Sound analysis of the magnetically levitated left ventricular assist device HeartMate 3™.

INTRODUCTION: The HeartMate 3™ has shown lower rates of adverse events compared to previous devices due to the design and absence of mechanical bearings. For previous devices, sound analysis emerged as a way to assess pump function. The aims of this study were to determine if sound analysis can be applied to the HeartMate 3 in vivo and in vitro and to evaluate an electronic stethoscope. METHOD: Sound recordings were performed with microphones and clinical accessible electronic stethoscope. The recordings were studied in both the time and the frequency domains. Recordings from four patients were performed to determine if in vivo and in vitro recordings are comparable. RESULTS: The results show that it is possible to detect sound from HeartMate 3 and the sound spectrum is clear. Pump frequency and frequency of the pulsatile mode are easily determined. Frequency spectra from in vitro and in vivo recordings have the same pattern, and the major proportion (96.7%) of signal power is located at the pump speed frequency ±40 Hz. The recordings from the patients show low inter-individual differences except from location of peaks originating from pump speed and harmonics. Electronic stethoscopes could be used for sound recordings, but the dedicated equipment showed a clearer sound spectrum. DISCUSSION: The results show that acoustic analysis can also be performed with the HeartMate 3 and that in vivo and in vitro sound spectrum is similar. The frequency spectra are different from previous devices, and methods for assessing pump function or thrombosis need further evaluation.

Can predilatation in transcatheter aortic valve implantation be omitted? - a prospective randomized study.

BACKGROUND: The use of a balloon expandable stent valve includes balloon predilatation of the aortic stenosis before valve deployment. The aim of the study was to see whether or not balloon predilatation is necessary in transcatheter aortic valve replacement (TAVI). METHODS: Sixty consecutive TAVI patients were randomized to the standard procedure or to a protocol where balloon predilatation was omitted. RESULTS: There were no significant differences between the groups regarding early hemodynamic results or complication rates. CONCLUSIONS: TAVI can be performed safely without balloon predilatation and with the same early results as achieved with the standard procedure including balloon predilatation. The reduction in the number of pacing periods required may be beneficial for the patient.

Transvenous Implantation of a Stent Valve in Patients With Degenerated Mitral Prostheses and Native Mitral Stenosis.

BACKGROUND: The purpose of this study was to report the use of a transvenous transseptal approach using a stent valve in patients with degenerated biological mitral valve prostheses, regurgitation after mitral repair, and native mitral stenosis. METHODS: Ten patients (median age, 74 years; range, 20-89 years; 5 men and 5 women) with degenerated mitral bioprosthetic valves (n = 7), failed mitral repair (n = 1), or calcified native stenotic valves (n = 2) underwent transvenous implantation of a stent valve. RESULTS: The procedure was initially successful in all patients. Predilation was performed for balloon sizing only in the 2 patients with native mitral stenosis. The stent valve was deployed during 1 period of rapid pacing. A guidewire, as a loop from the right femoral vein and through the left ventricular apex, facilitated a good angle and secure positioning of the stent valve. An ultrasonographically guided puncture of the apex was carried out in 6 patients, and in the other 4 we performed a minithoracotomy before apical puncture. All valves were implanted in a good position with improved function and without significant paravalvular leakage (PVL). There were no periprocedural deaths. The 30-day survival was 80% (8 of 10 patients), and 60% (6 of 10) of patients were still alive a median time of 290 days after the procedure. CONCLUSIONS: Transvenous transseptal implantation of a stent valve was performed in 10 patients with mitral valve disease, with good early functional results. These high-risk patients must be carefully selected by a multidisciplinary team because the procedure carries a high mortality.

Transvenous Implantation of a Stent Valve for Calcified Native Mitral Stenosis.

We used a modified combination of the transseptal and transapical methods to facilitate the controlled delivery and use of a stent valve in a patient with calcified native mitral stenosis. A loop from the right femoral vein passing transseptally and then through the apex of the left ventricle was created, enabling highly controlled positioning and deployment of the stent valve.

Young woman with breast cancer and cardiotoxicity with severe heart failure treated with a HeartMate IITM for nearly 6 years before heart transplantation.

Cardiotoxicity is a multifactorial problem, which has emerged with the improvement of cancer therapies and survival. Heart transplantation is relatively contraindicated in patients with breast cancer, until at least 5 years after complete remission. We present a case where a young woman who in 2001, at the age of 31, was diagnosed with breast cancer. She was considered cured, but 4 years later she suffered a relapse. During her second treatment, in 2006, she suffered from severe heart failure. She received a HeartMate II, as a long-term bridge to transplantation and 6 years later she was successfully transplanted. In this case report we discuss the use of mechanical circulatory support in cancer patients with drug-induced heart failure.

Real-time intraoperative visualization of myocardial circulation using augmented reality temperature display.

For direct visualization of myocardial ischemia during cardiac surgery, we tested the feasibility of presenting infrared (IR) tissue temperature maps in situ during surgery. A new augmented reality (AR) system, consisting of an IR camera and an integrated projector having identical optical axes, was used, with a high resolution IR camera as control. The hearts of five pigs were exposed and an elastic band placed around the middle of the left anterior descending coronary artery to induce ischemia. A proximally placed ultrasound Doppler probe confirmed reduction of flow. Two periods of complete ischemia and reperfusion were studied in each heart. There was a significant decrease in IR-measured temperature distal to the occlusion, with subsequent return to baseline temperatures after reperfusion (baseline 36.9 ± 0.60 (mean ± SD) versus ischemia 34.1 ± 1.66 versus reperfusion 37.4 ± 0.48; p < 0.001), with no differences occurring in the non-occluded area. The AR presentation was clear and dynamic without delay, visualizing the temperature changes produced by manipulation of the coronary blood flow, and showed concentrically arranged penumbra zones during ischemia. Surface myocardial temperature changes could be assessed quantitatively and visualized in situ during ischemia and subsequent reperfusion. This method shows potential as a rapid and simple way of following myocardial perfusion during cardiac surgery. The dynamics in the penumbra zone could potentially be used for visualizing the effect of therapy on intraoperative ischemia during cardiac surgery.

Microwave Ablation in Mitral Valve Surgery for Atrial Fibrillation (MAMA).

Objective: Microwave ablation in conjunction with open heart surgery is effective in restoring sinus rhythm (SR) in patients with atrial fibrillation (AF). In patients assigned for isolated mitral valve surgery no prospective randomized trial has reported its efficacy. Methods: 70 patients with longlasting AF where included from 5 different centres. They were randomly assigned to mitral valve surgery and atrial microwave ablation or mitral valve surgery alone. Results: Out of 70 randomized, 66 and 64 patients were available for evaluation at 6 and 12 months. At 12 months SR was restored and preserved in 71.0 % in the ablation group vs 36.4 % in the control group (P=0.006), corresponding figures at 6 months was 62.5 % vs 26.5 % (P=0.003). The 30-day mortality rate was 1.4 %, with one death in the ablation group vs zero deaths in the control group. At 12 months the mortality rate was 7,1 % (Ablation n=3 vs Control n=2). No significant differences existed between the groups with regard to the overall rate of serious adverse events (SAE) during the perioperative period or at the end of the study. 16 % of patients randomized to ablation were on antiarrhytmic drugs compared to 6 % in the control group after 1 year (p=0.22). Conclusion: Microwave ablation of left and right atrium in conjunction with mitral valve surgery is safe and effectively restores sinus rhythm in patients with longlasting AF as compared to mitral valve surgery alone.

Improved model for myocardial diffuse reflectance spectra by including mitochondrial cytochrome aa3, methemoglobin, and inhomogenously distributed RBC.

The aim of this study was to compare a previously used light transport model (I) comprising the chromophores hemo- and myoglobin, fat, and water, with two extended models, where the chromophores of cytochrome aa3, methemo- and metmyoglobin are added (model II), and in addition, accounting for an inhomogenous hemoglobin distribution (model III). The models were evaluated using calibrated diffuse reflectance spectroscopy measurements on the human myocardium. Model II proved a significantly better spectral fitting, especially in the wavelength ranges corresponding to prominent absorption characteristics for the added chromophores. Model III was significantly better than model II and displayed a markedly higher tissue fraction and saturation of hemo- and myoglobin. The estimated tissue chromophore fractions, saturation and oxidation levels, were in agreement with other studies, demonstrating the potential of diffuse reflectance spectroscopy measurements for evaluating open heart surgery. However, the choice of chromophores and vessel packaging effects in the light transport model has a major effect on the results.

Intramyocardial oxygen transport by quantitative diffuse reflectance spectroscopy in calves.

Intramyocardial oxygen transport was assessed during open-chest surgery in calves by diffuse reflectance spectroscopy using a small intramuscular fiber-optic probe. The sum of hemo- and myoglobin tissue fraction and oxygen saturation, the tissue fraction and oxidation of cytochrome aa3, and the tissue fraction of methemoglobin were estimated using a calibrated empirical light transport model. Increasing the oxygen content in the inhaled gas, 21%-50%-100%, in five calves (group A) gave an increasing oxygen saturation of 19+/-4%, 24+/-5%, and 28+/-8% (p<0.001, ANOVA repeated measures design) and mean tissue fractions of 1.6% (cytochrome aa3) and 1.1% (hemo- and myoglobin). Cardiac arrest in two calves gave an oxygen saturation lower than 5%. In two calves (group B), a left ventricular assistive device (LVAD pump) was implanted. Oxygen saturation in group B animals increased with LVAD pump speed (p<0.001, ANOVA) and with oxygen content in inhaled gas (p<0.001, ANOVA). The cytochrome aa3 oxidation level was above 96% in both group A and group B calves, including the two cases involving cardiac arrest. In conclusion, the estimated tissue fractions and oxygenation/oxidation levels of the myocardial chromophores during respiratory and hemodynamic provocations were in agreement with previously presented results, demonstrating the potential of the method.

Myocardial tissue oxygenation estimated with calibrated diffuse reflectance spectroscopy during coronary artery bypass grafting.

We present a study using a method able to assess tissue oxygenation, taking into account the absorption and the level of scattering in myocardial tissue using a calibrated fiber optic probe. With this method, interindividual comparisons of oxygenation can be made despite varying tissue optical properties during coronary artery bypass grafting (CABG). During CABG, there are needs for methods allowing continuous monitoring and prediction of the metabolism in the myocardial tissue. 14 patients undergoing CABG are investigated for tissue oxygenation during different surgical phases using a handheld fiber optic spectroscopic probe with a source-detector distance of less than 1 mm. The probe is calibrated using a light transport model, relating the absorption and reduced scattering coefficients (mu(a) and mu(s)') to the measured spectra. By solving the inverse problem, absolute measures of tissue oxygenation are evaluated by the sum of oxygenized hemoglobin and myoglobin. Agreement between the model and measurements is obtained with an average correlation coefficient R2 of 0.96. Oxygenation is found to be significantly elevated after aorta cross-clamping and cardioplegic infusion, as well as after reperfusion, compared to a baseline (p<0.05). Tissue oxygenation decreases during cardiac arrest and increases after reperfusion.

HeartMate II left ventricular assist device; early European experience.

OBJECTIVE: The novel axial flow left ventricular assist device HeartMate II was introduced into clinical practice in Europe as part of the pilot study and after CE approval in November 2005. In order to get an overview of the use and performance of the device in Europe a group of investigators was founded to compare the initial results. METHODS: In a retrospective analysis of the first 101 consecutive cases in Europe, data were collected with regard to postoperative outcome and severe adverse events and anticoagulation protocols. Results were stratified by intention to treat as a bridge to transplant or as chronic support therapy in heart failure (destination therapy). RESULTS: In 70% of patients, the HeartMate II was intended as a bridge to transplant therapy, in 30%, it was used as a destination therapy device. The perioperative mortality post implant was 20% in the bridge to transplant patients and 7% in the destination therapy arm. However, after 1 year a comparable survival was observed in both groups (69% destination therapy, 63% bridge to transplant). Main causes of death were multiple organ failure (n=12) and cerebrovascular accidents (n=5). All, but one cerebrovascular accident occurred in the first 9 days after surgery. Only one other death was reported thereafter and there was no mechanical failure of the device. CONCLUSIONS: Even in the early experience the HeartMate II was used as a chronic support device in a substantial number of patients in Europe. Although the total experience is still limited, the incidence of cerebrovascular accidents is very low and the survival beyond the perioperative period is excellent.

Report generation and data mining in the domain of thoracic surgery.

As a part of AssistMe system, the reporting system has been developed for the thoracic surgery domain. Reporting System is defined as software for dynamic report generation purpose and based on the data-mining techniques. The target users of the future reporting system-physicians, administrative staff, and patients-have been identified. Two major types of clinical reports have been found: predefined and customized. The decision of splitting reports into groups has been taken mainly because users were heterogeneous and had different access rights to the sensitive information. Data-mining process in the reporting system is based on descriptive statistics. It allows dynamically mined AssistMe databases and generates statistical reports about patient's morbidity, mortality, and comorbidity. Information is visualized in the chart way and can be also observed in tabular form. User interaction is also supported by the system.

Risk factor analysis of Swedish Left Ventricular Assist Device (LVAD) patients.

BACKGROUND: The use of left ventricular assist devices (LVADs) is established as a bridge to heart transplantation. METHODS: All Swedish patients on the waiting list for heart transplantation, treated with LVAD since 1993 were retrospectively collected into a database and analyzed in regards to risk factors for mortality and morbidity. RESULTS: Fifty-nine patients (46 men) with a median age of 49 years (range, 14 to 69 years), Higgins score median of 9 (range, 3 to 15), EuroScore median of 10 (range, 5 to 17) were investigated. Dominating diagnoses were dilated cardiomyopathy in 61% (n = 36) and ischemic cardiomyopathy in 18.6% (n = 11). The patients were supported with LVAD for a median time of 99.5 days (range, 1 to 873 days). Forty-five (76%) patients received transplants, and 3 (5.1%) patients were weaned from the device. Eleven patients (18.6%) died during LVAD treatment. Risk factor analysis for mortality before heart transplantation showed significance for a high total amount of autologous blood transfusions (p < 0.001), days on mechanical ventilation postoperatively (p < 0.001), prolonged postoperative intensive care unit stay (p = 0.007), and high central venous pressure 24 hours postoperatively and at the final measurement (p = 0.03 and 0.01, respectively). Mortality with LVAD treatment was 18.6% (n = 11). High C-reactive protein (p = 0.001), low mean arterial pressure (p = 0.03), and high cardiac index (p = 0.03) preoperatively were risk factors for development of right ventricular failure during LVAD treatment. CONCLUSIONS: The Swedish experience with LVAD as a bridge to heart transplantation was retrospectively collected into a database. This included data from transplant and nontransplant centers. Figures of mortality and morbidity in the database were comparable to international experience. Specific risk factors were difficult to define retrospectively as a result of different protocols for follow-up among participating centers.

A Web-based patient information system--identification of patients' information needs.

Research described here was carried out to explore possibilities of creating a web-based patient information system within the areas of thoracic surgery. Data were collected to distinguish and assess the actual information needs of patients (1) prior to surgical treatment, (2) before discharge, and (3) 8 months after the hospitalization using a follow-up questionnaire. Interviews were performed with patients undergoing heart surgery. The study included material of 19 consecutive patients undergoing coronary artery bypass surgery (12) and valve replacement (7), age 35-74, 13 males and 6 females with nonacademic background. Patient satisfaction with given information was high. Analysis of the interviews held at the hospital resulted in seven different categories describing and giving a picture of the patients' information needs and apprehension of received care. The results found in this study can be used as guidance for developers in their design and development process of a health information system.