bluuebunny/crossref_metadata_2025 huggingface dataset:
Incidence of heart failure after acute coronary syndrome in multivessel patients a subanalysis of the coralys registry
Authors: Marengo G , D'Ascenzo F , De Filippo O , Bruno F
Published: October 2022

Introduction

Potential protective role of complete revascularization for development of Heart Failure (HF) after an Acute Coronary Syndrome (ACS) remains to be elucidated.

Methods

CORALYS is a multicenter, retrospective, observational registry enrolling consecutive patients admitted for ACS and treated with PCI. Patients with known history of HF or reduced left ventricular ejection fraction (LVEF) before index admission were excluded. The composite of first hospitalization for HF or cardiovascular (CV) death was the primary endpoint, while its single components along with all-cause death were the secondary ones. Complete vs. non complete revascularization (CR vs. non-CR) strategies were compared with Inverse Probability Treatment Weighting (IPTW) across all patients and for those admitted for STEMI and NSTEMI ACS and with Ejection Fraction (EF) at discharge above or below 50%.

Results

Out of 14699 patients, 5054 presented with multivessel disease. Of them, 1473 (29.2%) underwent CR. Over 5 years follow up, complete revascularization reduced the primary combined endpoint (9.2% vs. 16.2%, p<0.001) and the secondary endpoints of HF hospitalization (6.3% vs. 11.7%, p<0.001), CV death (3.7% vs. 6.6%, p<0.001), and all-cause death (9.3% vs. 14.9%, p<0.001). These results remained consistent according to ACS presentation with STEMI or NSTEMI (respectively with an incidence of the primary end point of 5.4% vs. 8.8%, p<0.001; and of 7.4% vs. 13.2%, p<0.001) and according to EF at discharge ≥ or <50% (respectively the primary end point occurred in 3.7% vs. 8.5%, p<0.001; and 10.9% vs. 15.9%, p=0.003).

Conclusions

Complete revascularization after ACS reduces risk of CV death and of hospitalizations for HF, providing another explanation of the prognostic role of CR apart from prevention of recurrent infarctions and a clear therapeutic strategy.

Funding Acknowledgement

Type of funding sources: None.
The vascular response to ultrathin biodegradable polymer sirolimus-eluting stent at 2-weeks and 1-year follow up in patients with ST-elevation myocardial infarction
Authors: Oishi Y , Tsujita H , Arai T , Sakai R , Sato S , Tanaka H , Ogura K , Masaki R , Kondo S , Tsukamoto S , Higuchi S , Sumida A , Matsumoto H , Shinke T
Published: October 2022

Background

Recent clinical study suggests newer-generation drug-eluting stents (DES) that combine ultrathin strut and nano-coating with biodegradable polymers sirolimus-eluting stent (BP-SES) could improve long-term clinical outcomes in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) over current generation DES. However, the details of vascular response in very early and chronic phase have not been systematically addressed.

Objective and method

We exploratory investigate early and chronic vascular response following BP-SES implantation in patients with STEMI to reveal mechanism of the favorable clinical outcomes in recent studies using frequency domain-optical coherence tomography (FD-OCT).

Consecutive twenty-four patients with STEMI who underwent FD-OCT after primary PCI and were eligible for follow-up FD-OCT at 2 weeks and 1 year after implantation were enrolled between June 2018 and August 2020.

OCT was performed immediately after PCI, at 2-weeks (2W) and 1-year (1Y) after the primary PCI. Struts were recorded as uncovered if any part was visibly exposed in the lumen or covered if a layer of tissue covered all reflecting surfaces. Struts of stents that are smaller than 3.0mm of diameter with more than 80μm between the center reflection and the adjacent vessel surface were recorded as malapposed. The reduction of atherothrombotic protrusion burden within the stent was also assessed.

Results

Twenty-four patients (age 64.9±11.4 years, male 83.3%) were enrolled.

The percentage of uncovered struts significantly decreased from post-PCI to 2W follow-up and from 2W follow-up to 1Y follow-up (62±20% post-PCI versus 27±11% at 2W follow up, p<0.0001 and 2W follow-up versus 3.3±3.3% at 1Y follow up, p<0.0001). Malapposed struts also decreased from post-PCI to 2W follow-up (4.1±3.6% post-PCI versus 1.5±2.2% at 2W follow-up, p<0.0001), but no significant difference was shown between 2W follow-up and 1Y follow-up (2W follow-up versus 1.0±2.3 at 1Y follow up, p=0.12). The average protrusion area of athero-thrombotic burden decreased (0.57±0.32 at post-PCI versus 0.42±0.22 mm2 at 2W follow up, p<0.0001) and its volume showed similar tendency (16.6±10.7 at post-PCI versus 12.9±8.23 mm3 at 2W follow up, p=0.0011). Thrombus was shown in all patients at post-PCI, but two patients (8.0%) showed it at 1Y follow-up.

Conclusion(s)

This study elucidated very early and chronic vascular responses following ultrathin strut BP-SES implantation in STEMI patients by FD-OCT. It showed resolution of athero-thrombotic materials in very early phase and favorable progression of strut coverage in very early and chronic phase.

Funding Acknowledgement

Type of funding sources: None.
Diagnostic accuracy of instantaneous wave-free ratio at rest and during dobutamine provocation to assess myocardial bridging relevance
Authors: Aleksandric S , Al-Lamee R , Djordjevic-Dikic A , Giga V , Tesic M , Banovic M , Zobenica V , Vukcevic V , Tomasevic M , Stojkovic S , Orlic D , Nedeljkovic M , Stankovic G , Davies J , Beleslin B
Published: October 2022

Background

Diastolic fractional flow reserve (d-FFR) during dobutamine provocation (DOB) was found to be a more reliable physiological index for the functional assessment of myocardial bridging (MB). However, d-FFR calculation is complicated and time-consuming, and therefore several authors have suggested the use of instantaneous wave-free ratio (iFR) to overcome these issues.

Purpose

The aim of our study was to assess diagnostic performance of d-FFR and iFR at rest and during DOB with exercise-induced myocardial ischemia as reference.

Methods

Twenty-four symptomatic patients (17 males, mean age 58±8 years) with MB and systolic compression ≥50% diameter stenosis on the left anterior descending (LAD) artery were included. Exercise stress-echocardiography test (SE), and both d-FFR and iFR in the distal segment of LAD at rest and peak DOB (30–50μg/kg/min), were performed in all patients. Optimal cut-off values and diagnostic performance of resting and hyperemic d-FFR and iFR were assessed using SE.

Results

Exercise-SE was positive for myocardial ischemia in 7/24 patients (29%). The area-under-the-receiver-operating-characteristic curve (ROC-AUC) for exercise-induced myocardial ischemia was 0.64 (95% CI: 0.400–0.885) for resting d-FFR, 0.62 (95% CI: 0.378–0.866) for resting iFR, 1.000 (95% CI: 0.999–1.000) for d-FFR at peak DOB, and 0.96 (95% CI: 0.895–1.000) for iFR at peak DOB. No significant difference in ROC-AUC was observed between d-FFR and iFR at peak DOB (p=0.243). The best cut-off value for both d-FFR and iFR at peak DOB was <0.76 with similar sensitivity and negative predictive values (100 vs. 100% for both), but lower specificity and positive predictive value for iFR in identifying MB associated with exercise-induced ischemia (94% vs. 82%; 88% vs. 70%, respectively). Compared with exercise-induced myocardial ischemia, the diagnostic accuracy of d-FFR and iFR at peak DOB was 96% (kappa=0.903, p<0.001) and 88% (kappa=0.731, p<0.001), respectively.

Conclusions

iFR during DOB provocation showed similar diagnostic accuracy as d-FFR to identify the functionally significant MB when compared with exercise-induced myocardial ischemia.

Funding Acknowledgement

Type of funding sources: None.
Consenting practices in interventional cardiology: an analysis from the European Association of Percutaneous Cardiovascular Interventions (EAPCI)
Authors: Rajkumar C A , Bello O , McInerney A , Tilsted H H , Johnson V , Fovino L N , Fitzsimons D , Al-Lamee R , Byrne R
Published: October 2022

Background

Consenting practices in interventional cardiology vary across different procedures, operators, centres and nations.

Purpose

In order to define best practice for obtaining informed patient consent, it is first necessary to understand how consenting practice differs.

Methods

An online survey of 20 questions was sent to all members of the European Association of Percutaneous Cardiovascular Interventions, addressing consenting practices in elective and emergency scenarios.

Results

We received 483 responses from 74 countries. The majority of respondents (77%) were European operators. Responses were received from consultant cardiologists (n=370), fellows in training (n=55), allied health professionals (n=36) and others (n=21).

Across all respondents, in elective practice, 427 (88.4%) operators obtain written consent for every procedure, the remainder (9.5%) obtain verbal consent only. Consent is obtained by the consultant or fellow who directly performs the procedure in 56.9% cases. For coronary angiography, pre-emptive consent for possible additional procedures (pressure wire and PCI) is taken by operators in all cases (58.6%), some cases (30.6%) and never (11.0%). Prior to interventional therapies, written information detailing the risk of the procedure is provided in every case by 63.8% of operators, sometimes by 25.1% of operators, and is never provided by 11.0% of operators.

In emergency settings, where patients are conscious and have capacity to consent, 274 (56.7%) of respondents obtain written consent, 155 (33.1%) obtain verbal consent only and 52 (10.8%) stated that a consent process was not required. Where consciousness and capacity are impaired, 218 (45.1%) always, 118 (24.4%) sometimes and 145 (30%) never document a written capacity and best interests' assessment.

When asked to rate the overall quality of consenting practices in their own institution, 279 (57.8%) stated these were “excellent” or “above average”, 165 (34.2%) were “average” and 39 operators described consenting practices in their institution as “below average” or “poor”.

Conclusions

Diversity in consenting practice spans elective and emergency procedures. These results suggest that there is substantial variation in the understanding of the rationale, legal requirement, and perceived best practices for consent. Further work should consider the merits of standardisation of consent processes across Europe.

Funding Acknowledgement

Type of funding sources: None.
Impact of vessel morphology on computed tomography derived fractional flow reserve (FFRCT) in normal coronary artery disease: a novel marker for the predictor of FFRCT changes
Authors: Tsugu T , Tanaka K , Nagatomo Y , Belsack D , Argacha J F , Cosysns B , De Maeseneer M , De Mey J
Published: October 2022

Background

Computed tomography (CT) derived fractional flow reserve (FFRCT) decreases continuously from the proximal to the distal segments of the vessel even in normal coronary arteries. It has been empirically proved that the degree of FFRCT decline varies based on vessel morphology even in the same vessel length.

Purpose

To investigate the vessel morphological factors that influence FFRCT in normal coronary arteries.

Methods

A total of 1402 outpatients with suspected CAD who underwent CT angiography (CTA) with FFRCT analysis between January 2017 and October 2021 were evaluated. Among them, 234 consecutive patients who underwent both CT angiography including FFRCT and invasive coronary angiography, resulting in <20% stenosis in right coronary artery (RCA) were evaluated. RCA vessels from ostium to just proximal site of the posterior descending branch were analysed and divided into two groups according to distal FFRCT: FFRCT >0.80 (n=219) and FFRCT ≤0.80 (n=15). FFRCT was measured at proximal and distal segments of the RCA. Vessel morphology (vessel length, lumen diameter and volume, and plaque volume) and left ventricular mass were assessed. The ratio of lumen volume and vessel length was defined as the V/L ratio.

Results

Whereas vessel length was almost the same between FFRCT >0.80 and ≤0.80 (>0.80 vs. ≤0.80, 115.9±17.3 vs. 119.6±28.7 mm), lumen volume (1135.2±369.3 vs. 906.2±362.6 mm3, p<0.05) and V/L ratio (9.8±2.6 vs. 7.5±2.3, p<0.01) were significantly higher in FFRCT >0.80. Distal FFRCT correlated with plaque-related parameters [low-attenuation plaque, intermediate-attenuation plaque, and calcified plaque (CP)] and vessel-related parameters (proximal and distal vessel diameter, vessel length, lumen volume, and V/L ratio). Among all vessel-related parameters, V/L ratio showed the highest correlation with distal FFRCT (r=0.44, p<0.0001) (Figure 1). Multivariable analysis showed that CP volume was the strongest predictor of distal FFRCT (β-coefficient = −0.38, p<0.0001), followed by V/L ratio (β-coefficient = 0.95, p=0.007). V/L ratio was the strongest predictor of a distal FFRCT ≤0.80 (cut-off 8.2, AUC 0.73, sensitivity 66.7%, specificity 69.3%, 95% CI 0.60–0.86) (Figure 2).

Conclusions

Our study findings suggest that the V/L ratio can be a measure to predict subclinical coronary perfusion disturbance.

Funding Acknowledgement

Type of funding sources: None.
Stent length and -diameter and long-term clinical outcomes following percutaneous coronary intervention with drug-eluting stent implantation
Authors: Van Hemert N , Stella P R , Rozemeijer R , Kraaijeveld A O , Rittersma S Z , Leenders G E H , Stein M , Frambach P , Van Der Harst P , Agostoni P , Voskuil M
Published: October 2022

Background

Long total stent length and small stent diameter have been associated with adverse events following percutaneous coronary intervention (PCI).

Purpose

To assess whether stent length and -diameter influence long-term target-lesion failure (TLF) following implantation of contemporary drug-eluting stents (DES) in an all-comers population undergoing PCI.

Methods

Patients included in the ReCre8 trial were stratified for troponin status and diabetes and randomized to implantation of a permanent polymer (PP-ZES) or polymer-free stent (PF-AES). Troponin negative patients were treated with dual antiplatelet therapy for one month, and troponin positive patients for twelve months. For the analysis on stent length, patients were divided in the quartiles of total stent length implanted per patient. Group 1a had a stent length of ≤18mm, Group 2a had a total stent length between 18 and 30mm, Group 3a had a total stent length of ≥30mm and lower than 49mm, and Group 4a had a total stent length of 49mm or more. For the analysis on stent diameter, patients were divided in the quartiles of the smallest stent diameter implanted per patient. Group 1b had a minimal stent diameter of ≤2.5mm, Group 2b had a minimal stent diameter between 2.5 and 3mm, Group 3b had a minimal stent diameter of ≥3mm and lower than 3.5mm, and Group 4b had a minimal stent diameter of 3.5mm or higher. The primary endpoint of TLF and its components – cardiac death, target-vessel myocardial infarction and target-lesion revascularization (TLR) – were assessed after three years.

Results

After division of patients in subgroups based on stent length, Group 1a included 409 patients (27.6%), Group 2a included 322 patients (20.7%), Group 3a included 376 patients (25.3%) and Group 4a included 377 patients (25.4%). After three years, TLF occurred more frequently in Group 4a with 6.6% in Group 1a, 8.4% in Group 2a, 7.7% in Group 3a and 18.0% in Group 4a (p<0.001) as shown in Figure 1. This was driven by a higher rate of TLR (p<0.001) and target-vessel myocardial infarction (p<0.001) in Group 4a. After division of patients in subgroups based on stent diameter, Group 1b included 408 patients (27.5%), Group 2b included 214 patients (14.4%), Group 3b included 477 patients (32.1%) and Group 4b included 386 patients (26.0%). After three years, TLF occurred more frequently in Group 1b with 14.0% vs. 7.9% in Group 2b, 8.6% in Group 3b and 9.3% in Group 4b (p=0.0241) as shown in Figure 2. The difference in TLF was driven by a higher rate of TLR in Group 1b (8.6% vs. 3.7% vs. 4.4% vs. 4.9%; p=0.016).

Conclusion

In an all-comers population undergoing PCI with implantation of contemporary DES, a stent length ≥49mm and a stent diameter ≤2.5mm were associated with a higher rate of TLF after three years.

Funding Acknowledgement

Type of funding sources: None.
Ten-year trends of clinical outcomes after percutaneous coronary intervention
Authors: Choi J H , Lee S H , Kim H Y , Choi J M
Published: October 2022

Objectives

Mortality following percutaneous coronary intervention (PCI) is a key quality measurement in clinical practice. This study investigated the 10-year trends of mortality following PCI in an unselected nationwide cohort.

Design

Retrospective cohort study.

Setting

A nationwide study in South Korea.

Participants

PCI claim data from 2006 to 2015 of the National Health Insurance Service and the Statistics of Korea.

Measures

1-year cardiovascular or non-cardiovascular death.

Results

In total, 437,436 patients were included. The annual number of PCI increased from 32,098 to 51,990 over the decade studied (p<0.001). Patients were divided into quartile subgroups according to clinical score for predicting 1-year all-cause death. The proportion of patients in the high-risk quartiles increased, whereas those in the low-risk quartiles decreased (p<0.001). The 1-year cumulative incidence rate of all-cause death did not change in the population with risk scores in the 1st (0.9% to 0.8%) and 2nd (1.3% to 1.3%) quartiles, whereas it increased in the population with risk scores in the 3rd (3.4% to 5.1%) and 4th (15.5% to 19.4%) quartiles (p<0.001). Compared to year 2006, the mean survival time in year 2015 was shorter by 0, 3.3, and 12.4 days in patients with risk scores in the 1st or 2nd, 3rd, 4th quartiles, respectively. These findings were also consistent for cardiovascular or non-cardiovascular deaths.

Conclusion

The number, proportion, and the overall risk of patients with a high risk for mortality after PCI increased over the decade in Korea.

Funding Acknowledgement

Type of funding sources: None.
Default distal radial approach for all coronary procedures – a prospective study
Authors: Pati P K , Arstall M , Pati A
Published: October 2022

Background

Radial artery approach for coronary interventions has substantially improved the outcome especially in acute coronary syndrome patients. However, radial artery occlusion is the achilles' heel of such an approach.

Purpose

To obviate such problems, distal radial artery (DRA) approach is evolving but technical challenge is the small size of the artery. We looked at the feasibility, safety and advantages of it.

Methods

Patient population included any patient requiring a diagnostic or percutaneous coronary interventions (PCI) in our catheterization laoratory from March 2020 to March 2022. A primary operator performed all procedures as default, if the patient had a palpable DRA. After local anaesthesia infiltration, using seldinger technique and micropuncture kit, 5 to 7F hydrophilic sheaths were introduced and a cocktail of verapamil and heparin was given routinely. Sheaths were removed immediately after procedure but dedicated side specific compression devices were used but removed 45 min after diagnostic and 2 hours after PCI. Clinical patency of radial artery was assessed at discharge and follow up.

Results

A total of 682 procedures were performed (50% were diagnostic). Out of all PCIs 59% were for ACS). Elective PCIs included very complex cases including PCI for bifurcation, left main and rota assisted complex PCIs. 651 patients had right distal radial approach and 28 had left. Mean age of patients were 66.8±12.9 years (26 to 97). Females constituted 218 (32%). Mean time from 1st needle puncure to successful vascular access took 1.2±0.8 min (20 sec to 6 min). Average attempts to obtain successful vascular access was 1.3±0.7 (1 to7 attempts). There were 15 failures (2%) to obtain DRA access requiring change over to 6 ipsilateral radial, 2 ulnar, 4 contralateral distal radial, 2 femoral and 1 brachial access. Interestingly, in 5 different occaisions previous procedure related occluded radial arteries were recanalized through this access. Most importantly, no case of radial artery occlusion was encountered at discharge or at follow up by clinical examinations. No other vascular complications were encountered except mild transient bruising in 6 cases and early small hematoma in 3 cases. Patient's comfort, nursing staffs' satisfaction and trend towards early discharges were also noticed. There was a distinct improvement in obtaining faster access with lower failure rates by the operator after initial 90, especially after 150 procedures.

Conclusions

A default approach through distal radial artery in anatomical snuff box for all coronary interventions is feasible, safe and possibly superior to conventional radial access with better patient comfort and caring staff's satisfaction. Though learning curve is longer and more challenging, success rates were much higher and vascular access was faster after initial phase. Clinically radial artry occlusion was not seen but needs further study and more objective evidence.

Funding Acknowledgement

Type of funding sources: None.
Effect of aspirin discontinuation according to individualised patient bleeding and ischemic risks after PCI: a TWILIGHT trial sub-analysis
Authors: Mendieta Badimon G , Mehta S , Baber U , Collier T , Dangas G , Sharma S K , Cohen D J , Angiolillo D , Briguori C , Escaned J , Gabriel Steg P , Huber K , Michael Gibson C , Pocock S , Mehran R
Published: October 2022

Background

The TWILIGHT trial demonstrated a reduction in BARC 2, 3 or 5 (BARC-235) bleeding without an increase in ischemic events at 1-year in high-risk PCI patients randomized to placebo or aspirin (ASA) on a background of ticagrelor 3-months after PCI. However, the effect of ASA discontinuation according to baseline risk of bleeding and ischemic events remain unclear.

Purpose

To a) develop separate models to predict the risk of bleeding and ischemic events, and b) to assess treatment effect of ASA discontinuation across the risk strata.

Methods

Using the TWILIGHT patient database (N=7,119), two multivariable models, one for BARC-235 bleeding and one for CV death, nonfatal MI or nonfatal ischemic stroke (ischemic endpoint) were developed, and their predictive capacity was assessed. The effect of randomized treatment on bleeding and ischemic events across different patient risk-group categories as determined by the risk scores was investigated.

Results

At 1-year, 350 (5.4%) patients experienced a BARC-235 bleeding event and 258 (3.6%) experienced an ischemic event. Independent predictors of BARC-235 included haemoglobin levels at index PCI, proton-pump inhibitor non-use at discharge, age, liver disease and active smoking (c-statistic 0.64). Independent predictors of the ischemic outcome included a positive troponin ACS, prior CABG, diabetes, age, peripheral artery disease, prior PCI, a history of congestive heart failure, active smoking, the level of index PCI complexity, and prior MI (c-statistic 0.71). The risk of a BARC-235 almost doubled between patients in lower versus higher bleeding risk categories (4.3% versus 7.9%) and ischemic risk more than tripled between patients in lower versus higher ischemic risk categories (2.0% versus 7.0%) (see Figure 1). There was no evidence of a differential treatment effect for dual antiplatelet therapy versus ticagrelor monotherapy across the different risk categories of bleeding (interaction P=0.54) and ischemic risk (interaction P=0.95) (Table 1).

Conclusion

Individual patient bleeding and ischemic risks after PCI can both be readily characterised with good discrimination. The effect of ASA discontinuation in preventing bleeding in ticagrelor-treated patients was consistent regardless of baseline bleeding risk. There was no evidence for increased ischemic events with ASA discontinuation according to baseline ischemic risk.

Funding Acknowledgement

Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): AstraZenecaIcahn School of Medicine at Mount Sinai
Procedural outcomes and annual operator volume among patients treated with percutaneous coronary intervention of chronic total occlusions – analysis based on a large national registry
Authors: Januszek R , Bryniarski L , Siudak Z , Malinowski K P , Surowiec S , Wanha W , Wojakowski W , Bryniarski K , Legutko J , Kambis M , Di Mario C , Bartus K , Bartus S
Published: October 2022

Background

It has been demonstrated that low operator and institutional volume is associated with poorer procedural and long-term clinical outcomes in general population of patients treated with percutaneous coronary interventions (PCI).

Purpose

The aim of the current study was to assess the relationship between operator volume and procedural outcomes of patients treated with PCI within chronic total occlusion (CTO).

Methods

Data for conducting the current analysis were obtained from the national registry of percutaneous coronary interventions (ORPKI) maintained in cooperation with the Association of Cardiovascular Interventions (AISN) of the Polish Cardiac Society. The study covered data obtained from the registry from January 2014 to December 2020. To investigate the association between operator and all periprocedural complications, coronary artery perforation (CAP) and TIMI flow grade 2/3 after PCI in the presence of confounding and clustering effects, we used multivariable, mixed effects logistic regression modelling.

Results

During the investigated period, there were 162 active CathLabs, at which 747,033 PCI procedures were performed during the time of observation. Of those 14,924 were CTO-PCI procedures. Considering the number of CTO-PCIs performed annually by individual operators during the analyzed 7 years we assessed differences between four groups (≤10; >10≤20; >20≤30 and >30 procedures). We demonstrated by nonlinear relationship with annualised CTO-PCI operator volume that operators performing more than 40 PCI with CTO per year have lower number of the overall periprocedural complications (Fig. 1) including CAP, as well greater procedural success rates (Fig. 2) compared to operators performing less procedures (p<0.0001).

Conclusions

High-volume CTO operators achieve a greater procedural success with a lower frequency of periprocedural complications. This study suggests that the cut-off of 50 CTO-PCIs per year recommended in the EuroCTO Consensus remains a reasonable compromise to optimize outcome and maintain local availability. Special CTO training programs and a higher annual case load might increase the overall quality of CTO PCI.

Funding Acknowledgement

Type of funding sources: None.
Pulmonary vein stenosis – ballooning vs. stenting: a systematic review and meta-analysis
Authors: Almakadma A , Simard T J , Sarma D , Hassett L , Alkhouli M , Packer D L , Holmes D R
Published: October 2022

Background

Pulmonary vein stenosis (PVS), which is often unrecognized, may arise from a variety of conditions resulting in major morbidity and mortality. In some patients, pharmacological therapy may help but more often in advance stages, mechanical treatment must be considered. Transcatheter approaches, both balloon angioplasty (BA) and stent implantation have been applied. While both may be effective, they continue to be limited by restenosis. Herein, we compare the outcomes following BA and stenting for PVS.

Purpose

PVS presents a challenge for both diagnosis and therapy, with BA and stenting being primarily limited by restenosis. Stenting is performed in most cases and is associated with improved patency rates. Historical comparisons of BA and stenting for PVS have yielded similar results. Our analysis incorporates more conventional studies (2010–2021) and provides a larger stent (N=361) versus BA (N=229) contemporary analysis of the current state of PV intervention practice.

Methods

From January 1, 2010 to August 2, 2021, studies, limited to English language and humans, were assessed in Ovid MEDLINE®, Ovid Embase, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and Scopus. Two independent reviewers screened articles including those in which balloon angioplasty or stenting was performed for pulmonary vein stenosis with reporting of restenosis outcomes and data was independently extracted. Systematic review was performed, and overall restenosis rates were reported across all included studies. Meta-analysis was then performed using RevMan 5.4 assessing rates of restenosis and restenosis requiring repeat intervention.

Results

Our systematic review yielded 34 studies reporting on BA and/or stenting for PVS. Of these, 7 studies (1–7), treating a total of 343 patients with 590 PV interventions (229 BA and 361 Stents) reported restenosis rates with mean follow-up ranging from 10 to 60 months. Stenting was associated with a lower risk of restenosis compared to balloon angioplasty [risk ratio 0.35, 95% CI (0.18, 0.64), p=0.0008] (Figure 1). Restenosis requiring repeat intervention was reported in 5 studies, including 303 patients with 502 PV interventions (160 BA and 342 Stents) with stenting similarly associated with a lower risk of restenosis requiring re-intervention [risk ratio 0.34, 95% CI (0.16, 0.72), p=0.005].

Conclusion

Stenting for pulmonary vein stenosis is associated with reduced risk of restenosis and re-intervention as compared to balloon angioplasty.

Funding Acknowledgement

Type of funding sources: None.
Transcatheter aortic valve implantation outcomes in patients with low flow low gradient aortic stenosis
Authors: Castelo A , Grazina A , Mendonca T , Rodrigues I , Bras P , Ferreira V , Viegas J , Ramos R , Fiarresga A , Cacela D , Ferreira R
Published: October 2022

Background

There are limited data about the outcomes of transcatheter aortic valve implantation (TAVI) in patients with low flow – low gradient (LF-LG) aortic stenosis (AS), but some studies suggest that these patients may have worse results.

Purpose

To compare outcomes between LF-LG AS and high gradient AS patients submitted to TAVI.

Methods

Retrospective analysis of consecutive patients (P) submitted to TAVI between 2009 and 2020 in a tertiary center. Baseline characteriscs and outcomes after the procedure were collected. LF-LG AS was considered in patients with mean gradient <40mmHg, valve area <1mm2, stroke volume index <35mL/m2 and at least one other criteria of contractile reserve confirmed by stress echocardiography, with elevation of mean gradient to >40mmHg, or high aortic calcium score in angio-CT.

Results

A total of 480P (56.9% female) were included, with a mean age of 82±7 years. Patients with LF-LG AS (81P, 16.9%) had worse baseline characteriscs, with higher new euroscore (10.4% vs 6.3%, p<0.0001), and natriurec peptide B (11252 vs 3095 pg/mL, p=0.001), more frequent left ventricular ejection fraction (LVEF) <40% (33.3% vs 8.8%, p<0.0001), more coronary artery disease (58% vs 37.1%, p<0.0001), including previous myocardial infarction (28.4% vs 14.1%, p=0.002) and coronary artery bypass graft (29.6% vs 12.3%, p<0.0001). In univariable analysis, LF-LG AS was associated with worse 1 year and long-term functional class (NYHA 3–4 – 17.8% vs 3.8% p<0.0001 and 20.5% vs 6.0%, p<0.0001, respectively), 1 year mortality (21.3% vs 10.8%, p=0.012) and 1 year and long-term heart failure hospitalizations (16.6% vs 3.3%, p<0.0001 and 24.3% vs 6.3%, p<0.0001). When adjusted to the differences in baseline characteristics, in a mulvariable analysis, LF-LG AS was still associated with worse functional class at 1 year (p=0.023) and long-term (p=0.004) and with heart failure hospitalizations at 1 year and long-term (p=0.001 and p<0.0001, respectively). In a sub-analysis considering only the patients with LF-LG AS, those with LVEF <40% have the worst outcomes, with more global, intra-hospital and 30 days mortality (48.1% vs 18.5%, p=0.005; 14.8% vs 1.9%, p=0.040; 18.5% vs 1.9%, p=0.014), global cardiovascular mortality (25.9% vs 7.4%, p=0.036), worse 1 year functional class (31.8% vs 11.8%, p=0.040) and more long-term heart failure hospitalizations (40.9% vs 17.3%, p=0.031).

Conclusion

Patients with LF-LG AS have worse short and long-term outcomes, even when adjusted for baseline characteriscs differences. The sub-group of patients with LVEF <40% have the worst global outcomes.

Funding Acknowledgement

Type of funding sources: None.
Quantitative angiographic assessment of aortic regurgitation post 11 different types of TAVI devices a multicentre pooled analysis of 2665 valves
Authors: Abdelshafy M , Soliman O , Kim W , Ruck A , Elkoumy A , Elzomor H , Wang R , Tao L , Garg S , Mylotte D , Onuma Y , Serruys P
Published: October 2022

Background

Regurgitation following TAVR impacts all-cause mortality. So far, no quantitative comparison of regurgitation by the same core lab has been performed among the various commercially available transcatheter heart valves (THV) We aimed to compare quantitative angiographic aortic regurgitation (AR) of 11 different types of THVs.

Method

This is a multicentre retrospective corelab pooled analysis of aortograms from 2704 consecutive patients treated with 11 different THV devices. Analysis was done by quantitative videodensitometric aortography (LVOT-AR), which is an objective, accurate, and reproducible tool for assessment of AR following TAVR. This method relies on time density changes in contrast medium after injection in the ascending aorta and its regurgitation (and subsequent density increase) in the LVOT. The ratio between the areas under the two-time density curves of these regions quantifies the AR in absolute percentage. The valves evaluated include ACURATE neo2 (n=120), Lotus (n=546), Myval (n=108), VitaFlow (n=105), Evolut PRO (n=95), SAPIEN 3 (n=397), Evolut R (n=295), SAPIEN XT (n=239), ACURATE neo (n=120), Venus-A (n=113) and CoreValve (n=532). Stratification of continuous variable regurgitation into categorical variables was performed according to the following pre-determined threshold criteria: 1) none/trace regurgitation (LVOT-AR<6%); 2) mild (6%≤ LVOT-AR ≤17%); and 3) moderate or severe (LVOT-AR >17%).

Results

The addition of anti PVR sealing features to the new generations ACURATE neo2 THV proved to be effective in reduction the incidence of significant PVR In comparison with the first generation ACURATE neo.

Myval, VitaFlow and Venus-A THVs are showing promising results.

Although the incidence of moderate/severe AR has regressed over time with new generations of THVs, the incidence of mild AR is still prominent with all THVs still exhibiting mild AR with an incidence ranging between 30% and 50% with the exception of the Lotus valve that had an 19% incidence of mild AR

Conclusion

ACURATE neo2 had the lowest severe/moderate percentage of AR showing significant improvements in comparison to ACURATE neo. Myval, VitaFlow and Venus-A are promising options in the THV armamentarium. These results should be confirmed in prospective randomized, head-to-head comparisons between THVs.

Funding Acknowledgement

Type of funding sources: None.
Peri-procedural, 30-day and 1 year-outcomes in chronic dialysis patients undergoing transcatheter aortic valve implantation
Authors: Albuquerque F , Lima R , Campante Teles R , Gomes D , Lopes P , Felix Oliveira A , Goncalves M , Brito J , Raposo L , Leal S , Mesquita Gabriel H , De Araujo Goncalves P , De Sousa Almeida M , Mendes M
Published: October 2022

Background

Patients on chronic dialysis (CD) due to end-stage renal disease (ESRD) with symptomatic severe aortic stenosis eligible for transcatheter aortic valve implantation (TAVI) were excluded from randomized clinical trials. Our study aimed to investigate the outcomes of patients with chronic dialysis who underwent TAVI.

Methods

Single center analysis on prospectively collected data of all consecutive patients who underwent TAVI between January 2011 and December 2020 according to baseline renal function: chronic dialysis group (CD) and control group (CTRL). Procedural, 30-day and 1-year outcomes were assessed. Outcomes were defined in accordance with the VARC-3 criteria.

Results

A total of 875 patients underwent TAVI during the study period, of whom 22 (2.5%) were on chronic dialysis. Patients on CD were younger (median age 80 years, [IQR 73–84] vs 84 years, [IQR 80–87]; p<0.001), more likely to be men [365/863 (42.8%) vs 18/22 (81.8%); p<0.001] and more likely to have peripheral vascular disease [41/853 (4.8%) vs 7/22 (31.8%); p=0.031] and lower body mass index (median 24.1 kg/m2, [IQR 21.5–26.5] vs 26.3 kg/m2, [IQR 23.7–29.3]). Short-term major or life-threatening bleeding were significantly higher in CD patients (odds ratio [95% confidential interval]: 3.67 [1.50–8.96], p 0.005). In contrast, no differences were found regarding rates of vascular complications requiring intervention (OR [95% CI]: 1.35 [0.31–5.90], p=0.662), permanent pacemaker implantation (OR [95% CI]: 0.87 [0.25–2.98], p=1.000) or stroke (OR [95% CI]: 1.51 [0.20–11.64], p=0.504). Importantly, dialysis patients had significantly higher rates of in-hospital, 30-day and 1-year mortality rates (13.6 vs 2.1%, p<0.001; 18.9% vs 2.9, p<0.001 and 26.4% vs 10.7%, p<0.001, respectively). On multivariate analysis, after adjusting for age, gender, relevant co-morbidities, and procedure-related complications, CD remained independently associated with mortality at 1-year. Survival curves during follow up are presented in Figure 1.

Conclusions

Chronic dialysis patients submitted to TAVI had significantly higher rates of short-term life threatening and/or major bleeding, short-term and long-term mortality. Careful selection of patients who would benefit from TAVI among patients with ERDS requiring dialysis is necessary to prevent high rates of postprocedural complications and improve outcomes of this high-risk population.

Funding Acknowledgement

Type of funding sources: None.
Radiation exposure during transcatheter aortic valve implantation (TAVI): comparison of balloon-expandable versus self-expandable prostheses
Authors: Arnold M , Nemec S , Kondruweit M , Marwan M , Achenbach S
Published: October 2022

Transcatheter aortoc valve implantation (TAVI) is performed under fluoroscopic control and can be associated with the need for long fluoroscopy times and repeated cine acquisitions in angulated projections. The procedural steps for TAVI with balloon-expandable and self-expanding prostheses differ and may be associated with significant differences in radiation exposure. Published data regarding patient or operator radiation exposure in TAVI are limited to small series. We therefore analyzed the influence of prosthesis type on radiation exposure in a consecutive series of 1185 patients who underwent TAVI between 2016 and 2021.

A cohort of 1185 consecutive patients undergoing TAVI between 2016 and 2021 was analyzed. Radiation exposure was determined by evaluating overall fluoroscopy time, the number of acquired cine sequences, and total dose-area product (DAP). After eliminating patients treated via a non-transfemoral approach, data between patients underging TAVI with self-expanding prostheses and patients undergoing TAVI with balloon-expandable prostheses were compared.

Out of the total patient cohort, 46 patients were excluded due to treatment via a non-transfemoral approach. Of the remaining 1139 patients, 437 (38%) were treated with self-expandable prostheses and 702 (62%) were treated with balloon-expandable prostheses. Median age was 81 years, 45% of patients were female. Body weight was slightly but significantly higher in patients treated by balloon-expandable prostheses (median 73 kg vs. 79 kg, p<0.001). Median fluoroscopy time was 453 s (IQR 365–603 s) for self-expandable prostheses vs. 414 s (IQR 341–540 s) for balloon-expandable prostheses (p=0.002). Also, the number of cine acqusitions was significantly higher (median 12 vs. 7; p<0.001), and total DAP was 6442 mGy cm2 (IQR 4452–9669 mGy cm2) for self-expandable vs. 4798 (IQR 3353–6981 mGy cm2) for balloon-expandable prostheses (p<0.001, see Fig. 1). In multivariable analysis, male sex, higher body weight and use of a self-expandable prosthesis were independently associated with higher total DAP.

Transcatheter aortic valve implantation using balloon-expandable prostheses is associated with significantly lower total dose-area product than treatment with self-expandable prostheses. This may be particularly relevant for operators who perform the procedure frequently.

Funding Acknowledgement

Type of funding sources: None.
Prognostic value of left ventricular global longitudinal strain in patients with severe aortic stenosis for transcatheter aortic valve implantation-related morbidity and mortality: a meta-analysis
Authors: Stens N A , Van Iersel O , Rooijakkers M J P , Van Wely M H , Nijveldt R , Bakker E A , Van Royen N , Thijssen D H J
Published: October 2022

Aims

Current methods, including left ventricular ejection fraction (LVEF), demonstrate limited prognostic value for post-Transcatheter Aortic Valve Implantation (TAVI) outcomes. Studies elaborating on LV global longitudinal strain (GLS) showed promising results, but are often underpowered.

Purpose

This meta-analysis aims to evaluate the prognostic value of preprocedural global longitudinal strain (GLS) for post-TAVI mortality and morbidity.

Methods

A systematic search was conducted in PubMed, Embase and Web of Science from 2001 to 2021. All studies that comprised patients with severe aortic stenosis who underwent TAVI and investigated the association between preprocedural speckle-tracking-derived GLS and clinical outcomes, were included. An inversely-weighted random effects meta-analysis was adopted to investigate the association between preprocedural GLS vs primary (i.e. all-cause mortality) and secondary (i.e. major cardiovascular events [MACE]) post-TAVI outcomes.

Results

Of the 1,057 identified records, 12 were eligible, all of which had a low-to-moderate risk of bias (Newcastle-Ottawa scale). On average, the 2,068 unique patients demonstrated preserved ejection fraction but impaired longitudinal function (mean LVEF 52.2±4.4%, GLS −13.5±1.6%). Patients with a lower GLS had a higher all-cause mortality (pooled hazard ratio (HR) 1.99 [95% confidence interval (CI): 1.59, 2.50]) and MACE (1.26 [95% CI: 1.08, 1.46]) risk compared to patients with higher GLS. In addition, each 1% decrease of GLS was associated with an increased postprocedural mortality (HR 1.06 [95% CI: 1.03, 1.08]) and MACE risk (pooled HR 1.08 [95% CI: 1.01, 1.15]).

Conclusion

Preprocedural GLS was significantly associated with post-TAVI mortality and morbidity. This suggests a potential clinically important role of pre-TAVI evaluation of GLS for risk stratification of patients with severe aortic stenosis.

Funding Acknowledgement

Type of funding sources: Public hospital(s).
Life expectancy and early to mid-term dysfunction of transcatheter aortic prostheses: incidence, modes, correlates, and outcome
Authors: Nitsche C , Koschutnik M , Dona C , Mutschlechner D , Spinka G , Dannenberg V , Mascherbauer K , Sinnhuber L , Kammerlander A , Winter M P , Bartko P E , Goliasch G , Hengstenberg C , Mascherbauer J
Published: October 2022

Backgrounds

Bioprosthetic valve dysfunction (BVD) is a major concern regarding transcatheter aortic valve implantation (TAVI) in low-risk patients.

Aims

To assess incidence, determinants, modes, and outcome of early to mid-term BVD after TAVI in relation with life expectancy.

Methods

Consecutive TAVI recipients (2007–2020) with a post-interventional follow-up ≥1-year were prospectively included. BVD components and bioprosthetic valve failure (BVF) were assessed according to updated Valve-Academic-Research-Consortium-3 criteria. Echocardiographic and laboratory follow-up was performed prior to discharge, at 3- and 12-months, and yearly thereafter. BVD/BVF and all-cause death served as endpoints. Average life expectancy was calculated from National Open Health Data and patients were stratified according to tertiles (1st: <6.85y, 2nd: 6.85–9.7y, 3rd: >9.7y).

Results

Of 1047 patients (81.6±6.8 y/o, 52.7% female, EuroSCORE II 4.5±2.5), ≥2 follow-ups were available from 622 (serial echo cohort). After a median echo follow-up of 12.2 months, incidence rates of BVD and BVF were 8.4% [95% confidence interval 6.7–10.3], and 3.5% [2.5–4.9] per valve-year, respectively, without differences between life expectancy tertiles (Figure 1). BVD incidence was double within the first year of implant (9.9% [7.7–12.6] per valve-year; mostly non-structural VD) vs. beyond (4.8% [3.1–7.2] per valve-year; structural and non-structural VD). Valve-in-valve procedure, and stenosis severity (both p<0.05), but not age/life expectancy (p>0.5) predisposed for BVD.

After 4.4±3.0 years, mortality was 36.7%. Time-dependent BVD/BVF were independently associated with outcome for patients in the first (adjusted hazard ratio [AHR] 1.72 [1.06–2.88]/ 2.97 [1.72–6.22]) and second (AHR 1.96 [1.02–3.73]/ 2.31 [1.00–5.30]), but not the third tertile of life expectancy (AHR 1.42 [0.66–3.12]/ 1.84 [0.71–4.79]; Figure 1).

Conclusions

In this large prospective observational cohort, early to mid-term BVD after TAVI occurred at the same rate across the spectrum of life expectancy and was not prognostic among those with the longest life expectancy.

Funding Acknowledgement

Type of funding sources: None.
Dual versus single antiplatelet therapy after transcatheter aortic valve replacement: a systematic review and meta-analysis
Authors: Eikelboom R , Qiu Y , Kim K , Whitlock R , Belley-Cote E
Published: October 2022

Background

Transcatheter aortic valve replacement (TAVR) is the intervention of choice for patients with severe symptomatic aortic stenosis who have high or intermediate surgical risk. TAVR valves are at risk of thrombosis and serious sequelae including stroke, peripheral embolism, and valve dysfunction requiring intervention. The optimal method of antithrombotic therapy to reduce risk of thrombosis with an acceptable increase in risk of bleeding is uncertain.

Objectives

This systematic review and meta-analysis assesses the effects of dual antiplatelet therapy (DAPT) versus single antiplatelet therapy (SAPT) on mortality, thrombosis and bleeding in patients undergoing TAVR.

Methods

We systematically searched EMBASE, MEDLINE and CENTRAL from January 1, 2002 until February 9, 2021 for randomized trials comparing DAPT to SAPT after TAVR. Two reviewers independently screened titles and abstracts, and then the full text of potentially relevant articles in duplicate. Data abstraction and risk of bias was also performed in duplicate. Risk ratios and 95% confidence intervals were pooled using the Mantel-Haenzel method and random effects modelling. We assessed the certainty of the evidence for each outcome using the Grading of Recommendations, Assessments, Development and Evaluation (GRADE) approach.

Results

We included 4 randomized controlled trials of 1086 patients. Risk of bias was low or somewhat concerning for all studies. We found no difference in mortality (risk ratio (RR) 1.02, 95% confidence interval (CI), 0.63 to 1.63) or stroke (RR 1.03, 95% CI 0.57–1.84), but a significant increase in major bleeding (RR 2.04, 95% CI, 1.31–3.19), with DAPT compared to SAPT. There were too few events to conduct meta-analysis for clinical valve thrombosis, subclinical valve thrombosis, transvalvular gradients on echocardiography, or aortic valve reintervention. The certainty of the evidence was low or very low due to risk of bias, inconsistency, and imprecision.

Conclusions

There is very low certainty evidence that DAPT has little to no effect compared to SAPT on mortality and stroke. There is low certainty evidence that DAPT likely causes more major bleeding than SAPT.

Funding Acknowledgement

Type of funding sources: None.