The use of venous blood gas in assessing arterial acid-base and oxygenation status - an analysis of aggregated data from multiple studies evaluating the venous to arterial conversion (v-TAC) method.

BACKGROUND: Several methods exist to reduce the number of arterial blood gases (ABGs). One method, Roche v-TAC, has been evaluated in different patient groups. This paper aggregates data from these studies, in different patient categories using common analysis criteria. RESEARCH DESIGN AND METHODS: We included studies evaluating v-TAC based on paired arterial and peripheral venous blood samples. Bland-Altman analysis compared measured and calculated arterial values of pH, PCO2, and PO2. Subgroup analyses were performed for normal, chronic hypercapnia and chronic base excess, acute hyper- and hypocapnia, and acute and chronic base deficits. RESULTS: 811 samples from 12 studies were included. Bias and limits of agreement for measured and calculated values: pH 0.001 (-0.029 to 0.031), PCO2 -0.08 (-0.65 to 0.49) kPa, and PO2 0.04 (-1.71 to 1.78) kPa, with similar values for all sub-group analyses. CONCLUSION: These data suggest that v-TAC analysis may have a role in replacing ABGs, avoiding arterial puncture. Substantial data exist in patients with chronic hypercapnia and chronic base excess, acute hyper- and hypocapnia, and in patients with relatively normal acid-base status, with similar bias and precision across groups and across study data. Limited data exist for patients with acute and chronic base deficits.

Use of coronary physiology to guide revascularization in clinical practice: results of the F(FR)2 registry.

BACKGROUND: Despite the recommendation of coronary physiology to guide revascularization in angiographically intermediate stenoses without established correlation to ischemia, its uptake in clinical practice is slow. AIMS: This study aimed to analyze the use of coronary physiology in clinical practice. METHODS: Based on a multicenter registry (Fractional Flow Reserve Fax Registry, F(FR)2, ClinicalTrials.gov identifier NCT03055910), clinical use, consequences, and complications of coronary physiology were systematically analyzed. RESULTS: F(FR)2 enrolled 2,000 patients with 3,378 intracoronary pressure measurements. Most measurements (96.8%) were performed in angiographically intermediate stenoses. Out of 3,238 lesions in which coronary physiology was used to guide revascularization, revascularization was deferred in 2,643 (78.2%) cases. Fractional flow reserve (FFR) was the most common pressure index used (87.6%), with hyperemia induced by an intracoronary bolus of adenosine in 2,556 lesions (86.4%) and intravenous adenosine used for 384 measurements (13.0%). The route of adenosine administration did not influence FFR results (change-in-estimate -3.1% for regression model predicting FFR from diameter stenosis). Agreement with the subsequent revascularization decision was 93.4% for intravenous and 95.0% for intracoronary adenosine (p = 0.261). Coronary artery occlusion caused by the pressure wire was reported in two cases (0.1%) and dissection in three cases (0.2%), which was fatal once (0.1%). CONCLUSIONS: In clinical practice, intracoronary pressure measurements are mostly used to guide revascularization decisions in angiographically intermediate stenoses. Intracoronary and intravenous administration of adenosine seem equally suited. While the rate of serious complications of wire-based intracoronary pressure measurements in clinical practice seems to be low, it is not negligible.

MEMS Technology in Cardiology: Advancements and Applications in Heart Failure Management Focusing on the CardioMEMS Device.

Heart failure (HF) is a complex clinical syndrome associated with significant morbidity, mortality, and healthcare costs. It is characterized by various structural and/or functional abnormalities of the heart, resulting in elevated intracardiac pressure and/or inadequate cardiac output at rest and/or during exercise. These dysfunctions can originate from a variety of conditions, including coronary artery disease, hypertension, cardiomyopathies, heart valve disorders, arrhythmias, and other lifestyle or systemic factors. Identifying the underlying cause is crucial for detecting reversible or treatable forms of HF. Recent epidemiological studies indicate that there has not been an increase in the incidence of the disease. Instead, patients seem to experience a chronic trajectory marked by frequent hospitalizations and stagnant mortality rates. Managing these patients requires a multidisciplinary approach that focuses on preventing disease progression, controlling symptoms, and preventing acute decompensations. In the outpatient setting, patient self-care plays a vital role in achieving these goals. This involves implementing necessary lifestyle changes and promptly recognizing symptoms/signs such as dyspnea, lower limb edema, or unexpected weight gain over a few days, to alert the healthcare team for evaluation of medication adjustments. Traditional methods of HF monitoring, such as symptom assessment and periodic clinic visits, may not capture subtle changes in hemodynamics. Sensor-based technologies offer a promising solution for remote monitoring of HF patients, enabling early detection of fluid overload and optimization of medical therapy. In this review, we provide an overview of the CardioMEMS device, a novel sensor-based system for pulmonary artery pressure monitoring in HF patients. We discuss the technical aspects, clinical evidence, and future directions of CardioMEMS in HF management.

Expanded application of wearable cardioverter defibrillators beyond current guidelines: proposal for a European register explained through single clinical scenarios.

The wearable cardioverter defibrillator (WCD) is becoming a more and more widely used instrument for the prevention of sudden cardiac death of patients either with a secondary prevention implantable cardioverter defibrillator indication or with a transient high risk of sudden cardiac death. Although clinical practice has demonstrated a benefit of protecting patients for a period as long as 3-6 months with such devices, the current European guidelines concerning ventricular arrhythmias and sudden cardiac death are still extremely restrictive in the patient selection in part because of the costs derived from such a prevention device, in part because of the lack of robust randomised trials.To illustrate expanded use cases for the WCD, four real-life clinical cases are presented where patients received the device slightly outside the established guidelines. These cases demonstrate the broader utility of WCDs in situations involving acute myocarditis, thyrotoxicosis, pre-excited atrial fibrillation and awaiting staging/prognosis of a lung tumour. The findings prompt expansion of the existing guidelines for WCD use to efficiently protect more patients whose risk of arrhythmic cardiac death is transient or uncertain. This could be achieved by establishing a European register of the patients who receive a WCD for further analysis.

Fusion Imaging of Non-Invasive and Invasive Cardiac Electroanatomic Mapping in Patients with Ventricular Ectopic Beats: A Feasibility Analysis in a Case Series.

In patients with premature ventricular contractions (PVCs), non-invasive mapping could locate the PVCs' origin on a personalized 3-dimensional (3D) heart model and, thus, facilitate catheter ablation therapy planning. The aim of our report is to evaluate its accuracy compared to invasive mapping in terms of assessing the PVCs' early activation zone (EAZ). For this purpose, non-invasive electrocardiographic imaging (ECGI) was performed using the Amycard 01C system (EP Solutions SA, Switzerland) in three cases. In the first step, a multichannel ECG (up to 224 electrodes) was recorded, and the dominant PVCs were registered. Afterward, a cardiac computed tomography (in two cases) or magnetic resonance imaging (in one case) investigation was carried out acquiring non-contrast torso scans for 8-electrode strip visualization and contrast heart acquisition. For the reconstructed epi/endocardial meshes of the heart, non-invasive isochronal maps were generated for the selected multichannel ECG fragments. Then, the patients underwent an invasive electrophysiological study, and the PVCs' activation was evaluated by a 3D mapping system (EnSite NavX Precision, Abbott). Finally, using custom-written software, we performed 3D fusion of the non-invasive and invasive models and compared the resulting isochronal maps. A qualitative analysis in each case showed the same early localization of the dominant PVC on the endocardial surface when comparing the non-invasive and invasive isochronal maps. The distance from the EAZ to the mitral or tricuspid annulus was comparable in the invasive/non-invasive data (36/41 mm in case N1, 73/75 mm in case N2, 9/12 mm in case N3). The area of EAZ was also similar between the invasive/non-invasive maps (4.3/4.5 cm2 in case N1, 7.1/7.0 cm2 in case N2, 0.4/0.6 cm2 in case N3). The distances from the non-invasive to invasive earliest activation site were 4 mm in case N1, 7 mm in case N2, and 4 mm in case N3. Such results were appropriate to trust the clinical value of the preoperative data in these cases. In conclusion, the non-invasive identification of PVCs before an invasive electrophysiological study can guide clinical and interventional decisions, demonstrating appropriate accuracy in the estimation of focus origin.

Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable-polymer coronary stent - five-year results of the TARGET All Comers randomised clinical trial.

BACKGROUND: In the prospective, multicentre, randomised TARGET All Comers study, percutaneous coronary intervention (PCI) with the FIREHAWK biodegradable-polymer sirolimus-eluting stent (BP-SES) was non-inferior to the durable-polymer everolimus-eluting stent (DP-EES) for the primary endpoint of target lesion failure (TLF) at 12 months. AIMS: We aimed to report the final study outcomes at 5 years. METHODS: Patients referred for PCI were randomised to receive either a BP-SES or DP-EES in a 1:1 ratio in 10 European countries. Randomisation was stratified by centre and ST-elevation myocardial infarction (STEMI) presentation, and clinical follow-up extended to 5 years. The primary endpoint was TLF (composite of cardiac death, target vessel myocardial infarction [MI], or ischaemia-driven target lesion revascularisation). Secondary endpoints included patient-oriented composite events (POCE; composite of all-cause death, all MI, or any revascularisation and its components). RESULTS: From December 2015 to October 2016, 1,653 patients were randomly assigned to the BP-SES or DP-EES groups, of which 93.8% completed 5-year clinical follow-up or were deceased. At 5 years, TLF occurred in 17.1% of the BP-SES group and in 16.3% of the DP-EES group (p=0.68). POCE occurred in 34.0% of the BP-SES group and 32.7% of the DP-EES group (p=0.58). Revascularisation was the most common POCE, occurring in 19.3% of patients receiving BP-SES and 19.2% receiving DP-EES, of which less than one-third was ischaemia-driven target lesion-related. In the landmark analysis, there were no differences in the rates of TLF and POCE between groups from 1 to 5 years, and these results were consistent across all subgroups. CONCLUSIONS: In an all-comers population requiring stent implantation for myocardial ischaemia, the BP-SES was non-inferior to the DP-EES for the primary endpoint of TLF at 12 months, and results were sustained at 5 years, confirming the long-term safety and efficacy of the FIREHAWK BP-SES.

Crystalline sirolimus-coated balloon (cSCB) angioplasty in an all-comers, patient population with stable and unstable coronary artery disease including chronic total occlusions: rationale, methodology and design of the SCORE trial.

BACKGROUND: A decade ago, the iopromide-paclitaxel coated balloon (iPCB) was added to the cardiologist's toolbox to initially treat in-stent restenosis followed by the treatment of de novo coronary lesions. In the meantime, DES technologies have been substantially improved to address in-stent restenosis and thrombosis, and shortened anti-platelet therapy. Recently, sirolimus-coated balloon catheters (SCB) have emerged to provide an alternative drug to combat restenosis. METHODS: The objective of this study is to determine the safety and efficacy of a novel crystalline sirolimus-coated balloon (cSCB) technology in an unselective, international, large-scale patient population. Percutaneous coronary interventions of native stenosis, in-stent stenosis, and chronic total occlusions with the SCB in patients with stable coronary artery disease or acute coronary syndrome were included. The primary outcome variable is the target lesion failure (TLF) rate at 12 months, defined as the composite rate of target vessel myocardial infarction (TV-MI), cardiac death or ischemia-driven target lesion revascularization (TLR). The secondary outcome variables include TLF at 24 months, ischemia driven TLR at 12 and 24 months and all-cause death, cardiac death at 12 and 24 months. DISCUSSION: Since there is a wealth of patient-based all-comers data for iPCB available for this study, a propensity-score matched analysis is planned to compare cSCB and iPCB for the treatment of de novo and different types of ISR. In addition, pre-specified analyses in challenging lesion subsets such as chronic total occlusions will provide evidence whether the two balloon coating technologies differ in their clinical benefit for the patient. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT04470934.

Impact of chronic coronary syndromes on cardiovascular hospitalization and mortality: the ESC-EORP CICD-LT registry.

AIMS: In Europe, global data on guideline adherence, geographic variations, and determinants of clinical events in patients with chronic coronary syndrome (CCS) remain suboptimal. The European Society of Cardiology (ESC) EURObservational Research Programme (EORP) Chronic Ischemic Cardiovascular Disease Long-Term (CICD-LT) registry is a prospective European registry, and was designed to describe the profile, management, and outcomes of patients with CCS across the ESC countries. METHODS AND RESULTS: We aimed to investigate clinical events at 1-year follow-up from the ESC EORP CICD-LT registry.One-year outcomes of 6655 patients from the 9174 recruited in this European registry were analysed. Overall, 168 patients (2.5%) died, mostly from cardiovascular (CV) causes (n = 97, 1.5%). Northern Europe had the lowest CV mortality rate, while southern Europe had the highest (0.5 vs. 2.0%, P = 0.04). Women had a higher rate of CV mortality compared with men (2.0 vs. 1.3%, P = 0.02). During follow-up, 1606 patients (27.1%) were hospitalized at least once, predominantly for CV indications (n = 1220, 20.6%). Among the population with measured low-density lipoprotein-cholesterol level at 1 year, 1434 patients (66.5%) were above the recommended target. Age, history of atrial fibrillation, previous stroke, liver disease, chronic obstructive pulmonary disease or asthma, increased serum creatinine, and impaired left ventricular function were associated with an increased risk of CV death or hospitalization. CONCLUSION: In the CICD registry, the majority of patients with CCS have uncontrolled CV-risk factors. The 1-year mortality rate is low, but these patients are frequently hospitalized for CV causes. Early identification of comorbidities may represent an opportunity for enhanced care and better outcomes.

His bundle pacing guided by automated intrinsic morphology matching is feasible in patients with narrow QRS complexes.

Pace mapping and visual comparison of the local pacing response with the intrinsic QRS morphology form the mainstay of His bundle pacing (HBP). We evaluated the performance of a surface lead morphology match algorithm for automated classification of the pacing response in patients with narrow intrinsic QRS undergoing electroanatomic mapping (EAM)-guided HBP. HBP was attempted in 43 patients. In 28 cases with narrow QRS, the EnSite AutoMap Module was used for automated assessment of the QRS morphology resulting from pace mapping in the His cloud area with either a diagnostic catheter or the His lead. An intrinsic morphology match score (IMS) was calculated for 1.546 QRS complexes and assessed regarding its accuracy and performance in classifying the individual pacing response as either selective HBP (S-HBP), nonselective HBP (NS-HBP) or right ventricular stimulation. Automated morphology comparison of 354 intrinsic beats with the individual reference determined a test accuracy of 99% (95% CI 98.96-99.04) and a precision of 97.99-99.5%. For His-lead stimulation, an IMS ≥ 89% identified S-HBP with a sensitivity, specificity and positive predictive value of 1.00 (0.99, 1.00) and a negative predictive value of 0.99 (0.98, 1.00). An IMS between 78 and < 89% indicated NS-HBP with a sensitivity and specificity of 1.00 (0.99, 1.00) and 0.99 (0.98, 1.00), respectively. IMS represents a new automated measure for standardized individual morphology classification in patients with normal QRS undergoing EAM-guided HBP.Clinical trial registration: NCT04416958.

Perioperative Sensor and Algorithm Programming in Patients with Implanted ICDs and Pacemakers for Cardiac Resynchronization Therapy.

BACKGROUND: ICDs and pacemakers for cardiac resynchronization therapy (CRT) are complex devices with different sensors and automatic algorithms implanted in patients with advanced cardiac diseases. Data on the perioperative management and outcome of CRT carriers undergoing surgery unrelated to the device are scarce. METHODS: Data from 198 CRT device carriers (100 with active rate responsive sensor) were evaluated regarding perioperative adverse (device-related) events (A(D)E) and lead parameter changes. RESULTS: Thirty-nine adverse observations were documented in 180 patients during preoperative interrogation, which were most often related to the left-ventricular lead and requiring intervention/reprogramming in 22 cases (12%). Anesthesia-related events occurred in 69 patients. There was no ADE for non-cardiac surgery and in pacemaker-dependent patients not programmed to an asynchronous pacing mode. Post-operative device interrogation showed significant lead parameter changes in 64/179 patients (36%) requiring reprogramming in 29 cases (16%). CONCLUSION: The left-ventricular pacing lead represents the most vulnerable system component. Comprehensive pre and post-interventional device interrogation is mandatory to ensure proper system function. The type of ICD function suspension has no impact on each patient's outcome. Precautionary activity sensor deactivation is not required for non-cardiac interventions. Routine prophylactic device reprogramming to asynchronous pacing appears inessential. Most of the CRT pacemakers do not require surgery-related reprogramming.

Minielectrode catheter technology for near zero-fluoroscopy substrate-guided ablation of typical atrial flutter.

BACKGROUND: MicroFidelity catheter technology may facilitate voltage-guided ablation by high-resolution electroanatomic mapping (HR-EAM) and precisely targeted energy application. OBJECTIVE: To evaluate the performance of minielectrode (ME) technology for zero-fluoroscopy substrate-guided cavotricuspid isthmus (CTI) ablation. METHODS: Eighty-two patients underwent near zero-fluoroscopy substrate-guided CTI ablation using a nonirrigated large-tip catheter with 3 MEs. The CTI was subdivided into 15 electroanatomic segments. Bipolar voltage maps were compared with ME signals. The outcome was compared with a historic cohort of 92 patients who underwent linear ablation. RESULTS: Compared with linear ablation, the substrate-guided approach was associated with an almost halved ablation duration (336 ± 228 vs 649 ± 409 seconds, P < .001), halved radiofrequency energy applied (14.2 ± 10.6 vs 28.6 ± 19.6 kJ, P < .001), and shorter procedure duration (60.8 ± 33.8 vs 76.3 ± 40.9 minutes, P = .008) limiting the extent of energy delivery to 22.7% of the CTI area. HR-EAM visualized 2.03 ± 0.88 conductive pathways with a diameter of 5.35 ± 1.98 mm. A higher number of ME-detected bundles and a larger channel diameter correlated with increased ablation requirements. In 97.6% of the voltage-guided and 88.0% of the linear procedures, fluoroscopy was not used. CONCLUSION: HR-EAM-based substrate-guided CTI ablation may improve procedural outcome compared with the linear approach. Enhanced identification of discrete conductive pathways correlates with ablation efficacy. The electroanatomic subdivision of the CTI into 15 segments was feasible and may improve the understanding and comparability of anatomic variants and ablation results. Independent of the ablation strategy, modern EAM technology enables safe zero-fluoroscopy procedures in the majority of cases.

Profile and treatment of chronic coronary syndromes in European Society of Cardiology member countries: The ESC EORP CICD-LT registry.

BACKGROUND: International guidelines recommend pharmacotherapy combinations for chronic coronary syndromes (CCSs) but medical management remains suboptimal. DESIGN: The CICD-LT registry is investigating short- and long-term outcomes and management in patients in European Society of Cardiology (ESC) member countries, in a longitudinal ESC EURObservational Research Programme aimed at improving CCS management. METHODS: Between 1 May 2015 and 31 July 2018, 9174 patients with previous ST-elevation myocardial infarction (STEMI), non-STEMI or coronary revascularisation, or other CCS, were recruited during a routine ambulatory visit or elective revascularisation procedure. Baseline clinical data were recorded and prescribed medications analysed at initial contact and discharge, and according to patient gender and age (<75 vs. ≥75 years). RESULTS: Poorly controlled cardiovascular risk factors, including current smoking (18.5%), obesity (33.9%), diabetes (25.8%), raised low-density lipoprotein cholesterol (73.3%) and persistent hypertension (24.7%), were common across all cohorts. At ambulatory visit or admission, the guidelines-recommended combination of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, beta-blocker, aspirin, statin and any antiplatelet agent was prescribed to 57.8% of patients with STEMI/NSTEMI. Differences in prescribing rates, including for combination therapies, were observed based on age and gender and persisted after adjustment for demographic factors. CONCLUSIONS: Cardiovascular risk factors were common in contemporary CCS patients and secondary prevention prescribing was suboptimal. Patients aged ≥75 years and, to some extent, female patients were less likely to receive guidelines-recommended drug combinations than younger and male patients. One- and two-year follow-up will study prescribing changes and associations between baseline characteristics/prescribing and subsequent clinical outcomes.

Evaluation of Mathematical Arterialization of Venous Blood in Intensive Care and Pulmonary Ward Patients.

BACKGROUND: Arterial blood gases are important when assessing acute or critically ill patients. Capillary blood and mathematical arterialization of venous blood have been proposed as alternative methods, eliminating pain and complications of arterial puncture. OBJECTIVES: This study compares the arterial samples, arterialized venous samples, and capillary samples in ICU and pulmonary ward patients. METHOD: Ninety-one adult patients with respiratory failure were included in the analysis. Arterial, peripheral venous, and mathematically arterialized venous samples were compared in all patients using Bland-Altman analysis, with capillary samples included in 36 patients. RESULTS: Overall for pH and PCO2, arterialized venous values, and in the subset of 36 patients, capillary values, compared well to arterial values and were within the pre-defined clinically acceptable differences (pH ± 0.05 and PCO2 ± 0.88 kPa). For PO2, arterialized or capillary values describe arterial with similar precision (PO2 arterialized -0.03, LoA -1.48 to 1.42 kPa and PO2 capillary 0.82, LoA -1.36 to 3 kPa), with capillary values underestimating arterial. CONCLUSIONS: Mathematical arterialization functions well in a range of patients in an ICU and ward outside the country of development of the method. Furthermore, accuracy and precision are similar to capillary blood samples. When considering a replacement for arterial sampling in ward patients, using capillary sampling or mathematical arterialization should depend on logistic ease of implementation and use rather than improved measurements of using either technique.

Impact of Different Geriatric Conditions on Choice of Therapy and In-Hospital Outcomes in Elderly Patients with Acute Coronary Syndrome.

INTRODUCTION: The clinical benefit of invasive therapy in elderly patients with acute coronary syndrome (ACS) remains unclear. Furthermore, the decision-making process to treat this growing patient group is also debatable. The purpose of this study was to assess the association between elderly ACS patients, the treatment choice and their in-hospital outcomes after non-ST-elevation (NSTE)-ACS in a consecutive series of patients >75 years of age. METHODS AND RESULTS: Consecutive patients >75 years presenting with NSTE-ACS in our hospital between July 2017 and July 2018 were included during the first 2 days of hospital admission. Demographic data, prior medical history and present medical condition were documented. During day 0 and day 2, geriatric assessments (Clinical Frailty Scale [CFS], Barthel index, Charlson comorbidity index, "timed up and go" test [TUG], Mini-Mental Status Test [MMS], Geriatric Depression Scale [GDS], SF-36 for quality of life, instrumental activities of daily living [IADL], Killip-score, Grace-score and Euro-score) were conducted. After 6 months, patients were re-evaluated. In 106 patients (mean age 81.9±5.3 years, 57% male gender), 68 patients (64%) were treated interventionally, and 38 patients had conservative treatment (36%). Patients treated with intervention were significantly younger (80.9±4.7 years vs 83.5±6.0 years, p=0.015), had a lower rate of prior cerebral events (17.6% vs 26.3%; p=ns) and suffered more often from chronic obstructive pulmonary disease (17.6% vs 34.2%; p=0.050). All other demographic variables were comparable between both groups. The composite clinical endpoint (death, re-infarction, bleeding) was reached in 7 patients (10.3%) of the invasive and in 2 patients (5.3%) of the conservative group. They were not significantly different between both groups. A frailty index, consisting of commonly used parameters of functional impairment in elderly patients, namely, MMS ≤2 at baseline, IADL ≤7, CFS ≥7 and age ≥85 years, significantly predicted conservative treatment. CONCLUSION: Effective revascularization techniques are still underused in patients of older age in the case of ACS. For decision-making, geriatric tests alone may not predict treatment in those patients, but the combination of different tests may better predict treatment and perhaps the clinical outcomes in those patients. Furthermore, frail patients are at higher risk for not receiving guideline recommended therapy.

High-density mapping-guided corrective HIS bundle pacing after failed CRT upgrade for persistent left superior vena cava.

In patients with persistent left superior vena cava (PLSVC), transvenous device implantation for cardiac resynchronization therapy (CRT) may be challenging. We present a complex case with successful, high-density electroanatomic mapping (EAM) guided corrective His bundle pacing (CHBP) following failed CRT upgrade in a patient with PLSVC, congenital heart disease, and pacing-associated heart failure. CHBP restored physiological conduction in left bundle branch block with complete conduction block leading to clinical improvement and cardiac remodeling. The presented case supports the growing evidence that EAM-guided CHBP may be considered a feasible alternative to conventional CRT when venous anatomy is not favorable for left ventricular lead implantation.

Endpoint selection for noninferiority percutaneous coronary intervention trials: a methodological description.

BACKGROUND: The objective of this review is to provide a practical update on endpoint selection for noninferiority (NI) studies in percutaneous coronary intervention studies. METHODS: A PubMed search was conducted for predefined terms to explore the use of NI designs and intrapatient comparisons to determine their current importance. Sample size calculations for the most frequently used endpoints with NI hypotheses were done to increase statistical awareness. RESULTS: Reported NI trials, with the most frequently chosen clinical endpoint of major adverse cardiac events (MACE), had NI margins ranging from 1.66% to 5.00%, resulting in patient populations of 400-1500 per treatment group. Clinical study endpoints comprising of MACE complemented with rates of bleeding complications and stent thrombosis (ST) are suggested to conduct a statistically and clinically meaningful NI trial. Study designs with surrogate endpoints amenable to intrapatient randomizations, are a very attractive option to reduce the number of necessary patients by about half. Comparative clinical endpoint studies with MACE and ST/bleeding rates to study a shortened dual antiplatelet therapy (DAPT) in coronary stent trials are feasible, whereas ST as the sole primary endpoint is not useful. CONCLUSIONS: Expanded composite clinical endpoints (MACE complemented by ST and bleeding rates and intrapatient randomization for selected surrogate endpoints) may be suitable tools to meet future needs in device approval, recertification and reimbursement.

2-Year Clinical Outcomes of an Abluminal Groove-Filled Biodegradable-Polymer Sirolimus-Eluting Stent Compared With a Durable-Polymer Everolimus-Eluting Stent.

OBJECTIVES: The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove-filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent. BACKGROUND: The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial. METHODS: The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. RESULTS: At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34). CONCLUSIONS: The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.

Quinidine-A legacy within the modern era of antiarrhythmic therapy.

Quinidine has a very long history as antiarrhythmic medication. The alkaloid has been used in the treatment of almost all cardiac arrhythmias, especially atrial fibrillation, since the early twentieth century. Despite decreases in clinical prescription over the last two decades, mainly due to side effects like pro-arrhythmia, leading to increased mortality and to the availability of newer anti-arrhythmic drugs and catheter ablation, Quinidine remains an invaluable drug in the modern era of antiarrhythmic therapy. We present a review of the pharmacological properties of quinidine and its pivotal therapeutic role in the treatment of life-threatening arrhythmic storms in patients with congenital arrhythmogenic syndromes like Brugada's syndrome, early repolarization syndrome, short QT syndrome and idiopathic ventricular fibrillation.

Differences of patients' perceptions for elective diagnostic coronary angiography and percutaneous coronary intervention in stable coronary artery disease between elderly and younger patients.

AIMS: There is limited evidence of the differences in expectations between elderly (≥80 years) and younger patients (<80 years) regarding treatment success of percutaneous coronary interventions (PCI). We conducted a survey in patients undergoing diagnostic coronary angiography (DA) and/or intervention (PCI) to identify differences in patient perceptions between elderly and younger patients. METHODS AND RESULTS: This is an all-comers study of consecutive patients who underwent DA and/or PCI. Patients were asked to fill out a questionnaire prior to DA/PCI. This questionnaire consisted of ten questions with potential patient expectations based on an increasing scale of importance from 0 to 5 which were related to the procedure (eg, extend life, decrease symptoms etc.) and the value of "hard" cardiac endpoints like death, stroke, acute myocardial infarction and target lesion revascularization for the patient. Among 200 patients (mean age 76.6±9.3 years, 60.5% male, ejection fraction 63.7%±13.2%), 100 patients (50%) were ≥80 years. For these elderly patients the questions "to remain independent," "to maintain mobility, so that I can maintain my current life," and "to prevent myocardial infarction" were rated highest. Regarding "hard" cardiac endpoints "to avoid PCI in the future" was rated lowest in younger and in elderly patients. Significant differences were found between the age groups with the items "to avoid myocardial infarction," "avoid heart insufficiency," "to extend my life" and "to maintain mobility so that I can maintain my current life" (P<0.001). CONCLUSIONS: In our survey we found significant differences in patient expectations between elderly and younger patients regarding the outcome of DA/PCI.