Year : 2016 | Volume
: 2 | Issue : 2 | Page : 75--78
Cardiology update 2016
Sunil Kumar Verma1, Harish Gupta2,
1 Department of Cardiology, AIIMS, New Delhi, India
2 Department of Medicine, CSM Medical University, Lucknow, Uttar Pradesh, India
Sunil Kumar Verma
Suite No. 24, 7th Floor, Department of Cardiology, CTC, AIIMS, Ansari Nagar, New Delhi - 110 029
In the latter half of 2016, the important trials were ATMOSPHERE, INOVATE-HF, and IMPEDANCE-HF. The inclusion of angiotensin receptor–neprilysin inhibitor (valsartan/sacubitril) and sinoatrial node modulator (ivabradine) in the guidelines was a significant change. HOPE-3 was a major trial in 2016 expanding the dimension of statin use. ixCELL-DCM trial evaluated stem cells in dilated cardiomyopathy. Mobile-health and medication event monitoring system technology showed increasing use of technology in both prevention and treatment in cardiology. RIDDLE-non-ST-segment elevation myocardial infarction (NSTEMI) studied the immediate versus delayed intervention in NSTEMI. In STEMI, DANAMI 3-DEFER trial evaluated the concept of immediate stent implantation or deferred stent implantation 48 h after the index procedure with standard primary percutaneous coronary intervention. EARLY-BAMI tested intravenous metoprolol in acute STEMI with the use of magnetic resonance imaging. The utility of “Chest Pain Choice” tool demonstrated shared decision-making between physician and patients in the context of chest pain. Risk factors profile and demographic and angiographic features of aorto-ostial atherosclerotic coronary artery disease are evaluated extensively. Transcatheter aortic valve replacement results in comparison to surgery and its association with volume, and in-hospital outcomes are also analyzed. The VANISH trial addressed a very critical issue in post-MI ICMP. Factors associated with erosion related to Amplatzer septal occluder in atrial septal defect closure are described in detail.
|How to cite this article:|
Verma SK, Gupta H. Cardiology update 2016.J Pract Cardiovasc Sci 2016;2:75-78
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Verma SK, Gupta H. Cardiology update 2016. J Pract Cardiovasc Sci [serial online] 2016 [cited 2022 Dec 6 ];2:75-78
Available from: https://www.j-pcs.org/text.asp?2016/2/2/75/191533
The American College of Cardiology, the American Heart Association, and the Heart Failure Society of America recently released updated recommendations for the management of heart failure to include the use of two novel therapies: An angiotensin receptor–neprilysin inhibitor ([ARNI]; valsartan/sacubitril) and a sinoatrial node modulator (ivabradine).
Ivabradine, which selectively inhibits the I (f) current in the sinoatrial node, slows down the heart rate. Trials have shown a reduction in heart failure hospitalizations. Patients would benefit who have already had their beta-blockers optimized but still have a heart rate >70 beats/min.
The second new medication angiotensin receptor–neprilysin inhibitor (valsartan/sacubitril) a combination of an angiotensin receptor blocker with a neprilysin inhibitor (ARNI).
In the ATMOSPHERE  trial in patients with chronic heart failure, the addition of aliskiren to enalapril led to more adverse events without an increase in benefit. Noninferiority was not shown for aliskiren as compared with enalapril.
In the INOVATE-HF trial  with 407 CardioFit pacemaker systems implanted in individuals with stable HF, vagus nerve stimulation did not reduce the rate of death or hospitalization for heart failure. Reverse remodeling also did not improve with vagus nerve stimulation. However, quality of life, New York Heart Association class, and 6-min walking distance were favorably affected by vagus nerve stimulation.
In a randomized controlled trial noninvasive lung impedance-guided preemptive treatment in chronic heart failure patients (IMPEDANCE-HF trial), it was demonstrated for the first time that the lung impedance-guided preemptive therapy of the worsening pulmonary congestion prevents heart failure hospitalization and reduces all-cause CV and HF mortality in these patients.
HOPE-3 investigators  tested the hypothesis of extended benefits of statin therapy to intermediate-risk, ethnically diverse population without cardiovascular disease. About 12,000 individuals from 21 countries constituted the two-by-two factorial design of the trial. Inclusion criteria were: Women aged >60 years and men >55 years, at least one additional CV risk factor including (1) waist/hip ratio ≥0.90 in men and ≥0.85 in women, (2) history of current or recent smoking (regular tobacco use within 5 years), (3) low high-density lipoprotein (HDL) cholesterol, (4) dysglycemia, (5) renal dysfunction, (6) family history of premature coronary heart disease in the first-degree relatives. The tested statin was rosuvastatin 10 mg or placebo. The first coprimary outcome was the composite of death from cardiovascular causes, nonfatal myocardial infarction (MI), or nonfatal stroke, and the second coprimary outcome additionally included revascularization, heart failure, and resuscitated cardiac arrest. The median follow-up was 5.6 years. The HOPE-3 investigators concluded that the treatment with rosuvastatin at a dose of 10 mg/day resulted in a significantly lower risk of cardiovascular events than placebo in an intermediate-risk, ethnically diverse population without cardiovascular disease.
Particulate air pollution is associated with cardiovascular risk, but most studies of the association have not assessed long-term outcomes. In a 10-year prospective study, investigators analyzed data from 6795 individuals (age range, 45–84) participating in the Multi-Ethnic Study of Atherosclerosis and Air Pollution, who underwent serial measurements of coronary artery calcium (CAC, by computed tomography) and carotid artery intima-media thickness (CIMT, by ultrasound). The concentration of fine particulate matter <2.5 µm in diameter (PM2.5) was significantly associated with CAC progression (by 4.1 Agatston units for each 5-µg PM2.5 increase) but not with CIMT progression.
Stem Cell Therapy
Ixmyelocel-T is a patient-specific, expanded multicellular therapy manufactured from the patient's own bone marrow using Vericel's proprietary, highly automated, fully closed cell-processing system. This process selectively expands the population of mesenchymal stromal cells and alternatively activated macrophages, which are responsible for the production of anti-inflammatory and pro-angiogenic factors known to be important for repair of damaged tissue. The ixCELL-DCM trial  showed a statistically significant reduction in clinical events driven by both cardiac mortality and cardiac hospitalizations at 12 months compared to placebo. These results are consistent with two previous Phase 2a studies which showed that ischemic DCM patients treated with ixmyelocel-T experienced fewer major adverse cardiovascular events during follow-up compared to control patients.
Technology and Cardiology
The concept of mobile-health (M-health) was tested in Stepathlon trial  by Flinders University of South Australia, Adelaide. This was a low-cost, M-health intervention that focuses on the getting people moving leading to significant improvements in physical activity and weight loss. Sixty-nine thousand individuals from 64 different countries from 2012 to 2014, who participated in the program lost approximately 1.5 kg of body weight over 100 days and reduced their sitting duration by approximately 45 min.
A 6 months follow-up study in heart failure patients with reduced ejection fraction utilizing the technology of medication event monitoring system (MEMS) in Cardio-MEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in Class III Heart Failure (CHAMPION) trial monitored the pulmonary artery (PA) pressure. It found that incorporation of a PA pressure-guided treatment algorithm to decrease filling pressures led to targeted changes, particularly in diuretics and vasodilators, and was more effective in reducing HF hospitalizations than management of patient clinical signs or symptoms alone.
Acute Coronary Syndromes
Results of the EARLY-BAMI randomized trial  show no reduction in infarct size for ST-segment elevation myocardial infarction (STEMI) patients who receive intravenous (IV) metoprolol before undergoing percutaneous coronary intervention (PCI). Acute STEMI patients within 12 h of symptom onset to receive IV administration of the beta-blocker metoprolol (two 5-mg bolus doses, with the first given in the ambulance) or placebo before undergoing angioplasty. Infarct size on magnetic resonance imaging at 30 days, the study's primary end-point, was similar between the metoprolol and placebo groups.
The RIDDLE-non-STEMI (NSTEMI) study  studied the clinical impact of the intervention (immediate versus delayed) in NSTEMI. The immediate intervention group received intervention <2 h after randomization (n = 162). The delayed intervention group received intervention 2–72 h after randomization (n = 161). The primary end-point was the occurrence of death or new MI at 30-day follow-up. The results concluded that immediate invasive strategy in NSTEMI patients is associated with lower rates of death or new MI compared with the delayed invasive strategy at early and mid-term follow-up, mainly due to a decrease in the risk of new MI in the precatheterization period.
In DANAMI 3-DEFER trial, standard primary PCI with immediate stent implantation or deferred stent implantation 48 h after the index procedure if a stabilized flow could be obtained in the infarct-related artery was tested. This was an open-label, randomized controlled trial at four primary PCI centers in Denmark conducted between 2011 and 2014 involving 1200 patients with 42 months median follow-up. The investigators were trying to test the hypothesis that despite successful treatment of the culprit artery lesion by primary PCI with stent implantation, thrombotic embolization occurs in some cases, which impairs the prognosis of patients with STEMI. They concluded that in patients with STEMI, routine deferred stent implantation did not reduce the occurrence of death, heart failure, MI, or repeat revascularization compared with conventional PCI.
“Chest Pain Choice”  is the first patient-oriented tool designed to facilitate shared decision-making between physician and patients in the context of chest pain, a complaint that accounts for about 8 million emergency department visits and is the second most common complaint in the US emergency department visits. Patients visiting a hospital emergency department with chest pain who engage with their physician in shared decision-making using this tool showed improved knowledge of their health care status and follow-up care options compared with patients who received standard counseling from a physician without the use of this tool. The tool itself does not recommend a specific management decision; it just makes transparent what the options are.
Coronary Artery Disease
In an attempt to explore the risk factors profile and demographic and angiographic features of aorto-ostial atherosclerotic coronary artery disease, about 8000 coronary angiograms were analyzed over a period of 2 years in a tertiary care center. The overall prevalence of aorto-ostial atherosclerotic coronary artery disease was 1.5%. Mean age was 59 ± 10 years and prevalence in males was 5.7 times greater than females. Isolated ostial left main coronary artery disease was 2 times more prevalent than ostial right coronary artery disease. Hypercholesterolemia, hypertriglyceridemia, and high total cholesterol/HDL ratio can be considered as risk factors for aorto-ostial atherosclerotic coronary artery disease.
Dual Antiplatelet Therapy
On reviewing the evidence from 11 randomized controlled trials that enrolled 33,051 patients who received predominantly newer-generation drug-eluting stents (DESs), duration of dual antiplatelet therapy (DAPT) got new recommendations. For patients with acute coronary syndrome (ACS), at least 12 months of DAPT are recommended as a Class I level of recommendation. At the 1-year mark, DAPT may be continued if the ACS patient did not have any overt bleeding in the 1st year and if the patient does not have a high-risk of bleeding. This extension of DAPT is given a Class IIb level of recommendation. Regarding stable patients treated with newer-generation DES, at least 6 months of DAPT is recommended as a Class I recommendation; continuing beyond that point in patients at low risk of bleeding is given a Class IIb recommendation.
Transcatheter Aortic Valve Replacement
Data from propensity score analysis of PARTNER 2 trial  demonstrated that rates of composite primary end-points of transcatheter aortic valve replacement (TAVR) with SAPIEN 3 transcatheter valve (Edwards Lifesciences) were both noninferior and superior to surgery. Intermediate-risk patients with severe aortic stenosis implanted with SAPIEN 3 by TAVR are associated with low mortality, strokes, and regurgitation at 1 year.
Data were presented from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry (TAVR module from November 2011 through the third quarter of 2015) from 14 sites of the USA. This observational study evaluated the possible association between cumulative TAVR volume and in-hospital outcomes in the US clinical practice. Throughout 400 cases, Dr. Carroll and colleagues reported significant improvements in in-hospital mortality and reductions in bleeding complications and vascular injury. Learning curve and volume-outcome analysis showed that in the early period, steepest relationship for the outcome was seen at low site volumes. The later period, after achieving the modest volumes (>100 cases), shows further improvement in outcomes.
An important problem in patients with ischemic cardiomyopathy following MI with an implantable cardioverter defibrillator (ICD) is recurrent ventricular tachycardia and frequent ICD shocks and its consequences. The VANISH trial (multicenter, randomized, and controlled) with 259 patients addressed this critical issue in this high-risk study group. In search of a most effective approach, catheter ablation (ablation group, n = 132) or escalated antiarrhythmic drug therapy (escalated therapy group = 127) was compared. In the escalated therapy group, amiodarone was increased if it had been <300 mg/day or mexiletine was added if the dose was already at least 300 mg/day. The trial concluded that in patients with ischemic cardiomyopathy and an ICD who had ventricular tachycardia despite antiarrhythmic drug therapy, there was a significantly lower rate of the composite primary outcome of death, ventricular tachycardia storm, or appropriate ICD shock among patients undergoing catheter ablation than among those receiving an escalation in antiarrhythmic drug therapy.
Congenital Heart Disease
Amplatzer septal occluder (St. Jude Medicals)-related erosion into pericardial space or aorta following transcatheter closure of ostium secundum atrial septal defect (ASD) was studied in a study by McElhinney. All erosions (cases) were compared with controls (matched 2:2) who underwent ASD closure but did not develop an erosion. There were total 125 erosions between 2002 and 2014. The median duration of the implant to erosion was 14 days. The aortic rim deficiency was universal among erosion cases. Those who died (nine patients, all ages ≥17 years) were more likely to have an oversized device and to have eroded into the aorta, than survivors. Aortic or superior vena cava deficiencies were more common in cases than in control. The other relative risk factors associated with erosion were larger balloon-sized ASD diameter, Amplatzer septal occluder device size and device size-ASD diameter difference, and smaller weight: Device size ratio, deficiency of any rim and device >5 mm larger than ASD diameter.
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