Alerta monitoramento do horizonte tecnológico: MITRACLIP® para insuficiência mitral grave em pacientes de alto risco cirúrgico / Alert technological horizon monitoring: MITRACLIP® for severe mitral regurgitation in high surgical risk patients

DESCRIÇÃO DA TECNOLOGIA: O dispositivo Mitraclip®, através do acesso femoral, chega ao átrio esquerdo por meio de uma punção transeptal. As extremidades livres dos folhetos da valva mitral são clipadas, criando um duplo orifício e reduzindo o volume regurgitante. O procedimento é guiado através da ecocardiografia transesofágica (ETE), e se a insuficiência mitral não for controlada de maneira satisfatória, um segundo clipe pode ser utilizado, ou o clipe pode ser removido sem aparente dano do folheto. REGISTRO DA TECNOLOGIA NO MUNDO: Trata-se de uma tecnologia nova em fase de adoção, pois já possui registro na Agência Nacional de Vigilância Sanitária (Anvisa). Aprovado para utilização no Brasil sob o número 25351.099555/2013-99, publicado no diário oficial em 24 de março de 2014. Também aprovado pelo CE Mark em 2008 e pelo FDA em 2013, o Mitraclip® foi aprovado para uso restrito nos casos de regurgitação mitral degenerativa moderada à grave ou grave, em pacientes sintomáticos e com risco cirúrgico considerado proibitivo. PESQUISA CLÍNICA: Para coletar informações sobre eficácia e segurança do dispositivo, foram selecionados ensaios clínicos randomizados, concluídos e em andamento. Estudos concluídos: Embora muitas intervenções percutâneas estejam em desenvolvimento, apenas duas encontram-se atualmente disponíveis no mercado internacional: MitraClip® e Carillon®. A MitraClip®, única aprovada pelo FDA e pela Anvisa, possui uma base de evidências mais desenvolvida, embora ainda limitada, com apenas um ensaio clínico randomizado, o EVEREST II. ESTUDOS EM ANDAMENTO: Foram identificados dois estudos em andamento. O estudo COAPT (NCT01626079), ainda recrutando, está selecionando pacientes com IM funcional moderada à grave ou grave, sintomáticos, considerados inaptos à cirurgia. Os pacientes, estimativa de 610, serão randomizados para Mitraclip® ou tratamento padrão. Estudo com término programado para 201416. O segundo estudo, RESHAPE-HF (NCT02444338) também randomizou pacientes com IM funcional e tem como comparador o tratamento padrão. Os resultados, inicialmente programados para 2015, foram adiados devido ao lento recrutamento, expectativa de término em 2017. Os resultados destes dois estudos podem impactar significativamente a indicação do Mitraclip® nos pacientes com IM funcional.

Single-Center Experience With Adjustable Annuloplasty Ring in Degenerative Mitral Regurgitation.

OBJECTIVE: Owing to the complex anatomy of the mitral valve, successful surgical repair of degenerative regurgitation remains a challenging procedure in cardiac surgery. METHODS: This paper aimed to report on our single-center experience with 20 patients who received an adjustable annuloplasty ring (Cardinal ring, ValtechCardio Ltd, Or Yehuda, Israel) as part of their mitral valve repair procedure. The device allows for intraoperative echocardiography-guided ring size adjustments under beating-heart conditions. RESULTS: All of the 20 patients left the operating room without any residual mitral regurgitation. There was no risk of systolic anterior movement (SAM) because of image-guided fine tuning of the ring before weaning the patient from bypass. CONCLUSIONS: Further multicenter data are required to prove the concept of adjustable annuloplasty devices.

Manual Skill Acquisition During Transesophageal Echocardiography Simulator Training of Cardiology Fellows: A Kinematic Assessment.

OBJECTIVE: To investigate whether a transesophageal echocardiography (TEE) simulator with motion analysis can be used to impart proficiency in TEE in an integrated curriculum-based model. DESIGN: A prospective cohort study. SETTING: A tertiary-care university hospital. PARTICIPANTS: TEE-naïve cardiology fellows. INTERVENTIONS: Participants underwent an 8-session multimodal TEE training program. Manual skills were assessed at the end of sessions 2 and 8 using motion analysis of the TEE simulator's probe. At the end of the course, participants performed an intraoperative TEE; their examinations were video captured, and a blinded investigator evaluated the total time and image transitions needed for each view. Results are reported as mean±standard deviation, or median (interquartile range) where appropriate. MEASUREMENTS AND MAIN RESULTS: Eleven fellows completed the knowledge and kinematic portions of the study. Five participants were excluded from the evaluation in the clinical setting because of interim exposure to TEE or having participated in a TEE rotation after the training course. An increase of 12.95% in post-test knowledge scores was observed. From the start to the end of the course, there was a significant reduction (p<0.001 for all) in the number of probe. During clinical performance evaluation, trainees were able to obtain all the required echocardiographic views unassisted but required a longer time and had more probe transitions when compared with an expert. CONCLUSION: A curriculum-based approach to TEE training for cardiology fellows can be complemented with kinematic analyses to objectify acquisition of manual skills during simulator-based training.

Hemodynamic assessment of ventilated ICU patients with cardiorespiratory failure using a miniaturized multiplane transesophageal echocardiography probe.

PURPOSE: To assess the feasibility, image quality, diagnostic accuracy, therapeutic impact and tolerance of diagnostic and hemodynamic assessment using a novel miniaturized multiplane transesophageal echocardiography (TEE) probe in ventilated ICU patients with cardiopulmonary compromise. STUDY DESIGN: Prospective, descriptive, single-center study. METHODS: Fifty-seven ventilated patients with acute circulatory or respiratory failure were assessed, using a miniaturized multiplane TEE probe and a standard TEE probe used as reference, randomly by two independent experienced operators. Measurements of hemodynamic parameters were independently performed off-line by a third expert. Diagnostic groups of acute circulatory failure (n = 5) and of acute respiratory failure (n = 3) were distinguished. Hemodynamic monitoring was performed in 9 patients using the miniaturized TEE probe. TEE tolerance and therapeutic impact were reported. RESULTS: The miniaturized TEE probe was easier to insert than the standard TEE probe. Despite lower imaging quality of the miniaturized TEE probe, the two probes had excellent diagnostic agreement in patients with acute circulatory failure (Kappa: 0.95; 95% CI: 0.85-1) and with acute respiratory failure (Kappa: 1; 95% CI: 1.0-1.0). Accordingly, therapeutic strategies derived from both TEE examinations were concordant (Kappa: 0.82; 95% CI: 0.66-0.97). The concordance between quantitative hemodynamic parameters obtained with both TEE probes was also excellent. No relevant complication secondary to TEE probes insertion occurred. CONCLUSIONS: Hemodynamic assessment of ventilated ICU patients with cardiopulmonary compromise using a miniaturized multiplane TEE probe appears feasible, well-tolerated, and relevant in terms of diagnostic information and potential therapeutic impact. Further larger-scale studies are needed to confirm these preliminary results.

Hemodynamic assessment of critically ill patients using a miniaturized transesophageal echocardiography probe.

INTRODUCTION: Hemodynamic management in intensive care patients guided by blood pressure and flow measurements often do not sufficiently reveal common hemodynamic problems. Trans-esophageal echocardiography (TEE) allows for direct measurement of cardiac volumes and function. A new miniaturized probe for TEE (mTEE) potentially provides a rapid and simplified approach to monitor cardiac function. The aim of the study was to assess the feasibility of hemodynamic monitoring using mTEE in critically ill patients after a brief operator training period. METHODS: In the context of the introduction of mTEE in a large ICU, 14 ICU staff specialists with no previous TEE experience received six hours of training as mTEE operators. The feasibility of mTEE and the quality of the obtained hemodynamic information were assessed. Three standard views were acquired in hemodynamically unstable patients: 1) for assessment of left ventricular function (LV) fractional area change (FAC) was obtained from a trans-gastric mid-esophageal short axis view, 2) right ventricular (RV) size was obtained from mid-esophageal four chamber view, and 3) superior vena cava collapsibility for detection of hypovolemia was assessed from mid-esophageal ascending aortic short axis view. Off-line blinded assessment by an expert cardiologist was considered as a reference. Inter-rater agreement was assessed using Chi-square tests or correlation analysis as appropriate. RESULTS: In 55 patients, 148 mTEE examinations were performed. Acquisition of loops in sufficient quality was possible in 110 examinations for trans-gastric mid-esophageal short axis, 118 examinations for mid-esophageal four chamber and 125 examinations for mid-esophageal ascending aortic short axis view. Inter-rater agreement (Kappa) between ICU mTEE operators and the reference was 0.62 for estimates of LV function, 0.65 for RV dilatation, 0.76 for hypovolemia and 0.77 for occurrence of pericardial effusion (all P<0.0001). There was a significant correlation between the FAC measured by ICU operators and the reference (r=0.794, P (one-tailed)<0.0001). CONCLUSIONS: Echocardiographic examinations using mTEE after brief bed-side training were feasible and of sufficient quality in a majority of examined ICU patients with good inter-rater reliability between mTEE operators and an expert cardiologist. Further studies are required to assess the impact of hemodynamic monitoring by mTEE on relevant patient outcomes.

Three-dimensional echocardiography in the assessment of cardiac tumors: the added value of the extra dimension.

Echocardiography is the most frequently used imaging modality in the assessment of cardiac tumors. Historically, this evaluation had been based on the analysis of 2-dimensional (2D) echocardiographic sectors of the heart. The information obtained from orthogonal tomographic planes from several acoustic windows was used in an attempt to mentally reconstruct a model of how the tumor would actually look in 3 dimensions and how it would relate to its adjacent structures. New technology using matrix-array-transducers has permitted the development of real-time three-dimensional echocardiography (RT3DE), bringing cardiac imaging to a new dimension. Now it is possible to capture and analyze the entire volume of a cardiac tumor in a single cardiac cycle. This new imaging modality provides valuable clinical information that empowers echocardiographers with new levels of confidence in the diagnosis of heart disease. This manuscript discusses the added value of this new technology in the echocardiographic assessment of cardiac tumors.

Use of hand carried ultrasound, B-type natriuretic peptide, and clinical assessment in identifying abnormal left ventricular filling pressures in patients referred for right heart catheterization.

BACKGROUND: The estimation of left ventricular filling pressure (LVFP) remains a critical component in the management of patients with known or suspected acute heart failure syndromes. Although right heart catheterization (RHC) remains the gold standard, several noninvasive parameters, including clinical assessment, B-type natriuretic peptides (BNP), and echocardiography can approximate LVFP. We sought to use a combination of these measures to noninvasively predict high or low LVFP in a population referred for RHC. METHODS AND RESULTS: The study consisted of validation of hand-carried ultrasound (HCU)-derived measurement of mitral E/E' against standard echocardiograms in 50 patients, as well as direct comparison of jugular venous pressure (JVP), a clinical congestion score, HCU-derived E/E' and maximum inferior vena cava diameter (IVCmax), and BNP with pulmonary capillary wedge pressure (PCWP) in another 50 patients. The mean age was 61 years, ejection fraction 40%, JVP 9 cm, BNP 948 pg/mL, IVCmax 2.1 cm, E/E' 13, and PCWP 21. All parameters performed well in determining PCWP >or=15 mm Hg, with clinical score performing the worst (area under the receiver-operator characteristic curve [AUC] 0.74), and IVCmax performing the best (AUC 0.89). JVP, in combination with HCU-derived parameters and BNP performed better than any of the individual tests alone (AUC 0.97 for combination of all 3). CONCLUSIONS: Clinical score, JVP, HCU indices, and BNP perform well at identifying patients with a PCWP >or=15 mm Hg. Use of these indices alone or in combination can be used to identify and potentially monitor patients with high LVFP in the inpatient and outpatient settings.

The accuracy of preload assessment by different transesophageal echocardiographic techniques in patients undergoing cardiac surgery.

OBJECTIVES: The aim of this study was to compare the following approaches to assess left ventricular preload by transesophageal echocardiography (TEE): left ventricular end-diastolic volume index (LVEDVI) determined by using the method of disc summation (LVEDVI(Md)) and left ventricular end-diastolic area index (LVEDAI) were compared with LVEDVI assessed by the modified Simpson formula (LVEDVI(Si)). Global end-diastolic volume index (GEDVI) and stroke volume index (SVI) measured by the PiCCO(plus) system (Pulsion Medical Systems, Munich, Germany) were used as TEE-independent reference variables. DESIGN: Prospective observational study. SETTING: Community hospital. PARTICIPANTS: Twenty-two patients undergoing elective cardiac surgery. INTERVENTIONS: After the induction of anesthesia, hemodynamic assessment by TEE and the PiCCO(plus) system was made 20 (T(1)) and 10 minutes (T(2)) before and 10 (T(3)) and 20 minutes (T(4)) after a fluid trial. At each time point, LVEDVI(Md), LVEDAI, LVEDVI(Si), GEDVI, and SVI were determined. MEASUREMENTS AND MAIN RESULTS: The fluid trial resulted in a significant increase of all preload variables measured at T(3). At T(4), all preload variables but LVEDVI(Md) showed a significant decrease. The mean bias +/- 2 SD for percent changes (Delta) of LVEDVI(Md) - DeltaLVEDVI(Si) was 1.5% +/- 59.0% and for DeltaLVEDAI - Delta LVEDVI(Si) 0.9% +/- 23.6%. The correlation between LVEDVI(Md) and LVEDVI(Si) was significantly weaker than between LVEDAI and LVEDVI(Si) (p < 0.001). Comparing TEE measurements with GEDVI and SVI, strong correlations were observed for LVEDAI and LVEDVI(Si) only. CONCLUSION: The method of disc summation cannot be recommended for preload assessment during a fluid challenge in cardiac surgery patients. By contrast, single-plane area measurements provided reliable information when compared with the application of the modified Simpson formula.

Esophageal Doppler monitoring for hemodynamic assessment.

This article reviews the importance of hemodynamic monitoring in adding to the clinical assessment of critically ill patients. The esophageal Doppler monitor (EDM) provides a less invasive way of obtaining hemodynamic information quickly and safely at the bedside. The concepts of Doppler signal acquisition and important nursing considerations are reviewed. Case studies are provided to understand how data from the EDM can impact patient care decisions at the bedside.

Transesophageal assessment of left atrial thrombus using a 3.3-mm monoplane probe.

OBJECTIVES: Our study was designed to demonstrate that transesophageal echocardiography using a 3.3-mm monoplane probe can accurately evaluate the left atrium for patients with arrhythmias before cardioversion. BACKGROUND: Standard probes cause discomfort during intubation requiring sedation, but miniature probes do not. METHODS: With topical anesthesia alone, a 3.3-mm probe was used for transesophageal echocardiography in 60 patients. After intravenous sedation, standard transesophageal echocardiography was then performed. RESULTS: In 51 of 60 patients, the left atrium was visualized with the 3.3-mm probe. In 43 of 51 patients the appendage was clear. A thrombus was seen in 7 patients on both studies. In one patient spontaneous echocontrast was seen only with the 3.3-mm probe (sensitivity 100%, specificity 97%). In 9 of 60 patients, the appendage could not be assessed. CONCLUSIONS: In many patients the 3.3-mm probe can visualize the appendage and obviate the need for sedation. Technical advances will improve image quality with miniature probes.

Usefulness of intraoperative transesophageal echocardiography in the assessment of surgical repair of pediatric ventricular septal defects with video-assisted endoscopic techniques in children.

BACKGROUND: Mini cardiac operative procedures with video-assisted endoscopic techniques for closure of ventricular septal defects (VSDs) in pediatric patients have become quite popular for cardiac surgery. A precise diagnosis is very important for determining the surgical approach, and evaluation by intraoperative transesophageal echocardiography (TEE) plays a major role in confirmation of the preoperative diagnosis, residual defects, and the need to return to the bypass after repair. METHODS: Sixty-five patients (30 boys and 35 girls; aged 8.7 +/- 5.3 years) who were undergoing minimally invasive closure of VSDs were monitored with a Hewlett-Packard color Doppler pediatric TEE throughout the procedure. RESULTS: Closure of the defect was successfully performed in all patients. Sixty-two patients showed neither residual shunt nor aortic regurgitation after the repair. Residual leaks were detected intraoperatively in 3 patients after the repair. One patient required a return to the bypass with an immediate reoperation due to a residual color jet diameter of > 3 mm. One patient was changed from video-assisted endoscopic techniques to a surgical approach for closure of the VSD from a conventional median sternotomy after identification by TEE of an outlet-type perimembranous VSD with 2 additional muscular VSDs. CONCLUSIONS: Our study showed that, with refinement of surgical closure of VSD via video-assisted endoscopic techniques, intraoperative TEE provides valuable and accurate information for decision-making in surgical management, provides immediate assessment of surgical repairs, and prevents reintervention and the morbidity associated with residual flow.

Expert consensus for training in perioperative echocardiography in the province of Quebec.

PURPOSE: Establish an expert consensus for training in perioperative echocardiography in the province of Quebec. METHODS: Cardiac anesthesiologists practicing in the province of Quebec with expertise in echocardiography were involved in the development of a multicentre expert consensus on training in perioperative echocardiography. Guidelines for training in adult echocardiography, transesophageal echocardiography and perioperative echocardiography by the American Society of Echocardiography (ASE), the American College of Cardiology (ACC) and/or the Society of Cardiovascular Anesthesiologists (SCA) were reviewed. RESULTS: A basic, advanced and director level of expertise were identified for training in perioperative echocardiography. The total number of echocardiographic examinations to achieve each of these levels of expertise remains unchanged from the 2002 ASE-SCA guidelines. However, the recommended proportion of examinations performed personally is increased in the Quebec expert consensus for both the basic and the advanced level of training to ensure proficiency in echocardiography while providing anesthesia care to the patient. A level of autonomy in perioperative echocardiography is also identified in the basic level of training as defined in the Quebec expert consensus. Maintenance of competence, certification in the perioperative transesophageal echocardiography (PTE) examination and duration of training are outlined for each of the three levels of training in the Quebec expert consensus but are not part of the recent 2002 ASE-SCA guidelines. CONCLUSION: Adequate perioperative echocardiographic training is an important aspect of cardiovascular anesthesia. The ACC, ASE and SCA guidelines for training in echocardiography were modified to reflect the expert consensus of anesthesiologists in the province of Quebec.

Newer trends in monitoring: the esophageal Doppler monitor.

The esophageal Doppler monitor is a recent development in hemodynamic monitoring that is used for surgical patients. It is relatively noninvasive and measures descending aortic blood flow by the Doppler effect. A comparison of this new monitor with the pulmonary artery catheter is cited numerous times throughout the literature and overall correlates well. Studies of the esophageal Doppler monitor show it to be a safe addition to operating room monitors for use by the anesthetist.

Assessment of transmural coronary blood flow with intraoperative transesophageal color Doppler echocardiography during coronary revascularization.

Intraoperative color Doppler transesophageal echocardiography with a 4- to 7-MHz transducer was performed on 28 consecutive patients who underwent coronary artery bypass grafting to image and evaluate the transmural coronary blood flow before and after cardiopulmonary bypass. The transmural coronary flow was visualized in 26 (92.8%) of 28 patients in the inferior wall and in 13 (46.4%) of 28 patients in the lateral wall. The peak diastolic flow velocity of the transmural coronary artery in the inferior and lateral wall was significantly increased after coronary revascularization in patients with a successful bypass graft to the right coronary artery (from 34.0 +/- 19.7 to 64.9 +/- 30.9 cm/s, P <.001, n = 10) and to the left circumflex coronary artery (from 35.1 +/- 18.6 to 62.1 +/- 21.1 cm/s, P <.001, n = 10). No significant changes were observed in patients with no bypass graft to the right or left circumflex coronary artery. Coronary blood flow can be mapped and the velocity measured with Doppler transesophageal echocardiography with a high-frequency (4- to 7-MHz) transducer. Assessment of the transmural coronary flow may provide valuable information and aid in decision making during surgical revascularization.

[The measurement of jet width at its origin in assessing mitral prosthetic regurgitation. The effect of the spatial disposition of the jet]. / Medida de la anchura del jet en su origen en la valoración de la regurgitación protésica mitral. Influencia de la disposición espacial del jet.

INTRODUCTION AND OBJECTIVES: The study was performed to test the influence of the jet spatial disposition on the correlation degree between the measurement of the jet width at its origin and the severity of mitral prosthetic regurgitation by transesophageal Doppler color flow imaging. MATERIAL AND METHODS: In 165 patients with mitral valve prosthesis which were submitted for transesophageal echocardiography examination due to suspected prosthetic dysfunction, we studied 126 with pathological mitral regurgitation. On these patients, studies of jet spatial disposition, maximum width in its origin and severity quantification by means of maximum regurgitation area were performed. RESULTS: For the free jet group of patients (90), jet width at its origin correlated with maximal regurgitation area (r = 0.75); whereas for the wall jet group (36), the correlation degree was 0.59. We observed a relationship (p < 0.05) between severe mitral regurgitation assessed by maximal regurgitant jet size and jet width > or = 5 mm in both groups: the sensitivity and specificity of 72.7% and 95% respectively for free jets, and 70.7% and 64.4% for wall jets. CONCLUSIONS: The correlation between the area measurement and the width in its origin is better for free jets than for wall jets. A statistically significant relationship between the presence of severe mitral regurgitation and width in its origin > or = 5 mm could be observed, independently of the jet spatial disposition.

Preoperative two- and three-dimensional transesophageal echocardiographic assessment of heart tumors.

BACKGROUND: Two-dimensional transesophageal echocardiography is the most widely used diagnostic approach in the rare entity of heart tumors. The aim of this study was to assess the diagnostic usefulness of three-dimensional echocardiography in comparison with the two-dimensional technique in a rare clinical setting. METHODS: Twenty-seven patients (18 women; mean age, 49.7 +/- 14 years) with a histologically proven diagnosis of a cardiac tumor were studied. The primary diagnosis was done by a two-dimensional transthoracic echocardiography (n = 9) and transesophageal echocardiography (n = 18). In addition, we performed three-dimensional transesophageal assessment in 5 patients with left atrial myxomas. The echocardiographic findings were compared with the intraoperative appearance and pathologic diagnosis. RESULTS: The echocardiographically suspected diagnosis of a heart tumor in 29 cases was histologically correct in 27 patients (myxomas, 20; epicardial lipoma, 1; malignant epicardial mesothelioma, 1; metastatic processes of hypernephromas, 2; and undifferentiated tumors of the pericardium, 3). Only the combination of multiplane transesophageal and three-dimensional echocardiography was able to demonstrate the shape, dimensions, location, origin, surface, three-dimensional movement, and involvement of valves and was most useful in the preoperative diagnosis and planning. CONCLUSIONS: Three-dimensional transesophageal echocardiography yields important additional clinical information and improves the operative planning. Three-dimensional echocardiography may become the best approach to study the anatomy and pathology of the heart as it provides an objective display of cardiac size and shape in heart tumors.