality of candidaemia among critically ill patients: role of antifungal prophylaxis in its development and in selection of non-<Emphasis Type="Italic">albicans</Emphasis> species

Purpose

The aim of the present study is to identify risk factors for development and predictors of mortality of candidaemia among critically ill patients.

Methods

A 1:7 case–control study was conducted during a 4-year period (2012–2015) in a Greek Intensive Care Unit (ICU). Candidaemia was confirmed by positive blood cultures. All yeasts were identified using API 20C AUX System or Vitek 2 Advanced Expert System. Epidemiologic data were collected from the ICU computerized database and patients’ chart reviews.

Results

Fifty-three patients developed candidaemia with non-albicans species being the predominant ones (33 patients, 62.3%). Multivariate analysis found that prior emergency surgery, malignancy, hospitalization during summer months, prior septic shock by KPC-producing Klebsiella pneumoniae and number of antibiotics administered were independently associated with candidaemia, while, prior administration of azole was a protective factor. Non-albicans candidaemia was associated with number of antibiotics administered and prior administration of echinocandin. Mortality of 14 days was 28.3% (15 patients) and was associated with SOFA score upon infection onset and septic shock, while, appropriate empirical antifungal treatment was associated with better survival.

Conclusions

Prophylactic azole administration prevents development of candidaemia, while, echinocandin administration predisposes to non-albicans candidaemia. Empirical administration of an appropriate antifungal agent is associated with better survival.

     

Receipt of Cancer Screening Is a Predictor of Life Expectancy

Background

Obtaining cancer screening on patients with limited life expectancy has been proposed as a measure for low quality care for primary care physicians (PCPs). However, administrative data may underestimate life expectancy in patients who undergo screening.

Objective

To determine the association between receipt of screening mammography or PSA and overall survival.

Design

Retrospective cohort study from 1/1/1999 to 12/31/2012. Receipt of screening was assessed for 2001–2002 and survival from 1/1/2003 to 12/31/2012. Life expectancy was estimated as of 1/1/03 using a validated algorithm, and was compared to actual survival for men and women, stratified by receipt of cancer screening.

Participants

A 5 % sample of Medicare beneficiaries aged 69–90 years as of 1/1/2003 (n?=?906,723).

Interventions

Receipt of screening mammography in 2001–2002 for women, or a screening PSA test in 2002 for men.

Main Measures

Survival from 1/1/2003 through 12/31/2012.

Key Results

Subjects were stratified by life expectancy based on age and comorbidity. Within each stratum, the subjects with prior cancer screening had actual median survivals higher than those who were not screened, with differences ranging from 1.7 to 2.1 years for women and 0.9 to 1.1 years for men. In a Cox model, non-receipt of screening in women had an impact on survival (HR?=?1.52; 95 % CI?=?1.51, 1.54) similar in magnitude to a diagnosis of complicated diabetes or heart failure, and was comparable to uncomplicated diabetes or liver disease in men (HR?=?1.23; 1.22, 1.25).

Conclusions

Receipt of cancer screening is a powerful marker of health status that is not captured by comorbidity measures in administrative data. Because life expectancy algorithms using administrative data underestimate the life expectancy of patients who undergo screening, they can overestimate the problem of cancer screening in patients with limited life expectancy.

     

Aortic balloon valvuloplasty before transcatheter valve replacement in high-risk patients with aortic stenosis

Background

Balloon aortic valvuloplasty (BAV) has been revived as a bridge to transcatheter aortic valve replacement (TAVR). The aim of the current prospective study was to define a safe time period from BAV to TAVR and to determine hemodynamic variables that predict event-free survival after BAV.

Patients and methods

The present prospective study included 68 consecutive patients with severe aortic stenosis who were treated initially with BAV from 2009 to 2012. Echocardiographic and invasive hemodynamic assessments were performed before BAV. The patients were followed up at regular intervals and events were defined as cardiac hospitalization or death.

Results

Invasive hemodynamic evaluation yielded more favorable results than echocardiographic assessment: aortic stenosis was less severe, cardiac output was higher, and pulmonary capillary wedge pressure (PCWP) was lower. Post-BAV event-free survival was 80.4?% at 30 days, 64.5?% at 6 months, 37?% at 1 year, 22.3?% at 2 years, and 9.3?% at 3 years. After excluding pre-discharge deaths (n?=?7), the 30-day event-free survival rate was 90?%. Predictors of events after BAV were atrial fibrillation, cardiogenic shock, elevated euroSCORE (European System for Cardiac Operative Risk Evaluation), elevated PCWP, and elevated pulmonary artery systolic pressure. Invasively measured PCWP was the only independent predictor of events (hazard ratio, 1.07; 95?% confidence interval, 1.03–1.11; p?=?0.001).

Conclusion

A 30-day post-BAV period may be considered a bridge to TAVR. Furthermore, invasive assessment of PCWP before BAV is an independent hemodynamic predictor of events after BAV.

     

Cardiogenic Shock: Recent Developments and Significant Knowledge Gaps

Purpose of review

Patients with cardiogenic shock (CS) continue to have high rates of morbidity and mortality. We aimed to describe current principles in the management of CS including coronary revascularization, medical management, mechanical circulatory support, and supportive care.

Recent findings

Revascularization is still recommended, but trials have not found a benefit in the revascularization of nonculprit artery lesions. New mechanical circulatory support options are available, but optimal use remains uncertain. Overall improvement in outcomes appears to have plateaued.

Summary

There remain substantial knowledge gaps about the management of CS. The ideal timing and selection criteria for mechanical support remain under-developed. There has been little systematic study to inform medical management or supportive care of this patient population. A more expansive research focus is necessary to improve the care of CS.

     

Using additional pressure control lines when connecting a continuous renal replacement therapy device to an extracorporeal membrane oxygenation circuit

Background

The introduction of a continuous renal replacement therapy (CRRT) device into the extracorporeal membrane oxygenation (ECMO) circuit is widely used. However, excessive pressure transmitted to the CRRT device is a major disadvantage. We investigated the effects of using additional pressure control lines on the pressure and the lifespan of the CRRT circuit connected to the ECMO.

Methods

This is an observational study using prospectively collected data from consecutive patients receiving CRRT connected into the ECMO circuit at a university-affiliated, tertiary hospital from January 2013 to December 2016. The CRRT circuit was connected into the ECMO circuit through the Luer Lock connection without an additional pressure control line in 16 patients (9%, no line group), an additional pressure control line on the inlet line in 36 patients (23%, single line group), and additional pressure control lines on both the inlet and outlet lines in 118 patients (77%, double line group). The outcome measures of interest were compared among the three groups.

Results

The median access pressure was higher in the no line group compared to the groups. However, median filter pressure, effluent pressure, and return pressure were higher in the double line group compared to the other groups. There were no significant differences in platelets, lactate dehydrogenase, and plasma hemoglobin among the 3 groups over the time period studied. Median lifespan of the CRRT circuits in the double line group was 45.0 (29.0–63.7) hours, which was higher compared to 21.8 (11.6–31.8) hours in the no line group and 23.0 (15.0–34.6) hours in the single line group, respectively. In addition, in-hospital mortality was lower in the double line group (48.3%) compared to the no line group (68.8%) and the single line group (75.0%).

Conclusions

Additional tubing can be considered a simple and safe method for pressure control and lengthening circuit survival when connecting the CRRT device to the ECMO circuit.

     

Amiodarone Compared with Lidocaine for Out-Of-Hospital Cardiac Arrest with Refractory Ventricular Fibrillation on Hospital Arrival: a Nationwide Database Study

Purpose

The latest resuscitation guidelines recommend the use of amiodarone in adult patients with out-of-hospital cardiac arrest (OHCA) and refractory ventricular fibrillation (VF) to improve the rates of return of spontaneous circulation. However, there is limited evidence to suggest that amiodarone is superior to lidocaine with respect to survival at discharge. The purpose of the present study was to evaluate the hypothesis that amiodarone is superior to lidocaine with regard to the rate of survival to hospital discharge for OHCA patients with VF/pulseless VT (pVT) on hospital arrival.

Methods

Using the Japanese Diagnosis Procedure Combination inpatient database, we identified 3951 patients from 795 hospitals who experienced cardiogenic OHCA and had refractory ventricular fibrillation on hospital arrival between July 2007 and March 2013. The patients were categorized into amiodarone (n = 1743) and lidocaine (n = 2208) groups, from which 801 propensity score-matched pairs were generated.

Results

There was no significant difference in the rate of survival to hospital discharge between the amiodarone and lidocaine groups (15.2 % vs. 17.1 %; difference, ?1.9 %; 95 % CI, ?5.5 to 1.7) in propensity score-matched analyses. Cox regression analyses did not indicate significant in-hospital mortality differences between the amiodarone and lidocaine groups for the propensity score-matched groups (hazard ratio, 1.05; 95 % CI, 0.94 to 1.17).

Conclusions

The present nationwide study suggested that there was no significant difference in the rate of survival to hospital discharge between cardiogenic OHCA patients with persistent ventricular fibrillation on hospital arrival treated with amiodarone or lidocaine.

     

Cholangiozelluläres Karzinom

Background

At diagnosis, the majority of patients with cholangiocarcinoma (CCC) cannot be offered curative resection.

Objectives

The current state of knowledge concerning palliative treatment options (endoscopic interventions, selective internal radiotherapy, systemic chemotherapy) for CCC are summarized.

Materials and methods

A summary of key publications is presented and differential treatment considerations are discussed.

Results

The basis of palliative treatment is biliary decompression to avoid liver failure and infectious complications. In selected patients—without extrahepatic tumor spread—photodynamic therapy (PDT) and biliary radiofrequency ablation (RFA) offer prolonged overall survival. In patients with intrahepatic CCC or with hepatic metastases, selective internal radiotherapy is well tolerated and can offer marked survival benefit. Infrequently, downstaging to resectable disease stages can be achieved. Standard systemic palliative therapy of CCC combines gemcitabine with cisplatin or oxaliplatin. A number of targeted therapy approaches are under investigation.

Conclusion

Palliative therapy of CCC consists of biliary drainage with/without locoregional therapy and systemic chemotherapy. Multimodal approaches are promising, but to date are still insufficiently evaluated.

     

Tumor vasculogenic mimicry predicts poor prognosis in cancer patients: a meta-analysis

Background

Vasculogenic mimicry (VM) is the formation of vascular channels by tumor cells or tumor cell-derived, trans-differentiated cells in highly aggressive, solid tumors. However, the disease features and prognostic value of VM for overall survival of cancer patients remain controversial.

Method

To systematically investigate the roles of VM in cancer progression and its prognostic values, we performed a meta-analysis based on 36 studies (33 eligible articles) including 3609 patients. The pooled hazard ratios (HRs) with 95 % confidence intervals (95 % CIs) were used to assess the relationship between VM and overall survival in cancer patients.

Results

Vasculogenic mimicry was significantly associated with cancer differentiation, lymph node metastasis, distant metastasis, and TNM stage. The prognostic value of VM was significant in overall survival (HR 2.16; 95 % CI 1.98–2.38; P < 0.001). Analyses stratified by confounders, such as cancer type, ethnicity, VM detection methods, sample size, and Newcastle–Ottawa quality score, found similar significant results.

Conclusions

The presence of VM predicts poorer survival outcomes in cancer patients.

     

Identifying and Managing Hibernating Myocardium: What’s New and What Remains Unknown?

Purpose of Review

Hibernation is an important and reversible cause of myocardial dysfunction in ischaemic heart failure.

Recent Findings

Hibernation is an adaptive process that promotes myocyte survival over maintaining contractile function. It is innate to mammalian physiology, sharing features with physiological hibernation in other species. Advanced imaging methods have reasonable accuracy in identifying hibernating myocardium. Novel superior hybrid methods may provide diagnostic potential. New evidence supports the role of surgical revascularisation in ischaemic heart failure, but the role of viability tests in planning such procedures remains unclear. Research to date has exclusively involved patients with ambulatory heart failure: Investigating the role of hibernation in ADHF is a key avenue for the future.

Summary

Whilst our understanding of hibernation pathophysiology has improved dramatically, the clinical utility of identifying and targeting hibernation remains unclear.

     

Effects of a Video on Organ Donation Consent Among Primary Care Patients: A Randomized Controlled Trial

BACKGROUND

Low organ donation rates remain a major barrier to organ transplantation.

OBJECTIVE

We aimed to determine the effect of a video and patient cueing on organ donation consent among patients meeting with their primary care provider.

DESIGN

This was a randomized controlled trial between February 2013 and May 2014.

SETTING

The waiting rooms of 18 primary care clinics of a medical system in Cuyahoga County, Ohio.

PATIENTS

The study included 915 patients over 15.5 years of age who had not previously consented to organ donation.

INTERVENTIONS

Just prior to their clinical encounter, intervention patients (n?=?456) watched a 5-minute organ donation video on iPads and then choose a question regarding organ donation to ask their provider. Control patients (n?=?459) visited their provider per usual routine.

MAIN MEASURES

The primary outcome was the proportion of patients who consented for organ donation. Secondary outcomes included the proportion of patients who discussed organ donation with their provider and the proportion who were satisfied with the time spent with their provider during the clinical encounter.

KEY RESULTS

Intervention patients were more likely than control patients to consent to donate organs (22 % vs. 15 %, OR 1.50, 95%CI 1.10–2.13). Intervention patients were also more likely to have donation discussions with their provider (77 % vs. 18 %, OR 15.1, 95%CI 11.1–20.6). Intervention and control patients were similarly satisfied with the time they spent with their provider (83 % vs. 86 %, OR 0.87, 95%CI 0.61–1.25).

LIMITATION

How the observed increases in organ donation consent might translate into a greater organ supply is unclear.

CONCLUSION

Watching a brief video regarding organ donation and being cued to ask a primary care provider a question about donation resulted in more organ donation discussions and an increase in organ donation consent. Satisfaction with the time spent during the clinical encounter was not affected.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01697137

     

The clinicopathological significance of heat shock protein 70 and glutamine synthetase expression in hepatocellular carcinoma

Background/purpose

Heat shock protein 70 (HSP70) and glutamine synthetase (GS) have been proposed to be promising markers for the differentiation of malignant and benign hepatocellular lesions. The aim of this study was to investigate the clinicopathological significance of the expression of HSP70 and GS in surgically resected hepatocellular carcinoma (HCC).

Methods

The authors collected 412 HCC samples and 120 non-neoplastic hepatic tissue samples and performed an immunohistochemical study.

Results

HSP70 staining was observed in 282 of 392 HCC samples (71.9%), and GS immunoreactivity was observed in 212 of 395 HCC cases (53.7%). Of the several clinicopathological parameters examined, microscopic vascular invasion, a large tumor size, and a high Edmonson–Steiner grade were found to be correlated with positive staining for HSP70 (P = 0.032, 0.002, and 0.012, respectively). Survival analysis showed a correlation between HSP70 expression and disease-free survival. GS was not found to be related to clinicopathological parameters.

Conclusions

The findings of the present study suggest that HSP70 be viewed as a predictor of prognosis as well as a useful diagnostic marker for HCC.

     

Prediction Model for Two-Year Risk of Opioid Overdose Among Patients Prescribed Chronic Opioid Therapy

Background

Naloxone is a life-saving opioid antagonist. Chronic pain guidelines recommend that physicians co-prescribe naloxone to patients at high risk for opioid overdose. However, clinical tools to efficiently identify patients who could benefit from naloxone are lacking.

Objective

To develop and validate an overdose predictive model which could be used in primary care settings to assess the need for naloxone.

Design

Retrospective cohort.

Setting

Derivation site was an integrated health system in Colorado; validation site was a safety-net health system in Colorado.

Participants

We developed a predictive model in a cohort of 42,828 patients taking chronic opioid therapy and externally validated the model in 10,708 patients.

Main Measures

Potential predictors and outcomes (nonfatal pharmaceutical and heroin overdoses) were extracted from electronic health records. Fatal overdose outcomes were identified from state vital records. To match the approximate shelf-life of naloxone, we used Cox proportional hazards regression to model the 2-year risk of overdose. Calibration and discrimination were assessed.

Key Results

A five-variable predictive model showed good calibration and discrimination (bootstrap-corrected c-statistic?=?0.73, 95% confidence interval [CI] 0.69–0.78) in the derivation site, with sensitivity of 66.1% and specificity of 66.6%. In the validation site, the model showed good discrimination (c-statistic?=?0.75, 95% CI 0.70–0.80) and less than ideal calibration, with sensitivity and specificity of 82.2% and 49.5%, respectively.

Conclusions

Among patients on chronic opioid therapy, the predictive model identified 66–82% of all subsequent opioid overdoses. This model is an efficient screening tool to identify patients who could benefit from naloxone to prevent overdose deaths. Population differences across the two sites limited calibration in the validation site.

     

Evolving Landscape of Clinical Trials in Heart Failure: Patient Populations,Endpoint Selection,and Regions of Enrollment

Purpose of Review

Clinical trial design and execution are evolving as increasingly important considerations with respect to the success of heart failure trials. The current review highlights temporal trends in characteristics of heart failure clinical trials.

Recent Findings

Recent trials in heart failure have required longer recruitment phases, displayed inefficient enrollment rates, increased use of composite and nonfatal endpoints, undergone rapid globalization, and gradually increased focus on heart failure with preserved ejection fraction.

Summary

Understanding patterns and trends in clinical trial design and execution may inform future planning and conduct of trials of heart failure therapeutics.

     

Reduced Effectiveness of Interruptive Drug-Drug Interaction Alerts after Conversion to a Commercial Electronic Health Record

Background

Drug-drug interaction (DDI) alerts in electronic health records (EHRs) can help prevent adverse drug events, but such alerts are frequently overridden, raising concerns about their clinical usefulness and contribution to alert fatigue.

Objective

To study the effect of conversion to a commercial EHR on DDI alert and acceptance rates.

Design

Two before-and-after studies.

Participants

3277 clinicians who received a DDI alert in the outpatient setting.

Intervention

Introduction of a new, commercial EHR and subsequent adjustment of DDI alerting criteria.

Main Measures

Alert burden and proportion of alerts accepted.

Key Results

Overall interruptive DDI alert burden increased by a factor of 6 from the legacy EHR to the commercial EHR. The acceptance rate for the most severe alerts fell from 100 to 8.4%, and from 29.3 to 7.5% for medium severity alerts (P?<?0.001). After disabling the least severe alerts, total DDI alert burden fell by 50.5%, and acceptance of Tier 1 alerts rose from 9.1 to 12.7% (P?<?0.01).

Conclusions

Changing from a highly tailored DDI alerting system to a more general one as part of an EHR conversion decreased acceptance of DDI alerts and increased alert burden on users. The decrease in acceptance rates cannot be fully explained by differences in the clinical knowledge base, nor can it be fully explained by alert fatigue associated with increased alert burden. Instead, workflow factors probably predominate, including timing of alerts in the prescribing process, lack of differentiation of more and less severe alerts, and features of how users interact with alerts.

     

Application of the qSOFA score to predict mortality in patients with suspected infection in a resource-limited setting in Malawi

Purpose

To determine the predictive value of qSOFA (quick Sequential Organ Failure Assessment) in Malawian patients with suspected infection.

Methods

Prospective observational study in a tertiary referral hospital in Malawi.

Results

Predictive ability of qSOFA was reasonable [AUROC 0.73 (95% CI 0.68–0.78)], increasing to 0.77 (95% CI 0.72–0.82) when classifying all patients with altered mental status as high risk. Adding HIV status as a variable to the qSOFA score did not improve predictive value.

Conclusion

qSOFA is a simple tool that can aid risk stratification in resource-limited settings.

     

Response of 33 UK patients with infantile-onset Pompe disease to enzyme replacement therapy

Background

Enzyme replacement therapy (ERT) for infantile-onset Pompe disease has been commercially available for almost 10 years. We report the experience of its use in a cohort treated at three specialist lysosomal treatment centres in the UK.

Methods

A retrospective case-note review was performed, with additional data being gathered from two national audits on all such patients treated with ERT. The impact on the outcome of various characteristics, measured just prior to the initiation of ERT (baseline), was evaluated using logistic regression.

Results

Thirty-three patients were identified; 13/29 (45 %) were cross-reactive immunological material (CRIM) negative, and nine were immunomodulated. At baseline assessment, 79 % were in heart failure, 66 % had failure to thrive and 70 % had radiological signs of focal pulmonary collapse. The overall survival rate was 60 %, ventilation-free survival was 40 % and 30 % of patients were ambulatory. Median follow-up of survivors was 4 years, 1.5?months (range 6 months to 13.5 years). As with previous studies, the CRIM status impacted on all outcome measures. However, in this cohort, baseline failure to thrive was related to death and lack of ambulation, and left ventricular dilatation was a risk factor for non-ventilator-free survival.

Conclusion

The outcome of treated patients remains heterogeneous despite attempts at immunomodulation. Failure to thrive at baseline and left ventricular dilation appear to be associated with poorer outcomes.

     

Die Rolle der Selbsthilfegruppen in der Onkologie

Background

Little is known about self-help associations and their possibilities. Obstacles often prevent early contacts between affected people.

Objectives

The psychosocial support given by self-help associations in different phases is evaluated.

Materials and methods

Based on the experience of the Deutsche ILCO and from cooperation with other organizations and institutions, various dimensions of self-help groups are investigated.

Results

On the professional side, there is a lack of knowledge and of attitude. Suitable structures are rare.

Conclusions

The removal of barriers and development of effective structures are overdue.