Cusp overlap method for self-expanding transcatheter aortic valve replacement.

BACKGROUND: Conduction disturbances and the need for permanent pacemaker (PPM) implantation remains a common complication for transcatheter aortic valve replacement (TAVR), particularly when self-expanding (SE) valves are used. AIMS: We compared in-hospital and 30-day rates of new PPM implantation between patients undergoing TAVR with SE valves using the conventional three-cusp coplanar implantation technique and the cusp-overlap technique. METHODS: We retrospectively compared patients without a pre-existing PPM who underwent a TAVR procedure with SE Evolut R or PRO valves using the cusp-overlap technique from July 2018 to September 2020 (n = 519) to patients who underwent TAVR using standard three-cusp technique from April 2016 to March 2017 (n = 128) in two high volume Canadian centers. RESULTS: There was no significant difference in baseline RBBB between the groups (10.4% vs. 13.2; p = 0.35). The rate of in-hospital new complete heart block (9.4% vs. 23.4%; p ≤ 0.001) and PPM implantation (8% vs. 21%; p ≤ 0.001) were significantly reduced when using the cusp-overlap technique. The incidence of new LBBB (30.4% vs. 29%; p = 0.73) was similar. At 30 days, the rates of new complete heart block (11% vs. 23%; p ≤ 0.001) and PPM implantation (10% vs. 21%, p ≤ 0.001) remained significantly lower in the cusp-overlap group, while the rate of new LBBB (35% vs. 30%; p = 0.73) was similar. CONCLUSION: Cusp-overlap approach offers several potential technical advantages compared to standard three-cusp view, and may result in lower PPM rates in TAVR with SE Evolut valve.

Preoperative planning for transaortic septal myectomy using cardiac computed tomography in patients with subaortic septal hypertrophy associated with aortic stenosis: case series.

Background: Electrocardiogram-gated cardiac computed tomography (CT) imaging enables a more accurate understanding of the patient's cardiac anatomy. Preoperative planning for transaortic septal myectomy (TASM), based on cardiac CT, may be useful in patients with subaortic septal hypertrophy associated with severe aortic stenosis (AS). Case summary: Two elderly patients (age >80 years) with subaortic septal hypertrophy associated with AS underwent surgical aortic valve replacement (SAVR) and concomitant TASM after preoperative planning based on cardiac CT. Both patients showed subaortic septal hypertrophy with blood flow acceleration, left ventricular (LV) hypercontractility, and a short distance from the coaptation point of the mitral valve to the septum, resulting in possible dynamic LV outflow tract (LVOT) obstruction after resolution of AS. Optimal mid-diastolic images, selected from the 70-80% phase, were used for preoperative TASM planning. Planned sizes for myectomy based on multi-planar reconstruction were 10 × 26 × 9 mm (width × length × depth) and 10 × 25 × 9 mm for patient 1 and 2, respectively, while resected tissue size was 10 × 24 × 8 mm and 9 × 24 × 8 mm in patient 1 and 2, respectively. After TASM procedure, SAVR was performed with bioprosthetic valve. Postoperative course of both patients was uneventful with no evidence of complete atrioventricular block, septal perforation, or blood flow acceleration at the LVOT. Discussion: Preoperative planning based on cardiac CT images is safe and useful for guiding adequate myectomy and preventing associated complications in patients with subaortic septal hypertrophy associated with AS.

Predictors of procedural complications in balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension.

BACKGROUND: Balloon pulmonary angioplasty (BPA) is an effective treatment for inoperable chronic thromboembolic pulmonary hypertension, with good results reported for residual pulmonary hypertension (PH) after pulmonary endarterectomy (PEA). However, BPA is associated with complications, such as pulmonary artery perforation and vascular injury, which can lead to critical pulmonary hemorrhage requiring embolization and mechanical ventilation. Furthermore, the risk factors for occurrence of complications in BPA are unclear; therefore, this study aimed to evaluate predictors of procedural complications in BPA. METHODS: In this retrospective study, we collected clinical data (patient characteristics, details of medical therapy, hemodynamic parameters, and details of the BPA procedure) from 321 consecutive sessions involving 81 patients who underwent BPA. Procedural complications were evaluated as endpoints. RESULTS: BPA for residual PH after PEA was performed in 141 sessions (43.9 %), which involved 37 patients. Procedural complications were observed in 79 sessions (24.6 %), including severe pulmonary hemorrhage requiring embolization in 29 sessions (9.0 % of all sessions). No patients experienced severe complications requiring intubation with mechanical ventilation or extracorporeal membrane oxygenation. Age ≥ 75 years and mean pulmonary artery pressure ≥ 30 mmHg were independent predictors of procedural complications. Residual PH after PEA was a significant predictor of severe pulmonary hemorrhage requiring embolization (adjusted odds ratio, 3.048; 95 % confidence interval, 1.042-8.914, p = 0.042). CONCLUSIONS: Older age, high pulmonary artery pressure, and residual PH after PEA increase the risk of severe pulmonary hemorrhage requiring embolization in BPA.

Impact of High Implantation of Transcatheter Aortic Valve on Subsequent Conduction Disturbances and Coronary Access.

BACKGROUND: Data regarding the impact of high transcatheter heart valve (THV) implantation on coronary access after transcatheter aortic valve replacement (TAVR) as assessed by postimplantation computed tomography (CT) are scarce. OBJECTIVES: The authors sought to assess the impact of high THV implantation on coronary access after TAVR. METHODS: We included 160 and 258 patients treated with Evolut R/PRO/PRO+ and SAPIEN 3 THVs, respectively. In the Evolut R/PRO/PRO+ group, the target implantation depth was 1 to 3 mm using the cusp overlap view with commissural alignment technique for the high implantation technique (HIT), whereas it was 3 to 5 mm using 3-cusp coplanar view for the conventional implantation technique (CIT). In the SAPIEN 3 group, the HIT employed the radiolucent line-guided implantation, whereas the central balloon marker-guided implantation was used for the CIT. Post-TAVR CT was performed to analyze coronary accessibility. RESULTS: HIT reduced the incidence of new conduction disturbances after TAVR for both THVs. In the Evolut R/PRO/PRO+ group, post-TAVR CT showed that the HIT group had a higher incidence of the interference of THV skirt (22.0% vs 9.1%; P = 0.03) and a lower incidence of the interference of THV commissural posts (26.0% vs 42.7%; P = 0.04) with access to 1 or both coronary ostia compared with the CIT group. These incidences were similar between the HIT and CIT groups in the SAPIEN 3 group (THV skirt: 0.9% vs 0.7%; P = 1.00; THV commissural tabs: 15.7% vs 15.3%; P = 0.93). In both THVs, CT-identified risk of sinus sequestration in TAVR-in-TAVR was significantly higher in the HIT group compared with the CIT group (Evolut R/PRO/PRO+ group: 64.0% vs 41.8%; P = 0.009; SAPIEN 3 group: 17.6% vs 5.3%; P = 0.002). CONCLUSIONS: High THV implantation substantially reduced conduction disturbances after TAVR. However, post-TAVR CT revealed that there is a risk for unfavorable future coronary access after TAVR and sinus sequestration in TAVR-in-TAVR. (Impact of High Implantation of Transcatheter Heart Valve during Transcatheter Aortic Valve Replacement on Future Coronary Access; UMIN000048336).

Association of the severity of vascular damage with discordance between the fractional flow reserve and non-hyperemic pressure ratios.

BACKGROUND: While there is a discordance between fractional flow reserve (FFR) and non-hyperemic pressure ratios (NHPRs) in some cases, the mechanisms underlying these discordances have not yet been fully clarified. We examined whether vascular damage as assessed by measurement of the brachial-ankle pulse wave velocity (baPWV), a marker of arterial stiffness, or ankle brachial pressure index (ABI), a marker of atherosclerotic arterial stenosis, might be associated with their discordances. METHODS: FFR and NHPRs were measured in 283 consecutive patients (69 ±â€¯10 years old). Based on previously established cut-off values of the two markers (i.e. +/- = FFR ≤/> 0.80 or =NHPRs ≤/> 0.89), the study participants were divided into four groups (the + and - signs denoting "predictive of significant stenosis" and "not predictive of significant stenosis," respectively): the FFR+/NHPRs+ group (n = 124), FFR-/NHPRs+ group (n = 16), FFR+/NHPRs- group(n = 65), and FFR-/NHPRs- group (n = 78). The baPWV and ABI were also measured in all the participants, and values of <2000 cm/s and ≥1.00 of the baPWV and ABI, respectively, were considered as representing relatively less advanced atherosclerotic systemic vascular damage. RESULTS: The prevalence of subjects with ABI ≥1.00 was higher in the FFR+/NHPRs- group than in the FFR-/NHPRs- group (p < 0.05). When the study subjects were divided into 2 groups, namely, the FFR+/NHPRs- group and the combined group, the prevalence of ABI ≥1.00 and that of baPWV <2000 cm/s were higher in the FFR+/NHPRs- group as compared with those in the combined group (p < 0.05). The results of binary logistic regression analysis demonstrated that ABI ≥1.00 was associated with a significant odds ratio (2.34, p < 0.05) for the FFR+/NHPRs- discordance. CONCLUSION: The FFR+/NHPRs- discordance appears to be observed in patients with relatively less advanced atherosclerotic systemic vascular damage. Thus, ABI ≥1.00 may be a marker of the presence of the FFR+/NHPRs- discordance.

Low Incidence of Prosthesis-Patient Mismatch Following Extremely Small Transcatheter Aortic Valve Replacement with 20-mm Sapien 3.

Transcatheter aortic valve replacement has been developed as an emerging technique to treat patients with aortic valve disease. However, safety and outcome data on extremely small transcatheter heart valves (THV) is limited. We aimed to assess hemodynamic profiles and clinical outcome of very small balloon expandable THVs with 20-mm Sapien 3 (SP3). We examined data for all patients who received third-generation SP3 THV at a single hospital. Complications and clinical outcomes were defined based on the VARC-2 criteria. Postoperative prosthesis-patient mismatch (PPM) was defined as indexed effective orifice area (EOA) < 0.85 cm 2 /m 2 . We compared clinical characteristics and outcome between patients with 20-mm ( n = 21), 23-mm ( n = 67), and 26- or 29-mm ( n = 113) sized valves. The 20-mm group included significantly higher number of Asian and female populations with lower body surface area. The baseline CT annular area in the 20-mm group was 316.5 ± 24.9 mm 2 . There was no significant difference between groups in procedural mortality or early safety at 30 days. The higher procedural complication was observed in 20-mm group due to significant differences in minor vascular and bleeding complications. Despite higher post-THV gradients and smaller indexed EOA in 20-mm group, no PPM was observed in 20-mm group. The mortality at 30 days and 1 year in 20-mm group was 4.8% and 16.7%, respectively. The patients who received very small THVs with 20-mm SP3 did not result in PPM and experienced favorable early safety and midterm outcome in our cohort.

Distribution of C-arm projections in native and bioprosthetic aortic valves cusps: Implication for BASILICA procedures.

OBJECTIVES: We sought to document aortic cusps fluoroscopic projections and their distributions using leaflet alignment which is a novel concept to optimize visualization of leaflets and for guiding BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent coronary artery obstruction) and determine whether these projections were feasible in catheter laboratory. BACKGROUND: Optimal fluoroscopic projections of aortic valve cusps have not been well described. METHODS: A total of 128 pre-transcatheter aortic valve replacement (pre-TAVR) computed tomographies (CT) (72 native valves and 56 bioprosthetic surgical valves) were analyzed. Using CT software (3Mensio, Pie medical imaging, the Netherlands), leaflet alignment was performed and the feasibility of these angles, which were defined as rate of obtainable with efforts (within LAO/RAO of 85° and CRA/CAU of 50°) were evaluated. RESULTS: High feasibility was seen in right coronary cusp (RCC) front view (100%) and left coronary cusp (LCC) side view (99.2%), followed by noncoronary cusp side view (95.3%). In contrast, low feasibility of RCC side view (7.8%) and LCC front view (47.6%) was observed. No statistical differences were seen between the distribution of native valves and bioprosthetic surgical valves. With patient/table tilt of 20°LAO and 10°CRA, the feasibility of RCC side view and LCC front view increased to 43.7 and 85.2%, respectively. CONCLUSION: Distributions of each cusp's leaflet alignment follows "sigmoid curve" which can provide better understanding of aortic valve cusp orientation in TAVR and BASILICA. RCC side view used in right cusp BASILICA is commonly unachievable in catheter laboratory and may improve with patient/table tilt.

Risk of Coronary Obstruction Due to Sinus Sequestration in Redo Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to evaluate the risk of coronary obstruction due to sinus sequestration in redo transcatheter aortic valve replacement (TAVR) using post-TAVR computed tomography (CT). BACKGROUND: Little information is available regarding the risk of coronary obstruction due to sinus sequestration in redo TAVR inside a previously implanted TAV. METHODS: Post-TAVR CT of 66 patients who received an Evolut R or Evolut PRO and 345 patients who received a SAPIEN 3 were analyzed. Redo TAVR was considered at risk of coronary obstruction due to sinus sequestration if: 1) the prior TAV commissure level was above sinotubular junction (STJ); and 2) the distance between TAV and STJ was <2.0 mm in each coronary sinus. RESULTS: In total, 45.5% in the Evolut R/Evolut PRO group and 2.0% in the SAPIEN 3 group had CT-identified risk of sinus sequestration at 1 or both coronary arteries (p < 0.001). CT-identified risk of sinus sequestration was observed in 39.4% for the left coronary artery and 24.2% for the right coronary artery in the Evolut R/Evolut PRO group, while those percentages were 2.0% for the left coronary artery and 0.6% for the right coronary artery in the SAPIEN 3 group. In a coronary-level analysis, overlaps between the first TAV commissural posts and coronary ostium were observed in 45.2% in the Evolut R/Evolut PRO group and 11.1% in in the SAPIEN 3 group among coronary arteries at CT-identified risk of sinus sequestration. CONCLUSIONS: The risk of sinus sequestration in redo TAVR should be carefully screened by CT, especially in patients with low STJ height. TAV with low commissure height that was designed to achieve commissure-to-commissure alignment with the native aortic valves may be preferable to avoid the risk of coronary obstruction due to sinus sequestration and allow for a preventive leaflet laceration procedure in future redo TAVR. (Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation [RESOLVE]; NCT02318342).

Preprocedural valvuloarterial impedance as a predictor of left ventricular ejection fraction improvement after transcatheter aortic valve replacement in patients with reduced left ventricular ejection fraction.

BACKGROUND: Predictors of left ventricular ejection fraction (LVEF) improvement after transcatheter aortic valve replacement (TAVR) in patients with a preoperative reduced LVEF are limited. OBJECTIVES: This study aimed to investigate the relationship between preprocedural valuvuloarterial impedance (ZVa), which represents the global LV afterload, and LVEF improvement after TAVR. METHODS: This was a single-center, retrospective study, which included patients with symptomatic aortic valve stenosis (AS) with a reduced baseline LVEF (< 50%) underwent TAVR. Based on the difference in the LVEF before and 1 month after the procedure, they were divided into two groups: improved group (≥ 10% improvement) and non-improved group (< 10% improvement or worsening). Preprocedural ZVa and clinical outcomes were then compared. ZVa was calculated using preprocedural transthoracic echocardiography data. RESULTS: Among 473 cases of TAVR performed from May 2012 to July 2017 at Queen's Medical Center (Honolulu, HI, USA), 99 patients (improved group, n = 42; mean age 82.0 ± 8.6 years vs. non-improved group, n = 57, mean age 81.4 ± 9.5 years) were included. The improved group had a higher baseline ZVa {4.83 (4.15-6.89) mmHg/ml/m2 vs. 4.04 (3.56-4.63) mmHg/ml/m2, respectively, p = 0.0009} and prevalence of ZVa > 5 mmHg/ml/m2 (45.2% vs. 17.5%, respectively, p = 0.0028). Multivariable analysis of predictors of LVEF improvement ≥ 10% at 1 month identified ZVa > 5 mmHg/ml/m2 [odds ratio (OR): 3.31, 95% confidence interval (CI): 1.05-11.8] as a predictor. The improved group had a lower readmission rate due to heart failure than the non-improved group (log-rank test, p = 0.043). CONCLUSION: In conclusion, Zva is a simple, noninvasive marker that shows promise as a predictor of LVEF improvement after TAVR in reduced LVEF patients.

Coronary ostial eccentricity in severe aortic stenosis: Guidance for BASILICA transcatheter leaflet laceration.

BACKGROUND: Eccentricity of coronary ostial positions in relation to the aortic valve cusp may influence the target laceration location in BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Coronary Artery obstruction). Eccentricity of the coronary ostia in relation to coronary cusps of native and valve-in-valve transcatheter aortic valve replacement (TAVR) was not well described before. METHODS: A total of 121 pre-TAVR patients' CT data (72 native valves TAVR and 49 bioprosthetic surgical valves TAVR) was included and coronary ostial eccentricity angles were measured and compared. Coronary ostial angles were measured between mid-cusp line to coronary ostium in CT perpendicular images. RESULTS: In the overall cohort, the right coronary artery (RCA) had an eccentric origin in the majority of cases, favoring the commissure between the right and the non coronary cusp (17.0°, IQR; 10-25). On the other hand, the left coronary artery (LCA) originated most commonly near center of the cusp position (0°, IQR; -8 -7.5) In comparison of native and bioprosthetic valves, RCA ostial angles were more eccentric in native valves (19.0°, IQR; 12-26) than in bioprosthetic valves (14.0°, IQR; 3-20) (p = 0.004). Whereas, LCA ostial angle has no significant differences between native valves (-2.0°, IQR;-7.75-5.75) and bioprosthetic valves (1°, IQR;-8-13), (p = 0.6). CONCLUSION: RCA ostia often have an eccentric origin towards the non-coronary cusp, especially in native aortic valves, while LCA ostia commonly originate near the center of the cusp. This finding may contribute to better performance of BASILICA procedures.

Impact of Coronary Artery Severity and Revascularization Prior to Transcatheter Aortic Valve Implantation.

The prevalence of coexisting coronary artery disease (CAD) is high in patients who underwent transcatheter aortic valve implantation (TAVI). Our objective was to first determine if the severity of CAD before TAVI had an important impact on post-TAVI outcomes and second, if revascularization with percutaneous coronary intervention (PCI) before TAVI modified this relation. In this retrospective population-based study in Ontario, Canada, we identified all patients with obstructive CAD who underwent TAVI from April 1, 2012 to March 31, 2017. Our primary outcomes of interest were all-cause mortality within 30-day and 1-year post-TAVI procedure. Secondary outcomes included 30-day and 1-year all-cause readmissions. We developed multivariable Cox proportional hazard models, with a robust sandwich-type variance estimator to account for clustering within TAVI centers. These models included an interaction term between severity of CAD and PCI before TAVI. The study cohort included 888 of whom 444 (50%) patients underwent PCI before TAVI procedure. In the Cox models, we found that severity of CAD before TAVI was not significantly associated with post-TAVI outcomes. The only exception was 1 to 2 vessel/s disease which was a significant predictor of 1-year readmission. Pre-TAVI PCI was not significantly associated with outcomes, nor did it modify the relation between severity of CAD pre-TAVI and outcomes. In conclusion, we did not find a consistent relation between severity of CAD and revascularization with post-TAVI outcomes.

Transcatheter Mitral Valve Edge-to-Edge Repair with the New MitraClip XTR System for Acute Mitral Regurgitation Caused by Papillary Muscle Rupture.

Treatment of patients presenting with cardiogenic shock due to acute mitral regurgitation related to papillary muscle rupture poses significant challenges, owing to the high risk associated with conventional surgery. We hereby report successful transcatheter mitral valve edge-to-edge repair with the new Mitraclip XTR device (Abbott Vascular, Santa Clara, CA) in a patient with acute myocardial infarction and cardiogenic shock. Although surgical intervention remains the standard of care, the new MitraClip XTR system offers a novel treatment option for patients with papillary muscle rupture by overcoming the anatomic challenges often seen in this pathology.

Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction. Part 1: how to evaluate patients for BASILICA.

Coronary obstruction is a life-threatening complication of transcatheter aortic valve replacement. BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) seems to be an effective method for preventing that complication. In this article, we describe how to assess patients for their risk of coronary obstruction and how to evaluate for BASILICA, including defining coronary cusp fluoroscopic projections and analysing coronary ostia eccentricity.

Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction. Part 2: how to perform BASILICA.

Coronary obstruction is a life-threatening complication of transcatheter aortic valve replacement. Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) seems to be an effective approach for preventing coronary obstruction by maintaining blood flow towards the coronary artery by an intentionally created leaflet laceration. In this report, we aimed to provide step-by-step guidance on how to perform a BASILICA procedure. The technique includes several steps that can be challenging without proper guidance. Assistance by operators who have already performed BASILICA seems to be crucial, and formal proctorship during initial procedures can ensure good clinical outcomes.

Novel strategies in aortic valve-in-valve therapy including bioprosthetic valve fracture and BASILICA.

An ageing population and increased utilisation of tissue valves in younger patients imply that the number of patients receiving transcatheter aortic valve implantation within failed bioprostheses will continue to increase. There are two major adverse events associated with aortic valve-in-valve procedures that may temper the enthusiasm for these appealing interventions. Residual stenosis is the "Achilles' heel" of aortic valve-in-valve, while coronary obstruction is an uncommon but life-threatening adverse event. Prevention of these adverse events is essential. Emerging tools and techniques enable operators to manipulate existing devices and to implant new ones inside them safely. Considering the available evidence, it seems that bioprosthetic valve ring fracture and bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction (BASILICA) may enable some solution. Until we have prosthetic valves that are both very durable and non-thrombogenic, we can expect that techniques and tools chosen to treat failed bioprosthetic valves effectively will continue to be designed and utilised.

Paradoxical high augmentation index in females with diabetes mellitus.

The relationship between diabetes mellitus (DM) and augmentation index (AIx) remains unclear. We conducted an observational cross-sectional study. Subjects were patients who underwent coronary angiography. We examined the relationship between high AIx and several factors. The total number of diabetic patients was 144, and median AIx was 0.256. In diabetic patients, the significant relationship between female gender and high AIx (median cut-off value, ≥0.256) was found by the multivariate logistic analysis (adjusted odds ratio = 2.888; 95% confidence interval: 1.032-8.081). The significant relationship between female gender and high AIx was found in patients with DM.