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Platypnea-orthodoxia syndrome (POS) is a clinical condition that causes dyspnea and hypoxia in the sitting and standing positions. In this case, a 67-year-old man showed hypoxemia after undergoing the Bentall procedure that worsened in the standing position during rehabilitation. Contrast-enhanced computed tomography of the thorax and abdomen revealed no cause of respiratory failure. POS was suspected as the cause of the positional exacerbation of oxygen saturation. A bubble study showed a positive grade IV within three heartbeats on transthoracic echocardiography, which also confirmed an intracardiac shunt caused by a patent foramen ovale (PFO). Percutaneous PFO closure was performed, and hypoxemia was immediately resolved. Various factors were considered to cause the POS, including right heart failure, constrictive pericarditis, and postoperative adhesions, and each of these factors was discussed. POS after open-heart surgery is very rare. This is the first reported case of POS treated with a closure device following the Bentall procedure.
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Atrial septal defects (ASDs) often present with multiple foramina, including a patent foramen ovale (PFO) and atrial septal aneurysms (ASAs). Transcatheter device closure of an ASD may require additional supportive techniques in complex cases. Here, we report a case of a secundum ASD complicated by an ASA and a PFO in a man in his 50s. A GORE® Cardioform ASD Occluder (GCA) device of the optimal size for balloon sizing was implanted. However, edge leakage occurred from the front of the device because of a large, moving ASA. Implantation of a two-size-up GCA device successfully closed the ASD under controlled ASA movement.
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BACKGROUND: The AmplatzerTM PFO Occluder was approved for marketing in Japan in May 2019, and the Amplatzer PFO Occluder Japan Post-marketing Surveillance (PFO Japan PMS) study was initiated in December 2019. This analysis presents 30-day clinical outcomes for PFO Japan PMS study patients.MethodsâandâResults: PFO Japan PMS is a prospective single-arm non-randomized multicenter clinical study. Eligible patients were indicated for patent foramen ovale (PFO) closure and underwent an implant attempt with the AmplatzerTM PFO Occluder. Technical success was defined as successful delivery and release of the occluder; procedural success was defined as technical success with no serious adverse events (SAEs) within 1 day of the procedure. The primary safety endpoint includes predefined device- and/or procedure-related SAEs through 30 days after the procedure. From December 2019 to July 2021, 500 patients were enrolled across 53 Japanese sites. The mean (±SD) patient age was 52.7±15.4 years, and 29.8% of patients were aged >60 years. Technical and procedural success rates were both high (99.8% and 98.8%, respectively). Further, there was only one primary safety endpoint event (0.2%): an episode of asymptomatic paroxysmal atrial fibrillation that occurred 26 days after the procedure. CONCLUSIONS: In this real-world Japanese study with almost one-third of patients aged >60 years, PFO closure with the AmplatzerTM PFO Occluder was performed successfully and safely, with a low incidence of procedure-related atrial arrhythmias.
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For pre-procedural planning of left atrial appendage (LAA) closure, sizing is crucial. Although transesophageal echocardiography (TEE) is a standard modality, cardiac computed tomography (CT) is also widely used. The virtual TEE (V-TEE) that our group developed enables us to reconstruct images similar to TEE images from CT images. The software should be helpful to understand and plan the procedure strategy. Accordingly, we investigated the utility of V-TEE. Sixty-six patients at 4 participating sites who completed both CT and TEE prior to LAA closure were included. The LAA diameter at the landing zone (LZ) for WATCHMAN™ device implantation was statistically compared at 0°, 45°, 90°, and 135° between V-TEE and TEE. Among 66 cases, only 3 cases were excluded due to poor imaging quality, and 63 cases were analyzed. The device LZ diameters based on V-TEE were strongly correlated with those based on TEE, despite the significantly greater diameter based on V-TEE with mean differences of 2.4 to 3.0 mm (all of them: P < 0.001). The discordances (V-TEE/TEE ratio) at most angles were significantly larger in the elliptical LAAs. V-TEE provides a valuable method for the evaluation of the LAA diameters. V-TEE-based measurements were larger than conventional TEE-based measurements, especially in cases of elliptical LAAs. The assessment by V-TEE has the potential benefit of ensuring proper device sizing regardless of the LAA morphology.
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Apêndice Atrial , Fibrilação Atrial , Ecocardiografia Transesofagiana , Humanos , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Ecocardiografia Transesofagiana/métodos , Feminino , Masculino , Idoso , Fibrilação Atrial/cirurgia , Fibrilação Atrial/fisiopatologia , Tomografia Computadorizada por Raios X/métodos , Idoso de 80 Anos ou mais , Estudos Retrospectivos , Cateterismo Cardíaco/métodos , Dispositivo para Oclusão Septal , Pessoa de Meia-Idade , Tomografia Computadorizada Multidetectores/métodos , Reprodutibilidade dos TestesAssuntos
Cateterismo Cardíaco , Insuficiência da Valva Mitral , Valva Mitral , Humanos , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico , Cateterismo Cardíaco/métodos , Valva Mitral/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Ecocardiografia Transesofagiana , Próteses Valvulares Cardíacas/efeitos adversos , Dispositivo para Oclusão Septal , Feminino , Falha de Prótese , Masculino , IdosoRESUMO
BACKGROUND: Percutaneous left atrial appendage closure (LAAC) has increased for those who need alternative to long-term anticoagulation with non-valvular atrial fibrillation (NVAF). METHODS AND RESULTS: From September 2019, after initiating WATCHMAN (Boston Scientific, Maple Grove, MN, USA) device implantation, we established Transcatheter Modification of Left Atrial Appendage by Obliteration with Device in Patients from the NVAF (TERMINATOR) registry. Utilizing 729 patients' data until January 2022, we analyzed percutaneous LAAC data regarding this real-world multicenter prospective registry. A total of 729 patients were enrolled. Average age was 74.9â¯years and 28.5â¯% were female. Paroxysmal AF was 37.9â¯% with average CHADS2 3.2, CHA2DS2-VASc 4.7, and HAS-BLED score of 3.4. WATCHMAN implantation was successful in 99.0â¯%. All-cause deaths were 3.2â¯%, and 1.2â¯% cardiovascular or unexplained deaths occurred during follow-up [median 222, interquartile range (IQR: 93-464) days]. Stroke occurred in 2.2â¯%, and the composite endpoint which included cardiovascular or unexplained death, stroke, and systemic embolism were counted as 3.4â¯% [median 221, (IQR: 93-464) days]. Major bleeding defined as BARC type 3 or 5 was seen in 3.7â¯%, and there was 8.6â¯% of all bleeding events in total [median 219, (IQR: 93-464) days]. CONCLUSIONS: These preliminary data demonstrated percutaneous LAAC with WATCHMAN device might have a potential to reduce stroke and bleeding events for patients with NVAF. Further investigation is mandatory to confirm the long-term results of this strategy using this transcatheter local therapy instead of life-long systemic anticoagulation.
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Apêndice Atrial , Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Feminino , Idoso , Masculino , Fibrilação Atrial/complicações , Fibrilação Atrial/terapia , Apêndice Atrial/cirurgia , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Anticoagulantes , Sistema de Registros , Resultado do TratamentoRESUMO
The number of TV-PM implantations in elderly people is increasing. Although frailty syndrome is common in elderly patients, the relationship between the pre-procedural frailty status and clinical outcomes has not been fully elucidated in elderly TV-PM recipients.This study included 103 consecutive patients over 80 years old who were newly implanted with a TV-PM (age 85.7 ± 4.2, 41.7% male). We assessed the relationship between the clinical outcome and predictive factors, especially for the pre-procedural frailty status after the TV-PM implantation. The pre-procedural frailty status was retrospectively assessed from the medical records and classified on the basis of impairments in 3 domains (walking, cognition, and activities of daily living). The primary endpoint was defined as a heart failure admission.During the follow-up period (4.1 ± 2.3 years), 20 patients (19.4%) met the primary endpoint. Frailty syndrome was identified in 40 patients (38.8%). In univariate analysis, the LVEF (HR 0.97, 95% CI 0.96-1.00 P = 0.0492), an RV pacing burden over 40% (HR 1.58, 95% CI 1.00-2.54 P = 0.0473), and presence of a frailty status (HR 1.82, 95% CI 1.13-2.87 P = 0.0134) were found to be statistically significant predictors for the study endpoint. In multivariate analysis, having frailty syndrome was the only predictive factor for a heart failure admission (HR 1.83, 95% CI 1.12-2.93 P = 0.0157).The presence of frailty syndrome and incidence of clinical events were high and a pre-procedural frailty status assessment was key in determining the clinical outcomes in TV-PM recipients over 80 years old.
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Fragilidade , Insuficiência Cardíaca , Marca-Passo Artificial , Humanos , Masculino , Idoso , Idoso de 80 Anos ou mais , Feminino , Fragilidade/epidemiologia , Idoso Fragilizado , Estudos Retrospectivos , Atividades Cotidianas , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapiaRESUMO
AIMS: Left atrial appendage closure (LAAC) has been demonstrated to be cost-saving relative to oral anticoagulants for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF) in the United States and Europe. This study assessed the cost-effectiveness of LAAC with the Watchman device relative to warfarin and direct oral anticoagulants (DOACs) for stroke risk reduction in NVAF from a Japanese public healthcare payer perspective. METHODS: A Markov model was developed with 70-year-old patients using a lifetime time horizon. LAAC clinical inputs were from pooled, 5-year PROTECT AF and PREVAIL trials; warfarin and DOAC inputs were from published meta-analyses. Baseline stroke and bleeding risks were from the SALUTE trial on LAAC. Cost inputs were from the Japanese Medical Data Vision database. Probabilistic and one-way sensitivity analyses were performed. RESULTS: Over the lifetime time horizon, LAAC was less costly than warfarin (savings of JPY 1,878,335, equivalent to US $17,600) and DOACs (savings of JPY 1,198,096, equivalent to US $11,226). LAAC also provided 1.500 more incremental quality-adjusted life years (QALYs) than warfarin and 0.996 more than DOACs. In probabilistic sensitivity analysis, LAAC was cost-effective relative to warfarin and DOACs in 99.98% and 99.73% of simulations, respectively. LAAC dominated (had higher cumulative QALYs and was less costly than) warfarin and DOACs in 89.94% and 83.35% of simulations, respectively. CONCLUSIONS: Over a lifetime time horizon, LAAC is cost-saving relative to warfarin and DOACs for stroke risk reduction in NVAF patients in Japan and is associated with improved quality-of-life.
This study examined the cost-effectiveness of left atrial appendage closure (LAAC) compared to oral anticoagulants for stroke risk reduction among individuals with a specific type of irregular heart rhythm called non-valvular atrial fibrillation (NVAF). This study evaluated the cost-effectiveness of LAAC using the Watchman device in comparison to warfarin and direct oral anticoagulants (DOACs) from the perspective of Japan's public healthcare system. To investigate this, a computer-based model was developed involving 70-year-old patients over their lifetime. Data from notable studies such as the PROTECT AF and PREVAIL trials (covering 5 years) for LAAC and published meta-analyses for warfarin and DOACs were incorporated into the model. Baseline stroke and bleeding risks were derived from the SALUTE trial on LAAC. Cost inputs were based on data from the Japanese Medical Data Vision database. Additionally, we performed thorough cost-effectiveness analyses, including probabilistic and one-way sensitivity assessments. Our findings revealed that, over a lifetime, LAAC was more cost-effective than both warfarin and DOACs. Further, LAAC contributed an additional 1.500 quality-adjusted life years (QALYs) compared to warfarin and 0.996 QALYs compared to DOACs. In the long-term, adopting LAAC as an alternative to warfarin and DOACs is a cost-effective strategy for reducing stroke risk in NVAF patients in Japan. Moreover, it is associated with enhanced quality-of-life. These findings hold significant implications for informing decision-making in healthcare policies and clinical practices for NVAF patients.
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Apêndice Atrial , Fibrilação Atrial , Acidente Vascular Cerebral , Humanos , Idoso , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Varfarina/uso terapêutico , Análise Custo-Benefício , Japão , Apêndice Atrial/cirurgia , Anticoagulantes/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/complicações , Resultado do TratamentoAssuntos
Insuficiência Cardíaca , Miocardite , Humanos , Miocardite/diagnóstico , Miocárdio , Células GigantesRESUMO
OBJECTIVES: The aim of this study is to establish a guidance for device retrieval based on comprehensive bench tests. BACKGROUND: Device embolisation remains a major complication in transcatheter closure of atrial septal defect and patent ductus arteriosus. Although percutaneous retrieval is feasible in the majority of cases, surgical retrieval may be required in complicated circumstances. However, the methods of transcatheter device retrieval have not been completely established. METHODS: Bench tests of device retrieval were performed to verify the appropriate retrieval method according to device type/size. The devices used for testing were Amplatzer Septal Occluder (Abbott, Chicago, IL, United States of America), Figulla Flex II (Occlutech GmbH, Jena, Germany), Amplatzer Duct Occluder-I (Abbott), Amplatzer Duct Occluder-II (Abbott), and Amplatzer Vascular Plug-II (Abbott). The retrieval equipment constituted diagnostic catheters (multipurpose catheter and right Judkins catheter, 4-Fr or 5-Fr, Gadelius Medical, Tokyo, Japan), delivery sheath and cables for each device, Amplatz goose neck snares (Medtronic, Minneapolis, MN, United States of America), OSYPKA CATCHER (Osypka ag, Rheinfelden-Herten, Germany), and OSYPKA LASSOS (Osypka). We investigated the retrieval equipment and sheath sizes required for a successful retrieval procedure for variously sized devices. RESULTS: For patent ductus arteriosus devices, the type of snare and the snaring position are considered important. For atrial septal defect devices, simple snare capture or a double-snare technique with a sufficiently large sheath is effective. Special care should be taken when using the OSYPKA CATCHER for device retrieval. CONCLUSIONS: The results of this study may assist in the selection of both capture devices and a retrieval sheath or a catheter for complete retrieval.
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Permeabilidade do Canal Arterial , Comunicação Interatrial , Dispositivo para Oclusão Septal , Humanos , Permeabilidade do Canal Arterial/diagnóstico , Permeabilidade do Canal Arterial/cirurgia , Resultado do Tratamento , Cateterismo Cardíaco/métodos , Comunicação Interatrial/diagnóstico , Comunicação Interatrial/cirurgiaRESUMO
Heart failure (HF) is challenging public medical and healthcare systems. This study aimed to develop and validate a novel deep learning-based prognostic model to predict the risk of all-cause mortality for patients with HF. We also compared the performance of the proposed model with those of classical deep learning- and traditional statistical-based models. The present study enrolled 730 patients with HF hospitalized at Toho University Ohashi Medical Center between April 2016 and March 2020. A recurrent neural network-based model (RNNSurv) involving time-varying covariates was developed and validated. The proposed RNNSurv showed better prediction performance than those of a deep feed-forward neural network-based model (referred as "DeepSurv") and a multivariate Cox proportional hazard model in view of discrimination (C-index: 0.839 vs. 0.755 vs. 0.762, respectively), calibration (better fit with a 45-degree line), and ability of risk stratification, especially identifying patients with high risk of mortality. The proposed RNNSurv demonstrated an improved prediction performance in consideration of temporal information from time-varying covariates that could assist clinical decision-making. Additionally, this study found that significant risk and protective factors of mortality were specific to risk levels, highlighting the demand for an individual-specific clinical strategy instead of a uniform one for all patients.
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Percutaneous mitral annuloplasty is widely used for the treatment of functional mitral regurgitation. There are limited imaging options to guide MitraClip procedure (Abbott Vascular, Santa Clara, CA, USA) in patients intolerant to transesophageal echocardiography. We describe a case using a 3-dimensional electro anatomical mapping system to facilitate the successful MitraClip procedure. Learning objectives: There are situations in which percutaneous mitral valve repair (MitraClip) for mitral regurgitation is difficult to perform under transesophageal echocardiography due to esophageal disease.3D mapping system may be useful when performing MitraClip under transthoracic echocardiography.
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Identifying patient prognostic phenotypes facilitates precision medicine. This study aimed to explore phenotypes of patients with heart failure (HF) corresponding to prognostic condition (risk of mortality) and identify the phenotype of new patients by machine learning (ML). A unsupervised ML was applied to explore phenotypes of patients in a derivation dataset (n = 562) based on their medical records. Thereafter, supervised ML models were trained on the derivation dataset to classify these identified phenotypes. Then, the trained classifiers were further validated on an independent validation dataset (n = 168). Finally, Shapley additive explanations were used to interpret decision making of phenotype classification. Three patient phenotypes corresponding to stratified mortality risk (high, low, and intermediate) were identified. Kaplan−Meier survival curves among the three phenotypes had significant difference (pairwise comparison p < 0.05). Hazard ratio of all-cause mortality between patients in phenotype 1 (n = 91; high risk) and phenotype 3 (n = 329; intermediate risk) was 2.08 (95%CI 1.29−3.37, p = 0.003), and 0.26 (95%CI 0.11−0.61, p = 0.002) between phenotype 2 (n = 142; low risk) and phenotype 3. For phenotypes classification by random forest, AUCs of phenotypes 1, 2, and 3 were 0.736 ± 0.038, 0.815 ± 0.035, and 0.721 ± 0.03, respectively, slightly better than the decision tree. Then, the classifier effectively identified the phenotypes for new patients in the validation dataset with significant difference on survival curves and hazard ratios. Finally, age and creatinine clearance rate were identified as the top two most important predictors. ML could effectively identify patient prognostic phenotypes, facilitating reasonable management and treatment considering prognostic condition.
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Recently, balloon pulmonary angioplasty (BPA) for chronic thromboembolic pulmonary hypertension (CTEPH) and chronic thromboembolic pulmonary disease (CTEPD) has become an established procedure with stable results. The number of elderly CTEPH/CTEPD patients has also increased due to the widespread recognition of the disease concept. However, the reports of BPA in the elderly are limited. The aim of this study was to evaluate the efficacy and safety of BPA in elderly patients (>80 years). From April 2016 to December 2020, 344 BPA sessions (74 patients) were performed. The safety and efficacy of the BPA procedures were compared in the younger group (<80 years; 278 sessions) and the elderly group (≥80 years; 66 sessions). The hemodynamic parameters were significantly improved in both groups (mean pulmonary arterial pressure: 34.4 ± 9.9 â 21.2 ± 6.2 mmHg, p < 0.001 and 33.2 ± 9.6 â 21.8 ± 8.5 mmHg, p < 0.001; pulmonary vascular resistance: 474.5 ± 248.6 â 201.3 ± 108.7 dyne sec cm-5, p < 0.001 and 496.4 ± 290.9 â 260.5 ± 120.2 dyne sec cm-5, p = 0.002, in younger and elderly group, respectively). The rate of death within 30 days of BPA (0.3% vs. 0%, p = 1.000) and use of positive pressure ventilation (1.4% vs. 3.0%, p = 0.600) were not different between the groups (younger vs. elderly, respectively). BPA significantly improved the hemodynamic parameters of elderly CTEPH/CTEPD patients, and the safety is comparable to that of younger patients.
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Balloon pulmonary angioplasty (BPA) for chronic thromboembolic pulmonary hypertension (CTEPH) or pulmonary disease (CTEPD) is performed worldwide. High mean pulmonary arterial pressure (mPAP) during BPA is associated with aggravation of procedure-related complications. Inhaled nitric oxide (NO) acts as a pulmonary vasodilator in CTEPH patients. The aim of this retrospective observational study was to evaluate the effects of inhaled NO in CTEPH/CTEPD patients during BPA. We assessed hemodynamic changes and the frequency of procedure-related complications with or without NO inhalation. We performed 338 consecutive BPA in 72 CTEPH/CTEPD patients between April 2016 and November 2020. Since December 2019, all 16 patients (72-BPA sessions) inhaled NO during the procedure as a routine. Inhaled NO significantly reduced mPAP from 31.3 ± 8.5 to 27.2 ± 6.8 mmHg (p < 0.001) without lowering systemic blood pressure (systolic: 139.9 ± 19.9 vs. 135.3 ± 21.8 mmHg; p = 0.247, diastolic: 82.8 ± 13.0 vs. 79.0 ± 9.3 mmHg; p = 0.085, before vs. after NO inhalation, respectively). Procedure-related complications were observed in 46 sessions (13.6%). The incidence of hemoptysis was significantly higher in the NO group than in the non-NO group (20.8% vs. 10.9%; p = 0.031). In contrast, all fatal complications (death and use of positive pressure ventilation) occurred in the non-NO group, but the difference was not statistically significant (0 sessions [0.0%] vs. 7 sessions [2.6%], p = 0.353). Inhaled NO acts as a selective pulmonary vasodilator in CTEPH/CTEPD patients during the BPA procedure.
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BACKGROUND: Transcatheter mitral valve repair with the MitraClip system has been established in selected high-risk patients. The MitraClip procedure results in a relatively large iatrogenic atrial septal defect (iASD). This study aimed to investigate the prevalence and clinical course of iASD requiring transcatheter closure following the MitraClip procedure.MethodsâandâResults: This study was conducted at all 59 institutions that perform transcatheter mitral valve repair with the MitraClip system in Japan. The data of patients on whom transcatheter iASD closure was performed were collected. Of the 2,722 patients who underwent the MitraClip procedure, 30 (1%) required transcatheter iASD closure. The maximum iASD size was 9±4 mm (range, 3-18 mm). The common clinical course of transcatheter iASD closure was hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt. Of the 30 patients, 22 (73%) required transcatheter closure within 24 h following the MitraClip procedure, including 12 with hypoxemia and 5 with right-sided heart failure complicated with cardiogenic shock. Of the 5 patients, 2 required mechanical circulatory support devices. Twenty-one patients immediately underwent transcatheter iASD closure, and hemodynamic deteriorations were resolved; however, 1 patient died without having undergone transcatheter closure. CONCLUSIONS: Transcatheter iASD closure was required in 1% of patients who underwent the MitraClip procedure. Many of these patients immediately underwent transcatheter iASD closure because of hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt.
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Insuficiência Cardíaca , Comunicação Interatrial , Insuficiência da Valva Mitral , Humanos , Valva Mitral/cirurgia , Cateterismo Cardíaco/efeitos adversos , Doença Iatrogênica , Comunicação Interatrial/cirurgia , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/complicações , Hipóxia , Resultado do TratamentoRESUMO
Balloon pulmonary angioplasty (BPA) has improved the survival rate of patients with chronic thromboembolic pulmonary hypertension (CTEPH). The resolution of symptoms is one of the remaining goals of BPA. Frailty affects the outcome of cardiovascular diseases or treatments. The aim of this study is to assess the association between frailty and outcome of BPA. The resolution of symptoms is evaluated by the post-BPA World Health Organization functional class (WHO-FC). A total of 54 patients with CTEPH were divided into 2 groups by post-BPA WHO-FC (WHO-FC I group; n = 34 vs. WHO-FC ≥ II group; n = 20). Frailty was assessed by physicians using the clinical frailty scale (CFS) at the point of patient admission for their first BPA sessions. Compared to the WHO-FC ≥ II group, the WHO-FC I group was younger (65.6 ± 13.9 years vs. 74.3 ± 8.0 years) and had a lower CFS (3 [3, 4] vs. 4 [4, 6]) (median [25th, 75th percentiles]). The WHO-FC I achievement rates for each CFS score were CFS 3: 82.8%; 4: 53.8%; 5: 25.0%; 6: 33.3%; and 7: 20.0%. Logistic regression analysis showed that CFS was an independent predictor of WHO-FC I achievement (odds ratio 0.50, p = 0.012), but pre-BPA hemodynamic parameters and age were not independent predictors. Whether WHO-FC I can be achieved is predicted by pre-BPA patient frailty but not by pre-BPA hemodynamic parameters and age.