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BACKGROUND: The benefit of percutaneous coronary intervention (PCI) in patients with stable coronary artery disease and severe aortic stenosis who are undergoing transcatheter aortic-valve implantation (TAVI) remains unclear. METHODS: In an international trial, we randomly assigned, in a 1:1 ratio, patients with severe symptomatic aortic stenosis and at least one coronary-artery stenosis with a fractional flow reserve of 0.80 or less or a diameter stenosis of at least 90% either to undergo PCI or to receive conservative treatment, with all patients also undergoing TAVI. The primary end point was a major adverse cardiac event, defined as a composite of death from any cause, myocardial infarction, or urgent revascularization. Safety, including bleeding events and procedural complications, was assessed. RESULTS: A total of 455 patients underwent randomization: 227 to the PCI group and 228 to the conservative-treatment group. The median age of the patients was 82 years (interquartile range, 78 to 85), and the median Society of Thoracic Surgeons-Procedural Risk of Mortality score (on a scale from 0 to 100%, with higher scores indicating a greater risk of death within 30 days after the procedure) was 3% (interquartile range, 2 to 4). At a median follow-up of 2 years (interquartile range, 1 to 4), a major adverse cardiac event (primary end point) had occurred in 60 patients (26%) in the PCI group and in 81 (36%) in the conservative-treatment group (hazard ratio, 0.71; 95% confidence interval [CI], 0.51 to 0.99; P = 0.04). A bleeding event occurred in 64 patients (28%) in the PCI group and in 45 (20%) in the conservative-treatment group (hazard ratio, 1.51; 95% CI, 1.03 to 2.22). In the PCI group, 7 patients (3%) had PCI procedure-related complications. CONCLUSIONS: Among patients with coronary artery disease who were undergoing TAVI, PCI was associated with a lower risk of a composite of death from any cause, myocardial infarction, or urgent revascularization at a median follow-up of 2 years than conservative treatment. (Funded by Boston Scientific and the Danish Heart Foundation; NOTION-3 ClinicalTrials.gov number, NCT03058627.).
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BACKGROUND: Both surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) are Class Ia recommended therapies for specific subgroups of severe aortic stenosis (AS) patients in the latest 2021 European guidelines. AIMS: We aimed to report on the multidisciplinary Heart Team evaluation process and real-world practice of treating severe symptomatic AS in East Denmark in the context of the latest European guideline recommendations. METHODS: All consecutive patients with severe AS referred for intervention in 2021 (N=672) were discussed in a multidisciplinary Heart Team meeting. All patients (100%) had a cardiac computed tomography (CT) analysis prior to the meeting. Baseline characteristics, Heart Team decision-making, final treatment and 30-day clinical outcomes were prospectively recorded. RESULTS: The majority of severe AS patients (N=456, 68%) were referred for TAVI following discussion in the Heart Team. Ultimately, 94% of patients (N=632) received the Heart Team-recommended treatment. Patients undergoing TAVI (N=439) were significantly older (78.4±6.7 vs 67.2±8.3 years; p<0.001) and more comorbid than patients undergoing SAVR (N=189). The overall 30-day clinical outcomes were satisfactory for both treatment groups (overall 30-day mortality: 1.1%). The mean index hospitalisation length was markedly longer in the SAVR group (8.6±8.3 days) as compared to the TAVI group (1.8±3.2 days). CONCLUSIONS: TAVI was routinely performed in low surgical risk patients in 2021 with two-thirds of all severe AS patients undergoing TAVI, thereby applying the latest European guidelines. A dedicated Heart Team meeting, including CT evaluation for all AS patients, is needed to make individualised management decisions in this new era of aortic valve interventions.
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Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Corazón , Hospitalización , Pacientes , Estenosis de la Válvula Aórtica/cirugíaRESUMEN
BACKGROUND: Despite transcatheter aortic valve implantation (TAVI) having become a routine procedure, access site bleeding and vascular complications are still a concern which contribute to procedure-related morbidity and mortality. AIMS: The TAVI-MultiCLOSE study aimed to assess the safety and efficacy of a new vascular closure algorithm for percutaneous large-bore arterial access closure following transfemoral (TF)-TAVI. METHODS: All consecutive TF-TAVI cases in which the MultiCLOSE vascular closure algorithm was used were prospectively included in a multicentre, observational study. This stepwise algorithm entails the reinsertion of a 6-8 Fr sheath (primary access) following the initial preclosure with one or two suture-based vascular closure devices (VCDs). This provides the operator with the opportunity to perform a quick and easy angiographic control and tailor the final vascular closure with either an additional suture- or plug-based VCD, or neither of these. RESULTS: Among 630 patients who underwent TF-TAVI utilising the MultiCLOSE algorithm, complete arterial haemostasis was achieved in 616 patients (98%). VCD failure occurred in 14 patients (2%), treated with either balloon inflation (N=1), covered stent (N=12) or surgical repair (N=1). Overall, this vascular closure approach resulted in a minor and major vascular complication rate of 2.2% and 0.6%, respectively. At 30 days, only one new minor vascular complication (0.2%) was noted. In-hospital and 30-day all-cause mortality rates were 0.2% and 1.0%, respectively. CONCLUSIONS: Use of the MultiCLOSE vascular closure algorithm was demonstrated to contribute to an easy, safe, efficacious and durable vascular closure after TF-TAVI, resulting in a major vascular complication rate of less than 1%.
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Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Dispositivos de Cierre Vascular , Humanos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Arteria Femoral/cirugía , Hemorragia/etiología , Hemorragia/prevención & control , Técnicas Hemostáticas/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del Tratamiento , Dispositivos de Cierre Vascular/efectos adversosRESUMEN
Encouraged by randomized controlled trials demonstrating non-inferiority of transfemoral transcatheter aortic valve implantation (TAVI) compared to surgical aortic valve replacement (SAVR) across all surgical risk categories, there has been a dramatic increase in the use of TAVI in a younger patient cohort with severe aortic stenosis, endorsed by both European and American Cardiac Societies. However, the standard use of TAVI in younger, less co-morbid patients with a longer life expectancy can only be supported if there is sound data demonstrating long-term durability of transcatheter aortic valves (TAVs). In this article, we have reviewed available randomized and observational registry clinical data pertaining to TAV long-term durability, placing emphasis on trials and registries using the new standardized definitions of bioprosthetic valve dysfunction (BVD) and bioprosthetic valve failure (BVF). Despite inherent difficulties in interpreting the available data, the determination reached is that the risk of structural valve deterioration (SVD) is potentially lower after TAVI than SAVR at 5 to 10 years, and that the two treatment modalities have a similar risk of BVF. This supports the adoption of TAVI in younger patients evident in current practice. However, the routine use of TAVI in younger patients with bicuspid aortic valve stenosis should be cautioned due to insufficient long-term TAV durability data in this particular patient population. Finally, we highlight the importance of future research into the unique potential mechanisms that can potentially contribute to TAV degeneration.
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Aortic-to-right ventricle fistula is a rare complication after transcatheter aortic valve implantation (TAVI). In this case report, an 87-year-old male was admitted with signs of congestion six weeks after TAVI. Two days later, he developed severe epigastric and back pain, elevated D-dimer, lactic acidosis and renal failure. Transthoracic echocardiography revealed a progressing aortic-to-right ventricle fistula which in retrospect had been present since the TAVI-procedure. The patient died despite supportive treatment.
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Enfermedades de la Aorta , Estenosis de la Válvula Aórtica , Fístula , Reemplazo de la Válvula Aórtica Transcatéter , Masculino , Humanos , Anciano de 80 o más Años , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Ventrículos Cardíacos , Resultado del Tratamiento , AortaRESUMEN
Significant coronary artery disease (CAD) is a frequent finding in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI), and the management of these two conditions becomes of particular importance with the extension of the procedure to younger and lower-risk patients. Yet, the preprocedural diagnostic evaluation and the indications for treatment of significant CAD in TAVI candidates remain a matter of debate. In this clinical consensus statement, a group of experts from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) in collaboration with the European Society of Cardiology (ESC) Working Group on Cardiovascular Surgery aims to review the available evidence on the topic and proposes a rationale for the diagnostic evaluation and indications for percutaneous revascularisation of CAD in patients with severe aortic stenosis undergoing transcatheter treatment. Moreover, it also focuses on commissural alignment of transcatheter heart valves and coronary re-access after TAVI and redo-TAVI.
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Estenosis de la Válvula Aórtica , Cardiología , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/etiología , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Resultado del TratamientoAsunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estenosis de la Válvula Aórtica/cirugía , Prótesis e Implantes , Diseño de Prótesis , Resultado del TratamientoRESUMEN
BACKGROUND: Use of a right-left (R-L) cusp overlap view for transcatheter aortic valve replacement (TAVR) with self-expanding valves has recently been proposed aiming to reduce permanent pacemaker implantation (PPMI). An objective, data-driven explanation for this observation is missing. AIMS: To assess the impact of different implantation techniques on the risk of PPMI following TAVR with the Portico/NavitorTM transcatheter heart valve (THV; Abbott). METHODS: A TAVR-population treated with Portico/NavitorTM had the THV implanted in a right versus left anterior oblique (RAO/LAO) fluoroscopic view with no parallax in the delivery system. The impact of these different implantation views on the spatial relationship between THV and native aortic annulus and the risk of conduction disturbances and PPMI after TAVR was studied. RESULTS: A total of 366 matched TAVR patients were studied: 183 in the RAO group and 183 in the LAO group. The degree of aortic annulus plane tilt was significantly smaller in the RAO versus LAO group (median: 0° vs. 23°, p < 0.001), with no plane tilt in 105 out of 183 cases (57.3%) in the RAO group. At 30 days after TAVR, the overall PPMI and guideline-directed PPMI rates were 12.6% versus 18.0% (p = 0.15) and 8.2% versus 15.3% (p = 0.04) in the RAO versus LAO group, respectively. CONCLUSIONS: Use of a R-L cusp overlap (RAO-caudal) view for implantation of the Portico/NavitorTM valve results in less tilt of the native aortic annulus plane and a clear trend toward a lower 30-day PPMI rate as compared to TAVR using the conventional LAO implantation view.
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PURPOSE: To describe a completely percutaneous approach for endovascular arch repair (arch-percutaneous endovascular aortic repair [PEVAR]) with a triple inner-branch device: the "Innominate Approach." TECHNIQUE: After right axillary and single common femoral arteries percutaneous access, the arch stent-graft is introduced and deployed transfemorally using fusion overlay. The brachiocephalic artery (BCA) and the corresponding inner branch are cannulated from the axillary access. Through this access, a steerable-sheath guides antegrade cannulation of the left common carotid artery (LCCA) through its inner branch. Optionally, a wire preloaded through the left subclavian artery (LSA) and the LCCA branch, is snared from the BCA access providing LCCA through and through access. A 10 Fr sheath is then positioned from the BCA branch in the LCCA branch and a second, trans-axillary wire through the same sheath is used to catheterize the LCCA. The LCCA is then stented antegradely (regardless of approach). Finally, the BCA and LSA are bridged to complete the procedure. An additional novelty described is the use of VBX (W. L. Gore) as a bridging stent for the BCA. CONCLUSION: Arch-PEVAR is feasible with the use of adjuncts that are well-known for physicians performing complex endovascular repair. The "Innominate Approach" avoids access and exposure of the carotid arteries. CLINICAL IMPACT: We aim to describe the feasibility of the axillary artery as the main route to perform the brachiocephalic artery (BCA) and the left common carotid artery bridging stenting in case of arch endovascular repair (arch-EVAR) with a triple Inner-Branch Device. According to the present "Innominate Approach", percutaneous arch-EVAR is feasible using either a steerable sheath or a preloaded through-&-through wire. The Innominate approach, including a VBX bridging stent for the BCA, avoids carotid access and exposure, reduces the number of vascular accesses, and allows the downsizing of the trans-axillary devices.
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OBJECTIVES: This study aimed to assess the rate of difficult interatrial septum (IAS) crossing with the intracardiac echocardiography (ICE) probe during percutaneous left atrial appendage (LAA) closure and to identify techniques that facilitate IAS crossing with the ICE probe. BACKGROUND: Percutaneous LAA closure is increasingly performed by ICE guidance. Although such an approach omits the need for general anesthesia, crossing of the IAS with the ICE probe may sometimes be challenging. METHODS: All consecutive patients that underwent ICE-guided percutaneous LAA closure with an Amplatzer Amulet (Abbott) or WatchmanFLX (Boston Scientific) at our center in the period 2018-2021 were included. Cases in which IAS crossing with ICE was difficult were identified and techniques used to facilitate IAS crossing were identified and listed. RESULTS: In 17 (5%) out of 354 cases, IAS crossing with the ICE probe was difficult and required use of additional techniques. Ultimately, IAS crossing was also successful in these 17 cases by using one of three possible facilitation techniques: the probing technique (12 cases), the double-wire technique (3 cases), and the snaring technique (2 cases). In one case, the double-wire technique was converted to the snaring technique, as crossing of the ICE probe remained challenging despite the use of two stiff guidewires. CONCLUSION: Crossing of the IAS with the ICE probe can be challenging in 5% of ICE-guided percutaneous LAA closure procedures. Operators should be aware of possible facilitation techniques in challenging cases, as these show to be safe and effective.
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Apéndice Atrial , Fibrilación Atrial , Humanos , Apéndice Atrial/diagnóstico por imagen , Ecocardiografía Transesofágica , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/métodos , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/terapia , Ultrasonografía Intervencional/métodos , Resultado del TratamientoAsunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Humanos , Factores de Riesgo , Tasa de Supervivencia , Resultado del TratamientoAsunto(s)
Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Hydra , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Animales , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Diseño de PrótesisRESUMEN
This case report describes the first transcatheter aortic valve replacement (TAVR) with the latest-generation Navitor Titan™ transcatheter heart valve (Abbott, USA) in a European patient with severe symptomatic aortic valve stenosis (AS). The Navitor Titan™ transcatheter heart valve has been developed to treat patients with large aortic annuli, namely aortic annulus perimeter 85 to 95 mm. In combination with the low profile FlexNav™ delivery system, the Navitor Titan™ valve offers the unique possibility to treat AS patients with large aortic annuli and suboptimal vascular access.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Humanos , Diseño de Prótesis , Factores de Riesgo , Resultado del TratamientoRESUMEN
During the last decade, transcatheter aortic valve implantation (TAVI) has evolved as a well-established therapy for aging patients suffering from symptomatic severe aortic valve stenosis. This is also reflected in the recently updated international guidelines on managing patients with valvular heart disease. A transfemoral (TF) TAVI approach has proven superior to alternative access strategies. With the introduction of intravascular lithotripsy (IVL), patients with calcified iliofemoral vascular disease and borderline intraluminal diameters have also become candidates for percutaneous TF-TAVI. Moreover, IVL reduces the risk of major vascular complications by modifying the superficial and deep vascular calcium, thereby changing the vessel compliance and controlling luminal expansion. In this way, IVL has shown to safely facilitate TF delivery of TAVI devices in patients with calcified peripheral artery disease. The present article aims to provide a detailed step-by-step description on how to perform IVL-assisted TF-TAVI safely and efficiently. Furthermore, a literature review on the outcomes obtained with this technology is included, along with a concise discussion on this unique TAVI approach.
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Estenosis de la Válvula Aórtica , Litotricia , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Arteria Femoral/cirugía , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoAsunto(s)
Estenosis de la Válvula Aórtica , Enfermedad de la Válvula Aórtica Bicúspide , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/etiología , Estenosis de la Válvula Aórtica/cirugía , Calcio , Constricción Patológica , Humanos , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
OBJECTIVES: The aim of this study was to assess cusp symmetry and coronary ostial eccentricity and its impact on coronary access following transcatheter aortic valve replacement (TAVR) using a patient-specific commissural alignment implantation technique. BACKGROUND: TAVR implantation techniques to obtain neocommissural alignment have been introduced. The impact of cusp symmetry and coronary ostial eccentricity on coronary access after TAVR remains unknown. METHODS: Cardiac computed tomographic scans from 200 tricuspid aortic valves (TAVs) and 200 type 1 bicuspid aortic valves (BAVs) were studied. Cusp symmetry and coronary ostial eccentricity were assessed. In addition, the right coronary cusp/left coronary cusp and right coronary artery (RCA)/left coronary artery (LCA) ostia overlap views were calculated and compared. RESULTS: Severe cusp asymmetry (>135°) was more frequent in BAVs (52.5%) than in TAVs (2.5%) (P < 0.001), with the noncoronary cusp being the most common dominant cusp. The RCA ostium was found to be more often eccentric (>20°) than the LCA ostium (28% vs 6%, respectively; P < 0.001). Considering the right/left cusp overlap view, there was <20° deviation between the right coronary cusp-left coronary cusp centered line and the RCA-LCA centered line in 95% of all patients (TAV, 97%; BAV, 93%). The right/left cusp and coronary ostia overlap view differed by <10° and <20° fluoroscopic angulation in 75% and 98% of all cases, respectively. CONCLUSIONS: Using the right/left cusp overlap view to obtain commissural alignment in TAVR is also an effective approach to implant one of the transcatheter heart valve commissures in the near center between both coronary ostia in most TAVs and type 1 BAVs. Preprocedural CT assessment remains crucial to assess cusp symmetry and coronary ostial eccentricity.
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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/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento , Válvula Tricúspide/cirugíaRESUMEN
BACKGROUND: There are limited data on the association of membranous septum (MS) morphology and transcatheter heart valve (THV) implantation depth, and the development of new conduction abnormalities (CA) after transcatheter aortic valve implantation (TAVI). AIMS: The aim of this study was to describe the morphology of the MS and predict the risk of new CA after TAVI based on the MS morphology and THV implantation depth. METHODS: Based on preprocedural CT scans, the MS depth was measured for every 25% of the entire MS width in 272 TAVI patients without preprocedural bundle branch block (BBB) or pacemaker. Post-procedural CT scans for THV implantation depth assessment were available in 130 of these patients. RESULTS: The MS depth was a median of 2.5 mm (IQR 1.4-3.8) deeper at the posterior edge when compared to the anterior edge of the MS. New CA developed in 7.1% of patients in whom the THV did not cross the lower MS border at its anterior edge (3.6% with new BBB and high degree CA, respectively), in 18.8% of patients (15.6% with new BBB and 3.1% with new high-degree CA) where the THV overlapped the lower MS border by <2.5 mm and in 47.1% of patients (24.3% with new BBB and 22.9% with new high-degree CA) with THV overlap of the lower MS border by ≥2.5 mm. CONCLUSIONS: The difference of the MS depth and THV implantation depth measured at the anterior edge of the MS predicted new CA after TAVI.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Marcapaso Artificial , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Bloqueo de Rama/terapia , Humanos , Estudios Retrospectivos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: An inferoposterior transseptal puncture (TSP) is generally recommended for percutaneous left atrial appendage (LAA) closure. However, the LAA is a highly variable anatomical structure. This may have an impact on the preferred TSP site. AIMS: This study aimed to determine the optimal TSP site for percutaneous LAA closure in different LAA morphologies. METHODS: In this prospective study, 182 patients undergoing percutaneous LAA closure were included. The spatial relationship of the LAA to the fossa ovalis and its consequence for TSP was assessed at preprocedural cardiac computed tomography (CCT). RESULTS: Based on CCT analysis, it was predicted that coaxial alignment between the delivery sheath and the LAA would be obtained by an inferoposterior, inferocentral, or inferoanterior TSP in 75%, 16% and 8% of cases, respectively. This was also confirmed by procedural LAA angiogram in 175 cases (96%) with <30° angle between the delivery sheath and the LAA central axis. Multivariate logistic regression analysis identified reverse chicken wing LAA (odds ratio [OR] 6.36 [1.85-29.3]; p=0.005) and posterior bending of the proximal LAA (OR 17.2 [3.3-96.2]; p<0.001) as independent predictors of a central or anterior TSP - this to increase the chance of obtaining coaxial alignment between the delivery sheath and the LAA. CONCLUSIONS: An inferoposterior TSP is recommended in the majority of percutaneous LAA closure procedures in order to obtain coaxial alignment between the delivery sheath and the LAA. An inferior but more central/anterior TSP should be recommended in case of a reverse chicken wing LAA or posterior bending of the proximal LAA, which occurs in 20-25% of cases.