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El Sistema de Balón Ajustable Spatz3 was developed to achieve:

  • Adjustment to prevent early extraction for intolerance
  • Adjustment to achieve renewed balloon effect after the 4th month
  • Adjustments in combination with 1 year implantation
  • Medically significant weight loss maintenance two years after balloon removal

Why do we need to adjust balloons?

  • Prevents early extractions for intolerance
  • 22% of Orbera balloons extracted early in FDA trials [1]
  • Approximately 10-12% of Spatz3 patients undergo down adjustments for intolerance[2,3,4,9]
  • Prevents weight regain at months 4-5 after balloon implantation
  • publications document that balloons lose their effect at 3-5 months [5,6,7]

Does that improve results?

  • Published results report response rates (>10%TBL or >25%EWL)
  • Orbera balloon response rates 46.4% and 45.6%, respectively [1,7]
  • Reshape Balloon 48% response rate [8]
  • Spatz3 Adjustable balloon 71.5% – 88.5% response rate [9,10,11,12]
  • That means that with a non-adjustable balloon less than half the patients have a good response. With an adjustable balloon, >80% have a good response.

Why do adjustments improve response rates?

2 reasons

  • Down adjustments save patients from early extractions
  • 22% of Orbera patients had early extractions in FDA trials [1]
  • 14% of Reshape patients had early extractions in FDA trials [8]
  • Approximately 10-12% of Spatz3 patients undergo down adjustments for intolerance[2,3,4,9]
  • 87%-91% of Spatz3 intolerant patients that underwent down adjustment were saved from early extraction [2,3,4,9]

Up adjustments save patients from weight regain after 4-5 months

  • Additional weight loss of 8.2kg, 8.9kg, 5kg, and 5.7 kg were achieved after the up adjustment in 4 different studies [2,3,4,9]
  • Mean 300 ml addition yields better results than mean 227 ml [9]

Will 1 year implantation of a non-adjustable balloon yield more weight loss?

  • Probably not
  • It has been well documented that on average balloon effect diminishes after 4 months [5,6,7]
  • In fact Orbera studies document weight gain at 4-5 month [7]
  • While the balloon is still implanted
  • Keeping the ineffective balloon in for a longer period of time is not likely to help. But studies need to be done.

Courcoulas published results of 255 patients in a randomized controlled study (modified intention to treat). The patients achieved 10% TBL (loss of 10% of initial weight). Notice that the weight regain begins at 4-5 months – that is 1-2 months prior to Orbera balloon removal. This means that balloon effect diminishes and weight regain begins already at 4-5 months. This is most likely true of all balloons.

References:

  1. FDA SSED Orbera Balloon. PMA P140008: FDA Summary of Safety and Effectiveness Data. August 5, 2015.
  2. Machytka E, Brooks J, Buzga M and Mason J (2014) One year adjustable intragastric balloon: safety and efficacy of the Spatz3 adjustable balloons [v1; http://f1000r.es/471] F1000Research 2014, 3:203
  3. Machytka E, Marinos G2, Kerdahi R, Srivastava ED, AlLehibi A ,Mason J, Brooks J. Spatz Adjustable Balloons: Results of Adjustment for Intolerance and for Weight Loss Plateau. DDW 2015, IFSO 2015
  4. Brooks J, Tsvang E, Ganon M, Arnon R. Spatz3 Adjustable Balloon: Early adjustment to prevent premature extraction. DDW 2016
  5. Bonazzi P, Petrelli MD, Lorenzini I, et al. Gastric emptying and intragastric balloon in obese patients. Eur Rev Med Pharmacol Sci. 2005; 9(5 Suppl 1):15–21.
  6. Totte E, Hendricks L, Pauwels M, et al. Wt reduction by means of an intragastric device; experience with BIB. Obes Surg. 2001; 11(4):519–23.
  7. Courcoulas A et al. Intragastric balloon as an adjunct to lifestyle intervention: A randomized controlled trial. International Journal of Obesity (2017) 41, 427–433
  8. FDA SSED Reshape Duo Balloon. PMA P140012: FDA Summary of Safety and Effectiveness Data. July 28, 2015
  9. Machytka, Evzen; Puig Divi, Valenti; Saenger, Fernando; Sorio, Ricardo; Brooks, Jeffrey. Adjustable Balloons for Weight Loss: A Higher Yield of Responders Compared with Non-Adjustable Balloons. DDW 2017 Abstract.
  10. Usuy Eduardo, Brooks Jeffrey. Response Rates with the Spatz3 Adjustable Balloon. Obes Surg. 2017 Oct 31. doi: 10.1007/s11695-017-2994-x. [Epub ahead of print]
  11. Almeida Leonardo S. Spatz3 Adjustable Balloon; Weight Loss And Response Rates In Brazil. DDW 2018 Abstract
  12. Brooks J. Adjustable Intragastric Balloons Improve Response Rates. DDW 2018 Abstract.

Since May 2012 over 35,000 Spatz3 devices have been implanted.

“Band-Off”
Remove bands with ease before implantation

Valve-Hold
Prevents valve separation from white catheter during inflation
– Prevents inflation tube rupture

Early Adjustment to Prevent Early Extraction

S. Brooks* 1, 1, E. Tsvang2, M. Ganon2, et al

 

Introduction: Approximately 250,000 intragastric balloons (IGB) have been utilized for weight loss since the 1980’s, with well over 5,000 patients reported in the literature. To date, balloonists have been unable to reliably choose the appropriate volume per patient. Premature extraction in the first months has been reported in 3% -10% of BIB (Orbera) balloon patients due to intolerance characterized by persistent nausea, vomiting, abdominal pain or acid reflux symptoms. The SSED for the recently approved Orbera balloon in the US has reported a 22% premature extraction rate. In addition, approximately 5% of patients experience insufficient balloon effect in the first 6 weeks. For these situations, a change in balloon volume can prevent premature extraction. Balloon volume adjustments can be performed with the Spatz3 adjustable balloon with a 15 minute outpatient endoscopy.

Aims & Methods: The adjustability function of the Spatz3 adjustable balloon was assessed for its ability to alleviate 1) early intolerance and 2) insufficient balloon effect in the first 6 weeks. Between February 2015 and November 2015, 161 patients (76% females) ; mean age 45 (19-70); mean wt 98.3 kg (70-144.6); mean BMI 35.4(29.3-75.3); were implanted with the Spatz3 Adjustable balloon (Spatz FGIA Inc., NY, USA) with a mean balloon volume of 483 ml (400-600). The dietician was in direct contact daily with patients for at least 3 days or until the symptoms abated, and thereafter twice weekly for the first month, followed by once every 3 weeks.
Intolerance: Patients with persistent symptoms of nausea, vomiting, abdominal pain, pyrosis, or bloating who were unresponsive to PPI or prokinetic drugs beyond 1 week and requested balloon extraction, were adjusted downward (13 patients). Group A (6 patients) had 50-100 ml removed regardless of balloon starting volume, and group B (7 pts) had 150 ml removed (100 ml if starting volume was 400 ml).
Unresponsive: Patients with minimal or no balloon effect from the start or lost effect prior to 6 weeks underwent upward adjustments of balloon volume.

Results: 13/161patients (8.1%) with persistent intolerance underwent downward adjustments at a mean 2.8 weeks (1-4.5 weeks) with immediate relief of symptoms. Within Group A (≤100 ml), 3/6 (50%) had sustained relief and 3/6 required balloon extraction 1 week later for recurrent intolerance. Within Group B (150 ml, or 100 ml with a 400 ml balloon), 7/7(100%) had sustained relief for at least 1 month or more.
10/161 patients (6.2%) had minimal or no balloon effect or lost balloon effect prior to 6 weeks. They underwent balloon volume addition at a mean 12.5 weeks (6-24.5 weeks) with mean addition 292 ml (200-400 ml). 8/10 (80%) experience improved balloon effect and yielded an additional mean weight loss of 5 kg (0-17 kg) after the adjustment.

Conclusion:  1) Premature extraction due to early intolerance can be prevented by reducing balloon volume by 150 ml (or 100 ml if starting balloon volume is 400 ml).  2)  Early loss of balloon effect or total lack of balloon effect in the first 6 weeks can be successfully rectified in 80% of patients by adding a mean 292 ml (200-400 ml) to the balloon. Larger controlled trials will be needed for confirmation and to determine appropriate volume additions.

A Highly Effective Anti-voming Regimen Post Intragastric Balloon Implantation

S. Brooks* 1, 1, E. Tsvang2, M. Ganon2, et al

Introduction: Approximately 250,000 intragastric balloons (IGB) have been utilized for weight loss since the 1980’s, with well over 5,000 patients reported in the literature. Nausea and vomiting has been a consistent complaint in almost all patients during the first 3-4 days post balloon implantation.  The anti-emetic regimen of ondansetron or other serotonin 5-HTreceptor antagonists in combination with prokinetic agents such as metachlopramide or domperidone have little if any effect. At the suggestion of an oncology nurse, we report our experience with an anti-emetic regimen (used for chemotherapy induced nausea and vomiting) for the immediate post IGB implantation period.

Aims & Methods: Our study assessed the efficacy of aprepitant, an NK1 receptor antagonist, in combination with ondansetron in alleviating the immediate post IGB implantation nausea and vomiting. Between February 2015 and November 2015, 161 patients (76% females) ; mean age 45 (19-70); mean wt 98.3 kg (70-144.6); mean BMI 35.4(29.3-75.3); were implanted with the Spatz3 Adjustable balloon (Spatz FGIA Inc., NY, USA) with a mean balloon volume of 483 ml (400-600). All patients were prescribed aprepitant (125 mg PO day 1, and 80 mg days 2 and 3) plus ondansetron (8mg PO Q6H) for 3 days. Patients were asked to record the presence of nausea and the number of vomiting and retching episodes. The dietician was in direct contact daily with patients for at least 3 days or until the symptoms abated. 151 out of 161 were able to give accurate reports of their symptoms.

Results: 27/151 patients (17.9%) reported episodes of nausea and vomiting over 1-4 days with a mean 6.8 vomits/patient (range 1-25). 10 patients had 1 day of vomiting. 6 patients had 2 days of vomiting. 4 patients had 3 days of vomiting. 7 patients had 4 days of vomiting.  2 patients with > 15 vomits over 4 days had moderate non-erosive gastritis.
110/151(72.8%) reported nausea without vomiting for a mean 2.3 days.
14/151(9.3%) reported no nausea or vomiting. No untoward drug reactions were noted.

Conclusion: In our experience, the combination of aprepitant and ondansetron effectively prevented vomiting in 82% of patients in the early post implantation period. However, it was not effective in preventing nausea, as it was present in 91%. The combination was not effective in the presence of moderate non-erosive gastritis. This study demonstrates the safety and efficacy of this drug combination in preventing the immediate post IGB implantation vomiting.

Adjustment Results - DDW Abstract – Review of 7 Centers

Spatz Adjustable Balloons: Results of Adjustment for Intolerance and for Weight Loss Plateau

Machytka E1, Marinos G2, Kerdahi R3, Srivastava ED4, AlLehibi A5 ,Mason J6, Brooks J7

 

1. University Hospital of Ostrava, Ostrava, Czech Republic. 2. The Prince of Wales Hospital,Randwick, NSW,

Australia 3. Olaya Medical Complex, Riyadh, KSA 4. Spire Hospital, Cardiff, UK 5. King Fahad Medical city, KSA

6. Trafford General Hospital, National Obesity Surgery Center, Manchester, UK. 7. Spatz FGIA

 

ABSTRACT

 

Background: The Spatz3 Adjustable balloon system is approved for 1 year implantation and allows multiple

changes in the balloon volume during the course of implantation. Other intragastric balloons are approved for 6

months and their balloon volumes remain the same for the entire 6 months of implantation.

 

Aims: To determine the utility and efficacy of adjustment of the Spatz intragastric balloon.

 

Methods: The results of 239 patients in 7 series of Spatz balloon patients were reviewed to determine the effect of

balloon volume adjustment during the 1 year course of therapy with the Spatz and Spatz3 adjustable balloons.

Patient weights were measured prior to balloon volume adjustment and at extraction. Adjustments were made for

intolerance or weight loss plateau.

 

Results: The group’s mean BMI was 37.1(28.7-73); mean weight 102.1 kg (71.6-210.3); mean age 41 (19-70);

168 female and 71 males; mean balloon volume at implantation 468 ml (400-600 ml). Balloon volume adjustments

were performed in 132 patients: 26 downward adjustments of a mean 170 cc (100-200) which alleviated early

intolerance in all pts;

106 upward adjustments were performed as shown in the Table below:

table-106

133 pts that did not undergo upward adjustment lost a mean 1.4 kg from month 5 to month 12 compared with the

8.9 kg weight lost by the adjusted group of patients. The 1 year mean wt loss for the 106 upward adjusted pts was

20.4 kg with 18.2 %wt loss and 43.4 %EWL. The 1 year mean wt loss for the non-adjusted patients was 16.4 kg

with 15.2 %wt loss and 39.7 %EWL.

 

Conclusions: The adjustability function of the Spatz balloon serves 2 functions: alleviating early intolerance, and

yielding extra weight loss for those with weight loss plateau.

 

Keywords: Obesity; Weight loss; Intragastric balloons; Adjustable gastric balloon; Weight loss plateau;

intolerance.

Medically Significant Weight Loss Maintenance Two Years After Balloon Removal

WEIGHT MAINTENANCE 2 YEARS AFTER EXTRACTION OF THE SPATZ ADJUSTABLE BALLOON

Lopez Nava G, Bene L, Kupka T, Buzga M,  Machytka E

 

Background: The Spatz Adjustable Balloon System was developed to provide an adjustable intragastric balloon approved for 1 year implantation. Weight loss results > 20 kg/year have been reported in the literature. The question is whether treatment with an intragastric balloon also leads to better weight loss maintenance after balloon removal. A prospective study on the BIB balloon has reported maintenance of > 10% weight loss in 25% of patients for up to 2.5 years after BIB balloon removal.

Methods: 79 patients from 3 centers who were implanted with the Spatz Adjustable Balloon for 1 year were contacted and asked to provide their weight 1 year and 2 years post balloon extraction. Net weight changes were recorded, and % weight loss was calculated based on weight prior to balloon implantation. Net weight loss > 10% was considered successful weight maintenance.

Results: 70 of the 79 patients contacted (88.6%) were responsive in providing their weight data. The group’s data at the original implantation was as follows: mean weight 120.3 kg (80-180); mean BMI 38.8 (30-65). At the time of balloon extraction (12 months) the group’s mean weight loss was 24 kg with a 23.8 % weight loss.  All of the 70 patients had reached at least 12 months post Spatz balloon extraction. Fifty three of the seventy (75.7%) retained at least 10% weight loss at 1 year post balloon extraction. 34 of the 70 patients had reached 2 years post extraction, and 26 (76.4%) retained at least 10% weight loss. The group’s mean weight change was +6.7 kg at 1 year and +3.4 kg at 2 years after balloon extraction.

Conclusions: The maintenance of > 10% Weight loss at 1 year and 2 years after Spatz Adjustable Balloon extraction has been retrospectively documented in 75.7% and 76.4% of patients, respectively. This study is limited by its retrospective review and the small numbers in year 2 and requires prospective review to confirm these findings. Nonetheless, it suggests a long term benefit to longer implantation time and/or adjustable balloon function and warrants further study.

First Reports of the New Spatz3 Adjustable Balloon System

FIRST REPORTS OF THE NEW SPATZ 3 ADJUSTABLE BALLOON SYSTEM

Presentation at Canadian DDW Conference, February 2014

Jeffrey Brooks1, Zbigniew Kowalcyk2, Sameer Al Awadhi3, M. Al Falasi3, John Mason4, Laszlo Bene5, Evgen Machytka6, Samer El Asala7, Valenti Puig-Divi8

1. Spatz FGIA, NY, United States. 2. Bariatric Clinic of Lodz, Lodz, Poland.3. Rashid Hospital, Dubai, United Arab Emirates. 4. National Obesity Surgery Center, Manchester, United Kingdom.5. Rozsakert Medical Center, Budapest, Hungary.6. University Hospital of Ostrava, Ostrava, Czech Republic.7. Alain Hospital, Dubai, United Arab Emirates. 8. Opcion Medical Clinic, Barcelona, Spain.

Background: The original Spatz Adjustable Balloon System for weight loss was introduced in 2010. It was the first intragastric balloon approved for 1 year implantation with the added feature of balloon volume adjustability. This enabled changes to balloon volume during the course of the 1 year implantation period. It contained a rigid catheter and metal chain that caused duodenal migration. The new Spatz 3 intragastric balloon device, CE Mark approval in 2012, has a soft catheter to simplify the procedure and decrease complications. In addition, reports of volume adjustments using a mean 177 ml yields additional 1.7 kg/month wt loss. It has been suggested that adjusting with larger volumes will yield better results. We report our experience with the Spatz 3 device in 7 centers.

Aims: To determine the difference between the reported results of the original Spatz Adjustable balloon System and the new Spatz3 Adjustable balloon System with respect to ease of use, complications, weight loss results and the effect of larger volume adjustments.

Methods: 158 patients with mean BMI 40.1; mean weight 109 kg; mean age 37; were implanted with the Spatz3 device. Mean balloon volume was 473 ml (400-600). Adjustments were made for intolerance or weight loss plateau.

Results: All endoscopists felt that the Spatz 3 device was easier to use than the original Spatz adjustable balloon system device. Mean wt loss at 12 weeks was 12.5 kg with an 11.7% wt loss and 28.8 % EWL (% excess wt loss). At 24 weeks mean wt loss was 16.2 kg; 16.7% wt loss, and 35.3 % EWL. 94 patients reached 9 months with a reported mean wt loss of 23.2 kg; 20.4 % weight loss; and 44.9 % EWL. 48 patients reached 12 months with a reported mean wt loss of 24.1 kg; 20.6 % weight loss; and 48.1 % EWL. There were 49 balloon volume adjustments: 11 downward adjustments of 100 cc alleviated early intolerance, with added mean wt loss of 15.3 kg after the adjustment; 38 upward adjustments (mean 327 ml; range 150-500) at a mean 4.1 months yielded additional mean wt loss of 8.7 kg after the adjustment. 7 balloons were extracted; early intolerance and refusal to adjust volume downward (4); gastric ulcer (2); deflation (1).

Insertion Facilitator

The guidewire has been removed and the balloon is now implanted with an insertion facilitator:

New Features

“Easy Grasp” Cap:

  • A loop of suture that protrudes from the cap
    Enables easy grasping with any standard grasping forceps:
    –   Used for valve capture during adjustment procedure
    –   Used for valve capture to deflate the balloon prior to the extraction procedure.

Spatz 1 Publications

Presented at DDW 2012

Adjustable Intragastric Balloon: The first patient experience in Spain

Lopez-Nava G 1, Nebreda J 2,  Gostout C 3, Brooks, J 4.

 

Hospital Sanchinaro, Madrid, Spain, Opcion Medica Group, Barcelona, Spain,  3 Mayo Clinic, Rochester, United States,  Consultant Gastroenterologist, Spatz FGIA INC, New York, United States

 

Background: A new intragastric balloon (IGB) has been released that has volume adjustment capability and has been approved for one year implantation. These new functions have been developed to address the following limitations of current IGB technology; (1) up to 7% intolerance in the first two weeks requiring explantation; (2) loss of balloon effect within three to four months; (3) patient’s request for a longer implantation time.

After implanting more than 3,500 BIB balloons, we are reporting our preliminary experience with the Spatz adjustable IGB in 152 patients in Madrid and Barcelona, Spain.

Methods: 152 patients with a mean BMI of 38.5 (29.1 to 55.7); mean weight of 104.9 kg (79.4 to 180); mean age of 39.3 (17 to 63); were implanted with the SpatzAdjustable Balloon system (ABS) for twelve months. Mean balloon volume was 469.8 cc (400 to 600 cc). Balloon volume adjustments were made for intolerance or weight loss plateau. Post implantation and post adjustment symptoms were monitored. Patients were seen once or twice monthly by the endocrinologist, dietician or gastroenterologist.

Results: Implantation times averaged 12 minutes, although the first 5 implantation times took approximately 20 minutes each. Adjustment times averaged 5 to 15 minutes, depending on stomach contents. Post implantation symptoms of nausea, vomiting and pain were stronger than post adjustment symptoms, yet symptoms lingered a day longer post adjustment.

 

See Table for results.

Weeks Implanted # PatientsWeight Loss (kg)% EWL
1212514.836.2
246521.145.7
362726.757.1
521530.659.7

 

17 adjustments were successfully performed. Five downward adjustments performed (mean 160 cc with a range of 150 to 200 cc) within the first two weeks alleviated intolerance, with continued weight loss averaging 3.9 kg/month. Twelve upward adjustments (mean 186 cc with a range of 100 to 300 cc) performed on average at month 3.2 produced a mean additional weight loss of 1.7 kg/month. Ten balloons were extracted for various reasons; reached goal weight (3); psychological intolerance (2); symptom intolerance in the first 2 weeks and refusal to proceed with downward adjustment (3); gastric ulcer (1); pyloric entry of the distal catheter tip with duodenal ulcer(1).

Conclusion: The Spatz adjustable balloon has been successfully implanted in 152 patients.  1) Implantation and adjustment times were quick and reflect a short learning curve. 2) Upward adjustments yielded additional weight loss.  2) Downward adjustments alleviated intolerance, yet yielded continued weight loss. 3) Extraction is readily performed by snare. 4) Symptoms post implantation were stronger than post-adjustment, but averaged a day longer post-adjustment.  5) The results thus far from scheduled one year implantation with an adjustable balloon are encouraging.

 

References:

1. Mathus-Vliegen EM. Intragastric balloon treatment for obesity: what does it really offer? Dig Dis.

2008; 26(1):40-4. Epub 2008 Feb 15. Review

sep-line-1

 

Results reported from Wales, UK

(Publication submitted and currently under review)

Adjustable Intragastric Balloons: One-year results in 73 consecutive patients in the UK.

Brooks J, Srivastava ED, Mathus-Vliegen EMH

 

Reports 24 kg weight loss at 12 months. 

 

sep-line-2

 

Our clinical trial has been published in Obesity Surg Journal** and are summarized below:

  • In this feasibility study of a novel adjustable IGB, we report a mean wt loss of:

        –   15.6 kg (26.4% EWL) at 24 weeks

        –   20.4 kg (40.4% EWL) at 36 weeks

        –   24.4 kg (48.8% EWL) at 52 weeks

  • After weight loss plateau, balloon volume upward adjustments produced 8.1 kg additional weight loss in 10 patients.
  • Intolerance was treated with downward volume adjustments in 6 patients yielding patient comfort, and additional weight loss of 4.6 kg.
  • Early nausea in 2 patients that would have required IGB removal was successfully managed with downward volume adjustment.

 

Adjustable Intragastric Balloons: A 12-Month Pilot Trial in Endoscopic Weight Loss Management.

Machytka E, Klvana P, Kornbluth A, Peikin S, Mathus-Vliegen LE, Gostout C, Lopez-Nava G, Shikora S, Brooks J.

Obes Surg. 2011 Oct;21(10):1499-507.

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