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.

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.

Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial.

BACKGROUND: Drug-coated balloons (DCB) are a novel therapeutic strategy for small native coronary artery disease. However, their safety and efficacy is poorly defined in comparison with drug-eluting stents (DES). METHODS: BASKET-SMALL 2 was a multicentre, open-label, randomised non-inferiority trial. 758 patients with de-novo lesions (<3 mm in diameter) in coronary vessels and an indication for percutaneous coronary intervention were randomly allocated (1:1) to receive angioplasty with DCB versus implantation of a second-generation DES after successful predilatation via an interactive internet-based response system. Dual antiplatelet therapy was given according to current guidelines. The primary objective was to show non-inferiority of DCB versus DES regarding major adverse cardiac events (MACE; ie, cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation) after 12 months. The non-inferiority margin was an absolute difference of 4% in MACE. This trial is registered with ClinicalTrials.gov, number NCT01574534. FINDINGS: Between April 10, 2012, and February 1, 2017, 382 patients were randomly assigned to the DCB group and 376 to DES group. Non-inferiority of DCB versus DES was shown because the 95% CI of the absolute difference in MACE in the per-protocol population was below the predefined margin (-3·83 to 3·93%, p=0·0217). After 12 months, the proportions of MACE were similar in both groups of the full-analysis population (MACE was 7·5% for the DCB group vs 7·3% for the DES group; hazard ratio [HR] 0·97 [95% CI 0·58-1·64], p=0·9180). There were five (1·3%) cardiac-related deaths in the DES group and 12 (3·1%) in the DCB group (full analysis population). Probable or definite stent thrombosis (three [0·8%] in the DCB group vs four [1·1%] in the DES group; HR 0·73 [0·16-3·26]) and major bleeding (four [1·1%] in the DCB group vs nine [2·4%] in the DES group; HR 0·45 [0·14-1·46]) were the most common adverse events. INTERPRETATION: In small native coronary artery disease, DCB was non-inferior to DES regarding MACE up to 12 months, with similar event rates for both treatment groups. FUNDING: Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, Basel Cardiovascular Research Foundation, and B Braun Medical AG.

Immediate unselected coronary angiography versus delayed triage in survivors of out-of-hospital cardiac arrest without ST-segment elevation: Design and rationale of the TOMAHAWK trial.

Patients experiencing out-of-hospital cardiac arrest (OHCA) without ST-segment elevation are a heterogenic group with a variety of underlying causes. Up to one-third of patients display a significant coronary lesion compatible with myocardial infarction as OHCA trigger. There are no randomized data on patient selection and timing of invasive coronary angiography after admission. METHODS AND RESULTS: The TOMAHAWK trial randomly assigns 558 patients with return of spontaneous circulation after OHCA with no obvious extracardiac origin of cardiac arrest and no ST-segment elevation/left bundle-branch block on postresuscitation electrocardiogram to either immediate coronary angiography or initial intensive care assessment with delayed/selective angiography in a 1:1 ratio. The primary end point is 30-day all-cause mortality. Secondary analyses will be performed with respect to initial rhythm, electrocardiographic patterns, myocardial infarction as underlying cause, neurological outcome, as well as clinical and laboratory markers. Clinical follow-up will be performed at 6 and 12 months. Safety end points include bleeding and stroke. CONCLUSION: The TOMAHAWK trial will address the unresolved issue of timing and general indication of angiography after OHCA without ST-segment elevation.

Patients' preferences for coronary bypass grafting or staged percutaneous coronary intervention in multi-vessel coronary artery disease.

BACKGROUND: The decision for coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in patients with multi-vessel coronary artery disease (mCAD) is currently made by a heart-team approach. Patients' preference is less well investigated. METHODS: All consecutive patients with prior CABG and at least 2 PCI procedures were interviewed whether they would elect bypass surgery or staged PCI in case of a hypothetical scenario in which they had mCAD and CABG or PCI will equally improve symptoms and survival. RESULTS: A total 213 patients were surveyed. About 21 (10%) patients had multiple CABG, and mean number of PCI per patient was 4.0 ± 2.7. Complications during CABG were reported in 19.7% and in 14% after PCI, respectively. About 15% experienced complications after both CABG and PCI, and 51% had no complications at all. Mean symptom-free period was 5.2 (following CABG) vs 1.8 years (following PCI); P<.001. Duration of recovery was significant shorter after PCI (mean 9.2 ± 1.2 vs 136.4 ± 57.9 days; P<.01). Based on their personal experience with both procedures, 15% of the participants elected CABG in the hypothetical scenario and 67% choose staged PCI, 18% were equally happy with either. More participants preferred PCI when age was ≥70, complications following CABG occurred, and when undergoing CABG first. Gender, number of CABG or PCI procedures per patient, and complications following PCI did not affect participants' preference. CONCLUSIONS: In our hypothetical scenario, the majority of participants preferred staged PCI over CABG. Preferences were related to age, complications following CABG, and whether CABG was performed first.

Interaction between shock coils increased the incidence of inappropriate therapies and lead failure in implantable cardioverter defibrillator.

AIMS: Shock coil interaction in patients with multiple implantable cardioverter defibrillator (ICD) leads is occasionally observed. We aimed to evaluate the incidence of shock coil interaction and its clinical relevance. METHODS AND RESULTS: All ICD patients (646 patients) who came to follow up control in our ICD ambulance between January 1, 2011, and December 31, 2011 in the department of cardiology in Bad Berka hospital were retrospectively evaluated in this study. All baseline demographic, clinical, and procedural characteristics and postoperative chest x ray in postero-anterior and lateral view as well as clinical and ICD follow up data were evaluated. Among 646 patients 42 had multiple ICD leads (6.5%) of whom 36 patients (5.5% of total cohort patients and 85.7% of patients with multiple ICD leads) had shock coil interaction and presented the study group (Group I). The control group (Group II) consisted of 610 patients without coil-coil interaction including patients with single shock lead (604 patients) or patients with multiple leads but without interaction between shock coils (6 patients). Inappropriate anti-tachycardia therapies and RV lead revisions were more frequent in patients with interaction between shock coils (Group I vs Group II: 27.7% and 5.7%; p = 0.049 and 30.6% vs 6.4; p = 0.0001, respectively). CONCLUSIONS: Interaction between shock coils may be one of possible causes of lead failure and resulted in inappropriate therapies and subsequent lead revision.

Effect of intraoperative local application of 3% hydrogen peroxide on pocket infections following cardiac implantable electronic device implantation: An observational study.

AIMS: The aim of this study was to analyze whether local application of 3% hydrogen peroxide (H2O2) additionally to standard antibiotic prophylaxis following implantation of cardiac implantable electronic devices (CIED) reduces the incidence of pocket infections (PI). METHODS: In this observational case-control study every patient from the group additionally treated with H2O2 was matched with two patients out of the control group for age, male-gender, body-mass-index and operation time. The incidence of PI within 365 days after device implantation was compared. RESULTS: During the 5-year study period, 429 consecutive patients were additionally treated with H2O2 and matched with 858 patients undergoing standard treatment (mean age 69 ±â€¯12 years, 876 males (67.4%), body-mass-index 28 ±â€¯4.0 kg/m2 and operation time 45 ±â€¯23 min). Except for a more frequent use of dual-platelet-inhibition in the H2O2-group, clinical characteristics were otherwise similar. A total of 23 (1.78%) PIs occurred, most of them (14/23; 61%) during the first 45 days after implantation procedure. The use of H2O2 was associated with a significant reduction (3/429 = 0.69% versus 20/858 = 2.33%; p = 0.04), although patients of the H2O2 treated group received more complex procedures increasing the risk of PI. CONCLUSION: Intraoperative local application of 3% H2O2 seems to be associated with a significant reduced incidence of PI following implantation of CIED. Because of its non-randomized character this trial should be considered as a hypothesis generating study.

Comparative Case-Control analysis of a dedicated self-expanding Biolimus A9-eluting Bifurcation stent versus provisional or mandatory side branch intervention strategies in the treatment of coronary bifurcation lesions.

BACKGROUND: In a number of coronary bifurcation lesions, both the main vessel and the side branch (SB) need stent coverage. OBJECTIVES: To analyze the procedural performance and the impact on radiation times (RT) and contrast medium consumption (CMC) of the Axxess™ stent system (Biosensors, Switzerland) treating de novo bifurcation lesions (DBL). METHODS: One hundred and ten consecutive prospectively enrolled cases (Axxess Group) and 110 age, sex, and lesion location matched controls undergoing mandatory (Group A, n = 56) or provisional (Group B, n = 54) SB intervention were analyzed. RESULTS: Although more pre-dilatation was performed in the Axxess Group (92.7% vs. 46.4% [Group A] vs. 24.1% [Group B]), and more stents were used (2.4 vs. 1.2 vs. 1.05), RT and CMC were significantly lower in the Axxess Group [7.9 min/129 ml vs. 14.2 min/209 ml vs. 7.8 min/152 ml; P < 0.001]. Final Thrombolysis In Myocardial Infarction three flow in both branches was significantly more frequent in the Axxess Group (98.2% vs. 94.6% vs. 88.9%; P = 0.02), and post-interventional troponin T elevations were the lowest in the Axxess Group. Eighty one percent of the Axxess-stents could be implanted without technical difficulties. Difficult implantations procedures were mainly related to coronary anatomy. There was no safety concerns (cardiac death, stent-thrombosis) compared to controls. Cumulative 6-months MACE rates were 11% versus 23% versus 25%. TLR rates at 6-months were 5%, 18%, and 15%, respectively. CONCLUSIONS: Axxess bifurcation stent system procedures were associated with significantly less RT and CMC compared to conventional DBL therapy strategies. Difficult coronary anatomy may hinder successful implantation and a learning curve has to be considered. © 2016 Wiley Periodicals, Inc.

Comorbidities and Complications in Nonagenarians Undergoing Coronary Angiography and Intervention.

Elderly people represent the fastest growing portion of cardiovascular patients. We aimed to analyze the clinical presentation, risk factors, co-morbidities, complications, and mortality in patients 90 years or more who underwent coronary angiography and intervention.We retrospectively studied 108 (0.25% of 43,385) consecutive patients ≥ 90 years undergoing cardiac catheterization and/or intervention in a tertiary specialist hospital between 2003 and 2014.Most patients (68.5%) were introduced on an emergency basis, especially with acute coronary syndrome (ACS) (63.8%). Non-STEMI accounted for two-thirds of the myocardial infarctions. We found higher prevalences of previous coronary artery disease (CAD) (38%), other atherosclerotic diseases (20.4%), cardiac risk factors such as hypertension (84.3%), diabetes (49.1%), hyperlipidemia (50.9%), heart failure (42.6%), atrial fibrillation (AF) (25.0%), severe aortic stenosis (13.0%), severe mitral regurgitation (3.7%), and implantable devices (25.0%), and co-morbidities such as renal impairment (48.1%), COPD (12.0%), and previous stroke (6.5%). Three-vessel disease was present in 34.6% of the patients. The left anterior descending artery (LAD) was the most affected coronary artery (67.6%). Percutaneous coronary intervention (PCI), mostly with bare metal stents (BMS), was used to manage 54.6% of the patients, and it failed in 4 of the patients. Conservative treatment was used in 39.8% of the patients and 15.7% had no significant CAD.The incidences of vascular complications, such as bleeding (6.5%), bleeding in other organs (6.5%), blood transfusion (6.5%), in-hospital paroxysmal atrial fibrillation (7.4%), in-hospital successful reanimation (2.8%), complete heart block (5.6%), acute renal impairment (23.1%), associated infection (25.9%), cardiogenic shock (14.8%), and death (15.7%) were high.Considering the more extensive risk factors, CAD and co-morbidities, acute presentation and age per se, we believe that the reported higher rates of complications and mortality are still acceptable.

Incidence, predictors, and outcome of inadvertent malposition of transvenous pacing or defibrillation lead in the left heart.

AIMS: Inadvertent lead malposition (ILM) in the left heart is a potential cause of thromboembolism and, therefore, a complication of heart rhythm device implantation [HRDI: pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT)]. The aim of the study was to report the incidence and clinical outcome of ILM. METHODS AND RESULTS: Postoperative lateral and posterior-anterior chest X-rays of all consecutive patients undergoing HRDI from 2007 through 2012 were retrospectively analysed. During the study period, 2579 patients underwent HRDI at our institution. ILM was present in six patients (0.34%, 50% male, mean age 71.5 ± 9.4 years). In one and four patients, malposition was in the left atrium and ventricle, respectively. In one case, the RV-lead was placed in a coronary sinus branch. In four patients, ILM was detected intra-operatively or in the early postoperative period. In the remaining two patients, malposition was not recognized and they suffered cerebral embolism 4 months and 1 year after implantation. ILM was corrected during the same hospital stay (four cases), or during follow-up by percutaneous extraction (two cases). Patients with ILM had significantly more scoliosis (16.7 vs. 0.17%; P = 0.01), congenital heart disease (CHD: 33.3 vs. 0.4%; P = 0.003), or prior surgery for CHD (16.7 vs. 0.5%; P = 0.03). The likelihood of ILM was also increased when HRDI was performed by an inexperienced operator (<100 HRDI; P < 0.01). CONCLUSION: The incidence of ILM was 0.34% in our series. Scoliosis, CHD, prior correction of CHD, and limited operator experience were identified as risk factors.

Incidence of ineffective safety margin testing (<10 J) and efficacy of routine subcutaneous array insertion during implantable cardioverter defibrillator implantation.

The purpose of this study was to assess (1) the incidence of safety margin testing <10 J (SMT) and (2) the efficacy/safety of routinely adding a subcutaneous array (SQA) (Medtronic 6996SQ) for these patients. Patients with SMT smaller than a 10-J safety margin from maximum output were considered to have very high readings and underwent SQA insertion. These patients were compared with the rest of the patients who had acceptable SMT (≥10 J). A total of 616 patients underwent ICD implantation during the analysis period. Of those, 16 (2.6%) had SMT <10 J. By univariate analysis, younger age, and non-ischemic cardiomyopathy, were all significant predictors of SMT <10 J (p < 0.05). In all 16 cases, other methods to improve SMT prior to array insertion were attempted but failed for all patients: reversing shock polarity (n = 15), removing the superior vena cava coil (n = 14), reprogramming shock waveform (n = 9), and repositioning right ventricular lead (n = 9). Addition of the SQA successfully increased SMT to within safety margin for all patients (32 ± 2 versus 21 ± 3 J; p < 0.001). Follow-up (mean 48.1 ± 21 months) was available for all patients with SQA, only 2 cases with inappropriate shocks due to atrial fibrillation had to be noted. None of the patients experienced complications due to SQA implantation. SMT <10 J occur in about 2.6% of patients undergoing ICD implantation. SQA insertion corrects this problem without procedural/mid-term complications.

Acute coronary syndrome without critical epicardial coronary disease: prevalence, characteristics, and outcome.

BACKGROUND: Absence of significant epicardial coronary artery stenosis in patients with acute onset of chest pain and elevation of myocardial necrosis markers is occasionally observed. The aim of this study was to retrospectively analyze the clinical characteristics and the outcome of such patients. METHODS: All patients with myocardial infarction (MI) but without significant coronary artery stenosis (≥50%) on angiography from May 2002 to April 2011 were compared with patients undergoing percutaneous coronary intervention due to non-ST-elevation MI (NSTEMI). RESULTS: Of 4311 consecutive patients with MI, 272 patients (6.3%) did not show significant coronary artery stenosis (group I) and were compared with 253 NSTEMI patients (group II). Younger age (61.9±14.0 vs 65.4±12.0 years; P=.003), female sex (49.3% vs 28.9%; P<.001), less severe anginal symptoms (Canadian Cardiovascular Society class III/IV 41.9% vs 49.8%; P=.05), lower level of myocardial necrosis marker (1.9±6.7 vs 27.4±68.7 ng/mL [troponin], 3.3±4 vs 14.2±20 mmol/L [creatine kinase]; P<.001 for both), and higher left ventricular ejection fraction (58.7%±12.6% vs 48.1%±12.4%; P<.01) were associated with group I patients. At a mean follow-up of 22.3±22.9 months, all-cause and cardiac mortality was lower in group I patients (4.9% vs 14.3%; and 2.9% vs 10.1%; P<.01, for both). Event-free survival was more frequent in group I patients (58.4% vs 28.8%; P<.0001) and inversely related to the troponin level. CONCLUSIONS: Absence of significant coronary stenosis accounts for a minority of patients presenting with MI and is associated with a better outcome compared to patients with NSTEMI, and the prognosis is inversely related to the troponin level.

Incidence of adverse cardiac events 5 years after polymer-free sirolimus eluting stent implantation: Results from the prospective Bad Berka Yukon Choice™ registry.

OBJECTIVES: Drug-eluting stents (DES) constitute a major achievement in preventing re-stenosis, concerns remain regarding the increased inflammatory responses associated with the polymers used. This analysis focuses on outcomes in patients receiving the polymer-free sirolimus-eluting stent system YUKON-Choice (Yukon-DES, Translumina, Germany). METHODS: From 01/2006-09/2008 all patients receiving Yukon-DES (≥2.5 mm diameter) were prospectively enrolled in our registry. The primary endpoint was long-term major adverse cardiac events (MACE). RESULTS: 701 patients were included in our registry. Mean age was 65.7 ± 10 years (73% male gender, 35.5% diabetes, and 32.2% acute coronary syndrome). 76% of the lesions were of Type B2/C. Lesion length was 24.6 ± 5.2 mm and mean stent diameter was 2.8 ± 0.4 mm. A total of 511 pts (72%) underwent 6-months angiographic follow-up, target vessel revascularization was noted in 23.5%. At 5 years clinical outcomes were: cardiac death 5.8%; myocardial infarction 3.4%; and TVR 24.6%. The incidence of MACE differed significantly between "on-label" and "off-label" indications (14.8% vs. 40.8% MACE; P < 0.001). Incidence of definitive/probable stent thrombosis (ST) was 1.14% (8/701); very late (>1 year) ST occurred in 0.29%. CONCLUSION: Our data suggests that the implantation of the sirolimus-coated polymer-free YUKON-DES is safe and feasible with a very low incidence of ST in this real world patient cohort with high percentage of diabetes and small vessels.

Characteristics and outcome of primary congenital left ventricular aneurysm and diverticulum: analysis of cases from the literature.

OBJECTIVE: Congenital left ventricular aneurysm (LVA) and diverticulum (LVD) are rare cardiac anomalies. We aimed to analyse the characteristics and long-term outcome of prenatal diagnosed patients with LVA/LVD. METHODS: We performed a systematic review of the literature to identify and analyse patients diagnosed prenatally with LVA/LVD. RESULTS: Twenty-six fetuses with prenatal diagnosis of LVA (50% male subjects) and 16 with LVD (38% male subjects) were identified. Fetal age at diagnosis was 23.8 ± 6.1 weeks. Mean maternal age was 30.6 ± 6.1 years old. LVA was larger (375 ± 237 vs 60 ± 71 mm(2); p = 0.002), and LVA/LVD was frequently observed in an apical location (62%). Associated cardiac/extracardiac defects were reported in 13/42 (31%). Symptomatic patients presented with arrhythmias (LVA 16% vs LVD 0%), hydrops fetalis (LVA 27% vs LVD 18.8%), or rupture (LVA 4% vs LVD 38%; p = 0.02). Size changes of the LVA/LVD during pregnancy were reported in 17%. Fetal death occurred in nine cases (21.4%); termination of pregnancy was performed in six cases (14.3%). All other babies were delivered at term. During follow-up (mean 29.1 ± 38.2 months), the rate of adverse events was significantly increased in patients with LVA (40 vs 0%; p = 0.04) CONCLUSION: The rate of fetal complications including fetal death is high. Long-term outcome among the survivors is significantly worse in patients with LVA.

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.

Incidence and predictors of pericardial effusion after permanent heart rhythm device implantation: prospective evaluation of 968 consecutive patients.

BACKGROUND: Pericardial effusion (PE) may complicate permanent heart rhythm device (HRD: pacemaker, implantable cardioverter-defibrillator, and cardiac resynchronization therapy) placement. Incidence of and risk factors for this complication have never been prospectively evaluated. METHODS AND RESULTS: The subjects of this prospective observational study were 968 consecutive patients undergoing HRD implantation or upgrade, and underwent echocardiographic evaluation before and 24h after the operation. PE was documented in 98 patients (10%), 14 (1.5%) of whom progressed to cardiac tamponade requiring pericardiocentesis (n=12; 86%) or surgical treatment (n=2; 14%). In 70% (10/14) of those patients a bloody effusion suggested cardiac perforation of an implanted lead; acute pericarditis was observed in the remaining 30% (4/14). At multivariate analysis, female gender (hazard ratio [HR], 2.7; 95% confidence interval [CI]: 1.4-3.5, P=0.01) was predictive in the case of any post-procedural PE, whereas intake of antiplatelet medication (HR, 3.1; 95% CI: 2.1-3.8, P=0.01) was predictive for cardiac tamponade. Previous cardiac surgery (HR, 0.70; 95% CI: 0.50-0.92, P=0.02) was a protective factor in any PE and cardiac tamponade. None of the 84 patients with small or moderate PE required pericardial drainage. After 3.1±0.5 months, a PE was no longer observed at echocardiography in 71% of those patients. CONCLUSIONS: PE is frequently seen after HRD implantation, but rarely requires any therapy. Female gender and antiplatelet therapy are risk factors, whereas previous cardiac surgery was a protective factor.

The Use of a Quadripolar Left Ventricular Lead Increases Successful Implantation Rates in Patients with Phrenic Nerve Stimulation and/or High Pacing Thresholds Undergoing Cardiac Resynchronisation Therapy with Conventional Bipolar Leads.

BACKGROUND: Phrenic nerve stimulation (PNS) and high pacing thresholds (HPT) hinder biventricular stimulation in patients (pts) undergoing cardiac resynchronization therapy (CRT). A new quadripolar left ventricular (LV) lead (Quartet 1458Q, St. Jude Medical) with increased number of pacing configuration, might overcome this problem. METHODS: All consecutive pts in whom a standard bipolar lead intraoperatively resulted in PNS and/or HPT (≥4.00V/1mV), received, during the same implant, a quadripolar LV lead. Aim of the study was to evaluate acute and short term outcome. RESULTS: 26 pts [24 (92%) male, mean age 74±6 years)] with PNS (22 pts; 85%) and HPT (4 pts; 15%) were included. Permanent right ventricular pacing was the reason for broad QRS complex in 4 (15%) pts, whereas all other pts had a left bundle branch block. Severely symptomatic (NYHA Class ≥3) heart failure with reduced ejection fraction (EF 31±9%) was mostly caused by ischemic heart disease (14 pts; 54%). Idiopathic dilated cardiomyopathy and valvular heart disease were diagnosed in 6 (23%) pts each. In most (24/26, 92%) pts the use of the Quartet lead led to successful biventricular pacing due to a significant reduction in intraoperative pacing threshold (5.2V/1.0ms vs. 1.4V/0.8ms; p=0.03), which was maintained (1.2V/0.7ms) at follow-up. PNS never represented reason for failed LV pacing, neither acutely nor during follow-up. CONCLUSION: Excessively HPT and/or PNS are frequently encountered when conventional bipolar leads are used for CRT. A new quadripolar LV lead increases the rate of successful biventricular stimulation. Lower pacing threshold and freedom from PNS are maintained at follow-up.

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.

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.