Inoue Balloon Catheter Research Articles

Combination Use of Inoue-Balloon and Self-Expandable Transcatheter Valves in Managing Aortic Stenosis Not Amenable to Balloon-Expandable Valves.

Data on the combined use of aortic Inoue-Balloon catheter and self-expandable transcatheter valve for patients undergoing transcatheter aortic valve replacement (TAVR) are lacking. This study aimed to assess the feasibility and safety of this combination, particularly in patients who cannot be safely managed with balloon-expandable valves.Between 2018 and 2021, 140 consecutive patients who had Inoue-Balloon catheters with self-expandable valves were retrospectively examined. Self-expandable transcatheter valves were deployed using the heart team approach in patients with calcification on the left ventricular outflow tract, which could not be safely addressed with the current-generation balloon-expandable valves.The 20- and 22 mm Inoue-Balloon catheters were used with the 26- and 29 mm Evolut valves, respectively. According to the Valve Academic Research Consortium-2 criteria, the procedural success rate was 95.0%, with an early safety at 30 days rate of 6.5%. A total of 27 patients required post-dilation with the same Inoue-Balloon catheter used for pre-dilation after adjustment to appropriate sizes. Post-dilation, with balloon size adjusted to be 1.4 ± 0.9 mm larger than that in pre-dilation, was effective in 19 out of 27 patients (70.3%) for decreasing paravalvular leak after transcatheter valve deployment. The procedural complication rates between patients with and without post-dilation were not different.The combined use of the size-adjustable Inoue-Balloon catheter and self-expandable valve is safe, particularly in patients who cannot be safely managed with balloon-expandable valves. However, further studies are warranted to elucidate concerns regarding the durability of self-expandable transcatheter valves after post-dilation using the Inoue-Balloon catheter.

A novel “proximal first” Inoue balloon catheter for retrograde aortic valvuloplasty: Initial case report

The Inoue balloon, invented for percutaneous transseptal mitral commissurotomy for mitral stenosis, is initially dilated in the distal portion and then the proximal portion, forming an hourglass shape that stabilizes the balloon at the mitral valve orifice with a pulling action. The device has been successfully applied to antegrade aortic valvuloplasty; the hourglass shape stabilizes the balloon across the aortic valve without rapid ventricular pacing. Subsequently, an Inoue balloon was developed for retrograde aortic valvuloplasty using the same design as the antegrade balloon. The hourglass-shaped balloon, however, has difficulty maintaining stability across the aortic valve because the distal portion of the balloon, which inflates first, directly receives systolic pressure from the left ventricle. A novel Inoue balloon was invented to overcome this issue by altering the manner of inflation: the proximal portion inflates first, followed by the distal portion. Theoretically, the proximal portion, which initially inflates just above the aortic valve, remains secure across the valve by applying a pressing force that counteracts the systolic forward pressure. Furthermore, a radiopaque marker is placed at the center of the balloon to enable rapid and precise balloon adjustment. We present a case involving a 65-year-old female hemodialysis patient with severe symptomatic aortic stenosis who we successfully treated with balloon aortic valvuloplasty using the novel Inoue balloon followed by transcatheter aortic valve implantation. The present case demonstrates the feasibility and effectiveness of the novel "proximal first" Inoue balloon for retrograde balloon aortic valvuloplasty for severe aortic stenosis.

C96. The First Percutaneous Transvenous Mitral Commissurotomy guided by Three Dimensional Transesophageal Echocardiography in Haji Adam Malik General Hospital Medan

Abstract Background Percutaneous Transvenous Mitral Commissurotomy (PTMC) has become the treatment of choice for patients with mitral stenosis. PTMC guided by three-dimensional Transesophageal Echocardiography (3D-TEE) promise of greater safety and efficacy. Case Summary We report a 29-year-old woman who came to our outpatient clinic with shortness of breath as a chief complaint for the past three months. ECG depicted sinus rhythm. Transthoracic Echocardiography (TTE) and 3D-TEE showed severe mitral stenosis with MVA planimetry: 0.8 cm2, MV mean PG 12 mmHg, MV PHT 403 ms, Wilkins score was 4 and no thrombus was found. Therefore, we decided to do PTMC. We successfully done the antegrade transseptal puncture by fluoroscopy guided by two-dimensional (2D) TEE . Then, we used Inoue-balloon catheter No. 24 to dilate the mitral valve. Afterthat, we did 3D-TEE evaluation of the mitral valve area and it showed a significant improvement, with MVA 3D planimetry: 2.0 cm2 and MV mean PG: 4 mmHg and we found moderate mitral regurgitation (MR VC 0.4 cm, MR PISA: 0.3 cm), so we decided to end the procedure. Discussion In this case, the PTMC procedure was carried with 2D and 3D-TEE guiding, where process run more easily because interventionist can ensure the targeted site during transeptal puncture, navigation to the mitral valve and post inflation inspection. 3D-TEE guiding can also directly ensure the success of PTMC in real time by evaluating the MVA planimetry (pre and post PTMC) and the mitral regurgitation.

C96. The First Percutaneous Transvenous Mitral Commissurotomy guided by Three Dimensional Transesophageal Echocardiography in Haji Adam Malik General Hospital Medan

Abstract Background Percutaneous Transvenous Mitral Commissurotomy (PTMC) has become the treatment of choice for patients with mitral stenosis. PTMC guided by three-dimensional Transesophageal Echocardiography (3D-TEE) promise of greater safety and efficacy. Case Summary We report a 29-year-old woman who came to our outpatient clinic with shortness of breath as a chief complaint for the past three months. ECG depicted sinus rhythm. Transthoracic Echocardiography (TTE) and 3D-TEE showed severe mitral stenosis with MVA planimetry: 0.8 cm2, MV mean PG 12 mmHg, MV PHT 403 ms, Wilkins score was 4 and no thrombus was found. Therefore, we decided to do PTMC. We successfully done the antegrade transseptal puncture by fluoroscopy guided by two-dimensional (2D) TEE . Then, we used Inoue-balloon catheter No. 24 to dilate the mitral valve. Afterthat, we did 3D-TEE evaluation of the mitral valve area and it showed a significant improvement, with MVA 3D planimetry: 2.0 cm2 and MV mean PG: 4 mmHg and we found moderate mitral regurgitation (MR VC 0.4 cm, MR PISA: 0.3 cm), so we decided to end the procedure. Discussion In this case, the PTMC procedure was carried with 2D and 3D-TEE guiding, where process run more easily because interventionist can ensure the targeted site during transeptal puncture, navigation to the mitral valve and post inflation inspection. 3D-TEE guiding can also directly ensure the success of PTMC in real time by evaluating the MVA planimetry (pre and post PTMC) and the mitral regurgitation.

The effect of multiple-inflation balloon aortic valvuloplasty.

Recent improvements of balloon aortic valvuloplasty (BAV) devices and procedures have provided improved outcomes, but it is not clear whether the multiple-inflation BAV technique is effective in patients with symptomatic severe aortic valve stenosis (AS). We conducted an analysis of the impact of multiple-inflation BAV (at least 6 times inflation) on the mean aortic valve area (AVA) and mean aortic valve pressure gradient (AV-PG) in patients with symptomatic severe aortic stenosis as compared with conventional BAV (from single to three times inflation). We identified two studies of multiple-inflation BAV with antegrade approach using Inoue-balloon catheter (425 patients) and four studies of conventional BAV (170 patients) with retrograde approach. Using a random intercept model, we found that multiple-inflation BAV significantly increased mean AVA (mean difference (MD) [95% indicates confidence interval (CI)] = 0.25 [0.16-0.34], P < 0.001) and significantly decreased mean AV-PG (MD [95% CI] = - 20.2 [- 27.8, - 12.70], P < 0.001) as compared with the conventional BAV. Furthermore, despite an extremely high Society of Thoracic Surgeons (STS) score (9.2-14.5), the all-cause mortality rate at one year of multiple-inflation BAV was 16-17%. The results of our analyses indicate that the multiple-inflation BAV technique seem to be effective for patients with symptomatic severe AS as compared with conventional BAV.

Long-Term Follow-Up of Atrial Septal Defect Closure after Percutaneous Balloon Mitral Valvuloplasty by Transesphageal Echocardiography?

Percutaneous Balloon Mitral Valvuloplasty (PBMV) involves atrial septostomy during the procedure. One of the consequences of transseptal puncture is the creation of an Atrial Septal Defect (ASD). Transesophageal Echocardiography (TEE) can detect Left to Right (L-R) shunts too small to be detected by other methods. The aim of this study was to evaluate the 3 years follow-up of ASD closure after PBMV by TEE. 200 consecutive patients with rheumatic Mitral Stenosis (MS) who underwent successful PBMV by using the Inoue balloon catheter were studied prospectively. ASD with small L-R atrial shunting occurred in all the patients (100%) immediately after PBMV. Total study 200 patients. All the ASDs were small in size (≤ 5 mm). The puncture site (ASD site) occurred in the fossa ovalis (Fo.Ov) in 120 patients (60%), while it occurred outside the Fo.Ov (either in the superior limbus or in the inferior limbus of the Interatrial Septum (IAS)) in the other 80 patients (40%). 180 patients presented at 6 month follow-up. ASD was closed in 117 patients (65%), while it was persisted in 63 patients (35%). 95 patients presented at 3 years follow-up. ASD was closed in 76 patients (80%) (Group I), while it was persisted in 19 patients (20%) (Group II). All the 74 patients who had ASD immediately after PBMV in the Fo.Ov, presented with ASD closure at 3 years follow-up. Only 2 patients who had ASD immediately after PBMV outside the Fo.Ov, presented with ASD closure at 3 years follow-up. All the 19 patients who presented at 3 years follow-up with ASD persistence had ASD immediately after PBMV outside the Fo.Ov (14 in the superior limbus and 5 in the inferior limbus). No patient presented at 3 years follow-up with ASD persistence, had ASD immediately after PBMV in the Fo.Ov Large LAD, high total Echocardiographic (echo) score of the Mitral Valve (MV), thick Fo.Ov, thick superior limbus, thick inferior limbus and ASD site immediately after PBMV outside the Fo.Ov were significant predictors of ASD persistence at 3 years follow-up. In conclusion, ASD with L-R atrial shunting occurs in all the patients after PBMV by using the Inoue balloon catheter. ASD after PBMV persists in 20% of the patients at 3 years follow-up. Predictors of ASD persistence at 3 years follow-up are: large LAD, high total echo score of the MV, thick Fo.Ov, thick superior limbus, thick inferior limbus and ASD site immediately after PBMV outside the Fo.Ov. ASD closes at 3 years follow-up in all the patients who had ASD in the Fo.Ov immediately after PBMV. All the patients with ASD persistence at 3 years follow-up had ASD outside the Fo.Ov after PBMV. It is recommended that operators doing transseptal puncture during PBMV by using the Inoue balloon catheter should aim to do it in the Fo.Ov.

Percutaneous balloon valvuloplasty with Inoue balloon catheter technique for pulmonary valve stenosis in adolescents and adults

BackgroundPercutaneous balloon pulmonary valvuloplasty is the procedure of choice for uncomplicated severe or symptomatic pulmonary stenosis. The present study describes our experience in balloon pulmonary valvuloplasty using the Inoue balloon catheter in adolescent and adult patients. AimsTo assess the immediate and mid-term outcomes of percutaneous balloon valvuloplasty with Inoue balloon catheter in adolescent and adult patients. Methods and resultsBetween June 2010 and July 2015, we performed percutaneous balloon pulmonary valvuloplasty with Inoue balloon catheter in 32 patients (59.37% females) aged 8 to 54 years (mean 23.6±11.5). Following the procedure, the mean right ventricular systolic pressure and the pulmonary valvular peak-to-peak systolic gradient decreased from (121.6±42.4 to 61.19±24.5mmHg, p=0.001) and (100.9±43.3 to 36.4±22.5mmHg, p=0.001), respectively. Twenty patients (Group A) showed immediate optimal results with post-procedure peak systolic gradient <36mmHg while 12 patients (Group B) had suboptimal results. An increase in pulmonary regurgitation by one grade was detected in 17 patients (53.2%). Twenty-three patients available for follow-up (mean duration, 2.75 years [range 0.25–5 years]) had a mean residual peak gradient of 23.6±2.51mmHg on Doppler echocardiography with attenuation of reactive RVOT stenosis in all Group B patients. There was no further increase in grade of pulmonary regurgitation or restenosis on mid-term follow-up. ConclusionPercutaneous Inoue balloon technique is an attractive alternative with excellent mid-term results for adolescents and adults with isolated pulmonary stenosis.

Atrial Septostomy for Left Atrial Decompression During Extracorporeal Membrane Oxygenation by Inoue Balloon Catheter.

Refractory pulmonary edema is an infrequent but serious complication in patients receiving venoarterial extracorporeal membrane oxygenation (VA-ECMO) for myocardial failure. Left atrial (LA) decompression in this setting is important. Although a few methods have been reported, the experience is mostly limited to children. We aimed to evaluate the feasibility of Inoue balloon catheter in percutaneous trans-septal LA decompression in adult cardiogenic patients.Methods and Results:We retrospectively analyzed 16 procedures of trans-septal LA decompression by Inoue balloon catheter in 15 VA-ECMO patients (aged 22-65 years, 6 men) with refractory pulmonary edema from May 2012 to December 2014. Mean left ventricular ejection fraction was 15%. The cause of cardiogenic shock included 7 cases of ischemic heart disease, 1 of dilated cardiomyopathy, 5 of myocarditis, and 2 of fatal ventricular arrhythmia.The procedures were performed 4.3 days after ECMO. Inoue balloon size was 24-27 mm. LA septostomy were successfully created in 14 patients. Procedure time on average was 36.8 min (range, 15-85 min). There were no procedure-related complications.Radiography on the next day showed rapid resolution of pulmonary edema. Trans-septal LA decompression by Inoue balloon catheter is a feasible alternative method for adult patients with refractory pulmonary edema under ECMO.

20. Immediate EIN-hospital results of percutaneous transvenous mitral commissurotomy in patients with mitral restenosis after closed mitral commissurotomy

Rheumatic mitral stenosis is a very common problem in our population having an incidence of 54 percent among rheumatic heart disease with a female preponderance of 2:1. Percutaneous transvenous initral conimissurotomy (PTMC) using an Inoue balloon catheter is of established efficacy and safety and is an alternative to surgical valvotomy in selected patients with rheumatic mitral stenosis. Nine hundred and ninety (990) patients with rheumatic mitral stenosis who underwent PTMC were evaluated clinically, by echocardiography and by catheter during and after procedure. Out of 990 patients 90 patients had history of previous surgical commissurotomy (Group-1) and rest 900 patients had no history of previous surgical commissurotomy (Group-2) PTMC is an effective procedure for patients with mitral restenosis following surgical commissurotomy.

Antegrade transcatheter aortic valve implantation using the looped Inoue balloon technique: A pilot study in a swine model

BackgroundTranscatheter aortic valve implantation (TAVI) is an established therapy for patients who are inoperable or at high risk for open heart surgery. The retrograde transfemoral approach is the most widely used and is the first choice in TAVI. However, existence of peripheral vascular disease or a small iliofemoral artery often limits the application of the transfemoral approach. Transvenous antegrade transseptal TAVI is an attractive option, but has already been abandoned due to its technical complexities. Methods and resultsWe have previously described a novel technique to simplify antegrade transseptal balloon aortic valvuloplasty, which utilizes a custom-made Inoue balloon catheter with two stylets. The technique is named as the looped Inoue balloon technique, and its feasibility and efficacy were proven in an animal model and a clinical case. We applied this technique to TAVI. The present study aimed to assess the feasibility of the looped Inoue balloon technique for TAVI in two healthy pigs. The valve implantation was successful in both pigs, although the pigs died soon after the implantation (2 and 24h). The causes of death were access site bleeding (Case 1) and migration of the prosthetic valve (Case 2). ConclusionsAlthough several improvements and further studies are required, the study results indicate that antegrade TAVI using the looped Inoue balloon technique is feasible.

IMMEDIATE OUTCOME OF PERCUTANEOUS TRANSVENOUS MITRAL COMMISSUROTOMY IN ELDERLY SEVERE MITRAL STENOSIS PATIENTS

Rheumatic mitral stenosis is a very common problem in our population having an incidence of 54 percent among rheumatic heart disease with a female preponderance of 2:1. Percutaneous transvenous mitral commissurotomy (PTMC) using an Inoue balloon catheter is of established efficacy and safety and is

Percutaneous balloon valvuloplasty with inoue balloon catheter technique for pulmonary valve stenosis in adolescents and adults

Percutaneous balloon valvuloplasty with inoue balloon catheter technique for pulmonary valve stenosis in adolescents and adults

TCTAP A-088 Trans-Septal Decompression of the Left Atrium During Extracorporeal Membrane Oxygenation by Inoue Balloon Catheter

TCTAP A-088 Trans-Septal Decompression of the Left Atrium During Extracorporeal Membrane Oxygenation by Inoue Balloon Catheter

Percutaneous balloon valvuloplasty for bioprosthetic mitral valve stenosis

Percutaneous transcatheter mitral valvuloplasty is the indicated treatment of choice for symptomatic native mitral valve stenosis, but there have been limited reports of successful procedures of balloon valvuloplasty for bioprosthetic mitral valve stenosis. We present the case of a 62-year-old woman suffering from progressive dyspnea due to bioprosthetic mitral valve stenosis. The measured mean pressure gradient across the mitral valve was 30 mmHg and the mitral valve area was 0.73 cm(2). Redoing mitral replacement was considered high risk and was refused by the patient. Percutaneous balloon valvuloplasty was performed with an Inoue balloon catheter inflated to 20 mm. The patient's symptoms immediately improved after the procedure, with no procedure-related complications. The mean pressure gradient across the valve decreased to 19 mmHg, and the mitral valve area increased to 1.21 cm(2) in postprocedural echocardiography. We conducted a literature search and identified 26 cases of balloon valvuloplasty for degenerated bioprosthetic valves. Of these, 14 cases were bioprosthetic mitral valves, and the results were favorable. However, more case reports are required to establish an evidence base for future expert recommendation of balloon valvuloplasty of prosthetic mitral valve. Meanwhile, balloon valvuloplasty will serve a niche role in highly selected patients with prosthetic mitral valve stenosis.

ANALYSIS OF 293 CASES AFTER PERCUTANEOUS BALLOON MITRAL VALVULOPLASTY

ObjectivesTo observe the short-term results and appropriateness of the use of percutaneous balloon mitral valvuloplasty (PBMV) on the patients with rheumatic mitral stenosis.Methods293 patients with rheumatic mitral stenosis underwent percutaneous...

Deflation failure of Accura Balloon In Left Atrium During Balloon Mitral Valvuloplasty

Currently Percutaneous Balloon Mitral Valvuloplasty has established itself as a standard treatment for patients with severe mitral stenosis. A patient with severe mitral stenosis was posted for the above procedure. After dilatation of mitral valvular apparatus the Accura balloon failed to deflate on repeated aspirations, probably due to rupture of internal lumen. Finally, a guide wire was passed through the injection port which recanalized the lumen and dye was slowly aspirated after diluting with saline. INTRODUCTION Almost all mitral stenosis (MS) is rheumatic in etiology. 1 PBMV using the Accura or Inoue balloon catheter is now an established mode of therapy for suitable cases of mitral stenosis with a success rate of more than 90% in various studies. Balloon valvuloplasty occasionally is associated with complications, including death in 0 to 1%, moderate or severe valvular regurgitation in 2 to 3%, and systemic embolization in 1 to 3%. We hereby report an unusual complication of deflation failure of Accura balloon (Vascular Concepts Limited, China) after dilatation of the mitral valve inside the left atrium.

Prosthetic mitral valvuloplasty

A 78-year-old man underwent mitral valve replacement with a no. 33 Hancock porcine bioprosthesis for severe mitral regurgitation. Postoperatively, a transthoracic echocardiogram (TTE) revealed a mean mitral valve gradient (MVG) of 4 mm Hg, a calculated mitral valve area (MVA) of 2.8 cm(2), and no mitral regurgitation. Eighteen months later, he presented to the emergency room with progressive dyspnea. Repeat TTE demonstrated severe mitral stenosis (MVG, 16 mm Hg; MVA, 0.9 cm(2)). The patient was deemed high risk for a repeat valve replacement, and percutaneous valvuloplasty was performed with an Inoue balloon catheter inflated to 26 mm. The patient's symptoms dramatically improved, as did his hemodynamics (MVG, 5 mm Hg; MVA, 1.6 cm(2)). There was no evidence of mitral regurgitation and the successful results were maintained after 10 months of follow-up. Since its introduction in 1987, there have been only nine cases reporting successful balloon valvulotomy in prosthetic mitral valves. While percutaneous valvulotomy is the intervention of choice for native mitral stenosis, it is rarely performed in prosthetic valves, with surgical valve replacement being the treatment of choice. Our case was successful and may suggest a niche to reconsider using the procedure in certain clinical circumstances.

Clinical and echocardlographic spectrum of mitral valve and papillary muscle injury as a complication related to percutaneous transvenous mitral commissurotomy with inoue balloon catheter: experience from 6,800 patients

Clinical and echocardlographic spectrum of mitral valve and papillary muscle injury as a complication related to percutaneous transvenous mitral commissurotomy with inoue balloon catheter: experience from 6,800 patients

A Case Report on the Inflation Failure of Distal Portion of Inoue Balloon during Percutaneous Mitral Valvuloplasty in a Patient with Rheumatic Mitral Stenosis

Since Inoue et al introduced a specially designed balloon catheter for percutaneous mitral valvuloplasty (PMV) in 1984, the Inoue balloon catheter has been a popular device for the management of mitral stenosis. During the procedure several fatal complications, such as cardiac tamponade, perforation of a cardiac chamber, atrial septal defect, thromboembolism, mitral regurgitation and death have all been reported in the literature. There have also been several international reports regarding deformities of the Inoue balloon, but few reports in Korea. We recently experienced a case of an inflation failure of the distal portion of the Inoue balloon during a percutaneous mitral valvuloplasty in a 34 year old female patient with a tight mitral stenosis. To the best of our knowledge, a similar deformity of an Inoue balloon has never been reported in Korea. (Korean Circulation J 2002;32(10):906-910)

Successful Inoue balloon mitral commissurotomy in double-orifice mitral stenosis

We report a rare case of stenotic double-orifice mitral valve of incomplete bridge type in a 40-year-old male. The fibrous bridge tissue between the leaflets was successfully split with a 24-mm Inoue balloon catheter using the stepwise dilation technique. Cathet. Cardiovasc. Intervent. 49:200-203, 2000.