bluuebunny/crossref_metadata_2025_split huggingface dataset:
The use of floating wire technique and intravascular ultrasound for precise aorto-ostial stenting
Authors: Daibes J A , Reddy P K , Fujisaki T , Skaf M , Abed R , Ochoa R , Patel A , Kwan T W 
Published: October 2021

Abstract

Background
Aorto-ostial interventions often lead to imprecise ostial demarcation, suboptimal stent implantation, and worse clinical outcomes when compared to non-ostial interventions. The floating wire technique (bumper or sepal wire technique) employs a second guidewire placed in the aortic root to both mark the ostium and prevent prolapse of the guide catheter past the target ostial lesion. Its use has been described in the literature and is used often in daily practice however, procedural and long-term clinical endpoints have not been assessed using the gold standard of post-implant IVUS to determine technical success. The aim of the study is therefore to objectively assess the rate of geographic miss using the floating wire technique as well as long-term clinical outcomes.

Methods
A single center retrospective study was conducted. Patients who underwent ostial lesion percutaneous coronary intervention (PCI) with the floating wire technique between January 2019 and September 2020 were identified. Procedural and clinical outcomes at 6 months follow up were investigated. The co-primary endpoints include 1) Geographic miss defined as inadequate ostial coverage by IVUS or excess stent protrusion on angiography and 2) Target lesion failure (TLF) at 6 months after PCI, defined as the composite of cardiovascular death, target-vessel myocardial infarction (MI), and target lesion revascularization.

Results
In total, 48 patients were identified. The average age was 71.7 years old, and 85.4% were male. Indication for PCI was acute coronary syndrome in about a third of patients. Twenty-six patients had left main ostial lesion, and 22 patients had right coronary artery ostial lesions. The average syntax score was 24.2. IVUS assessment was performed in 45 patients. Four (8.3%) patients had more than 2mm of excess stent proximal protrusion. Ostial miss occurred in 1 (2.2%) patient. Seven patients had loss to follow up. TLF, stroke, or major bleeding were not observed in any patients. One non-cardiovascular death, three type 2 MIs, and 1 type 4 MI were observed, which occurred in non-target vessels.

Conclusions
The floating wire technique was safe and efficient with low rates of geographic miss or adverse clinical outcomes. This is the first study to confirm precise aorto-ostial stent implantation using the floating wire technique with IVUS assessment.

Funding Acknowledgement
Type of funding sources: None. Floating Wire Technique for LM Stenting
Drug-coated balloon versus drug-eluting stent following orbital atherectomy for calcified coronary artery: one-year outcomes of a retrospective cohort study
Authors: Mitsui K , Lee T , Miyazaki R , Hara N , Nagamine S , Nakamura T , Terui M , Okata S , Nagase M , Nitta G , Watanabe K , Kaneko M , Nagata Y , Nozato T , Ashikaga T 
Published: October 2021

Abstract

Background
Percutaneous coronary intervention (PCI) for calcified coronary artery remains challenging in the drug-eluting stent (DES) era. The effectiveness of drug-coated balloons (DCBs) and orbital atherectomy system (OAS) is unknown.

Methods
In this retrospective, single-center study, we compared the use of DCBs with second- and third-generation DESs following orbital atherectomy (OA) for calcified de novo coronary lesions. All patients underwent PCI with intravascular imaging. The primary endpoint was major cardiac event, that was a composite of cardiac death, death for unknown cause, non-fatal myocardial infarction, or target lesion revascularization at 1 year.

Results
Between June 2018 and December 2019, 107 patients with coronary lesions were enrolled in this study and divided into two groups: 23 patients in DCB group and 84 patients in DES group. The post-procedure segment percentage diameter stenosis was 23.1% (interquartile range [IQR], 17.7 to 32.5) with DCB versus 14.4% (IQR, 10.0 to 21.2) with DES (P&lt;0.001). Overall adverse event rate for PCI procedure was low: one dissection with DES group, no persistent slow/no-flow, and no perforation with both group. The primary endpoint was not significantly different between 2 groups [DES: 6.0% (5/84), DCB: 0.0% (0/23), log-rank P=0.24].

Conclusions
In calcified coronary artery disease, using DCB following OA is as safe and effective as using DES following OA with respect to 1-year clinical outcomes.

Funding Acknowledgement
Type of funding sources: None.
Use of sirolimus-coated balloon in de novo small vessel coronary lesions; Long-term follow-up from a single centre registry
Authors: Loku Waduge B H , Kalkat H , Saif A , Fawzy A M , Athukorala S , Bhatia G , Kumar N , Freestone B , Ment J , Lee K , Pitt M , Pulikal G , Basavarajaiah S 
Published: October 2021

Abstract

Background
Drug coated balloons (DCBs) in Europe are mainly used in restenotic lesions as endorsed by the European Society of Cardiology, with a class IA recommendation. However, some of the recent data suggest, it can also be considered in a subset of denovo lesions, especially in small vessels. Most DCBs used, are coated with Paclitaxcel. There is no data on the efficacy of Sirolimus in DCBs, the drug of choice in drug eluting stents. In this study, we report outcomes from the use of a Sirolimus coated balloon (SCB) in de novo small-vessel coronary lesions, from a single high yield centre.

Methods
A retrospective analysis was conducted on all patients treated with an SCB between March 2018 and October 2020. Follow-up was achieved with clinic visits, telephone calls and admission records. The outcomes measured include cardiac death, target-vessel myocardial-infarction (TVMI), target lesion revascularisation (TLR) and MACE (combination of cardiac death, target-vessel MI and TLR).

Results
During the study period, 279-patients (with 332-lesions) with de novo lesions were treated with an SCB. The mean age of patients was 65±12 years, 219 (79%) were male, 36% (n=100) had diabetes, 16% (n=45) had chronic kidney disease and 61% were in the setting of acute coronary syndrome (n=169). Predilatation was performed in 96% (320-lesions). Bailout stenting (with DES) was required in 5% of lesions (n=18) of which 16 were due to dissections and 2 were due to recoil &gt;30% following DCB use. The mean diameter and length of DCBs were 2.35 mm and 26 mm respectively.
During a median follow-up of 584-days (19-months) cardiac death was reported in 8 patients (3%). Target vessel MI was in 3% (n=9), TLR per lesion was 8% (n=26) and the MACE rate was 11% (n=31). There were no documented cases of acute vessel closure.

Conclusion
The long-term outcome from the first ever study on sirolimus eluting balloons in de novo small vessel lesions appears promising with low rates of hard endpoints, and acceptable repeat rates of TLR despite a complex group of patients (50% ACS, 36% diabetics and 19% CKD) and lesion subsets (small vessel and diffuse disease). Implanting stents in these subsets renders them vulnerable to restenosis, making treatment challenging and resulting in high rates of recurrence.

Funding Acknowledgement
Type of funding sources: None.
Long term clinical outcomes from use of Sirolimus coated balloon in coronary intervention; data from a real-world population
Authors: Loku Waduge B H , Kalkat H , Saif A , Fawzy A M , Athukorala S , Bhatia G , Kumar N , Freestone B , Ment J , Lee K , Pitt M , Pulikal G , Basavarajaiah S 
Published: October 2021

Abstract

Background
The use of drug coated balloons (DCBs) in coronary intervention is escalating. There are two drugs of choice for coating either DCBs or drug eluting stents: Paclitaxel or Sirolimus. Most available DCBs are coated with Paclitaxcel, due to pre-existing, extensive data that support good clinical outcomes. With drug eluting stents both the literature and hence clinical practice favour Sirolimus over Paclitaxcel. This is due the cytostatic properties and wide therapeutic window of Sirolimus. However, there is very limited data on Sirolimus coated balloons (SCBs). We report a long-term follow-up with this relatively new technology from our centre.

Methods
A retrospective analysis was conducted on all patients treated with an SCB between March 2018 and October 2020. Follow-up was achieved with clinic visits, telephone calls and admission records. The outcomes measured include cardiac death, target-vessel myocardial-infarction (TVMI), target lesion revascularisation (TLR) and MACE (combination of cardiac death, target-vessel MI and TLR).

Results
533 patients (690-lesions) with a mean age of 65.4 (range; 37–90) were treated with an SCB. 79% (n=419) were male, 314 (59%) were in the setting of acute coronary syndrome, 40% (n=211) had diabetes and 60% (n=414) had DCB in de-novo lesions. Small vessels accounted for 59% of cases (n=406). Pre-dilatation was performed in 97% (n=670) of cases. Bailout stenting (with a drug eluting stent) was required in 6.5% lesions (n=45), of which 11 were due to dissections and 34 were due to &gt;50% recoil following DCB use. The mean diameter and length of DCBs were 2.8 mm and 26.3 mm respectively.
During a median follow-up of 572 days (IQR: 381 - 868); cardiac death occurred in 15 patients (3%). Target vessel MI was in 4%; n=21, TLR per lesion and per patient were 10% (n=72 and n=55 respectively). The overall MACE rate was 12%. There were no documented cases of acute vessel closure.

Conclusions
The results from long term follow-up with this relatively new technology DCB are encouraging with low rates of hard endpoints and acceptable rates of TLR and MACE despite complex group of patients (59% ACS and 40% diabetics) and lesion subsets (40% restenotic lesions and 59% small vessels). However, in order to further inform clinical practice, more longer-term data on SCBs compared with Paclitaxel coated balloons is needed.

Funding Acknowledgement
Type of funding sources: None.
Coronary perforations and its clinical impact during CTO recanalization: a 2054 patients pooled analysis from the Latin American (LATAM) CTO registry
Authors: Harada Ribeiro M , Quadros A , Padilla L T , Belli K C , Piccaro P , Dallan L A , Silveira C E , Quesada F H , Morales N , Santiago R , Mashayekhi K C , Azzalini L A , Galassi A R , Campos C M 
Published: October 2021

Abstract

Introduction
Percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) are the most challenging procedures and still associated with the highest complications rates. Coronary perforation is a life-threatening acute PCI complication, but data are limited regarding its impact on mid-term outcome. We aimed to assess 30-days and 1-year outcomes in CTO PCI patients with coronary perforations.

Purpose
Analyze the clinical impact of Cto perforations during CTO PCI at short and mid-term in a muticenter continental registry in Latin America (LATAM).

Methods
We analyzed data from the continental multicenter Latin America CTO Registry including patients who underwent CTO PCI in 57 centers from 9 countries. Coronary perforation during the index procedure were categorized according to Ellis classification. We assessed 30-days adverse events and 1-year major adverse cardiac and cerebrovascular (MACCE) defined as the composite of all-cause death, myocardial infarction (MI), target vessel revascularization and stroke. MI was defined according both the LATAM CTO protocol and SCAI definitions.

Results
From January 2015 to October 2018, 2054 patients underwent CTO PCI. The median J-CTO score was 2.0 (1.0–3.0) and the median Progress score was 1.0 (0.0–2.0). The overall perforation rate was 3.7% (n=76) in which 55% were Ellis class 1, 24% Ellis class 2 and 21% Ellis class 3. No differences were found in any baseline clinical characteristics. Patients with perforation had more frequently retrograde instrumentation (P&lt;0.01) and antegrade knuckle wire (P&lt;0.01) and lower success rate (P&lt;0.01). At 30-days, perforations were associated with more heart failure (6.6% vs 1.5%, p&lt;0.01), bleeding (15.2% vs 3.7%, p&lt;0.01), transfusion (7.9% vs 1.1%, p&lt;0.01) and cardiac tamponade (13.2% vs 0.4%, p&lt;0.01). After 1-year follow-up, patients with perforations had higher MACCE rates according to both LATAM CTO protocol (18.2 vs. 9.4%; P=0.02) and SCAI definitions (22.7% vs. 11.3%; P&lt;0.01).

Conclusions
In this multicenter continental real-world analysis, coronary perforation in CTO PCI was infrequent and was related with higher anatomical and procedural complexity characteristics. Despite the similarity in clinical characteristics, patients that had coronary perforation were exposed to an increased risk of both hemorrhagic and ischemic events.

Funding Acknowledgement
Type of funding sources: None.
Long-term follow-up of early leaflet thrombosis after transcatheter aortic valve replacement
Authors: Hein M H , Schoechlin S S , Schulz U S , Minners J M , Breitbart P B , Neumann F J N , Ruile P R 
Published: October 2021

Abstract

Background
The long term impact of early leaflet thrombosis (LT) after transcatheter aortic valve implantation (TAVI) on clinical endpoints is unclear.

Purpose
Define the long term risk of leaflet thrombosis post TAVI.

Methods
We analysed data of our prospective observational in-house registry including all 821 patients with available post-TAVI computed tomography angiography (CTA) (between May 2012 and December 2017). Endpoints were mortality, cardiovascular mortality, transient ischemic attack (TIA) or stroke and symptomatic hemodynamic valve deterioration.

Results
In 131 (15.9%) of 821 patients early LT was diagnosed in post-TAVI-CTAs after a median of 5 [IQR 4; 6] days. Median FU was 1188 days (interquartile range (IQR) [784; 1840]). LT was observed more frequently in female [85 (64.9%) vs. 46 (35.1), P=0.013] and in patients in sinus rhythm [285 (41.3%) vs. 38 (29.0%), P=0.008]. The primary endpoint all-cause and secondary endpoint cardiovascular mortality did not differ significantly between patients without LT and with LT (Kaplan-Meier 3 years estimates for survival 74.1% vs. 71.1%, P=0.619; for cardiovascular mortality 88.7% vs. 88.2% P=0.662). The tertiary combined endpoint stroke and transient ischemic attack (TIA) was comparable between both groups (3-year stroke- and TIA-free survival 95.6% vs. 96.3; P=0.662). Patients with LT exhibited more often symptomatic hemodynamic valve deterioration (11/131 (8.3%) vs. 14/690 (2.0%), log-rank P=0.003). Predictors for all-cause mortality in multivariate Cox regression analysis were atrial fibrillation and paravalvular leakages, whereas LT was not predictive (P&lt;0.001; P=0.035 and P=0.619).

Conclusion
During a median follow-up of more than 3 years, LT was not associated with mortality, TIA or stroke. LT was, however, associated with an increased risk of symptomatic hemodynamic valve deterioration.

Funding Acknowledgement
Type of funding sources: None.
Impact of new-onset left bundle branch block on clinical and echocardiographic outcomes after TAVR with SAPIEN-3 valve
Authors: Lak H , Sammour Y , Chahine J , Chawla S , Kadri A , Popovic Z , Tarakji K , Svensson L G , Reed G , Puri R , Krishnaswamy A , Kapadia S 
Published: October 2021

Abstract

Background
New left bundle branch block (LBBB) is a common finding after transcatheter aortic valve replacement (TAVR) that can result in worse outcomes after TAVR. We aim to investigate the impact of new-onset LBBB after TAVR using the SAPIEN-3 (S3) valve.

Methods
Consecutive patients who underwent transfemoral-TAVR with S3 valve between April 2015 and December 2018 were included. Exclusion criteria included pre-existing LBBB, right bundle branch block, left anterior hemiblock, left posterior hemiblock, wide QRS ≥120 msec, prior permanent pacemaker (PPM), and non-transfemoral access.

Results
Among 612 patients, 11.4% developed new-onset LBBB upon discharge. Implantation depth was the only predictor of new-onset LBBB (OR 1.294; 95% CI 1.121–1.493; p&lt;0.001). The median (IQR) length of stay was longer with new-onset LBBB [3 (2–5) days vs. 2 (1–3) days; p&lt;0.001]. New-onset LBBB was associated with higher thirty-day PPM requirement (18.6% vs. 5.4%; p&lt;0.001) including those implanted after discharge (4.3% vs. 0.9%; p=0.02). There was no difference in 3-year all-cause mortality between both groups (30.9% vs. 30.6%; log-rank p=0.829). Further, new-onset LBBB was associated with lower left ventricular ejection fraction (LVEF) at both 30 days (55.9±11.4% vs. 59.3±9%; p=0.026) and 1 year (55±12% vs. 60.1±8.9%; p=0.002) despite no differences at baseline. These changes were still present when we stratified patients according to baseline LVEF (≥50% or &lt;50%). We also noted higher mean LV end-diastolic volume index (51.4±18.6 vs. 46.4±15.1 ml/m2; p=0.036), and LV end-systolic volume index (23.2±14.1 vs. 18.9±9.7 ml/m2; p=0.009) with new-onset LBBB at 1 year. Lastly, there were significantly higher rates of heart failure readmissions at 1 year with new-onset LBBB (10.7% vs. 4.4%; log-rank p=0.033).

Conclusion
Among our cohort of S3 recipients, new-onset LBBB was associated with higher PPM requirement, worse LVEF, higher LV volumes and increased risk of heart failure hospitalizations. However, it did not affect mortality in the short-to-intermediate post-TAVR period.

Funding Acknowledgement
Type of funding sources: None. Figure 1. All-cause Survival
Transcatheter aortic valve implantation in degenerated trans-catheter and surgical bioprosthetic aortic valve
Authors: Chanchai R , Ancona M R , Ancona M , Montorfano M 
Published: October 2021

Abstract

Background
The moving forward indication of transcatheter aortic valve implantation (TAVI) to younger aortic valve stenosis (AS) patients might lead to degenerated trans-catheter heart valve (TAV) issues which need re-intervention. TAVI in a degenerated bioprosthetic surgical valve (SAV) is feasible. However, the results of TAVI-in-TAV when compare to TAVI-in-SAV have been rarely reported.

Purpose
The aims of this study is to compare device success, early safety events at 30 days, clinical efficacy events after 30 days, and time related valve safety events between TAVI-in-TAV and TAVI-in-SAV.

Methods
Retrospectively analysed data from 62 consecutive patients with degenerated TAV or SAV who received TAVI at our Scientific institute from January 2016 to June 2020.

Results
10 patients who received TAVI-in-TAV and 52 patients who received TAVI-in-SAV were included. The patient median age was 78 years and 60% was male. The median STS score was significantly higher in TAVI-in-TAV compared to TAVI-in-SAV groups; 7.80% vs. 3.30% respectively, p=0.006. The age of the first bioprosthetic was longer in TAVI-in-SAV compared to TAV-in-SAV group; 9.8 versus 5.3 years, respectively. All TAVI devices used in both groups were second generation. The device success rate, early safety at 30 days, clinical efficacy events at median 2-years follow up were comparable; 90% vs. 88.5%, 80% vs. 76.9%, 70% vs. 44.2%, in TAVI-in-TAV and TAVI-in-SAV groups respectively. All-cause mortality at 2-years follow up was comparable; 10% vs. 9.8% in TAVI-in-SAV and TAVI-in-SAV groups, respectively. Time related valve safety events at 2-years follow up was comparable; 30% vs. 26.9% in TAVI-in-TAV and TAVI-in-SAV groups respectively. Most valve safety events were related to residual high trans-aortic valve gradient which found only in small first bioprosthetic valve. The rate of new permanent pacemaker implantation was 16.7% in both groups. The coronary obstruction found was 19.2% in TAVI-in-SAV group.

Conclusions
TAVI-in-TAV is feasible and comparable on device success, immediate and 2-years follow up outcomes compared to TAVI-in-SAV. Larger studies with longer-term follow-up time are needed to confirm these results as well as the upstream management of AS patient with long life expectancy.

Funding Acknowledgement
Type of funding sources: None. Conclusion
Valve-in-valve transcatheter aortic valve replacement or re-surgical aortic valve replacement in degenerated bioprostheses: a systematic review and meta-analysis of short and mid-term results
Authors: Bruno F , Elia E , D'Ascenzo F , Marengo G , De Filippo O , Gallone G , Andreis A , Fortuni F , Salizzoni S , Rinaldi M , La Torre M , Conrotto F , De Ferrari G M 
Published: October 2021

Abstract

Introduction
Despite limited to short and mid-term outcomes, Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has emerged as a less invasive alternative to redo surgery for high and intermediate-risk patients with good outcomes across different surgical risk profiles.

Purpose
The aim of the resent meta-analysis is to compare short and mid-term outcomes of VIV and surgical redo fo patients with a degenerative aortic bioprosthesis.

Methods
All studies comparing with multivariate adjustment between ViV TAVI and re-SAVR were screened. All-cause mortality at 30-day and at follow-up were the primary endpoints, while Valve Academy research Consortium (VARC) endpoints at 30 days including stroke, myocardial infarction (MI), major vascular complications, major bleeding, new onset atrial fibrillation (AF) and permanent pacemaker implantation (PPI) during the index hospitalization were the secondary endpoints. Subgroup analysis were performed according to the surgical risk. All the analyses were stratified according to the design of the study (observational vs propensity-matched study).

Results
We obtained data from 11 studies, encompassing 8570 patients, 4224 undergoing ViV TAVI and 4346 re-SAVR. Four studies included intermediate-risk patients and seven high-risk patients. Mean age was 76 and 71.5 years in the ViV and re-SAVR group respectively, with a 60.2% and 61.3% of male. For the ViV procedure, BE prostheses were used in the 49.6% of patients and SE prostheses in the 45.8%. The ViV group have higher prevalence of previous CAD (53.8% vs 41.1%) and CABG (35% vs 23.6%) and more history of HF (72.1% vs 65.6%), CKD (26.6% vs 14.8%) and COPD (25.4 vs 14.8%). 30-day all-cause and CV mortality were significantly lower in ViV (OR 0.43, 0.29–0.64 and OR 0.44, 0.26–0.73 respectively), while after a mean follow-up of 717 (180–1825) days, there were no difference between the two groups (OR 1.04, 0.87–1.25 and OR 1.05, 0.78–1.43 respectively). The result were consistent both in intermediate and high-risk classes. The risk of stroke (OR 1.03, 0.59–1.82), MI (OR 0.70, 0.34–1.44), major vascular complications (OR 0.92, 0.50–1.67) and permanent pacemaker implantation (OR 0.67, 0.36–1.25) at 30 days did not differ, while major bleedings and new onset atrial fibrillation were significantly lower in ViV patients (OR 0.41, 0.25–0.67 and OR 0.23, 0.12–0.42 respectively, all CI 95%).

Conclusions
In patients with a degenerated aortic bioprosthesis, ViV TAVI is associated with better short-term outcomes, including all-cause mortality, without any difference in all-cause and cardiovascular mortality at mid-term follow-up compared to surgical redo.

Funding Acknowledgement
Type of funding sources: None.