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.

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.

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.

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.

The Palatal Fistula Closure Using Buccal Fat Graft After Palatoplasty for Cleft Palate: Two Case Reports.

Fistula recurrence is high after secondary follow-up operation to close the fistula after primary palatal surgery. Therefore, preventing fistula recurrence is important. Here, we describe the technique of closing palatal fistula after palatal surgery with a buccal fat graft in 2 cases. We elevate the mucosal flap around the palatal fistula, suture the nasal mucosa, transplant the buccal fat between the nasal and oral mucosa for the palatal fistula after palatal surgery, and suture the oral mucosa. Palatal fistula did not recur after surgery. This method is simple and useful for suturable fistula and does not require a local flap.

Comparison of 6-month vascular healing response after bioresorbable polymer versus durable polymer drug-eluting stent implantation in patients with acute coronary syndromes: A randomized serial optical coherence tomography study.

OBJECTIVES: This study was conducted to use optical coherence tomography (OCT) to compare vascular healing between bioresorbable polymer (BP) and durable polymer (DP) everolimus-eluting stents (EES) in patients with acute coronary syndromes (ACS). BACKGROUND: Whether BP-EES induce better vascular healing compared to contemporary DP-EES remains controversial, especially for ACS. METHODS: In this prospective, randomized, non-inferiority trial, we used OCT to compare 6-month vascular healing in patients with ACS randomized to BP versus DP-EES: percent strut coverage (primary endpoint, non-inferiority margin of 2.0%) and neointimal thickness and percent neointimal hyperplasia (NIH) volume. As an exploratory analysis, morphological factors related to the endpoints and the effect of underlying lipidic plaque on stent healing were evaluated. RESULTS: A total of 104 patients with ACS were randomly assigned to BP-EES (n = 52) versus DP-EES (n = 52). Of these, 86 patients (40 BP-EES and 46 DP-EES) were included in the final OCT analyses. Six-month percent strut coverage of BP-EES (83.6 ± 11.4%) was not non-inferior compared to those of DP-EES (81.6 ± 13.9%), difference 2.0% (lower 95% confidence interval-2.6%), pnon-inferiority  = 0.07. There were no differences in neointimal thickness 70.0 ± 33.9 µm versus 67.2 ± 33.9 µm, p = 0.71; and percent NIH volume 7.5 ± 4.7% versus 7.3 ± 5.3%, p = 0.85. By multivariable linear regression analysis, stent type was not associated with percent strut coverage or percent NIH volume; however, percent baseline embedded struts or stent expansion was positively associated with percent NIH volume. Greater NIH volume was observed in lipidic compared with non-lipidic segments (8.7 ± 5.6% vs. 6.1 ± 5.2%, p = 0.005). CONCLUSIONS: Six-month strut coverage of BP-EES was not non-inferior compared to those of DP-EES in ACS patients. Good stent apposition and expansion were independently associated with better vascular healing.

Clinical outcomes of transcatheter aortic valve implantation (TAVI) in nonagenarians from the optimized catheter valvular intervention-TAVI registry.

OBJECTIVES: The purpose of this study was to investigate 30-day and 2-year clinical outcomes, and predictors of 2-year mortality in nonagenarians undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: TAVI has been applied to nonagenarians. However, sufficient clinical data in nonagenarians who could benefit from TAVI are limited. METHODS: We evaluated the data from the optimized catheter valvular intervention-TAVI registry. Clinical outcomes were compared between patients' age ≥90 years and age <90 years. Predictive factors of 2-year mortality were assessed by multivariable Cox regression analyses. RESULTS: From October 2013 to May 2017, a total of 375 nonagenarians (age ≥90 years) and 2,213 younger patients (age <90 years) were included. Although nonagenarians had a higher surgical risk score, 30-day clinical outcomes were similar between two groups. There were no significant differences in 2-year mortality (22.0% vs. 17.3%; p = .11) and stroke (5.5% vs. 3.9%; p = .31); however, 2-year heart failure readmission was higher in nonagenarians (13.3% vs. 9.0%; p = .03). After adjusting covariates, age ≥90 years was not independent predictor for 2-year outcomes. In nonagenarians, female sex (hazard ratio [HR] = 0.43; 95% confidence interval [CI] = 0.26-0.74; p = .002), chronic kidney disease grade ≥4 (HR = 2.14; 95% CI = 1.21-3.64; p = .01), and Clinical Frailty Scale ≥4 (HR = 1.82; 95% CI = 1.02-3.42; p = .04) were independently associated with 2-year mortality. CONCLUSIONS: Clinical outcomes of TAVI in selected nonagenarians were favorable. Severe renal dysfunction and frailty may be important factors to predict mid-term mortality after TAVI in nonagenarians.

Network meta-analysis of treatment strategies in patients with coronary artery disease and low left ventricular ejection fraction.

OBJECTIVE: The optimal treatment strategy in patients with coronary artery disease (CAD) and low left ventricular ejection fraction (LVEF) remains controversial. Herein, we conducted a network meta-analysis comparing coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), and optimal medical therapy (OMT) in patients with CAD and low LVEF. METHODS: MEDLINE and EMBASE were searched through March, 2021 to identify randomized controlled trials (RCTs) and propensity-score matched (PSM) studies comparing CABG, PCI, and OMT. We extracted hazard ratios (HRs) of the outcomes. RESULTS: A total of three RCTs and 10 PSM trials were identified, yielding a total of 18,855 patients with CAD with low EF who were treated with CABG (n = 9241), PCI (n = 8771), or OMT (n = 1003). All-cause mortality was significantly lower in patients with CABG compared with those with PCI or OMT (HR [95% confidence interval (CI)] = 0.72 [0.62-0.82], p < .001, HR [95% CI] = 0.65 [0.51-0.82], p = .004, respectively), while no difference was observed between PCI and OMT. The rates of MI were significantly lower in patients treated with CABG compared to those treated with PCI or OMT. However, the subgroup analysis by limiting the PCI group to patients who received drug-eluting stent (DES) showed similar all-cause mortality between CABG and PCI, while both CABG and PCI were associated with lower all-cause mortality compared with OMT. CONCLUION: The present study demonstrated that CABG was the appropriate treatment strategy in patients with CAD and low LVEF. Further long-term trials were warranted to investigate outcomes of PCI with DES compared with CABG.

Oronasal Transfixion Suture to Prevent Uplifted Nasal Floor Deformity in Cleft Lip and Palate Patients: A 5-Year Follow-Up.

OBJECTIVE: In unilateral cleft lip and palate, the reconstructed nasal floor is sometimes uplifted regardless of the reconstructive method used. We used a 5-0 absorbable anchoring suture, the oronasal transfixion suture (ONT suture), to fasten the reconstructed nasal floor to the orbicularis oris muscle to prevent this deformity. This study was performed to evaluate the effects of the ONT suture. DESIGN: Blind retrospective study of photography and chart review. SETTING: Shinshu University Hospital, tertiary care, Nagano, Japan. Private practice. PATIENTS: Ninety-three consecutive patients with unilateral complete cleft lip and palate who had undergone primary nasolabial repair in our department and affiliated hospitals between 1999 and 2011 participated in this study. Finally, 45 patients were included. INTERVENTIONS: The ONT suture was put in place at the time of primary nasolabial repair. MAIN OUTCOME MEASURE: The height of the nasal floor was evaluated on submental view photographs at 5 years old. RESULTS: The ONT suture was applied in 21 patients. The height of the nasal floor on the cleft side was significantly closer to that on the noncleft side with the ONT suture than without the ONT suture ( P = .008). CONCLUSIONS: The ONT suture is effective to prevent uplifted nasal floor deformity on the cleft side// in unilateral complete cleft lip and palate at the time of primary nasolabial repair.

A Foxtail-Shaped Vermilion Flap to Reconstruct the Medial Tubercle in Asymmetric Bilateral Cleft Lip With Contralateral Lesser Form Defect.

OBJECTIVE: There have been few reports addressing asymmetric bilateral cleft lip repair with contralateral lesser form defects. Two studies have described the thin medial tubercle as the most common remaining labial deformity. In this study, we aimed to evaluate the use of a foxtail-shaped vermilion flap to reconstruct the median tubercle in primary repair. DESIGN: A blinded retrospective study of photography and chart review. SETTING: Shinshu University Hospital, tertiary care. Private practice. PATIENTS: Forty-nine patients with asymmetric bilateral cleft lip with lesser form defects treated using a primary "unilateral" repair by the senior author (S.Y.) between 2007 and 2017. INTERVENTIONS: The foxtail-shaped vermilion flap was applied at the time of the primary nasolabial repair. This flap is similar to Noordhoff laterally based triangular vermilion flap but with modifications to the shape and length. The body of the flap is wider than the pedicle to add tissue to the center of the vermilion, and the length is sufficiently elongated to reach the lesser side. MAIN OUTCOME MEASURE: Lip shape was graded on a 4-point scale when patients were 1 year old. RESULTS: Twenty-two patients were treated with the foxtail-shaped vermilion flap (group A) and 27 patients with Noordhoff triangular vermilion flap (group B). Group A had a better lip shape than group B (P = .006). CONCLUSIONS: The foxtail-shaped vermilion flap is useful to reconstruct the median tubercle in asymmetric bilateral cleft lip repair with contralateral lesser form defects.

Safety and efficacy of noncardiac surgical procedures in the management of patients with trisomy 13: A single institution-based detailed clinical observation.

Intensive treatment including surgery for patients with trisomy 13 (T13) remains controversial. This study aimed to evaluate the safety and efficacy of noncardiac surgical intervention for T13 patients. Medical records of patients with karyotypically confirmed T13 treated in the neonatal intensive care unit in Nagano Children's Hospital from January 2000 to October 2016 were retrospectively reviewed, and data from patients who underwent noncardiac surgery were analyzed. Of the 20 patients with T13, 15 (75%) underwent a total of 31 surgical procedures comprising 15 types, including tracheostomy in 10 patients and gastrostomy in 4. Operative time, anesthesia time, and amount of bleeding are described for the first time in a group of children with T13. All the procedures were completed safely with no anesthetic complications or surgery-related death. The overall rate of postoperative complications was 19.3%. Patients receiving tracheostomy had stable or improved respiratory condition. Six of them were discharged home and were alive at the time of this study. These results suggest at least short-term safety and efficacy of major noncardiac surgical procedures, and long-term efficacy of tracheostomy on survival or respiratory stabilization for home medical care of children with T13. Noncardiac surgical intervention is a reasonable choice for patients with T13.

Modifiable factors associated with prolonged door to balloon time in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Door to balloon (D2B) time was reported an important factor of the clinical outcome of patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI). D2B time is influenced by various factors; however, modifiable factors have not been adequately evaluated. The purpose of this study was to identify modifiable factors associated with prolonged D2B time. We historically included 239 consecutive STEMI patients who visited emergency department and underwent primary PCI between April 2013 and September 2016. We evaluated baseline characteristics, mode and timing of hospital arrival, symptoms and signs, treatment times and angiographic characteristics. Patients with D2B time > 90 min were compared with those with D2B time ≤ 90 min. Modifiable factors associated with prolonged D2B time (> 90 min) were analyzed by multivariable logistic regression model. The median D2B time for the entire cohort was 69 min (interquartile range 54-89) and 24% had a D2B time of > 90 min. Modifiable factors associated with prolonged treatment time (D2B time > 90 min) were electrocardiogram (ECG) to puncture time > 50 min [odds ratios (OR) 96.0, 95% confidence intervals (95% CI) 25.1-652.5, P < 0.0001), door to ECG time > 10 min (OR 49.8, 95% CI 11.8-357.5, P < 0.0001), and puncture to balloon time > 30 min (OR 48.5, 95% CI 12.0-333.8, P < 0.0001). ECG to puncture time > 50 min was the most important modifiable factor associated with prolonged D2B time in STEMI patients.

Preoperative Treatment With Pazopanib in a Case of Chemotherapy-Resistant Infantile Fibrosarcoma.

Clinical and radiological diagnosis of infantile fibrosarcoma (IFS) is challenging because of its similarity to vascular origin tumors. Treatment involves complete resection. Although chemotherapy may allow more conservative resection, treatment guidelines are not strictly defined. One IFS patient with an unresectable tumor had disease progression during chemotherapy. A primary tumor sample showed high VEGFR-1/2/3 and PDGFR-α/ß expression. After pazopanib therapy, most tumor showed necrosis within 29 days and could be removed completely, with no relapse in 8 months post-resection. When IFS features hypervascularity, VEGFR and PDGFR expression may be high, thus allowing consideration of VEGFR inhibitors such as pazopanib.

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.

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.

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.

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.

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.

Initial Results of Intra-Annular Self-Expandable Valves: Insights From the OCEAN-TAVI Registry.

Background: Navitor, an intra-annular self-expanding heart valve (IA-SEV), is the third transcatheter heart valve introduced in Japan (in April 2022) as the next generation of the Portico valve ahead of other Asian countries. Objectives: The purpose of this study was to assess the patient-prosthesis mismatch (PPM) after IA-SEV implantation in Asian patients. Methods: All clinical data were collected from the database of an ongoing prospective Japanese multicenter registry (OCEAN-TAVI [Optimised Catheter Valvular Intervention transcatheter aortic valve implantation]). The primary endpoint was the rate of no PPM; the secondary endpoint included the rate of in-hospital mortality and hemodynamics after IA-SEV implantation. Results: A total of 463 patients (median age 86; 69.7% female) were enrolled in the registry. The percentages of implanted valves sized 23 mm, 25 mm, 27 mm, and 29 mm were 26.1% (n = 121), 41.7% (n = 193), 22.9% (n = 106), and 9.3% (n = 43), respectively. The primary endpoint of no PPM was achieved in 91.7% of the entire cohort and in 87.3%, 94.2%, 91.4%, and 93.0% of each valve size. The rate of in-hospital mortality was 1.9%. Postprocedural mean pressure gradient was 8.3 ± 4.3 mm Hg. The overall rate of pacemaker implantation was 9.7%; the incidence of pacemaker rate tended to be reduced when dividing the first and second half of operator experiences (13.0% vs. 8.0%; P = 0.08). Conclusions: The initial results for the IA-SEV were excellent regarding hemodynamics and reduction of paravalvular leakage regardless of valve size. The IA-SEV is a useful transcatheter heart valve, especially for Asian patients with a high prevalence of small annulus.