Incidence and patterns of adverse event onset during the first 60 days after ventricular assist device implantation.

BACKGROUND: Although ventricular assist devices (VADs) provide effective treatment for end-stage heart failure, VAD support remains associated with significant risk for adverse events (AEs). To date there has been no detailed assessment of the incidence of a full range of AEs using standardized event definitions. We sought to characterize the frequency and timing of AE onset during the first 60 days of VAD support, a period during which clinical observation suggests the risk of incident AEs is high. METHODS: A retrospective analysis was performed utilizing prospectively collected data from a single-site clinical database including 195 patients aged 18 or greater receiving VADs between 1996 and 2006. Adverse events were coded using standardized criteria. Cumulative incidence rates were determined, controlling for competing risks (death, transplantation, recovery-wean). RESULTS: During the first 60 days after implantation, the most common AEs were bleeding, infection, and arrhythmias (cumulative incidence rates, 36% to 48%), followed by tamponade, respiratory events, reoperations, and neurologic events (24% to 31%). Other events (eg, hemolysis, renal, hepatic events) were less common (rates <15%). Some events (eg, bleeding, arrhythmias) showed steep onset rates early after implantation. Others (eg, infections, neurologic events) had gradual onsets during the 60-day period. Incidence of most events did not vary by implant era (1996 to 2000 vs 2001 to 2006) or by left ventricular versus biventricular support. CONCLUSIONS: Understanding differential temporal patterns of AE onset will allow preventive strategies to be targeted to the time periods when specific AE risks are greatest. The AE incidence rates provide benchmarks against which future studies of VAD-related risks may be compared.

Right heart failure after left ventricular assist device implantation in patients with chronic congestive heart failure.

BACKGROUND: Right heart failure (RHF) is not an infrequent complication of left ventricular assist device (LVAD) implantation. Few studies have examined outcomes for LVAD patients who subsequently develop RHF. This study details one center's experience with RHF in chronic congestive heart failure (CHF) patients. METHODS: One hundred eight patients with chronic CHF (>or=6 months) who underwent HeartMate LVAD implantation were identified during June 1996 to July 2004. Acute heart failure patients requiring LVADs were excluded to eliminate the impact of confounding non-cardiac factors. RHF was defined as the need for a subsequent right ventricular assist device (RVAD), >or=14 days of intravenous inotropes/pulmonary vasodilators, or both. Forty-two (38.9%) RHF patients were identified. Fourteen of these required RVAD insertion. Outcome parameters included early (

Clinical outcomes in patients with chronic congestive heart failure who undergo left ventricular assist device implantation.

OBJECTIVE: The use of left ventricular assist devices as a bridge to transplantation for patients with chronic congestive heart failure is well accepted. However, few studies have examined outcomes solely for these patients. This study details one center's left ventricular assist device experience with this population. METHODS: Two hundred one patients received HeartMate left ventricular assist devices (Thoratec Corp, Pleasanton, Calif) from January 1, 1996, to April 30, 2004. Of these, 119 (59.2%) had chronic congestive heart failure (diagnosis >6 months) as the primary indication. Outcome parameters included early mortality after left ventricular assist device placement (<30 days), bridge-to-transplantation rate, and posttransplantation survival. Variables examined included patient demographic data; preoperative pacemaker, internal defibrillator, and balloon pump use; and preoperative laboratory values. RESULTS: Advanced age, female sex, and diabetes were independent predictors of early death (P = .048, odds ratio 1.879 per 10 years of age, 95% confidence interval 1.005-3.515; P = .002, odds ratio 10.029, 95% confidence interval 2.256-44.583; P = .040, odds ratio 3.974, 95% confidence interval 1.063-14.861). Advanced age, female sex, and low preoperative albumin were independent predictors of poor bridge-to-transplantation rate (P = .029, odds ratio 0.135 per 10 years of age, 95% confidence interval 0.022-0.819; P = .002, odds ratio 0.013, 95% confidence interval 0.001-0.197; P = .023, odds ratio 19.178 per 1 g/dL albumin, 95% confidence interval 1.504-244.598). There were no independent predictors of poor posttransplantation survival and prolonged intensive care unit stay. Overall bridge-to-transplantation rate was 81.5%. The 1-, 3-, 5-, and 7-year posttransplantation survivals were 88.4%, 84.5%, 78.4%, and 76.0%. CONCLUSION: Among patients with chronic congestive heart failure, advanced age, female sex, diabetes, and low preoperative albumin predict poor clinical course. Careful risk stratification and comprehensive evaluation by care providers should be performed for candidates who are female, are elderly, and have diabetes, and preoperative nutritional optimization should be encouraged to enhance patient outcomes.

Simplified placement of multiple artificial mitral valve chords.

BACKGROUND: The use of artificial chords for the replacement of diseased mitral valve chordae and the correction of anterior and posterior leaflet prolapse is well described, although it is infrequently applied because of technical challenges. METHODS: A simplified approach to attaching the new chords to a single papillary muscle base within the left ventricle has been reported, and we present a series of 13 patients with moderate-severe mitral regurgitation (MR) who underwent chordal replacement using this improved technique. RESULTS: The MR grade by echocardiogram improved from 3.7 +/- 0.4 preoperatively to 1.0 +/- 0.8 postoperatively. All patients were doing well at a mean follow-up interval of 285 +/- 62 days. CONCLUSION: Chordal replacement for both anterior and posterior leaflet prolapse is an effective treatment for MR when combined with standard mitral valve repair techniques. The authors' technique of determining proper chordal height and placing multiple chordae is also discussed.