ORIGINAL ARTICLE

Percutaneous trans uminal septal myocardial

ablation

(PTSMA)

for symptomatic patients

with hypertrophic obstructive cardio-

myopathy:

first

experience

J.M. ten Berg, H.H.D. Idzerda, W. Jaarsma

Background. Recently, percutaneous transluminal septal myocardial ablation (PTSMA) has been introduced as treatment for symptomatic patients with hypertrophic obstructive cardiomyopathy (HOCM). Methods. We describe our first experience in 24 patients who were treated in our institution during the year 2000. Results. The procedure was initially successful in all but one patient. In that patient the septal branch that was perfusing the proximal septum could not be found. The procedure was complicated in three patients. One patient died suddenly on the second day after the procedure. Two additional patients needed a permanent pacemaker for persisting total heart block. In the other 22 patients the procedure was successful with an acute decrease ofthe mean outflow tract gradient from 89±43 mmHg to 21±19 mmlHg. In those 19 patients who had a follow-up of at least three months (mean followup 172±87 days), the mean NYHA class decreased from 2.7±0.7 before PTSMA to 0.6±0.9 at the last follow-up. The echocardiographic gradient decreased from 92±39 mmHg before the procedure to 26±23 mmHg at the last follow-up. Conclusions. Our preliminary results demonstrate that PTSMA is an effective treatment for symptomatic patients with HOCM. (Neth Heart J2001;9:318-22.) Keywords: Hypertrophic obstructive cardiomyopathy (HOCM), percutaneous transluminal septal myocardial ablation (PTSMA)

J.M. ten Berg. H.H.D. Idzerda. W. Jaarsma. Department of Cardiology, St. Antonius Hospital, Koekoekslaan 1, 3435 CM Nieuwegein. Address for correspondence: J.M. ten Berg. E-mail: [email protected].

318

Patients with hypertrophic obstructive cardiomyopathy (HOCM) who remain symptomatic despite optimal medication are candidates to undergo a Morrow septal myectomy."-2 Although this procedure is safe when performed by experienced surgeons, it is invasive with the need for thoracotomy and extracorporal circulation. A percutaneous technique has recently been introduced: percutaneous transluminal septal myocardial ablation (PTSMA) using alcohol to locally ablate the septal hypertrophy. In this report we describe our first experience with this technique and review the literature. Patients and methods Patient selection We consider patients to be candidates for PTSMA when they remain symptomatic (NYHA functional class >II) despite maximal tolerated doses of (blockers, verapamil, or disopyramide and have a resting or provocable - post-ventricular extrasystole or with Valsalva - left ventricular outflow tract gradient over 50 mmHg. Also patients previously unsuccessfully treated with a DDD-pacemaker or myectomy are candidates. How to perform PTSMA Encouraged by previous results of other groups, we started to perform PTSMA in February 2000 using the technique developed and described by Seggewiss and colleagues.4 In short: a complete angiogram is performed and a temporary pacemaker is placed in the right ventricle to intercept possible total heart block. Then the gradient is measured using an angioplasty catheter in the aorta ascendens and a pigtail catheter in the left ventricular apex. The gradient is measured at rest, after a post-ventricular extrasystole and during a Valsalva manoeuvre. Next, the presumed target septal branch is wired. A short balloon, 10 mm over the wire, is introduced into the septal branch to prevent leakage of alcohol into the left anterior descending coronary artery (LAD) and sized not to cause dissection of the septal branch when inflated. The inflated balloon is

Ne3hehd ands Heart Journal, Volume 9, Number 8, Novenber 2001

Percutaneous transluminal septal myocardial ablation (PTSMA) for symptomatic patients with hypertrophic obstructive cardiomyopathy

checked to ensure that it does not occlude the LAD. After retrieval ofthe wire, angiographic contrast (1 ml) is introduced through the inflated balloon to exclude leakage into the LAD and then echo contrast (1 ml Levovist®) is injected to confirm, by 2D echocardiography, that the selected septal branch perfuses only the target myocardial area and no other structures. After correct positioning ofthe catheter and balloon, two to four dosages of 1 ml of 96% alcohol are slowly introduced through the inflated balloon under rhythm control and with direct echocardiographic visualisation of the alcohol, which is very echogenic. The amount ofalcohol used depends on the mass of the septum as well as the acute haemodynamic changes (disappearance of systolic anterior movement, gradient and mitral regurgitation) during the procedure. The development of a total heart block also ends the procedure. After the last dose, the balloon remains in place for ten minutes to ensure that no alcohol enters the LAD when removing the balloon. During the procedure the patient is given analgesic medication. After the procedure an angiogram of the LAD is performed to ensure patency of the LAD and closure of the septal branch. Post-procedure, the patient is monitored for at least 48 hours to intercept late total heart block and any other complications.

Results During the year 2000, 31 patients with HOCM were referred for intervention. Of these, one patient underwent Morrow resection in combination with mitral valve replacement for endocarditis. Six patients were in NYHA functional class .Il and for this reason did not undergo intervention. In these six patients optimisation ofmedication was suggested. In the year 2000, 24 patients were treated by PTSMA in our institution. The procedure was initially successful in all but one patient. In that patient the septal branch that was perfusing the proxunmal septum could not be found. The procedure was complicated in three patients. A 42-year-old man underwent PTSMA for dyspnoea NYHA class III and a gradient at rest of 50 mmHg. The procedure was successful with a drop of the gradient to 20 mmHg, but a total heart block developed. The next day normal conduction returned and the temporary pacemaker was removed. Later that day, total heart block recurred with rapidly progressing heart failure for which the temporary pacemaker was reintroduced. After the patient had recovered with pacing and diuretics, an electromechanical dissociation developed during the night and the patient died. Autopsy showed septal infarction and congestion of the lungs. Two additional patients needed a permanent

Table 1. Clinical, angiographic and echocardiographic data. Pt

Age

1 2 3 4 5 6 8 9 10 12 13 14 15 16 17 18 19

65 64 53 41 61 64 61 77 35 50 64 75 66 73 73 43 63

Mean SD

60 12

NYHA Pre Post

IVS Pre Post

LVOTGI Pre Post

LVOTGE Pre Post

MR Pre Post

LA Pre Post

LVEDD Pre Post

234 356 265 257 241 186 219 156 102 120 224 128 94 102 79 50 41

4 2 2 2 2 3 3 2 4 3 2 2 3 3 3 3 3

2 0 0 0

150 100 50 35 60 70 75 50 90 60 100 175 150 160 100 50 75

138 34 63 20

2 1 1 1

0

21 17 17 18 23 18 15 16 17 20 22 15 18 18 21 13 16

0

37 52 52 44 45 47 59 47 52 51 42 40 56 39 54 53 48

38 44 50 40 45 40 42 36 42 45 52 36 51 32 44 47 36

168 88

2.7 0.7

0.6 0.9

17.9 14.1 2.7 2.3

0.6 0.7

48.1 48 6.3 6.0

FU

0

2 1 1 0 0 0

1 0

2 2 0

17 10 11 16 15 14 15 11 14 19 13 13 13 16 14 14 15

75 13 0 0 0 18 10 15 35 10 40 28 30 30 40 0 30

91.2 22.0 43.4 19.7

7

100 51 63 100 91 97 160 130 57 70 159 90 100

29 16 60 9 16 35 31 7 10 8 98 20 10 74 30

96 26 35 23

0

1 0 0

0

0

2 1

0

2

0

1 1 2 1

0

0

0

2 2

2 2 2 2 1 1.2 0.8

0

1 1 1

37 50 52 52 45 44 39 49 52 50 41 45 63 50 48 47 48

32 43 49 38 43 40 26 40 43 46 51 36 51 33 37 46 37

41 42 5.7 6.9

Pt: Patient number; FU: Follow-up duration in days; IVS pre and post: Interventricular septum thickness (mm) before the procedure and at latest follow-up; LVOTGI pre and post: Invasive measurement of left ventricular outflow tract (mmHg) just before and immediately after the procedure; LVOTGE pre and post: Echocardiographic measurement of left ventricular outflow tract gradient (mmHg) before the procedure and at latest follow-up; MR pre and post: Mitral regurgitation (x/4) before the intervention and at latest follow-up; LA pre and post: Left atral diameter (mm) measurement before the procedure and at latest follow-up; LVEDD pre and post: Left ventricular end-diastolic diameter (mm) before the procedure and at latest follow-up.

Netherlands Heart Journal, Volume 9, Number 8, November 2001

319

Percutaneous transluminal septal myocardial ablation (PTSMA) for symptomatic patients with hypertrophic obstructive cardiomyopathy

Figure 1. Coronary angiogramns during PTSMA. The first angiogram shows the wire placed in the target septal branch, the second

pacemaker for persisting total heart block. Table 1 shows the clinical, angiographic and echocardiographic data before and after successful PTSMA of those patients with a follow-up >3 months. Discussion The first PTSMA for symptomatic HOCM was performed by Sigwart in 1994.3 To date, an estimated 800 HOCM patients have been treated with PTSMA worldwide. The initial series by the groups of Seggewiss, Spencer III, and Kuhn showed high success rates: about 90% of the patients had a significant drop in gradient without serious complications.57 However, in the early days, a relatively high percentage ofpatients (up to 33%) needed permanent pacing. By employing contrast echocardiography, Seggewiss at al. and Spencer III et al. were able to bring down the need for permanent pacing to below 10%. There is probably also a learning curve, as the complication rate in the series of Kuhn et al. has decreased equally while they still base their decisions during intervention on haemodynamic parameters only, and do not use contrast echocardiography. Seggewiss' group have reported the largest series. In the first 175 of their patients, two died: one due to pulmonary embolism and one due to ventricular fibrillation nine days after the procedure. Overall, 8% ofpatients needed permanent pacing. With the use of contrast echocardiography, this last figure was brought down from 20% to 6%. Symptomatic improvement was drastic: NYHA decreased from 2.±0.6 to 1.2±0.9 directly after the procedure and continued to drop slightly thereafter (NYHA 1.1±1.1 at one year).4 Late follow-up (mean 27±5, range 2448 months) of the first 110 patients shows that the improvements in NYHA class and gradient are sustained. Maximum workload improved significantly from 88±57 watts at baseline to 122±43 watts at followup. Late complications were infrequent: one death due to stroke, two total heart blocks at 23 and 32 months and one successful out-of-hospital resuscitation.8 Kuhn and colleagues made an additional important obser320

shows the balloon inflated in the septal brancb, the third shows occlusion of the most distal part of the septal branch.

vation. They evaluated the effect of PTSMA in symptomatic patients without a resting gradient but only a provocable gradient. The early and seven months' haemodynamic and clinical results of PTSMA in 98 patients with a resting gradient were comparable with those in 59 patients with only a provocable gradient (mean post-extrasystolic gradient 111±43).9

Our results are in agreement with those from larger series. These series have demonstrated PTSMA to be successful in most symptomatic HOCM patients with a low procedural risk. Most patients show a significant improvement of symptoms after septal ablation; the outflow tract gradient also regresses over time. However, PTSMA is not without complications. First, patients have to be informed, before intervention, about the possibility ofthe development of a total heart block and so the need for a permanent pacemaker. Second, frequently HOCM patients do not tolerate ventricular pacing with the loss of the atrial kick. In these patients, DDD-pacing has to be started as soon as possible. The patient that died in our series might have suffered from this complication. Concomitant coronary artery disease requiring surgery is a relative contraindication since a Morrow procedure can be combined with coronary artery bypass graffing. However, combining bypass surgery with Morrow septal myectomy increases the procedural risk. Therefore, in three of our patients, percutaneous coronary intervention several months before PTSMA was considered a better treatment option. In patients in whom the outflow tract obstruction is mainly due to an abnormally large anterior mitral leaflet or due to a papillary muscle inserted directly to the anterior mitral valve, we consider Morrow septal myectomy combined with valve and/or papillary surgery the treatment of

choice.'0"'1 Conclusion We consider the non-invasiveness of PTSMA an important advantage over Morrow septal myectomy.

Netherlands Heart Joumal, Volume 9, Number 8, November 2001

Percutaneous transluminal septal myocardial ablation (PTSMA) for symptomatic patients with hypertrophic obstructive cardiomyopathy

Fiqurc 2. 21) cchoctnidioqi -a befoict and threc months afterPTI7SU'IA. After- tht pi ocedniti- the septnmili thjicknssc decreased.

Most of our patients felt an improvement and were already able to get out of bed on the day after the intervention. In addition, a redo PTSMA, when necessary, is easy to perform while a rethoracotomy is not without risk. However, whether PTSMA is as effective as Morrow septal myectomy is unknown. This asks for a randomised (multicentre) trial. c References 1 2

3 4

5

Spirito P, Seidman CE, McKenna WJ, Maron BJ. The management of Hypertrophic Cardiomyopathy. N Engl J Med 1997; 336:775-85. Berg JM ten, Suttorp MJ, Knaepen PJ, et al. Hypertrophic Obstructive Cardiomyopathy. Initial results and long-term follow-up after Morrow septal myectomy. Circulation 1994;90:1781-5. Sigwart U. Non-surgical myocardial reduction of hypertrophic obstructive Cardiomyopathy. Lancet 1995;346:21 1-4. Seggewiss H, Gleichmann U, Faber L, et al. Percutaneous transluminal septal myocardial ablation in hypertrophic obstructive cardiomyopathy: acute results and 3-months follow-up in 25 patients. JAm Coll Cardiol 1998;31:252-8. Lakkis NM, Naguch SF, Kleiman NS, et al. Echocardiographyguided ethanol septal reduction for hypertrophic obstructive cardiomyopathy. Circulation 1998;98:1750-5.

Netherlands Heart Journal, Volume 9, Number 8, November 2001

Gietzen FH, Leuner ChJ, Raute-Kreinsen U, et al. Acute and longterm results after transcoronary ablation of septal hypertrophy (TASH). Catheter interventional treatment for hypertrophic obstructive cardiomyopathy. Eur HeartJ 1999;20:1342 - 54. 7 Seggewiss H, Faber L, Ziemssen P. Alcohol septal ablation for hypertrophic obstructive cardiomyopathy. Cardiology in review 1999;7:316-23. 8 Faber L, Krater L, Meissner A, Seggewiss H. Continuous clinical and hemodynamic improvement after septal ablation for hypertrophic obstructive Cardiomyopathy. Circulation 2000;(Suppl II):II-420. 9 Gietzen FH, Leuner ChJ, Obergassel L, Strunk-Mueller, Kuhn HJ. Transcoronary ablation of septal hypertrophy (TASH) for hypertrophic obstructive cardiomyopathy. Acute and long-term results in patients with provocable outflow obstruction. Circulation 2000;(Suppl II):II-421. 10 Maron BJ, Nishimura RA, Danielson GK. Pitfalls in clinical recognition and a novel operative approach for hypertrophic cardiomyopathy with severe oufflow obstruction due to anomalous papillary muscle. Circulation 1998;98:2505-8. 11 Kofflard MJ, Herwerden LA van, Waldstein DJ, Ruygrok P, et al. Initial results of combined mitral leaflet extension and myectomy in patients with obstructive hypertrophic cardiomyopathy. JAm Coll Cardiol 1996;28:197-202. 6

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Percutaneous transluminal septal myocardial ablation (PTSMA) for symptomatic patients with hypertrophic obstructive cardiomyopathy: first experience.

Recently, percutaneous transluminal septal myocardial ablation (PTSMA) has been introduced as treatment for symptomatic patients with hypertrophic obs...
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