bluuebunny/crossref_metadata_2025_split huggingface dataset:
Observational, multicenter registry of Impella-assisted high-risk percutaneous coronary interventions and cardiogenic shock in Poland (IMPELLA-PL): efficacy and safety outcomes
Authors: Pietrasik A , Gasecka A , Sacha J , Pawlowski T , Grygier M , Bielawski G , Sukiennik A , Witkowski A , Bartus S , Cacko A , Gil R , Kuliczkowski W , Wanczura P , Legutko J , Kochman J 
Published: November 2023

Abstract

Introduction
Impella (Abiomed, Danvers, MA, USA) is the smallest and the least invasive mechanical circulatory support device used in the setting of cardiogenic shock (CS) and high-risk percutaneous coronary interventions (HR-PCI). Data regarding the efficacy and safety of Impella in the real-life setting are urgently needed.

Purpose
The main goal of the IMPELLA-PL registry is to evaluate the efficacy and safety of Impella in patients with CS and undergoing HR-PCI, identify independent predictors of in-hospital and 12-month outcomes and compare it with other registries.

Methods
IMPELLA-PL is a national, multicentre, retrospective registry including consecutive patients treated with Impella for CS and high-risk PCI in 20 Polish interventional cardiological centres from January 2014 until December 2021, with 12-month follow-up until December 2022. The main efficacy and safety endpoints included (i) in-hospital mortality, (ii) 12-month mortality, (iii) 12-month rate of major adverse cardiovascular events (MACE) following hospital discharge, evaluated according to the prespecified definitions.

Results
A total of 308 patients were enrolled in the registry: 55 had CS (56.4%) and 253 underwent HR-PCI (43.6%). In the CS group, in-hospital mortality rate was 76.4%, 12-month mortality rate was 80.0% and post-discharge MACE rate was 9.1%. Device-related complications included access site bleeding (30.9%), limb ischaemia (12.7%) and haemolysis (10.9%). In the HR-PCI group, in-hospital mortality rate was 8.3%, 12-month mortality rate was 18.2% and MACE rate post-discharge was 22.5%. Device-related complications included access site bleeding (14.6%), limb ischaemia (2.4%) and haemolysis (1.6%). The independent predictors of 12-month mortality included atrial fibrillation (OR 3.50, 95% CI 1.38-8.95), chronic kidney disease (OR 2.77, 95% CI 1.06-7.26).

Conclusions
The mortality and complications rate in patients with CS remains high, despite the use of Impella, and higher than reported in other registries. The mortality and complications rate in patients undergoing HR-PCI is acceptable and consistent with other registries.
Impact of trial results and guidelines on the practice of Primary PCI over 14 years
Authors: Doerler J , Edlinger M , Alber H , Berger R , Binder R , Hasun M , Wintersteller W , Lassnig E , Huber K , Von Lewinski D , Rab A , Roithinger F X , Schuchlenz H , Steinwender C , Weidinger F 
Published: November 2023

Abstract

Aim
We aimed to present an overview of changes in daily practice of primary PCI in relation to on the growing evidence in device and adjunctive pharmacologic therapy.

Methods and results
Clinical outcomes, data on treatment as well as characteristics of 19,054 patients prospectively enrolled in a nation-wide registry of primary PCI between 2005 and 2018 were analysed. A year-by-year trend analysis was done to show the dynamic of changes following landmark trial publications and new guideline recommendations. Patient characteristics remained stable except a slight increase of patients needing resuscitation (from 8% to 12%) and treatment delays showed improvements over time. The prescription of new P2Y12 Inhibitors rapidly increased after approval in 2009. Femoral access was predominant in 2011 (over 90%) followed by a steady decrease to under 30% in 2018. The use of thrombus aspiration increased since 2008 with a maximum in 2013 followed by a decrease after publication of two negative randomised trials. Mortality was in average 6%.

Conclusion
Trial results and guideline recommendations had a strong impact on the practice of PPCI in this national registry. Despite improved treatments, the average in-hospital mortality of 6% indicates the necessity of continuous reassessment of treatment delays and other quality indicators to further improve patient outcome after STEMI.Changes over time
Efficacy of the tip-detection method over the retrograde approach for chronic total occlusion percutaneous coronary intervention
Authors: Kashiyama T , Okamura A , Koyama Y , Watanabe H , Iwakura K 
Published: November 2023

Abstract

Background
The tip-detection method has been acknowledged as a novel strategy for chronic total occlusion (CTO) percutaneous coronary intervention (PCI) when conventional antegrade wiring strategies are ineffective, but a comparison with the retrograde approach has yet to be carried out.

Method
We retrospectively enrolled 170 consecutive CTO PCI cases and separated them according to the adopted strategies. The wire-manipulation time for each strategy was compared between the tip-detection method and the retrograde approach. The rate of successful wire crossing was analyzed according to the variables in the complexity scores.

Results
Fifty-six attempts with the tip-detection method were observed, with 46 (82.1%) successful cases. Sixty-one retrograde approaches were performed, in which 29 (47.5%) cases achieved procedural success. In the successful attempts, the wire-manipulation time was significantly shorter with the tip-detection method (20.0 [12.2-36.7] min) than with the retrograde approach (35.0 [20.7-49.7] min) (p=0.008). Incomplete tip-detection wire crossing (taking &gt;30 min) was seen in severely tortuous lesions (odds ratio: 0.26, 95% confidence interval: 0.06–0.97, p = 0.037).

Conclusions
The tip-detection method can improve the rate and time required for successful CTO PCI compared with the retrograde approach. However, the success rate of the tip-detection method is hampered by lesion tortuosity.Figure
Characteristics and outcomes of elderly patients undergoing protected percutaneous coronary intervention with impella mechanical circulatory support
Authors: Jakob P , Falah B , Abu-Much A , Lansky A , Basir M B , Schonning M , Zhou Z , Batchelor W , Grines C , O'neill W , Stahli B A R B A R 
Published: November 2023

Abstract

Background/Introduction
In high-risk patients, percutaneous coronary intervention (PCI) with Impella mechanical circulatory support has become an important part of the revascularization strategy. However, data regarding the impact of age in patients undergoing Impella-supported PCI are limited.

Purpose
The aim of this study was to describe the characteristics and outcomes of Impella mechanical circulatory support in patients ≥75 years of age undergoing high-risk PCI.

Methods
Using the PROTECT III study, a prospective, multicenter, FDA-audited cohort of the Catheter-based Ventricular Assist Device (cVAD) registry, we compared baseline characteristics and clinical outcomes of patients ≥75 years of age with those of patients &lt;75 years of age treated with Impella-supported high-risk PCI. Rates of major adverse cardiovascular and cerebral events (MACCE), defined as the composite of all-cause death, myocardial infarction (MI), stroke/transient ischemic attack, and revascularization, were assessed at 30 days and 90 days, and mortality was assessed to 1 year. A multivariable Cox regression model (including covariates significant in univariable analysis) was used to examine associations between age and clinical outcomes.

Results
A total of 1237 patients (26.8% female) were included in the analysis; of whom 493 (39.9%) were ≥75 years of age. Patients ≥75 years of age had lower body mass index (27 kg/m² vs. 30 kg/m²), a lower prevalence of diabetes (49% vs. 61%) and prior MI (37% vs. 43%), and lower estimated glomerular filtration rates (eGFR, 60 vs. 74 mL/min/1.73 m²). They more often suffered from severe valvular heart disease (17% vs. 7%), and more frequently underwent left main PCI (58% vs. 39%). Left ventricular ejection fraction was higher in patients ≥75 years of age (37.7±15.9% vs. 32.0±14.5%). (p&lt;0.05 for all comparisons). Baseline SYNTAX scores did not differ among groups. Rates of death and MACCE did not differ between age groups at either 30 days or 90 days (Figure 1). Mortality at 1 year was 24.0% in patients ≥75 years of age and 17.9% in those &lt;75 years of age. Age ≥75 years was associated with an increased risk of mortality at 1 year (unadjusted HR 1.40, 95% CI 1.05-1.86, p=0.02) and the association remained significant after multivariable adjustment (adjusted HR 1.99, 95% CI 1.24-3.18, p=0.004; Figure 2).

Conclusion(s)
This study demonstrates that increased age ≥75 years was not associated with a higher risk of mortality or MACCE at 30 or 90 days following protected PCI with Impella mechanical circulatory support, suggesting that protected high-risk PCI in elderly patients is safe and feasible. However, age ≥75 years remained an independent predictor for 1-year mortality after protected PCI.30-day and 90-day MACCE1-year All-cause death
Evidence of early bioprosthetic valve dysfunction after TAVR in aortic valve stenosis during one-year follow-up according to VARC-3
Authors: Heermann J , Hokken T W , Hecht S , Goh S , Maier O , Adrichem R , Nuis R J , Abdel-Wahab N , Van Mieghem N M , Kelm M , Zeus T , Veulemans V 
Published: November 2023

Abstract

Objectives
Transcatheter aortic valve replacement (TAVR) has become a frequent treatment method for severe aortic stenosis and has increased significantly in younger patients and at lower surgical risk. Therefore, long-time considerations and the performance of TAVR devices are highly interesting. The Valve Academic Research Consortium 3 endpoint definitions (VARC-3) were released recently, offering updated and clear classifications of bioprosthetic valve dysfunction (BVD). In this retrospective multicenter study, we aimed to assess the prevalence of BVD during one-year follow-up and potential differences between self-expandable (SEV) and balloon-expandable valves (BEV).

Methods
Underlying conditions were evaluated by univariate analysis. Normality was tested using the Shapiro-Wilk normality test. The primary clinical endpoint was defined as immediate failure in device success, secondary endpoints were defined as prevalence of BVD during one year FU and composite endpoints according to VARC-3.

Results
The final study cohort consisted of 1478 patients from three tertiary care centers that underwent TAVR between 01/2015 and 12/2018. Mean Follow-up (FU) was 361 ± 26 days. During this time span overall BVD was documented in one-fourth of all patients (-BVD[-]: n=1090 (73.7%); BVD[+]: n=388; 26.3%). Further discrimination into the four main categories of BVD presented following results: Structural valve deterioration (SVD) n=142 (9.6%), Non-Structural valve deterioration (NSVD) n=235 (15.9%), hypo-attenuated leaflet thickening n=18 (1.2 %), and endocarditis n=31 (2.1%). Two-thirds of all events were identified within 30-days post implantation, accounting for new-onset of BVD during time course in one-third of all documented BVD. Device success was significantly lower in the +BVD cohort (80.6% vs. 70.1%, p&lt;0.01*). When comparing SEV and BEV, there were significant differences in overall BVD at 30-days post implantation (13.8% vs 18.5%, p&lt;0.01*), as well as in device success (74.1% vs. 81.5%, p&lt;0.01*), early safety (63.8% vs. 69.8%, p=0.014) and clinical efficacy (94.1% vs. 89.9%, p&lt;0.01*). Again, discrimination into the four main categories of BVD showed differences in NSVD at 30-days post implantation (9.8% vs. 14.3%, p&lt;0.01*) as well as at 1-year FU (7.6% vs 14.8%, p&lt;0.01*).

Conclusion
In this large retrospective multicenter study, we could observe that NSVD was the BVD category most frequently detected after TAVR in tricuspid aortic valves during 1-year FU. NSVD occurred mainly within 30 days post-implantation in patients with balloon-expandable valves, being one factor that significantly diminished device success, early safety, and clinical efficacy.
End of life after transcatheter aortic valve implantation
Authors: Strange J E , Holt A , Christensen D M , Nouhravesh N , Petersen J K , Schou M , Backer O D , Koeber L , Fosbol E L 
Published: November 2023

Abstract

Background
Survival after transcatheter aortic valve implantation (TAVI) has drastically improved over time. Thus, patients may be more susceptible to experience multimorbidity and non-cardiovascular hospitalizations in their final years of life; however, the extent of which comorbidities impact end of life after TAVI is unknown.

Purpose
To describe end of life after TAVI in terms of the burden and causes of hospitalization compared with non-TAVI controls from the general population.

Methods
All Danish patients who underwent TAVI during 2008–2021 were identified at date of death. Patients who died within one year from TAVI were excluded. Matching was performed on sex, age at death, and calendar year of death in a 1:10 ratio. Patient characteristics at time of death were reported. Cumulative time in hospital was calculated and compared for the TAVI group and matched controls. Further, the cause for all inpatient hospitalizations were categorized as heart failure, cardiovascular (excluding heart failure), non-cardiovascular, and symptoms (e.g., dyspnea, vomiting) according to the primary discharge code.

Results
After exclusion, 2,041 deaths among patients with TAVI (median time from TAVI to death: 1,352 days [25th-75th percentile: 841–1,980]) were matched to 20,410 deaths among controls (standardized mean differences &lt; 0.1 for all matching variables). Due to matching, age was 86 years, and 54.7% were males in both groups. However, frailty was higher in the TAVI group (frail TAVI group: 86.5% vs. controls: 76%). Cardiovascular and non-cardiovascular comorbidity burden was higher in the TAVI group (e.g., heart failure: 57.6% vs. 18.4%; chronic obstructive pulmonary disease: 27.9% vs. 18.8%; chronic kidney disease: 25.7% vs. 12.9%). However, history of cancer was lower in the TAVI group (21.7% vs. 26.3%).
Time in hospital in the last year of life was higher in the TAVI group: 27.2% were hospitalized &gt;28 days and 11.5% were never hospitalized compared with 17.1% and 22.7% for controls, respectively (Figure 1). In both groups, non-cardiovascular hospitalizations were most common towards end of life. Indeed, 70.5% of hospitalizations during the last year of life for TAVI patients were due to non-cardiovascular causes. Moreover, in both groups, non-cardiovascular hospitalizations became more frequent closer to time of death (Figure 2). However, heart failure hospitalizations were more common in the TAVI group compared with controls.

Conclusion
End of life for TAVI patients was characterized by substantial multimorbidity and hospitalizations are frequent. Although heart failure hospitalizations were more common for TAVI patients than their matched controls, non-cardiovascular hospitalizations were more frequent in both groups. This highlights the need for a multidisciplinary approach to improve quality of life towards end of life after TAVI.Figure 1
High-risk admission prior to transcatheter aortic valve implantation and subsequent outcomes
Authors: Strange J E , Schou M , Nouhravesh N , Christensen D M , Holt A , Oestergaard L , Koeber L , Olesen J B , Fosbol E L 
Published: November 2023

Abstract

Background
Severe symptomatic aortic stenosis may cause heart failure, acute myocardial infarction, or syncope; however, limited data exist on the occurrence of such events before transcatheter aortic valve implantation (TAVI) and their impact on subsequent outcomes.

Purpose
To investigate the association between a preceding event (hospitalization for heart failure, acute myocardial infarction, or syncope) and outcomes after TAVI.

Methods
Using nationwide registries, all Danish patients undergoing TAVI from 2014 through 2021 were identified. Preceding events up to 180 days before TAVI were identified. Patients were then stratified into two groups: 1) patients with a preceding event. 2) patients without a preceding event.
The primary outcome of interest was 1-year risk of all-cause death estimated with Kaplan-Meier for patients with a preceding event compared with patients without. The secondary outcome of interest was 1-year cardiovascular rehospitalization amongst patients discharged alive. Here, we used Aalen-Johansen with the competing risk of death among patients alive at discharge. Finally, adjusted analyses were performed with Cox regression analyses.

Results
The main findings are summarized in Figure 1. The study population comprised 5,851 patients. Of these, 759 (13.0%) had a preceding event. Median age was 81 years in both groups. Frailty and male sex were more prevalent among patients with a preceding event (males: 64.7%, intermediate/high frailty: 49.6%) compared with patients without a preceding event (males: 55.2%, intermediate/high frailty 40.6%). A hospitalization for heart failure was the most common preceding event (n=524).
The risk of 1-year all-cause death was 11.7% (95% CI: 9.4%–14.1%) for patients with a preceding event compared with 8.0% (95%CI: 7.2%–8-7%) for patients without a preceding event (Figure 2). This resulted in an adjusted hazard ratio of 1.29 (95%CI: 1.01–1.64). Moreover, the 1-year risk of cardiovascular rehospitalization was 15.0% (95 CI: 12.4%–17.6%) versus 8.2% (95 CI: 7.4%–8.9%) for patients with and without a preceding event (adjusted hazard ratio 1.60 [95%CI: 1.29–1.99]) (Figure 2).

Conclusion
A hospitalization for heart failure, acute myocardial infarction, or syncope prior to TAVI is associated with a higher risk of mortality and cardiovascular rehospitalization. These patients should be carefully evaluated prior to and after TAVI to improve outcomes.
Impact of right ventricular to pulmonary artery coupling on remodeling and outcome in patients undergoing transcatheter edge-to-edge mitral valve repair
Authors: Koschutnik M , Dona C , Nitsche C , Kammerlander A , Dannenberg V , Koschatko S , Mascherbauer K , Heitzinger G , Halavina K , Winter M P , Huelsmann M , Bartko P , Hengstenberg C , Mascherbauer J , Goliasch G 
Published: November 2023

Abstract

Background
Right ventricular to pulmonary artery (RV-PA) coupling has recently been shown to be associated with outcome in valvular heart disease. However, longitudinal data on RV dysfunction and reverse cardiac remodeling in patients following transcatheter edge-to-edge mitral valve repair (M-TEER) are scarce.

Methods
Consecutive patients with primary as well as secondary mitral regurgitation (MR) were prospectively enrolled and had comprehensive echocardiographic and invasive hemodynamic assessment at baseline. Kaplan-Meier estimates and multivariable Cox-regression analyses were performed using a composite endpoint of heart failure hospitalization and death.

Results
Between April 2018 to January 2021, 156 patients (median 78 y/o, 55% female, EuroSCORE II: 6.9%) underwent M-TEER. On presentation, 64% showed impaired RV-PA coupling defined as tricuspid annular plane systolic excursion to pulmonary artery systolic pressure (TAPSE/PASP) ratio &lt;0.36. Event-free survival rates at 2 years were significantly lower among patients with impaired coupling (57 vs. 82%, p&lt;0.01), both in patients with primary (64 vs. 91%, p=0.01) and secondary MR (54 vs. 76%, p=0.03). On multivariable Cox-regression analyses adjusted for baseline, imaging, hemodynamic, and procedural data, TAPSE/PASP ratio &lt;0.36 was independently associated with outcome (adj.HR 2.74, 95%CI: 1.17-6.43, p=0.02).
At 1-year follow-up, RV-PA coupling improved (TAPSE: ∆ +3mm, PASP: ∆ -10mmHg, p for both &lt;0.01), alongside with a reduction in tricuspid regurgitation (TR) severity (grade ≥II: 77 to 54%, p&lt;0.01).

Conclusion
TAPSE/PASP ratio was associated with outcome in patients undergoing M-TEER for primary as well as secondary MR. RV-PA coupling, alongside with TR severity, improved after M-TEER and might thus provide prognostic information in addition to established markers of poor outcome.Graphical Abstract
Head-to-head comparison of two embolic protection devices in carotid artery stenting
Authors: Silva A , Santos T , Simoes M , Batista G , Martins J , Costa M , Goncalves L 
Published: November 2023

Abstract

Introduction
Embolic protection devices (EPD) have been developed to reduce the risk of distal embolization and have become ubiquitous in carotid interventions. There are two classes of EPD: distal filter EPD (f-EPD) and proximal EPD (p-EPD). However, the best device for carotid artery stenting (CAS) has yet to be established.

Purpose
We aimed to assess and compare the early prognosis between the f-EPD and p-EPD groups in patients undergoing CAS.

Methods
Single-center, retrospective study. Patients who underwent CAS from 2000 to 2022 were included. The composite of transient ischemic attack(TIA)/stroke and death at 24 hours and 30 days were evaluated. Statistical analysis was performed using SPSS 28.0.1.1 software.

Results
A total of 436 patients were included (380 and 56 patients used f-EPD and p-EPD, respectively). The population's mean age (±SD) was 71,8 (±8,2) years, 74,8% men. There was a significant prevalence of arterial hypertension (88,3%), dyslipidemia (75,9%), diabetes (33,9%), and smoking background (25,9%). Regarding baseline clinical characteristics, arterial hypertension was more prevalent in the f-EPD group, with statistical significance (91,7% vs. 78,8%; p=0,003).
Concerning the indications for carotid intervention, 16,1% of patients were asymptomatic but had severe stenosis, and 39,4% had neurological symptoms. In 41,9% of patients, the procedure was accomplished before cardiac surgery (coronary artery bypass graft or valvular surgery).
Regarding the first 24 hours after the procedure, the combined endpoint of TIA/stroke or death occurred in 3,4% of patients in the f-EPD group and 3,6% in the p-EPD group, with no statistically significant difference (p=1,000). The incidence of TIA/stroke was also similar in both groups (3,2% and 3,6% in the f-EPD and p-EPD groups, respectively; no statistical difference was found; p=0,694). The early mortality rate was slightly lower in the f-EPD group (0,8%) compared with the p-EPD group (1,8%), though this difference did not reach statistical significance (p=0,424).
During the 30-day follow-up, the combined endpoint of TIA/stroke or death occurred in 1,6% of patients in the f-EPD group and 1,8% in the p-EPD group, with no statistically significant difference (p=1,000). The incidence of TIA/stroke was lower in the f-EPD group (1,1%) compared to the p-EPD group (1,8%), however, no statistical difference was found (p=0,499). Regarding mortality rate, the incidence in the f-EPD group was 0,5%, in contrast with no events in the p-EPD group (statistical analysis not possible to compute).

Conclusion
In this cohort, no significant differences were found between the distal filter and proximal embolic protection devices in the risk of TIA/stroke and death at 24 hours and 30 days after carotid artery stenting. However, conclusions should be carefully drawn since the distal filter EPD was used more often than the proximal EPD, making direct comparisons challenging.