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BACKGROUND: Vascular complications increase morbidity and mortality in transcatheter aortic valve replacement (TAVR). Data involving suture-based percutaneous vascular closure devices (VCDs) have been extensive. Although promising, data regarding the efficacy and safety of the MANTA VCD (Teleflex) are scarce. We sought to assess the safety and effectiveness of the MANTA device in a real-life unselected cohort of patients undergoing transfemoral-TAVR (TF-TAVR). METHODS: This single-center retrospective observational study included a cohort of consecutive patients with severe aortic stenosis (AS) treated by our team using TAVR between January 2020 to December 2022. The primary outcome measure was access-related major and minor vascular complications according to the Valve Academic Research Consortium (VARC-3) definition criteria. RESULTS: From January 2020 to December 2022, a total of 347 patients underwent TF-TAVR were treated using the MANTA 18 Fr VCD system for vascular closure. Mean age was 82.4 ± 6.1 years (56-98 years). There were no significant differences in preoperative and procedural characteristics between patients with and without VCD-related major vascular complications. Access site-related major and minor vascular complications occurred in 20 of 347 patients (5.7%). Overall, major vascular complications occurred in 5 patients (1.4%) and device failure was seen in 17 patients (4.9%). CONCLUSION: This French real world evaluation of large-bore arteriotomy closure in TF-TAVR indicated that MANTA VCD is a feasible alternative with an acceptable low rate of access-site-related complications.
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Cateterismo Periférico , Reemplazo de la Válvula Aórtica Transcatéter , Dispositivos de Cierre Vascular , Humanos , Anciano , Anciano de 80 o más Años , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento , Cateterismo Periférico/efectos adversos , PuncionesRESUMEN
Background: Shockwave intravascular lithotripsy (IVL) coronary system is a very useful new technology for de novo severely calcified coronary artery plaques before percutaneous coronary intervention (PCI). The device uses a semi-compliant low-pressure balloon, integrated into a sterile catheter, to deliver by vaporizing fluid an expanding bubble that generates high-pressure ultrasonic energy by waves that create multiplane longitudinal micro-macro fractures in calcified plaques, which facilitate optimal stent placement and expansion, and luminal gain. Methods: The use of Shockwave IVL coronary system in our cardiac catheterization laboratory (Cath lab) at the "Clinique Saint-Hilaire" in Rouen, France, started in March 2019, with 42 procedures performed since this date: two patients in 2019, two patients in 2020, seven patients in 2021, 23 patients in 2022, and eight patients since the beginning of 2023. Results: We had experienced problems at the beginning of our activity for the first 11 patients (two patients in 2019, two patients in 2020, and seven patients in 2021): after less than five pulses, the shock therapy stopped. We used initially for Shockwave IVL semi-compliant low-pressure integrated balloons a mixture of 50% contrast and 50% water preparations injectable (PPI). After changing water PPI by sodium chloride physiological saline solution, we never encountered this problem again for the following 31 patients (23 patients in 2022, and eight patients since the beginning of 2023). In fact, the proper functioning of Shockwave IVL system requires ions in balloon mixture in addition to the contrast. It is thanks to the ions contained in sodium chloride physiological saline solution that the spark necessary for shocks delivery after balloon inflation is produced. Conclusions: Water PPI or sodium chloride physiological saline solution is used in angioplasty balloons in a lot of Cath labs worldwide. It is therefore essential to disseminate in the worldwide Cath lab the obligation to put in Shockwave IVL semi-compliant low-pressure integrated balloons sodium chloride physiological saline solution, rather than water PPI for optimal performance, and the importance of Shockwave Medical reporting this to interventional cardiologists.
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Early mortality post-ST-segment elevation myocardial infarction (STEMI) in France remains high. The multicentre France Percutaneous Coronary Intervention Registry includes every patient undergoing coronary angiography in France. We analyzed the prevalence and impact of unmodifiable and modifiable risk factors on 30-day survival in patients experiencing STEMI. Patients admitted for STEMI between 01/2014 and 12/2016 were included in the analysis. Patients with nonobstructive coronary artery disease, with cardiogenic shock or cardiac arrest without STEMI, were excluded. Prehospital, clinical and procedural data were collected prospectively by the cardiologist in the cath lab using medical reporting software. Information on outcomes, including mortality, was obtained by a dedicated research technician by phone calls or from medical records. Marginal Cox proportional hazards regression was used to test the predictive value for survival at 30 days in a multivariable analysis. Included were 2590 patients (74% men) aged 63 ± 14 years. During the first month, 174 patients (6.7%) died. After adjustment, unmodifiable variables significantly associated with reduced 30-day survival were: age > 80 years (prevalence 15%; hazard ratio [HR] 2.7; 95% confidence interval [CI] 1.5-4.7), chronic kidney disease (2%; HR 5.3; 95% CI 2.6-11.1), diabetes mellitus (14%; HR 1.6; 95% CI 1.0-2.5), anterior or circumferential electrical localization (39%; HR 2.0; 95% CI 1.4-2.9), and Killip class 2, 3, or 4 (7%; HR 3.4; 95% CI 1.9-5.9; 2%; HR 10.1; 95% CI 5.3-19.4; 4%; HR 18; 95% CI 10.8-29.8, respectively). Among modifiable variables, total ischemic time > 3 hours (68%; HR 1.8; 95% CI 1.1-3.0), lack of appropriate premedication (18%; HR 2.2; 95% CI 1.5-3.3), and post-PCI TIMI < 3 (6%; HR 4.9; 95% CI 3.2-7.6) were significantly associated with reduced 30-day survival. Most predictors of 30-day survival post-STEMI are unmodifiable, but outcomes might be improved by optimizing modifiable factors, most importantly ischemic time and appropriate premedication.
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Infarto del Miocardio , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Femenino , Francia/epidemiología , Humanos , Masculino , Infarto del Miocardio/etiología , Intervención Coronaria Percutánea/efectos adversos , Sistema de RegistrosRESUMEN
BACKGROUND: The ACURATE neo™ transcatheter heart valve (Boston Scientific, Marlborough, Massachusetts) is predominantly implanted via femoral access. Transcarotid use of this prothesis has never been reported. CASE PRESENTATION: We present the case of an 89-year-old woman referred to us for a transcatheter aortic valve replacement (TAVR). After apparatus imaging of the aortic annulus and the peripheral vascular pathway, the heart team was confronted with a triple challenge: (i) The preferable choice of a self-expanding valve because of a small aortic annulus in an obese woman. (ii) Gaining favorable access to the coronary ostia, considering multiple recent coronary stenting. (iii) Utilizing an alternative arterial access because of iliac and femoral severely calcified stenosis. Implanting the ACURATE neo™ transcatheter heart valve (THV) via carotidal access allowed us to overcome these challenges. The procedure was performed successfully without any short-term complications. CONCLUSION: We report the first case of implantation of an ACURATE neo™ transcatheter heart valve (Boston Scientific, Marlborough, Massachusetts) via the right common carotid artery.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Arteria Carótida Común/cirugía , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano de 80 o más Años , Femenino , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentaciónRESUMEN
There is currently no consensus on the duration of hospitalization required after transfemoral transcatheter aortic valve implantation (TAVI). We report the feasibility and safety of early discharge after TAVI with the Edwards SAPIEN-XT prosthesis. From 2009 to 2013, 337 patients underwent transfemoral TAVI with the Edwards SAPIEN-XT prosthesis using local anesthesia and were discharged home either early (≤3 days, Early Discharge group, n = 121) or after 3 days (Late Discharge group, n = 216). The primary end point of the study combined death and rehospitalization from discharge to 30-day follow-up. Patients in the Early Discharge group were less symptomatic (New York Heart Association class ≥III: 64.5% vs 75.5%, p = 0.01) and had less renal failure (creatinine: 102.1 ± 41.0 vs 113.3 ± 58.9 µmol/L, p = 0.04), atrial fibrillation (33.1% vs 46.3%, p = 0.02), and previous balloon aortic valvuloplasty (11.6% vs 23.1%, p = 0.01) and were more likely to have a pacemaker before TAVI (16.5% vs 8.3%, p = 0.02). Pre-existing pacemaker (p = 0.05) and the absence of acute kidney injury (p = 0.02) were independent predictors of an early discharge, whereas previous balloon aortic valvuloplasty (p = 0.03) and post-TAVI blood transfusions (p = 0.002) were independent predictors of late discharge. The primary end point occurred in 4 patients (3.3%) in the Early Discharge group and in 11 patients (5.1%) in the Late Discharge group (p = 0.58). In conclusion, the results of our study suggest that early discharge after transfemoral TAVI using the Edwards SAPIEN-XT prosthesis is feasible and safe in selected patients.
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Estenosis de la Válvula Aórtica/cirugía , Cateterismo Cardíaco/métodos , Prótesis Valvulares Cardíacas , Alta del Paciente/tendencias , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico , Ecocardiografía , Electrocardiografía , Estudios de Factibilidad , Femenino , Arteria Femoral , Estudios de Seguimiento , Humanos , Tiempo de Internación/tendencias , Masculino , Diseño de Prótesis , Estudios Retrospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Aortic regurgitation (AR) is an important complication of transcatheter aortic valve implantation (TAVI) and even moderate AR is associated with increased mortality after TAVI. The association with decreased survival is unclear. We aimed to analyse the impact of AR after TAVI as a function of baseline NT-proBNP. METHODS: We included 236 consecutive patients implanted in our centre with the SAPIEN and SAPIEN XT valves, via the transfemoral route. AR was evaluated by transthoracic echocardiography. NT-proBNP was measured 24h before implantation and patients were divided according to the median value. RESULTS: Median age was 85 years (80-89) and 137 (58.1%) were women. Patients with high NT-proBNP had lower left ventricular ejection fraction: 52% (35-65) vs. 63% (55-70), p<0.001, larger telediastolic diameters: 56 mm (49-61) vs. 52 mm (46-56), p=0.01, and more severe aortic stenosis: 0.62 ± 0.15 cm(2) vs. 0.70 ± 0.2 cm(2), p<0.001. Pre-procedural moderate or severe AR (42% vs. 26%, p=0.013) and mitral regurgitation (56% vs. 36%, p=0.004) were more common in the high NT-proBNP group. After TAVI, moderate or severe AR occurred in 26% of patients and was associated with increased 2-year mortality only in the low NT-proBNP group, while patients in the high NT-proBNP group were not affected. CONCLUSIONS: Moderate or severe AR after TAVI was not associated with increased 2-year mortality in patients with high baseline NT-proBNP. Our data suggest that the impact of AR after TAVI is absent in patients with significant pre-procedural AR or mitral regurgitation and more severe aortic stenosis.
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Insuficiencia de la Válvula Aórtica/sangre , Insuficiencia de la Válvula Aórtica/mortalidad , Péptido Natriurético Encefálico/sangre , Fragmentos de Péptidos/sangre , Complicaciones Posoperatorias/sangre , Complicaciones Posoperatorias/mortalidad , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Anciano de 80 o más Años , Insuficiencia de la Válvula Aórtica/diagnóstico , Biomarcadores/sangre , Causas de Muerte/tendencias , Femenino , Estudios de Seguimiento , Humanos , Masculino , Complicaciones Posoperatorias/diagnóstico , Sistema de Registros , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/tendenciasRESUMEN
BACKGROUND: The use of balloon aortic valvuloplasty (BAV) has resurged since the development of transcatheter aortic valve replacement (TAVR). The aim of our study was to determine the procedural and long-term outcomes of patients treated by BAV in the early TAVR era. METHODS: From 2005 to 2008, 323 consecutive patients presenting with severe aortic stenosis were treated by BAV in our institution. RESULTS: Mean age and logistic EuroSCORE were 80.5 ± 9.9 years and 28.7% ± 12.5%, respectively. The effective orifice area increased from 0.68 ± 0.25 to 1.12 ± 0.39 cm(2) (P < .001) after BAV. Inhospital major complications occurred in 22 patients (6.8%), with a mortality rate of 2.5%. Eighty-five patients (26.3%) were bridged to surgical aortic valve replacement (SAVR, 9.6%) or TAVR (16.7%). Twenty-eight patients (8.7%) had at least 1 repeat BAV. Two hundred ten patients (65%) received only medical therapy post-BAV. Mean duration of follow-up was 20.7 ± 20.0 months. Kaplan-Meier analysis demonstrated that survival after single BAV was poor. Patients treated by BAV followed by SAVR or TAVR had the highest long-term survival rate (P < .001). Multivariable analysis revealed that logistic EuroSCORE, severe aortic regurgitation and stroke complications post-BAV, and medical therapy post-BAV were independent predictors of mortality. CONCLUSIONS: The results of our study suggest that BAV is an acceptable bridge to SAVR or TAVR in a very high-risk population not immediately suitable for definitive therapy. Balloon aortic valvuloplasty remains only a brief temporizing procedure with a poor long-term outcome without subsequent definitive therapy.
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Estenosis de la Válvula Aórtica/cirugía , Valvuloplastia con Balón/métodos , Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico , Ecocardiografía , Femenino , Estudios de Seguimiento , Humanos , Masculino , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Factores de Tiempo , Resultado del TratamientoRESUMEN
AIMS: It is currently unknown whether the expandable sheath (e-sheath) for transfemoral Edwards transcatheter aortic valve replacement (TAVR) has a lower rate of access complications than the 18/19F fixed size sheath (f-sheath). Our aim was to compare the incidence of procedural complications when using f-sheath vs. e-sheath during TAVR. METHODS: We included 162 consecutive patients, implanted with the Edwards SAPIEN XT valve in our center. Access closure was obtained with the Prostar system in all cases. E-sheath was used in 80 patients (49%). RESULTS: Minimal ilio-femoral diameter was comparable in e-sheath and f-sheath groups: 6.7 (6.1-7.7) vs. 7 (6.2-8) mm, P = 0.25, as was the frequency of peripheral artery disease: 12.5% vs. 13.4%, P = 1.0. VARC major vascular complications rate was similar in the 2 groups: e-sheath 7 (8.8%) vs. f-sheath 6 (7.3%), P = 0.74, as was the incidence of minor vascular complications: 8 (10%) vs. 14 (17.1%), P = 0.19, life-threatening bleeding: 6 (7.5%) vs. 6 (7.3%), P = 0.96, major and minor bleeding and use of covered vascular stents: 9 (11%) vs. 6 (7.5%), P = 0.59. CONCLUSIONS: The e-sheath for TAVR with the Edwards valve did not show an advantage over the f-sheath in reducing vascular and bleeding complications.
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Estenosis de la Válvula Aórtica/terapia , Cateterismo Cardíaco/instrumentación , Vena Femoral , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Dispositivos de Acceso Vascular , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico , Cateterismo Cardíaco/efectos adversos , Diseño de Equipo , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Hemorragia/etiología , Hemorragia/prevención & control , Humanos , Masculino , Punciones , Factores de Riesgo , Resultado del TratamientoRESUMEN
OBJECTIVES: To evaluate the incidence, predictors and impact of bleeding after transcatheter aortic valve implantation (TAVI). DESIGN: Single-centre prospective observational study. SETTING: Charles Nicolle University Hospital, Rouen, France. INTERVENTIONS: We included 250 consecutive patients who underwent TAVI between May 2006 and October 2011. All procedures were performed using Edwards SAPIEN and SAPIEN XT valves via transfemoral (TF) and transapical (TA) routes. Surgical cutdown was used for TF access when implanting the SAPIEN valve, while percutaneous access was used for SAPIEN XT implantation. Life-threatening bleeding (LTB), major and minor bleeding and other complications were defined using Valve Academic Research Consortium criteria. RESULTS: TAVI was performed via TF access in 190 cases (76%) and the SAPIEN XT valve was used in 123 cases (49.2%). Bleeding after TAVI was noted in 68 patients (27.2%): LTB in 33 (13.2%), major bleeding in 23 (9.2%) and minor bleeding in 12 (4.8%). By multivariate analysis, only TA access was an independent predictor of LTB (OR 3.7, 95% CI 1.73 to 7.9, p = 0.001). Patients presenting with LTB after TAVI had a higher 30-day mortality (33.3% vs 3.7%, p < 0.001) and 1-year mortality (54% vs 18%, p < 0.001). LTB was an independent predictive factor of 1-year mortality (HR 2.54, 95% CI 1.3 to 4.9, p = 0.002). CONCLUSIONS: Bleeding is a frequent complication of TAVI, occurring in 27% of cases. LTB is associated with higher 30-day and 1-year mortality.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Hemorragia Posoperatoria/epidemiología , Medición de Riesgo/métodos , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/mortalidad , Cateterismo Cardíaco/efectos adversos , Femenino , Arteria Femoral , Estudios de Seguimiento , Francia/epidemiología , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Incidencia , Masculino , Hemorragia Posoperatoria/etiología , Pronóstico , Estudios Prospectivos , Diseño de Prótesis , Factores de RiesgoRESUMEN
A good selection of patients is a crucial step before transcatheter aortic valve implantation (TAVI) in order to select the good indications and choose the access route. TAVI should be considered only in patients with symptomatic severe aortic stenosis and either contraindication or high surgical risk. Indication for TAVI should be discussed in a multidisciplinary team meeting. Echocardiography and/or CT scan are mandatory to evaluate the aortic annulus size and select the good prosthesis size. The possibility of transfemoral implantation is evaluated by angiography and CT scan, and based on the arterial diameters, but also on the presence of tortuosities and arterial calcifications.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Angiografía , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Ecocardiografía , Prótesis Valvulares Cardíacas , Humanos , Selección de Paciente , Tomografía Computarizada por Rayos XRESUMEN
Intraoperative aortic dissection is a rare but potentially fatal complication of cardiac surgery. In this report, we present a case of intraoperative aortic dissection that was complicated by intestinal ischaemia. The aorta was successfully repaired using both open and endovascular techniques.