Operator decision-making in angiography-only guided revascularization for lesions not indicated for FFR: a QFR-based functional assessment in chronic coronary syndrome.

Background: Discordance between coronary angiographic findings and invasive functional significance is well-established. Yet, the prevalence of this mismatch in an era increasingly utilizing invasive functional assessments, such as fractional flow reserve (FFR), remains unclear. This study examines the extent of such discrepancies in current clinical practice. Methods: This single-center prospective registry included consecutive patients with chronic coronary syndrome (CCS) who underwent elective coronary angiography, with or without revascularization. Coronary angiograms deemed not requiring FFR due to clear anatomical distinctions, either anatomically severe indicating a need for revascularization or mild suggesting no need for intervention, were selected for evaluation. These were then subjected to post-hoc analysis by three independent operators who were blinded to the definitive treatment strategies. Importantly, the post-hoc analysis was conducted in two distinct phases: firstly, a re-evaluation of coronary stenosis, and secondly, a separate functional assessment, each carried out independently. Coronary stenosis severity was assessed visually, while functional relevance was determined by quantitative flow ratio (QFR), calculated using a computational fluid dynamics algorithm applied to angiographic images. Analysis focused on discrepancies between QFR-based functional indications and revascularization strategies actually performed. Results: In 191 patients, 488 vessels were analyzed. Average diameter stenosis (DS) was 37 ± 34%, and QFR was 0.87 ± 0.15, demonstrating a moderate correlation (r = -0.84; 95% CI: -0.86 to -0.81, p < 0.01). Agreement with QFR at conventional anatomical cutoffs was 88% for 50% DS and 91% for 70% DS. Mismatches between revascularization decisions and QFR indications occurred in 10% of cases. Discrepancies were more frequent in the left anterior descending artery (14%) compared to the left circumflex (6%) and the right coronary artery (9%; p = 0.07). Conclusion: In a cardiac-center where FFR utilization is high, discordance between coronary angiography and functional significance persists, even when operators are confident in their decisions not to use functional interrogation. This gap, most evident in the left anterior descending artery, highlights the potential need for integrated angiography-based functional assessments to refine revascularization decisions in CCS.

Changes in Lipoprotein(a) Levels in People after ST Elevation Myocardial Infarction-The STEMI-Lipids Study.

Lipoprotein(a) (Lp(a)) is considered an independent risk factor for cardiovascular diseases. The plasma concentration of Lp(a) is largely genetically determined but varies over a wide range within the population. This study investigated changes in Lp(a) levels after an acute myocardial infarction. Patients who underwent coronary angiography due to an ST elevation myocardial infarction were enrolled (n = 86), and Lp(a) levels were measured immediately after the intervention, one day, two days, and at a post-discharge follow-up visit at 3 to 6 months after the acute myocardial infarction. Median Lp(a) levels increased from a median of 7.9 mg/dL (3.8-37.1) at hospital admission to 8.4 mg/dL (3.9-35.4) on the following day, then to 9.3 mg/dL (3.7-39.1) on day two (p < 0.001), and to 11.2 mg/dL (4.4-59.6) at the post-discharge follow-up (p < 0.001). Lp(a) levels were the lowest during the acute myocardial infarction and started to increase significantly immediately thereafter, with the highest levels at the post-discharge follow-up. The moderate but significant increase in Lp(a) in people with acute myocardial infarction appears to be clinically relevant on an individual basis, especially when specific Lp(a) cut-off levels are supposed to determine the initiation of future treatment. Hence, a repeated measurement of Lp(a) after myocardial infarction should be performed.

Arterial stiffness and its influence on cerebral morphology and cognitive function.

Background: Recently, arterial stiffness has been associated with cerebral small vessel disease (SVD), brain atrophy and vascular dementia. Arterial stiffness is assessed via pulse wave velocity (PWV) measurement and is strongly dependent on arterial blood pressure. While circadian blood pressure fluctuations are important determinants of end-organ damage, the role of 24-h PWV variability is yet unclear. Objectives: We here investigated the association between PWV and its circadian changes on brain morphology and cognitive function in community-dwelling individuals. Design: Single-centre, prospective, community-based follow-up study. Methods: The study cohort comprised elderly community-based participants of the Austrian Stroke Prevention Family Study which was started in 2006. Patients with any history of cerebrovascular disease or dementia were excluded. The study consists of 84 participants who underwent ambulatory 24-h PWV measurement. White matter hyperintensity volume and brain volume were evaluated by 3-Tesla magnetic resonance imaging (MRI). A subgroup of patients was evaluated for cognitive function using an extensive neuropsychological test battery. Results: PWV was significantly related to reduced total brain volume (p = 0.013), which was independent of blood pressure and blood pressure variability. We found no association between PWV with markers of cerebral SVD or impaired cognitive functioning. Only night-time PWV values were associated with global brain atrophy (p = 0.005). Conclusions: This study shows a relationship of arterial stiffness and reduced total brain volume. Elevations in PWV during night-time are of greater importance than day-time measures.

May Measurement Month 2018-2019: an analysis of blood pressure screening results from Austria.

Arterial hypertension is a global burden leading to over 10.8 million deaths per year worldwide. May Measurement Month (MMM) is a global project initiated by the International Society of Hypertension to raise the awareness of high blood pressure (BP) in the population. Following the MMM protocol 2508 participants ≥18 years had their BP measured in Austria in MMM18 and MMM19. Of those screened, 54.6% were found to be hypertensive, defined as a BP ≥140/90 mmHg and/or being on treatment for hypertension. Among those individuals with hypertension, 56.1% were on medication but only 42.0% of those treated had controlled BP (<140/90 mmHg). Lower BPs were found in those with previous myocardial infarction (MI), probably explained by a medical monitoring system of patients with MI in Austria. Those with hypertension were referred for further medical investigations and were provided lifestyle advice. Among a high number of individuals receiving antihypertensive treatment, BP is still not controlled. Further screening and monitoring of therapeutic effects is urgently required.

How do type of preoperative P2Y12 receptor inhibitor and withdrawal time affect bleeding? Protocol of a systematic review and individual patient data meta-analysis.

INTRODUCTION: In order to reduce the risk of bleeding in patients on P2Y12 receptor inhibitors presenting for non-emergent coronary artery bypass grafting (CABG), current guidelines recommend a preoperative discontinuation period of at least three, five and seven days for ticagrelor, clopidogrel and prasugrel, respectively, to allow for recovery of platelet function. However, there is still substantial interinstitutional variation in preoperative management and relevant covariates of CABG-related bleeding are largely elusive so far. METHODS AND ANALYSIS: We will search PubMed (July 2013 to November 2021) and EMBASE (January 2014 to November 2021) using the following terms, MeSH terms and their synonyms: clopidogrel, prasugrel, ticagrelor, dual antiplatelet, P2Y12 receptor inhibitor, CABG, bleeding, haemorrhage. Two independent reviewers will screen all abstracts and full papers for eligibility. Disagreements will be solved by consulting with a third reviewer.The primary outcome is the incidence of Bleeding Academic Research Consortium type-4 bleeding depending on type of P2Y12 receptor inhibitor and preoperative withdrawal period. The secondary outcomes are mortality and ischaemic events according to the Academic Research Consortium 2 Consensus Document. We will perform an individual patient data meta-analysis (IPD-MA) with drug-specific preoperative withdrawal time and adjust for demographic and procedural variables. Subgroup analyses will be performed for anaemic patients and patients undergoing non-emergent versus urgent/emergent surgery. ETHICS AND DISSEMINATION: This IPD-MA consists of secondary analyses of existing non-identifiable data and meets the criteria for waiver of ethics review by the local Research Ethics Committee. Data sharing and transfer will be subject to a confidentiality agreement and a data use agreement. Findings will be disseminated through peer-reviewed publication and conference presentation. PROSPERO REGISTRATION NUMBER: CRD42022291946.

A case report of recurrent acute myocardial infarction and cardiac arrest due to aortic dissection secondary to IgG4-related aortitis.

Occlusion of the right coronary artery is a relatively rare complication of type A aortic dissection and an example of type 2 myocardial infarction (MI) as well but when it occurs, it may have a fatal result for the patient. Aortic pseudoaneurysms are local type A dissections with a restricted extent in which the majority of the aortic wall has been breached and luminal blood is held in only by a thin rim of the remaining wall, mainly purely the adventitia. They typically occur from iatrogenic trauma by interventional procedures or previous cardiac surgery. We present a case of a 56 years old patient who suffered an acute functional MI due to such pseudoaneurysm formed in the context of an undiagnosed aortitis. The etiology remained unclear until the surgical aortic prosthesis was deemed necessary, finding chronic IgG4 infiltrates in the aortic tissue. To our knowledge, this is the first case of IgG4-related aortitis causing functional MI and cardiogenic shock.

Lipid lowering therapy in primary and secondary prevention in Austria: are LDL-C goals achieved? : Results from the DA VINCI study.

BACKGROUND: Cardiovascular disease (CVD) is the most frequent cause of death in Austria. The European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines recommend intensive lipid lowering therapy (LLT) in patients at high or very high CV risk. Lipid management and achievement of low-density lipoprotein cholesterol (LDL-C) goals in Austria have not recently been assessed. METHODS: Subgroup analysis for Austria of a European 18 country, cross-sectional, observational study. Patients received LLT for primary (PP) or secondary prevention (SP). Data including LLT in the preceding 12 months and most recent LDL­C were collected during a single visit between June 2017 and November 2018. Achievement of the risk-based 2016 and 2019 ESC/EAS LDL­C goal while receiving stabilized LLT was assessed. RESULTS: A total of 293 patients were enrolled from 8 Austrian sites, of which 200 (PP = 104, SP = 96) received stabilized LLT at the LDL­C measurement date. Overall, 58% (71% PP, 43% SP) and 38% (52% PP, 23% SP) achieved the risk-based 2016 and 2019 goals, respectively. Most patients received moderate-intensity statin monotherapy (46%), while 34% used high-intensity statin monotherapy. Combination therapy of moderate/high-intensity statin with ezetimibe (12%), or proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors with statin ± ezetimibe (1%), was used infrequently. CONCLUSION: The current Austrian routine lipid management using mainly moderate-intensity or high-intensity statin monotherapy is insufficient to attain ESC/EAS guideline goals, in particular the more stringent 2019 recommendations, a situation comparable to other participating European countries. In addition to switching to and optimizing doses of high-intensity statins, a combination with ezetimibe or PCSK9 inhibitors will be needed in many cases.

Twenty-Four-Hour Central (Aortic) Systolic Blood Pressure: Reference Values and Dipping Patterns in Untreated Individuals.

Central (aortic) systolic blood pressure (cSBP) is the pressure seen by the heart, the brain, and the kidneys. If properly measured, cSBP is closer associated with hypertension-mediated organ damage and prognosis, as compared with brachial SBP (bSBP). We investigated 24-hour profiles of bSBP and cSBP, measured simultaneously using Mobilograph devices, in 2423 untreated adults (1275 women; age, 18-94 years), free from overt cardiovascular disease, aiming to develop reference values and to analyze daytime-nighttime variability. Central SBP was assessed, using brachial waveforms, calibrated with mean arterial pressure (MAP)/diastolic BP (cSBPMAP/DBPcal), or bSBP/diastolic blood pressure (cSBPSBP/DBPcal), and a validated transfer function, resulting in 144 509 valid brachial and 130 804 valid central measurements. Averaged 24-hour, daytime, and nighttime brachial BP across all individuals was 124/79, 126/81, and 116/72 mm Hg, respectively. Averaged 24-hour, daytime, and nighttime values for cSBPMAP/DBPcal were 128, 128, and 125 mm Hg and 115, 117, and 107 mm Hg for cSBPSBP/DBPcal, respectively. We pragmatically propose as upper normal limit for 24-hour cSBPMAP/DBPcal 135 mm Hg and for 24-hour cSBPSBP/DBPcal 120 mm Hg. bSBP dipping (nighttime-daytime/daytime SBP) was -10.6 % in young participants and decreased with increasing age. Central SBPSBP/DBPcal dipping was less pronounced (-8.7% in young participants). In contrast, cSBPMAP/DBPcal dipping was completely absent in the youngest age group and less pronounced in all other participants. These data may serve for comparison in various diseases and have potential implications for refining hypertension diagnosis and management. The different dipping behavior of bSBP versus cSBP requires further investigation.

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.

[Austrian Consensus on High Blood Pressure 2019]. / Österreichischer Blutdruckkonsens 2019.

Elevated blood pressure remains a major cause of cardiovascular disease, disability, and premature death in Austria, with suboptimal rates of detection, treatment and control also in recent years. Management of hypertension is a common challenge for physicians with different spezializations. In an attempt to standardize diagnostic and therapeutic strategies and, ultimately, to increase the rate of patients with controlled blood pressure and to decrease the burden of cardiovascular disease, 13 Austrian medical societies reviewed the evidence regarding prevention, detection, workup, treatment and consequences of high blood pressure in general and in various clinical scenarios. The result is presented as the first national consensus on blood pressure. The authors and societies involved are convinced that a joint national effort is needed to decrease hypertension-related morbidity and mortality in our country.

Efficacy and Safety of Ticagrelor Monotherapy in Patients Undergoing Multivessel PCI.

BACKGROUND: Data on optimal antiplatelet treatment regimens in patients who undergo multivessel percutaneous coronary intervention (PCI) are sparse. OBJECTIVES: This post hoc study investigated the impact of an experimental strategy (1-month dual antiplatelet therapy [DAPT] followed by 23-month ticagrelor monotherapy) versus a reference regimen (12-month DAPT followed by 12-month aspirin monotherapy) according to multivessel PCI. METHODS: The GLOBAL LEADERS trial is a prospective, multicenter, open-label, randomized controlled trial, allocating all-comer patients in a 1:1 ratio to either the experimental strategy or the reference regimen. The primary endpoint was the composite of all-cause death or new Q-wave myocardial infarction at 2 years. The secondary safety endpoint was Bleeding Academic Research Consortium type 3 or 5 bleeding. RESULTS: Among the overall study population (n=15,845), 3,576 patients (22.4%) having multivessel PCI experienced a significantly higher risk of ischemic and bleeding events at 2 years, compared to those having single-vessel PCI. There was an interaction between the experimental strategy and multivessel PCI on the primary endpoint (hazard ratio: 0.62; 95% confidence interval: 0.44 to 0.88; pinteraction = 0.031). This difference was largely driven by a lower risk of all-cause mortality. In contrast, the risk of Bleeding Academic Research Consortium type 3 or 5 bleeding was statistically similar between the 2 regimens (hazard ratio: 0.92; 95% confidence interval: 0.61 to 1.39; pinteraction = 0.754). CONCLUSIONS: Long-term ticagrelor monotherapy following 1-month DAPT can favorably balance ischemic and bleeding risks in patients with multivessel PCI. These findings should be interpreted as hypothesis-generating and need to be replicated in future dedicated randomized trials. (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-platelet Therapy After Stent Implantation; NCT01813435).

Functional status and life satisfaction of patients with stable angina pectoris in Austria.

OBJECTIVES: Although substantial progress in the treatment of stable angina pectoris (sAP) has been made, little is known about the functional status and quality of life (QoL) of patients in different healthcare systems. DESIGN AND METHODS: We undertook a survey using the Seattle Angina Questionnaire (SAQ) (five domains scored form 0-worst assessment to 100-best assessment) to assess symptoms, QoL (including limitation of activities), demographics, geographic distribution and individual disease data in patients with stable coronary artery disease in Austrian cardiology practices. RESULTS: A total of 660 patients with sAP with a mean age of 69.2 years were included. SAQ scores were 67.5±24.4 for physical limitation, 65.5±26.6 for angina stability, 79.3±23.2 for angina frequency, 86.3±16.2 for treatment satisfaction and 63.7±24.2 for overall QoL. Multiple regression identified male gender, but also female gender, Eastern Austrian residence and high body mass index as predictive factors for SAQ scoring. A total of 35.6% of the patients reported at least one desirable activity that was limited through AP symptoms. CONCLUSIONS: Activity and QoL assessments are in accordance with published literature: The number and the diversity of desired activities indicate the need to focus on patient's individual activity level to improve symptom management.

Blood pressure changes after renal denervation are more pronounced in women and nondiabetic patients: findings from the Austrian Transcatheter Renal Denervation Registry.

OBJECTIVES: Three recently published sham-controlled studies proved the efficacy of renal denervation (RDN) in hypertensive patients. The study presented here analyzed a nationwide multicentre registry database to clarify which patient subgroups benefit most from radiofrequency RDN. METHODS: This is a post hoc analysis from the multicentre Austrian Transcatheter Renal Denervation Registry hosted by the Austrian Society of Hypertension. We correlated change of SBP after RDN to sex and presence/absence of comorbidities. Univariable correlation and multiple linear regression analyses were performed. RESULTS: Two hundred and ninety-one patients (43% women, median age 64 years) undergoing RDN between April 2011 and September 2014 were included in this analysis. Mean baseline ambulatory 24 h BP (systolic/diastolic) was 150 ±â€Š18/89 ±â€Š14 mmHg and mean baseline office BP was 170 ±â€Š16/94 ±â€Š14 mmHg.After RDN, mean ambulatory 24 h BP reduction was 9 ±â€Š19/6 ±â€Š16 mmHg. The following features were associated with a good response to RDN: high baseline systolic ambulatory BP, high baseline diastolic office BP, female sex, absence of diabetes mellitus, and absence of peripheral artery disease. Multivariable analysis identified female sex and absence of diabetes mellitus as strongest predictors for ambulatory BP reduction, although those groups had the lowest baseline ambulatory BP. DISCUSSION: Ambulatory BP reductions after RDN were substantially more pronounced in female and in nondiabetic patients despite lower baseline BP. It is concluded that in terms of efficacy female patients and nondiabetic patients might benefit more from RDN.

Ranolazine: impact on quality of life in patients with stable angina pectoris, results from an observational study in Austria - the ARETHA AT study.

OBJECTIVE: Assessment of treatment routine and outcome for ranolazine in clinical practice as second-line treatment for stable angina pectoris (AP). DESIGN AND SETTING: Multicenter, prospective, uncontrolled, non-interventional study at 88 sites including internal specialists, cardiologists, pneumologists, angiologists and primary care practices in Austria. PARTICIPANTS: In this study 292 patients receiving ranolazine in the course of routine treatment on top of beta blockers or calcium channel blockers after failure of first-line therapy. MAIN OUTCOME MEASURES: Dosage and symptoms were recorded at two visits (at intervals of 12 weeks), complemented by treatment rationale and disease characteristics at baseline. Disease intensity was quantified by angina symptoms, nitrate use and by Canadian Cardiovascular Society (CCS) grading. Quality of life (QoL) was assessed through a 10-grade scale. Data were analyzed by descriptive statistics. RESULTS: Ranolazine was prescribed in order to improve exercise capacity (84.3%), reduce symptoms (83.2%) and reduce AP (77.1%). Of the patients 87.3% received the recommended starting dose of 375 mg and subsequent dose changes were reported for 39.8%. The number of AP attacks was reduced from 5.3 ± 4.5 to 0.8 ± 1.3 per week; nitrate use was reduced from 3.4 ± 4.1 to 0.4 ± 0.9 applications per week. Of the patients 94.0% reported improved exercise capacity and 93.7% reduced symptoms. For the majority of patients, the CCS improved from grade II to I and QoL improved accordingly. Of the patients 3 experienced adverse drug reactions and 95.5% continued ranolazine. CONCLUSION: In this real-world study, ranolazine was shown to be effective, safe and well tolerable. Symptoms of AP were improved, as illustrated by the reduced number of angina attacks, reduced rate of nitrate use, reduced CCS scores and improved QoL.

Thermic sealing in femoral catheterization: First experience with the Secure Device.

BACKGROUND: Devices currently used to achieve hemostasis of the femoral artery following percutaneous cardiac catheterization are associated with vascular complications and remnants of artificial materials are retained at the puncture site. The Secure arterial closure Device induces hemostasis by utilizing thermal energy, which causes collagen shrinking and swelling. In comparison to established devices, it has the advantage of leaving no foreign material in the body following closing. This study was designed to evaluate the efficacy and safety of the Secure Device to close the puncture site following percutaneous cardiac catheterization. METHODS: The Secure Device was evaluated in a prospective non-randomized single-center trial with patients undergoing 6 F invasive cardiac procedures. A total of 67 patients were enrolled and the device was utilized in 63 patients. Fifty diagnostic and 13 interventional cases were evaluated. Femoral artery puncture closure was performed immediately after completion of the procedure. Time to hemostasis (TTH), time to ambulation (TTA) and data regarding short-term and 30-day clinical follow-up were recorded. RESULTS: Mean TTH was 4:30 ± 2:15 min in the overall observational group. A subpopulation of patients receiving anticoagulants had a TTH of 4:53 ± 1:43 min. There were two access site complications (hematoma > 5 cm). No major adverse events were identified during hospitalization or at the 30 day follow-up. CONCLUSIONS: The new Secure Device demonstrates that it is feasible in diagnostic and interventional cardiac catheterization. With respect to safety, the Secure Device was non-inferior to other closure devices as tested in the ISAR closure trial.

Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial.

BACKGROUND: To describe the baseline characteristics of patients with heart failure and preserved left ventricular ejection fraction enrolled in the PARAGON-HF trial (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in HFpEF) comparing sacubitril/valsartan to valsartan in reducing morbidity and mortality. METHODS AND RESULTS: We report key demographic, clinical, and laboratory findings, and baseline therapies, of 4822 patients randomized in PARAGON-HF, grouped by factors that influence criteria for study inclusion. We further compared baseline characteristics of patients enrolled in PARAGON-HF with those patients enrolled in other recent trials of heart failure with preserved ejection fraction (HFpEF). Among patients enrolled from various regions (16% Asia-Pacific, 37% Central Europe, 7% Latin America, 12% North America, 28% Western Europe), the mean age of patients enrolled in PARAGON-HF was 72.7±8.4 years, 52% of patients were female, and mean left ventricular ejection fraction was 57.5%, similar to other trials of HFpEF. Most patients were in New York Heart Association class II, and 38% had ≥1 hospitalizations for heart failure within the previous 9 months. Diabetes mellitus (43%) and chronic kidney disease (47%) were more prevalent than in previous trials of HFpEF. Many patients were prescribed angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (85%), ß-blockers (80%), calcium channel blockers (36%), and mineralocorticoid receptor antagonists (24%). As specified in the protocol, virtually all patients were on diuretics, had elevated plasma concentrations of N-terminal pro-B-type natriuretic peptide (median, 911 pg/mL; interquartile range, 464-1610), and structural heart disease. CONCLUSIONS: PARAGON-HF represents a contemporary group of patients with HFpEF with similar age and sex distribution compared with prior HFpEF trials but higher prevalence of comorbidities. These findings provide insights into the impact of inclusion criteria on, and regional variation in, HFpEF patient characteristics. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01920711.

Drug-coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET-SMALL 2.

The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug-eluting stents (DES) have limited efficacy due to increased rates of instent-restenosis, mainly caused by late lumen loss. Drug-coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten-Effektivitäts Trial: Drug-Coated Balloons vs. Drug-Eluting Stents in Small Vessel Interventions (BASKET-SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty-eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target-vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long-term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long-term safety and efficacy for the treatment of SVD in a large all-comer population.

Pulsatile Hemodynamics Are Associated With Exercise Capacity in Patients With Exertional Dyspnea and Preserved Left Ventricular Ejection Fraction.

BACKGROUND: Pulsatile hemodynamics are associated with left ventricular filling pressures and diastolic dysfunction. We investigated their relationship with maximum workload and peak oxygen uptake (peak VO2) in patients with exertional dyspnea and preserved left ventricular ejection fraction (LVEF). METHODS: Radial waveforms from tonometry were processed with a transfer function, pulse wave analysis and wave separation analysis, yielding central aortic pressures and measures of forward (amplitude of forward wave-Pf) and reflected waves (augmentation index-AIx, augmentation pressure-AP, amplitude of backward wave-Pb) and their ratio (reflection magnitude). Aortic pulse wave velocity (aoPWV) was estimated with a validated formula from single-point waveforms. Ergospirometry for assessment of exercise capacity was performed on a bicycle ergometer, using a ramp protocol. RESULTS: Sixty-six patients were included (43 females; mean age 66 years; 83% hypertensives; mean body mass index 28.3 kg/m2). Mean peak VO2 was 17.0 ml/min/kg, mean achieved maximum workload 104.5 watts (80.9% of a reference population). Maximum workload and peak VO2 showed significant inverse relationships with AIx, AP, Pb, and aoPWV (r = -0.26 to -0.57). In multiple adjusted regression models, brachial and aortic pulse pressure, AP, Pf, Pb, and aoPWV were significant independent predictors of maximum workload, whereas AP, AIx75, Pf, Pb, and aoPWV were independently related to peak VO2. CONCLUSIONS: Pulsatile hemodynamics are independently associated with objective measures of exercise capacity in patients with normal LVEF.

Relationship Between 24-Hour Ambulatory Central Systolic Blood Pressure and Left Ventricular Mass: A Prospective Multicenter Study.

We investigated the relationship between left ventricular mass and brachial office as well as brachial and central ambulatory systolic blood pressure in 7 European centers. Central systolic pressure was measured with a validated oscillometric device, using a transfer function, and mean/diastolic pressure calibration. M-mode images were obtained by echocardiography, and left ventricular mass was determined by one single reader blinded to blood pressure. We studied 289 participants (137 women) free from antihypertensive drugs (mean age: 50.8 years). Mean office blood pressure was 145/88 mm Hg and mean brachial and central ambulatory systolic pressures were 127 and 128 mm Hg, respectively. Mean left ventricular mass was 93.3 kg/m2, and 25.6% had left ventricular hypertrophy. The correlation coefficient between left ventricular mass and brachial office, brachial ambulatory, and central ambulatory systolic pressure was 0.29, 0.41, and 0.47, respectively (P=0.003 for comparison between brachial office and central ambulatory systolic pressure and 0.32 for comparison between brachial and central ambulatory systolic pressure). The results were consistent for men and women, and young and old participants. The areas under the curve for prediction of left ventricular hypertrophy were 0.618, 0.635, and 0.666 for brachial office, brachial, and central ambulatory systolic pressure, respectively (P=0.03 for comparison between brachial and central ambulatory systolic pressure). In younger participants, central ambulatory systolic pressure was superior to both other measurements. Central ambulatory systolic pressure, measured with an oscillometric cuff, shows a strong trend toward a closer association with left ventricular mass and hypertrophy than brachial office/ambulatory systolic pressure. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01278732.