Predictive role of regional thigh tissue oxygen saturation monitoring during cardiopulmonary bypass in lung injury after cardiac surgery.

Acute respiratory distress syndrome (ARDS) is a serious complication following cardiac surgery mainly associated with the use of cardiopulmonary bypass (CPB), which could increase the risk of mortality and morbidity. This study investigated the association of regional oxygen saturation (rSO2) during CPB with postoperative outcomes, including respiratory function. Patients who underwent cardiac surgery with CPB from 2015 to 2019 were included. Near-infrared spectroscopy was used to monitor rSO2 at the forehead, abdomen, and thighs throughout the surgery. Postoperative markers associated with CPB were assessed for correlations with PaO2/FiO2 (P/F) ratios at intensive care unit (ICU) admission. Postoperative lung injury (LI) was defined as moderate or severe ARDS based on the Berlin criteria, and its incidence was 29.9% (20/67). On multiple regression analysis, the following were associated with P/F ratios at ICU admission: vasoactive-inotropic scores at CPB induction (P = 0.03), thigh rSO2 values during CPB (P = 0.04), and body surface area (P < 0.001). A thigh rSO2 of 71% during CPB was significantly predictive of postoperative LI with an area under the curve of 0.71 (P = 0.03), sensitivity of 0.70, and specificity of 0.68. Patients with postoperative LI had longer ventilation time and ICU stays. Thigh rSO2 values during CPB were a potential predictor of postoperative pulmonary outcomes.

Initial thickness of the crescent may not be a reliable predictor of complications in type A intramural haematoma.

OBJECTIVES: This study aimed to investigate changes in haematoma thickness during the early period and their association with disease progression in patients who received initial medical treatment for type A intramural haematoma (IMH). METHODS: Medical records and serial computed tomography angiography (CTA) images of patients who did not undergo emergency aortic repair for type A IMH upon presentation were retrospectively reviewed. The haematoma remodelling rate was determined using the following equation: thickness of the haematoma on the first CTA (mm) - thickness of the haematoma on the second CTA (mm)time between the first and second CTAs (h). RESULTS: Among the 40 patients included in this study, 38 were indicated for initial watch-and-wait strategy, whereas 2 were indicated for emergency aortic repair but declined it. During hospitalization, 10 patients developed disease progression, with 2 in-hospital mortality cases. Analysis of the haematoma remodelling rate in 39 patients revealed that such a rate was significantly associated with the reciprocal of the time from onset. Analysis of all 70 CTA examinations performed within 24 h after the onset of IMH showed that haematoma thickness was significantly associated with the logarithm of the time from onset. Initial regression of the haematoma was not necessarily associated with avoidance of disease progression. CONCLUSIONS: In type A IMH, the thickness of the haematoma in the ascending aorta tended to decrease in the very early period; however, prompt regression of the haematoma was not necessarily associated with avoidance of disease progression.

Recurrent left ventricular thrombus due to essential thrombocythemia complicated by COVID-19.

Essential thrombocythemia is a risk factor for thrombosis and hemorrhage. During the perioperative period of cardiac surgery, the risk of thrombosis and hemorrhage increases. Coronavirus disease 2019 (COVID-19) is also associated with thrombosis. We present the case of a 69-year-old man with essential thrombocythemia complicated by COVID-19 who developed a left ventricular thrombus. We performed thrombectomy, but the patient developed recurrent left ventricular thrombus 8 days after surgery. Emergency redo thrombectomy was performed followed by aggressive blood-thinning therapy. The postoperative course was complicated by cardiac tamponade requiring surgical drainage 8 days after the second surgery. The patient was discharged home 25 days after the second operation without any complications. Learning objective: Left ventricular thrombus is a rare but fatal complication associated with essential thrombocythemia. COVID-19 has also been reported to cause coagulopathy. This case suggested that after surgery for left ventricular thrombus complicated by multiple risk factors including essential thrombocythemia and COVID-19, aggressive blood-thinning therapy with combination of anticoagulation, antiplatelet, and metabolic antagonist may help prevent recurrent thrombosis.

Watch-and-wait strategy for selected patients with type A intramural hematoma.

OBJECTIVE: This single-center retrospective study evaluated early and midterm outcomes of 100 consecutive patients with type A intramural hematoma. METHODS: Initial watch-and-wait strategy was indicated if the maximum aortic diameter was < 50 mm, pain score was < 3/10 on the numerical rating scale, and no ulcer-like projection was observed in the ascending aorta. The primary endpoints of this study were all-cause and aorta-related deaths, and the secondary endpoint was aortic events. RESULTS: Initial watch-and-wait strategy was indicated in 52 patients. Emergency aortic repair was indicated in the remaining 48 patients; 2, 31, and 15 patients died before surgery, underwent emergency surgery, and declined emergency surgery, respectively. Among the watch-and-wait group, 11 (21%) patients underwent aortic repair during hospitalization. In-hospital mortality rates, 5-year survival rates, and 5-year freedom from aorta-related death were not significantly different between the initial watch-and-wait strategy and emergency surgery (2% vs. 6%, 92% vs. 82%, and 100% vs. 94%, respectively). In the initial watch-and-wait strategy group, 5-year freedom from aortic events and freedom from aortic events involving the ascending aorta were 60% and 66%, respectively. CONCLUSIONS: The early and midterm outcomes with the initial watch-and-wait strategy in patients with type A intramural hematoma with a maximum aortic diameter of ≤ 50 mm, pain score of ≤ 3/10, and no ulcer-like projection in the ascending aorta were favorable with no aorta-related death.

Trajectory of Abdominal Skeletal Muscle Changes During Cardiac Rehabilitation in Patients With Aortic Disease.

OBJECTIVE: This study focused on routine computed tomography imaging for aortic disease management and evaluated the trajectory of skeletal muscle changes through inpatient and outpatient cardiac rehabilitation. DESIGN: Prospective observational study included patients who underwent abdominal computed tomography three times (baseline, postacute care, and follow-up). The area and density of the all-abdominal and erector spine muscles and intramuscular adipose tissue were measured. A generalized linear model with patients as random effects was used to investigate skeletal muscle changes. RESULTS: Thirty-nine patients completed outpatient cardiac rehabilitation, and 60 were incomplete. Skeletal muscle area significantly decreased from baseline to the follow-up period only in the incomplete rehabilitation group. Skeletal muscle density significantly decreased from baseline to postacute care and increased at the follow-up period, but only patients who completed rehabilitation showed recovery up to baseline at the follow-up period. These trajectories were more pronounced in the erector spine muscle. Intramuscular adipose tissue showed a trend of gradual increase, but only the incomplete rehabilitation group showed a significant difference from baseline to the follow-up period. CONCLUSIONS: The density of skeletal muscle may reflect the most common clinical course; skeletal muscle area and intramuscular adipose tissue are unlikely to improve positively, and their maintenance seemed optimal.

Coil-in-Plug Method for Left Subclavian Artery Embolization in Thoracic Endovascular Aortic Repair with Arch Vessel Debranching.

Objectives: Since 2018, we have routinely placed an Amplatzer vascular plug (AVP) in the proximal left subclavian artery (LSCA) to prevent embolic events during thoracic endovascular aortic repair with arch vessel debranching (d-TEVAR). Type II endoleaks of LSCA origin were observed in two patients (20%), and the coil-in-plug (CIP) method, i.e., microcatheter insertion through the plug and addition of coil embolization, which has been used since August 2019, was performed. This study aims to evaluate the effectiveness of the CIP method for LSCA embolization. Methods: A total of 26 patients who underwent d-TEVAR for an aortic arch aneurysm between 2018 and 2022 were retrospectively reviewed. Ten patients who underwent d-TEVAR with a simple AVP placement (the control group) and 16 patients who underwent d-TEVAR with the CIP method (the CIP group) were compared. Results: Two patients had type II endoleaks in the control group, whereas none had them in the CIP group. LSCA length was significantly shorter in patients with endoleaks than in those without endoleaks (24.5 vs. 50.3 mm; p<0.01). No perioperative deaths or cerebral infarctions occurred in either group. Conclusions: AVP placement in the LSCA during d-TEVAR effectively prevented perioperative cerebral infarction. d-TEVAR with CIP was especially useful in patients with a short LSCA.

Trends and Outcomes of Early Rehabilitation in the Intensive Care Unit for Patients With Cardiovascular Disease: A Cohort Study With Propensity Score-Matched Analysis.

BACKGROUND: The effectiveness of acute-phase cardiovascular rehabilitation (CR) in intensive care settings remains unclear in patients with cardiovascular disease (CVD). This study aimed to investigate the trends and outcomes of acute-phase CR in the intensive care unit (ICU) for patients with CVD, including in-hospital and long-term clinical outcomes. METHOD: This retrospective cohort study reviewed a total of 1,948 consecutive patients who were admitted to a tertiary academic ICU for CVD treatment and underwent CR during hospitalisation. The endpoints of this study were the following: in-hospital outcomes: probabilities of walking independence and returning home; and long-term outcomes: clinical events 5 years following hospital discharge, including all-cause readmission or cardiovascular events. It evaluated the associations of CR implementation during ICU treatment (ICU-CR) with in-hospital and long-term outcomes using propensity score-matched analysis. RESULTS: Among the participants, 1,092 received ICU-CR, the rate of which tended to increase with year trend (p for trend <0.001). After propensity score matching, 758 patients were included for analysis (pairs of n=379 ICU-CR and non-ICU-CR). ICU-CR was significantly associated with higher probabilities of walking independence (rate ratio, 2.04; 95% CI 1.77-2.36) and returning home (rate ratio, 1.22; 95% CI 1.05-1.41). These associations were consistently observed in subgroups aged >65 years, after surgery, emergency, and prolonged ICU stay. ICU-CR showed significantly lower incidences of all-cause (HR 0.71; 95% CI 0.56-0.89) and cardiovascular events (HR 0.69; 95% CI 0.50-0.95) than non-ICU-CR. CONCLUSIONS: The implementation of acute-phase CR in ICU increased with year trend, and is considered beneficial to improving in-hospital and long-term outcomes in patients with CVD and various subgroups.

[Mitral Valve Surgery for Active Infective Endocarditis:Techniques to Preserve Native Valve].

OBJECTIVE: In surgery for active infective endocarditis (aIE), it is often difficult to achieve balance between thorough debridement and preservation of native valve. This study aimed to evaluate the validity of our native valve preservation techniques including leaflet peeling and autologous pericardial reconstruction. METHODS: From January 2012 to December 2021, 41 consecutive patients underwent mitral valve surgery for aIE. Twenty-four patients who underwent mitral valve plasty (group P) and 17 patients who underwent mitral valve replacement (group R) were retrospectively compared regarding early and long-term outcomes. RESULTS: Patients in the group P were significantly younger and had fewer preoperative shock, congestive heart failure and cerebral embolism. There was 18% in-hospital mortality in the group R, but none in the group P. In the group P, one patient underwent valve replacement for recurrence of mitral regurgitation 3-years after surgery, and 5-year freedom from mitral reoperation was 93%. CONCLUSIONS: Techniques of leaflet peeling and autologous pericardial reconstruction improved the feasibility of mitral valve plasty for aIE, and the early and long-term outcomes were favorable.

Hybrid surgery for blunt aortic injury with rupture: a case report.

BACKGROUND: Blunt thoracic aortic injury is one of the most lethal traumatic injuries. Ruptured cases often result in cardiac arrest before arrival at the hospital, and survival is rare. CASE PRESENTATION: A female patient in her 30 s was struck by an automobile while she was walking across an intersection. She was in a state of shock when emergency services arrived and was in cardiac arrest shortly after arriving at the hospital. A left anterolateral thoracotomy revealed a massive hemothorax secondary to thoracic aortic rupture. In addition, the patient had multiple traumas, including maxillary, pelvic, and lumbar burst fractures. We attempted to directly suture the aortic lesion; however, the increasing blood pressure caused the suture to break. We used a thoracic stent graft while ensuring permissive hypotension. Her postoperative prognosis was positive, and she was transferred to another hospital 85 days later. CONCLUSIONS: We successfully performed a hybrid surgery combining thoracotomy and endovascular repair for this emergency case of blunt thoracic aortic injury with rupture.

Acute Kidney Injury after High-Flow Regional Cerebral Perfusion in Neonatal and Infant Aortic Arch Repair.

OBJECTIVES: We applied high-flow regional cerebral perfusion (HFRCP) for aortic arch reconstruction in neonates and infants by monitoring regional oxygen saturation of the thigh (rSO2T) using near-infrared spectroscopy to maintain peripheral perfusion. This study was designed to investigate the optimal perfusion flow of HFRCP for renal protection. METHODS: From 2009 to 2021, 28 consecutive neonates and infants who underwent aortic arch reconstruction with HFRCP were enrolled. The median age of the patients was 27 days; the median body weight was 3.0 kg. In HFRCP, perfusion flow was targeted at approximately 80-100 mL/kg/min and then lowered corresponding to brain rSO2 levels and blood gas data. Isosorbide dinitrate and chlorpromazine were administered to enhance peripheral perfusion flow. Regional oxygen saturation of the forehead and thighs were monitored. The stage of acute kidney injury (AKI) was classified based on the Kidney Disease Improving Global Outcomes criteria. RESULTS: No patients had neurological events and peritoneal dialysis after surgery. The incidence of AKI was 39.3% with only three patients having greater than stage 2 AKI. The maximum postoperative serum creatinine concentration was negatively associated with the lowest rSO2T during HFRCP. The rSO2T during HFRCP was a predictive factor for postoperative creatinine increase of ≧0.3 mg/dL. The area under receiver operating characteristic curve was 0.78 with the cutoff value of 48% for rSO2T. CONCLUSIONS: The rSO2T during HFRCP is a potential predictor of postoperative renal function. To prevent AKI, the rSO2T should be preserved more than 48% by increasing HFRCP flow.

[The Initial Learning Curve of Robot-assisted Cardiac Surgery].

Initial 37 cases of robot-assisted cardiac surgery were reviewed. The early outcomes were favorable with low transfusion rate and no mortality, but some of the very early cases required reoperation after discharge. In our cohort, in terms of aortic cross-clamp time, the learning curve seemed to mature at shortly after the 30th case, but in view of the whole operation time, it did not plateau as of the 37th case.

Degos disease complicated by constrictive pericarditis in remote phase: a case report.

BACKGROUND: Degos disease, also known as malignant atrophic papulosis, is characterised by cutaneous manifestations due to chronic thrombo-obliterative vasculopathy. There have been reports of the rare late-onset Degos disease complicated by constrictive pericarditis (CP). This study reports a case of CP caused by Degos disease that developed 20 years after diagnosis. CASE PRESENTATION: A 62-year-old woman who had been taking aspirin for 20 years for Degos disease was hospitalised for worsening of heart failure. The patient was diagnosed with CP and underwent pericardiectomy. Pathological findings suggested the involvement of Degos disease. The postoperative course was uneventful, and her heart failure and Degos disease did not worsen. CONCLUSIONS: The study findings suggests that Degos disease can cause long-term CP. Aspirin effectively inhibited the progression of Degos disease, and surgical treatment was necessary when heart failure due to CP was refractory to treatment.

Outcomes after Rivaroxaban Treatment of Extensive Deep Vein Thrombosis.

BACKGROUND: Regression of thrombus in response to treatment with direct oral anticoagulants (DOACs) in patients with extensive deep vein thrombosis (DVT) has not been fully evaluated. This study aimed to determine the therapeutic efficacy of rivaroxaban in the treatment of extensive DVT. METHODS: We retrospectively evaluated 76 patients treated with rivaroxaban among 728 new DVT patients, at our hospital from January 2018 to March 2021. Extensive DVT was defined as thrombus connecting to 2 or more segments of the inferior vena cava (IVC), iliac vein, femoral vein, or popliteal vein. Localized DVT was defined as a thrombus confined to 1 segment of the inferior vena cava (IVC), iliac vein, femoral vein, or popliteal vein. We compared the changes in thrombus between the extensive DVT group (36 patients) and the localized DVT group (40 patients). RESULTS: In the localized DVT group, 14 (37%) had total recanalization within 3 weeks after DOAC initiation, and 30 (79%) had total recanalization within 3 months. In the extensive DVT group, only 3 (9%) had total recanalization within 3 weeks after starting DOAC, and even after 3 months, only 5 (15%) had total recanalization. Symptoms (P = 0.01) and extensive DVT (P < 0.01) were significantly associated with the risk for failure of total recanalization. CONCLUSIONS: Rivaroxaban was highly effective for total recanalization of localized DVT but not for symptomatic or extensive DVT. In patients with symptomatic extensive DVT, catheter-based thrombolysis may be considered in selected cases.

Features of trunk muscle wasting during acute care and physical function recovery with aortic disease.

BACKGROUND: Low skeletal muscle area or density, such as myosteatosis, identified on computed tomography (CT) is associated with poor prognosis in patients with cardiovascular diseases. However, there is a lack of evidence regarding the clinical process of skeletal muscle decline as a short-term change during acute care settings. This study focused on the use of routine CT imaging for aortic disease management and investigated the changes in skeletal muscle before and after acute care. METHODS: This prospective study included 123 patients who underwent abdominal CT before and after acute care. The all-abdominal and each abdominal muscle areas were divided into eight parts (e.g. rectus abdominis, psoas, and erector spine), and their areas and densities were measured at the third lumbar vertebra level after the patients were discharged and de-identified with blinding to avoid measurement bias. Short physical performance battery (SPPB) was measured at the start and end of in-hospital cardiac rehabilitation. A generalized linear model with patients as random effects was made to investigate skeletal muscle loss during acute care. Multivariate linear regression analysis was also used to assess the relationship between the change in skeletal muscle during acute care and SPPB during in-hospital cardiac rehabilitation. RESULTS: The median age of the patients was 70 (interquartile: 58-77) years, and 69.9% (86/123) were men. The median day between acute care from the day of surgery or hospital admission and follow-up CT was 7 (interquartile: 3-8) days. Overall muscle density declined after acute care (estimate value: -3.640, 95% confidence interval [CI]: -4.538 to -2.741), and each abdominal muscle density consistently declined (interaction: F value = 0.099, P = 0.998). In contrast, there was no significant change in the overall muscle area (estimate value: -0.863, 95% CI: -2.925 to 1.200). Changes in the muscle area were different for each skeletal muscle (interaction: F value = 2.142, P = 0.037), and only the erector spine muscle significantly declined (estimate value: -1.836, 95% CI: -2.507 to -1.165). After adjusting for confounding factors, a greater decline in muscle density was associated with lower recovery score on SPPB (ß = 0.296, 95% CI: 0.066 to 0.400). CONCLUSIONS: Muscle density consistently declined after acute care, especially the erector spine muscles, which also significantly decreased in size. A higher decline in muscle density was associated with a slower recovery of physical function during in-hospital cardiac rehabilitation in patients with aortic diseases.

Near-infrared spectroscopy device selection affects intervention management for cerebral desaturation during cardiopulmonary bypass surgery.

OBJECTIVE: Currently, several near-infrared spectroscopy oximetry devices are used for detecting cerebral ischemia during cardiopulmonary bypass (CPB) surgery. We investigated whether two different models of near-infrared spectroscopy oximetry devices affect the assessment of cerebral ischemia and its management during CPB. METHODS: From January 2017 to August 2017, 70 adult cardiovascular surgery cases were randomly assigned to 1 of 2 different near-infrared spectroscopy oximetry devices. The devices were INVOS 5100C (Medtronic, Minneapolis, MN, USA) (group I; n = 35) and FORE-SIGHT ELITE (CAS Medical Systems, Branford, CT, USA) (group F; n = 35). RESULTS: There were no significant differences in patient characteristics. The rSO2 values were significantly higher for patients in group F than for patients in group I. Scalp-Cortex distance showed negative correlations with the mean rSO2 values in group I (P = 0.01). Interventions for low rSO2 during CPB for groups I and F were increase perfusion flow (13:5; P = 0.03), blood transfusion (7:1; P = 0.02), and both (6:1; P = 0.04), respectively. The Scalp-Cortex distance in group I was significantly longer in patients who required intervention than in patients who did not (17.1 ± 2.5 vs 15.1 ± 1.6 mm; P = 0.007). CONCLUSIONS: It is inappropriate to use the same intervention criteria for different near-infrared spectroscopy oximetry devices. Moreover, brain atrophy influence rSO2 values depending on device selection. It is important to note that inappropriate device selection may misguide perfusionists into performing unnecessary or excessive intervention during CPB.

Neutrophil-to-lymphocyte ratio is prognostic factor of prolonged pleural effusion after pediatric cardiac surgery.

OBJECTIVES: Postoperative pleural effusion (PE) is common after pediatric cardiac surgery, and if prolonged can lead to the deterioration of the general condition due to malnutrition and result in death. This study aims at identifying the prognostic factors of prolonged PE after pediatric cardiac surgery.Design and settings: Patients were divided into the effective (with chest tube removal within 10 days after medical therapy) and ineffective (with chest tube in place for more than 10 days) groups. The factors were compared between the two groups retrospectively. PARTICIPANTS: Participants included patients who had prolonged PE after cardiac surgery in national center for child and health development between October 2014 and October 2017. MAIN OUTCOME MEASURES: Baseline characteristics and procedure details were compared between the two groups to determine the predictor of prolonged PE. White blood cell count, platelet count, neutrophil-to-lymphocyte ratio, hemoglobin level, serum total protein level, serum albumin level, blood fibrinogen level, serum creatinine level, etc. were examined. RESULTS: Twenty patients were included. Between the two groups, no significant differences in baseline characteristics, such as age, weight, and sex were found, and significant differences were observed only in the NLR change ratio (effective group, 5.1 [4.1-8.0] versus ineffective group, 11.9 [9.9-14.1]; P = 0.01). CONCLUSIONS: NLR change ratio is a potential prognostic factor of prolonged PE, including chylothorax, after pediatric cardiac surgery.

Low skeletal muscle density combined with muscle dysfunction predicts adverse events after adult cardiovascular surgery.

BACKGROUND AND AIMS: Although muscle dysfunctions are widely known as a poor prognostic factor in patients with cardiovascular disease, no study has examined whether the addition of low skeletal muscle density (SMD) assessed by computed tomography (CT) to muscle dysfunctions is useful. This study examined whether SMDs can strengthen the predictive ability of muscle dysfunctions for adverse events in patients who underwent cardiovascular surgery. METHODS AND RESULTS: We retrospectively reviewed 853 patients aged ≥40 years who had preoperative CT for risk management purposes and who measured muscle dysfunctions (weakness: low grip strength and slowness: slow gait speed). Low SMD based on transverse abdominal CT images was defined as a mean Hounsfield unit of the psoas muscle <45. All definitions of muscle dysfunction (weakness only, slowness only, weakness or slowness, weakness and slowness), the addition of SMDs was shown to significantly improve the continuous net reclassification improvement and integrated discrimination improvement for adverse events in all analyses (p < 0.05). Low SMDs combined with each definition of muscle dysfunction had the highest risk of all-cause death (hazard ratio: lowest 3.666 to highest 6.002), and patients with neither low SMDs nor muscle dysfunction had the lowest risk of all-cause and cardiovascular-related events. CONCLUSION: The addition of SMDs consistently increased the predictive ability of muscle dysfunctions for adverse events. Our results suggest that when CT is performed for any clinical investigation, the addition of the organic assessment of skeletal muscle can strengthen the diagnostic accuracy of muscle wasting.

Transcatheter Aortic Valve Replacement in Patients With a Small Annulus　- From the Japanese Nationwide Registry (J-TVT).

BACKGROUND: The details and consequences of a small aortic annulus among transcatheter aortic valve replacement (TAVR) patients remain uncertain. This study investigated the short-term outcomes in patients with small annular size and compared the 30-day outcome between intra- and supra-annular devices, with similar outer casing diameter in this subgroup.Methods and Results:Cases registered in the Japanese national TAVR registry between August 2013 and December 2017 were analyzed. Among a total of 5,870 registered patients, 647 (11.0%) had small annulus (area ≤314 mm2) measured by multi-detector computed tomography. Patients with a small annulus had a significantly smaller indexed effective orifice area (iEOA, 1.10 cm2/m2[0.92-1.35] vs. 1.16 cm2/m2[0.96-1.39], P<0.001) and higher mean pressure gradient (mPG, 10.0 mmHg [6.9-14.2] vs. 8.5 mmHg [6.0-11.5], P<0.001) compared with a normal-sized annulus. Among patients with a small annulus, those receiving a 20 mm intra-annular device had a smaller iEOA (0.94 cm2/m2[0.78-1.06] vs. 1.07 cm2/m2[0.8-1.24], P=0.001) and higher mPG (14.0 mmHg [10.0-18.5] vs. 11.0 [7.0-14.0], P<0.001) compared with those receiving a 23-mm supra-annular device, although the incidence of paravalvular leakage (≥moderate) was similar (14.4% vs. 16.5%, P=0.69). CONCLUSIONS: Patients with a small annulus were associated with less hemodynamic improvement. A supra-annular device is associated with better echocardiographic improvement in patients with a small annulus, without increasing paravalvular leakage.