bluuebunny/crossref_metadata_2025 huggingface dataset:
A study of intracoronary thrombolytic agents in high thrombotic burden lesions during primary PCI
Authors: Palaparthi V , Palaparti P R R , Koduru K G K , Parvathaneni P S S , Ghanta G S S , Koduru K P R , Maganti M P , Boppana B D , Yendapalli Y S R , Yellampati Y R K , Veeramachineni V S L , Yerajani Y V , Mirthipati M R K
Published: October 2024

Objectives

High thrombus burden during Primary PCI begets worst possible outcomes, studies on adjunctive intracoronary thrombolytic agents show heterogeneous1,2 results & have limited long term follow-up.

Although early studies support mechanical thrombectomy devices, larger randomized trial show that they are not able to reduce the MACE3, 4. There is no randomised clinical data for sustained mechanical thrombectomy devices till now.

Purpose of the study

The main purpose of this study is to analyse long term outcomes of low bleeding risk group patients undergoing Primary PCI with high thrombus burden, receiving intracoronary thrombolytic agents as an adjunctive therapy.

Methods

In this prospective observational single centre study, we analysed one year follow-up data of 108 consecutive primary PCI patients with high thrombus burden (G4, G5) and low bleeding risk, who were stratified into two groups basing on whether they receive intracoronary thrombolytic agent as an adjunctive agent before stent implantation. The primary outcome was NACE (Net Adverse Clinical Events, which include MACE, Death, ST/MI, major bleeding events), secondary outcomes include the individual components of the primary outcomes when analysed separately.

Results

The primary outcome events occurred in 21 patients (26%) in Primary stent group(PS, n=80), whereas it occurred in 2 patients(6%) in primary intra coronary thrombolysis group(PIT, n=28). Log-Rank (Mantel Cox) NACE curves show that PS group has high events when compared to PIT group(26% Vs 7%, p value – 0.042, Hazard ratio - 2.56; 95% CI - 0.76 – 8.57), there is no statistically significant difference in all other key secondary outcome event curves.

Conclusion

In patients presenting with STEMI, undergoing primary PCI, with high thrombus burden & low bleeding risk group, those receiving intracoronary thrombolytic agent as the adjunctive therapy before stent implantation, are able to reduce the NACE event rates during the one year of follow-up.Fig1:Log Rank (Mantel Cox) NACE curve
Optimizing elective high-risk PCI with ECMO support: the value of completely percutaneous use of VA-ECMO
Authors: Griffioen A M , Van Wely M H , Van Nunen L X , Van Den Oord S C H , Van Wetten H B , De Jong S F , Damman P , Van Royen N , Van Geuns R J M
Published: October 2024

Background

Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a suitable manner to prevent hemodynamic deterioration during high-risk percutaneous coronary intervention (PCI). VA-ECMO is mainly surgically deployed under general anaesthesia. New developments now facilitate completely percutaneous insertion of VA-ECMO with only local anaesthesia, reducing operating team size and hospital costs.

Purpose

The aim of this study is to provide data on the outcomes of completely percutaneous use of VA-ECMO during high-risk PCI with local anaesthesia.

Methods

A retrospective single-centre registry was performed including all patients undergoing ECMO-assisted high-risk PCI, who were rejected for coronary artery bypass graft (CABG) as primary treatment option. Primary endpoint was the incidence of major adverse cardiac events (MACE), assessed during hospital admission and after discharge up to 90 days.

Results

Between January 2020 and February 2024, 34 patients undergoing ECMO-assisted high-risk PCI were included. The mean age of the population is 71.9 (± 8.4) and 27 (79.4%) patients are male. The mean left ventricular ejection fraction is 28.5 (± 11.1) percent and complexity indices were high, including STS mortality score: 4.1 (± 2.8), SYNTAX score I: 31.7 (± 9.4), SYNTAX score II: (PCI) 54.8 (± 10.8). Femoral artery was used for cannulation in 30 (88.2%) patients, of which one patient required an additional femoral backflow cannula due to prolonged ECMO support. Local anaesthesia in combination with preprocedural oral benzodiazepine was the preferred choice of anaesthesia (85.3%). Closure was predominantly performed with a percutaneous closure device (97.1%). Successful revascularization and procedural success were achieved in all patients. In-hospital MACE occurred in 2 (6.1%) patients. MACE occurred within 90 days in 5 (20.8%) patients after discharge.

Conclusion

High-risk PCI with completely percutaneous use of VA-ECMO with local anaesthesia is a novel concept, providing a suitable alternative to the standard surgical use of VA-ECMO with general anaesthesia.
The risk factors for in-stent restenosis following drug-eluting stent implantation in end-stage renal disease patients receiving renal replacement therapy
Authors: Issarawattana T , Meemook K , Vathesatogkit P , Sasiprapha T
Published: October 2024

Background

Chronic renal disease is a recognized risk factor for in-stent restenosis (ISR) following percutaneous coronary intervention (PCI) with a drug-eluting stent (DES). However, the specific risk of ISR among individuals with end-stage renal disease (ESRD) remains unclear or insufficiently studied.

Purpose

It is imperative to identify the risk factors associated with ISR among patients with ESRD and coronary artery disease following the implantation of DES. This identification is crucial for generating evidence-based strategies aimed at preventing ISR.

Methods

ESRD patients undergoing renal replacement therapy with concomitant coronary artery disease who underwent PCI with their initial DES implantation at our hospital between January 2013 and December 2022 were included in the study cohort. Clinical data, laboratory test results, and PCI specifics were compared between patients with and without ISR. Univariate and multivariate analyses utilizing Cox proportional hazard regression were employed to identify independent risk factors for DES-ISR.

Results

Among the 321 patients with ESRD who underwent PCI with DES implantation, totaling 874.5 patient-years of follow-up, 53 cases of ISR occurred during this period, yielding an incidence rate of 6.1 per 100 patient-years. Several baseline characteristics, angiographic findings, and procedural details were found to elevate the risk of ISR significantly. These included underlying diabetes mellitus, peripheral artery disease (PAD), high serum parathyroid hormone levels, LDL-C levels, acute coronary syndrome as the clinical presentation, the presence of triple vessel disease, duration of dual antiplatelet therapy less than 1 year, target lesion involving the left main (LM) or left anterior descending (LAD) artery, target vessel size less than 3 mm, ostial lesion, bifurcation lesion, number of stents implanted equal to or more than 3, and stent size less than 3 mm. In the multivariate Cox proportional hazard model, bifurcation lesion (HR 14.70, 95% CI 4.66-46.38), PCI of LM or LAD (HR 5.29, 95% CI 1.14-24.60), target vessel size less than 3 mm (HR 4.10, 95% CI 1.77-9.50), PAD (HR 3.92, 95% CI 1.52-10.08), and ostial lesion (HR 2.92, 95% CI 1.16-7.38) were identified as independent risk factors for ISR (all p-values < 0.05).

Conclusions

Among ESRD patients with coronary artery disease, bifurcation lesion, PCI involving the LM or LAD, target vessel size less than 3 mm, PAD, and ostial lesion are identified as independent risk factors for ISR. These findings hold significance in enhancing risk stratification and decision-making concerning treatment planning for this population.Univariate analysis risk factors for ISR
Long-term clinical and imaging outcomes of patients undergoing percutaneous femoral intervention following TAVI-related vascular access complications
Authors: Lima M R L , Reis Santos R R S , Almeida A R A , Oliveira A F O , Mesquita Gabriel H M G , Brito J B , Madeira S M , Vale N V , Leal S L , Infante De Oliveira E I O , Raposo L R , Araujo Goncalves P A G , Teles R C T , Almeida M S A
Published: October 2024

Introdcution: Vascular access complications (VAC) are the most common in-hospital adverse event following transcatheter aortic valve implantation (TAVI). Often, ileo-femoral VAC requires bail-out percutaneous interventions with either prolonged balloon inflation and/or stent implantation. The long-term outcomes of these procedures have not been characterized. We aim to assess the clinical and imaging outcomes of patients who underwent bailout percutaneous vascular interventions due to VAC following TAVI.

Methods

Single-centre prospective study including all consecutive patients with a VAC following trans-femoral TAVI, between 2015-July 2023. VAC was defined as uncontrolled bleeding, acute occlusion or flow limiting stenosis of the femoral vessel leading to percutaneous treatment. Clinical and imaging follow-up was performed with bilateral arterial ultrasound (US) Doppler to assess patency and peak systolic velocity of common femoral arteries.

Results

A total of 1518 patients underwent TF-TAVI, of which 107 (7%) underwent concomitant ileo-femoral percutaneous angioplasty (PTA) intervention in the same day as TAVI. In patients submitted to PTA, 7 were treated to gain access for TAVI, and 100 (7%) were performed to treat vascular access complications. At a mean follow-up time of 23±3 months, 37 patients died (37%), 6 (16%) from in-hospital complications and 31 (84%) from non-vascular causes after discharge. From the surviving 63 patients (study group) – mean age 83±6 years-old, 29% male, 46% with previous peripheral arterial disease –, 24 underwent bilateral US. Unable to perform imaging on 39 patients due to geographical or mobility issues. At a mean follow-up time of 30±23 months, only 6 patients (10%) reported intermittent claudication, of which 4 (67%) had pre-TAVI symptoms. No patient had at rest symptoms or amputation history. All but one had patent vessel on US. The mean peak systolic velocity of the treated vessel and the contralateral vessel were 71.1±22.9cm/s and 73.1±23.8cm/s, respectively, with no statistically significant difference between them in each patient (mean difference 1.9±25.4, p=0.709). We found no statistically significant differences between peak systolic velocities between both vessels in each patient, accordingly with the treated vessel (Table 2).

Conclusion

This prospective study shows that patients submitted to percutaneous bailout iliofemoral interventions have a very low rate of lower limb adverse events with very good patency rates at mean follow up of 2.5 years.
Procedural and clinical outcomes according to ultrasound-guided access in TAVI: a propensity-matched comparative sub-analysis from the PULSE registry
Authors: Grundmann D , Rudolph T , Adam M , Kellner C , Braun D , Tamm A , Sedaghat A , Leistner D , Renker M , Blankenberg S , Vorpahl M , Frank D , Scholtz S , Kim W , Seiffert M
Published: October 2024

Background

Access-related vascular and bleeding complications during transcatheter aortic valve implantation (TAVI) are associated with significant morbidity and mortality. Ultrasound-guided (USG) puncture may reduce the incidence of these events, particularly in large-bore arterial access. However, large-scale data on this approach are limited and it has not yet fully been implemented into standard clinical practice during TAVI.

Purpose

We compared access-related vascular and bleeding complications in USG versus fluoroscopy-guided (FG) access from a large multicenter TAVI registry.

Methods

The PULSE registry (Plug or sUture based vascuLar cloSurE after TAVI) retrospectively evaluated data of 9,295 patients who underwent transfemoral TAVI at 10 high-volume German heart centers from 2016 to 2021. USG and FG access were performed in 1,992 (21.4%) and 7,303 (78.6%) patients, respectively. A propensity score was used to match 1,023 FG with 1,023 USG access patients in a 1:1 fashion. The primary endpoint was a composite of minor and major vascular complications at the TAVI-access site or bleeding type II-IV. Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions.

Results

Mean age was 81.9±6.25 years and 48.0% of patients were female. Comorbidities and clinical variables were well-balanced in matched groups. The overall risk profile was comparable in USG vs. FG (mean EuroSCORE II: 3.4 [2.1, 6.4] vs. 3.6 [2.2, 5.7], p=0.54). The primary end point occurred in 12.0% in the USG and 17.7% in the FG group, p<0.001. While major large bore access-related vascular complications did not differ significantly (3.5% vs. 4.2%, p=0.49), there was a trend towards lower minor complications for USG compared to FG (5.9% vs. 7.8%, p=0.096). Large bore access-related bleeding occurred in 5.5% versus 7.8% (p=0.04) of patients. Endovascular balloon inflation was required in 0.6% and 3.3% (p<0.001) of all large-bore access vascular complications. Stroke (1.7% vs. 1.5%, p=0.86) and stage III/IV acute kidney injury (3.0% vs. 2.2%, p=0.42) were similar in both groups.

Conclusion

In patients treated with transfemoral TAVI, ultrasound-guidance for gaining access was associated with lower rates of access-related vascular complications or type II-IV bleeding. Endovascular treatment was required more frequently in case of a fluoroscopy-guided approach. These findings challenge the fact that most TAVI procedures were performed with fluoroscopy-guidance.
Coronary access after Transcatheter Aortic Valve Replacement (TAVR): a systematic review and meta-analysis of observational studies
Authors: Giacobbe F , Morena A , Bruno F , Di Pietro G , Nebiolo M , Odeh Y , De Filippo O , Conrotto F , Omede' P , D'ascenzo F , De Ferrari G M
Published: October 2024

Introduction

Over the past two decades, transcatheter aortic valve replacement (TAVR) has transformed the management of aortic stenosis, initially for high-risk surgical candidates and subsequently for low-risk patients. However, with the expanding indications for TAVR to younger, lower-risk patients, it is crucial to assess not only the short-term clinical outcomes but also the long-term considerations for future interventions. The prevalence of coronary artery disease (CAD) in TAVR patients is relevant, and the optimal timing of percutaneous coronary intervention (PCI) remains a question, given the technical challenges associated with coronary access in TAVR patients.

Methods

We conducted a systematic literature review and meta-analysis according to Cochrane Collaborations and PRISMA guidelines. We included 19 eligible trials involving 1533 patients who underwent coronary angiography after TAVR. The primary endpoint was the incidence of successful selective coronary re-access. Secondary endpoints included semi-selective and non-selective access rates. The analysis was stratified by balloon-expandable (BEVs) and self-expandable valve (SEVs) types.

Results

Successful coronary access after TAVR was feasible in the majority of patients, with a higher success rate observed for the left main coronary artery (LM) compared to the right coronary artery (RCA). Balloon-expandable valves demonstrated the highest success rates in coronary ostia cannulation, achieving nearly 100% success for both LM and RCA.

Among self-expandable valves, the Evolut R/PRO showed superior success rates in selective coronary access (76,85% (95%CI 53,34-100%) for LM and 57,27% (95%CI 32,8-81,74%) for RCA) compared to the CoreValve (45,62% (95%CI 0-92,78%) for LM and 49,19% (95%CI 0-100%) for RCA). Notably, the majority of coronary angiograms were performed due to acute coronary syndrome, primarily non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina (UA), 26,5% for NSTEMI and 23,4% for UA, respectively.

Conclusions

Selective coronary engagement after TAVR is generally achievable, with BEVs demonstrating superior success rates compared to SEVs. Among self-expandable valves, the Evolut R/PRO showed better outcomes than the CoreValve. These findings provide valuable insights into post-TAVR coronary access feasibility, reducing concerns about valve selection based on this criterion
Comparison of the effects of pre-dilatation with conventional versus larger balloon sizes on clinical outcomes in transcatheter aortic valve implantation with self-expandable valves
Authors: Takahashi N , Doi S , Nishio R , Iwata H , Okazaki S , Higuchi R , Takamisawa I , Saji M , Sato K , Tamura H , Yokoyama H , Tobaru T , Takanashi S , Tabata M , Minamino T
Published: October 2024

Background

Transcatheter aortic valve implantation (TAVI) is considered an established treatment option for patients with severe aortic stenosis. When implanting self-expandable valve, pre-dilatation is often necessary to facilitate optimal transcatheter heart valve (THV) deployment. Traditionally, balloon sizes chosen for pre-dilatation are smaller than the minimum annulus diameter. Insufficient pre-dilatation can result in under-expansion of the THV, necessitating post-dilatation, and can increase the risk of complications. However, this conventional approach may not always yield the best outcomes, prompting a reassessment of balloon sizing strategies to improve procedural success and patient outcomes.

Purpose

The aim of this study was to investigate the impact on procedural outcomes of using larger balloons, sized less than the mean annulus diameter, for pre-dilatation compared to the traditional practice of using balloons sized less than the minimum annulus diameter during the implantation of self-expandable valves.

Methods

We analyzed 785 patients who underwent TAVI with self-expandable valve with pre-dilatation out of a consecutive 3880 cases at 6 centers from 2010 to 2023 (Figure 1). Among them, we divided the patients into two groups: those who underwent pre-dilation with balloons smaller than the minimum annulus diameter defined as the Conventional-size group and those who underwent pre-dilatation with balloons smaller than the mean annulus diameter defined as the Large-size group. The primary endpoint of this study was procedural success, stroke and need for permanent pacemaker implantation as designated by the VARC-3criteria.

Results

Of patients (69% female; mean age 84.9), there were 563 (71.7%) patients in the Conventional-size group and 222 (28.2%) patients in the Large-size group. There was no annulus rupture in either group. The incidence of post-dilatation was significantly higher in the Conventional-size group than in the Large-size group (109 of 563 [19.4%] vs. 23 of 222 [10.3%], p=0.001) (Figure 2). There was no significant difference in the incidence of primary endpoints (all p > 0.05). In post-echocardiographic outcomes, there was no significant difference in effective orifice area, mean pressure gradient, patients-prosthesis mismatch, or paravalvular leakage between the groups (P > 0.05).

Conclusions

This study demonstrates that a large-size strategy using a balloon smaller than the mean annulus diameter in the deployment of self-expandable valves is safe and may avoid the need for post-dilatation compared to the traditional strategy using a balloon smaller than the smallest diameter.
Multidomain cognitive improvement in patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation
Authors: Van Nieuwkerk A C , Hemelrijk K I , Leeuwis A E , Majoie C B L M , Daemen M J A P , Bron E E , Moonen J E , De Sitter A , Bouma B J , Harms A , Van Der Flier W , Baan J , Piek J J , Biessels G J , Delewi R
Published: October 2024

Background

Cognitive impairment is prevalent in one third of patients with symptomatic severe aortic valve stenosis scheduled for transcatheter aortic valve implantation (TAVI). How TAVI affects cognitive functioning in these patients remains unknown.

Purpose

The CAPITA study (CArdiac outPut, cerebral blood flow and cognition In patients with severe aortic valve stenosis undergoing Transcatheter Aortic valve implantation) assessed the effects of TAVI on cerebral lesions and cognitive functioning.

Methods

CAPITA is a prospective study of cerebral and cognitive outcomes in 148 patients undergoing TAVI. One day before and three months after TAVI, patients underwent a standardized multidomain neuropsychological assessment, and simultaneous brain magnetic resonance imaging. The primary outcome was change in global cognitive functioning as measured with z-scores. Also, we assessed the cognitive subdomains of attention/psychomotor speed, memory, language, and executive functioning. Z-scores for each cognitive domain were constructed as: (test score - mean baseline score) / standard deviation. Global cognitive function was calculated as the mean from the four domain scores.

Results

Mean age was 80.5±5.7 years, 43% was female and median STS-PROM (Society for Thoracic Surgeons Predicted Risk for 30-day Mortality) was 2.0% (IQR 1.4%-2.9%). MoCA scores improved from 23.3±3.7 to 24.4±3.3, (p<0.001) and MMSE scores from 26.4±2.6 to 26.9±2.4 (p=0.01). There was an overall increase in global cognitive z-scores (0.02±0.52 to 0.15±0.48, p<0.001). Cognitive domains of memory (0.03±0.77 to 0.18±0.80, p=0.003) and language (-0.07±1.07 to 0.20±0.80, p=0.02) significantly improved, whereas executive function (0.01±0.70 to 0.06±0.76, p=0.42) and attention (0.10±0.69 to 0.17±0.69, p=0.06) did not significantly change. Quality of life on the visual analogue scale improved from 66.4±15.9 to 72.9±12.8, (p<0.001).

Patients in the lowest tertile of baseline cognitive functioning (i.e., those with worst baseline cognitive functioning), had the largest increase in cognitive functioning, compared with patients in the intermediate or highest tertile of baseline cognitive functioning (0.30±0.55 vs 0.09±0.27 vs 0.01±0.16, p=0.002).

Patients with >0.5 SD decline in cognitive functioning (12%), had a higher volume of new white matter hyperintensities on follow-up MRI than patients with stable or improved cognitive functioning (1.26±2.96, vs 0.29±0.45 vs 0.31±0.91 mL, p=0.06).

Conclusions

In 148 patients who underwent TAVI, there was an overall improvement in cognitive functioning at three months follow-up. This improvement was consistent through different cognitive domains and most prominent in patient with lowest baseline cognitive functioning.Change in cognitive functionin
Trans catheter edge to edge repair for mitral regurgitation and left ventricular outflow obstruction in hypertrophic cardiomyopathy
Authors: Carasso S , Marmor D B , Glikson M , Shuvy M
Published: October 2024

Background

Based on previous reports, mitral valve transcatheter edge to edge repair (TEER) may be considered in patients with severe mitral regurgitation (MR) and left ventricular obstruction in patients with hypertrophic obstructive cardiomyopathy (HOCM) that are high risk for surgery.

Objective

We aimed to evaluate the feasibility, and immediate and short-term outcomes of mitral TEER in symptomatic patients with severe MR and HOCM.

Methods

Five patients (age 75±6, 3 men) with severe MR and HOCM with high surgical risk, and anatomy not suitable for septal ethanol ablation, who remained symptomatic despite maximally tolerated drug therapy were selected for TEER using the MitrClip system.

Result

The procedure was performed successfully on all 5 patients. Devices were deployed at the A2-P2 scallops of the mitral valve. MR severity declined from severe to mild in all patients, left ventricular outflow (LVOT) maximal gradient decreased from 140±46 to 8±5 mmHg after TEER, and was 41±32 mmHg at 4±2 month follow- up, Clinically, all patients reported improvement of their symptoms to Class I-II NYHA functional Class.

Conclusion

TEER may be a beneficial procedure for severely symptomatic patients with severe MR and obstructive HOCM on maximal tolerated medical therapy, who are not amenable to surgery because of excessive risk, old age, and frailty.Pre and Post procedure EchoPre and Post Cath
Prevalence, determinants, and impact of significant shunt after percutaneous patent foramen ovale closure
Authors: Guedeney P , Farjat-Pasos J , Dauphin C , Abtan J , Roule V , Ohlmann P , Huang F , De Ferrari G M , Gabrion P , Auffret V , Cayla G , Barsoum P , Meneveau N , Rodes-Cabau J , Montalescot G
Published: October 2024

Introduction

Percutaneous closure of patent foramen ovale closure is increasingly performed for secondary prevention of PFO-related arterial embolic event. The clinical significance of postclosure residual right-to-left significant shunt remains unclear.

Purpose

To describe the prevalence, determinants, and clinical impact of a significant post-closure.

Methods

The AIR-FORCE is an ongoing prospective international registry of patients undergoing PFO closure from 19 centers in France, Canada and Italy. Only patients undergoing PFO for secondary prevention of an arterial embolic event with at least one available post-closure contrast transthoracic echocardiography (TTE) with agitated saline injection and Valsalva maneuvers were analyzed. Residual shunt was categorized according to the number of bubbles in the left atrial within 3 cardiac cycles at the first available contrast TTE as small (<10), moderate (10-20) or severe (> 20). Determinants of the presence of moderate or severe shunt were evaluated with multivariate logistic regression and its impact on the primary outcome (stroke, transient ischemic attack or peripheral arterial emboly) was evaluated with Cox model adjusted on age and sex.

Results

A total of 2413 patients, with a median age of 49.3 [40.4-57.4] years, 56% male, undergoing PFO closure between 2001 and 2023 were included. The first contrast TTE, which was performed after a median delay of 3.4 [0.9-5.8] months, reported the presence of moderate or severe residual shunt in 214 (8.9% 95%CI 7.8-10.1) patients. Determinants of the presence of moderate or severe residual shunt at the first contrast TTE were decreased body mass index (per 1kg/m², aOR 0.96 95%CI 0.93-0.99), severe shunt prior to PFO closure (aOR 3.54 95%CI 2.25-5.55) and increased device left disc diameter (per 1mm, aOR 1.08 95%CI 1.05-1.12). With a median follow-up of 2.2 [0.9-4.9] years, a total of 60 events were reported and the presence of moderate or severe residual shunt was associated with an increased risk of the primary outcome (aHR 2.46 95%CI 1.15-5.24) (Figure 1).

Conclusions

A moderate to severe residual right-to-left intracardiac shunt is not uncommon after PFO percutaneous closure and seems to be associated with an increased risk of arterial emboly recurrence.
Transcatheter patent foramen ovale closure in patients with and without documented nickel hypersensitivity
Authors: Apostolos A , Gregoriou S , Trantalis G , Drakopoulou M , Chatzidimitriou E , Kleidona I A , Tsalamandris S , Vaina S , Aggeli C , Stratigos A , Tsioufis C , Toutouzas K
Published: October 2024

Background

Transcatheter PFO closure has been established as a safe and feasible approach for secondary prevention in appropriately selected patients with previous cryptogenic stroke. The two FDA-approved devices, widely used, consist of a nitinol frame; a nickel-titanium alloy. Although nickel is recognized as the primary metal causing hypersensitivity reactions worldwide, the potential occurrence of nickel hypersensitivity following PFO closure remains a subject of debate.

Purpose

The aim of this study is to investigate whether patients with nickel hypersensitivity are more susceptible to experiencing adverse events after PFO closure and to explore the potential role of device selection.

Methods

We prospectively enrolled patients undergoing PFO closure at our tertiary hospital. Before the procedure, all patients underwent nickel skin patch tests, considered the gold standard for diagnosing nickel hypersensitivity. Subsequently, patients were randomized to receive one of the two FDA-approved devices. During a three-month follow-up period, we evaluated the primary endpoint, a composite outcome including patient-reported chest pain, palpitations, headaches, and rash. Blinding was maintained for the patients, the operator, and the assessor of endpoints regarding the results of the nickel skin patch tests. The chi-squared test was utilized to evaluate the primary endpoint. Results for continuous variables are expressed as mean ± standard deviation or, for non-normally distributed variables, as median (interquartile range).

Results

Between January 2021 and November 2023, a total of 63 patients were included in our analysis. The majority were men (n=33, 52.4%) with a mean age of 46.1 ± 10.1 years. The median RoPE score was 7 (6-8). Nickel hypersensitivity was documented in 30.8% of the patients. The primary endpoint was met in 37.7% (n=23) of the total sample, with a significantly higher incidence in patients with nickel hypersensitivity than in those without (61.1% versus 27.9%, p=0.015, OR: 4.060, 95% CI: 1.275 – 12.930). No significant difference was observed when analyzing the two devices separately (p=0.096 and p=0.078, respectively). No recurrent ischemic stroke, severe anaphylactic reaction, or requirement for device surgical removal was observed in any patient.

Conclusions

Our findings indicate that patients with documented nickel hypersensitivity are more likely to develop symptoms such as chest pain, palpitations, headaches, and rash following the procedure. However, these findings do not raise major safety concerns. The completion of our study is necessary to acquire more reliable and conclusive results.
Impact of left atrial appendage closure on left atrial function: insights from the OCEAN-LAAC registry
Authors: Nonaka H , Asami M , Horiuchi Y , Tanaka J , Yoshiura D , Komiyama K , Yuzawa H , Tanabe K
Published: October 2024

Background

Percutaneous left atrium appendage closure (LAAC) is an effective therapy to prevent thromboembolic events among patients with atrial fibrillation (AF) (Ref 1). However, since the left atrium appendage (LAA) potentially serves as a part of the left atrium (LA) volume and a buffer for increasing LA pressure, this procedure may impair LA compliance (Ref 2).

Purpose

In this study, we sought to investigate the effect of LAAC on LA function.

Methods/Results

The OCEAN-LAAC registry is an ongoing, multicentre Japanese registry including patients who underwent LAAC in Japan (Ref 3). Among 225 patients from the registry, LA volume index (LAVI) and tricuspid regurgitation pressure gradient (TRPG) at baseline and 6 months after the procedure were analysed. In the overall population, no significant increase in LAVI (Abstract Picture 1A) and TRPG (Abstract Picture 1B) was observed (LAVI baseline vs 6 months, 55.0 [44.0, 70.0] ml/m2 vs 55.0 [42.0, 75.6] ml/m2; P = 0.31; TRPG, 25.0 [20.3, 32.0] mmHg vs 25.0 [20.0, 32.0] mmHg; P = 0.85). However, particular patients underwent an increase in LAVI (Abstract Picture 1C), and multivariable analysis showed smaller LAVI and elevated TRPG at baseline, rather than any procedural factors, were significantly associated with an increase in LAVI (Odds ratio (OR) for baseline LAVI: 0.98 [95% confidential interval (CI): 0.97 - 0.996]; OR for baseline TRPG: 1.04 [95% CI: 1.00 - 1.08]). A 5 ml/m2 increase in LAVI at a 6-month follow-up was significantly associated with subsequent heart failure hospitalization (HFH) (Hazard ratio: 3.37 [95% CI: 1.18 - 9.65]) (Abstract Picture 2A). However, this predictive value was not observed in patients with lower LAVI (≤ 55 ml/m2) at baseline; instead, it was observed in those with a baseline LAVI over 55 ml/m² (Abstract Picture 2B).

Conclusions

In summary, our study did not elucidate the negative impact of LAAC on LA function, yet demonstrated an increase in LAVI at 6 month follow-up was frequently observed in patients with lower LAVI and higher TRPG at baseline. Additionally, increase in LAVI was significantly associated with subsequent HFH, which was more evident in patients with higher LAVI at baseline.
Prevalence and prognostic value of thrombocytopenia in aortic valve replacement surgery: bioprosthesis versus mechanical prosthesis
Authors: Seoane L , Espinoza J C , Piccinini F , Furmento J , Cagnone L , Spaccavento A , Sigal A , Carugno A , Navia D , Costabel J P
Published: October 2024

Background

Thrombocytopenia is a frequent complication of valve surgery, and is associated with different postoperative outcomes. Concern has recently arisen about thrombocytopenia following aortic valve replacement (AVR), as some authors have reported increased postoperative thrombocytopenia with certain biological aortic valves. In adittion, it is unclear whether thrombocytopenia predicts mortality in this type of surgery.

Purpose

The aim of this study was to determine the prevalence and prognostic value of thrombocytopenia in biological and mechanical aortic valve replacement.

Methods

The study was an observational analysis of patients undergoing AVR with or without associated coronary artery bypass grafting (CABG) at a single center between October 2014 and October 2023. Cardiac Surgery database was computerized and prospectively completed. Preoperative and first 4 days postoperative platelet counts were analyzed. Thrombocytopenia was defined as platelet count < 100 × 10³/mm³. To obtain comparable populations, a propensity score matching analysis was performed.

Results

A total of 1,197 patients underwent AVR with (n = 494) or without CABG (n = 703). Patients received either a mechanical prosthesis (n = 320), or a biological prosthesis (n = 877). The mean population age was 68 years (SD 6), with the majority being male (68%). Univariate analysis of the baseline characteristics of both groups of patients showed that they were not comparable. A risk-adjusted subanalysis was performed according to a propensity score (n=278). The nadir of bioprostheses was on the third postoperative day with an average of 93.8 × 10³/mm³, while in mechanical prostheses was also on the same day but with an average of 114.7 × 10³/mm³ (p: 0.001). (Figure 1) Bioprosthesis implantation was significantly associated with a higher prevalence of thrombocytopenia (72.7% vs. 45.3%, p<0.001). The presence of postoperative thrombocytopenia has been associated with higher in-hospital mortality (6.7% vs. 0.9%, p=0.019); but not with other postoperative complications. (Figure 2)

Conclusions

Patients undergoing AVR with bioprostheses had a significantly higher prevalence of thrombocytopenia, and also lower platelet counts than mechanical prothesis within the first 4 postoperative days. Thrombocytopenia was associated with higher in-hospital mortality in a risk score-adjusted population.Platelet counts after AVROutcomes according to platelet count
The severity of metabolic derangement predicts survival of out-of-hospital cardiac arrest and the benefit of extracorporeal life support
Authors: Jeong D , Choi J H , Shin S D , Shin T G , Hwang S Y , Lee G T , Park J E
Published: October 2024

Aims

This study aimed to develop Metabolic Derangement score and validate its prognostic performance in patients with out-of-Hospital Cardiac Arrest (OHCA) and also its discriminative performance in guiding the application of extracorporeal life support (ECLS).

Methods and Results

From 5,100 patients (average age 67 years, 69% male), Metabolic Derangement score was developed to predict primary outcome (death or poor neurologic outcome, cerebral performance category ≥ 3 at day 30) from initial blood laboratory test including pH, PaCO2, PaO2, potassium, haemoglobin, lactate, and creatinine. It was created using machine learning algorithms and a training set (60%), and validated with a test set (40%). The risk of primary outcome consistently increased from 34% to 100% as the Metabolic Derangement score ranged from 0 to 7. Patients with Metabolic Derangement score ≤ 2 showed no difference in the primary outcome risk between those with or without ECLS. Conversely, those with a Metabolic Derangement score ≥3 had a lower risk with ECLS (difference of restricted mean survival time=6.5 days, 95% CI=3.3-9.6 days, ratio of restricted mean time lost=0.76, 95%CI=0.65-0.88, all p<0.001). Clinical subgroup analyses showed generally consistent results. Metabolic Derangement score also outperformed OHCA-, CAHP-, and NULL-PLEASE-scores in prediction the primary outcome (p<0.05, all).

Conclusions

The severity of metabolic derangement predicted the clinical outcome of OHCA, and could also identify patients likely to benefit from ECLS.Metabolic Derangement score
Relationship between renin, aldosterone, aldosterone-to-renin ratio and left ventricular mass index in young adults
Authors: Ananda R , Gwini S M , Beilin L J , Schlaich M P , Stowasser M , Young M J , Fuller P J , Adler B , Mori T A , Yang J
Published: October 2024

Background

Primary aldosteronism (PA), characterised by excessive aldosterone production and mineralocorticoid receptor activation, is associated with adverse cardiovascular outcomes including left ventricular hypertrophy and failure. Elevated cardiovascular risk is observed even in milder and subclinical forms of PA, especially in middle-aged and elderly populations. It is unclear if early changes in PA biomarkers can affect left ventricular mass index (LVMI), which is a strong predictor of cardiovascular diseases.

Aim

To evaluate the relationship between PA biomarkers, namely renin concentration, aldosterone concentration and aldosterone-to-renin ratio (ARR), and LVMI in young adults.

Methods

The Raine Study is a longitudinal, population-based cohort study in Western Australia that enrolled women during pregnancy. We analysed the data from the offspring of these women at age 27. Participants with PA biomarkers and LVMI measured by cardiac magnetic resonance imaging were included. Females who were on oral contraception were excluded due to its confounding effect on the ARR. We examined the relationship between LVMI and plasma renin, aldosterone, and ARR using multivariate-adjusted linear regression and used mediation analysis to test whether these relationships were dependent on systolic blood pressure (SBP).

Results

Of 758 participants, 252 (33.2%) were females and the mean (SD) age was 26.7 (0.4) years. Females had lower median plasma renin concentration (12.0 vs 15.4mU/L; p<0.001) and higher median ARR (21.0 vs 15.6; p<0.001) than males. There was no sex-difference in median plasma aldosterone concentration (257 vs 237pmol/L in males; p=0.143). Females had lower LVMI (52.2 vs 70.2 g/m²; p<0.001) than males. A significant association between LVMI and aldosterone was detected in males (β-coefficient 0.009; 95% CI 0.001 to 0.017; p=0.027), and between LVMI and ARR in females (β-coefficient 0.098; 95% CI 0.001 to 0.196; p=0.050) after adjusting for confounders. This relationship was not mediated by brachial SBP.

Conclusion

An elevated aldosterone concentration or ARR was associated with higher LVMI in young adults, independent of brachial SBP. Long-term follow-up is required to determine if the relationship persists over time and leads to reduced cardiac function. One may speculate that an intervention trial in young adults with subclinical PA is warranted to determine the role of aldosterone blockade in preventing future cardiovascular diseases.
Exploring the association between hypertension and atherosclerotic cardiovascular disease in adults with familial hypercholesterolemia: insights from the HELLAS-FH registry
Authors: Rizos C , Liamis G , Skoumas I , Rallidis L , Garoufi A , Kolovou G , Tziomalos K , Sfikas G , Skalidis E , Kotsis V , Doumas M , Lambadiari V , Anagnostis P , Giannakopoulou V , Liberopoulos E
Published: October 2024

Aim

While the link between hypertension and atherosclerotic cardiovascular disease (ASCVD) is well-established, its impact on patients with familial hypercholesterolemia (FH) remains less explored. This study aims to assess the association between hypertension and ASCVD in adult FH patients.

Material-Methods: Participants from the HELLAS-FH registry were divided into two groups based on the presence or absence of hypertension. We compared demographic information, lipid profile and history of ASCVD between the two groups.

Results

The study included 2367 FH patients, of whom 602 (25.4%) had a diagnosis of hypertension. Hypertensive patients were generally older and exhibited higher rates of ASCVD risk factors such as increased body mass index (28.6 vs 26.3 kg/m2), waist circumference (98 cm in men and 97 cm in women compared with 95 cm and 88 cm in non-hypertensive counterparts), and more prevalent history of smoking (44.2% vs 35.8%) (p<0.01 for all comparisons). Patients with hypertension had higher triglyceride levels (148 vs 123 mg/dL; p<0.05), lower high-density lipoprotein cholesterol (HDL-C) levels (48 vs 53 mg/dL; p<0.05) while total cholesterol and non-HDL-C levels were not significantly different. When adjusted for age, sex, and major ASCVD risk factors, hypertension was significantly associated with prevalent coronary artery disease (CAD) (adjusted odds ratio [OR] 3.10; 95% CI 2.29-4.19; p<0.001), ischemic stroke (OR 1.89; 95% CI 1.02-3.49; p=0.04), and peripheral arterial disease (PAD) (OR 3.15; 95% CI 1.62-6.13; p<0.001).

Conclusions

Hypertension is frequent and is independently associated with an increased risk of CAD, stroke, and PAD in patients with FH.
Association of cardio-cerebrovascular death with isolated diastolic hypertension: a nationally representative survey of 85, 138 adults
Authors: Zhao S , Zhang Y
Published: October 2024

Background

Recently, the 2023 European Society of Hypertension (ESH) guideline for hypertension management include isolated diastolic hypertension (IDH) as a distinct classification. But, studies have yielded inconsistent associations between IDH and cardiovascular disease (CVD) events.

Method

We obtained data from 85138 participants without CVD and antihypertensive medication use who included in the China Chronic Disease and Risk Factors Surveillance (CCDRFS) project 2010. We extracted data on deaths from any cause, cardiovascular diseases, and stroke during follow up. The hazard ratios (HR) and 95% confidence intervals (CI) for all-cause mortality, cardiovascular mortality, and stroke mortality associated with each blood pressure (BP) group were calculated using Cox proportional hazards models, with the normotension group as the reference. Our analyses were performed with sequential adjustment. In the first step, we carried out unadjusted analyses (model 1). In model 2, we added age, sex, ethnic, location, educational attainment, smoking status, alcohol drinking status, exercise, BMI, high-density-lipoprotein cholesterol, low-density-lipoprotein cholesterol, fasting glucose level as adjustment covariates.

Results

Overall, 57144 (67.1%) participants had normotension, 3826 (4.5%) participants had IDH, 11013 (12.9%) participants had isolated systolic hypertension (ISH), 13155 (15.5%) participants had systolic and diastolic hypertension (SDH). Compared with normotension, IDH was not statistically associated with a significantly increased risk of all-cause mortality (HR, 1.09 [95% CI, 0.86–1.39], model 2), or cardiovascular mortality (HR, 1.21 [95% CI, 0.74–1.96], model 2). On the contrary, IDH was significantly associated with a modestly higher risk of stroke mortality (HR, 1.84 [95% CI, 1.13–3.00], model 2). IDH was significantly associated with a modestly higher risk of stroke mortality in middle aged and older adults, but not young adults (age <45years). Similar results were obtained for men, while for women the associations between the prevalence of IDH and a higher incidence of stroke mortality were not significant. Stage 1 to stage 3 ISH or SDH were associated with a higher risk for all-cause mortality, cardiovascular mortality, and stroke mortality.

Conclusion

IDH was associated with an increased risk of stroke mortality among the large nationally representative Chinese population. Intervention for IDH may be effective in reducing the burden of stroke in China.
Relationship between fibrosis-4 index and new onset hypertension in the general population
Authors: Takase H , Kawakatsu N , Hayashi K , Kin F , Isogaki T , Dohi Y
Published: October 2024

Background/Introduction

Non-alcoholic fatty liver disease (NAFLD) is a risk for cardiovascular events and malignant tumors as well as liver cirrhosis, and the risk increases with increasing fibrosis of the liver. Thus, the fibrosis-4 (FIB-4) index, developed as a noninvasive test to stage liver fibrosis, may predict the development of hypertension.

Purpose

The present study investigated the relationship of FIB-4 index with the prevalence and future development of hypertension in the general population.

Methods

A total of 16125 participants who visited our hospital for a physical check-up at least twice from 2008 to 2018 (male=9700, 52.0±12.3 year-old) were subjected for cross-sectional analysis. Among them, 3995 participants were hypertensive. The remaining 12111 normotensive participants (male=6984, 49.5±11.9 year-old) were followed up for the median of 1643 days with the endpoint being the development of hypertension, defined as systolic blood pressure ≥140mmHg, diastolic blood pressure ≥90mmHg or the use of antihypertensive medication. FIB-4 index was calculated as follows; (age×AST)/(platelet number×√ALT).

Results

Cross-sectional analysis revealed that FIB-4 index was higher in hypertensive than normotensive participants (1.40±0.74 vs. 1.09±0.54, p<0.001). During the follow-up, 2819 participants (45.7 per 1000 person-year) developed hypertension. The incidence was more frequent in male (55.6 per 1000 person-year) than female participants (32.7 per 1000 person-year, p<0.001). High level of FIB-4 index (≥2.67, n=194) showed a significant impact on the incident hypertension (80.5 per 1000 person-year) as compare with middle (≥1.30, <2.67, n=3082) or low level (<1.30, n=8835) of FIB-4 index (65.4 and 38.8 per 1000 person-year, respectively). Non-adjusted hazard ratio (HR) (95% confidence interval [CI]) of FIB-4 index for the new onset of hypertension was 1.483 (1.416-1.553). In multivariate Cox hazard analysis adjusted for sex, body mass index, systolic blood pressure, pulse rate, serum creatinine, uric acid, HbA1c, LDL-cholesterol, triglyceride, hemoglobin, current smoking, frequent alcohol consumption and family history of hypertension, FIB-4 index was an independent predictor of the development of hypertension (HR 1.321, 95%CI [1.213-1.438]). Similar results were obtained in analyses of male (HR 1.382, 95%CI [1.300-1.470]) and female subgroups (HR 1.369, 95%CI [1.230-1.524]). History of viral hepatitis or frequent alcohol consumption did not affect the results (data not shown).

Conclusions

FIB-4 index is a useful predictor of the development of hypertension in the general population. Increased risk of cardiovascular events in patients with NAFLD may partially be attributable to the development of or coexistence with hypertension.