Kaplan-Meier Estimates Of Freedom Research Articles

Thymoglobulin Induction Therapy and Renal Graft Survival in Patients at the Hospital de Especialidades, Centro Medico Nacional de Occidente, Jalisco, Mexico.

Introduction. Induction with Thymoglobulin offers advantages such as reducing the frequency of acute rejection and improved graft function. Objective. To evaluate renal graft function and graft survival in patients receiving Thymoglobulin induction. Materials and Methods: A retrospective cohort, in the period June 2010 to December 2013 included renal transplants patients who has over 15 years of age, any kind donor and who received induction therapy with Thymoglobulin. Excluded patients with graft loss in the 1st week of renal transplantation, or its follow up was lost. Was recorded the dose cumulative mean of Thymoglobulin, and serum creatinine at 12 months, 2 years and 3 years of renal transplantation (Table 1), to assess graft function. Kaplan-Meier estimates of freedom from death and graft loss. The frequency of acute rejection-free period it was obtained, and secondarily, freedom from infection- related death and posttrasplant frequency of infections and lymphoproliferative disorders (Table 2). Results: 250 patients were included, which received initial doses of Thymoglobulin 0.7mg/kg- 1.5mg/kg. A 70 percent received living donor transplants and 30 percent of deceased donor.Table: No Caption available.Table: No Caption available.Actual patient and graft survival were 98% (n=250) at 12 months. Kaplan-Meier estimates of freedom from death and graft loss, through 2 years were 98.3% and 97.8% (n=185), respectively, and 96% (4/98) and 93.9% (n=98), through 3 years. Discussion. Induction with Thymoglobulin allowed good graft function and survival. The mean cumulative dose of Thymoglobulin induction was consistent with recent literature reporting similar outcomes and safety profile, during the course of the registry, we observed a decline in mean dose. We can conclude that the use of Thymoglobulin as induction agent in our patients at high immunological risk, is safe and associate with excellent patient survival and low rates of acute rejection renal graft survival.

Are Repeat Prostate Biopsies Safe? A Cohort Analysis From the SEARCH Database

Patients question whether multiple biopsy sessions cause worse prostate cancer outcomes. Therefore, we investigated whether there is an association between the number of prior biopsy sessions and biochemical recurrence after radical prostatectomy. Men in the SEARCH (Shared Equal Access Regional Cancer Hospital) database who underwent radical prostatectomy between 1988 and 2010 after a known number of prior biopsies were included in the analysis. Number of biopsy sessions (range 1 to 8) was examined as a continuous and categorical (1, 2 and 3 to 8) variable. Biochemical recurrence was defined as a prostate specific antigen greater than 0.2 ng/ml, 2 values at 0.2 ng/ml or secondary treatment for an increased prostate specific antigen. The association between number of prior biopsy sessions and biochemical recurrence was analyzed using the Cox proportional hazards model. Kaplan-Meier estimates of freedom from biochemical recurrence were compared among the groups. Of the 2,739 men in the SEARCH database who met the inclusion criteria 2,251 (82%) had only 1 biopsy, 365(13%) had 2 biopsies and 123 (5%) had 3 or more biopsies. More biopsy sessions were associated with higher prostate specific antigen (p<0.001), greater prostate weight (p<0.001), lower biopsy Gleason sum (p=0.01) and more organ confined (pT2) disease (p=0.017). The Cox proportional hazards model demonstrated no association between number of biopsy sessions as a continuous or categorical variable and biochemical recurrence. Kaplan-Meier estimates of freedom from biochemical recurrence were similar across biopsy groups (log rank p=0.211). Multiple biopsy sessions are not associated with an increased risk of biochemical recurrence in men undergoing radical prostatectomy. Multiple biopsy sessions appear to select for a low risk cohort.

Gamma Knife Radiosurgery in the Treatment of Tumor-Related Facial Pain

Background: Intracranial neoplasms can cause pain similar to trigeminal neuralgia. Literature regarding radiosurgery for this is limited. We present a retrospective review of patients with tumor-related facial pain from benign lesions treated with gamma knife radiosurgery (GKRS) at Wake Forest University. Objectives: The primary objectives were to determine long-term pain relief and predictive factors for pain alleviation. Methods: We reviewed 515 patients treated with GKRS for benign meningioma, vestibular schwannoma or trigeminal schwannoma between August 1999 and August 2010. Twenty-one eligible patients had tumor-related facial pain prior to GKRS. The median marginal tumor dose was 12 Gy. Long-term pain relief data were obtained by chart review and telephone interview. Results: The median follow-up for symptom evaluation was 3.8 years. Seventeen of 21 patients (81%) experienced a Barrow Neurological Institute (BNI) score of I–III at 6 months following GKRS. Kaplan-Meier estimates of freedom from BNI IV–V relapse were 66% at 1 year and 53% at 2 years. No pain relapses occurred after 2 years. Conclusion: GKRS of benign lesions is a noninvasive option for patients with tumor-related facial pain. Pain relief is modest, with the majority of pain relapses occurring within 2 years and approximately one half of patients maintaining relief beyond 2 years.

Aspergillus Infection and Extracorporeal Membrane Oxygenation Support

The clinical characteristics of patients with Aspergillus isolation while supported on extracorporeal membrane oxygenator (ECMO) remain unclear. We present a case report of angioinvasive Aspergillus infection on an infant supported on ECMO and also investigate outcomes among patients with Aspergillus infection reported to the Extracorporeal Life Support Organization (ELSO) registry. Case report and retrospective analysis of ELSO registry data set from 1985 to 2009. One hundred and seventy ECMO centers contributing data to the ELSO registry. Single case report and patients 0 to 90 years of age with Aspergillus infection requiring ECMO support as reported to the ELSO registry. Besides presenting details of our institutional case, we compared clinical characteristics and outcomes between pediatric and adult patients with Aspergillus isolation. Risk factors for in-hospital mortality were investigated. Kaplan-Meier estimates for freedom from death on ECMO for pediatric and adult patients were investigated. (a) we report a case with Aspergillus supported on ECMO, (b) the ELSO registry yielded 46 patients with 59% (n = 27) in the pediatric data set (≤20 years of age) and 41% (n = 19) in the adult data set (>20 years of age) with Aspergillus infection requiring ECMO support. Overall survival to hospital discharge was 30% (14/46) with 22% (6/27) in children as compared to 42% (8/18) in adults (P = .19). Table 1 shows a comparison of clinical characteristics between children and adults. The comparison between adults and pediatric groups differed significantly in age (P = .0001), more use of venoarterial ECMO in children (P = .028). The median age of pediatric group was 1.95 years (range 0-17.3 years) versus 30.2 years (range 22-60 years) among adults. Aspergillus infection/colonization is associated with a 70% overall mortality among patients supported on ECMO. The ELSO registry data confirms that Aspergillus infection among ECMO supported patients occurs often in hosts who do not have known immunodeficiencies. The case stresses the need for a high level of suspicion for Aspergillus infection in nonimproving lung disease in patients on ECMO support.

The Ross Operation in Children and Young Adults: A Fifteen-Year, Single-Institution Experience

The optimal operation for aortic valve disease in children and young adults remains controversial. The Ross operation offers avoidance of anticoagulation and the potential for growth but is technically demanding and creates double-valve disease. The goal of this study is to report our experience with the Ross operation and the need for reintervention at intermediate follow-up. A retrospective review of Ross operations in a single surgeon experience from 1992 to 2007 was conducted. All echocardiograms were reevaluated by a single cardiologist. The cohort included 54 patients with a mean age of 13.5 years (range 0.5 to 35 years). Pulmonary autograft implantation was accomplished using root replacement (n=43), root inclusion (n=9), and Dacron tube root replacement (n=2). Follow-up was available for 47 patients (87%) at a mean length of 6.4 years. There were no deaths. Kaplan-Meier estimates of freedom from explantation at 10 years were 100% for the autograft and 71% for the homograft. Autograft insufficiency at latest follow-up was trivial in 37 patients (82%), mild in 6 patients (13%), and moderate in 2 patients (4%). Reintervention for the homograft included balloon dilation in 3 children and conduit change in 5 children (all≤2 years old at initial operation). The Ross operation can be performed in children and adults with low mortality and can provide a durable result for the aortic valve with a low incidence of aortic insufficiency. The need for homograft replacement during follow-up in our series was primarily limited to children who were age 2 years or younger at initial operation.

Infectious complications after pulsatile-flow and continuous-flow left ventricular assist device implantation

Infection is a significant source of morbidity and mortality after left ventricular assist device (LVAD) implantation. Newer generation continuous-flow (CF) LVADs are smaller, requiring smaller pump pockets and drive-line exit sites as compared with pulsatile-flow (PF) devices. With their recent adoption, CF device patients benefit from improved provider experience in the detection and treatment of infectious complications. Given these advances in design and experience, we examined the incidence of infectious complications in patients receiving CF and PF devices. We reviewed patients who received CF or PF LVADs (June 2000 to May 2009) at our institution. Incidences and timing of systemic infections (bacteremia, sepsis, severe sepsis, septic shock), device-associated infections (drive-line, LVAD pocket, sternal wound) and non-device-associated infections (catheter-related bloodstream, pneumonia, urinary tract) were compared between devices. Primary outcomes were sepsis, severe sepsis, a composite of drive-line and LVAD pocket infection, and catheter-related bloodstream infection. Of 133 LVADs, 86 were CF. CF patients had lower pre-operative risk, more recent device implantation, and longer LVAD support time. Device type was highly correlated with reduced infections; however, on multivariate analysis, implantation date appeared to drive this association. Kaplan-Meier estimates of freedom from all primary outcomes were improved with more recent implantation (p < 0.05). On multivariate analysis, implantation date was predictive of all primary outcomes except severe sepsis, for which advanced age and worse Seattle Heart Failure Model score were predictive. In this institutional review of post-LVAD infections, a decrease in infectious complications in CF patients was likely related to increased provider experience associated with a more recent date of implantation.

Open surgery remains a valid option for the treatment of recurrent carotid stenosis

The choice between open surgery (OS) and transluminal carotid angioplasty with stenting (CAS) for the treatment of primary carotid stenosis remains controversial. However, CAS is considered a valid option for selected cases, such as recurrent carotid stenosis (RCS). Tertiary RCS seems to be a concerning issue after CAS but few large reports focused on the durability of CAS and OS. We report our early and long-term results with OS for RCS. From 1989 to 2006, perioperative data regarding 4245 consecutive surgical carotid reconstructions was prospectively collected. Patients whose indication was RCS were subjected to further analysis. Indications for surgery were symptomatic RCS >50% or asymptomatic RCS >80%. Freedom from neurologic event was defined as the absence of any ipsilateral symptom at any time after the procedure. Kaplan-Meier analysis was used to estimate freedom from reintervention, freedom from restenosis >50% and occlusion, freedom from neurologic event and survival. A total of 119 patients (2.8%) with RCS underwent OS. The average time from the primary OS was 59.4 +/- 54.5 months (range, 2-204). Forty-nine patients (41%) were symptomatic. In 103 patients (87%), the technique did not differ from a primary approach. Postoperative (<30 days) combined stroke and death rate was 3.3%. Cranial nerve injury occurred in 5 cases (4.2%). With a mean follow-up of 53 +/- 48 months (range, 1-204), 3 patients had an ipsilateral stroke (including one hemorrhagic stroke) and 7 were diagnosed with a tertiary RCS >50%. At 5 years, Kaplan-Meier estimates of freedom from reintervention, freedom from restenosis and occlusion, freedom from neurologic event, and survival were 99%, 91%, 89%, and 91%, respectively. OS for RCS is not a high-risk procedure and provides excellent long-term results, with low rates of tertiary RCS and reinterventions. The comparison between OS and CAS in this indication suffers from the absence of standardized follow-up paradigms after primary OS and the lack of prospective randomized trial comparing the two techniques. Despite these limitations in the available data, we conclude that OS should remain the first line therapy when treatment of RCS is indicated.

Endoluminal Stent-Graft Placement for Repair of Abdominal Aortic Aneurysms in the Community Setting

To demonstrate that results similar to high-volume academic centers can be achieved in the community setting when treating abdominal aortic aneurysm (AAA) using endovascular techniques, given appropriate volume and skill sets. A retrospective review was conducted of 342 consecutive patients who underwent endovascular aneurysm repair (EVAR) by surgeons in a community hospital group from October 1999 through September 2005. In this population, 245 (71.6%) patients were treated with EVAR and 97 (28.4%) with open surgical repair. Of the 245 EVAR patients (203 men; mean age 73.4+/-9.2 years), 218 AneuRx, 19 Ancure, 6 Excluder, and 2 Zenith stent-grafts were implanted by 2 vascular surgeons to exclude AAAs with a mean diameter of 54+/-11 mm. Patients were followed postoperatively with office visits and computed tomography at 1, 6, and 12 months and annually thereafter. Technical success was achieved in 99.6% (244/245) with 1 intraoperative conversion. Mean operative time was 131+/-57 minutes, with a mean contrast load of 161.6+/-65.5 mL. Thirty-five (14.3%) patients required intraoperative blood transfusion. Length of stay was 2.3+/-4.5 days. Thirty-day mortality was 0.8% (2/245). Secondary procedures were required in 15 (6.1%) patients. Kaplan-Meier estimates of freedom from secondary interventions were 98%, 98%, 95%, and 90% at 12, 24, 36, and 48 months, respectively. At the same time points, freedom from surgical conversion was 99%, 99%, 97%, and 96%, and freedom from aneurysm-related death was 97%, 96%, 96%, and 96%. Endovascular AAA repair provides a less invasive method of managing aortic disease with resultant low perioperative mortality. Results in our community hospital demonstrate that this technology can be applied outside an academic environment in nearly three quarters of the population with excellent short and long-term results.

Atrial Arrhythmias After Single-Ring Isolation of the Posterior Left Atrium and Pulmonary Veins for Atrial Fibrillation

Background— Single-ring isolation of the posterior left atrium is feasible, but the incidence and mechanisms of postprocedural arrhythmias have not been described in detail. Methods and Results— The first 100 consecutive patients (58.8�11.2 years old, 80 male) who underwent single-ring isolation for atrial fibrillation (66 intermittent, 18 persistent, 16 long-standing persistent) were followed up for 9.1�4.5 months. Recurrences were diagnosed by clinical symptoms and Holter monitoring. Patients with recurrences of sustained atrial arrhythmia &gt;3 months after the procedure were offered a repeat procedure and were studied to determine the mechanisms of recurrence. Forty-six patients (46%) experienced sustained postprocedural atrial arrhythmias (35 had atrial fibrillation, and 34 had atrial flutter). Of these, 34 required a second procedure 7.0�3.1 months after their initial procedure. Reconnection of the posterior left atrium was seen in all patients with atrial fibrillation. Atrial flutter was most commonly due to mitral isthmus-dependent macroreentry (n=8, cycle length 368�116 ms) or macroreentry through 2 gaps in the ring of lesions (n=6, cycle length 328�115 ms). Posterior left atrium reisolation was achieved at the second procedure in all patients. Atrial flutter was successfully ablated and rendered noninducible in all patients. Six months after their last procedure, the Kaplan-Meier estimate of freedom from recurrence for all 100 patients was 81�5%. Conclusions— Atrial fibrillation and atrial flutter recurrence is common after single-ring isolation. Reconnection of the posterior left atrium and macroreentry are the common mechanisms. Repeat ablation results in satisfactory short-term outcomes.

Outcome of 200 patients after an extracardiac Fontan procedure

Despite the known advantages of the extracardiac conduit Fontan procedure, the long-term outcomes related to the longevity of the conduit and anticoagulation therapy have not been determined. The purpose of this study was to evaluate the outcome of hospital survivors with an extracardiac Fontan circulation. Between 1996 and 2006, 200 patients had the extracardiac conduit Fontan operation. The median age at operation was 3.4 years. Most patients (89.5%) underwent a bidirectional cavopulmonary shunt. Fenestration was required in 85 patients. Overall, the 10-year survival was 92.4% +/- 2.1%. Multivariate analysis identified severe infection during the early postoperative period and a high pulmonary arterial pressure during the preoperative period as independent risk factors for patient mortality. The Kaplan-Meier estimate for freedom from reoperation was 82.4% +/- 4.1% at 10 years. Arrhythmia occurred in 32 patients after the Fontan operation; freedom from arrhythmia was 85.1% +/- 4.4% at 10 years. The risk factors for arrhythmia were the heterotaxy syndrome, follow-up duration, and age at Fontan operation. Freedom from thromboembolism at 10 years was 92.9% +/- 1.9%. Among all of the patients, 95.2% were classified in New York Heart Association class I. The results of this study showed that during 10 years of follow-up, the overall survival and the functional status of the survivors after an extracardiac Fontan procedure were satisfactory. We might infer that fenestration provided benefit inasmuch as the high-risk Fontan patients fenestrated had similar outcomes to those not fenestrated, who were presumably low risk. The incidence of late death, reoperation, obstruction of the cavopulmonary pathway, arrhythmias, and thromboembolism was low.

Presentation, management and outcomes of thrombosis for children with cardiomyopathy

Thrombosis in children with dilated and inflammatory cardiomyopathy is an unpredictable complication with potentially important morbidity. To determine the prevalence, associated factors, management and outcomes of thrombosis in this setting. Data were obtained from review of medical records. Factors associated with thrombosis and the impact on outcome were sought. From 1990 to 1998, 66 patients that presented with dilated cardiomyopathy were followed for a median interval of 1.4 years (range 0 to 9.79 years) from first presentation. Thrombosis was diagnosed in four patients at presentation and in four patients during follow-up. Thrombosis was noted in one additional patient at examination after death. The overall nine-year period prevalence of thrombosis was 14%. Anticoagulation was started at presentation in 31% of patients. The mean left ventricular ejection fraction at presentation was significantly lower in those given anticoagulation (19+/-8%) versus those who were not (32+/-15%; P < 0.001). The mean ejection fraction at presentation was similar in those patients with (25+/-10%) versus those without thrombosis (28+/-15%; P = 0.44). During follow-up, 11 patients died and seven underwent cardiac transplantation. Kaplan-Meier estimates of freedom from death or transplantation were 88% at three months, 81% at one year and 70% at five years. Survival free of transplantation was not affected by thrombosis. Thrombosis is common in children with cardiomyopathy, can occur at any time in the patients' clinical course and is not related to clinical features or survival free of transplantation. The relevance and prevention of thrombosis in this setting remains unclear.

Sirolimus-Eluting Stents at Two Years: A Pooled Analysis of SIRIUS, E-SIRIUS, and C-SIRIUS With Emphasis on Late Revascularizations and Stent Thromboses

Prospective follow-up at 2 years was obtained for 98.7% of the pooled 1,510 patients enrolled in SIRIUS, E-SIRIUS and C-SIRIUS, 3 randomized controlled trials that compared sirolimus-eluting stents (SESs) with bare metal stents (BMSs) to treat long stenoses in small coronary arteries. By 720 days, clinically driven target lesion revascularizations were performed in 5.7% of patients with SESs versus 22.6% of patients with BMSs (risk ratio 0.25, 95% confidence interval 0.18 to 0.35, p <0.001). Of these, late target lesion revascularization (from 271 to 720 days) was performed in 12 patients who received SESs (1.6%) compared with 37 patients with BMSs (4.9%) (risk ratio 0.32, 0.17 to 0.61, p <0.001). Stent thromboses occurred in 7 of 758 patients with SESs (0.9%, 4 subacute, 3 late) and 5 of 752 patients with BMSs (0.7%, 1 subacute, 4 late) (risk ratio 1.39, 95% confidence interval 0.44 to 4.36, p = 0.774). The Kaplan-Meier estimate of freedom from major cardiac adverse events was 89.3% for patients with SESs versus 73.4% for patients with BMSs (p <0.001). This analysis demonstrates the sustained efficacy and safety of sirolimus-eluting stents at 2 years, characterized by a persistent significant benefit in freedom from repeat revascularization compared with BMSs and a low risk of late stent thrombosis, not different from BMSs.

Comparison of the effectiveness of sirolimus‐ and paclitaxel‐eluting stents for small coronary artery lesions

The sirolimus-eluting stent (SES) and the paclitaxel-eluting stent (PES) reduce restenosis in small coronary artery lesions. However, it is not clear which of these stents is superior in terms of clinical outcomes. The authors retrospectively examined 197 patients with 245 de novo small coronary artery lesions (<or=<or=2.75 mm) that were treated with either the SES (156 lesions) or the PES (89 lesions). Six-month angiographic restenosis rates and the 9-month target lesion revascularization (TLR) rates were compared between the two groups. In terms of baseline clinical and angiographic parameters, the two groups well matched together. Six-month angiographic follow-up was performed on 170 patients (86.3%), comprising 135 SES lesions (86.5%) and 76 PES lesions (85.4%). At 6-month angiographic follow-up, the late lumen loss was less in the SES group than in the PES group (0.29 +/- 0.42 vs. 0.69 +/- 0.63 mm, P < 0.01). Therefore, the SES group showed a lower rate of angiographic restenosis than the PES group (6.7% vs. 27.7%, P < 0.01). At 9 months there were no deaths or myocardial infarctions in either group. The 9-month TLR rate was lower in the SES group than in the PES group (3.3% vs. 14.4%, P < 0.01). The Kaplan-Meier estimate of freedom from TLR at 9 months was 96.7% for the SES patients and 86.5% for the PES patients (P < 0.01). The SES treatment may be superior to the PES treatment in terms of long-term clinical and angiographic outcomes in patients with small coronary artery lesions.

Feasibility and Intermediate Term Outcome of Repair of Prolapsing Anterior Mitral Leaflets With Artificial Chordal Replacement in 152 Patients

Mitral valve repair of the anterior leaflet has been more difficult than at other sites. Between February 1983 and June 2004, 607 mitral valve repairs were performed on one service. Of these, 410 patients had leaflet repair procedures: 152 were anterior leaflet repairs; isolated in 94, and combined with posterior repair in 58 patients. The results in these patients were compared with the results of posterior leaflet repair in 258 patients. All patients received flexible ring annuloplasty. Age and sex of the anterior leaflet and posterior leaflet patients were similar: mean age 62.5 +/- 14.3, 62.9 +/- 14.9 years; males, 50.6%, p = not significant (NS). Preoperative ejection fraction was for anterior repairs 52.6 +/- 12.8%; posterior repair, 58.2 +/- 11.8%, p = NS. Coronary artery bypass was more frequently performed with anterior leaflet repair in 18 patients (19.1%) versus 45 (6.6%) for posterior leaflet repair (p = NS). The median number of chordae was similar in the anterior leaflet and posterior leaflet patients 4 (2-8), 4 (2-6), p = NS. Perioperative mortality was similar: anterior leaflet patients, 3.3% (2/94); posterior leaflet patients, 1.1% (2/258), p = NS. Hospital stay was for anterior leaflet patients and posterior leaflet patients: 12.86 +/- 13.3 vs 11.0 +/- 12.3, p = NS. Kaplan-Meier estimates of freedom from reoperation at 3 years were: for anterior leaflet patients, 91.9%: for posterior leaflet patients, 90.7%, p = 0.77. No structural polytetrafluoroethylene (PTFE) chordal failures were observed. Late echocardiographic data were obtained in 136 patients on 222 occasions at a mean of 3.2 +/- 3.34 years. Severe mitral regurgitation was present in 10 patients (7.3%). Repair of the anterior leaflet is facilitated by the use of PTFE replacement. Anterior leaflet repair can be performed reproducibly with the same results as posterior leaflet repair.

Intermediate outcomes after the Fontan procedure in the current era

This study was undertaken to investigate the intermediate outcomes after the Fontan operation in the current era. A cross-sectional analysis was performed by using data gathered between October 13, 2003, and February 22, 2005, on all 310 survivors of the Fontan procedure between January 1, 1992, and December 31, 1999. Medical records were reviewed, and a customized questionnaire was administered to caregivers. Outcome variables included failure of the Fontan operation (ie, death, takedown of Fontan, or transplantation), number of cardiac-related rehospitalizations, parental assessment of health, school performance, and cardiac functional status. A total of 332 patients underwent the Fontan procedure during the study period. A lateral tunnel was constructed in 281 (85%), and an extracardiac Fontan procedure was performed in 51 (15%). A total of 210 (63%) children had undergone previous stage I reconstruction, and 162 (49%) had received an initial diagnosis of hypoplastic left heart syndrome. There were 310 hospital survivors of the Fontan procedure (93.4%), with an additional 16 deaths (5.2%) during follow-up and 1 living heart transplant patient before the cross-sectional period. For initial hospital survivors, Kaplan-Meier estimates of freedom from death or transplantation were 98.0% (95% confidence interval, 95.6%-99.1%) at 1 year after the Fontan procedure, 94.9% (91.6%-97.0%) at 5 years, and 93.9% (90.1%-96.2%) at 8 years. Questionnaires were completed for 240 (81.9%) of the 293 available patients. By parental recollection, a total of 130 (54.2%) children required cardiac-related rehospitalization at some point during the follow-up period. At a median follow-up of 8.6 years (range, 4.1-12.8 years), 94.6% of guardians described their child's overall health as excellent or good, and 5.4%, as fair or poor. School performance was described as above average in 30.2%, average in 39.9%, and below average in 29.8%. With regard to cardiac functional status, 34.2% responded that their child had no limitations to physical activity, 52.5% reported a slight limitation, 12.1% reported a significant limitation, and 1.2% reported a severe limitation. Acceptable survival outcomes have been observed at intermediate follow-up of the Fontan operation in this cohort; a significant proportion of patients had hypoplastic left heart syndrome. Although cardiac-related rehospitalization is common, the parents and guardians believed that overall health, school performance, and cardiac functional status were good to excellent for most patients.

Long-term follow up of patients with follicular lymphoma (FL) receiving high dose therapy (HDT) with autologous haematopoietic progenitor cell support at St. Bartholomew’s Hospital (SBH)

6568 Background: HDT supported by autologous haematopoietic progenitor cells has been investigated as consolidation of 2nd or subsequent remission of FL at SBH. Long-term follow up data are reported. Methods: Between June 1985 and Dec. 2001, 125 patients (pts) median age 45 years (range 25–62) received cyclophosphamide + total body irradiation (CY+TBI), supported by either antibody purged marrow (100 pts), or peripheral blood progenitor cells (PBPC) (5 pts) until Feb 1997, and thereafter, BCNU, etoposide, cytarabine and melphalan with PBPC (20 pts). At the time of HDT, 85 pts were in 2nd remission, 28 in 3rd, and 12 in ≥4th; 45 pts were in CR and 80 in PR following a median of 3 (2–9) prior therapies. Median follow-up is 11.7 yrs (0–19.1) and 10.8 yrs (1.3–19.1) for surviving pts. Results: At 5, 10 and 15 yrs, Kaplan-Meier estimates for freedom from recurrence (FFR) are: 56%, 46%, and 43% respectively, for progression free survival: 45%, 32%, 28% and for overall survival (OS): 69%, 48% and 39%. To date, there is no difference in OS according to regimen. OS was superior in pts receiving HDT in 2nd compared to subsequent remissions (p<0.005). Sixty-one patients have recurred (median time to recurrence 1.6 yrs (0.2 to 12.0), 90% within 6 yrs; 17 asymptomatic recurrences were detected following annual surveillance CT and bone marrow examination. Histology at recurrence was FL in 48 pts, transformation to DLBCL in 13 pts. Comparison of pts receiving HDT in 2nd remission with conventionally treated historical controls treated at SBH demonstrates a continuing significant superiority in FFR (p<0.01) and a trend towards significant improvement in OS (p=0.05). Duration of 2nd remission exceeded that of 1st remission in 73% of pts. tMDS/tAML has developed in 21 pts (17%), all post CY+TBI, at a median 4.7 yrs (0.7–13.9). Death in remission occurred in 24 pts (5 early treatment-related, 11 tMDS/tAML, 4 other 2nd malignancy, 3 unrelated causes,1 unknown). Conclusions: For a subset of patients with FL, HDT has resulted in prolonged FFR however this benefit has been tempered by late toxicity. Performed in 2nd remission, HDT significantly modifies the clinical course of FL. No significant financial relationships to disclose.

Impact of Re-Coarctation Following the Norwood Operation on Survival in the Balloon Angioplasty Era

The objective of this study was to determine the efficacy of balloon angioplasty (BA) by comparing the immediate and long-term outcomes of patients with and without re-coarctation after a Norwood procedure. Although BA has become the standard means for treating recurrent coarctation following a Norwood operation, it has been suggested that re-coarctation remains a significant cause of morbidity and mortality. Patients who survived a Norwood operation from December 1986 through June 2001 were studied. Differences between groups were evaluated by t test and logistic regression. Survival differences were tested by log-rank tests using Kaplan-Meier survival curves. Fifty-eight of 633 patients underwent treatment for re-coarctation (9.2%). Thirty-five patients underwent BA (before 1988, 23 had surgery). Median age at catheterization was 6.6 months (1.9 to 35.6 months). Balloon angioplasty was successful (gradient <10 mm Hg) in 32 of 35 patients (92%). There were no BA-related deaths or neurologic complications. Recurrent obstruction after BA occurred in seven patients (20%); five underwent re-dilation. Kaplan-Meier estimates of freedom from recurrent obstruction after initial BA were 97% at one month, 79% at one year, and 79% at five years. There were no differences in survival between patients with re-coarctation treated by BA and patients who did not undergo treatment for re-coarctation. We found that 9.2% of patients underwent treatment for re-coarctation following a Norwood operation. Balloon angioplasty is effective, with low morbidity, no early mortality, and no difference in long-term survival when compared with patients who did not have re-coarctation. Recurrent coarctation following BA occurred in 17% of patients, usually within the first year after BA.

Clinical effect of abdominal aortic aneurysm endografting: 7-year concurrent comparison with open repair

We compared the effectiveness and clinical outcome of open repair versus endovascular aortic aneurysm repair (EVAR) in achieving prevention of abdominal aortic aneurysm (AAA)-related death and graft-related complications. Over 7 years from 1997 to 2003, 1119 consecutive patients underwent elective treatment of infrarenal AAAs, 585 with open repair and 534 with EVAR. Patients were regularly followed up at 1, 6, 12 months, and every 6 months thereafter, in EVAR group, and at 3 and 12 months, and yearly thereafter after open repair. Preoperative, intraoperative, and follow-up data were stored in a prospective database. Median follow-up was similar in the 2 groups: 33 months (interquartile range [IQR], 13-50 months) in the EVAR group vs 35 months (IQR, 15-54 months) in the open repair group. EVAR group patients were older than patients in the open repair group: 73 years vs 72 years (P = .04). There were statistical significant differences between the EVAR group and the open repair group with respect to AAA median diameter (52 mm vs 56 mm), coronary disease rate (46% vs 37%; P = .001), pulmonary disease rate (56% vs 38%; P < .0001), and American Society of Anesthesiologists IV score rate (16% vs 6%; P < .0001). Thirty-day mortality in the EVAR group was 0.9% (5 of 534 patients), compared with 4.1% (24 of 585 patients; P = .001) in the open repair group, and major morbidity was 9.1% (49 of 534 patients) vs 18.6% (109 of 585 patients; P < .0001), respectively. The incidence of secondary procedures in the EVAR group was 15.7%, compared with 3% in the open repair group (P < .0001). There were no deaths related to secondary procedures in either group. Six AAAs (1.1%) ruptured after EVAR, 3 of which were fatal; in the open repair group 1 patient (0.2%) underwent successful repeat operatation to treat iliac pseudoaneurysm rupture 5 years after the original procedure. Kaplan-Meier estimates for freedom from aneurysm-related death at 84 months were 97.5% in the EVAR group and 95.9% in the open repair group (log rank test, P = .008). Kaplan-Meier survival estimates at 84 months were 67.1% in the open repair group and 66.9% in the EVAR group (P = NS). At the same interval the risk for secondary procedures was 49.4% for the EVAR group and 7.1% for the open repair group. Of the 11 variables analyzed with logistic analysis, open surgery (hazard ratio [HR], 11; 95% confidence interval [CI], 2.5-54.2; P = .002), American Society of Anesthesiologists IV score (HR, 7.1; 95% CI, 2.7-18.8; P = .0001), and age (HR, 1.06; 95% CI, 1.04-1.13; P = .04) were positive independent predictors of perioperative mortality. Our data suggest that at a maximum follow-up of 7 years, patients who undergo EVAR show lower perioperative and late aneurysm-related mortality compared with a younger and substantially healthier group of patients with aneurysms treated with open repair. The higher need for secondary procedures in the endovascular group did not affect superiority of the overall performance of EVAR in the early and late intervals.

Transperineal interstitial permanent prostate brachytherapy for Japanese prostate cancer patients in Hawaii.

Our aim was to report clinical and biochemical outcomes of transperineal interstitial permanent prostate brachytherapy in the treatment of Japanese patients with clinically organ-confined prostate cancer in Hawaii. Ninety-five Japanese patients underwent transperineal interstitial permanent prostate brachytherapy using either iodine-125 or palladium-103 for clinical T1c-T2b N0 M0 prostate cancer. These procedures were carried out between December 1998 and December 2002 at The Queen's Medical Center in Honolulu, Hawaii. Prostate-specific antigen measurements were collected from all patients at follow up. Biochemical failure was defined by three consecutive rises in prostate-specific antigen levels, based on the criteria of the American Society for Therapeutic Radiology and Oncology Consensus panel. The median patient age was 71 years (range, 46-87 years). Thirty-six patients were implanted with either iodine-125 or palladium-103 as monotherapy; 59 patients received moderate-dose external beam irradiation first, followed by a prostate brachytherapy boost. The median follow-up length, calculated from the day of implantation, was 801 days (range, 237-1421 days). During this follow-up period, The Kaplan-Meier estimate of freedom from biochemical failure in this series was 94%. No major complications were observed. Clinical and biochemical outcomes in the treatment of Japanese patients in Hawaii suffering from localized prostate cancer, using transperineal interstitial permanent prostate brachytherapy, with or without external beam irradiation, compared favorably to results in similarly treated patients in the general US population.

Aortic aneurysm repair with endovascular grafts: Developing a graft surveillance program

The objective of this study was to describe the development of a comprehensive surveillance program for monitoring the long-term follow-up of endoluminal stent graft (ELG) patients. Despite high procedural success rates, ELG patients remain at ongoing risk for aneurysm sac expansion, rupture, and other adverse events that make long-term surveillance imperative. As they perform more ELG, practitioners face increased logistical difficulty performing appropriate patient follow-up. A computer-based data ELG registry was created using Epi Info, a program developed by the Centers for Disease Control and Prevention that enables users to design a data entry form, enter data, and perform statistical analyses. The database has been used to track 259 patients (214 men and 45 women) who underwent ELG between November 1999 and October 2003. One-year follow-up was available for 182 patients, 2-year follow-up for 104 patients, and 3-year surveillance data for 40 patients, which represent follow-up rates of 89.6%, 78.8%, and 61.5%, respectively. There were 25 late deaths. The Kaplan-Meier estimate for 1-year survival was 92.5%. Twenty-one patients underwent 24 secondary angiographic procedures at a mean 8.6 +/- 10.3 months (range, 1-37.6) after stent-graft repair. No mortality was observed in association with a secondary intervention. There were no late conversions to open aneurysm repair. The Kaplan-Meier estimate for freedom from secondary intervention for all patients at 1 year was 91.0%. A computer-based registry facilitates appropriate and timely patient follow-up and may improve the long-term outcome from ELG.