Prior Balloon Research Articles

Middle meningeal artery pseudoaneurysm and pterygoid plexus fistula following percutaneous radiofrequency rhizotomy: illustrative case.

Percutaneous treatment for trigeminal neuralgia is a safe and effective therapeutic methodology and can be accomplished in the form of balloon compression, glycerol rhizotomy, and radiofrequency thermocoagulation. These procedures are generally well tolerated and demonstrate minimal associated morbidity. Moreover, vascular complications of these procedures are exceedingly rare. We present the case of a 64-year-old female with prior microvascular decompression and balloon rhizotomy who presented after symptom recurrence and underwent a second balloon rhizotomy at our institution. Soon thereafter, she presented with pulsatile tinnitus and a right preauricular bruit on physical examination. Subsequent imaging revealed a middle meningeal artery (MMA) to pterygoid plexus fistula and an MMA pseudoaneurysm. Coil and Onxy embolization were used to manage the pseudoaneurysm and fistula. This case illustrates the potential for MMA pseudoaneurysm formation as a complication of percutaneous trigeminal balloon rhizotomy, which has not been seen in the literature. Concurrent MMA-pterygoid plexus fistula is also a rarity demonstrated in this case.

Pre-operative endoscopic balloon dilatation and its impact on outcome of laparoscopic Heller cardiomyotomy for patients with achalasia: does the frequency and interval matter?

Many surgeons believe that pre-operative balloon dilatation makes laparoscopic myotomy more difficult in achalasia patients. Herein, we wanted to see if prior pneumatic balloon dilatation led to worse outcomes after laparoscopic myotomy. We also assessed if the frequency of dilatations and the time interval between the last one and the surgical myotomy could affect these outcomes. The data of 460 patients was reviewed. They were divided into two groups: the balloon dilation (BD) group (102 patients) and the non-balloon dilatation (non-BD) group (358 patients). Although pre-operative parameters and surgical experience were comparable between the two groups, the incidence of mucosal perforation, operative time, and intraoperative blood loss significantly increased in the BD group. The same group also showed a significant delay in oral intake and an increased hospitalization period. At a median follow-up of 4 years, the incidence of post-operative reflux increased in the BD group, while patient satisfaction decreased. Patients with multiple previous dilatations showed a significant increase in operative time, blood loss, perforation incidence, hospitalization period, delayed oral intake, and reflux esophogitis compared to single-dilatation patients. When compared to long-interval cases, patients with short intervals had a higher incidence of mucosal perforation and a longer hospitalization period. Pre-operative balloon dilatation has a significant negative impact on laparoscopic myotomy short and long term outcomes. It is associated with a significant increase in operative time, blood loss, mucosal injury, hospitalization period, and incidence of reflux symptoms. More poor outcomes are encountered in patients with multiple previous dilatations and who have a short time interval between the last dilatation and the myotomy.

Outcomes of reverse total shoulder arthroplasty following subacromial balloon spacer implantation

BackgroundSubacromial balloon spacer implantation can be used in the treatment of irreparable rotator cuff tears; but in cases of treatment failure reverse total shoulder arthroplasty (RTSA) may be indicated. The effect of a previously performed subacromial balloon implantation on the outcomes of a subsequent RTSA is unknown. MethodsA single-center retrospective matched cohort study was performed on patients with a history of subacromial balloon spacer implantation who subsequently underwent RTSA in the same shoulder between 2010 and 2021 (Balloon group). A control group of patients who underwent RTSA for irreparable cuff tear/cuff tear arthropathy during the same time period without prior subacromial balloon implantation history was identified and matched by the number of previous rotator cuff repair surgeries and age (No Balloon group). The minimum follow-up was 1 year. Data collected included range of motion, subjective shoulder value, visual analog scale for pain, Quick Disabilities of the Arm, Shoulder, and Hand (QDASH) score, and the proportion of patients achieving patient acceptable symptomatic state (PASS). ResultsThirty cases were included, equally distributed between the two groups. The mean follow-up was 46 ± 23 months without significant differences between groups. The Balloon group included only male patients, whereas the No Balloon group comprised of 47% female patients. The Balloon group had a less advanced arthritic disease as evidenced by a lower Hamada grade compared to the No Balloon group (P = .03). There were no significant differences in preoperative or postoperative range of motion between groups, with an average forward flexion increase of 39° and no gain in rotations. Patient-reported outcomes were comparable between groups: visual analog scale, 4.7 vs. 3.3; subjective shoulder value, 50 vs. 64; and QDASH, 65 vs. 49 (all P > .05). There were four (27%) postoperative complications leading to reintervention in the Balloon group and one (7%) in the No Balloon group (P = .15). ConclusionIn this preliminary study, patients undergoing RTSA for irreparable cuff tear/cuff tear arthropathy had comparable outcomes irrespective of a history of previous subacromial balloon spacer implantation. Further studies in a larger population are indicated to examine the trend toward inferior patient-reported outcomes observed in this small series.

Performance Characteristics of Endoscopic Sleeve Gastroplasty in Patients with Prior Intragastric Balloon: Results of a Propensity Score Matched Study.

The performance characteristics of endoscopic sleeve gastroplasty (ESG) for weight recurrence after intragastric balloon (IGB) are unknown. This is a retrospective propensity score matched study of ESG after IGB (IGB-to-ESG) vs ESG without prior IGB (ESG-only). The primary outcome was total weight loss (TWL) at 12months. Secondary outcomes included TWL at 3 and 6months, 12-month excess weight loss (EWL), procedural characteristics, and safety. Thirty-nine adults underwent ESG from August 2020 to September 2022 after IGB explantation a median of 24months (range 2-56months) prior and a median post-IGB nadir weight increase of 100.0% (range 0 to 3200%). An ESG-only 2:1 age- sex- and BMI- propensity score matched cohort was derived from 649 patients (Pearson's goodness-of-fit: 0.86). TWL for IGB-to-ESG vs. ESG-only was 12.3 ± 13.5% vs. 12.4 ± 3.7% at 3months (p = 0.97), 10.1 ± 7.1% vs. 15.4 ± 4.6% at 6months (p < 0.001), and 8.7 ± 7.7% vs. 17.1 ± 5.7% at 12months (p < 0.001). Twelve-month EWL for IGB-to-ESG vs ESG-only was 27.8 ± 46.9% vs 62.0 ± 21.0% (p < 0.001). There was no difference in mean procedural duration of ESG; however, more sutures were used with IGB-to-ESG vs. ESG-only (7 vs. 6, p < 0.0002). There were no serious adverse events in either cohort. ESG after IGB produces safe, acceptable weight loss but with an attenuated effect compared to ESG alone. Further study is required to understand the factors driving this discrepancy.

Outcomes of Adults with Severe Aortic Stenosis Undergoing Urgent or Emergent vs. Elective Transcatheter Aortic Valve Replacement Within an Integrated Health Care Delivery System

BackgroundTranscatheter aortic valve replacement (TAVR) may be used to urgently or emergently treat severe aortic stenosis, but outcomes for this high-risk population have not been well-characterized. We sought to describe the incidence, clinical characteristics, and outcomes of patients undergoing urgent or emergent vs. elective TAVR. MethodsWe identified all adults who received TAVR for primary aortic stenosis between 2013 and 2019 within an integrated health care delivery system in Northern California. Elective or urgent/emergent procedure status was based on standard Society of Thoracic Surgeons definitions. Data were obtained from electronic health records, the Society of Thoracic Surgeons-American College of Cardiology Transcatheter Valve Therapy Registry, and state/national reporting databases. Logistic regression and Cox proportional hazard models were performed. ResultsAmong 1564 eligible adults that underwent TAVR, 81 (5.2%) were classified as urgent/emergent. These patients were more likely to have heart failure (63.0% vs. 47.4%), reduced left ventricular ejection fraction (21.0% vs. 11.8%), or a prior aortic valve balloon valvuloplasty (13.6% vs. 5.0%) and experienced higher unadjusted rates of 30-day and 1-year morbidity and mortality. Urgent/emergent TAVR status was independently associated with non-improved quality of life at 30-days (hazard ratio, 4.87; p < 0.01) and acute kidney injury within 1-year post-TAVR (hazard ratio, 2.11; p = 0.01). There was not a significant difference in adjusted 1-year mortality with urgent/emergent TAVR. ConclusionsUrgent/emergent TAVR status was uncommon and associated with high-risk clinical features and higher unadjusted rates of short- and long-term morbidity and mortality. Procedure status may be useful to identify patients less likely to experience significant short term improvement in health-related quality of life post-TAVR.

OGBN P12 Minimising the systemic effects of an oesophageal leak following high risk myotomy repair using Prophylactic Endoluminal Vacuum Therapy (EVT) - time for a change?

Abstract Background Endoluminal Vacuum Therapy (EVT) continues to gain momentum as a first line treatment for oesophageal perforations. Outside the emergency setting there is growing interest in using EVT prophylactically to protect high-risk elective oesophageal repairs. We present a case which demonstrates the benefit of prophylactic EVT in preventing extraluminal contamination, mediastinitis and sepsis following elective oesophageal surgery. Methods An 80-year-old female underwent laparoscopic Hellers Myotomy and Dor Fundoplication for Type 2 Achalasia following worsening symptoms including weight loss despite nutritional optimisation. She had multiple prior balloon dilatations without long term symptom control and remained frail, with a performance status of 0 and an ASA 2. During surgery the oesophageal myotomy was challenging due to extensive scarring. Endoscopy was performed on completion of the myotomy to confirm adequacy and a 1cm oesophageal perforation at 38cm was noted. Primary repair was performed with 5 interrupted 3/0 maxon sutures. An ad-hoc EVT device was constructed using V.A.C granufoam (KCI) sutured to the end of an 18Fr nasogastric tube, and placed intraluminally in the oesophagus across the repair. Continuous negative pressure of 75mmHg was applied. Post operatively the patient was kept nil by mouth and received parenteral nutrition. Her clinical and biochemical parameters were monitored, and the progress of her oesophageal repair was assessed endoscopically. Results The first post-operative endoscopy was performed at day 4. On visual inspection a full thickness oesophageal defect was seen at the proximal aspect of the oesophageal repair. There was no associated leak cavity or other endoscopic evidence of extraluminal contamination. A further ad-hoc EVT device was constructed and placed intraluminally in the oesophagus across the suture repair and oesophageal wall defect. A second endoscopy was performed on day 10 post-operative and the oesophageal defect had completely healed. Despite having a documented full thickness oesophageal wall defect the patient remained clinically well throughout her post-operative recovery with no clinical signs of sepsis. The highest recorded CRP was 131 and WCC was 12.7 on day 1 and day 8 respectively. At no point was a higher level of care or input required than the general surgical ward. Her total LOS was 14 days. Conclusions A leak following elective oesophageal surgery is a serious complication which may result in mediastinitis, sepsis and death. This case demonstrates the utility of prophylactic EVT in reducing the impact of an oesophageal leak in patients where breakdown of the oesophageal repair occurs. Without prophylactic EVT in this case, we are certain the breakdown of the oesophageal repair would have resulted in a significant oesophageal leak with mediastinitis and sepsis which an 80-year-old patient with limited physiological reserve may not have survived. While prophylactic EVT is not a substitute for sound surgical technique, it should be considered in high-risk patients undergoing elective oesophageal surgery to reduce or prevent the septic hit consequent to an oesophageal leak if breakdown of an oesophageal repair occurs.

Central extracorporeal membrane oxygenation with left-ventricular vent for fulminant myocarditis: a retrospective study.

Fulminant myocarditis presents as acute severe heart failure and requires mechanical cardiocirculatory support. Left-ventricular (LV) decompression is necessary for the successful recovery of these patients. This retrospective study aimed to evaluate the functional outcomes of providing central extracorporeal membrane oxygenation (ECMO) with LV decompression for the treatment of refractory fulminant myocarditis. Between January 2015 and February 2021, seven consecutive fulminant myocarditis patients (mean age: 41.1 ± 26.1years) received central ECMO support with transapical LV decompression, with an 18 French cannula integrated into the ECMO circuit in a Y-fashion. The baseline characteristics and postoperative outcomes of the patients were collected. On admission, all patients received prior peripheral ECMO, and 85.7% (6/7) of patients received prior intra-aortic balloon pumping. However, all patients had refractory cardiogenic shock that failed prior to decompression. Six patients recovered successfully after a mean ECMO support of 20.0 ± 11.5days and five patients had no recurrence of cardiac decompensation. The mean ICU and mean hospital stays were 36.7 ± 23.5days and 60.6 ± 24.9days, respectively. Hospital mortality was 28.6% (2/7). Two patients died due to sepsis and stroke during hospitalization. Central ECMO with an LV vent was effective for fulminant myocarditis refractory to percutaneous cardiopulmonary support therapy and other therapies.

Prevention and therapy of massive obstetric bleeding with placenta percreta 3b

The objective: to reduce the intra- and postoperative complications, massive intraoperative blood loss during abdominal delivery of pregnant women with placenta percreta 3b using endovascular technique of temporary balloon occlusion of the infrarenal abdominal aorta. Materials and methods. Caesarean section in the uterus fundus was performed in 21 pregnant women with placenta percreta and invasion of perivesical tissue, partial invasion to the posterior wall of the bladder (degree of invasion 3b). The main group included 7 pregnant women who had lower median laparotomy and caesarean section in the uterine fundus with balloon occlusion of the infrarenal abdominal aorta after fetal removal and subsequent hysterectomy without uterine appendages and bladder fundus plastics. The comparison group included 14 pregnant women with caesarean section in the uterus fundus without prior balloon occlusion of the abdominal aorta with subsequent hysterectomy without uterine appendages and suturing of the bladder fundus defect in the area of ​​its invasion of placental tissue. Pregnant women of both groups were representative for age, parity, somatic pathology. The diagnosis in all cases was confirmed by ultrasound examination with Doppler and magnetic resonance imaging. All pregnant women were delivered in 36-37 weeks of gestation. The article also presents a clinical case: delivery of a pregnant woman with placenta percreta and invasion in the posterior wall of the bladder using an innovative technique to minimize blood loss, which was conducted at the Kyiv Regional Perinatal Center. Results. It was determined that delivery by caesarean section with balloon occlusion of the abdominal aorta and subsequent hysterectomy without uterine appendages and bladder fundus plastics reduces blood loss (from 1758.0±110.0 ml to 955.0±70.0 ml), duration of surgery (from 112.0±11.0 min to 87.0±9.0 min), duration of hospitalization (from 11±2 days to 7±1 days), the need for blood transfusions and improves long-term consequences. Conclusions. Innovative technology for temporary balloon occlusion of infrarenal abdominal aorta after cesarean section in the uterus fundus and subsequent hysterectomy without uterine appendages in women with placenta percreta 3b significantly reduces blood loss, the likelihood of massive bleeding, organ damage, duration of hospitalization.

Prediction Factors of Early Postoperative Bleeding after Bariatric Surgery.

Identifying the possible predictors of postoperative bleeding is advantageous to reduce healthcare costs and promote patients' recovery. The aim of this study was to determine early postoperative bleeding predictors after bariatric surgery. This retrospective study was conducted using data from 2260 patients who underwent bariatric surgery. We diagnosed early postoperative bleeding by the following symptoms: abdominal pain, hypotension, tachycardia, hematemesis, melena, decreased hemoglobin level, the need for at least two units of packed red blood cells (PRBCs) transfusion, and reoperation within the first 48h after surgery. Our results showed the odds of early postoperative bleeding in laparoscopic Roux-en-Y gastric bypass (LRYGB) were higher than in laparoscopic sleeve gastrectomy (LSG) (OR 3.49, 95% CI 1.79 to 6.80). In addition, prior intragastric balloon (IGB) (OR 3.14, 95% CI 1.18 to 8.34) and oral non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) (OR 5.91, 95% CI 1.79 to 20.63) were positively associated with the occurrence of postoperative bleeding. In contrast, there was an inverse relationship between staple line oversewing and the odds of postoperative bleeding (OR 0.18, 95% CI 0.04 to 0.81). After stratification data based on the type of the surgery, the positive association between IGB and the odds of bleeding was constant in the LRYGB group. In the LSG group, use of non-aspirin NSAIDs was linked to a higher incidence of postoperative bleeding, while oversewing of the staple line lowered the incidence of this event. Our results demonstrated a positive association between type of procedure, history of IGB, and oral non-aspirin NSIADs use, as well as an inverse relationship between staple line oversewing and the odds of bleeding after bariatric surgery.

Surgical tracheoplasty for children with congenital tracheal stenosis undergoing previous balloon dilatation or tracheal metal stent placement: a series of 9 cases

Objective: To examine the outcomes of Slide tracheoplasty for the children with severe congenital tracheal stenosis received previous repeated balloon dilatation or metal stent placement under endoscopy. Methods: A retrospective study was conducted in 9 children with congenital tracheal stenosis undergoing previous interventional therapy under tracheoscopy and later received Slide tracheoplasty due to obvious respiratory symptoms at Department of Cardiac Surgery, Qilu Children's Hospital of Shandong University between February 2017 and July 2021. There were 7 males and 2 females with a median age at operation of 72.4 months (range: 13.3 to 98.9 months), and the median weight was 19.0 kg (range: 9.0 to 33.0 kg). Among the 9 patients, 2 patients began to receive repeated balloon dilatation (more than 3 times) 17.8 and 51.8 months ago respectively. One patient received metal stents placement into the trachea for 4 days and the other 6 children for median 56.8 months (range: 21.6 to 74.2 months). Complete tracheal cartilage rings and long segmental stenosis were present. in all 9 children. Operative details and outcome measures, including the need for endoscopic airway intervention and mortality, were collected. Results: Slide tracheoplasty was performed in all cases. Two patients with repeated balloon dilatation had different thickness of tracheal wall, local scar hyperplasia and irregular lumen. Among them, 1 case had obvious local calcification of tracheal wall, which was difficult to suture. The metal stent in one patient with short time of placement was completely removed. However, only part of the metal stents could be removed due to the long placement time in the other 6 cases. There was no operative death in the 9 children. The median postoperative tracheal intubation time was 25.3 hours (range: 17.4 to 74.5 hours). A silicone stent was placed in the trachea of 1 child due to obvious respiratory symptoms. Follow-up of median 11 months (range: 1 to 23 months) showed that no death occurred after discharge and all children had basically normal activity tolerance with no obvious respiratory symptoms. Conclusions: Slide tracheoplasty is feasible for children undergoing prior balloon dilatation or metal stents placement. Previously repeated balloon dilatation or metal stent placement under endoscopy increased the difficulty of slide tracheoplasty, the metal stent could not be completely removed after a long time.

508 Incidence and determinants of prosthesis-patient mismatch after transcatheter aortic valve replacement using predicted indexed effective orifice area

Abstract Aims A small effective orifice area (EOA) by body surface area (BSA), defined as prosthesis–patient mismatch (PPM), is associated with elevated transprosthetic pressure gradients, less ventricular remodelling, and a worse prognosis. Calculating PPM by dividing the normal reference value of EOA for the model and size of the prosthetic valve (predicted PPM), instead of using the continuity equation has been recently confirmed as more accurate after trans catheter aortic valve intervention (TAVI), providing a stronger association with post-procedural haemodynamic outcomes. However, current evidence using this new definition is still limited, thus impairing generalizability. Accordingly, this analysis aims to extend such evidence providing incidence, and determinants of predicted PPM (PPMp) in an all-comers population undergoing TAVR with a high prevalence of self-expandable devices. Methods 395 patients who underwent TAVI at our Institution from September 2008 to November 2020 were included in this analysis. PPMp was then classified as moderate if ≤ 0.85 cm2/m2 and severe if ≤ 0.65 cm2/m2 as well as moderate if ≤ 0.70 cm2/m2 and severe if ≤ 0.55 cm2/m2 for patients with a body mass index &amp;gt; 30, as recommended by the Valve Academic Research Consortium-3 definition. The independent association between baseline clinical and procedural variables and the presence of moderate or severe PPMp was investigated with cross-sectional logistic regression analysis. Results 11 patients (2.78%) had severe and 33 (8.35%) moderate PPMp. Patients with moderate or severe PPMp (m/s PPMp) were younger, female, with a higher prevalence of hypercholesterolaemia, prior aortic valve implantation and balloon expandable device and lower prevalence of chronic obstructive disease (COPD). Post-procedural mean gradient was higher in patients with m/s PPMp. The independent clinical and procedural correlates associated with higher likelihood of m/s PPMp were valve in valve procedure (ViV) and the use of a balloon-expandable device. Conclusions Moderate or severe PPMp was observed only in a small part of patients underwent TAVI, leading, however, a higher post-procedural mean gradient compared to those without PPMp. Balloon expandable devices and ViV were the strongest determinant of moderate or severe PPM.

Factors Influencing Reintervention Following Ductal Artery Stent Implantation for Ductal-Dependent Pulmonary Blood Flow: Results From the Congenital Cardiac Research Collaborative.

Stenting of the patent ductus arteriosus (PDA) is an established palliative option for infants with ductal-dependent pulmonary blood flow. Following initial palliation, reintervention on the PDA stent is common, but risk factors have not been characterized. Infants with ductal-dependent pulmonary blood flow palliated with PDA stent between 2008 and 2015 were reviewed within the Congenital Cardiac Research Collaborative. Rates and risk factors for reintervention were analyzed. Among 105 infants who underwent successful PDA stenting, 41 patients (39%) underwent a total of 53 reinterventions on the PDA stent, with all but one occurring within 6 months of the initial intervention. Stent redilation constituted the majority of reintervention (n=35; 66%) followed by additional stent placement (n=11; 21%) and surgical shunt placement (n=7; 13%). The majority of reintervention was nonurgent, and there were no deaths during the reintervention procedure. All but one reintervention occurred within 6 months of the initial procedure. On univariate analysis, risk factors for reintervention included anticipated single-ventricle physiology, lack of prior balloon pulmonary valvuloplasty, use of drug-eluting stent, and increased ductal tortuosity. In infants with ductal-dependent pulmonary blood flow palliated with PDA stent implantation, reintervention is common, can be performed safely, and is associated with both anatomic/procedural factors and anticipated final physiology.

Preliminary Experience of Neuroform Atlas Stenting as a Rescue Treatment after Failure of Mechanical Thrombectomy Caused by Residual Intracranial Atherosclerotic Stenosis.

ObjectiveThe low-profile Neuroform Atlas stent can be deployed directly without an exchange maneuver by navigating into the Gateway balloon. This retrospective study assessed the safety and efficacy of Neuroform Atlas stenting as a rescue treatment after failure of mechanical thrombetomy (MT) for large artery occlusion. MethodsBetween June 2018 and December 2019, a total of 31 patients underwent Neuroform Atlas stenting with prior Gateway balloon angioplasty after failure of conventional MT caused by residual intracranial atherosclerotic stenosis (ICAS). Primary outcomes were successful recanalization and patency of the vessel 24 hours after intervention. Secondary outcomes were vessel patency after 14 days and 3-month modified Rankin Scale. Peri-procedural complications, intracerebral hemorrhage (ICH), and 3-month mortality were reviewed. ResultsWith a 100% of successful recanalization, median value of stenosis was reduced from 79.0% to 23.5%. Twenty-eight patients (90.3%) showed tolerable vessel patency after 14 days. New infarctions occurred in three patients (9.7%) over a period of 14 days; two patient (6.5%) underwent stent occlusion at 24 hours, and the other patient (3.2%) with delayed stent occlusion had a non-symptomatic dot infarct. There were no peri-procedural complications. Two patients (6.5%) developed an ICH immediately after the procedure with one of them is symptomatic. ConclusionNeuroform Atlas stenting seems to be an effective and safe rescue treatment modality for failed MT with residual ICAS, by its high successful recanalization rate with tolerable patency, and low peri-procedural complication rate. Further multicenter and randomized controlled trials are needed to confirm our findings.

Impact of ventricular assistance devices on patients submitted to heart transplantation

Abstract Background The introduction of veno-arterial extracorporeal life support (v-a ECLS) widens the spectrum of patients that can be included in the heart transplant program, some examples are extended myocardial infarction, fulminant myocarditis or advanced cardiac insufficiency. In addition to this, the implementation of extracorporeal cardiopulmonary resuscitation (ECPR) extends even more the range of patients that can be benefitted of this therapy as a bridge to transplant. Purpose Our objective is to describe the incidence of v-a ECLS in those patients submitted to a heart transplant and to establish whether or not this technique increases the risk of mortality in this population. Methods Retrospective and descriptive statistical analysis of 82 consecutive patients submitted to heart transplant between 2015 and 2019 in a High Technology University Hospital. Demographic and clinical data, extracorporeal life support, extracorporeal cardiopulmonary resuscitation and assistance device type, together with survival at 30 days and one year were collected. Results 82 patients were transplanted during the study period distributed as follows: 47 (51.69%) were elective and 35 (48.1%) emergent being 25 (30.12%) of grade 1A and 10 (12.19%) of grade 1B. 52% had prior intra-aortic balloon contrapulsation. Patients transplanted under ECLS were 80% men and average age of 53 (SD 15) years old. The most prevalent diagnosis was acute myocardial infarction Killip IV (32%), followed by terminal heart failure (28%). 32% of the patients were under peripheral ECMO, 36% under left ventricular assistance, 20% under biventricular assist device, and 12% required ECPR. 72% of devices were implanted in the operating room and 16% in the ICU. The one-year survival of the sample was 88%. 2 patients died after transplantation (8%) during the first month, and 1 patient died within the first year. All three patients had terminal heart failure and the VAD implant was inserted electively Conclusions ECLS prior to cardiac transplantation allow selected patients to arrive alive to the transplant. The choice among devices is related to the diagnosis and expected duration of the therapy but we have not found in our series effects on subsequent mortality. Survival at one year in the subjects analysed is greater than the national registry of the last 10 years, although the tendency is to improve every year. This new scenario implies an increment of the complexity in the management of these patients and requires an special effort in terms of staff ratio and training. In our centre, the implementation of ECLS resulted in an increment of our staff and formative sessions. Funding Acknowledgement Type of funding source: None

Transpapillary tissue sampling of biliary strictures: balloon dilatation prior to forceps biopsy improves sensitivity and accuracy

The early and definitive diagnosis of malignant bile duct stenoses is essential for a timely and adequate therapy. However, tissue sampling with transpapillary brush cytology (BC) or forceps biopsy (FB) remains challenging. With this study, we aimed to compare the effectiveness and safety of different tissue sampling modalities (BC, FB without/after previous balloon dilatation). Standardized database research identified all patients, who underwent endoscopic retrograde cholangiography with BC and/or FB for indeterminate bile duct stenosis between January 2010 and April 2018 and with a definitive diagnosis. 218 patients were enrolled (149 cases with malignant and 69 with benign disease). FB had a significant higher sensitivity than BC (43% vs. 16%, p < 0.01). Prior balloon dilatation of the stenosis improved the sensitivity of FB from 41 to 71% (p = 0.03), the NPV from 36 to 81% (p < 0.01) and the accuracy from 55 to 87% (p < 0.01). The complication rates did not differ significantly between the modalities. In our center FB turned out to be the diagnostically more effective procedure. Balloon dilatation of the stenosis before FB had a significant diagnostic benefit and was not associated with a higher complication rate.

ACUTE VASOREACTIVITY TESTING DURING RIGHT HEART CATHETERIZATION IN CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION: RESULTS FROM THE PULMONARY VASCULAR DISEASE OMICS PROJECT

SESSION TITLE: Advances in the Diagnosis and Management of Pulmonary Hypertension SESSION TYPE: Original Investigations PRESENTED ON: October 18-21, 2020 PURPOSE: Chronic thromboembolic pulmonary hypertension (CTEPH) is believed to involve both vascular obstruction and vasoconstriction; hence vasodilators such as riociguat may be beneficial. Acute vasoreactivity testing is seldom performed, so there is limited understanding of frequency and significance of acute response. Systematic vasodilator testing with oxygen and oxygen plus inhaled nitric oxide was performed as part of the Pulmonary Vascular Disease Omics (PVDOMICS) NHLBI project, providing opportunity to examine this issue. METHODS: Patients with CTEPH enrolled in PVDOMICS underwent right heart catheterization including vasodilator challenge with 100% oxygen (02) and 100% oxygen plus 40 PPM of inhaled nitric oxide (02 + NO). Mean pulmonary artery pressure, pulmonary artery wedge pressure, and cardiac output by thermodilution with calculation of pulmonary vascular resistance (PVR) was obtained at baseline and with each intervention. We examined acute vasoreactivity defined as > 20% drop in PVR, > 20% drop in both mPAP and PVR, and as a drop in mPAP > 10 mmHg to a value < 40 mmHg with normal cardiac output. RESULTS: Of the 61 patients who underwent vasoreactivity testing, 32 (52%) were on PH therapy (15 riociguat, 8 PDE5i, 9 other) and 29 (48%) were on no targeted PH therapy. Fourteen (23%) had prior pulmonary thromboendarterectomy, 1 (2%) had prior balloon pulmonary angioplasty. In the overall cohort, mean PVR was 5.49 WU at baseline, 4.81 with 02, and 4.01 with O2 + NO (mean ± SD change from baseline: -1.43 ± 1.32, 26%), p < .0001). In the subset who were on no PH therapy, mean PVR was 6.26 at baseline, 5.75 with 02, and 4.55 with 02 + NO (change from baseline of -1.62 ± 1.36, 26%), p < .0001). Overall, 25 (43%) had > 20% drop in PVR with 02. With 02 + NO, 36 (62%) had > 20% drop in PVR (decline of 1.43 ± 1.32 WU), including 9 (64%) of those with prior thromboendarterectomy and 19 who were on PH therapy. Six (10%) had a drop in mPAP by > 10 mmHg to < 40 mmHg with normal cardiac output. Thirteen (21%) had > 20% drop in both mPAP and PVR, 6 of whom were on no PH therapy and 4 out of 8 (50%) of those who were on PDE5i. Only 2/15 (13%) of those on riociguat had > 20% drop in both mPAP and PVR. CONCLUSIONS: An element of acute vasoreactivity is common in CTEPH including in those with prior pulmonary thromboendarterectomy. The 26% decline in PVR with acute testing for those who were on no PH therapy is similar to what was achieved chronically on average with riociguat in the pivotal randomized study [(29%, 226 dyn.sec.cm -5 = 2.83 WU,) from baseline of 791]. Whether acute vasoreactivity testing is predictive of clinical response to riociguat or other pulmonary vasodilators is worthy of additional investigation. CLINICAL IMPLICATIONS: Vasoconstriction is a significant contributor to the elevation in pulmonary artery pressure and resistance in the majority of patients with CTEPH. DISCLOSURES: No relevant relationships by Erika Berman Rosenzweig, source=Web Response Advisory Committee Member relationship with Liquidia Please note: $1001 - $5000 Added 03/19/2020 by Robert Frantz, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Altavant Please note: $1001 - $5000 Added 03/19/2020 by Robert Frantz, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Actelion Please note: $5001 - $20000 Added 07/16/2020 by Robert Frantz, source=Web Response, value=Consulting fee No relevant relationships by Paul Hassoun, source=Web Response Advisory Committee Member relationship with bayer Please note: $1001 - $5000 Added 04/14/2020 by Anna Hemnes, source=Web Response, value=Consulting fee Advisory Committee Member relationship with Complexa Please note: $1-$1000 Added 04/14/2020 by Anna Hemnes, source=Web Response, value=Consulting fee Advisory Committee Member relationship with United Therapeutics Please note: $1001 - $5000 Added 04/14/2020 by Anna Hemnes, source=Web Response, value=Consulting fee Advisory Committee Member relationship with actelion Please note: $1001 - $5000 Added 04/14/2020 by Anna Hemnes, source=Web Response, value=Consulting fee Scientific Medical Advisor relationship with PHPreMedicine Please note: $1-$1000 Added 04/14/2020 by Anna Hemnes, source=Web Response, value=Ownership interest no disclosure on file for Evelyn Horn; No relevant relationships by Armand Larive, source=Web Response My spouse/partner as a Consultant relationship with Cellectis Please note: >$100000 Added 05/28/2020 by Jane Leopold, source=Web Response, value=Consulting fee no disclosure on file for Franz RIschard; Consultant relationship with Sequana Medical AG Please note: $5001 - $20000 Added 05/28/2020 by Wai Hong Tang, source=Web Response, value=Consulting fee Editor/Author relationship with Springer Nature Please note: $1-$1000 Added 05/29/2020 by Wai Hong Tang, source=Web Response, value=Honoraria My spouse/partner as a Consultant relationship with Cardiac Community Core Lab, LLC Please note: $1001 - $5000 Added 05/28/2020 by Wai Hong Tang, source=Web Response, value=Honoraria

Sa1251 PREDICTOR OF CLINICAL FAILURE OF PER-ORAL ENDOSCOPIC MYOTOMY: A LARGE SINGLE-CENTER EXPERIENCE

Per-oral endoscopic myotomy (POEM) is considered as an effective and safe minimally invasive endoscopic treatment for esophageal achalasia and achalasia related motility disorders, and more than 2000 cases have been performed at our institution. Although POEM is a highly efficacious treatment, there have been reports of clinical failure and the cause of these failure is unknown. This study aimed to identify the predictor of clinical failure of POEM. We conducted a retrospective analysis of a prospectively maintained database comprised of consecutive patients who underwent POEM for esophageal achalasia or achalasia related motility disorders at a tertiary-referral center between 2008 and 2019. Clinical failure of POEM was defined as primary failure with Eckardt score not decreasing to 3 or under during one-year follow-up. Patients were divided into two groups according to whether they had clinically successful POEM or failed POEM. Baseline characteristics (Age, sex, BMI, duration of symptoms, esophageal diameter, manometric diagnosis), anti-thrombotic agents, prior treatments, myotomy orientation, myotomy length were retrieved. Univariate and multivariate logistic regression analyses were performed to assess the predictive factors of clinical failure (Table 1, 2). A total of 2091 POEM were performed, 1770 of whom had available 3-12 months follow-up data. Of those, 75 cases (4.2%) were considered failed POEM in short term follow-up. Multivariate analysis revealed that younger age (odd ratio [OR] 0.98, 95% confidence interval [95% CI] 0.97-0.99, P=0.009) , prior Heller myotomy ([OR] 4.13, [95%CI] 1.88-9.09, P<0.001), prior endoscopic balloon dilatation ([OR] 1.90, [95%CI] 1.15-3.15, P=0.012) were independent factors associated with clinical failure of POEM. Younger age, prior Heller myotomy, and prior endoscopic balloon dilatation were identified as the independent predictors of clinical failure of POEM in this single center large cohort study.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Comparison of tandem ureteral stents, cryoplasty, and cutting balloon ureteroplasty in treatment of refractory transplant ureteral strictures.

The objective of study was to compare clinical outcome of cryoplasty, tandem stents, and cutting balloon ureteroplasty as "bailout procedures" to prevent surgical intervention or stent dependency in renal transplant patients with refractory ureteral stricture. All patients who underwent a bailout procedure from June 11, 2003, to August 8, 2015, at a single institution were reviewed retrospectively. Refractory ureteral stricture was defined as ureteral stenosis not responding to at least two prior percutaneous plain balloon ureteroplasties. Primary patency was defined as stable allograft function following the procedure with unobstructed urine outflow, not requiring indwelling ureteral stent, repeat ureteroplasty, or surgical revision. Sixty-one procedures were performed on 51 patients. Patients were followed up for a median of 286days. Overall primary patency rate was 26.1%. Primary patency rate by method was 38.1%, 23.1%, and 14.3% after cryoplasty, tandem stent placement, and cutting balloon dilatation, respectively (P=.260). Primary patency rate was higher in early (<3months post-transplant) ureteral strictures (35.7% vs 13.3%; P=.047). More complications identified in patients who had tandem ureteral stents (P=.00754). As some renal transplant patients may not be good operative candidates for ureteral revision, it would be reasonable to attempt one of these "bailout" interventions as long as the clinical team and patient are aware of overall low potential for achieving primary patency.

Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement: Results From the DIRECTAVI Trial

ObjectivesThe aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV). BackgroundRandomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV. MethodsDIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events. ResultsDevice success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: −4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation. ConclusionsDirect TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519)

3:54 PM Abstract No. 19 Comparing efficacy of pharmacologic and plain angioplasty interventions in restenotic hemodialysis accesses in patients with prior plain balloon angioplasty

3:54 PM Abstract No. 19 Comparing efficacy of pharmacologic and plain angioplasty interventions in restenotic hemodialysis accesses in patients with prior plain balloon angioplasty