Initial in-human experience with the conveyor cardiovascular system for the delivery of large profile transcatheter valve devices.

OBJECTIVES: To determine the safety and efficacy of the conveyor cardiovascular system (CCS) to facilitate the delivery of large profile transcatheter valve devices. BACKGROUND: Transcatheter valve devices rely on force provided by the operator to be delivered to their intended position. This delivery may be challenging in a variety of anatomic scenarios. The ability to provide steering from the tip of the device by forming an arterial venous loop may help overcome these challenges. METHODS: Between May, 2019 and October, 2020, five patients were recruited for delivery of transcatheter valve devices with the CCS. These patients were deemed by the operators to have challenging anatomy which could make conventional valve delivery difficult or impossible. These patients were recruited as part of an FDA approved early feasibility study or through an institutional review board approved compassionate use protocol. RESULTS: Three patients underwent transcatheter mitral valve replacement with a SAPIEN-3 valve. One patient each underwent transcatheter aortic valve (TAVR) implantation with a SAPIEN 3 and 1 patient underwent TAVR implantation with a Lotus valve. All patients underwent successful implantation of the valve and removal of the CCS and valve delivery systems. There was no more than trivial mitral regurgitation post procedure in any patient and there was no more than trivial paravavular leak. There were no major in-hospital complications. CONCLUSIONS: The CCS facilitates the delivery of large profile transcatheter valve devices in challenging anatomic scenarios. Further studies are needed with additional valve technologies.

Access options for transcatheter mitral valve implantation in patients with prior surgical bioprosthesis.

BACKGROUND: Transcatheter mitral valve-in-valve (TMVIV) procedure, either transapical (TA) or trans-septal (TS) has become a valuable alternative to conventional redo surgery in case of failing mitral bioprosthesis with good clinical outcomes. Here we present our fourteen-year institutional experience. METHODS: All consecutive patients treated with TMVIV with either TA or TS access at our centre between July 2007 and July 2020 were included. Periprocedural and 30-day follow-up (FU) results are reported and TA and TS data are compared. RESULTS: Eighty-two patients were included, of those 60 (73.2%) were TA while 22 (26.8%) were TS. Men represented 51.2% of the population with a mean age of 77.3±9.0 years. STS score and EuroSCORE II were 11.4%±6.2% and 11.5%±6.5% respectively. Baseline characteristics of TA and TS groups were comparable. TMVIV was performed at a median time of 9.3 years [interquartile range (IQR), 7.9-12.0 days] from the initial mitral valve surgery. Balloon expandable transcatheter heart valve (THV) prostheses (Edwards LifeSciences Corp., Irvine, CA, USA) were used exclusively. Technical success was 97.6% (96.7% and 100.0% for TA and TS respectively) with two (2.4%) periprocedural death, both in the TA group (P=0.533). We observed four (4.9%) left ventricular outflow tract (LVOT) obstructions with one being hemodynamically significant. Six (7.3%) major bleeding occurred in the TA group, not significantly different from TS group (P=0.279). The median length of stay was 6 days (IQR, 4-12 days, 1.5 vs. 7.0 days for TS and TA groups respectively, P=0.001). The overall 30-day mortality rate was 3.7%. We also observed three (3.7%) structural valve deteriorations and in one (1.2%) case the patient required redo mitral surgery at two months. Eighty-seven-point-eight percent of patients were I-II New York Heart Association (NYHA) class. At 30-day FU mean transmitral valve gradient was 7.3±2.7 mmHg and one patient (1.2%) had mitral regurgitation greater than mild. TA and TS groups were comparable. CONCLUSIONS: Our 14-year single-center experience with TMVIV confirms procedural safety and is an effective alternative to redo surgery with comparable results with both TA and TS. With device, technical improvements and increasing operators' experience, TS is the preferred option for TMVIV. However, in some highly selected patient, TA may still play an important role.

Quilting sutures compared with sponge packing in septolplasty and turbinoplasty.

INTRODUCTION: There is a lack of consensus regarding the need for nasal packing after a septoplasty. The use of nasal packing has been proposed to reduce bleeding, synechiae and haematomas. Despite these advantages evidence is scant to support postoperative packing. Furthermore, packing is not an innocuous procedure and can cause complications. OBJECTIVE: The purpose of this study was to investigate the efficacy of quilting sutures compared with sponge nasal packing on haemostasis, haematomas and wound healing following septoplasty. MATERIAL AND METHODS: Seventy-six patients with nasal septum deviation requiring septoplasty and turbinoplasy with radiofrequency were included. Following surgery, fifty patients were selected randomly for septoplasty with one quilting suture. And twenty-six patients had sponge nasal packing. Haemostatic properties, formation of haematomas, formation of synechiae, the patients' pain and bleeding on removal of the packing were evaluated. RESULTS: Both techniques were equally effective in the control of postoperative bleeding, haematoma and synechiae formation following septoplasty. Sponge packing was associated with significant pain and bleeding on removal. CONCLUSION: The use of quilting sutures like sponge packing is efficient in controlling bleeding, synechiae and haematomas after septoplasty and turbinoplasty.

Comparación entre una sutura transfixiante y el taponamiento nasal en la septoplastia y turbinoplastia / Quilting sutures compared with sponge packing in septolplasty and turbinoplasty

Introducción: No existe un consenso sobre la necesidad del taponamiento nasal después de una septoplastia. El uso de los taponamientos ha sido propuesto con el fin de reducir las hemorragias, sinequias o hematomas después de este procedimiento. A pesar de estas ventajas la evidencia del uso de un taponamiento nasal es baja. Adicionalmente este procedimiento no es agradable para el paciente y puede tener complicaciones.ObjetivoEl propósito de este estudio es investigar la eficacia de la sutura transfixiante o transeptal comparada con el taponamiento nasal. Analizar el control de la epistaxis, hematomas y sinequias después de una septoplastia.Material y métodosSetenta y seis pacientes con indicación de septoplastia y turbinoplastia con radiofrecuencia fueron incluidos en el estudio. Pseudoaleatoriamente se utilizó una sutura transfixiante en 50 pacientes y taponamiento nasal en 26 pacientes después de la cirugía. En los 2 grupos se comparó el porcentaje de epistaxis, hematomas y sinequias. Además, el dolor y la epistaxis de los pacientes al retirar el taponamiento nasal.ResultadosTanto la sutura transfixiante como el taponamiento nasal tienen resultados similares en cuanto al control de las epistaxis, sinequias y hematomas después de la septoplastia con radiofrecuencia de cornetes. Los pacientes con taponamiento nasal presentaron dolor y epistaxis autolimitada en el momento de retirar el taponamiento nasal.ConclusiónEl uso de la sutura transfixiante después de una septoplastia y turbinoplastia con radiofrecuencia es igual de eficaz que el taponamiento nasal para el control de epistaxis, sinequias y hematomas. (AU)

Introduction: There is a lack of consensus regarding the need for nasal packing after a septoplasty. The use of nasal packing has been proposed to reduce bleeding, synechiae and haematomas. Despite these advantages evidence is scant to support postoperative packing. Furthermore, packing is not an innocuous procedure and can cause complications.ObjectiveThe purpose of this study was to investigate the efficacy of quilting sutures compared with sponge nasal packing on haemostasis, haematomas and wound healing following septoplasty.Material and methodsSeventy-six patients with nasal septum deviation requiring septoplasty and turbinoplasy with radiofrequency were included. Following surgery, fifty patients were selected randomly for septoplasty with one quilting suture. And twenty-six patients had sponge nasal packing. Haemostatic properties, formation of haematomas, formation of synechiae, the patients’ pain and bleeding on removal of the packing were evaluated.ResultsBoth techniques were equally effective in the control of postoperative bleeding, haematoma and synechiae formation following septoplasty. Sponge packing was associated with significant pain and bleeding on removal.ConclusionThe use of quilting sutures like sponge packing is efficient in controlling bleeding, synechiae and haematomas after septoplasty and turbinoplasty. (AU)

Transcatheter Valve-in-Valve Procedures for Bioprosthetic Valve Dysfunction in Patients With Rheumatic vs. Non-Rheumatic Valvular Heart Disease.

Background: Bioprosthetic heart valve has limited durability and lower long-term performance especially in rheumatic heart disease (RHD) patients that are often subject to multiple redo operations. Minimally invasive procedures, such as transcatheter valve-in-valve (ViV) implantation, may offer an attractive alternative, although data is lacking. The aim of this study was to evaluate the baseline characteristics and clinical outcomes in rheumatic vs. non-rheumatic patients undergoing ViV procedures for severe bioprosthetic valve dysfunction. Methods: Single center, prospective study, including consecutive patients undergoing transcatheter ViV implantation in aortic, mitral and tricuspid position, from May 2015 to September 2020. RHD was defined according to clinical history, previous echocardiographic and surgical findings. Results: Among 106 patients included, 69 had rheumatic etiology and 37 were non-rheumatic. Rheumatic patients had higher incidence of female sex (73.9 vs. 43.2%, respectively; p = 0.004), atrial fibrillation (82.6 vs. 45.9%, respectively; p < 0.001), and 2 or more prior surgeries (68.1 vs. 32.4%, respectively; p = 0.001). Although, device success was similar between groups (75.4 vs. 89.2% in rheumatic vs. non-rheumatic, respectively; p = 0.148), there was a trend toward higher 30-day mortality rates in the rheumatic patients (21.7 vs. 5.4%, respectively; p = 0.057). Still, at median follow-up of 20.7 [5.1-30.4] months, cumulative mortality was similar between both groups (p = 0.779). Conclusion: Transcatheter ViV implantation is an acceptable alternative to redo operations in the treatment of patients with RHD and severe bioprosthetic valve dysfunction. Despite similar device success rates, rheumatic patients present higher 30-day mortality rates with good mid-term clinical outcomes. Future studies with a larger number of patients and follow-up are still warranted, to firmly conclude on the role transcatheter ViV procedures in the RHD population.

Quilting sutures compared with sponge packing in septolplasty and turbinoplasty. / Comparación entre una sutura transfixiante y el taponamiento nasal en la septoplastia y turbinoplastia.

INTRODUCTION: There is a lack of consensus regarding the need for nasal packing after a septoplasty. The use of nasal packing has been proposed to reduce bleeding, synechiae and haematomas. Despite these advantages evidence is scant to support postoperative packing. Furthermore, packing is not an innocuous procedure and can cause complications. OBJECTIVE: The purpose of this study was to investigate the efficacy of quilting sutures compared with sponge nasal packing on haemostasis, haematomas and wound healing following septoplasty. MATERIAL AND METHODS: Seventy-six patients with nasal septum deviation requiring septoplasty and turbinoplasy with radiofrequency were included. Following surgery, fifty patients were selected randomly for septoplasty with one quilting suture. And twenty-six patients had sponge nasal packing. Haemostatic properties, formation of haematomas, formation of synechiae, the patients' pain and bleeding on removal of the packing were evaluated. RESULTS: Both techniques were equally effective in the control of postoperative bleeding, haematoma and synechiae formation following septoplasty. Sponge packing was associated with significant pain and bleeding on removal. CONCLUSION: The use of quilting sutures like sponge packing is efficient in controlling bleeding, synechiae and haematomas after septoplasty and turbinoplasty.

Incomplete Left Atrial Appendage Closure Successfully Treated With a Redo Procedure.

A 68 year's old man with permanent atrial fibrillation, underwent a left atrial appendage closure because of high bleeding risk. However, after one month, an incomplete occlusion of the left atrial appendage due to a too deep position of the device, was detected by a transesophageal echocardiogram. Considering the residual high risk of thrombi formation, a new different device was successfully implanted with a correct closure of the appendage.

Haptics and the heart: Force and tactile feedback system for cardiovascular interventions.

BACKGROUND/PURPOSE: Interventional cardiovascular procedures are performed while operators view multiple visual displays including fluoroscopic and ultrasonic images, intracardiac electrical signals, electroanatomic mapping data, and hemodynamic indices. Operators are unable to palpate physiologic and biophysical signals or feel intracardiac anatomy due to the attenuation and dampening properties of cardiac catheters. This poses a significant limitation when performing higher risk procedures such as complex coronary interventions, transeptal or epicardial puncture to gain access to the left atrium or pericardium for ablation of heart rhythm disorders, cardiac device delivery, and when attempting to maintain stable tissue contact force ("CF") during ablation of cardiac arrhythmia. METHODS/MATERIALS: We utilized signals acquired from a prototype sensorized cardiac guiding catheter, conventional transeptal puncture kit with end hole manometry, commercially available contact force sensing ablation catheter, and epicardial puncture needle, input these signals into a novel signal processing system and generated palpable sensations to blinded subjects using a proprietary tactile/force (haptic) feedback system. Qualitative and quantitative analysis of the system was performed. RESULTS/CONCLUSION: The proprietary haptic (tactile and force) feedback system provides sense of touch during cardiovascular interventions recreating palpable, real-time biophysical events and physiologic information and enables operators to react to critical cardiovascular signals with minimal delay relative to visual motor reaction time to simple display data. SUMMARY: We describe a proprietary haptic (tactile and force) feedback system that provides sense of touch during cardiovascular interventions recreating palpable, real-time biophysical events and physiologic information.

Valve in Valve mitral por vía transapical en el Hospital México, reporte de dos casos y revisión de la literatura / Transapical mitral Valve in Valve in Hospital México, report of two cases and literatura review

Resumen La reoperación en pacientes con cirugía cardiaca previa en bioprótesis disfuncionantes representa una situación de alto riesgo quirúrgico, con elevada morbi-mortalidad perioperatoria. En la actualidad en casos seleccionados, el tratamiento percutáneo transcateter permite reemplazar la válvula mitral con acceso transapical o transeptal. El reemplazo percutáneo de la válvula mitral, tiene menor morbilidad y mortalidad comparado con la cirugía convencio nal, representando una alternativa terapéutica, la cual representa la única opción en pacientes de alto riesgo quirúrgico. Se presentan dos casos tratados de forma exitosa en nuestro centro con acceso transapical y válvula percutánea balón expandible Sapien XT.

Abstract Transapical mitral Valve in Valve in Hospital México, report of two cases and literatura review Surgical reintervention in patients with previous open heart surgery represents a high risk condition, with high morbidity and mortality in the perioperative period. Nowdays in selected clinical situations of patiens with failing bioprosthesis in mitral position, transcatheter percutaneous treatment allows the replacement of the mitral valve with transapical or transseptal access. The transcatheter percutaneous mitral valve replacement has lower morbidity and mortality in comparison with conventional surgery, representing a therapeutic alternative, wich migth be the only option in high risk patients. We present two cases done at our center with success using apical access and the ballon expandable device Sapien XT.

Abordaje endoscópico transeptal de tumores benignos de cavidades paranasales / Transseptal endoscopic approach of benign tumors of paranasal sinuses

RESUMEN La cirugía endoscópica nasosinusal es un procedimiento frecuente en la práctica otorrinolaringológica, y en la última década se han introducido nuevas técnicas para ayudar a la resección de tumores en regiones tradicionalmente consideradas de difícil acceso. Una de estas técnicas es el abordaje transeptal, que permite el abordaje de la pared anterior y lateral del seno maxilar, así como el trabajo a cuatro manos para el abordaje de estos tumores. El objetivo de esta revisión es describir el abordaje endoscópico transeptal, como técnica complementaria en la cirugía endoscópica de tumores nasales benignos, específicamente de papiloma invertido y angiofibroma nasofaríngeo juvenil.

ABSTRACT Endoscopic sinus surgery is a frequent procedure in Otorhinolaryngology practice, in the last decade new techniques have been introduced to help the resection of tumors in regions traditionally considered of difficult access. One of these techniques is the trans-septal approach, which allows the approach of the anterior and lateral wall of the maxillary sinus, as well as four-handed work for approach of these tumors. The aim of this review is to describe the transeptal endoscopic approach as a complementary technique in the endoscopic surgery of benign nasal tumors, specifically inverted papilloma and juvenile nasopharyngeal angiofibroma.

Simultaneous transcatheter transfemoral aortic and transeptal mitral valve replacement using Edward SAPIEN S3.

Patients with concomitant severe aortic stenosis (AS) and severe mitral stenosis (MS) with mitral annular calcification (MAC) constitute an elderly high-risk population with multiple baseline comorbidities that coexist even before they develop severe valvular dysfunction. Transcatheter mitral valve replacements (TMVR) offer an alternative option for high-risk patient with severe MS with MAC. A simultaneous transfemoral Transcatheter aortic valve replacement (TAVR) and transseptal TMVR is feasible and offers the least invasive approach of management. We are reporting a case of an 83-year-old man with very symptomatic severe AS and severe native MS with associated severe MAC and moderate mitral regurgitation with high STS score who underwent a simultaneous transfemoral TAVR and transseptal TMVR with good results and great improvement in symptoms that was maintained on 10 months follow-up.

Transeptal suturing - a cost-efficient alternative for nasal packing in septal surgery / Sutura transeptal - uma alternativa custo-benefício para tamponamento nasal em cirurgia do septo

ABSTRACT INTRODUCTION: Nasal packing is routinely used in septal surgery to prevent postoperative bleeding. OBJECTIVE: To demonstrate the possibility of transeptal suture as a safe and effective way to avoid nasal packing and to improve efficiency. METHODS: This is a prospective, descriptive, inferential cost study comprising 92 patients. Two randomized groups of patients were analyzed, one with nasal packing and the other with transeptal suture. RESULTS: In the group of transeptal suture no patient experienced postoperative bleeding, and a statistically significant reduction of pain and headache was demonstrated. At the same time, we improved efficiency by saving on material costs. CONCLUSIONS: Transeptal suture is an effective and safe alternative to classic nasal packing in septal surgery. Moreover, it improves the efficiency of the intervention by saving costs.

Resumo Introdução: O tamponamento nasal é usado rotineiramente na cirurgia septal para evitar sangramentos no pós-operatório. Objetivo: Demonstrar a possibilidade de se realizar uma sutura transeptal como alternativa eficaz e segura ao tamponamento nasal, com melhora na eficiência da intervenção. Método: Este é um estudo prospectivo, descritivo e de custo inferencial, compreendendo 92 pacientes. Dois grupos aleatórios foram estudados: um com tamponamento nasal e o outro com sutura transeptal. Resultado: No grupo de sutura transeptal, nenhum paciente experimentou sangramento no pós-operatório, tendo sido estatisticamente demonstrada uma significante redução de cefaléia e dor. Ao mesmo tempo, houve melhora na eficiência da intervenção, com economia no custo de material. Conclusões: A sutura transeptal é uma alternativa eficaz e segura ao tamponamento nasal clássico. Além do mais, melhora a eficiência da intervenção, economizando no custo de material.

The endoscopic transseptal approach for choanal atresia repair.

BACKGROUND: There are many standard repair options for choanal atresia including puncture, dilatation and drilling of the atretic plate. Most of these techniques involve postoperative stenting, which may promote granulation and scarring, with possible progression to restenosis. This article describes a novel approach for choanal atresia repair without postoperative stenting. METHODS: This article describes our experience with this choanal atresia repair technique utilized in 16 pediatric patients and 1 adult patient across multiple tertiary pediatric and rhinology centers during 2008 through 2015. Seven cases were bilateral and 10 were unilateral. Surgery was performed using an endoscopic transseptal approach with preservation of the mucosa and creation of flaps. No stents or packing was used. The main outcome measures were: response to treatment based on endoscopic examination, need for further revision and incidence of complications. RESULTS: All patients underwent routine postoperative endoscopic inspection of their nasal cavity, postnasal space, and assessment of neochoanal patency. The neochoanae of all patients remained patent to a minimum follow-up duration of 9 months with most patients follow up for 2 years or more. Two neonatal patients required transfusion postoperation from intraoperative bleeding. Two pediatric patients developed postoperative respiratory complications. One patient required revision surgery for nasal vestibule scarring from incision made on the nasal alar to facilitate the initial endoscopic approach. CONCLUSION: This novel endoscopic transseptal repair technique is effective in the management of choanal atresia. Careful fashioning of mucosal flaps and the omission of stenting has resulted in lasting patency of the neochoanae.

Transeptal suturing - a cost-efficient alternative for nasal packing in septal surgery.

INTRODUCTION: Nasal packing is routinely used in septal surgery to prevent postoperative bleeding. OBJECTIVE: To demonstrate the possibility of transeptal suture as a safe and effective way to avoid nasal packing and to improve efficiency. METHODS: This is a prospective, descriptive, inferential cost study comprising 92 patients. Two randomized groups of patients were analyzed, one with nasal packing and the other with transeptal suture. RESULTS: In the group of transeptal suture no patient experienced postoperative bleeding, and a statistically significant reduction of pain and headache was demonstrated. At the same time, we improved efficiency by saving on material costs. CONCLUSIONS: Transeptal suture is an effective and safe alternative to classic nasal packing in septal surgery. Moreover, it improves the efficiency of the intervention by saving costs.

The role of hemodynamic catheterization in the evaluation of hypertrophic obstructive cardiomyopathy: A case series.

Confirmation of the presence and magnitude of left ventricular outflow tract (LVOT) obstruction is a critical component of the evaluation of symptoms in patients with hypertrophic cardiomyopathy (HCM). The presence of LVOT obstruction in patients with severe symptoms refractory to pharmacologic therapy identifies a subgroup of HCM patients who may benefit from septal reduction therapy. Two-dimensional echocardiography with continuous wave Doppler is the main tool for confirming the presence and severity of LVOT obstruction in HCM. However, when uncertainty remains following non-invasive evaluation, invasive hemodynamics studies are required to confirm and quantify LVOT obstruction. In this manuscript we describe a series of 6 cases in which hemodynamic catheterization is instrumental in supplementing non-invasive imaging in the assessment of LVOT obstruction in HCM.