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1.
Catheter Cardiovasc Interv ; 103(6): 1015-1022, 2024 May.
Article in English | MEDLINE | ID: mdl-38577931

ABSTRACT

BACKGROUND: Previous studies have documented a high rate of implantation success with the ACURATE neo2 valve, as well as a reduction in paravalvular leak (PVL) compared to its predecessor, the ACURATE neo. However, there are no studies that have reviewed and compared the long-term clinical and hemodynamic outcomes of these patients. AIMS: This study aimed to evaluate the results of the ACURATE neo transcatheter aortic valve in a real-world context, and to compare the results of the outcomes of both generations of this device (ACURATE neo and ACURATE neo2), with a specific focus on procedural success, safety, and long-term effectiveness. METHODS: A prospective study including all consecutive patients treated with the ACURATE neo device in seven hospitals was conducted (Clinical Trials Identification Number: NCT03846557). The primary endpoint consisted of a composite of adverse events, including mortality, aortic insufficiency, and other procedural complications. As the second-generation device (ACURATE neo2) replaced the ACURATE neo during the study period, hemodynamic and clinical results before admission, at 30 days, and at 1 year of follow-up were compared between the two generations. RESULTS: A total of 296 patients underwent transcatheter aortic valve implantation with the ACURATE device, with 178 patients receiving the ACURATE neo and 118 patients receiving the ACURATE neo2. In the overall population, the absence of device success occurred in 14.5%. The primary reason for the absence of device success was the presence of para-valvular regurgitation ≥ 2. There were no instances of coronary occlusions, valve embolization, annulus rupture, or procedural deaths. ACURATE neo2 was associated with a significantly higher device success rate (91.7% vs. 82%, p = 0.04), primarily due to a significantly lower rate of para-valvular regurgitation, which remained significant at 1 year. CONCLUSION: The use of ACURATE neo and neo2 transcatheter aortic valves is associated with satisfactory clinical results and an extremely low rate of complications. The ACURATE neo2 enables a significantly higher device success rate, primarily attributed to a significant reduction in the rate of PVL.


Subject(s)
Aortic Valve Stenosis , Aortic Valve , Heart Valve Prosthesis , Hemodynamics , Prosthesis Design , Registries , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Female , Humans , Male , Aortic Valve/surgery , Aortic Valve/physiopathology , Aortic Valve/diagnostic imaging , Aortic Valve Insufficiency/physiopathology , Aortic Valve Insufficiency/etiology , Aortic Valve Insufficiency/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/physiopathology , Aortic Valve Stenosis/diagnostic imaging , Postoperative Complications , Prospective Studies , Recovery of Function , Risk Factors , Spain , Time Factors , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome
4.
J Cardiovasc Surg (Torino) ; 57(4): 615-9, 2016 Aug.
Article in English | MEDLINE | ID: mdl-25673098

ABSTRACT

BACKGROUND: The most frequent complications of transfemoral aortic valve implantation are vascular (15-25%) and are related to an increase in mortality. We sought to assess the rate of vascular complications, its treatment and outcomes using a surgical approach for transfemoral implantation of Edwards-SAPIEN (Edwards Lifescience, Irvine, CA, USA) aortic valve. METHODS: We have conducted a multicenter registry including 4 hospitals using a systematic surgical exposure approach. Vascular complications have been collected following the definitions of the Valve Academic Research Consortium. RESULTS: From 2008 to 2013 a total of 312 consecutive patients have been included. Vascular complications were reported in 22 (7%), among those 6 (1.9%) were major whereas 16 (5.1%) were minor. Patients suffering vascular complications had significantly more previous history of peripheral vascular disease. All but one major complications occurred in women, aged 82-88 and with chronic renal failure. Hospital stay was longer in cases suffering complications (17.8±11 days vs. 9±7 days; P<0.0001). The 30 days mortality was 13.6% in patients with vascular complications, 33.3% in patients with major complications and 5.5% in patients with no complications (P=0.05). CONCLUSIONS: In this registry, the systematic use of a surgical exposure of the femoral artery for TAVR has been associated with a lower rate of vascular complications.


Subject(s)
Aortic Valve Stenosis/therapy , Balloon Valvuloplasty , Cardiac Catheterization , Femoral Artery/injuries , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Vascular System Injuries/etiology , Aged , Aged, 80 and over , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/mortality , Balloon Valvuloplasty/adverse effects , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Cardiac Catheterization/methods , Cardiac Catheterization/mortality , Female , Femoral Artery/diagnostic imaging , Heart Valve Prosthesis Implantation/adverse effects , Heart Valve Prosthesis Implantation/instrumentation , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/mortality , Humans , Male , Prosthesis Design , Punctures , Registries , Risk Factors , Spain , Treatment Outcome , Vascular System Injuries/diagnostic imaging
5.
Rev. esp. cardiol. Supl. (Ed. impresa) ; 15(supl.C): 17c-26c, 2015. tab, ilus
Article in Spanish | IBECS | ID: ibc-165840

ABSTRACT

El implante valvular aórtico transcatéter es actualmente una opción terapéutica aceptada para pacientes con estenosis aórtica grave sintomática y alto riesgo quirúrgico. En particular, se ha demostrado en ensayos aleatorizados que el implante valvular aórtico transcatéter reduce la mortalidad respecto al tratamiento médico de pacientes inoperables y que es no inferior a la cirugía convencional para pacientes de alto riesgo quirúrgico. Desde sus inicios, el implante valvular aórtico transcatéter mostró tener un gran potencial, por lo que se ha puesto mucho interés en diseñar nuevos dispositivos con el objetivo de mejorar los resultados e incrementar las indicaciones en anatomías cada vez más complejas y en pacientes con múltiples comorbilidades. En esta revisión, se presentan los avances en el diseño de nuevas prótesis transcatéter y se discute la evidencia actual sobre estas prótesis de nueva generación (AU)


Transcatheter aortic valve implantation has become an accepted treatment option for patients with severe symptomatic aortic stenosis who are at a high surgical risk. In particular, randomized trials have shown that the technique is associated with lower mortality in inoperable patients than medical treatment and is noninferior to conventional surgery in patients at a high surgical risk. From its inception, transcatheter aortic valve implantation has shown great potential and, consequently, considerable effort has been devoted to designing new devices that can provide better outcomes and that can expand indications to ever more complex anatomies and to patients with multiple comorbidities. This review describes developments in the design of novel transcatheter prostheses and discusses recent findings with the application of these new-generation prostheses (AU)


Subject(s)
Humans , Aortic Valve Stenosis/surgery , Transcatheter Aortic Valve Replacement/methods , Heart Valve Prosthesis/classification , Endoleak/prevention & control , Postoperative Complications/prevention & control , Prosthesis Design/methods
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