Publications

No abstract is provided for this article.

ObjectivesThe aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials.In addition, this document is intended to expand the understanding of patient risk stratification and case selection.

Aims Coronary computed tomography angiography (CCTA) is inferior to intravascular imaging in detecting plaque morphology and quantifying plaque burden. We aim to, for the first time, train a deep-learning (DL) methodology for accurate plaque quantification and characterization in CCTA using near-infrared spectroscopy–intravascular ultrasound (NIRS–IVUS). Methods and results Seventy patients were prospectively recruited who underwent CCTA and NIRS–IVUS imaging. Corresponding cross sections were matched using an in-house developed software, and the estimations of NIRS–IVUS for the lumen, vessel wall borders, and plaque composition were used to train a convolutional neural network in 138 vessels. The performance was evaluated in 48 vessels and compared against the estimations of NIRS–IVUS and the conventional CCTA expert analysis. Sixty-four patients (186 vessels, 22 012 matched cross sections) were included. Deep-learning methodology provided estimations that were closer to NIRS–IVUS compared with the conventional approach for the total atheroma volume (ΔDL-NIRS–IVUS: −37.8 ± 89.0 vs. ΔConv-NIRS–IVUS: 243.3 ± 183.7 mm3, variance ratio: 4.262, P < 0.001) and percentage atheroma volume (−3.34 ± 5.77 vs. 17.20 ± 7.20%, variance ratio: 1.578, P < 0.001). The DL methodology detected lesions more accurately than the conventional approach (Area under the curve (AUC): 0.77 vs. 0.67, P < 0.001) and quantified minimum lumen area (ΔDL-NIRS–IVUS: −0.35 ± 1.81 vs. ΔConv-NIRS–IVUS: 1.37 ± 2.32 mm2, variance ratio: 1.634, P < 0.001), maximum plaque burden (4.33 ± 11.83% vs. 5.77 ± 16.58%, variance ratio: 2.071, P = 0.004), and calcific burden (−51.2 ± 115.1 vs. −54.3 ± 144.4, variance ratio: 2.308, P < 0.001) more accurately than conventional approach. The DL methodology was able to segment a vessel on CCTA in 0.3 s. Conclusions The DL methodology developed for CCTA analysis from co-registered NIRS–IVUS and CCTA data enables rapid and accurate assessment of lesion morphology and is superior to expert analysts (Clinicaltrials.gov: NCT03556644).

Objective Vital exhaustion is associated with the pathogenesis of cardiovascular disease (CVD), but its prevalence after percutaneous coronary intervention (PCI) with drug-eluting stent implantation, as well as the impact of personality on exhaustion, is not known. In PCI patients, we examined (a) the prevalence of exhaustion, (b) the impact of type-D personality on exhaustion over time, and (c) the clinical significance of type-D personality compared with gender and age as predictors of exhaustion. Methods Consecutive patients (n=419) with stable or unstable angina treated with PCI with drug-eluting stent implantation completed the Type-D Scale (DS14) at baseline and the Maastricht Questionnaire (which assesses exhaustion) at baseline and at 1 year. Results Of all patients, 53% were exhausted at baseline and at 1 year, with 41% experiencing chronic symptoms. Type-D patients [F(1, 417)=98.688; P<.001] had significantly higher exhaustion levels than non type-D patients both at the time of the index PCI and at 1 year. There was a general improvement in symptoms of exhaustion over time [F(1, 417)=5.005; P=.03], but type-D exerted a stable effect on exhaustion (P=.06). In multivariable analysis, type-D (OR=3.53; 95% CI=1.88–6.64) remained an independent predictor of exhaustion at 1 year, adjusting for demographic and clinical risk factors and exhaustion at baseline. The impact of type-D on exhaustion was large compared with a small effect for gender and age, as measured by Cohen's effect size index. Conclusions Symptoms of exhaustion were still highly prevalent in PCI patients 1 year post-PCI despite treatment with the latest technique in interventional cardiology. Type-D exerted a large and stable effect on exhaustion compared with that of gender and age. CVD research and clinical practice may benefit by adopting a personality approach in order to identify high-risk patients.

To assess the long-term outcome of patients who underwent radioactive stent (RS) implantation.The RS study population consisted of 133 consecutive patients who underwent RS implantation between November 1997 and July 2000. They were matched using the propensity score method with 266 patients who underwent bare metal stenting (BMS) in the same span. Long-term survival status and information on MACE (death, non-fatal myocardial infarction or any re-intervention) was retrospectively obtained. Eight-year cumulative survival (90.2% vs. 87.4%, p = 0.57) was similar between the RS and BMS group respectively, while 8-year cumulative MACE-free survival was significantly lower in RS patients (42.1% vs. 64.3%, p < 0.001) due to the difference in events (mainly target lesion revascularisations [TLRs]) during the first year of follow-up (cumulative 1-year MACE-free survival: 59.4% vs. 86.7%, p < 0.001); there was no difference in the MACE rate after the first year (p = 0.71). The TLR rate at six months in the RS group was 29.3%, mainly due to edge restenosis and at one year 36.2% (control group: 9.5%, p < 0.001).A high incidence of MACE and re-intervention was observed during the first year following RS implantation, mainly related to TLR for edge restenosis. After the first year, the clinical outcome of RS patients was similar to the control group indicating that there are no late adverse effects related to low dose-rate intracoronary radiation therapy.

No abstract is provided for this article.

Purpose: Retrospective evaluation of the accuracy of manual multisegmental irradiation with a source train for irradiation of long (re)stenotic lesions in coronary arteries, following percutaneous transluminal coronary angioplasty (PTCA). Material and methods: Thirty-six patients were treated with intracoronary irradiation following PTCA with manual multisegmental irradiation. These patients were included in the multicenter, multinational ‘European Surveillance Registry with the Novoste Beta-Cath system’ (RENO). In all 36 patients the target length (i.e. PTCA length plus 5-mm margin at each side) was too long for the available source train lengths (30 and 40 mm). In 33 patients the radiation delivery catheter was manually positioned twice and in three patients three times in series, trying to avoid any gap or overlap. The total number of junctions was 39. Following a successful PTCA procedure the site of angioplasty was irradiated using the Novoste Beta-Cath afterloader with a 5-F non-centered catheter which accommodates the sealed beta-emitting 90Sr/90Y source train or dummy source train. Radiation was delivered first to the distal part of the target length. Fluoroscopic images of this source position were stored in the computer memory. For irradiation of the proximal part of the target length, the delivery catheter had to be retracted over a distance equal to the source length used for the distal part. This was done by a continuous overlay video loop with ECG-gated replay of the image stored in the computer memory. The dummy source was used to position the delivery catheter so that the junction between both source positions was as precise as possible. Measurements of gap or overlap between the source positions were performed retrospectively on printed images. Doses were calculated, in accordance with the Novoste study protocol, at a distance of 2 mm from the source axis (=dose prescription distance) in several points along the irradiated length. Results: Interventional or PTCA length varied between 33 and 95 mm. The lesion sites were in the left anterior descending artery, (n=6), right coronary artery (n=20), left circumflex artery (n=6) and one vein graft. The administered radiation dose was determined by the vessel diameter and the presence of a stent. This dose, prescribed at a distance of 2 mm from the source axis, varied between 16 and 22 Gy. No gap or overlap was seen between the two source trains in only two out of 39 cases. In 16 cases there was a gap ranging between 0.6 and 9.6 mm and 18 cases showed an overlap of 0.5–14.4 mm. In three patients the measurement was not possible. In case of a gap the minimal dose calculated at 2 mm from the source axis varies between 0 and 87% of the prescribed dose, depending on the distance between both sources. In case of overlap the maximal dose varies between 110 and 200% of the prescribed dose at 2 mm from the source axis. Conclusions: The results show the inaccuracy of manual multisegmental irradiation using a source train in coronary arteries, causing unacceptable dose inhomogeneities at a distance of 2 mm from the source axis at the junction between both source positions. Moreover, a perfect junction will never be possible due to movement of the non-centered radiation delivery catheter in the vessel lumen, as applied in this study. Manual multisegmental irradiation is therefore not recommended. Using longer line sources or source trains or preferably an automated stepping source is a more reliable and safer technique for treatment of long lesions.

Background: Patients with multivessel or left main CAD treated with CABG have a small but significant improvement in angina as compared to those treated with PCI. However, there is uncertainty as to the mechanism of greater angina relief with CABG and whether the greater need for repeat revascularization in PCI patients could account for this treatment difference. Methods: In the SYNTAX trial, 1800 patients with three-vessel or left main CAD were randomized to CABG (n=897) or PCI with paclitaxel-eluting stents (n=903). Health-related quality of life was assessed at baseline, 1, 6, and 12 months using the Seattle Angina Questionnaire and the SF-36 General Health Survey. Longitudinal random effect growth curve models were used to examine the association between patient-related factors, treatment-related factors, clinical outcomes, and follow-up health status. Results: Older age, male sex, and absence of angina at baseline were associated with less angina at 12 months, whereas completeness of revascularization was not. The need for repeat revascularization was associated with worse angina frequency scores in both treatment groups, with differences in PCI patients of 7.8 points at 6 months (p&lt;0.001) and 2.9 points at 12 months (p=0.07) and in CABG patients of 16.4 points at 6 months (p&lt;0.001) and 9.1 points at 12 months (p&lt;0.001). Among patients who did not require repeat revascularization, the effect of CABG vs. PCI on 12-month angina frequency scores was 1.6 points–nearly identical to the overall benefit in the intention-to-treat analysis. Conclusions: Patients with multivessel or left main CAD who required repeat revascularization had substantially worse angina and overall health status during follow-up. However, this factor explained little of the treatment benefit observed with CABG over PCI in the overall population, suggesting that some of the anti-anginal benefit of CABG may result from mechanisms unrelated to relief of myocardial ischemia. In addition, there was a substantial difference in the magnitude of association between repeat revascularization and anginal status in patients treated with CABG as compared with PCI, suggesting that this endpoint should play a limited role in any direct comparison of the two treatment strategies.