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1.
Catheter Cardiovasc Interv ; 104(1): 134-144, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38736247

RESUMO

BACKGROUND: In transcatheter aortic valve replacement (TAVR), transfemoral (TF) access offers several advantages over alternative access routes. Advances in sheaths and valve delivery technology have catalyzed the feasibility of TF-TAVR, even in challenging anatomies. AIMS: Report procedural characteristics and outcomes of a TAVR program aiming for a 100% TF access rate. METHODS: Consecutive patients undergoing TAVR were enrolled in a prospective registry. Equipment used to facilitate TF-access in challenging anatomies included low-profile sheaths, dilatators, peripheral balloons, covered and uncovered self-expanding and balloon-expandable stents, and intravascular lithotripsy (IVL). RESULTS: A total of 400 patients with a mean age of 81 ± 6 years (42% female) were analyzed. Minimal iliofemoral artery diameter (MLD) of the main access side was <5 mm in 42 (10.5%), extreme tortuosity was present in 65 (16.3%), and severe calcification in 59 (14.8%). TF-access was successful in 399 (99.8%) patients. A transaxillary access was used in one patient. In multivariable analysis, an MLD < 5 mm was the strongest predictor for vascular complications (11.9% vs. 3.9%, OR: 3.86, 95% CI: 1.38-10.8, p = 0.01). Such patients also had more major/life-threatening bleeding (14.2% vs. 3.1%, p < 0.001) and required more planned and unplanned peripheral interventions to enable TF access (35.8% vs. 3.4%, p < 0.001). CONCLUSION: Our study shows that utilization of dedicated sheaths, peripheral balloons, stents, and IVL enables TAVR via TF access in >99% of patients. However, rates of vascular and bleeding complications in patients with narrow iliofemoral arteries (MLD < 5 mm) were high.


Assuntos
Estenose da Valva Aórtica , Valva Aórtica , Cateterismo Periférico , Artéria Femoral , Punções , Sistema de Registros , Substituição da Valva Aórtica Transcateter , Humanos , Feminino , Masculino , Artéria Femoral/diagnóstico por imagem , Idoso de 80 Anos ou mais , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento , Idoso , Cateterismo Periférico/efeitos adversos , Fatores de Risco , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Estudos Prospectivos , Fatores de Tempo , Próteses Valvulares Cardíacas
2.
Catheter Cardiovasc Interv ; 104(1): 115-124, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38764320

RESUMO

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is increasingly being used to treat severe aortic stenosis in younger patients. Accordingly, lifetime management regarding future reintervention and coronary access is a concern. AIMS: To assess the impact of commissural alignment on ACURATE neo2 transcatheter aortic valve (TAV) performance. METHODS: COMALIGN-neo2 was an observational, retrospective study enrolling consecutive TAVR patients treated with the ACURATE neo2 (October 2021 to October 2022). The degree of commissural (mis)-alignment (CMA) with the native aortic valve commissures was determined and transvalvular gradient, effective orifice area, patient-prosthesis mismatch (PPM), and aortic regurgitation (AR) were assessed. RESULTS: Among 825 patients, the mean age was 80.7 years and 42% were female. Commissural alignment was achieved in 60% of cases; mild (26%), moderate (9%), and severe misalignment (5%) were found less often. Severe PPM occurred more frequently in patients with severe CMA (14.7%) compared to aligned valves (p = 0.034). By multivariate analysis, severe CMA (odds ratio [OR]: 3.12, 95% confidence interval [CI] [1.09-8.90]; p = 0.033) and lack of postdilatation (OR: 3.85, [1.33-11.1]; p = 0.012) were associated with severe PPM. Higher rates of ≥mild AR (51.4%) were found in TAVs implanted with severe CMA compared to aligned (34.3%), mildly (38.1%) or moderately (36.0%) misaligned TAVs (p = 0.030). Multivariate analysis identified severe CMA (OR: 2.05, [1.05-4.02]; p = 0.037) to be an independent predictor of ≥mild AR. CONCLUSIONS: COMALIGN-neo2 is the largest study to date assessing the impact of commissural alignment on acute TAV performance. Severe CMA with the ACURATE neo2 platform was associated with worse valve hemodynamics and increased risk for mild AR.


Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Valva Aórtica , Próteses Valvulares Cardíacas , Hemodinâmica , Desenho de Prótese , Recuperação de Função Fisiológica , Substituição da Valva Aórtica Transcateter , Humanos , Feminino , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/efeitos adversos , Estudos Retrospectivos , Masculino , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Idoso de 80 Anos ou mais , Idoso , Valva Aórtica/fisiopatologia , Valva Aórtica/cirurgia , Valva Aórtica/diagnóstico por imagem , Resultado do Tratamento , Insuficiência da Valva Aórtica/fisiopatologia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/etiologia , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo
3.
Catheter Cardiovasc Interv ; 102(2): 339-347, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37232417

RESUMO

BACKGROUND: Growing interest in neuroprotection in transcatheter aortic valve replacement (TAVR) has catalyzed the development of cerebral protection systems (CPS). OBJECTIVES: Report insights from consecutive real-world patients undergoing TAVR with the Sentinel-CPS. METHODS: Patients with severe aortic stenosis undergoing TAVR from April 2019 to May 2022 were enrolled in a prospective registry. The reason for unsuccessful Sentinel-CPS deployment and the amount of debris captured by the filters were prospectively recorded. RESULTS: The Sentinal CPS was successfully deployed in 330 patients (85%, Group 1). Deployment was not attempted, unsuccessful or only partially successful in 59 patients (15%, Group 2), caused by anatomical factors such as tortuosity, heavy calcification or small dimensions of radial or brachial artery in 46, technical aspects such as puncture failure or dissection in 5 or use of right radial access for the pigtail in 6. Debris was captured in 98% of patients in Group 1. In 40%, the amount of debris was graded moderate or extensive. Predictors for moderate/extensive debris were moderate/severe aortic calcification (OR 1.50, CI 1.05-2.15, p = 0.03), pre- and postdilatation (OR 1.97, CI 1.02-3.79, p = 0.04 and OR 1.71, CI 1.01-2.89, p = 0.048). The risk of stroke was numerically lower in patients who underwent TAVR with the Sentinel CPS (2.1 vs. 5.1%, respectively, p = 0.15). There was no stroke during CPS deployment, but one patient had a stroke immediately after device retrieval. CONCLUSIONS: The Sentinel-CPS was successfully deployed in 85% of patients. Predictors for moderate/extensive debris captured were moderate/severe aortic calcification, pre- and postdilatation.


Assuntos
Estenose da Valva Aórtica , Dispositivos de Proteção Embólica , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Humanos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/etiologia , Resultado do Tratamento , Acidente Vascular Cerebral/etiologia , Fatores de Risco
4.
Catheter Cardiovasc Interv ; 96(6): E640-E645, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-31971346

RESUMO

OBJECTIVES: This study aimed to investigate the safety and efficacy of ACURATE neo transcatheter aortic valve replacement (TAVR) facilitated by predilatation with the nonocclusive TrueFlow balloon catheter. BACKGROUND: Now that TAVR is moving forward, physicians have attempted to simplify and streamline the procedure and the so-called minimalist approach has become more popular. METHODS: We enrolled 142 patients (mean age: 82 ± 5 years, 61% female) in a prospective registry. Patients at low risk for intraprocedural third-degree atrioventricular block (AVB) underwent TAVR with the TrueFlow balloon without rapid pacing and without insertion of a provisional pacemaker (n = 121). The remaining 21 patients were predilated with rapid pacing using a provisional pacemaker and a standard balloon. RESULTS: Predilatation with the TrueFlow balloon was successful in all 121 patients. Postdilatation was less frequently required after predilatation with the TrueFlow (25% vs. 57%, p = .003). Moreover, median procedural duration with the TrueFlow was significantly shorter (42 [interquartile range, IQR: 34-53] vs. 55 [IQR: 46-61] min, p = .004). In-hospital outcomes were similar. At 30 days, there was no mortality, two (1%) patients had suffered a stroke and only four (3%) had required implantation of a new pacemaker. CONCLUSION: Among patients with a low risk for intraprocedural third-degree AVB, the TrueFlow nonocclusive balloon catheter facilitates implantation of the ACURATE neo without the necessity of rapid pacing and a provisional pacemaker.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Valvuloplastia com Balão/instrumentação , Cateteres Cardíacos , Cateterismo Periférico , Artéria Femoral , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter/instrumentação , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/fisiopatologia , Bloqueio Atrioventricular/etiologia , Bloqueio Atrioventricular/fisiopatologia , Bloqueio Atrioventricular/prevenção & controle , Valvuloplastia com Balão/efeitos adversos , Cateterismo Periférico/efeitos adversos , Feminino , Humanos , Masculino , Estudos Prospectivos , Desenho de Prótese , Recuperação de Função Fisiológica , Sistema de Registros , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
5.
Artigo em Inglês | MEDLINE | ID: mdl-38987046

RESUMO

BACKGROUND: In patients undergoing transcatheter aortic valve replacement (TAVR), elevated pre-procedural C-reactive protein (CRP) levels are frequently observed. Its impact on long-term results of TAVR is unclear. The aim of the study was to investigate the long-term (up to six years) clinical outcomes of TAVR patients with normal compared to elevated CRP levels before TAVR. METHODS: Consecutive patients undergoing TAVR between August 2012 and January 2023 at a tertiary cardiology facility were included. Patients were divided into two cohorts based on the baseline CRP levels: normal CRP (≤ 5 mg/l) and elevated CRP (>5 mg/l). The cohorts were followed clinically for up to six years after TAVR. RESULTS: From a total of 1000 TAVR patients (mean age 81 ± 6 years), 268 patients (27 %) were found to have elevated baseline CRP (>5 mg/l). Such patients had significantly more co-morbidities (e.g. chronic obstructive pulmonary disease, atrial fibrillation, heart failure, concomitant valvopathies). They also developed periprocedural infections more frequently (3 % vs. 1 %, p = 0.007) and required more commonly repeat hospitalizations for infections during follow-up (HR 1.97, CI 1.47-2.64, p < 0.001). All-cause mortality and development of valve dysfunction did not significantly differ between patients with elevated and normal baseline CRP levels. CONCLUSION: Albeit long-term results of TAVR patients with elevated pre-procedural CRP levels seem favorable in terms of survival and development of valve dysfunction, they have an increased risk for periprocedural infections and re-admissions due to infections of any type during the follow-up period.

6.
J Invasive Cardiol ; 2024 07 18.
Artigo em Inglês | MEDLINE | ID: mdl-39052516

RESUMO

Objectives: Percutaneous closure of a patent foramen ovale (PFO) to prevent recurrent paradoxical thromboembolic events has become the standard of care. However, it remains uncertain if transesophageal echocardiography (TOE) guidance improves procedural success with an existing comprehensive pre-procedural TOE. The aim of the study was to compare the effectiveness of percutaneous PFO closure guided by fluoroscopy (FS) only vs TOE plus FS. Methods: Consecutive patients undergoing percutaneous PFO closure between February 2017 and April 2023 were analyzed. Based on pre-procedural echocardiography, patients were scheduled either for an FS-only or TOE/FS-guided procedure. The primary-endpoint was effective PFO-closure (residual-shunt grade 0/1 at 6-month follow-up). The secondary-endpoints included procedural safety/efficacy and major adverse cardiovascular events during hospital stay and at the 6-month follow-up. Results: Two hundred-three patients (mean age 51.8 ± 12.5 years, 39.4% women, Risk of Paradoxical Embolism score = 7 [IQR = 6-7]) underwent PFO closure with FS-only guidance (88 patients, 43.3%) or TOE/FS guidance (115 patients, 56.7%). The main indications for PFO closure were cryptogenic stroke (179 patients, 88.2%) and peripheral embolism (13 patients, 6.4%). At baseline, a right-to-left shunt of grade 2 or higher was present in 199 patients (98%). The procedure time in the FS group was shorter (13 minutes in the FS group vs 16.5 minutes in the TOE/FS group, P = .002). The immediate procedural success was 99.5%. At 6 months, effective closure was achieved in 195 patients (96.1% [FS group: 97.7% vs TOE/FS group 97.8%, P = .29]). The rates of atrial fibrillation and recurrent thromboembolic events were not different among the procedural strategies (3.9% [P = .47] and 0.5% [P = .43]). Conclusions: After comprehensive pre-procedural echocardiography workup, PFO closure with FS guidance only seems equally safe and effective as TOE/FS guidance. A standardized pre-procedural echocardiography protocol facilitates procedural planning with excellent echocardiographic and clinical outcomes.

7.
J Am Heart Assoc ; 13(5): e032250, 2024 Mar 05.
Artigo em Inglês | MEDLINE | ID: mdl-38390801

RESUMO

BACKGROUND: Chronic inflammatory disease (CID) accelerates atherosclerosis and the development of aortic stenosis. Data on long-term outcomes after transcatheter aortic valve implantation (TAVI) in those patients are missing. The aim of this study was to investigate the clinical long-term outcomes of patients with and without autoimmune-related CID undergoing TAVI for the treatment of severe aortic stenosis. METHODS AND RESULTS: From a prospective registry, consecutive patients with TAVI were included. Baseline clinic and imaging data (echocardiographic and computed tomography) were analyzed. Long-term (up to 5 years) clinical and echocardiographic outcomes were studied. Of 1000 consecutive patients (mean age 81±6 years, 46% female), 107 (11%) had CID; the most frequent entities included polymyalgia rheumatica (31%) and rheumatoid arthritis (28%). Patients with CID were predominantly female (60% versus 44%, P=0.002) and more often had pulmonary disorders (21% versus 13%, P=0.046) and atrial fibrillation (32% versus 20%, P=0.003). The presence of CID was associated with a higher rate of postinterventional infection (5% versus 1%, P=0.007) and further emerged as a risk factor for rehospitalization for bleeding or infection (hazard ratio, 1.93 and 1.62, respectively). Premature valve degeneration, endocarditis, and all-cause mortality were not increased among patients with CID. CONCLUSIONS: This real-world analysis found that patients with CID undergoing TAVI were associated with a higher risk of postinterventional infectious complications and rehospitalization due to infection. However, valve durability and survival seem not to differ between patients with TAVI with versus without CID.


Assuntos
Estenose da Valva Aórtica , Fibrilação Atrial , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Masculino , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Resultado do Tratamento , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Fatores de Risco , Fibrilação Atrial/complicações , Doença Crônica , Sistema de Registros
8.
J Invasive Cardiol ; 36(4)2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38412438

RESUMO

OBJECTIVES: Percutaneous closure of a patent foramen ovale (PFO) for the prevention of recurrent paradoxical thromboembolic events has been shown to be safe and effective in randomized controlled trials. However, it remains uncertain if differences in the structure and design of the occluder devices impact the outcomes. The aim of this study was to compare results of percutaneous PFO closure using 2 widely used double-disc occluders. METHODS: Consecutive patients who underwent percutaneous PFO closure with the Abbott Amplatzer occluder (APO) or the Occlutech Figulla-Flex-II occluder (OPO) at the Heart Center Lucerne between February 2017 and December 2022 were included in a registry. The primary endpoint was effective closure of the PFO, defined as a residual shunt grade 0 or 1, assessed by contrast echocardiogram at 6-month follow-up. Secondary endpoints included procedural efficacy/safety and major adverse cardiovascular events during the hospital stay and at 6-month follow-up. RESULTS: One hundred ninety-three consecutive patients (mean age 51.7 ± 12.5 years; 39% women; Risk of Paradoxical Embolism (RoPE) score = 7, IQR = 6-8) underwent percutaneous PFO closure with the APO (120 patients, 62.2%) or the OPO (73 patients, 37.8%). Main indications for closure were crypotogenic stroke in 168 patients (87.1%) and peripheral embolism in 13 patients (6.7%). At baseline, right-to-left shunt (RLS) greater than or equal to grade 2 was present in 189 patients (97.9%). Immediate procedural success was 99.5%. In 1 patient, an air embolism occurred during positioning of the APO occluder with transient chest pain and electrocardiogram changes, but without further sequelae to the patient. At 6-month follow-up, effective closure was achieved in 185 patients (95.8%; APO: 96.6% vs OPO: 94.5%, P = .30). Rates of atrial fibrillation and recurrent thromboembolic events were 4.2 and 0.5%, respectively. CONCLUSIONS: PFO closure is safe and effective when performed with either the self-expanding Abbott Amplatzer or Occlutech Figulla Flex II PFO occluder.


Assuntos
Forame Oval Patente , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral , Tromboembolia , Humanos , Feminino , Adulto , Pessoa de Meia-Idade , Masculino , Forame Oval Patente/diagnóstico , Forame Oval Patente/cirurgia , Forame Oval Patente/complicações , Resultado do Tratamento , Ecocardiografia , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Dispositivo para Oclusão Septal/efeitos adversos , Tromboembolia/etiologia , Cateterismo Cardíaco/métodos
9.
Struct Heart ; 7(6): 100214, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-38046862

RESUMO

Background: Motion artifacts in planning computed tomography (CT) for transcatheter aortic valve implantation (TAVI) can potentially skew measurements required for procedural planning. Whether such artifacts may affect safety or efficacy has not been studied. Methods: We conducted a retrospective analysis of 852 consecutive patients (mean age, 82 years; 47% women) undergoing TAVI-planning CT at a tertiary care center. Two independent observers divided CTs according to the presence of motion artifacts at the annulus level (Motion vs. Normal group). Endpoints included surrogate markers for inappropriate valve selection: annular rupture, valve embolization or misplacement, need for a new permanent pacemaker, paravalvular leak (PVL), postprocedural transvalvular gradient, all-cause death. Results: Forty-six (5.4%) patients presented motion artifacts on TAVI-planning CT (Motion group). These patients had more preexisting heart failure, moderate-severe mitral regurgitation, and atrial fibrillation. Interobserver variability of annular measurement (Normal vs. Motion group) did not differ for mean annular diameter but was significantly different for perimeter and area. Presence of motion artifacts on planning CT did not affect the prevalence of PVL (≥moderate PVL 0% vs. 2.5% p = 0.5), mean transvalvular gradient (6±3 mmHg vs 7±5 mmHg, p = 0.1), or the need for additional valve implantation (0% vs. 2.8%, p = 0.6). One annular rupture occurred (Normal group). Pacemaker implantation, procedural duration, hospital stay, 30-day outcomes, and all-cause mortality did not differ between the groups. Conclusions: Motion artifacts on planning CT were found in about 5% of patients. Measurements for valve selection were possible without the need for repeat CT, with mean diameter-derived annulus measurement being the most accurate. Motion artifacts were not associated with worse outcomes.

10.
Am J Cardiol ; 186: 216-222, 2023 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-36333149

RESUMO

The increasing prevalence of aortic stenosis (AS) and the increasing number of patients indicated for transcatheter aortic valve implantation (TAVI) can lead to increased hospital constraints. This study aimed to compare, from the hospital perspective, the costs, resource use, and 30-day clinical outcomes of patients who underwent TAVI under an optimized or standard clinical pathway. A single-center, retrospective study was conducted among patients with native AS who underwent TAVI between January 2018 and March 2021. Patients who underwent optimized lean TAVI were propensity-score matched 1:1 to those who underwent standard TAVI. In-hospital costs and 30-day clinical outcomes were compared between the 2 groups. A total of 182 patients (91 in each group) were included in the final analysis. Baseline covariates were well balanced after matching. Patients who underwent lean TAVI had shorter length of stay (median [interquartile range] 3.0 days [2.0 to 6.0] vs 6.0 days [5.0 to 9.0], p <0.001). Patients in the lean TAVI group incurred lower total costs than did those in the standard TAVI group (mean ± SD: $41,346 ± 10,062 vs $50,471 ± 15,115, p = 0.002). There was no between-group difference in 30-day all-cause mortality (2.2% vs 1.1%, p = 0.573) and pacemaker implantations (5.5% vs 6.6%, p = 0.788). Rates of procedural complications were comparable between groups. In conclusion, lean TAVI leads to hospital efficiencies without compromising patient safety. Efforts to streamline the TAVI procedure should be encouraged to improve access to TAVI for patients with AS, amid resource constraints.


Assuntos
Estenose da Valva Aórtica , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/métodos , Estudos Retrospectivos , Resultado do Tratamento , Pontuação de Propensão , Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Fatores de Risco
11.
J Invasive Cardiol ; 35(12)2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-38108869

RESUMO

OBJECTIVES: The Allegra-THV is a novel, self-expanding THV with supra-annular bovine leaflets. The valve is available in 3 different sizes and is delivered through an 18 French sheath. To determine the safety and efficacy of the Allegra transcatheter heart valve (THV; Biosensors) for the treatment of severe aortic valve stenosis under real-world conditions. METHODS: Consecutive patients undergoing transcatheter aortic valve replacement (TAVR) at the Heart-Centre Lucerne with the Allegra-THV were included. Echocardiographic data were collected at baseline, before discharge, and at 1-year follow-up; clinical outcomes were recorded for up to 3 years. Clinical endpoints were defined according to the definitions of the Valve-Academic-Research-Consortium. RESULTS: One hundred-three patients (age 81 ± 7 years, 63% women) were enrolled. Median European System for Cardiac Operative Risk Evaluation II score was 4.1% (IQR 1.8%-4.2%). Mean aortic valve gradient was 6.9 ± 3.3 mm Hg and 7.7 ± 3.3 mm Hg, and an effective orifice area was 2.1 ± 0.5 cm2 and 2.0 ± 0.5 cm2 at 30 days and 1-year follow-up, respectively. More than mild paravalvular leak was observed in 2.0% of patients at 30 days and 3.3% at 1 year. At 1-year follow-up, 14.7% of patients required implantation of a new permanent pacemaker, 1 patient had endocarditis with an uneventful clinical course and good THV-function after antibiotic therapy, and no thrombosis, structural-valve-detoriation (SVD), or non-SVD had occurred. At 3-year follow-up, rates of all-cause and cardiovascular mortality were 31.4% and 18.8%, respectively. CONCLUSIONS: Transfemoral implantation of the Allegra-THV resulted in favorable clinical and echocardiographic outcomes at up to 3-year follow-up. Head-to-head randomized clinical trials are necessary to determine if the Allegra-THV valve performs as well as current generation valves.


Assuntos
Ecocardiografia , Valvas Cardíacas , Humanos , Animais , Bovinos , Feminino , Idoso , Idoso de 80 Anos ou mais , Masculino , Terfenadina , Catéteres
12.
Am J Cardiol ; 200: 146-152, 2023 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-37321028

RESUMO

Subclinical leaflet thrombosis, identified as hypoattenuated leaflet thickening (HALT) on cardiac computed tomography scan, has been observed after transcatheter aortic valve replacement (TAVR). However, data on HALT after the implant of the supra-annular ACURATE neo/neo2 prosthesis are limited. This study aimed to determine the prevalence and risk factors for the development of HALT after TAVR with the ACURATE neo/neo2. A total of 50 patients who received the ACURATE neo/neo2 prosthesis were prospectively enrolled. Patients underwent a contrast-enhanced multidetector row cardiac computed tomography scan at before, after, and 6 months after TAVR. At the 6-month follow-up, HALT was detected in 16% (8 of 50 patients). These patients had a lower implant depth of the transcatheter heart valve (8 ± 2 mm vs 5 ± 2 mm, p = 0.001), less calcified native valve leaflets, a better expansion of the frame at the level of the left ventricular outflow tract, and were less often hypertensive. Thrombosis of the sinus of Valsalva occurred in 18% (9/50). There was no difference in the anticoagulation regimen between patients with and without thrombotic findings. In conclusion, HALT was present in 16% of patients at 6 months follow-up, patients presenting with HALT had a lower implant depth of the transcatheter heart valve, and HALT was detected in patients on oral anticoagulation therapy.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Trombose , Substituição da Valva Aórtica Transcateter , Humanos , Próteses Valvulares Cardíacas/efeitos adversos , Resultado do Tratamento , Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Desenho de Prótese , Trombose/diagnóstico por imagem , Trombose/epidemiologia , Trombose/etiologia , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/etiologia
13.
JACC Cardiovasc Interv ; 16(4): 396-411, 2023 02 27.
Artigo em Inglês | MEDLINE | ID: mdl-36858659

RESUMO

BACKGROUND: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined. OBJECTIVES: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD. METHODS: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site-related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score). RESULTS: Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site-related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (Pinteraction = 0.049). CONCLUSIONS: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.


Assuntos
Ataque Isquêmico Transitório , Doença Arterial Periférica , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Humanos , Resultado do Tratamento , Sistema de Registros
16.
Heart ; 104(24): 2058-2066, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30030336

RESUMO

OBJECTIVES: To investigate the association of the CharlsonComorbidity Index (CCI) with clinical outcomes after transcatheter aortic valve implantation (TAVI). BACKGROUND: Patients undergoing TAVI have high comorbid burden; however, there is limited evidence of its impact on clinical outcomes. METHODS: Data from 1887 patients from the UK, Canada, Spain, Switzerland and Italy were collected between 2007 and 2016. The association of CCI with 30-day mortality, Valve Academic Research Consortium-2 (VARC-2) composite early safety, long-term survival and length of stay (LoS) was calculated using logistic regression and Cox proportional hazard models, as a whole cohort and at a country level, through a two-stage individual participant data (IPD) random effect meta-analysis. RESULTS: Most (60%) of patients had a CCI ≥3. A weak correlation was found between the total CCI and four different preoperative risks scores (ρ=0.16 to 0.29), and approximately 50% of patients classed as low risk from four risk prediction models still presented with a CCI ≥3. Per-unit increases in total CCI were not associated with increased odds of 30-day mortality (OR 1.09, 95% CI 0.96 to 1.24) or VARC-2 early safety (OR 1.04, 95% CI 0.96 to 1.14) but were associated with increased hazard of long-term mortality (HR 1.10, 95% CI 1.05 to 1.16). The two-stage IPD meta-analysis indicated that CCI was not associated with LoS (HR 0.97, 95% CI 0.93 to 1.02). CONCLUSION: In this multicentre international study, patients undergoing TAVI had significant comorbid burden. We found a weak correlation between the CCI and well-established preoperative risks scores. The CCI had a moderate association with long-term mortality up to 5 years post-TAVI.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Próteses Valvulares Cardíacas , Medição de Risco/métodos , Substituição da Valva Aórtica Transcateter , Adulto , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/epidemiologia , Canadá/epidemiologia , Comorbidade/tendências , Feminino , Seguimentos , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , Fatores de Risco , Índice de Gravidade de Doença , Espanha/epidemiologia , Suíça/epidemiologia , Fatores de Tempo , Adulto Jovem
17.
Circ Cardiovasc Interv ; 11(3): e005727, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29870383

RESUMO

BACKGROUND: Chronic liver disease is a known risk factor for perioperative morbidity and mortality in patients undergoing cardiac surgery. Very little data exist about such patients treated with transcatheter aortic valve replacement (TAVR). Our objective was to evaluate early and late clinical outcomes in a large cohort of patients with liver disease undergoing TAVR and to determine predictive factors of mortality among these patients. METHODS AND RESULTS: This multicenter study collected data from 114 patients with chronic liver disease who underwent TAVR in 12 institutions. Perioperative and long-term outcomes were compared with a cohort of 1118 patients without liver disease after a propensity score-matching analysis (114 matched pairs). In-hospital mortality and vascular and bleeding complications were similar between matched groups. Acute kidney injury was more common in liver disease group (30.8% versus 13.5%; P=0.010). Although cardiovascular mortality was similar between groups (9.4% versus 6.5%; P=0.433) at 2-year follow-up, noncardiac mortality was higher in the liver group (26.4% versus 14.8%; P=0.034). Lower glomerular filtration rate (hazard ratio, 1.10, for each decrease of 5 mL/min in estimated glomerular filtration rate; 95% confidence interval, 1.03-1.17; P=0.005) and Child-Pugh class B or C (hazard ratio, 3.11; 95% confidence interval, 1.47-6.56; P=0.003) were the predictors of mortality in patients with chronic liver disease, with a mortality rate of 83.2% at 2-year follow-up in patients with both factors (estimated glomerular filtration rate <60 mL/min and Child-Pugh B or C). CONCLUSIONS: These findings suggested that TAVR is a feasible treatment for severe aortic stenosis in patients with early-stage liver disease or as bridge therapy before a curative treatment of the hepatic condition. Patients with Child-Pugh class B-C, especially in combination with renal impairment, had a very low survival rate, and TAVR should be carefully considered to avoid a futile treatment. These results may contribute to improve the clinical decision-making process and management in patients with liver disease.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Cirrose Hepática/mortalidade , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/mortalidade , Canadá , Doença Crônica , Tomada de Decisão Clínica , Europa (Continente) , Estudos de Viabilidade , Feminino , Humanos , Cirrose Hepática/diagnóstico , Cirrose Hepática/terapia , Masculino , Complicações Pós-Operatórias/mortalidade , Pontuação de Propensão , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento
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