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Catheter Ablation vs Surgery For A-Fib: Finally an Apples-to-Apples Comparison

Update July 27, 2018 Which is better from a patient’s perspective―Catheter Ablation or Surgery (Mini-Maze)? A new study compares the two head-to-head.

An article in Cardiac Rhythm News (no author), describes the SCALAF trial (Surgical vs. Catheter Ablation of paroxysmal and early persistent Atrial Fibrillation).

SCALAF Trial Design

The SCALAF study is the first randomized control trial of patients with symptomatic A-Fib. In a 1:1 ratio, 52 patients received either a catheter ablation or surgery as their first invasive procedure. Follow-up data in all patients was collected for 2 years using implantable loop recorders (Medtronic Reveal XT).

The measurement of success was freedom from A-Fib (atrial tachyarrhythmia) and off antiarrhythmic drugs with safety measured by procedure-related complications.

PV Isolation Direct Comparison: The catheter ablation arm only isolated the PVs without additional lesion sets. The surgical arm (Mini-Maze) only isolated the PVs (and removed the left atrial appendage).

Trial Results

Efficacy: Catheter ablation vs. surgical patients (60% vs. 27%) were free from A-Fib without drugs.

Efficacy: After 2 years, a significantly greater number of catheter ablation patients (60%) were free from A-Fib without having to take A-Fib drugs compared to a much smaller number of surgical patients (27%).

Safety: Surgery patients had a higher procedure-related complication rate (34.8% vs. 11.1%) and a higher rate of major complications (22% vs. 0.0%) compared to catheter ablation patients. That’s about 1-in-4 surgical patients who had significant complications.

Safety: Surgery patients had a higher procedure-related complication rate (34.8% vs. 11.1%).

Hospital Stay: Hospitalization was longer for surgical patients with an average hospital stay of nine (6–10) days compared to three (2–3) days for catheter ablation.

Trial Conclusions

The investigators concluded that catheter ablation of the PVs in the treatment of paroxysmal and early persistent A-Fib is safer and results in higher long-term arrhythmia free survival compared to surgical (Mini-Maze) PV isolation. Follow-up with continuous monitoring using implantable loop recorders was important for true and accurate outcomes.

What Patients Need to Know

Don’t Make Surgery Your First Choice: Following the 2014 Guidelines for the Management of Patients with Atrial Fibrillation, your first treatment option should not be surgery (Mini-Maze).

Catheter Ablation Higher Success and Safer: Though this was a small study, this trial showed that catheter ablation is safer with better long-term freedom from A-Fib (and without medication) when compared head-to-head with surgical Mini-Maze. Follow-up monitoring of each patient with an implantable loop recorder (for 24/7, 365 days for two years) produced unbiased, non-disputable results.

The 2011 FAST Trial: The SCALAF trial results might be compared to the 2011 FAST Trial sponsored by AtriCure, Inc. The FAST trial compared AtriCure’s own system for Mini-Maze surgery to catheter ablation. The results favoring surgery don’t hold up under close scrutiny. More important was the high complication rate of the surgical approach. For more, see Surgical Versus Catheter Ablation―Flawed Study.

SCALAF: Catheter ablation is safer with better long-term freedom from A-Fib (and without medication) when compared head-to-head with surgical Mini-Maze.
 The Bottom Line: We now have an unbiased clinical trial comparing catheter ablation with surgery.

According to the SCAFAL trial, catheter ablation has higher success for long-term freedom from A-Fib than the surgery approach. Just as important, data from both FAST and SCAFAL demonstrate that catheter ablation is much safer than surgery.

Update July 27, 2018: In response to this post about the SCAFAL trial, we received this statement from surgeon Dr. John H. Sirak who performs the “5 box surgery” for A-Fib. Especially relevant is his statement that surgical PVI alone tends to produce Flutter. (The FAST study did compare more complex surgeries to catheter ablation.)

“I must be direct and say this study is next to worthless. First, it isn’t clear how the cohorts compare in terms of AF chronicity. Surgical PVI should at least be no worse than percutaneous. PVI is the most foolproof step of a surgical maze. If the randomization were truly accurate, why was the surgical arm so much smaller? My suspicion is that the surgical arm had a significantly higher number of non-paroxysmal patients. And who were the orangutans operating with a 35% complication rate? Along the same lines, since surgical PVI alone is now widely known to be fluttergenic and thus contraindicated, no reputable surgeon would offer a patient such an outdated operation! This study is not only pathetically executed, but also has no relevance to current standard-of-care practice.” 
Resources for this article
• Surgical treatment of atrial fibrillation results in higher complication rates when compared to catheter ablation. Cardiac Rhythm News (no author). May 18, 2018, Issue 41, p. 9.

• Surgical or Catheter Ablation of Lone Atrial Fibrillation (AF) Patients (SCALAF). ClinicalTrials.gov Identifier: NCT00703157. Sponsor: Medtronic Bakken Research Center Note: Principal Investigators are NOT employed by the organization sponsoring the study. https://clinicaltrials.gov/ct2/show/results/NCT00703157.

• AHA/ACC/HRS 2014 Guideline for the Management of Patients With Atrial Fibrillation. Circulation. published online March 28, 2014, 4.2.1. Antiplatelet Agents, p 29.doi: 10.1161/CIR.0000000000000041 Last accessed Nov 23, 2014.URL: From http://content.onlinejacc.org/article.aspx?articleid=1854230

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