Search

The medical field has seen a rapid increase in the development of artificial intelligence (AI)-based prediction models. With the introduction of such AI-based prediction model tools and software in cardiovascular patient care, the cardiovascular researcher and healthcare professional are challenged to understand the opportunities as well as the limitations of the AI-based predictions. In this article, we present 12 critical questions for cardiovascular health professionals to ask when confronted with an AI-based prediction model. We aim to support medical professionals to distinguish the AI-based prediction models that can add value to patient care from the AI that does not., Competing Interests: Conflict of interest: The authors declare no conflict of interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: Post-procedure conduction abnormalities (CA) remain a common complication of transcatheter aortic valve implantation (TAVI), highlighting the need for personalized prediction models. We used machine learning (ML), integrating statistical and mechanistic modelling to provide a patient-specific estimation of the probability of developing CA after TAVI., Methods and Results: The cohort consisted of 151 patients with normal conduction and no pacemaker at baseline who underwent TAVI in nine European centres. Devices included CoreValve, Evolut R, Evolut PRO, and Lotus. Preoperative multi-slice computed tomography was performed. Virtual valve implantation with patient-specific computer modelling and simulation (CM&S) allowed calculation of valve-induced contact pressure on the anatomy. The primary composite outcome was new onset left or right bundle branch block or permanent pacemaker implantation (PPI) before discharge. A supervised ML approach was applied with eight models predicting CA based on anatomical, procedural and mechanistic data. CA occurred in 59% of patients ( n  = 89), more often after mechanical than first or second generation self-expanding valves (68% vs. 60% vs. 41%). CM&S revealed significantly higher contact pressure and contact pressure index in patients with CA. The best model achieved 83% accuracy (area under the curve 0.84) and sensitivity, specificity, positive predictive value, negative predictive value, and F1-score of 100%, 62%, 76%, 100%, and 82%., Conclusion: ML, integrating statistical and mechanistic modelling, achieved an accurate prediction of CA after TAVI. This study demonstrates the potential of a synergetic approach for personalizing procedure planning, allowing selection of the optimal device and implantation strategy, avoiding new CA and/or PPI., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: In coronary bifurcations assessment, evaluation of side-branch (SB) ostia by an optical coherence tomography (OCT) pullback performed in the main branch (MB) could speed up lesion evaluation and minimize contrast volume. Dedicated software that reconstructs the cross-sections perpendicular to the SB centreline could improve this assessment. We aimed to validate a new method for assessing the SB ostium from an OCT pullback performed in the MB., Methods and Results: Thirty-one sets of frequency-domain OCT pullbacks from 28 patients, both from the MB and the SB of a coronary artery bifurcation were analysed. Measurements of the SB ostium from the SB pullback were used as a reference. Measurements of the SB ostium from the MB pullback were then performed in a laboratory setting by (i) conventional analysis and (ii) cut-plane analysis, and the measurement error for each analysis was estimated. Correlations of SB ostium measurements acquired from the MB pullback in comparison with reference measurements acquired from the SB pullback were higher with cut-plane analysis compared with conventional analysis, albeit not reaching statistical significance (area: rcut-plane = 0.927 vs. rconventional = 0.870, P = 0.256; mean diameter: rcut-plane = 0.918 vs. rconventional = 0.788, P = 0.056; minimum diameter: rcut-plane = 0.841 vs. rconventional = 0.812, P = 0.734; maximum diameter: rcut-plane = 0.770 vs. rconventional = 0.635, P = 0.316). Cut-plane analysis was associated with lower absolute error than conventional analysis (area: 0.56 ± 0.45, vs. 1.50 ± 1.31 mm(2), P < 0.001; mean diameter: 0.18 ± 0.14 vs. 0.44 ± 0.30 mm, P < 0.001)., Conclusion: Measurements of SB ostium performed in a laboratory setting by cut-plane analysis of an OCT pullback of the main branch have high correlation with reference measurements performed in a SB OCT pullback and lower error compared with conventional analysis., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

Aim: The aim of this study was to determine the effects of advanced chronic kidney disease (CKD) on early and late outcomes after transcatheter aortic valve implantation (TAVI), and to evaluate the predictive factors of poorer outcomes in such patients., Methods and Results: This was a multicentre study including a total of 2075 consecutive patients who had undergone TAVI. Patients were grouped according the estimated glomerular filtration rate as follows: CKD stage 1-2 (≥60 mL/min/1.73 m(2); n = 950), stage 3 (30-59 mL/min/1.73 m(2); n = 924), stage 4 (15-29 mL/min/1.73 m(2); n = 134) and stage 5 (<15 mL/min/1.73 m² or dialysis; n = 67). Clinical outcomes were evaluated at 30-days and at follow-up (median of 15 [6-29] months) and defined according to the VARC criteria. Advanced CKD (stage 4-5) was an independent predictor of 30-day major/life-threatening bleeding (P = 0.001) and mortality (P = 0.027), and late overall, cardiovascular and non-cardiovascular mortality (P < 0.01 for all). Pre-existing atrial fibrillation (HR: 2.29, 95% CI: 1.47-3.58, P = 0.001) and dialysis therapy (HR: 1.86, 95% CI: 1.17-2.97, P = 0.009) were the predictors of mortality in advanced CKD patients, with a mortality rate as high as 71% at 1-year follow-up in those patients with these 2 factors. Advanced CKD patients who had survived at 1-year follow-up exhibited both a significant improvement in NYHA class (P < 0.001) and no deterioration in valve hemodynamics (P = NS for changes in mean gradient and valve area over time)., Conclusions: Advanced CKD was associated with a higher rate of early and late mortality and bleeding events following TAVI, with AF and dialysis therapy determining a higher risk in these patients. The mortality rate of patients with both factors was unacceptably high and this should be taken into account in the clinical decision-making process in this challenging group of patients., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

Aims: To evaluate the feasibility of procedural planning for transcatheter aortic valve implantation (TAVI) using rotational angiography (R-angio) by comparison with multislice computed tomography (MSCT) and to investigate determinants of the image quality of R-angio., Methods and Results: Patients who underwent R-angio of the left ventricle and cardiac MSCT were eligible. R-angio acquisition was performed during contrast injection through a 6F pigtail catheter positioned in the left ventricle. On 3D R-angio and MSCT data sets, diameter measurements were made on short-axis images at the level of the aortic annulus (D(perimeter), D(area)), ascending aorta, sino-tubular junction (ST-junction), and the sinus of Valsalva. At the level of the aortic annulus, diagnostic image quality was obtained in 49 of 56 patients. In all patients with a body mass index (BMI) < 29 kg/m(2), image quality was acceptable whether or not rapid pacing was used. In patients with BMI ≥ 29 kg/m(2), the image quality was poor in 1 of 9 (11%) who were rapidly paced compared with 6 of 12 (50%) who were not. The correlation between R-angio and MSCT measurements was high for aortic annulus D(perimeter), D(area), ST-junction, Valsalva sinus, and ascending aorta (respectively, R = 0.90, 0.90, 0.91, 0.92, and 0.89). The correlations improved further when the analysis was limited to patients with a BMI < 29 kg/m(2) (respectively, 0.92, 0.92, 0.92, 0.92, and 0.93)., Conclusion: R-angio of the left ventricle allows precise measurement of the aortic root and annulus and was feasible for sizing at the time of TAVI. Diagnostic image quality was obtained without rapid pacing in all patients with a BMI < 29 kg/m(2).

Aims: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development., Methods and Results: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation., Conclusion: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.

Aims: To compare the global characteristics of patients with and without evidence of plaque rupture (PR) in their coronary tree and to evaluate the phenotype of ruptured plaques using intravascular ultrasound (IVUS) radiofrequency data analysis (IVUS-VH)., Methods and Results: Forty patients underwent three-vessel IVUS-VH interrogation. Twenty-eight PRs were diagnosed in 26 vessels (25.7% of the vessels studied) of 20 patients (50% of the population). Ruptures located in the left anterior descending were clustered in the proximal part of the vessel, whereas ruptures located in the right coronary artery were more distally located (P=0.02). Patients with at least one PR presented larger body mass index (BMI) (28.4+/-3.7 vs. 25.8+/-2.6 kg/m(2), P=0.01) and plaque burden (40.7+/-7.6 vs. 33.7+/-8.4%, P=0.01) than patients without rupture, despite showing similar lumen cross-sectional area (9.6+/-3.3 vs. 9.2+/-2.3 mm(2), P=0.60). Among current smokers, 66.7% presented a PR in their coronary tree. Finally, PR sites showed a higher content of necrotic core compared with minimum lumen area sites (17.48+/-10.8 vs. 13.10+/-6.5%, P=0.03) and a trend towards higher calcified component., Conclusion: Patients with at least one PR in their coronary tree presented larger BMI and worse IVUS-derived characteristics compared with patients without PR.

Aims: Revascularization in patients with coronary artery disease changed over the last two decades, favouring the number of patients treated by means of percutaneous coronary interventions (PCI) when compared with coronary artery bypass grafting (CABG). Many randomized controlled trials (RCTs) have been performed to compare these two competing revascularization techniques. Because of the strict enrolment criteria of RCTs in which highly selected patients are recruited, the applicability of the results may be limited in clinical practice. The current study evaluates to what extent patients in clinical practice were similar to those who participated in RCTs comparing PCI with CABG., Methods and Results: Clinical characteristics and 1-year outcome of 4713 patients enrolled in the Euro Heart Survey on Coronary Revascularization were compared with 8647 patients who participated in 14 major RCTs, comparing PCI with CABG. In addition, we analysed which proportion of survey patients would have disqualified for trial participation (n=3033, 64%), aiming at identifying differences between trial-eligible and trial-ineligible survey patients. In general, important differences were observed between trial participants and survey patients. Patients in clinical practice were older, more often had comorbid conditions, single-vessel disease, and left main stem stenosis when compared with trial participants. Almost identical differences were observed between trial-eligible and trial-ineligible survey patients. In clinical practice, PCI was the treatment of choice, even in patients who were trial-ineligible (46% PCI, 26% CABG, 28% medical). PCI remained the preferred treatment option in patients with multi-vessel disease (57% in trial-eligible and 40% in trial-ineligible patients, respectively, P<0.001); yet, the risk profile of patients treated by PCI was better than that for patients treated either by CABG or by medical therapy. In the RCTs, there was no mortality difference between PCI and CABG. In clinical practice, however, we observed 1-year unadjusted survival benefit for PCI vs. CABG (2.9 vs. 5.4%, P<0.001). Survival benefit was only observed in trial-ineligible patients (3.3 vs. 6.2%, P<0.001)., Conclusion: Many patients in clinical practice were not represented in RCTs. Moreover, only 36% of these patients were considered eligible for participating in a trial comparing PCI with CABG. We demonstrated that RCTs included younger patients with a better cardiovascular risk profile when compared with patients in everyday clinical practice. This study highlights the disparity between patients in clinical practice and patients in whom the studies that provide the evidence for treatment guidelines are performed.

Aims: Relative plaque composition, more than its morphology alone, is thought to play a pivotal role in determining propensity to vulnerability. Thus, we investigated in vivo whether the distance from coronary ostium to plaque location independently affects plaque composition in humans. This may help explaining the recently reported non-uniform distribution of culprit lesions along the vessel in acute coronary syndromes., Methods and Results: In 51 consecutive patients (45 men), aged 38-76 years (mean age: 58+/-10), a non-culprit vessel was investigated through spectral analysis of IVUS radiofrequency data (IVUS-Virtual Histology). The study vessel was the left anterior descending artery in 23 (45%) patients; the circumflex artery in nine (18%), and right coronary artery in 19 (37%). The overall length of the region of interest, subsequently divided into 10 mm segments, was 41.5+/-13 mm long (range: 30.2-78.4). No significant change was observed in terms of relative plaque composition along the vessel with respect to fibrous, fibrolipidic, and calcified tissue, whereas the percentage of lipid core resulted to be increased in the first (median: 8.75%; IQR: 5.7-18) vs. the third (median: 6.1%; IQR: 3.2-12) (P=0.036) and fourth (median: 4.5%; IQR: 2.4-7.9) (P=0.006) segment. At multivariable regression analysis, distance from the ostium resulted to be an independent predictor of relative lipid content [beta=-0.28 (95%CI: -0.15, -0.41)], together with older age, unstable presentation, no use of statin, and presence of diabetes mellitus., Conclusion: Plaque distance from the coronary ostium, as an independent determinant of relative lipid content, is potentially associated to plaque vulnerability in humans.

Aims: The purpose of the Euro Heart Survey Programme of the European Society of Cardiology is to evaluate to which extent clinical practice endorses existing guidelines as well as to identify differences in population profiles, patient management, and outcome across Europe. The current survey focuses on the invasive diagnosis and treatment of patients with established coronary artery disease (CAD)., Methods and Results: Between November 2001 and March 2002, 7769 consecutive patients undergoing invasive evaluation at 130 hospitals (31 countries) were screened for the presence of one or more coronary stenosis >50% in diameter. Patient demographics and comorbidity, clinical presentation, invasive parameters, treatment options, and procedural techniques were prospectively entered in an electronic database (550 variables+29 per diseased coronary segment). Major adverse cardiac events (MACE) were evaluated at 30 days and 1 year. Out of 5619 patients with angiographically proven coronary stenosis (72% of screened population), 53% presented with stable angina while ST elevation myocardial infarction (STEMI) was the indication for coronary angiography in 16% and non-ST segment elevation myocardial infarction or unstable angina in 30%. Only medical therapy was continued in 21%, whereas mechanical revascularization was performed in the remainder [percutaneous coronary intervention (PCI) in 58% and coronary artery bypass grafting (CABG) in 21%]. Patients referred for PCI were younger, were more active, had a lower risk profile, and had less comorbid conditions. CABG was performed mostly in patients with left main lesions (21%), two- (25%), or three-vessel disease (67%) with 4.1 diseased segments, on average. Single-vessel PCI was performed in 82% of patients with either single- (45%), two- (33%), or three-vessel disease (21%). Stents were used in 75% of attempted lesions, with a large variation between sites. Direct PCI for STEMI was performed in 410 cases, representing 7% of the entire workload in the participating catheterization laboratories. Time delay was within 90 min in 76% of direct PCI cases. In keeping with the recommendations of practice guidelines, the survey identified under-use of adjunctive medication (GP IIb/IIIa receptor blockers, statins, and angiotensin-converting enzyme-inhibitors). Mortality rates at 30 days and 1 year were low in all subgroups. MACE primarily consisted of repeat PCI (12%)., Conclusion: The current Euro Heart Survey on coronary revascularization was performed in the era of bare metal stenting and provides a global European picture of the invasive approach to patients with CAD. These data will serve as a benchmark for the future evaluation of the impact of drug-eluting stents on the practice of interventional cardiology and bypass surgery.

Objectives: A study was set up to validate the safety and feasibility of intravascular ultrasound-guided stenting without subsequent anticoagulation, and its impact on the 6 months restenosis rate., Methods: The study was designed to be multicentred, prospective, and observational., Results: One hundred and sixty-one patients with stable angina and a de novo coronary artery lesion were enrolled. In four patients, the implantation of a Palmaz-Schatz (with spiral bridge) stent had failed. One of these four patients died 3 days following bypass surgery. In two other patients, intravascular ultrasound assessment was not performed. One hundred and twenty-five of the remaining 155 patients (81%) were treated with aspirin (100 mg x day(-1)), because all three criteria for optimized stent expansion were met. Twenty-two of the remaining 38 patients (25%), in whom at least one criterion was not met were treated with aspirin and acenocoumarol (3 months, INR 2.5-3.5), while 16 patients only received aspirin. Stent thrombosis was documented in two patients (1.3%) for which repeat angioplasty was performed. During the hospital stay, there were no deaths or Q-wave myocardial infarctions. Five patients (3.2%) sustained a non-Q-wave myocardial infarction. During the follow-up period (198+/-38 days, complete for all patients, except one), one patient (0.6%) sustained a Q-wave myocardial infarction, one (0.6%) underwent bypass surgery, and repeat angioplasty was performed in nine patients (5.7%). In two of the nine patients, repeat angioplasty involved another lesion. Therefore, the target lesion revascularization rate during follow-up was 4.5% (seven patients). At quantitative coronary angiography, the minimal lumen diameter (mean+/-SD) increased from 1.12+/-0.34 mm before to 2.89+/-0.35 mm after stenting. Repeat angiography at 6 months was performed in 144 patients (92%). The minimal lumen diameter at follow-up was 2.12+/-0.67 mm. Restenosis (diameter stenosis of 50% or more) was documented in 12 patients or 8.3%. When the two patients with documented stent thrombosis are included, the restenosis rate amounts to 97%., Conclusions: These data confirm that, in selected patients, stents can safely be implanted without the use of systemic anticoagulation, provided optimal stent expansion is achieved. The exact role of intravascular ultrasound in the achievement of these results needs to be established by appropriately designed studies. In the meantime, intravascular ultrasound coupled with the Palmaz-Schatz stent incorporating a spiral bridge, may have contributed considerably to the immediate angiographic outcome, which in turn may explain the favourable clinical and angiographic outcome at 6 months.

Unlabelled: To study the in-hospital outcome of all coronary angioplasty procedures performed in a single centre over a 1 year period, with regard to angiographic success and the clinical complications of death, myocardial infarction, emergency coronary bypass surgery and abrupt coronary occlusion necessitating reintervention., Methods: One thousand one hundred and thirty-three lesions were treated in 970 procedures in 799 patients between October 1993 and October 1994. Clinical, procedural, angiographic and outcome data were entered into a dedicated computer data-base and variables tested with respect to outcome using the chi-square test and univariate and multivariate analysis techniques., Results: Angioplasty was performed for stable angina in 473 (49%) patients, unstable angina in 410 (42%) and 80 procedures were emergency--primary myocardial infarction in 44 (4.5%), shock in two, abrupt closure in 34 (3.5%) and other indications in seven patients. There were 10 (1.0%) deaths and 71 (7.3%) patient were documented to have suffered a myocardial infarction as a result of angioplasty. Nineteen (2.0%) patients underwent emergency coronary artery bypass surgery. Age >60 and a type C lesion were found to be associated with angiographic failure. The chance of a complication was increased if the patient was aged >60 years, suffered unstable angina, had an ejection fraction <50%, was treated with a new device or suffered a significant dissection., Conclusion: Despite refinement in techniques and increased experience, coronary angioplasty retains a significant associated chance of angiographic failure. The complication rate remains significant and there has been little reduction in mortality, infarction and abrupt closure rates over the last 15 years. The requirement for emergency coronary artery bypass surgery appears to be diminishing with the introduction of improved bail-out techniques, in particular intracoronary stenting.

With the increasing clinical application of new devices for percutaneous coronary revascularization, maximization of the acute angiographic result has become widely recognized as a key factor in maintained clinical and angiographic success. What is unclear, however, is whether the specific mode of action of different devices might exert an additional independent effect on late luminal renarrowing. The purpose of this study was to investigate such a difference in the degree of provocation of luminal renarrowing (or 'restenosis propensity') by different devices, among 3660 patients, who had 4342 lesions successfully treated by balloon angioplasty (n = 3797), directional coronary atherectomy (n = 200), Palmaz-Schatz stent implantation (n = 229) or excimer laser coronary angioplasty (n = 116) and who also underwent quantitative angiographic analysis pre- and post-intervention and at 6-month follow-up. To allow valid comparisons between the groups, because of significant differences in coronary vessel size (balloon angioplasty = 2.62 +/- 0.55 mm, directional coronary atherectomy = 3.28 +/- 0.62 mm, excimer laser coronary angioplasty = 2.51 +/- 0.47 mm, Palmaz-Schatz = 3.01 +/- 0.44 mm; P < 0.0001), the comparative measurements of interest selected were the 'relative loss' in luminal diameter (RLoss = loss/vessel size) to denote the restenosis process, and the 'relative lumen at follow-up' (RLfup = minimal luminal diameter at follow up/vessel size) to represent the angiographic outcome. For consistency, lesion severity pre-intervention was represented by the 'relative lumen pre' (RLpre = minimal luminal diameter pre/vessel size) and the luminal increase at intervention was measured as 'relative gain' (relative gain = gain/ vessel size). Differences in restenosis propensity between devices was evaluated by univariate and multivariate analysis. Multivariate models were constructed to determine relative loss and relative lumen at follow-up, taking account of relative lumen pre-intervention, lesion location, relative gain, vessel size and the device used. In addition, model-estimated relative loss and relative lumen at follow-up at given relative lumen pre-intervention relative gain and vessel size, were compared among the four groups. Significant differences were detected among the groups both with respect to these estimates, as well as in the degree of influence of progressively increasing relative gain, on the extent of renarrowing (relative loss) and angiographic outcome (relative lumen at follow-up), particularly at higher levels of luminal increase (relative gain). Specifically, lesions treated by balloon angioplasty or Palmaz-Schatz stent implantation (the predominantly 'dilating' interventions) were associated with more favourable angiographic profiles than directional atherectomy or excimer laser (the mainly 'debulking' interventions). Significant effects of lesion severity and location, as well as the well known influence of luminal increase on both luminal renarrowing and late angiographic outcome were also noted. These findings indicate that propensity to restenosis after apparently successful intervention is influenced not only by the degree of luminal enlargement achieved at intervention, but by the device used to achieve it. In view of the clinical implications of such findings, further evaluation in larger randomized patient populations is warranted.