bluuebunny/crossref_metadata_2025 huggingface dataset:
Association of ticagrelor vs clopidogrel with net adverse clinical events in patients with mild thrombocytopenia undergoing PCI
Authors: Jiang C , Zhang Y K , Hu S T , Gu T S , Zhang J K , Wu X , Liu X , Liu T , Chen K Y
Published: October 2024

Backgrounds

Current guidelines recommend aspirin plus ticagrelor as the preferred dual antiplatelet therapy (DAPT) for managing ST-elevation myocardial infarction (STEMI). However, there is a lack of consensus or guidelines to direct clinicians on managing patients with mild thrombocytopenia, defined as a platelet count of 100~150×109/L, undergoing percutaneous coronary intervention (PCI).

Purpose

This study aims to investigate the association between ticagrelor and clopidogrel with ischemic and hemorrhagic events for patients with mild thrombocytopenia undergoing PCI.

Methods

A retrospective cohort study of patients with mild thrombocytopenia undergoing PCI who received DAPT consisting of aspirin and a P2Y12 receptor antagonist (includinig clopidogrel or ticagrelor) was conducted using Health and Medical Big Data Super Platform from January 2010 to June 2023. All patients meeting the criteria were included in the analysis, with a follow-up of at least one year. Propensity Score Matching (PSM) was performed to equalize the effects of following characteristics: age, sex, hypertension, diabetes, dyslipidemia, stroke, atrial fibrillation, Killip class, percutaneous coronary intervention (PCI), beta-blockers, statins, calcium channel blockers (CCB), angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (ACEI or ARB), angiotensin receptor-neprilysin inhibitor (ARNI), diuretic, organic nitrates, and oral anticoagulation. The primary endpoint was net adverse clinical events (NACE) at 1 year, composed of ischemic events (recurrent myocardial infarction or ischemic stroke), Bleeding Academic Research Consortium (BARC) classification ≥ 3, and cardiac death. Secondary outcomes included the components of NACE.

Results

A total of 3647 patients met the inclusion criteria, with 2684 receiving aspirin plus clopidogrel and 963 receiving aspirin plus ticagrelor, matched by a 1:3 ratio using the PSM method. Demographic characteristics were well balanced between the clopidogrel and ticagrelor groups. The 1-year risk of NACE did not significantly differ between ticagrelor and clopidogrel (11.1% vs. 8.4%, p=0.370). Similarly, there was no significant difference in the risk of cardiac death (7.3% vs. 4.2%, p=0.720), recurrent myocardial infarction (9.3% vs. 5.8%, p=0.550), ischemic stroke (8.8% vs. 6.7%, p=0.055), or BARC type ≥ 3 bleeding (7.9% vs. 4.5%, p=0.990).

Conclusion

In routine clinical practice, among patients with a platelet count of 100~150×109/L undergoing PCI, ticagrelor compared with clopidogrel was not associated with a significant difference in the risk of NACE at 1 year. Further research is warranted to assess whether ticagrelor is more effective than clopidogrel in this setting, considering potential unmeasured confounders.
OSDOKINA crush technique for the management of side branch ostial lesion ISTANBOL study
Authors: Acar E , Donmez I , Gunes Y , Sincer I , Izgi I A , Kirma C
Published: October 2024

Background

Isolated ostial bifurcation lesions (Medina type 0.0.1) represent <20% of coronary bifurcation lesions. Percutaneous coronary intervention (PCI) of this subset of lesions is challenging for the interventional cardiologist because of the technical difficulty and potential risk of serious complications.

Purposes

Recently, we devised a new technique, called the OSDOKINA crush technique, for the treatment of Medina type 0.0.1 coronary bifurcation lesions. The aim of this study was to evaluate the technical feasibility, safety and short-term and midterm procedural and clinical results achieved with OSDOKINA crush technique for Medina type 0.0.1 coronary bifurcation lesions.

Materials and Methods

Between September 2020 and January 2024, we included 49 patients who had Medina type 0,0,1 coronary bifurcation lesions. The vessel size had to be ≥2.5 mm by visual estimation on coronary angiography. Demographic, clinical and lesion characteristics of the cases were recorded. Quantitative coronary angiography analyses were performed using dedicated bifurcation angiographic software. Procedural success was defined as successful implantation of the stent into the target lesion, causing a final residual stenosis ≤30%. Major adverse cardiac events(MACE) were defined as cardiac death, myocard infarction and target lesion revascularisation. All patients were followed up to twelve months after the intervention.

Results

The lesion localisations were the ostium of diagonal branch in 19 (38.7%), ostium of the obtuse marginalis branch in 17 (34.6%), ostium of right posterior descending or right posterolateral branch in 13 (26.7%). SB RVD, SB lesion length and SB diameter stenosis by QCA were 2.65±0.35 mm, 9.4±3.9 mm, and 79.8±12.6, respectively. SB predilatation was applied in all cases. In 1 patient (2.1%), a stent had to be placed in the main branch using the double-kissing mini crush technique due to flow-limiting dissection that developed after the second kissing balloon inflation. Considering all cases, the angiographic success rate was 97.9% (n: 48). All patients had 12-month follow-up results. Acute myocardial infarction occurred in 1 patient (2.1%) due to side branch stent thrombosis. No patient had main branch revascularization. Cardiac or non-cardiac death was not observed. Cumulative MACE was 2.1%(n:1).

Conclusion

The OSDOKINA crush technique has excellent acute results and midterm clinical outcomes in the management of Medina type 0.0.1 coronary bifurcation lesions. Multicenter studies with large patient groups are needed.
Comparison of ridaforolimus-eluting and zotarolimus-eluting coronary stents: 5-Year outcomes from the BIONICS and NIREUS trials
Authors: Zornitzki L , Smits P C , Love M P , Stone G W , Kandzari D E , Redfors B , Ozan M O , Konigstein M
Published: October 2024

Introduction

Despite similarities between different modern drug eluting stents (DES), their comparative short and long-term safety and efficacy has generated much interest and yielded conflicting results. The BIONICS and the NIREUS randomized clinical trials showed non-inferiority of the Ridaforolimus eluting stent (RES) compared to the Zotarolimus-eluting stent (ZES) with respect to 1-year target lesion failure (TLF) and 6-month angiographic late lumen loss.

Aim

To evaluate clinical outcomes between treatment groups over 5 years follow-up

Methods

BIONICS and NIREUS were prospective, randomized, single-blind multicenter trials comparing RES and ZES in patients undergoing PCI. Patients were blinded to treatment assignment and randomized to RES or ZES in a 1:1 fashion in BIONICS, and in 2:1 fashion in NIREUS. Clinical events were assessed during hospital stay, at 30 days, 1 year, and yearly thereafter, up to 5 years. The The primary endpoint in the current study was the 5-year rate of target lesion failure (TLF).

Results

The study population included 2221 patients enrolled in the BIONICS (n=1919) and NIREUS (n=302) studies. Median follow-up was 1822 days (interquartile range 1783 to 1847 days). Mean age was 63.2±10.3 years, and most patients were men (79.7%). Clinical presentation with ACS was similar between groups (38.9% versus 37.9%, RES versus ZES, respectively, p=0.38).

Procedural characteristics were similar for patients treated with RES and ZES. A mean of 1.6±0.9 and 1.5±0.8 stents were implanted in RES and ZES patients, respectively, p=0.08. Post dilatation was performed more frequently in the RES group (63.3% versus 60.1%, p=0.02) and procedure duration was longer in RES versus ZES patients (47.0±31.8 minutes versus 44.6±29.2 minutes, p=0.01). Device success was high in both groups but slightly higher in the ZES group (98.2% versus 99.5% for RES and ZES, respectively, p=0.002) yet with similar procedural success (97.9% versus 97.3%, p=0.49).

At 5 years, the primary endpoint of TLF was similar between treatment groups (12.2% RES versus 11.3% ZES, p=0.52). Rates of TLR (7.6% RES versus 6.8% ZES, p=0.42), target vessel-related MI (4.8% RES versus 4.9% ZES, p=0.95) and stent thrombosis (0.9% RES versus 0.9% ZES, p=0.87), also did not differ between groups. Target vessel revascularization (TVR) and cardiac death were higher among the RES group (12.3% versus 9.5% p=0.037, and 3.6% versus 2.2 % p=0.042, respectively). However, after correction for baseline characteristics there was no significant difference in cardiac death between groups.

Conclusions

In a pooled analysis of two randomized trials, 5-year clinical outcomes were similar between patients undergoing PCI with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of patients with coronary artery disease.Central illustrationZES vs. RES
Impact of the thin-walled sheath on the distal radial artery occlusion: a randomized trial
Authors: Cai G , Lu W , Chen T , Yang A N , Li L M , Shi G W , Xue S L , Xiao J Q , Gu J , Zhang L Y , Liang X F , Li F , Wang H B , Li W H
Published: October 2024

Background

Distal transradial access (dTRA) has been increasingly accepted as an alternative to the transradial access (TRA) for coronary angiography (CAG) and/or percutaneous coronary intervention (PCI). Although the dTRA has been significantly associated with better patient comfort, shorter haemostasis time, and fewer vascular access-related complications, such as haematoma and proximal radial artery occlusion (pRAO), it has also been associated with an increased risk of distal radial artery occlusion (dRAO).

Purpose

The aim of the present study was to investigate whether the 6-Fr thin-walled sheath was superior to the conventional radial sheath with respect to the incidence of distal radial artery occlusion (dRAO) at 24 h after CAG and/or PCI via dTRA.

Methods

A prospective, single-centre trial of patients who were randomized to undergo CAG and/or PCI with either a 6-Fr thin-walled sheath or a 6-Fr conventional sheath. The primary endpoint was the incidence of dRAO at 24 h postoperatively, as evaluated by Doppler ultrasound. The second endpoints included the puncture success rate, puncture time, the incidence of pRAO, pain during the sheath placement, and other vascular-associated complications.

Results

A total of 620 patients were included in the study. The mean age of the patients was 66.6± 9.7 years (median age 69.0 years [interquartile range 60.0- 74.0 years]), and 66.3% were men. The baseline patient and procedural characteristics were similar between the two groups. For the primary endpoint, the incidence of dRAO at 24 h after the procedure was 1.0% (3/314) in the thin-walled sheath group and 3.6% (11/306) in the conventional sheath group (RR= 0.266, 95%CI= 0.075-0.943, P= 0.027) according to the intention-to-treat (ITT) analysis. For secondary endpoints, the incidence of pRAO was 0.3% (1/314) in the thin-walled sheath group and 2.3% (7/306) in the conventional sheath group (P= 0.029). No significant difference was observed between the thin-walled sheath and the conventional sheath groups regarding the puncture success rate (92.4% vs. 92.5%, P= 0.952). The severity of pain experienced during the sheath placement was similar between the two groups (VAS 2 vs. 2 P=0.426). Other secondary endpoints, including procedural outcomes and other puncture-related outcomes and access-related complications, were not significantly different between the two groups.

Conclusion

A thin-walled sheath can reduce the incidence of early-term dRAO in patients who underwent CAG and/or PCI via the dTRA.The primary endpoint of the trial
Predictors of acute ischemic strokes and subsequent mortality in patients hospitalized for percutaneous coronary interventions
Authors: Bay B , Gossling A , Remmel M , Becher P M , Schrage B , Rimmele D L , Thomalla G , Blankenberg S , Clemmensen P , Brunner F J , Waldeyer C
Published: October 2024

Background

Acute ischemic strokes (AIS) occurring post percutaneous coronary intervention (PCI) are an infrequent but severe complication, resulting in increased mortality rates and morbidity in survivors.

Purpose

We aimed to investigate independent predictors of AIS and subsequent mortality in patients hospitalized for PCI in a nationwide cohort.

Methods

A retrospective analysis using on ICD-10-GM and OPS-codes obtained from 2006-2021 from the German Federal Statistical Office was performed. Patients with a peri-interventional AIS aged ≥18 years which were admitted for PCI were included in this analysis. A stepwise regression analysis was employed to identify factors independently associated with AIS and to determine variables linked to in-hospital mortality.

Results

From 4,910,430 PCI cases registered from 2006-2021, AIS occurred in 4,098 (0.08%) patients. Patients with an AIS were 70.9±11.3 years of age, predominantly male (65.3%) and displayed a high burden of comorbidities such as diabetes (36.1%), a prior medical history of atrial fibrillation (34.6%) and chronic kidney disease (19.4%). In patients with AIS, 27.4% presented with a ST-elevation myocardial infarction (STEMI), whilst 38.9% were admitted with a Non-STEMI. Concerning procedural characteristics, 84.2% underwent a coronary stent implantation, and in 5.5% cases a coronary thrombectomy was carried out.

Important predictors of peri-interventional AIS after a PCI were: carotid artery disease, history of stroke, presentation with myocardial infraction, atrial fibrillation, and coronary thrombectomy. For variables like hyperlipoproteinemia, obesity and stent implantation an inverse association was noted (also see Figure 1A). With regard to mortality, during a mean in-hospital stay of 18 ± 15.1 days, a total of 18.1% (n=742) patients died. We identified several independent predictors of mortality including clinical presentation with cardiogenic shock, dialysis and STEMI as indication for PCI. A negative correlation with in-hospital mortality was seen for variables such as arterial hypertension and coronary stent implantation (see Figure 1B for full set of independently associated variables).

Conclusion

In a nationwide cohort of patients hospitalized for PCI over 16 years, we identified important predictors of AIS including carotid artery disease and coronary thrombectomy. Moreover, a substantial rate of in-hospital mortality as well as several predictors of death were recognized. Our findings might help clinicians identify patients undergoing PCI who are at highest risk for ischemic cerebral complications and subsequent mortality.
Sheathless versus standard guiding catheters for transradial percutaneous coronary interventions: a systematic review and meta-analysis
Authors: Majeed Z , Tariq M H , Ahmed A , Usama M , Khan A , Bajwa M S , Umar M F , Khan U , Abuelazm M , Amin A M , Abouzid M
Published: October 2024

Introduction

The sheathless trans-radial (TR) technique is a novel approach that may offer potential benefits over the conventional TR approach. We aim to comprehensively compare and analyze the safety and effectiveness of these two catheter types in trans-radial percutaneous coronary interventions (PCI).

Methods

We conducted comprehensive searches across PubMed, CENTRAL, WOS, Scopus, and EMBASE until July 2023. Pooled data were reported using risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, along with a 95% confidence interval (CI).

Results

We included 12 studies with 16,988 patients. Notably, the radial artery spasm (RAS) (RR: 0.26, 95% CI: [0.09, 0.77], p = 0.02) and cross-over to the femoral site (RR: 0.22 [0.08, 0.60], p = 0.003) were significantly lower in the sheathless group. However, post-procedural radial artery occlusion (RAO) was significantly higher in the sheathless group (RR: 2.30, 95% CI: [1.52, 3.49], p = 0.0001). Also, we did not find a significant difference between both groups in success rate (RR: 1.03, 95% CI: [0.95, 1.06], p = 0.10) and all-cause mortality (RR: 0.41, 95% CI: [0.16, 1.04], p = 0.06).

Conclusion

The sheathless TR approach showed lower rates of RAS and femoral conversion. However, it also increased RAO. Thus, more trials are needed to confirm this technique's long-term outcomes and complications.Figure 1
Provisional stenting : drug-coated versus uncoated balloon for side branch in coronary bifurcation lesions: randomized study
Authors: Meftah A , Lounes L , Allal A , Belhadi B
Published: October 2024

Introduction

The rePOT technique is a novel and easily applied approach for coronary bifurcations. Drug-Coated Balloon (DCB) angioplasty is increasingly being utilized in management of small vessels and coronary bifurcation lesions. Herein, we propose a new approach for treating coronary bifurcation lesions with the application of DCB to treat the side-branch in addition to the rePOT technique: the POT-sideDCB-POT technique.

Materiel and Method: We described for the first time the POT-sideDCB-POT method for true bifurcation lesions (including the side-branch ostium), which is in line with the recommended management algorithm of the European Bifurcation Club8 consisting of a sequential approach to bifurcation stenting using the provisional strategy. The POT-sideDCB-POT is easy to perform and respects the geometry of all the three bifurcation segments.

Results

Overall, 100 patients with CBLs treated with provisional stenting using DES were included from our studie,50 with DCB side branche and 50 with UCB With a follow-up duration of 12 months, SB protection with DCB was associated with a lower degree of postoperative diameter stenosis (mean difference (MD): −10.35%, 95% confidence interval (CI): −13.17 to−8.53, p < 0.001; I2 = 0%) and less late lumen loss (MD: −0.18 mm, 95% CI:−0.28 to−0.10, p < 0.001; I2 = 69%) of SB compared to those with UCB. Moreover, SB protection with DCB was associated with reduced risks of target lesion revascularization (risk ratio [RR]: 0.45, 95% CI: 0.27 to 0.88, p = 0.02; I2 = 0%) and major adverse cardiovascular events (RR: 0.42, 95% CI: 0.27 to 0.66, p < 0.01; I2 = 0%). Subgroup analysis according to the study design showed similar results.

Conclusions

For patients with CBL treated with provisional stenting using DES, SB protection with DCB was associated with better angiographic and clinical outcomes than those with UCB.
Baseline right ventricular-pulmonary artery uncoupling and mortality following transcatheter aortic valve replacement: a meta-analysis
Authors: Theofilis P , Mantzouranis E , Vlachakis P K , Sakalidis A , Soulaidopoulos S , Tsioufis K
Published: October 2024

Background

In severe aortic stenosis (AS) patients, elevated left-sided filling pressures can lead to pulmonary hypertension and right ventricular (RV) systolic dysfunction. These conditions signal advanced disease and predict poor outcomes in transcatheter aortic valve replacement (TAVR) cases. However, recent studies indicate potential recovery post-TAVR, with improved prognosis. The newly recognized index, RV to pulmonary artery (RV-PA) coupling, reflects the RV's ability to handle pulmonary afterload and is associated with adverse outcomes.

Purpose

This study aimed to delineate the prognostic role of baseline RV-PA uncoupling in patients undergoing TAVR.

Methods

We conducted a systematic literature search for studies assessing RV-PA coupling indices at baseline in patients undergoing TAVR. We recorded the year of publication, method of RV-PA assessment, the proposed cutoffs, patients’ age-sex, and follow-up duration. The primary outcome of interest was all-cause mortality at maximal follow-up and the adjusted hazard ratios of RV-PA uncoupling for all-cause mortality were extracted. Pooling of the hazard ratios was conducted according to a random effects model. I2 was chosen as the measure of between-study heterogeneity, with values exceeding 50% being significant.

Results

We identified a total of 316 studies, of which 5 were ultimately selected for data extraction and inclusion in the meta-analysis after screening of title/abstract/full-text. All but one study utilized the Tricuspid Annular Plane Systolic Excursion/Pulmonary artery systolic pressure (TAPSE/PASP) as the method of RV-PA assessment. The mean age of the participants across the studies was approximately 81 years old, with a balanced male:female ratio. The median follow-up duration was 23 months (range: 6-40 months). According to the results of the meta-analysis, the presence of baseline RV-PA uncoupling was associated with a 2.8-fold increased risk of all-cause mortality at maximal follow-up (Figure). Significant between-study heterogeneity was detected. An asymmetric funnel plot was inspected, indicative of publication bias (Egger’s test intercept: 6.76, 95% confidence interval 5.07-8.44, p=0.004). The results, although attenuated, remained significant even after a trim-and-fill analysis (3 studies added, hazard ratio: 1.27, 95% confidence interval: 0.03-2.51, p=0.04). Furthermore, the results were unaffected following a sensitivity analysis with the leave-one-out method.

Conclusion

This meta-analysis suggests that baseline RV-PA uncoupling prior to TAVR is associated with all-cause mortality and it could serve as an imaging biomarker of prognosis in this patient population.Figure
Procedure-related radiation and contrast use during TAVI procedures with balloon-expandable versus self-expanding devices
Authors: Andreka J , Deharo P , Adamaszek M M , Regueiro A , Pranevicius R , Stark C , Prunea D , Kanoun Schnur S S , Bugger H , Wolf A , Cuisset T , Schmidt A , Brugaletta S , Toth G G
Published: October 2024

Background

Transcatheter aortic valve implantation (TAVI) procedures show some fundamental differences, depending on the use of balloon-expandable (BEV) or self-expanding (SEV) devices. We aimed to assess, how it translates into contrast use and radiation exposure.

Methods

From five high volume European centers consecutive patients were included, who underwent transfemoral TAVI procedure. Patient- and procedural characteristics were recorded and compared in relation to the used TAVI device.

Results

In total 3131 patients were included. 53% were male and the mean age was 80±9 years. 1273 (41%) patients were treated with BEV, while 1858 (59%) with a SEV system. Patients, receiving SEV were older (81±9 vs 79±9 years, respectively; p<0.01) and were more often females (57% vs 33%, respectively; p<0.01). There was also a trend for less peripheral artery disease (14% vs 17%, respectively; p=0.06).

Overall total radiation time was 15±9 min., that was markedly shorter for BEV than for SEV (13±8 vs. 17±10 min., respectively; p<0.01). On average 130±65 mL contrast media was used, that was less for BEV than for SEV (104±52 vs. 148±67 mL, respectively; p<0.01)

In terms of contrast use, retrievable- and non-retrievable SEVs were comparable (148±71 vs. 146±63 mL, respectively; p=0.41), but both markedly higher, than for BEVs (p<0.01 for both). Non-retrievable SEVs required less radiation (14±7 vs. 18±10 mins, respectively; p<0.01), but still markedly more than BEVs (p<0.01).

Conclusion

TAVI procedures with BEV require shorter radiation exposure for the team and markedly less contrast, than with SEV. This might be reasonable to consider during patient-tailored procedure planning.Radiation and contrast usage during TAVI
Incidence, determinants, and impact of in-hospital complications during percutaneous patent foramen ovale closure
Authors: Souquet A , Guedeney P , Dauphin C , Roule V , Ohlmann P , Huang F , De Ferrari G M , Gabrion P , Silvain J , Auffret V , Cayla G , Barsoum P , Meneveau N , Abtan J , Montalescot G
Published: October 2024

Introduction

The incidence, types, determinants, and clinical impact of in-hospital complications after contemporary patent foramen ovale (PFO) percutaneous closure is unclear.

Purpose

To describe the incidence, types, determinants, and clinical impact of in-hospital complications after percutaneous PFO closure.

Methods

This study included consecutive patients undergoing PFO percutaneous closure for any indication in 18 centers in France and Italy from the ongoing AIR-FORCE registry. Periprocedural complications were collected, including death, bleeding, myocardial infarction (MI), supraventricular arrhythmia, pericardial effusion or tamponade, cardiac perforation, device embolization, intracardiac thrombus, venous thrombosis, atrioventricular block, brachial paraesthesia, oesophageal hematoma, and veno-arterial fistula. Determinants of periprocedural complications were evaluated using a logistic multivariate model. The clinical impact of periprocedural complications on cardiovascular events after discharge measured by the composite endpoint of death, stroke, transient ischemic attack, MI atrial arrhythmia, pulmonary embolism, deep veinous thrombosis, BARC ≥2 bleeding, or percutaneous or surgical re-intervention on the PFO) at longest follow-up was evaluated using a Cox model adjusted on age, sex, body mass index, diabetes mellitus, hypertension, dyslipidemia, and shunt severity prior to closure.

Results

We analyzed a total of 2,799 patients undergoing PFO closure with median age 50.7 [41.7-58.6] years and 57.9% male. A total of 109 (3.9% 95%CI 3.2%-4.7%) patients presented at least one in-hospital complication, the most frequent being supraventricular arrhythmia in 39 (1.4% 95%CI 1.0-1.9%) patients and BARC bleeding type ≥2 in 26 (0.9% 95%CI 0.6-1.4%) patients. Determinants of in-hospital complications were older age (per on year aOR 1.02 95%CI 1.01-1.04), diabetes mellitus (aOR 2.58 95%CI 1.36-4.89) and PFO closure for secondary prevention of an arterial embolic event (aOR 2.12 95%CI 1.18-3.82). With a median follow-up of 1.1 [0.3-3.1] years, the occurrence of an in-hospital complication was associated with an increased risk of cardiovascular events after discharge (aHR 1.90 95%CI 1.26-2.89) (Figure 1).

Conclusions

Although relatively rare, the occurrence of in-hospital complication during PFO percutaneous closure is associated with an increased risk of cardiovascular events in the year following the procedure.
A novel bionic constructional left atrial appendage occlude device: the result of preclinical experiment and first-in-human study
Authors: Lin D , Zhang X , Zhou D
Published: October 2024

Objectives

Left atrial appendage occlusion (LAAO) has emerged as a viable substitute for oral anticoagulation (OAC) for stroke prevention among individuals with atrial fibrillation (AF) these years. The high variability of left atrial appendage (LAA) in different individuals would lead to failure of LAAO or significant PDL post procedure using the existing occluders. Therefore, novel occluder which could address these issues is of great urgent.

Methods

SimuLock® occluders were implanted in 18 healthy canines percutaneously. Angiography and transesophageal echocardiography were employed to evaluate the effect of closure. The canines were sacrificed post-procedure immediately or on 30th, 90th and 180th. Subsequently, the gross anatomy was examined and endothelialization of device surface was evaluated by HE staining. 3 patients who had non-valvular AF and underwent LAAO in Zhongshan hospital, Fudan University using SimuLock® were enrolled in this study. They all had a follow-up of 3 months.

Results

All animals were implanted with the SimuLock® device. In 27.8% of animal cases, a LAA occluder of the "large umbrella and small disc" type which could adapt to LAA morphology well was employed, and all surpassed the specifications of existing occluders. None of residual shunt was observed all canines in 180 days post procedure. In addition, none adverse events were documents during the 6-month follow-up. In the first-in-human study, the SimuLock® occluder were successfully implanted in 3 subjects, all subjects achieved complete occlusion, without residual shunt > 3mm. The incidence of major adverse events, operation-related serious adverse events and device-related serious adverse events in all subjects were not documented in 3 months after operation.

Conclusions

In the animal experiment and first-in-human study, SimuLock® device showed the ability of adapting to various LAA morphology well and rapid endothelialization. The utilization of SimuLock® for LAAO exhibited high efficacy and safety.Central figure
Impact of surgical technique on postoperative ventricular arrhythmias in arrhythmic mitral valve prolapse
Authors: Lodin K , Wang A , Dalen M , Shahim B
Published: October 2024

Background

Mitral valve prolapse (MVP) is associated with progressive mitral regurgitation (MR) requiring surgical correction. A subset of patients with MVP may also constitute an "arrhythmic" phenotype suffering from malignant ventricular arrhythmias (VAs).

Purpose

To assess the impact of surgical technique for correction of degenerative MR including repair using artificial chords, repair with resection and mitral valve replacement (MVR) on longitudinal risk of VAs in patients with arrhythmic MVP.

Methods

Patients who had undergone mitral valve surgery for MVP with moderate to severe degenerative MR between 2010-2022 at a university hospital in Sweden were retrospectively included. Patients with ischemic heart disease, primary cardiomyopathy, channelopathy, or endocarditis were excluded. To examine changes in VAs (defined as sustained- or non-sustained ventricular tachycardias) as assessed by continuous Holter monitoring before and after surgery, generalized estimating equation (GEE) models were performed to account for the correlations between repeated monitoring in each patient and for differences in the time of measurement.

Results

Of 599 patients undergoing mitral valve surgery, 423 (71%) underwent repair using artificial chords, 62 (10%) repair with resection and 114 (19%) MVR. For those presenting with symptoms such as palpitations, presyncope, and/or syncope, Holter monitoring was conducted before (n=171; 29%) and/or after mitral valve surgery (n=184; 31%) (Figure 1). The distribution of VAs before and after surgery, stratified by surgical technique, is illustrated in Figure 2. In GEE models, repair using artificial chords was associated with increased postoperative VAs compared with the other surgical techniques (OR 2.14; 95% CI 1.19-3.83; p=0.01), repair with resection with reduced postoperative VAs compared with the other surgical techniques (OR 0.15; 95% CI 0.04-0.61; p=0.01), and no change in postoperative VAs was observed for MVR compared with the other surgical techniques (OR 0.724; 95% CI 0.39-1.35; p=0.31). The results remained similar after adjustment for age, sex, myxomatous disease/fibroelastic deficiency or bileaflet prolapse.

Conclusion

In patients with symptoms of palpitations, presyncope and/or syncope before or after mitral valve surgery, repair using artificial chords was associated with an increased risk of postoperative VAs. Prospective studies including continuous monitoring before and after surgery are needed to confirm these findings.
Social determinants of health, blood pressure classification, and incident stroke in community-dwelling adults: a prospective cohort study
Authors: Chen C L , Ou Y Q , Huang Y Q , Feng Y Q , Nie Z Q
Published: October 2024

Objective

To determine whether the association of blood pressure (BP) categories, defined by the 2017 American College of Cardiology (ACC)/American Heart Association (AHA) BP guideline, with stroke differ among Chinese adults with low or high burden of unfavorable social determinants of health (SDOH).

Design and Methods: Analyses were conducted in the prospective sub-cohort of the China Patient-Centered Evaluative Assessment of Cardiac Events Million Persons Project, started in 1, July 2017 and followed stroke events until 31, June 2023. Participants were divided into groups with low and high burden of unfavorable SDOH, which consisted of educational attainment, economic stability, health care access, social support, and neighborhood relationship. Within each group, participants were categorized as having normal BP (systolic BP [SBP] <120 mm Hg and diastolic BP [DBP] <80 mm Hg), elevated BP (SBP 120-129 mm Hg and DBP <80 mm Hg), stage 1 hypertension (SBP 130-139 mm Hg or DBP 80-89 mm Hg), and stage 2 hypertension (SBP ≥140 mm Hg or DBP ≥90mm Hg). The association between BP categories and stroke risk were examined within each SDOH group, separately, using multivariable-adjusted Cox proportional hazards models.

Results

Of the 96,686 adults included in this study (mean [SD] age, 53.8 [10.1] years; 59,080 [61.1%] women), 64,823 (67.0%) were categorized as having high burden of unfavorable SDOH. Over a median follow-up of 5.0 years, 4,673 (4.8%) incident stroke events occurred. In the group of low burden of SDOH, hazard ratios (95% CI) for stroke events for elevated BP, stage 1 hypertension, and stage 2 hypertension vs normal BP were 1.09 (0.86-1.37), 1.14 (0.94-1.37), and 1.59 (1.33-1.90), respectively. In the group of high burden of SDOH, hazard ratios for stroke events for elevated BP, stage 1 hypertension, and stage 2 hypertension vs normal BP were 1.20 (1.04-1.38), 1.45 (1.29-1.62), and 1.71 (1.53-1.91), respectively. Results were similar after excluding those taking antihypertensive medications.

Conclusion

Lower BP categories were closely associated with increased risk of stroke in the context of high burden of SDOH. Early counseling and surveillance of high BP should be emphasized within socioeconomically disadvantaged populations.
Epidemiological, clinical, paraclinical, evolutionary, and therapeutic aspects of hypertensive patients infected by COVID-19: about 702 patients in our city
Authors: Ngaide A A , Fortes L , Wade I , Gaye N D , Mingou J S , Dioum M , Kane A
Published: October 2024

Introduction

Hypertension (HT) is a major cardiovascular risk factor frequently observed in COVID-19 patients. This study aimed to determine the frequency of hypertensive patients infected with COVID-19 at a national hospital, describe their epidemiological, clinical, paraclinical, and therapeutic profile, their disease progression, and identify factors associated with death.

Methodology

A retrospective, descriptive, and analytical study was conducted over 24 months and 4 days, from 27 March 2020 to 30 March 2022, at national hospital. Included were hospitalized patients at a hospital with a confirmed COVID-19 diagnosis, known hypertensives, regardless of gender, and with a hospitalization record. COVID-19 diagnosis was based on a positive SARS-CoV-2 RT-PCR or a positive COVID Rapid Diagnostic Test. Data were collected using a survey form, with a p-value less than 0.05 considered statistically significant for bivariate analysis.

Results

The study enrolled 702 patients, a hospital frequency of 23.95%. The average age was 65.14 ± 12.24 years with a sex ratio of 0.81. Comorbidities were predominantly diabetes (40.5%) and dyslipidemia (4.8%). Common symptoms included cough (65%), dyspnea (42.3%), fever (47.4%), and asthenia (35.9%). Blood pressure was normal in 15.2%, high-normal in 16.8% of patients. HT was Grade I in 12.1%, Grade II in 10%, and Grade III in 6.8% of the population, with blood pressure unmeasurable in 0.3% of known hypertensive patients. SARSCOV2 infection was mild in 34.2% and moderate in 42.8% of cases. CT scans showed extensive (31.8%), severe (25.9%), moderate (25.6%), critical (8.5%), and minimal (7.9%) lung damage. Treatment mainly consisted of ACE inhibitors (29%), ACE inhibitors in combination with another antihypertensive (8.4%), and ARBs in combination with an antihypertensive (). The average hospital stay was 12.85 days with a favorable outcome in 81% and a mortality rate of 15.5%. Factors associated with death included not being vaccinated against COVID-19 (HR: 11.70; 95% CI: 1.324-103.519), critical clinical form (HR: 11.70; 95% CI: 1.324-103.519), pulmonary consolidation (HR: 8.87; 95% CI: 7.539-24.207), high creatinine (HR: 4.69; 95% CI: 1.360-16.181), critical CT thoracic level (HR: 2.42; 95% CI: 1.020-5.745), and not taking ARBs (HR: 6.02; 95% CI: 2.812-12.889).

Conclusion

HT can be associated with COVID-19, impacting the disease's prognosis with significant mortality. Preventing its incidence and morbidity/mortality is crucial.
Relationships among intensive blood pressure control, morning blood pressure surge and 24-hour blood pressure variability
Authors: Wang W T , Cheng H M C , Chen C H C , Lee Y H L
Published: October 2024

Objectives

This study aimed to investigate the relationships between cardiovascular outcomes and blood pressure (BP) reduction, 24-hour BP variability (BPV), morning BP surge (MBPS), and visit-to-visit BPV.

Methods

This study involved 897 participants from the Systolic Blood Pressure International Trial (SPRINT), for whom biochemical and demographic data, medication history, and various blood profile information were collected. Univariate and multivariate linear regression models were used to assess the impact of intensive BP management on 24-hour BPV and the MBPS.

Results

Among the 897 participants (average age 71.48 ± 9.42 years; 640 males), 453 received intensive treatment. Those in the intensive group were more likely to be on ACE inhibitors, CCBs, or diuretics. This group showed significant reductions in 24-hour systolic and diastolic BP, as well as in both short-term and long-term BPVs, such as average real variability (ARV) and MBPS. The analysis demonstrated strong associations between intensive BP management and improvements in various BPV measures, including systolic ARV, diastolic BP ARV, and cumulative BP loads. A significant correlation was also found between intensive BP lowering and the primary composite outcome of the SPRINT study.

Conclusions

This study highlighted the significant associations between intensive BP management and reductions in the MBPS and 24-hour BPV, which affect both short-term and long-term health outcomes. The primary benefits of intensive BP control appear to stem from direct BP reduction rather than changes in BPV. However, further extensive randomized controlled trials are needed to confirm these findings.
Blood pressure and cardiovascular risk in relation to birth weight and urinary sodium: an individual-participant meta-analysis of European family-based population studies
Authors: Yu Y L , Moliterno P , Raaijmakers A , Stolarz-Skrzypek K , Tikhonoff V , Malyutina S , Casiglia E , Filipovsky J , Rajzer M , Allegaert K , Kawecka-Jaszcz K , Verhamme P , Nawrot T S , Staessen J A , Boggia J
Published: October 2024

Background

While the relation of salt intake with blood pressure (BP) is linear, it is U-shaped for mortality and cardiovascular disease (CVD).

Purpose

This individual-participant meta-analysis explored whether the relation of hypertension, death or CVD with 24 h urinary sodium excretion (UVNA) or sodium-to-potassium (UNAK) ratio was modified by birth weight.

Methods

Families were randomly enrolled in the Flemish Study on Genes, Environment and Health Outcomes (1985-2004) and the European Project on Genes in Hypertension (1999-2001). Categories of birth weight, UVNA and UNAK (≤2500, >2500-4000, >4000 g; <2.3, 2.3-4.6 and >4.6 g; and <1, 1-2 , >2, respectively) were coded using deviation-from-mean coding and analyzed by Kaplan-Meier survival functions and linear and Cox regression.

Results

The study population was subdivided into the Outcome (n=1945), Hypertension (n=1460) and BP cohorts (n=1039) to analyze the incidence of mortality and cardiovascular endpoints, hypertension and BP changes as function of UVNA changes. The prevalence of low/medium/high birth weight in the Outcome Cohort was 5.8/84.5/9.7%. Over 16.7 years (median), rates were 4.9%, 8.0% and 27.1% for mortality, CVD and hypertension, respectively, but were not associated with birth weight. Multivariable-adjusted hazard ratios were not significant for any endpoint in any of the BW, UVNA and UNAK strata. Adult body weight tracked with birth weight (P<0.0001). The partial r in the low birth weight group associating changes from baseline to follow-up in UVNA and systolic BP was 0.68 (P=0.023), but not significant in other birth weight groups.

Conclusion

This study did not substantiate its prior hypothesis, but showed tracking of adult with birth weight and suggest that low birth weight increases salt sensitivity.Figure 1Figure 2
Association between the cumulative excessive systolic blood pressure and left ventricular mass index
Authors: Lee Y , Kim B S , Kim H J , Shin J H , Park H C , Shin J
Published: October 2024

Background

Ambulatory blood pressure (ABP) has been increasingly adopted in day-to-day clinical practices. Although clinicians can access an enormous amount of information regarding an individual’s blood pressures (BPs) through the ABP monitoring (ABPM), to date, only the mean BP is utilized as the diagnostic threshold of hypertension and the therapeutic target for BP control and no other indices were widely used to assess the burdens of high BP in the ABPM. Because elevated systolic BPs (SBPs) cumulatively damage the myocardium and induce hypertrophy and fibrosis, we hypothesized that the summated value of BP readings beyond a target level may be the better indicator of the overall BP loads than the mean BP value.

Methods

The Korean ABP registry is a multicenter prospective longitudinal cohort study performed in outpatients with hypertension. Among 5,965 patients enrolled in the registry, 951 patients with valid ABPM records and appropriate echocardiography measurements included in the study. The left ventricular mass (LVM) was normalized using the height2.7(m) (LVM index [LVMIH2.7] = LVM/Height2.7). The cumulative excessive SBP CE-SBP) was defined as the summation of the products of excessive SBPs (≥135 mmHg during wake, ≥10 mmHg during sleep) and the durations of the excessive SBP (Figure 1).

Results

The CE-SBP was non-linearly associated with both the office SBP and the mean SBP, but the association strength was much greater with the mean SBP than with the office SBP (R2=0.902 vs. R2=0.430). In linear regression models, the association of the CE-SBP with the LVMIH2.7 (R2=0.112 [0.074-0.149]) was greater than that of the office SBP (R2=0.072 [0.040-0.103]), the mean SBP (R2=0.082 [0.049-0.116]) or the mean SBP during sleep (R2=0.99 [0.063-0.134]). Non-linear regression models using restrictive cubic spline fits also showed that the association strength was greater with the CE-SBP (R2=0.117 [0.078-0.155]) than with the office SBP, mean SBP or mean SBP during sleep (Figure 2). Left ventricular hypertrophy (LVH) defined as the LVMIH27 ≥54 g/m2.7 was better predicted with the CE-SBP than with the other SBPs. The association between the CE-SBP and LVMIH27 was stronger in the patients not taking antihypertensive medications (R2=0.121) and strongest in those with the non-dipper pattern (R2=0.125). Combination with the variability indices (successive variation and average real variability) during sleep or the maximum SBP during sleep significantly improved the association strength of CE-SBP with LMMIH27, whereas the combination with the mean SBP or the variability indices during the entire period did not, in the linear models.

Conclusion

The CE-SBP was more strongly associated with the LVMIH27 than the office SBP and the mean SBP in the ABPM. This result suggests that the CE-SBP may be the better indicator of overall BP loads than the office SBP or the mean SBP in the ABPM, in patients with hypertension.Figure 1Figure 2
The expanding role of semaglutide in cardiovascular disease and its the effect on blood pressure
Authors: Kennedy C , Hayes P , Cicero A F G , Dobner S , Le Roux C , Mc Evoy J W , Zgaga L , Hennessy M
Published: October 2024

Background

Following the SELECT and STEP-HF trials, the use of GLP1 agonists in cardiovascular disease is expanding. The effect of these treatments on blood pressure (BP) is an important consideration when targeting excess body weight (BW) to improve cardiovascular risk. In particular, the BP response of participants with extreme BW reduction is unknown.

Purpose

To determine relationship between the BP response to semaglutide treatment and change in BW.

Methods

Individual participant data from two randomised placebo-controlled trials (STEP 1 and 3) examining the effect of semaglutide 2.4mg on BW over 68 weeks were included. Firstly, the change in SBP comparing those on semaglutide to placebo was analysed with baseline systolic BP (SBP) and change in BW as covariates in an ANCOVA model. Then, Pearson’s correlation coefficient for changes in SBP and BW was assessed for participants on semaglutide treatment. Finally, the SBP and diastolic (DBP) response on semaglutide was analysed for five categories of BW change. Super responders were identified – those with >30% body weight reduction. Analyses were performed using R Software version 4.0.3.

Results

2365 trial participants were included in the pooled analysis, of which 1590 were treated with semaglutide. When adjusted for baseline SBP and change in BW, the reduction in SBP on semaglutide compared with placebo was -1.78mmHg (95%CI -2.94 to -0.62). This compared with a SBP change of -5.07 (95%CI -6.09 to -4.05) when adjusted for baseline BP alone. For those on semaglutide, the correlation between SBP and BW change was weak but significant (r=0.1978, p<0.001; Figure 1). A strong correlation was evident for categories of BW change and both SBP (r=0.9824, p<0.001; Figure 2) and DBP (r=0.9925, p<0.001). 9.7% of those on semaglutide were super responders and this group had a mean SBP change of -12.55mmHg.

Conclusions

The effect of semaglutide on SBP, compared to placebo, is attenuated when adjusted for change in BW. Consistent with this, for those on semaglutide treatment, BP change correlates with BW change. When treating patients with semaglutide regular BP review is required, particularly for those with large reductions in BW.
Do more with less? Impact of personalized very low doses of amlodipine in the PERSONAL-CovidBP trial
Authors: Collier D , Taylor M , Godec T , Shiel J , Saxena M , Patel M , Goldsmith P , Deeming N , Poulter N , Gabe R , Mcmanus R , Caulfield M
Published: October 2024

Introduction

The Personal-CovidBP study1 tested remote patient use of a drug-device combination of a smartphone application (App) to record blood pressure (BP), novel personalized milligram-by-milligram drug (amlodipine) dose, and relevant side effects daily during the COVID-19 pandemic.

Purpose

In supplementary data analyses, we examined the effect of using small doses (1 mg) and small increments (1-2 mg) of amlodipine on the BP response and side effects.

Methods

In this community-based trial with remote monitoring and remote medical management from the investigational site, hypertensive participants aged 18 years + with poor BP control (prior 7 day mean of 135 mmHg systolic BP or above and/or 85 mmHg diastolic BP and above) were enrolled to intervention with open label dose titration over 14 weeks, allowing personalized dosing of liquid amlodipine (1–2 mg steps from 1–10 mg daily).

Results

205 patients were enrolled into the intervention group between October 2020 and July 2021. Average BP in intervention fell from 141/87 to 131/81 (difference −10/6 p < 0.001). Even low doses or small increments: 1 or 2 mg amlodipine or 5 mg to 6 mg, produced meaningful BP responses. Here we report that the addition of amlodipine during the study reduced blood pressure regardless of being amlodipine naive at baseline (n=141), or receiving amlodipine 2.5mg or 5mg at baseline (n=62). The response slopes were comparable, and mean reductions in SBP were consistent across groups: -11.7 (95% CI: -12.9 to -10.6); -9.4 (-11.1 to -7.7); respectively (Figure 1). For the amlodipine naive, the majority (76%) achieved BP control at low doses (<1 to 3mg) with occurrence of side effects increasing with dose (Figure 2).

Conclusions

Our real-world remote care study demonstrated that very low doses of amlodipine as little as 1 mg were effective and for 1mg-3mg gained BP control in the majority and were associated with fewer side effects which is consistent with previous meta-analyses.2

Personalized treatment titration was effective even at very low doses and also regardless of whether amlodipine naive or not at baseline.Changes in SBP- baseline amlodipine useAmlodipine dose at control vs oedema