Prophylaxis versus preemptive anti-cytomegalovirus approach for prevention of allograft vasculopathy in heart transplant recipients.
BACKGROUND
Cytomegalovirus (CMV) infection may influence the development of cardiac allograft vasculopathy (CAV). Prophylactic or preemptive administration of anti-CMV agents effectively prevents acute CMV manifestations. However, studies comparing allograft-related outcomes between these anti-CMV approaches are lacking. Herein we report a longitudinal observational study comparing CAV development between prophylactic and preemptive approaches.


METHODS
The 1-year change in maximal intimal thickening (MIT) assessed by intravascular ultrasound at 1 and 12 months after heart transplantation (the major surrogate for late survival) was compared in groups of patients routinely assigned to a preemptive strategy (from November 2004 to October 2005; n = 21) or receiving valganciclovir prophylaxis (from November 2005 to October 2006; n = 19). CMV infection was monitored with pp65 antigenemia.


RESULTS
The 1-year increase in MIT was significantly lower in patients receiving prophylaxis compared with those managed preemptively (0.15 +/- 0.17 vs 0.31 +/- 0.20 mm; p = 0.01). Prophylaxed recipients presented less frequently with MIT change > or =0.3 mm (p = 0.03) and > or =0.5 mm (p = 0.10) than those managed preemptively. Prophylaxis was also associated with later onset of CMV infection (p = 0.01), lower peak CMV detection (p < 0.01) and reduced incidence of CMV disease/syndrome (p = 0.04). After adjusting for metabolic risk factors and other possible confounders, prophylaxis remained independently associated with lower risk for MIT change > or =0.3 mm (odds ratio = 0.09, 95% confidence interval 0.01 to 0.93; p = 0.04).


CONCLUSIONS
Universal prophylaxis was associated with delayed onset of CMV infection, lower viral burden, reduced CMV disease/syndrome and less intimal thickening, as compared with a preemptive anti-CMV approach. Randomized studies are required to confirm the potential benefits of prophylaxis vs a preemptive approach in heart transplant recipients.
Potena
Luciano
L
Cardiovascular Department, Heart Transplant Program, University of Bologna, Bologna, Italy. luciano.potena2@unibo.it
Grigioni
Francesco
F
Magnani
Gaia
G
Lazzarotto
Tiziana
T
Musuraca
Anna C
AC
Ortolani
Paolo
P
Coccolo
Fabio
F
Fallani
Francesco
F
Russo
Antonio
A
Branzi
Angelo
A
D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D003586:Cytomegalovirus Infections / Q000150:complications* / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000401:mortality; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D015774:Ganciclovir / Q000009:adverse effects / Q000627:therapeutic use*; D016027:Heart Transplantation; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010750:Phosphoproteins / Q000097:blood; D011183:Postoperative Complications / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D011446:Prospective Studies; D012307:Risk Factors; D016019:Survival Analysis; D018084:Ultrasonography, Interventional; D019562:Viral Load; D014763:Viral Matrix Proteins / Q000097:blood
D000998:Antiviral Agents; D007166:Immunosuppressive Agents; D010750:Phosphoproteins; D014763:Viral Matrix Proteins; C065418:cytomegalovirus matrix protein 65kDa; D015774:Ganciclovir