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Estenosis de la Válvula Aórtica , Válvula Aórtica , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Stents , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Resultado del Tratamiento , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Masculino , Anciano de 80 o más Años , Índice de Severidad de la Enfermedad , FemeninoRESUMEN
BACKGROUND AND AIMS: This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction. METHODS: This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board. RESULTS: Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all [100%; 95% confidence interval (CI) 94%-100.0%, P < .001] patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9â min. Freedom from the primary safety endpoint was achieved in 59 [98.3%; 95% CI (91.1%-100%)] patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1%-99.0%). Within 90 days, freedom from mortality was 95% [95% CI (86.1%-99.0%)], without any cardiovascular deaths. CONCLUSIONS: Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favourable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.
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Estenosis de la Válvula Aórtica , Bioprótesis , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Femenino , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Masculino , Anciano , Estudios Prospectivos , Estenosis de la Válvula Aórtica/cirugía , Falla de Prótesis , Diseño de Prótesis , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Resultado del Tratamiento , Oclusión Coronaria/cirugía , Complicaciones Posoperatorias/epidemiologíaRESUMEN
OBJECTIVES: To investigate the effect of an audiovisual distraction system on the dose of remifentanil for perioperative sedation during transcatheter aortic valve implantation under monitored anesthesia care. DESIGN: Single-center prospective randomized nonblinded study. SETTING: Tertiary referral academic hospital. PARTICIPANTS: Ninety patients who underwent transfemoral transcatheter aortic valve implantation between July 2019 and July 2021. INTERVENTIONS: Patients were randomized to use either a novel audiovisual distraction system during the intervention (n = 45) or standard care without an audiovisual distraction system (n = 45). MEASUREMENTS AND MAIN RESULTS: Standardized questionnaires were given to each patient at admission and before and after the intervention to assess their levels of anxiety. Primary endpoints were the average and peak infusion rates of remifentanil. All patients were considered for the final analysis according to an intention-to-treat design. No relevant differences in pre- and postinterventional anxiety status were observed between the groups. Similarly, there were no significant differences in reported pain scores (p = 0.364). The average infusion rate (p = 0.028) and peak infusion rate (p = 0.025) of remifentanil were lower in the group with an audiovisual distraction system. CONCLUSIONS: Audiovisual distraction is a useful adjunct to reduce the dose of remifentanil under monitored anesthesia care during transcatheter aortic valve implantation. Larger studies are needed to evaluate potential positive effects on patient satisfaction, incidence of delirium, and possible economic benefits.
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Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Femenino , Estudios Prospectivos , Masculino , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano , Anciano de 80 o más Años , Remifentanilo/administración & dosificación , Manejo del Dolor/métodos , Recursos Audiovisuales , Anestesia/métodosRESUMEN
BACKGROUND: Coronary obstruction (CO) is a potentially life-threatening complication of transcatheter aortic valve replacement (TAVR). Chimney stenting or leaflet laceration with transcatheter electrosurgery (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction [BASILICA]) are 2 techniques developed to prevent CO. OBJECTIVES: The aim of the present study was to compare periprocedural and 1-year outcomes of chimney and BASILICA in TAVR patients at high risk of CO. METHODS: This multicenter observational registry enrolled consecutive TAVR patients at high risk of CO, undergoing either preventive chimney stenting or BASILICA. Clinical success was defined as successful performance of the chimney or BASILICA technique without clinically relevant ostial CO. The primary endpoint was major adverse cardiovascular events, a composite of death, myocardial infarction, stroke, or unplanned target lesion coronary revascularization at 1 year. RESULTS: A total of 168 patients were included: 71 (42.3%) received chimney stenting, and 97 (57.7%) underwent BASILICA. Patients undergoing BASILICA had higher preprocedural risk of CO, as indicated by lower sinotubular junction height (18.2 ± 4.8 mm vs 14.8 ± 3.4 mm; P < 0.001) and diameter (28.2 ± 4.5 vs 26.8 ± 3.4; P = 0.029). Rates of periprocedural complications were similar between the 2 groups. Clinical success was 97.2% and 96.9% in chimney and BASILICA, respectively (P = 0.92). At 1-year follow-up, the cumulative incidence of major adverse cardiovascular events was 18.7% (95% CI: 11%-30.6%) in the chimney group and 19.9% (95% CI: 12.1%-31.5%) in the BASILICA group (log-rank P = 0.848), whereas chimney was associated with a numerically higher cardiovascular mortality than BASILICA (6.7% vs 1.3%; log-rank P = 0.168). CONCLUSIONS: Chimney stenting and BASILICA effectively prevent TAVR-induced acute CO. Both techniques seem to have comparable acceptable periprocedural and 1-year outcomes.
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Estenosis de la Válvula Aórtica , Oclusión Coronaria , Prótesis Valvulares Cardíacas , Laceraciones , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Laceraciones/complicaciones , Laceraciones/cirugía , Prótesis Valvulares Cardíacas/efectos adversos , Resultado del Tratamiento , Oclusión Coronaria/etiología , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Diseño de PrótesisRESUMEN
BACKGROUND: There are limited data on the impact of transcatheter heart valve (THV) type on the outcomes of surgical explantation after THV failure. AIMS: We sought to determine the outcomes of transcatheter aortic valve replacement (TAVR) explantation for failed balloon-expandable valves (BEV) versus self-expanding valves (SEV). METHODS: From November 2009 to February 2022, 401 patients across 42 centres in the EXPLANT-TAVR registry underwent TAVR explantation during a separate admission from the initial TAVR. Mechanically expandable valves (N=10, 2.5%) were excluded. The outcomes of TAVR explantation were compared for 202 (51.7%) failed BEV and 189 (48.3%) failed SEV. RESULTS: Among 391 patients analysed (mean age: 73.0±9.8 years; 33.8% female), the median time from index TAVR to TAVR explantation was 13.3 months (interquartile range 5.1-34.8), with no differences between groups. Indications for TAVR explantation included endocarditis (36.0% failed SEV vs 55.4% failed BEV; p<0.001), paravalvular leak (21.2% vs 11.9%; p=0.014), structural valve deterioration (30.2% vs 21.8%; p=0.065) and prosthesis-patient mismatch (8.5% vs 10.4%; p=0.61). The SEV group trended fewer urgent/emergency surgeries (52.0% vs 62.3%; p=0.057) and more root replacement (15.3% vs 7.4%; p=0.016). Concomitant cardiac procedures were performed in 57.8% of patients, including coronary artery bypass graft (24.8%), and mitral (38.9%) and tricuspid (14.6%) valve surgery, with no differences between groups. In-hospital, 30-day, and 1-year mortality and stroke rates were similar between groups (allp>0.05), with no differences in cumulative mortality at 3 years (log-rank p=0.95). On multivariable analysis, concomitant mitral surgery was an independent predictor of 1-year mortality after BEV explant (hazard ratio [HR] 2.00, 95% confidence interval [CI]: 1.07-3.72) and SEV explant (HR 2.00, 95% CI: 1.08-3.69). CONCLUSIONS: In the EXPLANT-TAVR global registry, BEV and SEV groups had different indications for surgical explantation, with more root replacements in SEV failure, but no differences in midterm mortality and morbidities. Further refinement of TAVR explantation techniques are important to improving outcomes.
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Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Femenino , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Masculino , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Remoción de Dispositivos , Catéteres , Válvulas Cardíacas , Sistema de RegistrosRESUMEN
OBJECTIVES: Aortic valve regurgitation (AR) frequently complicates the clinical course after left ventricular assist device (LVAD) implantation. Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement (SAVR) in this cohort with a mostly high surgical risk profile. The unique challenges in LVAD patients, such as presence of non-calcified aortic valves and annular dilatation, raise concerns about device migration and paravalvular leakage (PVL) leading to missing device success. This study evaluates procedural outcomes and survival rates in LVAD patients who underwent TAVI, emphasizing strategies to enhance device success. METHODS: Between January 2017 and April 2023, 27 LVAD patients with clinically significant AR underwent elective or urgent TAVI at our centre. Primary end-points were procedural success rates, without the need for a second transcatheter heart valve (THV) and postprocedural AR/PVL. Secondary outcomes included survival rates and adverse events. RESULTS: Among the cohort, 14.8% received AR-dedicated TAVI devices, with none requiring a second THV. There was no intraprocedural AR, and 1 patient (25%) had AR > 'trace' at discharge. Additionally, 25.9% underwent device landing zone (DLZ) pre-stenting with a standard TAVI device, all without needing a second THV. There was no intraprocedural AR, and none to trace AR at discharge. Among the 59.3% receiving standard TAVI devices, 37.5% required a second THV. In this subgroup, intraprocedural AR > 'trace' occurred in 12.5%, decreasing to 6.25% at discharge. In-hospital mortality was 3.7%, and median follow-up survival was 388 days (interquartile range 208-1167 days). CONCLUSIONS: TAVI yields promising procedural outcomes and early survival rates in LVAD patients with AR. Tailored TAVI devices and pre-stenting techniques enhance procedural success. Continued research into these strategies is essential to optimize outcomes in this complex patient cohort.
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Insuficiencia de la Válvula Aórtica , Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Corazón Auxiliar , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Corazón Auxiliar/efectos adversos , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Insuficiencia de la Válvula Aórtica/etiología , Insuficiencia de la Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/métodosRESUMEN
BACKGROUND: Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction. OBJECTIVES: This study aimed to determine whether device position and asymmetry are associated with these outcomes. METHODS: Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ≥5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated. RESULTS: A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027). CONCLUSIONS: Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered.
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Fibrilación Atrial , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Humanos , Femenino , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Masculino , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Constricción Patológica/etiología , Resultado del Tratamiento , Cateterismo Cardíaco/efectos adversos , Hemodinámica , Sistema de Registros , Diseño de PrótesisRESUMEN
Objective: The use of transcatheter mitral valve repair (TMVr) devices is increasing in elderly and high-risk patients. However, the increasing number of patients with recurrent mitral regurgitation (MR) has confronted surgeons with the issue of how to explant the devices and whether the mitral valve should be repaired or replaced. The aim of the study is to summarize our clinical experience with the explantation of different TMVr devices and to provide alternative surgical techniques that can be performed in different clinical scenarios. Methods: A simulator system including a dummy valve representing native valves was used to create video documentation and to develop alternative surgical methods for clip explantation. Moreover, the clip explantation techniques were shown in 2 patients undergoing minimally-invasive mitral valve repair after a failed TMVr. Results: Alternative explantation techniques were described for each TMVr device; 2 techniques for MitraClip and 3 techniques for PASCAL (Precision Transcatheter Valve Repair System), which may be adjusted for each individual according to the underlying valve pathology and the degree of device encapsulation. The patients were discharged without residual MR and remained MR free at the follow-up. Conclusions: Transcatheter edge-to-edge repair devices can be surgically explanted without damaging the MV leaflets. Removal of each device may require a different technique tailored to the degree of device encapsulation and valve pathology. Increasing experience may facilitate repair in patients with recurrent MR after TMVr.
RESUMEN
BACKGROUND: Preprocedural computed tomography planning improves procedural safety and efficacy of transcatheter aortic valve implantation (TAVI). However, contemporary imaging modalities do not account for device-host interactions. AIMS: This study evaluates the value of preprocedural computer simulation with FEops HEARTguideTM on overall device success in patients with challenging anatomies undergoing TAVI with a contemporary self-expanding supra-annular transcatheter heart valve. METHODS: This prospective multicenter observational study included patients with a challenging anatomy defined as bicuspid aortic valve, small annulus or severely calcified aortic valve. We compared the heart team's transcatheter heart valve (THV) planning decision based on (1) conventional multislice computed tomography (MSCT) and (2) MSCT imaging with FEops HEARTguideTM simulations. Clinical outcomes and THV performance were followed up to 30 days. RESULTS: A total of 77 patients were included (median age 79.9 years (IQR 74.2-83.8), 42% male). In 35% of the patients, preprocedural planning changed after FEops HEARTguideTM simulations (change in valve size selection [12%] or target implantation height [23%]). A new permanent pacemaker implantation (PPI) was implanted in 13% and >trace paravalvular leakage (PVL) occurred in 28.5%. The contact pressure index (i.e., simulation output indicating the risk of conduction abnormalities) was significantly higher in patients with a new PPI, compared to those without (16.0% [25th-75th percentile 12.0-21.0] vs. 3.5% [25th-75th percentile 0-11.3], p < 0.01) The predicted PVL was 5.7 mL/s (25th-75th percentile 1.3-11.1) in patients with none-trace PVL, 12.7 (25th-75th percentile 5.5-19.1) in mild PVL and 17.7 (25th-75th percentile 3.6-19.4) in moderate PVL (p = 0.04). CONCLUSION: FEops HEARTguideTM simulations may provide enhanced insights in the risk for PVL or PPI after TAVI with a self-expanding supra-annular THV in complex anatomies.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Masculino , Anciano , Anciano de 80 o más Años , Femenino , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Simulación por Computador , Estudios Prospectivos , Resultado del Tratamiento , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Tomografía Computarizada Multidetector/métodos , Diseño de PrótesisRESUMEN
BACKGROUND: Patients with severe aortic regurgitation (AR) are often not considered for surgery because of increased surgical risk. Because of unique anatomical characteristics among patients with AR, interventional treatment options are limited, and implantation results are inconsistent compared with those among patients with aortic stenosis. OBJECTIVES: The authors describe the initial commercial experience of the first Conformité Européenne-marked transfemoral transcatheter aortic valve replacement system (JenaValve Trilogy [JV]) for the treatment of patients with AR. METHODS: This multicenter registry included 58 consecutive patients from 6 centers across Germany. Transcatheter aortic valve replacement was performed with the JV system for isolated severe and symptomatic AR. Patient characteristics, primary implantation outcomes, and valve performance up to 30 days were analyzed using Valve Academic Research Consortium 3 definitions. RESULTS: The mean patient age was 76.5 ± 9 years, with a mean Society of Thoracic Surgeons score of 4.2% ± 4.3%. Device success was achieved in 98% of patients. The mean gradient was 4.3 ± 1.6 mm Hg, and no moderate or severe paravalvular regurgitation occurred. No conversion to open heart surgery or valve embolization was reported. There were no major vascular complications or bleeding events. The rate of new permanent pacemaker implantation was 19.6%. At 30 days, 92% of the patients were in NYHA functional class I or II, and the 30-day mortality rate was 1.7%. CONCLUSIONS: Treatment of patients with severe symptomatic AR using the transfemoral JV system is safe and effective. Given its favorable hemodynamic performance and low complication rates, this system may offer a new treatment option for patients with AR not suitable for surgery.
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Insuficiencia de la Válvula Aórtica , Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Anciano , Anciano de 80 o más Años , Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Insuficiencia de la Válvula Aórtica/etiología , Insuficiencia de la Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento , Corazón , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugíaRESUMEN
BACKGROUND: The real-world outcomes of the use of the BASILICA (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction) transcatheter technique in Europe have not been described. AIMS: We sought to evaluate the procedural and one-year outcomes of BASILICA in patients at high risk for coronary artery obstruction (CAO) undergoing transcatheter aortic valve implantation (TAVI) in a multicentre European registry (EURO-BASILICA). METHODS: Seventy-six patients undergoing BASILICA and TAVI at ten European centres were included. Eighty-five leaflets were identified as targets for BASILICA due to high risk for CAO. The updated Valve Academic Research Consortium 3 (VARC-3) definitions were used to determine prespecified endpoints of technical and procedural success and adverse events up to one year. RESULTS: Treated aortic valves included native (5.3%), surgical bioprosthetic (92.1%) and transcatheter valves (2.6%). Double BASILICA (for both left and right coronary cusps) was performed in 11.8% of patients. Technical success with BASILICA was achieved in 97.7% and resulted in freedom from any target leaflet-related CAO in 90.6% with a low rate of complete CAO (2.4%). Target leaflet-related CAO occurred significantly more often in older and stentless bioprosthetic valves and with higher implantation levels of transcatheter heart valves. Procedural success was 88.2%, and freedom from VARC-3-defined early safety endpoints was 79.0%. One-year survival was 84.2%; 90.5% of patients were in New York Heart Association Functional Class I/II. CONCLUSIONS: EURO-BASILICA is the first multicentre study evaluating the BASILICA technique in Europe. The technique appeared feasible and effective in preventing TAVI-induced CAO, and one-year clinical outcomes were favourable. The residual risk for CAO requires further study.
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Estenosis de la Válvula Aórtica , Bioprótesis , Oclusión Coronaria , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Anciano , Resultado del Tratamiento , Diseño de Prótesis , Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Oclusión Coronaria/cirugía , Estenosis de la Válvula Aórtica/cirugíaRESUMEN
BACKGROUND: Valve reintervention after transcatheter aortic valve replacement (TAVR) failure has not been studied in detail. OBJECTIVES: The authors sought to determine outcomes of TAVR surgical explantation (TAVR-explant) vs redo-TAVR because they are largely unknown. METHODS: From May 2009 to February 2022, 396 patients in the international EXPLANTORREDO-TAVR registry underwent TAVR-explant (181, 46.4%) or redo-TAVR (215, 54.3%) for transcatheter heart valve (THV) failure during a separate admission from the initial TAVR. Outcomes were reported at 30 days and 1 year. RESULTS: The incidence of reintervention after THV failure was 0.59% with increasing volume during the study period. Median time from index-TAVR to reintervention was shorter in TAVR-explant vs redo-TAVR (17.6 months [IQR: 5.0-40.7 months] vs 45.7 months [IQR: 10.6-75.6 months]; P < 0.001], respectively. TAVR-explant had more prosthesis-patient mismatch (17.1% vs 0.5%; P < 0.001) as the indication for reintervention, whereas redo-TAVR had more structural valve degeneration (63.7% vs 51.9%; P = 0.023), with a similar incidence of ≥moderate paravalvular leak between groups (28.7% vs 32.8% in redo-TAVR; P = 0.44). There was a similar proportion of balloon-expandable THV failures (39.8% TAVR-explant vs 40.5% redo-TAVR; P = 0.92). Median follow-up was 11.3 (IQR: 1.6-27.1 months) after reintervention. Compared with redo-TAVR, TAVR-explant had higher mortality at 30 days (13.6% vs 3.4%; P < 0.001) and 1 year (32.4% vs 15.4%; P = 0.001), with similar stroke rates between groups. On landmark analysis, mortality was similar between groups after 30 days (P = 0.91). CONCLUSIONS: In this first report of the EXPLANTORREDO-TAVR global registry, TAVR-explant had a shorter median time to reintervention, with less structural valve degeneration, more prosthesis-patient mismatch, and similar paravalvular leak rates compared with redo-TAVR. TAVR-explant had higher mortality at 30 days and 1 year, but similar rates on landmark analysis after 30 days.
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Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Factores de Riesgo , Sistema de Registros , Diseño de PrótesisRESUMEN
BACKGROUND: Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement (TAVR) procedures. Current preventive strategies are suboptimal. OBJECTIVES: The aim of this study was to describe bench testing and clinical experience with a novel device that splits valve leaflets that are at risk for causing coronary obstruction after TAVR, allowing normal coronary flow. METHODS: The ShortCut device was initially tested in vitro and preclinically in a porcine model for functionality and safety. The device was subsequently offered to patients at elevated risk for coronary obstruction. Risk for coronary obstruction was based on computed tomography-based anatomical characteristics. Procedure success was determined as patient survival at 30 days with a functioning new valve, without stroke or coronary obstruction. RESULTS: Following a successful completion of bench testing and preclinical trial, the device was used in 8 patients with failed bioprosthetic valves (median age 81 years; IQR: 72-85 years; 37.5% man) at 2 medical centers. A total of 11 leaflets were split: 5 patients (63.5%) were considered at risk for left main obstruction alone, and 3 patients (37.5%) were at risk for double coronary obstruction. All patients underwent successful TAVR without evidence of coronary obstruction. All patients were discharged from the hospital in good clinical condition, and no adverse neurologic events were noted. Procedure success was 100%. CONCLUSIONS: Evaluation of the first dedicated transcatheter leaflet-splitting device shows that the device can successfully split degenerated bioprosthetic valve leaflets. The procedure was safe and successfully prevented coronary obstruction in patients at risk for this complication following TAVR.
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Estenosis de la Válvula Aórtica , Bioprótesis , Oclusión Coronaria , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Masculino , Humanos , Porcinos , Animales , Anciano de 80 o más Años , Prótesis Valvulares Cardíacas/efectos adversos , Factores de Riesgo , Falla de Prótesis , Resultado del Tratamiento , Bioprótesis/efectos adversos , Diseño de Prótesis , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/etiología , Oclusión Coronaria/prevención & control , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicacionesRESUMEN
OBJECTIVES: In aortic valve replacement (AVR), the treatment strategy as well as the model and size of the implanted prosthesis have a major impact on the postoperative hemodynamics and thus on the clinical outcome. Preinterventional prediction of the hemodynamics could support the treatment decision. Therefore, we performed paired virtual treatment with transcatheter AVR (TAVI) and biological surgical AVR (SAVR) and compared hemodynamic outcomes using numerical simulations. METHODS: 10 patients with severe aortic stenosis (AS) undergoing TAVI were virtually treated with both biological SAVR and TAVI to compare post-interventional hemodynamics using numerical simulations of peak-systolic flow. Virtual treatment procedure was done using an in-house developed tool based on position-based dynamics methodology, which was applied to the patient's anatomy including LVOT, aortic root and aorta. Geometries were automatically segmented from dynamic CT-scans and patient-specific flow rates were calculated by volumetric analysis of the left ventricle. Hemodynamics were assessed using the STAR CCM+ software by solving the RANS equations. RESULTS: Virtual treatment with TAVI resulted in realistic hemodynamics comparable to echocardiographic measurements (median difference in transvalvular pressure gradient [TPG]: -0.33 mm Hg). Virtual TAVI and SAVR showed similar hemodynamic functions with a mean TPG with standard deviation of 8.45 ± 4.60 mm Hg in TAVI and 6.66 ± 3.79 mm Hg in SAVR (p = 0.03) while max. Wall shear stress being 12.6 ± 4.59 vs. 10.2 ± 4.42 Pa (p = 0.001). CONCLUSIONS: Using the presented method for virtual treatment of AS, we were able to reliably predict post-interventional hemodynamics. TAVI and SAVR show similar hemodynamics in a pairwise comparison.
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Estenosis de la Válvula Aórtica , Implantación de Prótesis de Válvulas Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Estenosis de la Válvula Aórtica/cirugía , Resultado del Tratamiento , Hemodinámica , Factores de RiesgoRESUMEN
Coronary artery obstruction is a life-threatening complication of transcatheter aortic valve replacement procedures, and current preventive strategies are suboptimal. The novel ShortCut device splits bioprosthetic valve leaflets that are at risk of causing coronary artery obstruction after transcatheter aortic valve implantation, allowing for normal coronary flow. In this video tutorial, we demonstrate a valve-in-valve transcatheter aortic valve implantation using a dedicated leaflet-splitting device for prevention of coronary artery obstruction in transcatheter aortic valve replacement.
Asunto(s)
Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Vasos Coronarios , CatéteresRESUMEN
Minimally invasive aortic valve replacement has become a feasible approach to treat various aortic valve pathologies with limited procedural trauma. Several minimally invasive aortic valve replacement approaches with different levels of complexity and technical requirements are currently available.
Asunto(s)
Válvula Aórtica , Procedimientos Quirúrgicos Mínimamente Invasivos , Humanos , Válvula Aórtica/cirugíaRESUMEN
In this backstory, researchers from Swiss Federal Institute of Technology (ETH Zurich) who initiated an interdisciplinary program to generate innovative solutions for different cardiovascular diseases, such as myocardial infarction, valvular replacement, and movement-based rehabilitation therapy, discuss the benefits and challenges of interdisciplinary research.
RESUMEN
The introduction of the transcatheter aortic valve implantation procedure has revolutionized the standards of care in patients with aortic valve pathologies and has significantly increased the quality of the medical treatment provided. The durability and constant technical improvements in the modern transcatheter aortic valve implantation procedure have broadened the indications towards younger patient groups with low-risk profiles. Therefore, transcatheter aortic valve implantation now represents an effective alternative for surgical aortic valve replacement in a large number of cases. Currently, various technical methods for the transcatheter aortic valve implantation procedure are available. The contemporary transcatheter aortic valve implantation procedure focuses on optimization of postoperative results and reduction of complications such as paravalvular leakage and permanent pacemaker implantation. Another goal of transcatheter aortic valve implantation is the achievement of a valid lifetime concept with secure coronary access and conditions for future valve-in-valve interventions. In this case report, we demonstrate a standard transfemoral transcatheter aortic valve implantation procedure with a self-expandable supra-annular device, one of the most commonly performed methods.