Mid Term Results of Pneumatic Balloon Dilatation in Patients With Achalasia
Mid Term Results of Pneumatic Balloon Dilatation in Patients With Achalasia
Mid Term Results of Pneumatic Balloon Dilatation in Patients With Achalasia
Mid
term results of pneumatic balloon dilatation in patients with achalasia
Original article
SUMMARY
INDRODUCTION
AIM: In this retrospective study we report the mid term results of a single center in patients with primary achalasia undergoing balloon dilatation. Methods: Between April 1997
and May 2007, 82 patients with primary symptomatic achalasia (diagnosed by clinical presentation, manometry, esophagoscopy, and barium esophagogram) underwent endoscopic
balloon dilatation. They were followed up clinically for 1 year
after the last session. Results: Symptoms were dysphagia
(n = 82, 100%), regurgitation (n = 13, 16%), chest pain (n =
4, 8%), and weight loss (n = 36, 43%). A total of 98 dilatations were performed; 68 patients (83%) underwent a single dilatation, 12 (15%) required a second procedure within
a median of 1,7 mo (range 0.8- 2,0 mo), and only 2 patients,
(2%) who were poor surgical candidates underwent a third
procedure. Post-procedural seven of the 12 patients with no
improvement after the second dilatation were considered for
surgical myotomy and they were lost to follow up. Seven patients (5.4%) had esophageal pain and one patient had upper gastrointestinal bleeding. No perforations occurred. After one year 58 of the 75 remaining patients (78%) were in
clinical remission, 10 (13%) presented the same symptomatology and only 7 patients (9%) deteriorated. Conclusion: Balloon dilatation is a safe and effective treatment
for primary achalasia. The beneficial results remain after
one year of follow up.
Achalasia is a rare primary motility disorder of the esophagus characterized by aperistalsis of the body of the
esophagus, and incomplete Lower Eosopageal Sphincter
(LES) relaxation with swallowing. The pathogenesis of idiopathic achalasia remains unclear, although a viral cause,
genetic influences (associations with HLA loci) and autoimmune processes have been postulated. Degeneration
and significant loss of nerve fibers, associated with an inflammatory infiltration of the myenteric plexus in idiopathic achalasia, provide evidence of an immune-mediated destruction of the myenteric plexus, possibly through
an apoptotic process.1,2,3
62
T. Maris, et al
lasia, prior endoscopic or surgical therapy and inadequate data. A clinical record was obtained especially
for dysphagia, regurgitation, chest pain and weight loss.
Esophageal manometry was performed in all patients after an overnight fast using a low compliance, pneumohydraulic, water infusion system (Synectics Medical USA)
and an eight lumen, manometric catheter. The catheter
had four ports radially oriented (90) near the tip and
four more centrally positioned, 5 cm apart (5, 10, 15, and
20 cm from the tip). The recording sites were connected to an eight-channel polygraph (Synetics Medical AB,
Stockholm, Sweden). The manometric catheter assembly
was passed transnasally without any sedation into the
stomach. The LES pressure was determined using the
station pull through technique and recorded as the mean
of four measurements at mid-respiration. Completeness
of LES relaxation (normal >85%) was assessed as percent decrease from resting LES pressure to gastric baseline, following wet swallows. Esophageal body motility
was recorded at 3, 8, 13, and 18 cm above the LES in response to 5 mL swallows of water at 30-second intervals.
The diagnostic criteria for primary achalasia were aperistalsis of the esophageal body and/or incomplete LES
relaxation after exclusion of malignancy or peptic strictures by upper gastrointestinal endoscopy. Once the diagnosis was confirmed, the patients were offered pneumatic dilatation or Heller myotomy as treatment options
and they signed informed consent. All patients chose balloon dilation as an initial therapeutic procedure and surgical intervention if the dilatations were unsuccessful.
All dilatations were performed with a 30mm Rigiflex
(Microvasive, Boston Scientific Corporation, Boston,
MA, USA) achalasia balloon dilator by an experienced
gastroenterologist. After a liquid diet for 48 h and an
overnight fast, sedation for upper gastrointestinal endoscopy was administered using intravenous midazolam (2-5 mg), as required. Submucosal contrast injection
was performed in order to mark the gastroesophageal
junction. A stiff guidewire was placed into the stomach through the endoscope and the balloon dilator was
passed over the guidewire and positioned at the esophagogastric junction under fluoroscopic control. While
maintaining the balloon catheter into position by fixation against the bite guard, the balloon was fully inflated with air up to 9 psi. Full inflation was confirmed
visually by the loss of the waist at the midpoint of the
balloon and inflation was maintained for 1-3 min. A
through the scope water-soluble contrast examination
immediately after the dilatation to exclude perforation,
was performed in all patients.
The result of treatment was classified as follows: (a)
RESULTS
Symptoms at presentation were dysphagia (n = 82,
100%), regurgitation (n = 13, 16%), chest pain (n = 4,
8%), and weight loss (n = 36, 43%). The mean duration
of symptoms was 29.136.2m. Vigorous achalasia was
diagnosed by esophageal manometry in all four patients
with chest pain.A total of 98 dilatations were performed;
68 patients (83%) underwent a single dilatation, 12 (15%)
required a second procedure within a median of 1,7 mo
(range 0.8-2,0 mo), and only 2 patients (2%) with severe
cardiac failure who were poor surgical candidates underwent a third procedure. (Table) Seven patients (5.4%) experienced esophageal pain a few hours after dilatation and
had a gastrograffin swallowing which was normal in all.
One patient had a melena, followed by a fall of hematocrit from 44% to 36%. Endoscopy showed a single linear
mucosal tear (Mallory-Weiss). Bleeding stopped spontaneously and the patients course was uneventful. No patient had an emergency surgery.
Seven of the 12 patients had no clinical improvement
after the second dilatation and were considered for surgical myotomy but they were lost to follow up. After one
year, 58 of the 75 remaining patients (78%) were in clinical remission, 10 (13%) presented with the same symptomatology and 7 patients (9%) deteriorated. All 17 the
patients of the last two groups were considered for Heller- myotomy.
DISCUSSION
Pneumatic dilatation has been the first-line therapeutic
1 procedure
68
2 procedures
12
3 procedures
2
Mid
term results of pneumatic balloon dilatation in patients with achalasia
option for achalasia. The reported success rate varies widely, with figures ranging from 59% The differences may be
due to variable definitions of success, and to the techniques
applied. The Rigiflex balloon dilator has been used in our
department for the last 10 years, and data from the group
of patients studied in this report compare favorably with
data from previous studies, with an initial success rate of
more than 80% in the 1st year. So far there is no standardized protocol for the size of the Rigiflex dilator.
The perforation rate with the Rigiflex balloon dilator
ranges from 0% to 6.6%10, and gradual balloon dilatation
starting with a 30-mm balloon dilator and progressing to
35 and 40 mm if necessary appears to be the safest ap11
proach. In our study no perforation occurred as demonstrated by Gastrograffin swallowing, performed following
dilatation. The use of immediate contrast studies to exclude perforation has become routine and this approach is
generally recommended. However it must be emphasized
that an immediate contrast study may not always exclude
a perforation, that may become clinically evident several
12
hours later . Less common complications, including intramural hematoma, diverticula of the gastric cardia, mucosal tears, reflux esophagitis, prolonged post-procedure
chest pain, fever, hematemesis with or without changes in
hematocrit, and angina, may occur after pneumatic dilata5
tion . In our series, a patient developed hematemesis due
to a Mallory-Weiss lesion, which is an uncommon complication.
Finally, there is no consensus as to whether repeated
pneumatic dilatations are associated with longer remission rates. A number of studies have shown that the additional sessions of pneumatic dilatation are followed by a
longer duration of remission (10 years follow -up), while
others believe that subsequent pneumatic dilatations after the second or third dilatation are less likely to result
in a sustained remission, and surgical intervention should
be considered for patients who have had two (or three)
[12,13,14,15,16,)
unsuccessful sessions of pneumatic dilatations.
To our experience, before recommendin surgery a second
procedure is required and can be successful in the majority of patients.
In conclusion, this study shows that pneumatic dilatation is a safe and effective treatment for achalasia. The
beneficial results persisit for at least one year.
63
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