Clinical characteristics of phenotypes of fecal incontinence.

PURPOSE: Fecal incontinence (FI) is common, but its etiology is complex with large knowledge gaps. Several phenotypes of FI are known, but the phenotype is often not decisive in the chosen therapy. In this study we aimed to assess the association of the clinical characteristics of patients with FI and the various phenotypes, in order to establish a targeted clinical treatment decision tree. METHODS: We retrospectively studied the charts of patients with FI, who visited our institute from January 2018 until December 2020. Patients were divided into the following groups: passive fecal loss, urge incontinence, combined fecal incontinence with predominantly passive fecal loss, and combined fecal incontinence with predominantly urge incontinence. We compared the characteristics between the passive and urge incontinence groups, the passive  and combined mainly passive groups, and the urge and combined mainly urge groups. RESULTS: Patients with passive incintinence were older, more often had a flaccid anus with presence of a mucosal prolapse, and had a lower resting pressure on anorectal manometry. Patients with urge incontinence were younger and more often had a history of birth trauma. The combined groups showed characteristics of both of the main types of FI. CONCLUSION: Differentiating into phenotypes of FI can be clinically meaningful. The patient history and clinical judgement of the consulting specialist, rather than the physical characteristics, seem to be decisive in the categorization. Additional diagnostic testing can be helpful in complicated cases, but should not be used routinely.

Resting and exercise haemodynamic characteristics of patients with advanced heart failure and preserved ejection fraction.

AIMS: This study aimed to describe haemodynamic features of patients with advanced heart failure with preserved ejection fraction (HFpEF) as defined by the Heart Failure Association (HFA) of the European Society of Cardiology (ESC). METHODS AND RESULTS: We used pooled data from two dedicated HFpEF studies with invasive exercise haemodynamic protocols, the REDUCE LAP-HF (Reduce Elevated Left Atrial Pressure in Patients with Heart Failure) trial and the REDUCE LAP-HF I trial, and categorized patients according to advanced heart failure (AdHF) criteria. The well-characterized HFpEF patients were considered advanced if they had persistent New York Heart Association classification of III-IV and heart failure (HF) hospitalization < 12 months and a 6 min walk test distance < 300 m. Twenty-four (22%) out of 108 patients met the AdHF criteria. On evaluation, clinical characteristics and resting haemodynamics were not different in the two groups. Patients with AdHF had lower work capacity compared with non-advanced patients (35 ± 16 vs. 45 ± 18 W, P = 0.021). Workload-corrected pulmonary capillary wedge pressure normalized to body weight (PCWL) was higher in AdHF patients compared with non-advanced (112 ± 55 vs. 86 ± 49 mmHg/W/kg, P = 0.04). Further, AdHF patients had a smaller increase in cardiac index during exercise (1.1 ± 0.7 vs. 1.6 ± 0.9 L/min/m2 , P = 0.028). CONCLUSIONS: A significantly higher PCWL and lower cardiac index reserve during exercise were observed in AdHF patients compared with non-advanced. These differences were not apparent at rest. Therapies targeting the haemodynamic compromise associated with advanced HFpEF are needed.

Transcatheter aortic valve replacement: impact of pre-procedural FEops HEARTguide assessment on device size selection in borderline annulus size cases.

OBJECTIVES: The aim of this study is to evaluate device size selection in patients within the borderline annulus size range undergoing transcatheter aortic valve replacement (TAVR) and to assess if pre-procedural patient-specific computer simulation will lead to the selection of a different device size than standard of care. BACKGROUND: In TAVR, appropriate device sizing is imperative. In borderline annulus size cases no standardised technique for tailored device size selection is currently available. Pre-procedural patient-specific computer simulation can be used, predicting the risk for paravalvular leakage (PVL) and need for permanent pacemaker implantation (PPI). METHODS: In this multicentre retrospective study, 140 patients in the borderline annulus size range were included. Hereafter, device size selection was left to the discretion of the operator. After TAVR, in 24 of the 140 patients, patient-specific computer simulation calculated the most appropriate device size expected to give the lowest risk for PVL and need for PPI. In these 24 patients, device size selection based on patient-specific computer simulation was compared with standard-of-care device size selection relying on a standardised matrix (Medtronic). RESULTS: In a significant proportion of the 140 patients (26.4%) a different device size than recommended by the matrix was implanted. In 10 of the 24 patients (41.7%) in whom a computer simulation was performed, a different device size was recommended than by means of the matrix. CONCLUSIONS: Device size selection in patients within the borderline annulus size range is still ambiguous. In these patients, patient-specific computer simulation is feasible and can contribute to a more tailored device size selection.

Non-dynamic graciloplasty is an effective treatment for patients with passive fecal incontinence.

BACKGROUND: Fecal incontinence is a multifactorial problem and its etiology is complex. Various therapies are available and different success rates have been described. The aim of this study was to assess the effectiveness and safety of non-dynamic graciloplasty in patients with passive fecal incontinence. METHODS: We retrospectively studied charts of patients with fecal incontinence treated with graciloplasty at our institution from November 2015 until June 2018. Patients were included according to the following criteria: (1) presence of predominantly passive fecal incontinence and (2) presence of a lax perineal body. Primary outcome was the effectiveness, defined as a significant reduction or absence of the complaints of passive fecal incontinence at 3, 6 and 12 months after surgery. Second, we studied the safety of the procedure evaluating the complications within 30 days after surgery. RESULTS: Thirty-one patients met the inclusion criteria. Twenty-six of them, in addition to passive incontinence as the main symptom, had some degree of fecal urgency. The median age at the first visit to the outpatient clinic was 64.0 years (IQR 52-68). Most patients were female (n = 29, 94%). At 3 months after graciloplasty, 71% (22 of 31) of patients were successfully treated for their passive fecal incontinence. At 6 months, the success rate of the graciloplasty increased to 77%. At 12 months among the patients who were still seen in the clinic, the success rate was 58% (18/31). Two patients cancelled follow-up visits after 3 months, because of failure to control symptoms in 1 case. After 6 months, 9 patients were given the choice to do telephone follow-up only. Of these 11 patients without in-person follow-up, 10 were contacted 1 year after surgery and in 7 of them, the graciloplasty was effective in controlling their passive fecal incontinence for an overall success rate of 80% (25/31). Of the 26 patients with mixed passive and urge incontinence, 6 (23%) still complained of urge incontinence at 1 year. Of these patients with persistent urge incontinence, 6 underwent sacral nerve stimulation which was successful in 4. Two serious complications occurred within 30 days. A rectal perforation requiring temporary colostomy and a recto-vaginal fistula which was successfully repaired. CONCLUSION: Non-dynamic graciloplasty is an effective treatment for passive fecal incontinence. Differentiation based on subtypes of fecal incontinence might be important for a pattern-specific approach to treatment. More research is necessary to determine the right indications for more invasive treatments of fecal incontinence.

Assessment of the MANTA closure device in transfemoral transcatheter aortic valve replacement: a single-centre observational study.

OBJECTIVES: The present study aims to evaluate the efficacy and safety of the MANTA vascular closure device (VCD) (Teleflex, Morrisville, NC, USA) in transfemoral transcatheter aortic valve replacement (TF-TAVR). BACKGROUND: To close the femoral artery in TF-TAVR a VCD is the treatment of choice. Data involving suture-based VCDs have been extensive. Although scarce, results on the MANTA device are promising. There is no consensus yet as to whether the MANTA device is associated with fewer access-site-related vascular/bleeding complications when compared to suture-based VCDs. METHODS: In this prospective single-arm study, performed at a single centre, a total of 73 patients eligible for TF-TAVR were included and consecutively treated with the MANTA device. RESULTS: Access-site-related vascular complications were seen in 13.7% of patients treated with the MANTA device. In this group of patients only minor vascular complications were observed. Access-site-related bleeding complications were rare (6.8%), and device failure was seen in 13.7% of the patients. CONCLUSIONS: This single-centre study confirms that use of the MANTA device in TF-TAVR is feasible with an acceptable rate of access-site-related complications and no major vascular complications.

Percutaneous mitral valve repair: the necessity to redefine secondary mitral regurgitation.

Interest in percutaneous mitral valve repair has increased during recent years. This is mainly driven by the significant number of patients being declined for mitral valve surgery because of a high risk of surgery-related complications or death. In this subset of patients, percutaneous edge-to-edge repair using the MitraClip device (Abbott, Menlo Park, CA, USA) has become an established treatment option, proven to be safe, efficient and associated with improved functional status. In contrast to primary mitral regurgitation (MR), clinical outcomes after mitral valve surgery appear to be less favourable as regards secondary MR due to heart failure. In the MITRA-FR and COAPT trials, patients with moderate to severe and severe secondary MR with reduced left ventricular function received either medical treatment (control group) or MitraClip implantation plus medical treatment (device group). Results were conflicting, with only the COAPT trial showing better clinical outcomes in the device group. However, both trials are now seen as complementary and provide useful information especially regarding patient selection for MitraClip therapy. The goal of this review is to delineate which subset of patients with secondary MR will potentially benefit from percutaneous mitral valve repair.

Integrated Care Models for Managing and Preventing Frailty: A Systematic Review for the European Joint Action on Frailty Prevention (ADVANTAGE JA).

Frailty requires concerted integrated approaches to prevent functional decline. Although there is evidence that integrating care is effective for older people, there is insufficient data on outcomes from studies implementing integrated care to prevent and manage frailty. We systematically searched PubMed and Cochrane Library database for peer-reviewed medical literature on models of care for frailty, published from 2002 to 2017. We considered the effective and transferable components of the models of care and evidence of economic impact, where available. Information on European Union-funded projects or those registered with the European Innovation Partnership on Active and Healthy Ageing, and grey literature (including good practices) were also considered. We found 1,065 potential citations and 170 relevant abstracts. After excluding reports on specific diseases, processes or interventions and service models that did not report data, 42 full papers met the inclusion criteria. The evidence showed that few models of integrated care were specifically designed to prevent and tackle frailty in the community and at the interface between primary and secondary (hospital) care. Current evidence supports the case for a more holistic and salutogenic response to frailty, blending a chronic care approach with education, enablement and rehabilitation to optimise function, particularly at times of a sudden deterioration in health, or when transitioning between home, hospital or care home. In all care settings, these approaches should be supported by comprehensive assessment and multidimensional interventions tailored to modifiable physical, psychological, cognitive and social factors.

Appropriate use criteria for optical coherence tomography guidance in percutaneous coronary interventions : Recommendations of the working group of interventional cardiology of the Netherlands Society of Cardiology.

INTRODUCTION: Optical coherence tomography (OCT) enables detailed imaging of the coronary wall, lumen and intracoronary implanted devices. Responding to the lack of specific appropriate use criteria (AUC) for this technique, we conducted a literature review and a procedure for appropriate use criteria. METHODS: Twenty-one of all 184 members of the Dutch Working Group on Interventional Cardiology agreed to evaluate 49 pre-specified cases. During a meeting, factual indications were established whereupon members individually rated indications on a 9-point scale, with the opportunity to substantiate their scoring. RESULTS: Twenty-six indications were rated 'Appropriate', eighteen indications 'May be appropriate', and five 'Rarely appropriate'. Use of OCT was unanimously considered 'Appropriate' in stent thrombosis, and 'Appropriate' for guidance in PCI, especially in distal left main coronary artery and proximal left anterior descending coronary artery, unexplained angiographic abnormalities, and use of bioresorbable vascular scaffold (BVS). OCT was considered 'Rarely Appropriate' on top of fractional flow reserve (FFR) for treatment indication, assessment of strut coverage, bypass anastomoses or assessment of proximal left main coronary artery. CONCLUSIONS: The use of OCT in stent thrombosis is unanimously considered 'Appropriate' by these experts. Varying degrees of consensus exists on the appropriate use of OCT in other settings.

Veno-arterial extracorporeal membrane oxygenation in addition to primary PCI in patients presenting with ST-elevation myocardial infarction.

INTRODUCTION: Primary percutaneous coronary intervention (pPCI) in ST-elevation myocardial infarction (STEMI) can cause great haemodynamic instability. Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can provide haemodynamic support in patients with STEMI but data on outcome and complications are scarce. METHODS: An in-hospital registry was conducted enrolling all patients receiving VA-ECMO. Patients were analysed for medical history, mortality, neurological outcome, complications and coronary artery disease. RESULTS: Between 2011 and 2016, 12 patients underwent pPCI for STEMI and received VA-ECMO for haemodynamic support. The majority of the patients were male (10/12) with a median age of 63 (47-75) years and 4 of the 12 patients had a history of coronary artery disease. A cardiac arrest was witnessed in 11 patients. The left coronary artery was compromised in 8 patients and 4 had right coronary artery disease. All patients were in Killip class IV. Survival to discharge was 67% (8/12), 1­year survival was 42% (5/12), 2 patients have not yet reached the 1­year survival point but are still alive and 1 patient died within a year after discharge. All-cause mortality was 42% (5/12) of which mortality on ECMO was 33% (4/12). Patient-related complications occurred in 6 of the 12 patients: 1 patient suffered major neurological impairment, 2 patients suffered haemorrhage at the cannula site, 2 patients had limb ischaemia and 1 patient had a haemorrhage elsewhere. There were no VA-ECMO hardware malfunctions. CONCLUSION: VA-ECMO in pPCI for STEMI has a high survival rate and neurological outcome is good, even when the patient is admitted with a cardiac arrest.

Feasibility of multiplane microtransoesophageal echocardiographic guidance in structural heart disease transcatheter interventions in adults.

INTRODUCTION: Structural heart interventions are guided by transoesophageal or intracardiac echocardiography (TEE/ICE). MicroTEE, developed for paediatric purposes, is smaller and therefore less invasive and traumatic, avoiding the need for general anaesthesia. We aimed to show feasibility of procedural guidance by comparing image quality of microTEE with standard TEE and ICE during adult transcatheter interventions, and assess the accuracy in obtaining left atrial appendage (LAA) measurements between the microTEE probe and standard TEE. METHODS AND RESULTS: We prospectively included 49 patients (20 women, 64 ± 18 years). Intraprocedural images were obtained by using the microTEE probe and standard (2D and 3D) TEE (LAA closure, MitraClip implantation) or ICE (interatrial communication closure, transseptal puncture for left atrial ablation). Two echocardiographers independently assessed image quality from 1 (excellent) to 4 (poor) and performed LAA measurements. Use of microTEE was not related to significant discomfort. Image quality obtained with the microTEE probe was lower than with standard TEE (2 [1-2] vs. 1 [1-2]; p = 0.04) and comparable with ICE images (2 [1-2] vs. 2 [1-2], p = 0.13). MicroTEE showed a wider field of view than ICE. LAA measurements on images obtained by microTEE were strongly associated with standard TEE. CONCLUSIONS: MicroTEE seems feasible for guidance during transcatheter heart interventions in adults. MicroTEE imaging offers a wider field of view than ICE, and its accuracy is comparable with TEE. In transcatheter interventions performed under conscious sedation, microTEE might be a viable and advantageous alternative to standard TEE or ICE.

The last frontier: transcatheter devices for percutaneous or minimally invasive treatment of chronic heart failure.

Heart failure has a high prevalence in the general population. Morbidity and mortality of heart failure patients remain high, despite improvements in drug therapy, implantable cardioverter-defibrillators and cardiac resynchronisation therapy. New transcatheter implantable devices have been developed to improve the treatment of heart failure. There has been a rapid development of minimally invasive or transcatheter devices used in the treatment of heart failure associated with aortic and mitral valve disease and these devices are being incorporated into routine clinical practice at a fast rate. Several other new transcatheter structural heart interventions for chronic heart failure aimed at a variety of pathophysiologic approaches are currently being developed. In this review, we focus on devices used in the treatment of chronic heart failure by means of left ventricular remodelling, left atrial pressure reduction, tricuspid regurgitation reduction and neuromodulation. The clinical evaluations of these devices are early-stage evaluations of initial feasibility and safety studies and additional clinical evidence needs to be gathered in appropriately designed clinical trials.

Current MitraClip experience, safety and feasibility in the Netherlands.

PURPOSE: Data on MitraClip procedural safety and efficacy in the Netherlands are scarce. We aim to provide an overview of the Dutch MitraClip experience. METHODS: We pooled anonymised demographic and procedural data of 1151 consecutive MitraClip patients, from 13 Dutch hospitals. Data was collected by product specialists in collaboration with local operators. Effect on mitral regurgitation was intra-procedurally assessed by transoesophageal echocardiography. Technical success and device success were defined according to modified definitions of the Mitral Valve Academic Research Consortium (MVARC). RESULTS: Median age was 76 (interquartile range 69-82) years and 59% were males. Patients presented with ≥moderate mitral regurgitation and a predominance of functional mitral regurgitation (72%). Overall, 611 (53%) patients were treated with one Clip, 486 (42%) with ≥2 Clips and 54 (5%) received no Clip. The number of patients with ≥2 Clips increased from 22% in 2009 to 52% in 2016. Device success and technical success were 91 and 95%, respectively, and were consistent over the years. Significant reduction of mitral regurgitation by MitraClip was achieved in 94% of patients and was observed more often in patients with functional mitral regurgitation (95% vs. 91%, p = 0.025). Device time declined from 145 min in 2009 to 55 min in 2016. CONCLUSION: MitraClip experience in the Netherlands is growing with excellent technical success and device success. Over the years, device time decreased and more patients were treated with ≥2 Clips.

Echocardiographic pulmonary hypertension probability is associated with clinical outcomes after transcatheter aortic valve implantation.

AIMS: Pulmonary hypertension (PH) is associated with mortality after transcatheter aortic valve implantation (TAVI). However, diagnosis based on tricuspid regurgitant velocity (TRV) is often inaccurate and unreliable. The updated PH guidelines introduced a PH probability grading implementing additional PH signs on transthoracic echocardiography (TTE), from which we aimed to analyse its effects on clinical outcomes in patients undergoing TAVI. METHODS AND RESULTS: We included 591 consecutive patients (mean age 80.2±8.4years, 58.0% female, mean STS risk score 6.2±3.8%) undergoing TAVI. Patients were divided into "low" (n=270; TRV ≤2.8m/s without additional PH signs), "intermediate" (n=131; TRV ≤2.8m/s with additional PH signs, or TRV 2.9-3.4m/s without additional PH signs), and "high" PH probability (n=190; TRV 2.9-3.4m/s with additional PH signs, or TRV >3.4m/s). The overall 30-day and 2-year mortality rates were 10.2% and 33.8%, respectively. "High" PH probability was an independent predictor of mortality at 30days (HR 3.68, 95% CI 2.03 to 6.67, p<0.01) and 2years (HR 2.19, 95% CI 1.57 to 3.04, p<0.01), compared to "low" PH probability. The "intermediate" group did not show an increased risk. The presence of additional PH signs resulted in a significantly higher mortality at 30days (19.6% vs. 5.1%, p<0.01) and two years (54.2% vs. 22.5%, p<0.01). CONCLUSIONS: The updated echocardiographic PH probability model incorporating additional PH signs independently predicts early and late mortality after TAVI. Additional PH signs are of great value in assessing one's risks since its presence is strongly associated with early and late mortality.

Regional differences in the validity of self-reported use of health care in Belgium: selection versus reporting bias.

BACKGROUND: The Health Care Module of the European Health Interview Survey (EHIS) is aimed to obtain comparable information on the use of inpatient and ambulatory care in all EU member states. In this study we assessed the validity of self-reported information on the use of health care, collected through this instrument, in the Belgian Health Interview Survey (BHIS), and explored the impact of selection and reporting bias on the validity of regional differences in health care use observed in the BHIS. METHODS: To assess reporting bias, self-reported BHIS 2008 data were linked with register-based data from the Belgian compulsory health insurance (BCHI). The latter were compared with similar estimates from a random sample of the BCHI to investigate the selection bias. Outcome indicators included the prevalence of a contact with a GP, specialist, dentist and a physiotherapist, as well as inpatient and day patient hospitalisation. The validity of the estimates and the regional differences were explored through measures of agreement and logistic regression analyses. RESULTS: Validity of self-reported health care use varies by type of health service and is more affected by reporting than by selection bias. Compared to health insurance estimates, self-reported results underestimate the percentage of people with a specialist contact in the past year (50.5 % versus 65.0 %) and a day patient hospitalisation (7.8 % versus 13.9 %). Inversely, survey results overestimated the percentage of people having visited a dentist in the past year: 58.3 % versus 48.6 %. The best concordance was obtained for an inpatient hospitalisation (kappa 0.75). Survey data overestimate the higher prevalence of a contact with a specialist [OR 1.51 (95 % CI 1.33-1.72) for self-report and 1.08 (95 % CI 1.05-1.15) for register] and underestimate the lower prevalence of a contact with a GP [ORs 0.59 (95 % CI 0.51-0.70) and 0.41 (95 % CI 0.39-0.42) respectively] in Brussels compared to Flanders. CONCLUSION: Cautiousness is needed to interpret self-reported use of health care, especially for ambulatory care. Regional differences in self-reported health care use may be influenced by regional differences in the validity of the self-reported information.

The predictive value of conventional surgical risk scores for periprocedural mortality in percutaneous mitral valve repair.

BACKGROUND: Surgical risk scores are used to identify high-risk patients for surgical mitral valve repair. There is no scoring system to estimate the mortality risk for patients undergoing percutaneous treatment. The aim of this analysis is to evaluate the predictive value of the EuroSCOREs and the Society of Thoracic Surgeons Predicted Risk of Mortality Score (STS) for periprocedural mortality in percutaneous edge-to-edge mitral valve repair. METHODS: From 2009 to 2013, 136 high-risk patients were included who underwent 143 procedures. Observed periprocedural mortality was compared with predicted mortality using the logistic EuroSCORE, EuroSCORE II and STS. The predictive value was analysed by receiver operating characteristic curves for each score. RESULTS: Observed periprocedural mortality was 3.5 %. The predicted surgical mortality risk was: 23.1 ± 15.7 % for the logistic EuroSCORE, 9.6 ± 7.7 % for the EuroSCORE II and 13.2 ± 8.2 % for the STS. The predictive value estimated by the area under the curve was: 0.55, 0.54 and 0.65 for the logistic EuroSCORE, EuroSCORE II and STS respectively. Severe pulmonary hypertension and acute procedural success were significant predictive parameters in univariate analysis. CONCLUSION: Contemporary surgical scores do not adequately predict periprocedural mortality for high-risk patients undergoing edge-to-edge mitral valve repair, but they can be used to help decision-making in the selection process for this procedure.

TIDES-ACS Trial: comparison of titanium-nitride-oxide coated bio-active-stent to the drug (everolimus)-eluting stent in acute coronary syndrome. Study design and objectives.

Drug-eluting stents (DES), delivering antiproliferative drugs from a durable polymer, have shown to reduce in-stent restenosis after percutaneous coronary intervention (PCI) compared to bare-metal stents (BMS). However, they have been associated with a hypersensitivity reaction, delayed healing, and incomplete endothelialization, which may contribute to an increased risk of late stent thrombosis. Consequently, a prolonged duration of dual antiplatelet therapy (DAPT) is needed, with an increased risk of bleeding complication. A number of stent technologies are being developed in an attempt to modify late thrombotic events and DAPT duration. The Optimax™ stent is such a novel, next generation bioactive stent (BAS), in which a thicker layer of titanium-nitride-oxide coating is inserted over the stent struts. The rationale of this is to obtain more efficient and rapid vascular healing at the site of the stent implantation. The aim of TIDES-ACS Trial is to compare clinical outcome in patients presenting with ACS, treated with PCI using Optimax-BAS versus Synergy™-EES. Second objective is to explore whether the Optimax™-BAS use is superior compared with Synergy™-EES use with respect of hard end points (cardiac death, myocardial infarction [MI] and major bleeding). A prospective, randomized, multicenter trial (ClinicalTrials.gov Identifier: NCT02049229), will be conducted in interventional centres in Finland (six centres), France (five centres) and Holland (two centres), including a total of 1800 patients.

Environmental and genomic factors as well as interventions influencing smoking cessation: a systematic review of reviews and a proposed working model.

BACKGROUND: Smoking behaviour is a major public health problem worldwide. Several sources have confirmed the implication of genomic factors in smoking behaviour. These factors interact both with environmental factors and interventions to develop a certain behaviour. OBJECTIVES: Describing the environmental and genomic factors as well as the interventions influencing smoking cessation (SC) and developing a working model incorporating the different factors influencing SC were our main objectives. METHODS: Two systematic reviews were conducted using articles in English from the Cochrane library, PubMed and HuGENet from January 2000 to September 2012: (1) a systematic review of systematic reviews and meta-analyses and (2) a systematic review of original research for genomic factors. The proposed working model was developed by making use of previous models of SC and applying an iterative process of discussion and re-examination by the authors. RESULTS: We confirmed the importance of the 4 main factors influencing SC: (1) environmental factors, (2) genomic factors, (3) gene-environment interactions, and (4) evidence-based interventions. The model demonstrates the complex network of factors influencing SC. CONCLUSION: The working model of SC proposed a global view of factors influencing SC, warranting future research in this area. Future testing of the model will consolidate the understanding of the different factors affecting SC and will help to improve interventions in this field.

Complications during percutaneous edge-to-edge mitral valve repair.

Transcatheter edge-to-edge mitral valve repair is an approach for treating mitral regurgitation, which is an alternative for surgery in patients with a high surgical risk. Although the safety and efficacy of the technique have been demonstrated, it is still associated with potentially life-threatening complications. The aim of this paper is to discuss the nature, management, and prevention of the most important procedural complications associated with this procedure.

High versus standard clopidogrel loading in patients undergoing carotid artery stenting prior to cardiac surgery to assess the number of microemboli detected with transcranial Doppler: results of the randomized IMPACT trial.

AIM: The aim of this study was to compare the effects of 300 mg or 600 mg clopidogrel loading dose, prior to carotid artery stenting (CAS) on the number of transcranial Doppler (TCD)-detected microembolic signals (MES) and to investigate the relationship between the magnitude of platelet reactivity and MES. METHODS: In this prospective randomized, double-blind study, 35 consecutive asymptomatic patients (17.1% females), scheduled for CAS and cardiac surgery were included. The primary endpoint was the number of TCD-detected MES. The secondary endpoints were the absolute magnitude of on-treatment platelet reactivity and the adverse cerebral events. Negative binomial regression to find predictors for sum of single emboli, the student's t-test to assess the association between platelet function tests and randomized dose of 300 mg or 600 mg clopidogrel, and the R2 calculation for the assessment of the association between platelet function tests and embolic load, were used. RESULTS: No statistically significant difference in the number of TCD-detected MES, in the sum of all the single emboli or showers and platelet aggregation measurements between the two groups was observed (aggregometry: 21.7±18.3 versus 23±18%, P=0.8499 and 45.8±17.5 versus 46.5±14.5%, P=0.9003) (verifyNow P2Y12 assay: 231±93 PRU versus 222±86 PRU, P=0.7704). In one patient a transient ischemic attack occurred. CONCLUSION: A loading dose of 300 mg of clopidogrel in combination with aspirin is as effective as 600 mg of clopidogrel in achieving adequate platelet inhibition and preventing periprocedural events in asymptomatic patients undergoing CAS prior to cardiac surgery.