bluuebunny/crossref_metadata_2025_split huggingface dataset:
Rotational atherectomy versus orbital atherectomy for the treatment of calcified coronary lesions: a systematic review and meta-analysis of 81,873 patients
Authors: Altobaishat O , Abuelazm M , Amin A M , Tanashat M , Turkmani M , Manasrah A , Sharaf I , Abouzid M 
Published: October 2024

Abstract

Background
Previous studies have suggested that pre-treatment of coronary artery calcification with rotational atherectomy (RA) prior to stent deployment can enhance procedural success, but this does not necessarily translate into improved clinical outcomes. Recently, the Orbital Atherectomy (OA) system has been introduced into clinical practice to enhance lesion preparation.

Purpose
Our study aims to evaluate the safety and efficacy of both RA and OA as pre-treatment strategies before stent deployment in patients with coronary artery calcification.

Methods
We conducted a comprehensive systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies. These were identified through systematic PubMed, Web of Science, Scopus, Embase, and Cochrane searches until January 2024. Dichotomous data were pooled using risk ratio (RR), and continuous data were pooled using mean difference (MD), both with a 95% confidence interval (CI), using Stata version 17.

Results
Our analysis included eleven studies encompassing 81,873 patients. No significant difference was observed between RA and OA in terms of major adverse cardiovascular events (MACE) (RR: 0.81 with 95% CI [0.64, 1.02], P= 0.07). However, OA was significantly associated with a decreased incidence of all-cause mortality (RR: 0.60 with 95% CI [0.52, 0.70], P&lt; 0.01), target vessel revascularization (TVR) (RR: 0.43 with 95% CI [0.22, 0.82], P= 0.01), coronary artery bypass grafting (CABG) (RR: 0.78 with 95% CI [0.62, 0.97], P= 0.03), and fluoroscopy time (MD: -3.93 with 95% CI [-7.39, -0.48], P= 0.03).
There was no significant difference between RA and OA in cardiac death (RR: 2.65 with 95% CI [0.94, 7.51], P= 0.07), target lesion revascularization (TLR) (RR: 0.57 with 95% CI [0.23, 1.41], P= 0.22), myocardial infarction (RR: 0.79 with 95% CI [0.62, 1.01], P= 0.06), stent thrombosis (RR: 0.33 with 95% CI [0.09, 1.23], P= 0.10), stroke (RR: 0.76 with 95% CI [0.57, 1.01], P= 0.06), re-admission (RR: 0.76 with 95% CI [0.48, 1.19], P= 0.23), vessel closure (RR: 0.78 with 95% CI [0.18, 3.33], P= 0.74), procedural duration (MD: -5.43 with 95% CI [-21.71, 10.84], P= 0.51), length of hospital stay (MD: 0.21 with 95% CI [-0.47, 0.90], P= 0.54), and contrast amount (MD: -3.68 with 95% CI [-9.37, 2.01], P= 0.21).

Conclusion
Both RA and OA as pre-treatment strategies before stent deployment demonstrate similar outcomes for numerous cardiovascular events. However, OA is associated with lower rates of all-cause mortality, TVR, CABG, and fluoroscopy time.
Reduction of thrombus burden by cangrelor in ticagrelor-loaded st-elevation myocardial infarction patients with high residual platelet reactivity: the imaging sub-study of the ERMIT randomized trial
Authors: Beygui F , Peron C , Lacote C , Stettler R , Guillemot V , Blanchart K , Bignon M , Lemaitre A , Schwob L , Roule V 
Published: October 2024

Abstract

Background
Residual high platelet reactivity (HPR) at the time of primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) is associated with higher residual thrombus burden and the subsequent suboptimal reperfusion.

Purpose
We sought to determine the impact of intravenous Cangrelor on the residual post-PCI thrombus burden in patients with HPR admitted for primary PCI in a prespecified intracoronary optical coherence tomography (OCT) sub-study of the ERMIT randomized trial.

Methods
In the ERMIT trial patients pre-treated with ticagrelor and aspirin with residual HPR (baseline platelet reactivity unit &gt;208) were randomly assigned in a 1:1 ratio to receive cangrelor on top of standard therapy or standard therapy alone prior to PCI. The primary endpoint of the sub-study was the relative thrombus volume quantified on OCT. Other OCT quantified parameters were predefined as secondary endpoints.

Results
After screening of 128 patients, a total of 60 patients with HPR were enrolled and randomized. The OCT sub-study included 53 patients, 29 in the cangrelor and 24 in the control group.
As reported in the table, baseline characteristics were similar between the groups. The post-PCI PRU was dramatically lower in the cangrelor as compared to the standard group (p&lt;0.001). The primary endpoint was 4.5% [3.4;7.2] versus 6.9% [5.2;8.5], (p=0.03) in the cangrelor and control groups respectively. All other imaging parameters confirmed the significantly lower thrombus burden in patients receiving cangrelor (Table).

Conclusion
The imaging sub-study of the randomized ERMIT trial shows that cangrelor use is associated with a more effective platelet inhibition and lower post-PCI residual thrombus burden in ticagrelor-loaded STEMI patients with residual HPR. The clinical implications of such finding warrant larger size trials.Table
Comparison of different calcium modification strategies for coronary calcified nodules: insights from optical coherence tomography
Authors: Yasumura K , Koshy A , Vengrenyuk Y , Minatoguchi S , Krishnamoorthy P , Hooda A , Sharma R , Kapur V , Sweeny J , Sharma S , Kini A 
Published: October 2024

Abstract

Background
The optimal treatment strategy for coronary calcified nodules (CN) remains uncertain.

Purpose
We sought to compare the safety and efficacy of different calcium modification strategies for managing CN using optical coherence tomography (OCT).

Methods
In this single-center retrospective cohort study, consecutive patients undergoing OCT-guided percutaneous coronary intervention (PCI) for severely calcified lesions using rotational atherectomy (RA), orbital atherectomy (OA), or intravascular lithotripsy (IVL) between January 2017 and December 2022 were included. OCT analysis was performed through our institutional core-laboratory to identify CN, assess plaque characteristics, and evaluate post-stent optimization. Primary outcomes were minimum stent area (MSA) and MSA at CN site post-PCI. One-year target vessel failure (TVF), defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target vessel revascularization, was also recorded.

Results
Among a total of 154 patients with 158 lesions, CN was identified in 54 lesions (34.2%) and managed with RA (39%, n=21), OA (33%, n=18), or IVL (28%, n=15). The IVL group exhibited a larger minimal lumen diameter, maximum calcium arc, and maximum calcium thickness at baseline. Post-PCI OCT demonstrated comparable MSA (RA: 5.91 ± 0.33mm², OA: 5.94 ± 0.38mm², IVL: 6.46 ± 0.45mm²; p=0.61) and MSA at CN site (6.77 ± 0.49mm², 6.71 ± 0.51mm², 7.13 ± 0.59mm², respectively; p=0.87) after adjusting for procedural and morphologic factors among the groups. The incidence of TVF at one year was similar among the groups.

Conclusions
In patients undergoing PCI for severely calcified lesions with CN, comparable procedural and clinical outcomes can be achieved using RA, OA, or IVL. The equivalence across these techniques underscores a role for individualized decision-making integrating patient- and lesion-specific characteristics, as well as center expertise when selecting a treatment strategy for CN.OCT findings and clinical outcomes
Retrograde coronary chronic total occlusion intervention (JR-CTO) score: from the Japanese CTO-PCI expert registry
Authors: Tanaka H , Tsuchikane E , Kishi K , Okada H , Oikawa Y , Ito Y , Muramatsu T , Yoshikawa R , Kawasaki T , Okamura A , Sumitsuji S , Muto M , Katoh O 
Published: October 2024

Abstract

Background
Despite the effectiveness of the retrograde approach for chronic total occlusion (CTO) lesions, there are no standardized tools to predict the success of retrograde percutaneous coronary intervention (PCI).

Purpose
The objective of this study was to develop a prediction tool to identify CTO lesions that will achieve successful retrograde PCI.

Methods
This study evaluated data from 2,374 patients who underwent primary retrograde CTO-PCI and were enrolled in the Japanese CTO-PCI Expert Registry between January 2016 and December 2022. All observations were randomly assigned to the derivation and validation cohorts at a 2:1 ratio. The prediction score for guidewire failure in retrograde CTO-PCI was determined by assigning one point for each factor and summing all accrued points.

Results
The JR-CTO score (moderate–severe calcification, tortuosity, Werner collateral connection grade ≤ 1, and non-septal collateral channel) demonstrated a c statistic for guidewire failure of 0.72 (95% confidence interval: 0.67–0.76) and 0.71 (95% confidence interval: 0.64–0.77) in the derivation and validation cohorts, respectively. Patients with lower scores had higher guidewire and technical success rates and decreased guidewire crossing time and procedural time (P &lt; 0.01).

Conclusions
The JR-CTO score, a simple four-item score that predicts successful guidewire crossing in patients undergoing retrograde CTO-PCI, has the potential to support clinical decision-making for the retrograde approach.
Flow adjusted predicted prosthesis patient mismatch in patients undergoing transcatheter aortic valve implantation
Authors: Tomii D , Heg D K , Nakase M N , Samim D S , Lanz J L , Praz F P , Stortecky S S , Reineke D R , Windecker S W , Pilgrim T P 
Published: October 2024

Abstract

Background
Effective orifice area (EOA) is flow dependent. However, established methods for the assessment of prosthesis-patient mismatch (PPM) do not consider flow status, and therefore may underestimate the rate and impact of PPM in patients with abnormal flow status.

Objectives
To investigate the clinical impact of flow-adjusted predicted PPM in patients undergoing transcatheter aortic valve implantation (TAVI).

Methods
Patients undergoing TAVI in a prospective TAVI registry were stratified by the presence of moderate or severe PPM (EOA index to body surface area [EOAi]: 0.65-0.85 or ≤0.65 and 0.55-0.70 or ≤0.55 cm2/m2 if obese). PPM was defined according to echocardiographically measured EOAi (measured PPM) or unadjusted or flow-adjusted predicted EOAi. Predicted EOAs were based on reference values of EOA for each valve generation and size (predicted PPMTHV) or native aortic annulus dimension (predicted PPMCT).

Results
Among 1,510 patients included (August 2007-June 2022), rates of moderate or severe PPM differed according to method of assessment; 27.0% and 8.7% according to measured PPM, 11.3% and 1.2% according to predicted PPMTHV, 12.0% and 0.1% according to PPMCT, 21.6% and 0.2% according to flow-adjusted predicted PPMTHV, and 25.1% and 0.4% according to flow-adjusted predicted PPMCT. Five-year mortality was comparable in patients with and without flow-adjusted predicted PPM defined by either method. These results were consistent when patients were stratified by flow status.

Conclusions
Rates of PPM differ considerably when flow status is considered. There was no consistent signal of increased risk of adverse events up to 5 years in patients with flow-adjusted predicted PPM.Frequency of PPM afteer TAVICumulative event curves for death
Transcatheter versus surgical aortic valve replacement in aortic stenosis patients requiring mechanical circulation support: a nationwide Japanese study
Authors: Mitsui K , Takagi K , Kataoka Y , Nakao K , Otsuka F , Asaumi Y , Kawamoto N , Fukushima S , Kanzaki H , Sumita Y , Kanaoka K , Miyamoto Y , Yamamoto K , Tsujita K , Noguchi T 
Published: October 2024

Abstract

Introduction
Transcatheter aortic valve replacement (TAVR) has demonstrated comparable clinical outcomes to surgical aortic valve replacement (SAVR) in patients with aortic stenosis (AS). However, previous trials excluded patients who had required mechanical circulatory support (MCS) for cardiogenic shock. Thus, the clinical feature of aortic valve replacement requiring MCS and the efficacy of TAVR compared to SAVR has not been fully exhibited in AS patients.

Purpose
This study investigated the demography and clinical outcomes comparing TAVR and SAVR for AS demanding MCS.

Methods
The current study was an observational retrospective study using Japanese nationwide data from the Japanese Registry Of All cardiac and vascular Diseases-Diagnostic Procedure Combination (JROAD-DPC). Between April 1, 2012, and March 31, 2022, AS patients undergoing TAVR or SAVR who required MCS were evaluated. The primary outcome was 30-day mortality. In addition, we assessed ischemic stroke, hemorrhagic stroke during hospitalization.

Result
During the period, 80,752 patients (TAVR=36,546 and SAVR=44,206) were identified. The frequency of MCS (intra-aortic balloon pumping and/or extracorporeal membrane oxygenation) was 3.0% (1,097 patients) of the TAVR group and 4.8% (2,133 patients) of the SAVR group. In the TAVR group, 78% of patients were implanted balloon-expandable valve and 7.1% of patients were transapical apical approach. TAVR was performed in older (median age: 85 years vs. 76 years, p&lt;0.001), lower body mass index (BMI) (median BMI: 21.5 kg/m2 vs. 22.7 kg/m2, p&lt;0.001), and more female patients (42% vs. 27%, p&lt;0.001) than SAVR. The 30-day mortality was lower in TAVR than SAVR (12% in TAVR and 19% in SAVR, p&lt;0.001) (Figure). After adjusting age, gender, TAVR was significantly associated with decreased 30-day mortality compared to SAVR (adjusted HR 0.52 (0.41–0.67), p&lt;0.001). In contrast, the incidence of ischemic stroke and hemorrhagic stroke were comparable in 2 groups (ischemic stroke; 4.2% in TAVR vs. 4.1% in SAVR, p=0.93 and hemorrhagic stroke; 0.3% vs. 0.3%, respectively).

Conclusion
According to nationwide real-world clinical data on aortic valve replacement for AS, the frequency of patients requiring MCS due to cardiogenic shock was 3.0% in the TAVR group and 4.8% in the SAVR group. Our findings demonstrated short-term outcomes following TAVR for patients requiring MCS for cardiogenic shock was better than those following SAVR.
Safety and quality of life assessment at 6 months follow-up of the valvosoft pivotal study
Authors: Van Wely M , Van Belle E , Puymirat E , Iung B , Van Gameren M , Eltchaninoff H , Amoroso G , Faroux L , Kim W K , Schewel D , Lepage L , Messas E 
Published: October 2024

Abstract

Background
Calcific Aortic stenosis (CAS) is currently the most common heart valve disease. Patients suffering from severe CAS are treated with invasive surgeries based on valve replacement. Symptoms heavily impact quality of life, including chest pain, shortness of breath, dizziness, fatigue, and major risks as heart failure or sudden death, and daily activities might also be strongly impacted.

Purpose
A prospective, multi-centre, single-arm, pivotal study (NCT05235568) was initiated in 2021 to treat severe CAS patients with Valvosoft, a medical device based on Non-Invasive Ultrasound Therapy (NIUT) intended to treat CAS in patients not eligible for immediate aortic valve replacement (SAVR/TAVR) or refusing such a treatment, to confirm safety and performance at 1-, 3-, 6- and 12 months. We present here the safety and quality of life results at 6M follow-up.

Methods
Valvosoft NIUT procedure is based on a trans-thoracic delivery of focused, high intensity short therapeutic ultrasound pulses, to precisely generate a cavitation bubble cloud on the aortic valve. Echocardiographic imaging enables to monitor the valve in real-time while cavitation causes both non-thermal tissue softening and calcification fractionation of the diseased valve.
60 planned subjects, suffering from severe calcific aortic stenosis, not recommended for aortic valve replacement or refusing such a procedure, were enrolled in 11 centres in Europe. Patients were awake or lightly sedated, NIUT was delivered during up to 70 minutes per patient per procedure.
DSMB and CEC were installed to monitor safety, performance and effectiveness of Valvosoft device, and safety related to participation in the clinical investigation.

Results
Sixty high-risk patients advanced in age (85.2 ± 9.1) with multiple severe comorbidities were included. Primary safety endpoint (less than 25% MACE) was met at 30D (p=0.002). Furthermore patients experienced an overall quality of life improved. 6 minutes’ walk test increases from baseline towards 6 months with 10 %.
At 6M follow-up, no stroke was reported, an average KCCQ score improvement of 17% was noticed, and NYHA class improved or stabilized for 78% of patients. The calcium score or volume on the aortic did not change pre- and post-procedure.

Conclusion
Valvosoft NIUT safety and quality of life improvement are proven at 6MFU, and the technology is presented as potentially disruptive, in the treatment of severe calcific aortic stenosis.
Venous thrombo-embolic events as the probable cause of arterial ischemic event in patients with patent foramen ovale
Authors: Chevrot G , Montalescot G , Larbi-Messaoud S , Zeitouni M , Devos P , Procopi N , Charpentier E , Hammoudi N , Wallet T , Toledano D , Boussouar S , Silvain J , Redheuil A , Guedeney P 
Published: October 2024

Abstract

Introduction
The origin of the emboli involved in patent foramen ovale (PFO)-related embolic events remains mostly unknown.

Purpose
To evaluate the venous thrombo-embolic (VTE) origin of patients with PFO-related embolic event.

Methods
Patients planned for PFO closure for secondary prevention of PFO-related arterial embolic event had a systematic venous thrombo-embolic (VTE) risk evaluation that included : an extensive questionnaire on past history of VTE events, clinical situations at high risk of VTE including complicated hemorrhoids, prior saphenectomy or venous sclerosis, varicocele, intrapelvic tumor, pregnancy, surgery or prolonged travel or presence of hyperthrombotic state (i.e., thrombophilia, active cancer or covid) and an abdominopelvic magnetic resonance venography (MRV) evaluation to identify any intrapelvic venous disease.

Results
From July 2020 to May 2023, 366 consecutive patients (Median age 51 [42-58] years, 42.9% female) were prospectively included. A past medical VTE events, a high risk VTE situation, a hyperthrombotic state and a pelvic venous abnormality on MRV were present in 8.5% (95%CI 6.0-11.8), 22.7% (95%CI 18.7-27.2), 7.1% (95%CI 4.9-10.2), and 36.3% (95%CI 31.6-41.4), respectively, and 58.5% (95%CI 53.4-63.4) of the patients presented at least one of the previous conditions. MRV identified various undiagnosed pelvic venous abnormalities with 20.0% of pelvic varices, 9.8% of May-Thurner-Cockett and 7.4% of Nutcracker phenomenons (Figure 1). Imaging abnormalities were more frequent among younger patients (aOR 1.02 95%CI:1.00-1.04) and women (aOR 1.94 ; 95%CI:1.25-3.02).

Conclusion
A majority of patients undergoing PFO closure for secondary prevention have a potential VTE source of paradoxical emboli suggesting that VTE events is the probable cause of arterial ischemic event in these patients.
Feasibility and early outcomes of atrial septal defect prostheses use for percutaneous closure of widely open patent foramen ovale
Authors: Dupuy M , Guedeney P , Silvain J , Zeitouni M , Devos P , Wallet T , Bouziri N , Procopi N , Hammoudi N , Montalescot G 
Published: October 2024

Abstract

Background
The efficient closure of patent foramen ovale (PFO) with short canal length and large width, usually associated with atrial septal aneurysm (ASA), remains challenging. These cases frequently require the use of larger PFO devices to avoid the risk of device embolism at the cost of a higher rate of residual shunting, mostly due to interdisk spacing. The use of atrial septal defect (ASD) prosthesis could be useful in these patients.

Purpose
To describe feasibility and early outcomes of the use of ASD device for percutaneous closure of widely open PFO representing an "ASD-like anatomy".

Methods
Since January 2022 in a high volume French university center, we started to use ASD device for percutaneous closure of selected cases of PFO with complex anatomy as mainly defined by a sheathed width of PFO ≥ 5 mm and sheathed canal length ≤ 10 mm (Figure 1) facing major per-operative residual shunt with PFO prostheses in some patients. In addition to the descriptive results, we compared this ASD device subgroup with a cohort of patients with similar anatomy but previously treated in our center with PFO device. All available transesophageal echocardiography (TEE) examinations were reviewed. The main objective was to describe the feasibility of the procedure (success and safety), the secondary endpoint was immediate post-procedural moderate to severe residual right-to-left shunt (RLS), defined as ≥ 10 bubbles in the left atrium within 3 cardiac cycles after transfemoral agitated saline injection.

Results
A total of 65 patients was treated with ASD devices, procedural success was achieved in all patients with a low rate (4,2%) of intrahospital complications (two supraventricular arrythmia, one anaphylactic shock and one minor laryngeal injury) and without device embolism. As compared with a cohort of 127 patients of similar anatomy treated with PFO device, patients in the ASD device group had more complex characteristics especially higher mean sheathed PFO width and shorter mean sheathed PFO canal length. Immediate post-procedural residual moderate to severe RLS did not differ significatively between groups (Table 1). No or minimal shunting was observed in 91% and 92% of cases (p=NS) but the three patients with severe RLS were all in the PFO device group.

Conclusion
Percutaneous closure of "ASD-like" PFO with ASD prostheses is feasible and safe. Larger studies and longer follow-ups are now required to confirm the expected improved sealing effect with this strategy.