Comparison of cardiac output estimates obtained from the Antares oscillometric pulse wave analysis algorithm and from Doppler transthoracic echocardiography.

BACKGROUND: In cardiology, cardiac output (CO) is an important parameter for assessing cardiac function. While invasive thermodilution procedures are the gold standard for CO assessment, transthoracic Doppler echocardiography (TTE) has become the established method for routine CO assessment in daily clinical practice. However, a demand persists for non-invasive approaches, including oscillometric pulse wave analysis (PWA), to enhance the accuracy of CO estimation, reduce complications associated with invasive procedures, and facilitate its application in non-intensive care settings. Here, we aimed to compare the TTE and oscillometric PWA algorithm Antares for a non-invasive estimation of CO. METHODS: Non-invasive CO data obtained by two-dimensional TTE were compared with those from an oscillometric blood pressure device (custo med GmbH, Ottobrunn, Germany) using the integrated algorithm Antares (Redwave Medical GmbH, Jena, Germany). In total, 59 patients undergoing elective cardiac catheterization for clinical reasons (71±10 years old, 76% males) were included. Agreement between both CO measures were assessed by Bland-Altman analysis, Student's t-test, and Pearson correlations. RESULTS: The mean difference in CO was 0.04 ± 1.03 l/min (95% confidence interval for the mean difference: -0.23 to 0.30 l/min) for the overall group, with lower and upper limits of agreement at -1.98 and 2.05 l/min, respectively. There was no statistically significant difference in means between both CO measures (P = 0.785). Statistically significant correlations between TTE and Antares CO were observed in the entire cohort (r = 0.705, P<0.001) as well as in female (r = 0.802, P<0.001) and male patients (r = 0.669, P<0.001). CONCLUSIONS: The oscillometric PWA algorithm Antares and established TTE for a non-invasive estimation of CO are highly correlated in male and female patients, with no statistically significant difference between both approaches. Future validation studies of the Antares CO are necessary before a clinical application can be considered.

Invasively measured and estimated central blood pressure using the oscillometric algorithm Antares in patients with and without obesity.

BACKGROUND: Obesity is a global health concern and risk factor for cardiovascular disease. The assessment of central blood pressure (cBP) has been shown to improve prediction of cardiovascular events. However, few studies have investigated the impact of obesity on cBP in adults, and invasive data on this issue are lacking. This study aimed to evaluate cBP differences between patients with and without obesity, identify cBP determinants, and evaluate the accuracy of the algorithm Antares for non-invasive cBP estimation. METHODS: A total of 190 patients (25% female; 39% with BMI ≥30kg/m2; age: 67±12 years) undergoing elective cardiac catheterization were included. cBP was measured invasively and simultaneously estimated non-invasively using the custo screen 400 device with integrated Antares algorithm. RESULTS: No significant cBP differences were found between obese and non-obese patients. However, females, especially those with obesity, had higher systolic cBP compared to males (P<0.05). Multiple regression analysis showed that brachial mean arterial pressure, pulse pressure, BMI, and heart rate predicted cBP significantly (adjusted R2 = 0.82, P<0.001). Estimated cBP correlated strongly with invasive cBP for systolic, mean arterial, and diastolic cBP (r = 0.74-0.93, P<0.001) and demonstrated excellent accuracy (mean difference <5 and SD <8 mmHg). CONCLUSIONS: This study discovered no significant difference in cBP between obese and non-obese patients. However, it revealed higher cBP values in women, especially those with obesity, which requires further investigation. Additionally, the study highlights Antares' effectiveness in non-invasively determining cBP in obese individuals. This could improve the diagnosis and treatment of hypertension in this special patient population.

Sex-specific inequalities in the use of drug-coated balloons for small coronary artery disease: a report from the BASKET-SMALL 2 trial.

BACKGROUND AND OBJECTIVES: Recent data have established non-inferiority of drug-coated balloons (DCB) compared to drug-eluting stents (DES) for treatment of small-vessel coronary artery disease. Since coronary vessels in women might have anatomical and pathophysiological particularities, the safety of the DCB strategy among women compared to men needs to be assessed in more detail. METHODS: In BASKET-SMALL 2, patients with de novo lesions in coronary vessels < 3 mm and an indication for percutaneous coronary intervention were randomly allocated (1:1) to DCB vs. DES after successful lesion preparation. The primary objective of the randomized trial was to establish non-inferiority of DCB vs. DES regarding major adverse cardiac events (MACE; i.e., cardiac death, non-fatal myocardial infarction, and target vessel revascularization) after 12 months. The aim of the current sub-analysis is to evaluate whether the DCB strategy is equally safe among women and men after 12 and 36 months. RESULTS: Among 758 randomized patients, 382 were assigned to DCB (23% women) and 376 to DES (30% women). In general, women were older, had more often diabetes mellitus and renal insufficiency, and presented more often with an acute coronary syndrome, whereas men were more often smokers, had multivessel disease and a previous history of acute myocardial infarction, and received a treatment with a statin. After 3 years, the primary clinical end point was not significantly different between groups (13% women vs. 16% men, HR 0.82; 95% CI 0.52-1.30; p = 0.40). There was no interaction between sex and coronary intervention strategy regarding MACE at 36 months (10% women vs. 16% men in DCB, 16% women vs. 15% men in DES; pinteraction = 0.31). CONCLUSION: In small native coronary artery disease, there was no statistically significant effect of sex on the difference between DCB and DES regarding MACE up to 36 months. CLINICAL TRIAL REGISTRATION: URL: http://www. CLINICALTRIALS: gov . Unique identifier: NCT01574534. CAD coronary artery disease, MACE major adverse cardiovascular events, HR Hazard ratio, DCB drug-coated balloon, DES drug-eluting stent.

Impact of Insulin-Treated Compared to Non-Insulin-Treated Diabetes Mellitus on Outcome of Percutaneous Coronary Intervention with Drug-Coated Balloons versus Drug-Eluting Stents in De Novo Coronary Artery Disease: The Randomized BASKET-SMALL 2 Trial.

BACKGROUND: We evaluated the outcome of PCI of de novo stenosis with drug-coated balloons (DCB) versus drug-eluting stents (DES) in patients with insulin-treated diabetes mellitus (ITDM) versus non-insulin-treated diabetes mellitus (NITDM). METHODS: Patients were randomized in the BASKET-SMALL 2 trial to DCB or DES and followed over 3 years for MACE (cardiac death, non-fatal myocardial infarction [MI], and target vessel revascularization [TVR]). Outcome in the diabetic subgroup (n = 252) was analyzed with respect to ITDM or NITDM. RESULTS: In NITDM patients (n = 157), rates of MACE (16.7% vs. 21.9%, hazard ratio [HR] 0.68, 95% confidence interval [CI] 0.29-1.58, p = 0.37), death, non-fatal MI, and TVR (8.4% vs. 14.5%, HR 0.30, 95% CI 0.09-1.03, p = 0.057) were similar between DCB and DES. In ITDM patients (n = 95), rates of MACE (DCB 23.4% vs. DES 22.7%, HR 1.12, 95% CI 0.46-2.74, p = 0.81), death, non-fatal MI, and TVR (10.1% vs. 15.7%, HR 0.64, 95% CI 0.18-2.27, p = 0.49) were similar between DCB and DES. TVR was significantly lower with DCB versus DES in all diabetic patients (HR 0.41, 95% CI 0.18-0.95, p = 0.038). CONCLUSIONS: DCB compared to DES for treatment of de novo coronary lesions in diabetic patients was associated with similar rates of MACE and numerically lower need for TVR both for ITDM and NITDM patients.

Invasive validation of the Antares algorithm for determining central blood pressure based on upper arm oscillometric pulse waves in patients with type 2 diabetes.

INTRODUCTION: Antares is a pulse wave analysis (PWA) algorithm designed to allow a non-invasive estimation of central (aortic) blood pressure (cBP) using automated oscillometric blood pressure (BP) devices. Diabetes may affect elastic and muscular arteries differently, resulting in disparate pulse wave characteristics in central and peripheral arteries, which may limit the accuracy of PWA devices. The aim of our study was to evaluate the accuracy of Antares for estimating cBP as compared with invasively measured cBP in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: In this study, consecutive patients undergoing elective coronary angiography were recruited between November 2017 and September 2020. In 119 patients with type 2 diabetes, cBP was measured invasively and simultaneously determined non-invasively using the custo screen 400 device with the integrated Antares algorithm. RESULTS: The mean difference between the estimated and invasively measured cBP was 1.2±6.3 mmHg for central systolic BP (cSBP), 1.0±4.3 mmHg for central mean arterial pressure (cMAP) and 3.6±5.7 mmHg for central diastolic BP (cDBP). High correlations were found between estimated cBP and invasively measured cBP (cSBP: r=0.916; cMAP: r=0.882; cDBP: r=0.791; all p<0.001). CONCLUSIONS: The present study suggests that the Antares algorithm incorporated into the custo screen 400 device can estimate cBP with high accuracy turning a conventional oscillometric BP device into a type II device for the non-invasive estimation of cBP, which is applicable in patients with type 2 diabetes. Integration of Antares into commercially available BP devices could facilitate the introduction of cBP into routine clinical practice as a part of disease and risk management.

Results from the "Me & My Heart" (eMocial) Study: a Randomized Evaluation of a New Smartphone-Based Support Tool to Increase Therapy Adherence of Patients with Acute Coronary Syndrome.

PURPOSE: This study evaluated whether patient support, administered via an electronic device-based app, increased adherence to treatment and lifestyle changes in patients with acute coronary syndrome (ACS) treated with ticagrelor in routine clinical practice. METHODS: Patients (aged ≥ 18 years) with diagnosed ACS treated with ticagrelor co-administered with low-dose acetylsalicylic acid were randomized into an active group (with support tool app for medication intake reminders and motivational messages) and a control group (without support tool app), and observed for 48 weeks (ClinicalTrials.gov Identifier: NCT02615704). Patients were asked to complete the 36-item Short-Form Health Survey (SF-36) and Lifestyle Changes Questionnaire (LSQ), and were assessed for blood pressure and body mass index (BMI) at baseline (visit 1) and at the end of the study (visit 2). Medication adherence was measured using the Brilique Adherence Questionnaire (BAQ). RESULTS: Patients (N = 676) were randomized to an active (n = 342) or a control (n = 334) group. BAQ data were available for 174 patients in the active group and 174 patients in the control group. Over the 48-week period, mean (standard deviation) adherence for the active and control groups was 96.4% (13.2%) and 91.5% (23.1%), respectively (effect of app intervention, p < 0.05). There were no significant differences in blood pressure and BMI between visits. General improvements in SF-36 and LSQ scores were observed for both groups. CONCLUSION: The patient support tool app was associated with significant improvements in patient-reported treatment adherence compared with a data collection app alone in patients prescribed ticagrelor for ACS.

Efficacy and safety of drug-coated balloons according to coronary vessel size. A report from the BASKET-SMALL 2 trial.

Introduction: In BASKET-SMALL 2, drug-coated balloons (DCB) were non-inferior to drug-eluting stents (DES) in de-novo stenosis of small coronary vessels (≤ 2.75 mm) regarding clinical endpoints up to 36 months. Aim: In the present subgroup analysis, we aimed to analyze the effect of the two treatment strategies in different vessel sizes. Material and methods: Patients were analyzed according to the size of the device used (small > 2.5 mm vs. very small ≤ 2.5 mm). The primary endpoint was major adverse cardiac events (MACE), while secondary endpoints were target vessel revascularization (TVR), non-fatal myocardial infarction, cardiac death, and all-cause mortality, all at 36 months. Interactions for the different groups were assessed with Cox regression analysis. Results: Overall, 758 patients were enrolled in this analysis, of which 437 (58%) had very small vessel disease. There were similar results in both treatment groups for the primary endpoint in both small and very small vessels (DCB vs DES, MACE at 3 years in small vessels HR = 1.31, 95% CI: 0.74-2.32, p = 0.355, and very small vessels HR = 0.82, 95% CI: 0.49-1.39, p = 0.468). Second generation paclitaxel-eluting stents showed significantly higher rates for MACE (p = 0.041), TVR (p = 0.004) and non-fatal myocardial infarction (p = 0.036) compared to DCB in very small coronary arteries at 3 years, while results were similar in small coronary arteries. Conclusions: Efficacy and safety of DCB are similar irrespective of vessel size. However, there is a beneficial effect of DCB over paclitaxel-eluting stents regarding TVR, non-fatal myocardial infarction and MACE that is most pronounced in very small coronary arteries.

Drug-Coated Balloon for Small Coronary Artery Disease in Patients With and Without High-Bleeding Risk in the BASKET-SMALL 2 Trial.

BACKGROUND: Patients at high-bleeding risk (HBR) undergoing percutaneous coronary intervention represent a challenging patient population. The use of drug-coated balloon (DCB) allows shorter duration of dual antiplatelet therapy compared with drug-eluting stents (DES) and reduces thrombotic risk due to the absence of a permanent implant. The present analysis aimed to investigate if the effect of DCB versus DES differed between patients with and without HBR treated with percutaneous coronary intervention in small coronary arteries. METHODS: This prespecified subgroup analysis of a multicenter, randomized, noninferiority trial included 758 patients with de novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention, randomized to DCB (n=382) or second-generation DES (n=376). Patients were followed over 3 years for major adverse cardiac events. RESULTS: Of the 758 patients randomized, 155 (20%) had HBR; these patients had higher mortality at 3 years (hazard ratio [95% CI], 3.09 [1.78-5.36]; P<0.001). Rates of major bleeding events were overall low but tended to be lower after DCB versus DES (1.6% versus 3.7%; P=0.064), were similar in patients with HBR (4.5% versus 3.4%) but less frequent in DCB-versus DES-treated patients without HBR (0.9% versus 3.8%). There was no difference in major adverse cardiac events between DCB and DES regardless of bleeding risk (HBR, hazard ratio: 1.16 [0.51-2.62]; P=0.719 versus non-HBR, 0.96 [0.62-1.49]; P=0.863). CONCLUSIONS: DCBs were similarly safe and effective as current-generation DES in the treatment of coronary arteries <3 mm, regardless of bleeding risk. In patients treated with DCB, there was a trend towards a reduction of severe bleeding events at 3 years. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01574534.

Drug-coated balloons for small coronary artery disease in patients with chronic kidney disease: a pre-specified analysis of the BASKET-SMALL 2 trial.

BACKGROUND: Data on the safety and efficacy of drug-coated balloon (DCB) compared to drug-eluting stent (DES) in patients with chronic kidney disease (CKD) are scarce, particularly at long term. This pre-specified analysis aimed to investigate the 3-year efficacy and safety of DCB versus DES for small coronary artery disease (< 3 mm) according to renal function at baseline. METHODS: BASKET-SMALL-2 was a large multi-center, randomized, controlled trial that tested the efficacy and safety of DCBs (n = 382) against DESs (n = 376) in small vessel disease. CKD was defined as eGFR < 60 ml/min/1.73m2. The primary endpoint was the composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization (MACE) during 3 years. RESULTS: A total of 174/758 (23%) patients had CKD, out of which 91 were randomized to DCB and 83 to DES implantation. The primary efficacy outcome during 3 years was similar in both, DCB and DES patients (HR 0.98; 95%-CI 0.67-1.44; p = 0.937) and patients with and without CKD (HR 1.18; 95%-CI 0.76-1.83; p = 0.462), respectively. Rates of cardiac death and all-cause death were significantly higher among patients with CKD but not affected by treatment with DCB or DES. Major bleeding events were lower in the DCB when compared to the DES group (12 vs. 3, HR 0.26; 95%-CI 0.07-0.92; p = 0.037) and not influenced by presence of CKD. CONCLUSIONS: The long-term efficacy and safety of DCB was similar in patients with and without CKD. The use of DCB was associated with significantly fewer major bleeding events (NCT01574534). Central Illustration. Drug-coated balloon versus drug-eluting stents in small coronary artery disease with and without chronic kidney disease, a prespecified subgroup analysis of the BASKET-SMALL 2 trial.

Safety and Efficacy of Drug-Coated Balloons Versus Drug-Eluting Stents in Acute Coronary Syndromes: A Prespecified Analysis of BASKET-SMALL 2.

BACKGROUND: Drug-coated balloons (DCBs) are an established treatment strategy for coronary artery disease. Randomized data on the application of DCBs in patients with an acute coronary syndrome (ACS) are limited. We evaluated the impact of clinical presentation (ACS versus chronic coronary syndrome) on clinical outcomes in patients undergoing DCB or drug-eluting stent (DES) treatment in a prespecified analysis of the BASKET-SMALL 2 trial (Basel Kosten Effektivitäts Trial-Drug-Coated Balloons Versus Drug-Eluting Stents in Small Vessel Interventions). METHODS: BASKET-SMALL 2 randomized 758 patients with small vessel coronary artery disease to DCB or DES treatment and followed them for 3 years regarding major adverse cardiac events (cardiac death, nonfatal myocardial infarction, and target vessel revascularization). RESULTS: Among 758 patients, 214 patients (28.2%) presented with an ACS (15 patients [7%], ST-segment-elevation myocardial infarction; 109 patients [50.9%], non-ST-segment-elevation myocardial infarction; 90 patients [42.1%], unstable angina pectoris). At 1-year follow-up, there was no significant difference in the incidence of the primary end point by randomized treatment in patients with ACS (hazard ratio, 0.50 [95% CI, 0.19-1.26] for DCB versus DES) or chronic coronary syndrome (hazard ratio, 1.29 [95% CI, 0.67-2.47] for DCB versus DES). There was no significant interaction between clinical presentation and treatment effect (P for interaction, 0.088). For cardiac death (P for interaction, 0.049) and nonfatal myocardial infarction (P for interaction, 0.010), a significant interaction between clinical presentation and treatment was seen at 1 year with lower rates of these secondary end points in patients with ACS treated by DCB. At 3 years, there were similar major adverse cardiac event rates throughout groups without significant interaction between clinical presentation and treatment (P for interaction, 0.301). All-cause mortality was higher in ACS compared with chronic coronary syndrome; however, there was no difference between DCB and DES irrespective of clinical presentation. CONCLUSIONS: In this subgroup analysis of the BASKET-SMALL 2 trial, there was no interaction between indication for percutaneous coronary intervention (acute versus chronic coronary syndrome) and treatment effect of DCB versus DES in patients with small vessel coronary artery disease. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01574534.

Pre-procedural predictors for multiple clips in percutaneous edge-to-edge mitral valve repair.

BACKGROUND: Percutaneous mitral valve (MV) clipping for mitral regurgitation (MR) revolutionized MV repair; however, valve anatomies and pathologies vary. Often multiple clips are required, and predicting this pre-procedurally would be useful. We evaluated pre-procedural predictors for multiple clips. RESULTS: We retrospectively analyzed 127 severe MR patients treated by mitral clipping between January 2011 and August 2018. Patients were grouped according to the use of a single (group I) or multiple clips (group II) and pre-procedure echocardiographs compared. No demographic differences existed except group II had more males (68.1%) than group I (48.3%). Mean left atrial diameter was larger in group II, 51 ± 9 mm, than group I, 48 ± 5 mm, p = 0.026. Mean mitral annular diameter differed: 34 ± 4mm (group II) versus 33 ± 3 mm (group I), p = 0.017. The vena contracta was broader in group II than group I (6.6 ± 1 mm vs. 6 ± 0.9 mm, p = 0.001). Severe mitral annular calcification occurred more in group I (36.2%) than group II (10.1%), p = 0.0001. On multivariate analysis, vena contracta width correlated positively with multiple clips (B 0.125, p = 0.013), but severe annular calcification correlated inversely (B - 0.35, p = 0.002). CONCLUSIONS: Vena contracta width and severe annular calcification are factors to consider when planning MV clipping.

Impact of Diabetes on Outcome With Drug-Coated Balloons Versus Drug-Eluting Stents: The BASKET-SMALL 2 Trial.

OBJECTIVES: The study sought to evaluate the impact of diabetes mellitus on 3-year clinical outcome in patients undergoing drug-coated balloon (DCB) or drug-eluting stent (DES) treatment for de novo lesions. BACKGROUND: For treatment of de novo coronary small vessel disease, DCBs are noninferior to DES. METHODS: In this prespecified analysis of a multicenter, randomized, noninferiority trial, including 758 patients with de novo lesions in coronary vessels <3 mm who were randomized 1:1 to DCB or DES and followed over 3 years for major adverse cardiac events (MACE) (cardiac death, nonfatal myocardial infarction [MI], and target vessel revascularization [TVR]), outcome was analyzed regarding the presence or absence of diabetes mellitus. RESULTS: In nondiabetic patients (n = 506), rates of MACE (DCB 13.0% vs DES 11.5%; hazard ratio [HR]: 1.24; 95% confidence interval [CI]: 0.73-2.09; P = 0.43), cardiac death (2.8% vs 2.9%; HR: 0.97; 95% CI: 0.32-2.92; P = 0.96), nonfatal MI (5.1% vs 4.8%; HR: 1.00; 95% CI: 0.44-2.28; P = 0.99), and TVR (8.8% vs 6.1%; HR: 1.64; 95% CI: 0.83-3.25; P = 0.16) were similar. In diabetic patients (n = 252), rates of MACE (19.3% vs 22.2%; HR: 0.82; 95% CI: 0.45-1.48; P = 0.51), cardiac death (8.8% vs 5.9%; HR: 2.01; 95% CI: 0.76-5.31; P = 0.16), and nonfatal MI (7.1% vs 9.8%; HR: 0.55; 95% CI: 0.21-1.49; P = 0.24) were similar in DCB and DES. TVR was significantly lower with DCBs vs DES (9.1% vs 15.0%; HR: 0.40; 95% CI: 0.17-0.94; P = 0.036; P = 0.011 for interaction). CONCLUSIONS: The rates of MACE are similar in DCBs and DES in de novo coronary lesions of diabetic and nondiabetic patients. In diabetic patients, need for TVR was significantly lower with DCB versus DES. (Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs Drug Eluting Stents in Small Vessel Interventions [BASKET-SMALL2]; NCT01574534).

Very early discharge after cardiac implantable electronic device implantations: is this the future?

PURPOSE: To limit the ever-increasing healthcare costs, strategies to minimize hospitalization length are warranted. In this perspective, early discharge (the same day or after < 24 h) post-cardiac implantable electronic device (CIED) implantation might represent a useful strategy; nevertheless, it is imperative first to understand the timing of (potentially lethal) complications and evaluate whether this is not only an effective but also a safe clinical decision. METHODS: A retrospective cohort analysis of all patients undergoing new CIED implantation from Jan 2008 to Dec 2014 was conducted. Patient demographics, comorbidities, and timing of complications post CIED implantation were evaluated, and the timing of complications was divided into intra-operative, 0-6 h (h), 6 to 24 h, and > 24 h post-implant. One-year post-implant follow-up (FU) was performed in our CIED clinic. RESULTS: A total of 1868 patients (68% men, average age 70 years, 85% hypertension, 39% diabetes, 57% coronary artery disease, and average left ventricular ejection fraction (LVEF) 41%) received 703 (38%) pacemaker, 448 (24%) implantable cardioverter-defibrillator (ICD), 639 (34%) cardiac resynchronization therapy (CRT) devices, and 78 (4.2%) cardiac contractility modulation. A total of 199 (11%) patients experienced 214 complications. Most (75%) occurred > 24 h post-implantation (with a median of 7 days). At univariate analysis, complications occurred more often in patients with a lower LVEF, on anticoagulation/antiplatelet therapy, and undergoing ICD/CRT-D implantation (p < 0.05 for all). CONCLUSION: Most complications occur > 24 h after first time CIED implantation. Therefore, it might not be optimal to discharge patients in ≤ 24 h, unless extensive ambulatory monitoring for complications is available.

Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial.

BACKGROUND: In the treatment of de-novo coronary small vessel disease, drug-coated balloons (DCBs) are non-inferior to drug-eluting stents (DESs) regarding clinical outcome up to 12 months, but data beyond 1 year is sparse. We aimed to test the long-term efficacy and safety of DCBs regarding clinical endpoints in an all-comer population undergoing percutaneous coronary intervention. METHODS: In this prespecified long-term follow-up of a multicentre, randomised, open-label, non-inferiority trial, patients from 14 clinical sites in Germany, Switzerland, and Austria with de-novo lesions in coronary vessels <3 mm and an indication for percutaneous coronary intervention were randomly assigned 1:1 to DCB or second-generation DES and followed over 3 years for major adverse cardiac events (ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation [TVR]), all-cause death, probable or definite stent thrombosis, and major bleeding (Bleeding Academic Research Consortium bleeding type 3-5). Analyses were performed on the full analysis set according to the modified intention-to-treat principle. Dual antiplatelet therapy was recommended for 1 month after DCB and 6 months after DES with stable symptoms, but 12 months with acute coronary syndromes. The study is registered with ClinicalTrials.gov, NCT01574534 and is ongoing. FINDINGS: Between April 10, 2012, and Feb 1, 2017, of 883 patients assessed, 758 (86%) patients were randomly assigned to the DCB group (n=382) or the DES group (n=376). The Kaplan-Meier estimate of the rate of major adverse cardiac events was 15% in both the DCB and DES groups (hazard ratio [HR] 0·99, 95% CI 0·68-1·45; p=0·95). The two groups were also very similar concerning the single components of adverse cardiac events: cardiac death (Kaplan-Meier estimate 5% vs 4%, HR 1·29, 95% CI 0·63-2·66; p=0·49), non-fatal myocardial infarction (both Kaplan-Meier estimate 6%, HR 0·82, 95% CI 0·45-1·51; p=0·52), and TVR (both Kaplan-Meier estimate 9%, HR 0·95, 95% CI 0·58-1·56; p=0·83). Rates of all-cause death were very similar in DCB versus DES patients (both Kaplan-Meier estimate 8%, HR 1·05, 95% CI 0·62-1·77; p=0·87). Rates of probable or definite stent thrombosis (Kaplan-Meier estimate 1% vs 2%; HR 0·33, 95% CI 0·07-1·64; p=0·18) and major bleeding (Kaplan-Meier estimate 2% vs 4%, HR 0·43, 95% CI 0·17-1·13; p=0·088) were numerically lower in DCB versus DES, however without reaching significance. INTERPRETATION: There is maintained efficacy and safety of DCB versus DES in the treatment of de-novo coronary small vessel disease up to 3 years. FUNDING: Swiss National Science Foundation, Basel Cardiovascular Research Foundation, and B Braun Medical.

Life in the fast lane: clinical and immunohistological characteristics of tachycardia-induced cardiomyopathy-a retrospective study in 684 patients.

BACKGROUND: Tachycardia-induced cardiomyopathy (TCM) has been known for decades as a reversible form of non-ischemic cardiomyopathy. However, its mechanism and characteristics remain poorly understood. OBJECTIVES: This retrospective study investigated endomyocardial biopsy (EMB) samples from consecutive patients with TCM and compared them with samples from patients with dilated cardiomyopathy (DCM) and inflammatory cardiomyopathy (InCM). MATERIALS AND METHODS: A total of 684 patients (18 TCM, 170 DCM, 496 InCM) with recent-onset heart failure and reduced ejection fraction unrelated to valvular or ischemic heart disease were analyzed. RESULTS: In the TCM group, 81% were male, the mean age was 60 ± 13 years, and 94% had heart failure symptoms ≥2 New York Heart Association (NYHA) class. At baseline (BL), 78% had atrial fibrillation/flutter and 12% other forms of tachycardia or frequent extrasystole. The ventricular rate was higher compared to DCM and InCM patients (122 ± 25 versus 78 ± 21; p < 0.001). Mean ejection fraction at BL was lower compared to DCM and InCM (27 ± 12% versus 39.0 ± 14.6%; p = 0.001), but improved to a significantly greater extent during follow-up (FU) (20% versus 6%; p < 0.001). At FU, heart rate and presence of sinus rhythm were similar in all groups; 69% of TCM patients underwent cardioversion or ablation. Compared with DCM patients, TCM patients had stronger myocardial expression of major histocompatibility complex (MHC) class II and an equal amount of infiltration with T­cells/macrophages. Compared with InCM patients, the presence of T­cells/macrophages was significantly lower in TCM. The marker of apoptosis (caspase 3) was comparably elevated in TCM/InCM patients. CONCLUSION: Tachycardia-induced cardiomyopathy is characterized by immunohistological changes comparable to DCM except for caspase 3 levels, which were similar to those in InCM.

Decision regret in implantable cardioverter-defibrillator recipients : A cross-sectional analysis on patients that regret their decision after ICD implantation.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) are designed to deliver therapy in the event of malignant ventricular arrhythmias. Despite their benefits, some ICD recipients regret their decision on device implantation. OBJECTIVES: The aim of this study was to evaluate the incidence, predictors, and consequences of recipients that regretted their decision after implantation. METHODS: A questionnaire-based cross-sectional survey of consecutive ICD recipients examined during a routine outpatient follow-up visit was conducted. Their level of depression and anxiety was assessed with the hospital anxiety and depression scale (HADS). Quality of life (QOL) was assessed using the Minnesota living with heart failure questionnaire. RESULTS: Of 434 ICD recipients invited to the study, 423 (97.5%) agreed and completed the survey, 349 (83%) had a primary prevention indication, and 339 (80%) ischemic cardiomyopathy. A total of 41 recipients (9.7%) regretted their decision to undergo ICD implantation. These patients were: (1) younger (63 versus 69 years), (2) more frequently in New York Heart Association (NYHA) ≥2 functional class (63% versus 22%), (3) had higher education levels (more than high-school: 76% versus 60%), (4) felt that preoperative information was lacking (22% versus 4%), (5) had more complications in the perioperative period (15% versus 3%), (6) felt less safe after ICD implantation (54% versus 5%), and (7) considered more frequently ICD deactivation during near end-of-life situations (54% versus 29%). Mean QOL and HADS scores were significantly worse in these patients (36 versus 30 and 12 versus 8.8 points, respectively; p < 0.01 for all). CONCLUSION: Almost 10% of ICD recipients regretted their decision after implantation. Predictors included younger age, higher education levels, complicated perioperative period, and lack of preoperative information.

Drug-coated balloon versus drug-eluting stent in small coronary artery lesions: angiographic analysis from the BASKET-SMALL 2 trial.

BACKGROUND: The randomized BASKET-SMALL 2 trial showed non-inferiority for treatment with drug-coated balloon (DCB) compared with drug-eluting stents (DES) in patients undergoing percutaneous coronary intervention (PCI) for de novo lesions in small coronary arteries regarding clinical endpoints at 1 year. In this predefined substudy, we investigated the angiographic findings in patients undergoing a clinically indicated follow-up angiography during the study phase. METHODS: Eight-hundred and eighty-three patients underwent PCI with either DES or DCB in a culprit vessel < 3 mm in diameter for stable coronary artery disease or acute coronary syndrome. Event-driven re-angiographies and the corresponding images at baseline were analyzed for angiographic endpoints. RESULTS: One-hundred and eleven patients (117 lesions, 66 DES versus 51 DCB) presented for an unscheduled re-angiography at median 5.7 months after the index procedure. At baseline, mean reference vessel diameter was 2.05 mm and the residual in-segment stenosis after the index procedure was less in DES compared to DCB (23.7% vs 33.8%, p = 0.001). At follow-up angiography, diameter stenosis in the DES group (29.0%) was still somewhat smaller than after DCB angioplasty (35.8%) when adjusting for time since PCI (p = 0.047), whereas lumen loss (LL) did not differ between the two treatment arms (LL-DES 0.06 mm vs LL-DCB 0.10 mm, p = 0.20). Eight patients following DES implantation presented with a complete occlusion of the target lesion compared to no occlusion in the DCB group (p = 0.009). CONCLUSIONS: The clinically indicated follow-up angiography within 1 year showed no difference in LL. Complete thrombotic vessel occlusions were found only in the DES group. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov ; number, NCT01574534.

Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial.

AIMS: Drug-coated balloons (DCB) may avoid stent-associated long-term complications. This trial compared the clinical outcomes of patients with non-ST-elevation myocardial infarction (NSTEMI) treated with either DCB or stents. METHODS AND RESULTS: A total of 210 patients with NSTEMI were enrolled in a randomised, controlled, non-inferiority multicentre trial comparing a paclitaxel iopromide-coated DCB with primary stent treatment. The main inclusion criterion was an identifiable culprit lesion without angiographic evidence of large thrombus. The primary endpoint was target lesion failure (TLF; combined clinical endpoint consisting of cardiac or unknown death, reinfarction, and target lesion revascularisation) after nine months. Secondary endpoints included total major adverse cardiovascular events (MACE) and individual clinical endpoints. Mean age was 67±12 years, 67% were male, 62% had multivessel disease, and 31% were diabetics. One hundred and four patients were randomised to DCB, 106 to stent treatment. In the stent group, 56% of patients were treated with BMS, 44% with current-generation DES. In the DCB group, 85% of patients were treated with DCB only whereas 15% underwent additional stent implantation. During a follow-up of 9.2±0.7 months, DCB treatment was non-inferior to stent treatment with a TLF rate of 3.8% versus 6.6% (intention-to-treat, p=0.53). There was no significant difference between BMS and current-generation DES. The total MACE rate was 6.7% for DCB versus 14.2% for stent treatment (p=0.11), and 5.9% versus 14.4% in the per protocol analysis (p=0.056), respectively. CONCLUSIONS: In patients with NSTEMI, treatment of coronary de novo lesions with DCB was non-inferior to stenting with BMS or DES. These data warrant further investigation of DCB in this setting, in larger trials with DES as comparator (ClinicalTrials.gov Identifier: NCT01489449).