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Anticoagulation in Subclinical Atrial Fibrillation and the Prevention of Stroke

May is National Stroke Awareness Month. This initiative began in May 1989 to promote public awareness and reduce the incidence and associated burden of stroke in the United States.1  Despite ongoing efforts, stroke remains a leading cause of death and long-term disability in the United States.2-4 Every year about 795,000 people in the United States have a stroke.2    

Stroke can be preventable. One of its major risk factors, atrial Fibrillation, affects as many as 2.2 million Americans.  In people over 80 years of age, atrial fibrillation remains the direct cause of 1 in 4 strokes.5-6 There are documented benefits to the administration of direct oral anticoagulants and vitamin K antagonists in new-onset atrial fibrillation (> 24-hour duration).  There is controversy on the use of these agents with asymptomatic, subclinical atrial fibrillation (SCAF), or atrial fibrillation (< 24 hour duration).7-8   Results from a meta-analysis of 50 studies suggested SCAF being commonly detected within in patients after a stroke.9   Studies also report shorter episodes of SCAF associated with a higher likelihood of subsequent longer episodes of SCAF and nearly six times higher risk of clinical atrial fibrillation.10-11

It has been well documented that the use of cardiac implantable electronic devices and wearable monitors leading to increased detection of subclinical atrial fibrillation in patients. It is argued that in efforts to reduce the stroke risk, with the detection of subclinical atrial fibrillation, clinicians may have a window of opportunity in the initiation of anticoagulation. The American Heart Association published a scientific statement on the prevalence, clinical significance, and management of subclinical atrial fibrillation. It also highlighted current gaps in knowledge and areas of controversy around the treatment of subclinical atrial fibrillation.8

With the lack of clearly defined thresholds of atrial fibrillation burden to initiate oral anticoagulation, clinicians are faced with having to weight the clinical benefits and contraindications to anticoagulation therapy for patients with SCAF.8  A population health approach, leveraging the use of the electronic medical record may present alternatives into risk stratification and therapeutic management of direct oral anticoagulants .6 Options such as the use of anticoagulation clinics may need to be explored in the case of oral anticoagulant agents that do not require routine laboratory monitoring.

 Findings from two ongoing clinical trials in patients with Cardiac Implanted Electronic Devices-detected SCAF will inform on the management of SCAF in the prevention of strokes: the ARTESiA (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Subclinical Atrial Fibrillation; NCT 01938248)41 and NOAH (Non–Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes; NCT 02618577).8  Until then, it will be important for clinicians to continue working, following a patient centered approach. Factors such as patient goals and preferences, adherence, gaps in knowledge, will need to be addressed in order to support a more personalized, therapeutic approach.8

References:

  1. Bush, George. Peters, Gerhard; Woolley, John T. (eds.). “Proclamation 5975—National Stroke Awareness Month, 1989”. The American Presidency Project. University of California at Santa Barbara.
  2. Kochanek KD, Xu JQ, Murphy SL, Arias E. Mortality in the United States, 2013. NCHS Data Brief, No. 178. Hyattsville, MD: National Center for Health Statistics, Centers for Disease Control and Prevention, Department of Health and Human Services; 2014.
  3. Mozzafarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al., on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation 2016;133(4):e38–360.
  4. Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Associationexternal icon. Circulation. 2020;141(9):e139–e596.
  5. National Institute of Neurological Disorders and Stroke. Atrial fibrillation and stroke information. 2019. https://www.ninds.nih.gov/Disorders/All-Disorders/Atrial-Fibrillation-and-Stroke-Information-Page
  6. Jame S, Barnes G. Stroke and thromboembolism prevention in atrial fibrillation. Heart. 2020;106(1):10-17. doi:10.1136/heartjnl-2019-314898
  7. Healey JS, Amit G, Field TS. Atrial fibrillation and stroke: how much atrial fibrillation is enough to cause a stroke?. Curr Opin Neurol. 2020;33(1):17-23. doi:10.1097/WCO.0000000000000780
  8. Noseworthy PA, Kaufman ES, Chen LY, Chung MK, Elkind MSV, Joglar JA, Leal MA, McCabe PJ, Pokorney SD, Yao X; on behalf of the American Heart Association Council on Clinical Cardiology Electrocardiography and Arrhythmias Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; and Stroke Council. Subclinical and device-detected atrial fibrillation: pondering the knowledge gap: a scientific statement from the American Heart Association. Circulation. 2019;140:e944–e963. doi: 10.1161/CIR.0000000000000740.
  9. Sposato LA, Cipriano LE, Saposnik G, Ruíz Vargas E, Riccio PM, Hachinski V. Diagnosis of atrial fibrillation after stroke and transient ischaemic attack: a systematic review and meta-analysis. Lancet Neurol. 2015; 14:377–387. doi: 10.1016/S1474-4422(15)70027-X
  10. Mahajan R, Perera T, Elliott AD, Twomey DJ, Kumar S, Munwar DA, Khokhar KB, Thiyagarajah A, Middeldorp ME, Nalliah CJ, et al.. Subclinical device-detected atrial fibrillation and stroke risk: a systematic review and meta-analysis. Eur Heart J. 2018; 39:1407–1415. doi: 10.1093/eurheartj/ehx731
  11. Swiryn S, Orlov MV, Benditt DG, DiMarco JP, Lloyd-Jones DM, Karst E, Qu F, Slawsky MT, Turkel M, Waldo AL; RATE Registry Investigators. Clinical implications of brief device-detected atrial tachyarrhythmias in a cardiac rhythm management device population: results from the Registry of Atrial Tachycardia and Atrial Fibrillation Episodes. Circulation. 2016; 134:1130–1140. doi: 10.1161/CIRCULATIONAHA.115.020252

“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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Catheter Ablation as First Line Therapy for Atrial Fibrillation: Are we there yet?

For the last two decades, the management of patients with atrial fibrillation (AF) had stayed in an “equipoise” between rate and rhythm control as shown by AFFIRM and RACE trials 1,2. However, rate control strategy remained the predominant mantra in AF management for the majority of patients in clinical practice.

The most recent American College of Cardiology/American Heart Association/Heart Rhythm Society AF guidelines were written in 2014 followed by a guideline update in 2019 3,4. At that time, most randomized controlled trials comparing CA with medical therapy included patients after they had failed at least 1 anti-arrhythmic drug (AAD), and very few trials utilized AF ablation as first-line therapy. These guidelines recommend CA for paroxysmal AF in symptomatic patients if they are intolerant to at least 1 AAD as a Class I-A recommendation. Guidelines also suggest that CA is reasonable as an initial rhythm control strategy for some patients with recurrent symptomatic AF even before the therapeutic trial of AAD (Class II-B).

Over the last 3 years, the pendulum has swung dramatically in the favor of rhythm control with much credit to CA. The “big bang” started with CASTLE-AF showing the benefit of catheter ablation in reducing all-cause mortality or heart failure hospitalizations in AF patients with heart failure 5. While the CABANA trial did not deliver the paradigm shifting results everyone in the electrophysiology community had hoped for, it still demonstrated the safety of CA and its superior role in preventing recurrent AF 6.

The last 6 months have been incredible in AF management with mounting evidence in favor of early rhythm control. EAST-AFNET 4 trial showed that early rhythm control with Flecainide (35.9%), Amiodarone (19.6%), and Dronaderone (16.7%) results in an improvement in the composite outcome of death, stroke or major adverse effects as compared with rate control (HR 0.79; 96% CI 0.66-0.66; p=0.005) 7. Important to note that only 8% of patients in this trial underwent CA.

Following this momentum 3 landmark trials in the last 4 months have demonstrated the benefits of CA with cryoballoon as the initial therapy in AF. The STOP AF First Trial randomized 203 paroxysmal AF patients to cryoablation or drug therapy and showed that CA was superior to AAD in preventing recurrent AF (P<0.001) 8. Similarly, the EARLY AF investigators randomized 303 patients to cryoablation or AAD and showed a significantly lower rate of recurrent AF with cryoablation using continuous cardiac rhythm monitoring post-ablation 9.  The CRYO FIRST trial continued the same theme and showed that CA was superior to AAD as initial therapy for the management of symptomatic paroxysmal AF 10.  Importantly, all 3 trials also demonstrated the safety profile of cryoablation. Now there are several reasons why CA is superior to AAD.

  1. AAD has limited efficacy and they have rare but life-threatening side effects. A significant proportion of patients discontinue AAD due to these side effects. The most feared side effects include prolonged QTc related arrhythmias like Torsade de Pointes or multiorgan side effects from Amiodarone.
  2. The safety profile of CA is excellent and it continues to improve.
  3. The advances in ablation techniques have resulted in improved efficacy of CA in maintaining long-term sinus rhythm.

3 older randomized trials have also compared CA to drug therapy and when the pooled evidence is considered for CA as first-line therapy in AF, similar results are observed 11. Overall, CA results in a 38% reduction in recurrent atrial arrhythmia (P<0.001), and the number needed to treat (NNT) to prevent 1 arrhythmia was 5 with effects consistent across radiofrequency or cryoablation 11. The hospitalization rates in CA were also significantly lower (68% reduction, P<0.001). These results were achieved without any significant increase in major adverse events.  The possible rationale for these results is that early effective rhythm control may modify the electrical and structural substrate that sustains AF and thus prevents atrial myopathy as it is well known that recurrent paroxysmal AF episodes can potentially progress to persistent AF (AF begets AF).

Based on this data, I believe there is sufficient evidence to consider CA as first line therapy in symptomatic patients with paroxysmal AF after a careful discussion of risks and benefits. Of course, such decision making should be patient centered. It is possible that future guideline updates may upgrade CA as a Class 1-A recommendation in this patient population.

References

  1. Van Gelder IC, Hagens VE, Bosker HA, Kingma JH, Kamp O, Kingma T, et al. A Comparison of Rate Control and Rhythm Control in Patients with Recurrent Persistent Atrial Fibrillation. New England Journal of Medicine 2002;347:1834–1840. doi:10.1056/NEJMoa021375.
  2. A Comparison of Rate Control and Rhythm Control in Patients with Atrial Fibrillation. New England Journal of Medicine 2002;347:1825–1833. doi:10.1056/NEJMoa021328.
  3. January Craig T., Wann L. Samuel, Calkins Hugh, Chen Lin Y., Cigarroa Joaquin E., Cleveland Joseph C., et al. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society in Collaboration With the Society of Thoracic Surgeons. Circulation 2019;140:e125–e151. doi:10.1161/CIR.0000000000000665.
  4. January Craig T., Wann L. Samuel, Alpert Joseph S., Calkins Hugh, Cigarroa Joaquin E., Cleveland Joseph C., et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation. Journal of the American College of Cardiology 2014;64:e1–e76. doi:10.1016/j.jacc.2014.03.022.
  5. Marrouche NF, Brachmann J, Andresen D, Siebels J, Boersma L, Jordaens L, et al. Catheter Ablation for Atrial Fibrillation with Heart Failure. New England Journal of Medicine 2018;378:417–427. doi:10.1056/NEJMoa1707855.
  6. Packer DL, Mark DB, Robb RA, Monahan KH, Bahnson TD, Poole JE, et al. Effect of Catheter Ablation vs Antiarrhythmic Drug Therapy on Mortality, Stroke, Bleeding, and Cardiac Arrest Among Patients With Atrial Fibrillation: The CABANA Randomized Clinical Trial. JAMA 2019;321:1261. doi:10.1001/jama.2019.0693.
  7. Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, et al. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. New England Journal of Medicine 2020;383:1305–1316. doi:10.1056/NEJMoa2019422.
  8. Wazni OM, Dandamudi G, Sood N, Hoyt R, Tyler J, Durrani S, et al. Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation. New England Journal of Medicine 2021;384:316–324. doi:10.1056/NEJMoa2029554.
  9. Andrade JG, Wells GA, Deyell MW, Bennett M, Essebag V, Champagne J, et al. Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation. New England Journal of Medicine 2021;384:305–315. doi:10.1056/NEJMoa2029980.
  10. Kuniss M, Pavlovic N, Velagic V, Hermida JS, Healey S, Arena G, et al. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation. EP Europace 2021. doi:10.1093/europace/euab029.
  11. Turagam MK, Musikantow D, Whang W, Koruth JS, Miller MA, Langan M-N, et al. Assessment of Catheter Ablation or Antiarrhythmic Drugs for First-line Therapy of Atrial Fibrillation: A Meta-analysis of Randomized Clinical Trials. JAMA Cardiology 2021. doi:10.1001/jamacardio.2021.0852.

“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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Optimal Management of Periprocedural Anticoagulation for Catheter Ablation of Atrial Fibrillation

Catheter ablation (CA) of atrial fibrillation (AF) is a safe procedure and the overall complication rates are low. Periprocedural thromboembolic events are one of the most feared complications of this procedure. A large systematic review of 192 studies showed the pooled complication rate of stroke or transient ischemic attacks was only  0.6%1. Despite the low rates of these thromboembolic complications, it is important to explore the factors that contribute to periprocedural thromboembolic events and more importantly ways to prevent them.

It turns out that the periprocedural anticoagulation (AC) strategy has a significant impact on the thromboembolic complications during CA of AF, and the peri-procedural management of AC has been continuously evolving. In the Vitamin K antagonist (VKA) era, the usual practice was to interrupt AC before ablation and then resume it after the procedure with the rationale of minimizing periprocedural bleeding. However, the pendulum moved rapidly after the landmark COMPARE trial. This study enrolled 1584 patients with CHADS2 score ≥1 and assigned them in 1:1 fashion to discontinue VKA or continue VKA during ablation and observed thromboembolic events in the 48 hours after ablation. The study showed that uninterrupted VKA use was associated with a reduction in periprocedural stroke and minor bleeding (odds ratio 13; 95% CI 3.1-55.6; p<0.001)2.

With the advent of direct oral anticoagulants (DOACS) and their improved efficacy in preventing thromboembolic events in patients with AF, an increasing number of patients in clinical practice are on DOACS when they present for CA. Multiple head-to-head trials have shown that uninterrupted DOACS are safe or even better as compared with uninterrupted VKA in preventing procedural thromboembolic events and current guidelines recommend uninterrupted or minimally interrupted DOACS for patients undergoing CA of AF3,4.

Currently, there is wide variability in clinical practice on whether to perform CA with completely uninterrupted DOAC or to omit a single dose or more than one dose? And is there any difference in procedural outcomes between these different strategies?

There is limited data on the comparison of procedural complications with different periprocedural AC strategies with DOACS. Data from randomized trials suggest that there is no difference in thromboembolic and bleeding outcomes whether uninterrupted, single-dose interruption, or more than one dose interruption strategy is used 5. One limitation to this data is that with the low rates of thromboembolic procedural complications in patients taking DOACS, it is hard to demonstrate that one strategy is better than the other. Silent cerebral ischemic lesions are increasingly recognized in patients undergoing CA and it is unclear if in the long term they are associated with dementia or cognitive impairment. An important finding from observational studies is that an uninterrupted DOAC strategy may be preventive against silent cerebral ischemic lesions, however, these results were not observed in randomized trials 6–8.

In summary, a strategy of uninterrupted or minimally interrupted DOACS appears to be safe in reducing periprocedural thromboembolic events for patients undergoing CA.

References

  1. Gupta Aakriti, Perera Tharani, Ganesan Anand, et al. Complications of Catheter Ablation of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2013;6(6):1082-1088. doi:10.1161/CIRCEP.113.000768
  2. Di Biase L, Burkhardt JD, Santangeli P, et al. Periprocedural stroke and bleeding complications in patients undergoing catheter ablation of atrial fibrillation with different anticoagulation management: results from the Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation (COMPARE) randomized trial. Circulation. 2014;129(25):2638-2644. doi:10.1161/CIRCULATIONAHA.113.006426
  3. January CT, Wann LS, Calkins H, et al. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019;74(1):104-132. doi:10.1016/j.jacc.2019.01.011
  4. Romero Jorge, Cerrud-Rodriguez Roberto C., Alviz Isabella, et al. Significant Benefit of Uninterrupted DOACs Versus VKA During Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2019;5(12):1396-1405. doi:10.1016/j.jacep.2019.08.010
  5. Jafry Ali H, Akhtar Khawaja H, Chaudhary Amna M, et al. Abstract 13721: Is Single Dose Interruption of Direct Oral Anticoagulants Necessary Before Atrial Fibrillation Ablation? A Systematic Review and Meta-analysis. Circulation. 2020;142(Suppl_3):A13721-A13721. doi:10.1161/circ.142.suppl_3.13721
  6. Müller P, Halbfass P, Szöllösi A, et al. Impact of periprocedural anticoagulation strategy on the incidence of new-onset silent cerebral events after radiofrequency catheter ablation of atrial fibrillation. J Interv Card Electrophysiol Int J Arrhythm Pacing. 2016;46(3):203-211. doi:10.1007/s10840-016-0117-6
  7. Nakamura K, Naito S, Sasaki T, et al. Uninterrupted vs. interrupted periprocedural direct oral anticoagulants for catheter ablation of atrial fibrillation: a prospective randomized single-center study on post-ablation thrombo-embolic and hemorrhagic events. EP Eur. 2019;21(2):259-267. doi:10.1093/europace/euy148
  8. Nakamura R, Okishige K, Shigeta T, et al. Clinical comparative study regarding interrupted and uninterrupted dabigatran therapy during perioperative periods of cryoballoon ablation for paroxysmal atrial fibrillation. J Cardiol. 2019;74(2):150-155. doi:10.1016/j.jjcc.2019.02.003

“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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Late-Breaking Highlights: “To Screen Or Not To Screen And Then What? Studies of Detection and Treatment of AF”

This was an exciting session at AHA 2020 which focused on clinical trials of screening, monitoring, and early intervention in Atrial Fibrillation (AF). Screening of AF is a controversial topic and for individuals >65 years, current AHA guidelines give a Grade 2a recommendation for screening whereas USPSTF guidelines suggest that there is insufficient evidence for screening. In this article, I will be discussing studies that addressed AF screening and their implications on clinical practice with Dr. Stavros Stavrakis who is an electrophysiologist and Associate Professor at the University of Oklahoma Health Sciences Center, Oklahoma City.

Question: What are the important goals when we think about screening for AF?

Dr. Stavrakis: The important goals for screening in AF are to establish a diagnosis of new AF in patients at high risk of stroke so they can be anticoagulated, ultimately reducing the risk of stroke.

There were 3 important trials that addressed AF screening in different patient populations.

SEARCH AF

  • In patients who have undergone cardiac surgery and have a higher risk of stroke but no history of pre-operative or pre-discharge AF, what is the risk of developing AF/Aflutter in the sub-acute post discharge period?
  • 336 post-cardiac surgery patients (median CHADS2Vasc Score 4) but with little or no AF in the post-operative period (<24 hours of AF but no intent to anticoagulate at discharge) were randomized to continuous cardiac rhythm monitoring vs usual care during the sub-acute post discharge period.
  • In the enhanced cardiac rhythm monitoring group 19.6% participants developed AF/Aflutter as compared with 1.7% in the usual care group with an absolute rate difference 17.9% (p<0.001, NNS=6).

Question: What are the implications of this trial on clinical practice?

Dr. Stavrakis: Risk of POAF, although peaking at 48-72hours post-op, is not confined to the index hospitalization, continuous monitoring for POAF can identify AF in a significant proportion of patients (20%) that may need treatment with anticoagulation. Whether anticoagulation improves outcomes in these patients, remains to be determined.

VITAL-AF Trial

  • Among older adults (age>65) presenting to primary care visits, does point of care rhythm assessment with a single lead ECG result in increased diagnosis of AF?
  • 30,722 patients were randomized to screening vs control.
  • Screening did not significantly affect AF diagnosis in the overall study sample (1.74% vs 1.60%, p=0.33)
  • Increased likelihood of AF diagnosis at primary care encounter (p<0.02)
  • Effectiveness of screening varied by age with effective screening in age>85 (risk difference 1.88%, NNS=53)
  • Overall no difference in the initiation of anticoagulation

Question: What are the implications of this trial on clinical practice?

Dr. Stavrakis: There are 2 important implications from this trial.

  1. Screening everyone age>65 for AF at a single time point is not an efficient way to detect AF, especially if the usual care is very good in detecting AF by pulse palpation or BP device.Screening at age>85 may be more effective than usual care to identify silent AF, but it is uncertain if it changes management or outcomes

mSTOPS

  • Can screening for AF by wearing an ECG patch improve clinical outcomes at 3-years?
  • 1718 actively monitored participants vs 3371 matched observational controls with analysis of 3-year clinical outcomes.
  • Mean duration of follow-up was 29 months
  • 11.4% of actively monitored patients developed AF vs 7.3% of matched controls
  • No difference in anticoagulation prescription between both arms (45.2% vs 44%, p=0.84)
  • 3-year Primary combined end point (death, stroke, systemic embolism or MI) for entire cohort was 4.5 vs 5.5 per 100 person-year (HR 0.79, p<0.01) and for diagnosed AF patients it was 8.4 vs 13.8 per 100 person-year (HR 0.53, p<0.01).

Question: What are the implications of this trial on clinical practice?

Dr. Stavrakis: Clinical outcomes can be improved with AF screening provided these patients are followed up for extended periods of time. However, this was not a randomized trial and unknown confounders may have influenced the outcome.

Question: What are 3 important unanswered questions pertinent to screening of AF?

  1. What is the impact of AF screening on clinical outcomes? Large studies, adequately powered to detect clinical outcomes, are underway (SAFER, HEARTLINE, GUARD-AF).
  2. What is the optimal screening intensity that identifies AF which would benefit from anticoagulation?
  3. What is the minimum AF burden that, if identified with screening, would benefit from anticoagulation?

“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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The Future of Wearable Technology & Detecting Atrial Fibrillation – An Update!

Last November at AHA18, I was lucky enough to catch a talk from one of the investigators, Dr. Marco Perez, working on the Apple Heart Study, where he described the goals of the project. I even wrote about it for the blog I wrote at AHA18 in Chicago, which you can find here.

To quickly recap, this unprecedented collaboration between Apple and Stanford is a progressive clinical trial that uses data from Apple Watch devices from over 400,000 participants. The main purpose of this study was to examine if atrial fibrillation (AFib) can be reliably diagnosed from irregular pulse notification data from wearable devices. In November, Dr. Perez mentioned that they wouldn’t have data until early 2019, and this past March, they released some results that are really exciting.

Highlights from the findings include:

  • Around 0.5% of participants received irregular pulse notifications, which was particularly important since people were concerned that these devices would potentially over-notify people.
  • The pulse detection algorithm of the Apple Watch has a 71% positive predictive value – this was compared to simultaneous electrocardiography patch recordings.
  • The majority of the time (84%) when participants received irregular pulse notifications, they were found to be in AFib at the time of the notification.
  • 1/3 of the participants who received irregular pulse notifications and were then followed up by using an ECG patch over a week later were found to have AFib. This isn’t entirely surprising since AFib is an intermittent condition, so it’s not uncommon for it to go undetected in subsequent monitoring.
  • 57% of people who received irregular pulse notifications sought medical attention afterwards.
  • A clinical trial could be conducted in this large-scale virtual manner

The last point is particularly important because this is the first study of its kind. It was almost completely virtual, at least from the standpoint that the researchers analyzing the data never once had any contact with the participants. Additionally, the scope of the number of people who were analyzed is impressive – 400,000 participants is quite the sample size, especially for someone like me who studies heart disease in mice!

Because AFib is an extremely common condition, affecting between 2-6 million people in the United States, that often goes undiagnosed, understanding that wearable technology can aid patients in detecting their condition is huge. Also, with the increase in technology in our health care sphere (specifically in cardiology), something that was expertly discussed by Dr. John Chen earlier this year on his blog is that this is just the beginning in understanding how wearable technology can help us treat disease. We now have another tool in our kit, and this one looks promising.

In Stanford’s press release, Dr. Perez said, “The performance and accuracy we observed in this study provides important information as we seek to understand the potential impact of wearable technology on the health system. Further research will help people make more informed health decisions.”

Interestingly, Johnson & Johnson and Apple recently announced their plans to build off these preliminary results by partnering together in a new project called HEARTLINE. This study will focus on an older population (~ 65 years) of around 150,000 participants who, due to their age, are at a higher risk of AFib. It’s a really exciting time to be in the cardiology field since this is just the beginning of this type of research, which is full of therapeutic potential.

It’s also really thrilling to be able to follow-up with this study, especially since it all started with my father-in-law, who has AFib, being nervous about using wearable technology to detect his condition. I’m excited to share this data with him as well since maybe he’ll feel a little more comfortable using it now.

Examples of the notifications that participants in the Apple Heart Study receive. Courtesy of Apple

Examples of the notifications that participants in the Apple Heart Study receive. Courtesy of Apple

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Management of Stroke Patients: A One Man Show or A Tag-Team?

Atrial fibrillation (AF) increases risk of stroke up to 5 folds, resulting in considerable physical, cognitive impairment and high mortality1. Thus, AF related strokes are very expensive to treat compared to non-AF strokes2. Oral anticoagulation is a well-established therapy in the majority of stroke cases3. Warfarin reduces the risk of stroke by 64% and mortality by 30% compared to placebo3.

Recent data from the pinnacle registry presented by ‘Roopinder Sandhu, Edmonton, AB, Canada’ at the Scientific Sessions 2018, highlighted three key challenges in anti-coagulants management in stroke patients4. Data from a national outpatient registry reported over 700,000 patients had a diagnosis of atrial fibrillation5. Although oral anticoagulation use increased over time, around 40% of patients who are eligible for anti-coagulation never got started on therapy5. The second gap is sub-therapeutic dosing. Recent data from the orbit registry evaluated over 5700 patients who were recently started on a new drug and reported that one in eight patients were either underdosed or overdosed6. Further, there was a higher rate of adverse events in patients who had dosing that was sub therapeutic. The third gap is non-adherence. Data from administrative claims based on a large U.S. commercial insurance database, calculated adherence based on the fill date and the days of supply on the pharmacy claims over a median of 1.1 years7. Less than half of patients who were started on a drug therapy reached the threshold of proportion days covered of 80% or higher. This proportion was less for patients who were on Warfarin.

Given the public health consequences of untreated AF, it is necessary to evaluate different strategies to deliver stroke prevention therapy. Data from 30 randomized clinical trials evaluating the impact of pharmacists, versus standard care, showed superior results in the pharmacist care group in reducing systolic blood pressure (by 8 mm HG), diastolic blood pressure (by 4 mm HG) and total cholesterol (by 17 milligrams DL) and LDL (by 13 mg DL)10. This was done through educational intervention and identification of drug related problems followed by early feedback to the treating physician.

Roopinder added a few possible explanations to what could be driving such impact in the Canadian setting. Typically, a general practitioner would be dealing with patients with a higher evidence of chronic diseases. Further, patient demands often exceed the available physician capacity.

While these results collectively suggest that pharmacist led strategies may be a promising way forward because of their accessibility, drug expertise and their ability to build a trusted relationship. A few key things should be considered. First, that anticoagulation remains to be a complicated problem when it comes to individual patients, with many factors playing a role in the decision process including; medical history (as prior bleeding) and patient preferences. Second, while these interventions seem beneficial in the short-term it may lead to the same shortcomings in the long-term with the increase in demand on the pharmacists as the main provider.

Finally, a key question remains, would a collaborative approach between physicians and pharmacists yield better outcomes through reducing the burden on both providers and simultaneously increasing the time allocated to stroke patients on a case-by-case basis?

 

REFERENCES

  1. Developed with the special contribution of the European Heart Rhythm Association (EHRA), Endorsed by the European Association for Cardio-Thoracic Surgery (EACTS), Authors/Task Force Members, Camm, A. J., Kirchhof, P., Lip, G. Y., … & Al-Attar, N. (2010). Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). European heart journal31(19), 2369-2429.
  2. Stewart, S., Murphy, N., Walker, A., McGuire, A., & McMurray, J. J. V. (2004). Cost of an emerging epidemic: an economic analysis of atrial fibrillation in the UK. Heart90(3), 286-292.
  3. Ruff, C. T., Giugliano, R. P., Braunwald, E., Hoffman, E. B., Deenadayalu, N., Ezekowitz, M. D., … & Yamashita, T. (2014). Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. The Lancet383(9921), 955-962.
  4. Sandhu, R. K., Guirguis, L. M., Bungard, T. J., Youngson, E., Dolovich, L., Brehaut, J. C., … & McAlister, F. A. (2018). Evaluating the potential for pharmacists to prescribe oral anticoagulants for atrial fibrillation. Canadian Pharmacists Journal/Revue des Pharmaciens du Canada151(1), 51-61.
  5. Marzec, L. N., Wang, J., Shah, N. D., Chan, P. S., Ting, H. H., Gosch, K. L., … & Maddox, T. M. (2017). Influence of direct oral anticoagulants on rates of oral anticoagulation for atrial fibrillation. Journal of the American College of Cardiology69(20), 2475-2484.
  6. Steinberg, B. A., Peterson, E. D., Kim, S., Thomas, L., Gersh, B. J., Fonarow, G. C., … & Piccini, J. P. (2015). Use and outcomes associated with bridging during anticoagulation interruptions in patients with atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Circulation131(5), 488-494.
  7. Yao, X., Abraham, N. S., Alexander, G. C., Crown, W., Montori, V. M., Sangaralingham, L. R., … & Noseworthy, P. A. (2016). Effect of adherence to oral anticoagulants on risk of stroke and major bleeding among patients with atrial fibrillation. Journal of the American Heart Association5(2), e003074.
  8. Santschi, V., Chiolero, A., Burnand, B., Colosimo, A. L., & Paradis, G. (2011). Impact of pharmacist care in the management of cardiovascular disease risk factors: a systematic review and meta-analysis of randomized trials. Archives of internal medicine171(16), 1441-1453.

 

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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.

 

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WATCHMAN: An Alternative to Warfarin for the High Risk Patient

“Wisdom consists of the anticipation of consequences”
Norman Cousins

I recently saw Mr. John Doe for atrial fibrillation (AF). Well into his eighties, he enjoys a good quality of life. This elderly gentleman is mostly unaware of his paroxysms of AF. However, he had also suffered a stroke in the past, and as such was managed with warfarin. He was lucky. Recently, he experienced a gastrointestinal hemorrhage, requiring temporary reversal of his anticoagulant in addition to receiving a few pints of blood. There were no apparent clinical triggers for this event. Mr. Doe is not a fictional person but is a typical example of what is a common clinical dilemma: how best to protect against stroke in a patient who is at high risk, yet becomes intolerant to warfarin.

Previously, these patients were commonly switched to aspirin alone as a poor alternative to anticoagulation. Most clinicians would feel apprehensive of taking a gamble switching to novel oral anticoagulants which do not have available reversal agents (at the time this blog was written).

So, what then?

Enter the “Watchman.”

The majority of thromboembolic strokes in patients with AF originate in the left atrial appendage (LAA). The function of this structure is to assist with atrial transport, however during AF, atrial blood flow becomes impaired and stasis can occur in the LAA leading to thrombus formation at this location. Fragmentation and embolization of thrombi can lead to stroke, which is commonly disabling. The presence of comorbid factors such as diabetes, heart failure among other clinical variables can further increase this risk [1].

The last several years has witnessed the development and refinement of procedures referred to as left atrial appendage occlusion. Although there are several of the devices available worldwide, I will refer to the WATCHMAN system which is approved for use in the United States. In brief, the WATCHMAN device resembles a small umbrella (Figure 1). The FDA approved the device for the purpose of preventing embolic stroke with non-valvular AF. The available data that lead to its approval implies a non-inferiority to warfarin [2,3]

the WATCHMAN device resembles a small umbrella

Figure 1. (accessed from www.bostonscientific.com; www.modernhealthcare.com)

The method of device introduction is via a femorally placed venous sheath delivered transseptally (from right to left atrium). The destination of the device is the ostium of the LAA (Figure 2). The ultimate goal of the procedure is to totally exclude the LAA from the chamber, thus preventing flow into and from the LAA, in effect precluding thrombus formation. The procedure is performed with the guidance of transesophageal echocardiography, and typically under general anesthesia. The duration of the implant typically does not exceed an hour. Patients are continued on warfarin during the initial perioperative phase.

the destination of the device is the ostium of the LAA

Figure 2. (Accessed from www.bostonscientific.com; openaccessjournals.com)

Generally, after a forty-five-day period, transesophageal echocardiography is repeated to confirm the absence of peri-device leaks and verify device endothelialization. If the results are favorable, patients can often stop warfarin and switch to antiplatelet therapy. Presently, the available evidence compares WATCHMAN to warfarin, and comparisons to other anticoagulants is lacking.

It appears that enthusiasm for the WATCHMAN appears to be growing. For patients who require long-term warfarin use, but are at risk for hemorrhagic complications, this device appears to be a very good option. Cumulative experience will invariably lead to further improvements in design and greater safety [4,5].
 
References

  1. Lip GY, Lane DA. Stroke prevention in atrial fibrillation: a systematic review. JAMA. 2015;313:1950-62
  2. Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial.J Am Coll Cardiol. 2014;64:1-12
  3. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=2 81&bc=ACAAAAAAAgAAAA%3d%3d&
  4. Reddy VY1, Doshi SK2, Kar S3, Gibson DN4, Price MJ4, Huber K5, Horton RP6, Buchbinder M7, Neuzil P8, Gordon NT9, Holmes DR Jr10; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials.J Am Coll Cardiol. 2017;70:2964-2975
  5. Obeyesekere MN.Watchman Device: Left Atrial Appendage Closure For Stroke Prophylaxis In Atrial Fibrillation.J Atr Fibrillation. 2014; 7: 1099

Christian Perzanowski Headshot

Christian Perzanowski is an electrophysiologist in Tampa, FL. His main interests are in ablation techniques for atrial fibrillation and device therapy for congestive heart failure. He reports no conflicts of interests.

Apollo Beach, FL (05/17, CP)

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Deciphering the CABANA trial and what if anything do the results mean to the management of atrial fibrillation?

“The truth is rarely pure and never simple.”
Oscar Wilde

“Facts do not cease to exist because they are ignored.”
Aldous Huxley

As is apparent from my previous blogs, I am very passionate about atrial fibrillation (AF). Undoubtedly, the most common arrhythmia nationally, and likely worldwide, can cause disabling symptoms, lead to a stroke and exacerbate heart failure. In my experience, patients with AF can be categorized as either asymptomatic, or highly affected. Essentially the former are unaware of their diagnosis, and are often found to have AF by serendipity. Life is in fact very easy for them, as well as their clinicians: anticoagulate, rate control and move on.

Now, for those who are symptomatic, there exist management challenges. AF is classified as paroxysmal, which is an intermittent or periodic form of arrhythmia; persistent, which is a sustained form and generally felt to be a progressed state of AF; or permanent, where no interventions are done. There is a paucity of available antiarrhythmic agents to treat and suppress AF. Antiarrhythmic drugs have earned a reputation of not being very effective while causing significant systemic adverse effects. Clinicians who care for symptomatic AF patients have certainly observed them to often experience shortness of breath, chest discomfort, loss of stamina, sensation of tachycardia and in some cases heart failure. Not uncommonly, these symptoms lead to anxiety as well as a compromised quality of life. In short, these patients must be treated.

Over the last decade, the techniques employed to treat AF by catheter-based means have improved in efficacy, even for more advanced forms of persistent AF. Although far from ideal, a number of studies have demonstrated ablation methods (e.g. radiofrequency, referred to colloquially as “heat” or cryoablation, “freezing”) to be superior to attempts at drug suppression. This is no surprise, as ablation addresses the problem directly (e.g. preventing AF from initiating) by calculated tissue destruction. While repeat studies are sometimes needed, the improvement in quality of life and improvement in heart failure class (such as observed with CASTLE-AF, AATAC) are known benefits1,2.

CABANA (Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial) sought to determine whether AF ablation versus antiarrhythmic drug therapy could prevent a composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest1. This was a large randomized study with over 2,000 patients. The results, which were presented at the annual Heart Rhythm Society last month, yielded a rather disappointing result: ablation was not superior to drugs for preventing the above composite endpoint2. That’s a rather dubious final score.

In spite of acknowledging what Wilde and Huxley might say, I would like to reconcile several of CABANA’s limitations:

– Personally, I have a grievance with the use of a “composite score” in the above scenario; stroke and “serious bleeding” are in no way equivalent; mechanistically, how would the investigators theorize that ablation could prevent a cardiac arrest?
– Death, while inevitable is indeed a categorical variable, one is either alive or not. Given that the causes of death are innumerable, it does not seem appropriate to consider that ablation could prevent all causes of death. Rather than try to postulate that ablation, or a potpourri of antiarrhythmics could stave of death, a more appropriate measure would be to ascertain prevention of death from heart failure.
– Approximately 25% of patients assigned to drug therapy crossed to ablation. Notably, some sources cited difficulty in enrollment as patients and referring physicians likely felt that ablation would be more beneficial.
– The ablation techniques used, as were the drugs prescribed, were left to the discretion of the treating physicians. Hence, the methods employed were not uniform, and paroxysmal AF cases were pooled with more advanced forms of persistent AF.
– How about continued drug therapy after ablation? The POWDER-AF investigators were able to show less AF burden with continued antiarrhythmic support following AF ablation. This should be expanded upon with larger studies.

From my perspective, I do not believe that CABANA results will affect my practice. Many of us will be curious to see publications regarding future subanalysis. In my opinion, patients who are very symptomatic with AF and have not responded to antiarrhythmics should be treated with AF ablation, and especially those who have developed cardiomyopathy or worsened heart failure as a result of AF6.

References

  1. http://circ.ahajournals.org/content/early/2016/03/30/CIRCULATIONAHA.115.019406
  2. https://www.nejm.org/doi/full/10.1056/NEJMoa1707855
  3. https://clinicaltrials.gov/ct2/show/NCT00911508
  4. https://www.nhlbi.nih.gov/news/2018/atrial-fibrillation-catheter-ablation-or-drug-therapy-results-are
  5. Duytschaever M, Demolder A, Phlips T, Sarkozy A, El Haddad M, Taghji P, Knecht S, Tavernier R, Vandekerckhove Y, De Potter T. Pulmonary vein isolation With vs. without continued antiarrhythmic Drug treatment in subjects with Recurrent Atrial Fibrillation (POWDER AF): results from a multicentre randomized trial. Eur Heart J. 2018;39:1429-1437
  6. https://www.hrsonline.org/Policy-Payment/Clinical-Guidelines-Documents/2017-HRS-EHRA-E CAS-APHRS-SOLAECE-Expert-Consensus-Statement-on-Catheter-and-Surgical-Ablation-of-Atrial-Fibrillation

Christian Perzanowski Headshot
Christian Perzanowski is an electrophysiologist in Tampa, FL. His main interests are in ablation techniques for atrial fibrillation and device therapy for congestive heart failure. He reports no conflicts of interests.

sunset in tampa, florida

Tampa, FL (8/17 CP)

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Shared Decision Making In Cardiac Care

Illustration of seniors with life insurance

Shared decision making (SDM) is an approach both patients and clinicians can use to improve patient education and discussion in decision making. Decision aids are tools that promote SDM by improving patient-clinician communication about all treatment options and how the risks and benefits fit with their personal values and preferences. Today, we’ll chat about SDM in the context of cardiac care, with examples from atrial fibrillation and heart failure, as well as the entire CAD spectrum.

A Chronological Look at SDM
In 2012, Karen Sepucha reflected on shared decision-making and patient decision aids in an editorial for Circulation: Cardiovascular Quality and Outcomes. Two studies published in the same issue evaluated the impact of decision aids in urgent management of acute coronary syndrome (The Chest Pain Choice Decision Aid) and vascular access choice for coronary angiogram procedures. These studies reflect scenarios that are not traditionally thought to be amenable to SDM, but the results show that SDM in the emergency department and regarding technical treatment decisions, such as femoral versus radial access, had a positive impact on patient knowledge and decisional conflict. Sepucha’s concluding statement still rings true today: “Despite considerable evidence from many studies of decision aids, few of these tools are used routinely in practice.”

There are several challenges to using decision tools in practice. Decision aids should be brief and easily incorporated into the workflow of clinical practice, as well as easily accessible in the public domain. In 2015, CMS implemented a policy around healthcare for atrial fibrillation patients requiring all non-implanting physicians to use evidence-based decision tools and SDM practices. A 2017 article by Megan Coylewright and David Holmes in Circulation caution against this CMS mandate for SDM for patients with atrial fibrillation. The authors cite reasons reminiscent of Sepucha’s conclusions in 2012. Coylewright and Holmes point out that there is limited guidance on navigating SDM for patients with atrial fibrillation at risk for stroke. Specifically, while research consistently shows that “decision aids improve patient outcomes including knowledge, engagement, and satisfaction”, SDM has yet to become an integral part of clinical practice for a variety of reasons, both on the patient side and the clinician side. For example, barriers to use of SDM by physicians include insufficient training in the skillsets necessary to implement SDM, such as “inadequate assessment of patient preferences,” in addition to logistic challenges to implementation, whether at the institutional level, the lack of publicly available decision aids, or the time availability during patient-clinician interactions to thoroughly discuss patient preferences.

Atrial Fibrillation
Atrial fibrillation presents a particularly challenging case for optimizing treatment, due to low prescription, low adherence due to side effects and frequent testing, as well as increased risk of negative reactions due to polypharmacy. Thomson et al. found that atrial fibrillation patients at risk of stroke may deicide to forgo treatment with anticoagulants to avoid the medications’ adverse effects, with the knowledge that their stroke risk later on increased. However, professional guidelines on treatment of atrial fibrillation promote SDM and use of evidence-based decision tools while recognizing that inviting patients to participate in care decisions can be challenging to physicians.

A recent systematic review, “Availability of Patient Decision Aids for Stroke Prevention in Atrial Fibrillation” by O’Neill and colleagues summarize the current state of decision aids for patients with atrial fibrillation at risk for stroke and their treating physicians. The current landscape of pharmacologic therapy for stroke reduction includes multiple DOACs, implantable LAA closure devices, aspirin, and warfarin – each treatment with benefits and trade-offs that must be considered “in the context of individual values and preferences and willingness to adhere to therapy”. Many of the decision aids in the studies reviewed by O’Neill et al. did not display all therapeutic choices, were delivered to patients primarily by nonphysicians, and were not publicly available.

Depression and CAD
SDM and decision tools pair nicely with assessment of depression in heart disease patients. In a recent paper, “Identifying and Managing Depression in Patients with CAD,” Aimee Salzer Pragle and Susan Salashor discuss the epidemiology and risk factors, clinical presentation, assessment tools, and treatment options for depression in patients with heart disease. In a 2011 review, Christopher Celano and Jeff Huffman estimated that 20-40% of patients with CAD may suffer from depression, and despite the availability of screening tools brief enough for clinical practice (such as the Patient Health Questionnaire-9 or -2), depression often goes unrecognized in cardiac care. Depression in patients with CAD is associated with progression of heart disease, poor quality of life and physical functioning, repeat cardiac events, and 2-2.5 fold increased risk of mortality [link]. Risk factors for depression in patients with CAD include “younger age, female sex, a history of depression, social isolation, previous cardiac events, and diabetes” and depression can increase risk of suicide, homicide, and substance abuse (which can exacerbate cardiac symptoms and promote further degeneration).

Innovative Frameworks – A Segue to Implementing SDM?
From the clinician side, disease-specific evaluation frameworks inclusive of all relevant aspects of a patient’s health provide another avenue towards optimizing patient-clinician communication. For example, in a recent paper, Gorodeski et al. present a multi-domain framework for managing heart failure and the associated questionnaires and tools that go with each task.

Gorodeski image
These tools include the Mini Nutritional Assessment Short Form (MNA-SF), the Mini-Cog and PHQ-2 (Patient Health Questionnaire) for mental and emotional state, gait speed, timed Up and Go test, FRAIL questionnaire, and ADL/IADL discussion for assessing physical function, as well as inquiries to social support at home, adaptable and safe environment plans, access to nutrition and transportation, as well as abilities and support in medication management (Table 1, Gorodeski et al).

 Does your department or institution use shared decision making or decision aids in practice?

 What barriers to implementation do you see in incorporating these tools into everyday patient interactions?

SDM and Decision Aids Resources
The Ottawa Hospital Research Institute hosts an up-to-date A to Z inventory of patient decision aids, and includes tools for angina, atrial fibrillation, CABG and other cardiac procedures, blood pressure medications, peripheral artery disease surgery, type 2 diabetes, depression, kidney disease and dialysis, and many others. Many of the tools geared towards cardiac care were in the form of informative articles for patients to read, or interactive tutorial-style pages for patients. None that I found were visual or brief enough to be used in clinical practice. Additionally, purely text-based “decision aids” are not useful for low-literacy populations, and online-only resources are not easily accessible for patients who are less tech-savvy. However, the Heart to Heart tool developed by the University of North Carolina General Internal Medicine department provides a user-friendly interface, even for the less technologically-savvy patients, that guides the user through several slides on how to join the discussion of their own treatment with their doctor. Similarly, the AHA Rise above Heart Failure initiative has two resources heart failure patients and physicians might find particularly useful: a guide to overcoming barriers to shared-decision making and a list of questions to ask the doctor. If you are a physician, reviewing these materials provides you with the guidance of what questions and topics to address during the clinic visit.

Quick links to select decision aids related to heart disease:

 

Bailey DeBarmore Headshot

Bailey DeBarmore is a cardiovascular epidemiology PhD student at the University of North Carolina at Chapel Hill. Her research focuses on diabetes, stroke, and heart failure. She tweets @BaileyDeBarmore and blogs at baileydebarmore.com. Find her on LinkedIn and Facebook.