bluuebunny/crossref_metadata_2025_split huggingface dataset:
Heparin reversal for coronary artery perforation
Authors: Sawayama Y , Sasaki K , Taninobu N , Ikuta A , Osakada K , Kubo S , Tada T , Fuku Y , Tanaka H , Kadota K 
Published: October 2024

Abstract

Background/Introduction
In the management of coronary artery perforation (CAP) during percutaneous coronary intervention (PCI), heparin reversal can provide hemostatic effects but raises concerns about potential coronary thrombosis if an intracoronary artery guidewire or balloon is in place.

Purpose
We aimed to evaluate the safety and efficacy of heparin reversal during device insertion for CAP. We also aimed to determine the optimal target activated clotting time (ACT) to maintain when performing heparin reversal.

Methods
We analyzed cases of CAP which occurred during PCI procedures in a single center from January 2006 to October 2023. Patients were assigned to two groups according to whether they received heparin reversal with a device in place. The safety outcome was the periprocedural myocardial infarction (creatine kinase-MB &gt;5 times the upper normal limit), and the efficacy outcome was successful hemostasis at the end of the procedures (complete absence of CAP on angiography).

Results
Among the 22,368 cases, 368 (1.6%) developed CAP, consisting of main vessels 45%, distal vessels 43%, and collateral vessels 12%. Heparin reversal with a device in place was implemented in 211 (57%) cases. Of these, 16 (7.6%) experienced coronary thrombosis. After adjusting covariates by the multivariable logistic regression model, heparin reversal with a device in place was significantly associated with a higher incidence of periprocedural myocardial infarction (11% vs 4.5%; adjusted OR: 3.11; 95% CI: 1.24–7.78; P = 0.015) and a higher rate of successful hemostasis (91% vs 73%; adjusted OR: 2.78; 95% CI: 1.27–6.09; P = 0.011). In the analysis of cases where minimum ACT value was available (n = 251), this value was significantly correlated with coronary thrombosis (r = −0.16, P = 0.012). When the cutoff values of minimum ACT were set at 200, 150, and 120 seconds as a binomial variable, the correlation coefficient was r = −0.08 (P = 0.158), r = −0.16 (P = 0.009), r = −0.20 (P = 0.001), respectively.

Conclusions
Heparin reversal after CAP with an intracoronary artery device in place was significantly associated with a higher incidence of periprocedural MI but also a higher rate of successful hemostasis. A minimum ACT value &lt;150 seconds was significantly correlated with coronary thrombosis. These results propose a novel algorithm for CAP management strategies.Management algorithm for CAP
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

Abstract

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

Abstract

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

Abstract

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 &lt; 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

Abstract
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

Abstract

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&lt;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&lt;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

Abstract

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

Abstract

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 &gt; 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 &gt; 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.