The Thoratec Implantable Ventricular Assist Device (IVAD): Initial Clinical Experience

Wednesday, October 25, 2006 Cardiac Surgery, continued SERUM CORTISOL LEVEL AND CORONARY ARTERY BYPASS SURGERY PATIENTS N. Mansuroglu MD* M. Ali MD C. Oribabor MD V. Matatov MD L. Bernstein MD W. Elzomoor PA A Tinker PA M. Nazares RN D Koloyian RN L. Y. Lee MD A. J. Tortolani MD New York Methodist Hospital, Brooklyn, NY PURPOSE: 1.To determine whether adrenal insufficiency in the perioperative cardiac surgery patients would be predicted by preoperative cortisol level.2.To evaluate the effectiveness of perioperative hydrocortisone therapy in this patients poplations in reducing the duration of postoperative pressors in patients identified as being adrenal insufficiency. METHODS: Forty-four patients were prospectively studied from December 1st 2005 to February 28th 2006, with an average age of 65 years, 31 (70%) patients were male. No patients in cardiogenic shock included in the study.Patients with history of adrenal insufficiency or on steroid therapy as outpatient prior to hospitalization were excluded. All patients had serum morning cortisol obtained on the day of surgery. We define the adrenal insufficiency if morning cortisol was ⬍ 15mcg/dl. Sixteen patients (group 1), with cortisol ⬍15 mcg/dl placed on hydrocortisone. Eleven patients (group 2), with cortisol level ⬍15 mcg/dl, and 17 patients (group3), with cortisol level ⬎15mcg/dl, were not placed on hydrocortisone. Post-surgery Cardiac index, pulmonary diastolic pressure, central venous pressure, CBC, and fluid balance in 24 hr post-surgery were obtained. RESULTS: Postoperative cardiac index, CVP, PAD, CBC, and fluid balance were not significant different between test groups.The duration of vasopressors needs in postoperative hypotension (Systolic blood pressure ⬍100 mmHg), were significantly lower in group 1 than group 2 and 3, respectively ((8.4hr vs. 16.8hr, p ⬍0.033), (8.4hr vs. 21.5hr, p ⬍0.002)). CONCLUSION: 1.Preoperative cortisol levels consistently and predictably identified patients with perioperative adrenal insufficiency. 2.Treating this group of patients with hydrocortisone, reduce in a statistically significant manner; the duration of pressors reduced postoperatively. 3.Patients with preoperative adrenal insufficiency have longer period of pressors requirement and hypotension if not treated. CLINICAL IMPLICATIONS: 1.The early ascertainment of perioperative adrenal insufficiency in open-heart surgery patients will improve postoperative management decision regarding predictability for pressors requirement.2.A better understanding of the physiology of the normal adrenal response in setting of coronary artery bypass is needed. DISCLOSURE: N. Mansuroglu, None. ENDOSCOPIC RADIAL HARVESTING WITH A NOVEL NANOSCALE-CONTROLLED BIPOLAR RADIOFREQUENCY DEVICE Gianluigi Bisleri MD* Tomasz Hrapkowicz MD Jerzy Nozynski MD Marian Zembala MD, PhD Claudio Muneretto MD Division of Cardiac Surgery University of Brescia Medical School, Brescia, Italy PURPOSE: The Enseal device(SurgRx, Palo Alto, CA), a novel nanoscale-controlled bipolar radiofrequency instrument, has been recently introduced in the surgical armamentarium as a vessel sealing system, albeit to date its use was restricted to settings other than cardiovascular surgery. We therefore aimed to assess the feasibility and safety of endoscopic radial artery harvesting(ERAH) with this novel tool. METHODS: Sixteen patients scheduled for coronary surgery underwent ERAH combining the Enseal device with a reusable retractor(Endovein retractor, Karl Storz, Germany): the Enseal is a 5 mm large, 35 cm long grasper; it allows adjustment of tissue-dynamic energy delivery at the electrode-tissue interface according to the specific tissutal impedance. A 2 cm incision is performed at the wrist crease; endoscopic dissection around the radial artery is carried out just by means of the Enseal; finally, a 1.5 cm counterincision is performed near the antecubital space. After fixation with 6% neutral formalin, paraffin embedding was used for histology. Five micron sections were stained by means of haematoxylineosin, Masson trichrome and acid orcein. A semiquantitative 0- to 4-point scale was used for histology. RESULTS: ERAH was successfully performed in all patients(mean harvesting time: 33⫾7 minutes); no bleeding was observed from the sealed side branches. No complications requiring conversion to the open technique occurred. No considerable charring or sticking were macroscopically evident. At histology, endothelial loss was 0.9⫾0.7, loss of internal lamina elastica was 0.5⫾0.8, advential hemorrhage was 0.5⫾0.5, vasa vasorum heat associated damage and margination of white blood cells

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were 0.1⫾0.5 and 0.2⫾0.5 respectively. No hand neurological impairment, vascular compromise or haematoma were reported. CONCLUSION: ERAH combining the Enseal system and a reusable retractor is a feasible procedure. The Enseal device proved to be safe and effective with negligible damage to the harvested conduits at histological analysis. CLINICAL IMPLICATIONS: This novel tool adds to the surgical armamentarium for ERAH, filling a definitive need in the field of minimally invasive conduit harvesting. DISCLOSURE: Gianluigi Bisleri, None. THE IMPACT OF PULMONARY ARTERY THROMBOENDARTERECTOMY ON RIGHT VENTRICULAR STROKE WORK INDEX Gonzalo V. Gonzalez-Stawinski MD* Bruce W. Lytle MD Nicholas G. Smedira MD The Cleveland Clinic Foundation, Cleveland, OH PURPOSE: To detemine the impact of pulmonary artery thromboendarterectomy (PTE) on right ventricular stroke work index (RVSWI). METHODS: A retrospective chart rewiew was conducted of patients undergoing PTE. We extracted demographics, symptoms, pre- and post PTE hemodynamics, and outcomes. RESULTS: Between Dec 1994 and Dec 2003 a total of 30 patients underwent PTE at our institution. Most common presenting symptom was SOB (96.7%). Pre PTE mean PAP was 48.5 mmHg. with associated SPAP, DPAP, PVR and RVSWI of 77.9 mmHg, 27.0 mmHg, 562.5 dynes and 1033.3 respectively. Post PTE mean PAP decreased to 26.9 mmHg (p ⬍0.05). This improvement in PAP resulted in a decrease in PVR (232 dynes, p ⬍0.05) and a decrease in RVSWI (624. 9, p ⬍0.05). At a mean f/u of 3.5 yrs the survival for the entire group was 80.3%. CONCLUSION: PTE is associated to a significant decrease in pulmonary artery pressures which ultimately results in a decrease in the amount of load bestowed upon the right ventricle. Survival in this group of patients seems to be in part related to the improvemnt in RVSWI. CLINICAL IMPLICATIONS: Findings in this study would suggest that RVSWI may be used as a predictor of clinical improvement following PTE. DISCLOSURE: Gonzalo Gonzalez-Stawinski, None. THE THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD): INITIAL CLINICAL EXPERIENCE Louis E. Samuels MD* Elena C. Holmes CPNP Kevin Hagan CPNP Radha Gopalan MD Christopher Droogan DO Francis Ferdinand MD Lankenau Hospital, Wynnewood, PA PURPOSE: The Thoratec Implantable Ventricular Assist Device (IVAD™) is the only FDA-approved intracorporeal biventricular cardiac assist device. It is a titanium-coated version of its predecessor, the Paracorporeal Ventricular Assist Device (PVAD™). The bloodpump is compatible with the portable TLC-II™ driver making home discharge feasible. The purpose of this report is to describe the initial clinical experience with this technology. METHODS: Nine consecutive patients were implanted with the IVAD™ from June 2005 through March 2006. The indications for support were acute heart failure in six cases and chronic heart failure in three cases. All patients were managed with maximal medical therapies including intravenous inotropic drugs prior to implant. RESULTS: All patients survived the surgical implant. Six patients were considered successful: three patients discharged to home and subsequently transplanted and two are awaiting transplantation (one at home and one in-house), and one patient was successfully explanted. Three patients expired postoperative of multiple organ system failure (two patients) and pulmonary hemorrhage (one patient). There were no device malfunctions. There was one localized driveline site infection and one thromboembolic event with partial visual loss. CONCLUSION: The IVAD™ is a unique device capable of providing uni- or bi-ventricular support for either acute or chronic heart failure conditions. Its versatility permits bridge to transplant or recovery options. Home discharge is feasible. CLINICAL IMPLICATIONS: The IVAD™ system can be used in a variety of clinical scenarios: acute cardiogenic shock and chronic heart failure, uni- or bi-ventricular support, bridge to transplant or recovery, and conceivably as a destination unit. Lastly, it is the only implantable mechanical biventricular system with home discharge capability. DISCLOSURE: Louis Samuels, None. CHEST 2006 —Poster Presentations