Impact of the clinical frailty scale on long-term outcomes after transcatheter aortic valve implantation.

BACKGROUND: The semiquantitative Clinical Frailty Scale (CFS) is reportedly a useful marker for predicting short- and mid-term mortality after transcatheter aortic valve implantation (TAVI). We assessed the long-term prognostic impact of CFS in patients with severe aortic stenosis undergoing TAVI. METHODS: We prospectively assessed patients undergoing TAVI in Kokura Memorial Hospital using a 9-level CFS and enrolled 1594 patients after excluding patients with CFS 8-9. The patients were divided into the low (CFS level, 1-3; N = 842), intermediate (4; N = 469), and high (5-7; N = 283) groups according to their CFS levels. RESULTS: In the low, intermediate, and high groups, 3-year all-cause mortality rates were 17.4%, 29.4%, and 41.7% (P < .001) and composite rates of cardiovascular mortality and heart failure hospitalization were 12.1%, 19.1%, and 23.9% (P < .001), respectively. Multivariable analysis showed that higher frailty was independently associated with all-cause mortality (intermediate group: adjusted hazard ratio [HR], 1.63, 95% confidence interval [CI], 1.24-2.15, P < .001; high group: adjusted HR, 2.18, 95% CI, 1.59-2.99, P < .001) and composite of cardiovascular mortality and heart failure hospitalization (intermediate group: adjusted HR, 1.47, 95% CI, 1.04-2.08, P = .030; high group: adjusted HR, 1.66, 95% CI, 1.09-2.51, P = .018) and this result was consistent, irrespective of stratification based on age, sex, body mass index, left ventricular ejection fraction, Society of Thoracic Surgeons score, and New York Heart Association functional class without significant interaction. CONCLUSIONS: The simple CFS tool predicts the long-term adverse outcomes post-TAVI.

Efficacy of larger valve sizing with underfilling in balloon-expandable transcatheter aortic valve replacement.

OBJECTIVES: To investigate the efficacy and safety of larger valve sizing beyond the commercially recommended annular range in transcatheter aortic valve replacement (TAVR) with balloon-expandable transcatheter heart valve (THVs). BACKGROUND: The clinical implications of larger balloon-expandable THV implantation with underfilling are poorly evaluated. METHODS: This retrospective study included 692 consecutive patients who underwent TAVR with SAPIEN3. A total of 271 patients who underwent SAPIEN 3 implantation were analyzed based on three border zones (Zone 1: 300-345 mm2 , 23 vs. 20 mm; Zone 2: 400-430 mm2 , 26 vs. 23 mm; Zone 3: 500-546 mm2 , 29 vs. 26 mm). The primary endpoint was the effective orifice area (EOA) assessed by echocardiography at 1 year, and secondary endpoints were a 30-day mortality rate, procedural complications during TAVR, and a composite of death from any cause and heart failure requiring rehospitalization at 1 year. RESULTS: At 1-year follow-up, the EOA in the larger valve groups was greater than that in the recommended valve group in each zone (Zone 1: 1.45 ± 0.03 vs. 1.06 ± 0.06 cm2 , p < 0.001; Zone 2: 1.83 ± 0.05 vs. 1.41 ± 0.05 cm2 , p < 0.001; Zone 3: 1.93 ± 0.07 vs. 1.69 ± 0.07 cm2 , p = 0.02). No significant difference in the secondary endpoint was observed in any of the zones. CONCLUSIONS: Implantation of the out-of-range larger SAPIEN 3 THVs with underfilling was associated with greater EOA at the 1-year follow-up and feasible in the selected patients.

Impact of tapered-shape left ventricular outflow tract on pacemaker rate after transcatheter aortic valve replacement.

Mechanical compression of left ventricular outflow tract (LVOT) was reported to be a leading cause of conduction impairment requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement (TAVR). However, the association between tapered-shape LVOT and PPI after TAVR has not been elucidated. Of 272 consecutive patients treated with SAPIEN 3 in our institute, we retrospectively analyzed the clinical data of 256 patients without previous PPI or bicuspid valve. In-hospital PPI was performed in 20 (7.8%) patients at 8.2 ± 2.9 days after TAVR. Patients requiring PPI had smaller LVOT area (356.3 vs. 399.4 mm2, p ≤ 0.011). Moreover, receiver operating characteristic statistics showed that LVOT area /annulus area possessed significantly higher predictive ability than LVOT area (c-statistic: 0.91 [95% confidence interval [CI]: 0.84-0.95] vs. 0.67 [95% CI: 0.57-0.77], p < 0.001). Multivariable analysis revealed that LVOT area /annulus area (odds ratio [OR]: 1.93 [95% CI: 1.38-2.71]; p < 0.001 per % of decreasing), the difference between membranous septum length and implantation depth (ΔMSID) (OR: 6.82 [95% CI 2.39-19.48]; p < 0.001 per mm of decreasing) and pre-existing complete right bundle branch block (CRBBB) (OR: 32.38 [95% CI2.30-455.63]; p ≤ 0.002) were independently associated with PPI. In our study, tapered-shape LVOT as well as short ΔMSID and pre-existing CRBBB were identified as independent predictors for PPI after TAVR. Higher valve implantation is required to minimize the risk of post-procedural PPI especially for patients with short MS length, pre-procedural CRBBB, or tapered-shape LVOT.

Mid-term impact of underfilling and overfilling of the SAPIEN 3 balloon-expandable transcatheter aortic valve implantation on mortality and valve function.

At present, underfilling or overfilling the volume of the balloon-expandable transcatheter heart valve (THV) is generally utilized in transcatheter aortic valve implantation (TAVI). However, no research has assessed the clinical impact of filling volume variations of the current-generation SAPIEN 3 THV. We analyzed the clinical data of 331 patients who underwent TAVI with SAPIEN 3 at our institution. Post-procedural echocardiographic and multidetector computed tomography (MDCT) scan data and 3-year prognoses according to each filling volume were assessed. The procedural outcomes and 3-year mortality rates were comparable among the underfilling, nominal filling, and overfilling groups. For all THV sizes, the THV area evaluated on post-procedural MDCT scan increased stepwise along with an elevated filling volume, thereby covering a wide range of native annulus area. Compared with patients in the nominal filling and overfilling groups, those with 23-mm THVs in the underfilling group had a smaller effective orifice area (EOA) (1.38 [IQR: 1.18-1.56] vs. 1.57 [IQR: 1.41-1.84] vs. 1.58 [IQR: 1.45-1.71] cm2, P = 0.02) and a higher mean transvalvular gradient (13.6 [IQR: 11.0-15.7] vs. 12.1 [IQR: 9.0-14.9] vs. 12.0 [IQR: 8.1-14.8] cm2, P = 0.04). In conclusion, by adjusting the filling volume of SAPIEN 3 using THV with limited sizes, continuously distributed native annulus areas were covered. The underfilling implantation technique had a minimal negative effect on the valve function of 23-mm THVs only. In the entire cohort, the filling volume variations did not affect the mid-term prognosis negatively.

Clinical Outcomes After Percutaneous Coronary Intervention in Patients With Cancer.

BACKGROUND: The aim of this study is to evaluate clinical outcomes after percutaneous coronary intervention (PCI) in patients with cancer.Methods and Results:Cancer screening was recommended before PCI in consecutive 1,303 patients who underwent their first PCI. By using cancer screening, cancer was diagnosed in 29 patients (2.2%). In total, 185 patients had present or a history of cancer. Patients with cancer more often suffered from non-cardiac death than those without (4.4% vs. 1.5%, P=0.006), and patients with cancer requiring ongoing therapy (n=18) more often suffered from major bleeding compared with those with recently (≤12 months) diagnosed cancer who do not have ongoing therapy (n=59) (16.7% vs. 3.4%, P=0.049). During the 1-year follow up, 25 patients (2.0%) were diagnosed as having cancer, in which 48.0% of bleeding events led to a cancer diagnosis. Patients with high bleeding risk according to the Academic Research Consortium for high bleeding risk (ARC-HBR) were associated with a greater 1-year major bleeding risk than those without high bleeding risk in patients with (7.9% vs. 0.0%, P=0.02) and without cancer (7.1% vs. 2.5%, P<0.001), respectively. CONCLUSIONS: Cancer was diagnosed in 2.2% of 1,303 unselected patients before PCI by cancer screening and in 2.0% within 1-year after PCI. Cancer was associated with a greater risk of non-cardiac death, whereas ongoing active cancer was associated with greater risk of major bleeding. ARC-HBR criteria successfully identified high-bleeding risk patients, irrespective of the presence or absence of cancer.

Effect of postdilatation following balloon expandable transcatheter aortic valve implantation.

BACKGROUND: Postdilatation after transcatheter heart valve (THV) implantation was associated with larger aortic valve areas in large-scale registries; however, the specific effects of postdilatation are poorly understood. METHODS AND RESULTS: Among a total of 224 consecutive patients who underwent transcatheter aortic valve replacement using SAPIEN 3, 121 patients (54.0%) underwent postdilatation (same contrast volume: N = 101, +1 ml: N = 17, +2 ml: N = 3). THV diameter was assessed (a) during, (b) after implantation, (c) during postdilatation, and (d) after postdilatation by quantitative fluoroscopy. In the overall patients (N = 224), acute recoil was observed from during implantation (23.0 ± 2.0 mm) to after implantation (22.5 ± 2.0 mm, p < .001) with an absolute recoil of 0.52 ± 0.25 mm. After postdilatation (N = 121), THV diameter significantly increased from 22.5 ± 2.0 mm to 22.9 ± 2.1 mm (p < .001), with smaller absolute recoil (0.39 ± 0.21 mm, p < .001). Compared with those who did not undergo postdilatation, patients who underwent postdilatation had larger postprocedural THV area assessed by multi-slice computed tomography (471.4 ± 78.1 mm2 vs. 447.5 ± 76.3 mm2 , p = .02) and larger effective orifice area (EOA) assessed by echocardiography throughout 1 year (at 30 day, 1.66 ± 0.33 cm2 vs. 1.45 ± 0.27 cm2 , p < .001; at 6 month, 1.66 ± 0.33 cm2 vs. 1.44 ± 0.29 cm2 , p < .001; at 1 year, 1.69 ± 0.38 cm2 vs. 1.47 ± 0.30 cm2 , p < .001). CONCLUSIONS: Postdilatation after implantation of the SAPIEN 3 valve produced a larger THV diameter with less acute recoil, followed by larger EOA throughout 1 year. Further studies are needed to evaluate the impact of postdilatation on long-term clinical outcomes.

Valve Hemodynamics and Clinical Outcomes After Transcatheter Aortic Valve Replacement for a Small Aortic Annulus.

The hemodynamics and outcomes in patients with a small aortic annulus (SAA) after transcatheter aortic valve replacement (TAVR) with a second-generation transcatheter heart valve remain unclear. We investigated whether TAVR with a Sapien XT (Edwards Lifesciences, Irvine, California) influences postprocedural valve hemodynamics and long-term outcome in high-risk SAA patients compared with surgical aortic valve replacement (SAVR).We retrospectively identified 94 SAA patients who underwent aortic valve replacement (TAVR = 35 and SAVR = 59). SAA was defined as an aortic annulus diameter ≤ 20 mm, measured by preprocedural transesophageal echocardiography.The mean age was 80.2 years. The mean Society of Thoracic Surgeons-Predicted Risk of Mortality was 6.8%. The post-procedural peak transvalvular velocity and mean pressure gradient were significantly lower in the TAVR cohort than in the SAVR cohort, whereas the postprocedural aortic valve area was significantly higher in the TAVR cohort. Severe prosthesis-patient mismatch (PPM) occurred less frequently after TAVR than SAVR (TAVR 2.9% versus SAVR 22.0%, P = 0.01). The two-year mortality in SAA patients was similar between the two groups.TAVR with a Sapien XT in SAA patients improved the valve hemodynamics and reduced the incidence of PPM compared with SAVR. TAVR patients had a similar 2-year mortality despite higher risk baseline characteristics. To avoid PPM and the consequent poor outcomes, TAVR can be considered an alternative option to SAVR in high surgical risk patients with SAA.

Aortic Complex Rupture After Transcatheter Aortic Valve Implantation.

Aortic complex rupture is one of the most critical complications associated with transcatheter aortic valve implantation (TAVI). Its incidence is rare, and its mechanism varies by case; therefore, it is difficult to identify the predictors of complex rupture. Herein, we report a clinical case series of aortic complex rupture. Within our cohort, the frequency of complex rupture was 0.8% (4/497 consecutive patients) with an in-hospital mortality of 0. Among these four patients with complex rupture, two underwent emergent thoracotomy and surgical hemostasis without a heart-lung machine and surgical aortic valve replacement, whereas the other two were conservatively managed. The case overview revealed the following similarities: all the patients were elderly, small women; balloon-expandable valves were used; the annulus area was small with heavily calcified leaflet; and aggressive treatment strategy was used (i.e., oversizing and post-dilatation). In such cases, TAVI should be performed with a careful strategy. Once aortic complex rupture occurs, damage can be minimized through cooperation with an institutional heart team and calm management.

Early Safety and Efficacy of Transcatheter Aortic Valve Implantation for Asian Nonagenarians (from KMH Registry).

As Japan has one of the most rapidly aging populations in the world, transcatheter aortic valve implantation (TAVI) is likely to be performed in increasing numbers of older people. There is little information on either the efficacy or the safety of TAVI in nonagenarians in Asia.From October 2013 to June 2015, 112 consecutive patients underwent TAVI with Edwards SAPIEN XT valves in our institution. We compared 25 patients aged at least 90 years (mean 91.6 ± 1.7 years) with 87 patients aged under 90 years (mean 82.5 ± 6.0 years) at the time of TAVI. All definitions of clinical endpoints and adverse events were based on the Valve Academic Research Consortium 2 definitions.The median follow-up interval was 561.5 days (the first and third quarters, 405.0 and 735.8 days). Nonagenarians had a higher logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE), Euro II score, and the Society of Thoracic Surgeons predictive risk of mortality (STS) score, and a prevalence of clinical frailty scale ≥ 4. The rate of device success, and the 30-day and 6-month mortalities were not different between patients aged ≥ 90 years and < 90 years (96.0% versus 92.0%, P = 0.68; both 0%, P = 1.00; 4.0% versus 3.5%, P = 0.32, respectively). At six months, clinical efficacy and time-related valve safety were also similar in the two groups (12.5% versus 13.4%, P = 1.00; 4.5% versus 10.3%, P = 0.68, respectively). The cumulative 1-year mortalities were not significantly different between the two groups (8.4% versus 9.4%, P = 0.94, respectively).TAVI can contribute to acceptable clinical results and benefits in a carefully selected group of nonagenarians in Asia.

Carcinoid Heart Disease With Hypoxemia.

Patent foramen ovale (PFO) complicated with carcinoid heart disease (CHD) can cause severe hypoxia and worsening clinical conditions. We report the case of a patient with CHD in poor general condition with multiple severe valve regurgitations and PFO, who underwent successful percutaneous closure of the PFO.

Cerebrovascular Disease Detected on Preprocedural Computed Tomography in Patients With Severe Aortic Stenosis Undergoing Aortic Valve Replacement.

BACKGROUND: There is a scarcity of data on the prevalence and clinical impact of cerebrovascular disease detected on preprocedural computed tomography (CT) before aortic valve replacement (AVR) in patients with severe aortic stenosis. METHODS AND RESULTS: Among patients with severe aortic stenosis undergoing AVR, the authors compared clinical outcomes between patients with and without cerebrovascular disease detected on preprocedural CT, which was defined as chronic brain infarction or hemorrhage. The primary outcome measure in this study was a composite of all-cause death or stroke. Among 567 study patients, 200 patients (35.3%) had cerebrovascular disease on preprocedural CT. Among 200 patients with cerebrovascular disease on preprocedural CT, only 28.5% of patients had a clinical history of symptomatic stroke. The cumulative 3-year incidence of death or stroke was higher in patients with cerebrovascular disease on preprocedural CT than in those without cerebrovascular disease on preprocedural CT (40.7% versus 24.1%, log-rank P<0.001). After adjusting for confounders, the higher risk of patients with cerebrovascular disease on preprocedural CT relative to those without remained significant for death or stroke (hazard ratio [HR], 1.42 [95% CI, 1.02-1.98]; P=0.04). Among 200 patients with cerebrovascular disease on preprocedural CT, patients with prior symptomatic stroke compared with those without were not associated with higher adjusted risk for death or stroke (HR, 1.18 [95% CI, 0.72-1.94]; P=0.52). CONCLUSIONS: Among patients with severe aortic stenosis undergoing AVR, a substantial proportion had cerebrovascular disease on preprocedural CT, with a clinical history of symptomatic stroke in one-fourth of patients. Regardless of history of symptomatic stroke, patients with cerebrovascular disease on preprocedural CT had worse clinical outcomes compared with those without cerebrovascular disease on preprocedural CT.

Clinically significant incidental noncardiac findings on preprocedural computed tomography in patients with aortic stenosis undergoing aortic-valve replacement.

BACKGROUND: There is a scarcity of data on the prevalence of abnormal findings on preprocedural computed tomography (CT) before aortic valve replacement (AVR) in patients with aortic stenosis (AS). METHODS: Among consecutive 593 patients with severe AS who were planned to undergo AVR, we evaluated the prevalence of clinically significant incidental noncardiac findings on preprocedural CT. Clinically significant incidental noncardiac findings were defined as newly detected abnormalities that required therapy, consultation for expert, further investigation, or clinical follow-up. RESULTS: The mean age was 82.0 years and 39.5 % of the patients were men. Of those, 78.4 % of the patients were treated with transcatheter aortic valve implantation (TAVI) and 21.6 % of the patients were treated with surgical AVR (SAVR). There were 271 clinically significant incidental noncardiac findings in 227 patients (38.3 %) including 2.5 % of malignancy. The prevalence of clinically significant incidental noncardiac findings were higher in the TAVI group than in the SAVR group (40.2 % versus 31.3 %). The prevalence of clinically significant incidental noncardiac findings were lower in patients under 60 years of age (10.0 %) than in patients over 60 years of age (60-69 years: 40.0 %, 70-79 years: 34.3 %, 80-89 years: 39.7 %, and ≥90 years: 42.1 %). CONCLUSIONS: Clinically significant incidental noncardiac findings were newly identified on preprocedural CT in approximately 40 % of patients with severe AS undergoing AVR including 2.5 % of malignancy.

Impact of Transjugular Intracardiac Echocardiography-Guided Self-Expandable Transcatheter Aortic Valve Implantation on Reduction of Conduction Disturbances.

BACKGROUND: A high permanent pacemaker implantation (PPI) risk remains a concern of self-expandable transcatheter aortic valve implantation, despite the continued improvements in implantation methodology. We aimed to assess the impact of real-time direct visualization of the membranous septum using transjugular intracardiac echocardiography (ICE) during transcatheter aortic valve implantation on reducing the rates of conduction disturbances including the need for PPI. METHODS: Consecutive patients treated with Evolut R and Evolut PRO/PRO+ from February 2017 to September 2022 were included in this study. We compared outcomes between the conventional implantation method using the 3-cusps view (3 cusps without ICE group), the recent method using cusp-overlap view (cusp overlap without ICE group), and our novel method using ICE (cusp overlap with ICE group). RESULTS: Of the 446 patients eligible for analysis, 211 (47.3%) were categorized as the 3 cusps without ICE group, 129 (28.9%) were in the cusp overlap without ICE group, and 106 (23.8%) comprised the cusp overlap with ICE group. Compared with the 3 cusps without ICE group, the cusp overlap without ICE group had a smaller implantation depth (2.2 [interquartile range, 1.0-3.5] mm versus 4.3 [interquartile range, 3.3-5.4] mm; P<0.001) and lower 30-day PPI rates (7.0% versus 14.2%; P=0.035). Compared with the cusp overlap without ICE group, the cusp overlap with ICE group had lower 30-day PPI rates (0.9%; P=0.014), albeit with comparable implantation depths (1.9 [interquartile range, 0.9-2.9] mm; P=0.150). Multivariable analysis showed that our novel method using ICE with the cusp-overlap view was independently associated with a 30-day PPI rate reduction. There were no group differences in 30-day all-cause mortality (1.4% versus 1.6% versus 0%; P=0.608). CONCLUSIONS: Our novel implantation method using transjugular ICE, which enable real-time direct visualization of the membranous septum, achieved a predictably high position of prostheses, resulting in a substantial reduction of conduction disturbances requiring PPI after transcatheter aortic valve implantation.

Assessing Potential Risks of Future Redo Transcatheter Aortic Valve Replacement in Asian Patients.

Background: In the Asian cohort, data are limited on the risk for coronary obstruction due to sinus of Valsalva (SOV) sequestration in redo transcatheter aortic valve replacement (TAVR) procedures. Objectives: The aim of this study was to assess the potential risk for coronary obstruction in simulated redo TAVR in Asian patients. Methods: Post-TAVR computed tomographic data from 788 patients who received balloon-expandable (BE) SAPIEN 3 transcatheter aortic valves (TAVs) and 334 patients who received self-expanding (SE) Evolut R or Evolut PRO TAVs were analyzed. The risk for coronary obstruction due to SOV sequestration in redo TAVR, defined as the TAV commissure level above the sinotubular junction (STJ) and a TAV-to-STJ distance <2.0 mm in each coronary sinus, was retrospectively evaluated. Results: The potential risks for coronary obstruction due to SOV sequestration at 1 or both coronary arteries were identified in 52.1% of the BE TAV group and 71.3% of the SE TAV group (P < 0.001). After adjusting for multiple covariates, STJ diameter, STJ height, TAV oversizing degree by area, and implantation depth were independently associated with SOV sequestration risk in the BE TAV group, whereas STJ diameter and implantation depth were independently associated with SOV sequestration risk in the SE TAV group. Conclusions: Coronary obstruction due to SOV sequestration in redo TAVR may occur in a substantial number of Asian patients. This finding suggests the importance of considering the structural feasibility of future redo TAVR when implanting the first TAV, especially in Asian patients with long life expectancy.

Long-term prognostic value of the H2FPEF score in patients undergoing transcatheter aortic valve implantation.

AIMS: A considerable proportion of candidates for transcatheter aortic valve implantation (TAVI) have underlying heart failure (HF) with preserved ejection fraction (HFpEF), which can be challenging for diagnosis because significant valvular heart disease should be excluded before diagnosing HFpEF. This study investigated the long-term prognostic value of the pre-procedural H2FPEF score in patients with preserved ejection fraction (EF) undergoing TAVI. METHODS AND RESULTS: Patients who underwent TAVI between October 2013 and May 2017 were enrolled from the Optimized CathEter vAlvular iNtervention-Transcatheter Aortic Valve Implantation Japanese multicentre registry. After excluding 914 patients, 1674 patients with preserved EF ≥ 50% (median age: 85 years, 72% female) were selected for calculation of the H2FPEF score and were dichotomized into two groups: the low H2FPEF score [0-5 points; n = 1399 (83.6%)] group and the high H2FPEF score [6-9 points; n = 275 (16.4%)] group. Patients with high H2FPEF scores were associated with a higher prevalence of New York Heart Association Functional Class III/IV (59.3% vs. 43.7%, P < 0.001), diabetes (24.4% vs. 18.5%, P = 0.03), and paradoxical low-flow, low-gradient aortic stenosis (15.9% vs. 6.2%, P < 0.001). These patients showed worse prognoses than those with low H2FPEF scores regarding the cumulative 2 year all-cause mortality (26.3% vs. 15.5%, log-rank P < 0.001), cardiovascular mortality (10.5% vs. 5.4%, log-rank P < 0.001), HF hospitalization (16.2% vs. 6.7%, log-rank P < 0.001), and the composite endpoint of cardiovascular mortality and HF hospitalization (23.8% vs. 10.8%, log-rank P < 0.001). After adjustment for several confounders, the high H2FPEF scores were independently associated with increased risk for all-cause mortality [adjusted hazard ratio (HR), 1.48; 95% confidence interval (CI), 1.09-2.00; P = 0.011] and for the composite endpoint of cardiovascular mortality and HF hospitalization (adjusted HR, 1.95; 95% CI, 1.38-2.74; P < 0.001). Subgroup analysis confirmed the excess risk of high H2FPEF scores relative to low H2FPEF scores for the composite endpoint of cardiovascular mortality and HF hospitalization increased with a lower Society of Thoracic Surgeons (STS) score (STS score <8%: adjusted HR, 2.40; 95% CI, 1.50-3.85; P < 0.001; STS score ≥8%: adjusted HR, 1.34; 95% CI, 0.79-2.28; P = 0.28; Pinteraction = 0.030). CONCLUSIONS: The H2FPEF score is useful for predicting long-term adverse outcomes after TAVI, including all-cause mortality, cardiovascular mortality, and HF hospitalization for patients with preserved EF. More aggressive interventions targeting HFpEF in addition to the TAVI procedure might be relevant in patients with high H2FPEF scores, particularly in those with a lower surgical risk.

Effect of Radiolucent Line-Guided Balloon-Expandable Transcatheter Aortic Valve Implantation on Subsequent Pacemaker Rate.

In the era of expanding transcatheter aortic valve implantation (TAVI) indications for low surgical risk patients, conduction disturbances requiring permanent pacemaker implantation (PPI) after TAVI remain a serious concern. We aimed to assess the impact of the radiolucent line-guided technique for the SAPIEN 3 implantation on reducing the rates of new-onset PPI after TAVI. A total of 326 patients treated with the SAPIEN 3 using either the radiolucent line-guided technique (lucent group, 170 patients [52.1%]) or the center marker-guided technique (conventional group, 156 patients [47.9%]) were prospectively included in our database. The prosthesis position, and 30-day and 3-year clinical outcomes were retrospectively assessed. Compared with the conventional group, the lucent group had a higher prosthesis position (1.7 ± 0.9 mm vs 4.2±1.5 mm, p <0.001) and lower 30-day PPI rates (2.9% vs 13.5%, p <0.001). The other periprocedural complications including valve dislodgement and coronary obstruction, and 30-day and 3-year mortality were comparable between the groups. However, the prosthesis frame extending above sinotubular junction was more frequently observed in the lucent group on the side of left coronary sinus (53.4% vs 31.4%, p <0.001) and right coronary sinus (35.0% vs 20.2%, p = 0.001), signifying a potential risk for "subsequent difficulties to access coronary ostia" and "coronary obstruction during future redo TAVI." In conclusion, the radiolucent line-guided technique predictably provided an extremely high position of the SAPIEN 3, reducing the postprocedural PPI rates compared with the center marker-guided technique.

Initial practice of left atrial appendage closure device in Japan; single-center experience.

BACKGROUND: The left atrial appendage closure (LAAC) device for patients with nonvalvular atrial fibrillation (NVAF) has recently been introduced in Japan. However, clinical data of Japanese patients are insufficient. METHODS: In this single-center study, 55 consecutive patients (mean age, 74 years) who received LAAC therapy from September 2019 to December 2020 were analyzed. The WATCHMAN implant procedure (Boston Scientific, St. Paul, MN, USA) was performed under transesophageal echocardiography and general anesthesia for all cases. RESULTS: The baseline CHA2DS2-VASc score was 4.6 ± 1.4, and the baseline HAS-BLED score was 3.8 ± 0.9. All procedures (98.2%) were successful, except for one, and no procedure-related complications were observed. After the procedures, various antithrombotic regimens were employed according to the bleeding risk of each patient; warfarin was used in 27 patients (49%), direct oral anticoagulants (DOACs) were used in 22 patients (40%), and dual antiplatelet therapy (DAPT) was employed in 6 patients. During a mean follow-up of 360 days, three cases of device-related thrombus (DRT) were detected. One DRT case was related to ischemic stroke. Nine patients had major bleeding during follow-up: two patients received DOACs, six patients received DAPT, and one patient received aspirin. CONCLUSIONS: In this initial Japanese experience, LAAC therapy for high bleeding risk patients with NVAF seems feasible. Optimal antithrombotic regimens are warranted for better clinical outcomes.