bluuebunny/crossref_metadata_2025 huggingface dataset:
The utility of angiography-derived fractional flow reserve in predicting graft occlusions prior to bypass surgery
Authors: Buske M B , El Hadi H E , Fischer N F , Thiele H T , Majunke N M
Published: October 2024

Background

Occurrence of graft occlusion following coronary artery bypass graft (CABG) surgery has been linked to the presence of native coronary artery competitive flow (1). Despite its routine use in guiding revascularization, coronary angiography lacks sensitivity for assessing coronary stenosis significance. Data regarding the use of pressure-derived fractional flow reserve (FFR) to assess the hemodynamic significance of coronary stenoses prior to CABG are inconclusive (2) and the penetration of FFR in clinical routine is limited for various reasons (3).

Different systems have been developed to predict FFR based on coronary angiographic images, eliminating pressure wires or hyperemic agents (4). Preliminary data demonstrated a high concordance between off-site angiography-derived FFR and pressure wire–based FFR (5-7). However, the use of this technique prior to CABG is not well studied.

Purpose

This study aims to correlate pre-CABG angiography-derived FFR with graft occlusion. Secondary endpoint is the correlation between the presence of at least one occluded bypass graft and overall mortality.

Methods

Retrospective study of patients undergoing CABG in whom a follow-up angiogram has been performed. Angiography-based FFR was calculated with a dedicated software (vFFR, CAAS 8.2 Workstation, Pie Medical Imaging), obtaining each major native coronary vessel before CABG. Post-CABG angiograms were conducted at least 6 weeks post-surgery to exclude graft-failures due to technical factors and thrombosis.

Results

From 2005 and 2014, 204 patients underwent pre-CABG angiography, with post-CABG angiograms at a median of 3.85 years [IQR 1.33-8.80] post-surgery. In total, 125 patients had to be excluded due to inadequate angiogram quality for vFFR assessment (outdated imaging system, improper vessel angles, vessel overlap, insufficient contrast). Consequently, 79 patients were suitable for pre-CABG vFFR analysis, including 132 grafted vessels (93 arterial and 39 saphenous grafts). The median patient age was 68 years [IQR 58-72] and mean time for clinical follow-up was 9.9±3.6 years. Vessels analyzed using vFFR were left anterior descending (LAD) (n=60, 45.5%), left circumflex (LCX) (n=39, 29.5%), ramus intermedius (RIM) (n=8, 6.1%) and right coronary artery (RCA) (n=25, 18.9%). Mean pre-CABG vFFR was 0.59±0.15.

To predict graft occlusion, a vFFR cut-off value of 0.745 with an area under the curve (AUC) of 0.847 (95%CI 0.752–0.942) had a specificity of 0.722 and a sensitivity of 0.902 (Figure A).

There was no difference in overall-mortality when comparing patients with at least one occluded bypass graft to those without (57.1% vs. 57.9%, p=0.949, Figure B).

Conclusions

vFFR can be used as a noninvasive tool to predict graft patency in patients undergoing CABG with acceptable sensitivity and specificity. Bypass graft occlusion did not correlate with overall-survival in this cohort.
Core laboratory versus center-reported echocardiographic assessment of the native and bioprosthetic aortic valve
Authors: Velders B J J , Vriesendorp M D , Weissman N J , Sabik Iii J F , Reardon M J , Dagenais F , Moront M G , Rao V , Fukuhara S , Gunzinger R , Brown M , Groenwold R H H , Klautz R J M , Asch F M
Published: October 2024

Background

The use of a central echocardiographic core laboratory (ECL) is advised to minimize measurement variation and heterogeneity in clinical trials. Insights into quantitative differences between ECL and center-reported echocardiographic assessment of the native and bioprosthetic aortic valve are lacking. We aimed to explore clinically relevant differences between these evaluations.

Methods

Data were used from the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial for the Avalus valve. In this trial, patients with an indication for surgical aortic valve replacement (SAVR) due to aortic stenosis or regurgitation (AR) were enrolled. Serial echocardiographic examinations were performed at each center and reanalyzed by an independent ECL. For the bioprosthetic valve analysis, postoperative data throughout 5-year follow-up were pooled. Differences between the ECL and the centers in continuous parameters were quantified in mean differences and intraclass correlation coefficients (ICCs). Between-center differences were illustrated by plotting standardized mean differences (SMDs) between centers and the ECL for the 10 sites that implanted the most prostheses. Agreement on AR, paravalvular leak (PVL), and prosthesis-patient mismatch (PPM) classification was investigated using Cohen’s kappa coefficients.

Results

The analysis on the native aortic valve was performed on 1118 patients. The relative mean difference was largest for the left ventricular outflow tract (LVOT) area, followed by stroke volume and effective orifice area (index), with center-reported values being 11-7% higher (Table 1). High ICCs of around 0.90 were observed for peak aortic jet velocity, mean pressure gradient, and the velocity-time integral across the aortic valve. More than 5000 echocardiograms were available for the bioprosthetic valve analysis. Therein, comparable results were observed. In Figure 1, differences in assessment on center level are illustrated. The SMDs for peak velocity were between 0 and 0.5 for all centers, while there was more heterogeneity between centers for other parameters. The kappa coefficient was 0.59 (95% confidence interval [CI] 0.56, 0.63) for agreement on native AR, 0.28 (95% CI 0.18, 0.37) for PVL, and 0.42 (95% CI 0.40, 0.44) for PPM.

Conclusions

For echocardiographic assessment of the native and bioprosthetic aortic valve, agreement between the ECL and the clinical centers varies by parameter and by center. There is high agreement on continuous-wave Doppler-related measurements. On the contrary, agreement is low for parameters that involve measurement of the LVOT diameter. These results provide important context for the interpretation of aortic valve performance in studies that lack central ECL evaluation.
Clinical implications of hepatorenal function in patients undergoing percutaneous coronary intervention: insights from the SAKURA PCI2 registry
Authors: Sudo M , Murata N , Matsumoto M , Matsumoto N , Atsumi W , Tachibana E , Haruta H , Kougo T , Nomoto K , Arai M , Arima K , Koyama Y , Oiwa K , Okumura Y
Published: October 2024

Background

Hepatorenal function is a prognostic predictor for heart failure, cardiac surgery, and transcatheter intervention for structural heart disease. However, the clinical implications of hepatorenal function assessed by the Model for End-stage Liver Disease eXcluding International normalized ratio (MELD-XI) score is still unclear in patients undergoing percutaneous coronary intervention (PCI).

Purpose

This study aimed to clarify the association between clinical prognosis and the MELD-XI score.

Methods

We analyzed 993 patients who underwent PCI from June 2020 to July 2022 in the SAKURA PCI2 registry, a prospective multicenter registry. Patients were stratified into high (>10) or low (≤10) MELD-XI scores. Primary outcome was defined as 2-year major adverse cardio or cerebrovascular event (MACCE), including all-cause death, ischemic stroke, and non-fatal myocardial infarction. Secondary outcome was defined as major bleeding according to the Bleeding Academic Research Consortium 3 or 5.

Results

Of study participating patients, 253 patients (25.5%) were stratified into a high MELD-XI score group and had a higher prevalence of the high bleeding risk than patients with a low MELD-XI score (92.5% vs. 53.7%, p<0.01). Patients with a high MELD-XI score were associated with MACCE (13.1% vs. 2.7%, p<0.01; adjusted HR 3.78, 95%CI 1.78-8.03, p<0.01) and major bleeding (4.0% vs. 1.3%, p<0.01: unadjusted HR 3.32, 95%CI 1.35-8.18, p=0.01). Moreover, these associations remained consistent in patients with chronic and acute coronary syndrome (MACCE, p for interaction=0.89; major bleeding; p for interaction=0.64).

Conclusion

A high MELD-XI score was associated with an increased risk of MACCE and major bleeding within two years. Therefore, the MELD-XI score could provide information for risk stratification in patients undergoing PCI.Outcomes
Echocardiographic evaluation of right ventricle to pulmonary artery coupling in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis
Authors: Ananta M , Wijaya A D , Pragitara C F , Almutairi A A
Published: October 2024

Background

Right Ventricle to Pulmonary Artery (RV/PA) uncoupling, which depicts the inability of RV contractility to match the increasing RV afterload, has recently gained recognition as a simple echocardiography parameter to aid prognosis judgment in patients with RV dysfunction. In Aortic Stenosis (AS) patients, the extent of RV dysfunction and Pulmonary Hypertension (PH) has been linked with poor outcomes, but the prognostic value of RV/PA uncoupling in AS patients undergoing TAVI has not been well-defined.

Purpose

To investigate the prognostic value of RV/PA uncoupling and its association with echocardiographic parameters in AS patients undergoing TAVI.

Methods

We conducted a systematic search through Pubmed and Embase to include studies up to February 2024. Studies were eligible if they evaluated the prognostic performance of RV/PA uncoupling in AS patients undergoing TAVI. Random-effects model were employed to pool the adjusted Hazard Ratio (aHR) with inverse-variance weighting method or Relative Risk (RR) with 95% Confidence Interval (95% CI) using Mantel-Haenszel test for categorical outcomes or Weighted Mean Difference (WMD) for numerical outcomes. Risk of bias assessment was conducted using the Newcastle Ottawa Scale (NOS).

Results

Thirteen studies were included. Out of 4,146 patients, 55.21% were reported to have RV-PA uncoupling prior to TAVI. RV/PA uncoupling was customarily assessed with TAPSE/PASP ratio, with threshold for uncoupling ranging between <0.31–<0.63 mm/mmHg. Follow-up period ranged between 6–65 months. Patients with baseline RV/PA uncoupling had lower LVEF (WMD -9.94% [-4.36– -15.53%]; I2 = 78%), lower TAPSE (WMD -4.98 mm [95% CI -1.15– -8.80]; I2 = 95%), and higher PASP (WMD 19.77 [95% CI 17.02–22.51]; I2 = 0%) compared to patients with RV/PA coupling at baseline. Baseline RV-PA uncoupling was an independent predictor of all-cause mortality (pooled aHR = 2.26 (95% CI 1.36–3.76); I2 = 77%) and composite endpoint of mortality and adverse cardiac or cerebrovascular events (pooled aHR = 2.07 (1.30–3.29); I2 = 24%). However, RV/PA uncoupling was not significantly associated with a higher risk of permanent pacemaker implantation after TAVI (pooled Risk Ratio 1.02 [0.70–1.47]; I2 = 0%).

Conclusion

Pre-procedural RV/PA uncoupling emerges as an independent predictor of worse prognosis in AS patients undergoing TAVI, contributing to a better understanding of the impact of this parameter on patient outcomes.
Visual coronary artery calcium assessment on routine chest CT can readily and cheaply identify liver transplant recipients with a low cardiac risk
Authors: Groen R , Barbero F , Fischer S E , Bax J J , Tushuizen M E , Jukema J W , Coenraad M J , De Graaf M A
Published: October 2024

Background

Peri- and postoperative cardiac complications play an important role in survival of patients after liver transplantation (LT). However, the optimal approach for cardiac risk prediction in these patients has been debated on. LT recipients routinely receive non-gated computed tomography (CT) of the abdomen and chest to follow-up on their liver diseases. This study analyzed whether performance of coronary artery calcium (CAC) assessment on freely available scans can enhance cardiac risk stratification of LT recipients.

Methods

Consecutive LT recipients from 2008-2023 were included and analyzed retrospectively. CAC was scored visually on non-gated CT on a semi-quantitative ordinal scale and stratified in two groups according to CAC severity. Peri-operative (≤90 days) and post-operative all-cause mortality and cardiac events were analyzed. Furthermore, all-cause mortality and cardiac events were analyzed and compared between the groups with a Kaplan Meier curve and Cox proportional hazard regression.

Results

A total of 149 patients were included with a median age of 58 years. The median follow-up time was 5 years. The majority (74%) of patients had no or mild CAC. None of these patients died perioperatively due to cardiac causes, or experienced peri-operative cardiac events. The post-operative 10-year survival of LT recipients with no or mild calcifications was significantly better (p<0.01) than patients with severe CAC. The 10-year cardiac event-free survival was significantly better in patients with no or mild CAC (p<0.01) and the incidence increased >4-fold from only 4% in patients with no-mild CAC to 18% in patients with severe CAC. Of interest, severe CAC was a significant predictor of cardiac events (HR 4.6, p=0.02), while classical cardiovascular risk factors e.g. diabetes were not.

Conclusion

CAC assessment on routinely available non-gated CT can readily enhance peri- and postoperative cardiac risk stratification of LT recipients, as it identifies a selection of low-risk individuals for having peri- and post-operative cardiac events and all-cause mortality. Thereby, reducing test burden for the patients and saving healthcare expenses.
Location-specific prognostic significance of plaque burden, stenosis, and plaque morphology in coronary artery disease
Authors: Jukema R , Teemu Maaniitty T , Nurmohammed N S , Raijmakers P G , Planken R N , Twisk J , Van Der Harst P , Cramer M J M , Min J K , Earls J , Knaapen P , Saraste A , Knuuti J , Danad I
Published: October 2024

Background

The prognostic significance of coronary plaque localization, percentage atheroma volume (PAV), stenosis, and plaque morphology has been underexplored.

Purpose

To investigate the prognostic significance of plaque localization beyond plaque burden, presence of stenosis and plaque morphology.

Methods

Patients with no cardiac history who underwent coronary CTA were included. PAV, maximum diameter stenosis, and plaque morphology were assessed and classified into proximal, mid, or distal segments of the coronary tree. Major adverse cardiac events (MACE) were defined as death or non-fatal myocardial infarction.

Results

Among 2819 patients 267 events (9.5%) occurred during a median follow-up of 6.9 years. PAV of the proximal segments was strongly correlated to PAV localized at of the mid (R= 0.76) and distal segments (R = 0.74, p < 0.01 for both). When adjusted for traditional risk factors and presence of plaque on other locations, only proximal PAV was independently associated with MACE (3rd quartile HR 2.08, 95% 1.17–3.71, p=0.01 and 4th quartile HR 2.29, 95% CI 1.21–4.34, p=0.01). Similar results were seen for presence of stenosis. Proximal, mid, and distal PAV as a solitary metric (unadjusted) had similar predictive value for MACE with an AUC of 0.73 (95% CI 0.69-0.76) for proximal PAV and 0.72 (95% CI 0.68-0.76) for both mid and distal localized plaque). Similar results were obtained using diameter stenosis instead of PAV. The presence of low-attenuation plaque (LAP) in the proximal segments had additional prognostic value. Calcified or noncalcified PAV did not provide additional value beyond total location-specific PAV and presence of low-attenuation plaque.

Conclusions

Proximal located PAV is an independent predictor of death and non-fatal MI, while there was no incremental prognostic value of plaque localized at the mid or distal coronary segments. The presence of LAP in the proximal segments provided additional prognostic value for prediction of MACE.
Clinical experience of transapical off-pump mitral valve repair with NeoChord implantation
Authors: Kalompatsou A , Beneki E , Dimitroglou Y , Koukos M , Aggeli D , Tolis E
Published: October 2024

Introduction

Transapical off-pump mitral valve repair with NeoChord implantation is a novel minimally invasive surgical procedure to treat degenerative mitral valve regurgitation (MR). has gained widespread application for patients presenting with severe mitral regurgitation caused by leaflet prolapse or flail. However, there is a scarcity of data concerning the clinical experience with this device.

Purpose

This prospective study aims to assess 1-year clinical results of the Neochord Procedure in a consecutive cohort of patients.

Methods

Between March 2018 and December 2023, 38 patients with severe symptomatic degenerative MR were enrolled in the study. All patients presented with severe MR due to flail of 1 or both leaflets and they all completed postoperative echocardiographic assessment up to 1 year. We identified the primary endpoint as composed of procedural success , freedom from mortality, reintervention, recurrence of severe MR , and decrease of at least 1 New York Heart Association (NYHA) functional class at 1-year follow- up.

Results

Median age was 59 years (21% female). Acute procedure success (defined as successful placement of at least 3 neochords with reduction of residual MR to less than 2+) was achieved in all patients. The intraoperative and in-hospital mortality rate was 0%. At 1-year overall survival was 97% with the one reported death attributed to other causes. Following the procedure, almost all patients (94%) reported a decrease in NYHA functional class at 1-year follow-up along with a reduction in diuretic usage (18% of patients presented with NYHA Class I, while 76% of them presented with NYHA Class II). Moreover, 18% of patients exhibited mild MR, while 63% presented with moderate MR, and 10% had no detectable mitral leakage.

Conclusion

Transapical off-pump mitral valve repair with NeoChord implantation seem to be a safe procedure for patients. However, further investigations with a larger sample size and longer follow-up periods are warranted.
The usefulness of IVUS and OCT in patients treated with rotational atherectomy
Authors: Januszek R , Wanha W , Malinowski K P , Siudak Z , Kuzemczak M , Koltowski L , Jaguszewski M , Wojakowski W , Iwanczyk S , Silka W , Gladys K , Wacinski P , Grzegorek D , Dziarmaga M , Dascenzo F
Published: October 2024

Background

Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) have been shown to improve clinical outcomes of percutaneous coronary interventions (PCIs) in selected subsets of patients.

Purpose

To investigate whether the use of OCT or IVUS during PCI with rotational atherectomy (RA-PCI) will increase odds for successful revascularization defined as thrombolysis in myocardial infarction (TIMI) 3 flow.

Methods

Data were obtained from the national registry of PCIs (ORPKI) maintained by the Association of Cardiovascular Interventions (AISN) of the Polish Cardiac Society. The dataset includes PCIs spanning from January 2014 to December 2021

Results

A total of 6,522 RA-PCIs were analyzed, out of which 708 (10.9%) were guided by IVUS and 86 (1.3%) by OCT. The postprocedural TIMI 3 flow was achieved significantly more often in RA-PCIs guided by intravascular imaging (98.7% vs 96.6%, p<0.0001). Multivariable analysis revealed that using of IVUS and OCT was independently associated with an increased chance of achieving postprocedural TIMI 3 flow by 67% (odds ratio (OR), 1.67; 95% confidence interval (CI): 1.40–1.99; p<0.0001) and 66% (OR, 1.66; 95% CI: 1.09–2.54; p=0.02), respectively. Other factors associated with successful revascularization were as follows: previous PCI (OR, 1.72; p<0.0001) and coronary artery bypass grafting (OR, 1.09; p=0.002), hypertension (OR, 1.14; p<0.0001), fractional flow reserve assessment during angiogram (OR, 1.47; p<0.0001), bifurcation PCI (OR, 3.06; p<0.0001), and stent implantation (OR, 19.6, p<0.0001).

Conclusions

PCIs with rotational atherectomy guided by intravascular imaging modalities (IVUS or OCT) are associated with a higher procedural success rate compared to angio-guided procedures.
Aortic stenosis and the evolution of cardiac damage after transcatheter aortic valve replacement
Authors: Islas F , O'neill P , Gutierrez Ortiz E , Jimenez-Quevedo P , Mahia Casado P , Gil Abizanda S , De Agustin J A , Olmos Blanco C
Published: October 2024

Aims

Cardiac damage staging has been postulated as a prognostic tool in patients undergoing transcatheter aortic valve replacement (TAVR). The aim of our study is to show the echocardiographic and clinical outcome of patients one-year after TAVR.

Methods and results

Patients undergoing TAVR from 2017 to 2021 were included in a single-centre prospective registry. Transthoracic echocardiography was performed in all patients before TAVR and at one-year. Patients were classified according to a previously published staging model.1

496 patients (mean age 82.1±5.9 years, 53% female) were included. At baseline, Stage 0 included 24.5% of patients, Stage 1 included 42.8%, Stage 2 included 16.5%, and Stage 3 included 16.2% of patients. One-year overall mortality was 17.7% (n=88). Among patients who survived, after one-year of follow-up, the higher the baseline stage of cardiac damage, patients showed larger LVEDV (p= 0.223), LV mass (p= 0.207) and LAVI (p= <0.001); higher E/e’ ratio (p= 0.284) and PASP (p= <0.001). As for LVEF, at one-year; it was significantly lower the higher the baseline stage of cardiac damage (p= 0.005); the same was observed with GLS (p= <0.001) and right ventricle-arterial coupling (p= <0.001), Table 1.

Conclusions

The higher the stage of initial cardiac damage, the lower the possibility of morphological and functional improvement, despite undergoing TAVR. The use of staging systems and earlier intervention could help improve the prognosis of these patients.
Segmental post-PCI physiological gradients using ultrasonic or optical flow ratio
Authors: Chenniganahosahalli Revaiah P , Tsung-Ying T , Muramatsu T , Tanabe K , Kozuma K , Ozaki Y , Onuma Y , Serruys P W
Published: October 2024

Background

Segmental pressure gradients post percutaneous coronary intervention (PCI) may detect residual disease and potential targets for optimization. Ultrasonic flow ratio (UFR) or optical flow ratio (OFR) provide simultaneous physiological and morphological data using a single imaging catheter. Notably, both have been validated against wire based FFR

Objectives

To evaluate the utility of UFR and OFR to identify residual disease post-PCI.

Methods

The present study is a sub analysis of the ASET (Acetyl Salicylic Elimination Trial) JAPAN pilot study Phase I which showed the feasibility and safety of low dose prasugrel monotherapy following PCI in Japanese patients presenting with chronic coronary syndrome and an anatomical SYNTAX score <23. Patients with complete intra-vascular imaging pullback data were included with UFR/OFR acquired in all patients post-PCI. Quantitative and qualitative assessment of IVUS or OCT pullbacks was performed by automatically delineating vessel, lumen, and stent contours every 0.5 mm using QCU-CMS (version 4.69, Division of Image Processing, Leiden University Medical Centre).

UFR or OFR was calculated using the respective IvusPlus or OctPlus software, Pulse Medical, Shanghai, China.(13)(15) All UFR and OFR tracings, and IVUS and OCT pullbacks were analyzed at the CORRIB Core lab, Galway, Ireland by two analysts blinded to clinical and procedural data. Anatomically focal lesions distal and proximal to the stent were evaluated in segments ≥5mm long. UFR/OFR virtual pullback curves were used to calculate intra-stent pressure gradients and physiologically define lesions as focal or diffuse by segmental pressure drops ≥0.05 over lengths <10mm or ≥10mm, respectively.

Results

The median post-PCI UFR/OFR was 0.93 (0.88-0.96) with 69/195 vessels (35.4%) having a UFR/OFR≤0.90. There were significantly more focal anatomical and physiological lesions proximal and distal to the stent in vessels with a UFR/OFR≤0.90 versus >0.90. In vessels with a UFR/OFR≤0.90 there was moderate agreement (weighted kappa=0.553, p<0.001) between anatomical and physiological focal lesions proximal to the stent, whilst it was fair (weighted kappa=0.219, p=0.002) distally. In-stent gradient had poor discriminative ability to detect significant stent under-expansion. The performance of a proximal or distal virtual FFR gradient to detect proximal or distal anatomically focal disease was good (AUC–0.835 and 0.877, respectively)

Conclusions

UFR/OFR enables suboptimal vessel physiology post-PCI to be detected and helps identify the precise anatomical location with corroboration from intra-vascular imaging. Adequately powered physiology optimization trials using UFR/OFR will determine the role of combined morphology and physiological evaluation post PCI in improving clinical outcomes.
Effects of restrictive vs liberal transfusion strategies on mortality in patients with acute myocardial infarction and anemia: The 6-month follow up primary results of the MINT trial
Authors: Simon T , Brandon H E R B E T , Brooks M A R I A , Goodman S H A U N , Alexander J O H N , Steg P G , Lopes R E N A T O , Ghafghazi S H A H A B , Bouleti C L A I R E , Cooper H , Mccamant E R I C , Bainey K E V I N , Aronow H E R B E R , Hebert P A U L , Carson J
Published: October 2024

Background

The Myocardial Ischemia and Transfusion (MINT) trial identified a statistically non-significant increase in risk of 30-day death or myocardial infarction (MI) (primary endpoint) and all-cause death and a statistically significant increase in cardiac death in patients with an acute MI and anemia assigned to a restrictive transfusion strategy compared to a liberal transfusion strategy.

Purpose

To determine the effect of a restrictive versus a liberal transfusion strategy on all-cause and cause-specific death 6-months post-randomization (secondary endpoint).

Methods

The MINT trial randomized 3,504 patients with MI and hemoglobin <10 g/dL to a restrictive (hemoglobin threshold of 7 or 8 g/dL) or liberal (hemoglobin threshold of <10 g/dL) transfusion strategy implemented during the index hospitalization. Sites contacted patients at 30-days and 6-months post-randomization and recorded patient vital status, date of death, and site-reported cause of death (categorized as cardiac, non-cardiac, or unknown). A competing risk analysis (cumulative incidence estimation and Fine-Gray models) was conducted to estimate the effect of transfusion strategy on all-cause and cause-specific death.

Results

Patients were enrolled from 6 countries between 2017 and 2023; average age was 72 years, and 46% were female. Vital status at 6-months was obtained for 3419 (97.6%) randomized patients (restrictive: 98.1%; liberal: 97.0%); 2,690 (76.8%) patients were alive and 729 (20.8%) had died. At 6-months, all-cause death occurred in 376 patients in the restrictive arm (21.7%) and 353 in the liberal arm (20.5%), hazard ratio [HR]: 1.07, 95% CI: 0.93–1.24. Compared to the liberal arm, a greater proportion of deaths in the restrictive arm were cardiac (41.8% vs. 29.8%). The risk of cardiac death was significantly higher in patients in the restrictive arm (9.0% vs. 6.1%, HR: 1.52; 95% CI: 1.19–1.94) whereas risk of non-cardiac death (HR: 0.87; 95% CI: 0.70–1.08) and unknown cause of death (HR: 0.88; 95% CI: 0.64–1.21) did not differ between the restrictive and the liberal arms.

Conclusions

In patients with acute MI and anemia, the 6-month incidence of all-cause death did not differ with a restrictive versus a liberal transfusion strategy. However, the numerically higher rate of all-cause mortality, seen with the restrictive strategy at 30-days, persisted through 6-months and was driven by cardiac causes. The long-term findings from the MINT trial suggest that a restrictive transfusion strategy may be harmful for patients with MI and anemia.
Ranolazine therapy is associated with a reduced new diagnosis of diabetes mellitus in chronic coronary syndrome patients: the results of a real-world analysis of an Italian population
Authors: Fumagalli S , Dovizio M , Mazzoni S , Meto S , Fabrizzi P , Berni E , Santamaria E , Spanalatte G , Tariello A , Cagnoni C , Alla Viligiardi G , Melani L , Degli Esposti L , Marchionni N
Published: October 2024

Background

Ranolazine (Ran) is an anti-anginal drug acting as a late sodium current inhibitor at a cell membrane level. Some experimental and clinical studies showed an antihyperglycemic effect of the drug, possibly mediated by the increase of insulin secretion, the inhibition of glucagon release, and the protective action on beta-cell function. These effects, additive to the anti-anginal properties of Ran in patients with chronic coronary syndrome (CCS), could modulate and improve glucose metabolic balance. Indeed, data exploring at a population level the association of the drug with diabetes mellitus (DM) incidence are effectively lacking.

Aims

Aim of this study was to evaluate in CCS patients if the use of Ran, compared with other treatments (No-Ran), was associated with a lower incidence of DM in an Italian real-world clinical setting.

Methods

Patients included in the database of the National Health System were evaluated (N=6.1 million; about 10% of the Italian population); the recorded information concerned hospitalizations with the related diseases, clinical events, outpatient visits and drug therapy. Patients hospitalized for any cause and discharged with a diagnosis of angina between 2011 and 2020 (ICD-9-CM codes: 413-414) were included in the study after having proved the absence of DM in their medical history. Study population was divided into the Ran (at least one drug prescription) and in the No-Ran cohorts. The mean follow up was 4.3 years for the Ran and 5.0 years for the No-Ran cohorts, respectively.

Results

The study population included N=171,015 patients (mean age: 72 years, men: 66%). Among them, N=148,808 (No-Ran cohort) were treated with other therapies while N=22,207 (Ran cohort) received Ran. After propensity score matching, Ran (N=6,384) and No-Ran (N=25,536) cohorts did not differ for age, Charlson comorbidity index, use of aspirin and other antithrombotic agents, statins, beta-blockers, Ca-antagonists and nitrates. The incidence of a new diagnosis of DM during the follow-up period was 10.5 and 15.8% in the Ran and in the No-Ran cohorts, respectively (p<0.001). The Cox-regression analysis showed that Ran therapy was associated with a 30% risk reduction to present a new diagnosis of DM (HR=0.70, 95%CI: 0.64-0.76, p<0.001), independently of age, Charlson comorbidity index, heart failure, previous stroke, use of ivabradine, Ca-antagonists and nitrates.

Conclusions

This real-world study, performed in a whole subset of the Italian population, showed that, in the long-term, the incidence of a new DM diagnosis was lower in Ran users. This association could contribute to explain the benefits of the drug in patients with CCS.
Long-term outcomes of percutaneous coronary intervention versus coronary artery bypass grafting in women with severe coronary artery disease
Authors: An K R , Vervoort D , Qiu F , Tam D Y , Rocha R V , Harik L , Hirji S , Fremes S E , Wijeysundera H C , Gaudino M F L
Published: October 2024

Background

The optimal revascularization strategy for severe coronary artery disease (CAD) in women remains controversial. Despite differences between women and men in the development of CAD, there remains a paucity of comparative real-world observational evidence comparing percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in women.

Purpose

We evaluated short and long-term outcomes of PCI and CABG in women with severe CAD.

Methods

We conducted a propensity score-matched retrospective cohort study using linked clinical and administrative databases in Ontario, Canada to obtain records of women with left main, 3-vessel disease, or 2-vessel disease with proximal left anterior descending artery involvement undergoing PCI or CABG from April 1st, 2012 to December 31st, 2021. Patients who were >80 years of age and patients who underwent urgent or emergent procedures were excluded for the primary analysis. The primary outcome was a composite of myocardial infarction, stroke, repeat revascularization, and death (MACCE). Secondary outcomes included the individual components of MACCE and a composite of readmission for MI, heart failure, and stroke. Following multiple imputation and propensity score-matching, the Cox proportional hazards model and Fine-Gray sub-distribution hazard model with robust variance estimators accounting for death as a competing risk were used to evaluate long-term outcomes.

Results

In the primary cohort, 2469 patients underwent PCI and 3,721 patients underwent CABG. After propensity score matching, including by coronary disease territory, 2,033 well-balanced pairs were identified, with standardized mean differences <0.10 for all covariates. In-hospital death and stroke were significantly lower with PCI than with CABG (0.7% vs 1.5%, p=0.036) and (<0.2% vs 1.4%, p<0.001), respectively, and there was no difference in perioperative MI between PCI and CABG (1.1% vs 0.6%, p=0.121). At a median (IQR) of 5.1 (2.9-7.5) years, major adverse cardiac and cerebrovascular events (MACCE) was higher with PCI compared with CABG (37.7% vs 23.3%, HR 1.79, [95% CI: 1.66-1.91], p<0.001) (Figure 1). All-cause mortality was higher with PCI compared with CABG (17.8% vs 13.4%, HR 1.33, [95% CI: 1.21-1.45], p<0.001) (Figure 2). The composite readmission outcome (MI, heart failure, stroke) was higher with PCI compared with CABG (16.2% vs 11.2%, HR 1.42, [95% CI: 1.37-1.48], p<0.001).

Conclusion

In women with severe CAD, CABG appears to be associated with a long-term reduction in MACCE and mortality compared with PCI. Our findings provide evidence to suggest women with severe CAD may derive greater long-term benefit from CABG compared to PCI and suggest that the treatment recommendation should shift towards CABG in appropriately selected women.Figure 1.MACCE free survivalFigure 2.Overall survival
Association between average glucose concentration or glucose variability and acute kidney injury among CAD patients with prediabetes
Authors: Ren J , Wang G , Zhou Y , Gong W , Yan Y
Published: October 2024

Background

Prediabetes, impacting approximately 10% of adults, lacks comprehensive attention, and there is limited data on effective glycemic control strategies. Meta-analysis suggests that intensive glycemic control is linked to a lower incidence of major adverse cardiovascular events, mainly driven by decreased reinfarction and reduced microvascular complications in coronary artery disease (CAD) patients. However, despite these associations, existing evidence does not conclusively establish the efficacy of intensive glycemic control in enhancing cardio-renal outcomes.

Purpose

In the present study, we aimed to validate the utility of intensive glycaemic control on acute kidney injury (AKI) prevention using a prospective, pragmatic clinical data of patients with CAD.

Methods

This study utilized data from the Prospective Registry of the Current Status of Care for Patients with Coronary Artery Disease database, a nationwide and pragmatic registry project initiated on January 17th, 2022. Data, including demographics, medical history, and lab results, were collected from electronic medical records. The time-weighted average glucose (TWAG) and glucose variability (CV) for each patient to assess glycaemic control, and outcomes including AKI were assessed. Statistical analysis involved logistic models and sensitivity analyses. SAS 9.4 and R software were used, with p<0.05 considered significant.

Results

Between January 2022 and June 2023, 2,454 CAD patients with prediabetes were included for final analysis. Among them, the average age was 62.6 ± 10.3 years, of whom 27.1% were females. In univariate model, the incidence of AKI was 1.51 (1.36,1.68) times higher in patients with an increasing TWAG per mmol/L. After the stepwise adjusting of covariates, the OR was 1.50 (1.35,1.67). CV of glucose also had positive association with AKI. An increasing of 0.1 unit of CV increased the risk of about 44%. When adjusting the TWAG and CV of glucose at the same time, both still had positive association with AKI. A restricted cubic splines plot showed an increasing trend of the ORs for AKI as both TWAG and CV of glucose increased. Subgroups analyses also showed stable positive association between TWAG, CV and AKI.

Conclusions

Our study reveals an association between TWAG or CV and AKI in individuals with both CAD and prediabetes. These findings underscore the importance of continuous glucose monitoring and the implementation of intensive glycaemic control for CAD patients coexistence of prediabetes.Restricted cubic splines function
Effect of pre-procedural blood pressure on one-year cardiovascular events after percutaneous coronary intervention in patients with acute myocardial infarction
Authors: Muangsillapasart V , Shibahashi E S , Otsuki H , Jujo K , Oka T , Mori F , Tanaka H , Sakamoto T , Ishii Y , Terajima Y , Yagi M , Takagi A , Haruta S , Yamaguchi J
Published: October 2024

Background

Although high systolic blood pressure (SBP) and low diastolic blood pressure (DBP) are associated with adverse cardiovascular outcomes in coronary artery disease, their impact on patients with acute myocardial infarction (AMI) remains unclear.

Methods

This multicenter prospective study included 874 AMI patients undergoing percutaneous coronary intervention (PCI) with pre-procedural blood pressure recorded. Patients with cardiogenic shock and missing blood pressure data were excluded. The patients were categorized based on SBP (high ≥120 mmHg, low <120 mmHg) and DBP (high ≥70, low <70 mmHg) into four groups: high SBP and high DBP (HSHD), high SBP and low DBP (HSLD), low SBP and high DBP (LSHD), and low SBP and low DBP (LSLD) group. The primary endpoint was a composite of all-cause mortality, myocardial infarction, stroke, and major bleeding.

Results

The average age of the patients was 68.9 years, with a mean pulse pressure of 58 ± 19 mmHg. The Kaplan-Meier curves showed significant differences in the primary endpoints among the four groups (Log-rank test, p <0.001). At 12 months, the primary endpoint occurrence was highest in the HSLD group (13.3%) and lowest in the LSHD group (2.4%). Additionally, multivariate Cox regression analysis revealed that the HSLD group, compared to the HSHD group, was independently correlated with an increased risk of cardiovascular events (hazard ratio 2.43, 95% confidence interval 1.16-5.11; p = 0.019).

Conclusion

Pre-procedural HSLD serves as an independent predictor and is associated with one-year adverse cardiovascular outcomes in AMI patients.Patient diagramKaplan-Meier one-year outcome
Association of Neutrophil extracellular traps burden with clinical and angiographic characteristics in patients with ST-elevation myocardial infarction
Authors: Stalikas N , Tzorakoleftheraki S E , Karagiannidis E , Didagelos M , Ziakas A , Kamperidis V , Giannakoulas G , Vassilikos V , Koletsa T , Giannopoulos G
Published: October 2024

Background

The precise triggers for arterial plaque rupture and the underlying pathophysiology of thrombogenesis remain elusive. Polymorphonuclear neutrophils (PMN), particularly their formation of Neutrophil Extracellular Traps (NETs), have garnered attention in the context of coronary atherothrombosis. This study sought to explore the association of NETs burden with clinical and angiographic characteristics in ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (pPCI) and thrombus aspiration (TA).

Methods

This study included 336 consecutive STEMI patients undergoing pPCI and TA. Aspirated thrombi underwent histological analysis and NETs quantification via immunohistochemistry. Potential associations of clinical variables and angiographic outcomes with NETs burden were assessed.

Results

Manual TA was selectively performed in 72 cases with increased thrombotic burden and 60 thrombi were suitable for analysis. Most thrombi specimens displayed lytic features (63%) and almost three out of four specimens were identified as white thrombi. Increased NETs burden was significantly associated with prolonged pain-to-balloon time (>300 minutes) OR=10.29 (95% CI 2.11-42.22, p=0.001) and stress-induced hyperglycemia (SIH) OR=6.58 (95% CI 1.23-52.63, p=0.04) after multivariate regression analysis. Additionally, distal embolization (DE), a predictor of adverse outcomes, was more frequent among patients with an elevated NETs burden OR=16.9 (95% CI 4.23-44.52, p<0.001). Conversely, no significant association between NETs burden and final TIMI flow=3 was observed.

Conclusion

Elevated NETs burden in STEMI thrombi is linked to delayed reperfusion, SIH and increased risk of DE. Further research is needed to elucidate the role of NETs as a potential therapeutic target in acute atherothrombosis.
Genotype-phenotype correlation of transthyretin cardiomyopathy in patients with stage C/D heart failure: atrial and myocardial mechanics and fibrosis
Authors: Puwanant S , Phowthongkum P P , Osotthanakorn T M , Chettakulanurak K C , Bhumitrakul J B , Saicharoen K S , Tanawin Suksiriworaboot T S , Boonyaratavej S B
Published: October 2024

Objectives

We sought to investigate: (1) the relationship between transthyretin (TTR) pathogenic variants and their corresponding echocardiographic atrial and ventricular strains in patients with TTR cardiomyopathy (TTR-CM) and clinical evidence of heart failure (HF), and (2) the relationship between TTR pathogenic variants and atrial fibrosis assessed by cardiac MRI.

Methods and results

Fifty Asian patients with biopsy or scintigraphy proven TTR-CM and stage C or D (C/D) HF were identified from an advanced HF clinic in a tertiary-care university hospital. Genetic testing for the pathogenic variants in the TTR genes associated with hereditary TTR-CM (hTTR-CM) was available in 22 patients (67 ±13 years; 77% were male). Of these, 3 different mutations were identified. The most prevalent pathogenic variant was Ala97Ser (67%) followed by Val30Met (27%), and Gly67Glu (6%). Wild-type TTR-CM was diagnosed in 32% of the cohort. Strain analysis was performed using the TomTec Arena 2D-cardiac performance analysis (CPA) software. Atrial and left ventricular (LV) late gadolinium enhancement (LGE) was quantified using a 9-segment and a 17-segment model, respectively.

Patients with hTTR-CM had less impaired longitudinal strain (LS) (more negative strain values) than those with wild-type TTR-CM in the regional basal right ventricular free wall (RV-FW) (-21 ± -8.3 % vs.-12.6 ± -8.1%, p = 0.048) and LV basal inferoseptum (-7.3 ± -4.1 % vs.-3.1 ± -3.0 %, p = 0.045). In univariate analysis, more negative LS values in the basal LV inferoseptum and basal RV-FW were significant predictors of hTTR-CM (OR 5.1 and 2.3; p <0.05, respectively). However, MRI findings revealed similar regional LGE extent involving basal inferolateral segments between hTTR-CM and wild-type TTR-CM (38.3 ± 7.9 vs. 52.5 ± 34.5%, p =0.314). Left atrial (LA) and right atrial (RA) LGE was present in 90% and 81% of patients, respectively. Patients with hTTR-CM had reduced RA LGE when compared to those with wild-type TTR-CM (41% vs 67%, p =0.039).

Conclusions

In patients with TTR-CM and stage C/D HF, a reduced RA LGE extent and/or more preserved myocardial deformation in specific regions of basal LV and RV segments (basal LV inferoseptum and basal RV free wall) assessed by 2-D speckle tracking echocardiography were significantly more prevalent in patients with hTTR-CM than in wild-type TTR-CM. These echocardiographic and/or MRI findings may facilitate genotype testing in patients with TTR-CM, particularly in resource-limited settings. Further validation of these novel findings in patients with TTR-CM with HF is needed.
Combined activation of complement and coagulation is associated with myocardial injury in ST-elevation myocardial infarction
Authors: Kluge K , Halvorsen S , Andersen G Ø , Tonnessen T , Lunde I G , Hansen C H , Seljeflot I , Helseth R
Published: October 2024

Introduction

Experimental data indicates that the complement system and the coagulation cascade can activate each other. The magnitude of this interaction in acute myocardial infarction is not known. We aimed to investigate a possible association between complement activation and coagulation activation in patients with acute ST-elevation myocardial infarction (STEMI), as well as how they relate to myocardial injury estimated by troponin T (TnT) and myocardial function assessed by echocardiography.

Purpose

To increase the understanding of the interaction between complement activation and coagulation activation in STEMI, and the clinical relevance to myocardial injury.

Methods

Blood samples were drawn after percutaneous coronary intervention (PCI) in 864 patients with STEMI. Myocardial function was measured as left ventricular ejection fraction (LVEF), estimated by visual approximation or Simpson biplane method within 3 months. Complement activation was assessed by ELISA of circulating levels of the terminal complement complex (TCC). Activation of coagulation was assessed by ELISA of prothrombin fragment 1+2 (F1+2) and D-dimer, and endogenous thrombin potential (ETP), analyzed by calibrated automated thrombogram assay.

Results

TCC was weakly correlated to F1+2 (r=0.086, p=0.012), D-dimer (r=0.176, p<0.001) and ETP (r=0.144, p<0.001). In univariate linear regression analysis, this association persisted for D-dimer and ETP. When adjusting for associated covariables, the association only persisted for ETP (Table 1). Patients with above-median TCC and D-dimer had significantly higher peak TnT (Figure 1). In logistic regression, having combined above-median TCC and D-dimer was predictive of an LVEF ≤40% (Table 2).

Conclusion

In this large STEMI cohort, complement activation by TCC was weakly associated with coagulation activation. Combined high levels of TCC and D-dimer were linked to higher peak TnT and lower LVEF, possibly reflecting greater myocardial injury. The interaction between complement and coagulation activation might be relevant for clinical outcomes in STEMI patients and warrants further investigation.