Robert S. Poston

Conformal piezoelectric energy harvesting and storage from motions of the heart, lung, and diaphragm

Significance Heart rate monitors, pacemakers, cardioverter-defibrillators, and neural stimulators constitute broad classes of electronic implants that rely on battery power for operation. Means for harvesting power directly from natural processes of the body represent attractive alternatives for these and future types of biomedical devices. Here we demonstrate a complete, flexible, and integrated system that is capable of harvesting and storing energy from the natural contractile and relaxation motions of the heart, lung, and diaphragm at levels that meet requirements for practical applications. Systematic experimental evaluations in large animal models and quantitatively accurate computational models reveal the fundamental modes of operation and establish routes for further improvements. Here, we report advanced materials and devices that enable high-efficiency mechanical-to-electrical energy conversion from the natural contractile and relaxation motions of the heart, lung, and diaphragm, demonstrated in several different animal models, each of which has organs with sizes that approach human scales. A cointegrated collection of such energy-harvesting elements with rectifiers and microbatteries provides an entire flexible system, capable of viable integration with the beating heart via medical sutures and operation with efficiencies of ∼2%. Additional experiments, computational models, and results in multilayer configurations capture the key behaviors, illuminate essential design aspects, and offer sufficient power outputs for operation of pacemakers, with or without battery assist.

Simultaneous hybrid coronary revascularization reduces postoperative morbidity compared with results from conventional off-pump coronary artery bypass

OBJECTIVES Less-invasive options are available for surgical treatment of multivessel coronary artery disease. We hypothesized that stenting combined with grafting of the left anterior descending artery with the left internal thoracic artery through a minithoracotomy (hybrid procedure) would provide the best outcome. METHODS Patients with equivalent numbers of coronary lesions (2.8 +/- 0.4) underwent either hybrid (n = 15) or off-pump coronary artery bypass through a sternotomy (n = 30). Early and 1-year outcomes were compared. Blood drawn from the aorta and coronary sinus immediately postoperatively was analyzed for activation of coagulation (prothrombin fragment 1.2 and activated Factor XII), myocardial injury (myoglobin), and inflammation (interleukin 8) by using an enzyme-linked immunosorbent assay. Target-vessel patency was determined by means of computed tomographic angiographic analysis. RESULTS The hybrid procedure was associated with significantly shorter lengths of intubation and stays in the intensive care unit and hospital and perioperative morbidity (P < .05). Intraoperative costs were increased but postoperative costs were reduced for the hybrid procedure compared with off-pump coronary artery bypass through a sternotomy. As a result, overall total costs were not significantly different between the groups. After adjusting for potential confounders, assignment to the hybrid group was an independent predictor of shortened time to return to work (t = -2.12, P = .04). Patient satisfaction after the hybrid procedure, as judged on a 6-point scale, was greater versus that after off-pump coronary artery bypass through a sternotomy. Finally, the hybrid procedure showed significantly reduced transcardiac gradients of markers of coagulation, myocardial injury, and inflammation and a trend toward significant improvement in target-vessel patency. CONCLUSIONS Perhaps because of reduced myocardial injury, inflammation, and activation of coagulation, patients undergoing the hybrid procedure had better perioperative outcomes and satisfaction, with excellent patency at 1 years follow-up. These promising preliminary findings warrant further investigation of this procedure.

Comparison of economic and patient outcomes with minimally invasive versus traditional off-pump coronary artery bypass grafting techniques.

BACKGROUND Minimally invasive coronary artery bypass grafting (miniCABG) decreases in-hospital morbidity versus traditional sternotomy CABG. We performed a prospective cohort study (NCT00481806) to assess the impact of miniCABG on costs and metrics that influence quality of life after hospital discharge. METHODS One hundred consecutive miniCABG cases performed using internal mammary artery (IMA) grafting +/- coronary stenting were compared with a matched group of 100 sternotomy CABG patients using IMA and saphenous veins, both treating equivalent number of target coronaries (2.7 vs. 2.9), off-pump. We compared perioperative costs, time to return to work/normal activity, and risk of major adverse cardiac/cerebrovascular events (MACCE) at 1 year: myocardial infarction (elevated troponin or EKG changes), target vessel occlusion (CT angiography at 1 year), stroke, or death. RESULTS For miniCABG, robotic instruments and stents increased intraoperative costs; postoperative costs were decreased from significantly less intubation time (4.80 +/- 6.35 vs. 12.24 +/- 6.24 hours), hospital stay (3.77 +/- 1.51 vs. 6.38 +/- 2.23 days), and transfusion (0.16 +/- 0.37 vs. 1.37 +/- 1.35 U) leading to no significant differences in total costs. Undergoing miniCABG independently predicted earlier return to work after adjusting for confounders (t = -2.15; P = 0.04), whereas sternotomy CABG increased MACCE (HR, 3.9; 95% CI, 1.4-7.6), largely from lower target-vessel patency. CONCLUSIONS MiniCABG shortens patient recovery time, minimizes MACCE risk at 1 year, and showed superior quality and outcome metrics versus standard-of-care CABG. These findings occurred without increasing costs and with superior target vessel graft patency.Background:Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) has been demonstrated to have an improved survival over systemic chemotherapy for patients with colorectal peritoneal carcinomatosis (CRPC) in a randomized controlled trial. Despite the increasing clinical evidence, controversies still exist regarding the standard treatment for these patients. Methods:Between January 1997 and October 2007, 50 patients with isolated CRPC underwent CRS and HIPEC at the St. George Hospital, Sydney. All patients underwent preoperative chest, abdominal and pelvic computed tomography scans, and positron emission tomography. All clinicopathologic and treatment-related data were obtained prospectively and computed in univariate and multivariate analyses to determine their prognostic significance for overall survival. Results:The mean age at the time of CRS was 55 (SD = 14) years. There were 19 (38%) male patients. The overall median survival was 29 months (range 1–102) with a 3-year survival rate of 39%. Three clinicopathologic factors were found to be significant for overall survival: tumor differentiation (P < 0.001), peritoneal cancer index (P = 0.021), and completeness of cytoreduction (P < 0.001). In the multivariate analysis of overall survival, 2 factors were identified to be independently associated with an improved survival: well-differentiated tumor (P = 0.045) and complete cytoreduction (P = 0.023). Conclusions:CRPC patients with low tumor volume, well/moderately differentiated tumors and complete cytoreduction may potentially benefit from the combined treatment. The combined treatment for patients with isolated colorectal peritoneal carcinomatosis should be considered to be the current standard of care.

Mortality Benefit With Prasugrel in the TRITON–TIMI 38 Coronary Artery Bypass Grafting Cohort : Risk-Adjusted Retrospective Data Analysis

OBJECTIVES The objective of this study was to characterize the bleeding, transfusion, and other outcomes of patients related to the timing of prasugrel or clopidogrel withdrawal before coronary artery bypass grafting (CABG). BACKGROUND There is little evidence to guide clinical decision making regarding the use of prasugrel in patients who may need urgent or emergency CABG. Experience with performing CABG in the presence of clopidogrel has raised concern about perioperative bleeding complications that are unresolved. METHODS A subset of the TRITON-TIMI 38 study (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis In Myocardial Infarction 38), in which patients with acute coronary syndrome were randomized to treatment with aspirin and either clopidogrel or prasugrel, underwent isolated CABG (N = 346). A supplemental case report form was designed and administered, and the data combined with the existing TRITON-TIMI 38 database. Baseline imbalances were corrected for using elements of the European System for Cardiac Operative Risk Evaluation and The Society of Thoracic Surgeons predictive algorithm. RESULTS A significantly higher mean 12-h chest tube blood loss (655 ± 580 ml vs. 503 ± 378 ml; p = 0.050) was observed with prasugrel compared with clopidogrel, without significant differences in red blood cell transfusion (2.1 U vs. 1.7 U; p = 0.442) or the total donor exposure (4.4 U vs. 3.0 U; p = 0.463). All-cause mortality was significantly reduced with prasugrel (2.31%) compared with 8.67% with clopidogrel (adjusted odds ratio: 0.26; p = 0.025). CONCLUSIONS Despite an increase in observed bleeding, platelet transfusion, and surgical re-exploration for bleeding, prasugrel was associated with a lower rate of death after CABG compared with clopidogrel.

Simultaneous "hybrid" percutaneous coronary intervention and minimally invasive surgical bypass grafting: feasibility, safety, and clinical outcomes.

Surgical and percutaneous coronary artery intervention revascularization are traditionally considered isolated options. A simultaneous hybrid approach may allow an opportunity to match the best strategy for a particular anatomic lesion. Concerns regarding safety and feasibility of such an approach exist. We examined the safety, feasibility, and early outcomes of a simultaneous hybrid revascularization strategy (minimally invasive direct coronary bypass grafting of the left anterior descending [LAD] artery and drug-eluting stent [DES] to non-LAD lesions) in 13 patients with multivessel coronary artery disease that underwent left internal mammary artery to LAD minimally invasive direct coronary bypass performed through a lateral thoracotomy, followed by stenting of non-LAD lesions, in a fluoroscopy-equipped operating room. Assessment of coagulation parameters was also undertaken. Inhospital and postdischarge outcomes of these patients were compared to a group of 26 propensity score matched parallel controls that underwent standard off-pump coronary artery bypass. Baseline characteristics were similar in both groups. All hybrid patients were successfully treated with DES and no inhospital mortality occurred in either group. Hybrid patients had a shorter length of stay (3.6 +/- 1.5 vs 6.3 +/- 2.3 days, P < .0001) and intubation times (0.5 +/- 1.3 vs 11.7 +/- 9.6 hours, P < .02). Despite aggressive anticoagulation and confirmed platelet inhibition, hybrid patients had less blood loss (581 +/- 402 vs 1242 +/- 941 mL, P < .05) and decreased transfusions (0.33 +/- 0.49 vs 1.47 +/- 1.53 U, P < .01). Six-month angiographic vessel patency and major adverse cardiac events were similar in the hybrid and off-pump coronary artery bypass groups. A simultaneous hybrid approach consisting of minimally invasive coronary artery bypass grafting with left internal mammary artery to LAD combined with revascularization of the remaining coronary targets using percutaneous coronary artery intervention with DES is a feasible option accomplished with acceptable clinical outcomes without increased bleeding risk.

Cardiac CT angiography after coronary bypass surgery: prevalence of incidental findings.

OBJECTIVE Cardiac CT angiography (CTA) is commonly performed after coronary artery bypass grafting surgery (CABG) to assess graft patency, but the images also include parts of the lungs, abdomen, and mediastinum. The purpose of our study was to retrospectively assess the prevalence of unsuspected disease identified on cardiac CTA examinations after CABG and to determine their potential clinical significance. MATERIALS AND METHODS CTA was performed postoperatively in 259 patients (mean, 5.2 days), and 40 patients underwent a follow-up CT scan (mean, 12.7 months). Cardiac CTA was acquired using a 16-MDCT scanner with ECG-gating and bolus timing with a small field of view centered on the heart. Two thoracic radiologists assessed each examination in consensus. The prevalence of graft disease and incidental findings (cardiac and noncardiac) was established. The electronic medical record was reviewed. A finding was judged potentially significant if a therapeutic intervention or radiologic follow-up was deemed advisable on the basis of the cardiac CTA. Bypass graft occlusions were analyzed separately. RESULTS In the immediate postoperative period, 51 patients (19.7%) had at least one unsuspected, potentially significant finding. Twenty-four patients (9.3%) had a cardiac finding such as a ventricular pseudoaneurysm, ventricular perfusion deficit, or intracardiac thrombus, and 34 patients (13.1%) had a noncardiac finding including pulmonary embolism, lung cancer, or pneumonia. At least one bypass graft was occluded in 17 patients (6.6%) in the immediate postoperative period. In the later postoperative period, seven patients (17.5%) had a potentially significant unsuspected finding. Four patients (10.0%) had at least one graft occlusion. CONCLUSION Cardiac CTA after CABG revealed a high prevalence of unsuspected cardiac and noncardiac findings with potential clinical significance. Interpreters of these studies should be familiar with the spectrum of these abnormalities.

LVAD bloodstream infections: therapeutic rationale for transplantation after LVAD infection.

INTRODUCTION Patients who have ventricular assist devices (VADs) and experience bloodstream infection (BSI) have high mortality. We addressed 2 questions raised by the United Network for Organ Sharing (UNOS) priority policy for this problem: 1) Are organs wasted on this ultra-high-risk group? 2) Can device-related BSI be differentiated from transient BSI? METHODS Patients with VADs who underwent heart transplantation from 1987 to 2001, who had BSI during VAD support, and who had positive cultures at VAD explant (device-related BSI, n = 10) were compared with those with negative cultures at explant (non-device-related BSI, n = 11). RESULTS Patients with device-related BSI had an 80% (8/10) rate of persistent bacteremia; 30 days and 1 year after transplantation, mortality was 14% and 26%, respectively. Non-device-related BSI (n = 11) persisted in 18% (2/11); peri-operative and 1-year mortalities were 9% and 13%. Duration of VAD support predicted infection (132 vs 48 days, p < 0.001); hypo-albuminemia (2.9 +/- 0.5 mg/dl vs 3.3 +/- 0.8 mg/dl, p < 0.05), and a resistant organism predicted a device-related BSI. These patients had increased intubation requirements and had increased creatinine concentration during the first post-operative week, with no difference in liver function, blood loss, transfusions (packed red blood cells, fresh frozen plasma, or platelets), or hemodynamic stability vs patients with non-device BSI. Despite decreased immunosuppression, we found no difference in acute rejection events with device-related BSI. Re-infection with the pre-operative organism occurred in only 1 patient per group. CONCLUSIONS These data suggest that urgent (Status 1A) cardiac transplantation is effective in stable patients with device-related BSI, and these data support the current UNOS policy. However, an extra-device source of BSI should be excluded by considering the isolated organism, the baseline nutritional status, and other risk factors.

Endovascular stenting for traumatic aortic injury: an emerging new standard of care.

BACKGROUND Thoracic aortic injury remains a leading cause of death after blunt trauma. Thoracic aortic stents have the potential to treat aortic tears using a less invasive approach. We have accumulated the largest series of patients treated with blunt thoracic aortic injury over a 2-year period. METHODS From July 2005 to present, 26 patients presenting with blunt aortic injury were treated with thoracic aortic endografting; these patients were retrospectively compared with the prior 26 patients presenting with similar aortic injury who were treated by open surgical repair. A Severity Characterization of Trauma score calculated for each patient predicts mortality based on severity of injury and degree of physiologic derangement on presentation. RESULTS Patients treated with endografting had a significantly shorter length of stay, less intraoperative blood loss, decreased 24-hour blood transfusion, and lower incidence of postoperative tracheostomy compared with patients undergoing open repair. Survival in both groups was similar despite a trend toward higher injury severity among patients treated with endografting. CONCLUSIONS This early experience suggests that aortic endografting may provide a safe and efficient treatment of aortic tears that cardiac surgeons can be successful in employing.

Preserving and evaluating hearts with ex vivo machine perfusion: an avenue to improve early graft performance and expand the donor pool

Cardiac transplantation remains the first choice for the surgical treatment of end stage heart failure. An inadequate supply of donor grafts that meet existing criteria has limited the application of this therapy to suitable candidates and increased interest in extended criteria donors. Although cold storage (CS) is a time-tested method for the preservation of hearts during the ex vivo transport interval, its disadvantages are highlighted in hearts from the extended criteria donor. In contrast, transport of high-risk hearts using hypothermic machine perfusion (MP) provides continuous support of aerobic metabolism and ongoing washout of metabolic byproducts. Perhaps more importantly, monitoring the organs response to this intervention provides insight into the viability of a heart initially deemed as extended criteria. Obviously, ex vivo MP introduces challenges, such as ensuring homogeneous tissue perfusion and avoiding myocardial edema. Though numerous groups have experimented with this technology, the best perfusate and perfusion parameters needed to achieve optimal results remain unclear. In the present review, we outline the benefits of ex vivo MP with particular attention to how the challenges can be addressed in order to achieve the most consistent results in a large animal model of the ideal heart donor. We provide evidence that MP can be used to resuscitate and evaluate hearts from animal and human extended criteria donors, including the non-heart beating donor, which we feel is the most compelling argument for why this technology is likely to impact the donor pool.

Impact of the learning curve for endoscopic vein harvest on conduit quality and early graft patency.

BACKGROUND Recent studies have suggested that endoscopic vein harvest (EVH) compromises graft patency. To test whether the learning curve for EVH alters conduit integrity owing to increased trauma compared with an open harvest, we analyzed the quality and early patency of conduits procured by technicians with varying EVH experience. METHODS During coronary artery bypass grafting, veins were harvested open (n=10) or by EVH (n=85) performed by experienced (>900 cases, >30/month) versus novice<100 cases, <3/month) technicians. Harvested conduits were imaged intraoperatively using optical coherence tomography and on day 5 to assess graft patency using computed tomographic angiography. RESULTS Conduits from experienced (n=55) versus novice (n=30) harvesters had similar lengths (33 versus 34 cm) and harvest times (32.4 versus 31.8 minutes). Conduit injury was noted in both EVH groups with similar distribution among disruption of the adventitia (62%), intimal tears at branch points (23%), and intimal or medial dissections (15%), but the incidence of these injuries was less with experienced harvesters and rare in veins procured with an open technique. Overall, the rate of graft attrition was similar between the two EVH groups (6.45% versus 4.34% of grafts; p=0.552). However, vein grafts with at least 4 intimal or medial dissections showed significantly worse patency (67% versus 96% patency; p=0.05). CONCLUSIONS High-resolution imaging confirmed that technicians inexperienced with EVH are more likely to cause intimal and deep vessel injury to the saphenous vein graft, which increases graft failure risk. Endoscopic vein harvest remains the most common technique for conduit harvest, making efforts to better monitor the learning curve an important public health issue.