Biomedical subjects

Walter E Pae

Publications and source records attributed to Walter E Pae.

5 recordsLinked to original sources

PubMed2006

Initial United States experience with the Paracor HeartNet myocardial constraint device for heart failure.

OBJECTIVE: This study was undertaken to review the initial results and surgical safety data for the US Food and Drug Administration safety and feasibility trial of the Paracor HeartNet (Paracor Medical, Inc, Sunnyvale, Calif.) myocardial constraint device. METHODS: Patients with New York Heart Association functional class II or III heart failure underwent device implantation (n = 21) through a left minithoracotomy. RESULTS: The average age was 53 years (31-72 years). There were 18 men and 3 women, and 17 patients had nonischemic etiology of heart failure. Mean heart failure duration was 8.3 years (1.4-18.8 years). Average ejection fraction was 22% (11%-33%), with an average left ventricular end-diastolic dimension of 74 mm (55-94 mm). Previous medical therapy included angiotensin-converting enzyme inhibitors, beta-blockers, diuretics, digoxin, and aldosterone receptor blockers. At implantation, 17 patients had implantable electronic devices: 1 biventricular pacemaker, 11 biventricular pacemakers with cardioverter-defibrillators, and 5 implantable cardioverter-defibrillators. Patient comorbidities included hypertension in 10 cases, diabetes mellitus in 8, myocardial infarction in 1, and ventricular tachycardia in 8. Mean operative time was 68 minutes (42-102 minutes), and implantation time averaged 15 minutes (5-51 minutes). The average time to ambulation was 1.6 days (1-4 days). The intensive care unit stay averaged 3.3 days (1-16 days), and hospital stay averaged 6.3 days (4-16 days). Atrial fibrillation occurred in 2 patients, and there were 2 in-hospital deaths. CONCLUSIONS: The Paracor device can be implanted in patients with heart failure and reduced left ventricular function with a high degree of success. Significant surgical complications were infrequent. The initial US experience supports the conduct of a randomized, controlled, pivotal trial.

Adult↗

PubMed2006

Preoperative pulmonary hypertension is associated with postoperative left ventricular dysfunction in chronic organic mitral regurgitation: an echocardiographic and hemodynamic study.

BACKGROUND: Some degree of pulmonary hypertension (PHTN) is common in patients with chronic mitral regurgitation. The aim of this study was to determine whether preoperative PHTN is associated with postoperative left ventricular (LV) dysfunction. METHODS: The study included 79 patients with chronic organic mitral regurgitation. Preoperative and postoperative LV function was assessed by echocardiography. Preoperative and postoperative hemodynamics were evaluated by a pulmonary artery catheter. RESULTS: Pulmonary artery systolic pressure decreased postoperatively (pre 49 +/- 14 vs. post 36 +/- 11 mm Hg, P < .01). Postoperative LV ejection fraction was significantly reduced in patients with preoperative PHTN (pre 61 +/- 11% vs post 49 +/- 12%, P < .01). A stepwise multivariate regression analysis showed that preoperative pulmonary artery systolic pressure and LV end-systolic dimension were independent predictors of postoperative LV ejection fraction (r = -0.53, P < .001, and r = -0.34, P < .05, respectively). CONCLUSION: Preoperative PHTN is associated with postoperative LV dysfunction in patients with chronic organic mitral regurgitation undergoing mitral valve operation.

Chronic Disease↗

PubMed2003

Preliminary experience with the LionHeart left ventricular assist device in patients with end-stage heart failure.

BACKGROUND: The Arrow LionHeart LVD 2000 left ventricular assist device is the first fully implantable system designed for destination therapy. We report on 2 years of experience with this device, which we implanted for the first time in October 1999. METHODS: Since October 1999, 6 male patients between 55 and 69 years of age (mean 65 +/- 6 years) have received the device at our center; all were in New York Heart Association functional class IV and ineligible for heart transplantation. RESULTS: All surgical procedures were uneventful, with a timely extubation in 5 of 6 patients. Duration of support was 17 to 670 (mean 245 +/- 138) days, with a cumulative experience of 4.5 years. Three patients recovered to be discharged from hospital under support and are long-term survivors. Three patients died 17, 31, and 112 days after implantation from multiple organ failure without being discharged to their homes. The survival rate is 50% after 18 months. There were no major system-related problems or any device-related infections, which are otherwise commonly found among vertricular assist device patients. CONCLUSIONS: Our preliminary experience demonstrates the reliability and efficacy of the different parts of the system. Nevertheless, further sophistication is needed to reduce the size of its components, which so far still constitutes a limiting factor.

Aged↗

PubMedDate not supplied

Microtextured materials for circulatory support devices: preliminary studies.

Thromboembolic events (TE) associated with circulatory support devices are a major source of mortality and morbidity. Clinically, the lowest TE rates are claimed with devices that incorporate textured blood-contacting materials. The textured materials currently used in circulatory assist devices are composed of small, attached fibers that form the boundaries of connected cavities. These cavities entrap blood components to form a "neointimal" layer, which is believed to minimize thromboembolic events. We believe that the three-dimensional surface topography of blood-contacting materials is a major controlling factor in the formation of a stable neointimal layer upon the material. Particle-cast cavities were used to form geometric features in segmented polyurethane. This microtextured material was incorporated as part of a flexible blood-contacting surface in a blood pump that was implanted as a left ventricular assist device in calves. The structure, thickness, stability, and development of the neointimal layer were then evaluated. These preliminary studies have shown that a stable neointimal layer can be formed upon the particle-cast surfaces. The results also indicate that the cavity size on the particle-cast surfaces has a significant effect on neointimal adhesion. The methods employed can be used in the design of future circulatory support devices.

Animals↗

PubMedDate not supplied

Report of the first U.S. patient successfully supported long term with the LionHeart completely implantable left ventricular assist device system.

We report our first successful long-term survivor in the United States with the LionHeart (Arrow International, Inc., Reading, PA) completely implantable left ventricular assist device system. The patient was initially deemed a poor candidate for cardiac transplantation and had inotrope-dependent, end-stage cardiac failure. The patient was supported for 13 months with this system. During this period of support, the patient returned to independent living and derived obvious benefits toward his daily activities with the completely implanted system. The device proved to be reliable during this period of support. Through lifestyle modification, the patient was ultimately deemed an appropriate candidate for heart transplantation and ultimately received successful transplantation.

Activities of Daily Living↗