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Patient Selection for Ventricular Assist Device Therapy in the Elderly: Application of the HeartMate II Risk Score J.A. Cowger, K. Sundareswaran, J.G. Rogers, S.S. Kushwaha, F.D. Pagani, A. Tatooles, R.M. Adamson, M.S. Slaughter, D.J. Farrar. Univ. of Michigan Health System, Ann Arbor, MI; Thoratec Corporation, Pleasanton, CA; Duke University Medical Center, Durham, NC; Mayo Clinic, Rochester, MN; Advocate Christ Medical Center, Oak Lawn, IL; Sharp Memorial Hospital, San Diego, CA; Univ. of Louisville, Jewish Hospital, and St. Mary’s HealthCare, Louisville, KY.

Traditionally, blood pressure measurements have been performed in office settings and have provided the basis for all diagnostic and therapeutic decisions. However, the develop- ment of a clinically relevant 24-hour blood pressure monitoring system has added greatly to the ability of blood pressure values to confer additional clinical information, including prognostic value. Mechanistically, the circadian rhythm of blood pressure is mediated by a complex pro- cess as a part of the neurohormonal cascade. Pattern recognition of blood pressure peaks and troughs over a 24-hour period has led to categorization into specific subsets namely, ie, dip- pers, nondippers, extreme dippers, and reverse dippers. Cardiovascular risk is associated with certain pattern types, as has been demonstrated in large observational and prospective studies. The development of therapies for the purpose of restoring more pathological patterns to normal ones continues to grow. These include both pharmaceutical and device therapy. This article describes the development of 24-hour blood pressure monitoring systems, the identification of circadian blood pressure patterns, and the treatment strategies studied thus far which affect these newer blood pressure parameters.

Purpose Patterns of weight change following implantation of continuous flow LVADs (CF LVADs) affect transplant candidacy and contribute to adverse outcomes and survival. We evaluated changes in weight over a 24 month period in a large LVAD clinical trial database. Methods and Materials A retrospective analysis of 896 patients enrolled in the HeartMate II Clinical trials for bridge to transplant and destination therapy from March 2005 - January 2009 was performed. Patients were divided into 4 groups: underweight (UW: body mass index (BMI) 2 ]), normal (NM:18.5-30), obese (OB:30-35), and morbidly obese (MO>35). BMI was analyzed at 6 month intervals through 24 months (linear mixed effects modeling). Pre-albumin levels were also determined. Results At 6 months there were significant changes in BMI (p 10%. Pre-albumin trended up at 6 months (18.4±7.2 vs. 22.8±6.9, p NS) and remained stable at 24 months with no intergroup differences. Intragroup changes were significant. Download high-res image (40KB) Download full-size image Table 1 . Pre-Albumin Changes Group Baseline 6 Months P Value BMI 15.2±5.4 21.8±7.5 0.001 18.5≤BMI 18.2±7.5 22.8±6.8 30≤BMI 19.3±7.3 22.5±7.4 0.007 BMI≥35 17.6±6.9 22.5±6.8 0.001 Conclusions The lowest BMI patients gain weight to normal ranges during CF LVAD support. OB and MO patients stay within 10% of baseline weight. 1 in 5 lose more than 10%. Nutritional status improves in all groups. Aggressive weight control strategies (e.g. bariatric surgery referral) should be considered and emphasized in CF LVAD patients.

Establishing and maintaining arterial access in pediatric cardiac operations is a frequent and sometimes frustrating problem. We have modified a procedure commonly used in our research laboratory for arterial pressure monitoring and applied it successfully to the pediatric cardiac surgical patient. The internal mammary artery can provide reliable arterial access in the postoperative period.

Wound infections after coronary artery bypass operations have been continuously monitored at the Minneapolis Veterans Affairs Hospital for 15 years. All patients were followed up for 30 days. From 1977 to 1991, 2,402 coronary artery bypass operations were performed, and wound infections developed in 125 (5%) patients. There were 71 (3%) chest infections of which 33 (1.4%) were major and 38 (1.6%) superficial. Greater than 94% of these grew only a single organism, of which 74% were Staphylococcus species. There were 63 (2.6%) leg wound infections. More than 50% of these grew multiple organisms, of which 68% were enteric in origin. Nine (0.4%) patients had simultaneous chest and leg infections. Wound infections were diagnosed an average of 15.3 +/- 6.7 (range, 4 to 30) days postoperatively, with 50% occurring after discharge from the hospital. Of 14 variables evaluated by multivariate logistic regression analysis, only steroids (p = 0.005) and diabetes (p = 0.003) were identified as independent risk factors for wound infections. Patients taking steroids or with diabetes tended to have chest infections, whereas obese patients tended to have more leg infections (p = 0.08). During an interval in the surveillance program, a trend toward increasing infections was identified and successfully reversed.

Extracorporeal membrane oxygenation (ECMO) has proven to be life-saving in cases of reversible lung injury. One potential application of ECMO in the field of lung transplantation is the support of the patient with acute pulmonary failure immediately after transplantation until the transplanted lung has resumed satisfactory gas transfer function. The authors have had experience with ECMO in three patients who have had acute pulmonary failure and inadequate oxygenation after bilateral single lung (BSLT) or heart-lung transplantation (HLT). Patient 1 is a 47-year-old woman with alpha-1 antitrypsin deficiency who underwent a HLT and experienced fulminant pulmonary edema secondary to an intraoperative coagulopathy that required massive transfusion. Patient 2 was a 45-year-old man with a patent ductus arteriosus (PDA) that resulted in Eisenmenger's complex. Patient 2 underwent an HLT and experienced acute pulmonary failure. Patient 3 is a 58-year-old woman with an atrial septal defect (ASD) and pulmonary hypertension who underwent repair of the ASD and BSLT. Patient 3 experienced complete atelectatic collapse of the right lung and pulmonary edema of the left lung. These three patients had PO2 measurements of 23, 39, and 23 mmHg, respectively, despite receiving 100% FiO2 and maximal ventilatory support. All three patients were subsequently placed on ECMO and had improvement of their oxygenation. Patients 1 and 3 were successfully weaned from ECMO and extubated on post-operative day (POD) 21 and 16, respectively. Patient 2 had significant improvement in oxygenation but died on POD 4 of persistent mediastinal hemorrhage.(ABSTRACT TRUNCATED AT 250 WORDS)

Mortality was recorded as the composite of death (n 81), urgent (UNOS Ia) heart transplantation (n 10), and left ventricular assist device implantation (n 2). We compared the SHFM-predicted vs. observed (method: life tables) survival for the first 5 years at 1-year increments; we also evaluated SHFM score as a predictor of mortality in this cohort. Results: Mean follow-up was 3.4 2.2 years (total time at risk 312 patient-years). The average annual mortality rate was 29.8% with a median survival of 2.8 years. The SHFM significantly underestimated mortality by 2.5% at 1yr, 12.5% at 2yrs, 26.2% at 3yrs, 29.2% at 4yrs, and 33.1% at 5yrs (Figure). The SHFM-predicted mean survival for this cohort was 6.9 yrs (actual: 3.4 yrs). A Cox proportional hazards model (bootstrapped, 1000 samples, random seed) using the SHFM score as predictor of mortality in this cohort achieved a Wald chi-square of 1.36 (p 0.244) and a c-statistic of 0.558. Conclusions: The SHFM significantly underestimated mortality in this medically-treated advanced HF population; in addition, the SHFM score appears to be of suboptimal prognostic value in this setting.

(pts) are more likely to sustain a stroke. We apply only a moderate AC protocol to manage RBP. Data analysis in this study was done with regard to thrombembolic complications in association with the AC therapy. Methods and Materials: We analyzed data of 24 RBP pts (mean age 54.8 years, range 27 -73, 3 female, 21 male). 6 pts were supported with the HM II, 10 with the DuraHeart and 8 with VentrAssist. Underlying causes for endstage cardiac failure requiring MCS were e.g.: ICM (n 10), DCM (n 5), AMI (n 4), PPCM (n 1), Cardiogenic shock (n 1), HOCM (n 1), 7 pts had previous cardiac surgery, 1 Aortic valve replacement. All pts received mild AC therapy with coumadin, target INR level is 2-2-5, in addition to aspirin 100 mg daily. Results: Mean duration of support was 153.92 days /125.22 SD. There were 3 deaths (12.5%). One patient was successfully transplanted (4.2%) and 20 pts (83.3%) are still on support. No device thrombosis occurred. Moreover, we found no major thrombembolic complications in the 24 pts included in this analysis, especially no hemorrhagic stroke or ischemic stroke was found. One patient sustained a mild TIA, which resolved totally. Conclusions: This study proves the safety of running RBP with moderate AC and the results justify the application of these systems particularly in an older patient cohort.

Objective The Thoratec Implantable Ventricular Assist Device (Thoratec Corporation, Pleasanton, Calif) can be used for univentricular or biventricular support in patients with a body surface area as low as 1.3 m 2 . Results of the multicenter clinical trial are reviewed. Methods Between October 2001 and June 2004, a total of 39 patients at 12 institutions were supported with the Thoratec Implantable Ventricular Assist Device. Twenty-four patients (62%) received left ventricular assist devices and 15 (38%) received biventricular assist devices. Indications included bridge to transplantation (n = 30) and postcardiotomy failure (n = 9). The control group included 100 patients from the Food and Drug Administration approval submissions for the paracorporeal version of the ventricular assist device. Results Twenty-eight male and 11 female patients, with mean age of 48 years (16–71 years) and body surface area of 1.9 m 2 (1.3–2.4 m 2 ) were supported for 3938 patient-days (10.8 patient-years). Mean left ventricular assist device flow index on the first postoperative day was 2.5 ± 0.5 L/(min·m 2 ). Mean duration of support was 101 days (9–597 days). Eighteen patients were discharged after a mean duration of 96 days. There were no ventricular assist device failures. Complications included 13 cases of bleeding requiring reexploration (33.3%), 1 embolic and 2 hemorrhagic strokes (7.7%), 5 driveline infections (12.8%), and 2 pocket infections (5%). Support to successful outcomes was 70% for bridge to transplantation and 67% for postcardiotomy recovery, versus historical results for the paracorporeal ventricular assist device of 69% for bridge to transplantation and 48% for postcardiotomy recovery. Conclusion The Thoratec Implantable Ventricular Assist Device is a new implantable pulsatile ventricular assist device that allows hospital discharge for patients as a bridge to transplantation or for postcardiotomy failure. It is the first Food and Drug Administration–approved implantable ventricular assist device with biventricular capability.

XVE group (50%). Mean BSA was lower in the HM II group (1.6 0.2 vs. 2.0 0.1; p 0.07). All patients required inotropic support. Two patients in the HM II group were ineligible for IABP support because of size. One (33%) in the HM II group and 2 (50%) patients in the HM XVE group received IABP support pre-operatively. Baseline biochemical markers were not significantly different in both groups (sodium 128 6 vs. 134 5 mmol/L; creatinine 1.1 0.3 vs. 1.5 0.1 mg/dl; hematocrit 31 4 vs. 33 9 %; and albumin 3.5 0.4 vs. 3.4 0.4 g/dl, respectively. p NS for all). Patients in both groups had normal biochemical markers on discharge. There was a significantly shorter post-operative length of stay for patients in the HM II group compared to those in the HM XVE group (28 7 vs. 49 10, p 0.048). Conclusions: The small axial flow LVAD in heart failure patients as a bridge to transplant is associated with a reduced length of postoperative hospitalization compared to the use of the large pulsatile flow LVAD.

A technique is described for minimally invasive harvesting of the greater saphenous vein. This technique requires no new or disposable equipment, thus adding no additional cost to the procedure. It is rapid and reliable, and it can be performed in the majority of patients requiring greater saphenous vein for coronary artery bypass grafting.

THE THORATEC IVAD: A NEW IMPLANTABLE VENTRICULAR ASSIST DEVICE M.S. Slaughter, S.S.L. Tsui, A. El-Banayosy, R.L. Kormos, T.B. Icenogle, J.D. Hill, Surgery, Cardiothoracic Division, Advocate Christ Medical Center, Oak Lawn, IL; Surgery, Papworth Hospital, Cambridge, United Kingdom; Surgery, Heart Center NRW, Bad Oeynhausen, Germany; Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA; Surgery, Sacred Heart Medical Center, Spokane, WA; Surgery, California Pacific Medical Center, San Francisco, CA