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This study was designed to assess the surgical outcomes of two commonly used techniques for turbinate reduction (diode laser and bipolar diathermy) in selected group of patients with chronic nasal obstruction which resulted from inferior turbinate hypertrophy. The current study was conducted on adult patients with a diagnosis of inferior turbinate hypertrophy. 42 patients (21 in each group) with an age range of 21-38 years (mean = 26.0 ± 4.1) were included in this work and were randomly distributed in 2 groups: one group was scheduled for diode laser turbinectomy (DLT) while the other group was managed by bipolar diathermy (BDT). In DLT, the machine was on a continuous mode with intermittent loading, with laser energy level set to 6 W (0.3-s pulse, 0.1-s break). Pre- and postoperative assessments were statistically compared via tests from SPSS 19.0 (IBM, Chicago, Illinois; USA). Percentage of categorical variables were compared using the Chi-square (χ2) test. P < 0.05 was considered significant, PË0.05 was considered non-significant, and P < 0.001 was considered highly significant. At 6 months postoperatively, in cases of DLT, there was high significant improvement as regards nasal obstruction and headache (χ2 = 64.78 and 39 respectively; P < 0.0001). There was insignificant difference as regards rhinorrhea (χ2 = 5.524; P = 0.137). In comparison to the postoperative data of both groups, significant difference was reported as regards nasal obstruction and headache (P < 0.001) and rhinorrhea (P < 0.05). This study demonstrated that both laser and bipolar cautery are effective in improving nasal obstruction and rhinorrhea. Preservation of the nasal mucociliary function was better in the diode laser group.
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Diatermia , Obstrução Nasal , Adulto , Humanos , Hipertrofia/cirurgia , Lasers Semicondutores/uso terapêutico , Obstrução Nasal/cirurgia , Resultado do Tratamento , Conchas Nasais/cirurgia , Adulto JovemRESUMO
PURPOSE: To evaluate differential surgical interventions for obstructive sleep apnea (OSA) patients with single-level retropalatal based on the preoperative topographical diagnosis using nasoendoscopy with Müller's maneuver during supine position (MM-P). SUBJECTS AND METHODS: This case series included adult patients with OSA who showed a predominant single-level retropalatal collapse on MM-P. An anteroposterior pattern of collapse was managed by an anterior advancement procedure, while a transverse pattern of collapse was managed by lateral/anterolateral advancement procedures (double suspension sutures). A combined procedure was provided to the concentric type of collapse. All patients underwent evaluation of the polysomnography, Epworth Sleepiness Scale (ESS) values and snoring scores both preoperatively and 6-8 months after surgery. RESULTS: Among 102 patients, the most commonly reported pattern of collapse at the retropalatal level was the concentric pattern (48.04%) followed by the transverse pattern (27.45%). The AP-pattern of collapse was reported in 24.51%. In the postoperative follow-up visits, no early or late complications were reported. All included groups showed significant improvement in polysomnographic data (mean AHI and lowest O2 saturation level). Significant improvement of VAS of snoring was reported. The overall success rate was Ë90%. CONCLUSION: Preoperative differential diagnosis of OSA with MM-P allows for tailored surgical management. Tailored procedures could yield good surgical outcomes when patients are properly selected and the technique is chosen according to preoperative topographical diagnostic assessment. This study might provide an available less-costly and effective preoperative planning for OSA intervention. LEVEL OF EVIDENCE: 4.
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Apneia Obstrutiva do Sono , Vigília , Endoscopia , Humanos , Polissonografia , Apneia Obstrutiva do Sono/diagnóstico , Apneia Obstrutiva do Sono/etiologia , Apneia Obstrutiva do Sono/cirurgia , Ronco/diagnóstico , Ronco/etiologia , Ronco/cirurgia , Resultado do TratamentoRESUMO
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has been demonstrated to be an established therapy for high-risk, inoperable patients with severe symptomatic aortic valve stenosis. For patients with moderate surgical risk, TAVR is equivalent to conventional aortic valve surgery. However, atrial fibrillation (AF) is also present in many of these patients, thus requiring post-implantation oral anticoagulation therapy in addition to the inhibition of thrombocyte aggregation, which poses the risk of bleeding complications. The aim of our work was to investigate the influence of AF on mortality and the occurrence of bleeding, vascular and cerebrovascular complications related to TAVR according to the VARC-2 criteria. METHODS: Two hundred eighty-three patients who underwent TAVR between March 2010 and April 2016 were retrospectively examined. In total, 257 patients who underwent transfemoral access were included in this study. The mean patient age was 81 ± 6 years, 54.1% of the patients were women, and 42.4% had pre-interventional AF. RESULTS: Compared to patients with sinus rhythm (SR, n = 148), patients with AF (n = 109) had an almost three-fold higher incidence of major vascular complications (AF 14.7% vs. SR 5.4%, p = 0.016) and life-threatening bleeding (AF 11.9% vs. SR 4.1%, p = 0.028) during the first 30 post-procedural days. However, the rate of cerebrovascular complications (AF 3.7% vs. SR 2.7%, p = 0.726) did not significantly differ between the two groups. Overall mortality was significantly higher in patients with AF during the first month (AF 8.3% vs. SR 2.0%, p = 0.032) and the first year (AF 28.4% vs. SR 15.3%; p = 0.020) following TAVR. CONCLUSION: Patients with AF had significantly more severe bleeding complications after TAVR, which were significantly related to mortality. Future prospective randomized studies must clarify the optimal anticoagulation therapy for patients with AF after TAVR. TRIAL REGISTRATION: DRKS00011798 on DRKS (Date 17.03.2017).
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Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Fibrilação Atrial/fisiopatologia , Doenças Cardiovasculares/epidemiologia , Cateterismo Periférico/efeitos adversos , Artéria Femoral , Frequência Cardíaca , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Fibrilação Atrial/mortalidade , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/fisiopatologia , Cateterismo Periférico/mortalidade , Causas de Morte , Transtornos Cerebrovasculares/epidemiologia , Transtornos Cerebrovasculares/fisiopatologia , Ensaios Clínicos como Assunto , Feminino , Alemanha/epidemiologia , Humanos , Incidência , Estimativa de Kaplan-Meier , Tempo de Internação , Masculino , Inibidores da Agregação Plaquetária/efeitos adversos , Hemorragia Pós-Operatória/epidemiologia , Hemorragia Pós-Operatória/fisiopatologia , Modelos de Riscos Proporcionais , Punções , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Doenças Vasculares/epidemiologia , Doenças Vasculares/fisiopatologiaRESUMO
BACKGROUND: The aim of this study was to compare treatment of moderate to severe symptomatic mitral regurgitation (MR) with either conventional surgery or the mitral valve edge-to-edge device (MitraClip®) in very elderly patients. The newly introduced MitraClip device has demonstrated promising acute results in treating this patient cohort. Also noteworthy is the fact that patients who otherwise would have been denied surgery are increasingly referred for treatment with the MitraClip device. We sought to review our institutional experience, comparing outcomes in both surgical and MitraClip arms of treatment in the elderly population with symptomatic MR. METHODS: From October 2008 through October 2014, 136 consecutive patients aged ≥ 80 with moderate to severe symptomatic MR were scheduled for either conventional surgery or MitraClip intervention. 56 patients ≥ 80 were operated for symptomatic MR and 80 patients ≥ 80 were treated with the mitraClip device. Patients suitable for this study were identified from our hospital database. Patients ≥80 with moderate/severe symptomatic MR treated with either conventional surgery or the MitraClip device were eligible for our analysis. We compared the surgical patient cohort with the mitraClip patient cohort after eliminating patients that did not meet our inclusion criteria. Forty-two patients were identified from the conventional cohort who were then compared with 42 patients from the mitraClip cohort. Forty-two patients (50%) underwent mitral valve repair or replacement (40.5% functional MR, 59.5% organic/mixed MR) and 42 patients (50%) underwent MitraClip intervention (50% functional MR, 50% organic/mixed MR). Associated procedures in the conventional surgical group were myocardial revascularization 38%, pulmonary vein ablation 23.8%, left atrial appendage resection 52.4% and PFO occlusion 11.9%. RESULTS: Patients who underwent MitraClip treatment were though slightly older but the differences did not attain statistical significance (mean, 82.2 ± 1.65 vs 81.7 ± 1.35 years, p = 0,100), had lower LVEF (mean, 47.6 ± 14.2 vs 53.4 ± 14.3, p = 0.072), lower logistic EuroScore II (mean, 11.3 ± 5.63 vs 12.1 ± 10.6, p = 0.655) but higher STS risk score (mean, 11.8 ± 6.7 vs 8.1 ± 5.6, p = 0.008) respectively compared to surgical patients. Procedural success was 100% vs 96% in surgery and MitraClip groups respectively. Thirty -day mortality was 7.1% vs 4.8% (p = 1.000) in surgery and MitraClip group respectively. Residual postoperative MR ≥2 at discharge was present in none of the patients treated surgically, whereas this was the case in 10 (23.8%) patients treated with the MitraClip device. At 1 year a cumulative number of four (9.52%) patients died in the surgical group vs 9 (21.4%) patients who died in the MitraClip group. CONCLUSIONS: Elderly patients presenting with moderate to severe symptomatic MR may either be treated by conventional surgery or with the MitraClip device with acceptable acute outcomes. The decision for treatment with the MitraClip device should not depend on age alone rather on cumulative risk of conventional surgery. Concomitant cardiac pathologies, often times treated simultaneously during surgery for symptomatic MR may be omitted, if patients are scheduled outright to MitraClip treatment. The effect of concomitant cardiac pathologies left untreated at the time of interventional mitral valve repair on outcome after MitraClip therapy remain widely unknown.
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Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Anuloplastia da Valva Mitral/instrumentação , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Idoso de 80 Anos ou mais , Feminino , Alemanha , Implante de Prótese de Valva Cardíaca/efeitos adversos , Hemodinâmica , Humanos , Estimativa de Kaplan-Meier , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/fisiopatologia , Anuloplastia da Valva Mitral/efeitos adversos , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/fisiopatologia , Seleção de Pacientes , Modelos de Riscos Proporcionais , Desenho de Prótese , Recuperação de Função Fisiológica , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Índice de Gravidade de Doença , Volume Sistólico , Fatores de Tempo , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
A patient in his 40s presented to the emergency department with chest pain and diaphoresis, which had also occurred 2 days earlier. He had a 20 pack-year history of smoking but no family history of cardiovascular disease. The patient's electrocardiogram showed biphasic T waves in leads V2 and V3. What would you do next?
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Dor no Peito , Humanos , Pessoa de Meia-Idade , Dor no Peito/etiologia , Angiografia Coronária , Eletrocardiografia , TóraxRESUMO
BACKGROUND: Surgical mitral valve repair is the gold standard for treatment of mitral regurgitation. Recently, the transcatheter treatment of mitral regurgitation with the MitraClip® device (Abbot Vascular Structural Heart, Menlo Park, CA) has demonstrated promising results in treating patients not amenable for surgical correction of mitral valve regurgitation. Most patients reported in the literature requiring surgical bailout after MitraClip treatment presented with residual or recurrent mitral valve regurgitation. Mitral valve stenosis after MitraClip treatment has been rarely reported. METHODS: From February 2010 to December 2014, four patients out of 165 patients who underwent MitraClip therapy developed symptomatic mitral valve stenosis (2.4%) and needed surgical correction. Data of the four patients were reviewed retrospectively. Follow-up data were obtained from each patient's general practitioner/cardiologist by phone calls and facsimile and were complete in all patients. RESULTS: All four patients were treated with ≥ 2 MitraClip (MC) devices during their initial presentation. All four patients underwent MV replacement with a tissue valve. The postoperative course was uneventful and there was no 30-day mortality. At 6-month follow-up, all patients were alive and in NYHA class I-III. CONCLUSION: Placement of multiple clip devices may lead to slightly elevated transmitral gradients. This may not necessarily interpret into symptomatic mitral stenosis. However, in some cases this is possible. Caution should be exercised at this phase of the learning curve of the percutaneous MC treatment, especially in use of multiple MC devices.
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Anuloplastia da Valva Cardíaca/métodos , Próteses Valvulares Cardíacas/efeitos adversos , Insuficiência da Valva Mitral/cirurgia , Estenose da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Complicações Pós-Operatórias/cirurgia , Idoso , Idoso de 80 Anos ou mais , Ecocardiografia Transesofagiana , Feminino , Seguimentos , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/diagnóstico , Estenose da Valva Mitral/diagnóstico , Estenose da Valva Mitral/etiologia , Complicações Pós-Operatórias/etiologia , Falha de Prótese , Reoperação , Estudos Retrospectivos , Fatores de TempoRESUMO
BACKGROUND: Accurate preoperative assessment of the aortic annulus dimension is crucial for successful transcatheter aortic valve implantation (TAVI). In this study we validated a new method using two-dimensional transesophageal echocardiography (2D-TEE) for measurement of the aortic annulus prior to TAVI. METHODS: We analysed 124 patients who underwent successful TAVI using a self-expandable prosthesis, divided equally into two groups; in the study group we used the cross sectional short axis 2D-TEE for measurement of the aortic annulus and in the control group we used the long axis 2D-TEE. RESULTS: Both groups were comparable regarding the clinical parameters. On the other hand, patients in the study group had less left ventricular ejection fraction (38.9 % versus 45.6 %, p = 0.01). The aortic valve annulus was, although not statistically significant, smaller in the study group (21.58 versus 23.28 mm, p = 0.25). Post procedural quantification of the aortic regurgitation revealed that only one patient in both groups had severe aortic regurgitation (AR), in this patient the valve was implanted deep. The incidence of significant AR was higher in the control group (29.0 % versus 12.9 %, p = 0.027). CONCLUSIONS: Sizing of the aortic valve annulus using cross-sectional 2D-TEE offers a safe and plausible method for patients undergoing TAVI using the self-expandable prosthesis and is significantly superior to using long axis 2D-TEE.
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Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/cirurgia , Ecocardiografia Transesofagiana/métodos , Ecocardiografia/métodos , Substituição da Valva Aórtica Transcateter/métodos , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estudos de Casos e Controles , Estudos de Viabilidade , Feminino , Humanos , Masculino , Estudos RetrospectivosRESUMO
BACKGROUND: Accurate preoperative assessment of the aortic annulus dimension is crucial for successful transcatheter aortic valve implantation (TAVI). In this study we examined the accuracy of a novel method using two-dimensional transesophageal echocardiography (2D-TEE) for measurement of the aortic annulus. METHODS: We evaluated the theoretical impact of the measurement of the annulus diameter and area using the circumcircle of a triangle method on the decision to perform the procedure and choice of the prosthesis size. RESULTS: Sixty-three consecutive patients were scheduled for TAVI. Mean age was 82 ± 4 years, and 25 patients (55.6 %) were female. Mean aortic annulus diameter was 20.3 ± 2.2 mm assessed by TEE on the mid-esophageal long-axis view and 23.9 ± 2.3 mm using CT (p < 0.001). There was a tendency for the TEE derived areas using the new method to be higher (p < 0.001). The TEE measurements were on average 42.33 mm(2) higher than the CT measurements without an evidence of a systematic over- or under-sizing (p = 1.00). Agreement between TEE and CT chosen valve sizes was good overall (kappa = 0.67 and weighted kappa = 0.71). For patients who turned out to have no AR, the two methods agreed in 84.6 % of patients. CONCLUSIONS: CT remanis the gold standard in sizing of the aortic valve annulus. Nevertheless, sizing of the aortic valve annulus using TEE derived area may be helpful. The impact of integration of this method in the algorithm of aortic annulus sizing on the outcome of patients undergoing TAVI should be examined in future studies.
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Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/terapia , Valva Aórtica/diagnóstico por imagem , Bioprótese , Cateterismo Cardíaco/instrumentação , Ecocardiografia Transesofagiana , Implante de Prótese de Valva Cardíaca/instrumentação , Próteses Valvulares Cardíacas , Desenho de Prótese , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Valvuloplastia com Balão , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/métodos , Feminino , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Interpretação de Imagem Assistida por Computador , Masculino , Variações Dependentes do Observador , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Tomografia Computadorizada por Raios X , Resultado do TratamentoRESUMO
BACKGROUND: "Depth of invasion" is an additional index incorporated in 8th AJCC staging system for oral cavity squamous cell carcinoma based on its prognostic significance. Pre-operative assessment by clinical palpation and imaging modalities has been used with limitations. The aim of the study is to compare different techniques including clinical palpation, ultrasound, and magnetic resonance imaging with histopathology for assessment of depth of tumor invasion. MATERIALS: Fifty patients of carcinoma tongue (T1-T3) were enrolled. Clinical palpation, Ultrasound tongue, and Magnetic resonance imaging were used to assess depth of tumor invasion. Microscopic depth of invasion was considered as reference. Statistical analysis was done to assess the level of agreement, reliability, and internal consistency. ROC analysis was done to find the "Area Under Curve" for microscopic depth versus ultrasound, MRI, and gross histopathological "depth of invasion". RESULTS: Ultrasound tongue showed highest "area under curve", Intra class correlation (ICC:0.786) with a good consistency (Cronbach's Alpha:0.880) with histological reference compared to MRI(ICC:0.689;CA:0.816). Clinical palpation showed weak agreement (Kappa:0.43) for assessing depth. To observe the concordance between ultrasound and microscopic depth, Lin's Concordance Correlation Coefficient (CCC = 0.782) was calculated with 95% limits of agreement. Lin's concordance correlation between ultrasound and microscopic depth showed a good agreement. CONCLUSIONS: Ultrasound tongue is a reliable imaging modality for pre-operative T staging by assessing tumor "depth of invasion" in carcinoma tongue patients with good internal consistency as per 8th AJCC staging system. LEVEL OF EVIDENCE: 2 (CEBM-Level of Evidence-2.1) Laryngoscope, 134:215-221, 2024.
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Neoplasias de Cabeça e Pescoço , Neoplasias da Língua , Humanos , Reprodutibilidade dos Testes , Estadiamento de Neoplasias , Invasividade Neoplásica/patologia , Neoplasias da Língua/diagnóstico por imagem , Neoplasias da Língua/patologia , Carcinoma de Células Escamosas de Cabeça e Pescoço/patologia , Língua/patologia , Imageamento por Ressonância Magnética/métodos , Neoplasias de Cabeça e Pescoço/patologia , Estudos RetrospectivosRESUMO
Background: Intra-atrial shunts are associated with an elevated risk of embolic stroke of undetermined source (ESUS). Percutaneous occluder implantation is recommended as secondary prevention in younger patients. This study aims to compare the outcome after shunt occlusion between younger and older patients with a history of presumed paradox embolism and to evaluate the impact of high-volume shunting in an elderly population. Methods: We conducted a single-center, retrospective, observational study, involving 187 patients who underwent interventional percutaneous PFO or ASD occlusion at our center between 2013 and 2023. Results: The mean age of participants was 51.8 ± 11.8 years, with 76 patients aged ≤50 years and 111 patients aged >50 years. Older patients presented more cardiovascular risk factors. The presence of atrial septum aneurysm or large shunting was evenly distributed (ASA 26.3% vs. 28.8%, p = 0.833, mean shunt defect size 6.67 vs. 7.23â mm, p = 0.151). There were no significant differences in procedural or intrahospital complications. The event rate during the 6-month follow-up was low. Recurrence of arterial embolism occurred in 1.6% of the younger and 3.8% of the older patients (p = 0.817). Comparison of high-volume shunts (defect size ≥10â mm or passage ≥20 bubbles during bubble study) with low-volume shunts in this elderly cohort with a mean age ≥50 years showed no significant difference in outcomes. There was a statistically non-significant trend toward a higher rate of residual shunt at the end of the procedure in the high-volume shunt group (2.9% vs. 9.8%, p = 0.0894). This difference was not observed at the 6-month follow-up anymore (14.5 vs. 12.1%, p = 0.628). Two unsuccessful implantation attempts were reported in the high-volume shunt group, while none were observed in the low-volume shunt group (p = 0.372). No intervention-related deaths occurred in this patient cohort during follow-up. Conclusion: Occlusion of relevant, intra-atrial shunting is a safe and effective option for secondary prevention of cryptogenic embolism in patients over 50 years of age. The beneficial outcome was irrespective of a high-volume shunting before implantation.
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Background: Percutaneous interventional left atrial appendage occlusion (LAAO) is a reliable, safe, and effective alternative for stroke prevention in selected patients with atrial fibrillation (AF). Methods: In a retrospective observational study, 149 patients underwent LAAO between 2016 and 2022 at the Department of Cardiology of the Charité-Universitätsmedizin Berlin, Campus Virchow, with AF for prevention of thromboembolic complications. We compared patient characteristics, intraoperative details and postoperative outcomes between single-occlusive plug-type (SOPT) and dual-occlusive disc-type (DODT) devices. Results: In all patients, the device implantation was successful. 60 patients received a SOPT occluder, including Watchman (35%) and Watchman FLX Occluders (65%), while 89 patients received a DODT occluder, including Amplatzer Cardiac Plug (37.1%), the Amplatzer Amulet (25.8%), and the LAmbre occluder (37.1%) systems. Procedure duration was significantly longer for DODT occluder implantation (49 ± 33 vs. 41 ± 25â min, p = 0.018). There were no in-hospital deaths or thromboembolic events reported after LAAO in both groups. Beyond that, a low rate of bleeding or access-side-related complications and pericardial tamponades were observed. Anticoagulation at discharge varied. About 60.8% of patients received dual antiplatelet therapy at hospital discharge, and 33.1% received direct oral anticoagulants. A 6-month follow-up was obtained in 85% of the patients. All implanted devices were in the desired position. However, in 5.7% of the patients, a device-related thrombus formation was detected in the SOPT group, while no thrombus was seen in the DODT group (p = 0.11). Thromboembolic events were noticed in 3.1%, without any difference between the device types. There was a statistically non-significant trend for less residual device leaks after SOPT vs. DODT implantation (no leak in 71.7% vs. 62.2%, p = 0.07; minor leaks <5â mm, 9.4% vs. 20.3%, p = 0.1). In the SOPT group, less bleeding complications were reported after LAAO (11.3% vs. 17.6%, p = 0.1). Conclusion: Our data suggest the safety and efficiency of LAAO with a very high procedural implantation success rate irrespective of the used LAA device. Furthermore, no relevant procedural or device-related complication occurred during the 6-month follow-up in all patients.
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Introduction: There is a lack of real-world data directly comparing different valve prostheses for transaortic valve replacement (TAVR). We aimed to compare early clinical outcomes at 30-days between the self-expandable Portico valve (Abbott) with the balloon-expandable Edwards Sapien 3 valve (Edwards Lifesciences) (ES3). Methods: Out of 1,901 patients undergoing TAVR between January 2018 and December 2021, all patients who received either Portico valve or ES3 valve via transfemoral TAVR were matched using nearest-neighbor (1:1) propensity scoring. Primary endpoints were single safety endpoints and early safety composite endpoints defined by Valve Academic Research Consortium-2 (VARC-2) criteria. The secondary endpoint was to analyze risk predictors for new permanent pacemaker (PPM) implantation in TAVR. Results: Out of 661 complete cases, a total of 434 patients were successfully matched based on age, sex, Euro Score II and STS-score. In the matched cohort, 217 received either a Portico or valve and 217 received an ES3 valve. The VARC-2 early safety composite scores indicated a significantly greater overall 30-day safety risk in the Portico group at 9.2% (n = 20) compared to 3.7% (n = 8) in the ES3 group (p = 0.032). The requirement for new permanent pacemaker (PPM) implantation was also higher in the Portico group, at 21.2% (n = 46) vs. 13.4% (n = 29) in the ES3 group (p = 0.042). 30-day mortality was higher was 3.7% (n = 8) in Portico group compared to 0.9% in ES3 group (p = 0.11). Furthermore, implantation of the Portico valve was identified as a significant risk predictor for new PPM implantation, alongside higher age, preprocedural atrioventricular block (AVB) and longer total procedure duration. Conclusion: This study shows significantly higher rates of early clinical complications for Portico valve prostheses compared to ES3. These findings should be especially taken into consideration when selecting valve prosthesis for high-risk patients.
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BACKGROUND: Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established. OBJECTIVES: The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study. METHODS: Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee-adjudicated 30-day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory-assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. RESULTS: A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30-day composite major adverse event rate was 6.8%. MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P < 0.001 vs baseline). One-year Kaplan-Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Significant functional and quality-of-life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4-point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6-minute walk distance (all P < 0.001 vs baseline). CONCLUSIONS: One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting. Results demonstrate high survival and freedom from heart failure hospitalization, significant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life.
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Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Seguimentos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Qualidade de Vida , Resultado do Tratamento , Implante de Prótese de Valva Cardíaca/efeitos adversos , Cateterismo Cardíaco/efeitos adversosRESUMO
BACKGROUND: There is a lack of comparative data on transcatheter aortic valve implantation (TAVI) in degenerated surgical prostheses (valve-in-valve [ViV]). AIMS: We sought to compare outcomes of using two self-expanding transcatheter heart valve (THV) systems for ViV. METHODS: In this retrospective multicentre registry, we included consecutive patients undergoing transfemoral ViV using either the ACURATE neo/neo2 (ACURATE group) or the Evolut R/PRO/PRO+ (EVOLUT group). The primary outcome measure was technical success according to Valve Academic Research Consortium (VARC)-3. Secondary outcomes were 30-day all-cause mortality, device success (VARC-3), coronary obstruction (CO) requiring intervention, rates of severe prosthesis-patient mismatch (PPM), and aortic regurgitation (AR) ≥moderate. Comparisons were made after 1:1 propensity score matching. RESULTS: The study cohort comprised 835 patients from 20 centres (ACURATE n=251; EVOLUT n=584). In the matched cohort (n=468), technical success (ACURATE 92.7% vs EVOLUT 88.9%; p=0.20) and device success (69.7% vs 73.9%; p=0.36) as well as 30-day mortality (2.8% vs 1.6%; p=0.392) were similar between the two groups. The mean gradients and rates of severe PPM, AR ≥moderate, or CO did not differ between the groups. Technical and device success were higher for the ACURATE platform among patients with a true inner diameter (ID) >19 mm, whereas a true ID ≤19 mm was associated with higher device success - but not technical success - among Evolut recipients. CONCLUSIONS: ViV TAVI using either ACURATE or Evolut THVs showed similar procedural outcomes. However, a true ID >19 mm was associated with higher device success among ACURATE recipients, whereas in patients with a true ID ≤19 mm, device success was higher when using Evolut.
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Insuficiência da Valva Aórtica , Bioprótese , Oclusão Coronária , Substituição da Valva Aórtica Transcateter , Humanos , Catéteres , Insuficiência da Valva Aórtica/etiologia , Insuficiência da Valva Aórtica/cirurgia , Valvas Cardíacas , Sistema de Registros , Substituição da Valva Aórtica Transcateter/efeitos adversosRESUMO
We report on a 72 years old male patient with recurrent heart failure hospitalizations caused by severe mitral regurgitation due to severe restriction of the posterior mitral leaflet treated with the transfemoral mitral valve replacement (TMVR) system Cardiovalve. Immediate interventional success was obtained resulting in a quick mobilization and discharge.
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Background: In most cases of transcatheter valve embolization and migration (TVEM), the embolized valve remains in the aorta after implantation of a second valve into the aortic root. There is little data on potential late complications such as valve thrombosis or aortic wall alterations by embolized valves. Aims: The aim of this study was to analyze the incidence of TVEM in a large cohort of patients undergoing transcatheter aortic valve implantation (TAVI) and to examine embolized valves by computed tomography (CT) late after TAVI. Methods: The patient database of our center was screened for cases of TVEM between July 2009 and July 2021. To identify risk factors, TVEM cases were compared to a cohort of 200 consecutive TAVI cases. Out of 35 surviving TVEM patients, ten patients underwent follow-up by echocardiography and CT. Results: 54 TVEM occurred in 3757 TAVI procedures, 46 cases were managed percutaneously. Horizontal aorta (odds ratio [OR] 7.51, 95% confidence interval [CI] 3.4-16.6, p < 0.001), implantation of a self-expanding valve (OR 4.63, 95% CI 2.2-9.7, p < 0.01) and a left ventricular ejection fraction < 40% (OR 2.94, 95% CI 1.1-7.3, p = 0.016) were identified as risk factors for TVEM. CT scans were performed on average 26.3 months after TAVI (range 2-84 months) and detected hypoattenuated leaflet thickening (HALT) in two patients as well as parts of the stent frame protruding into the aortic wall in three patients. Conclusion: TVEM represents a rare complication of TAVI. Follow up-CT detected no pathological findings requiring intervention.
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BACKGROUND: Recent case reports and small studies have reported activation of the magnet-sensitive switches in cardiovascular implantable electronic devices (CIEDs) by the new iPhone 12 series, initiating asynchronous pacing in pacemakers and suspension of antitachycardia therapies in implantable cardioverter-defibrillators (ICDs). OBJECTIVE: The purpose of this prospective single-center observational study was to quantify the risk of magnetic field interactions of the iPhone 12 with CIEDs. METHODS: A representative model of each CIED series from all manufacturers was tested ex vivo. Incidence and minimum distance necessary for magnet mode triggering were analyzed in 164 CIED patients with either the front or the back of the phone facing the device. The magnetic field of the iPhone 12 was analyzed using a 3-axis Hall probe. RESULTS: Ex vivo, magnetic interference occurred in 84.6% with the back compared to 46.2% with the front of the iPhone 12 facing the CIED. In vivo, activation of the magnet-sensitive switch occurred in 30 CIED patients (18.3%; 21 pacemaker, 9 ICD) when the iPhone 12 was placed in close proximity over the CIED pocket and the back of the phone was facing the skin. Multiple binary logistic regression analysis identified implantation depth (95% confidence interval 0.02-0.24) as an independent predictor of magnet-sensitive switch activation. CONCLUSION: Magnetic field interactions occur only in close proximity and with precise alignment of the iPhone 12 and CIEDs. It is important to advise CIED patients to not put the iPhone 12 directly on the skin above the CIED. Further recommendations are not necessary.
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Desfibriladores Implantáveis , Marca-Passo Artificial , Desfibriladores Implantáveis/efeitos adversos , Eletrônica , Humanos , Campos Magnéticos , Imãs , Marca-Passo Artificial/efeitos adversos , Estudos ProspectivosRESUMO
BACKGROUND: Despite widespread penetration of drug-eluting stents (DES) in clinical practice, a relevant percentage of patients with coronary artery disease are still treated with bare-metal stents (BMS). Contemporary BMS, however, are less well investigated and comparative data on clinical outcome are lacking. METHODS AND RESULTS: This single-center registry aimed to assess characteristics and outcome of patients treated with 2 different new-generation cobalt-chromium BMS, the MULTI-LINK VISION and PRO-Kinetic stents. During the study, adopted criteria for BMS selection were: (1) limited compliance to dual antiplatelet therapy, (2) ST-elevation myocardial infarction (MI) or saphenous vein graft (SVG) interventions, and (3) noncomplex lesions located either in the right coronary artery or in the nonproximal segments of the left coronary artery. During a 24-month period 1,176 patients were treated with the VISION (n = 438) or PRO-Kinetic stent (n = 738). Median duration of follow-up was 549.5 and 528.5 days, respectively. Target lesion revascularization (TLR) and target vessel revascularization were numerically lower in the VISION group (10.4 vs. 12.3% and 11.9 vs. 15.2%, P = 0.24 and 0.11). Death (4.1 vs. 4.3%, P = 0.85), MI (2 vs. 2.3%, P = 0.78), and ARC definite stent thrombosis (0.5 vs. 0.5%, P = 0.84) were similar. By multivariate analysis, variables associated with TLR were SVG interventions (HR 2.21, 95% CI 1.26-3.86), total stent length (HR 1.01, 95% CI 1.00-1.02), and smoking (HR 1.51, 95% CI 1.05-2.16). CONCLUSION: In the DES era, the use of last-generation thin-strut BMS in selected patients is associated with acceptable clinical outcome, with similar clinical results for both the MULTI-LINK VISION and PRO-Kinetic stents.
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Reestenose Coronária/prevenção & controle , Stents Farmacológicos , Idoso , Cromo , Cobalto , Intervalos de Confiança , Angiografia Coronária , Reestenose Coronária/terapia , Feminino , Humanos , Masculino , Estudos Prospectivos , Sistema de Registros , Estatística como Assunto , Fatores de Tempo , Resultado do TratamentoRESUMO
AIMS: This study aimed to evaluate the impact of coronavirus disease 2019 (Covid-19) outbreak on admissions for acute myocardial infarction (AMI) and related mortality, severity of presentation, major cardiac complications and outcome in a tertiary-care university hospital in Berlin, Germany. METHODS AND RESULTS: In a single-centre cross-sectional observational study, we included 355 patients with AMI containing ST-elevation or non-ST-elevation myocardial infarction (STEMI or NSTEMI), admitted for emergency cardiac catheterization between January and April 2020 and the equivalent time in 2019. During the early phase of the Covid-19 pandemic (e-COV) in Berlin (March and April 2020), admissions for AMI halved compared with those in the pre-Covid-19 time (January and February 2020; pre-COV) and with those in the corresponding months in 2019. However, mortality for AMI increased substantially from 5.2% pre-COV to 17.7% (P < 0.05) during e-COV. Severity of presentation for AMI was more pronounced during e-COV [increased levels of cardiac enzymes, reduced left ventricular ejection fraction (LVEF), an increase in the need of inotropic support by 25% (P < 0.01)], while patients' demographic and angiographic characteristics did not differ between pre-COV and e-COV. Time from symptom onset to first medical contact was prolonged in all AMI during e-COV (presentation > 72 h +21% in STEMI, p = 0.04 and presentation > 72 h in NSTEMI +22%, p = 0.02). Door to balloon time was similar in STEMI patients, while time from first medical contact to revascularization was significantly delayed in NSTEMI patients (p = 0.02). Major cardiac complications after AMI occurred significantly more often, and cardiac recovery was worse in e-COV than in pre-COV, demonstrated by a significantly lower LVEF (39 ± 16 vs. 46 ± 16, p < 0.05) at hospital discharge and substantially higher NTproBNP levels. CONCLUSIONS: The Covid-19 outbreak affects hospital admissions for acute coronary syndromes. During the first phase of the pandemia, significantly less patients with AMI were admitted, but those admitted presented with a more severe phenotype and had a higher mortality, more complications, and a worse short-term outcome. Therefore, our data indicate that Covid-19 had relevant impact on non-infectious disease states, such as acute coronary syndromes.
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COVID-19/epidemiologia , Infarto do Miocárdio/mortalidade , Doença Aguda , Idoso , Berlim/epidemiologia , COVID-19/complicações , Estudos Transversais , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/etiologia , Resultado do TratamentoRESUMO
Increased risk of cardiovascular complications during and post-COVID-19 infection is more and more recognized-including myocarditis, arrhythmias, and myocardial infarctions (MIs). The mechanisms leading to these complications are direct virus-induced injuries, as well as potential thrombotic and inflammatory-induced mechanisms. To the latter, inflammatory plaque instability and plaque rupture are discussed entities contributing to MI-induced post-COVID-19 complications. Our case report describes the first time, when a temporary impairment of LVEF in the COVID-19-convalescence phase unmasks a silent MI due to coronary plaque rupture by using invasive (OCT) and non-invasive (CMR) modalities. Myocardial infarction might be an important differential diagnosis to consider in deteriorating patients with COVID-19, especially if dyspnoea persists after acute infection.