When it comes to risking your life by undergoing a catheter ablation for atrial fibrillation, “operator experience counts” says Hugh Calkins, MD – who, unbeknownst to patients, routinely lets trainees perform the procedure.
Initial Measure of Afib Ablation Success Often Misleads Nov. 25, 2015
“My husband had an ablation in 10th October 2013, the Doctor who did the ablation bunt a hole into his esoficus, he died in 14th November…”
“Finally someone telling the truth, mine sure didnt last, and now i am in a living hell with my irregular heart rhythms way worse then before, ill never do this again, i was totally lied to so the Drs can get paid” 7/4/2013
“I’ve had AFibrillation and now AFlutter. 5 cardioversions and one ablation. I totally agree with you and my own doctor, who is a professor at a very important medical school in my country Brazil, disencouraged me of undergoing catheter for AFib. Catheter for Afib is still very uncertain and in most cases it would pose more risks than benefits.” 6/11/2013
“Sobering” Long-Term Outcomes Following Ablation of Atrial Fibrillation
Commenting on the results of the study for heartwire , Dr Hugh Calkins (Johns Hopkins University School of Medicine, Baltimore, MD), who was not affiliated with the study, said the gradual attrition rate in arrhythmia-free survival–in this trial there was an 8.9% annual recurrence rate following the last ablation attempt–confirms results observed in other studies.
“The bottom line is that everybody’s results show the same thing, that atrial fibrillation is a complex arrhythmia, and that the longer you follow patients, the more recurrences they have,” said Calkins. He added that those arguing ablation “cures” atrial fibrillation have been disproven. “Catheter ablation treats atrial fibrillation, it doesn’t cure atrial fibrillation, at least in many patients,” added Calkins. “And yes, you have to continue to follow patients, and this has important implications in terms of anticoagulation.”
Long‐term Outcomes of Catheter Ablation of Atrial Fibrillation: A Systematic Review and Meta‐analysis
J Am Heart Assoc.2013; 2: e004549originally published March 18, 2013,doi: 10.1161/JAHA.112.004549
Single‐Procedure Efficacy of Catheter Ablation
Outcome data regarding the efficacy of catheter ablation of AF were available in all studies. Most studies provided single‐procedure success rates, defined as the percentage of patients free of atrial arrhythmia or not requiring a second procedure at 12 months. The pooled overall success rate was 64.2% (95% CI 57.5% to 70.3%,Figure 2A). The pooled 12‐month success rate for the 11 studies reporting outcomes for PAF patients was 66.6% (95% CI 58.2% to 74.2%, Figure 2A), and for the 6 studies reporting outcomes for NPAF patients, it was 51.9% (95% CI 33.8% to 69.5%, Figure 2A). Heterogeneity exceeded 50% in each of these groups. At late follow‐up, the overall single‐procedure success, defined as freedom from atrial arrhythmia at latest follow‐up, was 53.1% (95% CI 46.2% to 60.0%, Figure 2B). Mean long‐term success in the studies separately reporting PAF outcome was 54.1% (95% CI 44.4% to 63.4%, Figure 2B), and in the 4 studies reporting NPAF outcome, it was 41.8% (95% CI 25.2% to 60.5%, P=0.3 versus PAF, Figure 2B). I2 exceeded 50% for long‐term single‐procedure outcome data, indicating significant heterogeneity (Figure 2B).
… We also specifically analyzed the impact of antiarrhythmic drugs by assessing late single‐procedure outcomes in the subgroup of 14 studies reporting drug‐free success. In this group, late single‐procedure success was 57.4% (95% CI 50.9% to 63.8%), which was similar to overall clinical outcomes.
Impact of Multiple Procedures
Thirteen studies provided outcome data taking into consideration the impact of multiple procedures. The overall multiple‐procedure long‐term success rate was 79.8% (95% CI 75.0% to 83.8%) in 13 studies (Figure 3). The I2 overall was >50%, indicating significant heterogeneity. The multiple‐procedure long‐term success in PAF was 79.0% in 8 studies (95% CI 67.6% to 87.1%, Figure 3), and that in NPAF was 77.8% in 4 studies (95% CI 68.7% to 84.9%, P=0.9 versus PAF, Figure 3). In the individual groups, heterogeneity exceeded 50%. The overall average number of procedures was 1.51 (95% CI 1.36 to 1.67). In PAF patients, the average number of procedures was 1.45 (95% CI 1.31 to 1.59) compared with 1.67 (95% CI 1.31 to 2.06) in NPAF patients (P=0.2).
Late Recurrence After AF Ablation
To evaluate the timing of late recurrence, pooled estimates of single‐ and multiple‐procedure arrhythmia‐free success were evaluated for the subset of studies providing yearly follow‐up data at up to 5 years from index ablation (Figure 4). After a single procedure, the 1‐year success rate in these studies was 65.3% (95% CI 57.5% to 72.4%), which decreased to 56.4% (95% CI 47.9% to 64.5%) at 3 years and stabilized at 51.2% (95% CI 37.3% to 65.0%) at 5 years (Figure 4A). For multiple‐procedure success, the 1‐year success rate was 85.7% (95% CI 81.9% to 88.7%), which decreased to 79.3% (95% CI 76.3% to 82.0%) at 3 years and 77.8% (95% CI 70.3% to 83.8%) at 5 years (Figure 4A).
A particular consideration in a study such as this one is that the studies were reports generated at highly experienced referral centers with considerable experience in the application of AF abation. Ablation procedures were performed by experienced operators in selected AF patients. An interesting observation in our study was that the funnel plots of procedure outcomes in larger studies tended to have higher rates of success, perhaps reflecting an experience effect. However, an alternative interpretation raised by these data is that of ascertainment bias, with the possibility that different results would be achieved for procedures undertaken in lower‐volume, less‐experienced clinical centers.
Single‐procedure ablation success was achieved in ≈50% of patients, although, importantly, there was significant heterogeneity in single‐procedure outcomes in the included studies. With the inclusion of multiple procedures, ≈80% of patients achieved long‐term freedom from atrial arrhythmia.
To evaluate the long‐term stability of AF ablation success, we evaluated the annualized arrhythmia‐free success of AF ablation from 1 to 5 years. Both single‐ and multiple‐procedure success rates showed relative stability at >3 years after index ablation. Including multiple procedures, ≈80% of patients in the included studies were free of atrial arrhythmia at long‐term follow‐up. These data combined suggest that medium‐term ablation success appears to portend relative stability of long‐term efficacy of AF ablation but with a significant residual risk of recurrence affecting a significant minority of patients.
In the case of AF ablation, the procedure is relatively new, with significant ongoing innovation in technology and technique, necessitating the inclusion of case series as well as randomized controlled trial data. In addition, the limitation of included data to published studies may lead to a risk of publication or “file drawer” bias, which may favor the publication of studies showing an improvement in outcomes.39 The “File Drawer Phenomenon: Suppressing Clinical Evidence.” … A further limitation of our study is that periprocedural complications, a critical consideration in evaluating the risks and benefits of the procedure, were variably reported in terms of level of detail, and in some studies not reported at all.
Dr Roberts‐Thomson has served on the advisory board of St Jude Medical. Dr Sanders reports having served on the advisory board of Bard Electrophysiology, Biosense‐Webster, Medtronic, St Jude Medical, Sanofi‐Aventis, and Merck, Sharpe and Dohme. Dr Sanders reports having received lecture fees and research funding from Bard Electrophysiology, Biosense‐Webster, Medtronic, and St Jude Medical.
In atrial fibrillation treatment, which is more effective?
Ross Hoffman, M.D. • Pls see this article for a recent review on the topic: Castellá M. Heart 2013;99:888–892. doi:10.1136/heartjnl-2012-302044- it is a balanced article which openly points out procedural risks- and concludes that we do not really have conclusive data regarding best practice.
As you probably know, the 2013 Boston AF mtg included presentations questioning the net benefit of any type of AF ablation. Its safe to say that this procedure should be done sparingly, and judiciously.
The practitioners experience is that the success of the procedure depends upon how we define success, and how the patient is monitored in follow up.
LinkedIn Post for above:
A recent study in the publication Circulation, compared the effectiveness of catheter ablation (CA) and minimally invasive surgical ablation (SA). These have become standard therapies for the treatment of atrial fibrillation. The case study states that researchers observed 124 patients in total, following up at 6 and 12 month marks with ECGs.
One key learning is that in atrial fibrillation, patients with a dilated left atrium and hypertension, or failed prior atrial fibrillation CA, SA is superior to CA. This superiority lies mostly in achieving freedom from left atrial arrhythmias after 12 months of follow-ups. Despite this, the procedural adverse event rate is significantly higher for SA than for CA.
Does this finding correlate with your own experience? How do you determine whether SA or CA would be more effective for each individual patient?
To read the full study, please follow this link: http://bit.ly/PoS1pf
_____________Calkins: Sept, 2013
This inconsistency of catheter ablation in achieving basic technical goals impacts on the results of the procedure. A recent study employing rigorous follow-up show that catheter ablation succeeded in long-term restoration of sinus rhythm without anti-arrhythmia drugs in only 34% of patients( Packer D, et al. CABANA Pilot Study. Presentation at the American College of Cardiology Meeting, Atlanta, 15 March 2010.)
A second study of only paroxysmal AF patients, who are relatively easy to cure, resulted in long-term success in only 57%, with a serious complication rate of 12%. (Packer D, et al. STOP-AF Pilot Study. Presentation at the American College of Cardiology Meeting, Atlanta, 15 March 2010)
“An estimated 500 people have died after being shocked by Tasers since 2001, according to data compiled last year by Amnesty International.”
Miami Taser death: Are police relying too much on stun guns? http://www.csmonitor.com/USA/2013/0811/Miami-Taser-death-Are-police-relying-too-much-on-stun-guns
I’ve had 4 unsuccessful ablations. http://health-friends.org/Discussion/176
Dan I have to agree with you, that is why I refused to have a Catheter ablation. I had two brothers that had Catheter ablations both came away in worse condition then they were before, one had his aortic valve infected the second try and had to have open heart surgery to replace his valve then they did a Cox maze III which worked. The other brother had his sinus node destroyed on his second try, but was fortunate to have had a pacemaker already implanted. The surgery I had made sense to me and he has better than 96% success without arithmetic meds. Check out http://www.OhioAfib.com
I had cardiac ablation performed on Christmas Eve 2008. I immediately began experiencing severe burning, cramping, and numbness in my right leg. The doctor was informed of the problems and ordered an ultrasound of the right groin (one of the entry sites). Nothing was found, and I was immediately discharged. On December 29th, 2008, I was rushed to the nearest ER because of excruciating pain in my right leg. I was told that I had a pseudo-annyurism at the insertion site and was sent (via ambulance) back to the original hospital that performed the ablation. Of course, they could not find any problems when I got there. Keep in mind that even Morphine (8 units) did not even begin to touch the pain. I stayed in the hospital for a grand total of 5 days and was finally given a diagnosis of lumbar plexitis. Now this could have happened during insertion of the catheters or while a 250lb man beared down with all his might on the right insertion site! Either way, prior to the ablation, I could walk, run, whatever. After the ablation, I spent a few weeks on a walker and so completely overmedicated that I could not even stay awake long enough to bathe, eat, or get up off the couch. My husband still has pick up my right leg for me to get into the bed at night. Not once did the EP or the hospital say anything about or provide written material concerning nerve damage severe enough that I still cannot walk across my living room without crying. There has to be something that can be done to get me back to playing soccer with my kids and being able to work (did I mention that I lost my job because of this) and fulfilling all the duties of a loving wife and mother.
My thoughts and prayers go out to you and your mother.http://www.medhelp.org/posts/Heart-Disease/Cardiac-Ablation—side-effects/show/709549
Advanced Medical Technology Association (), to which Atricure belongs, is the largest medical technology association in the world. Headquartered in Washington, DC, Advamed is a medical industry lobbying organization that represents more than 1100 manufacturers of medical devices, diagnostic products, and medical information systems. AdvaMed members manufacture 90% of $75 billion worth of heath care technology products purchased in the United States each year, and more than half of the $175 billion in medical technology sold annually worldwide.On Sept 3, 2003, AdvaMed adopted its . The AdvaMed member organizations realized that “ethical standards and compliance with applicable laws are critical to the medical device industry’s ability to continue its collaboration with Health Care Professionals (HCPs). As such AdvaMed adopted its voluntary Code of Ethics to facilitate ethical interations with HCPs, or ‘those individuals or entities that purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Member’s medical technology products in the U.S.’”Financial relationships between physicians and corporations are held to a high standard: specific guidelines for gifts to physicians (must serve a genuine educational function and have a fair market value of less than $100) and charitable donations were outlined:Members may make charitable donations to charitable organizations for a charitable purpose, such as independent medical research, indigent care, patient education and public education, and sponsorship of events where proceeds are charitable.Unfortunately, no such Code exists for the AdvaMed members’ dealings with patients. While reviewing the Code further, I identified only one statement regarding gifts to individuals (Page 5): “Donations should only be made to charitable organizations or, in rare instances, to individuals engaged in genuine charitable missions for the support of that mission.” Herein lays my concerns with what happened with the StopAfib.org website. I certainly have no beef with patients telling their story, offering advice or support to others with similar ailments, linking to informative or helpful information – this is what the internet is about after all. But when patients use their forum to discuss health care issues representing their sponsor’s products by name, rather than in principle, they open themselves to criticism as “potentially biased.”AdvaMed sets a standard here that the medical consumer should not ignore. A medical device company has given what seems to have been a “grant” in excess of $100 (disclaimer: I do NOT know the actual amount) to develop a highly sophisticated website to an individual patient, Ms. Mellanie Hills. I contacted her and confirmed that they contacted her first. She, it seems, did not solicit Atricure for the grant independently. In my view, this is marketing, advertising, collusion with patients, and although I am not a lawyer, perhaps even . Likewise, when a web developer (ETNA Interactive) pays for a press release on PRWEB.com for a website that they developed with the funds from the same medical technology company grant in association with “thousands of dollars” – are they not advertising – both their services and those of the website they developed? I was puzzled that Mr. Miller described Mr. Hills’ efforts as a “foundation” – did I miss something? Are there other members of the foundation’s board we aren’t familiar with? It is unfortunate that a patient (Ms. Hills) who appears to have good intentions and a reputation at stake has been subject to this event. The fact that Atricure, Inc. has opened her up to this scrutiny I am sure was unanticipated by Ms. Hills. My intent in this post was not to belittle Ms Hills’ knowledge of atrial fibrillation therapies or knowledge base or her well-meaning intentions – I regret if I sounded offensive in this regard. Patients are, after all, better informed than they ever have been, thanks to the wonders of the internet. But I take issue with industry issuing grants to individual patients for their personal agenda at a time when physicians and other health care providers are under increasing scrutiny regarding financial enticements by industry. Such double-standards cannot and should not be tolerated.