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AIMS: Mitral stenosis (MS) occasionally coexists with aortic stenosis (AS). Limited data are available regarding the functional class and clinical outcomes of patients who undergo transcatheter aortic valve implantation (TAVI) for combined AS and MS. This study compared the clinical outcomes in patients with and without MS who underwent TAVI for severe AS and assessed the impact of mitral annulus calcification (MAC) severity, transmitral gradient (TMG) and mitral valve area (MVA) on outcomes in patients with combined AS and MS. METHODS: We investigated patients in the OCEAN-TAVI registry who underwent TAVI. MS was defined as an MVA ≤ 1.5 cm2 or TMG ≥ 5 mmHg. The composite of all-cause death and admission for heart failure was compared between patients with and without MS. The impact of MAC, TMG and MVA on outcomes was assessed in patients with combined AS and MS. RESULTS: We identified 106 patients with MS (MAC 84%; TMG 6.4 ± 2.6 mmHg; MVA 1.10 ± 0.31 cm2) and 6570 without MS as controls. The MS group was older (85 ± 5 vs. 84 ± 5 years, P = 0.033), more of women (85 vs. 67%, P < 0.01), and had a higher risk of surgery (the Society of Thoracic Surgeons Mortality Score 8.7 ± 5.1 vs. 7.6 ± 5.9, P = 0.047) than the controls. In the MS group, the New York Heart Association Functional Class was 3 or 4 in 56% of the patients at baseline and 6% at 1 year after TAVI. Thirty-day mortality (2.8% vs. 1.3%, P = 0.18) and early composite outcomes (17% vs. 15%, P = 0.56) were comparable between patients with and without MS. During a median follow-up of 2.1 years, the presence of MS was associated with a higher incidence of adverse events compared with controls (adjusted hazard ratio [HR] 1.84; 95% confidence interval [CI] 1.34-2.51, P < 0.01), even on propensity score matched analysis (adjusted HR 1.91; 95% CI 1.14-3.22, P < 0.01). Moderate or severe MAC contributed to increased risk of adverse events in patients with MS (adjusted HR 2.89; 95% CI 1.20-6.99, P = 0.018), but TMG and MVA did not. CONCLUSIONS: In patients undergoing TAVI for severe AS, those with moderate or severe MS experienced worse outcomes after TAVI compared with those without MS. Patients with combined AS and MS sustained symptom improvement at 1-year post-TAVI. MAC severity was a useful predictor of adverse events compared with MS haemodynamics such as TMG and MVA in patients with combined AS and MS.
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In response to the International Commission on Radiological Protection (ICRP), which lowered the lens equivalent dose limit, Japan lowered the lens dose limit from 150 mSv/year to 100 mSv/5 years and 50 mSv/year, with this new rule taking effect on April 1, 2021. DOSIRIS® is a dosimeter that can accurately measure lens dose. Herein, we investigated lens dose in interventional cardiology physicians one year before and after the reduction of the lens dose limit using a neck dosimeter and lens dosimeter measurements. With an increase in the number of cases, both personal dose equivalent at 0.07 mm [Hp(0.07), neck dosimeter] and personal dose equivalent at 3 mm depth [Hp(3), lens dosimeter] increased for most of the physicians. The Hp(3) of the lens considering the shielding effect of the Pb glasses using lens dosimeter exceeded 20 mSv/year for two of the 14 physicians. Protection from radiation dose will become even more important in the future, as these two physicians may experience radiation dose exceeding 100 mSv/5 years. The average dose per procedure increased, but not significantly. There was a strong correlation between the neck dosimeter and lens dosimeter scores, although there was no significant change before and after the lens dose limit was lowered. This correlation was particularly strong for physicians who primarily treated patients. As such, it is possible to infer accurate lens doses from neck doses in physicians who primarily perform diagnostics. However, it is desirable to use a dosimeter that can directly measure Hp(3) because of the high lens dose.
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The hemodynamic performance of self-expandable valves (SEVs) is a preferable choice for small aortic annuli in transcatheter aortic valve replacement (TAVR). However, no data are, so far, available regarding the relation between the size of SEVs and clinical outcomes. This study aimed to evaluate the impact of prosthesis size on adverse events after TAVR using SEVs. We retrospectively analyzed 1,400 patients (23-mm SEV: 13.6%) who underwent TAVR using SEVs at 12 centers. The impact of SEV size on all-cause death and heart failure (HF) after TAVR was evaluated by multivariate Cox regression and propensity score (PS) matching analysis. During the follow-up period (median 511 days), 201 all-cause deaths and 87 HF rehospitalizations were observed. The incidence of all-cause death was comparable between small- (23-mm SEV) and larger-sized (26- or 29-mm SEV) (16.8% vs 13.9%, log-rank p = 0.29). The size of SEV was not associated with a higher incidence of all-cause death (hazard ratio [HR] 1.21, 95% confidence interval [CI] 0.79 to 1.86 in Cox regression; HR 1.31, 95% CI 0.77 to 2.23 in PS matching) and HF after TAVR (subdistribution HR 0.79, 95% CI 0.37 to 1.72 in Cox regression; subdistribution HR 1.00, 95% CI 0.44 to 2.30 in PS matching). The multivariate model including postprocedural prosthesis-patient mismatch showed consistent results. In conclusion, small SEVs had comparable midterm clinical outcomes to larger-sized SEVs, even if the prosthesis-patient mismatch was observed after TAVR.
Subject(s)
Aortic Valve Stenosis , Heart Valve Prosthesis , Postoperative Complications , Prosthesis Design , Transcatheter Aortic Valve Replacement , Aged , Aged, 80 and over , Female , Humans , Male , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Cause of Death/trends , Follow-Up Studies , Heart Failure , Incidence , Postoperative Complications/epidemiology , Propensity Score , Retrospective Studies , Risk Factors , Transcatheter Aortic Valve Replacement/adverse effects , Treatment OutcomeABSTRACT
BACKGROUND: Data on the performance of the latest-generation SAPIEN 3 Ultra RESILIA (S3UR) valve in patients who undergo transcatheter aortic valve replacement (TAVR) are scarce. AIMS: We aimed to assess the clinical outcomes, including valve performance, of the S3UR. METHODS: Registry data of 618 consecutive patients with S3UR and of a historical pooled cohort of 8,750 patients who had a SAPIEN 3 (S3) valve and underwent TAVR were collected. The clinical outcomes and haemodynamics, including patient-prosthesis mismatch (PPM), were compared between the 2 groups and in a propensity-matched cohort. RESULTS: The incidence of in-hospital death, vascular complications, and new pacemaker implantation was similar between the S3UR and the S3 groups (allp>0.05). However, both groups showed significant differences in the degrees of paravalvular leakage (PVL) (none-trivial: 87.0% vs 78.5%, mild: 12.5% vs 20.5%, ≥moderate: 0.5% vs 1.1%; p<0.001) and the incidence of PPM (none: 94.3% vs 85.1%, moderate: 5.2% vs 12.8%, severe: 0.5% vs 2.0%; p<0.001). The prevalence of a mean pressure gradient ≥20 mmHg was significantly lower in the S3UR group (1.6% vs 6.2%; p<0.001). Better haemodynamics were observed with the smaller 20 mm and 23 mm S3UR valves. The results were consistent in a matched cohort of patients with S3UR and with S3 (n=618 patients/group). CONCLUSIONS: The S3UR has equivalent procedural complications to the S3 but with lower rates of PVL and significantly better valve performance. The better valve performance of the S3UR, particularly in smaller valve sizes, overcomes the remaining issue of balloon-expandable valves after TAVR.
Subject(s)
Aortic Valve Stenosis , Aortic Valve , Heart Valve Prosthesis , Registries , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/methods , Female , Male , Aged, 80 and over , Aged , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/physiopathology , Treatment Outcome , Aortic Valve/surgery , Aortic Valve/physiopathology , Aortic Valve/diagnostic imaging , Prosthesis Design , Hemodynamics , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Hospital MortalityABSTRACT
Background: Few reports on pre-existing left bundle branch block (LBBB) in patients undergoing transcatheter aortic valve replacement (TAVR) are currently available. Further, no present studies compare patients with new onset LBBB with those with pre-existing LBBB. Objectives: This study aimed to investigate the association between pre-existing or new onset LBBB and clinical outcomes after TAVR. Methods: Using data from the Japanese multicenter registry, 5,996 patients who underwent TAVR between October 2013 and December 2019 were included. Patients were classified into 3 groups: no LBBB, pre-existing LBBB, and new onset LBBB. The 2-year clinical outcomes were compared between 3 groups using Cox proportional hazards models and propensity score analysis to adjust the differences in baseline characteristics. Results: Of 5,996 patients who underwent TAVR, 280 (4.6%) had pre-existing LBBB, while 1,658 (27.6%) experienced new onset LBBB. Compared with the no LBBB group, multivariable Cox regression analysis showed that pre-existing LBBB was associated not only with a higher 2-year all-cause (adjusted HR: 1.39; 95% CI: 1.06-1.82; P = 0.015) and cardiovascular (adjusted HR: 1.60; 95% CI: 1.04-2.48; P = 0.031) mortality, but also with higher all-cause (adjusted HR: 1.43, 95% CI: 1.07-1.91; P = 0.016) and cardiovascular (adjusted HR: 1.81, 95% CI:1.12-2.93; P = 0.014) mortality than the new onset LBBB group. Heart failure was the most common cause of cardiovascular death, with more heart failure deaths in the pre-existing LBBB group. Conclusions: Pre-existing LBBB was independently associated with poor clinical outcomes, reflecting an increased risk of cardiovascular mortality after TAVR. Patients with pre-existing LBBB should be carefully monitored.
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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.
Subject(s)
Aortic Valve Stenosis , Stroke Volume , Transcatheter Aortic Valve Replacement , Humans , Female , Transcatheter Aortic Valve Replacement/methods , Male , Aged, 80 and over , Prognosis , Aortic Valve Stenosis/surgery , Stroke Volume/physiology , Follow-Up Studies , Time Factors , Registries , Heart Failure/epidemiology , Japan/epidemiology , Survival Rate/trends , Retrospective Studies , Risk Factors , Aged , Risk Assessment/methodsABSTRACT
Intradialytic hypotension (IDH) is a common complication during hemodialysis that increases cardiovascular morbidity and mortality. Aortic stenosis (AS) is a cause of IDH. Transcatheter aortic valve replacement (TAVR) has become an established treatment for patients with severe AS. However, whether TAVR reduce the frequency of IDH has not been investigated. This study aims to verify the efficacy of TAVR for reduction of the frequency of IDH. Consecutive hemodialysis patients who underwent TAVR at Sendai Kosei Hospital from February 2021 to November 2021 with available records 1 month before and 3 months after TAVR were included in the study. IDH was defined as a decrease in systolic blood pressure by 20 mmHg or a decrease in the mean blood pressure by 10 mmHg associated with hypotensive symptoms or requiring intervention. Patients with ≥ 3 episodes of IDH in ten hemodialysis sessions comprised the IDH group. Overall, 18/41 (43.9%) patients were classified into the IDH group. In ten hemodialysis sessions, IDH events were observed 2.1, 4.3, and 0.4 times in the overall cohort, IDH group, and non-IDH group, respectively. After TAVR, the incidence of IDH decreased from 43.2 to 10.3% (p < 0.0001) and IDH improved significantly in 15 patients in the IDH group. The result suggested that severe AS was the major cause of IDH in this cohort, and TAVR may be an effective treatment option for reduction of the frequency of IDH in patients with severe AS.
Subject(s)
Aortic Valve Stenosis , Hypotension , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome , Renal Dialysis/adverse effects , Hypotension/etiology , Hypotension/surgery , Risk FactorsABSTRACT
OBJECTIVES: The clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis (AS) and concomitant active cancer remain insufficiently explored. This study aimed to assess the midterm outcomes of TAVR in patients diagnosed with AS and active cancer. METHODS: Data from the OCEAN-TAVI, a prospective Japanese registry of TAVR procedures, was analysed to compare prognoses and clinical outcomes in patients with and without active cancer at the time of TAVR. RESULTS: Of the 2336 patients who underwent TAVR from October 2013 to July 2017, 89 patients (3.8%) had active cancer, whereas 2247 did not. Among patients with active cancer, 49 had limited-stage cancer (stage 1 or 2). The prevalent cancers identified before TAVR were colon (21%), prostate (18%), lung (15%), liver (11%) and breast (9%). Although the periprocedural complications and 30-day mortality rates were comparable between the groups, the 3-year survival rate after TAVR was notably lower in patients with active cancer (64.7%) than in those without active cancer (74.7%; p=0.016). Nevertheless, the 3-year survival rate of patients with limited-stage cancer (stage 1 or 2) did not significantly differ from those without cancer (70.6% vs 74.7%, p=0.50). CONCLUSIONS: The patients with active cancer exhibited significantly reduced midterm survival rates. However, no distinct disparity existed in those with limited-stage cancer (stage 1 or 2). Although TAVR is a viable treatment in patients with AS with active cancer, the type and stage of cancer and prognosis should be carefully weighed in the decision-making process.
Subject(s)
Aortic Valve Stenosis , Neoplasms , Transcatheter Aortic Valve Replacement , Male , Humans , Transcatheter Aortic Valve Replacement/methods , Treatment Outcome , Prospective Studies , Time Factors , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Neoplasms/diagnosisABSTRACT
BACKGROUND: Individuals with heart failure displaying supra-normal left ventricular ejection fraction (snLVEF) may exhibit less favorable clinical outcomes in contrast to their counterparts with normal left ventricular ejection fraction (nLVEF). The distinctive characteristics and mid-term prognosis of individuals with severe aortic stenosis and snLVEF following transcatheter aortic valve replacement (TAVR) remain enigmatic. METHODS: Among 7393 patients diagnosed with severe aortic stenosis who underwent TAVR between 2013 and 2019 and were enlisted in the optimized transcatheter valvular intervention (OCEAN-TAVI) multicenter registry (UMIN000020423), we selected patients with left ventricular ejection fraction (LVEF) ≥ 50%. snLVEF was defined as LVEF exceeding 65%. We compared the baseline characteristics and assessed three-year post-TAVR mortality and heart failure readmission rates between the snLVEF (LVEF > 65%) and nLVEF cohorts (LVER 50-65%). RESULTS: Our study cohort comprised 5989 patients (mean age 84.4 ± 5.1 years and 1783 males). Among these, 2819 patients were categorized within the snLVEF cohort, while the remaining 3170 were allocated to the nLVEF group. Individuals within the snLVEF cohort were more likely to be female and displayed lower levels of natriuretic peptides, as well as smaller left ventricular dimensions in comparison to their nLVEF counterparts (p < 0.05 for all). The presence of snLVEF emerged as an independent predictor of the three-year composite endpoint relative to nLVEF, with an adjusted hazard ratio of 1.16 (95% confidence interval 1.02-1.31, p = 0.023) after accounting for several potential confounding factors. CONCLUSIONS: snLVEF was relatively common among candidates for TAVR with preserved ejection fraction. Patients harboring snLVEF appear to manifest a distinctive clinical profile and encounter less favorable clinical outcomes following TAVR in contrast to those characterized by nLVEF.
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BACKGROUND: Despite the wide implementation of transcatheter aortic valve implantation (TAVI), the optimal antithrombotic therapy after TAVI has not been established yet. Owing to the accumulating evidence supporting the efficacy and safety of single antiplatelet therapy (SAPT) over dual antiplatelet therapy, the latest guideline recommends life-long SAPT. However, there is scarce evidence supporting SAPT compared with non-antithrombotic therapy. Given the vulnerability of patients undergoing TAVI in terms of high bleeding risk, the benefit of SAPT may be canceled out by its potential increased bleeding risk. STUDY DESIGN AND OBJECTIVES: Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial is a prospective, randomized controlled, open-label blinded endpoint multicenter trial conducted in Japan, testing the non-inferiority of non-antithrombotic therapy compared with aspirin monotherapy in patients who underwent TAVI and had no indications for long-term oral anticoagulation therapy (OAC). Patients who successfully underwent trans-femoral TAVI for severe aortic stenosis with either balloon-expandable or self-expandable valves are eligible for inclusion. Key exclusion criteria are (i) occurrence of perioperative complications (ii) indications of taking antithrombotic drugs for other reasons; (iii) eGFR <30 ml/min/1.73 m2 or hemodialysis or peritoneal dialysis. A total of 360 patients will be randomized (1:1) to aspirin monotherapy vs. non-antithrombotic therapy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, and bleeding. All bleeding events based on the Valve Academic Research Consortium 3 are included as a component of the primary outcome. CONCLUSION: The NAPT trial will determine the non-inferiority of a non-antithrombotic therapy compared with aspirin monotherapy after TAVI.
Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Prospective Studies , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/drug therapy , Aortic Valve Stenosis/etiology , Aspirin/therapeutic use , Treatment OutcomeABSTRACT
Although interventional radiology (IVR) is preferred over surgical procedures because it is less invasive, it results in increased radiation exposure due to long fluoroscopy times and the need for frequent imaging. Nurses engaged in cardiac IVR receive the highest lens radiation doses among medical workers, after physicians. Hence, it is important to measure the lens exposure of IVR nurses accurately. Very few studies have evaluated IVR nurse lens doses using direct dosimeters. This study was conducted using direct eye dosimeters to determine the occupational eye dose of nurses engaged in cardiac IVR, and to identify simple and accurate methods to evaluate the lens dose received by nurses. Over 6 months, in a catheterization laboratory, we measured the occupational dose to the eyes (3 mm dose equivalent) and neck (0.07 mm dose equivalent) of nurses on the right and left sides. We investigated the relationship between lens and neck doses, and found a significant correlation. Hence, it may be possible to estimate the lens dose from the neck badge dose. We also evaluated the appropriate position (left or right) of eye dosimeters for IVR nurses. Although there was little difference between the mean doses to the right and left eyes, that to the right eye was slightly higher. In addition, we investigated whether it is possible to estimate doses received by IVR nurses from patient dose parameters. There were significant correlations between the measured doses to the neck and lens, and the patient dose parameters (fluoroscopy time and air kerma), implying that these parameters could be used to estimate the lens dose. However, it may be difficult to determine the lens dose of IVR nurses accurately from neck badges or patient dose parameters because of variation in the behaviors of nurses and the procedure type. Therefore, neck doses and patient dose parameters do not correlate well with the radiation eye doses of individual IVR nurses measured by personal eye dosimeters. For IVR nurses with higher eye doses, more accurate measurement of the radiation doses is required. We recommend that a lens dosimeter be worn near the eyes to measure the lens dose to IVR nurses accurately, especially those exposed to relatively high doses.
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Electrocardiogram (ECG) left ventricular hypertrophy (LVH) is associated with the prognosis of patients with aortic stenosis. However, the impact of the presence or absence of ECG-LVH on the clinical outcomes after transcatheter aortic valve implantation (TAVI) is limited. This study aimed to assess the prognostic value of ECG-LVH among patients with aortic stenosis treated by TAVI. A total of 1,667 patients who underwent TAVI were prospectively enrolled into the OCEAN-TAVI (Optimized CathEter vAlvular iNtervention-Transcatheter Aortic Valve Implantation) registry. A total of 1,446 patients (mean age 84 years; 29.9% men) were analyzed. The Sokolow-Lyon index was used to determine the presence of ECG-LVH. LVH was also assessed using transthoracic echocardiography (TTE). We investigated the association between ECG-LVH and all-cause and cardiovascular mortality. This study identified ECG-LVH and TTE-LVH in 743 (51.5%) and 1,242 patients (86.0%), respectively. The Kaplan-Meier analysis revealed that all-cause mortality was significantly higher among patients without ECG-LVH than among those with ECG-LVH (log-rank p <0.001). In the multivariable analysis, the absence of ECG-LVH was independently associated with all-cause mortality (hazard ratio 1.98, 95% confidence interval 1.39 to 2.82, p <0.001), regardless of the presence or absence of TTE-LVH. Furthermore, the presence of TTE-LVH with the absence of ECG-LVH was observed in 575 patients (40%), which was associated with cardiovascular mortality (hazard ratio 2.84, 95% confidence interval 1.56 to 5.17, p <0.001). In conclusion, the absence of ECG-LVH was independently associated with an increased risk of all-cause mortality after TAVI. Risk stratification using both ECG-LVH and TTE-LVH is a useful predictor of adverse clinical outcomes after TAVI.
Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Male , Humans , Aged, 80 and over , Female , Transcatheter Aortic Valve Replacement/adverse effects , Prognosis , Hypertrophy, Left Ventricular/diagnosis , Hypertrophy, Left Ventricular/epidemiology , Hypertrophy, Left Ventricular/etiology , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/complications , Registries , Aortic Valve/surgery , Treatment OutcomeABSTRACT
PURPOSE: Our objective was to evaluate the feasibility of performing endovascular therapy (EVT) for aortoiliac artery disease using transradial approach (TRA) as compared to transfemoral approach (TFA). METHODS: We analyzed 9671 cases with symptomatic lower extremity artery disease due to aortoiliac occlusive disease (AIOD) treated using EVT from a Japanese Nationwide EVT Registry between January and December 2021. We compared the baseline characteristics, procedural information, and 30-day outcomes of patients who received EVT only via TRA (n=863 [16.9%]) and those only via TFA (n=4255 [83.1%]) by using propensity score (PS) matching, after excluding those who required regular dialysis, those who underwent hybrid surgeries, and those who received EVT through 2 or more approach sites. RESULTS: After matching, the final study population consisted of 862 matched patients with similar baseline characteristics in each group. Technical success rate was comparable between the 2 groups (99.3% vs. 99.3%, p>0.99). No significant differences were observed with respect to the composite of all-cause death within 48 hours after EVT and post-procedural complications within 30 days, including severe bleeding that required transfusion, revascularization procedures, urgent surgeries, cerebral infarction, and major limb amputation (0.2% vs. 0.7%, p=0.29). Transradial approach was associated with shorter operation time (85 vs. 90 minutes, p=0.016), but longer fluoroscopy time (26 vs. 20 minutes, p<0.001) and higher contrast agent volume (80 vs. 75 mL, p<0.001). CONCLUSION: After PS matching, TRA showed the comparable rates of successful EVT and 30-day complications in patients with AIOD compared to TFA. Transradial approach was found to be safe and be a viable alternative of TFA for the treatment of AIOD. CLINICAL IMPACT: The efficacy of transradial approach (TRA) is established in percutaneous coronary intervention; however, its safety and feasibility are unclear in endovascular therapy (EVT). We analyzed 9,671 cases with symptomatic aortoiliac occlusive disease treated using EVT from a Nationwide Registry to compare the 30-day outcomes of those who received EVT only via TRA (n = 863 [16.9%]and those only via TFA (n=4,255 [83.1%]) by using propensity score matching. Technical success rate (99.3% vs. 99.3%, p > 0.99) and 30-day complications (0.2% vs. 0.7%, p = 0.29) were comparable between the two groups. EVT via TRA could be performed safely.
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Background: Drug-coated balloons (DCBs) and drug-eluting stents (DES) were available for treating femoropopliteal disease since 2017 and 2019. However, there are few reports to investigate whether approval of DCB and DES improved primary patency in clinical practice. Materials and Methods: We divided consecutive 407 patients into 2017 (n=93), 2018 (n=128), and 2019 (n=186) groups, undergoing endovascular therapy (EVT) for de novo femoropopliteal lesions in our hospital. We retrospectively compared clinical characteristics, procedure, and one-year patency between the three groups. Results: Baseline characteristics were not different except for the lower rate of popliteal lesions in 2017 (p=0.030). Use of DCB increased from 7.5% in 2017 to 38.7% in 2019, and use of DES from 0.0% in 2018 to 24.2% in 2019. One-year primary patency increased significantly both from 2017 to 2018 (62.7% vs. 70.8%, p=0.036) and from 2018 to 2019 (70.8% vs. 80.5%, p=0.025). Cox proportional multivariate analysis revealed that restenosis was independently associated with advanced age (p=0.036) and hemodialysis (p=0.003). Conversely, use of paclitaxel-based devices (p<0.001) and larger diameter of finalized devices (p=0.005) were protective factors against restenosis. Conclusion: One-year primary patency after EVT in femoropopliteal lesions was improved annually by utilizing DCB and DES, individually.
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BACKGROUND: Transcatheter aortic valve replacement (TAVR)-related coronary artery obstruction prediction remains unsatisfactory despite high mortality and novel preventive therapies. OBJECTIVES: This study sought to develop a predictive model for TAVR-related coronary obstruction in native aortic stenosis. METHODS: Preprocedure computed tomography and fluoroscopy images of patients in whom TAVR caused coronary artery obstruction were collected. Central laboratories made measurements, which were compared with unobstructed patients from a single-center database. A multivariate model was developed and validated against a 1:1 propensity-matched subselection of the unobstructed cohort. RESULTS: Sixty patients with angiographically confirmed coronary obstruction and 1,381 without obstruction were included. In-hospital death was higher in the obstruction cohort (26.7% vs 0.7%; P < 0.001). Annular area and perimeter, coronary height, sinus width, and sinotubular junction height and width were all significantly smaller in the obstructed cohort. Obstruction was most common on the left side (78.3%) and at the level of the coronary artery ostium (92.1%). Coronary artery height and sinus width, but not annulus area, were significant risk factors for obstruction by logistic regression but performed poorly in predicting obstruction. The new multivariate model (coronary obstruction IF cusp height > coronary height, AND virtual valve-to-coronary distance ≤4 mm OR culprit leaflet calcium volume >600 mm3) performed well, with an area under the curve of 0.93 (sensitivity = 0.93, specificity = 0.84) for the left coronary artery and 0.94 (sensitivity = 0.92, specificity = 0.96) for the right. CONCLUSIONS: A novel computed tomography-based multivariate prediction model that can be implemented routinely in real-world practice predicted coronary artery obstruction from TAVR in native aortic stenosis.