Size of Self-Expandable Transcatheter Heart Valve and Mid-Term Adverse Events After Transcatheter Aortic Valve Replacement.

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.

Successful intervention for decompensated heart failure with complicated pathophysiologies with complex interdependence: a case report.

Background: There is limited evidence regarding the optimal strategy for treating patients with acute decompensated heart failure complicated by severe left ventricular dysfunction, functional mitral regurgitation (FMR), and atrial septal defect (ASD) that cannot be controlled despite optimal medical treatment. Case summary: A 72-year-old man with non-ischaemic cardiomyopathy presented with acute heart failure and recurrent atrial fibrillation. An electrocardiogram after electrical cardioversion revealed left bundle block with QRS duration of 152 ms. Transthoracic echocardiography revealed severe left ventricular dysfunction, severe FMR, and a left-to-right shunt through an iatrogenic ASD (IASD). Despite initial optimal medical therapy for heart failure, the patient's condition was not completely controlled. After a discussion among the heart team, we performed cardiac resynchronization therapy (CRT) as the next strategy. Two weeks after CRT device implantation, heart failure was controlled, with improvement in cardiac function and FMR. The left-to-right shunts through the IASD also improved. Discussion: When treating decompensated heart failure with complicated pathophysiologies, it is crucial to prioritize the predominant pathophysiological factor and engage in thorough discussions with the heart team regarding the most appropriate intervention.

Performance and outcomes of the SAPIEN 3 Ultra RESILIA transcatheter heart valve in the OCEAN-TAVI registry.

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.

Pre-Existing Left Bundle Branch Block and Clinical Outcomes After Transcatheter Aortic Valve Replacement.

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.

Midterm outcomes of transcatheter aortic valve replacement in patients with active cancer.

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.

A case of ECPELLA-supported treatment for post-infarction cardiac rupture.

The efficacy and risk of a combination of veno-arterial extracorporeal membrane oxygenation and Impella (Abiomed, Inc., Danvers, MA, USA), an approach known as ECPELLA, for post-infarction cardiac rupture is unclear. We describe the case of a 72-year-old man who presented with acute myocardial infarction. The patient was managed with ECPELLA because of hemodynamic compromise. One week later, there was a sudden increase in venous oxygen saturation. Transthoracic echocardiography revealed ventricular septal rupture, and free wall rupture. Intraventricular thrombus was also observed despite standard anticoagulation therapy. Even with double cardiac rupture, ECPELLA could facilitate left ventricular unloading and sustain hemodynamics. However, because of the risk of device failure due to thrombus aspiration into the Impella, the patient underwent repair surgery. Postoperatively, the patient was temporarily weaned off ECPELLA, and his hemodynamics deteriorated again, and he finally died. Learning objectives: ECPELLA can effectively stabilize the hemodynamics in cases of post-infarction cardiac rupture. However, there are still challenges to address, such as determining optimal ventricular reloading and ECPELLA management for intraventricular thrombus prevention. When using ECPELLA to delay surgery for post-infarction cardiac rupture, it is crucial to strike a balance between hemodynamic stabilization and avoiding potential serious complications.

Clinical Implication of Supra-Normal Left Ventricular Ejection Fraction in Patients Undergoing Transcatheter Aortic Valve Replacement.

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.

Hindfoot Alignment and Ankle Stability Following Arthroscopic Lateral Ankle Ligament Repair.

BACKGROUND: Hindfoot varus deformity is a known risk factor for chronic lateral ankle instability (CLAI). The impact of this deformity on clinical results following arthroscopic lateral ankle ligament repair (ALLR) for CLAI has not been studied. METHODS: Sixty-three ankles from 62 patients who received ALLR for CLAI were retrospectively examined. Preoperative plain radiographs were used to measure tibial articular surface (TAS) angles, and long axial hindfoot alignment radiographs were used to measure tibiocalcaneal angles (TCAs) pre- and postoperatively. Results included ratings on the Self-Administered Foot Evaluation Questionnaire (SAFE-Q) and recurrent ankle instability (respraining of the operated ankle following surgery). RESULTS: Recurrent ankle instability, defined as incidence of any new ankle sprain after surgery reported in the follow-up period, occurred in 13 ankles. The TAS angles of these patients were significantly low, and their preoperative TCA was significantly high. Multivariate analysis showed that preoperative TCA was an independent risk factor for recurrent ankle instability. The threshold values for preoperative TCA for recurrent instability were determined via the receiver operating characteristic curve analysis to be 3.4 degrees. Patients were assigned to a low- or high-TCA group based on the reported average TCA (2.7 degrees) of healthy patients. In the high-TCA group, recurrent instability was significantly more frequent, and the scores on the pain subscale of the postoperative SAFE-Q were significantly lower. CONCLUSION: Hindfoot varus alignment was associated with pooreroutcomes after ALLR. LEVEL OF EVIDENCE: Level III, retrospective comparative study.

Addition of a Buccinator Musculomucosal Flap Improves Surgical Outcomes of Conventional two-Flap Palatoplasty: A Comparative Study.

OBJECTIVE: The surgical outcomes of novel two-flap palatoplasty adding a buccinator musculomucosal flap were compared with those of conventional two-flap palatoplasty to clarify the effects of lengthening the nasal mucosa of the soft palate using a BMMF in cleft lip and palate or cleft palate cases. DESIGN: Retrospective, comparative study. SETTING: Tertiary, cleft team. PATIENTS: Non-syndromic patients undergoing primary cleft palate repair using two-flap palatoplasty with BMMF (BMMF group) or conventional two-flap palatoplasty (non-BMMF group). INTERVENTIONS: Palatoplasty between January 2012 and March 2020. MAIN OUTCOME MEASURES: Perceptual Japanese speech evaluation, rate of an indication for additional speech surgery (AS), rate of incidence of oronasal fistula (IF) including spontaneously closing fistula, and rate of occurrence of oronasal fistula (OF) present for more than 3 months. RESULTS: Of 92 analyzed patients, 70 received two-flap palatoplasty with BMMF and 22 received two-flap palatoplasty. In the BMMF and non-BMMF groups, the respective percentage of hypernasality (no, mild) was 91.4% and 77.2%, no nasal emission was 71.4% and 63.6%, velopharyngeal function (competent, borderline competent) was 83.7% and 77.4%, intelligibility (very good, good) was 93.7% and 86.4%, AS was 1.4% and 13.6%, IF was 7.1% and 36.4%, and OF was 1.4% and 9.1%. Significant improvements were observed for AS (p = 0.0412) and IF (p = 0.00195) in the BMMF group, with no recorded major adverse effects. CONCLUSION: Adding a BMMF on the nasal side of the soft palate to conventional two-flap palatoplasty significantly improved postoperative outcomes. This approach may therefore be a good option for cleft palate treatment.

Anterior talofibular ligament remnant quality is important for achieving a stable ankle after arthroscopic lateral ankle ligament repair.

PURPOSE: The relationship between ligament remnant quality and postoperative outcomes after arthroscopic lateral ankle ligament repair for chronic lateral ankle instability is controversial. This study aimed to determine whether the signal intensity of the anterior talofibular ligament on preoperative magnetic resonance imaging and ligament remnant quality identified on arthroscopy are associated with recurrent ankle instability after arthroscopic lateral ankle ligament repair. METHODS: A total of 68 ankles from 67 patients with chronic lateral ankle instability who underwent arthroscopic lateral ankle ligament repair were retrospectively studied. The signal intensity of the anterior talofibular ligament was evaluated using T2-weighted magnetic resonance imaging. Arthroscopy was used to evaluate the thickness and mechanical resistance of the anterior talofibular ligament by hook palpation and to classify ankles into two groups: the present anterior talofibular ligament group with adequate mechanical resistance and the absent anterior talofibular ligament group with no mechanical resistance. The outcomes included recurrent ankle instability (respraining of the operated ankle after surgery) and Self-Administered Foot Evaluation Questionnaire scores. RESULTS: Thirteen ankles were diagnosed with recurrent ankle instability. Patients with a high anterior talofibular ligament T2 signal intensity experienced more recurrent ankle instability than those with a low intensity. As determined via arthroscopy, the absent anterior talofibular ligament group had a higher rate of recurrent ankle instability than the present anterior talofibular ligament group. There were no significant differences in Self-Administered Foot Evaluation Questionnaire scores between patients with high and low anterior talofibular ligament T2 signal intensity, as well as between absent and present anterior talofibular ligament groups based on arthroscopy. CONCLUSION: Poor quality of the anterior talofibular ligament remnant could result in recurrent ankle instability after arthroscopic lateral ankle ligament repair. Therefore, when treating chronic lateral ankle instability, surgeons should consider ligament quality. LEVEL OF EVIDENCE: IV.

Impact of Nonobstructive Left Main Coronary Artery Atherosclerosis on Long-Term Mortality.

BACKGROUND: Although the presence of severe stenosis in the left main coronary artery (LMCA) is a well-established predictor of mortality, whether this extends to nonobstructive atherosclerosis in the LMCA is unknown. OBJECTIVES: The aim of this study was to evaluate the association between LMCA disease by intravascular ultrasound (IVUS) and long-term mortality. METHODS: Between 2005 and 2013, 3,239 patients with LMCA IVUS imaging without LMCA revascularization (either before angiography or scheduled based on index angiography or IVUS) were included. The primary and secondary endpoints were all-cause and cardiac mortality at a minimum of 5 years obtained from the National Death Index. RESULTS: The IVUS-measured LMCA minimum lumen area (MLA) and plaque burden were 13.1 ± 5.0 mm2 and 41.7% ± 15.6%, respectively. The median follow-up was 8.2 years. The Kaplan-Meier estimated 12-year all-cause and cardiac death rates were 37.5% and 17.0%, respectively. Greater plaque burden (unadjusted HR per 10%: 1.17; 95% CI: 1.12-1.22; P < 0.0001) and smaller IVUS MLA (unadjusted HR per 1 mm2: 0.98; 95% CI: 0.96-0.99; P = 0.0008) were associated with all-cause death. After adjusting for clinical, angiographic, and IVUS factors, plaque burden (adjusted HR per 10%: 1.12; 95% CI: 1.04-1.21; P = 0.003) but not MLA (adjusted HR per 1 mm2: 1.02; 95% CI: 0.99-1.04; P = 0.18) was associated with long-term all-cause death. These findings were also consistent for long-term cardiac mortality. CONCLUSIONS: In the present large-scale study with a 12-year follow-up, increasing LMCA plaque burden was associated with long-term all-cause and cardiac mortality in patients not undergoing LMCA revascularization, even when the lumen area was preserved.

Prevalence and Impact of Neoatherosclerosis on Clinical Outcomes After Percutaneous Treatment of Second-Generation Drug-Eluting Stent Restenosis.

BACKGROUND: Clinical and morphological factors associated with lipidic versus calcified neoatherosclerosis within second-generation drug-eluting stents and the impact of lipidic versus calcified neoatherosclerosis on long-term outcomes after repeat intervention have not been well studied. METHODS: A total of 512 patients undergoing optical coherence tomography before percutaneous coronary intervention for second-generation drug-eluting stents in-stent restenosis were included. Neoatherosclerosis was defined as lipidic or calcified neointimal hyperplasia in ≥3 consecutive frames or ruptured lipidic neointimal hyperplasia. The primary outcome was target lesion failure (cardiac death, target vessel myocardial infarction, definite stent thrombosis, or clinically driven target lesion revascularization). RESULTS: The overall prevalence of neoatherosclerosis was 28.5% (146/512): 56.8% lipidic, 30.8% calcified, and 12.3% both lipidic and calcific. The prevalence increased as a function of time from stent implantation: 20% at 1 to 3 years, 30% at 3 to 7 years, and 75% >7 years. Renal insufficiency, poor lipid profile, and time from stent implantation were associated with lipidic neoatherosclerosis, whereas severe renal insufficiency, female sex, and time from stent implantation were associated with calcified neoatherosclerosis. Multivariable Cox regression revealed that female sex and lipidic neoatherosclerosis were associated with more target lesion failure, whereas stent age and final minimum lumen diameter after reintervention were related to lower target lesion failure. Calcified neoatherosclerosis was not related to adverse events after reintervention for in-stent restenosis given a large enough minimum lumen diameter was achieved. CONCLUSIONS: Lipidic but not calcified neoatherosclerosis was associated with poor subsequent outcomes after repeat revascularization if optimal stent expansion was achieved in lesions with calcified neoatherosclerosis.

Varus-Tilted Distal Tibial Plafond Is a Risk Factor for Recurrent Ankle Instability After Arthroscopic Lateral Ankle Ligament Repair.

BACKGROUND: Although varus-tilted distal tibial deformity is an established risk factor for chronic lateral ankle instability (CLAI), no studies have reported whether this deformity influences ankle instability after arthroscopic lateral ankle ligament repair (ALLR) for CLAI. METHODS: A total of 57 ankles from 57 patients who underwent ALLR for CLAI were retrospectively analyzed. Tibial articular surface (TAS) angles were measured on preoperative plain radiograph. After 12 months of follow-up, recurrent ankle instability and talar tilt angles on stress radiograph were evaluated as outcomes. Relationships between the TAS angle and these outcomes were assessed. RESULTS: Recurrent ankle instability was observed in 10 ankles. The TAS angles of patients with recurrent instability were significantly lower (85.2 degrees vs 87.9 degrees). The receiver operating characteristic curve analysis revealed that the cutoff value of TAS angle for recurrent instability was 86.2 degrees. Based on this cutoff value, our patients were divided into 2 groups: low-TAS and high-TAS group. Univariate and multivariate analysis revealed that low TAS was an independent risk factor for recurrent ankle instability and greater postoperative talar tilt angles. CONCLUSION: Varus-tilted distal tibial plafond appears to be a risk factor for recurrent ankle instability after ALLR.

Reasons for lesion uncrossability as assessed by intravascular ultrasound.

OBJECTIVES: The purpose of the current study was to use intravascular ultrasound (IVUS) to clarify anatomical and morphological lesion characteristics of uncrossable lesions. BACKGROUND: Uncrossable lesions are not always severely calcified. The prevalence of uncrossable lesions that are nonseverely calcified as well as other mechanisms for uncrossability has not been well clarified. METHODS: A total of 252 de novo uncrossable lesions in native coronary arteries that underwent either rotational or orbital atherectomy due to inability of any balloon to cross the lesion and 38 lesions with severe calcium in which IVUS crossed preatherectomy were included. Severe calcium is defined as maximum arc of calcium ≥270°. RESULTS: Severe calcification was absent in 16% of uncrossable lesions, 83% of which had a significant vessel bend. Compared with crossable lesions with severe calcium, uncrossable lesions with severe calcium more often had a bend in the vessel (71% vs. 21%, p < 0.001) and a longer length of continuous severe calcium (median length of calcium ≥270° 3.8 mm vs. 1.9 mm, p = 0.001). Other than severe calcium (especially long continuous calcium) or a bend in the vessel, anatomical factors associated with uncrossabilty were aorto-ostial lesion location and small vessels. CONCLUSIONS: Uncrossable lesions are not always severely calcified. The interaction of lesion morphology (continuous long and large arcs of calcium) and vessel geometry (bend in the vessel or ostial lesion location) affect lesion crossability.

Percutaneous Coronary Intervention Strategy for Spontaneous Coronary Artery Dissection of Left Main Coronary Artery with Extensive Intramural Hematoma in the Main Side Branch.

A 46-year-old pregnant woman, presented with worsening episodes of intermittent chest pain. The patient was diagnosed with a non-ST-elevation myocardial infarction. On arrival, she had a stable hemodynamic status without chest pain. She was initially treated with conservative medical therapy. One day later, she complained of severe chest pain, and an electrocardiogram showed ST elevation in leads I, aVL, and V2-5. Emergency coronary angiography showed total occlusion of the left anterior descending artery (LAD) and intermediate stenosis of the left main coronary artery (LMCA). The intravascular ultrasound (IVUS) revealed an intramural hematoma (IMH) from the LMCA to the LAD, extending to the left circumflex artery (LCX) ostium. This finding was consistent with spontaneous coronary artery dissection (SCAD). After stent implantation from the LMCA to the LAD, severe stenosis was noted at the proximal site of the LCX. IVUS showed that the IMH extended to the LCX. The provisional crush stent technique was performed, and the final angiography revealed satisfactory results with thrombolysis in myocardial infarction flow grade 3 in the LAD and LCX. This case report highlighted that stent implantation in the SCAD lesions facilitated the extension of the IMH longitudinally and laterally into the side branch, resulting in stenosis or occlusion. Therefore, the side branch should be evaluated using IVUS before stent implantation. In cases where the IMH extends to the ostium of the side branch, two-stent techniques that do not require guidewire recrossing, such as crush stents, should be considered to avoid side branch occlusion.

Revascularization strategies in patients with diabetes and stable ischemic heart disease: a systematic review and meta-analysis of randomized trials.

AIMS: The optimal treatment strategy comparing invasive revascularization versus optimal medical therapy (OMT) in patients with diabetes mellitus (DM) and stable ischemic heart disease (SIHD) still remains unclear. We aimed to investigate clinical outcomes of invasive revascularization (percutaneous coronary intervention, coronary artery bypass grafting or both) versus OMT in patients with DM and SIHD from updated published randomised-controlled trials (RCTs). METHODS: We conducted a comprehensive literature search through PubMed and EMBASE to investigate the effect of revascularization versus OMT for patients with DM and SIHD. The studies were limited to RCTs or their subgroup data for a meta-analysis. The outcomes of interest were major adverse cardiovascular events (MACE) in patients with DM and SIHD. RESULTS: Our search identified subgroup data with DM of four RCTs including a total of 5742 patients with SIHD. Our results showed that invasive revascularization was not associated with a decreased risk of MACE when compared to OMT [hazard ratio (95% confidence interval): 0.95 (0.85-1.05), P = 0.31; I2 = 0%]. CONCLUSION: Invasive revascularization was not associated with a decreased risk of MACE when compared with OMT.

Clinical outcomes in nonagenarians undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis.

To compare the risk of procedural complications and mortality after transcatheter aortic valve implantation (TAVI) in nonagenarians (age ≥ 90 years) compared to younger patients (< 90 years). Although TAVI could be considered as a treatment option in nonagenarians, several previous studies have shown conflicting outcomes between nonagenarians and younger patients who underwent TAVI. We conducted a comprehensive literature search through PubMed and EMBASE to investigate the clinical outcomes of nonagenarians after TAVI. The outcomes of interest were short- and long-term mortality and procedural complications. Our study identified 16 observational studies including a total of 179,565 patients (21,674 nonagenarian patients and 157,891 younger patients. Nonagenarians had a significantly higher rate of short- (hazard ratio [HR], 95% confidence interval [CI]: 1.48, 1.38-1.59; P < 0.001) and long-term mortality (HR, 95% CI: 1.34, 1.24-1.44; P < 0.001) than younger patients after TAVI. Furthermore, there were significant differences in major and/or life-threatening bleeding (risk ratio [RR], 95% CI: 1.21, 1.05-1.39; P = 0.008), stroke (HR, 95% CI: 1.24, 1.11-1.40; P < 0.001), and major vascular complication (RR, 95% CI: 2.15, 1.35-3.42; P = 0.001) between nonagenarians and younger patients after TAVI. Minor vascular complication, myocardial infarction and permanent pacemaker implantation rate were similar between the two groups. Nonagenarians had significantly higher rate of short- and long-term mortality, major and/or life-threatening bleeding, stroke, and major vascular complication after TAVI. Although TAVI is a treatment option in nonagenarians, careful and appropriate selection of patients is essential to improve clinical outcomes.

How does the postoperative medial arch height influence the patient reported outcomes of stage â ¡ acquired adult flatfoot deformity?

BACKGROUND: This study aimed to assess how the postoperative medial arch height influenced postoperative patient-reported clinical outcomes after surgery for stage Ⅱ acquired adult flatfoot deformity. METHODS: A total of 30 feet of 30 patients (7 males, 23 females) who underwent surgery for stage Ⅱ acquired adult flatfoot deformity and could be followed up for at least 2 years were included. The average age at surgery was 60.0 (standard deviation, 13.0) years, and the average follow-up period was 40 (standard deviation, 15.4) months. Among them, 16 patients underwent lateral column lengthening and 14 patients did not. Patient-reported clinical outcomes were evaluated using the Self-Administered Foot Evaluation Questionnaire. Radiographic alignment was evaluated by the talonavicular coverage angle, lateral talo-1st metatarsal angle, medial cuneiform height, medial cuneiform to 5th metatarsal height, and calcaneal pitch. The correlation between postoperative Self-Administered Foot Evaluation Questionnaire and radiographic alignment was assessed with Pearson's correlation analysis. RESULTS: Self-Administered Foot Evaluation Questionnaire and radiographic alignment significantly improved postoperatively in all patients (P < 0.0001). In patients with severe deformity who needed lateral column lengthening, lateral talo-1st metatarsal angle was negatively and medial cuneiform to 5th metatarsal height was positively correlated with physical functioning Self-Administered Foot Evaluation Questionnaire subscales (r = -0.56 and 0.55), and medial cuneiform height was positively correlated with physical functioning, social functioning and general health Self-Administered Foot Evaluation Questionnaire subscales (r = 0.70, 0.55 and 0.73, respectively). CONCLUSION: Postoperative medial arch height could influence physical functioning, social functioning, and general health in patients with severe stage II adult-acquired flatfoot deformity.

Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement.

BACKGROUND: It is controversial that cerebral embolic protection devices (CEPDs) reduce clinical stroke during transcatheter aortic valve replacement (TAVR). Herein, we investigated the impact of CEPDs on in-hospital clinical stroke using a nationally representative sample. METHODS AND RESULTS: Using the National Inpatient Sample (NIS) database, 109,240 patients who underwent TAVR between 2017 and 2018 were included. They were categorized into 2 groups according to usage of CEPDs; the CEPD and non-CEPD groups. After propensity score matching, 3805 pairs were acquired. Our main outcome was in-hospital clinical stroke. Other outcomes were in-hospital mortality, acute kidney injury (AKI), AKI leading to hemodialysis, bleeding requiring transfusion, overall bleeding complications, infectious complications, length of stay, and total cost. In-hospital clinical stroke did not significantly differ between the 2 groups (0.7% versus 1.1%, p = 0.449). The CEPD group was associated with a significantly lower in-hospital mortality (0.5% versus 1.4%, p = 0.029) and reduced total cost ($49,047 ± 19,666 versus $50,051 ± 23,190, p < 0.001), compared with the non-CEPD group, whereas there were no significant differences in the other outcomes. CONCLUSIONS: By using the NIS database with a large number of cases, TAVR with CEPDs was not associated with a lower incidence of in-hospital clinical stroke compared with no use of CEPDs after matching.