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VALVULAR AND STRUCTURAL HEART DISEASES Original Studies The Long-Term Outcomes of Transcoronary Ablation of Septal Hypertrophy Compared to Surgical Myectomy in Patients with Symptomatic Hypertrophic Obstructive Cardiomyopathy Himabindu Samardhi, 1,3 * MBBS, Darren L Walters, 1,3 MBBBS, MPhil, FRACP , FSCAI, FCSANZ, Christopher Raffel, 1,3 MBChB, Shruti Rateesh, 1,3 MBBS, Catherine Harley, 1,3 MBBS, Darryl Burstow, 1,3 MBBS, FRACP , FCSANZ, Peter Pohlner, 1,3 MBBS, FRACS, and Con Aroney 2,3 MBBS, MD, FRACP , FCSANZ Objectives: The aim of this study was to compare the long-term outcomes of transcoro- nary ablation of septal hypertrophy (TASH) with open surgical myomectomy (SM) in patients with symptomatic hypertrophic obstructive cardiomyopathy (HOCM). Methods: We reviewed patients who underwent either procedure at our institution. The demo- graphics, clinical outcomes, echocardiographic parameters, and complications were compared. Results: Seventy patients with HOCM were treated with either TASH (n 5 47, 26 male) or SM (n 5 23, 10 male). Compared to those treated with SM, patients undergoing TASH were older (571/2 14.7 years versus 47 1/2 20.6 years, P 5 0.021) and more symptomatic. A higher proportion of patients had syncope as a presenting feature in the TASH group compared to the SM group (57.5% vs. 17.4%, P 5 0.002) respectively. They were also more likely to be in New York Heart Association (NYHA) class III/IV compared to the patients who underwent SM (85.1% vs. 39.1%; P < 0.001). Patients were followed for a mean period of 43 months (TASH) and 46 months (SM). Repeat procedures were more common in the TASH group (17% vs. 0%, P 5 0.04) but mitral valve replacement was more common in the SM group (0% vs. 8.7%, P 5 0.105). Symptom improvement, the rate of complications and all cause mortality rates were similar in both groups. Conclusions: TASH compares favorably with surgical myec- tomy with regard to symptom resolution, rate of complications and mortality in a terti- ary referral centre and should be seen as an attractive alternative to surgical myectomy in the appropriate patient population. V C 2013 Wiley Periodicals, Inc. Key words: HCM; septal ablation; ANGO INTRODUCTION Hypertrophic Cardiomyopathy (HCM) is the most common genetic heart disease with a diverse pheno- typic expression. It remains a difficult condition to diagnose and treat. Dynamic left ventricular outflow tract (LVOT) obstruction can develop in a subset of patients and is an adverse prognostic marker associated with increased cardiovascular mortality. It is estimated that about 25% of patients with HCM develop left ven- tricular outflow tract obstruction at rest [1]. In addition 1 The Prince Charles Hospital, Rode Road, Chermside, Bris- bane, Queensland 4032, Australia 2 The Holy Spirit Northside Hospital, 627 Rode Road, Cherm- side, Brisbane, Queensland 4032, Australia 3 University of Queensland, Australia Conflict of interest: Nothing to report. *Correspondence to: Himabindu Samardhi, Rode Road, Chermside, Brisbane, Queensland 4034, Australia. E-mail: [email protected] Received 17 September 2012; Revision accepted 11 July 2013 DOI: 10.1002/ccd.25134 Published online 19 July 2013 in Wiley Online Library (wileyonlinelibrary.com) V C 2013 Wiley Periodicals, Inc. Catheterization and Cardiovascular Interventions 83:270–277 (2014)

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VALVULAR AND STRUCTURAL HEART DISEASES

Original Studies

The Long-Term Outcomes of TranscoronaryAblation of Septal Hypertrophy Compared to

Surgical Myectomy in Patients with SymptomaticHypertrophic Obstructive Cardiomyopathy

Himabindu Samardhi,1,3* MBBS, Darren L Walters,1,3MBBBS, MPhil, FRACP, FSCAI, FCSANZ,

Christopher Raffel,1,3MBChB, Shruti Rateesh,1,3

MBBS, Catherine Harley,1,3MBBS,

Darryl Burstow,1,3MBBS, FRACP, FCSANZ, Peter Pohlner,1,3

MBBS, FRACS, andCon Aroney2,3

MBBS, MD, FRACP, FCSANZ

Objectives: The aim of this study was to compare the long-term outcomes of transcoro-nary ablation of septal hypertrophy (TASH) with open surgical myomectomy (SM) inpatients with symptomatic hypertrophic obstructive cardiomyopathy (HOCM). Methods:We reviewed patients who underwent either procedure at our institution. The demo-graphics, clinical outcomes, echocardiographic parameters, and complications werecompared. Results: Seventy patients with HOCM were treated with either TASH(n 5 47, 26 male) or SM (n 5 23, 10 male). Compared to those treated with SM, patientsundergoing TASH were older (571/2 14.7 years versus 47 1/2 20.6 years, P 5 0.021)and more symptomatic. A higher proportion of patients had syncope as a presentingfeature in the TASH group compared to the SM group (57.5% vs. 17.4%, P 5 0.002)respectively. They were also more likely to be in New York Heart Association (NYHA)class III/IV compared to the patients who underwent SM (85.1% vs. 39.1%; P < 0.001).Patients were followed for a mean period of 43 months (TASH) and 46 months (SM).Repeat procedures were more common in the TASH group (17% vs. 0%, P 5 0.04) butmitral valve replacement was more common in the SM group (0% vs. 8.7%, P 5 0.105).Symptom improvement, the rate of complications and all cause mortality rates weresimilar in both groups. Conclusions: TASH compares favorably with surgical myec-tomy with regard to symptom resolution, rate of complications and mortality in a terti-ary referral centre and should be seen as an attractive alternative to surgicalmyectomy in the appropriate patient population. VC 2013 Wiley Periodicals, Inc.

Key words: HCM; septal ablation; ANGO

INTRODUCTION

Hypertrophic Cardiomyopathy (HCM) is the mostcommon genetic heart disease with a diverse pheno-typic expression. It remains a difficult condition todiagnose and treat. Dynamic left ventricular outflowtract (LVOT) obstruction can develop in a subset ofpatients and is an adverse prognostic marker associatedwith increased cardiovascular mortality. It is estimatedthat about 25% of patients with HCM develop left ven-tricular outflow tract obstruction at rest [1]. In addition

1The Prince Charles Hospital, Rode Road, Chermside, Bris-bane, Queensland 4032, Australia2The Holy Spirit Northside Hospital, 627 Rode Road, Cherm-side, Brisbane, Queensland 4032, Australia3University of Queensland, Australia

Conflict of interest: Nothing to report.

*Correspondence to: Himabindu Samardhi, Rode Road, Chermside,

Brisbane, Queensland 4034, Australia. E-mail: [email protected]

Received 17 September 2012; Revision accepted 11 July 2013

DOI: 10.1002/ccd.25134

Published online 19 July 2013 in Wiley Online Library

(wileyonlinelibrary.com)

VC 2013 Wiley Periodicals, Inc.

Catheterization and Cardiovascular Interventions 83:270–277 (2014)

more than 50% of patients generate an exercise-induced gradient [2]. The presence of the systolic ante-rior motion of the mitral valve (SAM) and consequentmitral regurgitation contribute to the pathophysiology.Surgical myectomy (SM) has been the gold standardmethod of treatment of this patient subgroup. Myectomyoffers good symptom resolution with low morbidity andmortality in experienced centers [3–10]. Transcatheteralcohol ablation of septal hypertrophy (TASH) is now aless invasive alternative with encouraging short- andmedium-term results [11–16]. There is paucity of clinicalevidence offering head to head comparisons of the twotreatment modalities. A recent meta-analysis derivedfrom observational studies suggested similar functionalstatus outcomes for both treatments in the absence of asignificant difference in mortality or re-intervention rate[17]. The incidence of conduction abnormalities and theneed for permanent pacemaker (PPM) implantation how-ever was increased in the TASH subgroup. The mostrecent guidelines released jointly by the American Col-lege of Cardiology Foundation and the American HeartAssociation task force give a Class I recommendation forSM for patients with severe drug refractory symptomsand LVOT obstruction in experienced centers with acomprehensive HCM clinical program (Level of Evi-dence: C). TASH has been given a Class IIa recommen-dation for the adult patient with an unacceptable surgicalrisk (Level of Evidence: B) in an experienced centre [18].

In this study, we compare long-term outcomes,symptom resolution, hemodynamics, and the rate ofcomplications and re-intervention between patientsundergoing either SM or TASH.

METHODS

Patients who underwent surgical myectomy or alco-hol septal ablation for the treatment of symptomaticleft ventricular outflow tract obstruction (since 1981)were identified by searching The Prince Charles Hospi-tal cardiac catheterization and surgical databases. Theseare prospective records of interventional and surgicalprocedures. This was complimented by reviewing theclinical records and the echocardiography reports. Thefollowing parameters were defined for the patientsincluded in the study: demographics, clinical outcomes,and echocardiographic parameters pre- and post-procedure. Complications including the need for perma-nent pacing and re-intervention rates between the groupswere compared. The echocardiographic parameters ana-lysed included septal thickness, left ventricular outflowgradients, left ventricular ejection fraction (LVEF),degree of mitral regurgitation (MR), and systolic ante-rior motion (SAM) of the mitral valve. Mortality rates

were obtained by a review of clinical record at follow-up and from the public deaths registry as of May 2012.

Transcoronary Ablation of Septal Hypertrophy

Septal ablation was performed by two operatorsaccording to standard techniques that have been previ-ously described [19]. Initially a five French pacing wireis placed in the right ventricle via a sheath in the rightinternal jugular artery or right femoral vein to providetemporary back up pacing as required. Coronary angiog-raphy is performed via the femoral artery. In the leftfemoral artery, separate arterial access is obtained and apigtail catheter is positioned in the left ventricular apexto allow simultaneous left ventricular and aortic pressuremeasurements. The left coronary artery is engaged witha guiding catheter, typically an extra back up guide. Abaseline outflow tract gradient is recorded invasivelyand echocardiographically with and without valsalvaand extra systole. Anticoagulation with IV unfractio-nated heparin at 100 U/kg is administered. Sedation andopioid analgesia consisting of fentanyl and midazalam isrecommended due to expected pain and anxiety relatedto septal infarction. A coronary medium support guide-wire such as a Hi-Torque Whisper (Abbott Vascular,Santa Clara) is then positioned into the first septal perfo-rator. The septal branch is sized and a compliant over-the-wire balloon typically 1.5–2.5 mm and 8–12 mm inlength is advanced over the coronary guide-wire into theseptal perforator. The balloon is inflated to nominalpressure and coronary angiography is performed to dem-onstrate septal perforator occlusion and confirm that theballoon is safely located in the septal branch and left an-terior descending artery flow is unaffected. Contrast(Levovist, Schering AG) is then injected into throughthe over-wire balloon to confirm that the optimal site isbeing targeted and no contrast enhancement is occurringremote to the intended site of ablation. The optimumsite is the proximal septal bulge, the site at which sys-tolic anterior motion of the mitral valve is triggered andwhere acceleration of blood through the outflow tract ismost increased. Over the course of the study, the volumeof alcohol injected changed from 2 cc or more to less a1 cc in line with changes in clinical practice demonstrat-ing less heart block and similar reductions in outflowtract gradient with lower alcohol volumes [20]. The av-erage volume of alcohol injected over the study periodwas 1.8 mL (0.4–4.0 mL), prior to December 2003 theaverage volume was 2.9 mL (2.5–4.0), and after 1.2 mL(0.4–3.0 mL) (P< 0.001).

Surgical Myectomy

Surgical myectomy was performed in manner to thatpreviously described [4]. The standard approach to

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cardiopulmonary bypass was undertaken with systemicmoderate hypothermia, typically left ventricular venting,and either blood or crystalloid antegrade and/or retro-grade cardioplegic solution was used. The muscle isresected using two parallel incisions directed towardsthe left ventricular apex that include the targeted area ofseptal hypertrophy. Typically a muscle section ofapproximately 1 cm in depth and 1–2 cm in width andthat extends 3–5 cm toward the apex is removed as ablock. The extension of the myectomy is limited to thearea proximal to the bases of the papillary muscles.This procedure is guided by intraoperative echocardiog-raphy. An evaluation at the end of the procedure is per-formed with intraoperative echocardiography and apersistent gradient in the left ventricular outflow ofgreater than 50 mm Hg or severe mitral regurgitationwould prompt further surgery and/or valve replacement.

Statistical Analysis

Data is presented as mean (SD). All analyses wereperformed using SPSS version 16.0. Categorical varia-bles were compared using Chi-square or Fisher exacttests. Quantitative variables were compared using thepaired samples t-test. A P value of <0.05 was consid-ered significant for comparison of clinical outcomes.

RESULTS

A total of 70 patients underwent septal reduction ther-apy with 47 patients having TASH and the remaining23 patients having SM. In the SM group, one patientalso underwent a mitral valve repair, one patient had amitral valve replacement, one patient had an aorticvalve replacement, and one patient had both the mitraland aortic valves replaced. Five patients underwent cor-onary artery bypass grafting. The demographics, clinical

presentation, the echocardiographic parameters pre-procedure are outlined in Table I. Patients who under-went TASH were older compared to the SM cohort. Asignificantly higher proportion of patients had syncopeas a presenting feature in the TASH group compared tothe SM (57.5% vs. 17.4%, P¼ 0.002), respectively.They were also more likely to be in New York HeartAssociation (NYHA) class III/IV compared to thepatients who underwent myectomy (85% vs. 39%;P< 0.001). One patient in the TASH group presentedwith a cardiac arrest and another patient had ventricu-lar tachycardia. One patient in the SM group also hadventricular tachycardia. The proportion of patients pre-senting with chest pain was similar in both groups(49% vs. 52%). The echocardiographic parameterswere similar across the groups.

Symptom Outcomes

Forty-seven patients in the TASH subgroup were fol-lowed for a mean period of 43 months (3.6 years) and23 patients in the SM subgroup were followed for amean period of 46 months (3.8 years).

There was a significant improvement in symptomsin both groups post-procedure (Table II). The numberof patients in the TASH group with symptoms of chestpain decreased from 49% to 9.5% (P< 0.001) and inthe surgical group from 52% to none (P< 0.001). Thenumber of patients in NYHA III/IV decreased from85% to 4.8% (P< 0.001) in the TASH group and inthe SM group from 39% to none (P¼ 0.002). Therewas however no statistical difference in these clinicaloutcomes between the two groups.

Echocardiographic Outcomes

The ejection fraction pre- and post-procedures werewithin normal ranges for both groups (Table II). The

TABLE I. Demographics, Clinical and Echocardiographic Features at Presentation

TASH SM P value

Mean age in years (SD) 57 (14.7) 47 (20.6) 0.021

Male (%) 26/47 (55.3%) 10/23 (43.5%) 0.352

Syncope (%) 27/47 (57.5%) 4/23 (17.4%) 0.002

Cardiac arrest (%) 1/47 (2%) 0/23 0.481

Chest pain (%) 23/47 (49%) 12/23 (52%) 0.799

NYHA III/IV (%) 40/47 (85%) 9/23 (39%) <0.001

Supraventricular tachycardia (%) 9/47 (19%) 2/23 (9%) 0.259

Ventricular tachycardia (%)

VT 1/47 (2%) 1/23 (4.3%) 0.601

NSVT 1/47 (2%) 0/23 0.481

Mean LVEF (SD) 70.1% (7) 67.6% (11) 0.289

MR grade 2 or more (%) 15/39 (38.5%) 9/20 (45.0%) 0.628

Mean LVOT gradient in mm Hg (SD) 72.8 (57.7) 78.4 (39.3) 0.707

Mean septal thickness in mm (SD) 20.3 (5.6) 22.6 (9.9) 0.275

SAM (%) 36/40 (90.0%) 16/20 (80.0%) 0.283

PPM/AICD 14/46 (30.4%) 4/22 (18.2%) 0.284

272 Samardhi et al.

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

mean left ventricular outflow gradient decreased from74 to 27 mm Hg in the TASH group (P< 0.001) andfrom 76 to 13 mm Hg in the SM group (P< 0.001) indi-cating a significant hemodynamic result with both pro-cedures. The residual resting gradient was howeverhigher in the TASH group. The septal thickness reducedfrom 20.5 to 15.9 mm in the TASH group (P< 0.001)and from 22.9 to 18.6 mm (P¼ 0.025) in the SM group.The number of patients with moderate (2þ) mitral re-gurgitation on echocardiography decreased in bothgroups. This was however not statistically significant.Three patients with moderate to severe mitral regurgita-tion in the SM groups had a mitral valve repair orreplacement. None of the patients in the TASH grouprequired mitral valve surgery. There was however a sig-nificant difference in the reduction in SAM between thegroups. It reduced from 90% to 61% in the TASH groupand from 80% to 20% in the SM group (P¼ 0.005).

Complications and Re-interventions

Eight (17%) patients in the TASH group required arepeat TASH seven of who had two procedures and onehad three procedures in total (Table III). None of thepatients in the SM group required a repeat procedure.Seven patients (15%) became pacemaker dependent dueto complete heart block in the TASH group and three(13%) in the surgical group. There were no intraproce-dural deaths in either group. Two patients in the TASHgroup had a VF arrest during the procedure. One of

those patients developed a ventricular septal defect as aresult of the chemical infarction induced by alcohol andrequired a percutaneous closure device. The septalthickness in this patient pre-procedure was 18 mm and2.5 mL of ethanol was injected during the procedure.He made a successful recovery thereafter. Complica-tions other than those involving the conduction systemare listed in Tables IV and V for the SM group andTASH group, respectively. One patient had a pulmonaryembolism and another developed sepsis requiring intra-venous antibiotics. Another patient required repeat thor-ocotomy secondary to bleeding. One patient requiresdrainage of a unilateral pleural effusion and anotherpatient was treated for a cardiotomy syndrome. Twopatients had postoperative atrial fibrillation with a re-sultant embolic stroke in one of them. One patientdeveloped a large pericardial effusion that was compli-cated by multi organ failure and needed a prolongedICU stay. The mean intensive care unit stay for the SMgroup was 2.56 days. All TASH patients were managedin the coronary care unit post-procedure.

Mortality

The mortality rates were obtained from the hospitalrecords for the duration of clinical follow-up and fromthe public deaths registry as of May 2012. The meanduration from the index procedure to May 2012 was85 (7.1 years) months for the TASH group and 109(9.1 years) months for the surgical group. Two patientsin the SM group died in the early post-operative period(<1 month post-procedure). This information wasobtained from the public deaths registry. The cause ofdeath was cardiac however detailed informationunfortunately is not available. One patient was dis-charged day 13 post-procedure (she underwent alsohad three coronary vein grafts) and another patient wasdischarged day 7 post-procedure (she had a left internalmammary graft to the left anterior descending artery).There were four late deaths (>12 months) in the SMgroup one of which was non-cardiac. There were twolate deaths (>12 months) in the TASH group, onefrom sepsis and another from progressive cardiac

TABLE III. Complications, morbidity, and Mortality

TASH SM P value

Number of patients requiring a

repeat procedure (%)

8/47 (17%) 0/23 0.04

ICU stay (in days) 0 2.56 <0.001

Permanent pacemaker

insertion due to heart

block from procedure (%)

7/47 (15%) 3/23 (13%) 1.00

Transient CHB (%) 4/47 (9%) 0/23 0.295

Mortality post-procedure

(<30 days)

0/47 2/23 (8.7%) 0.105

Late mortality (>1 year) 2/47 (4.3%) 4/23 (17.4%) 0.086

Other complications 4/47 (8.5%) 6/23 (26%) 0.07

TABLE II. Clinical Outcomes and Hemodynamic Result

TASH SMComparison of outcomes

PRE POST P value PRE POST P value P value

LV EF (SD) 70.1 (6.9)% 66.2 (8.2)% 0.006 68.8 (9.4)% 64.7 (10.8)% 0.204 0.942

LVOT Gradient in mm Hg (SD) 74.0 (59.5) 27.2 (37.5) <0.001 75.5 (38.4) 12.9 (27.0) <0.001 0.281

Septal thickness in mm (SD) 20.5 (5.6) 15.9 (6.2) <0.001 22.9 (10.4) 18.6 (8.4) 0.025 0.947

MR Grade 2 or more (%) 15/39 (38.5%) 14/47 (29.8%) 0.396 9/20 (45.0%) 6/23 (26.1%) 0.195 0.748

SAM (%) 36/40 (90.0%) 27/44 (61.4%) 0.003 16/20 (80.0%) 4/18 (22.2%) <0.001 0.005

NYHA (III, IV)* 40/47 (85.1%) 3/42 (7%) <0.001 9/23 (39.1%) 0/20 0.002 0.545

Chest pain 23/47 (48.9%) 4/42 (9.5%) <0.001 12/23 (52.2%) 0/20 (0%) <0.001 0.154

TASH Versus Surgical Myectomy 273

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failure. There was no statistically significant differencein all cause mortality rates between the two groups.

DISCUSSION

Transcoronary ablation of septal hypertrophy andsurgical myectomy are the main stay of treatmentoffering mechanical relief in patients with HOCMwhose symptoms are refractory to pharmacologicalmethods. The ACC/AHA guidelines give a class I rec-ommendation for surgical myectomy in this patientgroup and a class IIa recommendation in those whosesurgical risk is prohibitive [18].

An adequately powered randomized trial comparingthe two treatments has not been conducted and isunlikely to occur in the foreseeable future. There havebeen only a limited number of studies comparing SMand TASH, most have looked at short- to medium-termfollow-up. There is very limited data on medium tolong-term outcomes. Our study contributes further datato the literature on this subject in a moderate sizedcohort of patients (Fig. 1).

Complications and Mortality

No significant difference in short- [17,21–26] orlong-term [22,23,25,26] mortality has been demon-strated between patients who underwent TASH to thosewho underwent SM. Some of these studies had largerpatient groups whereas others had comparable samplesizes to our cohort with a comparable duration offollow-up. In our study, the TASH group was olderand had a greater proportion of symptomatic patients,

however the periprocedural and late all cause mortalityrates were similar. This would suggest that TASH is asafe alternative in experienced centers. Complicationsin the TASH group were lower then some reported se-ries with no coronary artery dissection as a result ofthe ablation while rates as high as 4.4% have beenreported [11]. The TASH patients had a lower compli-cation rate in our centre. Patients undergoing TASHwere significantly more likely to require re-intervention as compared to SM. A repeat TASH pro-cedure however remains a reasonable option given thelow morbidity compared to open surgery.

Symptoms at Follow-up

More than 90% of patients in both groups were inNYHA class I/II at follow-up indicating good sympto-matic relief from either procedure. Less than 10% ofpatients in the TASH group and none of the patients inthe surgical group complained of any chest pain duringfollow-up. It should be noted however that five patientshad coronary artery bypass grafting at the time of SMfor obstructive coronary disease.

Septal Thickness, LVOT Gradient, and MitralRegurgitation

At our centre, a change in the mean septal thicknessof 4.6 mm and 4.3 mm was observed for the TASHand SM groups, respectively. The hemodynamic resultachieved was significant for both groups with a meanreduction of 63 mm Hg for the SM group and 47 mmHg for the TASH group. Both treatments are thereforecomparable in terms of mechanical relief of hemody-namic LVOT obstruction. The data suggests that theresidual resting LVOT gradient is higher in the TASHgroup compared to the surgical group. This observation

TABLE V. Complications in the TASH Group Excluding Pace-maker Dependency

Complication

Patient 1 Pulmonary embolism.

Patient 2 Sepsis requiring IV antibiotics.

Patient 3 VF arrest during procedure, AF.

Patient 4 VF arrest during procedure and VSD

requiring percutaneous device closure.

TABLE IV. Complications in the SM Group Excluding Pace-maker Dependency

Complication

Patient 1 Atrial fibrillation.

Patient 2 Atrial fibrillation and embolic stroke.

Patient 3 Cardiotomy syndrome.

Patient 4 Unilateral pleural effusion

requiring drainage.

Patient 5 Bleeding requiring redo

thorocotomy.

Patient 6 Pericardial effusion requiring drainage,

multi organ failure, prolonged ICU stay.

Fig. 1. Kaplan–Meier curves demonstrating all cause mortal-ity between the two groups. [Color figure can be viewed inthe online issue, which is available at wileyonlinelibrary.com.]

274 Samardhi et al.

Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).

has been made previously in a meta-analysis [17]. Thisresult however does not translate into an adverse symp-tomatic outcome. Both groups have similar NYHA sta-tus at follow-up. This is reassuring as it has importantimplications particularly for the patient group in whomthe surgical risk is prohibitive and TASH is the recom-mended strategy as outlined by the recent ACCF/AHAguidelines [18]. However, not all patients routinely hadtheir gradients re-assessed after the procedure withstress testing. This could potentially have an effect onexercise induced symptoms particularly in the TASHgroup with higher residual LVOT gradients. Thedegree of moderate (2þ) mitral regurgitation and SAMdecreased post-procedure. While the residual SAM wasnot insignificant post-procedure in either group onlytwo patients in the TASH group and none in the surgi-cal group had grade 3þ mitral regurgitation. The SMgroup had a more significant reduction in SAM and itwould be important to explore if the incorporation ofspecific techniques to address this would result in animprovement in local outcomes.

Permanent Pacemaker Implantation

Permanent pacemaker implantation has been one ofthe important complications particularly with TASH.The rate of PPM implantation in recent studies has var-ied from 10% to 20% [21,25,27,28]. Our experiencehas been very similar. It is noteworthy that the rate ofpermanent pacemaker implantation was similar in bothgroups (15% for TASH and 13% for SM, P¼ 1).Therefore, while TASH compares favorably to surgeryat our institution the rate of PPM implantation post-surgery remains high. It is not dissimilar to the ratesdescribed in some series. Ralph-Edwards et al. [26]report a PPM implantation rate of 12.5% in their iso-lated myectomy group of 48 patients and Heric et al.[4] report a rate of 10% in their cohort of 178 patientswho underwent myectomy (isolated or in combinationwith other procedures). However, other series do reportrates as low as 3% to 4.5% post-surgical myectomy[27,29]. The rate of pacemaker implantation post-TASH has reduced as the technique has evolved withcareful sub-selective low volume ethanol injection. Inour centre of the seven patients who required a perma-nent pacemaker after TASH, only one of them requireda PPM after the adoption of sub-selective ethanolinjection. The pacemaker implantation rate post-procedure dropped from 31% to 3.5% post-sub-selective alcohol injection which is comparable to thefavorable rates post-surgical myectomy in experiencedcenters. This enforces the need for constant re-evaluation of current clinical methods and adoption ofnewer techniques to decrease the rate of complications.

Sudden Death and Defibrillator Implantation

Concerns have been raised about the arrhythmogenicpotential of the scar produced by TASH [30]. Threepatients each in the TASH and SM groups had a defib-rillator implant prior to the respective procedure. Ofthose who became pacemaker dependent one patient ineach group had a defibrillator implanted. The indicationwas primary prevention in the patient who underwentSM and ventricular tachycardia in the patient in theTASH group. In addition, three patients in the TASHgroup had a defibrillator implanted >12 months afterthe procedure for primary prevention. Two patients whounderwent TASH had ventricular fibrillation during theprocedure. No episodes of sudden cardiac death werereported during follow-up. However, no detailed recordsof appropriate or inappropriate shocks were available.Most of the events in the above study reported by Cateet al. occurred after four years of follow-up. Therefore,a longer follow-up period may be required to assess thearrhythmogenic complications. This would be particu-larly important in the follow-up of patients who under-went more than one alcohol ablation procedure whichwould possibly lead to a larger volume of infracted tis-sue. However, the amount of alcohol injected diddecrease with the development of sub-selective ethanolinjection which would of course have a direct role inthe volume of infracted tissue. Novel methods of quanti-fying the volume of infracted tissue with a cardiac MRIare likely to improve our understanding of the contribu-tion of the volume of scar tissue to future arrhythmoge-nicity if such a causal relationship exists.

Study Limitations

There are several major limitations to the study. Thestudy population is non-randomized and the sample sizesare modest. However the follow-up period is at leastequivalent to or longer than most other contemporaryreviews available. The different referral streams willalmost certainly lead to subtle referral biases that are notaccounted in this study. The lower number of patientsundergoing SM after the advent of TASH is probably areflection of this. The small number of surgical patientsalso makes drawing definite conclusions hard; but itseems reasonable to make the above observations. Giventhe retrospective nature of the study all the data requiredfor the individual patient were not always available.More stringent and longer follow-up would be requiredto assess the arrhythmic complications.

CONCLUSIONS

This study documents the immediate and long-termoutcomes of catheter based septal ablation and surgical

TASH Versus Surgical Myectomy 275

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myectomy. TASH compares favorably with surgicalmyectomy with regard to symptom resolution, rate ofcomplications, and mortality in a tertiary referral centreand should be seen as an attractive alternative to surgi-cal myectomy in the appropriate patient population.

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