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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<0.001) patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 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 favorable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI.
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AIMS: Conduction abnormalities post-transcatheter aortic valve implantation (TAVI) are common. Post-TAVI PR prolongation was mainly studied as an adjunct to new-onset bundle branch block. The net effect of isolated PR prolongation (IPRP) without post-TAVI QRS changes is not well known. The aim of this study was to define the incidence and clinical significance of post-TAVI IPRP. METHODS AND RESULTS: A total of 1108 consecutive TAVI patients were reviewed. Patients with IPRP were compared with patients without post-TAVI electrocardiogram (ECG) changes. Clinical outcomes included permanent pacemaker implantation (PPI) and overall mortality. A total of 146 patients with IPRP were compared with 290 patients without post-TAVI ECG changes. At 1 year follow-up, 4 (2.7%) and 7 (2.4%) patients underwent PPI (P = 0.838) and 10 (6.8%) and 25 (8.6%) died (P = 0.521), from the study and control groups, respectively. No patient with IPRP and narrow QRS underwent PPI during 1 year post-TAVI, and all death events were non-cardiac except one unknown cause. Permanent pacemaker implantation rates among patients with IPRP and wide QRS were higher (n = 4, 12.1%), compared with patients with wide QRS without post-TAVI ECG change (n = 3, 4%) however not reaching statistical significance (P = 0.126). Multivariate Cox proportional hazards model demonstrated that in patients with narrow QRS, neither PR prolongation nor baseline or maximal PR intervals was associated with the combined endpoint of PPI and mortality. However, in patients with wide QRS, baseline PR intervals and QRS width, but not PR prolongation were associated with the combined outcome. CONCLUSION: Post-TAVI IPRP in patients with narrow QRS is not associated with adverse outcome. This finding may translate clinically into a more permissive approach to these patients.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Marcapaso Artificial , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Marcapaso Artificial/efectos adversos , Incidencia , Relevancia Clínica , Estimulación Cardíaca Artificial/efectos adversos , Estimulación Cardíaca Artificial/métodos , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Resultado del Tratamiento , Bloqueo de Rama/diagnóstico , Bloqueo de Rama/epidemiología , Bloqueo de Rama/terapia , Electrocardiografía , Válvula Aórtica/cirugía , Prótesis Valvulares Cardíacas/efectos adversosRESUMEN
AIMS: Severe mitral regurgitation (MR) following acute myocardial infarction (MI) is associated with high mortality rates and has inconclusive recommendations in clinical guidelines. We aimed to report the international experience of patients with secondary MR following acute MI and compare the outcomes of those treated conservatively, surgically, and percutaneously. METHODS AND RESULTS: Retrospective international registry of consecutive patients with at least moderate-to-severe MR following MI treated in 21 centres in North America, Europe, and the Middle East. The registry included patients treated conservatively and those having surgical mitral valve repair or replacement (SMVR) or percutaneous mitral valve repair (PMVR) using edge-to-edge repair. The primary endpoint was in-hospital mortality. A total of 471 patients were included (43% female, age 73 ± 11 years): 205 underwent interventions, of whom 106 were SMVR and 99 PMVR. Patients who underwent mitral valve intervention were in a worse clinical state (Killip class ≥3 in 60% vs. 43%, P < 0.01), but yet had lower in-hospital and 1-year mortality compared with those treated conservatively [11% vs. 27%, P < 0.01 and 16% vs. 35%, P < 0.01; adjusted hazard ratio (HR) 0.28, 95% confidence interval (CI) 0.18-0.46, P < 0.01]. Surgical mitral valve repair or replacement was performed earlier than PMVR [median of 12 days from MI date (interquartile range 5-19) vs. 19 days (10-40), P < 0.01]. The immediate procedural success did not differ between SMVR and PMVR (92% vs. 93%, P = 0.53). However, in-hospital and 1-year mortality rates were significantly higher in SMVR than in PMVR (16% vs. 6%, P = 0.03 and 31% vs. 17%, P = 0.04; adjusted HR 3.75, 95% CI 1.55-9.07, P < 0.01). CONCLUSIONS: Early intervention may mitigate the poor prognosis associated with conservative therapy in patients with post-MI MR. Percutaneous mitral valve repair can serve as an alternative for surgery in reducing MR for high-risk patients.
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Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Infarto del Miocardio , Anciano , Anciano de 80 o más Años , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Insuficiencia de la Válvula Mitral/complicaciones , Insuficiencia de la Válvula Mitral/cirugía , Infarto del Miocardio/complicaciones , Infarto del Miocardio/terapia , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Objectives: This study was planned for evaluating the safety and efficacy of SPAS (stent positioning assistance system) device in first-in-human procedures. Background: SPAS is a novel device that can be used for improved positioning of coronary stents. Methods: Consecutive patients underwent percutaneous coronary intervention (PCI) with the SPAS device. Device-related adverse and serious adverse events were evaluated in addition to a dedicated questionnaire completed by operators immediately after using SPAS. Results: The SPAS device was deployed in 55 PCI procedures, comprising of heavily calcified lesions (33.3%), totally occluded (7.4%), and severely tortuous vessels (7.4%). In these procedures, nonbifurcation and nonostial (53.7%), bifurcation (22.2%), and edge-to-edge (24.1%) stenting techniques were employed. Analysis of the pooled scores for the five satisfaction-related questions gave an average score of 5.6 ± 1.5, with 40 (75.5%) operators providing an average satisfaction grade of >5; the average operator-rated SPAS device accuracy performance scores exceeded 6 out of 7 (on visual analog score). The time spent for positioning the stent with the SPAS device averaged 41 ± 68.0 seconds. The SPAS device was rated as easy to use (6.1 ± 1.6) and reliable (6.1 ± 1.7). No device-related adverse events were reported. Conclusion: This stent positioning device was evaluated in a consecutive cohort of standard and complex PCI procedures. The device was shown to be safe, easy, and precise to use, both in standard and complex cases.
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Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Estudios de Cohortes , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/etiología , Enfermedad de la Arteria Coronaria/cirugía , Humanos , Intervención Coronaria Percutánea/métodos , Stents , Resultado del TratamientoRESUMEN
OBJECTIVES: To evaluate the use and outcomes of percutaneous mechanical circulatory support (pMCS) utilized during transcatheter aortic valve implantation (TAVI) from high-volume centers. METHODS AND RESULTS: Our international multicenter registry including 13 high-volume TAVI centers with 87 patients (76.5 ± 11.8 years, 63.2% men) who underwent TAVI for severe aortic stenosis and required pMCS (75.9% VA-ECMO, 19.5% Impella CP, 4.6% TandemHeart) during the procedure (prior to TAVI 39.1%, emergent rescue 50.6%, following TAVI 10.3%). The procedures were considered high-risk, with 50.6% having severe left ventricular dysfunction, 24.1% biventricular dysfunction, and 32.2% severe pulmonary hypertension. In-hospital and 1-year mortality were 27.5% and 49.4%, respectively. Patients with prophylactic hemodynamic support had lower periprocedural mortality compared to patients with rescue insertion of pMCS (log rank = 0.013) and patients who did not undergo cardiopulmonary resuscitation during the TAVI procedure had better short and long term survival (log rank <0.001 and 0.015, respectively). CONCLUSIONS: Given the overall survival rate and low frequency of pMCS-related complications, our study results support the use of pMCS prophylactically or during the course of TAVI (bailout) in order to improve clinical outcomes in high-risk procedures or in case of acute life-threatening hemodynamic collapse.
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Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Femenino , Humanos , Masculino , Sistema de Registros , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
OBJECTIVES: We sought to document aortic cusps fluoroscopic projections and their distributions using leaflet alignment which is a novel concept to optimize visualization of leaflets and for guiding BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction) and determine whether these projections were feasible in catheter laboratory. BACKGROUND: Optimal fluoroscopic projections of aortic valve cusps have not been well described. METHODS: A total of 128 pre-transcatheter aortic valve replacement (pre-TAVR) computed tomographies (CT) (72 native valves and 56 bioprosthetic surgical valves) were analyzed. Using CT software (3Mensio, Pie medical imaging, the Netherlands), leaflet alignment was performed and the feasibility of these angles, which were defined as rate of obtainable with efforts (within LAO/RAO of 85° and CRA/CAU of 50°) were evaluated. RESULTS: High feasibility was seen in right coronary cusp (RCC) front view (100%) and left coronary cusp (LCC) side view (99.2%), followed by noncoronary cusp side view (95.3%). In contrast, low feasibility of RCC side view (7.8%) and LCC front view (47.6%) was observed. No statistical differences were seen between the distribution of native valves and bioprosthetic surgical valves. With patient/table tilt of 20°LAO and 10°CRA, the feasibility of RCC side view and LCC front view increased to 43.7 and 85.2%, respectively. CONCLUSION: Distributions of each cusp's leaflet alignment follows "sigmoid curve" which can provide better understanding of aortic valve cusp orientation in TAVR and BASILICA. RCC side view used in right cusp BASILICA is commonly unachievable in catheter laboratory and may improve with patient/table tilt.
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Estenosis de la Válvula Aórtica , Bioprótesis , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Humanos , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
PURPOSE OF REVIEW: A combination of evolving 3D printing technologies, new 3D printable materials, and multi-disciplinary collaborations have made 3D printing applications for transcatheter aortic valve replacement (TAVR) a promising tool to promote innovation, increase procedural success, and provide a compelling educational tool. This review synthesizes the knowledge via publications and our group's experience in this area that exemplify uses of 3D printing for TAVR. RECENT FINDINGS: Patient-specific 3D-printed models have been used for TAVR pre-procedural device sizing, benchtop prediction of procedural complications, planning for valve-in-valve and bicuspid aortic valve procedures, and more. Recent publications also demonstrate how 3D printing can be used to test assumptions about why certain complications occur during THV implantation. Finally, new materials and combinations of existing materials are starting to bridge the large divide between current 3D material and cardiac tissue properties. Several studies have demonstrated the utility of 3D printing in understanding challenges of TAVR. Innovative approaches to benchtop testing and multi-material printing have brought us closer to being able to predict how a THV will interact with a specific patient's aortic anatomy. This work to date is likely to open the door for advancements in other areas of structural heart disease, such as interventions involving the mitral valve, tricuspid valve, and left atrial appendage.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Prótesis Valvulares Cardíacas , Impresión Tridimensional , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/diagnóstico , Humanos , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del TratamientoRESUMEN
Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.
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Bioprótesis/clasificación , Enfermedades de las Válvulas Cardíacas/cirugía , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas/clasificación , Válvulas Cardíacas/cirugía , Falla de Prótesis , Terminología como Asunto , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Remoción de Dispositivos , Enfermedades de las Válvulas Cardíacas/diagnóstico por imagen , Enfermedades de las Válvulas Cardíacas/fisiopatología , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Válvulas Cardíacas/diagnóstico por imagen , Válvulas Cardíacas/fisiopatología , Humanos , Valor Predictivo de las Pruebas , Diseño de Prótesis , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
Bioprosthetic valve dysfunction was treated in the past with redo open heart surgery. The need to identify occult leaflet infection was not an important requirement as all valve tissue was removed during surgery. With the dramatic growth in transcatheter aortic valve replacement (TAVR) valve-in-valve (ViV) therapy, identification of occult infection is of major significance. TAVR should be rarely performed in infected prosthetic valves and the optimal approach should include open heart surgery and removal of infected tissue. With surgical implants, it can be challenging to distinguish infection from degeneration. The use of advanced imaging modalities, including 18F-fluorodeoxyglucose positron emission tomography/computed tomography, in the diagnosis of occult infection is emerging. We report the use of this imaging modality to identify or exclude endocarditis in patients with prosthetic valves who were candidates for ViV therapy.
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Bioprótesis/efectos adversos , Endocarditis/diagnóstico por imagen , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas/efectos adversos , Tomografía Computarizada por Tomografía de Emisión de Positrones , Infecciones Relacionadas con Prótesis/diagnóstico por imagen , Adulto , Anciano , Toma de Decisiones Clínicas , Remoción de Dispositivos , Diagnóstico Diferencial , Endocarditis/etiología , Endocarditis/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Masculino , Selección de Paciente , Valor Predictivo de las Pruebas , Falla de Prótesis , Infecciones Relacionadas con Prótesis/etiología , Infecciones Relacionadas con Prótesis/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/instrumentaciónRESUMEN
OBJECTIVE: To identify outcomes of patients undergoing emergency transcatheter aortic valve replacement (TAVR) and determine predictors of in-hospital mortality. BACKGROUND: Emergency TAVR has emerged as a viable treatment strategy for patients with decompensated severe aortic stenosis and/or regurgitation; however, data on patients undergoing emergency TAVR are limited. METHODS: All emergency TAVR procedures were identified from a single tertiary academic center between January 2015 and August 2018. RESULTS: 31 patients underwent emergency TAVR due to cardiogenic shock (26 patients), electrical instability with incessant ventricular tachycardia (2 patients), severe refractory angina (2 patients), and decompensated heart failure with hypoxemic respiratory failure requiring mechanical ventilation (1 patient). Mechanical circulatory support (MCS) was used in 16 (51.6%). MCS initiation occurred immediately prior to TAVR in 10 patients and placed post-TAVR in 6 patients. 6 patients died before hospital discharge (in-hospital mortality 19.4%). 1-year and 2-year survival rates were 61.0% and 55.9%, respectively. Univariate predictors of in-hospital mortality were preprocedural pulmonary artery pulsatility index (PAPi) ≤1.8 (66.7% vs. 20.0%, p=0.01), intraprocedural cardiopulmonary resuscitation (CPR) (83.3% vs 4.0%, p ≤ 0.001), acute kidney injury post-TAVR (80.0% vs. 4.2%, p ≤ 0.001), initiation of dialysis post-TAVR (60.0% vs. 4.2%, p ≤ 0.001), and MCS initiation post-TAVR (50.0% vs. 12.0%, p=0.03). MCS initiation before TAVR was associated with improved survival compared with post-TAVR initiation. CONCLUSION: Emergency TAVR in extreme risk patients with acute decompensated heart failure or cardiogenic shock secondary to severe aortic valve disease is associated with high in-hospital mortality rates. Careful patient selection taking into account right heart function, assessed by PAPi, and early utilization of MCS may improve survival following emergency TAVR.
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Insuficiencia de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Urgencias Médicas , Mortalidad Hospitalaria , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Lesión Renal Aguda/mortalidad , Anciano , Angina Inestable/cirugía , Reanimación Cardiopulmonar , Oxigenación por Membrana Extracorpórea , Femenino , Insuficiencia Cardíaca/cirugía , Humanos , Periodo Intraoperatorio , Masculino , Flujo Pulsátil , Diálisis Renal/mortalidad , Insuficiencia Respiratoria/cirugía , Choque Cardiogénico/cirugía , Taquicardia Ventricular/cirugía , Washingtón/epidemiologíaRESUMEN
Aims: There are limited data on coronary obstruction following transcatheter valve-in-valve (ViV) implantation inside failed aortic bioprostheses. The objectives of this study were to determine the incidence, predictors, and clinical outcomes of coronary obstruction in transcatheter ViV procedures. Methods and results: A total of 1612 aortic procedures from the Valve-in-Valve International Data (VIVID) Registry were evaluated. Data were subject to centralized blinded corelab computed tomography (CT) analysis in a subset of patients. The virtual transcatheter valve to coronary ostium distance (VTC) was determined. A total of 37 patients (2.3%) had clinically evident coronary obstruction. Baseline clinical characteristics in the coronary obstruction patients were similar to controls. Coronary obstruction was more common in stented bioprostheses with externally mounted leaflets or stentless bioprostheses than in stented with internally mounted leaflets bioprostheses (6.1% vs. 3.7% vs. 0.8%, respectively; P < 0.001). CT measurements were obtained in 20 (54%) and 90 (5.4%) of patients with and without coronary obstruction, respectively. VTC distance was shorter in coronary obstruction patients in relation to controls (3.24 ± 2.22 vs. 6.30 ± 2.34, respectively; P < 0.001). Using multivariable analysis, the use of a stentless or stented bioprosthesis with externally mounted leaflets [odds ratio (OR): 7.67; 95% confidence interval (CI): 3.14-18.7; P < 0.001] associated with coronary obstruction for the global population. In a second model with CT data, a shorter VTC distance predicted this complication (OR: 0.22 per 1 mm increase; 95% CI: 0.09-0.51; P < 0.001), with an optimal cut-off level of 4 mm (area under the curve: 0.943; P < 0.001). Coronary obstruction was associated with a high 30-day mortality (52.9% vs. 3.9% in the controls, respectively; P < 0.001). Conclusion: Coronary obstruction following aortic ViV procedures is a life-threatening complication that occurred more frequently in patients with prior stentless or stented bioprostheses with externally mounted leaflets and in those with a short VTC.
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Oclusión Coronaria/epidemiología , Tomografía Computarizada Multidetector/métodos , Falla de Prótesis/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Anciano , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/etiología , Femenino , Prótesis Valvulares Cardíacas , Humanos , Incidencia , Masculino , Análisis Multivariante , Sistema de Registros , Factores de RiesgoRESUMEN
OBJECTIVE: To determine the safety and efficacy of valve-in-valve transcatheter aortic valve replacement (ViV) versus redo surgical aortic valve replacement (SAVR) for the treatment of previously failed aortic bioprostheses. BACKGROUND: Valve-in-valve has emerged as a treatment option for patients with a failed aortic bioprosthesis. Evidence for safety and efficacy remains limited to small studies. METHODS: Medline and Embase were searched to 2017 for studies that directly compared ViV to redo SAVR. A random effects meta-analysis was performed. RESULTS: Four unadjusted (n = 298) and two propensity-matched (n = 200) observational studies were included. Valve-in-valve patients were 2.85-years older (P = 0.03) and were 23% higher in predicted mortality risk (ratio of means: 1.23, 95% confidence interval (95%CI): 1.02-1.48). There was no difference in peri-operative mortality (4.4% vs. 5.7%, P = 0.83;I2 = 0%) or late mortality, reported at median one year follow-up (incident rate ratio (IRR) 0.93, 95%CI: 0.74-1.16, P = 0.51, I2 = 0%) between ViV and redo SAVR. The incidence of permanent pacemaker implantation (8.3% vs 14.6%; P = 0.05;I2 = 0%) and dialysis (3.2% vs. 10.3%; P = 0.03; I2 = 0%) were lower in ViV. There was a reduction in the incidence of severe patient-prosthesis mismatch (3.3% vs 13.5%; P = 0.03; I2 = 0%) and mild or greater paravalvular leak (5.5% vs 21.1%; P = 0.03; I2 = 37%) in the redo SAVR group compared to ViV. CONCLUSIONS: Despite higher predicted surgical risk of ViV patients, there was no difference in mortality but less permanent pacemaker implantation and dialysis compared to redo SAVR. Choice of treatment must be individualized for both anatomical and patient risk factors; in high risk patients with favorable previous prosthesis size, valve-in-valve may be preferred.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Bioprótesis , Remoción de Dispositivos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Prótesis Valvulares Cardíacas , Falla de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/fisiopatología , Remoción de Dispositivos/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Hemodinámica , Humanos , Diseño de Prótesis , Recuperación de la Función , Reoperación , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Resultado del TratamientoRESUMEN
BACKGROUND: Transcatheter Aortic Valve Implantation (TAVI) is commonly used to deploy new bioprosthetic valves inside degenerated surgically implanted aortic valves in high risk patients. The three scoring systems used to assess risk of postprocedural mortality are: Logistic EuroSCORE (LES), EuroSCORE II (ES II), and Society of Thoracic Surgeons (STS). OBJECTIVE: The purpose of this study is to analyze the accuracy of LES, ES II, and STS in estimating all-cause mortality after transcatheter aortic valve-in-valve (ViV) implantations, which was not assessed before. METHODS: Using the Valve-in-Valve International Data (VIVID) registry, a total of 1,550 patients from 110 centers were included. The study compared the observed 30-day overall mortality vs. the respective predicted mortalities calculated by risk scores. The accuracy of prediction models was assessed based on calibration and discrimination. RESULTS: Observed mortality at 30 days was 5.3%, while average expected mortalities by LES, ES II and STS were 29.49 (± 17.2), 14.59 (± 8.6), and 9.61 (± 8.51), respectively. All three risk scores overestimated 30-day mortality with ratios of 0.176 (95% CI 0.138-0.214), 0.342 (95% CI 0.264-0.419), and 0.536 (95% CI 0.421-0.651), respectively. 30-day mortality ROC curves demonstrated that ES II had the largest AUC at 0.722, followed by STS at 0.704, and LES at 0.698. CONCLUSIONS: All three scores overestimated mortality at 30 days with ES II showing the highest predictability compared to LES and STS; and therefore, should be recommended for ViV procedures. There is a need for a dedicated scoring system for patients undergoing ViV interventions.
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Válvula Aórtica/cirugía , Bioprótesis , Técnicas de Apoyo para la Decisión , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Prótesis Valvulares Cardíacas , Falla de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Anciano , Anciano de 80 o más Años , Válvula Aórtica/fisiopatología , Femenino , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Humanos , Masculino , Valor Predictivo de las Pruebas , Diseño de Prótesis , Sistema de Registros , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
OBJECTIVE: To compare the safety and efficacy of transcathether aortic valve-in-valve implantation (ViV-TAVI) in degenerated stentless bioprostheses with failed stented valves and degenerated native aortic valves. INTRODUCTION: Little is known about ViV-TAVI in degenerated stentless valves. METHODS: Out of 45 ViV-TAVI procedures reported in the POL-TAVI registry, 20 failed stentless valves were compared with 25 stented prostheses and propensity-matched with 45 native TAVI cases. The mean follow-up was 633 (95% confidence interval [CI], 471-795) days and Valve Academic Research Consortium-2 (VARC-2) definitions were applied. RESULTS: Patients with degenerated stentless valves were younger (65.6, CI 58-73.1 years vs 75.6, CI 72.2-78 [stented] vs 80.1, CI 78.7-81.6 y. [native], P < 0.001). Implantation was required later after surgery (11.5, CI 8-14.9 years) in the stentless cohort as compared with the stented one (6.2, CI 4.7-7.6 years, P = 0.006). ViV-TAVI in the stentless group was also associated with larger amount of contrast (211, CI 157-266 mL vs 135, CI 104-167 mL [stented] vs 132 (119-145) mL [native], P = 0.022). Using VARC-2 composite endpoints, ViV-TAVI in stentless prostheses was characterized by a lower device success (50% vs 76% in stented vs 88.9% in native TAVI, P < 0.001), but comparable early safety up to 30 days (73.7% vs 84% vs 81.8%, respectively, log-rank P = 0.667) and long-term clinical efficacy beyond 30 days (72.2% vs 72% vs 73.8%, respectively, log-rank P = 0.963). CONCLUSIONS: Despite technical challenges and a lower device success, ViV-TAVI in stentless aortic bioprostheses achieves similar safety, efficacy, and functional improvement as in stented or degenerated native valves.
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Estenosis de la Válvula Aórtica/cirugía , Bioprótesis/efectos adversos , Prótesis Valvulares Cardíacas/efectos adversos , Falla de Prótesis/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Ecocardiografía , Femenino , Humanos , Masculino , Diseño de Prótesis/efectos adversos , Diseño de Prótesis/métodos , Sistema de Registros , Stents , Análisis de Supervivencia , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
Transcatheter aortic valves provide superior systolic hemodynamic performance in terms of valvular pressure gradient and effective orifice area compared with equivalent size surgical bioprostheses. However, in depth investigation of the flow field structures is of interest to examine the flow field characteristics and provide experimental evidence necessary for validation of computational models. The goal of this study was to compare flow field characteristics of the three most commonly used transcatheter and surgical valves using phase-locked particle image velocimetry (PIV). 26-mm Edwards SAPIEN 3, 26-mm Medtronic CoreValve, and 25-mm Carpentier-Edwards PERIMOUNT Magna were examined in a pulse duplicator with input parameters matching ISO-5840, that is, heart rate of 70 beats/min, cardiac output of 5 L/min, and mean aortic pressure of 100 mm Hg. A 2D PIV system was used to obtain flow velocity and viscous shear stress fields during the entire cardiac cycle. In vitro testing showed that the mean transvalvular pressure gradient was lowest for SAPIEN 3, followed by CoreValve, and PERIMOUNT Magna surgical bioprosthesis. In addition, the viscous shear stress magnitude within the jet boundary layer was higher in PERIMOUNT Magna than CoreValve and SAPIEN 3 at the peak of the flow. However, the measured shear stress values were below the known threshold for platelet activation and red blood damage. Therefore, shear-induced platelet activation is unlikely to take place during systole in the three bioprosthetic heart valves. The PIV measurements can be used for verification and validation of computational simulations.
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Prótesis Valvulares Cardíacas , Hemodinámica , Hidrodinámica , Válvula Aórtica/cirugía , Bioprótesis , Simulación por Computador , Humanos , Ensayo de Materiales , Modelos Cardiovasculares , Diseño de Prótesis , Reología , Estrés Mecánico , Reemplazo de la Válvula Aórtica TranscatéterRESUMEN
BACKGROUND: Off-label use of transcatheter aortic and pulmonary valve prostheses for tricuspid valve-in-valve implantation (TVIV) within dysfunctional surgical tricuspid valve (TV) bioprostheses has been described in small reports. METHODS AND RESULTS: An international, multicenter registry was developed to collect data on TVIV cases. Patient-related factors, procedural details and outcomes, and follow-up data were analyzed. Valve-in-ring or heterotopic TV implantation procedures were not included. Data were collected on 156 patients with bioprosthetic TV dysfunction who underwent catheterization with planned TVIV. The median age was 40 years, and 71% of patients were in New York Heart Association class III or IV. Among 152 patients in whom TVIV was attempted with a Melody (n=94) or Sapien (n=58) valve, implantation was successful in 150, with few serious complications. After TVIV, both the TV inflow gradient and tricuspid regurgitation grade improved significantly. During follow-up (median, 13.3 months), 22 patients died, 5 within 30 days; all 22 patients were in New York Heart Association class III or IV, and 9 were hospitalized before TVIV. There were 10 TV reinterventions, and 3 other patients had significant recurrent TV dysfunction. At follow-up, 77% of patients were in New York Heart Association class I or II (P<0.001 versus before TVIV). Outcomes did not differ according to surgical valve size or TVIV valve type. CONCLUSIONS: TVIV with commercially available transcatheter prostheses is technically and clinically successful in patients of various ages across a wide range of valve size. Although preimplantation clinical status was associated with outcome, many patients in New York Heart Association class III or IV at baseline improved. TVIV should be considered a viable option for treatment of failing TV bioprostheses.
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Bioprótesis/tendencias , Cateterismo Cardíaco/métodos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Internacionalidad , Falla de Prótesis/tendencias , Insuficiencia de la Válvula Tricúspide/cirugía , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Bioprótesis/efectos adversos , Niño , Preescolar , Femenino , Estudios de Seguimiento , Humanos , Tiempo de Internación/tendencias , Masculino , Persona de Mediana Edad , Sistema de Registros , Resultado del Tratamiento , Insuficiencia de la Válvula Tricúspide/diagnóstico , Adulto JovenRESUMEN
BACKGROUND: The most common reason for reintervention after a Björk modification of the Fontan procedure, in which the right ventricle (RV) is incorporated into the pulmonary circulation by connecting the right atrial (RA) appendage to the RV directly or with an extra-anatomic graft, is obstruction or regurgitation of the RA-RV connection. Transcatheter implantation of a valved stent is an appealing option for the treatment of RA-RV conduit dysfunction in these patients. In the present study, we assessed early and intermediate results after transcatheter valve implantation within an obstructed or regurgitant RA-RV modified Fontan pathway. METHODS: Through a retrospective multicenter registry, we collected data from 16 patients with a modified Fontan circulation who were treated with percutaneous Melody or Sapien valve implantation for dysfunction of an extra-anatomic RA-RV conduit or valve. RESULTS: All patients had successful and uncomplicated implantation of a Melody (n = 15) or Sapien 3 (n = 1) valve with hemodynamic and, in most cases, clinical improvement. During a median follow-up of 3.3 years, 3 patients died of cardiovascular causes unrelated to the procedure or the valve, and no major valve dysfunction was observed. CONCLUSION: Percutaneous transcatheter valve deployment to treat a dysfunctional RA-RV connection after a Björk modification of the Fontan procedure is a viable alternative to surgery, with low procedural risk, and appears to offer good early and intermediate results.© 2016 Wiley Periodicals, Inc.
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Implantación de Prótesis Vascular , Cateterismo Cardíaco/métodos , Procedimiento de Fontan/efectos adversos , Oclusión de Injerto Vascular/terapia , Cardiopatías Congénitas/cirugía , Enfermedades de las Válvulas Cardíacas/terapia , Implantación de Prótesis de Válvulas Cardíacas/métodos , Adulto , Bioprótesis , Prótesis Vascular , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/instrumentación , Canadá , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Europa (Continente) , Femenino , Procedimiento de Fontan/métodos , Oclusión de Injerto Vascular/diagnóstico por imagen , Oclusión de Injerto Vascular/etiología , Oclusión de Injerto Vascular/fisiopatología , Cardiopatías Congénitas/diagnóstico por imagen , Cardiopatías Congénitas/fisiopatología , Enfermedades de las Válvulas Cardíacas/diagnóstico por imagen , Enfermedades de las Válvulas Cardíacas/etiología , Enfermedades de las Válvulas Cardíacas/fisiopatología , Prótesis Valvulares Cardíacas , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Hemodinámica , Humanos , Masculino , Persona de Mediana Edad , América del Norte , Diseño de Prótesis , Falla de Prótesis , Recuperación de la Función , Sistema de Registros , Estudios Retrospectivos , Stents , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: To evaluate the association between markers of precapillary pulmonary hypertension (PH) and survival in transcatheter aortic valve replacement (TAVR). BACKGROUND: The importance of precapillary PH has been sparsely investigated in patients undergoing TAVR. It may prove an important risk factor for poor outcomes. METHODS: We identified patients at our institution undergoing TAVR with a baseline right heart catheterization (RHC) demonstrating PH. We evaluated the association between markers of precapillary PH and survival including the diastolic pulmonary gradient (DPG), transpulmonary gradient (TPG), and pulmonary vascular resistance (PVR). A multivariable analysis was performed using Cox Proportional Hazards Models, adjusting for age, gender, body mass index, and pulmonary artery systolic pressure (PASP) on echocardiography. RESULTS: We identified 133 patients with PH on RHC. Of these 111 had low DPG and 22 had high DPG. All 3 markers of precapillary PH were associated with worse survival post TAVR, with OR of 2.1 (95% CI 1.1-3.9, P = 0.02), 3.4 (95% CI 1.8-6.4, P < 0.001) and 2.5 (95% CI 1.4-4.5, P = 0.003) for high DPG, TPG, and PVR, respectively. On multivariable analysis, both TPG and PVR remained predictors of worse survival, with OR of 3.4 (95% CI 1.7-6.9, P = 0.001) and 2.5 (95% CI 1.4-4.5, P = 0.003). Echocardiographic PASP and DPG were not predictive of survival. CONCLUSIONS: In patients undergoing TAVR, parameters of precapillary PH are associated with lower survival, and provide incremental prognostication over echocardiographic PASP. RHC should continue to play an important role in risk stratification prior to TAVR. © 2017 Wiley Periodicals, Inc.
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Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Presión Arterial , Hipertensión Pulmonar/fisiopatología , Arteria Pulmonar/fisiopatología , Circulación Pulmonar , Reemplazo de la Válvula Aórtica Transcatéter , Resistencia Vascular , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/fisiopatología , Colombia Británica , Cateterismo Cardíaco , Distribución de Chi-Cuadrado , Ecocardiografía , Femenino , Humanos , Hipertensión Pulmonar/complicaciones , Hipertensión Pulmonar/diagnóstico , Estimación de Kaplan-Meier , Masculino , Análisis Multivariante , Oportunidad Relativa , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: We aimed to determine the incidence, predictors, clinical characteristics, management, and outcomes of infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: This multicenter registry included 53 patients (mean age, 79±8 years; men, 57%) who suffered IE after TAVI of 7944 patients after a mean follow-up of 1.1±1.2 years (incidence, 0.67%, 0.50% within the first year after TAVI). Mean time from TAVI was 6 months (interquartile range, 1-14 months). Orotracheal intubation (hazard ratio, 3.87; 95% confidence interval, 1.55-9.64; P=0.004) and the self-expandable CoreValve system (hazard ratio, 3.12; 95% confidence interval, 1.37-7.14; P=0.007) were associated with IE (multivariate analysis including 3067 patients with individual data). The most frequent causal microorganisms were coagulase-negative staphylococci (24%), followed by Staphylococcus aureus (21%) and enterococci (21%). Vegetations were present in 77% of patients (transcatheter valve leaflets, 39%; stent frame, 17%; mitral valve, 21%). At least 1 complication of IE occurred in 87% of patients (heart failure in 68%). However, only 11% of patients underwent valve intervention (valve explantation and valve-in-valve procedure in 4 and 2 patients, respectively). The mortality rate in hospital was 47.2% and increased to 66% at the 1-year follow-up. IE complications such as heart failure (P=0.037) and septic shock (P=0.002) were associated with increased in-hospital mortality. CONCLUSIONS: The incidence of IE at 1 year after TAVI was 0.50%, and the risk increased with the use of orotracheal intubation and a self-expandable valve system. Staphylococci and enterococci were the most common agents. Although most patients presented at least 1 complication of IE, valve intervention was performed in a minority of patients, and nearly half of the patients died during the hospitalization period.
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Endocarditis Bacteriana/etiología , Prótesis Valvulares Cardíacas/efectos adversos , Complicaciones Posoperatorias/etiología , Infecciones Relacionadas con Prótesis/etiología , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/cirugía , Endocarditis Bacteriana/mortalidad , Endocarditis Bacteriana/cirugía , Enterococcus , Contaminación de Equipos , Femenino , Infecciones por Bacterias Grampositivas/etiología , Infecciones por Bacterias Grampositivas/cirugía , Insuficiencia Cardíaca/etiología , Mortalidad Hospitalaria , Humanos , Incidencia , Intubación Intratraqueal/efectos adversos , Estimación de Kaplan-Meier , Masculino , Complicaciones Posoperatorias/mortalidad , Complicaciones Posoperatorias/cirugía , Modelos de Riesgos Proporcionales , Infecciones Relacionadas con Prótesis/mortalidad , Infecciones Relacionadas con Prótesis/cirugía , Sistema de Registros , Estudios Retrospectivos , Riesgo , Infecciones Estafilocócicas/etiología , Infecciones Estafilocócicas/cirugía , Resultado del TratamientoRESUMEN
Transcatheter treatment of calcific mitral valve disease with commercially available balloon-expandable valves is feasible Current clinical outcomes are suboptimal, consequently this should be considered only in severely symptomatic patients without other options Purpose-specific mitral valves may allow for this therapy to achieve its full potential.