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We demonstrated a first-in-human case of successful antegrade dissection and re-entry using an image-guided re-entry catheter that enables real-time high-resolution visualization with graphical augmentation, and precision steering and advancement of a guidewire. The total time from over-the-wire deployment in the proximity of the distal cap to successful re-entry was <20 minutes. (Level of Difficulty: Advanced.).
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BACKGROUND: This study assessed safety and feasibility of a novel extravascular implantable cardioverter defibrillator (ICD) lead when inserted anteriorly through a rib space and connected to various commercially available ICD pulse generators (PGs) placed in either a left mid-axillary or left pectoral pocket. Currently available or investigational, extravascular-ICDs include a subcutaneous or subxiphoid lead connected to customized extravascular-ICD PGs. METHODS: This novel extravascular-ICD (AtaCor Medical Inc, San Clemente, CA) employs a unique intercostal implant technique and is designed to function with commercial DF-4 ICD PGs. In this nonrandomized, single-center, acute study, 36 de novo or replacement ICD (transvenous ICD) patients enrolled to receive a concomitant extravascular-ICD lead inserted through an intercostal space along the left parasternal margin. extravascular-ICD leads were connected to DF-4 compatible ICD PGs positioned in either a left mid-axillary or pectoral pocket for acute sensing and defibrillation testing. Defibrillation testing started at 30 Joules (J) and stepped up or down in 5 to 10 joule increments depending on the success and limitations of the generator used. RESULTS: Successful acute defibrillation using ≤35 J was noted in 100% of left mid-axillary PG subjects (n=27, mean 16.3±8.6 J) and 83% of left pectoral PG subjects (n=6, mean 21.0±8.4 J). Furthermore, 24 of 27 (89%) of patients tested with a left, mid-axillary intermuscular PG had successful VF conversion with defibrillation energies at least 10 J below the maximum delivered output of the device. All evaluable episodes (n=93) were automatically sensed, detected, and shocked. No serious device-related intraoperative adverse events were observed. CONCLUSIONS: This first-in-human study documented the safe and reliable placement of a novel extravascular ICD lead with effective sensing and defibrillation of induced ventricular fibrillation using commercial DF-4 ICD PGs.
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Desfibriladores Implantables , Humanos , Fibrilación Ventricular , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/terapiaRESUMEN
INTRODUCTION: The long-term survival and low complication rate of autogenous fistulas for hemodialysis access is often offset by early thrombosis and slow or failed maturation leading to the use of central venous catheters. A regenerative material may have the potential to overcome these limitations. A completely biological acellular vascular conduit was investigated in this first-in-human clinical study. METHODS: With approval of the ethics board and patients' informed consent, five subjects were enrolled based on predetermined inclusion criteria. Five patients underwent implant of a novel acellular, biological tissue conduit (TRUE AVC™) in the upper arm in a curved configuration between brachial artery and axillary vein. After maturation, standard dialysis was commenced through the new access. Patients were followed up to 26 weeks with ultrasound and physical exam. Serum samples were evaluated for an immune response to the novel allogeneic human tissue implant. RESULTS: This new tissue conduit handled well surgically, with properties similar to that of native human vein. Post procedure conduit flow was excellent in all cases, averaging 1098 ± 388 ml/min at week 4 and remaining stable through 1248 ± 355 ml/min at 26 weeks. Surgical site healing was normal with no edema or erythema by week 4. Six-month primary assisted patency was 80% and secondary patency was 100%. Prescribed dialysis was successfully delivered without infection, and there was no significant change in conduit diameter. Serum testing showed no increase in PRA or IgG specific to the TRUE AVC. One implant required intervention at 5 months with thrombectomy and covered stent procedure. CONCLUSION: This first-in-human 6-month study with favorable patency and low complication rate establishes the initial safety and feasibility of this novel biological tissue conduit for dialysis access in patients with end-stage kidney disease. Its mechanical durability and lack of immune response establishes TRUE AVC as a potential regenerative material for clinical use.
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Background: ModulHeart (Puzzle Medical Devices Inc) is a modular device providing hemodynamic support through 3 endovascular pumps inserted in series and assembled in parallel into a self-expandable anchor implanted in the descending aorta. The current study evaluates the feasibility and safety of cardiorenal support with ModulHeart among patients undergoing high-risk percutaneous coronary intervention (PCI). Methods: This study was a prospective, single-center, first-in-human study. The primary end point was procedural success, defined as successful delivery, function, and removal of the ModulHeart device. Secondary end points included pump hemodynamics, cardiac hemodynamics, and urine output. Results: On June 28 and 29, 2022, 4 patients were enrolled and underwent high-risk PCI with ModulHeart implanted via transfemoral approach. All 4 patients achieved procedural success. The mean delivery time was 8 minutes, the mean support time was 49 minutes, and the mean pump removal time was 7 minutes. The mean pressure gradient across the pump was 5 ± 2 mm Hg. Under ModulHeart support, cardiac index increased by 25%, central venous pressure decreased by 37%, and left ventricular end-diastolic pressure decreased by 78%. Urine output increased by â¼9-fold after 15 minutes of support. No device malfunction or procedural or device-related adverse events occurred. There was no evidence of pump thrombosis. All 4 patients were alive at 30 days. Conclusions: This first-in-human study demonstrated the feasibility and safety of cardiorenal support with ModulHeart among patients undergoing high-risk PCI. ModulHeart demonstrated significant improvement in cardiac output, left ventricular end-diastolic pressure, and urine output. Future studies are planned to assess outcomes associated with ModulHeart support in patients with heart failure.
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[Figure: see text].
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Fibrilación Atrial/cirugía , Catéteres Cardíacos , Ablación por Catéter/instrumentación , Sistema de Conducción Cardíaco/fisiopatología , Venas Pulmonares/cirugía , Cirugía Asistida por Computador/métodos , Adulto , Anciano , Fibrilación Atrial/fisiopatología , Diseño de Equipo , Femenino , Fluoroscopía/métodos , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Recurrencia , Factores de Tiempo , Resultado del TratamientoRESUMEN
PURPOSE: To report the device performance and safety for the Surfacer Inside-Out access catheter system in patients with thoracic central venous obstruction (TCVO) requiring central venous access (CVA). MATERIALS AND METHODS: Five sites prospectively enrolled 30 patients requiring a tunneled dialysis catheter between February 2017 and September 2018 in the SAVE (Surfacer System to Facilitate Access in Venous Obstructions) registry. Patient demographics, medical history, and type of TCVO were documented at enrollment. Device performance and adverse events were collected during the procedure and upon hospital discharge. Twenty-nine of the 30 patients enrolled required CVA for hemodialysis. Retrospective classification of TCVOs according to SIR reporting standards showed 9 patients (30%) had Type 4 obstructions, 8 (26.7%) had Type 3, 5 (16.7%) had Type 2, and 8 (26.7%) had Type 1 obstruction. RESULTS: Central venous catheters (CVCs) were successfully placed in 29 of 30 patients (96.7%). The procedure was discontinued in 1 patient due to vascular anatomical tortuosity. All 29 patients with successful CVC placement achieved adequate catheter patency and tip positioning. There were no device-related adverse events, catheter malposition, or intra- or postprocedural complications. Mean time from device insertion to removal for the 29 patients who successfully completed the procedure was 24 ± 14.9 (range, 6-70) minutes. Mean fluoroscopy time was 6.8 ± 4.5 (range, 2.2-25.5) minutes. CONCLUSIONS: The Surfacer Inside-Out procedure provided an alternative option to restore right-sided CVA in patients with TCVO.
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Venas Braquiocefálicas , Cateterismo Venoso Central/instrumentación , Catéteres de Permanencia , Catéteres Venosos Centrales , Venas Yugulares , Diálisis Renal , Vena Subclavia , Enfermedades Vasculares , Vena Cava Superior , Adulto , Anciano , Anciano de 80 o más Años , Venas Braquiocefálicas/diagnóstico por imagen , Cateterismo Venoso Central/efectos adversos , Constricción Patológica , Diseño de Equipo , Europa (Continente) , Femenino , Humanos , Venas Yugulares/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sistema de Registros , América del Sur , Vena Subclavia/diagnóstico por imagen , Enfermedades Vasculares/diagnóstico por imagen , Enfermedades Vasculares/etiología , Vena Cava Superior/diagnóstico por imagenAsunto(s)
Cateterismo Cardíaco , Cateterismo Periférico , Cuerdas Tendinosas/cirugía , Arteria Femoral , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral/cirugía , Prolapso de la Válvula Mitral/cirugía , Válvula Mitral/cirugía , Cateterismo Cardíaco/instrumentación , Cuerdas Tendinosas/diagnóstico por imagen , Cuerdas Tendinosas/fisiopatología , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Humanos , Masculino , Persona de Mediana Edad , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/fisiopatología , Prolapso de la Válvula Mitral/diagnóstico por imagen , Prolapso de la Válvula Mitral/fisiopatología , Resultado del TratamientoRESUMEN
PURPOSE: Thoracic central venous obstruction is a common clinical complication in dialysis patients utilizing hemodialysis catheters. Thoracic central venous obstruction can lead to inability to utilize affected veins for catheter placement and sequential use of less preferred alternative venous access sites. The latter can affect the ability to create and/or mature permanent arteriovenous access and contribute to the future loss of thoracic veins for venous access. While alternative procedures exist for gaining venous access in patients who have exhausted routine venous access options, these procedures are complex, time-consuming, and associated with high patient risk. The Surfacer System provides a new approach in patients with right-sided thoracic central venous obstruction, enabling the ability to establish repeated access from the right side of the neck to the right atrium. METHODS: We describe the use of the Surfacer System to facilitate placement of hemodialysis catheters in a series of nine patients with thoracic central venous obstruction involving one or more central veins. Patient characteristics and procedure-related outcomes were recorded for all patients. RESULTS: Central venous access was successfully achieved in eight of nine patients using the Surfacer System. Significant venous tortuosity resulted in the inability to achieve venous access in one patient and prolonged procedural time to achieve access in another patient. The mean time required for Surfacer-related procedural steps and associated fluoroscopy time in the remaining seven patients was 13.3 and 3.7 min, respectively. CONCLUSION: The Surfacer System provides an efficient low-complexity alternative for gaining repeated right-sided central venous access in hemodialysis patients with obstructed thoracic veins.
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Cateterismo Venoso Central/instrumentación , Catéteres de Permanencia , Catéteres Venosos Centrales , Diálisis Renal , Tórax/irrigación sanguínea , Enfermedades Vasculares/fisiopatología , Venas/fisiopatología , Adulto , Anciano , Anciano de 80 o más Años , Cateterismo Venoso Central/efectos adversos , Constricción Patológica , Diseño de Equipo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Radiografía Intervencional , Diálisis Renal/efectos adversos , Resultado del Tratamiento , Enfermedades Vasculares/diagnóstico por imagen , Venas/diagnóstico por imagen , Adulto JovenRESUMEN
BACKGROUND: A completely extracardiac pacing system provides the potential for clinical advantages over existing device alternatives that require intravascular, endocardial, or epicardial contact. Preliminary studies evaluating the feasibility of cardiac pacing with a lead in the anterior mediastinum, outside the pericardium and circulatory system have been completed. These studies examined (1) the anatomic access route, (2) the usability of a delivery tool to facilitate lead placement, and (3) the pacing performance of the extracardiac lead. METHODS: Feasibility evaluations included (1) a retrospective computed tomography analysis to characterize anatomic variations related to lead access, (2) accessing the anterior mediastinum in cadavers and human subjects using a custom delivery tool, and (3) acute clinical pacing performance. RESULTS: Major findings: (1) A total of 166 (95%) out of 174 patients had a viable lead access path through the fourth, fifth, or sixth intercostal space. (2) Access to the targeted implant location using a delivery tool was successful in all 5 cadavers and 3 humans without use of fluoroscopy and with an average lead delivery time of 121±52 s. No damage to the lung, pericardium, heart, or internal thoracic vessels occurred. (3) Pacing performance was tested in 6 human subjects showing a threshold voltage of 4.7 V (2.7-6.7), threshold pulse width of 1.8 ms (1.0-2.5), and an impedance of 1205 Ω (894-1786). R-wave amplitudes measured 9.6 mV (5.6-12.0). CONCLUSIONS: Results support the feasibility for this completely extracardiac pacing method in a heterogeneous patient population, using a minimally invasive, parasternal, delivery approach and with adequate sensing and thresholds suited for temporary pacing.
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Arritmias Cardíacas/terapia , Estimulación Cardíaca Artificial , Mediastino , Marcapaso Artificial , Adulto , Anciano , Anciano de 80 o más Años , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/fisiopatología , Cadáver , Disección , Diseño de Equipo , Estudios de Factibilidad , Femenino , Humanos , Masculino , Mediastino/diagnóstico por imagen , Persona de Mediana Edad , Radiografía Intervencional , Estudios Retrospectivos , Tomografía Computarizada por Rayos X , Adulto JovenRESUMEN
BACKGROUND: The use of arteriovenous fistula (AVF) is hampered by long surgical wait times, slow maturation, and upwards of 60% that do not mature. We describe our clinical experience in using a system with a 4F catheter profile for endovascular AVF creation in patients on hemodialysis. METHODS: This was a multioperator, single-center, single-arm, prospective study intended to evaluate safety and efficacy of a 4 Fr endovascular AVF (endoAVF) system for the creation of vascular access in hemodialysis patients. The study was performed after institutional review board approval at Italian Hospital (Asuncion, Paraguay). Patients were followed up at regular intervals through 6 months to determine procedural, maturation, and cannulation success as well as intervention rate and patency. RESULTS: From May to November 2016, 32 patients underwent the endoAVF procedure with no device-related adverse events. An endoAVF was successfully created in the proximal forearm for all 32 patients (20 between the radial artery and radial vein; 12 between the ulnar artery and ulnar vein). Wrist access was used for 72% (23/32) of the procedures for the arterial catheter and 59% (19/32) of the procedures for the venous catheter. The device successfully created an endoAVF in every patient for a technical success rate of 100% (32/32). The device- or procedure-related serious adverse event rate was 3% (1/32); one patient experienced a venous guidewire perforation successfully managed with a stent graft. Primary and cumulative patency rates through 6 months were 83% and 87%, respectively, with an intervention rate of 0.21 per patient-year. Physiological suitability, as defined by target flow rates ≥500 ml/min and cannulation vessel diameters ≥4 mm, was achieved in 91% (29/32) of patients by 90 days. Successful 2-needle cannulation was achieved in 78% (21/27) by 90 days, with mean time to cannulation of 43 ± 14 days. Functional cannulation, as defined by successful 2-needle cannulation for two-thirds of the dialysis sessions within 1 month, was achieved in 95% (20/21) of the patients who were successfully cannulated for an overall rate of 74% (20/27). All patients who achieved functional cannulation had their central venous catheters (CVCs) removed before the 90-day follow-up for a CVC removal rate of 74% (20/27). CONCLUSIONS: The 4 Fr endoAVF system allowed for multiple access and fistula creation site options to tailor the procedure to individual patient anatomy. Furthermore, the outcomes are comparable to previous generation endoAVF technology, with a potentially improved safety profile because of the use of arteries at the wrist for access.
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Derivación Arteriovenosa Quirúrgica/instrumentación , Procedimientos Endovasculares/instrumentación , Diálisis Renal , Extremidad Superior/irrigación sanguínea , Dispositivos de Acceso Vascular , Adulto , Anciano , Derivación Arteriovenosa Quirúrgica/efectos adversos , Procedimientos Endovasculares/efectos adversos , Diseño de Equipo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Paraguay , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: There are limited options for percutaneous mechanical circulatory support (pMCS) in patients requiring high-risk percutaneous coronary intervention. OBJECTIVES: This first-in-human, single-center study aimed to evaluate the safety and feasibility of a novel pMCS device in high-risk percutaneous coronary intervention patients. METHODS: Aortix (Procyrion, Houston, Texas) is a pMCS device deployed in the descending aorta via the femoral artery that uses axial flow to provide cardiac unloading and augment renal and systemic perfusion. We assessed the use and effect of the Aortix device in six patients undergoing high-risk PCI. All patients had impaired left ventricular function, complex coronary disease, renal dysfunction, and suitable iliofemoral anatomy for Aortix placement via transfemoral approach. We recorded periprocedural events including hemodynamic effects of the device on cardiac output and urine output. We then followed patients up to 30 days following the PCI procedure for adverse events. RESULTS: Aortix delivery (18 Fr sheath) took 4-9 min, mean support time was 70 (range 47-95) min, and mean flow rate through the device was 3.5 L/min. During support, mean rate of urine output increased 10-fold (range 2.5-25.0x). Estimated GFR improved at discharge compared with baseline (mean increase 6.95 ± 8.09 mL/min). There were no device failures and PCI was successful in all patients. Aortix was removed and hemostasis was achieved with a vascular closure device and manual pressure. No patients experienced adverse events or hemodynamic compromise. No clinically significant hemolysis occurred (mean LDH 239.2 ± 73.6 mU/mL at baseline and 206.4 ± 82.2 mU/mL at discharge). No vascular access complications were observed. CONCLUSIONS: Aortix, a novel pMCS device, was successfully deployed and retrieved in all initial patients undergoing high-risk PCI. We noted no significant hemolysis with temporary use of this axial flow device. Improvement in eGFR suggests a potential renal protective effect and is an important area for future investigation in patients with impaired left ventricular function and renal dysfunction.
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Aorta/fisiopatología , Enfermedad de la Arteria Coronaria/terapia , Corazón Auxiliar , Intervención Coronaria Percutánea , Implantación de Prótesis/instrumentación , Disfunción Ventricular Izquierda/terapia , Anciano , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/fisiopatología , Circulación Coronaria , Remoción de Dispositivos , Estudios de Factibilidad , Femenino , Tasa de Filtración Glomerular , Hemodinámica , Humanos , Riñón/fisiopatología , Enfermedades Renales/fisiopatología , Masculino , Persona de Mediana Edad , Paraguay , Intervención Coronaria Percutánea/efectos adversos , Estudios Prospectivos , Diseño de Prótesis , Implantación de Prótesis/efectos adversos , Recuperación de la Función , Flujo Sanguíneo Regional , Circulación Renal , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Micción , Disfunción Ventricular Izquierda/diagnóstico , Disfunción Ventricular Izquierda/fisiopatología , Función Ventricular IzquierdaRESUMEN
This study aimed to evaluate the use of the HeartMate percutaneous heart pump, a catheter-based axial flow pump designed to provide partial left ventricular support, in patients who underwent high-risk percutaneous coronary intervention (PCI). Patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing PCI may require mechanical circulatory support. Fifty high-risk patients were enrolled in a prospective, nonrandomized, multicenter, open-label trial. Primary end points were freedom from hemodynamic compromise during PCI and a composite measure of major adverse events. Patients were followed for 30 days. No patient met the primary performance end point. Six safety end points in 5 patients occurred, including 1 access site complication requiring intervention, 1 cerebrovascular accident, 2 major bleeding complications, and 2 cases of new or worsening aortic insufficiency. No cardiac deaths, myocardial infarctions, or surgical interventions occurred. In conclusion, initial results of the HeartMate percutaneous heart pump for mechanical circulatory support during high-risk PCI are encouraging. Hemodynamic stability was achieved in all patients with a low incidence of adverse events.
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Enfermedad de la Arteria Coronaria/cirugía , Corazón Auxiliar , Hipotensión/prevención & control , Cuidados Intraoperatorios/métodos , Complicaciones Intraoperatorias/prevención & control , Intervención Coronaria Percutánea/métodos , Adulto , Anciano , Anciano de 80 o más Años , Insuficiencia de la Válvula Aórtica/epidemiología , Femenino , Hemodinámica , Humanos , Masculino , Persona de Mediana Edad , Hemorragia Posoperatoria/epidemiología , Estudios Prospectivos , Riesgo , Accidente Cerebrovascular/epidemiologíaAsunto(s)
Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas , Anuloplastia de la Válvula Mitral/instrumentación , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral/cirugía , Ecocardiografía Doppler en Color , Ecocardiografía Tridimensional , Ecocardiografía Transesofágica , Femenino , Humanos , Persona de Mediana Edad , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/fisiopatología , Anuloplastia de la Válvula Mitral/métodos , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/fisiopatología , Diseño de Prótesis , Recuperación de la Función , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
OBJECTIVES: Over 30% of critically ill patients on positive-pressure mechanical ventilation have difficulty weaning from the ventilator, many of whom acquire ventilator-induced diaphragm dysfunction. Temporary transvenous phrenic nerve pacing using a novel electrode-bearing catheter may provide a means to prevent diaphragm atrophy, to strengthen an atrophied diaphragm, and mitigate the harms of mechanical ventilation. We tested the initial safety, feasibility, and impact on ventilation of this novel approach. DESIGN: First-in-Humans case series. SETTING: Angiogram suite. PATIENTS: Twenty-four sedated, mechanically ventilated patients immediately prior to an elective atrial septal defect repair procedure. INTERVENTIONS: A 9.5-Fr central venous catheter with 19 embedded electrodes was placed via Seldinger technique into the left subclavian vein and superior vena cava and evaluated for up to 90 minutes. The electrode combinations determined to provide best transvenous stimulation of the right and left phrenic nerves were activated in synchrony with mechanically ventilated breaths. MEASUREMENTS AND MAIN RESULTS: One patient could not be tested for reasons unrelated to the device. In the 23 patients who underwent the full protocol, transvenous stimulation activated the diaphragm in 22 of 23 (96%) left phrenic capture attempts and 20 of 23 (87%) right phrenic capture attempts. In one subject, a congenital left-sided superior vena cava precluded right-sided capture. Significant reductions in ventilator pressure-time-product were achieved during stimulation assisted breaths in all 22 paced subjects (range, 9.9-48.6%; p < 0.001). There were no adverse events either immediately or at 2-week follow-up. CONCLUSIONS: In this First-in-Human series, diaphragm pacing with a temporary catheter was safe and effectively contributed to ventilation in conjunction with a mechanical ventilator.
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Diafragma/inervación , Terapia por Estimulación Eléctrica/métodos , Nervio Frénico , Respiración Artificial/efectos adversos , Parálisis Respiratoria/etiología , Parálisis Respiratoria/cirugía , Terapia por Estimulación Eléctrica/instrumentación , Humanos , Neuroestimuladores ImplantablesRESUMEN
BACKGROUND: Current surgical and medical treatment options for functional mitral regurgitation (FMR) are limited and additional interventional approaches are required. OBJECTIVES: This study sought to report the safety and performance data from the feasibility study with a novel direct annuloplasty system. METHODS: Seventy-one patients with moderate to severe FMR (mean 67.7 ± 11.3 years of age, left ventricular [LV] ejection fraction 34.0 ± 8.3%), on stable medical heart failure medication were prospectively enrolled. RESULTS: Device success rate was 70.4% (n = 50 of 71). No intraprocedural death occurred. In patients receiving implants, 4 patients (8.9%) experienced cardiac tamponade. Thirty-day (n = 45) and 6-month (n = 41) rates for all-cause mortality, stroke, and myocardial infarction were 4.4%, 4.4%, and 0.0% and 12.2%, 4.9%, and 0%, respectively. At 6 months, nonurgent mitral surgery was performed in 1 patient (2.4%) and nonurgent percutaneous repair in 7 patients (17.1%). Echocardiographic core analysis after 6 months showed mitral regurgitation reduction in 50% of treated patients by a mean of 1.3 grades. Concerning mitral valve (MV) annular geometry, we found significant reduction of anterior-posterior (-0.31 ± 0.4 cm) and septal-lateral dimensions (-0.21 ± 0.3 cm), a decreased MV-tenting area (-0.57 ± 1.1 cm(2)) and increase in MV coaptation length (0.13 ± 0.2 cm). Transthoracic echocardiography indicated reverse LV remodeling with reduction of LV end-diastolic diameter (-0.20 ± 0.4 mm) and volume (-22 ± 39 ml). Treatment was associated with significant improvement in 6-min walking distances (56.5 ± 92.0 m) and improvements in New York Heart Association functional class III/IV at 6 months from 53.3% to 23.3%. CONCLUSIONS: Percutaneous direct annuloplasty is feasible and safe in high-risk FMR patients. This treatment initiates LV reverse remodeling, and provides clinical improvement during 6 months after treatment. (Mitralign Percutaneous Annuloplasty First in Man Study; NCT01852149).
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Anuloplastia de la Válvula Mitral/instrumentación , Insuficiencia de la Válvula Mitral/cirugía , Anciano , Enfermedad Crónica , Estudios de Factibilidad , Femenino , Humanos , Masculino , Estudios Prospectivos , Resultado del TratamientoAsunto(s)
Estenosis de la Válvula Aórtica/terapia , Válvula Aórtica , Cateterismo Cardíaco/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas , Instrumentos Quirúrgicos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Cateterismo Cardíaco/métodos , Ecocardiografía Transesofágica , Estudios de Factibilidad , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Posicionamiento del Paciente , Diseño de Prótesis , Radiografía Intervencional , Resultado del TratamientoRESUMEN
OBJECTIVES: This study evaluated the first clinical use of a new endovascular approach to renal denervation, using chemical neurolysis, via periadventitial infusion of dehydrated alcohol (ethanol) to perform "perivascular" renal artery sympathetic denervation. BACKGROUND: Renal denervation remains a promising technology for the treatment of hypertension and other disorders. METHODS: A novel 3-needle delivery device (Peregrine System Infusion Catheter, Ablative Solutions, Inc., Kalamazoo, Michigan) was introduced into the renal arteries of 18 subjects with refractory hypertension. Microdoses of alcohol were infused bilaterally via the 3 needles into to the adventitial space (0.30 ml/artery, 37 arteries). Renal artery angiography was performed at the time of the procedure and at 6 months (n = 16). The primary safety endpoints were complications associated with the catheter insertion and delivery of the neurolytic agent or any major vascular access complications. The secondary performance endpoint was a reduction in office-based systolic blood pressure at 6 months compared with baseline. RESULTS: Procedural success was achieved in 100% of subjects (N = 18) and arteries (N = 37). There were no study-related adverse clinical events at follow-up. One death of a subject was recorded but determined by the investigator and an independent medical monitor to be non-study related. There were no angiographic observations of renal artery stenosis, aneurysms, or other renal artery abnormalities at 6 months (32 renal arteries). Sixteen of the 18 subjects had a 6-month follow-up. The mean office systolic blood pressure decreased from 175 ± 17 mm Hg to 151 ± 26 mm Hg (-24 mm Hg). There was an average reduction of antihypertensive medications from 3.4 (baseline) to 2.0 per subject at 6 months. CONCLUSIONS: Chemical renal denervation using the infusion of very low doses of alcohol directly into the adventitial space appears to be feasible and safe. This approach may be a promising alternative approach to perform catheter-based renal denervation. These results need to be confirmed in larger scale clinical studies.
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Presión Sanguínea , Etanol/administración & dosificación , Hipertensión/cirugía , Riñón/irrigación sanguínea , Arteria Renal/inervación , Simpatectomía/métodos , Técnicas de Ablación/efectos adversos , Técnicas de Ablación/instrumentación , Adulto , Anciano , Antihipertensivos/uso terapéutico , Catéteres , Diseño de Equipo , Etanol/efectos adversos , Estudios de Factibilidad , Femenino , Humanos , Hipertensión/diagnóstico , Hipertensión/fisiopatología , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Estudios Prospectivos , Arteria Renal/diagnóstico por imagen , Simpatectomía/efectos adversos , Simpatectomía/instrumentación , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: This study aimed to evaluate a novel device system for surgical aortic valve replacement (SAVR) using a unique new less invasive access approach. The hypothesis is that SAVR can be performed through a short transverse incision in the neck, similar to that used for transcervical thymectomy avoiding chest disruption. METHODS: A new device system was developed to provide retraction, step-by-step illumination, and on-screen visualization for the new approach. Preliminary feasibility studies were performed in cadavers. Comprehensive risk analysis was performed, and training was implemented in Thiel preserved cadavers. For the first-in-man clinical case, a 63-year-old woman with symptomatic critical aortic stenosis (The Society of Thoracic Surgeons risk, 11%) and heavily calcified aortic valve was selected. A short transverse incision was made in the neck; the device was introduced, and the sternum was elevated; femorofemoral cardiopulmonary bypass was established; substernal dissection was guided by the sequenced illumination, and high-definition visualization was provided by the device, allowing for optimal exposition of the aorta and aortic valve; and a 23-mm Medtronic ENABLE sutureless valve prosthesis was implanted. Procedure success was evaluated according to the standardized composite end point definition of "device success" proposed by the Valve Academic Research Consortium. RESULTS: Access, delivery, and deployment of the valve prosthesis were successful. The correct position and intended performance of the valve were demonstrated (mean gradient, 6 mm Hg; aortic valve area, 2.5 cm) with the absence of moderate or severe prosthetic aortic regurgitation. Only one valve prosthesis was used. CONCLUSIONS: Transcervical SAVR with sutureless valve is feasible using this novel access system. The new approach has potential to offer patients substantially shorter stay and fewer, less serious complications, as has been observed in transcervical thymectomy. Further studies are merited.
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Puente Cardiopulmonar/métodos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Puente Cardiopulmonar/instrumentación , Femenino , Humanos , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos/instrumentación , Cuello/cirugía , Cirugía Asistida por Computador/métodos , Resultado del TratamientoRESUMEN
PURPOSE: A lengthy healing and maturation period follows standard surgical preparation of a permanent arteriovenous access, often requiring or extending use of a venous catheter (VC) for hemodialysis. The InterGraft™ Anastomotic Connector System was developed for minimally invasive anastomosis of an arteriovenous graft (AVG). The venous and arterial InterGraft™ connectors are designed to provide optimized flow dynamics and may result in reduction of AVG stenosis. This pilot study evaluated placement procedure success, patency and safety of the InterGraft™ connectors. METHODS: Nine AVGs were implanted in nine patients currently receiving dialysis with a VC. The study allowed use of both connectors (n = 5) or use of the venous connector with a sutured arterial anastomosis (n = 4). Monthly ultrasound examinations were performed throughout the six-month follow-up. AVG angiography was performed at five months. Endpoints included procedure success (acceptable graft flow at end of procedure, without significant bleeding or need for emergent surgery), patency, and device-related major adverse events. RESULTS: Procedure success was attained in all patients. AVGs were used for dialysis within 17 days, on average, and VCs were removed. Three patients exited the study early for reasons unrelated to the InterGraft™ connectors. The remaining six patients had patent grafts: two with assisted and four with unassisted patency. AVG flow rates were greater than 1 L/minute. No dilatations or aneurysms were observed by angiography. There were no device-related major adverse events. CONCLUSIONS: The InterGraft™ connectors can be safely and successfully used for AVG anastomoses, with acceptable near-term patency. Further clinical evaluation is warranted.
Asunto(s)
Derivación Arteriovenosa Quirúrgica/instrumentación , Vena Axilar/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Arteria Braquial/cirugía , Diálisis Renal , Adulto , Anciano , Derivación Arteriovenosa Quirúrgica/efectos adversos , Vena Axilar/diagnóstico por imagen , Vena Axilar/fisiopatología , Velocidad del Flujo Sanguíneo , Implantación de Prótesis Vascular/efectos adversos , Arteria Braquial/diagnóstico por imagen , Arteria Braquial/fisiopatología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Paraguay , Proyectos Piloto , Estudios Prospectivos , Diseño de Prótesis , Flujo Sanguíneo Regional , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
BACKGROUND/PURPOSE: We update the pre-clinical and early clinical results using a novel endovascular approach, to perform chemical renal denervation, via peri-adventitial injection of micro-doses of dehydrated alcohol (ethanol-EtOH). METHODS/MATERIALS: A novel, three-needle delivery device (Peregrine™) was used to denervate the renal arteries of adult swine (n = 17) and in a first-in-man feasibility study (n = 18). In the pre-clinical testing EtOH was infused bilaterally with one infusion per renal artery into to the perivascular space, using EtOH doses of 0.3 ml/artery (n = 8), and 0.6 ml/artery (n = 9), and with saline sham control (0.4 ml/artery n = 3). Renal parenchymal norepinephrine (NE) concentration (performed blindly), and safety were the primary endpoints. Data from the first-in-man study (n = 18) to evaluate device performance, safety and peri-procedural pain are reported. RESULTS: In the pre-clinical testing renal function was unchanged at 3-month follow-up. Angiography at 90 days (n = 34 arteries) demonstrated normal appearing renal arteries, unchanged from baseline, and without stenosis or other abnormalities. The reductions in mean renal parenchymal NE reductions at 3 months were 68% and 88% at doses of 0.3 and 0.6 ml, respectively (p < 0.001 vs. controls). In the first-in-man study, there was 100% device success, no complications, a mean treatment time of 4.3 ± 3 minutes/artery, and minimal or no patient discomfort during treatment. Angiography at 6-months showed no evidence of renal artery stenosis, and evidence of a reduction of blood pressure from baseline. CONCLUSION: Perivascular RDN using micro-doses of alcohol is a promising alternative to energy-based systems to achieve dose-dependent, predictable, safe and essentially painless renal denervation. Further clinical evaluation is warranted. SUMMARY: (For annotated table of contents) This paper describes the preclinical results, in a porcine model, and the early first-in-man results, using the Peregrine™ chemical renal denervation catheter to perform renal sympathetic denervation using micro-doses of alcohol.