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Background: Patients with atrial fibrillation (AF) who are not suitable for long-term anticoagulant therapy undergo percutaneous left atrial appendage closure (LAAC). The safety and feasibility of left atrial catheter ablation (CA) procedures after LAAC remain unclear. This study aimed to clarify the feasibility and safety of CA after LAAC, including in the early phase within 180 days. Methods: Characteristics and clinical outcomes of 46 patients with AF who had undergone both CA and LAAC within 2 years (mean age, 72 years; 29 men) were compared between those who had undergone CA-first (31 patients) and LAAC-first (15 patients). Results: The mean CHA2DS2-VASc and HAS-BLED scores were 4.8 and 3.3 points, respectively. The LAAC-first strategy was often used in patients with prior major bleeding and LAA thrombosis or sludge. In the LAAC-first group, the mean duration between both procedures was 212 days, and all LAAC-first patients, including seven patients in the early phase, could undergo CA without LAAC device-related complications; moreover, no cardiovascular adverse events were reported after both procedures (mean periods: 420 days). After CA post-LAAC, no device-related adverse events (device-related thrombosis, new peri-device leak appearance, peri-device leak increase, or device dislodgement) were observed, whereas, after LAAC post-CA, 3 new peri-device leak appearance events and 1 peri-device leak increase event were observed, especially patients who underwent LAAC in the early phase post-CA. Conclusion: Based on single-center experience, left atrial CA in the presence of an LAAC device implanted including the early phase was safe and feasible.
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We have seen ischemic stroke associated with a high-grade device-related pedunculated thrombosis after left atrial appendage closure (LAAC) after discontinuation of oral anticoagulations (OACs). Continuation of OACs, including half-dose direct oral anticoagulations after LAAC, may be a better option for patients at high risk of thromboembolism to prevent further thromboembolic events.
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Currently, no consensus has been established on the most effective antithrombotic therapy to prevent thromboembolic and bleeding events in patients undergoing percutaneous left atrial appendage closure (LAAC) with preprocedural thromboembolic or bleeding events under oral anticoagulation (OAC) therapy. We retrospectively investigated the incidence of device-related thrombosis (DRT), thromboembolic events, and bleeding events in patients who underwent LAAC from September 2019 to October 2022. After categorizing patients into three groups based on preprocedural thromboembolic or bleeding events under OAC therapy, we compared the incidence of DRT and prognosis according to the postprocedural antithrombotic therapy. In patients who received the conventional antithrombotic therapy (OAC with and without single antiplatelet therapy for 45 days after LAAC and dual-antiplatelet therapy from 45 days to 6 months followed by single antiplatelet therapy), preprocedural thromboembolic events despite OAC were independently associated with DRT or postprocedural thromboembolic events at the 3 year follow-up (hazard ratio [HR] 4.55; 95% confidence interval [CI] 1.32-15.6; P = 0.016), whereas preprocedural bleeding events were independently associated with postprocedural bleeding events (HR 8.01, 95% CI 1.45-58.3; P = 0.036). Continuation of OAC for 12 months among patients who developed preprocedural thromboembolic events during OAC significantly decreased the incidence of DRT or postoperative thromboembolic events (P = 0.002) with no increase in the bleeding events (P = 0.522). Preprocedural thromboembolic and bleeding events can predict adverse events after LAAC with the conventional antiplatelet-based antithrombotic therapy. Patients who develop thromboembolic events under continuous OAC may benefit from continuous OAC for 1 year after LAAC.
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The MitraClip G4 device has controlled gripper actuation (CGA) system, which allows the anterior and posterior grippers operate separately in transcatheter edge-to-edge repair (TEER). We investigated the indications and outcomes of the use of CGA system during TEER for significant mitral regurgitation (MR). We reviewed 158 patients undergoing TEER with MitraClip G4 from September 2020 to July 2023. The CGA indications were: (1) for grasping and (2) for leaflet insertion confirmation. Leaflet grasping was completed with CGA in 18 patients (11 and 7 patients for grasping and leaflet insertion confirmation, respectively). Patients with flail leaflets or coaptation gap more frequently required CGA, indicating more complex mitral valve anatomy. The procedural success and adverse event rates (death, leaflet tear and single leaflet device attachment) were not different between the CGA and non-CGA groups. In patients requiring CGA, single leaflet device attachment was observed in 1 patient and leaflet tear in 1 patient during follow-up. In these two cases, CGA was required for grasping, and the clip was moved over a large distance (6.5 and 12.4 mm, respectively). In patients who had undergone CGA for confirmation, no device-related adverse event or MR recurrence was noted. In patients with complex mitral valve anatomy, CGA may be a safe and effective method for confirming leaflet insertion. It should be noted that when using CGA for leaflet grasping, especially when the clip is moved significantly, attention should be paid to leaflet adverse events.
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BACKGROUND: Patients with nonvalvular atrial fibrillation (AF) not suitable for long-term anticoagulant therapy undergo percutaneous left atrial appendage closure (LAAC) using the WATCHMAN device. The safety and efficacy of WATCHMAN-FLX (WM-FLX) compared with WATCHMAN-2.5 (WM-2.5), particularly in Asian populations, is unknown. METHODS: We evaluated the background, procedure, and clinical outcomes of 199 patients who underwent LAAC between September 2019 and December 2022 and compared WM-2.5 (72 patients) with WM-FLX (127 patients). RESULTS: The mean age was 76 years, with 128 men, and 100 had nonparoxysmal AF (non-PAF). The mean CHA2DS2-VASc, and HAS-BLED were 5.1, and 3.2 points, respectively. WM-FLX group demonstrated a shorter procedure time than WM-2.5 group (50 vs. 42 min, p = 0.001). The WM-FLX group demonstrated no procedural-related acute cardiac tamponade, which was significantly low (5.6% vs. 0%, p = 0.02), and a significantly higher rate of complete seal at 45-day (63% vs. 80%, p = 0.04). WM-FLX group had a significantly higher cumulative 1-year incidence of device-related thrombosis (DRT) than WM-2.5 group (3.4% vs. 7.0%, Log-rank p = 0.01). Univariate analysis identified two DRT risk factors in the WM-FLX group: non-PAF (odds ratio [OR] 7.72; 95% confidence interval [CI] 1.20-48.7; p = 0.04), and 35-mm device (OR 5.13; 95% CI 1.31-19.8; p = 0.02). CONCLUSIONS: WM-FLX significantly improved the procedural quality and safety of LAAC. However, DRT remains an important issue even in the novel LAAC device, being a hazard for patients with high DRT risk, such as having non-PAF and using 35-mm devices.
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Fibrilación Atrial , Cierre del Apéndice Auricular Izquierdo , Trombosis , Anciano , Femenino , Humanos , Masculino , Apéndice Atrial/fisiopatología , Apéndice Atrial/diagnóstico por imagen , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/terapia , Incidencia , Cierre del Apéndice Auricular Izquierdo/efectos adversos , Cierre del Apéndice Auricular Izquierdo/instrumentación , Diseño de Prótesis , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Trombosis/etiología , Trombosis/prevención & control , Factores de Tiempo , Resultado del TratamientoRESUMEN
Key Clinical Message: Atrial fibrillation ablation, including pulmonary vein isolation immediately after left atrial appendage closure (LAAC), is a rare and challenging issue. Intracardiac echocardiography guidance can help identify the LAAC device position for safe atrial fibrillation ablation without LAAC device-related adverse events even immediately after LAAC device implantation. Abstract: Early phase atrial fibrillation (AF) ablation after left atrial appendage closure (LAAC) is a rare and challenging issue. Here, we present a case illustrating the feasibility of AF ablation under intracardiac echocardiography guidance immediately after LAAC device implantation without LAAC device-related adverse events.
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An 81-year-old woman who had undergone transcatheter aortic valve implantation 3 months earlier underwent routine follow-up transthoracic echocardiography, which revealed a mobile thrombus adhering to the bioprosthetic valve. This thrombus differed in morphology from transcatheter aortic valve implantation valve thrombi commonly seen in daily practice.
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BACKGROUND: In left atrial appendage closure using WATCHMAN FLX, accurate device measurement by transesophageal echocardiography (TEE) is important. We aimed to experimentally validate appropriate methods of device measurement with two-dimensional (2D) and three-dimensional (3D) TEE compared with actual size. METHODS: We prepared a full range of device sizes (20, 24, 27, 31, 35 mm), each with five different compression rates. Each device was measured by 2D and 3D TEE at depths of 2, 4, and 6 cm in vitro using inner, outer, and middle line methods. We compared the difference between the actual size by caliper and measurements at each compression rate and depth by the three methods in 2D and 3D TEE. RESULTS: A total of 450 patterns of measurements were analyzed. The differences using the middle line method were much less than those using the inner and outer line methods in 2D and 3D TEE (2D TEE: 0.45 ± 0.36 vs. 2.55 ± 0.99 vs. 2.59 ± 0.72 mm, p < 0.01; 3D TEE: 0.34 ± 0.27 vs. 2.38 ± 0.69 vs. 1.86 ± 0.77 mm, p < 0.01). Moreover, the differences in measurements by 3D TEE were more accurate than those of 2D TEE in the inner (2.47 ± 1.86 vs. 1.86 ± 0.77 mm, p < 0.01) and middle (0.58 ± 0.37 vs. 0.34 ± 0.27 mm, p < 0.01) line methods. CONCLUSIONS: Middle line method by 3D TEE is the most reliable approach for device measurement at left atrial appendage closure using WATCHMAN FLX device.
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Apéndice Atrial , Fibrilación Atrial , Ecocardiografía Tridimensional , Humanos , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/cirugía , Cierre del Apéndice Auricular Izquierdo , Ecocardiografía Transesofágica/métodos , Fibrilación Atrial/cirugía , Cateterismo Cardíaco/métodos , Resultado del Tratamiento , Ecocardiografía Tridimensional/métodosRESUMEN
Contrast media are generally necessary for transcatheter left atrial appendage closure (LAAC), however, it should be avoided in patients with chronic kidney disease (CKD). The objective of this study was to evaluate the safety and feasibility of contrast-free LAAC with WATCHMAN FLX device for patients with CKD. Among 141 patients undergoing LAAC using the WATCHMAN FLX between May 2021 and March 2023, we performed LAAC without contrast media in 10 patients. Procedural and follow-up results were evaluated. The device size was selected based on the transesophageal echocardiographic (TEE) measurements. The device shape was assessed by fluoroscopy, and the device position was adjusted by TEE images. The mean age was 78 ± 4.9 years, CHADS2 score was 3.2 ± 1.1, and the estimated glomerular filtration rate (eGFR) was 28 ± 12 mL/min/1.73m2. The procedure was completed without contrast media in ten patients. Partial recapture of the device was required in four patients, but the initially selected device was finally implanted in all patients. Mean procedure time was significantly shorter in the contrast-free LAAC than in the contrast-use LAAC (41.6 ± 14.1 min vs 30.3 ± 7.6 min, p = 0.01). Postprocedural eGFR did not change from baseline, and there were no adverse events during the hospital stay. Follow-up TEE or cardiac computed tomography performed within 3 months after the procedure revealed no device-related thrombus or peri-device leak > 3 mm, and oral antithrombotic therapy was discontinued in all patients. Our experience shows that contrast-free LAAC using the WATCHMAN FLX device was safe and feasible. Non-contrast LAAC is one of the therapeutic options for patients with severe CKD.
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Apéndice Atrial , Fibrilación Atrial , Insuficiencia Renal Crónica , Accidente Cerebrovascular , Humanos , Anciano , Anciano de 80 o más Años , Cierre del Apéndice Auricular Izquierdo , Estudios de Factibilidad , Medios de Contraste , Resultado del Tratamiento , Fibrilación Atrial/cirugía , Fibrilación Atrial/etiología , Insuficiencia Renal Crónica/complicaciones , Cateterismo Cardíaco , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/cirugía , Ecocardiografía Transesofágica , Accidente Cerebrovascular/etiologíaAsunto(s)
Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Cateterismo Cardíaco , Tomografía , Resultado del TratamientoRESUMEN
BACKGROUND: Evidence is limited regarding long-term clinical outcomes after alcohol septal ablation (ASA) for patients with hypertrophic obstructive cardiomyopathy and its periprocedural predictive factors in Japan.MethodsâandâResults: This retrospective observational study included 44 patients who underwent ASA between 1998 and 2022 in a single center. We evaluated the periprocedural change in variables and long-term clinical outcomes after the procedure. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. The secondary outcome was all-cause death. Using multivariable Poisson regression with robust error variance, we predicted underlying periprocedural factors related to primary outcome development. ASA decreased the median pressure gradient at the left ventricular outflow tract from 88 to 33 mmHg and reduced moderate or severe mitral regurgitation (MR), present in 53% of patients before ASA, to 16%. Over a median 6-year follow-up, the cumulative incidence of the primary outcome at 5 and 10 years was 16.5% and 25.6%, respectively. After multivariable analysis, moderate or severe MR after ASA was significantly associated with the primary outcome (relative risk 8.78; 95% confidence interval 1.34-57.3; P=0.024). All-cause mortality after ASA was 15.1% and 28.9% at 5 and 10 years, respectively. CONCLUSIONS: This study presents long-term clinical outcomes after ASA in Japan. Moderate or severe MR after ASA was significantly associated with the composite of cardiovascular death or hospitalization for heart failure.
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Técnicas de Ablación , Cardiomiopatía Hipertrófica , Insuficiencia Cardíaca , Humanos , Técnicas de Ablación/efectos adversos , Técnicas de Ablación/métodos , Cardiomiopatía Hipertrófica/cirugía , Cardiomiopatía Hipertrófica/complicaciones , Etanol , Insuficiencia Cardíaca/cirugía , Insuficiencia Cardíaca/complicaciones , Japón , Estudios Retrospectivos , Resultado del Tratamiento , Tabiques CardíacosRESUMEN
When we implant leadless pacemaker in patients with contrast agent allergy or poor renal function, the use of sufficient contrast agent is hesitant. Aided by imaging assessment (e.g., intracardiac echocardiography), the procedure may be feasible with a small amount of contrast medium or no contrast medium. In this case, leadless pacemaker implantation was performed at the same time as the transcatheter mitral valve repair, and leadless pacemaker implantation was successful with the use of a very small amount of contrast medium under transesophageal echocardiography guidance.
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Background: Leaflet tear and perforation are serious complications of transcatheter edge-to-edge repair (TEER) using the MitraClip system for severe mitral regurgitation (MR). However, no optimal bailout strategy has been established. Case summary: An 80-year-old woman developed heart failure due to acute ischaemic severe MR after primary percutaneous coronary intervention. Given the requirement for inotropic drugs and an intra-aortic balloon pump to stabilize her heart failure, we decided to perform TEER using the MitraClip G4 system. The NTW clip was selected considering the limited posterior leaflet, wide central MR, and delivery to the central A2/P2. The leaflet was successfully grasped, and the MR jet dramatically decreased while the clip was closed. However, the MR jet suddenly appeared after completely closing the clip arm. A new eccentric jet was detected coming from the mid-portion of the posterior leaflet, indicating leaflet perforation. We decided to manage the leaflet perforation by covering the perforated portion with a longer type of clip. An XTW clip was then carefully delivered to the previously grasped portion, after which we confirmed that the tip of the clip arm was positioned more posteriorly to the leaflet perforation. After slowly closing the clip, MR decreased to mild, with transoesophageal echocardiography showing no eccentric MR. After her haemodynamics stabilized, she was discharged 28 days after the procedure. Discussion: This case details a successful bailout clipping of a leaflet perforation using an XTW clip. Leaflet anatomy evaluation is important to ensure that the injured portion is covered by the longer clip arm.
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BACKGROUND: Data on long-term outcomes of transcatheter aortic valve replacement (TAVR) in Japanese patients beyond 5â¯years are limited. METHODS: Between June 2010 and December 2014, 55 consecutive inoperable or high surgical risk patients underwent TAVR with SAPIEN XT valves (Edwards Lifesciences, Irvine, CA, USA) for severe aortic stenosis at our institution. Among them, 2 patients were excluded from the analysis because one was converted to open surgery during the TAVR procedure and the other could not undergo TAVR due to device delivery failure. We retrospectively analyzed long-term clinical outcomes of these 53 patients (mean age: 84.1â¯years; mean STS score: 8.4) who had at least a 7-year follow-up after TAVR. RESULTS: The rates of freedom from all-cause and cardiovascular deaths at 7â¯years were 35.8â¯% and 79.3â¯%, respectively. The moderate or severe structural valve deterioration (SVD) rate at 5 and 7â¯years was 7.2â¯% and 11.4â¯%, respectively. The rate of bioprosthetic valve failure (BVF) at 7â¯years was 6.2â¯%. CONCLUSIONS: The 7-year mortality rate of inoperable or high surgical risk patients treated with SAPIEN XT was high, while the cardiovascular mortality rate was acceptable. Although the poor survival rate limited the long-term assessment of SAPIEN XT valve durability, the incidence of SVD and BVF was not rare.
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Estenosis de la Válvula Aórtica , Pueblos del Este de Asia , Reemplazo de la Válvula Aórtica Transcatéter , Anciano de 80 o más Años , Humanos , Estenosis de la Válvula Aórtica/etnología , Estenosis de la Válvula Aórtica/cirugía , Estudios Retrospectivos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del Tratamiento , Factores de TiempoAsunto(s)
Fibrilación Atrial , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Fibrilación Atrial/complicaciones , Fibrilación Atrial/cirugía , Humanos , Japón , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/complicaciones , Insuficiencia de la Válvula Mitral/diagnóstico , Insuficiencia de la Válvula Mitral/cirugía , Resultado del TratamientoRESUMEN
BACKGROUND: The association between renal morphological findings and changes in renal function in patients undergoing transcatheter aortic valve implantation (TAVI) is unexplored. AIMS: We aimed to investigate the association between renal morphological findings and changes in renal function in patients undergoing TAVI. METHODS: Among 283 consecutive patients undergoing TAVI between 2018 and 2021, the study sample included 224 patients. Renal morphological measurements were performed by preoperative multidetector computed tomography. Estimated glomerular filtration rate (eGFR) improvement and deterioration were defined as positive or negative changes in an eGFR of ≥10% one month after TAVI. The renal cortex thickness index was defined as the ratio of total renal cortex thickness to body surface area. RESULTS: The incidences of eGFR improvement and deterioration were 33.9% and 24.1%, respectively. The renal cortex thickness index had a significant correlation with changes in eGFR (r=0.34, p<0.01). The index of the area under the curve of renal cortex thickness for eGFR improvement and deterioration were 0.73 and 0.68, respectively. The cut-off values were 5.82 mm/m2 for eGFR improvement (odds ratio [OR]: 0.10; 95% confidence interval: 0.05-0.20; p<0.01) and 4.89 mm/m2 for eGFR deterioration (OR: 9.07; 95% confidence interval: 4.55-18.6; p<0.01). CONCLUSIONS: The renal cortex thickness index was associated with changes in renal function in patients who underwent TAVI. Its measurements might be useful for predicting the renal function change in patients undergoing TAVI.
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Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Tasa de Filtración Glomerular , Humanos , Riñón/diagnóstico por imagen , Riñón/fisiología , Factores de Riesgo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: The clinical significance of concomitant mitral regurgitation (MR) has not been well addressed in patients with severe aortic stenosis (AS).MethodsâandâResults:We analyzed 3,815 patients from a retrospective multicenter registry of severe AS in Japan (CURRENT AS registry). We compared the clinical outcomes between patients with moderate/severe MR and with none/mild MR according to the initial treatment strategy (initial aortic valve replacement [AVR] or conservative strategy). The primary outcome measure was a composite of aortic valve-related death or heart failure hospitalization. At baseline, moderate/severe MR was present in 227/1,197 (19%) patients with initial AVR strategy and in 536/2,618 (20%) patients with a conservative strategy. The crude cumulative 5-year incidence of the primary outcome measure was significantly higher in patients with moderate/severe MR than in those with none/mild MR, regardless of the initial treatment strategy (25.2% vs. 14.4%, P<0.001 in the initial AVR strategy, and 63.3% vs. 40.7%, P<0.001 in the conservative strategy). After adjusting confounders, moderate/severe MR was not independently associated with higher risk for the primary outcome measure in the initial AVR strategy (hazard ratio [HR] 1.11, 95% confidence interval [CI] 0.67-1.83, P=0.69), and in the conservative strategy (HR 1.13, 95% CI 0.93-1.37, P=0.22). CONCLUSIONS: Concomitant moderate/severe MR was not independently associated with higher risk for the primary outcome measure regardless of the initial treatment strategy.