Illnesses and Injuries at a Remote American Residential Summer Camp Over 3 Seasons.

INTRODUCTION: Residential and wilderness excursion summer camps are safe, but outdoor activities can lead to injuries. The frequency of various illnesses and injuries at summer camps has been incompletely described. The treatments provided and the need for escalation to higher levels of care are variable. METHODS: A retrospective cohort analysis was conducted for all visits to a camp infirmary over 3 seasons at a residential summer camp in Minnesota. Seventeen descriptive categories of chief complaints and 13 categories of treatment disposition were created for all 695 eligible infirmary visits. The frequency and illness type for which escalation to a higher level of care beyond the camp infirmary was needed were reviewed. RESULTS: Four hundred one campers sought medical care 695 times over 3 seasons. The most common chief complaints were related to skin (35%), musculoskeletal injury (17%), and upper-respiratory symptoms (15%). The most common treatment and dispositions were over-the-counter medications (43%) and simple bandage or dressing (19%). Escalation of care to a clinic or emergency room was uncommon, with 35 (5%) infirmary visits requiring escalation. Musculoskeletal injuries were the most common reason for escalations of care. While overall less common than musculoskeletal injury, dental injury almost always resulted in escalation of care. CONCLUSIONS: An analysis of 3 y of visits to a summer camp infirmary was used by camp medical staff to update protocols and obtain new supplies for diagnosis and treatments. A more complete understanding of the prevalence of injuries and illnesses has the potential to allow better preparation for camp medical staff.

Investigation of the inherent left-right flow balancing of rotary total artificial hearts by means of a resistance box.

With the incidence of end-stage heart failure steadily increasing, the need for a practical total artificial heart (TAH) has never been greater. Continuous flow TAHs (CFTAH) are being developed using rotary blood pumps (RBPs), leveraging their small size, mechanical simplicity, and excellent durability. To completely replace the heart with currently available RBPs, two are required; one for providing pulmonary flow and one for providing systemic flow. To prevent hazardous states, it is essential to maintain balance between the pulmonary and systemic circulation at a wide variety of physiologic states. In this study, we investigated factors determining a CFTAH's inherent ability to balance systemic and pulmonary flow passively, without active management of pump rotational speed. Four different RBPs (ReliantHeart HA5, Thoratec HMII, HeartWare HVAD, and Ventracor VentrAssist) were used in various combinations to construct CFTAHs. Each CFTAH's ability to autonomously maintain pressures and flows within defined ranges was evaluated in a hybrid mock loop as systemic and pulmonary vascular resistance (PVR) were changed. The resistance box, a method to quantify the range of vascular resistances that can be safely supported by a CFTAH, was used to compare different CFTAH configurations in an efficient and predictive way. To reduce the need for future in vitro tests and to aid in their analysis, a novel analytical evaluation to predict the resistance box of various CFTAH configurations was also performed. None of the investigated CFTAH configurations fully satisfied the predefined benchmarks for inherent flow balancing, with the VentrAssist (left) and HeartAssist 5 (right) offering the best combination. The extent to which each CFTAH was able to autonomously maintain balance was determined by the pressure sensitivity of each RPB: the sensitivity of outflow to changes in the pressure head. The analytical model showed that by matching left and right pressure sensitivity the inherent balancing performance can be improved. These findings may ultimately lead to a reduced need for manual speed changes or active control systems.

Can We Improve Vaginal Tissue Healing Using Customized Devices: 3D Printing and Biomechanical Changes in Vaginal Tissue.

BACKGROUND: Determining biomechanical changes in vaginal tissue with tissue stretch is critical for understanding the role of mechanotransduction on vaginal tissue healing. Noncontact dynamic optical coherence elastography (OCE) can quantify biomechanical changes in vaginal tissues noninvasively. Improved vaginal tissue healing will reduce postoperative complications from vaginal surgery. AIMS: (1) To complete dimensional assessments (DAs) of the vaginal tract. (2) To elucidate biomechanical properties (BMP) of porcine vaginal tissues (PVT). (3) Compare BMPs of piglet and adult PVTs after placement of customized vaginal dilators (VD) by OCE and uniaxial mechanical testing (MT). METHODS: Pilot study using adult nulliparous pig and piglet PVTs (n = 20 each). DA of PVTs was performed using silicone molding. 3D-printed VDs were used to achieve different Relative Diameter Change (RDC) of the PVTs (no dilatation, and -50%, 0%, 50% RDC). Elastographic testing using OCE and MT. RESULTS: Using OCE, no significant differences (SD) were noted between adult and piglet PVT (p = 0.74) or by stretch direction (p = 0.300). SD was noted with increasing RDC (p = 0.023). Using MT, there were SD in tissue stiffness between adult and piglet PVT (p = 0.048), but no SD as a function of RDC (p = 0.750) or stretch direction (p = 0.592). CONCLUSIONS: This study quantified biomechanical changes in PVT with customized stretching by 3D printed VD using both OCE and MT. This work has implications for the mechanotransduction of vaginal wound healing and noninvasive assessment of vaginal diseases.

Experience with the HeartMate II Left Ventricular Assist Device in Patients Older than 60 Years.

BACKGROUND: Advanced age is a relative contraindication for heart transplantation, but no age cutoff has been defined for patients receiving mechanical circulatory support. METHODS: Between November 1, 2003 and November 1, 2012, we implanted the HeartMate II (HMII) left ventricular assist device (LVAD) in 319 patients. One hundred seven patients (89 men, 18 women) were over 60 years old (mean, 66 ± 4 years, range, 61-78 years) and received the HMII as a bridge to transplantation (n = 45) or as destination therapy (n = 62). We evaluated their experience by performing a retrospective analysis. RESULTS: Seventy-two patients had ischemic cardiomyopathy, and 34 had idiopathic cardiomyopathy. Three patients (2.8%) already had a HeartMate XVE LVAD, 54 (50.5%) were receiving intra-aortic balloon pump support, 52 (48.6%) had undergone a previous cardiac procedure, and 9 (8.4%) had received renal replacement therapy (RRT) (continuous venovenous hemofiltration, hemodialysis, or both) before HMII implantation. The median duration of HMII support was 313 days (range, 1-3339 days). After device implantation, 36 patients (33.6%) had gastrointestinal bleeding, 24 (23%) required RRT, 18 (17.5%) had ventricular arrhythmias, and 24 (22.4%) had LVAD-related infections, and 9 (8.4%) had right ventricular failure requiring mechanical support, and 28 (26.2%) had neurologic complications. The actual survival rate was 69% at 6 months, 63% at 1 year, and 54% at 2 years. Eighty-one patients died, 9 are still receiving HMII support, and 17 are alive after heart transplantation. CONCLUSIONS: Older patients can benefit from LVAD therapy, and advanced age should not preclude LVAD implantation.

Bridging to a Long-Term Ventricular Assist Device With Short-Term Mechanical Circulatory Support.

Implanting short-term mechanical circulatory support (MCS) devices as a bridge-to-decision is increasingly popular. However, outcomes have not been well studied in patients who receive short-term MCS before receiving long-term left ventricular assist device (LVAD) support. We analyzed outcomes in our single-center experience with long-term continuous-flow (CF)-LVAD recipients with pre-implantation short-term MCS. From November 2003 through March 2016, 526 patients (mean age, 54.7 ± 13.5 years) with chronic heart failure (mean ejection fraction, 21.7 ± 3.6%) underwent implantation of either the HeartMate II (n = 403) or the HeartWare device (n = 123). Before implantation, 269 patients received short-term MCS with the TandemHeart, the Impella 2.5/5.0, an intra-aortic balloon pump (IABP), venoarterial extracorporeal membrane oxygenation (VA-ECMO), or the CentriMag. The short-term MCS patients were compared with the CF-LVAD-only patients regarding preoperative demographics, incidence of postoperative complications, and long-term survival. The 269 patients received the following short-term MCS devices: 57 TandemHeart, 27 Impella, 172 IABP, 12 VA-ECMO, and 1 CentriMag. Survival at 30 days, 6 months, 1 year, and 2 years was 94.2, 87.2, 79.4, and 72.4%, respectively, for CF-LVAD-only patients versus 91.0, 78.1, 73.4, and 65.6%, respectively, for short-term MCS + CF-LVAD patients (P = 0.17). Within the short-term MCS group, survival at 24 months was poorest for patients supported with VA-ECMO or the TandemHeart (P = 0.03 for both), and survival across all four time points was poorest for patients supported with VA-ECMO (P = 0.02). Short-term MCS was not an independent predictor of mortality in multivariate Cox regression models (hazard ratio = 1.12, 95% confidence interval = 0.84-1.49, P = 0.43). In conclusion, we found that using short-term MCS therapy-except for VA-ECMO-as a bridge to long-term CF-LVAD support was not associated with poorer survival.

Systematic Design of a Magnetically Levitated Brushless DC Motor for a Reversible Rotary Intra-Aortic Blood Pump.

The IntraVAD is a miniature intra-aortic ventricular assist device (VAD) designed to work in series with the compromised left ventricle. A reverse-rotation control (RRc) mode has been developed to increase myocardial perfusion and reduce ventricular volume. The RRc mode includes forward rotation in systole and reverse rotation in diastole, which requires the IntraVAD to periodically reverse its rotational direction in synchrony with the cardiac cycle. This periodic reversal leads to changes in pressure force over the impeller, which makes the entire system less stable. To eliminate the mechanical wear of a contact bearing and provide active control over the axial position of the rotor, a miniature magnetically levitated bearing (i.e., the PM-Coil module) composed of two concentric permanent magnetic (PM) rings and a pair of coils-one on each side-was proposed to provide passive radial and active axial rotor stabilization. In the early design stage, the numerical finite element method (FEM) was used to optimize the geometry of the brushless DC (BLDC) motor and the maglev module, but constructing a new model each time certain design parameters were adjusted required substantial computation time. Because the design criteria for the module had to be modified to account for the magnetic force produced by the motor and for the hemodynamic changes associated with pump operation, a simplified analytic expression was derived for the expected magnetic forces. Suitable bearings could then be designed capable of overcoming these forces without repeating the complicated FEM simulation for the motor. Using this method at the initial design stage can inform the design of the miniature maglev BLDC motor for the proposed pulsatile axial-flow VAD.

Total artificial heart implantation for biventricular failure due to eosinophilic myocarditis.

Idiopathic hypereosinophilic syndrome is a condition of unknown etiology characterized by proliferation of eosinophils and their infiltration into tissues. Although cardiac involvement is rare, eosinophilic myocarditis can lead to life-threating fulminant congestive heart failure. Treatment of patients with eosinophilic myocarditis is challenging as heart failure can be caused by biventricular dysfunction. To our knowledge, this is the first case reported in the literature describing a patient with acute severe biventricular heart failure caused by eosinophilic myocarditis with mural left ventricular apical thrombus who was successfully treated with implantation of a total artificial heart as a bridge to heart transplant.

Safety and Feasibility of Open Chest Epicardial Mapping and Ablation of Ventricular Tachycardia During the Period of Left Ventricular Assist Device Implantation.

INTRODUCTION: Patients undergoing catheter ablation for ventricular tachycardia (VT) may require epicardial mapping. In patients with end-stage heart failure, hybrid surgical epicardial mapping and ablation during the period of left ventricular assist device (LVAD) implantation may be considered in select patients to reduce post-LVAD ventricular tachycardia. METHODS AND RESULTS: From March 2009 to October 2012, 5 patients (4 men and 1 woman, age range 52-73 years) underwent open chest electrophysiology study and epicardial mapping for recurrent ventricular tachycardia while the heart was exposed during the period of LVAD implantation. Epicardial mapping was considered if patients had recurrent VT despite failed prior endocardial ablation and/or electrocardiogram (EKG) features of an epicardial exit. Activation and/or a substrate mapping approach were employed during all procedures. Three of 5 patients (60%) had acute procedural success. In all patients, VT was either eliminated or significantly reduced with epicardial ablation. One patient had mediastinal bleeding delaying sternal closure. During a follow-up period of 363 ± 368 days, 4 patients died due to nonarrhythmic causes. CONCLUSIONS: Open-chest hybrid epicardial mapping and ablation for recurrent VT is feasible and can be considered in select patients during the period of LVAD implantation.

Through the Looking Glass: Real-Time Video Using 'Smart' Technology Provides Enhanced Intraoperative Logistics.

INTRODUCTION: In the setting of increasingly complex medical therapies and limited physician resources, the recent emergence of 'smart' technology offers tremendous potential for improved logistics, efficiency, and communication between medical team members. In an effort to harness these capabilities, we sought to evaluate the utility of this technology in surgical practice through the employment of a wearable camera device during cardiothoracic organ recovery. METHODS: A single procurement surgeon was trained for use of an Explorer Edition Google Glass (Google Inc., Mountain View, CA) during the recovery process. Live video feed of each procedure was securely broadcast to allow for members of the home transplant team to remotely participate in organ assessment. Primary outcomes involved demonstration of technological feasibility and validation of quality assurance through group assessment. RESULTS: The device was employed for the recovery of four organs: a right single lung, a left single lung, and two bilateral lung harvests. Live video of the visualization process was remotely accessed by the home transplant team, and supplemented final verification of organ quality. In each case, the organs were accepted for transplant without disruption of standard procurement protocols. Media files generated during the procedures were stored in a secure drive for future documentation, evaluation, and education purposes without preservation of patient identifiers. CONCLUSIONS: Live video streaming can improve quality assurance measures by allowing off-site members of the transplant team to participate in the final assessment of donor organ quality. While further studies are needed, this project suggests that the application of mobile 'smart' technology offers not just immediate value, but the potential to transform our approach to the practice of medicine.

Rapid Speed Modulation of a Rotary Total Artificial Heart Impeller.

Unlike the earlier reciprocating volume displacement-type pumps, rotary blood pumps (RBPs) typically operate at a constant rotational speed and produce continuous outflow. When RBP technology is used in constructing a total artificial heart (TAH), the pressure waveform that the TAH produces is flat, without the rise and fall associated with a normal arterial pulse. Several studies have suggested that pulseless circulation may impair microcirculatory perfusion and the autoregulatory response and may contribute to adverse events such as gastrointestinal bleeding, arteriovenous malformations, and pump thrombosis. It may therefore be beneficial to attempt to reproduce pulsatile output, similar to that generated by the native heart, by rapidly modulating the speed of an RBP impeller. The choice of an appropriate speed profile and control strategy to generate physiologic waveforms while minimizing power consumption and blood trauma becomes a challenge. In this study, pump operation modes with six different speed profiles using the BiVACOR TAH were evaluated in vitro. These modes were compared with respect to: hemodynamic pulsatility, which was quantified as surplus hemodynamic energy (SHE); maximum rate of change of pressure (dP/dt); pulse power index; and motor power consumption as a function of pulse pressure. The results showed that the evaluated variables underwent different trends in response to changes in the speed profile shape. The findings indicated a possible trade-off between SHE levels and flow rate pulsatility related to the relative systolic duration in the speed profile. Furthermore, none of the evaluated measures was sufficient to fully characterize hemodynamic pulsatility.

New continuous-flow total artificial heart and vascular permeability.

BACKGROUND: We tested the short-term effects of completely nonpulsatile versus pulsatile circulation after ventricular excision and replacement with total implantable pumps in an animal model on peripheral vascular permeability. METHODS: Ten calves underwent cardiac replacement with two HeartMate III continuous-flow rotary pumps. In five calves, the pump speed was rapidly modulated to impart a low-frequency pulse pressure in the physiologic range (10-25 mm Hg) at a rate of 40 pulses per minute (PP). The remaining five calves were supported with a pulseless systemic circulation and no modulation of pump speed (NP). Skeletal muscle biopsies were obtained before cardiac replacement (baseline) and on postoperative days (PODs) 1, 7, and 14. Skeletal muscle-tissue water content was measured, and morphologic alterations of skeletal muscle were assessed. VE-cadherin, phospho-VE-cadherin, and CD31 were analyzed by immunohistochemistry. RESULTS: There were no significant changes in tissue water content and skeletal muscle morphology within group or between groups at baseline, PODs 1, 7, and 14, respectively. There were no significant alterations in the expression and/or distribution of VE-cadherin, phospho-VE-cadherin, and CD31 in skeletal muscle vasculature at baseline, PODs 1, 7, and 14 within each group or between the two groups, respectively. Although continuous-flow total artificial heart (CFTAH) with or without a pulse pressure caused slight increase in tissue water content and histologic damage scores at PODs 7 and 14, it failed to reach statistical significance. CONCLUSIONS: There was no significant adherens-junction protein degradation and phosphorylation in calf skeletal muscle microvasculature after CFTAH implantation, suggesting that short term of CFTAH with or without pulse pressure did not cause peripheral endothelial injury and did not increase the peripheral microvascular permeability.

Percutaneous creation of an arteriovenous fistula for hemodialysis access.

PURPOSE: Arteriovenous fistulae (AVFs) created by conventional surgical techniques are associated with suboptimal short- and long-term patency. This study investigated the feasibility of creating fistulae with a percutaneous system and evaluated the utility of percutaneous AVFs (pAVFs) in providing hemodialysis access. MATERIALS AND METHODS: From August 2012 to September 2013, a percutaneous system was used to attempt pAVF creation between the proximal ulnar artery and a closely associated ulnar vein in 33 patients. Technical success, adverse events, and time to pAVF maturity were recorded, as was clinical effectiveness at 6 months. RESULTS: A pAVF was successfully created in 32 of 33 patients (97%). Four patients died during the follow-up period from causes unrelated to the procedure; one patient was lost to follow-up. Of the remaining 27 patients, 24 were undergoing successful dialysis via their pAVF at 6 months. Two additional patients had usable access but did not initiate dialysis during the study. One spontaneous pAVF thrombosis occurred in a patient with preexisting central vein stenosis. Cumulative pAVF patency at 6 months was 96.2% (26 of 27; standard error, 3.8%). Mean time to pAVF maturation was 58 days (range, 37-168 d). There was one serious procedure-related adverse event and five minor procedure-related adverse events. CONCLUSIONS: Although larger studies are required to validate efficacy in a wide range of patients, this study demonstrates hemodialysis access successfully created with an endovascular catheter-based system. Patency of pAVFs and time to maturation were superior to published results of surgical techniques.

Chemotaxis of Escherichia coli to norepinephrine (NE) requires conversion of NE to 3,4-dihydroxymandelic acid.

Norepinephrine (NE), the primary neurotransmitter of the sympathetic nervous system, has been reported to be a chemoattractant for enterohemorrhagic Escherichia coli (EHEC). Here we show that nonpathogenic E. coli K-12 grown in the presence of 2 µM NE is also attracted to NE. Growth with NE induces transcription of genes encoding the tyramine oxidase, TynA, and the aromatic aldehyde dehydrogenase, FeaB, whose respective activities can, in principle, convert NE to 3,4-dihydroxymandelic acid (DHMA). Our results indicate that the apparent attractant response to NE is in fact chemotaxis to DHMA, which was found to be a strong attractant for E. coli. Only strains of E. coli K-12 that produce TynA and FeaB exhibited an attractant response to NE. We demonstrate that DHMA is sensed by the serine chemoreceptor Tsr and that the chemotaxis response requires an intact serine-binding site. The threshold concentration for detection is ≤5 nM DHMA, and the response is inhibited at DHMA concentrations above 50 µM. Cells producing a heterodimeric Tsr receptor containing only one functional serine-binding site still respond like the wild type to low concentrations of DHMA, but their response persists at higher concentrations. We propose that chemotaxis to DHMA generated from NE by bacteria that have already colonized the intestinal epithelium may recruit E. coli and other enteric bacteria that possess a Tsr-like receptor to preferred sites of infection.

A hybrid mock circulation loop for a total artificial heart.

Rotary blood pumps are emerging as a viable technology for total artificial hearts, and the development of physiological control algorithms is accelerated with new evaluation environments. In this article, we present a novel hybrid mock circulation loop (HMCL) designed specifically for evaluation of rotary total artificial hearts (rTAH). The rTAH is operated in the physical domain while all vasculature elements are embedded in the numerical domain, thus combining the strengths of both approaches: fast and easy exchange of the vasculature model together with improved controllability of the pump. Parameters, such as vascular resistance, compliance, and blood volume, can be varied dynamically in silico during operation. A hydraulic-numeric interface creates a real-time feedback loop between the physical and numerical domains. The HMCL uses computer-controlled resistance valves as actuators, thereby reducing the size and number of hydraulic elements. Experimental results demonstrate a stable interaction over a wide operational range and a high degree of flexibility. Therefore, we demonstrate that the newly created design environment can play an integral part in the hydraulic design, control development, and durability testing of rTAHs.

HeartMate II left ventricular assist device implantation in patients with advanced hepatic dysfunction.

BACKGROUND: We sought to determine the outcomes for patients with advanced hepatic dysfunction undergoing HeartMate II left ventricular assist device (LVAD) implantation. METHODS: Between November 1, 2003 and December 1, 2012, we implanted the HeartMate II continuous-flow LVAD in 338 patients, either for bridging to heart transplantation or for destination therapy. Twenty-three of these patients (19 men and 4 women; mean age, 47 ± 16 years) had advanced hepatic dysfunction, as characterized by alanine aminotransferase (ALT) or aspartate transaminase (AST) levels five times normal; serum total bilirubin levels three times normal; and/or necessity for a liver biopsy before or during device implantation. Of this group, 17 patients received the LVAD as a bridge to transplantation, and six patients received it for destination therapy. RESULTS: Nine of the 23 patients required either a transjugular or a core liver biopsy during LVAD implantation. Three patients died within the first postoperative month; the 20 surviving patients had significant improvements in their hepatic parameters. The ALT decreased from 238 ± 296 to 27 ± 13 U/L (p = 0.022), AST decreased from 209 ± 199 to 29 ± 8 U/L (p = 0.009), and total bilirubin level decreased from 6.9 ± 6.0 to 0.6 ± 0.1 mg/dL (p = 0.044). The serum albumin level increased from 3.2 ± 0.6 to 4.3 ± 0.3 g/dL (p = 0.003), and creatinine clearance increased from 77.6 ± 35.2 to 110.2 ± 35.7 mL/min/1.73 m2 (p = 0.101). CONCLUSION: Continuous-flow LVAD support may significantly improve hepatic function, allowing patients with poor preimplant liver function to become better candidates for heart transplantation.

Novel Image-Guided Percutaneous Lung Tissue Excision Device With Integrated Sealing of Blood Vessels and Airways: An In Vivo Preclinical Study.

OBJECTIVE: This study evaluated the efficacy of the Minimally Invasive Targeted Resection (MiTR) device, a novel electrosurgical instrument that allows for targeted excision of a lung abnormality while using bipolar radiofrequency (RF) energy to seal blood vessels and airways. METHODS: The MiTR system was evaluated in 7 acute and 2 chronic porcine (7-day) models to evaluate the efficacy of tissue excision with bipolar RF sealing of blood vessels and airways and application of an autologous blood patch into the excised tissue cavity. Air leak was recorded for all evaluations. The study was approved by the institutional ethical board. RESULTS: Nineteen lung tissue samples, measuring 2.5 cm long × 1.2 cm diameter, were excised. In 8 of 9 animals (89%), hemostasis and pneumostasis were observed visually at the completion of the procedure. In 2 of 2 chronic animals (100%), hemostasis and pneumostasis persisted for the 7-day observation period. Histologic examination of the excised samples showed preservation of the core parenchymal architecture without evident tissue damage of the samples that would impair pathologic analysis. CONCLUSIONS: Percutaneous resection of targeted lung tissue with the MiTR system demonstrated hemostasis and pneumostasis while obtaining a histologically intact sample. After regulatory approval, the use of this device could offer more tissue for analysis than a transthoracic needle biopsy or bronchoscopy and a far less invasive alternative to video-assisted thoracic surgery or thoracotomy. This may also expand patient and physician options for the early diagnosis and treatment of lung cancer.

Anatomic fitting of total artificial hearts for in vivo evaluation.

Successful anatomic fitting of a total artificial heart (TAH) is vital to achieve optimal pump hemodynamics after device implantation. Although many anatomic fitting studies have been completed in humans prior to clinical trials, few reports exist that detail the experience in animals for in vivo device evaluation. Optimal hemodynamics are crucial throughout the in vivo phase to direct design iterations and ultimately validate device performance prior to pivotal human trials. In vivo evaluation in a sheep model allows a realistically sized representation of a smaller patient, for which smaller third-generation TAHs have the potential to treat. Our study aimed to assess the anatomic fit of a single device rotary TAH in sheep prior to animal trials and to use the data to develop a three-dimensional, computer-aided design (CAD)-operated anatomic fitting tool for future TAH development. Following excision of the native ventricles above the atrio-ventricular groove, a prototype TAH was inserted within the chest cavity of six sheep (28-40 kg). Adjustable rods representing inlet and outlet conduits were oriented toward the center of each atrial chamber and the great vessels, with conduit lengths and angles recorded for future analysis. A three-dimensional, CAD-operated anatomic fitting tool was then developed, based on the results of this study, and used to determine the inflow and outflow conduit orientation of the TAH. The mean diameters of the sheep left atrium, right atrium, aorta, and pulmonary artery were 39, 33, 12, and 11 mm, respectively. The center-to-center distance and outer-edge-to-outer-edge distance between the atria, found to be 39 ± 9 mm and 72 ± 17 mm in this study, were identified as the most critical geometries for successful TAH connection. This geometric constraint restricts the maximum separation allowable between left and right inlet ports of a TAH to ensure successful alignment within the available atrial circumference.

Intrapericardial delivery of amiodarone rapidly achieves therapeutic levels in the atrium.

BACKGROUND: Amiodarone is widely used worldwide as an important drug for managing supraventricular arrhythmias, regardless of its association with potentially severe side effects due to systemic toxicity. Amiodarone reduces the incidence of atrial fibrillation after cardiac surgery, but oral therapy requires a presurgery loading period, lasting from 1 to 4 weeks. In this study, we showed that it is possible to rapidly obtain therapeutic cardiac tissue levels of the drug by infusing aqueous amiodarone intrapericardially, without appreciable systemic exposure. We also examined the long-term histologic safety of intrapericardial infusion. METHODS: In this observational study, 9 adult sheep, randomized into 3 groups of 3 animals each, were given low (2.5 -mg/h), medium (10-mg/h), or high (50-mg/h) dosages of amiodarone by continuous infusion intrapericardially for 72 hours. An intrapericardial drain prevented tamponade from fluid build-up. Levels of amiodarone and its active metabolite, desethylamiodarone (DEA), were assessed both in plasma and in transmural biopsy specimens taken from the left atrial appendage and left and right ventricular myocardium. Cardiac, hepatic, and renal functions were also assessed. Humane euthanization was performed after 3 months, and cardiac and thoracic tissues were assessed for evidence of epicarditis, severe fibrotic changes, or other adverse effects potentially caused by the local amiodarone administration. RESULTS: Pericardial infusion resulted in rapid uptake and high concentrations of amiodarone and DEA in the myocardial tissues, without an appreciable systemic presence of either drug. The highest and lowest levels of these agents were observed in the left atrium and left ventricle, respectively. Drug concentrations in all cardiac biopsy specimens were similar to, or higher than, those reportedly observed in patients taking long-term oral amiodarone. At 90 days, postmortem microscopic, biochemical, and hematologic evaluation of end-organ tissues from the 8 surviving sheep showed no adverse effects. Excessive inflammation or fibrotic changes were not observed in these 8 sheep. The ninth sheep died prematurely, and its death was deemed not to be related to this study. CONCLUSIONS: Short-term intrapericardial delivery of amiodarone is a safe method for rapidly obtaining therapeutic atrial-tissue drug levels. When begun perioperatively, this method may prevent postoperative atrial fibrillation similarly to oral or intravenous amiodarone therapy. However, we have shown that pericardial administration avoids systemic drug distribution and thus may greatly decrease the systemic complicationsresulting from this drug.

HeartMate-II left ventricular assist device infections resulting from gastrointestinal-tract fistulas.

BACKGROUND: In patients with a left ventricular assist device (LVAD), pump-related infection can cause adverse effects that may result in death. METHODS: We describe three patients who had infections related to a fistula between the gastrointestinal (GI) tract and the LVAD pocket and who subsequently underwent successful heart transplantation without developing sepsis. In no case did the LVAD-related infection adversely affect the outcome of transplantation. CONCLUSIONS: For detecting the fistulas, full upper-GI endoscopy and colonoscopy were superior to other types of diagnostic imaging studies.