[Endovascular Repair of Aortic Injury Caused by Esophageal Foreign Body:Report of a Case].

A 51-year-old man visited to our hospital because of chest discomfort and hematemesis. He was diagnosed with Mallory-Weiss syndrome and followed in outpatient clinic. One week later, he visited our hospital again for fever and discomfort. Chest computed tomography (CT) showed a foreign body perforated in the mediastinum in the upper esophagus, and he was urgently hospitalized for surgical removal of esophageal foreign body. Before surgery he vomited the esophageal foreign body with a lot of blood. Hematemesis was stopped spontaneously and contrast-enhanced CT revealed a pseudoaneurysm in the distal aortic arch, so thoracic endovascular aortic repair (TEVAR) was performed to prevent rupture. Esophageal endoscopy found that the site of esophageal injury healed spontaneously, so the patient was followed conservatively with antibiotics. He was discharged on postoperative day 18 uneventfully. TEVAR was an effective treatment for aortic injury caused by esophageal foreign body in our case.

Learning Curve for Transcatheter Aortic Valve Implantation Under a Controlled Introduction System　- Initial Analysis of a Japanese Nationwide Registry.

BACKGROUND: The introduction of transcatheter aortic valve implantation (TAVI) into Japan was strictly controlled to optimize patient outcomes. The goal of this study was to assess if increasing experience during the introduction of this procedure was associated with outcomes.Methods and Results:The initial 1,752 patients registered in the Japanese national TAVI registry were included in the study. The association between operator procedure number and incidence of the early safety endpoint at 30 days (ESE30) as defined in the Valve Academic Research Consortium-2 consensus document was evaluated. Patients were divided into 4 groups by quartiles of procedure count (Groups I-IV in order of increasing number of procedures). Median patient age was 85 years, and 30.5% were male. The 30-day mortality rate was 1.4% (n=24), and 78 patients (7.9%) experienced 95 ESE30. Among the variables included in the model, ESE30 was associated with non-transfemoral approach (P=0.004), renal dysfunction (Cr >2.0 mg/dL) (P=0.01) and NYHA class III/IV (P=0.04). ESE30 incidence was not significantly different between Groups I-III and Group IV. Spline plots demonstrated that experience of 15-20 cases in total was needed to achieve a consistent low risk of ESE30. CONCLUSIONS: Increasing experience was associated with better outcomes, but to a lesser degree than in previous reports. Our findings suggested that the risks associated with the learning curve process were appropriately mitigated.

Midterm Outcomes With a Self-Expandable Transcatheter Heart Valve in Japanese Patients With Symptomatic Severe Aortic Stenosis.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a viable alternative to surgical aortic valve replacement in high-risk or inoperable patients with aortic stenosis (AS). Here we report the midterm outcomes of high-risk Japanese patients with severe AS who underwent TAVI with a self-expandable TAV.Methods and Results:The CoreValve Japan Trial was a prospective, multicenter trial of the CoreValve System. A group of 55 patients (mean age 82.5±5.5 years, 30.9% male, 100% NYHA class III/IV, STS 8.0±4.2%) were enrolled in the 26-mm/29-mm CoreValve study, and 20 patients (mean age 81.0±6.6 years, 5.0% male, 100% NYHA class III/IV, STS 7.0±3.3%) were enrolled in the 23-mm CoreValve study, which started 1 year later. For the 26-mm/29-mm cohort, the 3-year all-cause mortality rate was 32.6%; major stroke was 15.4%. Mean pressure gradient (MPG), effective orifice area (EOA), and NYHA class showed sustained improvement. Paravalvular regurgitation (PVR) at 3 years was 28.6% (none), 25.7% (trace), 40.0% (mild), 5.7% (moderate), and 0.0% (severe). For the 23-mm cohort, the 2-year all-cause mortality rate was 5.0%; major stroke was 5.0%. MPG, EOA, and NYHA class showed sustained improvement. PVR at 2 years was 16.7% (none), 33.3% (trace), 44.4% (mild), 5.6% (moderate), and 0.0% (severe). CONCLUSIONS: TAVI with the CoreValve System was associated with sustained clinical and functional cardiac improvement in high surgical risk Japanese patients with severe AS. (Clinicaltrials.gov Identifiers: NCT01437098 and NCT01634269.).

Clinical Outcomes and Bioprosthetic Valve Function After Transcatheter Aortic Valve Implantation Under Dual Antiplatelet Therapy vs. Aspirin Alone.

BACKGROUND: Dual antiplatelet therapy (DAPT) is commonly used after transcatheter aortic valve implantation (TAVI); however, the supporting evidence is limited. To determine if aspirin alone is a better alternative to DAPT, we compared the outcomes of patients treated with DAPT or aspirin alone after TAVI.Methods and Results:We analyzed a total of 144 consecutive patients (92 females, mean age 83±6 years) who underwent implantation of a balloon-expandable transcatheter valve (SAPIEN or SAPIEN XT, Edwards Lifesciences). Patients were divided into DAPT (n=66) or aspirin-alone treatment groups (n=78). At 1 year after TAVI, the composite endpoint, which consisted of all-cause death, myocardial infarction, stroke, and major or life-threatening bleeding complications, occurred significantly less frequently (Kaplan-Meier analysis) in the aspirin-alone group (15.4%) than in the DAPT group (30.3%; P=0.031). Valve function assessed by echocardiography was similar between the 2 treatment groups with respect to effective orifice area (1.78±0.43 cm2in DAPT vs. 1.91±0.46 cm2in aspirin-alone group; P=0.13) and transvalvular pressure gradient (11.1±3.5 mmHg in DAPT vs. 10.3±4.1 mmHg in aspirin-alone group; P=0.31). CONCLUSIONS: Treatment with aspirin alone after TAVI had greater safety benefits and was associated with similar valve function as DAPT. These results suggest that treatment with aspirin alone is an acceptable regimen for TAVI patients.

Early Outcomes in Japanese Dialysis Patients Treated With Transcatheter Aortic Valve Implantation.

BACKGROUND: Although transcatheter aortic valve implantation (TAVI) is a new alternative treatment with acceptable midterm results for high surgical risk patients, at present performing the procedure in dialysis patients is not reimbursed in Japan. METHODS AND RESULTS: The study group of 17 dialysis patients (mean age, 76.7±5.0 years) underwent TAVI with the SAPIEN/SAPIEN XT. EuroSCORE and STS score were 25.0±19.0% and 15.4±12.3%, respectively. Transiliofemoral and transapical approaches were performed in 7 (41.2%) and 10 patients (58.8%), respectively. ICU and hospital stays after TAVI were 1.8±1.6 and 12.9±12.7 days, respectively. Mean transvalvular gradients at discharge significantly decreased from 45.9±13.3 mmHg to 10.7±4.3 mmHg (P<0.0001) and effective orifice area significantly increased from 0.78±0.17 to 1.69±0.37 cm(2)(P<0.0001). Device success was 87.5%. One patient required a valve-in-valve procedure on 187-postoperative-day for an acute increase in paravalvular leakage caused by initial lower implantation of the device. The overall mortality at 1 year was 0% and clinical efficacies at 30 days, 6 months, and 1 year were 93.8%, 83.3%, and 69.2%, respectively. CONCLUSIONS: Satisfactory early results were achieved with TAVI in Japanese dialysis patients with a high surgical risk, indicating it is a safe and effective alternative for the treatment of aortic valve stenosis in such patients.

New Self-Expanding Transcatheter Aortic Valve Device for Transfemoral Implantation- Early Results of the First-in-Asia Implantation of the ACURATE Neo/TF(TM) System.

BACKGROUND: Feasibility and early results of transfemoral aortic valve implantation using the ACURATE neo/TF(TM)self-expanding stent are reported. METHODS AND RESULTS: The study group of 15 patients (mean age 83.3±6.0) was enrolled with a mean EuroSCORE and STS score of 21.9±11.6% and 7.5±3.1%, respectively. Clinical and echocardiographic evaluations were performed at baseline, discharge, 30 days and 6 months. The primary endpoint was all-cause mortality at 30 days. Transcatheter aortic valve implantation (TAVI) using the ACURATE neo/TF device was successful in 14 patients; 1 patient underwent valve-in-valve implantation because the prosthetic valve embolized during withdrawal of the delivery system. Conversion to surgery, coronary obstruction, peri-operative stroke, and pacemaker implantation did not occur at 30 days. Mean transvalvular gradients at discharge significantly decreased from 44.2±10.5 mmHg (preprocedural) to 7.7±3.1 mmHg (P<0.0001) and effective orifice area significantly increased from 0.77±0.12 to 1.69±0.25 cm(2)(P<0.0001). None or trace paravalvular leak was revealed in 50.0%, and no patient exhibited moderate or higher paravalvular leak. The overall mortality at 30 days and 6 months was 0% and 6.7%, respectively. CONCLUSIONS: A new self-expanding TF TAVI device, ACURATE neo/TF, is safe and effective in the treatment of severe aortic stenosis in elderly patients at high risk for surgery.

Predictors of Prolonged Hemodynamic Compromise After Valve Deployment During Transcatheter Aortic Valve Implantation.

OBJECTIVE: To identify the risk factors of prolonged hemodynamic compromise caused by rapid pacing for valve deployment during transcatheter aortic valve implantation. DESIGN: A retrospective study. SETTING: Academic hospital. PARTICIPANTS: Forty-seven patients with severe aortic stenosis who underwent transcatheter aortic valve implantation. INTERVENTIONS: The time after the end of rapid pacing until systolic arterial pressure and SvO2 recovery (systolic arterial pressure>90 mmHg and SvO2>65%) was defined as "the hemodynamic recovery time" and was measured from online anesthetic charts. The total study population was divided into 2 groups according to the recovery time (third quartile in all patients; 33 and 14 patients in the early and delayed recovery groups, respectively). Subsequently, the factors associated with prolonged hemodynamic compromise after rapid pacing for valve deployment were identified by univariate and multivariate analyses. MEASUREMENTS AND MAIN RESULTS: Multivariate analysis identified left ventricular end-diastolic diameter (odds ratio, 0.774; 95% confidence interval, 0.608-0.915) and SvO2 (odds ratio, 0.748; 95% confidence interval, 0.590-0.868) as independent factors associated with prolonged hemodynamic compromise after rapid pacing for valve deployment. CONCLUSIONS: SvO2 and left ventricular end-diastolic diameter were found to be significant independent predictors of prolonged hemodynamic compromise immediately after rapid pacing for valve deployment during transcatheter aortic valve implantation.

Urgent transcatheter aortic valve replacement for severe aortic valve stenosis with acute decompensated heart failure: report of a case.

Recent evidence suggests that transcatheter aortic valve replacement (TAVR) is feasible for treating severe aortic valve stenosis (AS) in patients who are considered high risk for elective surgery. However, it is still unclear whether TAVR is a better option than surgical aortic valve replacement for severe AS with acute decompensated heart failure. We report a case of severe AS with acute heart failure, which was treated successfully by urgent TAVR, with cardiopulmonary support.

Hybrid endovascular repair of a dissecting thoracoabdominal aortic aneurysm with stent graft implantation through the false lumen.

We report the first successful hybrid endovascular technique for treating a residual dissecting thoracoabdominal aortic aneurysm with a compressed true lumen in a 48-year-old man in whom multiple stent grafts were deployed through the false lumen. The first stage of the procedure involved debranching of the visceral vessels from the right external iliac artery. In the second stage, a Gore excluder iliac extender (W. L. Gore and Associates, Flagstaff, Ariz) was deployed through the false lumen of the left common iliac artery; then, a Powerlink bifurcated stent graft (Endologix, Irvine, Calif) was positioned at the false lumen of the abdominal aorta. Overlapping with this stent graft, three Gore TAG stent grafts were deployed upward toward the Dacron (DuPont, Wilmington, Del) graft implanted during a previous operation on the descending aorta. Subsequently, the patient had an uneventful postoperative course, with no complications at the 3-year follow-up. The successful results of our new hybrid endovascular technique suggest the feasibility and efficacy of stent graft implantation through the false lumen.

Aortic remodeling as a prognostic factor for late aortic events after thoracic endovascular aortic repair in type B aortic dissection with patent false lumen.

PURPOSE: To assess the significance of aortic remodeling in the prevention of the late aortic events after thoracic endovascular aortic repair (TEVAR) for aortic dissection. METHODS: The study involved 52 patients (41 men; mean age was 59.7±13.3 years) with type B aortic dissections and patent false lumens treated with TEVAR between 2004 and 2011. Of the 52 patients, 18 were treated in the acute phase for rupture (n=1), malperfusion (n=10), aortic diameter over 40 mm at onset (n=3), and rapid enlargement of the false lumen (n=4). In the chronic setting, the indications for TEVAR were rupture (n=1), malperfusion (n=2), aortic diameter >50 mm (n=18), and rapid enlargement of the false lumen (n=13). Aortic remodeling was evaluated at 6 months postoperatively, and risk factors for late aortic events were evaluated in multivariate analysis using aortic remodeling and other pre-, peri-, and postoperative factors. RESULTS: Over a mean 36.0±18.9 months, 19 aortic events were documented: enlargement of the false lumen (n=4), type I endoleak (n=2), and erosion at the stent-graft edges (n=13). Multivariate analysis revealed that failure to achieve aortic remodeling at 6 months postoperatively was the only significant risk factor for late aortic events (hazard ratio 0.20, p=0.037). Patients with aortic remodeling had a higher rate of freedom from aortic events compared with those without aortic remodeling (100% vs. 81.5% at 1 year and 79.3% vs. 48.4% at 3 years, respectively). CONCLUSION: Aortic remodeling after TEVAR is a significant prognostic factor for better long-term results for type B aortic dissection.

Clinical experience with the RELAY NBS PLUS stent-graft for aortic arch pathology.

PURPOSE: To assess the safety, efficacy and performance of the RELAY NBS PLUS stent-graft in patients with aortic arch pathology. METHODS: From July 2010 to December 2011, the RELAY NBS PLUS was used to treat 13 patients (eight males; mean age 59.8 years, range 29-78 years) suffering from aortic arch pathology. The distribution of the proximal landing zone was Zone 0 in one case, Zone 1 in three cases and Zone 2 in nine cases. Bypass of the cervical branches was performed in 11 patients. RESULTS: The surgery-related mortality within 30 days and postoperative morbidity were 0%. Postoperative computed tomography at discharge confirmed 100% clinical success without any endoleaks. The mean radius of the inner curve in the aortic arch was 16.2 mm (range 5.8-25.7 mm). We detected two bird-beak configurations with a severely angulated aortic arch with a radius of the inner curve <15 mm. At the mid-term follow-up (mean 22.1 months; range 13.8-28.2 months), all patients were alive without aorta- or device-related complications. CONCLUSIONS: RELAY NBS PLUS stent-grafts can be safely and effectively implanted with controlled deployment to satisfactorily repair aortic arch pathology, even in the cases considered to present with an unfavorable anatomy for the first generation commercially available stent-graft devices. These encouraging outcomes will need to be confirmed in a larger series with a longer follow-up.

A new staged hybrid total arch repair procedure using a branched proximal elephant trunk technique with implantation of stent grafts to the ascending aorta.

We report a new hybrid aortic arch repair procedure for the treatment of extensive thoracic aortic aneurysms involving the ascending aorta, arch, and descending aorta. In the first stage of this procedure, a "double-barrel tube graft" was inserted into the ascending aorta and fixed to the sinotubular junction under short-duration cardiopulmonary bypass in normothermia. In the next stage, after debranching of the left common carotid artery and left subclavian artery, stent grafts were deployed from the double-barrel tube graft to the descending aorta and the brachiocephalic artery to exclude the aneurysms. The patient's postoperative course was uneventful, with no endoleaks. The successful initial result suggests that this procedure could be an attractive treatment option for extensive aortic aneurysms.

Early experiences of transcatheter aortic valve replacement in Japan.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a new alternative treatment with acceptable early results for patients with aortic valve stenosis considered to be inoperable. The first TAVR was performed in Japan in October 2009, and a total of 51 have been performed up to February 2012. METHODS AND RESULTS: Because it is not possible to disclose details for 36 patients at the time of writing due to ongoing clinical trials, the early and mid-term results of 15 patients are presented for the Edwards SAPIEN valves. Age was 83.4 ± 6.1 years. Mean pressure gradient and aortic valve area were 60.3 ± 21.1 mmHg and 0.64 ± 0.19 cm(2), respectively. Left ventricular ejection fraction was 55.5 ± 15.4%. The Logistic EuroSCORE, EuroSCORE II, and Society of Thoracic Surgeons score were 28.5 ± 21.5%, 11.1 ± 15.8%, and 10.0 ± 7.4%, respectively. All of the procedures were successful and did not require conversion to surgery. Perioperative stroke did not occur, although pacemakers were implanted in 2 patients (13.3%). At discharge, mean pressure gradient and aortic valve area were improved to 10.8 ± 4.4 mmHg and 1.77 ± 0.36 cm(2), respectively. Except for 1 patient who died of cancer 7 months after operation, all patients were alive at the time of writing (11-848 days after procedure; mean follow-up period, 184 days). CONCLUSIONS: Satisfactory early and mid-term results have been achieved with TAVR, indicating that this is a good alternative to treat aortic valve stenosis.

Scallop technique of urgent endovascular repair for symptomatic throacoabdominal aortic aneurysm with a ready-made device.

A 72-year-old woman had a large thoracoabdominal aortic aneurysm (TAAA) with abdominal pain. This aneurysm involved the celiac artery and the superior mesenteric artery (SMA). The risk of open surgery was very high due to severe comorbidity, and there was no appropriate distal attachment for thoracic endovascular repair (TEVAR) with ready-made devices. Therefore, TEVAR with the scallop technique was performed in this urgent setting. A scallop was created in a Talent thoracic stent graft. The aneurysm was successfully excluded, and perfusion in the SMA was preserved using this scalloped endograft. The scallop technique with a ready-made device may be one of the treatment options for urgent TAAA.

Impact of electrocardiogram-gated multi-slice computed tomography-based aortic annular measurement in the evaluation of paravalvular leakage following transcatheter aortic valve replacement: the efficacy of the OverSized AortiC Annular ratio (OSACA ratio) in TAVR.

BACKGROUND: Even mild paravalvular leakage (PVL) after transcatheter aortic valve replacement (TAVR) is associated with increased late mortality. Electrocardiogram-gated multi-slice computed tomography (MSCT) enables detailed aortic annulus assessment. We describe the impact of MSCT for PVL following TAVR. METHODS: Congruence between the prosthesis and annulus diameters affects PVL; therefore, we calculated the OverSized AortiC Annular ratio (OSACA ratio) and OSACA (transesophageal echocardiography, TEE) ratio as prosthesis diameter/annulus diameter on MSCT or TEE, respectively, and compared their relationship with PVL ≤ trace following TAVR. RESULTS: Of 36 consecutive patients undergoing TAVR (Group A), the occurrence of PVL ≤ trace (33.3%) was significantly related to the OSACA ratio (p = 0.00020). In receiver-operating characteristics analysis, the cutoff value of 1.03 for the OSACA ratio had the highest sum of sensitivity (75.0%) and specificity (91.7%; AUC = 0.87) with significantly higher discriminatory performance for PVL as compared to the OSACA (TEE) ratio (AUC = 0.69, p = 0.028). In nine consecutive patients (Group B) undergoing TAVR based on guidelines formulated from our experience with Group A, PVL ≤ trace was significantly more frequent (88.9%) than that in Group A (p = 0.0060). CONCLUSIONS: The OSACA ratio has a significantly higher discriminatory performance for PVL ≤ trace than the OSACA (TEE) ratio, and aortic annular measurement from MSCT is more accurate than that from TEE.

Transcatheter aortic valve replacement using DynaCT.

We report a successful transcatheter aortic valve replacement (TAVR) using syngo DynaCT (Siemens AG, Forchheim, Germany) in an 86-year-old man who had severe aortic valve stenosis. Syngo DynaCT is a cross-sectional radiological imaging system that facilitates intraoperative imaging via interventional angiographic systems; this navigation system is useful during TAVR, especially in cases of poor calcification at the annulus.

On-pump transcatheter aortic valve replacement in patients with poor left ventricular function.

Transcatheter aortic valve replacement (TAVR) has recently been shown to be feasible in patients with severe aortic stenosis who are considered inoperable. We perform TAVR with cardiopulmonary support (CPS) for patients with low left ventricular (LV) function. We report two successful cases of TAVR on CPS in patients with low LV function and describe this technique.

Treatment of secondary mitral regurgitation by transcatheter edge-to-edge repair using MitraClip.

Transcatheter edge-to-edge repair (TEER) is becoming the standard invasive treatment for ventricular functional mitral regurgitation (MR). It is necessary to determine the severity of MR before treatment with MitraClip; however, the severity of secondary MR is usually underestimated compared with that of primary MR and varies temporally. Therefore, to accurately determine the severity of MR, it is important to correctly use the algorithm of the guidelines for valvular heart disease and aggressively perform stress echocardiography. Before performing TEER, the difficulty of the procedure should be evaluated. First, morphological features that make TEER unsuitable, such as cleft of the mitral leaflet, mitral stenosis (MS), or perforation of the mitral leaflet, should be checked. The mitral valve orifice area, transmitral valve pressure gradient, coaptation depth, coaptation length, and posterior leaflet length should be measured to determine the difficulty of the procedure based on the inclusion criteria of Endovascular Valve Edge-to-Edge Repair Study II and the German consensus. After MitraClip implantation, in addition to assessing the severity of MS and residual MR, the pulmonary venous flow pattern and stroke volume should be evaluated to comprehensively assess whether TEER improves the hemodynamics. MitraClip has also been used to treat atrial functional MR, another type of secondary MR. Several reports suggest that MitraClip is effective for atrial functional MR; however, evidence is still being accumulated.