Long-term outlook for transcatheter aortic valve replacement

Transcatheter aortic valve replacement (TAVR) revolutionized the treatment of severe symptomatic aortic stenosis (AS). TAVR is increasingly offered for lower-risk patients. The role and place of TAVR in the future treatment of AS is not clear yet. In this review, we discuss the long-term outlook for TAVR, its challenges and its relationship to conventional surgical aortic valve replacement

The clinical implications of body surface area as a poor proxy for cardiac output

Background Prosthesis-patient mismatch (PPM), routinely used to characterize the degree of hemodynamic obstruction caused by a prosthetic heart valve, is associated with adverse patient outcomes after aortic valve replacement (AVR). In the common definition of PPM, the opening area of the valve is related to the patients' cardiac output, by indexing effective orifice area (EOA) with body surface area (BSA). The aim of this study is to assess the implications of using BSA as a proxy for cardiac output. Methods 744 patients with normal LV function underwent echocardiographic assessment after surgical AVR. To validate the use of BSA as a proxy for cardiac output, the relation between these variables was analyzed. The effects of BSA on the classification of PPM (EOAi = 20 mmHg and/or Doppler velocity index < 0.35) were estimated. Results There was a weak correlation between BSA and cardiac output (r: 0.29, 95% CI: 0.22;0.35), and cardiac output was not proportional to BSA (Cardiac output = 1.5 x BSA +1.9). As a result, the increased risk of patients with a large BSA to be labelled with PPM (OR: 5.2, 95% CI: 2.5,11 per m(2) BSA), was not reflected by a significantly higher risk of hemodynamic obstruction (OR: 1.5, 95% CI: 0.5,4.9 per m(2) BSA). Conclusions The current definition of PPM results in a systematic overestimation of hemodynamic obstruction in patients with a larger BSA, and we recommend cautious use in this subgroup.Thoracic Surger

Virtual reality 3D echocardiography in the assessment of tricuspid valve function after surgical closure of ventricular septal defect

Background. This study was done to investigate the potential additional role of virtual reality, using three-dimensional (3D) echocardiographic holograms, in the postoperative assessment of tricuspid valve function after surgical closure of ventricular septal defect (VSD). Methods. 12 data sets from intraoperative epicardial echocardiographic studies in 5 operations (patient age at operation 3 weeks to 4 years and bodyweight at operation 3.8 to 17.2 kg) after surgical closure of VSD were included in the study. The data sets were analysed as two-dimensional (2D) images on the screen of the ultrasound system as well as holograms in an I-space virtual reality (VR) system. The 2D images were assessed for tricuspid valve function. In the I-Space, a 6 degrees-of-freedom controller was used to create the necessary projectory positions and cutting planes in the hologram. The holograms were used for additional assessment of tricuspid valve leaflet mobility. Results. All data sets could be used for 2D as well as holographic analysis. In all data sets the area of interest could be identified. The 2D analysis showed no tricuspid valve stenosis or regurgitation. Leaflet mobility was considered normal. In the virtual reality of the I-Space, all data sets allowed to assess the tricuspid leaflet level in a single holographic representation. In 3 holograms the septal leaflet showed restricted mobility that was not appreciated in the 2D echocardiogram. In 4 data sets the posterior leaflet and the tricuspid papillary apparatus were not completely included. Conclusion. This report shows that dynamic holographic imaging of intraoperative postoperative echocardiographic data regarding tricuspid valve function after VSD closure is feasible. Holographic analysis allows for additional tricuspid valve leaflet mobility analysis. The large size of the probe, in relation to small size of the patient, may preclude a complete data set. At the moment the requirement of an I-Space VR system limits the applicability in virtual reality 3D echocardiography in clinical practice

The rationale for heart team decision-making for patients with stable, complex coronary artery disease

Stable complex coronary artery disease can be treated with coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or medical therapy. Multidisciplinary decision-making has gained more emphasis over the recent years to select the most optimal treatment strategy for individual patients with stable complex coronary artery disease. However, the so-called 'Heart Team' concept has not been widely implemented. Yet, decision-making has shown to remain suboptimal; there is large variability in PCI-to-CABG ratios, which may predominantly be the consequence of physician-related factors that have raised concerns regarding overuse, underuse, and inappropriate selection of revascularization. In this review, we summarize these and additional data to support the statement that a multidisciplinary Heart Team consisting of at least a clinical/non-invasive cardiologist, interventional cardiologist, and cardiac surgeon, can together better analyse and interpret the available diagnostic evidence, put into context the clinical condition of the patient as well as consider individual preference and local expertise, and through shared decision-making with the patient can arrive at a most optimal joint treatment strategy recommendation for patients with stable co

Impact of left ventricular ejection fraction on clinical outcomes after left main coronary artery revascularization

Aim: To evaluate the impact of left ventricular ejection fraction (LVEF) on 3-year outcomes in patients with left main coronary artery disease (LMCAD) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in the EXCEL trial. Methods and results: The EXCEL trial randomized patients with LMCAD to PCI with everolimus-eluting stents (n = 948) or CABG (n = 957). Among 1804 patients with known baseline LVEF, 74 (4.1%) had LVEF <40% [heart failure with reduced ejection fraction (HFrEF)], 152 (8.4%) LVEF 40–49% [heart failure with mid-range ejection fraction (HFmrEF)] and 1578 (87.5%) LVEF ≥50% (heart failure with preserved ejection fraction). Patients with HFrEF vs. HFmrEF vs. preserved LVEF experienced a longer postoperative hospital stay (9.0 vs. 7.0 vs. 6.0 days, P = 0.02) with greater peri-procedural complications after CABG, while hospital stay after PCI was unaffected by LVEF (1.5 vs. 2.0 vs. 1.0 days, P = 0.20). The composite primary endpoint of death, stroke, or myocardial infarction at 3 years was 29.3% (PCI) vs. 27.6% (CABG) in patients with HFrEF, 16.2% vs. 15.0% in patients with HFmrEF, and 14.5% vs. 14.6% in those with preserved LVEF, respectively (Pinteraction = 0.90). Smoothing spline analysis demonstrated that the 3-year risk of all-cause death increased when LVEF decreased, both in patients undergoing CABG and PCI. Conclusion: In the EXCEL trial, the composite rate of death, stroke or myocardial infarction at 3 years was significantly higher in patients with HFrEF compared with HFmrEF or preserved LVEF, driven by an increased rate of all-cause death. No significant differences after PCI vs. CABG were observed among patients with HFrEF, HFmrEF and preserved LVEF. Longer-term follow-up could provide important insights on differences in clinical outcomes that might emerge over time. Clinical Trial Registration: ClinicalTrials.gov ID NCT01205776

Impact of non-respect of SYNTAX score II recommendation for surgery in patients with left main coronary artery disease treated by percutaneous coronary intervention: an EXCEL substudy

OBJECTIVES: The SYNTAX score II (SSII) was developed from the SYNTAX trial to predict the 4-year all-cause mortality after left main or multivessel disease revascularization and to facilitate the decision-making process. The SSII provides the following treatment recommendations: (i) coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) (equipoise risk), (ii) CABG preferred (excessive risk for PCI) or (iii) PCI preferred (excessive risk for CABG). We sought to externally validate SSII and to investigate the impact of not abiding by the SSII recommendations in the randomized EXCEL trial of PCI versus CABG for left main disease. METHODS: The calibration plot of predicted versus observed 4-year mortality was constructed from individual values of SSII in EXCEL. To assess overestimation versus underestimation of predicted mortality risk, an optimal fit regression line with slope and intercept was determined. Prospective treatment recommendations based on SSII were compared with actual treatments and all-cause mortality at 4 years. RESULTS: SSII variables were available from EXCEL trial in 1807/1905 (95%) patients. For the entire cohort, discrimination was possibly helpful (C statistic = 0.670). SSII-predicted all-cause mortality at 4 years overestimated the observed mortality, particularly in the highest-risk percentiles, as confirmed by the fit regression line [intercept 2.37 (1.51-3.24), P = 0.003; slope 0.67 (0.61-0.74), P < 0.001]. When the SSII-recommended treatment was CABG, randomized EXCEL patients treated with PCI had a trend towards higher mortality compared with those treated with CABG (14.1% vs 5.3%, P = 0.07) in the as-treat population. In the intention-to-treat population, patients randomized to PCI had higher mortality compared with those randomized to CABG (15.1% vs 4.1%, P = 0.02), when SSII recommended CABG. CONCLUSIONS: In the EXCEL trial of patients with left main disease, the SSII-predicted 4-year mortality overestimated the 4-year observed mortality with a possibly helpful discrimination. Non-compliance with SSII CABG treatment recommendations (i.e. randomized to PCI) was associated with higher 4-year all-cause mortality

Homes in Flux : Multiple Layers of Domesticity among Syrian Refugees in Istanbul

To date, Turkey has one of the highest refugee populations in the world. The Syrian conflict has played a major role in this as over 2,5 million Syrians have taken refuge in Turkey. Most of Syrian refugees are residing in the largest city of Turkey, Istanbul. Turkey is a signatory member of the Convention relating to the Status of Refugees, however has an exception for permanent residency granted only for European refugees. Thus, under Turkish refugee policy, Syrians are merely granted temporary protection that guarantees them a temporary residency permit. However, the policy does not cover; at the time of this research; the right to work. Syrian refugees, undocumented Syrians and Syrian Palestinians are especially vulnerable in Turkish society due to the lack of permanent residency and legal work. This research identifies how Syrian refugees create home as well as the factors that influence their home-making process in Istanbul. The factors are evaluated through the conditions under which Syrian refugees are residing in Istanbul including the right to work, housing and residency. The research also evaluates the refugees home-making in retrospective to their living conditions, feeling of home, legal position, access to a dwelling place as well as cultural identification. Although, this research focuses on the individual experience of home-making for Syrian refugees, it considers and examines Syrian refugees in a context of politicised bodies. As international refugees, Syrian refugees are highly politicized bodies, whose lives are affected by international politics as well as the domopolitics of the country in which they reside. Subsequently, their home and their home-making processes are also politicised. Beyond politics, refugeeness alters one's relationship to home and place, making home a complex concept attached with emotions and potential pain and loss. Literacy identifies that refugees displace their home through space and time. Hence, this research treats home as a socially and culturally produced metaphor that describes a person's belonging within socio-spatial narratives, but of which content is individually chosen to describe or to support a person's identity and psychological environment. The method of this research was a combination of two field trips to Istanbul, Turkey, fourteen in-depth interviews and qualitative analysis. The main reference of the research are the fourteen in-depth interviews that included ten men and four women; aged from 20 to 40 years old; Syrians residing in Istanbul. The interviewees were selected through social media online connections and face-to-face acquaintances during the field trips. The interviewees time of residence in Istanbul varied from two months to over four years. The eleven influencing factors identified in this research can be more commonly divided into two categories: the common factors and the personal factors. Common factors related to the responder's habitation environment; such as the city of Istanbul and the Turkish society. These common factors included: the city itself, the Turkish culture and society, the legislation, working life, housing, discrimination and relationships with their family and friends as well as with the Turkish people. The interviewees considered these factors as the ones that impacted everyday life and which they could not 'escape'. Personal factors that were identified are related to interviewees personality, world views and emotions. The interviewees could be divided into four main categories of personal factor denominators: their relationship to Syria, sense of belonging, definition of home and views of the future. This research concludes that displacement has an impact on how home is perceived and reflected by the interviewees. Its findings are in accordance to previous research literature on home-making among refugees, but it questions refugee policies that emphasis on repatriation as the most favourable long term solution for refugees as well as the position of housing as a most influential factor in refugees' home-making, by stating that other factors such as relationship to family and friends and earning a living, are higher in importance for those who have arrived into a new country less than two years ago.Syyrian kriisin myötä Turkissa asuu tänä päivänä maailman laajin pakolaisyhteisö: 2,5 miljoonaa. Suuri osa Syyrian pakolaisista on asettunut asumaan Turkin suurimpaan kaupunkiin, Istanbuliin. Syyrian pakolaisilla on Turkissa erikoisasema: heitä varten on säädetty erikseen pakolaisasetus, joka määrittelee syyrialaisten pakolaisten aseman Turkissa. Syyrialaiset saavat oleskella maassa niin kutsutun väliaikaisen suojeluksen nojalla, joka estää suojelusta hakevien palautukset Syyriaan, mutta tutkimuksen aikaan ei tarjonnut mahdollisuutta työskennellä laillisesti tai pysyvää oleskelulupaa. Tämä asetus laittaa syyrialaiset pakolaiset hyvin haavoittuvaan asemaan turkkilaisessa yhteiskunnassa, jossa suurin osa työskentelee laittomasti ja heillä on ongelmia muun muassa hankkia asuntoa. Tämä tutkimus perehtyy siihen, kuinka syyrialaiset pakolaiset tekevät kodin Istanbulissa ja mitkä tekijät vaikuttavat kodin tekemiseen. Näitä tekijöitä tarkastellaan niiden olosuhteiden kautta, jotka syyrialaisilla vallitsevat Istanbulissa. Huomioon otettuja seikkoja ovat muun muassa laillinen asema, asema asuntomarkkinoilla, työskentelymahdollisuudet, kulttuurinen identifioituminen sekä kodin kokeminen. Vaikka tämä tutkimus keskittyy yksilöllisiin kokemuksiin, syyrialaisten pakolaisten kodin tekemistä tarkastellaan myös pakolaiskontekstissa, jossa pakolaisten kodin tekeminen on politisoitunutta. Pakolaisina syyrialaiset ovat hyvin politisoituja henkilöitä, joiden kodin tekemiseen vaikuttaa isäntämaan domopolitiikka kuten myös kansainvälinen politiikka. Poliittisen näkökulman lisäksi tutkimus nojaa kirjallisuuteen pakolaisten kodin tekemisestä, joka huomioi pakolaisuuden muuttavan yksilön suhdetta ja käsitystä kodista. Kodin nähdään olevan merkityksellinen konsepti juuri siihen kohdistuvan menetyksen ja kivun vuoksi. Tutkimuksessa käytetyssä kirjallisuudessa pakolaisten nähdään sijoittavan kodin useisiin eri paikkoihin ja myös aikoihin. Tämä tutkimus käsittelee kotia sosiaalisesti ja kulttuurisesti tuotettuna metaforana, joka kuvaa henkilön kuulumista sosio-spatiaalisissa narratiiveissa, mutta jonka sisällön yksilö valitsee kuvatakseen tai tukeakseen omaa identiteettiään ja psykologista hyvinvointiaan. Tutkimuksen metodina on kvalitatiivinen analyysi. Sen aineisto on kerätty neljästätoista syvähaastattelusta ja kahdesta tutkimusmatkasta Istanbuliin. Haastateltavat olivat 20-40-vuotiaita syyrilaisia, jotka olivat eläneet Istanbulissa kahdesta kuukaudesta yli neljään vuoteen. Haastateltavat valittiin sosiaalisen median välityksellä luotujen suhteiden kautta. Tutkimuksessa selvisi yksitoista kodin tekemiseen vaikuttavaa tekijää, jotka on jaettu yleisiin ja yksilöllisiin tekijöihin. Yleiset tekijät ovat elinympäristöstä nousevia tekijöitä, jotka vaikuttivat kaikkiin haastateltaviin. Nämä tekijät olivat Istanbul kaupunkina, turkkilainen kulttuuri ja yhteiskunta, lainsäädäntö, työelämä, syrjiminen, ihmissuhteet perheeseen, ystäviin ja turkkilaisiin. Yksilölliset tekijät ovat haastateltavan persoonasta, maailmankatsomuksesta ja tunteista nousevia tekijöitä, jotka yleisten tekijöiden lailla vaikuttivat haastateltavien kodin kokemukseen. Yksilölliset tekijät jakautuivat neljään kategoriaan: haastateltavien suhteeseen Syyriaan, kuulumisen kokemukseen, kodin merkitykseen ja tulevaisuuden näkemyksiin. Tämän tutkimuksen tulokset tukevat aikaisempaa tutkimusta pakolaisten kodin tekemisestä ja siitä, kuinka kotimaassa sijainneen kodin menetys vaikuttaa siihen, kuinka pakolaiset käsittävät ja kokevat kodin. Tutkimus kuitenkin kyseenalaistaa pakolaisten kotouttamiseen liittyviä poliittisia ratkaisuja, kuten kotimaahan palauttamisen ensisijaisena vaihtoehtona. Tutkimuksessa kävi myös ilmi, että asumuksen sijaan kotoutumisen kannalta ensisijaisia tekijöitä olivat suhteet perheeseen ja ystäviin ja elannon ansaitseminen alle kaksi vuotta Istanbulissa asuneiden haastateltavien keskuudessa

Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis

OBJECTIVES: We assessed the safety, effectiveness and haemodynamic performance of a new bovine stented aortic valve bioprosthesis (Avalus™). METHODS: The PERIGON Pivotal Trial is a prospective, non-randomized, multicentre study. Subjects had symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. Death, valve-related adverse events (AEs), functional recovery and haemodynamic performance were assessed at discharge, 3-6 months and 1 year. The primary analysis compared 'late' (>30 days post-implant) linearized rates of valve-related thromboembolism, thrombosis, all and major haemorrhage, all and major paravalvular leak (PVL) and endocarditis after implantation with objective performance criteria (OPC) for AEs, in accordance with EN ISO 5840:2009. We hypothesized that the upper 95% confidence bounds of the true linearized AE rates would be ≥ 2 × OPC; rejection of the null hypothesis would demonstrate that these rates were below acceptable rates. The analysis was required to include at least 150 patients followed to 1 year and 400 valve-years. Kaplan-Meier survival analysis was also performed. RESULTS: Total number of valve-years was 459.5 (n = 686). Linearized rates were <2 × OPC for death and valve-related thromboembolism, valve thrombosis, all and major PVL, and endocarditis, but ≥2 × OPC for all and major haemorrhage. Survival at 1 year (n = 270) was 96.4%. Patients showed good functional recovery, and haemodynamic performance was within expected range. CONCLUSIONS: This analysis demonstrated a good safety profile and clinical effectiveness of the Avalus valve except for bleeding rates. The linearized rates of all and major haemorrhage may be related to long-term anticoagulation for non-valvular indications and the length of follow-up of this cohort. Trial registration: NCT02088554 (www.clinicaltrials.gov)

The fallacy of indexed effective orifice area charts to predict prosthesis-patient mismatch alter prosthesis implantation

Aims Indexed effective orifice area (EOAi) charts are used to determine the likelihood of prosthesis-patient mismatch (PPM) after aortic valve replacement (AVR). The aim of this study is to validate whether these EOAi charts, based on echocardiographic normal reference values, can accurately predict PPM.Methods and results In the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial, 986 patients with aortic valve stenosis/regurgitation underwent AVR with an Avalus valve. Patients were randomly split (50:50) into training and test sets. The mean measured EOAs for each valve size from the training set were used to create an Avalus EOAi chart. This chart was subsequently used to predict PPM in the test set and measures of diagnostic accuracy (sensitivity, specificity, and negative and positive predictive value) were assessed. PPM was defined by an EOAi <= 0.85 cm(2)/m(2) and severe PPM was defined as EOAi <= 0.65 cm(2)/m(2). The reference values obtained from the training set ranged from 1.27 cm(2) for size 19 mm up to 1.81 cm(2) for size 27 mm. The test set had an incidence of 66% of PPM and 24% of severe PPM. The EOAi chart inaccurately predicted PPM in 30% of patients and severe PPM in 22% of patients. For the prediction of PPM, the sensitivity was 87% and the specificity 37%. For the prediction of severe PPM, the sensitivity was 13% and the specificity 98%.Conclusion use of echocardiographic normal reference values for EOAi charts to predict PPM is unreliable due to the large proportion of misclassifications.Thoracic Surger