External validation of the preHEART score and comparison with current clinical risk scores for prehospital risk assessment in patients with suspected NSTE-ACS.

BACKGROUND: Emergency Medical Services (EMS) studies have shown that prehospital risk stratification and triage decisions in patients with suspected non-ST-elevation acute coronary syndrome (NSTE-ACS) can be improved using clinical risk scores with point-of-care (POC) troponin. In current EMS studies, three different clinical risk scores are used in patients suspected of NSTE-ACS: the prehospital History, ECG, Age, Risk and Troponin (preHEART) score, History, ECG, Age, Risk and Troponin (HEART) score and Troponin-only Manchester Acute Coronary Syndromes (T-MACS). The preHEART score lacks external validation and there exists no prospective comparative analysis of the different risk scores within the prehospital setting. The aim of this analysis is to externally validate the preHEART score and compare the diagnostic performance of the these three clinical risk scores and POC-troponin. METHODS: Prespecified analysis from a prospective, multicentre, cohort study in patients with suspected NSTE-ACS who were transported to an ED between April 2021 and December 2022 in the Netherlands. Risk stratification is performed by EMS personnel using preHEART, HEART, T-MACS and POC-troponin. The primary end point was the hospital diagnosis of NSTE-ACS. The diagnostic performance was expressed as area under the receiver operating characteristic (AUROC), sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV). RESULTS: A total of 823 patients were included for external validation of the preHEART score, final hospital diagnosis of NSTE-ACS was made in 29% (n=235). The preHEART score classified 27% as low risk, with a sensitivity of 92.8% (95% CI 88.7 to 95.7) and NPV of 92.3% (95% CI 88.3 to 95.1). The preHEART classified 9% of the patients as high risk, with a specificity of 98.5% (95% CI 97.1 to 99.3) and PPV of 87.7% (95% CI 78.3 to 93.4). Data for comparing clinical risk scores and POC-troponin were available in 316 patients. No difference was found between the preHEART score and HEART score (AUROC 0.83 (95% CI 0.78 to 0.87) vs AUROC 0.80 (95% CI 0.74 to 0.85), p=0.19), and both were superior compared with T-MACS (AUROC 0.72 (95% CI 0.66 to 0.79), p≤0.001 and p=0.03, respectively) and POC-troponin measurement alone (AUROC 0.71 (95% CI 0.64 to 0.78), p<0.001 and p=0.01, respectively). CONCLUSION: On external validation, the preHEART demonstrates good overall diagnostic performance as a prehospital risk stratification tool. Both the preHEART and HEART scores have better overall diagnostic performance compared with T-MACS and sole POC-troponin measurement. These data support the implementation of clinical risk scores in prehospital clinical pathways. TRIAL REGISTRATION NUMBER: NCT05243485.

Continuous thermodilution and microvascular resistance reserve during the index procedure in acute coronary syndrome without obstructive coronary artery disease: A pilot study.

BACKGROUND: In 5%-25% of non-ST-elevation acute coronary syndrome (NSTE-ACS) patients, coronary angiography reveals no obstructive coronary arteries (MINOCA). Coronary microvascular disease (CMD) is a potential causal pathophysiological mechanism in these patients and can be diagnosed by continuous thermodilution assessment. Recently, the microvascular resistance reserve (MRR) has been introduced as a novel index to assess the vasodilatory capacity of the microcirculation. However, continuous thermodilution and MRR have never been investigated in the acute setting in MINOCA patients and invasive assessment of the microcirculation in these patients are currently lacking. AIMS: The objectives of the study were to investigate the incidence of CMD (MRR ≤ 2.7) in patients with MINOCA and to evaluate the feasibility and safety of continuous thermodilution-based assessment during index coronary angiography in the acute setting. METHODS: This study was a prospective, observational, pilot study investigating coronary physiology in the acute setting in MINOCA patients. Patients admitted with a diagnosis of NSTE-ACS were eligible for inclusion. RESULTS: In total, 19 MINOCA patients were included in this analysis; the mean age was 70 ± 9 years, and 79% were females. CMD was present in 6 patients (32%). Qrest was significantly higher in the MRR ≤ 2.7 group compared to the MRR > 2.7 group (0.076 [0.057-0.100] vs. 0.049 [0.044-0.071] L/min, p = 0.03). Rµ,rest was significantly lower in the MRR ≤ 2.7 group compared to the MRR > 2.7 group (1083 [710-1510] vs. 1563 [1298-1970] WU, p = 0.04). No periprocedural complications or hemodynamic instability have occurred during continuous thermodilution assessment during the index coronary angiography. CONCLUSION: In patients admitted for MINOCA undergoing immediate coronary angiography, continuous thermodilution assessment and MRR are feasible and safe in the acute setting, and evidence of functional CMD could be observed in one-third of the MINOCA patients.

Cardiac Health Assessment Using a Wearable Device Before and After Transcatheter Aortic Valve Implantation: Prospective Study.

Background: Due to aging of the population, the prevalence of aortic valve stenosis will increase drastically in upcoming years. Consequently, transcatheter aortic valve implantation (TAVI) procedures will also expand worldwide. Optimal selection of patients who benefit with improved symptoms and prognoses is key, since TAVI is not without its risks. Currently, we are not able to adequately predict functional outcomes after TAVI. Quality of life measurement tools and traditional functional assessment tests do not always agree and can depend on factors unrelated to heart disease. Activity tracking using wearable devices might provide a more comprehensive assessment. Objective: This study aimed to identify objective parameters (eg, change in heart rate) associated with improvement after TAVI for severe aortic stenosis from a wearable device. Methods: In total, 100 patients undergoing routine TAVI wore a Philips Health Watch device for 1 week before and after the procedure. Watch data were analyzed offline-before TAVI for 97 patients and after TAVI for 75 patients. Results: Parameters such as the total number of steps and activity time did not change, in contrast to improvements in the 6-minute walking test (6MWT) and physical limitation domain of the transformed WHOQOL-BREF questionnaire. Conclusions: These findings, in an older TAVI population, show that watch-based parameters, such as the number of steps, do not change after TAVI, unlike traditional 6MWT and QoL assessments. Basic wearable device parameters might be less appropriate for measuring treatment effects from TAVI.

A randomised trial of selective intracoronary hypothermia during primary PCI.

BACKGROUND: While experimental data suggest that selective intracoronary hypothermia decreases infarct size, studies in patients with ST-elevation myocardial infarction (STEMI) are lacking. AIMS: We investigated the efficacy of selective intracoronary hypothermia during primary percutaneous coronary intervention (PCI) to decrease infarct size in patients with STEMI. METHODS: In this multicentre randomised controlled trial, 200 patients with large anterior wall STEMI were randomised 1:1 to selective intracoronary hypothermia during primary PCI or primary PCI alone. Using an over-the-wire balloon catheter for infusion of cold saline and a pressure-temperature wire to monitor the intracoronary temperature, the anterior myocardium distal to the occlusion was selectively cooled to 30-33°C for 7-10 minutes before reperfusion (occlusion phase), immediately followed by 10 minutes of cooling after reperfusion (reperfusion phase). The primary endpoint was infarct size as a percentage of left ventricular mass on cardiovascular magnetic resonance imaging after 3 months. RESULTS: Selective intracoronary hypothermia was performed in 94/100 patients randomised to cooling. Distal coronary temperature decreased by 6°C within 43 seconds (interquartile range [IQR] 18-113). The median duration of the occlusion phase and reperfusion phase were 8.2 minutes (IQR 7.2-9.0) and 9.1 minutes (IQR 8.2-10.0), respectively. The infarct size at 3 months was 23.1±12.5% in the selective intracoronary hypothermia group and 21.6±12.2% in the primary PCI alone group (p=0.43). The left ventricular ejection fraction at 3 months in each group were 49.1±10.2% and 50.1±10.4%, respectively (p=0.53). CONCLUSIONS: Selective intracoronary hypothermia during primary PCI in patients with anterior wall STEMI was feasible and safe but did not decrease infarct size compared with standard primary PCI. (ClinicalTrials.gov: NCT03447834).

Consecutive or selectively included high bleeding risk patients in the MASTER DAPT screening log and trial.

AIMS: Screening logs have the potential to appraise the actual prevalence and distribution of predefined patient subsets, avoiding selection biases, which are inevitably and potentially present in randomised trials and real-world registries, respectively. We aimed to assess the prevalence of high bleeding risk (HBR) characteristics in the real world and the external validity of the MASTER DAPT trial. METHODS AND RESULTS: All consecutive patients who underwent percutaneous coronary intervention (PCI) for at least two consecutive weeks across 65 sites participating in the trial were entered into a screening log. Of 2,847 consecutive patients, 1,098 (38.6 %) were HBR and 109 (9.9 %) consented for trial participation. PRECISE-DAPT score ≥ 25 was the most frequent HBR feature, followed by advanced age, use of oral anticoagulation (OAC) and anaemia. Compared with consecutive HBR patients, consenting patients were older (≥ 75 years: 69 % versus 62 %, absolute standardized difference [SD] 0.16), more frequently male (78 % versus 71 %, absolute SD 0.18), had higher use of OAC (38 % versus 20 %, absolute SD 0.39), treatment with steroids or nonsteroidal anti-inflammatory drugs (10 % versus 5 %, SD 0.16), and prior cerebrovascular events (10 % versus 6 %, absolute SD 0.18) but lower PRECISE DAPT score ≥ 25 (54 % versus 66 %, absolute SD 0.24). CONCLUSIONS: The HBR criteria distribution differed between consecutive versus selectively included HBR patients, suggesting the existence of selection biases in the trial population.

Diagnostic Value of Aortic Valve Calcification Levels in the Assessment of Low-Gradient Aortic Stenosis.

BACKGROUND: In patients with low-gradient aortic stenosis (AS) and low transvalvular flow, dobutamine stress echocardiography (DSE) is recommended to determine AS severity, whereas the degree of aortic valve calcification (AVC) supposedly correlates with AS severity according to current European and American guidelines. OBJECTIVES: The purpose of this study was to assess the relationship between AVC and AS severity as determined using echocardiography and DSE in patients with aortic valve area <1 cm2 and peak aortic valve velocity <4.0 m/s. METHODS: All patients underwent DSE to determine AS severity and multislice computed tomography to quantify AVC. Receiver-operating characteristics curve analysis was used to assess the diagnostic value of AVC for AS severity grading as determined using echocardiography and DSE in men and women. RESULTS: A total of 214 patients were included. Median age was 78 years (25th-75th percentile: 71-84 years) and 25% were women. Left ventricular ejection fraction was reduced (<50%) in 197 (92.1%) patients. Severe AS was diagnosed in 106 patients (49.5%). Moderate AS was diagnosed in 108 patients (50.5%; in 77 based on resting transthoracic echocardiography, in 31 confirmed using DSE). AVC score was high (≥2,000 for men or ≥1,200 for women) in 47 (44.3%) patients with severe AS and in 47 (43.5%) patients with moderate AS. AVC sensitivity was 44.3%, specificity was 56.5%, and positive and negative predictive values for severe AS were 50.0% and 50.8%, respectively. Area under the receiver-operating characteristics curve was 0.508 for men and 0.524 for women. CONCLUSIONS: Multi-slice computed tomography-derived AVC scores showed poor discrimination between grades of AS severity using DSE and cannot replace DSE in the diagnostic work-up of low-gradient severe AS.

Prognostic Value of Microvascular Resistance Reserve After Percutaneous Coronary Intervention in Patients With Myocardial Infarction.

BACKGROUND: The microvascular resistance reserve (MRR) has recently been introduced as a novel index to assess the vasodilatory capacity of the microcirculation, independent of epicardial disease. The prognostic value of MRR in ST-segment elevation myocardial infarction (STEMI) is unknown. OBJECTIVES: The aim of this analysis was to investigate the prognostic value of MRR in patients with STEMI and to compare MRR with cardiovascular magnetic resonance imaging parameters. METHODS: From a pooled analysis of individual patient data from 6 cohorts that measured the index of microcirculatory resistance (IMR) directly after primary percutaneous coronary intervention in patients with STEMI (n = 1,265), a subgroup analysis was performed in patients in whom both MRR and IMR were available. The primary endpoint was the composite of all-cause mortality or hospitalization for heart failure. RESULTS: Both MRR and IMR could be calculated in 446 patients. The optimal cutoff of MRR to predict the primary endpoint in this STEMI population was 1.25. During a median follow-up of 3.1 years (Q1-Q3: 1.5-6.1 years), the composite of all-cause mortality or hospitalization for heart failure occurred in 27.3% and 5.9% of patients (HR: 4.16; 95% CI: 2.31-7.50; P < 0.001) in the low MRR (≤1.25) and high MRR (>1.25) groups, respectively. Both IMR and MRR were independent predictors of the composite of all-cause mortality or hospitalization for heart failure. CONCLUSIONS: MRR measured directly after primary percutaneous coronary intervention was an independent predictor of the composite of all-cause mortality or hospitalization for heart failure during long-term follow-up.

Upper extremity versus lower extremity for secondary access during transcatheter aortic valve implantation: rationale and design of the randomised TAVI XS trial.

BACKGROUND: During transcatheter aortic valve implantation (TAVI), secondary access is required for angiographic guidance and temporary pacing. The most commonly used secondary access sites are the femoral artery (angiographic guidance) and the femoral vein (temporary pacing). An upper extremity approach using the radial artery and an upper arm vein instead of the lower extremity approach using the femoral artery and femoral vein may reduce clinically relevant secondary access site-related bleeding complications, but robust evidence is lacking. TRIAL DESIGN: The TAVI XS trial is a multicentre, randomised, open-label clinical trial with blinded evaluation of endpoints. A total of 238 patients undergoing transfemoral TAVI will be included. The primary endpoint is the incidence of clinically relevant bleeding (i.e. Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding) of the randomised secondary access site (either diagnostic or pacemaker access, or both) within 30 days after TAVI. Secondary endpoints include time to mobilisation after TAVI, duration of hospitalisation, any BARC type 2, 3 or 5 bleeding, and early safety at 30 days according to Valve Academic Research Consortium­3 criteria. CONCLUSION: The TAVI XS trial is the first randomised trial comparing an upper extremity approach to a lower extremity approach with regard to clinically relevant secondary access site-related bleeding complications. The results of this trial will provide important insights into the safety and efficacy of an upper extremity approach in patients undergoing transfemoral TAVI.

Fluid-filled versus sensor-tipped pressure guidewires for FFR and Pd/Pa measurement; PW-COMPARE study.

BACKGROUND: Fluid-filled pressure guidewires are unaffected by the previously inevitable hydrostatic pressure gradient (HPG). This study aimed to compare simultaneous pressure measurements with fluid-filled and sensor-tipped pressure guidewires. METHODS: Fifty patients underwent fractional flow reserve (FFR) and Pd/Pa measurement with a fluid-filled and a sensor-tipped pressure guidewire simultaneously. To assess maneuverability, patients were randomized with respect to which pressure guidewire was used to cross the lesion first. Lateral fluoroscopy was used to estimate height difference between catheter tip and distal wire position (and thus HPG). Agreement between pressure measurements was studied. RESULTS: Measurements were performed in LM (4% (n = 2)), LAD (44% (n = 22)), LCX (26% (n = 13)), and RCA (26% (n = 13)). Simultaneous pressure measurements showed excellent agreement (mean FFR difference - 0.01 ± 0.03 (r = 0.959, p < 0.001), mean Pd/Pa difference - 0.01 ± 0.04 (r = 0.929, p < 0.001)). FFR was ≤0.80 in 42.6% (n = 20) with fluid-filled FFR measurements versus 46.8% (n = 22) by sensor-tipped FFR measurements. Mean height difference was 15 ± 34 mm, and strongly dependent on the coronary artery (LAD 45 ± 10 mm, LCX -23 ± 16 mm, RCA -13 ± 17 mm). There was a strong correlation between height difference and difference in pressure ratios between sensor-tipped and fluid-filled pressure guidewires (FFR r = -0.850, p < 0.001; Pd/Par = -0.641, p < 0.001). Largest FFR differences were present in the LAD (-0.04 ± 0.02). After HPG correction, mean difference between HPG-corrected sensor-tipped FFR and fluid-filled FFR was 0.00 ± 0.02, mean Pd/Pa difference was 0.01 ± 0.03. CONCLUSIONS: This study shows excellent overall correlation between FFR and Pd/Pa measurements with both pressure guidewires. Differences measured with fluid-filled and sensor-tipped pressure guidewires are vessel-specific and attributable to hydrostatic pressure gradients (NCT04802681).

Cost-utility analysis of TAVI compared with surgery in patients with severe aortic stenosis at low risk of surgical mortality in the Netherlands.

BACKGROUND: There is growing evidence to support the benefits of transcatheter aortic valve implantation (TAVI) over surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis (sSAS) who are at high- or intermediate-risk of surgical mortality. The PARTNER 3 trial showed clinical benefits with SAPIEN 3 TAVI compared with SAVR in patients at low risk of surgical mortality. Whether TAVI is also cost-effective compared with SAVR for low-risk patients in the Dutch healthcare system remains uncertain. This article presents an analysis using PARTNER 3 outcomes and costs data from the Netherlands to inform a cost-utility model and examine cost implications of TAVI over SAVR in a Dutch low-risk population. METHODS: A two-stage cost-utility analysis was performed using a published and validated health economic model based on adverse events with both TAVI and SAVR interventions from a published randomized low risk trial dataset, and a Markov model that captured lifetime healthcare costs and patient outcomes post-intervention. The model was adapted using Netherlands-specific cost data to assess the cost-effectiveness of TAVI and SAVR. Uncertainty was addressed using deterministic and probabilistic sensitivity analyses. RESULTS: TAVI generated 0.89 additional quality-adjusted life years (QALYs) at a €4742 increase in costs per patient compared with SAVR over a lifetime time horizon, representing an incremental cost-effectiveness ratio (ICER) of €5346 per QALY gained. Sensitivity analyses confirm robust results, with TAVI remaining cost-effective across several sensitivity analyses. CONCLUSIONS: Based on the model results, compared with SAVR, TAVI with SAPIEN 3 appears cost-effective for the treatment of Dutch patients with sSAS who are at low risk of surgical mortality. Qualitative data suggest broader societal benefits are likely and these findings could be used to optimize appropriate intervention selection for this patient population.

Evaluation of models of sequestration flow in coronary arteries-Physiology versus anatomy?

BACKGROUND: Myocardial ischaemia results from insufficient coronary blood flow. Computed virtual fractional flow reserve (vFFR) allows quantification of proportional flow loss without the need for invasive pressure-wire testing. In the current study, we describe a novel, conductivity model of side branch flow, referred to as 'leak'. This leak model is a function of taper and local pressure, the latter of which may change radically when focal disease is present. This builds upon previous techniques, which either ignore side branch flow, or rely purely on anatomical factors. This study aimed to describe a new, conductivity model of side branch flow and compare this with established anatomical models. METHODS AND RESULTS: The novel technique was used to quantify vFFR, distal absolute flow (Qd) and microvascular resistance (CMVR) in 325 idealised 1D models of coronary arteries, modelled from invasive clinical data. Outputs were compared to an established anatomical model of flow. The conductivity model correlated and agreed with the reference model for vFFR (r = 0.895, p < 0.0001; ＋0.02, 95% CI 0.00 to ＋ 0.22), Qd (r = 0.959, p < 0.0001; -5.2 mL/min, 95% CI -52.2 to ＋13.0) and CMVR (r = 0.624, p < 0.0001; ＋50 Woods Units, 95% CI -325 to ＋2549). CONCLUSION: Agreement between the two techniques was closest for vFFR, with greater proportional differences seen for Qd and CMVR. The conductivity function assumes vessel taper was optimised for the healthy state and that CMVR was not affected by local disease. The latter may be addressed with further refinement of the technique or inferred from complementary image data. The conductivity technique may represent a refinement of current techniques for modelling coronary side-branch flow. Further work is needed to validate the technique against invasive clinical data.

Is the Corrected Carotid Flow Time a Clinically Acceptable Surrogate Hemodynamic Parameter for the Left Ventricular Ejection Time?

OBJECTIVE: The corrected left ventricular ejection time (cLVET) comprises the phase from aortic valve opening to aortic valve closure corrected for heart rate. As a surrogate measure for cLVET, the corrected carotid flow time (ccFT) has been proposed in previous research. The aim of this study was to assess the clinical agreement between cLVET and ccFT in a dynamic clinical setting. METHODS: Twenty-five patients with severe aortic valve stenosis (AS) were selected for transcatheter aortic valve replacement (TAVR). The cLVET and ccFT were derived from the left ventricular outflow tract (LVOT) and the common carotid artery (CCA), respectively, using pulsed wave Doppler ultrasound. Bazett's (B) and Wodey's (W) equations were used to calculate cLVET and ccFT. Measurements were performed directly before (T1) and after (T2) TAVR. Correlation, Bland-Altman and concordance analyses were performed. RESULTS: Corrected LVET decreased from T1 to T2 (p < 0.001), with relative reductions of 11% (B) and 9% (W). Corrected carotid flow time decreased (p < 0.001), with relative reductions of 12% (B) and 10% (W). The correlation between cLVET and ccFT was strong for B (ρ = 0.74, p < 0.001) and W (ρ = 0.81, p < 0.001). The bias was -39 ms (B) and -37 ms (W), and the upper and lower levels of agreement were 19 and -98 ms (B) and 5 and -78 ms (W), respectively. Trending ability between cLVET and ccFT was good (concordance 96%) for both B and W. CONCLUSION: In TAVR patients, the clinical agreement between cLVET and ccFT was acceptable, indicating that ccFT could serve as a surrogate measure for cLVET.

Prehospital risk assessment and direct transfer to a percutaneous coronary intervention centre in suspected acute coronary syndrome.

OBJECTIVE: Prehospital risk stratification and triage are currently not performed in patients suspected of non-ST-segment elevation acute coronary syndrome (NSTE-ACS). This may lead to prolonged time to revascularisation, increased duration of hospital admission and higher healthcare costs. The preHEART score (prehospital history, ECG, age, risk factors and point-of-care troponin score) can be used by emergency medical services (EMS) personnel for prehospital risk stratification and triage decisions in patients with NSTE-ACS. The aim of the current study was to evaluate the effect of prehospital risk stratification and direct transfer to a percutaneous coronary intervention (PCI) centre, based on the preHEART score, on time to final invasive diagnostics or culprit revascularisation. METHODS: Prospective, multicentre, two-cohort study in patients with suspected NSTE-ACS. The first cohort is observational (standard care), while the second (interventional) cohort includes patients who are stratified for direct transfer to either a PCI or a non-PCI centre based on their preHEART score. Risk stratification and triage are performed by EMS personnel. The primary endpoint of the study is time from first medical contact until final invasive diagnostics or revascularisation. Secondary endpoints are time from first medical contact until intracoronary angiography (ICA), duration of hospital admission, number of invasive diagnostics, number of inter-hospital transfers and major adverse cardiac events at 7 and 30 days. RESULTS: A total of 1069 patients were included. In the interventional cohort (n=577), time between final invasive diagnostics or revascularisation (42 (17-101) hours vs 20 (5-44) hours, p<0.001) and length of hospital admission (3 (2-5) days vs 2 (1-4) days, p=0.007) were shorter than in the observational cohort (n=492). In patients with NSTE-ACS in need for ICA or revascularisation, healthcare costs were reduced in the interventional cohort (€5599 (2978-9625) vs €4899 (2278-5947), p=0.02). CONCLUSION: Prehospital risk stratification and direct transfer to a PCI centre, based on the preHEART score, reduces time from first medical contact to final invasive diagnostics and revascularisation, reduces duration of hospital admission and decreases healthcare costs in patients with NSTE-ACS in need for ICA or revascularisation. TRIAL REGISTRATION: NCT05243485.

Generation of synthetic aortic valve stenosis geometries for in silico trials.

In silico trials are a promising way to increase the efficiency of the development, and the time to market of cardiovascular implantable devices. The development of transcatheter aortic valve implantation (TAVI) devices, could benefit from in silico trials to overcome frequently occurring complications such as paravalvular leakage and conduction problems. To be able to perform in silico TAVI trials virtual cohorts of TAVI patients are required. In a virtual cohort, individual patients are represented by computer models that usually require patient-specific aortic valve geometries. This study aimed to develop a virtual cohort generator that generates anatomically plausible, synthetic aortic valve stenosis geometries for in silico TAVI trials and allows for the selection of specific anatomical features that influence the occurrence of complications. To build the generator, a combination of non-parametrical statistical shape modeling and sampling from a copula distribution was used. The developed virtual cohort generator successfully generated synthetic aortic valve stenosis geometries that are comparable with a real cohort, and therefore, are considered as being anatomically plausible. Furthermore, we were able to select specific anatomical features with a sensitivity of around 90%. The virtual cohort generator has the potential to be used by TAVI manufacturers to test their devices. Future work will involve including calcifications to the synthetic geometries, and applying high-fidelity fluid-structure-interaction models to perform in silico trials.

Secondary retensioning of a tether-based device for transapical transcatheter mitral valve implantation.

OBJECTIVES: Relevant paravalvular leakage (PVL) due to prosthesis dislodgement is a rare but potentially severe complication after transcatheter mitral valve implantation (TMVI). Due to the epicardial anchoring mechanism of the Tendyne® TMVI system, repositioning of the valve stent may be possible by retensioning of the tether. This multicentre study aimed to investigate the procedural and short-term safety as well as efficacy of retensioning manoeuvres. METHODS: From 2017 to 2021, N = 18 patients who underwent secondary tether retensioning were identified. Baseline, procedural and follow-up data were available from N = 11 patients and analysed according to the Mitral Valve Research Consortium definitions. Continuous variables are shown as median with interquartile range. RESULTS: All patients [age 75 years (73.5, 85.0), 64% male (N = 7), EuroSCORE II 6.2% (5.8, 11.6)] presented with post-procedural PVL [63.6% (N = 7) with PVL ≥3+]. Of these, 54% (N = 6) showed signs of haemolysis. The majority were severely symptomatic [New York Heart Association ≥III (91%, N = 10)]. Procedural outcomes revealed no acute complications and no mortality. At discharge, PVL was completely eliminated in 91% (N = 10) of patients with 1 case of remaining moderate PVL. At 30 days, Mitral Valve Research Consortium device success was achieved in 82% (N = 9) of patients. Two patients required open surgical mitral valve replacement due to persistent and recurrent PVL. In 89% (N = 8) of patients with successful retensioning procedure, New York Heart Association class was I/II. There was no 30-day mortality. CONCLUSIONS: This multicentre study demonstrates technical feasibility, procedural safety and acute efficacy of retensioning procedures in the majority of patients. The potential to retension the tether in transapical TMVI may provide additional management advantages in populations at high surgical risk.

Predicting target lesion failure following percutaneous coronary intervention through machine learning risk assessment models.

Aims: Central to the practice of precision medicine in percutaneous coronary intervention (PCI) is a risk-stratification tool to predict outcomes following the procedure. This study is intended to assess machine learning (ML)-based risk models to predict clinically relevant outcomes in PCI and to support individualized clinical decision-making in this setting. Methods and results: Five different ML models [gradient boosting classifier (GBC), linear discrimination analysis, Naïve Bayes, logistic regression, and K-nearest neighbours algorithm) for the prediction of 1-year target lesion failure (TLF) were trained on an extensive data set of 35 389 patients undergoing PCI and enrolled in the global, all-comers e-ULTIMASTER registry. The data set was split into a training (80%) and a test set (20%). Twenty-three patient and procedural characteristics were used as predictive variables. The models were compared for discrimination according to the area under the receiver operating characteristic curve (AUC) and for calibration. The GBC model showed the best discriminative ability with an AUC of 0.72 (95% confidence interval 0.69-0.75) for 1-year TLF on the test set. The discriminative ability of the GBC model for the components of TLF was highest for cardiac death with an AUC of 0.82, followed by target vessel myocardial infarction with an AUC of 0.75 and clinically driven target lesion revascularization with an AUC of 0.68. The calibration was fair until the highest risk deciles showed an underestimation of the risk. Conclusion: Machine learning-derived predictive models provide a reasonably accurate prediction of 1-year TLF in patients undergoing PCI. A prospective evaluation of the predictive score is warranted. Registration: Clinicaltrial.gov identifier is NCT02188355.

Percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis.

OBJECTIVE: The importance of revascularisation of significant coronary artery disease (CAD) in patients undergoing transcatheter aortic valve implantation (TAVI) is unclear. Despite the lack of randomised controlled trials comparing different revascularisation strategies, guidelines currently recommend percutaneous coronary intervention (PCI) in patients with significant proximal CAD undergoing TAVI. METHODS: In this systematic review and meta-analysis, a systematic search was conducted to identify studies comparing TAVI with and without PCI in patients with significant CAD on pre-TAVI coronary angiography. Endpoints were all-cause mortality, cardiac death, stroke, myocardial infarction and major bleeding. RESULTS: In total, 14 studies were included, involving 3838 patients, of whom 1806 (47%) underwent PCI before TAVI. All-cause mortality did not differ significantly between TAVI with and without preceding PCI at 30 days, 1 year and > 1 year. There were no significant differences in risk of cardiac death, stroke or myocardial infarction between the groups. However, TAVI performed with PCI resulted in a higher risk of major bleeding within 30 days after TAVI (odds ratio: 0.66; 95% confidence interval: 0.46-0.94). CONCLUSION: This systematic review and meta-analysis showed no significant differences in clinical outcomes between patients with concomitant significant CAD who were treated with TAVI with and without preceding PCI at both short- and long-term follow-up. However, there was a higher risk of major bleeding at 30 days in patients undergoing TAVI with preceding PCI. In the context of serious risk of bias in the included studies, results of randomised controlled trials are warranted.

Outcomes of emergent cardiac surgery after transcatheter aortic valve implantation.

OBJECTIVE: The aim of this study was to evaluate the reasons for emergent cardiac surgery (ECS) after transcatheter aortic valve implantation (TAVI) and assess outcomes of these patients. METHODS: All patients undergoing ECS following a complicated TAVI procedure at a high-volume TAVI centre in the Netherlands from 1 January 2008 to 1 April 2022 were included. Baseline and procedural characteristics and outcome data (procedural, 30-day and 1­year mortality, in-hospital stroke, 30-day pacemaker implantation, 30-day vascular complications, 30-day deep sternal wound infections and 30-day re-exploration) were collected from patient files and analysed using descriptive statistics. RESULTS: During the study period, 16 of 1594 patients (1.0%) undergoing TAVI required ECS. The main reason for ECS was valve embolisation (n = 9; 56.3%), followed by perforation of the left/right ventricle with guide wire/pacemaker lead (n = 3; 18.8%) and annular rupture (n = 3; 18.8%). Procedural, 30-day and 1­year mortality was 0%, 18.8% (n = 3) and 31.3% (n = 5), respectively. In-hospital stroke occurred in 1 patient (6.3%), a pacemaker was implanted at 30 days in 2 patients (12.5%), and major vascular complications did not occur. CONCLUSION: ECS following complicated TAVI was performed in only a small number of cases. It had a high but acceptable perioperative and 30-day mortality, taking into account the otherwise lethal consequences. In case of valve embolisation, no periprocedural or 30-day mortality was observed for surgical aortic valve replacement (even in a redo setting), which supported the necessity to perform TAVI in centres with cardiac surgical backup on site.

Results of systematic patient outcome monitoring: Does post-dilatation during angiography-guided percutaneous coronary intervention improve clinical outcomes?

OBJECTIVES: This study evaluates clinical outcomes after implementing a liberal post-dilatation strategy during PCI. BACKGROUND: Post-dilatation after percutaneous coronary intervention (PCI) is performed to achieve optimal stent expansion and reduce complications. However, its prognostic effects are unclear and conflicting. METHODS: This study is a pre-post-intervention analysis of two cohorts, before (2015-2017) and after (2018-2020) implementation of a liberal post-dilatation strategy. The primary end point consisted of major adverse cardiovascular events (MACE) at 30 days. Secondary end points consisted of the individual components of the primary end point as well as 1 year mortality and target vessel revascularization. RESULTS: A total of 10,153 patients were included: 5,383 in the pre-cohort and 4,770 in the post-cohort. The 30-day MACE was 5.00% in the pre-cohort and 4.09% in the post-cohort (p = 0.008; OR 0.75 (CI 0.61-0.93)). There was a significant difference between the pre- and post-cohort in 30-day mortality, respectively, 2.91% and 2.25% (p = .01; OR 0.70 (CI 0.53-0.93)), and MI at 30 days, 1.17% versus 0.59% (p = .003; OR 0.49 (CI 0.31-0.78)). At 1 year, there was a significant difference in mortality between the pre-cohort, 5.84%, and post-cohort, 5.19% (p = .02; OR 0.79 (CI 0.66-0.96)). CONCLUSIONS: A liberal post-dilatation strategy after PCI was associated with a significant decrease in 30-day MACE, 30-day MI, 30-day mortality, and 1-year mortality. Future studies are warranted to validate the causality between post-dilatation and improvement of clinical outcomes.