Long-term results after Heller Dor operation for oesophageal achalasia

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1 European Journal of Cardio-thoracic Surgery 29 (2006) Long-term results after Heller Dor operation for oesophageal achalasia Alberto Ruffato a,b, Sandro Mattioli a,b, *, Maria Luisa Lugaresi a,b, Franco D Ovidio a,b, Filippo Antonacci a,b, Massimo Pierluigi Di Simone b a Division of Oesophageal and Pulmonary Surgery, Villa Maria Cecilia and San Pier Damiano Hospitals, Cotignola and Faenza, Ravenna, Italy b Center for the Study and Therapy of Diseases of the Oesophagus (Surgical Section), University of Bologna, Bologna, Italy Received 16 January 2006; received in revised form 15 March 2006; accepted 20 March 2006; Available online 3 May 2006 Abstract Objective: In the literature, reports on the definitive rate of cure of the surgical treatment of oesophageal achalasia are not numerous. The aim of this study is to assess the clinical instrumental-based patient s outcome related to long-term follow-up. Methods: One hundred and seventyfour patients (80 men, median age 57 years, range 7 83) consecutively submitted to first instance transabdominal Heller Dor in the period were considered. Follow-up consisted of clinical interview, endoscopy, barium-swallow and oesophageal manometry if required. Twenty-six cases (15%) were sigmoid achalasias. Results: One patient died post-operatively (severe haemorrhage in a patient previously operated upon for a cardiovascular malformation and suffering for portal hypertension), 173 were followed-up (mean 109 months, range , median 93 months) of whom 68 for more than 15 years. On the whole 151 patients (87.3%) had satisfactory and 22 (12.7%) had poor long-term results. Seven out of 173 patients (4%), 6 of whom were pre-operatively classified as sigmoid achalasia, subsequently underwent oesophagectomy, 3 for epidermoid cancer, 1 for Barrett s adenocarcinoma, 2 for stasis oesophagitis and recurrent sepsis, 1 for severe dysphagia. Fifteen patients (8.7%) had an insufficient result due to reflux oesophagitis which appeared in 2 (one erosion) after 184 and 252 months. All 22 patients, whether surgically or medically retreated, achieved satisfactory control of dysphagia and reflux symptoms. Conclusions: In the long term, insufficient results strictly related to Heller Dor failure, always due to reflux oesophagitis, were recorded in 15/173 patients (8.7%) although it is questionable whether reflux oesophagitis appearing after more than 15 years is due to the Dor incompetence or to ageing. In sigmoid achalasia, oesophagectomy rather than myotomy should be taken into consideration in the first instance. In the long-term, surgery is the best definitive treatment for oesophageal achalasia. # 2006 Elsevier B.V. All rights reserved. Keywords: Oesophageal achalasia; Heller myotomy; Dor antireflux procedure; Long-term results 1. Introduction Achalasia is a rare motility disorder of the oesophagus of unclear aetiology, with an incidence of around 1 case per 100,000 in the population of Western countries, characterized by several combinations of alterations that include neuronal degeneration of the oesophageal wall responsible for the incomplete relaxation of the lower oesophageal sphincter with swallow and for the lack of peristalsis in the oesophageal body [1]. At present there is no therapy able to repair degenerative neuronal lesions; the most effective treatments for oesophageal achalasia are aimed at the relief of symptoms and at preventing the complications through the Presented at the joint 19th Annual Meeting of the European Association of Cardio-thoracic Surgery and the 13th Annual Meeting of the European Society of Thoracic Surgeons, Barcelona, Spain, September * Corresponding author. Address: Department of Surgery, Intensive care and Organs Transplantation, University of Bologna, S. Orsola-Malpighi University Hospital, Via G. Massarenti 9, Bologna, Italy. Tel.: ; fax: address: sandro.mattioli@unibo.it (S. Mattioli). reduction or complete elimination of pressure of the lower oesophageal sphincter. Pneumatic dilation and cardiomyotomy associated with an antireflux procedure have been demonstrated to be the most effective and long-lasting techniques over the years and are, at the present time, the therapeutic options of choice. The Heller extramucosal oesophago-gastric myotomy associated with anterior hemifundoplication according to Dor is today one of the most used surgical options with both open and mini-invasive approaches and with high percentages of short and medium term satisfactory results [2 4]. The results of the Heller operation for achalasia tend to get worse in time [2 5]; in fact the main and most frequent causes of failure of the surgical treatment are the reappearance of dysphagia, due to an insufficient myotomy or to perioesophageal scarring and to gastro-oesophageal reflux and oesophagitis. Another adverse occurrence in the long term is represented by cancer, although there is not a univocal quantification of risk in the literature [6,7]. The aim of this study is to evaluate the clinical instrumental-based outcome of surgical therapy of patients /$ see front matter # 2006 Elsevier B.V. All rights reserved. doi: /j.ejcts

2 A. Ruffato et al. / European Journal of Cardio-thoracic Surgery 29 (2006) with a long follow-up, a period that, in our opinion, allows a careful analysis of the objective outcome and of how each complication can appear, and to make remarks and appraisals about the effectiveness and the appropriateness of a surgical procedure that can be considered as definitive. This information can have important implications in order to rediscuss the surgical indication in selected cases, and to focalize and optimize the follow-up protocols for these patients which present a wide variability in the main surgical series in the literature 2. Materials and methods A total of 174 patients affected by primary achalasia of the oesophagus operated on consecutively between January 1979 and December 2003 were considered. Surgery consisted of gastric oesophageal myotomy according to Heller, associated with anterior hemifundoplication according to Dor under manometric control. The surgical procedure was already described in detail elsewhere [8 10]; 162 patients were operated on by abdominal approach and 12 with a miniinvasive technique in the period The diagnosis of primary achalasia was made on the basis of symptoms and of the manometric, radiological and endoscopic examinations; 26 patients (15%) were affected by sigmoid oesophagus, socalled when the diameter of the oesophagus was >6 cm. All the patients were checked according to a post operative follow-up protocol adopted by our group since the early 1970s for assessing patients operated on for functional disorders of the oesophagus. This protocol was liberally accepted by patients after explaining them the purposes of the program [5,8,11]. It included clinical and instrumental periodical evaluations. The clinical examination was annual for the first 5 years after the operation and successively it occurred every 3 and 5 years. A complete instrumental check (X-ray, manometry and endoscopy) was carried out 12 months after the operation; radiological and endoscopic examinations were then repeated every 5 years while manometry was performed if required by the patient s clinical condition. Further checkups were carried out according to the clinical situation. Since 1979 the clinical and instrumental examinations were performed either directly by or under the supervision of one of us. The follow-up was measured from the time of operation until the time of the last clinical and instrumental control or the drop-out from the program. The symptoms relative to dysphagia and gastro-oesophageal reflux were evaluated according to a semi quantitative scale. For dysphagia (D), the classification criteria proposed by Van Trappen and subsequently modified were used, while to assess the gastro-oesophageal reflux symptoms (RS), the modified Visik criteria were adopted [5,11] (Table 1a). The radiological examination was always performed with the patient standing upright for the four orthogonal projections and lying down for the prone OPS projection with a constant focus-film distance of 105 cm. Post-operative data were compared to the pre-operative condition and values of p < 0.05 were considered significant. The differential diagnosis between insufficient myotomy and perioesophageal scarring was made on the basis of the radiological, Table 1 (a) Semiquantitative grading scale: dysphagia (D) and reflux symptoms (RS) D0 Absence of symptoms D1 Sticking of solid foods or liquids two to four times a month D2 Sticking of solid foods or liquids two to four times a week D3 Sticking of solid foods or liquids on a daily basis RS0 Absence of symptoms RS1 Spontaneous or postural retrosternal heartburn or pain and or regurgitation occurring two to four times a month RS2 Spontaneous or postural retrosternal heartburn or pain or regurgitation occurring two to four times a week associated or not with occasional aspiration RS3 Spontaneous or postural retrosternal heartburn or pain and regurgitation occurring on a daily basis associated or not with frequent aspiration (b) Semiquantitative grading scale: reflux oesophagitis (OE) OE0 Normal OE1 Hyperaemia, oedema and/or histology positive for reflux oesophagitis OE2 Single or multiple non-confluent erosions OE3 Multiple confluent erosions OE4 Deep ulcers, stenosis, Barrett s oesophagus (c) Semiquantitative grading scale: results of surgical therapy D0, RS0, OE0 0: excellent D1, RS1, OE0 1: good D2, RS2, OE1 2: fair D3, RS3, OE2 4 3: poor endoscopic and manometric patterns and on the basis of the operative findings when patients underwent reoperation. The diagnosis of insufficient myotomy was based on barium swallow that revealed persistence of a bird beak image of the cardia, and manometric assessment of a residual high pressure zone in the lower oesophageal sphincter [5,8]. The oesophagogastroscopic examination (EGDS) was always completed by taking biopsies aimed at determining the presence of reflux oesophagitis (OE), its complications (Barrett s oesophagus, stenosis, ulcers, etc.) and areas suspect for dysplasia or tumour [5]. Oesophagitis was assessed by adopting the modified Savary Miller endoscopic classification of reflux oesophagitis and the criteria proposed by Ismail-Beigi [5] (Table 1b). The presence of Barrett s oesophagus was diagnosed macroscopically and microscopically on the basis of the histological identification of columnar-lined oesophagus beyond the Z line; up to 1995 it was classified according to the Bremner criteria: (stage 1) slight replacement, (stage 2) development of Barrett s mucosa extending for less than 3 cm, (stage 3) development of Barrett s mucosa extending for more than 3 cm and circumferentially [5]. The presence of Barrett s oesophagus was subsequently classified by extension as short Barrett s oesophagus (<3 cm) and long Barrett s oesophagus (>3 cm) [12]. Dysplasia was defined as mild, moderate and severe [5]. In patients in whom reflux oesophagitis or Barrett s oesophagus was detected, the endoscopic examinations were repeated every year. On the basis of the assessment of the symptoms and of reflux oesophagitis, the overall results of the operation were classified as excellent to insufficient according to a semi

3 916 A. Ruffato et al. / European Journal of Cardio-thoracic Surgery 29 (2006) quantitative scale (Table 1c). The absence of dysphagia and oesophagitis as a result of cyclic medical treatment or endoscopic dilatation was considered a poor result. The time of onset of symptoms and complications related to the myotomy as well as dysplasia and cancer was established and recorded. Data on the appearance of dysphagia reflux symptoms and oesophagitis were analyzed similarly to the survival curves applying the actuarial method. For each symptom patients with grades 0 and 1 were grouped as alive and patients with grades 2 and 3 as dead. Data were expressed as median values unless stated otherwise. The Student s t-test for paired data was adopted for the analysis on the radiological data. A probability of <5% was assumed to be statistically significant ( p < 0.05). Statistical analyses were performed using a SPSS software package (SPSS Inc., Chicago, IL). 3. Results The objective assessment was performed in 173/174 operated patients (one patient, previously operated upon for a cardiovascular malformation and suffering for portal hypertension, died post-operatively for a severe haemorrhage), 80 males (mean age 56 years) and 94 females (mean age 56.3 years) with a mean post-operative follow-up of 109 months (range months) and a median of 93 months. The causes of patient drop-out were: 1. Patients who underwent redo surgery: 12 (6.8%); 7 oesophagectomies with neck oesophago-gastric anastomosis (3 for epidermoid carcinoma, 1 for Barrett s adenocarcinoma, 2 for stasis oesophagitis, 1 for severe dysphagia), 4 for reflux oesophagitis of which 2 with associated slipped fundoplication (2 Roux en Y distal gastrectomy, 2 fundoplication abdominal reposition) and 1 for cancer of the gastric antrum (Roux en Y distal gastrectomy). 2. Patients who passed away: 6 (3.5%); 3 for age-related diseases, 3 for tumour (1 vulval, 1 colic and 1 of unknown site). Table 2 shows the distribution of the study population by years of follow-up and by causes of patient drop-out. Dysphagia was episodic (D1) in 48 patients (27.5%), moderate (D2) in 11 cases (6.3%) and severe (D3) in 4 (2.3%). Moderate and severe dysphagia (D2 + D3) appeared at a mean time of 23.7 months after the operation (range between 12 and 72 months). In eight patients (seven moderate, one severe), dysphagia was secondary to reflux Table 2 Follow-up distribution and causes of patient drop-out Patients Years after surgery >20 Total In follow-up Reoperation Death Total 174 Fig. 1. Actuarial analysis of the onset of dysphagia (D), gastro-oesophageal reflux symptoms (RS) and oesophagitis (OE) in 173 achalasic patients undergoing the Heller Dor operation. Data were analyzed similarly to the survival curves applying the actuarial method. For each symptom patients with grades 0 and 1 were grouped as alive and patients with grades 2 and 3 as dead. oesophagitis, associated only in two cases with a slipped fundoplication. Seven patients (three with severe dysphagia D3) had a preoperative condition of sigmoid oesophagus. Considering the overall onset of dysphagia (D1 3) the symptom reappeared at a mean time of 27.1 months. Fig. 1 shows the percentage of patients free from dysphagia and reveals a decrease until the third post-operative year, then becoming stable until the end of the follow-up. Gastro-oesophageal reflux symptoms were recorded in 40 patients (23.1%) two to four times per month graded as slight (RS1), moderate (RS2) in 13 cases (7.5%) and severe (RS3) in 2 patients (1.2%). Moderate and severe reflux symptoms (RS2 + RS3) appeared at a mean of 57.9 months after the operation (range between 12 and 252 months). Fig. 1 shows the percentage of patients free from reflux symptoms; the curve shows a progressive decrement during the second 5 years after surgery, then it remains stable and shows a further drop after more than 20 years following surgery. As regards post-operative reflux oesophagitis, evaluated with the aid of the histological study of the oesophageal mucosa by ordinal classes, the following distribution was observed: the appearance of macroscopic reflux oesophagitis (OE2 3), absent before the operation, occurred in 15/173 (8.7%) patients with a mean age of years, with 9 cases of moderate oesophagitis (OE2) and 6 severe cases (OE3). All patients with reflux oesophagitis reported moderate or severe gastro-oesophageal reflux symptoms (RS2 3); in seven of these patients reflux oesophagitis was associated with moderate dysphagia (D2) and in one patient with severe dysphagia (D3) without any oesophagogastric transit impairment (see above). Reflux oesophagitis appeared at a mean of 74.8 months after the operation (range between 12 and 252 months). In two cases oesophagitis (one erosion) appeared after 184 and 252 months. Fig. 1 shows the actuarial curve of the onset of oesophagitis in our population over an observation period of 24 years and revealed two different ways of appearance: there is in fact a peak of reduction after 5 years with a percentage of about 90% of oesophagitis-free patients and another fall after 10 years, the curve then remaining stable until 20 years after surgery, followed by a further drop and reaching the end of the follow-up with a percentage of 72% of oesophagitis-free patients. Analyzing in particular the group of patients that underwent surgery by minimally invasive approach, an immediate conversion to laparotomy occurred

4 A. Ruffato et al. / European Journal of Cardio-thoracic Surgery 29 (2006) Fig. 2. Latency of CLE, dysplasia and cancer after myotomy. in 2 patients for bleeding; on the other 10 patients we globally recorded satisfactory results in 9 out of 10 in the long term: an excellent result in 3 patients, a good result in 4, a fair result in 2 and a poor results in one patient with a preoperative condition of sigmoid oesophagus. Columnar lined oesophagus, absent in all patients was detected in 4 of 15 patients affected by reflux oesophagitis (26.6%) a mean of 58.7 months after surgery (range months). A moderate dysplasia was found in one of four patients, after 88 months postoperatively. In the same group of 173 patients during the considered period time we observed the onset of severe dysplasia in epidermoid mucosa in one patient after 144 months from the operation (Fig. 2). In our case series four patients developed cancer after the operation; we found three cases (1.7%) of epidermoid cancer which appeared at 27, 46 and 132 months after the operation (mean of 68.3 months) and one case of oesophageal adenocarcinoma which appeared at 96 months after surgery in a patient affected by severe (OE3) postoperative reflux oesophagitis and Barrett s oesophagus (Fig. 2). Results obtained from the comparison of the radiological examinations before and after 60 months from operation show a mean percentage decrease of the diameter of 46% and a mean percentage decrease of the barium column of 80.06%, with a p < (Fig. 3a and b). On the basis of the overall assessment of the clinical and instrumental data, the final result consists of 94 patients (54.3%) with an excellent result (D0, RS0 OE0), 48 patients (28%) with a good result (D1, RS1, OE0), 9 patients (5%) with a fair result (D2, RS2, OE1) and 22 patients (12.7%) with an insufficient result (D3, RS3, OE2 4) (Table 3). In the long-term, insufficient results strictly related to Heller Dor failure were recorded in 15/166 patients (9%) always due to reflux oesophagitis. In seven patients the poor result was related to the pre-operative sigmoid condition of the oesophagus with a 27% (7/26) of insufficient results in this group of patients. The mean follow-up period in the other 19 patients with a condition of sigmoid oesophagus and a satisfactory results was months (range ) with a median of 84 months. 4. Discussion Our study evaluates the long-term results of patients affected by oesophageal achalasia who underwent extramucosal myotomy according to Heller and the antireflux procedure according to Dor with a carefully coded follow-up continued for more than 25 years by our group [5,8,11]. Dysphagia, gastro-oesophageal reflux symptoms and reflux oesophagitis which persist or appear after the operation are the parameters most commonly used to evaluate the results of the surgical treatment of oesophageal achalasia [2,4,5]. We decided to include other causes requiring reoperation, namely oesophagectomy, such as the appearance of tumours and the development of reflux oesophagitis [6]. Fig. 3. Comparison of the radiological examinations before and after 60 months from the operation. (a) Pre-operative (grey bar) and post-operative (white bar) oesophageal diameter, values are expressedin millimetres. (b) Pre-operative (grey bar) and post-operative (white bar) residual barium column, values are expressed in centimetres. Pre versus post: p < paired t-test.

5 918 A. Ruffato et al. / European Journal of Cardio-thoracic Surgery 29 (2006) Table 3 Results of Heller Dor operation for oesophageal achalasia Author Year Patients Follow-up (months) Dysphagia (%) GER (%) Excellent/Good Fair Poor (a) Review of open surgical results of the Heller Dor operation for the treatment of oesophageal achalasia Moreno Gonzales [15] Csendes [16] Desa [17] Bonavina [2] Picciocchi [18] Mattioli [11] Dempsey [19] Actual study (b) Review of mini-invasive surgical results of the Heller Dor operation for the treatment of oesophageal achalasia Graham [20] Rosati [21] Ackroyd [22] Finley [23] Zaninotto [24] Patti [4] Costantini [25] Moderate severe dysphagia (D2 3) was observed in 15 patients (8.7%) and in eight cases the symptom was secondary to reflux oesophagitis. A particular feature of this series is that if the dysphagia was due to an alteration in oesophageal transit it only reappeared in patients who had undergone the Heller Dor procedure with a pre-operative condition of sigmoid oesophagus. It can therefore be confirmed that a long extramucosal myotomy that divides the clasp fibers from the oblique fibers in the gastric part of the lower oesophageal sphincter [9] associated with an anterior fundoplication according to Dor which protects the surface of the myotomy [8] eliminates post-operative dysphagia caused by an insufficient myotomy and by scaring/fibrotic stenosis [11]. The subsequent need to perform an oesophagectomy in 6/ 26 (23%) cases with a pre-operative diagnosis of sigmoid oesophagus, in 1 case for severe dysphagia, in 3 for epidermoid carcinoma and in 2 cases for recurrent sepsis caused by stasis oesophagitis, must lead us to identify the cases in which oesophagectomy has to be the first choice operation [13]. Actually we offer esophagectomy in case of sigmoid oesophagus larger than 5 7 cm in the upper third (a) in patients younger than 55 years, (b) with severe mucosal inflammation and moderate to severe dysplasia. Post-operative gastro-oesophageal reflux was the cause of an insufficient result in 15 (8.7%) cases, one of whom subsequently underwent oesophagectomy due to Barrett s adenocarcinoma and four underwent re-operation (two Roux en Y distal gastrectomy and two fundoplication reposition below the diaphragm). Careful suturing of the fundoplication to the crura of the diaphragm, which became the rule for us after our first experiences, prevents the gastro-oesophageal junction from slipping into the chest. The average time of appearance of reflux oesophagitis symptoms was 60 months. As far as the overall long-term clinical results are concerned, our success rate was 87.3% with a mean followup of 109 months (range months) and a median of 93 months, a result which if compared with our previous retrospective evaluations on operated subjects and with the main case series present in the literature, as regards both the open approach and the mini-invasive technique, shows success rates close to the lower limit of the range of analysed results, which however refer to fairly shorter observation periods in most cases (Table 3a and b)[2 4,11,15 25]. It is also worth to point out that in the long term, insufficient results strictly related to Heller Dor failure, always due to reflux oesophagitis, were recorded in 15/173 patients (8.7%) although it is questionable whether reflux oesophagitis appearing after more than 15 years is due to the Dor incompetence. The relationship between ageing and gastro-oesophageal reflux [14] is another point that needs to be clarified for a correct evaluation of the results of surgery for achalasia. Studies carried out on healthy elderly subjects show a greater susceptibility to gastro-oesophageal reflux, and it is not therefore certain that the erosive oesophagitis which appeared at 184 and 252 months after surgery can be attributed to an insufficient antireflux procedure as we did in order to not over estimate our results. In conclusion, trans laparotomic gastro-oesophageal myotomy associated with anterior fundoplication according to Dor has proved to be a very efficient first choice surgical procedure also in the long term. When the laparoscopic techniques were introduced, we did a small number of cases with this new technique. It seemed to us that the myotomy although carried out under manometric control, could not be as perfect as the open myotomy, mainly on the gastric side. For this reason we continued to offer the patient a technique which had given us very good results. In fact today we have increased sufficiently our experience in laparoscopic techniques and in consideration of the results achieved by others we propose the patient both options, while giving him extensive information. The only reason for failure that can be attributed to the open Heller Dor technique is postoperative gastro-oesophageal reflux, while the treatment of dysphagia always gave excellent results, except in 27% of patients with a preoperative diagnosis of sigmoid oesophagus, suggesting that the indications for oesophagectomy in the first instance should be reconsidered. Reflux oesophagitis, correlated with the surgical procedure, can appear at five and even 10 years after the

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