bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of intravascular ultrasound parameters on revascularization decision in grey zone fractional flow reserve: data from IRIS FFR registry
Authors: Kang D Y , Lee J M , Ahn J M , Park Y S , Choi Y , Lee J H , Kim M J , Park D W , Park S J
Published: November 2023

Background

The optimal revascularization strategy for coronary stenosis with grey-zone fractional flow reserve (FFR) value (0.75-0.80) is still debated. This study investigated the prognostic impact of the lesion characteristics measured by intravascular ultrasound (IVUS) in grey-zone FFR.

Methods

A total of 734 native coronary stenoses with grey-zone FFR in 734 patients from the prospective multicenter IRIS-FFR registry were simultaneously evaluated by IVUS. The primary outcome was a composite of cardiac death, myocardial infarction and target vessel revascularization.

Results

Among the 734 patients, revascularization was deferred for 293 patients and performed for 441. During a median follow-up of 4.4 years, the primary outcome occurred in 31 (10.6%) patients in deferred group and 42 (9.5%) in performed group. With the best cut-off values of 2.62 mm2 (area under curve 0.64) and 75% (area under curve 0.63), respectively, the minimal lumen area (MLA) and plaque burden (PB) at the MLA site were significant predictors of the primary outcome in the deferred group, whereas they were not predictive in the performed group. Revascularization performed group showed lower incidence rate of the primary outcome than deferral group in 348 patients with smaller MLA (<2.62 mm2) and larger PB (>75%) (19.3% vs. 36.8%, hazard ratio 0.58, 95% confidence interval [CI] 0.34-0.91, P=0.017), whereas other patients showed similar incidence rate of primary outcome between two groups (15.7% vs. 19.8%, hazard ratio 0.78, 95% CI 0.47-1.31, P=0.35).

Conclusions

For coronary stenoses with grey-zone FFR and smaller MLA and larger PB measured by IVUS, revascularization was associated with better clinical outcomes than deferral. The incorporation of FFR and IVUS may improve the revascularization decision in native coronary stenoses with grey-zone FFR.
Preliminary results of the feasibility and precision of optical coherence tomography guided and robotic-assisted PCI (Robo-OCT) study
Authors: Rilinger J , Jeuck M , Heidt T , Hartikainen T S , Westermann D , Von Zur Muehlen C
Published: November 2023

Background/Introduction

Optical coherence tomography (OCT) allows high resolution characterisation of coronary lesions as well as optimization of stent implantation and detection of stent-related mechanical problems leading to restenosis. Robotic assisted PCI (R-PCI) additionally enables highly precise stent positioning. Therefore, the combination of OCT with R-PCI might further improve outcome of PCI – based on a highly individualized planning of the PCI procedure, highly precise conduction of the procedure, quality assessment of stent placement, and in parallel protection of the personnel.

Purpose

Analyse the technical feasibility and safety of R-PCI and OCT.

Methods

We report preliminary data of our ongoing feasibility study of combining R-PCI with OCT (DRKS-Nr. DRKS00024995). In this pilot study, first the technical feasibility and safety of a joint application of OCT and R-PCI were investigated. Moreover, R-PCI success and quality were evaluated by post-PCI OCT imaging.

Results

In the eight patients treated so far, a technical success rate of 100% was achieved. However, as the mechanics of the cassettes device drive damage the sensitive OCT catheter, manual insertion of the OCT catheter via the passive drive had to be performed in all cases. Rate of complications (MACE: cardiac death, cerebrovascular event (stroke), documented myocardial infarction, target lesion repeated revascularization (PCI and/or CABG), dissection or occlusion) was 0%.

Post-PCI OCT showed neither major (≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length) nor minor (<60 degrees of the circumference of the vessel and < 3 mm in length) edge dissections (both 0%). Furthermore, the rate of untreated reference segments (focal disease with untreated Mean Lumen Area (MLA) < 4.5 mm2 within 5 mm from the proximal and/or distal stent edges) was 0%.

Conclusion

Preliminary results of the Robo-OCT feasibility study showed a high technical success rate of the combination of OCT with robotic assisted PCI without any complications or vessel injuries proven by OCT.
Long-term association of post stent fractional flow reserve with clinical events
Authors: Hwang D , Chung J , Lee J M , Lee H J , Nam C W , Shin E S , Doh J H , Matsuo A , Matsuo H , Chen S L , Kakuta T , Koo B K
Published: November 2023

Background

Low fractional flow reserve (FFR) after percutaneous coronary intervention (PCI) is associated with procedural factors in the stented segment and residual disease in the non-stented segment. Even the prognostic value of post-PCI FFR has been reported, its long-term clinical relevance has not been thoroughly investigated.

Purpose

We sought to investigate the long-term prognostic value of post-PCI FFR and its relative significance on future events in stented and non-stented segments.

Methods

The International Post-PCI FFR extended registry (NCT04684043) followed the 2,200 patients who underwent PCI and measured post-PCI FFR between June 2011 and May 2018. The primary outcome was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction (TVMI), and target vessel revascularization (TVR) at 5 years. The secondary outcomes were a composite of cardiac death or TVMI at 5 years.

Results

The median value of post-PCI FFR of target vessels was 0.89 (IQR 0.84-0.93). The optimal cut-off value of post-PCI FFR for predicting TVF was 0.81, and that for predicting cardiac death or TVMI was 0.76, respectively. The cumulative incidence of TVF was significantly higher in the low post-PCI group (20.5%) than in the high post-PCI FFR group (10.3%) (adjusted hazard ratio [HR] 2.11, 95% confidence interval [CI] 1.56-2.86, p<0.001). The cumulative incidence of cardiac death or TVMI was also significantly higher in the low post-PCI FFR group (7.3%) than in the high post-PCI FFR group (3.2%) (adjusted HR 2.34, 95% CI 1.12-4.91, p=0.024). Landmark analysis at 2 years showed that the impact of post-PCI FFR on TVF was consistently found during the first 2 years (adjusted HR of low post-PCI FFR 2.22, 95% CI 1.54-3.21, p<0.001) and thereafter (adjusted HR of low post-PCI FFR 1.96, 95% CI 1.14-3.36, p<0.001). However, the impact of post-PCI FFR on cardiac death or TVMI was more significant after 2 years of follow-up (adjusted HR of low post-PCI FFR 2.01, 95% CI 0.66-6.11, p=0.217 for the first 2 years and adjusted HR of low-post PCI FFR 2.81, 95% CI 1.04-7.60, p=0.042). The cumulative incidence of TVR was 9.5% for 5 years, and 61.0% of TVRs occurred in the stented segment. However, the proportion of TVRs in the non-stented segment increased along with the decrease of post-PCI FFR (35.3% in post-PCI FFR more than 0.90, 34.1% in post-PCI FFR 0.81-0.90, 43.8% in post-PCI FFR 0.71-0.80, and 66.7% in post-PCI FFR 0.70 and less than 0.70, p-for trend<0.001).

Conclusions

The long-term outcome results of the Internation Post-PCI FFR Extended registry showed that the prognostic impact of post-PCI FFR on TVF was consistently found along with the follow-up. However, that of post-PCI FFR on cardiac death or TVMI was more prominent during the late period of follow-up. In addition, clinical event distribution was different according to post-PCI FFR values.
New criteria to identify patients at higher risk for cardiovascular complications after percutaneous coronary intervention
Authors: Brener S J , Spirito A , Sharma A , Cao D , Sartori S , Zhang Z , Nicolas J , Pivato C A , Cohen R , Baber U , Sweeny J , Sharma S K , Dangas G , Kini A , Mehran R
Published: November 2023

A universal definition to identify patients at higher risk of complications after percutaneous coronary intervention (PCI) is lacking. We aimed to validate a recently developed score to identify patients at increased risk of all-cause death after PCI. All consecutive patients from a large PCI registry not presenting with ST-elevation myocardial infarction or cardiogenic shock were included. Each patient was assigned a score obtained by summing the points associated with the following variables: age >80 years (3 points), dialysis (6 points), left ventricular ejection fraction <30% (2 points), and multivessel PCI (2 points). Patients were stratified in 3 groups: low risk (score 0), intermediate risk (score 2 to 3), or high risk (score ≥4). The primary outcome was all-cause death, and the secondary outcomes were major adverse cardiovascular events and major bleeding. Events were assessed at 1 year after PCI. Between January 2014 and December 2019, 12,689 patients underwent PCI. Compared with the 9,884 patients at low risk, those at intermediate and high risk had a fourfold (hazard ratio 3.99, 95% confidence interval 2.95 to 5.38) and ninefold (hazard ratio 9.55, 95% confidence interval 6.89 to 13.2) higher hazard for all-cause death at 1 year, respectively. The score had a good predictive value for all-cause death at 1 year (area under the curve 0.70). The risk of major adverse cardiovascular events and major bleeding increased consistently from the low- to the high-risk group. In conclusion, in patients who underwent PCI for stable ischemic heart disease or non−ST-elevation acute coronary syndrome, a score based on 4 variables well predicted the risk of all-cause death at 1 year.Derivation of risk scoreAll-cause death rate at 1 year
Incidence and determinants of non-radial vascular approach for coronary angiography among heart transplant recipients
Authors: Procopi N , Guedeney P , Zeitouni M , Kerneis M , Barthelemy O , Le Feuvre C , Silvain J , Berman E , Coutance G , Varnous S , Leprince P , Lebreton G , Collet J P , Montalescot G , Helft G
Published: November 2023

Background

Repeated coronary angiograms may be required among heart transplant (HT) recipients to detect coronary allograft vasculopathy (CAV), exposing to higher risk of non-radial vascular approach over time.

Objective

To describe the incidence and determinants of non-radial vascular approach in this specific population in a large HT center.

Methods

Consecutive HT recipients undergoing coronary angiography between October 2020 to November 2022 at our Hospital, the largest French HT center, were included and all previous coronary angiograms performed after heart transplantation were retrospectively reviewed. A radial vascular approach has systematically been the first-line approach for coronary angiography in the last two decades. Coronary angiography is routinely performed one year after heart transplantation and every couple of years thereafter or more frequently in case of CAV progression or clinical indication. Determinants of non-radial vascular approach were assessed using multivariate logistic regression analyses, which included the individual mean number of coronary angiographies per year after heart transplantation to account for disparities in follow-up between the two groups.

Results

A total of 326 patients were included during the period of interest, with a median number of 4 (1-7) coronary angiographies performed over a median duration of 7.0 (1.8-13.1) years (Table 1). A non-radial approach was used in 108 (33.1%) patients, after a median delay from HT of 3.0 (1.0 - 8.4) years (Figure 1). Independent determinants of non-radial approach were female sex (Odds Ratio [OR] 2.18, 95% confidence interval [CI] 1.06 – 4.50), older age at the time of HT (OR 0.98 95%CI 0.96-0.99), post-transplantation dialysis (OR 7.34, 95%CI 2.41 – 22.30) and the development of type 3 CAV according to the International Society Heart and Lung Transplantation (ISHLT) classification (OR 2.01, 95%CI 1.20 – 3.35. Severe complications related to the vascular approach remained rare.

Conclusions

Non-radial vascular approach remains frequent among HT recipients.

In a center of high HT volume and high radial access volume, non-radial vascular approach is used in one out of three HT recipients with multifactorial reasons.
Lipid lowering treatment after percutaneous coronary intervention: data from the large contemporary ZON-HR registry
Authors: Peeters D A M , Woelders E C I , Luijkx J J P , Winkler P J C , Damman P , Remkes W S , Van 'T Hof A W J , Van Geuns R J M
Published: November 2023

Background

Low density lipoprotein-C (LDL-C) reduction in patients who underwent percutaneous coronary intervention (PCI) is recommended by ESC guidelines to prevent ischemic events. This is mainly achieved by secondary prevention with lipid lowering treatment. The ‘’Zuid-Oost Nederland Heart Registry’’ (ZON-HR) is a multicentre prospective registry designed to improve secondary prevention after PCI by a patient-tailored approach.

Purpose

To describe the use of lipid lowering treatment in patients who underwent PCI in the ZON-HR.

Methods

Since November 2020 data from all 4628 patients who underwent PCI were included in four hospitals. Patient characteristics, LDL-C values at baseline and medication at discharge were collected. The association between predefined variables and lipid lowering treatment was assessed with multivariable logistic regression.

Results

LDL-C at baseline was available in 2325 patients. The mean age was 67.8 year and 73.5% was male (table 1). ACS patients had a significantly higher baseline LDL-C value compared with CCS patients (2.81 mmol/l vs 2.45 mmol/l). However, even in CCS patients LDL-C values were >2 mmol/L. There was a different pattern in lipid lowering treatment at discharge after ACS or CCS. Statins were prescribed significantly more frequent in ACS patients, while ezetimibe was prescribed significantly more frequent in CCS patients compared to ACS patients. Mono and combination therapy was prescribed more often in ACS patients compared to CCS patients.

Increasing age and CCS indication for PCI were predictors for not receiving any lipid lowering medication at discharge. Also, patients with a higher LDL-C baseline value had a smaller chance to receive lipid lowering medication at discharge.

Conclusion

LDL-C reduction is the cornerstone of secondary prevention after PCI for CCS and ACS. 8.9% of ACS and 18.2% of CCS patients receive no lipid lowering treatment. Also, patients with scheduled PCI (CCS) had LDL-C values above target. Age and CCS are independent predictors for not receiving lipid lowering treatment. ZON-HR will develop and integrate initiatives to improve lipid lowering secondary prevention.Baseline characteristicsPredictors lipid lowering medication
Impact of coronary computed tomography angiography derived full Moon calcifications in CTO-PCI
Authors: Panuccio G , Tonini G , Erbay A , Skurk C , Landmesser U , Werner G , Leistner D M , Abdelwahed Y
Published: November 2023

Background

There is an increasing incidence of chronic total coronary occlusions (CTO). CTO are complex coronary lesions and known to represent a technical challenge for percutaneous recanalization procedures. However, the success rates of CTO- percutaneous coronary interventions (CTO-PCI) have increased tremendously with the continuous innovations in equipment and procedural techniques. Circular heavily calcified "Full Moon"- like plaques have been observed in CTO patients, however their frequency and relevance for CTO-PCI outcomes remain unclear, despite they can be straightforward identified by Coronary Computed Tomographic Angiography (CCTA) during CT-scans to select the CTO-PCI recanalization strategy.

Purpose

The aim of this study was to investigate the clinical value of CCTA – derived "Full Moon"-like plaques and to analyze its impact on percutaneous CTO recanalization.

Methods

Out of the Charité CTO-PCI registry a total of 29 consecutive patients undergoing CTO-PCI and upstream CCTA-imaging for CTO planning were enrolled into the entire analysis. One patient was excluded due to stent artefacts with insufficient CCTA quality.

Results

Within the study cohort 17.9% (n=5) presented a "Full Moon"-like stenosis as CTO-causing target lesion. During CTO-PCI all these lesions (100%) required extensive debulking techniques as rotablation or ultrasound lithoplasty due to difficulties in device crossing compared to 13% (n=3) lesions in the non "Full Moon" group (p<0.001). In detail, 40% of lesions in the "Full Moon" group had to be prepared by rotablation-therapy (compared to 0% in the non- "Full Moon" group; p<0.05) and 20% of lesions underwent shockwave therapy as compared to 13% non- "Full Moon" lesions (n=3; p=.0.69). However, 40% of the "Full Moon" interventions resulted in a complete failure of crossing the device compared to 13.0% in the non- "Full Moon" group (p=0.15).

Conclusions

"Full Moon"- like calcification derived by CCTA represents a frequently observed phenomenon in CTO and represents an important predictor for complexity during CTO-PCI. Coronary Computed Tomography can be used to identify such a marker of calcium complexity and therefore to plan the procedure in advance.
Same day discharge after large bore vascular access in percutaneous coronary intervention of chronic total coronary occlusions
Authors: Somsen Y B O , Wilgenhof A , De Winter R W , Schumacher S P , Van Diemen P A , Jukema R A , Hoek R , Stuijfzand W J , Twisk J W R , Danad I , Verouden N J , Nap A , Henriques J P , Knaapen P
Published: November 2023

Background

Same day discharge (SDD) in patients undergoing percutaneous coronary intervention (PCI) of a chronic total coronary occlusion (CTO) appears feasible, safe, and carries economic advantage. However, SDD may be hampered by the application of large bore dual arterial access, due to its association with vascular complications. Nevertheless, increasing French size augments therapeutic options and is therefore considered fundamental in complex CTO PCI.

Purpose

The present study investigated the feasibility of SDD in patients undergoing CTO PCI with large bore dual arterial access.

Methods

Between 2013 and 2018, a total of 683 patients were prospectively enrolled in a single-center CTO registry and underwent single-vessel CTO PCI. Large bore arterial access was defined as the application of 7 and/or 8 French sheaths in at least one access site. Technical success was defined as Thrombolysis in Myocardial Infarction flow grade 3 and residual stenosis <30%. Vascular access complications were defined as a composite of clinically significant bleeding and/or hematoma, urgent transfusion, dissection, pseudoaneurysm, arteriovenous fistula formation, and thrombosis.

Results

Mean age was 66 ± 11 years; 83% were male. Large bore arterial access was applied in 87%; the most common set-up was radial-femoral (68%) and bifemoral (23%) access. In 432 (62%) patients, SDD was achieved. Patients within the SDD group were younger and had lower rates of prior MI, prior CABG, renal insufficiency, and peripheral artery disease. A high Japanese CTO score (≥2) was less common in patients with versus without SDD (58% vs. 72%, p<0.001). In addition, technical success rate was higher in the SDD group (96% vs. 89%, p<0.001). Vascular access complications were found in 22 (3,2%) cases, with 17 (77,2%) occurring in the non-SDD group. Local access site bleeding was found to be the most common complication (82,4% of total vascular access complications). Finally, multivariable analysis showed that female gender (OR 2.22, 95% CI: 1.30 – 3.78) and local access site bleeding (OR 12.0, 95% CI: 4.37 – 33.21) were significantly associated with a lower probability of SDD.

Conclusions

Our study demonstrates the feasibility of SDD in the majority of patients undergoing CTO PCI with large bore dual arterial access, with high rates of technical CTO PCI success and acceptable vascular access complication rates. Care should be taken to avoid local access site bleeding since this hinders SDD.
Clinical outcomes of percutaneous coronary intervention of chronic total occlusion vs. non-chronic total occlusion: a multicentre registry
Authors: Griffioen A M , Woelders E C I , Luijkx J J P , Peeters D A M , Ilhan M , Winkler P J C , Damman P , Remkes W S , Van 'T Hof A W J , Van Geuns R J M
Published: November 2023

Background

Revascularization of Chronic Total Occlusions (CTO) has gained popularity in recent decades. However, there is still debate about the benefits of treating a chronic total occlusion, resulting in a class IIa indication in the ESC Guidelines. Especially data regarding bleedings is scarce which could be expected due to the use of multiple and large-bore access and the use of prolonged and strong dual antiplatelet therapy after percutaneous coronary intervention (PCI). Providing more insight in the benefits and risks of CTO treatment in the context of PCI revascularization could be performed on a more evidence-based assessment.

Purpose

This study aims to provide additional data about outcomes and complications of patients undergoing revascularization of a CTO.

Methods

Patients from an ongoing, multicentre registry (‘Zuid-Oost Nederland Hart Registratie’ (ZON-HR)), which has started in November 2020, are included, in which patient- and angiography characteristics and 30-day and 1-year outcomes are collected. MACCE was defined as a composite endpoint of cardiovascular death, myocardial infarction, ischemic cerebrovascular accidents and stent thrombosis.

Results

A total of 3996 patients with complete 30-day follow-up were included in the registry, of which 185 patients underwent a PCI of a CTO and 3811 patients underwent a PCI of a non-CTO lesion between November 2020 and June 2022. Baseline characteristics are described in Table 1. The mean age of the entire population was 67.9 (± 12.1) years and predominantly male (72.7%). Analysis showed a significantly higher incidence of bleedings in patients treated with CTO (7.6% vs. 3.4%, p < 0.01) and especially access bleedings (5.9% vs. 1.9%, p < 0.01). In patients with access bleedings double access-site punction was more frequently applied for CTO PCI (80% vs. 25%, p < 0.01). Patients with CTO PCI showed more coronary dissection/perforation with the need for covered stent treatment (2.7% vs. 0.6%, p < 0.01) as well. No significant difference for MACCE within 30 days was present. Additionally, multivariate analysis were performed for baseline variables showing no association with the occurrence of access bleedings and peripheral artery vessel disease and the indication of PCI. Ancillary analyses were performed with patients with 1-year follow-up (n = 1356; CTO = 64 vs. non-CTO = 1292), showing no significant differences in MACCE and bleedings.

Conclusion(s)

This registry shows that CTO PCI results in higher incidence of complications and access bleedings. Access bleedings are possibly related to the frequent use of double access-site punction in patients with CTO PCI which should be investigated further, as well as the role of DAPT after PCI.
Impact of carotid artery stenosis on outcomes of transcatheter aortic valve replacement: a systematic review and meta-analysis
Authors: Gibicoski T B , Caetano L , Silva E P , Rodriguez F A , Scabello I , Iplinski B
Published: November 2023

Background/Introduction

Carotid Artery Stenosis (CAS) is common in elderly patients undergoing Transcatheter Aortic Valve Replacement (TAVR). However, the impact of CAS on the outcomes of TAVR is unclear.

Purpose

This systematic review and meta-analysis aimed to compare the clinical and periprocedural outcomes in patients with and without CAS undergoing TAVR.

Methods

PubMed, Embase, and Cochrane databases were searched up to February 2023. We included studies that performed a direct comparison of outcomes of TAVR in CAS versus non-CAS patients. Data were extracted from published reports and the ROBINS-I tool was utilised for quality assessment. Review Manager 5.1 was adopted for statistical analysis. A random-effects model was used to calculate a pooled effect size and 95% confidence interval.

Results

Five observational studies and 111,915 patients were included. Follow-up ranged from 30 days to 1 year. The mean age was 80.7 ± 8.2 years and 46.3% were female. The risk of stroke or transient ischaemic attack was elevated in the group of patients with CAS (OR 1.44; 95% CI 1.05-1.99; p=0.02; Figure 1A). Similarly, there was an increased risk of myocardial infarction in the CAS group (OR 1.25; 95% CI 1.06-1.47; p= 0.008; Figure 1B). In contrast, all-cause mortality (OR 0.99; 95% CI 0.71-1.37; p=0.94; Figure 2A) and major bleeding (OR 1.14; 95% CI 0.98-1.32; p=0.08; Figure 2B) were not significantly different between CAS and non-CAS groups. There was also no significant difference in acute kidney injury (OR 0.99; 95% CI 0.79-1.23; p=0.99) and new pacemaker implantation (OR 0.95; 95% CI 0.70-1.30; p=0.76) between patients with and without CAS.

Conclusions

Our findings suggest that CAS is significantly associated with cerebrovascular events and myocardial infarction in patients who undergo TAVR, without a significant impact on all-cause mortality. Further prospective studies are needed for a more granular assessment of additional determinants of this association, such as unilateral vs. bilateral involvement and whether there is a threshold of CAS severity for increased risk.
Pressure-regulated deployment for balloon-expandable TAVI is safe, effective and results in superior valve haemodynamics regardless of prosthesis size
Authors: Snir A , Wilson M , Ng M K
Published: November 2023

Background

A novel pressure-regulated deployment method for balloon-expandable transcatheter heart valves (THVs) has been developed(1) to improve clinical outcomes by regulating maximal annular wall tension during prosthesis expansion – to both optimise prosthesis-annulus apposition and diminish annular injury. The previous feasibility study(1) showed that THV deployment at wall tensions between 3-3.5 MPa may be associated with reduced paravalvular-leak (PVL) severity and avoidance of annular rupture.

Objective

To prospectively evaluate the safety and efficacy of the pressure-regulated THV deployment strategy.

Methods

341 consecutive patients with severe native aortic stenosis and moderate-severe surgical risk who underwent TAVI with Sapien 3 THVs using a pressure-regulated deployment strategy were included. Target (maximal) deployment pressure was adjusted according to valve size: 5 atm for 29mm, 5.5 atm for 26mm and 6.25 atm for 23mm THVs. Key procedural and clinical outcomes were recorded and analysed using uni- and multi-variate analyses.

Results

The average patient age was 82.1±6.9 years and 28.2% were female (see attached table). 29.3% had moderate-severe subannular calcification and 14.5% had estimated ≥20% THV oversizing based on TAVI CT. 112 patients (32.8%) were considered at high-risk of annular rupture(2). Post-dilatation rate was 8.2% and was independently associated only with the degree of THV oversizing (OR 3.5, p=0.007, for ≤5% oversizing). On TTE prior to discharge, 85.6% had none/trivial PVL and 14.4% had mild PVL with no observed moderate/severe PVL. Mild PVL was independently associated with age (OR 1.07, p=0.02, per year) and degree of THV oversizing (OR 2.4, p=0.02, for ≤5% oversizing). Resulting THV mean gradient on TTE was 9.7±3.5mmHg overall, with similar results between 23mm (10.5±3.2mmHg) and 26/29mm valves (9.6±3.5mmHg, p=0.2). New PPM rate was 9.6% and was independently associated only with pre-existing RBBB (OR 13.5, p<0.001). New LBBB rate was 11.2% was independently associated only with low THV implantation depth (OR 4.3, p=0.009, for ≤60% of THV length above native aortic annulus). There were no cases of aortic/annular rupture.

Conclusions

The pressure-regulated strategy for balloon-expandable THV deployment is associated with an excellent safety and efficacy outcomes profile. Notably, there was no significant difference in valve haemodynamics and degree of PVL post-implantation between the smaller (23mm) and larger (26/29mm) THV sizes. These findings suggest that standardisation of THV deployment pressure to achieve target wall tension results in improved haemodynamics, particularly in small-sized valves.Main Table (Truncated)PVL and MG according to THV size
Comparison of direct oral anticoagulants and vitamin-k antagonists after transcatheter mitral valve implantation
Authors: El Beze N , Himbert D , Suc G , Brochet E , Ajzenberg N , Cailliau A , Kikoine J , Delhomme C , Carrasco J L , Ou P , Iung B , Urena M
Published: November 2023

Background

No recommendation exists regarding antithrombotic treatment after transcatheter mitral valve implantation (TMVI). By analogy with surgical mitral bioprosthesis, vitamin-k antagonists (VKA) are mostly used after TMVI.

Purpose

To compare, in a prospective cohort of trans-septal TMVI using a prosthesis of the SAPIEN family, the bleeding and thrombotic risks according to the anticoagulant treatment by direct oral anticoagulants (DOAC) or VKA.

Methods

We included all consecutive patients undergoing trans-septal TMVI in our center from March 2011 to August 2022. Patients were followed up after the procedure at 1 month, 6 months and 1 year. The primary endpoint was the occurrence of bleeding under anticoagulant treatment. Patients were treated with VKA until October 2019 and with DOAC thereafter.

Results

A total of 145 patients were included. The mean age was 65.4 ± 18.6 years old and 96 patients (66.2%) were women. The mean EuroSCORE II was 10.3 ± 9,3 %. Regarding treatment, 24 patients were treated with DOAC and 121 patients with VKA. The occurrence of the primary endpoint was observed in 48 (40%) patients in the VKA group and 2 (8%) patients in the DOAC group (multivariate HR 0.21, 95%CI [0.05-0.97], p=0.047). In multivariate analysis, there were less vascular complications and stay duration was shorter in the DOAC group. There were no significant differences between groups regarding thromboembolic events, stroke, and death.

Conclusion

Treatment with DOAC after TMVI compared with VKA appears to decrease the risk of bleeding complications and to decrease the length of stay of patients without a significant increase in the risk of thromboembolic events.
Transcatheter mitral valve repair and its impact on reverse right ventricular remodelling
Authors: De Almeida Fernandes D , Guimaraes J , Costa G , Monteiro E , Gomes R , Rosa J , Campos G , Marinho A V , Paiva L , Oliveira-Santos M , Jorge E , Botelho A , Teixeira R , Costa M , Goncalves L
Published: November 2023

Introduction

Transcatheter edge-to-edge repair (TEER) has been proven to reduce cardiovascular events in a particular subset of patients with severe mitral insufficiency (MR) and left ventricle dysfunction. Nevertheless, its short and long-term impact on the right ventricle (RV) remained to be determined. Our goal was to assess the effect of TEER on the RV and right chamber pressures.

Methods

Patients were consecutively enrolled from Nov 2018 to Jul 2022. Clinical, laboratory echocardiographic and procedural data were collected. Follow-up information of admissions for heart failure, New York Heart Association (NYHA) functional class and survival was collected. The data was analysed prior to and at 3 and 12 months after the procedure. RV dysfunction was defined as Tricuspid Annular Plane Systolic Excursion (TAPSE) < 17mm or S’ < 9cm/s. Changes between baseline and follow-up parameters were assessed using the paired t-test.

Results

A total of 46 patients were included. Average age was 77.28 ± 7.92 years and 30 were male (65.2%). Twelve patients were on NYHA class III (26.1%) and most had functional mitral insufficiency (25; 54.3%) and mild to moderate tricuspid insufficiency (36; 78.3%). All patients had severe mitral insufficiency (estimated regurgitant orifice area 41.28 ± 16.77mm; regurgitant volume 62 ± 28.96mL). Seventeen patients had diabetes (37.0%), 10 had coronary artery disease (21.7%), 23 had atrial fibrillation (50.0%) and 6 had chronic kidney disease (13.0%).

At 3 months, mean right ventricular/right atrial gradient (RV/RAgrad) was significantly lower (37.26 ± 9.66 mmHg vs 30.81 ± 17.36 mmHg; p 0.017) as well as MR (2.98 ± 0.15 vs 1.67 ± 0.63; p < 0.001). There were no differences regarding severity of tricuspid regurgitation (TR) and RV and left ventricle (LV) function. At 1 year follow-up there was a marked improvement of RV/RAgrad (37.49 ± 10.87 mmHg vs 28.12 ± 10.13 mmHg; p 0.009), TAPSE (18.83 ± 4.22 mm vs 20.88 ± 3.08 mm; p 0.035), S’ (10.81 ± 4.00 cm/s vs 13.5 ± 1.97 cm/s, p 0.015) and MR severity (2.98 ± 0.15 vs 1.83 ± 0.71; p <0.001). Number of heart failure readmissions was also lower at 1 year follow-up post TEER (0.35 ± 0.80 vs 0.81 ± 0.87; p 0.032). Over a mean follow-up time of 1.72 ± 1.16 years, only 8.7% of patients died and 17.4% were readmitted due to heart failure.

Conclusion

TEER has a positive impact on right ventricle function and pressures. This effect was more prominent at 1 year follow-up and suggests reverse remodelling continues even after 3 months. Overall, patients with TEER had low rates of death and heart failure readmissions.
In-hospital safety of catheter based left atrial appendage closure in Germany 2016 - 2020
Authors: Maier A , Kaier K , Heidt T , Westermann D , Grundmann S , Von Zur Meuhlen C
Published: November 2023

Background

New catheter based left atrial appendage (LAA) occlusion devices were introduced in the past decade. Catheter based LAA occlusion can be performed through a permanently implanted intracardiac LAA occlusion device or a loop stitch around the base of the LAA via an additional pericardial access. Knowledge about recent in-hospital safety trends and center volume dependent outcomes is limited.

Methods

Catheter based LAA closures in Germany were identified via ICD and OPS codes from 2016 - 2020. Adjusted risk differences for loop stitch procedures were calculated using an inverse probability weighting approach taking into account 17 predefined baseline characteristics. Center volume dependent outcomes were calculated using a risk adjusted logistics regression analysis taking into account the same predefined baseline characteristics.

Results

28 039 permanently intracardiac implanted LAA occlusion device procedures and 213 loop stitch LAA occlusions were performed from 2016 - 2020. Numbers of permanently implanted occlusion device procedures increased from 5 259 in 2016 to 5 917 in 2020 (p = 0.020) without a significant trend for in-hospital safety parameters. Risk adjusted logistic regression analysis of center volume depended MACCE and pericardial puncture for permanently implanted occlusion devices did not show a significant trend.

Patients receiving the loop stitch procedure were younger (76.17 +/- 8.16 vs. 73.16 +/- 8.99, p < 0.001), had a lower comorbidity index (2.29 +/- 1.93 vs. 1.92 +/- 1.64, 0.005) and less previous myocardial infarctions (7.82 % vs. 3.29 %, p = 0.014) or cardiac surgeries (12.34 % vs. 6.57 %, p = 0.011). Adjusted risk difference of pericardial effusion (8.04 %; 95% CI: 3.01 % – 13.08 %; p = 0.002) and pericardial puncture (6.60 %; 95% CI: 3.85 % – 9.35 %; p < 0.001) was higher for the LAA loop stitch procedure, while risk of bleeding (-1.85 %; 95% CI: -3.01 % to -0.69 %; p = 0.002), intracerebral bleeding (-0.37 %; 95% CI: -0.59 % to -0.15 %; p = 0.001) and shock (-1.41 %; 95% CI: -2.44 % to -0.39 %; p = 0.007) was lower. No significant difference was observed for in-hospital MACCE.

Conclusions

Permanently implanted occlusion devices were the major catheter based LAA closure procedure in Germany without improvements in in-hospital safety from 2016 – 2020. Center volumes did not influence in-hospital MACCE and pericardial puncture for the permanently implanted LAAC devices. LAA loop stitch occlusion was used much less frequently and was associated with a higher risk of pericardial effusion and pericardial puncture, a lower risk of bleeding and shock and no significant risk difference in MACCE.
Aortic valve reconstruction in nonelderly adults: a systematic review, meta-analysis and microsimulation study
Authors: Notenboom M , Rhellab R , Veen K M , Etnel J R G , Taverne Y H J H , Van De Woestijne P C , Roos-Hesselink J W , Bogers A J J C , Takkenberg J J M
Published: November 2023

Background

Aortic valve disease (AVD) calls for careful planning of treatment strategies that adheres to a patient-tailored lifetime perspective, especially in younger patients. Aortic valve reconstruction (AVr) provides an attractive option in patients with aortic valve regurgitation (AR).

Purpose

This study aims to provide a comprehensive overview of published outcome after AVr in nonelderly adults and to use microsimulation to obtain age-specific estimates of outcomes.

Methods

A systematic review of published literature reporting clinical outcome after AVr in nonelderly adults (mean age ≥18y and ≤55y) published between 1/1/1990 and 17/10/2022 was conducted. Publications reporting outcome after AVr were considered for inclusion, including publications on valve-sparing root surgery. Studies that included patients without AVD as the primary indication for AVr were excluded. Early risks (<30d), late event rates (>30d) and time-to-event data were pooled and entered into a microsimulation model. Subgroup analyses were performed for AVr for isolated AR and AVr for bicuspid aortic valves (BAV).

Results

Thirty-seven studies, all retrospective cohort studies, were included, yielding a total of 4,573 patients with 16,524 patient-years of follow-up (median follow-up: 4.0y; range 0.6-10.5y). Pooled mean age for all repairs, AVr for AR and AVr for BAV was 48.1±13.8, 48.3±13.8, and 42.4±12.5 years, respectively. Pooled early mortality for all repairs, AVr for AR and AVr for BAV, respectively, was 1.7% (95%CI: 1.2-2.3%), 1.5% (1.0-2.1%), and 1.0% (0.6-1.9%), and late pooled mortality rate was 1.0%/y (0.7-1.5%/y), 1.3%/y (0.8-2.1%/y), and 0.8%/y (0.5-1.4%/y), respectively. Microsimulation-based life-expectancy relative to the general population 20 years postoperatively was 92.6% (95% Credible Interval: 90.1-95.3%) after all repairs, 89.0% (85.0-93.0%) after AVr for isolated AR and 94.9% (92.0-97.4%) after AVr for BAV. Microsimulation-based 20-year risk of aortic valve reintervention for all repairs, isolated AR and BAV, respectively, was 25.0%(23.8-26.2%), 25.1%(23.5-26.9%) and 49.9%(48.2-52.0%). The main cause for reintervention was repaired valve dysfunction for all three groups, followed by endocarditis. Estimates of other late complications are shown in Figure 2.

Conclusions

Aortic valve reconstruction for aortic valve regurgitation effectively postpones valve replacement in nonelderly with satisfactory long-term outcomes but reintervention risks are still considerable, especially in BAV patients. Reconstructive valve surgery is associated with low risks of bleeding and thrombo-embolic events and should be considered in nonelderly adults with aortic regurgitation and carefully weighed against hazards of primary aortic valve replacement.Pooled Kaplan-Meier curves for mortalityMicrosimulation-based event risks (20y)
Validation of miR-181A-5p as a biomarker of acute rejection after heart transplantation. Multicenter study
Authors: Crespo-Leiro M , Constanso-Conde I P , Almenar-Bonet L , De Antonio M , Garcia-Cosio M D , Lopez-Vazquez P , Miranda-Quintana P , Mirabet S , Lopez-Vilela R , Marco-Clement I , Villamarin-Lopez P , Domenech-Garcia N
Published: November 2023

Background

Acute Cellular Rejection (ACR) remains a major complication in heart transplantation (HT) being endomyocardial biopsy (EMB) the gold standard for ACR early detection. However, this invasive procedure has several limitations so last years new non-invasive ACR biomarkers have been evaluated. Previous studies have shown miR-181a-5p (miR-181) is overexpressed in serum samples from patients with moderate/severe ACR. However, techniques performed in these studies (mainly RT-qPCR) express miRs results as relative quantification and this leads to a lack of harmonization of both the technique and clinical decision-making. This would be solved with a new technique for absolute quantification of miRs, the digital PCR (dPCR). The aim of this study is the validation of miR-181a-5p as ACR biomarker in a multicentric collaboration. The results obtained by the conventional RT-qPCR technique will also be compared with those obtained by the new and promising dPCR.

Methods

four reference centers in HT from Spain were included in the study named "A,B,C, D". All centers performed a retrospective search in their serum libraries to find sera from patients with ACR≥2R. The same number of ACR=0R samples (control group) were also sent. All samples were processed at one center by RT-qPCR and dPCR. With the collected data we studied the correlation between both techniques, the expression of miR-181 in each ACR group (2R vs 0R) as well as in each center. Finally, the diagnostic accuracy was studied using ROC curves. A two-sided p<0.05 was considered statistically significant.

Results

ACR≥2R samples involved in the study were from: Center A, 41(42%), Center B, 32 (33%), Center C, 18(19%) and Center D 6 (6%). All centers sent the same number of samples with no rejection 0R. Correlation obtained between both techniques was not good (Spearman correlation coeficient, r = 0,60; [0,50-0,70]; p<0,0001). In both techniques, miR-181 is overexpressed in ACR≥2R group, although only RT-qPCR performed it significantly (p<0,0005). There was no significant difference between centers in miR-181 expression. Diagnostic accuracy achieved by RT-qPCR was similar to that of previous studies (AUC=0,65; [0,57-0,73], p=0,0006).

Conclusion

Our findings confirm previous results obtained by miR-181a-5p as ACR biomarker using conventional techniques as RT-qPCR. In addition, robustness of miR-181a-5p has been shown using serum samples from 4 different centers. Digital PCR shows promising results but we still optimize it for the quantification of miRs.miR181 expression
Assessing the accuracy of an online chat-based artificial intelligence model in providing recommendations on arterial hypertension in accordance with the 2018 ESC/ESH guidelines
Authors: Kassab J , El Dahdah J , Chedid El Helou M , Harb S C
Published: November 2023

Background

The rise of online chat-based artificial intelligence (AI) models has opened up new possibilities in the field of medicine. One of the promising contributions of AI chatbots could be their ability to provide accurate and accessible medical information to patients. This could help bridge the gap between patients and healthcare providers, especially in under-resourced areas where access to medical information and care is limited.

Purpose

We aimed to evaluate the ability of a commercially available AI-based online chat to provide answers to commonly asked questions related to arterial hypertension in accordance with the latest 2018 ESC/ESH guidelines (1).

Methods

We selected 30 commonly asked questions covering a range of arterial hypertension topics, including risk factors, symptoms, diagnosis, and treatment. These questions were submitted to the online AI interface, and the responses were recorded and evaluated by a team of four experienced cardiologists from our institution. To ensure consistency, each question was asked three times. All questions – except question 2 – were preceded by "according to the 2018 ESC/ESH Guidelines for the management of arterial hypertension". Each answer was rated as "accurate," "inaccurate," or "incomplete" based on the specialists’ clinical judgment, the 2018 ESC/ESH guidelines, and the content of the response. A response was considered "accurate" if it included all essential information, "inaccurate" if information provided was not in accordance with the guidelines, and "incomplete" if any essential information was missing.

Results

The AI model's responses to 24 out of the 30 questions (80%) were deemed accurate by cardiologists. Three responses were rated as incomplete (10%) and three responses were found to be inaccurate (10%). The AI responses were consistent in 28 out of the 30 questions (93%) (Tables 1-2).

Conclusion

We found that a popular online AI model provided largely accurate responses to commonly asked arterial hypertension questions. These answers were mostly in accordance with the 2018 ESC/ESH guidelines on the management of arterial hypertension. While the use of chat-based AI in medicine is still in its early stages and current models are not intended for medical use, the potential for such technology to improve the healthcare experience for patients is significant.Table 1:(1) Assessment of AnswersTable 2:(2) Assessment of Answers
Daytime blood pressure measurements performed by a cuffless blood pressure monitor compared to 24-hour ambulatory blood pressure monitor: preliminary comparative results of a single-centre study
Authors: Paggi De Almeida T , Cortes M , Perruchoud D , Alexandre J , Vermare P , Sola J , Shah J , Marques L , Pellaton C
Published: November 2023

Background

Ambulatory blood pressure (BP) monitors (ABPM) measure systolic and diastolic BP (SBP, DBP), limited to 24-48-hour snapshots, using uncomfortable cuff-based oscillometric sphygmomanometers. Some cuffless BP devices overcome these limitations, supporting continual BP monitoring. There is currently intense debate whether cuffless devices generate data comparable to ABPM.

Purpose

Here, we present preliminary results of daytime BP measurements performed by a validated and commercially available cuffless BP monitor compared to 24-hour ABPM.

Methods

52 out of 63 estimated total patients (NCT04548986, age 53.2±7.1 years, 18.9% female, arm circumference 28.5±2 cm) had been enrolled in a 12-week cardiac rehabilitation (CR) program. The patients used a validated, CE-marked, over-the-counter optical cuffless wrist BP monitor during the entire CR program, while 24-hour cuff-based ABPM was performed on the first and last day of the CR program. For each patient, average daytime (9am-9pm) SBP and DBP were calculated – and compared – for 1 day of ABPM and 7 days of cuffless monitor (session 1: ABPM first day vs. cuffless monitor first week; session 2: ABPM last day vs. cuffless monitor last week). Only sessions that had 20 or more valid daytime measurements on both modalities were included in the study.

Results

50 patients (35 in session 1, 15 in session 2) had 20 or more valid daytime measurements on both modalities, and were included in the study. Bias between the cuffless monitor and ABPM for daytime DBP was (mean ± SD [95% CI] ) -2.2±8.0 [-4.5, 0.1] mmHg, R2 = 0.66 (Figure 1A), with agreements of 78% and 96% within ±10 mmHg (dark grey) and ±15 mmHg (light grey) regions of interest (ROI), respectively. Bias between the cuffless monitor and ABPM for daytime SBP was 1.6±10.5 [-1.5, 4.6] mmHg, R2 = 0.70 (Figure 1B), with agreements of 60% and 84% within the ±10/±15 mmHg ROI, respectively.

Conclusions

The results suggest that 1-week monitoring with the investigated cuffless monitor yields equivalent daytime BP values to 24-h ABPM, which supports the use of cuffless BP monitor for long-term, continual daytime BP monitoring. The present preliminary study is limited by the partially recruited population and daytime measurements only. Night-time analysis will be covered in subsequent studies.Figure 1