Virtual implantations to transition from porcine to bovine animal models for a total artificial heart.

Realheart total artificial heart (TAH) is a novel, pulsatile, four-chamber total artificial heart which had been successfully tested acutely in a porcine animal model. However, the bovine model is better suited for long-term testing and thus an evaluation of how the design would fit the bovine anatomy was required. Virtual implantation is a method that enables a computer simulated implantation based on anatomical 3D-models created from computer tomography images. This method is used clinically, but not yet adopted for animal studies. Herein, we evaluated its suitability in the redesign of the outer dimensions and vessel connections of Realheart TAH to transition from the porcine to the bovine animal model. Virtual implantations in combination with bovine cadaver studies enabled a series of successful acute bovine implantations. Virtual implantations are a useful tool to replace the use of animals in early device development and refine subsequent necessary in vivo experiments. The next steps are to carry out human virtual implantations and cadaver studies to ensure the design is optimized for all stages of testing as well as the final recipient.

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.

Sound analysis of a left ventricular assist device: A technical evaluation of iOS devices.

INTRODUCTION: The use of left ventricular assist device (LVAD) has grown rapidly. Adverse events do continue to occur. In recent years, analysis of LVAD sound recordings emerged as a means to monitor pump function and detect pump thrombosis. The aim of this study was to characterize the sounds from HeartMate II and to evaluate the use of handheld iOS devices for sound recordings. METHOD: Signal analysis of LVAD sound recordings, with dedicated recording equipment and iOS devices, was performed. Two LVADs running in mock loop circuits were compared to an implanted LVAD. Spectral analysis and parametric signal models were explored to quantify the sound and potentially detect changes in it. RESULTS: The sound recordings of two LVADs in individual mock loop circuits and a third one implanted in a patient appeared to be similar. Qualitatively, sound characteristics were preserved following changes in pump speed. Recordings using dedicated equipment showed that HeartMate II sound comprises low-frequency components corresponding to pump impeller rotation, as well as high-frequency components due to a pulse width modulation of the electric power to the pump. These different signal components interact and result in a complicated frequency spectrum. The iPhone and iPod recordings could not reproduce the sounds as well as the dedicated equipment. In particular, lower frequencies were affected by outside disturbances. DISCUSSION: This article outlines a systematic approach to LVAD sound analysis using signal processing methods to quantify and potentially detect changes, and describes some of the challenges, for example, with the use of inexpensive recording devices.

More than 20 years' experience of left ventricular assist device implantation at a non-transplant Centre.

OBJECTIVES: Over recent decades implantable left ventricular assist devices (LVAD) have increased the possibility of improved survival in patients with advanced heart failure who also benefit from a better quality of life. The aim of this retrospective survey was to review the clinical results of LVAD implantation at a low-volume non-transplant centre (Linköping, Sweden) between 1993 and 2016. Our aim was also to assess the mortality and morbidity rates associated with implantation of three LVAD versions at our centre, and to compare our results with those from transplant centres. DESIGN: A retrospective cohort study was performed examining the medical records of patients who had a HeartMate® (HMI, HMII, HMIII) LVAD implanted as a bridge to heart transplantation (BTT) or as destination therapy (DT) at the University Hospital, Linköping. RESULTS: Our main finding was a survival to heart transplantation rate of 82% among our BTT LVAD patients. The most common adverse event among our patients was infection. A higher frequency of temporary dialysis was seen in the HMII group compared to the HMI group, and the frequency of right ventricular failure was higher in our HMII material. CONCLUSIONS: Our data suggests that patients requiring long-term LVAD support can safely have their device implanted and cared for at a non-transplant centre.

Endovascular Stenting of a LVAD Outflow Graft Thrombosis.

We report the endovascular stenting of an outflow tract thrombosis in a left ventricular assist device in a patient with relative contraindications to sternotomy and pump exchange. This report highlights the importance of simultaneous prevention of stroke using filter devices in the common carotid arteries.

Left Atrial Pressure Monitoring With an Implantable Wireless Pressure Sensor After Implantation of a Left Ventricular Assist Device.

After implantation of a continuous-flow left ventricular assist device (LVAD), left atrial pressure (LAP) monitoring allows for the precise management of intravascular volume, inotropic therapy, and pump speed. In this case series of 4 LVAD recipients, we report the first clinical use of this wireless pressure sensor for the long-term monitoring of LAP during LVAD support. A wireless microelectromechanical system pressure sensor (Titan, ISS Inc., Ypsilanti, MI) was placed in the left atrium in four patients at the time of LVAD implantation. Titan sensor LAP was measured in all four patients on the intensive care unit and in three patients at home. Ramped speed tests were performed using LAP and echocardiography in three patients. The left ventricular end-diastolic diameter (cm), flow (L/min), power consumption (W), and blood pressure (mm Hg) were measured at each step. Measurements were performed over 36, 84, 137, and 180 days, respectively. The three discharged patients had equipment at home and were able to perform daily recordings. There were significant correlations between sensor pressure and pump speed, LV and LA size and pulmonary capillary wedge pressure, respectively (r = 0.92-0.99, p < 0.05). There was no device failure, and there were no adverse consequences of its use.

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.

Acoustic analysis of a mechanical circulatory support.

Mechanical circulatory support technology is continually improving. However, adverse complications do occur with devastating consequences, for example, pump thrombosis that may develop in several parts of the pump system. The aim of this study was to design an experimental clot/thrombosis model to register and analyze acoustic signals from the left ventricular assist device (LVAD) HeartMate II (HMII) (Thoratec Corporation, Inc., Pleasanton, CA, USA) and detect changes in sound signals correlating to clots in the inflow, outflow, and pump housing. Using modern telecom techniques, it was possible to register and analyze the HMII pump-specific acoustic fingerprint in an experimental model of LVAD support using a mock loop. Increase in pump speed significantly (P<0.005) changed the acoustic fingerprint at certain frequency (0-23,000 Hz) intervals (regions: R1-3 and peaks: P1,3-4). When the ball valves connected to the tubing were narrowed sequentially by ∼50% of the inner diameter (to mimic clot in the out- and inflow tubing), the frequency spectrum changed significantly (P<0.005) in P1 and P2 and R1 when the outflow tubing was narrowed. This change was not seen to the same extent when the lumen of the ball valve connected to the inflow tube was narrowed by ∼50%. More significant (P<0.005) acoustic changes were detected in P1 and P2 and R1 and R3, with the largest dB figs. in the lower frequency ranges in R1 and P2, when artificial clots and blood clots passed through the pump system. At higher frequencies, a significant change in dB figs. in R3 and P4 was detected when clots passed through the pump system. Acoustic monitoring of pump sounds may become a valuable tool in LVAD surveillance.

Long-term left ventricular support in patients with a mechanical aortic valve.

OBJECTIVES: The presence of a mechanical prosthesis has been regarded as an increased risk of thromboembolic complications and as a relative contraindication for a left ventricular assist device (LVAD). Five patients in our center had a mechanical aortic valve at the time of device implantation and were studied regarding thromboembolic complications. DESIGN: Five patients operated upon with an LVAD (1 HeartMate I™, 4 HeartMate II™) between 2002 and 2011 had a mechanical aortic valve at the time of implantation. The first patient had a patch closure of the aortic valve. In four patients, the prosthesis was left in place. Anticoagulants included aspirin, warfarin, and clopidogrel. RESULTS: The average and accumulated treatment times were 150 and 752 days, respectively. Three of the five patients showed early signs of valve thrombosis on echo with concomitant valve dysfunction. Four patients were transplanted without thromboembolic events during pump treatment. One patient died from a hemorrhagic stroke after 90 days on the LVAD. CONCLUSIONS: The strategy of leaving a mechanical heart valve in place at the time of LVAD implantation in five patients led to valvular thrombosis in three but did not provoke embolic events. It increased the complexity of postoperative anticoagulation.

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.

Transcatheter versus surgical treatment for aortic stenosis: patient selection and early outcome.

OBJECTIVES: To describe short-term clinical and echocardiography outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). To explore patient selection criteria for treatment with TAVI. DESIGN: TAVI patients (n = 45) were matched to SAVR patients (n = 45) with respect to age within ± 10 years, sex and systolic left ventricular function. RESULTS: TAVI patients were older, 82 ± 8 versus 78 ± 5 years (p = 0.005) and they had higher logEuroSCORE, 16 ± 11% versus 8 ± 4% (p = 0.001). There were no significant differences in 30 days mortality, stroke and myocardial infarction. TAVI patients received less erythrocyte (53% vs. 78%, p = 0.03) and thrombocyte (7% vs. 27%, p = 0.02) transfusions. Postoperative atrial fibrillation was less common (18% vs. 60%, p = 0.001) in the TAVI group. Paravalvular regurgitation was more common in TAVI patients (87% vs. 0%, p = 0.001) and 27% had access site complications. Aortic transvalvular velocity was 2.3 ± 0.4 m/s versus 2.6 ± 0.5 m/s (p = 0.002) and mean valve pressure gradient was 12 ± 4 mmHg versus 15 ± 5 mmHg (p = 0.01) in the TAVI and SAVR groups, respectively. Twenty-nine (64%) of the TAVI patients had logEuroSCORE = 15%. CONCLUSIONS: Both TAVI and SAVR have good short term clinical outcome with excellent hemodynamic result. In clinical practice, factors other than high logEuroSCORE play an important role in patient selection for TAVI.

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.

Echo-guided presentation of the aortic valve minimises contrast exposure in transcatheter valve recipients.

OBJECTIVES: We have developed a method using transthoracic echocardiography in establishing optimal visualization of the aortic root, to reduce the amount of contrast medium used in each patient. BACKGROUND: During transcatheter aortic valve implantation, it is necessary to obtain an optimal fluoroscopic projection for deployment of the valve showing the aortic ostium with the three cusps aligned in the beam direction. This may require repeat aortic root angiograms at this stage of the procedure with a high amount of contrast medium with a risk of detrimental influence on renal function. METHODS: We studied the conventional way and an echo guided way to optimize visualisation of the aortic root. Echocardiography was used initially allowing easier alignment of the image intensifier with the transducer's direction. RESULTS: Contrast volumes, radiation/fluoroscopy exposure times, and postoperative creatinine levels were significantly less in patients having the echo-guided orientation of the optimal fluoroscopic angles compared with patients treated with the conventional approach. CONCLUSION: We present a user-friendly echo-guided method to facilitate fluoroscopy adjustment during transcatheter aortic valve implantation. In our series, the amounts of contrast medium and radiation have been significantly reduced, with a concomitant reduction in detrimental effects on renal function in the early postoperative phase.

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.

Second harmonic echocardiography and spontaneous contrast during implantation of a left ventricular assist device.

Implantable mechanical left ventricular assist devices (LVADs) are used as a bridge or alternative to heart transplantation. Peroperative transesophageal echocardiography is commonly applied during implantation. Significant air embolism may occur as a result of air leakage at connections and anastomoses when LV filling becomes inadequate, and this must be prevented. Early suspicion and detection of air is mandatory to avoid negative circulatory effects. We hypothesized that monitoring of heart chamber size and occurrence of single air bubbles using second harmonic imaging (SHI) echocardiography may prevent risk for significant air embolism. After implantation of the LVAD in 10 calves, invasive hemodynamic monitoring and epicardial SHI were performed while increasing pump speed. Air bubbles in the ascending aorta were monitored and the left heart visualized for off-line dimensional analysis. Detection of air bubbles in the ascending aorta preceded their appearance in the left ventricle. They occurred exclusively but not always after a decrease in left atrial (LA) size. Decrease in LA pressure did not predict bubble detection or reduction in LA size. We conclude that SHI detects spontaneous ultrasound contrast during implantation of a LVAD and that a decrease in LA size is a warning that air embolism is imminent.

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.

A single center experience with the HeartMate II left ventricular assist device (LVAD).

OBJECTIVES: Left ventricular assist devices (LVAD), used in the setting bridge-to-transplantation and destination therapy, for patients with deteriorating severe heart failure are continuously developing. The second generation, the axial flow pumps, have been introduced since some years. DESIGN: Eleven consecutive patients, seven male, with severe heart failure due to ischemic cardiomyopathy (n=5), dilated cardiomyopathy (n=5) and cytotoxic etiology (n=1) were implanted with the HeartMate-II. They were preoperatively treated with inotropic support (n=9), ventricular assist device (n=2) and mechanical ventilation (n=4). RESULTS: Eight patients were bridged to transplant after median 155 days (range, 65 to 316 days). One patient is ongoing for 748 days, intended for destination therapy. Ten of eleven patients were discharged after median 64 days (range, 40 to 105 days). Four patients were reoperated due to bleeding. Two embolic events were recorded. One perioperative death. CONCLUSION: Eleven HM-II LVAD's have been implanted in our institution with good early results. Eight patients were successfully bridged to heart transplantation. One patient is intended for destination therapy and is ongoing since November 2006. In these severely ill patients, this technique offers a good chance surviving until heart transplantation. In selected cases the technique also offers the possibility of a permanent support and longevity.