Introduction Pressure-volume (PV) loops offer a comprehensive evaluation of cardiac function. Impedance catheters enable the acquisition of synchronised intracardiac electrocardiogram (ECG), pressure, and volume data with high temporal resolution. However, current calibration methods are impractical and data interpretation is often inconsistent. Methods In the PREFER-CMR prospective, cohort study, 15 patients with suspected heart failure and preserved ejection fraction underwent same-day cardiac magnetic resonance (CMR) imaging and invasive impedance catheter studies. Signal processing algorithms were developed to semi-automatically determine PV-loop phases and calibrate impedance catheter volumes to CMR. Results of beat-by-beat and average loop analysis approaches were compared with reference methods and between each other. Results The second-order differential of the pressure-volume trace identified PV-loop phases on a beat-by-beat basis, but gradient smoothing prevented detection in average loops. Calibrated impedance catheter volumes, including left ventricular end diastolic (LVEDV) and end systolic (LVESV) volumes, correlated with CMR (r≥0.95, p<0.001) using both analysis methods. However, the average loop LVESV was overestimated by 8.1ml (p=0.031). For left ventricular end diastolic pressure, both beat-by-beat (r=0.73, p=0.002) and average loop (r=0.69, p=0.005) methods correlated with the fluid-filled manometer reference. Maximum pressure correlation was strong for both beat-by-beat (r=0.85, p<0.001) and average loop (r=0.80, p<0.001) methods, but was 10.1mmHg (p=0.040) lower in the average loop method. Between methods, significant correlations (r=0.73–0.99) were found across all pressures and volumes. Stroke work (r=0.94) and potential energy (r=0.96) significantly correlated (p<0.001) between methods, although Bland-Altman subgroup analysis suggested underestimation of stroke work in atrial fibrillation using the average loop method. Conclusions Impedance catheter volumes can be accurately calibrated using CMR. PV-loop phases can be robustly detected with a semi-automated algorithm. Both beat-by-beat and average loop approaches are viable for analysing multiple cardiac cycles, though beat-by-beat analysis may offer advantages for phase identification, pressure assessment, and in irregular rhythms. Trials registration ClinicalTrials.gov: NCT05114785. Registration date: 05/11/2021. https://clinicaltrials.gov/study/NCT05114785

BACKGROUND:Primary percutaneous coronary intervention (pPCI) with drug-eluting stents (DES) has emerged as the standard of care, but stent-related events have persisted. Drug-coated balloon (DCB)-only angioplasty is an emerging technology, although it is not fully evaluated compared with DES in the context of pPCI. OBJECTIVES:The aim of this study was to investigate the safety of DCB-only angioplasty compared with second-generation DES in pPCI. METHODS:All-cause mortality and net adverse cardiac events (cardiovascular mortality, acute coronary syndrome, ischemic stroke or transient ischemic attack, major bleeding, and unplanned target lesion revascularization [TLR]) were compared among all patients treated with DCBs only or with second-generation DES only for first presentation of ST-segment elevation myocardial infarction (STEMI) due to de novo disease between January 1, 2016, and November 15, 2019. Patients treated with both DCBs and DES were excluded. Data were analyzed using Cox regression models, Kaplan-Meier estimator plots and propensity score matching. RESULTS:Among 1,139 patients with STEMI due to de novo disease, 452 were treated with DCBs and 687 with DES. After a median follow-up period of >3 years, all-cause mortality was 49 of 452 and 62 of 687 in the DCB and DES groups, respectively (P = 0.18). On multivariable Cox regression analysis, there was no difference in mortality between DCBs and DES in the full and propensity score-matched cohorts. Age, frailty risk, history of heart failure, and family history of ischemic heart disease remained significant independent predictors of mortality. There was no difference in any of the secondary endpoints, including unplanned TLR. CONCLUSIONS:DCB-only angioplasty appears safe compared with DES for STEMI in terms of all-cause mortality and all net adverse cardiac events, including unplanned TLR. DCB may be an efficacious and safe alternative to DES in selected patient groups. (Drug Coated Balloon Only vs Drug Eluting Stent Angioplasty; NCT04482972).

The objective of this study is to compare the outcomes of patients treated with drug-coated balloons (DCBs) or second-generation drug-eluting stents (DESs) for de novo unprotected left main stem (LMS) disease. Previous studies comparing the treatment of LMS disease suggest that the mortality for DES PCI is not worse than CABG. There are limited data from studies investigating the treatment of de novo LMS disease with DCB angioplasty. We compared the all-cause and cardiac mortality of patients treated with paclitaxel DCB to those with second-generation DES for de novo LMS disease from July 2014 to November 2019. Data were analysed using Kaplan–Meier analyses and propensity-matched analyses. A total of 148 patients were treated with either a DCB or DES strategy. There was no significant difference in all-cause mortality in the DCB group (19.5%) compared to the DES group (15.9%) (HR 1.42 [0.61–3.32], p = 0.42). Regarding cardiac mortality, 2 (4.9%) were recorded for the DCB group and 7 (6.5%) for the DES group (HR 1.21 [0.31–4.67], p = 0.786); for target vessel myocardial infarction, there were 0 (0%) for the DCB group and 7 (6.5%) for the DES group; and for target lesion revascularisation, there were 3 (7.3%) in the DCB group and 9 (8.3%) in the DES group (HR: 0.89 [0.24–3.30]). p = 0.86. These remained not significant after propensity score matching. We found no difference in the mortality outcomes with DCB angioplasty compared to second-generation DES, with a median follow-up of 33 months. DCB can therefore be regarded as a safe option in the treatment of LMS disease in suitable patients.

Abstract Introduction The recent BASKETSMALL2 trial demonstrated safety and efficacy of drug coated balloon (DCB) angioplasty for de novo small vessel disease. Registry data have demonstrated that DCB angioplasty is safe; however, the majority of these studies are limited due to long recruitment time and small number of patients with DCB compared to drug eluting stents (DES). Our aim was to investigate if DCB-only strategy is safe to incorporate in routine clinical practice. Methods We identified all patients treated for stable angina and de novo disease in our institution from January 2015 till November 2019. During that period an equivalent number of patients were treated with DCB-only or DES-only strategy on a yearly basis. The primary endpoint was all cause mortality. The secondary endpoints were cardiovascular mortality, acute coronary syndrome (ACS), ischaemic stroke, major bleeding and target lesion revascularisation (TLR). Data were obtained from the hospital episodes statistics from NHS digital. Clinical and angiographic data were collected from our prospectively collated database and supplemented from electronic records as required. All angiograms were reviewed to confirm accuracy of angiographic data and determine TLR. On multivariable COX regression analysis (Table 1) age, frailty and hypercholesterolaemia were the only independent predictors of all cause mortality. Results A total of 1302 patients were identified. HES data were not obtained for 65 patients who had opted-out, therefore 1237 were included in the analysis; 544 were treated with DCB and 693 with DES. The average age for the DCB-group was 67.9±10.2 years old (79% male); while for the DES group it was 67.9±9.7 years old (78.1% male). The average follow up was 1339±514 days and 1354±527 days for the DCB and DES group respectively. Table 1 shows the differences between the groups in terms of clinical and angiographic characteristics. The DES group had more patients with history of COPD (6.3% vs 3%; p=0.01) and larger average vessel diameter (3.46±0.58 vs 3.09±0.53mm; p<0.001). The DCB group had more patients with true bifurcation disease and TIMI 0 or 1 pre-PCI (11.6% vs 8.1%; p=0.04) and TIMI 0 or 1 pre-PCI (11.7% vs 6.6%; p=0.001). Furthermore, more than 70% of patients in the DCB group had vessel diameter ≥3mm indicating that large vessels were treated. The all cause mortality was 35 (6.4%) and 59 (8.5%) for the DCB and DES group respectively. Kaplan Meier estimator plot did not show a significant difference between the groups. There was no difference between the groups in any of the secondary endpoints (cardiovascular mortality, ACS, stroke, major bleeding and TLR). Conclusion Our real world data from a large, contemporary cohort of stable angina patients, including predominantly large vessels, demonstrate that DCB only angioplasty is safe compared to DES in terms of all major cardiovascular endpoints including TLR. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): B Braun - investigator initiated research

We aimed to investigate the safety of drug-coated balloon (DCB)-only angioplasty compared to drug-eluting stent (DES), as part of routine clinical practice.The recent BASKETSMALL2 trial demonstrated the safety and efficacy of DCB angioplasty for de novo small vessel disease. Registry data have also demonstrated that DCB angioplasty is safe; however, most of these studies are limited due to long recruitment time and a small number of patients with DCB compared to DES. Therefore, it is unclear if DCB-only strategy is safe to incorporate in routine elective clinical practice.We compared all-cause mortality and major cardiovascular endpoints (MACE), including unplanned target lesion revascularisation (TLR) of all patients treated with DCB or DES for first presentation of stable angina due to de novo coronary artery disease between 1st January 2015 and 15th November 2019. Data were analysed with Cox regression models and cumulative hazard plots.We present 1237 patients; 544 treated with DCB and 693 treated with DES for de novo, mainly large-vessel coronary artery disease. On multivariable Cox regression analysis, only age and frailty remained significant adverse predictors of all-cause mortality. Univariable, cumulative hazard plots showed no difference between DCB and DES for either all-cause mortality or any of the major cardiovascular endpoints, including unplanned TLR. The results remained unchanged following propensity score-matched analysis.DCB-only angioplasty, for stable angina and predominantly large vessels, is safe compared to DES as part of routine clinical practice, in terms of all-cause mortality and MACE, including unplanned TLR.

Introduction In the setting of primary percutaneous coronary intervention (PPCI), it has been shown that stenting compared to balloon angioplasty (BA) reduces the need for repeat revascularisation but not overall mortality. A recent, small randomised trial showed that drug coated balloon (DCB) angioplasty for PPCI was non-inferior to drug eluting stent (DES) in terms of fractional flow reserve at 9 months. Our aim was to investigate the safety of DCB angioplasty in a STEMI population in terms of all-cause mortality. Methods We identified all patients treated for STEMI in our institution from January 2016 until November 2019. We excluded patients who died in hospital and patients with cardiac arrest, cardiogenic shock or requiring intubation; given that their mortality is more likely to be determined by the severity of their clinical presentation rather than the PCI strategy. The primary endpoint was all-cause mortality. Survival data were obtained through the UK Health and Social Care Information Service. Clinical and angiographic data were collected from our prospectively collated database and supplemented from electronic records where required. All angiograms were reviewed by an experienced operator to confirm treatment strategy, bifurcation lesions, coronary artery dissection and TIMI flow pre- and post-intervention. Results A total of 1190 patients were identified; 470 treated with DCB and 720 with DES. The average age for the DCB group was 65.5 ± 12.5 years old (73.6% male); while for the DES group it was 65.5 ± 11.6 years old (74.7% males). The average follow up was 882 ± 439 days and 978 ± 426 days for the DCB and DES group respectively. There were a few differences between the groups (table 1). There were no differences in all other clinical and angiographic characteristics. The all-cause mortality was 33/470 (7%) for the DCB group and 48/720 (6.7%) for the DES group. Kaplan Meier estimator plot for all-cause mortality (figure 1) did not show a significant difference between DCB and DES (p=0.54). On multivariable Cox regression analysis (table 2), age, prior stroke, coronary artery bypass graft, heart failure, chronic obstructive pulmonary disease (COPD) and diabetes were significant poor predictors of mortality. Conclusion Our real-world data from a large, contemporary cohort of STEMI patients demonstrate that DCB only angioplasty is safe compared to DES and may be considered as a treatment option. Conflict of Interest none

Introduction Stent thrombosis, with a 5-45% mortality and 15-20% recurrence rate at 5 years, represents the most severe end of the stent failure spectrum. There are no data regarding the outcomes of patients with stent thrombosis (ST) being treated with paclitaxel drug coated balloon (DCB) angioplasty. Our aim was to determine the all-cause mortality of patients treated with DCB angioplasty for ST. Methods We identified all patients treated for ST between June 2011 and November 2019. We excluded patients who died in the cath lab, patients with uncrossable lesions and patients who were treated with a staged CABG. The primary endpoint was all-cause mortality. The secondary endpoint was target lesion revascularisation (TLR). Survival data were obtained through the UK Health and Social Care Information Service. Clinical and angiographic data were collected from our prospectively collated database supplemented with data from electronic records where required. All angiograms were reviewed by two experienced operators to confirm ST, TIMI flow pre- and post-intervention and identify bifurcation lesions. Results A total of 178 patients were identified; 95 treated with DCB, 35 with balloon angioplasty (BA), 26 with drug eluting stent (DES), 19 with combination of DES and DCB and 3 with thromboaspiration only. The average age was 66.2 ± 10.5 years old, while male patients accounted for 76.8%. There were a few differences between DCB, BA and DES. The DES group had more patients with history of CABG, hypertension and lower average eGFR at presentation while the DCB group had more patients with history of smoking. Importantly, the great majority of patients treated with DCB had very late ST. The patients were followed-up for an average of 45.6 ± 29.8 months; 39.8±25.4, 49.8±28.1, 57.1±40.9 months for the DCB, BA and DES groups respectively. All-cause mortality at 9 months was 8.5% for whole cohort; 7.4%, 2.9%, 19.2% for the DCB, BA and DES groups respectively (DCB vs DES p=0.07; DCB vs BA p=0.34; DES vs BA p=0.03). Table 1 shows the only independent predictors of mortality up to 5 years in multivariable Cox regression analysis.When considering only the patients discharged alive, all-cause mortality at 9 months was 4.7% for whole cohort; 5.4%, 2.9%, 8.7% for DCB, BA and DES groups respectively (no statistical difference between any pairs). There was no statistical difference in all-cause mortality (figure 1) or local TLR (figure 2) up to 5 years of follow-up. Conclusion DCB-only angioplasty for patients with ST is safe and may be considered as a treatment option especially in patients with very late ST. Conflict of Interest no conflict of interest

Objectives We aimed to investigate long-term survival of paclitaxel DCB for percutaneous coronary intervention (PCI). Background Safety concerns have been raised over the use of paclitaxel devices for peripheral artery disease recently, following a meta-analysis suggesting increased late mortality. With regard to drug-coated balloon (DCB) angioplasty for coronary artery intervention however, there is limited data to date regarding possible late mortality relating to paclitaxel. Methods We compared all-cause mortality of patients treated with paclitaxel DCB to those with non-paclitaxel second-generation drug-eluting stents (DES) for stable, de novo coronary artery disease from 1st January 2011 till 31st December 2018. To have homogenous groups allowing data on safety to be interpreted accurately, we excluded patients with previous PCI and patients treated with a combination of both DCB and DES in subsequent PCIs. Data were analysed with Kaplan–Meier curves and Cox regression statistical models. Results We present 1517 patients; 429 treated with paclitaxel DCB and 1088 treated with DES. On univariate analysis, age, hypercholesterolaemia, hypertension, peripheral vascular disease, prior myocardial infarction, heart failure, smoking, atrial fibrillation, decreasing estimated glomerular filtration rate (eGFR) [and renal failure (eGFR < 45)] were associated with worse survival. DCB intervention showed a non-significant trend towards better prognosis compared to DES ( p = 0.08). On multivariable analysis age, decreasing eGFR and smoking associated with worse prognosis. Conclusion We found no evidence of late mortality associated with DCB angioplasty compared with non-paclitaxel second-generation DES in up to 5 years follow-up. DCB is a safe option for the treatment of de novo coronary artery disease.

We aimed to investigate long-term survival of paclitaxel DCB for percutaneous coronary intervention (PCI). Safety concerns have been raised over the use of paclitaxel devices for peripheral artery disease recently, following a meta-analysis suggesting increased late mortality. With regard to drug-coated balloon (DCB) angioplasty for coronary artery intervention however, there is limited data to date regarding possible late mortality relating to paclitaxel. We compared all-cause mortality of patients treated with paclitaxel DCB to those with non-paclitaxel second-generation drug-eluting stents (DES) for stable, de novo coronary artery disease from 1st January 2011 till 31st December 2018. To have homogenous groups allowing data on safety to be interpreted accurately, we excluded patients with previous PCI and patients treated with a combination of both DCB and DES in subsequent PCIs. Data were analysed with Kaplan–Meier curves and Cox regression statistical models. We present 1517 patients; 429 treated with paclitaxel DCB and 1088 treated with DES. On univariate analysis, age, hypercholesterolaemia, hypertension, peripheral vascular disease, prior myocardial infarction, heart failure, smoking, atrial fibrillation, decreasing estimated glomerular filtration rate (eGFR) [and renal failure (eGFR < 45)] were associated with worse survival. DCB intervention showed a non-significant trend towards better prognosis compared to DES (p = 0.08). On multivariable analysis age, decreasing eGFR and smoking associated with worse prognosis. We found no evidence of late mortality associated with DCB angioplasty compared with non-paclitaxel second-generation DES in up to 5 years follow-up. DCB is a safe option for the treatment of de novo coronary artery disease.

We report the case of a 64 year old man with two vessel coronary artery disease and a left main coronary artery to pulmonary artery fistula. He underwent coronary artery bypass grafting, but the coronary artery fistula was not closed. He developed recurrent angina due to coronary steal from the distal left anterior descending artery by the maturing coronary artery fistula. This was closed percutaneously by stenting the left main coronary artery with covered stents. The clinical implications and potential mechanisms of the coronary steal due to the coronary artery fistula are discussed.