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Right arrow Electrophysiology - arrhythmias

Ann Thorac Surg 2005;80:876-880
© 2005 The Society of Thoracic Surgeons

Original article: Cardiovascular

A Multi-Institutional Experience With the CryoMaze Procedure

James S. Gammie, MD a , * , John C. Laschinger, MD b , James M. Brown, MD a , Robert S. Poston, MD a , Richard N. Pierson, III, MD a , Linda G. Romar, BSN a , Kimberly L. Schwartz, MBA a , Mary J. Santos, PA-C a , Bartley P. Griffith, MD a

a Division of Cardiac Surgery, University of Maryland Medical Center, Baltimore
b St. Joseph Medical Center, Towson, Maryland

Accepted for publication March 18, 2005.

* Address reprint requests to Dr Gammie, Division of Cardiac Surgery, University of Maryland Medical Center, N4W94, 22 South Greene St, Baltimore, MD 21201 (Email: jgammie{at}smail.umaryland.edu).

Presented at the Fifty-first Annual Meeting of the Southern Thoracic Surgical Association, Cancun, Mexico, Nov 2–4, 2004.


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 Discussion
 References
 
BACKGROUND: The Cox Maze III operation remains the gold standard for the surgical treatment of atrial fibrillation (AF). We report our experience using a flexible argon-powered metal cryoprobe for creation of the complete Cox-Maze III lesion set in patients with AF (the CryoMaze operation).

METHODS: Beginning July 2002, 38 patients underwent the CryoMaze operation. Two patients had isolated CryoMaze procedures, whereas 36 patients had the CryoMaze performed in combination with coronary, valvular, or aortic surgery. All patients had electrocardiographic follow-up. Atrial fibrillation was continuous in 79%. Mean duration of AF before operation was 48 months.

RESULTS: There were no complications related to the use of cryoenergy. There was 1 hospital death (2.6%) and no late deaths. At a mean follow-up of 12 months, 35 of 37 patients (95%) were in normal sinus rhythm. One patient required pacemaker implantation 3 months after surgery, and 1 patient refused follow-up. There have been no early or late thromboembolic events.

CONCLUSIONS: The CryoMaze operation reliably cures atrial fibrillation at medium term follow-up, with rates identical to those reported for the classic Cox-Maze III operation.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 Discussion
 References
 
Atrial fibrillation (AF) is the most common sustained arrhythmia in the United States [1]. Adverse effects of AF include symptoms, stroke, hemodynamic compromise, and cardiomyopathy. In multivariable analyses, AF is an independent predictor of death [2, 3]. Cure of AF requires an atrial ablation strategy. The "cut-and-sew" Cox-Maze III operation restores normal sinus rhythm in 90% to 95% of patients and is the gold standard for the surgical cure of AF [4]. In the largest reported series of patients undergoing the Cox-Maze III operation, Cox and associates [4, 5] reported 95% freedom from AF with a median follow-up of 3.7 years in a series of 306 patients. The Cox-Maze III operation has been shown to be durable, with documented freedom from AF of 95% at 10 years [5, 6]. There is a very low incidence of perioperative and late stroke after the Cox-Maze III, with the majority of patients managed without warfarin anticoagulation [7]. Widespread adoption of this remarkably effective surgical treatment of atrial fibrillation has been hindered by concerns regarding prolonged cardiopulmonary bypass and cross-clamp times, technical complexities, and bleeding complications. A variety of energy sources have been designed to create linear transmural lesions capable of reliably creating atrial conduction block. We tested the hypothesis that cryoenergy, delivered with a flexible argon-powered metal cryoprobe, could be used to rapidly and safely perform the Cox-Maze III lesion set and result in long-term cure rates of AF that would be equivalent to the classic Cox-Maze III results.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 Discussion
 References
 
Patients
All patients with a diagnosis of atrial fibrillation and requiring cardiac surgery were considered for the CryoMaze operation. Demographics, perioperative, and follow-up data were retrospectively analyzed. Preoperative transthoracic echocardiographs were reviewed on all patients. This study was approved by the Institutional Review Board of the University of Maryland Medical Center.

Cryoablation
Cryoablation was performed exclusively using a flexible 6-cm-long metal cryoprobe (SurgiFrost CryoCath; Irvine, California; Fig 1). The cryoprobe uses argon gas to achieve rapid heat removal from atrial tissue. The device contains a thermocouple that monitors tissue temperature during application of cryoenergy and is capable of rapid tissue cooling to a target of –120° to –160° C.



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  		Fig 1. The flexible 6-cm-long argon-powered metal cryoprobe (Cryocath).

 
Operative Technique
All operations except one (a minimally invasive isolated CryoMaze procedure) were performed through a median sternotomy. In each patient, the cryolesion set was designed to replicate exactly the classic Cox-Maze III lesion set [8], without the septal lesion and without resection of the tip of the right atrial appendage (personal communication, J. L. Cox, MD). At one institution (University of Maryland Medical Center), the conduct of operation included creation of right atrial external lesions on a beating, working heart just before initiation of cardiopulmonary bypass (CPB). Duration of cryoablation for each lesion was 2 minutes. After administration of cardioplegia, the left atrium was entered through a standard incision in the interatrial groove. The left atrial appendage was oversewn from within using running 4-0 polypropelene suture. The circumferential cryolesion around the four pulmonary veins was performed with 1-minute cryolesions that connect to both ends of the left atriotomy. Two radial cryolesions were created from the circumferential pulmonary vein lesion: one extends to the left atrial appendage (1 minute) while the other extends to the base of the posterior mitral valve leaflet (P2, 2 minutes). After closure of the left atrium (and during rewarming), the right atrium was opened and the final two cryoablations were performed endocardially: both extended to the tricuspid valve annulus, and duration of ablation was 1 minute each. The second operative technique employed (St. Joseph Medical Center) differed in that the right and left pulmonary veins were encircled independently, with a connecting lesion. Radial lesions to the mitral valve annulus and the left atrial appendage were performed. Left-sided lesions were performed epicardially on-CPB with a vented, beating heart, or occasionally endocardially on the arrested heart as part of a mitral valve operation.

All cryolesions were 1 minute each, and the left atrial appendage was externally ligated at its base. All right-sided lesions (including the septal lesion) were performed endocardially.

Postoperative Management
All patients received routine postoperative care. Beta blockers were administered orally to all patients. Amiodarone was used routinely (St. Joseph Medical Center) or selectively (University of Maryland Medical Center) for patients with postoperative AF. Warfarin anticoagulation was prescribed for a minimum of 3 months after operation.

Follow-Up
Follow-up was conducted by telephone interview and chart review and was 97% complete. One patient refused follow-up. The mean follow-up was 12 months (range, 6 to 19). Results are reported based on recommendations for data analysis and reporting after atrial fibrillation surgery [9].


   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 Discussion
 References
 
Between July 2002 and November 2003, 38 patients at two institutions (29 male and 9 female) underwent the CryoMaze operation. In 2 patients, the CryoMaze was performed as an isolated procedure, whereas the remaining 36 patients had the CryoMaze performed in combination with coronary, valvular, or aortic surgery. Operations performed are detailed in Table 1. Mean age was 66 years (range, 28 – 82). Mean duration of AF before operation was 48 months (range, 4 weeks to 14 years). Atrial fibrillation was continuous in 79% and intermittent in 21% [10]. Mean left atrium size was 5.2 cm (range, 3.6 to 11.0 cm). Complete Cox Maze-III lesion sets were performed either endocardially or epicardially by two surgeons (J.S.G., n = 20; J.C.L., n = 18). Mean aortic cross-clamp time was 94 minutes (range, 35 to 193) and mean CPB time was 131 minutes (range, 89 to 246). One patient—a 56-year-old man with idiopathic cardiomyopathy, biventricular heart failure, and near-systemic pulmonary hypertension—died of sepsis and multiorgan failure 2 months after a combined mitral/tricuspid repair and CryoMaze procedure. There were no complications related to the use of cryoenergy. There were no perioperative CVAs, no patient required reoperation for bleeding, and no patient had a postoperative wound infection. Median postoperative length of stay was 6 days.


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  		Table 1. Operations Performed
 
Forty-five percent of patients experienced episodes of AF in hospital. At discharge, 6 of 37 (16%) were in AF whereas 31 of 37 (84%) were in normal sinus rhythm. Figure 2 demonstrates rates of AF at various postoperative intervals.



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  		Fig 2. Prevalence of atrial fibrillation (AF) at various postoperative intervals. (D/C = discharge; mos = months.)

 
No late deaths occurred. At a mean follow-up of 12 months (range, 6 to 19), 35 of 37 surviving patients (95%) were in normal sinus rhythm by 12-lead electrocardiography (Fig 3). One patient required placement of a permanent pacemaker 3 months after combined CABG/CryoMaze. This patient presented initially with nonsustained ventricular tachycardia as well as atrial fibrillation, and consequently had an implantable cardioverter-defibrillator implanted postoperatively. When readmitted 3 months later with incessant firing of the implantable cardioverter-defibrillator, device interrogation suggested persistent AF with a rapid ventricular response. This was successfully managed by atrioventricular node ablation and institution of permanent pacing. One patient (counted as a treatment failure) refused follow-up. There have been no early or late thromboembolic events (Fig 4). Among 19 evaluable patients, 5 were receiving antiarrhythmic therapy and 5 were receiving warfarin at latest follow-up. Freedom from pacemaker implantation is depicted in Figure 5. One patient (a 40-year-old man) developed atrial flutter 1 year after an isolated CryoMaze procedure; he underwent successful catheter ablation of the cavotricuspid isthmus and remains in normal sinus rhythm 5 months later.



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  		Fig 3. Freedom from atrial fibrillation (AF) after the CryoMaze operation.

 


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  		Fig 4. Freedom from stroke after the CryoMaze operation.

 


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  		Fig 5. Freedom from pacemaker implantation after the CryoMaze operation.

 

   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
Discussion
 References
 
The results of this study support the hypothesis that the CryoMaze procedure yields midterm results that are equivalent to those of the classic Cox-Maze III operation. Using a cryoprobe, we found that the complete Cox-Maze III lesion set could be performed in 15 to 20 minutes either in isolation or in combination with other cardiac operations. Consistent with the experience of others [11], we found that AF was common in the early weeks after operation, but that normal sinus rhythm was present in 95% of patients after the sixth postoperative month. Requirement for permanent pacemaker insertion was uncommon, with only 1 patient (3%) requiring a permanent pacemaker after the CryoMaze operation.

Interpreting reported results of surgery for atrial fibrillation is challenging because an assortment of new energy sources and delivery systems (microwave, laser, ultrasound, radiofrequency, radiofrequency cooled-tip, radiofrequency bipolar) have been used to create a wide variety of lesions sets (modified-Maze, mini-Maze, left-sided Maze, and so forth). The resulting permutations have shown variable efficacy in restoring normal sinus rhythm, with rates of cure of atrial fibrillation often 10% to 20% below results with the classic Cox-Maze III operation [12–15]. Reports of collateral damage with thermal energy sources have tempered enthusiasm for some energy sources [16, 17]. Efforts to simplify the lesion set and apply new devices are driven by the notion that a Maze operation that is easy and safe to perform will be applied more commonly, particularly if a less invasive approach is possible [18].

We have been reluctant to alter the traditional Cox-Maze III lesion set owing to the sound science used to generate the lesion pattern and its outstanding clinical track record of efficacy and durability [19, 20]. It is our belief that surgical procedures that do not meet this high standard of cure are destined to be replaced by less invasive and less effective catheter-based techniques. Our preliminary experience has shown that creation of the classic Cox-Maze III lesion set with a flexible metal cryoprobe is simple, rapid, reproducible, and safe, while proving to be equally effective as the traditional cut-and-sew Maze procedure in curing atrial fibrillation.

Cryotherapy has a long history in treating cardiac arrythmias [21], and is the only energy source that is an integral component of the classic Cox-Maze III procedure. Once a cryoprobe adheres to the atrial myocardium, it functions as a heat sink, extracting tissue heat. Intracellular ice formation is lethal to cardiomyocytes. After thawing, cell death (necrosis and apoptosis) can continue to occur in border zones surrounding the original lesion over days to months after ablation [22]. The resulting cryogenic lesion is characterized by sharply circumscribed necrosis and persistence of collagen fibers [23]. This is in sharp contrast to thermal energy sources, which are characterized by the presence of a nonvital char.

Cryoenergy has multiple distinct advantages over thermal energy sources in performing surgery for atrial fibrillation. Collateral injury has never been reported. Transmurality of atrial lesions, likely a critical component to successful lesion creation in atrial fibrillation surgery, is assured once "ice-ball" formation is observed. Once the cryoprobe adheres to the tissue, motion is nonexistent. The entire CryoMaze operation can be performed with one device; "hybrid" approaches with multiple energy sources are unnecessary [7].

The limitations of this study include a relatively small number of patients with only midterm follow-up. Careful long-term observation and continued accrual of patients will be required to demonstrate the late efficacy of the CryoMaze procedure. This multi-institutional experience does demonstrate, based on a consecutive series of 38 patients, that the CryoMaze procedure affords safe, rapid, and effective surgical cure of atrial fibrillation. Critical questions that we hope to answer in the future include evaluation of the presence and extent of left atrial function after the CryoMaze operation, long-term requirements for antiarrythmic agents and anticoagulants, and the efficacy of performing atrial cryoablation on the beating nonempty heart.


   Discussion
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Discussion
References
 
DR W. RANDOLPH CHITWOOD, JR (Greenville, NC): Thank you very much. Doctor Gammie, that was a very nice presentation. As you and I have discussed, we have operated upon 80 patients using cryoablation. We also believe that it is important to complete the full lesion set of the Cox MAZE III, especially on the left side for atrial fibrillation. We are not ready to report our follow-up data yet, but it looks that at 6 months, we have about 90% out of atrial fibrillation.

We also have found that we have more heart block in patients where we have done right-sided lesions. So we have returned to just doing the right side if we have either clinical or electrophysiological evidence of flutter. We found that right-sided lesions really have not changed our percentage of patients that returned to a normal sinus rhythm.

I have several comments and questions: You have had very low pacemaker requirements. As mentioned we found higher pacemaker requirements when we completed the right sided lesions. How do you explain the comparative differences? Some of the work that Paul Broca had done in the 1870s showed significant muscle fibers around the origin of the coronary sinus. I also discussed this with Jim Cox regarding surgical Maze failures. We now complete a dual cryo lesion first across the coronary sinus epicardially to the mitral valve and then from the right pulmonary vein to P3 of the mitral valve endocardially. These fibers could also contribute to atrial flutter postoperatively. Is it reasonable to only do the right-sided lesions when you have demonstrable flutter or electrophysiologic evidence?

DR GAMMIE: Thanks, Dr Chitwood. I am delighted that you are pursuing the CryoMaze operation as well. I agree with you that our incidence of pacemaker implantation was quite low compared with other reported series, and it could be that we have just been lucky. We certainly are careful to stay away from the sinus node. I think that when patients require a pacemaker after the maze operation, it is really a function of an unmasking of an underlying sinus node dysfunction. So it may be that as we accrue more patients we will see a higher rate.

And in terms of that lesion down to the mitral valve annulus, I agree with you that it is very important to do that, and in fact we freeze for a full 2 minutes from inside, and we believe that we get absolute transmural freeze. So I think that your approach is a good one and I think that that is important to get a high success rate.

And in terms of right versus left-sided, I don’t know the answer to that, and I would like to take a more selective approach, because obviously we want to simplify the operation as much as possible, and I hope that as we accrue more patients we can maybe answer that question. Maybe a randomized trial of biatrial versus simply left atrial lesions would make sense.

DR W. STEVES RING (Dallas, TX): It is an excellent series with obviously outstanding results. I would reiterate what Randy said about using the epicardial lesion. We have had very good success with that, combining the lesion going down to the mitral valve actually from your right atriotomy combined with an epicardial lesion. What was unclear to me from your presentation, however, was on your right-sided lesion, it looks like you are using a very atypical and not the classic Cox-Maze lesion set on the right side. Am I misinterpreting this? It looked like you are just doing a single perpendicular lesion. Are you not doing an isthmus lesion?

DR GAMMIE: Yes, we are. We do the SVC-IVC lesion. We are doing the classic Cox-Maze III operation. For sake of truth and completeness, the one lesion we do not do is the septal lesion. Doctor Cox has indicated that he hasn’t been doing that for some time and doesn’t feel that it is important. And we don’t amputate the tip of the right atrial appendage. But otherwise it is exactly as described in the textbook.

DR JOHN D. OSWALT (Austin, TX): I will be brief because Randy had many of the questions that we had. Two questions. How often were your patients discharged home at an acceptable junctional rhythm rate that later then came back to sinus rhythm? And also, would you describe exactly where you are talking about making your flutter lesion on the right side, because we found, exactly like Dr Chitwood, that when we made that lesion we ended up with a lot more complete heart block.

DR GAMMIE: You mean during the operation?

DR OSWALT: During the operation, yes. Describe anatomically where you are making that lesion.

DR GAMMIE: The right-sided lesions as we made them, lateral side, SVC to IVC, first of all, then a perpendicular lesion up to the AV groove; and I generally go up to the location where the retrograde catheter goes in, and then later on when I open the right atrium, I stick the probe through there and go right down to the tricuspid annulus; and similarly, we make an incision and go to the tricuspid annulus from above.

As to your other question, a lot of patients have junctional rhythm coming out of the operating room. It is very common, probably the most common rhythm immediately. At the time of discharge, though, I don’t believe that we had anybody that was still in a junctional rhythm. Some of them have very tiny P waves and you wonder, but the answer is, we didn’t seem to see a lot of people going home in a junctional rhythm.

DR OSWALT: That has been our difficulty in convincing our cardiologists that it is probably either okay to let them go home or that there may be a small P wave that we are missing in there when you map that out. They seem to want to slam a pacemaker in these people, and they get very nervous, and that may be the reason we are having a higher incidence of pacemaker implantation.

DR GAMMIE: I agree that the hardest part of the operation is the education that goes along with it.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Discussion
 References
 

  1. Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention. The AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) study JAMA 2001;285:2370-2375.[Abstract/Free Full Text]
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  16. Doll N, Borger MA, Fabricius A, et al. Esophageal perforation during left atrial radiofrequency ablationis the risk too high?. J Thorac Cardiovasc Surg 2003;125:836-842.[Abstract/Free Full Text]
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