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Clinical trials in interventional cardiology to watch out for at the virtual AHA20!!

Our virtual AHA20 has started with all of the science, engagement and excitement!!! Since many of us are working and still want to squeeze in some time to check out what is going on at AHA20, I have decided to summarize clinical trials to look out for at AHA20 with their brief description.

Friday 11/13/2020

Trial Name Arrest Trial

 

Trial title Advanced Reperfusion Strategies For Refractory Ventricular Fibrillation Out-of-hospital Cardiac Arrest

 

Description In this trial,  patients (18-75 years old) with refractory ventricular fibrillation/pulseless ventricular tachycardia out-of hospital cardiac arrest, who are transferred by emergency medical services (EMS) with ongoing mechanical cardiopulmonary resuscitation (CPR) or who are resuscitated, were randomized to receive either early Extracorporeal Membrane Oxygenation (ECMO) or standard Advanced Cardiac Life Support (ACLS) Resuscitation [1]

 

Saturday 11/14/2020:

ALPHEUS, ATLANTIS, and RIVER Trials

Trial Name Alpheus Trial

 

Trial title Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting.

 

Description This is a multicenter study in stable patients undergoing elective PCI with a randomization between clopidogrel and ticagrelor. The primary ischemic endpoint is peri-procedural MI and myocardial injury and safety endpoint is bleeding by BARC definition [2].

 

Trial Name Atlantis Trial

 

Trial title Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation (TAVI) for Aortic Stenosis

 

Description This trial looks at the strategy of anticoagulation with novel anticoagulant, apixaban, compared to the current standard of care in patients who had a successful TAVI. The randomization is performed according to the presence or absence of a mandatory indication for anticoagulation, including atrial fibrillation or venous thromboembolic disease [3].

 

Trial Name RIVER Trial

 

Trial title RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial

 

Description This trial compares Rivaroxaban Versus Warfarin In Patients With Bioprosthetic Mitral Valves And Atrial Fibrillation [4].

 

Sunday 11/15/2020:

One-Month DAPT

Trial Name One-Month DAPT

 

Description One month dual antiplatelet Therapy Followed By Aspirin Monotherapy After Drug Eluting Stent Implantation.

 

 

 

References:

  • ARREST trial: https://www.clinicaltrials.gov/ct2/show/NCT03880565
  • ALPHEUS trial: https://clinicaltrials.gov/ct2/show/NCT02617290
  • ATLANTIS trial: https://clinicaltrials.gov/ct2/show/NCT02664649
  • RIVER trial: https://clinicaltrials.gov/ct2/show/NCT02303795

 

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”

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Cardiac Intensivist – Just an Extension of an Interventionist?

Three pathways encompassing an intersection of the established subspecialties of critical care and cardiology have been proposed as a training framework for an aspiring ‘critical care cardiologist’ by the authors in a recent article1.  However, focusing specifically on the skill set outlined in the article,  a different and accelerated pathway for duly trained and interested interventionists may merit consideration.   With additional training in end of life/palliative care, intubation skills and advanced ventilator management a interventional cardiologist may likely fill the shoes in a modern ICU better than cardiologists from other subspecialties, including even those with additional critical care training.

Among the skill sets outlined in1, accredited interventional training likely prepares an individual to the greatest extent.  Issues of vascular access, sedation management and escalation of vasopressors for ‘crashing patients’ are daily routine in a busy catheterization suite.  Point-of-care ultrasounds (POCUS) should enhance the armamentarium of every thoughtful interventionist to identify regional wall motion abnormality and direct appropriate revascularization in area of myocardial dyskinesis/’stunning’. Additionally POCUS helps identify tamponade expediently,as well as potential advanced valvulopathy needing urgent invasive intervention. Pulmonary artery catheter insertion, monitoring of the hemodynamics, and management has gained resurgence in the era of valvular interventions and percutaneous mechanical circulatory support(MCS) for cardiogenic shock.  Post-procedure care for revascularized patients is one of the most important lesson for Fellowship trainees, as is early identification, and directed action in case of development of complications. Being integral to a heart team2 for complex decision making also allows contemporary interventional trainees to be involved in complex decision making, and working closely with the surgical team. With more patients requiring complex interventions in contemporary practice-often with need for atherectomy of a dominant coronary artery, and those with advanced conduction system disease-transvenous pacemaker placement is increasingly performed in the Cath Lab. Also pacemaker placement during transcatheter aortic valve replacements (TAVRs) forms an essential step of the procedure enabling deployment of the valve.  Assessment of managing patients with acute coronary syndrome including interpreting EKGs to identify hemodynamically significant arrhythmias emergently is definitely in the ‘day’s work’ for most interventional trainees,

When looking at structured training, the the COCATS 4 document3 has outlined some competencies for a budding cardiac critical care professional-and recognizes the importance of cath lab rotations in forming the foundation of solid procedural skills. The only skills outlined as those outside the realm of a general cardiology Fellowship were ‘Skill to place intra-aortic balloon pump emergently’-which most interventional trainees become competent at, and ‘Skill to perform endotracheal intubation’-which in most tertiary care institutions is done by anesthesia-and interventionists may acquire competency with additional training.

The Acute Cardiovascular Care Association (ACCA) of the European Society of Cardiology (ESC) have come-up with their own certification exam and a core curriculum4. In addition to the above, they have outlined need for identifying and appropriately managing renal dysfunction in critically ill patients. The focused interventional trainee gets ample exposure to preventing, identifying and treating acute kidney injury almost on a regular basis in this era of heightened awareness of limiting contrast, and contrast-sparing interventions. Also the document outlines the importance of early, aggressive and adequate treatment for pulmonary embolism(PE)-and most PE response teams across the nation are staffed and often led by an interventionist.

In summary, with additional training –interventional cardiologists, and those in-training, with appropriate interest should potentially be integral, and possibly in a leadership position in a critical care team of the future.

References:

  1. Miller PE, Kenigsberg BB, Wiley BM. Cardiac Critical Care: Training Pathways and Transition to Early Career. J Am Coll Cardiol. 2019 Apr 9;73(13):1726-1730.
  2. Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. EuroIntervention. 2019 Feb 20;14(14):1435-1534.
  3. O’Gara PT, Adams JE, Drazner MH, et al. Journal of the American College of Cardiology May 2015, 65 (17) 1877-1886.
  4. https://www.escardio.org/static_file/Escardio/Education-Subspecialty/Certification/ACCA/Documents/ACCA_Core_Curriculum.pdf . Last accessed April 19, 2019.
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Deep Learning in Cardiology

Thirteen years ago in my first anatomy class of Med School, the instructor asked us to make sure our learning is “deep.”

“You need to memorize the names of every single tiny nerve and muscle, because they all will be on your exam. One day you could be surgeons and if you cut out the wrong structure, you can kill someone!” he asserted as we all stood there in fear.

Later in Med School, we were told that half of what we’re learning will be wrong by the time we practice. But one thing we were not told is that the way we learn and the entire premise of what makes a good doctor would also change. For example, “deep learning” itself now means something different to me and to most healthcare professionals. If you are reading this article so far, then you are likely to have seen the term floating around in medical journals.

Deep learning is a type of machine learning in which the computer uses multiple layers of processing to extract features from otherwise vague data input, such as an ECG or a slice of an MRI.  Each layer uses outputs from the previous layer. Through deep learning, the computer simulates the neural network of the brain and is able to learn and make sense of abstraction.

Working at the Broad Institute of Harvard and MIT allowed me to recently be part of a team that uses deep learning to solve important problems in cardiology.  Over several weeks, cardiologists, scientists, and machine learning experts worked in teams to train computers on deep learning models so that they understand data such as medications, ECGs, genomic architecture, and cardiac MRIs of tens to hundreds of thousands of people.

The insights I gained were incredible.  Just like medical students perform better on their exam if they learn “deeper,” the longer you train a computer model, the more it learns and the better it performs in predicting – but it does so at much faster rates than any doctor could ever match. For example, in only two days, we trained a computer to read the ejection fraction from a cardiac MRI as good as a doctor would. Using the MRI, the computer could also predict with reasonable precision the presence of hypertension and coronary artery disease, without knowing anything else about the patient. The power of computer vision is beyond imagination. While it could take you a full day to read 100 ECGs, a well-trained deep learning model could read them in only few seconds. It could also identify patterns in the data that the human eye could not discern, which might or might not be biologically or clinically relevant.

As data availability and computing power continue to grow, we will be seeing more and more applications of deep learning in cardiology.  While we do so, we should stay mindful that human supervision and our role as doctors in charge of our patient’s health is more important than ever. This requires us to understand how computers work and how those models are built through working with multidisciplinary teams. If we do this right, we can probably do less deep learning ourselves by delegating to computers, and gain a whole lot of extra time that we can invest in taking care of our patients.

 

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To Clip or Not to Clip

Evidence based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient. It means integrating individual clinical expertise with the best available external clinical evidence from systematic research.” Dr.David Sackett, 1996

 

Randomized controlled clinical trials (RCTs) have been long considered as highest level evidence and have formed the basis of most current treatments in cardiovascular medicine. Despite their strengths, the limitations of RCTs are increasingly recognized in applying evidence in the clinical practice; this is especially true when various RCTs report conflicting findings. We have encountered this frequently in interventional cardiology where new technologies and treatments have to face intense scrutiny before becoming part of routine practice.

Last year two large much awaited RCTs–COAPT and MITRA-FR report their findings1, 2. To a cursory eye the results look conflicting and few of my colleagues in general internal medicine even describe them as ‘confusing’.

Larger of the two–the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) is a RCT conducted across 78 centers in the United States and Canada1. COAPT investigators randomized 614 patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy1. Patient in device group had significantly lower rate of hospitalization for heart failure [35.8% per patient-year in the device group as compared with 67.9% per patient-year in the control group (hazard ratio, 0.53; 95% confidence interval [CI], 0.40 to 0.70; P<0.001)  and  all-cause mortality [29.1% of the patients in the device group as compared with 46.1% in the control group (hazard ratio, 0.62; 95% CI, 0.46 to 0.82; P<0.001)] within 24 months of follow-up1. Further, rate of freedom from device-related complications exceeded a prespecified safety threshold1. Whereas investigators in MITRA-FR trial (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) randomized 152 patients with heart failure and severe secondary mitral regurgitation in a 1:1 ratio, to undergo percutaneous mitral-valve repair in addition to receiving medical therapy (intervention group) or to receive medical therapy alone (control group)2. At 12 month follow authors reported no significant difference in the rate of death [24.3% in the intervention group and 22.4% in the control group (hazard ratio, 1.11; 95% CI, 0.69 to 1.77)] or unplanned hospitalization for heart failure [48.7% in the intervention group and 47.4% in the control group (hazard ratio, 1.13; 95% CI, 0.81 to 1.56)] between patients who underwent percutaneous mitral-valve repair in addition to receiving medical therapy and those who received medical therapy alone2.

A closer look and detailed analysis of both RCTs can explain the differences in outcomes.

First, patient populations enrolled in these RCTs were different in terms of baseline valvular and ventricular characteristics1,2. Compared to MITRA-FR, COAPT enrolled patients with more severe mitral regurgitation [effective regurgitant orifice area-41 mm2 vs. 31 mm2]. Further, in COAPT the left ventricular end-diastolic volume (reflecting the status of the left ventricle) was smaller. Second, patient selection in COAPT was more stringent and only patients who are truly refractory to medical therapy [at the maximum tolerated dose before randomization] were included. This is reflected in higher baseline N-terminal pro–B-type natriuretic peptide levels among patients in COAPT trial. Also, percentage of patients who received more than a single clip was higher in COAPT. Whether this contributes to higher proportion of patients with moderate to severe MR at end of follow up in MITRA-FR remains unclear. Furthermore, the follow up period in MITRA-FR was 12 months, which could also contribute to difference in its finding with COAPT, where the Kaplan–Meier survival curves start diverging after 12 months. Long term follow up data from MITRA-FR can further clarify this.

In this era of evidence based medicine, results of COAPT and MITRA-FR once again exemplified how critical it is for clinicians to understand the methodology and patient characteristics enrolled in RCTs before extrapolating the finding to their patients. Not every secondary mitral regurgitation patient is a candidate for Clip. Patient selection is the key. The answer to ‘clip or not to clip’ is in knowing our patient well, including and not limited to their baseline clinical and echocardiographic parameters and optimal medical management of their heart failure before offering them this novel therapy.  Sir William Osler has summarized it well more than a century ago, “He who studies medicine without books sails an uncharted sea, but he who studies medicine without patients does not go to sea at all3.

 

References:

  1. Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318.
  2. Obadia JF, Messika-Zeitoun D, Leurent G et al. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306.
  3. Osler W. (1904) Aequanimitas, With Other Addresses to Medical Students, Nurses and Practitioners of Medicine, Books and men (P Blakiston, Philadelphia, PA)]

 

 

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The Significant Areas of Interest in the Field of Cardiac Imaging in 2018

There were several exciting developments in 2018 with regards to cardiac imaging. The role of the cardiac imager is becoming increasingly relevant in today’s cardiology practice environment and bridges across several subspecialties in Cardiology, such as electrophysiology with the use of transesophageal echocardiography (TEE) in the placement of left atrial appendage closure devices. These devices include Watchman and interventional cardiology with structural and valvular heart disease and echocardiographic guidance with transaortic valve replacement (TAVR), percutaneous mitral valve repair with MitralClip, as well as atrial septal and ventricular septal closure devices. The field of cardiac imaging has matured over the years and not only includes echocardiography and nuclear cardiology, but also includes advanced imaging with cardiac magnetic resonance imaging (cMRI) and cardiac computed tomography. In addition, there has been the rise of the interventional echocardiographer specializing in the use of echocardiography in guiding percutaneous and surgical treatment of structural heart disease. In fact, there has been recognition of cardiac imaging by several professional societies such as the American College of Cardiology with publication of the state-of-the-art paper, The Future of Cardiac Imaging Report of a Think Tank Convened by the American College of Cardiology1. There have also been several disease states that have been positively influenced by the development of new diagnostic technology in cardiac imaging, such as cardiac amyloidosis. Cardiac imaging has also positively influenced preventive cardiology with release of the latest American Heart Association (AHA)/ American College of Cardiology (ACC) 2018 Cholesterol Management Guidelines2. The following areas were, in my opinion, considered topics of great interest in 2018 in the field of cardiac imaging.

 

Nuclear Imaging

Cardiac Amyloidosis. For several years, cardiac amyloidosis, particularly transthyretin type (ATTR type), was thought to be a diagnosis that was very difficult to make with endomyocardial biopsy being the only method to confirm the diagnosis. However, nuclear cardiac imaging has changed the landscape of this disease with the novel application of old technology with the use of technetium 99m pyrophosphate (Tc-99m PYP) in the diagnosis of ATTR type cardiac amyloidosis3. The sensitivity and specificity of this technique in diagnosing this disease state is >95%, and oftentimes avoids the need for endomyocardial biopsy to make this diagnosis4. The development of this technique in diagnosing the disease has increased the recognition of this disease in many patients with diastolic heart failure, and even in patients with severe aortic valve stenosis undergoing TAVR. This has also led to greater research and development of new treatments for this disease, such as tafamidis, patisiran and inotersen. The development of these medications will hopefully improve the overall prognosis for patients with this disease.

 

Echocardiography

The Rise of the Interventional Echocardiographer in Structural Cardiac Imaging. There has been increasingly relevant areas of interest in structural heart disease, such as percutaneous mitral valve repair with MitralClip, especially with the release of the study findings from the COAPT trial5.  In addition, transaortic valve replacement (TAVR) has become increasingly available for many patients with severe aortic valve stenosis, and many institutions have began offering this therapy to many of their patients. Additionally, left atrial appendage occlusive devices such as the Watchman device are being increasingly used in patients with atrial fibrillation who are at high risk for hemorrhagic complications with anticoagulation, despite having indications for thromboembolic prophylaxis. With these new developments, there has been the rise of the interventional echocardiographer, who serves a vital role with the use of echocardiography in guiding the placement of these devices in the treatment of structural heart disease. Many fellows are now seeking additional training in this field to meet this demand, as this area has invited a growing interest in the cardiology field and has attracted many trainees.

 

Cardiac Computed Tomography

The revisiting of Coronary Calcium Score as a Powerful Tool in Preventive Cardiology. The release of the latest AHA/ACC Cholesterol Management Guidelines has been an area of great interest in the field. The latest guidelines have included the use of coronary calcium scoring with cardiac CT as a tool to further risk stratify patients to guide the use of pharmacologic therapy for patients with hyperlipidemia2. This has led to  the resurgence of Cardiac CT for coronary calcium scoring as a valuable tool for cardiologists in the field of preventive cardiology.

Utility of Cardiac CT in the assessment of Women with suspected Cardiovascular Disease.  There has also been the increasing recognition of Cardiac CT as a useful diagnostic tool for women suspected of having cardiovascular disease (CVD)6. Hopefully, this will result in the increased appropriate use of Cardiac CT in the management of CVD in women.

 

Cardiac MRI

The complementary role of Cardiac MRI with echocardiography and assessment of valvular and structural heart disease. Cardiac MRI has become an established imaging modality in the assessment of valvular heart disease. This has been embraced by the American Society of Echocardiography’s latest Valvular Guidelines, which includes cardiac MRI as playing a complementary role in the assessment of the severity and etiology of valvular heart disease7. The use of Cardiac MRI is also useful in the assessment of other disease states, such hypertrophic cardiomyopathy and risk assessment for sudden death8.

The rise of Cardiac MRI compatible devices. There has also been the development of Cardiac MRI compatible devices which now allows many patients with these devices to be able to have cardiac MRIs performed safely. Cardiac MRI is therefore a viable diagnostic tool for these patients.

The first administration of certification board exam in cardiovascular magnetic resonance imaging (CBCMR).  With the maturation of Cardiac MRI as a viable imaging modality, 2019 will see the inaugural administration of the first certification exam in cardiovascular magnetic resonance imaging (CBCMR), which will occur between May 7 – June 7, 2019, and the 2019 application window will open on January 15, 2019. ​​

 

Conclusion:

With the dawn of a new year in 2019, it is clear that the future of cardiac imaging is very bright. I am looking forward to many more promising developments in this field and hope that this field will continue to attract many more talented cardiologists in this area of cardiology.

 

References:

  1. Douglas PS, Cerqueira MD, Berman DS, Chinnaiyan K, Cohen MS, Lundbye JB, et al. The Future of Cardiac Imaging Report of a Think Tank Convened by the American College of Cardiology. J Am Coll Cardiol Img 2016;9:1211–23.
  2. Grundy SM, Stone NJ, Bailey AL, Beam LT, Birtcher KK, et al. 2018AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. JACC Nov 2018, 25709; DOI: 10.1016/j.jacc.2018.11.003.
  3. Dorbala S, Bokhari S, Miller E, Bullock-Palmer RP, Soman P, Thompson R. ASNC Practice Points: 99mTechnetium-Pyrophosphate Imaging for Transthyretin Cardiac Amyloidosis (American Society of Nuclear Cardiology website). 2018. Available at: https://www.asnc.org/Files/Practice%20Resources/Practice%20Points/ASNC%20Practice%20Point-99mTechnetiumPyrophosphateImaging2016.pdf.
  4. Gillmore JD, Maurer MS, Falk RH, Merlini G, Damy T, Dispenzieri A, et al. Nonbiopsy Diagnosis of Cardiac Transthyretin Amyloidosis. Circulation. 2016 Jun 14;133(24):2404-12. Doi: 10.1161/CIRCULATIONAHA.116.021612. Epub 2016 Apr 22.
  5. Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM,et al. COAPT Investigators.Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.
  6. Truong QA, Rinehart S, Abbara S, Achenbach S, Berman DS, Bullock-Palmer R,et al. SCCT Women’s Committee.Coronary computed tomographic imaging in women: An expert consensus statement from the Society of Cardiovascular Computed Tomography. J Cardiovasc Comput Tomogr. 2018 Nov – Dec;12(6):451-466. doi: 10.1016/j.jcct.2018.10.019. Epub 2018 Oct 23.
  7. Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, et al. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14.
  8. Weng Z, Yao J, Chan RH, He J, Yang X, Zhou Y, He Y.Prognostic Value of LGE-CMR in HCM: A Meta-Analysis. JACC Cardiovasc Imaging. 2016 Dec;9(12):1392-1402. doi: 10.1016/j.jcmg.2016.02.031. Epub 2016 Jul 20. Review.

 

 

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Is There An Intervention For Reducing All Cardiovascular-Related Diseases?

What ‘intervention’ reduces risk for all-cause and cardiovascular mortality, cardiac and cerebrovascular events, hypertension, type 2 diabetes, lipid disorders, and cancer of the bladder, breast, colon, endometrium, esophagus, kidney, stomach, and lung? As an interventional cardiologist and outcomes researcher, I would have been happy to attribute this to the latest device/procedure or a cure-all pill. But the answer is ‘none of the above’. The the answer is probably one of the biggest take aways from AHA Scientific Sessions 2018 for me.

As the AHA18 meeting drew to a close, amidst all the ‘buzz’ of the late-breaking clinical trials and other remarkable research, a largely less publicized session celebrated physical activity and their favorable impact on health outcomes.The ‘Physical Activity Guidelines Advisory Committee’ under the auspices of the Department of Health and Human Services (HHS) came out with a systematic review and proposed recommendations for physical activity for the American public:

  • A significant change since the 2008 Physical Activity Guidelines for Americans is that previously, aerobic physical activity for adults had to be accumulated in bouts, or sessions, that lasted at least 10 minutes to count toward meeting the key guidelines. Current evidence shows that the total volume of moderate-to-vigorous physical activity is related to many health benefits; bouts of a prescribed duration are not essential. Sufficient physical activity is defined as at least 150 minutes of moderate-intensity aerobic physical activity and 2 days per week of muscle-strengthening activity for adults and at least 60 minutes of moderate-intensity aerobic physical activity and 3 days per week of muscle-strengthening activity for youth.
  • Preschool-aged children (ages 3-5 years) should be physically active throughout the day to enhance growth and development. Increased physical activity is associated with improvements in bone health and weight status. Children and adolescents ages 6-17 years should do 60 minutes or more of moderate-to-vigorous physical activity daily. Increased physical activity is associated with improvements in bone health, weight status, cardiorespiratory fitness, and cardiometabolic health. Additional benefits include improved cognitive function and reduced risk of depression.
  • Adults should do at least 150-300 minutes a week of moderate-intensity, or 75-150 minutes a week of vigorous-intensity aerobic physical activity, or an equivalent combination of moderate- and vigorous-intensity aerobic activity. Adults should perform muscle-strengthening activities on 2 or more days a week. Older adults should do multicomponent physical activity that includes balance training as well as aerobic and muscle-strengthening activities. Benefits of increased physical activity include lower risk of mortality including cardiovascular mortality, lower risk of cardiovascular events and associated risk factors (hypertension and diabetes), and lower risk of many cancers (including bladder, breast, colon, endometrium, esophagus, kidney, lung, and stomach). Additional improvements have been seen in cognition, risk of dementia, anxiety and depression, improved bone health, lower risk of falls, and associated injuries.
  • Adults with chronic conditions or disabilities, who are able, should follow the key guidelines for adults and do both aerobic and muscle-strengthening activities. Pregnant and postpartum women should do at least 150 minutes of moderate-intensity aerobic activity a week.
  • Recommendations emphasize that moving more and sitting less will benefit nearly everyone. Individuals performing the least physical activity benefit most by even modest increases in moderate-to-vigorous physical activity. Both aerobic and muscle-strengthening physical activity are beneficial. Some health benefits begin immediately after exercising, and even short episodes or small amounts of physical activity are beneficial.
  • Technology, such as step counters or other wearable devices or fitness apps, can provide physical activity feedback directly to the user. Technology can be used alone or combined with other strategies, such as goal setting and coaching, to encourage and maintain increased physical activity. (Adapted from https://www.acc.org/latest-in-cardiology/ten-points-to-remember/2018/11/14/14/37/the-physical-activity-guidelines-for-americans)

As an interventional cardiologist, I feel that these interventions or recommendations, if observed, could have significant positive impact on the health and well-being of the US population, and I will try my best to incorporate these in my practice and encourage peers to do the same.

 

 

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Late Breaking Science Trial: ORBITA Debate at Scientific Sessions 2018

“Life is like riding a bicycle. To keep your balance you must keep moving.” -Albert Einstein.

There may scarcely be any other sphere of medicine than interventional cardiology where the quote is more applicable. In 2017, the paradigm shifting ‘Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina’ – ORBITA  trial was presented and published.The results of this trial indicated that among patients with stable angina, percutaneous coronary intervention/PCI does not result in greater improvements in exercise times or anginal frequency compared with a sham/placebo procedure. This was despite the presence of anatomically and functionally significant stenoses. PCI did however resolve ischemia more effectively, as ascertained by follow-up stress.

This was clearly a landmark trial, but several issues were put forward as limiting factors. The trial was well conducted, with careful assessments of ischemia pre- and post-procedure, and appropriate use of antianginal medications-which unfortunately has been hard to replicate outside of the controlled setting of a trial, in the tribulations of real-world medical practice. Although powered for exercise treadmill-based endpoints, the trial has been noted to be too small to address a question of clinical benefits with PCI. Moreover, changes in Duke treadmill score and exercise time were both numerically higher in the PCI arm, and it is unknown if a larger sample size would have detected more modest improvements in exercise capacity.

The controversies and ‘buzz’ had prompted me to follow the data as a early career interventionist-and I cued in keenly for the short debate session on the same at the Annual Scientific Sessions of the American Heart Association 2018 (#AHA18) .Dr. Brahmajee Nallamothu, Editor of the Circulation: Quality and Outcomes and a Professor of Medicine at the University of Michigan- speaking in favor (PRO) of the findings from the ORBITA trial mentioned that while the myth that percutaneous coronary intervention’s prolong the life has long been debunked, a commonly held notion, and indeed one of the main reasons for performing PCI was to improve the quality of life in patients with significant coronary artery disease and symptoms. And ORBITA actually indicated that in a relatively healthy patient population, in a carefully conducted placebo controlled trial, the postulated benefits imparted with PCI were likely minimal. He went on to note that the trial was representative of a “real world” population of middle-aged patients with symptomatic coronary artery disease and  also referred to images from the original Lancet publication which indicated that the lesions that were treated appeared quite significant indeed. He concluded that in spite of  ongoing debates, results from ORBITA changed the way he discussed planned coronary intervention with his patients where he has changed his practice by incorporating a more tempered discussion on anticipated benefits with PCI, and has had greater conviction in advocating for more aggressive “medical” therapy.

Dr. Jay Giri from the University of Pennsylvania next took the stand in presenting the antagonistic (CON) version of the debate. Vying away from the anticipated track of discussing largely well publicized limitations of ORBITA, Dr. Giri took an innovative approach in going back to the fundamentals of the expected benefits from PCI. He presented data from recent studies which showed that PCI did reduce symptoms in patients with significant ischemia to a greater extent than optimal medical therapy alone. He also pointed to the fact that PCI reduced ischemia as well, and based on current understanding may mean favorably impacting future risk of subsequent adverse cardiac events including spontaneous myocardial infarctions (although that hypothesis is under evaluation with the on going ISCHEMIA trial). He honed in on the fact that the results from ORBITA had been sensationalized in both directions by ardent proponents and the media alike, while the “reality” was probably in between. With ongoing sub group analyses from the ORBITA trial itself, as well as follow-up studies being conducted, this is a rapidly evolving arena- and trainees /early career interventionists would do well in keeping themselves abreast of the nuances of the evolving data.

 

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Highlights of the 1st Annual Sex and Gender Conference at AHA18

Walking into the Palmer House Hotel, the longest continuously operating hotel in the United States, you can’t help but pause in awe at the intricate décor and take in the most photographed ceiling in the world. I make my way to the Honoré Ballroom, named after Bertha Honoré Palmer, the wife of Palmer and an astute businesswoman and well-known Chicago socialite of her time, not knowing what to expect for the 1st annual Sex and Gender Influence on Cardiovascular Disease (CVD) conference.

Annabelle Volgman, medical director of the Rush Heart Center for Women, kicks off the evening by thanking the speakers and planning members, and encouraging photography and social media sharing. The many photos of the evening include Bertha Honoré’s portrait adjacent to the colorful and modern logo that, I think, will become a recognized image at future AHA Scientific Session meetings.

Dr. Annabelle Volgman welcomes attendees to the 1st Annual Sex and Gender Influences on Cardiovascular Disease at the Palmer Hotel in Chicago, IL (November 11, 2018).

 

Dr. Nanette Wenger of the Emory Women’s Heart Center starts the conversation with her presentation titled “Why is Mortality from Cardiovascular Disease Rising in Men and Women?” She flashes a graph of CVD mortality on the screen, highlighting the steep decline in the past decades, but the leveling off and reversal in recent years, particularly in women under the age of 55 years. The parallel rise in obesity and diabetes, as well as “non-traditional” CVD risk factors such as depression and perceived stress disproportionally affect women, she explains, and may be responsible for this reversal in CVD death rates. Summarizing the recent paper, “Defining the New Normal in Cardiovascular Risk Factors” by Dr. Donald Lloyd-Jones and Dr. Philip Greenland she points to a combination of health behaviors and ideal levels of total cholesterol, blood pressure, and fasting blood glucose, as key factors in achieving cardiovascular health.

“Behavior change,” she says, “is the ‘Holy Grail’ of heart health” and as “health professionals take back the role [of health educator] and address lifestyle behaviors” we will see favorable trends in biomarker targets we’re so interested in.

Later during the Q+A panel, when asked about the best way to approach behavior change with patients, she advises to first, “Give information – if your patient does not have the information, they can’t make a change. Then, let them start with what they would like to start with. Don’t give them 8-10 [health behaviors] to change – they will tune you out.” Dr. Gina Lundberg, co-director of the Emory Women’s Heart Center, chimes in that the clinician’s “approach to weight loss is similar to smoking cessation. Identify the obstacles in the patient’s way – money, time, desire – and often just identifying those hurdles will lead to improvement.”

Dr. Laxmi Mehta, director of the Women’s Cardiovascular Health Program at the Ohio State University Wexner Medical Center, adds that she includes an emotional appeal – “Where is the patient going and what do they want?” Seeing a child’s wedding or playing with their grandkids, developing rapport with patients and fitting your recommendations to their goals can start the health behavior change process, even in a 5 minute clinician-patient discussion.