The subcutaneous implantable defibrillator (S-ICD) provides an alternative to the transvenous ICD for the prevention of sudden cardiac death, but has not been well studied in the most commonly ...treated transvenous ICD patient population, namely, primary prevention (PP) patients with left ventricular dysfunction.
The analyses in the present study were designed to compare clinical outcomes for PP patients with and without a reduced ejection fraction (EF) and secondary prevention (SP) patients implanted with the S-ICD.
All patients 18 years and older from the S-ICD IDE study and the EFFORTLESS Registry with available data as of November 18, 2013, were included (n = 856; mean follow-up duration 644 days). Outcomes were evaluated in 2 analyses: (1) comparing all PP patients (n = 603, 70.4%) with all SP patients (n = 253, 29.6%) and (2) comparing all PP patients with an EF ≤35% (n = 379) with those with an EF >35% (n = 149, 17.4%).
No differences were observed in mortality, complications, inappropriate therapy, or ability to convert ventricular tachyarrhythmias between SP and PP patients. However, SP patients had a higher incidence of appropriate therapy than did PP patients (11.9% vs 5.0%; P = .0004). In the PP subanalysis, the cohort with an EF ≤35% had significantly older patients with more comorbidities and higher mortality (3.0% annually vs 0.0%). Despite these differences, device-related complications, conversion efficacy, and incidence of inappropriate shock therapies were not significantly different between PP subgroups.
The S-ICD performs well in protecting patients with either PP or SP implant indications from sudden cardiac death. Within PP patients, device performance was independent of EF.
Background
Reducing the transmission of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) is a global priority. Contact tracing identifies people who were recently in contact with an ...infected individual, in order to isolate them and reduce further transmission. Digital technology could be implemented to augment and accelerate manual contact tracing. Digital tools for contact tracing may be grouped into three areas: 1) outbreak response; 2) proximity tracing; and 3) symptom tracking. We conducted a rapid review on the effectiveness of digital solutions to contact tracing during infectious disease outbreaks.
Objectives
To assess the benefits, harms, and acceptability of personal digital contact tracing solutions for identifying contacts of an identified positive case of an infectious disease.
Search methods
An information specialist searched the literature from 1 January 2000 to 5 May 2020 in CENTRAL, MEDLINE, and Embase. Additionally, we screened the Cochrane COVID‐19 Study Register.
Selection criteria
We included randomised controlled trials (RCTs), cluster‐RCTs, quasi‐RCTs, cohort studies, cross‐sectional studies and modelling studies, in general populations. We preferentially included studies of contact tracing during infectious disease outbreaks (including COVID‐19, Ebola, tuberculosis, severe acute respiratory syndrome virus, and Middle East respiratory syndrome) as direct evidence, but considered comparative studies of contact tracing outside an outbreak as indirect evidence.
The digital solutions varied but typically included software (or firmware) for users to install on their devices or to be uploaded to devices provided by governments or third parties. Control measures included traditional or manual contact tracing, self‐reported diaries and surveys, interviews, other standard methods for determining close contacts, and other technologies compared to digital solutions (e.g. electronic medical records).
Data collection and analysis
Two review authors independently screened records and all potentially relevant full‐text publications. One review author extracted data for 50% of the included studies, another extracted data for the remaining 50%; the second review author checked all the extracted data. One review author assessed quality of included studies and a second checked the assessments. Our outcomes were identification of secondary cases and close contacts, time to complete contact tracing, acceptability and accessibility issues, privacy and safety concerns, and any other ethical issue identified. Though modelling studies will predict estimates of the effects of different contact tracing solutions on outcomes of interest, cohort studies provide empirically measured estimates of the effects of different contact tracing solutions on outcomes of interest. We used GRADE‐CERQual to describe certainty of evidence from qualitative data and GRADE for modelling and cohort studies.
Main results
We identified six cohort studies reporting quantitative data and six modelling studies reporting simulations of digital solutions for contact tracing. Two cohort studies also provided qualitative data. Three cohort studies looked at contact tracing during an outbreak, whilst three emulated an outbreak in non‐outbreak settings (schools). Of the six modelling studies, four evaluated digital solutions for contact tracing in simulated COVID‐19 scenarios, while two simulated close contacts in non‐specific outbreak settings.
Modelling studies
Two modelling studies provided low‐certainty evidence of a reduction in secondary cases using digital contact tracing (measured as average number of secondary cases per index case ‐ effective reproductive number (R eff)). One study estimated an 18% reduction in R eff with digital contact tracing compared to self‐isolation alone, and a 35% reduction with manual contact‐tracing. Another found a reduction in R eff for digital contact tracing compared to self‐isolation alone (26% reduction) and a reduction in R eff for manual contact tracing compared to self‐isolation alone (53% reduction). However, the certainty of evidence was reduced by unclear specifications of their models, and assumptions about the effectiveness of manual contact tracing (assumed 95% to 100% of contacts traced), and the proportion of the population who would have the app (53%).
Cohort studies
Two cohort studies provided very low‐certainty evidence of a benefit of digital over manual contact tracing. During an Ebola outbreak, contact tracers using an app found twice as many close contacts per case on average than those using paper forms. Similarly, after a pertussis outbreak in a US hospital, researchers found that radio‐frequency identification identified 45 close contacts but searches of electronic medical records found 13. The certainty of evidence was reduced by concerns about imprecision, and serious risk of bias due to the inability of contact tracing study designs to identify the true number of close contacts.
One cohort study provided very low‐certainty evidence that an app could reduce the time to complete a set of close contacts. The certainty of evidence for this outcome was affected by imprecision and serious risk of bias. Contact tracing teams reported that digital data entry and management systems were faster to use than paper systems and possibly less prone to data loss.
Two studies from lower‐ or middle‐income countries, reported that contact tracing teams found digital systems simpler to use and generally preferred them over paper systems; they saved personnel time, reportedly improved accuracy with large data sets, and were easier to transport compared with paper forms. However, personnel faced increased costs and internet access problems with digital compared to paper systems.
Devices in the cohort studies appeared to have privacy from contacts regarding the exposed or diagnosed users. However, there were risks of privacy breaches from snoopers if linkage attacks occurred, particularly for wearable devices.
Authors' conclusions
The effectiveness of digital solutions is largely unproven as there are very few published data in real‐world outbreak settings. Modelling studies provide low‐certainty evidence of a reduction in secondary cases if digital contact tracing is used together with other public health measures such as self‐isolation. Cohort studies provide very low‐certainty evidence that digital contact tracing may produce more reliable counts of contacts and reduce time to complete contact tracing. Digital solutions may have equity implications for at‐risk populations with poor internet access and poor access to digital technology.
Stronger primary research on the effectiveness of contact tracing technologies is needed, including research into use of digital solutions in conjunction with manual systems, as digital solutions are unlikely to be used alone in real‐world settings. Future studies should consider access to and acceptability of digital solutions, and the resultant impact on equity. Studies should also make acceptability and uptake a primary research question, as privacy concerns can prevent uptake and effectiveness of these technologies.
Chronic mesenteric ischemia (CMI) results from the inability to achieve adequate postprandial intestinal blood flow, usually from atherosclerotic occlusive disease at the origins of the mesenteric ...vessels. Patients typically present with postprandial pain, food fear, and weight loss, although they can present with acute mesenteric ischemia and bowel infarction. The diagnosis requires a combination of the appropriate clinical symptoms and significant mesenteric artery occlusive disease, although it is often delayed given the spectrum of gastrointestinal disorders associated with abdominal pain and weight loss. The treatment goals include relieving the presenting symptoms, preventing progression to acute mesenteric ischemia, and improving overall quality of life. These practice guidelines were developed to provide the best possible evidence for the diagnosis and treatment of patients with CMI from atherosclerosis.
The Society for Vascular Surgery established a committee composed of vascular surgeons and individuals experienced with evidence-based reviews. The committee focused on six specific areas, including the diagnostic evaluation, indications for treatment, choice of treatment, perioperative evaluation, endovascular/open revascularization, and surveillance/remediation. A formal systematic review was performed by the evidence team to identify the optimal technique for revascularization. Specific practice recommendations were developed using the Grading of Recommendations Assessment, Development, and Evaluation system based on review of literature, the strength of the data, and consensus.
Patients with symptoms consistent with CMI should undergo an expedited workup, including a computed tomography arteriogram, to exclude other potential causes. The diagnosis is supported by significant arterial occlusive disease in the mesenteric vessels, particularly the superior mesenteric artery. Treatment requires revascularization with the primary target being the superior mesenteric artery. Endovascular revascularization with a balloon-expandable covered intraluminal stent is the recommended initial treatment with open repair reserved for select younger patients and those who are not endovascular candidates. Long-term follow-up and surveillance are recommended after revascularization and for asymptomatic patients with severe mesenteric occlusive disease. Patient with recurrent symptoms after revascularization owing to recurrent stenoses should be treated with an endovascular-first approach, similar to the de novo lesion.
These practice guidelines were developed based on the best available evidence. They should help to optimize the care of patients with CMI. Multiple areas for future research were identified.
Background
Worldwide at least 100 million people are thought to have prevalent cardiovascular disease (CVD). This population has a five times greater chance of suffering a recurrent cardiovascular ...event than people without known CVD. Secondary CVD prevention is defined as action aimed to reduce the probability of recurrence of such events. Drug interventions have been shown to be cost‐effective in reducing this risk and are recommended in international guidelines. However, adherence to recommended treatments remains sub‐optimal. In order to influence non‐adherence, there is a need to develop scalable and cost‐effective behaviour‐change interventions.
Objectives
To assess the effects of mobile phone text messaging in patients with established arterial occlusive events on adherence to treatment, fatal and non‐fatal cardiovascular events, and adverse effects.
Search methods
We searched CENTRAL, MEDLINE, Embase, the Conference Proceedings Citation Index ‐ Science on Web of Science on 7 November 2016, and two clinical trial registers on 12 November 2016. We contacted authors of included studies for missing information and searched reference lists of relevant papers. We applied no language or date restrictions.
Selection criteria
We included randomised trials with at least 50% of the participants with established arterial occlusive events. We included trials investigating interventions using short message service (SMS) or multimedia messaging service (MMS) with the aim to improve adherence to medication for the secondary prevention of cardiovascular events. Eligible comparators were no intervention or other modes of communication.
Data collection and analysis
We used standard methodological procedures expected by Cochrane. In addition, we attempted to contact all authors on how the SMS were developed.
Main results
We included seven trials (reported in 13 reports) with 1310 participants randomised. Follow‐up ranged from one month to 12 months. Due to heterogeneity in the methods, population and outcome measures, we were unable to conduct meta‐analysis on these studies. All seven studies reported on adherence, but using different methods and scales. Six out of seven trials showed a beneficial effect of mobile phone text messaging for medication adherence. Dale 2015a, reported significantly greater medication adherence score in the intervention group (Mean Difference (MD) 0.58, 95% confidence interval (CI) 0.19 to 0.97; 123 participants randomised) at six months. Khonsari 2015 reported less adherence in the control group (Relative Risk (RR) 4.09, 95% CI 1.82 to 9.18; 62 participants randomised) at eight weeks. Pandey 2014 (34 participants randomised) assessed medication adherence through self‐reported logs with 90% adherence in the intervention group compared to 70% in the control group at 12 months. Park 2014a (90 participants randomised) reported a greater increase of the medication adherence score in the control group, but also measured adherence with an event monitoring system for a number of medications with adherence levels ranging from 84.1% adherence to 86.2% in the intervention group and 79.7% to 85.7% in the control group at 30 days. Quilici 2013, reported reduced odds of non‐adherence in the intervention group (Odds Ratio (OR) 0.43, 95% CI 0.22 to 0.86, 521 participants randomised) at 30 days. Fang 2016, reported that participants given SMS alone had reduced odds of being non‐adherent compared to telephone reminders (OR 0.40 95% CI 0.18 to 0.63; 280 patients randomised). Kamal 2015 reported higher levels of adherence in the intervention arm (adjusted MD 0.54, 95% CI 0.22 to 0.85; 200 participants randomised).
Khonsari 2015 was the only study to report fatal cardiovascular events and only reported two events, both in the control arm. No study reported on the other primary outcomes. No study reported repetitive thumb injury or road traffic crashes or other adverse events that were related to the intervention.
Four authors replied to our questionnaire on SMS development. No study reported examining causes of non‐adherence or provided SMS tailored to individual patient characteristics.
The included studies were small, heterogeneous and included participants recruited directly after acute events. All studies were assessed as having high risk of bias across at least one domain. Most of the studies came from high‐income countries, with two studies conducted in an upper middle‐income country (China, Malaysia), and one study from a lower middle‐income country (Pakistan). The quality of the evidence was found to be very low. There was no obvious conflicts of interest from authors, although only two declared their funding.
Authors' conclusions
While the results of this systematic review are promising, there is insufficient evidence to draw conclusions on the effectiveness of text message‐based interventions for adherence to medications for secondary prevention of CVD. Sufficiently powered, high‐quality randomised trials are needed, particularly in low‐ and middle‐income countries.
Despite numerous advances in the prevention and treatment of atherosclerosis, cardiovascular disease remains a leading cause of morbidity and mortality. Novel and inexpensive interventions that can ...contribute to the primary and secondary prevention of cardiovascular disease are of interest. Numerous studies have reported on the benefits of meditation. Meditation instruction and practice is widely accessible and inexpensive and may thus be a potential attractive cost-effective adjunct to more traditional medical therapies. Accordingly, this American Heart Association scientific statement systematically reviewed the data on the potential benefits of meditation on cardiovascular risk. Neurophysiological and neuroanatomical studies demonstrate that meditation can have long-standing effects on the brain, which provide some biological plausibility for beneficial consequences on the physiological basal state and on cardiovascular risk. Studies of the effects of meditation on cardiovascular risk have included those investigating physiological response to stress, smoking cessation, blood pressure reduction, insulin resistance and metabolic syndrome, endothelial function, inducible myocardial ischemia, and primary and secondary prevention of cardiovascular disease. Overall, studies of meditation suggest a possible benefit on cardiovascular risk, although the overall quality and, in some cases, quantity of study data are modest. Given the low costs and low risks of this intervention, meditation may be considered as an adjunct to guideline-directed cardiovascular risk reduction by those interested in this lifestyle modification, with the understanding that the benefits of such intervention remain to be better established. Further research on meditation and cardiovascular risk is warranted. Such studies, to the degree possible, should utilize randomized study design, be adequately powered to meet the primary study outcome, strive to achieve low drop-out rates, include long-term follow-up, and be performed by those without inherent bias in outcome.
Summary
Background
The nocebo effect is a negative effect of a pharmacological or nonpharmacological medical treatment that is induced by patients' expectations, and that is unrelated to the ...physiological action of the treatment. The nocebo effect can negatively affect treatment outcomes.
Aim
To develop evidence‐based consensus recommendations for the prevention and management of the nocebo effect in biosimilar‐treated patients with IBD.
Methods
The “NOCE‐BIO Consensus Group” was composed of 19 members from five European countries, and with different fields of expertise. A literature review on the nocebo effect, with specific focus on information about its prevention and management in biosimilar‐treated IBD patients, was performed. Preliminary statements were formulated and voted on during a consensus group meeting held in Milan, Italy, in July 2018. A statement was accepted if >75% of participants voted 4 (“agree”) or 5 (“strongly agree”) on a scale of 1‐5.
Results
Consensus was reached on 11 recommendation statements. Seven statements reached consensus after one voting round and four statements reached consensus after two voting rounds. All statements were supported by very low‐quality level of evidence. The panel agreed that patient‐health‐care provider relationship is a key driver of acceptance of biosimilars, which limits the risk of negative bias and the nocebo effect. Lack of knowledge among patients and health‐care providers about the effectiveness and safety of biosimilars should be minimized. Education about biosimilars needs to be tailored to the individual patient, and positive framing is recommended.
Conclusions
The nocebo effect is under‐recognised in the era of biosimilars, although it may negatively impact on the cost‐savings of biosimilars. Future research should focus on the magnitude, the risk factors, the impact, and the management of the nocebo effect in biosimilars‐treated IBD patients.
Cardiac rehabilitation (CR) is the subspecialty of clinical cardiology dedicated to the treatment of cardiac patients, early and in the long term after an acute event. The aim of CR is to improve ...both quality of life and prognosis through prognostic stratification, clinical stabilization and optimization of therapy (pharmacological and non), management of comorbidities, treatment of disability, as well as through the provision and reinforcement of secondary prevention interventions and maintenaince of adherence to treatment. The mission of CR has changed over time. Once centered on the acute phase, aimed primarily at short-term survival, the healthcare of cardiac patients now increasingly involves the chronic phase where the challenge is to guarantee continuity and quality of care in the medium and long-term. The aim of the present position paper is to provide the state-of-the-art of CR in Italy, discussing its trengths and weaknesses as well as future perspectives.
Background
The Seven Countries study in the 1960s showed that populations in the Mediterranean region experienced lower coronary heart disease (CHD) mortality probably as a result of different ...dietary patterns. Later observational studies have confirmed the benefits of adherence to a Mediterranean dietary pattern on cardiovascular disease (CVD) risk factors but clinical trial evidence is more limited.
Objectives
To determine the effectiveness of a Mediterranean‐style diet for the primary and secondary prevention of CVD.
Search methods
We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 9); MEDLINE (Ovid, 1946 to 25 September 2018); Embase (Ovid, 1980 to 2018 week 39); Web of Science Core Collection (Thomson Reuters, 1900 to 26 September 2018); DARE Issue 2 of 4, 2015 (Cochrane Library); HTA Issue 4 of 4, 2016 (Cochrane Library); NHS EED Issue 2 of 4, 2015 (Cochrane Library). We searched trial registers and applied no language restrictions.
Selection criteria
We selected randomised controlled trials (RCTs) in healthy adults and adults at high risk of CVD (primary prevention) and those with established CVD (secondary prevention). Both of the following key components were required to reach our definition of a Mediterranean‐style diet: high monounsaturated/saturated fat ratio (use of olive oil as main cooking ingredient and/or consumption of other traditional foods high in monounsaturated fats such as tree nuts) and a high intake of plant‐based foods, including fruits, vegetables and legumes. Additional components included: low to moderate red wine consumption; high consumption of whole grains and cereals; low consumption of meat and meat products and increased consumption of fish; moderate consumption of milk and dairy products. The intervention could be dietary advice, provision of relevant foods, or both. The comparison group received either no intervention, minimal intervention, usual care or another dietary intervention. Outcomes included clinical events and CVD risk factors. We included only studies with follow‐up periods of three months or more defined as the intervention period plus post intervention follow‐up.
Data collection and analysis
Two review authors independently assessed studies for inclusion, extracted data and assessed risk of bias. We conducted four main comparisons:
1. Mediterranean dietary intervention versus no intervention or minimal intervention for primary prevention;
2. Mediterranean dietary intervention versus another dietary intervention for primary prevention;
3. Mediterranean dietary intervention versus usual care for secondary prevention;
4. Mediterranean dietary intervention versus another dietary intervention for secondary prevention.
Main results
In this substantive review update, 30 RCTs (49 papers) (12,461 participants randomised) and seven ongoing trials met our inclusion criteria. The majority of trials contributed to primary prevention: comparisons 1 (nine trials) and 2 (13 trials). Secondary prevention trials were included for comparison 3 (two trials) and comparison 4 (four trials plus an additional two trials that were excluded from the main analyses due to published concerns regarding the reliability of the data).
Two trials reported on adverse events where these were absent or minor (low‐ to moderate‐quality evidence). No trials reported on costs or health‐related quality of life.
Primary prevention
The included studies for comparison 1 did not report on clinical endpoints (CVD mortality, total mortality or non‐fatal endpoints such as myocardial infarction or stroke). The PREDIMED trial (included in comparison 2) was retracted and re‐analysed following concerns regarding randomisation at two of 11 sites. Low‐quality evidence shows little or no effect of the PREDIMED (7747 randomised) intervention (advice to follow a Mediterranean diet plus supplemental extra‐virgin olive oil or tree nuts) compared to a low‐fat diet on CVD mortality (hazard ratio (HR) 0.81, 95% confidence interval (CI) 0.50 to 1.32) or total mortality (HR 1.0, 95% CI 0.81 to 1.24) over 4.8 years. There was, however, a reduction in the number of strokes with the PREDIMED intervention (HR 0.60, 95% CI 0.45 to 0.80), a decrease from 24/1000 to 14/1000 (95% CI 11 to 19), moderate‐quality evidence). For CVD risk factors for comparison 1 there was low‐quality evidence for a possible small reduction in total cholesterol (‐0.16 mmol/L, 95% CI ‐0.32 to 0.00) and moderate‐quality evidence for a reduction in systolic (‐2.99 mmHg (95% CI ‐3.45 to ‐2.53) and diastolic blood pressure (‐2.0 mmHg, 95% CI ‐2.29 to ‐1.71), with low or very low‐quality evidence of little or no effect on LDL or HDL cholesterol or triglycerides. For comparison 2 there was moderate‐quality evidence of a possible small reduction in LDL cholesterol (‐0.15 mmol/L, 95% CI ‐0.27 to ‐0.02) and triglycerides (‐0.09 mmol/L, 95% CI ‐0.16 to ‐0.01) with moderate or low‐quality evidence of little or no effect on total or HDL cholesterol or blood pressure.
Secondary prevention
For secondary prevention, the Lyon Diet Heart Study (comparison 3) examined the effect of advice to follow a Mediterranean diet and supplemental canola margarine compared to usual care in 605 CHD patients over 46 months and there was low‐quality evidence of a reduction in adjusted estimates for CVD mortality (HR 0.35, 95% CI 0.15 to 0.82) and total mortality (HR 0.44, 95% CI 0.21 to 0.92) with the intervention. Only one small trial (101 participants) provided unadjusted estimates for composite clinical endpoints for comparison 4 (very low‐quality evidence of uncertain effect). For comparison 3 there was low‐quality evidence of little or no effect of a Mediterranean‐style diet on lipid levels and very low‐quality evidence for blood pressure. Similarly, for comparison 4 where only two trials contributed to the analyses there was low or very low‐quality evidence of little or no effect of the intervention on lipid levels or blood pressure.
Authors' conclusions
Despite the relatively large number of studies included in this review, there is still some uncertainty regarding the effects of a Mediterranean‐style diet on clinical endpoints and CVD risk factors for both primary and secondary prevention. The quality of evidence for the modest benefits on CVD risk factors in primary prevention is low or moderate, with a small number of studies reporting minimal harms. There is a paucity of evidence for secondary prevention. The ongoing studies may provide more certainty in the future.
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