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Is routine surveillance biopsy obsolete? A multi-institutional analysis
The Journal of Heart and Lung Transplantation Volume 24, Number 2S
Methods: Between 1990 and 2003, 36 adult patients (pts) (out of 343 adult transplant recipients) received at least 3 months of photo (2 day treatment every 3 to 4 weeks for a target of 15 months) following HC rej (n⫽14), recurrent/recalcitrant rej (n⫽ 18), or as prophylaxis in the presence of anti-donor antibodies (n⫽4). Survival and risk factors were examined by multivariable hazard modulated renewal function analysis. Results: Pts selected for photo were at greater risk for rej (p⬍.0001) and HC rej (p⬍.0001) than non-photo pts. Following ⱖ 3 months of photo therapy, rej risk was decreased (p⫽.04). More importantly, the hazard for subsequent HC rej or rej death was significantly reduced toward the risk-adjusted level of lower risk non-photo pts (p⫽.006) (see figure). Furthermore, the risk of infection decreased following photo (p⬍.0001). Conclusions: 1. This study provides objective evidence that photopheresis reduces the risk of subsequent HC rejection and/or death from rejection when initiated for pts with high rejection risk. 2. Photopheresis is recommended as an important therapeutic modality following rejection with hemodynamic compromise. 3. Further studies are needed to define the precise mechanism of effect and the potential for benefit in other patient subsets.
77 IS ROUTINE SURVEILLANCE BIOPSY OBSOLETE? A MULTIINSTITUTIONAL ANALYSIS J. Stehlik,1 R. Starling,2 R. Brown,3 J. Fang,4 N. Lewis,5 M. Hess,6 M. Jessup,7 1VA Med Ctr, Salt Lake City, UT; 2Cleveland Clinic Fdn, Cleveland, OH; 3Univ of Alabama at Birmingham, Birmingham, AL; 4Brigham & Women’s Hosp, Boston, MA; 5VA Med Ctr, Richmond, VA; 6Med College of Virginia, Richmond, VA; 7 Univ of Pennsylvania, Philadelphia, PA Background: The frequency of acute graft rejection decreases with time post transplant. There is no consensus on whether or when routine surveillance endomyocardial biopsies (Bx) should be discontinued. Our goal was to examine institutional practices regarding surveillance Bx, related outcomes, and risk factors for late rejection (rej). Methods: Survivors of the first 2 yrs following cardiac transplantation (tx) (n⫽5246) in 33 centers comprised the study group. Late rej was defined as any rej occurring after the end of the second post-tx yr. Results: During a follow-up of 24,137 patient yrs, 9865 rej episodes were identified, of which 1626 (16%) were late. The risk of late rej remained low at .1 per patient yr at the 3rd yr anniversary and .05 at the 5th. Seventeen tx centers (52%) reported routine discontinuation of surveillance Bx, most within 5 yrs of tx. Sixteen centers continue surveillance indefinitely. Modulated renewal analysis of freedom from late rej confirmed higher rates of acute rej (RR⫽1.4, p⬍.0009) in the surveillance group, but with comparable rates of mortality. Predictors
Abstracts
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of late rej were shorter time since last rej, number of previous rej (RR⫽1.7, 1 vs 3, p⫽⬍.0001), anniversary yr (RR⫽3.4, yr 2 vs yr 7, p⫽⬍.0001) younger age (RR⫽1.6, 35 yrs vs. 65 yrs, p⫽⬍.0001), black race (RR⫽1.5, p⫽⬍.0001), and infection history. Patients rejection-free at the end of the second yr (37% of the study group), had an average risk of rej of 4% in the following yr, assuming continued surveillance. Conclusions: 1. Cessation of surveillance biopsies after the first 2 yrs does not increase morbidity or mortality for the typical patient. 2. Rejection and infection history, as well as certain demographic features, contribute to the ongoing risk of late rejection. 3. Cessation of surveillance biopsies appears justified in patients rejection-free in the first 2 yrs.
78 CLINICAL RESULTS WITH THE ORQIS威 MEDICAL CANCION威 CRS THERAPY B. Czerska,1 R.M. Oren,2 M. Bohm,3 J. Sadowsky,4 A.B. Van Bakel,5 W.T. Abraham,6 A. Wasler,7 B. Cabuay,2 S. Khanal,1 K. Bartus,4 M.R. Zile,5 M.A. Konstam,8 1Cardiology, Henry Ford Heart & Vascular Institute, Detroit, MI; 2Medicine, University of Iowa, Iowa City, IA; 3Internal Medicine, University Hospital Saarland, Homberg, Germany; 4Cardiology, John Paul II Hospital, Krakow, Poland; 5 Cardiology, Medical University of South Carolina, Charleston, SC; 6 Cardiovascular Medicine, The Ohio State University, Columbus, OH; 7 Surgery, University of Graz, Graz, Austria; 8Medicine, Tufts-New England Medical Center, Boston, MA The therapy is a novel, percutaneous (perc), low-flow circuit, producing continuous aortic flow augmentation. Entry criteria: 1) recently exacerbated CHF, 2) sustained (⬎24 hr) elevated PCWP despite iv inotropes; 3) reduced (red) Cr clearance and/or diuretic resistance. Pump inflow was via fem art cannula, and outflow was via perc aortic pigtail (n⫽19) or axillary graft (n⫽4) cannula. Cath lab insertion: ⬍30 mins. Avg therapy: 73 (24 –112) hrs. Avg pump flow: 1.33 (1.2–1.5) LPM. PCWP decreased (dec) and mean CI increased (inc) from baseline (B) at 24 and 72 hrs on pump (both p⬍0.005) with further CI inc 24 hrs post removal (PR) (favorable Starling relation shift). (Figure) Cumulative I/O avg ⫺3.5L and weight loss avg 2.2 (0 –7.5) Kg by day 4 PR. LV unloading was evident on echo by LA dim red (5.1⫾0.6 (B) to 4.4⫾0.5 cm (n⫽6; p⬍0.01)) and trends in LV dia and sys dims. Cr dec (1.37⫾0.32 to 1.22⫾0.33 mg% B vs 48 hrs; p⫽0.08; n⫽19) remaining red PR. Sustained improvement (imp) in KCCQ-assessed health status was seen at 14 and 30 days. The therapy induced progressive imp in hemodynamic, cardiac and overall patient status with persistent benefit pr.
Methods: Between 1990 and 2003, 36 adult patients (pts) (out of 343 adult transplant recipients) received at least 3 months of photo (2 day treatment every 3 to 4 weeks for a target of 15 months) following HC rej (n⫽14), recurrent/recalcitrant rej (n⫽ 18), or as prophylaxis in the presence of anti-donor antibodies (n⫽4). Survival and risk factors were examined by multivariable hazard modulated renewal function analysis. Results: Pts selected for photo were at greater risk for rej (p⬍.0001) and HC rej (p⬍.0001) than non-photo pts. Following ⱖ 3 months of photo therapy, rej risk was decreased (p⫽.04). More importantly, the hazard for subsequent HC rej or rej death was significantly reduced toward the risk-adjusted level of lower risk non-photo pts (p⫽.006) (see figure). Furthermore, the risk of infection decreased following photo (p⬍.0001). Conclusions: 1. This study provides objective evidence that photopheresis reduces the risk of subsequent HC rejection and/or death from rejection when initiated for pts with high rejection risk. 2. Photopheresis is recommended as an important therapeutic modality following rejection with hemodynamic compromise. 3. Further studies are needed to define the precise mechanism of effect and the potential for benefit in other patient subsets.
77 IS ROUTINE SURVEILLANCE BIOPSY OBSOLETE? A MULTIINSTITUTIONAL ANALYSIS J. Stehlik,1 R. Starling,2 R. Brown,3 J. Fang,4 N. Lewis,5 M. Hess,6 M. Jessup,7 1VA Med Ctr, Salt Lake City, UT; 2Cleveland Clinic Fdn, Cleveland, OH; 3Univ of Alabama at Birmingham, Birmingham, AL; 4Brigham & Women’s Hosp, Boston, MA; 5VA Med Ctr, Richmond, VA; 6Med College of Virginia, Richmond, VA; 7 Univ of Pennsylvania, Philadelphia, PA Background: The frequency of acute graft rejection decreases with time post transplant. There is no consensus on whether or when routine surveillance endomyocardial biopsies (Bx) should be discontinued. Our goal was to examine institutional practices regarding surveillance Bx, related outcomes, and risk factors for late rejection (rej). Methods: Survivors of the first 2 yrs following cardiac transplantation (tx) (n⫽5246) in 33 centers comprised the study group. Late rej was defined as any rej occurring after the end of the second post-tx yr. Results: During a follow-up of 24,137 patient yrs, 9865 rej episodes were identified, of which 1626 (16%) were late. The risk of late rej remained low at .1 per patient yr at the 3rd yr anniversary and .05 at the 5th. Seventeen tx centers (52%) reported routine discontinuation of surveillance Bx, most within 5 yrs of tx. Sixteen centers continue surveillance indefinitely. Modulated renewal analysis of freedom from late rej confirmed higher rates of acute rej (RR⫽1.4, p⬍.0009) in the surveillance group, but with comparable rates of mortality. Predictors
Abstracts
S67
of late rej were shorter time since last rej, number of previous rej (RR⫽1.7, 1 vs 3, p⫽⬍.0001), anniversary yr (RR⫽3.4, yr 2 vs yr 7, p⫽⬍.0001) younger age (RR⫽1.6, 35 yrs vs. 65 yrs, p⫽⬍.0001), black race (RR⫽1.5, p⫽⬍.0001), and infection history. Patients rejection-free at the end of the second yr (37% of the study group), had an average risk of rej of 4% in the following yr, assuming continued surveillance. Conclusions: 1. Cessation of surveillance biopsies after the first 2 yrs does not increase morbidity or mortality for the typical patient. 2. Rejection and infection history, as well as certain demographic features, contribute to the ongoing risk of late rejection. 3. Cessation of surveillance biopsies appears justified in patients rejection-free in the first 2 yrs.
78 CLINICAL RESULTS WITH THE ORQIS威 MEDICAL CANCION威 CRS THERAPY B. Czerska,1 R.M. Oren,2 M. Bohm,3 J. Sadowsky,4 A.B. Van Bakel,5 W.T. Abraham,6 A. Wasler,7 B. Cabuay,2 S. Khanal,1 K. Bartus,4 M.R. Zile,5 M.A. Konstam,8 1Cardiology, Henry Ford Heart & Vascular Institute, Detroit, MI; 2Medicine, University of Iowa, Iowa City, IA; 3Internal Medicine, University Hospital Saarland, Homberg, Germany; 4Cardiology, John Paul II Hospital, Krakow, Poland; 5 Cardiology, Medical University of South Carolina, Charleston, SC; 6 Cardiovascular Medicine, The Ohio State University, Columbus, OH; 7 Surgery, University of Graz, Graz, Austria; 8Medicine, Tufts-New England Medical Center, Boston, MA The therapy is a novel, percutaneous (perc), low-flow circuit, producing continuous aortic flow augmentation. Entry criteria: 1) recently exacerbated CHF, 2) sustained (⬎24 hr) elevated PCWP despite iv inotropes; 3) reduced (red) Cr clearance and/or diuretic resistance. Pump inflow was via fem art cannula, and outflow was via perc aortic pigtail (n⫽19) or axillary graft (n⫽4) cannula. Cath lab insertion: ⬍30 mins. Avg therapy: 73 (24 –112) hrs. Avg pump flow: 1.33 (1.2–1.5) LPM. PCWP decreased (dec) and mean CI increased (inc) from baseline (B) at 24 and 72 hrs on pump (both p⬍0.005) with further CI inc 24 hrs post removal (PR) (favorable Starling relation shift). (Figure) Cumulative I/O avg ⫺3.5L and weight loss avg 2.2 (0 –7.5) Kg by day 4 PR. LV unloading was evident on echo by LA dim red (5.1⫾0.6 (B) to 4.4⫾0.5 cm (n⫽6; p⬍0.01)) and trends in LV dia and sys dims. Cr dec (1.37⫾0.32 to 1.22⫾0.33 mg% B vs 48 hrs; p⫽0.08; n⫽19) remaining red PR. Sustained improvement (imp) in KCCQ-assessed health status was seen at 14 and 30 days. The therapy induced progressive imp in hemodynamic, cardiac and overall patient status with persistent benefit pr.