Asheville Heart

Research

Is Surgery the Optimal Therapy for the Treatment of Aortic Valve Stenosis for Patients with Intermediate STS Risk Score? Mark A Groh, MD, Ivan Diaz, PhD, Alan M. Johnson, MD, Stephen W. Ely MD, PhD, Oliver A. Binns, MD, Gerard L., Champsaur, MD.
Ann Thorac Surg 2017;103:1193–8

PMID: 27756470     DOI:10.1016/j.athoracsur.2016.08.012


STS 2016, Phoenix, AZ, 2016. Poster presentation. Is Surgery the Optimal Therapy for the Treatment of Aortic Valve Stenosis for Patients with Intermediate STS Risk Score?
Mark A Groh, MD, Ivan Diaz, PhD, Alan M. Johnson, MD, Stephen W. Ely MD, PhD, Oliver A. Binns, MD, Gerard L., Champsaur, MD

Patients in STS score intermediate risk are today frequently oriented toward the transfemoral aortic valve replacement (TAVR) option. Our goal was to evaluate best treatment strategies for intermediate risk patients with severe aortic stenosis.

Out of a consecutive series of 1144 surgical aortic valve replacement (AVR) performed in our Institution between 2008 and 2014, we reviewed the early and late outcomes of two different Groups: a LR group (low-risk, n= 470), and an IR group (Intermediate risk, n= 620). We eliminated from analysis 54 High Risk patients currently candidates for TAVR. All patients underwent surgical AVR with or without concomitant coronary artery bypass. Social Security database interrogation provided long-term information.

There were no between-group differences in early morbidity except for late onset atrial fibrillation, more common in IR group. Early mortality between LR and IR patients was not different (1.70% vs.2.74%, p= 0.25) and both lower than predicted mortality rates. However, cumulative 5-year survival (Fig.1) was significantly higher in LR patients (86.3% vs. 75.4% for IR cases, log-Rank test, p= .0007), although still excellent in IR group. There were 72 late deaths in IR compared to 26 in LR patients. When looking more precisely at IR patients, and comparing survivors and non-survivors, ages at surgery were 69.5 ± 12.7 years for survivors vs. 75.4 ± 9.6 years for those experiencing late deaths (p= 0.002). Other risk factors with same levels of significance were, in survivors, lower pre-operative creatinine level, lower incidence of diabetes, hemodialysis, chronic lung disease and smaller number of diseased coronary vessels.

The majority of IR patients should undergo SAVR, but due to excellent late survival combined with still unavailable late structural deterioration rates in TAVR valves. patients in the IR group with higher STS scores and advanced age may be better served with TAVR as data regarding late percutaneous valve function accrue.


Eastern Cardiothoracic Surgical Society 2015, Palm Beach. FL. Oral Presentation.
Alternate Approaches to Femoral Transcatheter Aortic Valve Replacement (TAVR) in High-risk Patients with Limited Peripheral Access or Challenging Aorta. Clinical Impact.

Mark A. Groh, William B. Abernethy, Joshua P. Leitner, Gerard L. Champsaur. 

As TAVR volumes increase, reducing risk for patients with access, aortic, or implantation issues is critical to improving implant results. We are increasingly seeking alternate approaches for TAVR and we are assessing in this work their potential clinical benefits.
METHODS:
Between 2012 and 2015, a consecutive series of 145 patients underwent a TAVR in our Institution. All data were entered prospectively in our local ACC/STS/TVT database and retrieved for analysis. The types of procedures were 8 cases of trans-apical (TA), 62 cases of trans-femoral (TF), and 75 cases of trans-aortic (TAo) approaches, including a trans-innominate artery route (TI) in 23 recent cases.
RESULTS:
Demographics and procedure data are displayed in Table-1 for the two approaches (TAo vs. TF) since there were no significant differences between original TAo and recent TI cases. TAo was performed in higher risk patients, with a more severe mean STS risk score and more frequent comorbidities although ages were not different. TAo procedures were shorter than TF ones and patients received smaller contrast volumes, radiation doses, and shorter fluoroscopy times.
There were 8 strokes in the whole series, 5 in TF patients and 3 after TAo, and 2 TIAs, one in each group. Pre-discharge mortality (4%) was equivalent in both groups.
CONCLUSIONS:
TAo and TI approaches have led to similar short-term outcomes in a higher risk population than our TF cases. Alternate access via the innominate artery is increasingly used at our Institution as it provides reliable easy access with minimal sternal disruption.


ISMICS 2016, 15-18 June, Montreal, Canada. Oral presentation
Proximal Arterial Access in Transcatheter Aortic Valve Replacement (TAVR): the Case for the Innominate Artery Approach.
Mark A. Groh, William B. Abernethy, Joshua P. Leitner, Gerard L. Champsaur

Since 2012, challenged by a growing number TAVR candidates with poor peripheral arteries, we initiated a systematic approach for alternative accesses. Initially developing the trans-aortic (TAo) route, we have progressively moved to the less invasive innominate artery (TI) and are reviewing here our current experience
Between 2/7/2012 and 10/10/2015, we performed a continuous series of 168 TAVR in the following chronology (Fig. 1). After the first 27 trans-femoral (TF) cases (current total n=70), we started our TAo approach (total of 56 current cases). Trans-apical approach had been used in 8 patients, not part of the current analysis. Starting on 2/26/2014 we started our first 34 cases of TI. A limited upper sternal “V” opening allowed access to the innominate artery or the aorta, exposed after a short dissection. Needle and over-the-wire-sheath were advanced through a pledgeted purse string on the aorta or after proximal and distal control of the innominate artery. After valve insertion purse string was closed onto the aorta and a continuous suture closed the innominate puncture. A couple of wires closed the sternum over a chest drain.
There were no significant demographic differences between TAo and TI patients and our global experience of “proximal arterial access” through both TAo and TI is now 90 consecutives cases. The main clinical features of the TAo-TI population are a higher risk with a STS score of 9.31 and 8.42 for TAo and TI, respectively, due to a high incidence of comorbidities. Compared to TF, TAo and TI procedure duration were significantly shorter, along with less exposure to fluoroscopy, radiation and contrast volume. Early morbidity was represented by one TIA and 3 strokes. A second valve was required in 2 patients. Early mortality (discharge) was 4.40%, and total 30-day mortality was 8%, including the early one.
We have increasingly moved our alternate access to the innominate artery, which combines ease of use, close and direct catheter control and minimal sternal disruption.  


Heart Valve Society, New-York, March 17-19 2016. Poster presentation. Single Center Experience with all Aspects of Tricuspid Valve Surgery, Including Long-term Outcomes .
M. Groh, A. Johnson, O. Binns, S. Ely, G. Champsaur

Evaluation of tricuspid valve surgery (TVS) is rare outside of the association with mitral valve surgery (MVS), where recent data shows no impact on early and long-term mortality. We hypothesized that isolated or combined with any valve surgery but mitral, TVS has a more severe early and long-term prognosis.

From 2008 to 2015, we performed a series of 315 consecutive TVS procedures, 23 (ITV) as an isolated procedure, 36 combined aorto-tricuspid surgeries (ATV), 60 triple valve operations (TVO) and 196 mitro-tricuspid (MTV) procedures with various degrees of tricuspid regurgitation (TR) based on clinical, echo and hemodynamic assessment. Additional concomitant coronary bypass procedures were performed in 109 cases (38.09%). Prospectively collected data were reviewed from our STS database and hemodynamic files. Main baseline variables are depicted in Table I by interventions, pooling together other than mitro-tricuspid procedures (OMT) for presentation purposes. Social Security database query provided long-term follow-up information

Concomitant coronary bypass procedures were performed in 47.90% of patients with OMT procedures vs. 32.14% after MVT (p= 0.005) and aortic regurgitation grade ≥2 was present in 44.6 % of OMT vs. 18.87% after MTV procedures (p<0.01). Early morbidity was not statistically different between the two populations, with identical rates of major complications. Early (30-day) mortality was significantly higher after OMT (globally 10.92% vs. 3.06% after MTV surgery). By sub-group, early mortality was 4.53% after ITV, 5.56% after ATV and .16.67% after TVO procedures. Post-operative mean follow-up was shorter after OMT (27.35 months) than after MTV (33 months, p=0.023). Cumulative probability of survival at 5 years (Kaplan-Meier, Fig.1) was 77.51 % for MTV patients and 48.35% for patients receiving TVS either isolated associated with other than mitral surgery (Log-Rank test, p = .00092). Comparatively, individual 5-year survival was 47.86% after ITV, 45.98% after ATV, and 52.40% after TVO procedures, respectively.

TVS when associated with MVS has low and early and late (5-year) mortality, not different from isolated MVS as previously reported. However, when performed as an isolated procedure or associated with aortic valve or part of a triple valve procedure, early and late mortality risks increase significantly.


STS meeting San Diego, January 2015. Poster presentation.
Early And Long-term Results of Mitral Valve Surgery Are not Altered by Concomitant Tricuspid Ring Valvuloplasty.
Mark Groh, Ivan Diaz, Alan Johnson, Oliver Binns, Steven Ely, Gerard Champsaur

Despite recent publications recommending systematic surgical correction of tricuspid regurgitation at the time of mitral valve surgery (MVR), there is little long term data to substantiate this approach. We reviewed our long-term outcomes of patients undergoing tricuspid ring annuloplasty (TRA) at the time of MVR.

From 2008 to 2014, we performed a series of 618 consecutive MVR, 436 (Group I) as an isolated procedure, and 182 (Group II) with a concomitant TRA in patients with mitral insufficiency and various degrees of tricuspid regurgitation based on clinical, echo and hemodynamic assessment. An additional concomitant CABG was performed in 267 cases (43.2%). Data have been reviewed retrospectively from our in-house STS database and hemodynamic files. Main baseline variables are depicted in Table I.

Early morbidity was not statistically different between Groups I and II except for heart block, more common in Group II (8.25%, p=0.005) and new onset atrial fibrillation, more common in Group I (23.6%, p<0.001). Early observed mortality was 1.83% in Group I and 3.30% in Group II (p=0.26). We used multivariate logistic regression analysis to adjust for 38 peri-operative variables. After adjustment early mortality was 1.79% vs.1.96% (p=0.85).

Cardiac index, age, presence of left main disease, CABG, and systolic Pulmonary Artey (PA) pressure were determined to be independent predictors of early mortality and, age, systolic PA pressure and presence of peripheral vascular disease were predictors of late mortality.

Kaplan-Meier cumulative probability of survival at 5 years (Fig.1) was similar in both Groups (81.35% and 77.52% in Group I and II, respectively): Log-Rank test p=0.24 after adjusting for baseline differences.

TRA concomitant to MVR does increase bypass and cardiac exclusion times. Despite those constraints, early major morbidity, mortality and length of stay were not adversely affected by the addition of TRA. Moreover, late survival in patients requiring TRA with MVR appears to be the same as MVR alone, suggesting the transformation of double valve to single valve disease.


11- STS meeting San Diego, January 2015. Poster presentation.
Trans-aortic Approach: Impact on Clinical Outcomes for Patients Receiving Transcatheter Aortic Valve Replacement (TAVR).
Mark Groh, William Abernathy, Joshua Leitner, Gerard Champsaur.

For candidates for TAVR with poor vascular access, the option is usually a trans-apical approach (TA). Given the results observed after the TA, the solution of the trans-aortic (TAo) route is appealing, based on the surgical familiarity with aortic cannulation and the proximity of the insertion site with the aortic valve.

We retrospectively reviewed our first 70 consecutive patients submitted to the ACC/STS/TVT registry (47% female) who received a TAVR using the Edwards Sapien valve from 02/7/2012 to 5/14/2014. We focused on two main groups, (TF, n=33) and (TAo, n=29), removing 8 patients with TA route from analysis. Table I summarizes patient demographics.  STS risk score was 6.75 in TF vs. 9.48 in TAo group (p=0.01).
Contrast volume, fluoroscopy time, and Fluorodose-DAP were significantly lower for TAo.  Procedure time was 127 minutes for TAo and 160 minutes for TF (p=0.08). More than one heart valve was required in 6 TF procedures and none in the TAo group.  There was one aortic dissection (TF) but no other vascular complications. TVT device success was 79% for TF and 97% for TAo (p=0.032).  LOS was similar in both groups (6.4 days vs 6.6). Before discharge, there were 3 TIAs, one in TF and 2 in TAo patients (3.03 and 6.90%, respectively), and 3 strokes, all in TF patients (9.09%). In-hospital deaths occurred in 3 TF patients (9%) and one TAo patient (3%). At 30-day follow-up, average aortic insufficiency severity was 1.33 for TF and 0.79 for TAo (p=0.03) and there were no neurological events but one death in each group.
Procedural advantages (fewer pacing runs, no balloon valvuloplasty, improved precision of valve deployment) afforded by the TAo approach have resulted in improved clinical outcomes in our highest risk profile TAVR patients. The TAo approach should be an integral part of every heart team’s armamentarium in patients who require TAVR.


ISMICS Boston May 28-31 2014. Oral presentation.
Is Surgical Aortic Valve Replacement Activity Really Stimulated by Trans-Catheter Alternatives in Active Centers?
Mark A. Groh, Steve W. Ely, Oliver A. Binns, Alan M. Johnson, Wendy Westling, Gerard L. Champsaur. 

Institutional support for trans-arterial aortic valve replacement (TAVR) is partly based on the “Halo effect” of increased surgical aortic valve replacement (SAVR) reported in centers participating in early US trials. We evaluated a mature regional program performing over 400 valve procedures annually to assess the reality of this purported effect on high risk patients undergoing SAVR.

From January 2008 through December 2012, 154 octogenarians (36.6% female) underwent SAVR via sternotomy with cardiopulmonary bypasswhile a multidisciplinary valve clinic (MVC) was established in September 2011. Global patient demographics are shown in Table I, and have remained identical in both Groups: “I” before and “II” after establishing the valve clinic. A concomitant coronary bypass procedure (CABG)was performed in a total of 80 patients with the same frequency in both Groups.

Early mortality was 5.8% and 7.6% in groups I and II, respectively (p=0.68) and between-groups differences did not reach statistical significance in STS risk scores, stroke rate, bleeding, renal failure, or arrhythmias. Number of high risk patients undergoing SAVR averaged 3.2 and 3.4 per month, unchanged over time in Group II. Hospital length of stay remained stable although patients requiring concomitant CABG had similar significantly longer hospital stays in both groups (10.1 vs. 7.7days, p<0.02). Global probability of survival is depicted in Graph 1 with 4-year survival at 71.36%.

So far, commitment of resources to a MVC has not increased the pool of patients referred for SAVR at our institution. This may be due to our history of aggressive management of older patients with aortic stenosis or to the short-term observation of the changes. Measuring the growth of SAVR from MVCs is mandatory to assess resource allocation and quality outcomes. This report can help other mature programs understand the realistic benefits of an integrated valve clinic program.


Heart Valve Society, New-York, May 8-10 2014. Oral presentation
Concomitant Bypass Grafts do not Alter Early or Long-term Outcomes of Patients Undergoing Isolated Aortic Valve Replacement

Mark A. Groh, Steve W. Ely, Oliver A. Binns, Alan M. Johnson, Wendy Westling, Gerard L. Champsaur

Perceived increased risk in patients requiring coronary artery bypass grafting (CABG) during surgical aortic valve replacement (SAVR) has led some to advocate a hybrid approach with percutaneous coronary intervention (PCI) and SAVR as an advantage over CABG with SAVR. We reviewed our current long term outcomes in patients undergoing SAVR with and without CABG to assess the contemporary risk in these patients.

A cohort of 956 consecutive patients who underwent SAVR ± CABG between January, 2008 and June, 2013 were retrospectively reviewed. Intervention was a redo in 152 cases (16%). Other variables are depicted in Table I. Concomitant CABG was performed in 442 patients (46%, Group I), and AVR alone in 514 patients (Group II).

Early preoperative morbidity was not statistically different between Groups I and II: atrial fibrillation, prolonged ventilation, renal failure, reoperation for bleeding, and TIA. Only stroke rate was higher in Group I receiving CABG (1.75% vs. 0.19%, p<0.01). Mortality was not significantly different between the 2 groups: 2.94% in Group I and 1.56% in Group II (p=0.13) despite a predicted higher mortality in Group I.

Using multivariate logistic regression analysis, redo surgery, presence of cardiogenic shock and higher trans-aortic gradient were independent predictors of early mortality while age, chronic lung disease, and diabetes were predictors for late mortality.

During a mean follow-up of 33.1 months, cumulative probability of survival at 5 years (Kaplan-Meier, Fig.1) was 76.9% and 81.6% for patients in Group I and II, respectively (Log- Rank test: p=0.47).

When considering revascularization in patients undergoing SAVR, CABG does increase bypass and cardiac exclusion times, as well as ICU and total length of stay. However, early and late mortality are not significantly altered by a single surgical procedure combining SAVR and CABG, with excellent long term durability.


Southern Thoracic Surgical Association, San Antonio, TX, November 9-12-2011. Oral presentation.
Successful Treatment of Atrial Fibrillation During Structural Heart Repair Lowers Long-Term Mortality Risk.

Mark Groh, Ben I. Groh, Oliver A. Binns, Stephen W. Ely, Alan M. Johnson, Gerard L. Champsaur

Preexisting atrial fibrillation (AF) at the time of cardiac surgical procedures leads to a higher late morbidity and mortality. We hypothesized that treating AF through surgical ablation at the time of structural heart repair would have a positive impact on the mid and long-term clinical outcomes.
We analyzed long-term outcomes in a consecutive series of 355 patients in AF (225 male and 130 female) operated on for structural heart repair and undergoing the same ablation procedure since 2005. Demographics are depicted in Table I. Surgery consisted of isolated or combined valvular and coronary artery surgery. All patients received a posterior left atrial isolation with an associated mitral isthmus line. Patients were reviewed systematically in the outpatient clinic at 6, 12, 24 and 36 post-operative months and were monitored by 24-hour or 7-day Holter or pacemaker interrogation.
There were five early deaths, cardiac in origin in four and due to sepsis in one case. Morbidity was prolonged ventilation (12.4%), pneumonia (5.1%), heart block (3.1%), re-operation for bleeding (2%), and 3 stroke episodes lasting longer than 24 hours (0.8%). With a mean follow-up of 31.1 months with 4 patients lost to follow-up, there were 42 late deaths. At univariate analysis, predictors of deaths were older age, higher NYHA Class, longer AF duration, and lower EF. Freedom from AF/ flutter was 80.8%, 79.6%%, 72.8% and 70% at 6, 12, 24 and 36 months, respectively. Actuarial survival is depicted in Figure 1. Late mortality was significantly lower in patients who were free from AF or flutter in the corresponding interval (p<0.04, 0.02 and 0.02 at 12, 24 and 36 months, respectively).
Durably eliminating AF after cardiac surgery leads to a higher probability of survival after structural heart repair combined with left atrial tissue ablation. The benefit on survival persists up to 3 years after surgery, with a trend toward improvement over time.


ISMICS- Washington, DC- June 2011. Poster presentation.
Similar Outcomes in Patients with Diastolic or Systolic Heart Failure Treated for Atrial Fibrillation (AF) and Structural Heart Disease.

A recent meta-analysis suggests that the presence of AF is associated with an adverse prognosis in HF patients irrespective of LV systolic function. Our hypothesis was that surgical ablation at the time of structural heart repair would improve long-term outcomes in elderly patients with AF and systolic or diastolic HF.

We reviewed a cohort of 273 consecutive patients (64% male, mean age 71.5±8.9 years) in HF characterized by a NYHA Class ≥II (73% were in Class III or IV). EF was preserved (> 40%) in 148 patients with diastolic HF and impaired in 125 patients with systolic HF. All underwent corrective cardiac surgery and combined AF ablation of the left atrium (LA). AF classification was long standing persistent (54%), persistent (21%) and paroxysmal (25%) with a mean duration of 56.2 months. Mean EF was 54±6.7%. Epicardial off-pump cardiac ablation performed on the beating heart resulted in a posterior LA isolation associated to a mitral isthmus line. Concomitant surgical procedures were isolated CABG (29%), isolated valve surgery (36%), combined CABG and valve surgery (32%) and 3% miscellaneous. Long-term rhythm monitoring was based on 24-hour Holter, 7-day Holter or pacemaker interrogation at 6 months and then yearly.

Adverse peri-operative events included two deaths (0.7%), 5 re-explorations for bleeding (1.8%), and 36cases (13.2%) of prolonged ventilation. There were 3 permanent strokes and 26 implantations of a new pacemaker. Over a mean follow-up of 33 months, with 2 patients lost to follow-up, there were 34 late deaths, of which 13 were cardiac. Freedom from AF or atrial flutter was 79% at 6 months, 78% at one year, 72% at 2 years and 70% at 36 months. Actuarial survival was 95.2% at 6-month, 93.3% at one year, 89% at 24-month and 87.9% at 36-month with no difference between systolic or diastolic HF subgroups (Log-Rank test, p= 0.23).

Restoration and maintenance of sinus rhythm through epicardial AF ablation combined with structural heart repair is a valid option in elderly patients with AF and either form of HF. Observed clinical outcomes compare favorably with those of historical controls up to 3 years after surgery.


Heart Failure Society of America Annual Scientific Meeting, Boston , 2011.
Elderly Patients with Advanced Heart Failure and Atrial Fibrillation Benefit from Cardiac Tissue Ablation at the Time of Structural Heart Repair

Mark A Groh, Benjamin I Groh, Oliver A Binns, Alan M Johnson, Stephen W Ely, Gerard L Champsaur. 

In patients with heart failure (CHF), atrial fibrillation (AF) is a known predictor of death and poor outcome. We hypothesized that restoring and maintaining sinus rhythm by surgical ablation at the time of structural heart repair would benefit elderly patients with CHF and AF.

Within a population of 355 prospectively treated patients (cardiac surgery for structural heart disease and concomitant cardiac tissue ablation) we reviewed a cohort of 98 patients in advanced CHF (NYHA Class II and EF 40%). Detailed demographics is displayed in Table I.

Epicardial off-pump cardiac tissue ablation created a posterior left atrial isolation and a routine mitral isthmus line. Concomitant surgical procedures were CABG, isolated or combined with a variety of valvular procedures. Long-term rhythm monitoring was assessed by 24-hour or 7-day Holter, or pacemaker interrogation at 6 months and yearly thereafter.

Adverse events included one early death, 8 early re-explorations (2 for bleeding) and one permanent stroke. Over a mean follow-up of 33.2 months, with 2 patients lost to follow-up, there were 17 late deaths (8 cardiac). Freedom from AF/flutter over time is displayed in Figure 1:

At last follow up, 12% of patients were on antiarrhythmic medications. Actuarial survival was 92.7% at 12 months, 84.3% at 24 months and 82.2% at 36 months when 43 patients were available.

In elderly patients with severely compromised left ventricular function, restoration and maintenance of sinus rhythm at the time of structural heart repair has a positive impact on both survival and morbidity persisting up to 3 years after surgery. The clinical outcomes of the cohort under study are similar to those of our own patients with less advanced heart failure and to published historical controls.


American Heart Association-2011 Scientific Sessions. Orlando, FL. Poster presentation. Surgical Therapy for Heart Failure Combining Structural Heart Repair with Left Atrial Ablation is Beneficial in Elderly Patients with Severe Cardiomyopathy and Atrial Fibrillation.Mark A Groh; Benjamin I Groh; Harry G Burton, III; Stephen W Ely; Oliver A Binns; Alan M Johnson; Wendy Westling; Gerard L Champsaur

Core 5. Myocardium: Function and Failure
Session Title: Surgical Treatment of Heart Failure, Transplantation and Arrhythmias II

Atrial fibrillation (AF) is a marker and mortality risk factor in patients with compromised left ventricular function. We tested the hypothesis that surgical ablation at the time of structural heart repair in patients with severe cardiomyopathy and AF would improve morbidity and mortality in the elderly. We reviewed a cohort of 125 consecutive patients with an ejection fraction (EF) less than 40% who underwent corrective cardiac surgery and concomitant AF ablation. The group was composed of 88 male and 37 female patients with a mean age of 70.8 +9.6 years, who underwent surgery while in AF. Mean duration of AF was 60 months and AF classification was long standing persistent in 56%, persistent in 19.5% and paroxysmal in 24.5%. Mean left atrial diameter was 50.7mm. Patients had a mean EF of 30.2 ± 8.7%, 95%CI 28.7 to 31.9%. Advanced heart failure was present in 86% of the patients who were in either NYHA Class III or IV. Prior to cardiac repair, epicardial off-pump cardiac ablation was performed on the beating heart. The lesion set resulted in posterior left atrial isolation in conjunction with the creation of the mitral isthmus line. Concomitant surgical procedures were CABG (37), isolated valve repair (31), combined CABG and valve surgery (42), Dor procedure (5) and miscellaneous (10). Adverse peri-operative events included one death, 2 re-explorations for bleeding and 5 episodes of renal insufficiency.

There were no permanent strokes. Over a mean follow-up of 30.6 months, with 2 patients lost to follow-up, there were 18 late deaths, of which 8 were cardiac. Long-term rhythm monitoring was carried out by 24 hour Holter, 7 day Holter or pacemaker interrogation at 6 months and yearly thereafter. Freedom from AF or atrial flutter was 79.8% at 6 months, 82% at one year, and 76.4% at 2 years. At last follow up, 12% of patients were on antiarrhythmic medications. Actuarial survival was 90.3% at 12 months, 85.8% at 24 months and 83% at 36 months. In elderly patients with severely compromised left ventricular function, restoration and maintenance of sinus rhythm through epicardial AF ablation performed at the time of structural heart repair has a positive impact on both survival and morbidity. Our study indicates these benefits persist through 3 years after surgery.


Society of Thoracic Surgeons, 2010, Fort Lauderdale, FL. Oral presentation.
Epicardial H-I-F-U Ablation of Atrial Fibrillation in Patients Undergoing Structural Heart Disease Repair.
M.A. Groh, O.A. Binns, H. Burton, S.W. Ely, A.M. Johnson,

Our goal was to review our success rate in ablating Atrial Fibrillation (AF) performed in patients undergoing surgery for structural heart disease.

Data from both, our prospective AF and the STS databases were retrospectively reviewed for 300 consecutive patients undergoing HIFU ablation from February of 2005 through June of 2008.

Population mean age was 71 years and mean AF duration 58 months.

Long-standing persistent (LSP) AF was observed in 52% of patients, persistent AF in 20% and paroxysmal in 28%. Primary surgical procedure was mitral valve surgery in 136 patients (45%), coronary artery bypass in 97 patients (32%), aortic valve surgery (AVS) in 60 patients (19%), and miscellaneous in 7 patients (2%). Hospital mortality rate was 1.3%, stroke rate was 1% and pacemaker implantation rate was 7%. There were no device-related complications. Freedom from AF (FFAF) was 81% in 276 patients at 6-month, 82% of 188 patients at 1-year, 74% of 98 patients at 2-year and 70% of 23 patients at 3-year, when 4 were still on antiarrhythmics.

At multivariate analysis, AVS and paroxysmal AF improved FFAF (p<0.05). Patients with preoperative stroke and longer duration of AF were more likely to remain in AF (p<0.05).

Survival at 12, 24 and 36 months were 94%, 92% and 91% respectively. At Cox regression analysis, BMI, cinch size, age, congestive heart failure and renal failure were each associated with increased risk of mortality.

This is the largest single center report of a single energy source creating a standard lesion set in patients undergoing concomitant AF ablation. HIFU creates epicardially a left atrial box lesion with mitral isthmus line during a 12-minute procedure performed off-pump and prior to the open intra-cardiac procedure. It can be used for AF ablation in patients with a variety of concomitant structural heart disease and associated risk factors, thus improving significantly surgical outcomes.


1-    AHA Scientific sessions, Chicago 2010. Abstract presentation.
Epicardial Surgical Ablation in Patients With Ischemic or Valvular Cardiomyopathy Undergoing Concomitant Cardiac Surgery
Mark A Groh, Oliver A Binns, Harry G Burton III, Stephen W Ely, Alan M Johnson, Benjamin I Groh, Asheville Heart, Asheville, NC; Gerard Champsaur, Palo Alto, CA

Atrial fibrillation is both a marker and an aggravating factor in patients with compromised left ventricular function. Ablating atrial fibrillation with low additional risk during cardiac surgical procedures may benefit patients with cardiomyopathy.

In a cohort of 108 consecutive patients with a mean age of 71.3±9.6 years undergoing open surgery-heart surgery for ischemic or valvular cardiomyopathy (all patients had an LVEF < 40%, mean 30±8.9%), a concomitant epicardial ablation using ultrasound energy was performed off-pump, prior to the intra-cardiac procedure. The lesion consisted of an epicardial circumferential left atrial ablation around the four pulmonary veins, associated in 98% of the cases to a linear ablation down to the coronary sinus groove. Mean duration of atrial fibrillation was 62±7.4 months and the type was Permanent in 37%, Paroxysmal in 25%, Persistent in 20.4% and long-standing Persistent in 17.6%.

Mean left atrial diameter was 49.3±10.9mm. Concomitant procedures were predominantly coronary bypass surgery, isolated or associated to a variety of valvular procedures. Post-operatively, patients were routinely evaluated by physical examination, ECG, and 24-hour Holter monitoring at 6-month intervals. During follow-up (mean 23.8±11.8 months), there were one early death and 15 late deaths, extra-cardiac in 50% and due to progressive heart failure in 50% of the cases.

Freedom from atrial fibrillation or flutter was 81% at 6 months, 78.20% at one year, and 75% at 2 years, when 13 patients out of 40 under follow-up were still receiving anti-arrhythmic drugs. Thirteen patients also received a pacemaker and four an implantable defibrillator.

Actuarial survival was 80.6±0.05 at 3 years, when 24 patients were still followed-up.

Epicardial ultrasound surgical ablation does not add any incremental intra-operative risk in elderly patients undergoing surgery for ischemic or valvular cardiomyopathy but may improve long-term outcomes in a challenging surgical population.


ISMICS-2010, Berlin. Oral Presentation.
Impact of beating heart surgical ablation in patients undergoing cardiac surgery associated with severe left ventricular dysfunction and atrial fibrillation

Mark A. Groh, Oliver A. Binns, Harry G. Burton, III, Gerard L. Champsaur, Stephen, W. Ely, Alan M. Johnson. Abstract presentation.

Atrial fibrillation (AF) is both a marker and aggravating factor in patients with compromised left ventricular function. We assessed the benefit of surgical ablation at the time of structural heart repair in patients with cardiomyopathy.

We reviewed a cohort of 108 patients with AF and a mean age of 71.3 +9.6 years undergoing cardiac surgery with severe cardiomyopathy, mean ejection fraction(EF)=30+8.9% , 35% of patients having an EF <40%. Before cardiac repair, epicardial off pump cardiac ablation was performed utilizing high intensity focused ultrasound (HIFU). The lesion set consisted of a circumferential pulmonary vein encircling line and mitral isthmus line.

Mean duration of AF was 62+7.4 months and the type of AF was: long standing persistent in 54.6%, persistent in 20.4% and paroxysmal in 25%. Mean left atrial diameter was 49+11 mm. Concomitant procedures were: isolated coronary artery bypass grafting (CABG), n=36 (33.3%), CABG + valvular surgery, n= 43 (39.8%), CABG+ ventricular restoration, n=4 (3.7%), valvular surgery alone, n=25 (23.1). Perioperatively, one patient died. There were no permanent strokes, 2 patients required re-exploration for bleeding and 5 patients developed renal insufficiency. Pacemakers were placed in 13 patients and implantable defibrillators in four. Postoperatively, patients were routinely evaluated by physical examination, ECG and 24 hour Holter monitoring at 6 months, then yearly intervals from surgery. During a mean follow-up of 23.8+11.8 months, there were 15 late deaths, 7 of which were non-cardiac in origin. Freedom from AF or atrial flutter was 81% at 6 months, 78.2% at one year, and 77.5% at 2 years. At last follow up 12% of patients were on antiarrhythmic medications. Follow-up was 98% complete at the reported intervals. Actuarial survival was 91.4% at 12 months, 83.4% at 24 months and 80.6% at 36 months, when 24 patients were still followed-up.

In this specific group of patients with severe left ventricular dysfunction, epicardial AF ablation with HIFU shows the same safety and efficacy levels as it did in previous publications. More importantly, epicardial ultrasound surgical ablation does not add any incremental intra-operative risk in elderly patients while potentially improving long-term outcomes.


1-    ISMICS-2009- San Francisco. Oral presentation.
Epicardial Ultrasonic Atrial Fibrillation Ablation During Coronary Artery Surgery Does Not Increase STS Risk Scores.

Mark Groh, Oliver A. Binns, Harry G. Burton, III, Stephen W. Ely, Alan M. Johnson, Susan E. Sutherland, Gerard L. Champsaur.
Asheville Cardiovascular & Thoracic Surgeons PA, Asheville, NC, USA.

Pre-operative atrial fibrillation (AF) is an established significant risk factor for morbidity and late mortality in patients undergoing bypass graft surgery (CABG).
In 47 patients with preoperative AF and requiring isolated CABG, a concomitant epicardial ultrasonic off pump ablation was performed during surgery. The lesion pattern was a pulmonary vein encircling lesion and an additional mitral line.
STS risk scores were computed and comparisons were established between this group (A) and a group of patients (B) receiving CABG in the same time period but who had no pre-operative AF hence were not subjected to an ablation.
Group A patients were significantly older (mean 70.6, 95% CI 68.2-73 years vs. mean 64.3, 95%CI 64-65.6 years*), and had more cerebro-vascular diseases (25.5% vs. 10.8%*) and pre-operative strokes (8.5% vs. 3.1%*). The STS risk scores were significantly higher in group A for predicted mortality, incidence of stroke and overall morbidity*. However, there were no differences between the 2 groups in bypass or cardiac exclusion times, since the ablation procedure was performed off pump, prior to the initiation of bypass.
The older patients of Group A had a significant increase in length of stay, prolonged ventilation and renal failure*. However, there were no post-operative stroke episodes and mortality was no different from that of Group B. There was also a lower incidence of peri-operative AF in Group A than in group B (4.3 % vs. 22.5%*),
Moreover, 84% of ablated patients in group A were still free from AF on routine 24-hour Holter monitoring at 6-month follow-up.
The addition of epicardial off pump cardiac ablation to CABG in patients with preoperative AF does not increase the operative risk and seems effective at preventing early and longer-term post-operative AF.
* p<0.05


Epicardial Ultrasonic Ablation of Atrial Fibrillation During Concomitant Cardiac Surgery Is a Valid Option in Patients With Ischemic Heart Disease. Mark A. Groh, Oliver A. Binns, Harry G. Burton, III, Gerard L. Champsaur, Stephen W. Ely and Alan M. Johnson. Circulation 2008;118;S78-S82


Ultrasonic Cardiac Ablation for Atrial Fibrillation During Concomitant Cardiac Surgery: Long-Term Clinical Outcomes. Mark A. Groh, Oliver A. Binns, Harry G. Burton, III, Stephen W. Ely and Alan M. Johnson. Ann Thorac Surg 2007;84:1978-1983


American Heart Association-2007, Orlando, Scientific Sessions. Poster Presentation. Epicardial Ultrasonic Ablation of Atrial Fibrillation During Concomitant Cardiac Surgery is a Valid Option in Patients with Ischemic Heart Disease

Mark A Groh, Oliver A Binns, Harry G Burton, III, Gerard L Champsaur, Stephen W Ely, Alan M Johnson

Atrial fibrillation has been shown to influence negatively early and long-term outcomes of patients operated on for the treatment of ischemic heart disease, Surgical therapy of atrial fibrillation concomitant to coronary bypass grafting and using epicardial, beating heart Ultrasound was assessed after a minimum 6-month follow-up,

A cohort of 98 consecutive patients with a mean age of 72 years and a primary diagnosis of ischemic heart disease had surgery for structural heart disease, Coronary artery bypass grafting was isolated in 42% or associated in 58% of the cases to various combinations of aortic, mitral and tricuspid surgery. A left ventricular restoration (Dor procedure) was also performed in 6 patients, Atrial fibrillation duration ranged from 6 to 360 months (mean 71 months and was permanent in 47 patients, paroxysmal in 34, and persistent in 17, Left atrial diameter ranged from 34 to 62 mm (mean 48±6 mm), Ablation was performed off-pump, prior to the concomitant procedure, and consisted of a single step circumferential line around the pulmonary veins created during an average 12-minute algorithm, An associated mitral line lesion was also routinely created epicardially, off-pump, with a hand-held device using the same technology, At 3, 6 and 12 month visits, patients were routinely evaluated by physical examination, 12-lead ECG, chest X-ray and 24 -hour Holter. Antiarrhythmic and anticoagulant therapies were prescribed for 3 and 12 months respectively.

No complications or deaths were related to the device or the procedure, There were 1 early death (1 %) and 4 extra-cardiac late deaths, A pacemaker was implanted in 3 patients, Mean follow-up time was 325 days, 2 patients being lost to follow-up, Freedom from atrial fibrillation and flutter at the 6-month visit was 84% for the entire population, 76% in patients with permanent, and 91 % in patients with paroxysmal atrial fibrillation. ln the 39 patients available for the 1-year visit, 33 or 85% were free from atrial fibrillation or flutter.

Conclusion. Epicardial, off-pump, beating heart ablation using therapeutic ultrasound is safe, reliable and can easily treat atrial fibrillation in a difficult surgical population of patients with primary ischemic heart disease.

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