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BACKGROUND: Balloon aortic valvuloplasty (BAV) has gained renewed interest as a bridge to transcatheter aortic valve replacement (TAVR) for patients with aortic stenosis (AS). However, it is unclear whether they patients should undergo TAVR directly or receive a staged bridge to BAV before TAVR is unclear. We used a national database to examine the association between BAV and TAVR in patients with TAVR and its effect on in-hospital mortality. METHODS: Using the nationwide inpatient database of the Japanese registry of all cardiac and vascular diseases and the combination of the diagnosis procedure combination, we retrospectively analyzed 27,600 patients with AS who underwent TAVR between October 2013 and March 2021. Outcomes of the direct TAVR group (n = 27,387) were compared with those of the BAV bridge to TAVR group (n = 213), which received BAV at least 1 day before TAVR. RESULTS: The median age was 85 (interquartile range: 82-88) years, with 33.3% (n = 9188) being male. Unplanned/emergent admissions increased with TAVR, whereas the use of BAV bridge to TAVR decreased. The in-hospital mortality rate was 1.3% and decreased over time. However, the BAV bridge to TAVR had a significantly higher in-hospital mortality than direct TAVR (5.6% vs. 1.3%; p < .0001). Factors associated with in-hospital mortality included age, body mass index, chronic renal disease, percutaneous coronary intervention, and BAV bridge to TAVR. CONCLUSIONS: In unplanned/emergent and planned admission settings, the in-hospital mortality rate for BAV bridge to TAVR is worse than that for direct TAVR. Practical criteria for BAV bridge to TAVR should be proposed to improve outcomes.
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BACKGROUND: Acute mesenteric ischemia is rare, and few large-scale trials have evaluated endovascular therapy (EVT) and open surgical revascularization (OS). This study aimed to assess clinical outcomes after EVT or OS for acute superior mesenteric artery occlusion and identify predictors of mortality and bowel resection. METHODS AND RESULTS: Data from the Japanese Registry of All Cardiac and Vascular Diseases-Diagnosis Procedure Combination (JROAD-DPC) database from April 2012 to March 2020 were retrospectively analyzed. Overall, 746 patients with acute superior mesenteric artery occlusion who underwent revascularization were classified into 2 groups: EVT (n=475) or OS (n=271). The primary clinical outcome was in-hospital mortality. The secondary outcomes were bowel resection, bleeding complications (transfusion or endoscopic hemostasis), major adverse cardiovascular events, hospitalization duration, and cost. The in-hospital death or bowel resection rate was ≈30%. In-hospital mortality (22.5% versus 21.4%, P=0.72), bowel resection (8.2% versus 8.5%, P=0.90), and major adverse cardiovascular events (11.6% versus 9.2%, P=0.32) were comparable between the EVT and OS groups. Hospitalization duration in the EVT group was 6 days shorter than that in the OS group, and total hospitalization cost was 0.88 million yen lower. Interaction analyses revealed that EVT and OS had no significant difference in terms of in-hospital death in patients with thromboembolic and atherothrombotic characteristics. Advanced age, decreased activities of daily living, chronic kidney disease, and old myocardial infarction were significant predictive factors for in-hospital mortality. Diabetes was a predictor of bowel resection after revascularization. CONCLUSIONS: EVT was comparable to OS in terms of clinical outcomes in patients with acute superior mesenteric artery occlusion. Some predictive factors for mortality or bowel resection were obtained. REGISTRATION: URL: www.umin.ac.jp/ctr/; Unique Identifier: UMIN000045240.
Subject(s)
Endovascular Procedures , Hospital Mortality , Mesenteric Artery, Superior , Mesenteric Vascular Occlusion , Registries , Humans , Male , Female , Endovascular Procedures/adverse effects , Endovascular Procedures/methods , Aged , Mesenteric Vascular Occlusion/surgery , Mesenteric Vascular Occlusion/mortality , Mesenteric Vascular Occlusion/complications , Mesenteric Artery, Superior/surgery , Retrospective Studies , Japan/epidemiology , Middle Aged , Treatment Outcome , Acute Disease , Databases, Factual , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/methods , Aged, 80 and over , Risk FactorsABSTRACT
Pulmonary vein stenosis might be caused by mediastinal migration into the vacated pleural space after pneumonectomy. In a patient complaining of worsening dyspnea in the left lateral decubitus position after left pneumonectomy, transthoracic echocardiography during different postures revealed pulmonary vein stenosis that worsened in the left lateral position.
Subject(s)
Angioplasty, Balloon, Coronary , Angioplasty, Balloon , Peripheral Arterial Disease , Humans , Femoral Artery/diagnostic imaging , Paclitaxel/pharmacology , Paclitaxel/therapeutic use , Tomography, Optical Coherence/methods , Treatment Outcome , Coated Materials, Biocompatible , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Popliteal ArteryABSTRACT
BACKGROUND: Worsening mitral regurgitation (MR) is a complication of intervention for atrial septal defect (ASD). Little is known about mitral valve (MV) characteristics associated with worsening MR. We aimed to elucidate MR outcomes and predictors of worsening MR after transcatheter ASD closure. METHODS: We analyzed changes in MR from prior to transcatheter ASD closure to 6 months after the procedure and predictors of worsening MR via baseline transthoracic echocardiography in 238 patients (64.7% females; mean age, 53 ± 22 years). RESULTS: Worsening MR was defined as worsening to moderate in patients with less than or equal to mild MR at baseline or vena contracta width increasing of ≥2 mm by 6-month follow-up in patients with moderate MR. Worsening MR was observed in 29 patients (12.2%). The associated echocardiographic findings were pseudoprolapse, hamstringing, stiffness, and anteroposterior and intercommissural mitral annulus diameter in the univariable logistic regression analysis (all P < 0.05). Multivariable analysis after adjusting for age; long-standing persistent atrial fibrillation; and ASD size showed that models combining MV leaflet findings such as pseudoprolapse or hamstringing, or anterior leaflet stiffness with the ratio of the sum of anterior and posterior leaflet lengths to intercommissural mitral annulus diameter were statistically significant for predicting worsening MR (R2 = 0.393, P < 0.001 and R2 = 0.385, P < 0.001, respectively). CONCLUSIONS: Worsening MR after transcatheter ASD closure might depend on MV leaflet findings and annulus size in patients with long-standing persistent atrial fibrillation.
Subject(s)
Atrial Fibrillation , Heart Septal Defects, Atrial , Mitral Valve Insufficiency , Female , Humans , Adult , Middle Aged , Aged , Male , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Mitral Valve Insufficiency/complications , Retrospective Studies , Mitral Valve , Heart Septal Defects, Atrial/diagnostic imaging , Heart Septal Defects, Atrial/surgeryABSTRACT
BACKGROUND: Residual regurgitation after transcatheter edge-to-edge mitral valve repair (TMVR) is a predictor of poor prognosis in patients with functional mitral regurgitation (FMR). This study sought to identify the mitral valve (MV) parameters measured by three-dimensional transesophageal echocardiography (3D-TEE) and MV leaflet features that predict residual mitral regurgitation (MR) after TMVR in patients with FMR. METHODS: Consecutive patients with FMR who underwent TMVR were classified into two groups based on the degree of residual MR just after TMVR: < 2+ in the optimal MR reduction group and ≥ 2+ in the suboptimal MR reduction group. The two groups were compared with respect to 3D-TEE parameters and the MV leaflet features, including the following parameters: stiffness, defined as a leaflet that remains at a fixed angle even during diastole, and thickness, measured in both clear and rough zones. RESULTS: Thirty-four of 46 patients (74%) were classified as the optimal MR reduction group. Multivariable analysis showed that anterior mitral leaflet + posterior mitral leaflet length/anteroposterior annulus diameter (p = .044) and MV leaflet stiffness (p = .007) were independent predictors of residual MR. CONCLUSION: MV leaflet stiffness and the ratio of MV leaflet lengths to the annulus diameter may be good predictors of residual MR after TMVR in patients with FMR.
Subject(s)
Cardiac Surgical Procedures , Echocardiography, Three-Dimensional , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency , Humans , Mitral Valve Insufficiency/diagnostic imaging , Mitral Valve Insufficiency/surgery , Mitral Valve/diagnostic imaging , Mitral Valve/surgery , Echocardiography, Three-Dimensional/methods , Echocardiography, Transesophageal/methods , Treatment OutcomeABSTRACT
Background: Left ventricular outflow tract obstruction (LVOTO) sometimes presents with aortic stenosis (AS). Echocardiography is used to assess the diagnosis and severity of LVOTO or AS. However, LVOTO is one of the conditions that makes AS assessment difficult, and catheter pressure measurement is frequently useful in such cases. Case summary: An 84-year-old female patient presented with New York Heart Association functional Class III dyspnoea. Transthoracic echocardiography revealed LVOTO caused by upper septal hypertrophy, mitral valve systolic anterior motion with moderate mitral regurgitation, and a highly calcified aortic valve, which suggested the possibility of severe AS. The continuous Doppler echocardiography revealed a late-systolic peaking dagger-shaped profile with a peak jet velocity of 5.6â m/s. Cardiac catheterization was performed to determine the contribution of AS or LVOTO to her symptoms. Catheter pressures were measured at the ascending aorta (using a coronary catheter) and the LV (using the Navvus RXi system). The initial mean pressure gradient between the apex of the LV, just below the aortic valve and aorta, was measured at 65 and 25â mmHg, respectively. The mean pressure gradient between the apex and the aorta decreased from 65 to 40â mmHg after a 50â mg disopyramide administration. Oral medication therapy effectively stabilized her symptom after catheterization. Discussion: To the best of our knowledge, this is the first reported case of assessing the severity of LVOTO and AS using the Navvus RXi system. Catheter pressure measurement using the Navvus RXi system is a useful method of determining the severity of LVOTO and AS.
Subject(s)
Angiodysplasia , Aortic Valve Stenosis , Gastrointestinal Diseases , Humans , Angiodysplasia/complications , Angiodysplasia/therapy , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Gastrointestinal Hemorrhage/etiology , Gastrointestinal Hemorrhage/therapy , Vascular DiseasesABSTRACT
PURPOSE: To determine the predictors of wound recurrence after complete wound healing in patients with chronic limb-threatening ischemia (CLTI) who underwent endovascular therapy (EVT) for infrapopliteal (IP) lesions with consideration of IP arterial anatomic severity, including classification by the Global Limb Anatomic Staging System (GLASS). MATERIALS AND METHODS: This retrospective single-center study assessed patients with de novo CLTI limbs with tissue loss treated via EVT for IP lesions from September 2016 to May 2021. Among these patients, 149 consecutive limbs from 133 patients who achieved complete wound healing were enrolled. The Kaplan-Meier method was used to estimate the wound recurrence rate after complete wound healing. The Cox proportional hazard model was used to assess the association between baseline characteristics and wound recurrence. RESULTS: The cumulative wound recurrence rate 1 year after complete wound healing was 30%. The mean time for wound recurrence was 7±5 months. Only IP arterial anatomic characteristics remained as a predictor of wound recurrence, whereas wound status and management, including the Wound, Ischemia, and foot Infection (WIfI) clinical stage and minor amputation, were not associated with wound recurrence. Multivariate analysis revealed independent associations between wound recurrence and IP 3-vessel occlusive disease (hazard ratio, 2.97; 95% confidence interval, 1.39-6.35), but not poor below-the-ankle runoff, IP Peripheral Arterial Calcium Scoring System (PACSS) grade, and the GLASS IP grade. CONCLUSION: The only independent predictor of wound recurrence after complete wound healing via EVT in patients with CLTI was IP 3-vessel occlusive disease. CLINICAL IMPACT: In patients with chronic limb-threatening ischemia (CLTI), wound recurrence after complete wound healing remains a challenge, and studies focused exclusively on wound recurrence are still limited. The present study aimed to determine the risk factors for wound recurrence after complete wound healing in patients with CLTI who underwent endovascular therapy (EVT) for infrapopliteal (IP) lesions, with consideration of IP arterial anatomic severity for the first time. The results showed that IP 3-vessel occlusive disease was the only predictor of wound recurrence, whereas wound status/management and other arterial anatomic characteristics including WIfI clinical stages and GLASS grades were not predictors.
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INTRODUCTION: Aortic stenosis (AS) is sometimes associated with gastrointestinal bleeding, and this phenomenon is known as Heyde's syndrome. Such bleeding is most often considered to originate from gastrointestinal angiodysplasias, but the frequency and endoscopic features of such bleeding remain unclear. This study aimed to determine the frequency and endoscopic features of gastrointestinal angiodysplasia in patients with severe AS. PATIENTS AND METHODS: In this multicenter, retrospective study, we evaluated consecutive patients who underwent transcatheter aortic valve implantation (TAVI) with severe AS from May 2016 to December 2019. We extracted the data on the clinicopathological features according to the status of anemia, the proportion of patients who underwent gastrointestinal endoscopic examinations and demonstrated gastrointestinal angiodysplasia, and identified the endoscopic features associated with such patients. RESULTS: In 325 patients, the rates of moderate/severe anemia (hemoglobin < 11 g/dL) were 52%. Regarding medicine, there were no significant differences between the patients with and without moderate/severe anemia. Patients were examined by esophagogastroduodenoscopy (21%), colonoscopy (12%), and balloon-assisted enteroscopy or small bowel capsule endoscopy (1.5%). Patients with moderate/severe anemia had significantly more angiodysplasia (38.3% vs. 7.7%; p < 0.0001) and active bleeding (23.4% vs. 0%; p < 0.01). Angiodysplasia was detected in 21 patients (stomach, n = 9; small intestine, n = 5, and colon, n = 10). CONCLUSIONS: The results suggest, for the first time, that patients with severe AS who underwent TAVI and moderate/severe anemia frequently had gastrointestinal angiodysplasia and active bleeding throughout the entire gastrointestinal tract.
Subject(s)
Anemia , Angiodysplasia , Aortic Valve Stenosis , Capsule Endoscopy , Colonic Diseases , Humans , Retrospective Studies , Gastrointestinal Hemorrhage/complications , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Angiodysplasia/diagnosis , Angiodysplasia/diagnostic imaging , Anemia/complicationsABSTRACT
We sought to clarify characteristics of patients with severe aortic stenosis (AS) in whom transvalvular mean pressure gradient (MPG) was underestimated with Doppler compared with catheterization. Study subjects included 127 patients with severe AS who underwent transcatheter aortic valve implantation. Between subjects with Doppler MPG underestimation ≥10 mm Hg (group U) and those without (group C), we retrospectively compared echocardiographic parameters and aortic valve calcification score using the Agatston method. Despite a strong correlation (rS = 0.88) and small absolute difference (2.1 ± 10.1 mm Hg) between Doppler and catheter MPG, 27 patients (21%) were in group U. Among 48 patients with catheter MPG ≥60 mm Hg, 10 patients (21%) revealed Doppler MPG of 40 to 59 mm Hg, suggesting they had been misclassified as having severe AS instead of very severe AS. According to the guidelines, indication of valve replacement for patients without symptoms should be considered for very severe AS but not for severe AS. Therefore, sole reliance on Doppler MPG could cause clinical misjudgments. Group U had larger relative wall thickness (median [interquartile range: 0.60 [0.50 to 0.69] vs 0.53 [0.46 to 0.60], p = 0.003) and higher calcification score (3,024 [2,066 to 3,555] vs 1,790 [1,293 to 2,501] arbitrary units, p <0.001). Both calcification score (per 100 arbitrary unit increment, odds ratio 1.10, 1.04 to 1.17, p = 0.002) and relative wall thickness (per 0.05 increment, odds ratio 1.29, 95% confidence interval 1.05 to 1.60, p = 0.02) were independently associated with Doppler underestimation. In conclusion, Doppler might underestimate transvalvular gradient compared with catheterization in patients with severe AS who have heavy valve calcification and prominent concentric remodeling left ventricular geometry.
Subject(s)
Aortic Valve Stenosis , Echocardiography, Doppler , Humans , Retrospective Studies , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/surgery , Aortic Valve/diagnostic imaging , Aortic Valve/surgery , Cardiac CatheterizationABSTRACT
AIMS: This study aimed to clarify the relationship between cardiovascular prognosis and left ventricular hypertrophy (LVH) in patients with severe aortic stenosis who underwent transcatheter aortic valve replacement (TAVR) and to investigate the relationship between cardiac sympathetic nerve (CSN) function and these factors using 123 I-metaiodobenzylguanidine scintigraphy. METHODS AND RESULTS: In this single-centre, retrospective observational study, 349 patients who underwent TAVR at our institution between July 2017 and May 2020 were divided into two groups: those with severe LVH pre-operatively [severe LVH (+) group] and those without LVH pre-operatively [severe LVH (-) group]. The rates of freedom from cardiovascular events (cardiovascular death and heart failure hospitalization) were compared. The relationship between changes in left ventricular mass index (LVMi) and changes in delay heart-mediastinum ratio (H/M) from before TAVR to 6 months after TAVR was also investigated. The event-free rate was significantly lower in the severe LVH (+) group (87.1% vs. 96.0%, log-rank P = 0.021). The severe LVH (+) group exhibited a significantly lower delay H/M value, scored by 123 I-metaiodobenzylguanidine scintigraphy, than the severe LVH (-) group (2.33 [1.92-2.67] vs. 2.67 [2.17-3.68], respectively, P < 0.001). Moreover, the event-free rate of post-operative cardiovascular events was lower among patients with a delay H/M value < 2.50 than that among other patients (87.7% vs. 97.2%, log-rank P = 0.012). LVMi was significantly higher (115 [99-130] vs. 90 [78-111] g/m2 , P < 0.001) and delay H/M value was significantly lower (2.53 [1.98-2.83] vs. 2.71 [2.25-3.19], P = 0.025) in the severe LVH (+) group than in the severe LVH (-) group at 6 months after TAVR. Patients with improved LVH at 6 months after TAVR also had increased delay H/M (from 2.51 [2.01-2.81] to 2.67 [2.26-3.02], P < 0.001), whereas those without improved LVH had no significant change in delay H/M (from 2.64 [2.23-3.06] to 2.53 [1.97-3.00], P = 0.829). CONCLUSIONS: Severe LVH before TAVR is a prognostic factor for poor post-operative cardiovascular outcomes. LVH associated with aortic stenosis and CSN function are correlated, suggesting their involvement in LVH prognosis.
Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Humans , Transcatheter Aortic Valve Replacement/methods , Hypertrophy, Left Ventricular/diagnosis , Hypertrophy, Left Ventricular/epidemiology , Hypertrophy, Left Ventricular/complications , Mediastinum/surgery , Treatment Outcome , Aortic Valve Stenosis/complications , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/surgeryABSTRACT
BACKGROUND: Balloon pulmonary angioplasty (BPA) is used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) and residual pulmonary hypertension after pulmonary endarterectomy (PEA) to improve hemodynamics, right ventricular function, and exercise capacity. However, the effectiveness and safety of guide extension catheters for BPA treatment in patients with CTEPH have not been demonstrated. METHODS: We retrospectively analyzed 91 lesions in 55 sessions of 28 patients with CTEPH who underwent BPA using a guide extension catheter. The purpose (backup, coaxial, and extension), efficacy, and safety of the guide extension catheters were explored. The efficacy of the guide extension catheter was assessed based on the success of the procedures and safety was evaluated based on procedure-related complications. RESULTS: Regarding the intended use, a guide extension catheter was used to strengthen the backup force of the guiding catheter in 52% of cases, extend the tip of the catheter in 38% of cases, and maintain the coaxiality of the guiding catheter in 10% of cases. Procedural success was achieved in 92.7% of 55 sessions and in 95.6% of 91 lesions. Complex lesions had a lower success rate than simple lesions (p = 0.04). Regarding safety concerns, complications were observed in 5 of 55 sessions (9.1%) and 6 of 91 lesions (6.6%). Only one case of pulmonary artery dissection using a guide extension catheter was reported. Except for this one case, extension catheter-related complications were not observed. CONCLUSIONS: A guide extension catheter can be used safely in BPA procedures with anatomically complex pulmonary artery branches and complex lesions by increasing backup support.
Subject(s)
Angioplasty, Balloon , Hypertension, Pulmonary , Pulmonary Embolism , Humans , Hypertension, Pulmonary/surgery , Hypertension, Pulmonary/etiology , Pulmonary Embolism/complications , Pulmonary Embolism/surgery , Retrospective Studies , Chronic Disease , Pulmonary Artery/surgery , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/methods , Catheters/adverse effects , Treatment OutcomeABSTRACT
BACKGROUND: To investigate the prognostic impact of femoropopliteal (FP) arterial anatomic severity including classification by the global limb anatomic staging system (GLASS) on wound healing in patients with chronic limb-threatening ischemia (CLTI) who had undergone endovascular therapy (EVT) only for FP lesions. METHODS: This was a retrospective single-center study. We treated 349 consecutive de novo CLTI limbs with tissue loss from January 2017 to May 2021. Among these, 91 limbs treated via EVT only for FP lesions were enrolled. We compared the clinical background, infrapopliteal (IP)/FP arterial anatomical characteristics, and EVT results between the limbs with GLASS FP grade 1 or 2 (low GLASS FP, n = 20) and those with GLASS FP grade 3 or 4 (high GLASS FP, n = 71). The Kaplan-Meier method was used to estimate the wound healing rate. The Cox proportional hazard model was used to assess the association between baseline characteristics and wound healing. RESULTS: No patient underwent EVT for IP lesions. IP arterial anatomical characteristics did not show any significant difference between the low and high GLASS FP groups. The cumulative wound healing rate after EVT was significantly higher in the high GLASS FP group than in the low GLASS FP group (88% vs. 39% at 6 months; P < 0.001). Multivariate analysis revealed that low wound, ischemia, and foot infection (WIfI) clinical stage (stage 1 or 2) (hazard ratio [HR] 2.33; 95% confidence interval [CI] 1.32-4.17) and high GLASS FP (grade 3 or 4) (HR 5.18; 95% CI 1.99-13.51) were independent factors for wound healing. CONCLUSIONS: High GLASS FP grade was positively associated with wound healing after EVT only for FP lesions.
Subject(s)
Endovascular Procedures , Peripheral Arterial Disease , Humans , Chronic Limb-Threatening Ischemia , Treatment Outcome , Risk Factors , Retrospective Studies , Limb Salvage/methods , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/therapy , Amputation, Surgical , Lower Extremity/blood supply , Endovascular Procedures/adverse effects , Ischemia/diagnostic imaging , Ischemia/surgery , Wound HealingABSTRACT
OBJECTIVES: To assess wound healing after simultaneous endovascular treatment (EVT) and minor forefoot amputation and identify the predictors of delayed wound healing in patients with chronic limb-threatening ischemia (CLTI) and bacterial infections of the wounds. METHODS: In this single-center retrospective cohort study, we evaluated 79 consecutive limbs with tissue loss from 73 CLTI patients who underwent simultaneous EVT and minor forefoot amputation between November 2017 and May 2020. To estimate the rate of wound healing after the simultaneous procedure, we used the Kaplan-Meier method. To assess the association between baseline characteristics and delayed wound healing, we used the Cox proportional hazard model. RESULTS: All patients who underwent the simultaneous procedure had ischemic wounds with bacterial infection. The rate of wound healing at 6 months reached 82%. The median time for wound healing was 76 days. According to multivariable analysis, Lisfranc/Chopart amputation (hazard ratio (HR) 2.46, 95% confidence interval (CI) 1.09-6.60), absence of above-the-knee (ATK) occlusive lesions (HR 1.89, 95% CI 1.04-3.45), and poor below-the-ankle (BTA) runoff (HR 1.77, 95% CI 1.01-3.11) were independent predictors of delayed wound healing. CONCLUSION: Lisfranc/Chopart amputation, absence of ATK occlusive lesions, and poor BTA runoff were independent predictors of delayed wound healing after simultaneous EVT and minor forefoot amputation in patients with CLTI and bacterial infections of the wound.
Subject(s)
Endovascular Procedures , Peripheral Arterial Disease , Wound Infection , Humans , Chronic Limb-Threatening Ischemia , Treatment Outcome , Risk Factors , Retrospective Studies , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/surgery , Limb Salvage , Amputation, Surgical , Ischemia/diagnostic imaging , Ischemia/surgery , Endovascular Procedures/adverse effects , Wound HealingSubject(s)
Cardiovascular Abnormalities , Transcatheter Aortic Valve Replacement , Humans , Subclavian Artery/diagnostic imaging , Subclavian Artery/surgery , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/surgery , Transcatheter Aortic Valve Replacement/adverse effects , Treatment Outcome , Cardiovascular Abnormalities/surgeryABSTRACT
PURPOSE: The underlying difference between intermittent claudication (IC) and critical limb-threatening ischemia (CLTI) still remains unclear. This prospective multicenter observational study aimed to clarify differences in clinical features and prognostic outcomes between IC and CLTI, and prognostic factors in patients undergoing endovascular therapy (EVT). MATERIALS AND METHODS: A total of 692 patients with 808 limbs were enrolled from 20 institutions in Japan. The primary measurements were the 3-year rates of major adverse cardiovascular event (MACE) and reintervention. RESULTS: Among patients, 79.0% had IC and 21.0% had CLTI. Patients with CLTI were more frequently women and more likely to have impaired functional status, undernutrition, comorbidities, hypercoagulation, hyperinflammation, distal artery disease, short single antiplatelet and long anticoagulation therapies, and late cilostazol than patients with IC. Aortoiliac and femoropopliteal diseases were dominant in patients with IC and infrapopliteal disease was dominant in patients with CLTI. Patients with CLTI underwent less frequently aortoiliac intervention and more frequently infrapopliteal intervention than patients with IC. Longitudinal change of ankle-brachial index (ABI) exhibited different patterns between IC and CLTI (pinteraction=0.002), but ABI improved after EVT both in IC and in CLTI (p<0.001), which was sustained over time. Dorsal and plantar skin perfusion pressure in CLTI showed a similar improvement pattern (pinteraction=0.181). Distribution of Rutherford category improved both in IC and in CLTI (each p<0.001). Three-year MACE rates were 20.4% and 42.3% and 3-year reintervention rates were 22.1% and 46.8% for patients with IC and CLTI, respectively (log-rank p<0.001). Elevated D-dimer (p=0.001), age (p=0.043), impaired functional status (p=0.018), and end-stage renal disease (p=0.019) were independently associated with MACE. After considering competing risks of death and major amputation for reintervention, elevated erythrocyte sedimentation rate (p=0.003) and infrainguinal intervention (p=0.002) were independently associated with reintervention. Patients with CLTI merely showed borderline significance for MACE (adjusted hazard ratio 1.700, 95% confidence interval 0.950-3.042, p=0.074) and reintervention (adjusted hazard ratio 1.976, 95% confidence interval 0.999-3.909, p=0.05). CONCLUSIONS: The CLTI is characterized not only by more systemic comorbidities and distal disease but also by more inflammatory coagulation disorder compared with IC. Also, CLTI has approximately twice MACE and reintervention rates than IC, and the underlying inflammatory coagulation disorder per se is associated with these outcomes. CLINICAL IMPACT: The underlying difference between intermittent claudication (IC) and critical limb-threatening ischemia (CLTI) still remains unclear. This prospective multicenter observational study, JPASSION study found that CLTI was characterized not only by more systemic comorbidities and distal disease but also by more inflammatory coagulation disorder compared to IC. Also, CLTI had approximately twice major adverse cardiovascular event (MACE) and reintervention rates than IC. Intriguingly, the underlying inflammatory coagulation disorder per se was independently associated with MACE and reintervention. Further studies to clarify the role of anticoagulation and anti-inflammatory therapies will contribute to the development of post-interventional therapeutics in the context of peripheral artery disease.