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BACKGROUND: The present study aimed to investigate whether proper sizing can improve the procedural and clinical outcomes of transcatheter aortic valve replacement (TAVR) with new-generation self-expanding valves (SEVs) and balloon-expandable valves (BEVs) for treating bicuspid aortic stenosis (BAS). METHODS: We retrospectively evaluated consecutive patients who underwent TAVR with Sapien 3 valves (Edwards Lifesciences, Irvine, CA) or Evolut R/PRO valves (Medtronic, Minneapolis, MN) for severe BAS from 2017 to 2022. The primary endpoints were device success rate and major adverse cardiac and cerebral events (MACCEs), including mortality, non-fatal myocardial infarction or disabling stroke, transcatheter heart valve failure, or clinically relevant valve thrombosis during follow-up. Our team employed a complementary approach of supra-annular sizing in addition to the conventional annular sizing method (Wei's method) to guide the TAVR procedures. RESULTS: We recruited a total of 75 consecutive patients, of whom 43 (57%) were treated with BEVs from October 2017 to June 2021, and 32 (43%) were treated with SEVs from July 2021 to December 2022. Device success was similar between the BEV and SEV groups (93% vs. 94%; p > 0.99), and no cases of annular rupture occurred in either group. Similar rates of moderate-to-severe paravalvular leak were observed in the BEV and SEV groups (5% vs. 6%, p > 0.99). At a median follow-up of 464 days, the MACCE rates were comparable between the two groups. In multivariate analysis, the presence of previous percutaneous coronary interventions (hazard ratio: 5.43; p = 0.039) and New York Heart Association functional class III/IV heart failure at 30 days of follow-up after TAVR (hazard ratio: 9.90; p = 0.037) were independently associated with long-term MACCEs. CONCLUSION: Our results demonstrated comparable efficacy and safety for BAS patients undergoing TAVR using either BEVs or SEVs when using Wei's sizing method.
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Background: The Laceration of the Anterior Mitral leaflet to Prevent Outflow ObtructioN (LAMPOON) procedure may be performed from the leaflet tip to base to prevent left ventricular outflow tract obstruction (LVOTO) in patients with high-risk anatomy undergoing valve-in-valve (VIV) or valve-in-(complete)-ring (VIR) transcatheter mitral valve replacement (TMVR). Methods and Results: Thirteen consecutive patients (6 females, average age 67.7 years) with a mean left ventricular ejection fraction of 60%, a median STS score of 3.2%, and degenerative surgical mitral bioprosthesis or ring were treated with a combined, single-stage procedure of preventive LAMPOON and trans-septal TMVR with SAPIEN 3 valves (Edwards Lifesciences, Irvine, CA). Under real-time 3-dimensional transesophageal echocardiography (RT 3D-TEE) guidance, we included the rendezvous technique in the LAMPOON procedure, and all 13 patients were successfully treated by tip-to-base LAMPOON and TMVR. The use of a modified LAMPOON procedure, aided by a rendezvous technique and guided by RT 3D-TEE imaging, offers precise guidance for positioning and aligning the guidewire. This approach not only reduces the need for fluoroscopy and shortens procedure times, but also significantly increases the likelihood of a successful outcome. Importantly, none of the patients in our study experienced unintentional aortic or aortic valve injuries, nor did they develop significant LVOTO following TMVR. In 11 of the 13 (85%) patients, we used a transcatheter SENTINELTM cerebral protection device (Boston Scientific, Marlborough, MA) for stroke prevention and capture of debris ≥ 2 mm were detected in 8/11 (73%) of the cases. Conclusions: Utilizing intra-operative RT 3D-TEE in conjunction with the rendezvous technique can make the tip-to-base LAMPOON procedure even safer and more effective for patients undergoing VIV or VIR TMVR. Our study also suggests that cerebral protection is indicated in patients undergoing TMVR.
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BACKGROUND: The risks of leaflet thrombosis and the associated cerebral thromboembolism are unknown according to different anticoagulation dosing after transcatheter aortic valve replacement (TAVR). The aim was to evaluate the incidence of leaflet thrombosis and cerebral thromboembolism between low-dose (30 mg) or standard-dose (60 mg) edoxaban and dual antiplatelet therapy (DAPT) after TAVR. METHODS: In this prespecified subgroup analysis of the ADAPT-TAVR trial, the primary endpoint was the incidence of leaflet thrombosis on 4-dimensional computed tomography at 6-months. Key secondary endpoints were new cerebral lesions on brain magnetic resonance imaging and neurological and neurocognitive dysfunction. RESULTS: Of 229 patients enrolled in this study, 118 patients were DAPT group and 111 were edoxaban group (43 [39.1%] 60 mg vs 68 [61.3%] 30 mg). There was a significantly lower incidence of leaflet thrombosis in the standard-dose edoxaban group than in the DAPT group (2.4% vs 18.3%; odds ratio [OR] 0.11; 95% confidence interval [CI], 0.01-0.55; P = .03). However, no significant difference was observed between low-dose edoxaban and DAPT (15.0% vs 18.3%; OR 0.79; 95% CI, 0.32-1.81; P = .58). Irrespective of different antithrombotic regiments, the percentages of patients with new cerebral lesions on brain MRI and worsening neurological or neurocognitive function were not significantly different. CONCLUSIONS: In patients without an indication for anticoagulation after TAVR, the incidence of leaflet thrombosis was significantly lower with standard-dose edoxaban but not with low-dose edoxaban, as compared with DAPT. However, this differential effect of edoxaban on leaflet thrombosis was not associated with a reduction of new cerebral thromboembolism and neurological dysfunction.
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Estenose da Valva Aórtica , Piridinas , Tiazóis , Tromboembolia , Trombose , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Inibidores da Agregação Plaquetária , Valva Aórtica/cirurgia , Resultado do Tratamento , Tromboembolia/epidemiologia , Tromboembolia/etiologia , Tromboembolia/prevenção & controle , Trombose/epidemiologia , Trombose/etiologia , Trombose/prevenção & controle , Anticoagulantes/uso terapêutico , Estenose da Valva Aórtica/complicaçõesRESUMO
BACKGROUND: Subclinical aortic valve complex (valvular and perivalvular) thrombus is not rare after transcatheter aortic valve replacement (TAVR). The risk factors and clinical implications of these findings remain uncertain. OBJECTIVES: This study sought to evaluate the frequency, predictors, and clinical outcome of aortic valve complex thrombus after TAVR. METHODS: In the ADAPT-TAVR (Anticoagulation Versus Dual Antiplatelet Therapy for Prevention of Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement) trial comparing edoxaban vs dual antiplatelet therapy in TAVR patients without an indication for chronic anticoagulation, the frequency of valvular (subclinical leaflet thrombus) and perivalvular (supravalvular, subvalvular, and sinus of Valsalva) thrombus was evaluated by 4-dimensional computed tomography at 6 months. The association of these phenomena with new cerebral thromboembolism on brain magnetic resonance imaging, neurologic and neurocognitive dysfunction, and clinical outcomes was assessed. RESULTS: Among 211 patients with 6-month computed tomography evaluations, 91 patients (43.1%) had thrombus at any aortic valve complex, 30 (14.2%) patients had leaflet thrombus, and 78 (37.0%) patients had perivalvular thrombus. A small maximum diameter of the stent at the valve level and low body surface area were independent predictors of aortic valve complex and perivalvular thrombus, and decreased renal function was an independent predictor of leaflet thrombus. No significant differences were observed in new cerebral lesions, neurologic or neurocognitive functions, or clinical outcomes among patients with or without valvular or perivalvular thrombus. CONCLUSIONS: Subclinical aortic valve complex (valvular and perivalvular) thrombus was common in patients who had undergone successful TAVR. However, these imaging phenomena were not associated with new cerebral thromboembolism, neurologic or neurocognitive dysfunction, or adverse clinical outcomes. (Anticoagulation Versus Dual Antiplatelet Therapy for Prevention of Leaflet Thrombosis and Cerebral Embolization After Transcatheter Aortic Valve Replacement [ADAPT-TAVR]; NCT03284827).
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Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Tromboembolia , Trombose , Substituição da Valva Aórtica Transcateter , Humanos , Anticoagulantes/uso terapêutico , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Valva Aórtica/patologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Tomografia Computadorizada Quadridimensional/efeitos adversos , Próteses Valvulares Cardíacas/efeitos adversos , Inibidores da Agregação Plaquetária , Fatores de Risco , Tromboembolia/etiologia , Trombose/diagnóstico por imagem , Trombose/etiologia , Trombose/prevenção & controle , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do TratamentoRESUMO
Hydrogels' exceptional mechanical strength and skin-adhesion characteristics offer significant advantages for various applications, particularly in the fields of tissue adhesion and wearable sensors. Herein, we incorporated a combination of metal-coordination and hydrogen-bonding forces in the design of stretchable and adhesive hydrogels. We synthesized four hydrogels, namely PAID-0, PAID-1, PAID-2, and PAID-3, consisting of acrylamide (AAM), N,N'-methylene-bis-acrylamide (MBA), and methacrylic-modified dopamine (DA). The impact of different ratios of iron (III) ions to DA on each hydrogel's performance was investigated. Our results demonstrate that the incorporation of iron-dopamine complexes significantly enhances the mechanical strength of the hydrogel. Interestingly, as the DA content increased, we observed a continuous and substantial improvement in both the stretchability and skin adhesiveness of the hydrogel. Among the hydrogels tested, PAID-3, which exhibited optimal mechanical properties, was selected for adhesion testing on various materials. Impressively, PAID-3 demonstrated excellent adhesion to diverse materials and, combined with the low cytotoxicity of PAID hydrogel, holds great promise as an innovative option for biomedical engineering applications.
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Background: Ascending aortic pseudoaneurysm due to coronary button dehiscence is a rare, yet life-threatening complication of reconstructive cardiac surgery. Because of its rare entity, large data are lacking, and therefore, treatment guidelines are missing. Case summary: We describe a case of a 53-year-old male with a past medical history of ascending aortic aneurysm and severe aortic regurgitation who underwent Bentall procedure with 26â mm conduit and mechanical aortic valve 1 year before. Follow-up chest computed tomography (CT) revealed coronary button dehiscence with a giant aortic root pseudoaneurysm and mural thrombus inside. Given the risk of rupture, the heart team decided to go for a percutaneous approach. Based on a pre-interventional 3D reconstructed CT scan and guided by transoesophageal echocardiography and intravascular ultrasound, the pseudoaneurysm was successfully occluded with a 6 × 4â mm Amplatzer Duct Occluder II and simultaneous left main coronary artery (LMCA) stenting with a 4.0 × 15â mm drug-eluting stent. Post-procedural chest CT and echocardiography revealed minimal contrast leakage posterior to the aortic root and para LMCA region, confirmed thrombosis formation post occluder and stent deployment, and patent flow of LMCA. Discussion: We describe the successful 3D reconstructed CT scan and peri-procedural transoesophageal echocardiography-guided percutaneous treatment of a giant aortic root pseudoaneurysm with an occluder and a drug-eluting stent with excellent results.
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OBJECTIVES: The effect of subclinical leaflet thrombosis, characterised by hypoattenuated leaflet thickening (HALT), on the valve haemodynamic function and durability of the bioprosthetic valve, is not yet determined. We determined the impact of HALT on valve haemodynamics after transcatheter aortic valve replacement (TAVR) and the predictors of haemodynamic structural valve deterioration (SVD). METHODS: The Anticoagulation vs Dual Antiplatelet Therapy for Prevention of Leaflet Thrombosis and Cerebral Embolization after Transcatheter Aortic Valve Replacement(ADAPT-TAVR) trial is a multicenter, randomised trial that compared edoxaban and dual antiplatelet therapy in patients who had undergone successful TAVR. The presence of HALT was evaluated by four-dimensional CT at 6 months and serial echocardiography performed at baseline, immediately post-TAVR and after 6 months. SVD was defined as at least one of the following: (1) mean transprosthetic gradient ≥20 mm Hg, (2) change in the mean gradient ≥10 mm Hg from baseline, or (3) new or increase in intraprosthetic aortic regurgitation of at least ≥1 grade, resulting in moderate or greater regurgitation. RESULTS: At 6 months, HALT was found in 30 of 211 (14.2%) patients. The presence of HALT did not significantly affect aortic valve mean gradients (with vs without HALT; 14.0±4.8 mm Hg vs 13.7±5.5 mm Hg; p=0.74) at 6 months. SVD was reported in 30 of 206 patients (14.6%) at 6-month follow-up echocardiography. Older age (OR: 1.138; 95% CI: 1.019 to 1.293; p=0.033), use of aortic valve size ≤23 mm (OR: 6.254; 95% CI: 2.230 to 20.569; p=0.001) and mean post-TAVR pressure gradient (OR: 1.233; 95% CI: 1.123 to 1.371; p<0.001) were independent predictors of haemodynamic SVD; however, the presence of HALT was not identified as a predictor of SVD. CONCLUSIONS: In patients who had undergone successful TAVR, aortic valve haemodynamic status was not influenced by the presence of HALT. Although HALT was not a predictor of haemodynamic SVD at 6 months, it warrants further longer-term follow-up to evaluate the effect on long-term valve durability. TRIAL REGISTRATION NUMBER: NCT03284827 (https://www. CLINICALTRIALS: gov).
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Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Trombose , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Inibidores da Agregação Plaquetária/uso terapêutico , Próteses Valvulares Cardíacas/efeitos adversos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Hemodinâmica , Trombose/diagnóstico por imagem , Trombose/etiologia , Trombose/prevenção & controle , Resultado do TratamentoRESUMO
It is unknown whether edoxaban versus dual antiplatelet therapy (DAPT) has differential treatment effects on leaflet thrombosis, cerebral thromboembolism, and neurologic or neurocognitive dysfunction according to clinical and anatomic factors after transcatheter aortic valve implantation. To investigate the relative effects of edoxaban and DAPT on leaflet and cerebral thromboembolism in patients with major risk factors. The primary end point of this study was the incidence of leaflet thrombosis on computed tomography at 6 months. The secondary end points were new cerebral lesions on brain magnetic resonance imaging and neurologic and neurocognitive dysfunction between baseline and 6-month follow-up. Cox regression models assessed the consistency of the treatment effects in the prespecified subgroups. The favorable effect of edoxaban versus DAPT on the leaflet thrombosis was consistent across multiple clinical or anatomic subgroups, without significant interaction between the drug effect and each subgroup (p for interaction for age = 0.597, gender = 0.557, body mass index = 0.866, Society of Thoracic Surgeons score = 0.307, valve type = 0.702, edoxaban reduction criteria = 0.604, and valve morphology = 0.688). However, the incidence of new cerebral lesions on brain magnetic resonance imaging and worsening of neurologic and neurocognitive function were not significantly different between the groups among the various key subgroups. The relative effects of edoxaban and DAPT on the risk of leaflet thrombosis, cerebral thromboembolism, and neurologic dysfunction were consistent across a diverse spectrum of clinical or anatomical factors. Further studies are required to define tailored antithrombotic therapy for high-risk groups with specific clinical or anatomic characteristics.
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Estenose da Valva Aórtica , Trombose Intracraniana , Tromboembolia , Trombose , Substituição da Valva Aórtica Transcateter , Humanos , Lactente , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Inibidores da Agregação Plaquetária , Tromboembolia/epidemiologia , Tromboembolia/etiologia , Tromboembolia/prevenção & controle , Trombose/epidemiologia , Trombose/etiologia , Trombose/prevenção & controle , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento , Masculino , FemininoRESUMO
BACKGROUND: The aim of this study is to describe, for the first time to our knowledge, the utilization of both two-dimensional (2D) and three-dimensional (3D) transesophageal echocardiography (TEE) in successfully performing transcatheter mitral valve (MV) in bioprosthetic MV/MV annulopasty ring implantation using the apical approach in 12 patients (pts) with co-existing left atrial appendage (LAA) and/or LA (left atrium) body thrombus, which is considered a contraindication for this procedure. METHODS AND RESULTS: All pts were severely symptomatic with severe bioprosthetic MV stenosis/regurgitation except one with a previous MV annuloplasty ring and severe native MV stenosis. Thrombus in LAA and/or LA body was noted in all by 2D and 3DTEE. All were at high/prohibitive risk for redo operation and all refused surgery. Utilizing both 2D and 3DTEE, especially 3DTEE, guidewires and the prosthesis deployment system could be manipulated under direct vision into the LA avoiding any contact with the thrombus. The procedure was successful in all with amelioration of symptoms and no embolic or other complications over a mean follow-up of 21 months. CONCLUSION: Our study demonstrates the feasibility of successfully performing this procedure in pts with thrombus in LAA and/or LA body without any complications.
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Open-heart patients often experience sleep problems postoperatively. This cross-sectional study is aimed to investigate open-heart patients' sleep quality and its influencing factors during intensive care. A consecutive sample of 117 eligible open-heart patients was recruited from an intensive care unit (ICU) of a general hospital. Data were collected using questionnaires. The respondents were 22-88 years, with a median age of 60.25 (13.51). Seventy-nine (67.5%) respondents were male. Most respondents reported a low-to-moderate postoperative pain level (average pain score = 2.02; range: 0-10). The average anxiety score was 4.68 (standard deviation [SD] = 4.2), and the average depression score was 6.91 (SD = 4.52; range: 0-21). The average sleep efficiency index was 70.4% (SD = 10.74%). Most (95.7%) respondents had a sleep efficiency index below 85%, indicating that most patients did not sleep well in the ICU. Linear regression analysis showed that the key predictors of the sleep quality of open-heart patients in the ICU were wound pain (ß = -1.9) and noise disturbance (ß = -1.86). These results provide information on sleep quality and the factors affecting postoperative patients in the ICU. These findings can be used as a reference for developing relevant interventions.
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Objectives: This study compared transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) in terms of short- and long-term effectiveness. Methods: This retrospective cohort study based on nationwide National Health Insurance claims data and Cause of Death data focused on adult patients (n = 3,643) who received SAVR (79%) or TAVR (21%) between 2015 and 2019. Propensity score overlap weighting was applied to account for selection bias. Primary outcomes included all-cause mortality (ACM), hospitalization for heart failure, and a composite endpoint of major adverse cardiac events (MACE). Secondary outcomes included medical utilization, hospital stay, and total medical costs at index admission for the procedure and in various post-procedure periods. The Cox proportional-hazard model with competing risk was used to investigate survival and incidental health outcomes. Generalized estimation equation (GEE) models were used to estimate differences in the utilization of medical resources and overall costs. Results: After weighting, the mean age of the patients was 77.98 ± 5.86 years in the TAVR group and 77.98 ± 2.55 years in the SAVR group. More than half of the patients were female (53.94%). The incidence of negative outcomes was lower in the TAVR group than in the SAVR group, including 1-year ACM (11.39 vs. 17.98%) and 3-year ACM (15.77 vs. 23.85%). The risk of ACM was lower in the TAVR group (HR [95% CI]: 0.61 [0.44-0.84]; P = 0.002) as was the risk of CV death (HR [95% CI]: 0.47 [0.30-0.74]; P = 0.001) or MACE (HR [95% CI]: 0.66 [0.46-0.96]; P = 0.0274). Total medical costs were significantly higher in the TAVR group than in the SAVR in the first year after the procedure ($1,271.89 ± 4,048.36 vs. $887.20 ± 978.51; P = 0.0266); however, costs were similar in the second and third years after the procedure. The cumulative total medical costs after the procedure were significantly higher in the TAVR group than in the SAVR group (adjusted difference: $420.49 ± 176.48; P = 0.0172). Conclusion: In this real-world cohort of patients with aortic stenosis, TAVR proved superior to SAVR in terms of clinical outcomes and survival with comparable medical utilization after the procedure.
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BACKGROUND: Although the COVID-19 pandemic has accelerated the adoption of telemedicine and virtual consultations worldwide, complex factors that may affect the use of virtual clinics are still unclear. OBJECTIVE: This study aims to identify factors associated with the utilization of virtual clinics in the experience of virtual clinic service implementation in Taiwan. METHODS: We retrospectively analyzed a total of 187,742 outpatient visits (176,815, 94.2%, in-person visits and 10,927, 5.8%, virtual visits) completed at a large general hospital in Taipei City from May 19 to July 31, 2021, after rapid implementation of virtual outpatient clinic visits due to the COVID-19 pandemic. Data of patients' demographic characteristics, disease type, physicians' features, and specialties/departments were collected, and physicians' opinions regarding virtual clinics were surveyed and evaluated using a 5-point Likert scale. Multilevel analysis was conducted to determine the factors associated with the utilization of virtual clinics. RESULTS: Patient-/visit-, physician-, and department-level factors accounted for 67.5%, 11.1%, and 21.4% of the total variance in the utilization of virtual clinics, respectively. Female sex (odds ratio [OR] 1.27, 95% CI 1.22-1.33, P<.001); residing at a greater distance away from the hospital (OR 2.36, 95% CI 2.15-2.58 if distance>50 km, P<.001; OR 3.95, 95% CI 3.11-5.02 if extensive travel required, P<.001); reimbursement by the National Health Insurance (NHI; OR 7.29, 95% CI 5.71-9.30, P<.001); seeking care for a major chronic disease (OR 1.33, 95% CI 1.24-1.42, P<.001); the physician's positive attitude toward virtual clinics (OR 1.50, 95% CI 1.16-1.93, P=.002); and visits within certain departments, including the heart center, psychiatry, and internal medicine (OR 2.55, 95% CI 1.46-4.46, P=.004), were positively associated with the utilization of virtual clinics. The patient's age, the physician's age, and the physician's sex were not associated with the utilization of virtual clinics in our study. CONCLUSIONS: Our results show that in addition to previously demonstrated patient-level factors that may influence telemedicine use, including the patient's sex and distance from the hospital, factors at the visit level (insurance type, disease type), physician level (physician's attitude toward virtual clinics), and department level also contribute to the utilization of virtual clinics. Although there was a more than 300-fold increase in the number of virtual visits during the pandemic compared with the prepandemic period, the majority (176,815/187,742, 94.2%) of the outpatient visits were still in-person visits during the study period. Therefore, it is of great importance to understand the factors impacting the utilization of virtual clinics to accelerate the implementation of telemedicine. The findings of our study may help direct policymaking for expanding the use of virtual clinics, especially in countries struggling with the development and promotion of telemedicine virtual clinic services.
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COVID-19 , Pandemias , Telemedicina , Instituições de Assistência Ambulatorial , COVID-19/epidemiologia , Feminino , Humanos , Masculino , Análise Multinível , Pacientes Ambulatoriais , Estudos Retrospectivos , Taiwan , Telemedicina/métodos , Telemedicina/tendênciasRESUMO
Objective: Current guidelines recommend that transcatheter aortic valve replacement (TAVR) for bicuspid aortic valve (BAV) with aortic stenosis (AS) should only be performed in selected patients. However, we consider it even more crucial to identify what the really important factors are while determining long-term outcomes in patients with BAV undergoing TAVR, which is precisely the aim of this study. Methods: We retrospectively evaluated consecutive patients who underwent TAVR with balloon-expandable Sapien XT or Sapien 3 valves (Edwards Lifesciences, Irvine, CA) for the treatment of severe bicuspid AS. The primary end points were major adverse cardiac and cerebral events (MACCE), that is, mortality, non-fatal myocardial infarction (MI), disabling stroke, valve failure needing reintervention, or clinically relevant valve thrombosis during follow-up. Results: A total of 56 patients who underwent TAVR with Sapien XT (n = 20) or Sapien 3 (n = 36) were included. The device and procedural success rates were similar between the two TAVR valves; however, the newer-generation Sapien 3 yielded a trend toward better long-term clinical outcomes than the early-generation Sapien XT did (MACCE rates 35 vs. 11%, p = 0.071). In the multivariate Cox proportional hazards analyses, the presence of calcified raphe > 4 mm was the only independent predictor of long-term MACCE (hazard ratio: 6.76; 95% confidence interval: 1.21-37.67, p = 0.029). Conclusion: TAVR performed by a skilled heart team, while using newer-generation balloon-expandable Sapien 3 valve, may yield better long-term clinical outcomes compared to TAVR using early-generation Sapien XT valve. Moreover, the presence of calcified raphe >4 mm is an independent determinant of adverse clinical outcomes.
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BACKGROUND: It is unknown whether the direct oral anticoagulant edoxaban can reduce leaflet thrombosis and the accompanying cerebral thromboembolic risk after transcatheter aortic valve replacement. In addition, the causal relationship of subclinical leaflet thrombosis with cerebral thromboembolism and neurological or neurocognitive dysfunction remains unclear. METHODS: We conducted a multicenter, open-label randomized trial comparing edoxaban with dual antiplatelet therapy (aspirin plus clopidogrel) in patients who had undergone successful transcatheter aortic valve replacement and did not have an indication for anticoagulation. The primary end point was an incidence of leaflet thrombosis on 4-dimensional computed tomography at 6 months. Key secondary end points were the number and volume of new cerebral lesions on brain magnetic resonance imaging and the serial changes of neurological and neurocognitive function between 6 months and immediately after transcatheter aortic valve replacement. RESULTS: A total of 229 patients were included in the final intention-to-treat population. There was a trend toward a lower incidence of leaflet thrombosis in the edoxaban group compared with the dual antiplatelet therapy group (9.8% versus 18.4%; absolute difference, -8.5% [95% CI, -17.8% to 0.8%]; P=0.076). The percentage of patients with new cerebral lesions on brain magnetic resonance imaging (edoxaban versus dual antiplatelet therapy, 25.0% versus 20.2%; difference, 4.8%; 95% CI, -6.4% to 16.0%) and median total new lesion number and volume were not different between the 2 groups. In addition, the percentages of patients with worsening of neurological and neurocognitive function were not different between the groups. The incidence of any or major bleeding events was not different between the 2 groups. We found no significant association between the presence or extent of leaflet thrombosis with new cerebral lesions and a change of neurological or neurocognitive function. CONCLUSIONS: In patients without an indication for long-term anticoagulation after successful transcatheter aortic valve replacement, the incidence of leaflet thrombosis was numerically lower with edoxaban than with dual antiplatelet therapy, but this was not statistically significant. The effects on new cerebral thromboembolism and neurological or neurocognitive function were also not different between the 2 groups. Because the study was underpowered, the results should be considered hypothesis generating, highlighting the need for further research. REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT03284827.
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Estenose da Valva Aórtica , Tromboembolia , Trombose , Substituição da Valva Aórtica Transcateter , Anticoagulantes/uso terapêutico , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/complicações , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Humanos , Inibidores da Agregação Plaquetária/efeitos adversos , Piridinas , Fatores de Risco , Tiazóis , Tromboembolia/diagnóstico por imagem , Tromboembolia/epidemiologia , Tromboembolia/etiologia , Trombose/diagnóstico por imagem , Trombose/tratamento farmacológico , Trombose/epidemiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do TratamentoRESUMO
BACKGROUND: Accumulated experience and advances in device technology have led to the increasing off-label use of transcatheter aortic valve replacement (TAVR) for pure native aortic valve regurgitation (PNAR). This study aimed to evaluate the procedural and long-term outcomes of using newer-generation transcatheter heart valves (THVs) versus early-generation self-expanding CoreValve (Medtronic, Minneapolis, USA) to treat PNAR. METHODS: TAVRs were performed with the use of early- (N=15) and newer-generation (N=10) THVs in a total of 25 consecutive PNAR patients at an intermediate-to-high risk for surgical aortic valve replacement [mean Society of Thoracic Surgeons (STS) score of 6.8±4.5]. Procedural and clinical outcomes were reported according to the Valve Academic Research Consortium 2 criteria. The primary end-point of the study was all-cause mortality, myocardial infarction (MI), disabling stroke, and readmission due to heart failure. RESULTS: The device success rate of the newer-generation THVs was significantly higher than that of the early-generation CoreValve (100% vs. 33%, P<0.01), which was mainly driven by less frequent need for implanting a second THV (0% vs. 53%, P<0.01). Although the procedural success rates were 100% for both early- and newer-generation valves, the mean procedure fluoroscopic times which the newer-generation device group required, were significantly shorter (P<0.01) and the amount of contrast medium used in this group, markedly smaller (P<0.01), compared to those of the early-generation CoreValve group. During a median follow-up of 14 months, event-free survival was better in patients undergoing TAVR with the newer-generation THVs, although the differences were not statistically significant (log-rank test, P=0.137). According to multivariate analysis, a higher baseline STS score and longer intensive care unit stays are independent predictors of adverse outcomes. CONCLUSIONS: Evidently, the treatment of PNAR with TAVR using the newer-generation THVs yielded better procedural outcomes and is a valuable therapeutic option in selective patients. KEYWORDS: Transcatheter aortic valve replacement (TAVR); pure native aortic regurgitation (AR); transcatheter heart valves (THVs); procedural and clinical outcomes.
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AIMS AND OBJECTIVES: To investigate the characteristics and prevalence of demoralisation syndrome among heart transplantation patients in Taiwan. BACKGROUND: Patients with end-stage heart failure who have undergone cardiac transplantation are at risk of demoralisation syndrome. Demoralisation syndrome has been studied in cancer populations, but our understanding of the syndrome among heart transplant recipients is limited. DESIGN AND METHODS: The study adopted a cross-sectional design and analysed the baseline data from a longitudinal study with cardiac transplant patients at a heart centre in northern Taiwan. A structured questionnaire, namely the Demoralization Scale-Mandarin Version (DS-MV), was used to assess demoralisation syndrome. Hierarchical regression was applied to determine the predictors of demoralisation. Reporting was consistent with the STROBE checklist. RESULTS: There were a total of 84 participants with an average age of 51.9 years and a time since heart transplantation of around 4.1 years. Among them, the prevalence of demoralisation syndrome was 35.8%, and 57.1% coped well with stress. In addition, on the DS-MV, participants tended to choose sentences with positive rather than negative wording. Our data showed that cardiac transplant recipients with stress have higher possibility suffering from demoralisation syndrome; poor renal function and those who cannot relive from stress are predictors for loss of meaning. CONCLUSIONS: Chinese individuals tend to hide their weaknesses; nevertheless, demoralisation syndrome among cardiac transplant recipients, as related to stress status and kidney function, is still remarkable. RELEVANCE TO CLINICAL PRACTICE: Since demoralisation is preventable, further research on this phenomenon in the cardiac transplant population is warranted and needs to be developed.
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Desmoralização , Transplante de Coração , Estudos Transversais , Transplante de Coração/efeitos adversos , Humanos , Estudos Longitudinais , Pessoa de Meia-Idade , Inquéritos e Questionários , SíndromeRESUMO
Purpose: In this study, transapical transcatheter mitral valve-in-valve implantation (TAMVI) was compared with surgical redo mitral valve replacement (SRMVR) in terms of clinical outcomes. Methods: We retrospectively identified patients with degenerated mitral bioprosthesis or failed annuloplasty rings who underwent redo SRMVR or TAMVI at our medical center. Clinical outcomes were based on echocardiography results. Results: We retrospectively identified patients with symptomatic mitral bioprosthetic valve dysfunction (n = 58) and failed annuloplasty rings (n = 14) who underwent redo SRMVR (n = 36) or TAMVI (n = 36). The Society of Thoracic Surgeons Predicted Risk of Mortality scores were higher in the TAMVI group (median: 9.52) than in the SRMVR group (median: 5.59) (p-value = 0.02). TAMVI patients were more severe in New York Heart Association (p-value = 0.04). The total procedure time (skin to skin) and length of stay after procedures were significantly shorter in the TAMVI group, and no significant difference in mortality was noted after adjustment for confounding factors (p-value = 0.11). The overall mean mitral valve pressure gradient was lower in the TAMVI group than in the SRMVR group at 24 months (p < 0.01). Both groups presented a decrease in the severity of mitral and tricuspid regurgitation at 3-24 months. Conclusions: In conclusion, the statistical analysis is still not robust enough to make a claim that TAMVI is an appropriate alternative. The outcome of the patient appears only to be related to the patient's pre-operative STS score. Additional multi-center, longitudinal studies are warranted to adequately assess the effect of TAMVI.
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AIM AND OBJECTIVES: The purpose of this study was to explore the inter-relationships among resilience, nutrition, and leisure activity of older patients with cardiovascular disease and possible sarcopenia. Besides, the patterns of these three variables over a long-term follow-up was examine. MATERIAL AND METHODS: Quantitative longitudinal study design was used in this study. Sarcopenia is related to aging, lack of physical activity, and malnutrition. Complex inter-relationships exist in patients with regards to their resilience, nutritional status, leisure activities. A generalized estimating equation (GEE) was used for long-term follow-up observations, and data were collected form one month (T1), three months (T2) and six months (T3). A demographic questionnaire and the Chinese versions of the Resilience Scale (CRS), the Mini-Nutritional Assessment (MNA), and the Leisure Time Activities Scale (LTAS), were used to collect data. RESULTS: A total of 267 eligible participants were enrolled in this study, of whom 53% were men and 47% were women. The interactions among resilience, nutrition, and leisure activity were reported. Resilience was positively correlated with nutrition. Higher resilience was developed higher participation in leisure activities was found in older adults with possible sarcopenia. CONCLUSION: Resilience is a key factor for greater participation in leisure activities. Health professionals should develop feasible resilience interventions that would enhance patient's participation in leisure activities. Nutritional consulting and physical activity interventions should be combined in the case of older adults to prevent the occurrence of possible sarcopenia.
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BACKGROUND: Possible sarcopenia, aortic valve stenosis, and malnutrition are important issues that afflict older adults. OBJECTIVE: The aims of this study were to compare the differences in nutritional status and family support in older adults with possible sarcopenia and those without sarcopenia after undergoing transcatheter aortic valve implantation (TAVI) and to identify the predictors of malnutrition and demonstrate changes in heart function over time after undergoing TAVI. METHODS: A case-control design was conducted. Possible sarcopenia was identified by measuring calf circumference, grip strength, and gait speed. The Mini Nutritional Assessment-Short Form and numerical family support rating scale were used to collect data. Left ventricular ejection fraction and New York Heart Association (NYHA) functional class were assessed at 5 time points to evaluate heart function. RESULTS: Eighty-one participants were categorized into those without sarcopenia (34) and those with possible sarcopenia (47). Logistic linear regression showed albumin and possible sarcopenia to be predictors of malnutrition (odds ratio, 5.5; 95% confidence interval, 1.02-30.19). Family support was associated with nutrition status (P = .019). For patient heart function, the results of NYHA functional class and left ventricular ejection fraction improved over time after TAVI. The improvement in NYHA functional class at T2 was significantly different between the 2 groups compared with that at T0. CONCLUSIONS: The nutrition level was higher among participants without sarcopenia than those with possible sarcopenia. Approximately 90% of the participants indicated that they had high family support. Demographic factors and albumin levels could be used to evaluate risk of malnutrition. Patients without possible sarcopenia showed greater improvement in NYHA class.