Apresentamos um robusto e crescente volume de dados clínicos que continua a demonstrar a segurança e eficácia de nosso procedimento Transoral Incisionless Fundoplication (TIF®) 2.0 com tecnologia EsophyX. Resumos múltiplos, apresentados no mês passado durante a Digestive Disease Week (DDW) virtual de 21 a 23 de maio de 2021, adicionados à base de evidências clínicas que apóiam o uso de TIF 2.0 com novas populações de pacientes e indicações adicionais.
Os oito resumos apresentados no DDW apóiam a utilização clínica de nossa tecnologia EsophyX no tratamento da doença do refluxo gastroesofágico (DRGE), com correção de hérnia hiatal concomitante, em conjunto com miotomia endoscópica peroral (POEM), após fundoplicatura laparoscópica, e em pacientes com esôfago de Barrett que são refratários à terapia de erradicação endoscópica. Vários dos estudos também fornecem novos insights sobre a seleção de pacientes com maior probabilidade de se beneficiar do TIF 2.0.
Tomados em conjunto, os dados apresentados no DDW posicionam ainda mais a EndoGastric Solutions como líder em terapia de procedimento sem incisão para DRGE. Além disso, esses dados fornecem aos pacientes e médicos as evidências clínicas de que precisam para se sentirem ainda mais confiantes ao escolher o TIF 2.0 como sua escolha de terapia. Isso é especialmente importante devido à crescente evidência de que o uso em longo prazo da terapia com inibidores da bomba de prótons (IBP) pode ter consequências negativas para a saúde, o que ressalta a necessidade de terapias alternativas que possam fornecer alívio duradouro dos sintomas da DRGE.
Resumos dos oito resumos DDW 2021 estão incluídos abaixo. Não hesite em entrar em contato com a nossa força de vendas local e tiver dúvidas sobre qualquer um desses dados ou se desejar obter informações adicionais sobre as soluções EndoGastric ou nossa tecnologia EsophyX e TIF.
Cordialmente,
Equipe TOP Med Brasil
Oral Presentations
SHORT TERM OUTCOMES OF TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) 2.0 FOR TREATING GERD: A MULTICENTER PROSPECTIVE COHORT STUDY (THE TIF REGISTRY)2
A prospective evaluation of patient-reported and clinical outcomes in patients with GERD undergoing TIF 2.0 using >/30 fasteners to create a >/3cm long, >/300-degree circumferential valve. Symptom improvement was achieved in 92% of the 70 patients evaluated.
GERD-HRQL scores decreased from a mean of 24.1 (SD 18.1) to 7.3 (SD 8.7), p 270 degrees was achieved.
Prior to TIF 2.0, 56 (80%) of all patients were taking daily or twice daily PPI; post TIF 2.0, 80% of all TIF 2.0 patients were off PPI
Using stepwise logistic regression, the only factor associated with clinical success (symptom and pH improvement) was a TIF 2.0 valve circumference of >270 degrees (p=0.037), after considering hiatal hernia length, Hill grade, valve length, and number of TIF 2.0 fasteners.
Median TIF 2.0 procedure time was 43 minutes (IQR 33-48).
All TIF 2.0 procedures were completed as ambulatory procedures with no serious adverse events.
Authors conclude: “TIF 2.0 with enhanced technique is a safe and effective endoscopic outpatient treatment for selected GERD patients.”
CONCOMITANT HIATAL HERNIA REPAIR AND TRANSORAL INCISIONLESS FUNDOPLICATION IMPROVES SUBJECTIVE AND OBJECTIVE MEASURES OF GERD: A SINGLE CENTER SERIES3
The purpose of this study was to evaluate the effectiveness of concomitant hiatal hernia repair and transoral incisionless fundoplication (cTIF) using wireless 48-hour pH monitoring in addition to quality-of-life measures. Results show that post cTIF, there was an 81.4% decrease in reflux episodes; at 12 months post-cTIF there was a 100% decrease in regurgitation and 68.3% decrease in heartburn as assessed by GERD-HRQL.
All 34 patients in the study successfully underwent cTIF (100% completion)
Five of the 34 underwent wireless 48-hour pH monitoring off PPI therapy both pre-and-post-cTIF
Mean scores by GERD-HRQL decreased by 51.6% at 6 months and 68.3% at 12 months for heartburn and decreased by 83% at 6 months and 100% at 12 months for regurgitation.
Decreases were also observed for acid exposure time (AET) (mean difference 14.3, 91.8% decrease, 95% CI 3.16-25.4), and DeMeester scores (mean difference 47.5, 91.0% decrease, 95% CI 12.2-82.7)
One patient had more reflux-type symptoms post-cTIF but normalized AET and DeMeester score, as a result likely had functional heartburn.
Authors conclude: “cTIF successfully strengthens the anti-reflux barrier and reduces pathologic GERD. … cTIF is effective in decreasing objective and subjective measures of reflux activity.”
TANDEM PER ORAL ENDOSCOPIC MYOTOMY AND TRANSORAL INCISIONLESS FUNDOPLICATION: A STRATEGY TO REDUCE REFLUX AFTER PER ORAL ENDOSCOPIC MYOTOMY4
This was a case report of a 41-year-old male patient with type II achalasia treated with POEM followed by TIF 2.0 in a single session with the goal of reducing reflux after POEM. Prior to the procedure the patient had dysphagia to solids and liquids for 3 years, nocturnal regurgitation, and 5-7 kg weight loss, with an Eckardt score of 11 out of 12, indicating severe symptoms. Post-procedure he had improved symptoms with no emesis or nocturnal regurgitation, regained weight, and had an Eckhardt score of 3.
Post-procedure patient also reported no reflux and was not taking a proton pump inhibitor.
Authors conclude: “Tandem per oral endoscopic myotomy and transoral incisionless fundoplication in a single session is a strategy to prevent reflux after POEM, especially in young patients.”
TRANSORAL INCISIONLESS FUNDOPLICATION FOR RECURRENT SYMPTOMS POSTLAPAROSCCOPIC FUNDOPLICATION5
This was a multicenter cohort study of 20 patients who underwent TIF 2.0 after failed laparoscopic fundoplication (TIFFF) at 11 academic and community centers between September 2017 and June 2019. With mean follow-up of 12 months post-TIFFF, 42% of patients completely discontinued PPI and mean AET decreased from 12% ± 17.8 to 0.8% ± 1.1 (p=0.028).
TIFFF technical success rate was 100%.
Mean GERD-HRQL score improved from 24.3 ± 22.9 to 14.75 ± 21.6 (p=0.014).
RSI score decreased from a mean of 14.1 to 9.1 (p=0.046).
Esophagitis decreased from 47.4% to 20%.
9/9 (100%) of patients who had post-TIF 2.0 pH testing had normal AET (<4%).
There was one minor intra-procedural adverse event involving a superficial mucosal tear distal to the gastroesophageal junction successfully treated with endoscopic clip placement; there were no moderate or serious adverse events.
Authors conclude: “TIF may be a safe alternative to re-operative laparoscopic fundoplication in carefully selected patients.”
Poster Presentations
TIF FAILURE AS A RESULT OF ENDOSCOPISTS UNDERESTIMATING HILL GRADE6
This prospective analysis of all 94 patients who underwent TIF 2.0 between July 2014 and December 2020 at a single center was undertaken to analyze the causes of TIF 2.0 failure and describe the outcomes of patients who had failed TIF 2.0 followed by cTIF salvage. TIF 2.0 failure occurred in 7 patients (7.4%), all of whom had Hill grade I/II anatomy but also had moderate or large diaphragmatic defects at cTIF. These patients all reported symptom improvement 3 months post cTIF.
In the 7 patients who failed TIF 2.0, average time to recurrence of symptoms post-TIF 2.0 was 7.8 months.
The 7 patients who failed TIF 2.0 remained PPI-dependent 6 months post-TIF 2.0 and 57% reported the same predominant symptom.
Authors conclude: “TIF failure…was likely a result of poor patient selection. Patients deemed Hill grade I/II on endoscopy had large crural defects at cTIF, suggesting the reason for failure was underestimation of the diaphragmatic defect.”
Results suggest that improved training for endoscopists and standardization of nomenclature and systems for measuring hiatal hernia size and crural defect is needed.
OUTCOMES OF TRANSORAL INCISIONLESS FUNDOPLICATION FOR PPI AVERSE OR INTOLERANT CHRONIC GERD PATIENTS7
As part of a multi-center prospective TIF 2.0 registry, adult patients with PPI-responsive GERD who were PPI-averse or intolerant underwent TIF 2.0 or cTIF and were evaluated for clinical success after a minimum of 6 months of follow up. Clinical success (defined as percentage of patients off PPI without worsening of baseline GERD-HRQL or RSI score >50%) was achieved in 91.7% of evaluable patients.
To date, 165 patients have been enrolled in the ongoing TIF 2.0 registry.
In this study, 30 of those 165 patients who were PPI-averse or intolerant underwent TIF 2.0 (hiatal hernia < 2cm and Hill grade < 2; n=25) or cTIF (hiatal hernia > 2cm or Hill grade > 2; n=5).
Technical success rate was 100%.
GERD-HRQL scores decreased from 13 pre-procedure to 2 post-procedure (p<0.001).
RSI score decreased from 9 to 2.5 (p=0.001).
AET off PPI decreased from 8.8% to 3.3% (p=0.002) and was normalized in 78% of patients.
Patient-reported satisfaction with therapy increased from 16.6% to 71%.
There were no adverse events.
Authors conclude: “TIF/cTIF is a safe and effective alternative to PPI use in GERD patients who are least partially responsive to PPIs, but averse or intolerant of long-term use.”
TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) FACILITATES REMISSION OF INTESTINAL METAPLASIA AND DYSPLASIA IN PATIENTS UNDERGOING ENDOSCOPIC ERADICATION OF BARRETT’S ESOPHAGUS8
This retrospective multi-center study was designed to examine the safety, feasibility and impact of TIF 2.0 on both Barrett’s esophagus (BE) surveillance and endoscopic eradication therapy (EET). Up to 10-15% of BE patients with dysplasia are refractory to EET, presumably due to ongoing esophageal refluxate exposure. Spontaneous resolution of both BE and dysplasia was seen post TIF 2.0/cTIF and there were no new cases of dysplasia or cancer post TIF 2.0/cTIF.
11 patients were included in this analysis (non-dysplastic [ND] BE=6; indefinite dysplasia [IND]=2; low-grade dysplasia [LGD]=1; high-grade dysplasia [HGD]=2).
Prior to TIF 2.0 (n=4)/cTIF (n=7), none of the ND patients and 1 of the IND patients had undergone EET, and 1 of the HGD patients was contraindicated for treatment; the remaining patients had all undergone two radiofrequency ablation (RFA) procedures with or without additional endoscopic mucosal resection (EMR). 1 ND and 1 IND patient each had a spontaneous complete remission of intestinal metaplasia (CR-IM) prior to TIF 2.0/cTIF.
Following TIF 2.0/cTIF, 2 of the ND patients, 1 of the IND patients and the LGD patient did not undergo EET; 1 ND patient and both HGD patients underwent RFA and 1 of the HGD patients also underwent EMR. 1 IND patient had no post-TIF 2.0 endoscopy, and 3 ND patients are awaiting follow-up.
Of the 11 patients, 8 have completed follow-up and were evaluable, of which 5 had CR-IM (2 ND, 1 IND and 2 HGD) and one had complete remission of dysplasia (IND); LGD patient continued to have LGD.
One of the HGD patients had a recurrence of non-dysplastic BE after CR-IM.
Of the 11 patients included in this analysis, 7 (64%) stopped or reduced their use of PPIs post-TIF 2.0/cTIF and 9 (82%) had improvement in symptoms.
Esophagitis was resolved in 4 of 4 patients (100%) with this symptom.
There were no adverse events.
Authors conclude: “TIF is safe and feasible in BE… and facilitated EET in patients with prior contraindications.”
THE RISK OF NEEDING AN ANTI-REFLUX PROCEDURE AFTER PERORAL ENDOSCOPIC MYOTOMY AND SALVAGE WITH TRANSORAL INCISIONLESS FUNDOPLICATION9
TIF 2.0 can serve as rescue therapy for post POEM GERD. This single-center retrospective cohort study was conducted in patients who underwent POEM and had at least one follow-up visit between March 2014 and September 2020 (n=132). While the occurrence of post POEM PPI-refractory GERD requiring an anti-reflux procedure was low (9.1%), it occurred most frequently in patients with non-achalasia spastic disorders.
22% of patients with non-achalasia spastic disorders required TIF 2.0 post POEM.
16% of patients with achalasia type 1 required TIF 2.0 post POEM, which may be due to redundant esophagus. These patients may benefit the most from straightening the esophagus during TIF 2.0.
No worsening of dysphagia was observed post TIF 2.0.
Authors conclude: “These results can help risk stratify individuals for GERD at the time of POEM and tailor post procedure anti-reflux management.”
Referências Bibliográficas
1 Jaynes M and Kumar AB. THE RISKS OF LONG-TERM USE OF PROTON-PUMP INHIBITORS: A CRITICAL REVIEW. Ther Adv Drug Saf. 2019;10: doi: 10.1177/2042098618809927
2 Canto MI, Chang KJ, Janus PG et al. SHORT TERM OUTCOMES OF TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) 2.0 FOR TREATING GERD: A MULTICENTER PROSPECTIVE COHORT STUDY (THE TIF REGISTRY). Digestive Disease Week; May 21-23, 2021; virtual. Abstract 556.
3 Roccato M, Choi AY, Kolb JM et al. CONCOMITANT HIATAL HERNIA REPAIR AND TRANSORAL INCISIONLESS FUNDOPLICATION IMPROVES SUBJECTIVE AND OBJECTIVE MEASURES OF GERD: A SINGLE CENTER SERIES. Digestive Disease Week; May 21-23, 2021; virtual. Abstract 557.
4 Hoerter NA, Greenwald DA, DiMaio CJ et al. TANDEM PER ORAL ENDOSCOPIC MYOTOMY AND TRANSORAL INCISIONLESS FUNDOPLICATION: A STRATEGY TO REDUCE REFLUX AFTER PER ORAL ENDOSCOPIC MYOTOMY. Digestive Disease Week; May 21-23, 2021; virtual. Abstract 557. Abstract 835.
5 Ghosh G, Choi A, Dbouk M et al. TRANSORAL INCISIONLESS FUNDOPLICATION FOR RECURRENT SYMPTOMS POSTLAPAROSCCOPIC FUNDOPLICATION. Digestive Disease Week; May 21-23, 2021; virtual. Abstract 775.
6 Kolb JM, Roccato MK, Shahi S et al. TIF FAILURE AS A RESULT OF ENDOSCOPISTS UNDERESTIMATING HILL. Digestive Disease Week; May 21-23, 2021; virtual. Abstract Su617.
7 Zhang L, Dbouk M, Choi A et al. OUTCOMES OF TRANSORAL INCISIONLESS FUNDOPLICATION FOR PPI AVERSE OR INTOLERANT CHRONIC GERD PATIENTS. Digestive Disease Week; May 21-23, 2021; virtual. Abstract Sa167.
8 Hoerter NA, Smith MS, Dixon RE et al. TRANSORAL INCISIONLESS FUNDOPLICATION (TIF) FACILITATES REMISSION OF INTESTINAL METAPLASIA AND DYSPLASIA IN PATIENTS UNDERGOING ENDOSCOPIC ERADIATION OF BARRETT’S ESOPHAGUS. Digestive Disease Week; May 21-23, 2021; virtual. Abstract Fr221.
9 Kolb JM, Nguyen PH, Ji SS et al. THE RISK OF NEEDING AN ANTI-REFLUX PROCEDURE AFTER PERORAL ENDOSCOPIC MYOTOMY AND SALVAGE WITH TRANSORAL INCISIONLESS FUNDOPLICATION. Digestive Disease Week; May 21-23, 2021; virtual. Abstract Su156.