Acute cardiovascular events triggered by the COVID-19 pandemic-related stress in non-infected individuals. The Jordan COVID-19 Acute Cardiovascular Events (JoCORE) study.

The Corona Virus Disease 2019 (COVID-19) has become an unprecedented global public health crisis and a pandemic associated with vicarious psychosocial and economic stresses. Such stresses were reported to lead to behavioral and emotional disturbances in individuals not infected with the COVID-19 virus. It is largely unknown if these stresses can trigger acute cardiovascular events (CVE) in such individuals. Covid-19-neagtive adults presenting with acute myocardial infarction (AMI), cerebrovascular accident (CVA), or out-of-hospital cardiac arrest (OHCA) during the COVID-19 pandemic in Jordan from March 15, 2020 through March 14, 2021 were enrolled in the study if they reported exposure to psychosocial or economic stresses related to the pandemic lockdown. Of 300 patients enrolled (mean age 58.7 ± 12.9 years), AMI was diagnosed in 269 (89.7%) patients, CVA in 15 (5.0%) patients, and OHCA in 16 (5.3%) patients. Triggering events were psychosocial in 243 (81.0%) patients and economic stressors in 157 (52.3%) patients. The psychosocial stresses included loneliness, hopelessness, fear of COVID-19 infection, anger, and stress-related to death of a significant person. The economic stressors included financial hardships, job loss or insecurity, volatile or loss of income. Exposure to more than one trigger was reported in 213 (71.0%) patients. In-hospital mortality of the patients admitted for AMI or CVA was 2.1%, and none of the OHCA survived the event. The COVID-19 pandemic continues to be a source of significant psychosocial and economic hardships that can trigger life-threatening acute CVE among individuals not infected with the virus.

Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial.

BACKGROUND: Atrial fibrillation (AF) is a common arrhythmia in patients undergoing cardiac surgery and may result in significant morbidity and increased hospital stay. This study was conducted to determine if colchicine administered preoperatively to patients undergoing cardiac surgery and continued during hospitalization is effective in reducing the incidence of postoperative AF. METHODS: In this multicenter prospective randomized open-label study, consecutive patients with no history of AF and scheduled to undergo elective cardiac surgery (n = 360) were randomized to colchicine (n = 179) or no-colchicine (n = 181). Main exclusion criteria were history of AF or supraventricular arrhythmias or absence of sinus rhythm at enrolment, and contraindications to colchicine. Colchicine was orally administered 12 to 24 hours preoperatively and continued until hospital discharge. The primary efficacy end point was documented AF lasting more than 5 minutes. Safety end point was colchicine adverse effects. RESULTS: In-hospital mortality was 3.3%. The primary end point of AF occurred in 63 patients (17.5%): 26 (14.5%) in the colchicine group and 37 (20.5%) in the no-colchicine group (relative risk reduction 29.3% [P = .14]). Diarrhea occurred in 54 patients, 44 (24.6%) on colchicine and 10 (5.5%) on no-colchicine (P < .001). Diarrhea led to discontinuation of colchicine in 23 (52%) of the 44 patients. CONCLUSION: Colchicine administered preoperatively to patients undergoing cardiac surgery and continued until hospital discharge failed to significantly reduce the incidence of early postoperative AF. Diarrhea was the most common adverse effect of colchicine leading to its discontinuation in more than half of the patients with this adverse effect.

Outcomes following implantation of the Biolimus A9-eluting BioMatrix coronary stent: Primary analysis of the e-BioMatrix registry.

OBJECTIVES: To assess the safety and efficacy of Biolimus A9-eluting stents (BES, BioMatrix™ and BioMatrix Flex™) in routine clinical practice. BACKGROUND: The LEADERS randomized trial has documented equivalent efficacy and superior safety of the BES when compared to a first generation Sirolimus-eluting Cypher(TM) stent. METHODS: 5,472 patients from 57 centers, treated with BES, were enrolled in an international multicenter registry and followed clinically up to 2 years. RESULTS: Mean patient age was 63.2 ± 11 years, 24% of patients had diabetes, and 49.8% presented with an acute coronary syndrome. 99.3% of patients were discharged on dual antiplatelet therapy (DAPT), 83.3% remained on DAPT at 1 year and 30.6% at 2 years. The incidence of the composite primary end point [major adverse cardiac events (MACE) at 12 months] was 4.5% [cardiac death 0.9%, myocardial infarction 1.7%, clinically indicated target vessel revascularization (ci-TVR) 2.8%]. MACE incidence was 6.8% at 24 months (cardiac death 1.5%, myocardial infarction 2.4%, ci-TVR 4.3%). At 12 months, 32 patients (0.6%) had suffered at least one definite or probable stent thrombosis (ST), and 91 patients (1.7%) a major bleed (MB). Nine patients with ST (27.3%) and 7 patients with a MB (7.7%) died during the first year after the index procedure. Between 12 and 24 months after implantation, there were 18 (0.4%) additional MB and 8 (0.2%) additional ST. CONCLUSIONS: This large international cohort documents a low 12 and 24 months MACE incidence and a very low ST incidence in an unselected patient population undergoing BES implantation. The results are in keeping with those of the randomized controlled LEADERS trial. Even though ST with this stent was a rare event, it was still associated with significant mortality. MB remains a problem, and warrants improved tailoring of DAPT in recipients of drug eluting stents.

Atherosclerotic Cardiovascular Disease Novel and Traditional Risk Factors in Middle Eastern Young Women. The ANCORS-YW Study.

Background: There is paucity of data on the prevalence of novel and traditional cardiovascular risk factors in young women with atherosclerotic cardiovascular disease (ASCVD) in the Middle East. We sought to evaluate clinical profiles and prevalence of novel and traditional risk factors in Middle Eastern young women with ASCVD compared with age-matched controls. Methods: Women 18-50 years of age who have ASCVD were enrolled and each was aged-matched with two women with no ASCVD. Prevalence of novel and traditional risk factors was compared in the two groups. Multivariable analyzes examined the independent association of 16 factors with ASCVD. Results: Of 627 young women enrolled mean age 44.1 ± 5.2 years; 209 had ASCVD and 418 served as controls. Women with ASCVD had significantly higher prevalence of five of the studied traditional risk factors (hypertension, type 2 diabetes [T2D], smoking, low-density lipoprotein cholesterol serum levels, and family history of premature ASCVD [FHx]) than women with no ASCVD. Additionally, of the 11 novel and psychosocial risk factors studied, four showed significantly higher prevalence in young women with ASCVD (preterm delivery, hypertensive disease of pregnancy gestational diabetes, and low level of education). Multivariable analyzes showed hypertension, T2D, smoking, FHx, persistent weight gain after pregnancy and low level of education were independently associated with ASCVD. Conclusions: In this study of young Middle Eastern women; traditional risk factors as well as persistent weight gain after pregnancy were more prevalent in women with ASCVD compared with controls.The study is registered with ClinicalTrials.gov, unique identifier number NCT04975503.

The Intersection of Atrial Fibrillation and Coronary Artery Disease in Middle Eastern Patients. Analysis from the Jordan Atrial Fibrillation Study.

Background: There is a scarcity of clinical studies which evaluate the association of atrial fibrillation (AF) and coronary artery disease (CAD) in the Middle East. The aim of this study was to evaluate the impact of CAD on baseline clinical profiles and one-year outcomes in a Middle Eastern cohort with AF. Methods: Consecutive AF patients evaluated in 29 hospitals and cardiology clinics were enrolled in the Jordan AF Study (May 2019-December 2020). Clinical and echocardiographic features, use of medications and one-year outcomes in patients with AF/CAD were compared to AF/no CAD patients. Results: Of 2020 AF patients enrolled, 216 (10.7%) had CAD. Patients with AF/CAD were more likely to be men and had significantly higher prevalence of hypertension, diabetes, dyslipidemia, heart failure and chronic kidney disease compared to the AF/no CAD patients. They also had lower mean left ventricular ejection fraction and larger left atrial size. Mean CHA2DS2 VASc and HAS-BLED scores were higher in AF/CAD patients than those with AF/no CAD (4.3 ± 1.7 vs. 3.6 ± 1.8, p < 0.0001) and (2.0 ± 1.1 vs. 1.6 ± 1.1, p < 0.0001), respectively. Oral anticoagulant agents were used in similar rates in the two groups (83.8% vs. 82.9%, p = 0.81), but more patients with AF/CAD were prescribed additional antiplatelet agents compared to patients with AF/no CAD (73.7% vs. 41.5%, p < 0.0001). At one year, AF/CAD patients, compared to AF/no CAD patients had significantly higher hospitalization rate (39.4% vs. 29.2%, p = 0.003), more acute coronary syndrome and coronary revascularization (6.9% vs. 2.4%, p = 0.004), and higher all-cause mortality (18.5% vs. 10.9%, p = 0.002). Conclusions: In this cohort of Middle Eastern patients with AF, one in 10 patients had CAD. The coexistence of AF and CAD was associated with a worse baseline clinical profile and one-year outcomes. Clinical study registration: the study is registered on clinicaltrials.gov (unique identifier number NCT03917992).

Coexistence of Standard Modifiable, Other Classical, and Novel and Classical Atherosclerotic Cardiovascular Disease Risk Factors in Middle Eastern Young Women.

Background: The coexistence of multiple standard modifiable risk factors (SMuRFs),classical and novel risk factors (RFs) for atherosclerotic cardiovascular disease (ASCVD) is common in the Middle East (ME). There is a paucity of data on the coexistence of these RFs in ME young women. Aim: Comparing the prevalence and the statistical patterns of the SMuRFs, classical and novel RFs in target population. Methods: In this case-control (1:2) study, consecutive young women aged 18-50 years were enrolled in 12 centers (July 2021 to October 2023). Prevalence and coexistence of 19 RFs were compared between cases with ASCVD and their controls. The RFs included SMuRFs (hypertension, type 2 diabetes, dyslipidemia, and cigarette smoking), other classical RF (obesity, family history of premature ASCVD, and physical inactivity), novel RFs and social determinants of health (health insurance, place of residence, depression, and level of education). Results: The study included 627 subjects; 209 had ASCVD (median age 46 years, IQR 49-42 years) and 418 controls (median age 45 years, IQR 48-41 years). The presence of 1-2 RFs; (ASCVD: 63.2%, Control: 54.1%, p=0.037) and 3-4 RFs; (ASCVD: 27.8%, Control: 3.3%, p < 0.001) SMuRFs was more prevalent in women with ASCVD. Similarly, the presence of 4-5 RFs; (ASCVD: 40.7%, Control: 14.6%, p<0.001), and 6-7 (ASCVD: 10.5%, Control: 1%, p < 0.001). The classical RF were also significantly common in these women. The distribution of multiple novel RF was not statistically significant across both groups. Finally, regarding the socioeconomic RFs in women with ASCVDs, the presence of 1-2 RFs (ASCVD: 59.8%, Control: 76.1%, p < 0.001) was significantly less common while the presence of 3-4 RFs (ASCVD: 39.2%, Control: 21.8%, p < 0.001) was vastly more common. Conclusion: An elevated rate of coexistence of classical RF in the case group, mainly socioeconomic and SMuRFs. By managing them primary and secondary ASCVDs prevention attained.

Protocolized Natriuresis-Guided Decongestion Improves Diuretic Response: The Multicenter ENACT-HF Study.

BACKGROUND: The use of urinary sodium to guide diuretics in acute heart failure is recommended by experts and the most recent European Society of Cardiology guidelines. However, there are limited data to support this recommendation. The ENACT-HF study (Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure) investigated the feasibility and efficacy of a standardized natriuresis-guided diuretic protocol in patients with acute heart failure and signs of volume overload. METHODS: ENACT-HF was an international, multicenter, open-label, pragmatic, 2-phase study, comparing the current standard of care of each center with a standardized diuretic protocol, including urinary sodium to guide therapy. The primary end point was natriuresis after 1 day. Secondary end points included cumulative natriuresis and diuresis after 2 days of treatment, length of stay, and in-hospital mortality. All end points were adjusted for baseline differences between both treatment arms. RESULTS: Four hundred one patients from 29 centers in 18 countries worldwide were included in the study. The natriuresis after 1 day was significantly higher in the protocol arm compared with the standard of care arm (282 versus 174 mmol; adjusted mean ratio, 1.64; P<0.001). After 2 days, the natriuresis remained higher in the protocol arm (538 versus 365 mmol; adjusted mean ratio, 1.52; P<0.001), with a significantly higher diuresis (5776 versus 4381 mL; adjusted mean ratio, 1.33; P<0.001). The protocol arm had a shorter length of stay (5.8 versus 7.0 days; adjusted mean ratio, 0.87; P=0.036). In-hospital mortality was low and did not significantly differ between the 2 arms (1.4% versus 2.0%; P=0.852). CONCLUSIONS: A standardized natriuresis-guided diuretic protocol to guide decongestion in acute heart failure was feasible, safe, and resulted in higher natriuresis and diuresis, as well as a shorter length of stay.

Clinical Features and Impact on One Year Prognosis of Prescribing Low Doses of Direct Oral Anticoagulant Agents in a Middle Eastern Population with Atrial Fibrillation: Analysis from the Jordan Atrial Fibrillation Study.

Introduction: Direct oral anticoagulant agents (DOACs) are indicated for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). Reduced doses of DOACs are indicated in patients who have renal impairment and according to age and weight criteria. The aim of this study was to investigate the frequency, clinical factors, and impact on 1-year prognosis of underdosing DOACs. Methods: Data of patients enrolled in the Jordan AF (JoFib) study and who were followed for 1 year was used to compare patients prescribed standard dose with those who were underdosed. Results: There were 672 patients (76.2%) who were prescribed standard dose and 210 patients (23.8%) who were underdosed. Baseline characteristics were similar between the 2 groups. Factors associated with underdosing were enrollment from an outpatient vs hospital site, moderate- or high-risk HAS-BLED score, an abnormal left ventricular ejection fraction (LVEF <50%), a history of heart failure, or current use of diuretics. At 1 year, the incidence of all-cause mortality was 12.2% in standard dose vs 13.3% in the underdose group (P = .82), stroke or systemic embolism was 3.6% in the standard dose vs 3.8% in the underdose group (P = .67), and major bleeding was 2.2% in the standard dose vs 3.3% in the underdose group (P = .35). Conclusions: About (25%) of patients were underdosed. Factors associated with underdosing were outpatient (vs hospital) center enrollment, moderate- or high-risk HAS-BLED score, abnormal LVEF (<50%), history of heart failure, and current use of diuretics. There were no significant differences in the incidence of adverse events of mortality and major morbidity at 1-year follow-up between the standard dose and the underdose groups.

Demographics and Risk Profile of Elderly Middle Eastern Patients with Atrial Fibrillation: The Jordan Atrial Fibrillation (JoFib) Study.

Background: Atrial fibrillation (AF) is the most common arrhythmia that is associated with high morbidity and mortality. The prevalence of AF increases with age and the elderly constitute a vulnerable cohort for higher stroke and bleeding complications. Methods: A total of 2163 adult consecutive patients with AF in 19 hospitals and 11 outpatient clinics in Jordan were enrolled in the Jordan AF study from May 2019 to January 2021. The clinical characteristics, demographics, and risk profiles of the elderly patients (≥80 years old) were compared to the younger patients (<80 years old). Results: Of 2163 patients, 379 (17.5%) constituted the elderly group. The elderly group had higher prevalence of hypertension (79.9% vs 73.5%, p=0.01), lower prevalence of smoking (5.0% vs 15.2%, p<0.001) and lower body mass index (28.1 ± 5.5 kg/m2 vs 29.8 ± 6.2 kg/m2, p<0.001) compared with younger patients. They also had more strokes or systemic emboli (25.6% vs 14.7%, p<0.001), heart failure (30.3% vs 22.9%, p=0.002), pulmonary hypertension (30.6% vs 24.8%, p=0.02), and chronic kidney disease (13.5% vs 8.3%, p=0.002). The elderly cohort had higher mean CHA2DS2-VASc (5.0 ± 1.5 vs 3.6 ± 1.8, p<0.001) and HAS-BLED scores (2.2 ± 1.1 vs 1.5 ± 1.1, p<0.001) compared to younger group. Among 370 elderly with non-valvular AF (NVAF), oral anticoagulant agents (OACs) were prescribed for 278 (84.2%) of eligible high-risk patients. Of the 1402 younger patients with NVAF, OACs were prescribed for 1133 (84.3%) of eligible patients. Direct oral anticoagulant agents (DOACs) were more frequently used in the elderly compared to the young (72.3% vs 62.3%, p<0.001). Conclusion: Elderly Middle Eastern AF patients have worse baseline clinical profiles and higher risk scores compared to younger patients. The majority of the elderly were prescribed guideline directed OACs, with higher use of DOACs than the younger cohort. Clinical Studies Registration: The study is registered on clinicaltrials.gov (unique identifier number NCT03917992).

Surviving a Decade or More after Coronary Revascularization in a Middle Eastern Population: The Impact of Diabetes Mellitus.

Introduction: Studies that evaluate Middle Eastern patients who have long-term survival after coronary artery revascularization are scarce. The prevalence of diabetes mellitus (DM) is high and rapidly increasing in our region. Methods: The study enrolled consecutive ambulatory or in-patients who had percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery at least 10 years earlier. Collected data included cardiovascular risk factors at the time of the index revascularization and evolution of risk factors since then, the occurrence of cardiovascular events, and the need for coronary revascularization after the index procedure. Events were compared between patients with DM and no DM at baseline. Results: The study population consisted of 891 consecutive patients with 351 patients (39.4%) had DM and 540 patients (60.6%) had no DM. The mean age at baseline was 53.9 ± 8.8 years for DM patients and 53.0 ± 9.8 years for no DM patients (P = 0.16). At baseline, the DM group had more hypertension (70.9% vs. 27.6%, P < 0.0001), more dyslipidemias (12% vs. 5.2%, P = 0.001) but less smokers compared to no DM group (44.4% vs. 58.3%, P < 0.001). DM and no DM groups had similar proportion of PCI (65.5% vs. 68.3%, P = 0.42) and CABG (34.5% vs. 31.7%, P = 0.43) at baseline. Following the index revascularization procedure, acute coronary events, heart failure, and stroke developed in similar proportions in the two groups. Repeat revascularization after the index procedure showed that the DM group had more PCI compared to no DM group (52.7% vs. 45.4%, P = 0.04) but similar proportions of CABG (7.1% vs. 9.8%, P = 0.20). Conclusions: In this retrospective observation of Middle Eastern patients who survived at least a decade after coronary revascularization, the DM group had more hypertension and dyslipidemias but fewer smokers compared to no DM at baseline. During follow-up, the DM group required more PCI revascularization compared with no DM group.

One-Year Clinical Outcome in Middle Eastern Patients with Atrial Fibrillation: The Jordan Atrial Fibrillation (JoFib) Study.

Background: Prevention of stroke and systemic embolism (SE) prevention in patients with atrial fibrillation (AF) has radically changed in recent years. Data on contemporary utilization of oral anticoagulants (OACs) and cardiovascular outcome in Middle Eastern patients with AF are needed. Methods: The Jordan atrial fibrillation (JoFib) study enrolled consecutive patients with AF in Jordan from May 2019 through October 2020 and were followed up for one year after enrollment. Results: Overall, 2020 patients were enrolled. The mean age was 67.9 + 13.0 years. Nonvalvular (NVAF) was diagnosed in 1849 (91.5%) patients. OACs were used in 85.7% of high-risk patients with NVAF (CHA2DS2-VASc score>3 in women, and>2 in men), including direct OACs (DOACs) in 64.1% and vitamin K antagonists (VKA) in 35.9%. Adherence rate to the use of the same OAC agent was 90.6% of patients. One-year cardiovascular (CV) mortality was 7.8%, stroke/SE was 4.5%, and major bleeding events were 2.6%. Independent predictors for all-cause mortality in patients with NVAF were age>75 years, heart failure, major bleeding event, type 2 diabetes mellitus, study enrollment as an in-patient, and coronary heart disease. The use of OACs was associated with lower all-cause mortality. The strongest independent predictors for stroke/SE were high-risk CHA2DS2-VASc score and prior history of stroke. Conclusions: This study of Middle Eastern AF patients has reported high adherence to OACs. The use of OACs was associated with a lower risk for all-cause mortality. One-year rates of stroke and major bleeding events were comparable to those reported from other regions in the world.

COVID-19 Pandemic and Volume of Cardiac Catheterization Procedures in Jordan: Impact of Strict Lockdown.

INTRODUCTION: Global surge of COVID-19 forced most countries to impose variable measures to curb the disease. Jordan imposed one of the strictest lockdowns from mid-March through April 2020. Hospitals deferred elective cardiac catheterization procedures and most of those performed during that period were limited to urgent presentations. Our purpose is to evaluate the impact of strict lockdown on cardiac catheterization procedural volume. METHODS AND RESULTS: We collected data about the numbers of all coronary angiography (CA) and percutaneous coronary intervention (PCI) procedures performed in 5 tertiary care hospitals in Amman, Jordan, from January through June 2020. We compared the volume of procedures performed in April 2020 (the strict lockdown month) to the corresponding period of prior year (April 2019) and to volumes performed prior to the lockdown in January-February 2020.There was a 64% decline in CA and PCI volumes in April 2020 compared to April 2019. Comparing number of procedures performed in April 2020 to those in January-February 2020, there was 59% decline in CA and a 60% decline in PCI volumes. Following partial lifting of lockdown in May-June 2020, procedural volumes increased gradually. CONCLUSION: Strict COVID-19-related lockdown in Jordan was associated with drastic declines in cardiac catheterization procedural volumes.

Adherence to the 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline on the Use of Oral Anticoagulant Agents in Middle Eastern Patients with Atrial Fibrillation: The Jordan Atrial Fibrillation (JoFib) Study.

BACKGROUND: There is a scarcity of studies that evaluate adherence to the utilization of guideline-recommended oral anticoagulant agents (OACs) in patients with atrial fibrillation (AF) in the Middle East. The Jordan Atrial Fibrillation (JoFib) Study evaluated baseline clinical profiles and the utilization of OACs, including vitamin K antagonists (VKAs) and direct OACs (DOACs), in patients with valvular AF (VAF) and nonvalvular AF (NVAF) according to the 2019 focused update of the 2014 AHA/ACC/HRS guidelines. METHODS: Consecutive patients with AF were enrolled in 29 hospitals and outpatient clinics. The use of OACs was evaluated in patients with VAF and NVAF according to the prespecified guideline. RESULTS: Of 2000 patients, 177 (8.9%) had VAF and 1823 (91.1%) had NVAF. A VKA was prescribed for 88.1% of the VAF group. In the NVAF group, 1468 (80.5%) of patients had a high CHA2DS2-VASc score, i.e., a score of ≥3 in women and ≥2 in men; 202 (11.1%) patients had an intermediate CHA2DS2-VASc score, i.e., a score of 2 in women and 1 in men; and 153 (8.4%) patients had a low CHA2DS2-VASc score, i.e., a score of 1 in women and 0 in men. Of patients with a high CHA2DS2-VASc score, 1204 (82.0%) received OACs, including DOACs for 784 (53.4%) and VKA for 420 (28.6%) patients. Among patients with an intermediate score, OACs were prescribed for 148 (73.3%) patients, including 107 (53.0%) who received DOACs and 41 (20.3%) patients who received VKA. In patients with a low score, OACs were omitted in 94 (61.4%) patients and prescribed for 59 (38.6%) patients. Multivariate analysis showed that age between 50 and 70 years, CHA2DS2-VASc score of ≥2, a diagnosis of stroke or systemic embolization, and nonparoxysmal AF were significantly associated with increased odds of OAC prescription. CONCLUSIONS: The current status of the utilization of OACs in Middle Eastern AF patients appears to be promising and is consistent with the 2019 focused update of the 2014 AHA/ACC/HRS guideline. This trial is registered with NCT03917992.

Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study.

AIMS: Although acute heart failure (AHF) with volume overload is treated with loop diuretics, their dosing and type of administration are mainly based upon expert opinion. A recent position paper from the Heart Failure Association (HFA) proposed a step-wise pharmacologic diuretic strategy to increase the diuretic response and to achieve rapid decongestion. However, no study has evaluated this protocol prospectively. METHODS AND RESULTS: The Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure (ENACT-HF) study is an international, multicentre, non-randomized, open-label, pragmatic study in AHF patients on chronic loop diuretic therapy, admitted to the hospital for intravenous loop diuretic therapy, aiming to enrol 500 patients. Inclusion criteria are as follows: at least one sign of volume overload (oedema, ascites, or pleural effusion), use ≥ 40 mg of furosemide or equivalent for >1 month, and a BNP > 250 ng/L or an N-terminal pro-B-type natriuretic peptide > 1000 pg/L. The study is designed in two sequential phases. During Phase 1, all centres will treat consecutive patients according to the local standard of care. In the Phase 2 of the study, all centres will implement a standardized diuretic protocol in the next cohort of consecutive patients. The protocol is based upon the recently published HFA algorithm on diuretic use and starts with intravenous administration of two times the oral home dose. It includes early assessment of diuretic response with a spot urinary sodium measurement after 2 h and urine output after 6 h. Diuretics will be tailored further based upon these measurements. The study is powered for its primary endpoint of natriuresis after 1 day and will be able to detect a 15% difference with 80% power. Secondary endpoints are natriuresis and diuresis after 2 days, change in congestion score, change in weight, in-hospital mortality, and length of hospitalization. CONCLUSIONS: The ENACT-HF study will investigate whether a step-wise diuretic approach, based upon early assessment of urinary sodium and urine output as proposed by the HFA, is feasible and able to improve decongestion in AHF with volume overload.

Effect of Low-dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Low Dose Trial.

BACKGROUND: Studies using 1 mg of colchicine to prevent postoperative atrial fibrillation (POAF) reported conflicting results. Moreover, colchicine was associated with significant gastrointestinal (GI) side effects. This study examined whether low-dose colchicine effectively prevents POAF and whether low-dose therapy is associated with lower rates of colchicine-induced GI side effects. METHODS: In this prospective, randomized, double-blind, placebo-controlled study, consecutive adult patients admitted for elective cardiac surgeries randomly received a 1-mg dose of colchicine (n = 81) or placebo (n = 71) orally 12 to 24 hours before surgery followed by a daily dose of 0.5 mg until hospital discharge. The primary efficacy endpoint was the development of at least one episode of POAF of ≥5 minutes. The primary safety endpoint was the development of adverse events, especially diarrhea. RESULTS: The in-hospital mortality rate was 3.9%. POAF occurred in 13 patients (16.1%) in the colchicine group and 13 patients (18.3%) in the placebo group (odds ratio 0.85 [95% Confidence Interval = 0.37-1.99]). Diarrhea occurred in two patients in each group and necessitated treatment discontinuation in one patient in each group. CONCLUSION: Low-dose colchicine did not prevent POAF in patients undergoing cardiac surgery. These results should be interpreted cautiously because of the small sample size and early study termination.ClinicalTrials.gov Unique Identifier number: NCT03015831.

Blood pressure control in treated hypertensive Middle Eastern patients: a post hoc analysis based on JNC8 definitions.

BACKGROUND: Long-term blood pressure (BP) control is challenging due to the asymptomatic nature of hypertension and poor treatment adherence among patients. We conducted a post hoc analysis to assess "target BP" attainment and maintenance and to identify their associated factors in a sample of hypertensive Middle Eastern patients. METHODS: We previously conducted an observational study between May 2011 and September 2012 to assess antihypertensive treatment adherence and its determinants in a sample of 1,470 hypertensive patients in Lebanon and Jordan. The study consisted of 3 visits: at baseline, 3 months, and 6 months, where BP control, health-related quality of life, and treatment adherence were assessed. This post hoc analysis of data from the ADHERENCE study examined BP control in terms of target attainment at 3 months and 6 months, and target maintenance at 6 months in treatment-eligible patients as well as the determinants of BP control including the impact of the new JNC8 (Eighth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) guideline on treatment eligibility and target BP attainment in these patients. RESULTS: Based on JNC8 definitions, our results revealed that 81.2% of patients achieved BP control at 6 months. At 3 months, 62.2% achieved BP control; of those, only 57.5% maintained BP control till 6 months. Factors associated with higher BP target attainment at 3 months were higher educational level, new hypertension diagnosis, older age, and lower waist circumference, systolic BP, and diastolic BP at baseline. Factors associated with higher BP target attainment at 6 months were Lebanese nationality, new hypertension diagnosis, absence of chronic kidney disease, lower systolic BP at baseline, reaching BP target at 3 months, and having a BP target of <150/90 mmHg. CONCLUSION: Older age, higher education levels, recent hypertension diagnosis, early achievement of target BP, and having milder disease at baseline were associated with better BP control. Moreover, JNC8 guideline reduced the number of treatment-eligible patients and increased BP target attainment.

Incidence and impact on prognosis of impaired kidney function in Middle Eastern patients undergoing percutaneous coronary intervention: results from the first Jordanian PCI Registry.

Aims: The aim of this study was to evaluate the impact on prognosis of renal impairment (RI) in Middle Eastern patients after percutaneous coronary intervention (PCI). Methods and results: PCI patients (N=2,426) were divided into three groups according to the estimated glomerular filtration rate (eGFR, ml/min/1.73 m2): normal renal function (eGFR ≥90), mild RI (eGFR 60-89), or moderate to severe RI (eGFR <60). Mean age of participants was 56±11 years. Normal renal function was present in 41.6%, mild RI in 44.2%, and moderate to severe RI in 14.2%. Patients with moderate to severe RI were older and had higher prevalence of hypertension and diabetes mellitus compared with other patients (p≤0.002). At one year, patients with moderate to severe RI had a higher incidence of cardiac mortality (3.78%) compared with patients with mild (1.77%) or no RI (1.49%), p=0.03. In multivariate analysis, moderate to severe RI was associated with higher one-year cardiac mortality compared to mild or no RI (odds ratio=3.7; 95% CI: 2.8-5.0, p=0.001). Conclusions: Impaired renal function was present in about six out of 10 Middle Eastern patients undergoing PCI. Moderate to severe RI carries a higher risk of cardiac mortality at one year compared with mild or no RI.

Reality of obesity paradox: Results of percutaneous coronary intervention in Middle Eastern patients.

Objective The aim of this study was to assess the baseline clinical characteristics, coronary angiographic features, and adverse cardiovascular events during hospitalization and at 1 year of follow-up in obese patients compared with overweight and normal/underweight patients. Methods A prospective, multicenter study of consecutive patients undergoing percutaneous coronary intervention was performed. Results Of 2425 enrolled patients, 699 (28.8%) were obese, 1178 (48.6%) were overweight, and 548 (22.6%) were normal/underweight. Obese patients were more likely to be female and to have a higher prevalence of diabetes, hypertension, hypercholesterolemia, or previous percutaneous coronary intervention. Acute coronary syndrome was the indication for percutaneous coronary intervention in 77.0% of obese, 76.4% of overweight, and 77.4% of normal/underweight patients. No significant differences in the prevalence of multi-vessel coronary artery disease or multi-vessel percutaneous coronary intervention were found among the three groups. Additionally, no significant differences were found in stent thrombosis, readmission bleeding rates, or cardiac mortality among the three groups during hospitalization, at 1 month, and at 1 year. Conclusion The major adverse cardiovascular event rate was the same among the three groups throughout the study period. Accordingly, body mass index is considered a weak risk factor for cardiovascular comorbidities in Arab Jordanian patients.

Contemporary outpatient percutaneous coronary intervention: feasible and safe.

BACKGROUND: Outpatient percutaneous coronary intervention (PCI) is safe in selected low risk population. Drug eluting stents (DESs) have expanded the indications of PCI to include more complex anatomies and multivessel disease. HYPOTHESIS: Outpatient PCI strategy (transfemoral access with manual sheath removal) is feasible and safe in the era wide utilization of DES. METHODS: We enrolled 150 consecutive patients (males=82%, smokers=43%, diabetics=40%) referred for elective or semielective PCI. All patients were treated in the catheterization laboratory short-stay area. RESULTS: Procedural success was achieved in 97% of the cases. DESs were used in 88% of patients. Seventy-one percent of patients had single vessel PCI and 29% had multivessel PCI. The majority (n=124, 83%) was discharged within 10 h post-PCI (outpatient group) and 26 patients (17%) were admitted to the hospital for longer observation (hospital group). Of the outpatient group; there were no in-hospital deaths, myocardial infarctions or repeat revascularization. Two patients developed small femoral access site hematoma (treated conservatively). No readmissions or complications within 24 h after discharge were found. Administration of glycoprotein inhibitors and type-C lesion were independent predictors of failed same-day discharge. CONCLUSION: (i) Transfemoral outpatient PCI with manual sheath removal is feasible and safe in the era of DES. (ii) The majority of patients undergoing single or multivessel PCI can be discharged within 10 h postprocedure. (iii) Out-patient PCI has the potential of decreasing cost and improving hospital bed utilization.