catheter ablation

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Optimal Management of Periprocedural Anticoagulation for Catheter Ablation of Atrial Fibrillation

Zain Ul Abideen Asad, MD, MBBS

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

Christian Perzanowski, MD

“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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Killing Cardiac Cells

Anberitha Matthews, PhD

chambers of the heart imageI was in the mall one day and the saleswoman started talking about her health issues. For starters, I am not sure why she entrusted me with this information, but okay. So why is that conversation interesting enough to write about? Well, the lady was 20 years of age and she had undergone several cardiovascular challenges, including a cardiac ablation. I had heard of other people having this procedure done but I had not thought much about it (I looked it up but not in much detail), until I met this young lady. So, I started wondering:

  1. What is the underlying pathology that causes one to need to have the procedure?
  2. What is the average age of patients undergoing the procedure?
  3. What is cardiac ablation?
  4. How commonly is this procedure done?

Cardiac ablation is the use of catheters to target and kill off specific cells within the heart, generally in the atrium. The adult mammalian myocardium has a negligible ability to regenerate once damage has occurred. Thus, rather than undergoing cardiomyogenesis (the formation of myocardium/heart muscles), fibrous tissue is instead formed. This phenomenon raised more questions for me, so I did literature searches…then more literature searches…then read more literature. The more I read, the more I felt I needed to read to understand why cardiologist would choose this procedure. Following a myocardial infarction (heart attack) a significant number of cardiomyocytes die leading to an enhanced inflammatory reaction. This cardiac event results in dead myocardial tissue being replaced with interstitial and perivascular collagen deposition. The presence of fibrosis can lead to pressure overload, increased blood pressure or potentially aortic stenosis. However, a patient that has suffered from myocardial infarction would not be a good candidate for cardiac ablation. So, who would be a good fit to undergo such a procedure? Usually it is a patient exhibiting cardiac arrhythmias, including atrial fibrillation (AF or AFib), supraventricular tachycardia (SVT), and Wolff-Parkinson-White Syndrome (WPW). Because this subject is enormous, I will only focus on AF due to the fact that it is the most common cause of arrhythmias treated with catheter ablation.

Pathophysiology of Atrial Fibrillation
AF is characterized by an abnormal heartbeat (quivering or irregular heartbeat) that causes the heart to ineffectively move blood into the ventricles. The onset of AF could be due to family history (genetics), but controllable risk factors are hypertension and valvular heart disease. The cardiovascular consequence of AF includes: 

  1. Coronary artery disease
  2. Mitral stenosis
  3. Mitral regurgitation
  4. Left atrial enlargement
  5. Hypertrophic cardiomyopathy
  6. Congenital Heart Disease
  7. Cerebrovascular Accident

AF is considered the most common arrhythmic disease and it affects about 4% of the population. The prevalence of AF increase with age (<0.2% under 50 year of age (yoa), 4% are 60-70 yoa, and ~15% >80 yoa), with patients suffering from it has an average age between 75-85 yoa. In the U.S., there was a significant number of deaths (>200,000) resulting from AF in 2015, which is reason enough to pursue aggressive therapies to control this heart rhythm disorder.

Treatment
The European Society of Cardiology (ESC) released guidelines that summarized the current evidence that is available to physicians in selecting the best strategy for managing diseases, taking into consideration the risk-benefit ratio of diagnosis and therapeutic means. The recommended guidelines has shifted to focus on the identification of ‘truly low-risk’ patients (<65 with AF alone that does not need antithrombotic therapy) rather than ‘high-risk’ patients. Based on the earlier guidelines for treating AF, a patient of age >20 would not be considered for ablation therapy, so I wondered…what are the alternative treatments? I found they can either be drugs, such as: 1) Novel oral anticoagulants (blood thinners) fall into two categories (Oral direct factor Xa inhibitors or Oral direct thrombin) and 2) Left atrial ablation—introduced by American College of Cardiology Foundation, American Heart Association, and the Heart Rhythm Society.

To read more about these treatment, please be directed to European Heart Journal for the ESC Guidelines. Here I will focus on cardiac ablation.

Cardiac Ablation
Cardiac ablationThe normal mammalian heart is composed of tight layers of myocytes that are separated by small clefts creating a matrix network. The cardiac matrix network is divided into three constituents. The matrix network is collagen-based and serves as a scaffold for various components of the cell as well as transmission of contractive forces that keep the cells in correct timing with neighboring cells. When the heart undergoes damage, the resulting fibrosis disrupts the coordination of this myocardial excitation-contraction leading to hypertension. Subsequently, loss of collagen impair transduction, which causes the uncoordinated contraction of the cardiac muscle bundles (the quivering or fluttering that is felt with AF) or generation of re-entry circuits (irregular heartbeat).

The ablation process will depend on the patient medical condition, past cardiac history, and the ablation technique chosen. There are several types of catheter ablation

a) Radiofrequency ablation-use radiofrequency generators to deliver a current, in a point by point fashion around the pulmonary vein, creating a circular scar around each vein.

b) Cryoablation—uses a single catheter that travels through the femoral vein in the groin to the left atrium. The balloon end (halo) of the catheter has a refrigerant that freezes the tissue it comes in contact with creating a scar.

c) Surgical ablation—generally used when open heart surgery is being conducted.
          i. Mini Maze-use 3-5 incisions on the front and side of the chest to insert the catheter to freeze/heat cardiomyocytes
          ii. Convergent—uses both surgical and catheter based techniques.

Catheter ablation is generally an outpatient procedure, but it should not be taken lightly. As with most consumers, cost comes to mind. How can cardiologist/electrophysiologist conduct such a procedure in so short of a time and charge so much? The answer is simple. The technology used in ablation is extensive; mapping equipment, cardioverter/defibrillator and catheter, recording apparatus, stimulators, and junction boxes. I am overwhelmed just thinking about it all!

Wrap it up…
Cardiovascular disease is a consequence of a lot of factors. Understanding the various procedures that the cardiologists are explaining can be daunting. Even with the expansive literature that is available it is difficult to determine how a procedure will work for each patient, especially with regard to the side effects. For example, in a 2010 study for rhythmic control (294 patients), there was no significant difference between patients that received the catheter ablation compared to those taking antiarrhythmic drugs as a first line of intervention. Catheter ablation is said to be more effective than antiarrhythmic drugs, but the recurrence of AF is significant during long term follow up. Early recurrence of AF is the best predictor of whether one will have a recurrence later. In an observational study conducted at high volume clinics, there was a 39% hospitalization rate post catheter ablation. However, catheter ablation has been deemed reasonable for first line of therapy for AF when patients have paroxysmal AF and low risk for procedures with complications; which is interesting since the majority of studies are inherently biased toward the experienced centers. It is reasonable to speculate that people, such as the saleswoman in the mall, who visit small low volume clinics, contribute to increased rates of hospitalization rates.

I am, furthermore interested in knowing whether there is a decrease in cardiac output post catheter ablation. If this procedure is killing off specific cells in the heart and leaving scar tissue, what are the downstream effects of this cardiac cell death? Especially in patients that have repeated catheter ablations. If there is a decrease in cardiac output, and the kidney filters 20% of the cardiac output daily, then what effect does cardiac ablation have on the renal system? Could this procedure enhance renal failure? I have had conversations with other people who have had cardiac ablations that later suffered from renal failure necessitating dialysis. Since all conditions are patient specific, there is no evidence that catheter ablation is connected to renal failure to my knowledge, but I wonder if anyone else had that observation.

To sum up the conversation I had with the young lady in the mall. She started her cardiac journey at an early age. She has gone through oral anticoagulant drugs, catheter ablation, and open-heart surgery. By the age of 20, that is a lot for one to have gone through. She was in such distress about having to undergo yet another catheter ablation that she was seeking answers to help her understand what she was going through and how to make informed decisions about her care. How can patients be better educated on what is going on with their bodies when visiting medical professionals? People are told to take responsibility for their care, but what if they do not understand enough to know what to ask?

Anberitha Matthews, PhD is a Postdoctoral Fellow at the University of Tennessee Health Science Center in Memphis TN. She is living a dream by researching vascular injury as it pertains to oxidative stress, volunteers with the Mississippi State University Alumni Association, serves as Chapter President and does consulting work with regard to scientific editing.