SEARCH · PubMed Health

Results for “Defining Death”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 541 records · Page 30Linked to original sources

PubMed2006

Impact of sirolimus-eluting and Paclitaxel-eluting stents on outcome in patients with diabetes mellitus and stenting in more than one coronary artery.

Randomized trials have shown that implantation of sirolimus-eluting stents (SESs) and paclitaxel-eluting stents (PESs) reduce the incidence of major adverse cardiac events (MACEs) compared with bare metal stents. We compared the impact of SESs and PESs on clinical outcome in medically treated diabetic patients with multivessel stents. In this study, the in-hospital and 9-month clinical outcomes of 260 consecutive diabetic patients who underwent implantation of SESs (147 patients) or PESs (113 patients) were compared. MACEs were defined as death, nonfatal myocardial infarction, and clinically driven target vessel revascularization. The baseline demographic and angiographic characteristics were well matched. An average of 3.0 +/- 1.3 versus 2.8 +/- 1.2 lesions were treated in the SES and PES groups, respectively (p = 0.34), with a mean stented length per patient of 73 +/- 43 versus 61 +/- 36 mm (p = 0.08). No significant difference was observed between the SES and PES groups for in-hospital (6.1% vs 3.5%, p = 0.34) or 9-month MACE (24.5% vs 19.5%, p = 0.34) rates or for subacute (1.4% vs 0.9%, p = 0.72) or late (0.7% vs 0.9%, p = 0.85) stent thrombosis. Insulin-requiring diabetic patients treated with SESs and PESs also had similar demographic and angiographic characteristics and rates of in-hospital (4.7% vs 7.7%, p = 0.57) and 9-month (28.0% vs 38.4%, p = 0.44) MACEs. Insulin-dependent diabetes was the only independent predictor of MACEs (odds ratio 2.68, 95% confidence interval 1.46 to 4.89, p = 0.001). In conclusion, our results demonstrated a relatively high incidence of MACEs in a diabetic population with multivessel disease, despite treatment with drug-eluting stents. In addition, we could not find any clear advantage of 1 type of stent versus the other.

Adult↗

PubMed2006

Long-term survival of patients with heart failure and ventricular conduction delay treated with cardiac resynchronization therapy.

This multicenter longitudinal observational trial was designed to analyze the long-term outcome of patients with heart failure (HF) treated with cardiac resynchronization therapy (CRT) alone or with implantable cardioverter-defibrillator (ICD) backup in a daily practice scenario. It is unknown whether the magnitude of survival benefits conferred by CRT in a daily practice scenario is comparable to what has been observed in randomized controlled trials and whether this benefit is sustained over the long term. The outcome of 1,303 consecutive patients with ischemic or nonischemic cardiomyopathy on optimal pharmacologic therapy treated from August 1, 1995 to August 1, 2004 at 4 European centers with CRT alone (44%) or with ICD backup for symptomatic HF and prolonged QRS duration was assessed. Cumulative event-free survival was evaluated for a combined end point, defined as death from any cause, urgent transplantation, or implantation of a left ventricular assist device. The cumulative incidence of competing events, HF, sudden cardiac death, and noncardiac death, was also assessed. Event-free survival was similar across the different centers. At 1 and 5 years, cumulative event-free survivals were 92% (95% confidence interval [CI] 91 to 94) and 56% (95% CI 48 to 64), respectively. The cumulative incidence of HF deaths was 25.1% (95% CI 19 to 31.7), whereas that of sudden death was 9.5% (95% CI 5.1 to 15.7). Using multivariate analysis, CRT with an ICD backup was associated with a nonsignificant decrease in mortality by 20% (hazard ratio 0.83, 95% CI 0.58 to 1.17, p = 0.284), with a highly significant protective effect against sudden cardiac death (hazard ratio 0.04, 95% CI 0.04 to 0.28, p <0.002). In conclusion, patients with advanced HF and a wide QRS complex routinely treated with CRT have a favorable long-term outcome that was reproducible at different centers. The leading cause of death in these patients remained HF, and this mode of death was competing with other causes in determining outcome. Total mortality was 20% lower with ICD backup (95% CI 42% lower to 17% higher) due to a protective effect against sudden cardiac death.

Aged↗

PubMed2005

Adverse 30-day outcomes after cardiac surgery: predictive role of intraoperative myocardial acidosis.

BACKGROUND: Regional myocardial acidosis in patients undergoing cardiac surgery has been shown to be reflective of regional myocardial ischemia. This study elucidates the relationship between intraoperative regional myocardial acidosis and 30-day postoperative outcomes after cardiac surgery. METHODS: Intramyocardial tissue pH in the anterior and posterior left ventricular walls was measured in 397 adult patients undergoing valve replacement or coronary revascularization surgery between 1987 and 2001. Dedicated nurses and research assistants prospectively collected preoperative, intraoperative, and outcomes data. Regional myocardial acidosis was defined in terms of pH thresholds identified by recursive partitioning. Adverse 30-day outcome, defined as death or any one of six complications, was the dependent variable in a multivariate logistic regression analysis. A morbidity score was developed on the basis of the sensitivity of each of the six complications in predicting death, and was the dependent variable in a multivariate linear regression analysis. RESULTS: During the period of aortic clamping, a mean intramyocardial tissue pH less than 6.85 was identified to be significant by recursive partitioning, and was encountered in either the anterior or posterior left ventricular wall in 85.4% of patients. After adjusting for preoperative and intraoperative variables, this pH threshold was found to be significantly associated with increased adverse outcomes within 30 days after surgery (p = 0.045). It was also significantly associated with increase in the morbidity score (p = 0.05). CONCLUSIONS: Regional myocardial acidosis of a magnitude frequently encountered during aortic clamping is an independent determinant of adverse 30-day outcomes after cardiac surgery. Its reversal by pH-guided myocardial management has the potential of improving postoperative patient outcomes.

Acidosis↗

PubMed2004

Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial.

Patients with diabetes mellitus have less favourable outcomes after percutaneous coronary intervention (PCI) than non-diabetics. We performed a subgroup analysis of the multicentre RAVEL trial to examine the impact of the sirolimus-eluting stent (SES) on outcomes in diabetic patients. The RAVEL study randomized 238 patients to treatment with either sirolimus-eluting or bare metal stents. Forty-four patients were diabetic; 19 received sirolimus-eluting stents and 25 were treated with bare metal stents. The differences in outcomes between diabetic and non-diabetic patients treated with SES (n=101) were also assessed. Follow-up angiography was performed at 6 months. Major adverse cardiac events (MACE) defined as death, myocardial infarction (MI), or target lesion revascularization (TLR) were analysed at 12-month follow-up. Six-month in-stent late lumen loss was significantly lower for the diabetic SES than the bare stent group (0.07+/-0.2 vs 0.82+/-0.5mm; P<0.001) and similar to that in non-diabetics treated with SES (-0.03+/-0.27mm). There was zero restenosis in the SES groups (diabetic and non-diabetic) compared to a 42% rate in the diabetic population assigned to bare metal stents (P=0.001). After 12 months, there was one non-Q-wave MI and one non-cardiac death in the diabetic SES group, while 12 patients in the bare metal stent group had MACE (one death, two MI, nine TLR) (P=0.01)-an event-free survival rate of 90% vs 52%, respectively (P<0.01). There were no TLRs in both SES groups compared to 36% rate in the diabetic bare metal stent group (P=0.007). Conclusion Diabetics treated with SES were associated with a virtual abolition of neointimal proliferation and low event rates at long-term follow-up.

Coronary Restenosis↗

PubMed2004

Mild and moderate aortic stenosis. Natural history and risk stratification by echocardiography.

AIMS: To define the natural history and predictors of outcome in mild and moderate aortic stenosis (AS). METHODS AND RESULTS: One hundred and seventy-six consecutive asymptomatic patients (73 women, age 58+/-19 years) with mild to moderate AS (jet velocity 2.5 to 3.9m/s) were followed for 48+/-19 months. Haemodynamic progression and clinical outcome was analysed. Event-free survival with end-points defined as death (n=34) or aortic valve surgery (n=33), was 95+/-2%, 75+/-3% and 60+/-5% at 1, 3 and 5 years, respectively. Both, cardiac and non-cardiac mortality were significantly increased, resulting in a 1.8 times higher mortality than expected (P<0.005). By multivariate analysis, moderate to severe aortic valve calcification, coronary artery disease (CAD) and peak jet velocity were independent predictors of outcome. Event-free survival for patients with moderate or severe valve calcification was 92+/-4%, 61+/-7% and 42+/-7% at 1, 3 and 5 years versus 100%, 90+/-4% and 82+/-5% for patients with no or mild calcification. Patients with calcified aortic valves, CAD or with an event had a significantly faster haemodynamic progression. Of 129 patients with a follow-up echocardiographic exam, 59 (46%) developed severe stenosis during follow-up. CONCLUSION: Outcome of mild and moderate AS is worse than commonly assumed. Rapid progression and excess mortality have to be considered. Significant valve calcification, CAD and rapid progression of aortic jet velocity indicate poor outcome. Patients with these characteristics may require closer follow-up than generally assumed.

Aged↗

PubMed2005

In-hospital operative mortality of ruptured abdominal aortic aneurysm: a population-based analysis of 5593 patients in The Netherlands over a 10-year period.

OBJECTIVE: To determine the operative mortality of ruptured abdominal aortic aneurysm (RAAA) in The Netherlands. DESIGN: Retrospective population-based study of nation-wide in-hospital mortality of RAAA repair. METHODS: Data were obtained from a national registry for medical diagnosis and procedures. In-hospital mortality of RAAA repair, defined as death during hospital admission irrespective of the cause of death, was determined in the period 1991-2000. Variables of potential influence on in-hospital mortality, including age, gender, date of surgery and hospital type (0-399 beds, > or =400 beds or university hospitals) were studied in a multivariate analysis. RESULTS: The overall in-hospital mortality of RAAA repair in 5593 patients in the 10-year period was 41% (95% confidence interval: 40-42%). In the multivariate analysis, age and hospital type were the most important independent predictors for in-hospital mortality. Gender, year and season of surgery could not be identified as significant risk factors. CONCLUSIONS: Over a recent decade, in-hospital mortality of RAAA repair remained unchanged at 41%. Age and hospital class were the most important independent risk factors.

Age Factors↗

PubMed2004

Previous thoracic surgery does not increase peri-operative mortality in pediatric heart-lung transplant recipients.

BACKGROUND: Heart-lung transplant (HLT) is indicated in select children with end-stage cardiopulmonary disease. We sought to determine whether previous thoracic surgery increases peri-operative morbidity and mortality. METHODS: Retrospective data were analyzed using unpaired Student's t-test and Fisher's exact test. Results are reported as mean +/- SD. Peri-operative mortality was defined as death at </=30 days post-transplant. RESULTS: From August 1993 through April 2001, 13 patients (mean age 7.9 +/- 5.3 years; 9 girls, 4 boys) underwent HLT at our center. Eight of 13 (62%) had previous thoracic surgery and 5 of 13 (38%) did not. Interval of last surgery to transplant date was 45.5 +/- 26.4 months (range 6 to 79 months). We compared HLT patients who had previous thoracic surgery to HLT recipients who did not. There was no significant difference in weight (18.6 +/- 14.3 vs 36.5 +/- 20.7 kg, p = 0.09), age (6.5 +/- 4.5 vs 10.2 +/- 6.1 years, p = 0.23) or duration of intubation (14.1 +/- 12.9 vs 17.0 +/- 30.3 days, p = 0.83). There were no caval or tracheal anastomotic stenoses in either group. There was no significant difference in blood products transfused </=48 hours after HLT: packed red blood cells (p = 0.16); fresh frozen plasma (p = 0.13); platelets (p = 0.59), and cryoprecipitate (p = 0.27). There was no difference in cardiopulmonary bypass time (129.3 +/- 48.2 vs 160.6 +/- 73.9 minutes, p 0.39); post-operative diaphragm dysfunction (4 of 8 vs 0 of 5, p = 0.1); re-exploration for bleeding (2 of 8 vs 1 of 5, p = 1.0); or peri-operative mortality (2 of 8 vs 0 of 5, p = 0.48). CONCLUSIONS: We conclude that previous thoracic surgery in HLT recipients does not significantly increase blood product transfusion, cardiopulmonary bypass time or peri-operative mortality.

Adolescent↗

PubMed2004

Heart failure survival score continues to predict clinical outcomes in patients with heart failure receiving beta-blockers.

BACKGROUND: The Heart Failure Survival Score (HFSS) has been previously shown to effectively risk-stratify patients under evaluation for heart transplantation. However, this model was developed before broad use of beta blockade. We hypothesized that the prognostic tool would retain its ability to risk stratify patients treated with beta-blockers. METHODS: We collected clinical data on 524 consecutive patients referred for heart transplantation from 1994 to 2001. Kaplan-Meier survival analysis and multivariable Cox regression analysis were performed with events defined as death, left ventricular assist device placement, or United Network of Organ Sharing 1 heart transplantation. RESULTS: Kaplan-Meier analysis of the patient population revealed effective discrimination by the survival score both for beta-blocker treated and untreated patients (both p <0.0001). Two-year event-free survival was 94% +/- 2% and 84% +/- 4% for beta-blocker and no beta-blocker patients in the low-risk HFSS strata. Cox proportional hazard modeling showed that HFSS strata (medium risk: HR 2.65, 95% CI 1.75-4.02, p <0.001; high risk: HR 5.51, 95% CI 3.64-8.33, p <0.001) and beta-blocker treatment (HR 0.45, 95% CI 0.31-0.64, p <0.001) were significant predictors of event-free survival. Receiver operating curves (area under the curve) for HFSS strata used to predict 2-year events were similar for beta-blocker treated (0.78 +/- 0.04) and untreated (0.80 +/- 0.03) patients. CONCLUSIONS: The HFSS provides effective risk stratification with or without beta-blocker therapy. Consideration of beta-blocker therapy with survival score strata improves outcome prediction in patients evaluated for heart transplantation.

Adrenergic beta-Antagonists↗

PubMed2004

Radial versus femoral approach for percutaneous coronary diagnostic and interventional procedures; Systematic overview and meta-analysis of randomized trials.

OBJECTIVES: We sought to compare, through a meta-analytic process, the transradial and transfemoral approaches for coronary procedures in terms of clinical and procedural outcomes. BACKGROUND: The radial approach has been increasingly used as an alternative to femoral access. Several trials have compared these two approaches, with inconclusive results. METHODS: The MEDLINE, CENTRAL, and conference proceedings from major cardiologic associations were searched. Random-effect odds ratios (ORs) for failure of the procedure (crossover to different entry site or impossibility to perform the planned procedure), entry site complications (major hematoma, vascular surgery, or arteriovenous fistula), and major adverse cardiovascular events (MACE), defined as death, myocardial infarction, emergency revascularization, or stroke, were computed. RESULTS: Twelve randomized trials (n = 3,224) were included in the analysis. The risk of MACE was similar for the radial versus femoral approach (OR 0.92, 95% confidence interval [CI] 0.57 to 1.48; p = 0.7). Instead, radial access was associated with a significantly lower rate of entry site complications (OR 0.20, 95% CI 0.09 to 0.42; p < 0.0001), even if at the price of a higher rate of procedural failure (OR 3.30, 95% CI 1.63 to 6.71; p < 0.001). CONCLUSIONS: The radial approach for coronary procedures appears as a safe alternative to femoral access. Moreover, radial access virtually eliminates local vascular complications, thanks to a time-sparing hemostasis technique. However, gaining radial access requires higher technical skills, thus yielding an overall lower success rate. Nonetheless, a clear ongoing trend toward equalization of the two procedures, in terms of procedural success, is evident through the years, probably due to technologic progress of materials and increased operator experience.

Angioplasty, Balloon, Coronary↗

PubMed2005

Electrocardiographic predictors of cardiovascular outcome in women: the National Heart, Lung, and Blood Institute-sponsored Women's Ischemia Syndrome Evaluation (WISE) study.

OBJECTIVES: We sought to analyze the value of infrequently measured parameters of the 12-lead electrocardiogram (ECG) in predicting cardiovascular events in women with suspected myocardial ischemia who were referred for cardiac catheterization. BACKGROUND: Routinely analyzed ECG parameters have low predictive value for cardiovascular events in women with preserved left ventricular function and suspected myocardial ischemia. The predictive value of ECG parameters for cardiovascular disease has not been fully determined. METHODS: Women enrolled in the National Heart, Lung, and Blood Institute-sponsored Women's Ischemia Syndrome Evaluation (WISE) study who had complete digital 12-lead ECG and quantitative angiography data were studied. Clinical and ECG predictors of cardiovascular disease events, defined as death, congestive heart failure, and non-fatal myocardial infarction, were determined. RESULTS: Of 143 women with ECG and angiographic data (mean age 59 +/- 13 years, left ventricular ejection fraction 64.1 +/- 8.6%), 13% had events during a mean follow-up period of 3.3 +/- 1.6 years. Independent predictors of event occurrences included a wider QRS-T angle (i.e., the spatial electrical angle between the QRS complex and the T-wave; p = 0.0005), wider QRS complex (p = 0.004), longer QTrr (i.e., age- and gender-adjusted QT interval; p = 0.0004), a more depressed ST-segment in precordial lead V5 (p = 0.0002), and a higher coronary artery disease severity score (p = 0.02). CONCLUSIONS: Several 12-lead ECG parameters, such as the QRS-T angle and the QRS and QTrr duration, are predictive of future cardiovascular events in women with suspected myocardial ischemia.

Aged↗

PubMed2006

Clinical outcomes for sirolimus-eluting stents and polymer-coated paclitaxel-eluting stents in daily practice: results from a large multicenter registry.

OBJECTIVES: We compared the clinical outcome of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a real-world scenario. BACKGROUND: In selected patients, SES has been associated with lower late luminal loss than PES. Whether this emerging biological difference could translate into different clinical efficacy in daily practice is presently unknown. METHODS: This analysis included 1,676 consecutive patients with de novo coronary lesions treated solely with drug-eluting stents (SES = 992; PES = 684). All patients were enrolled in a dynamic prospective registry comprising 13 hospitals. We assessed the cumulative incidence of major adverse cardiac events (MACE), defined as death, myocardial infarction (MI), and target vessel revascularization (TVR) during follow-up. RESULTS: Overall, 29% of the patients had diabetes, 23% had prior MI, and 9% had poor left ventricular function. ST-segment elevation MI was diagnosed at admission in 12%. Multivessel intervention was performed in 16%. At 1-year follow-up, SES was associated with a reduced incidence of MACE (9.2% SES vs. 14.1% PES; p = 0.007) and TVR (5.0% SES vs. 10.0% PES; p = 0.0008) compared to PES. A propensity analysis with many clinical and angiographic variables was carried out to adjust for baseline differences. In this analysis, SES was associated with a 44% risk reduction of MACE (hazard ratio 0.56, 95% confidence interval 0.39 to 0.78) and a 55% reduction of TVR (hazard ratio 0.45, 95% confidence interval 0.29 to 0.70). This result was consistent across most subgroups tested. Similar rates of death and MI were observed in the 2 treatment groups. CONCLUSIONS: In this large real-world population, SES improved 1-year clinical results as compared to PES.

Aged↗

PubMed2006

Long-term outcomes after management of restenosis or thrombosis of drug-eluting stents.

OBJECTIVES: The purpose of this study was to examine the outcomes of patients who developed coronary in-stent restenosis (ISR) or stent thrombosis (STH) inside drug-eluting stents (DES). BACKGROUND: Drug-eluting stents have markedly reduced the incidence of restenosis. However, when restenosis occurs within a DES, its optimal management remains unclear. METHODS: We retrospectively analyzed clinical and angiographic data from 92 patients who underwent revascularization for ISR (n = 84) or STH (n = 8) within a DES at our institution. Regular follow-ups were available up to 2 years. We recorded the occurrence of major adverse cardiac events (MACE), defined as deaths from all causes, myocardial infarction (MI), or target lesion revascularization (TLR), among patients treated by the "DES sandwich" technique or by other treatment methods. RESULTS: In-hospital MACE included 1 periprocedural MI and 2 deaths. Over a mean follow-up of 15 +/- 6 months, the overall rates of death, MI, and TLR were 8.7%, 2.2%, and 30.6%, respectively. By actuarial analysis, the 12-month TLR and MACE rates were 28.2% and 42.9%, respectively. CONCLUSIONS: Current treatments of ISR or STH in DES are associated with a high long-term rate of MACE.

Aged↗

PubMed2005

Simple partial status epilepticus in Chinese adults.

Simple partial status epilepticus (SPSE) is uncommon compared with generalized tonic-clonic status epilepticus. We evaluated the clinical profile and predictors of poor outcome in a group of Chinese patients with this condition. We identified 32 patients above the age of 14 years with SPSE from a large urban hospital over an eleven-year period. Factors for poor outcome, defined as death or morbidity, were analyzed. The most common underlying causes were due to cerebrovascular disease (46.9%), CNS infection (15.6%), metabolic derangement (12.5%) and tumor (12.5%). At 30 days from the onset of seizures, 13(40.5%) patients had recovered fully and seven (21.9%) had died. Poor outcome was associated with the presence of an acute symptomatic injury.

Adolescent↗

PubMed2005

The persistence of regulatory cells developing after rat spontaneous liver acceptance.

BACKGROUND: We have previously reported that the spontaneous acceptance of Lewis (LEW, RT1(l)) to Dark Agouti (DA, RT1(a)) rat orthotopic liver transplant (OLT) is eliminated by donor gamma-irradiation. The acceptance of the irradiated LEW liver is also reestablished in a naïve rat after the adoptive transfer of T regulatory (T-reg) cells from a LEW to a DA liver-tolerant long-term (>60 days) survivor (LTS) into a naïve DA rat. However, little is known about the growth conditions required to maintain T-reg function. In this study, we examined the need for continued donor-specific alloantigen stimulation for the maintenance and function of T-reg cells. METHODS: Splenocytes (SCs; 1.5 x 10(8) cells) from a LEW liver allograft-tolerant LTS DA recipient were adoptively transferred fresh or after in vitro stimulation into another naive DA rat on day 1, 4, or 7 before an irradiated (1000R) LEW liver transplant. For in vitro alloantigen stimulation, SCs from LEW to DA LTS were co-cultured with mitomycin-C (MMC)-treated naïve LEW (donor alloantigen-specific) or Brown Norway (BN) (RT1(n); third party) SCs for 72 hours. Graft rejection, as defined by death of the recipient, was confirmed histologically. RESULTS: All LEW liver grafts were accepted spontaneously by DA recipients for more than 60 days (n=32), while all irradiated LEW livers were acutely rejected (n=9; mean survival time [MST]=12.8 +/- 4.0 days). When LTS DA SCs were adoptively transferred into a naive DA rat 1 day before OLT, all irradiated LEW grafts were accepted greater than 60 days (n=9). However, when fresh LTS DA SCs were transferred to a new naïve DA rat on 4 or 7 days before OLT, all irradiated LEW liver grafts were acutely rejected (MST=10.2 +/- 0.5 days [n=4] and MST=13.5 +/- 5.0 days [n=4], respectively). When LTS DA SCs were stimulated in vitro before adoptive transfer, irradiated LEW liver grafts after 4 days (n=5) were then accepted. In vitro culture of LTS DA SCs with MMC-treated BN SCs (third-party) for 72 hours before adoptive transfer resulted in 3 of 5 irradiated LEW livers at day 4 being accepted (n=5). CONCLUSIONS: The maintenance of T-reg function requires continuous LEW donor-specific alloantigen stimulation.

Adoptive Transfer↗

PubMed2004

AdvHSV-tk gene therapy with intravenous ganciclovir improves survival in human malignant glioma: a randomised, controlled study.

Malignant glioma is a devastating brain tumor with no effective treatment. This randomised, controlled study involved 36 patients with operable primary or recurrent malignant glioma. Seventeen patients were randomized to receive AdvHSV-tk gene therapy (3 x 10(10) pfu) by local injection into the wound bed after tumor resection, followed by intravenous ganciclovir (GCV), 5 mg/kg twice daily for 14 days. The control group of 19 patients received standard care consisting of radical excision followed by radiotherapy in those patients with primary tumors. The primary end-point was survival as defined by death or surgery for recurrence. Secondary end-points were all-cause mortality and tumour progression as determined by MRI. Overall safety and quality of life were also assessed. Findings were also compared with historical controls (n = 36) from the same unit over 2 years preceding the study. AdvHSV-tk treatment produced a clinically and statistically significant increase in mean survival from 39.0 +/- 19.7 (SD) to 70.6 +/- 52.9 weeks (P = 0.0095, log-rank regression vs. randomized controls). The median survival time increased from 37.7 to 62.4 weeks. Six patients had increased anti-adenovirus antibody titers, without adverse effects. The treatment was well tolerated. It is concluded that AdvHSV-tk gene therapy with GCV is a potential new treatment for operable primary or recurrent high-grade glioma.

Adenoviridae↗

PubMed2003

Angiographically silent left main disease detected by intravascular ultrasound: a marker for future adverse cardiac events.

BACKGROUND: Concomitant moderate obstructive left main (LM) disease is associated with future cardiac events and poor prognosis in patients undergoing percutaneous intervention (PCI). Whether prognosis is similarly effected by LM disease not detected by angiography, but evident on intravascular ultrasound (IVUS) imaging, is not known. The purpose of this study was to evaluate the long-term prognosis of patients with angiographically insignificant LM coronary artery disease undergoing PCI. METHODS AND RESULTS: One hundred and seven consecutive patients undergoing PCI with angiographically normal or mild LM disease had 2- and 3-dimensional IVUS imaging. IVUS images were digitized, and 3-dimensional reconstruction was performed. Percent diameter and area stenosis by angiography were 4.8% +/- 3.5% and 18.2% +/- 9.8%, respectively. IVUS mean luminal area and area stenosis were 17.9 +/- 5.6 mm2 and 30.2% +/- 14.7%, respectively. Long-term follow-up was available in 102 (95%) patients at a median of 29 (range 8-52) months. Major adverse cardiac events, defined as death (6), myocardial infarction (4), repeat PCI (13), or CABG (16), were associated with female sex (P =.04), diabetes (P =.02), angiographic minimum lumen diameter (P =.04), and IVUS minimum (P =.01) and mean (P =.01) lumen area. Multivariate predictors of late cardiac events were diabetes (hazard ratio 2.69, P =.014) and minimum lumen area by IVUS (hazard ratio 0.59, P =.015). CONCLUSIONS: Despite being angiographically silent, LM disease detected by IVUS is an independent predictor of cardiac events and may serve as a marker for such events. These data extend the spectrum of LM disease severity and its relationship to cardiac prognosis in patients undergoing PCI.

Aged↗

PubMed1999

Long-term outcome of patients with very long stents for treatment of diffuse coronary disease.

OBJECTIVES: The study sought to determine the 6-month clinical outcome of patients who underwent implantation of very long coronary stents to treat diffuse disease and/or long dissections and to compare the findings with those reported in the literature for patients who underwent implantation of multiple short coronary stents. BACKGROUND: New designs of flexible stents enable the implantation of long stents rather than multiple short, older design stents. The initial experience is very promising but the long-term outcome has not been described yet. METHODS: Fifty-seven consecutive patients in whom 67 long stents (>/=30 mm) were successfully deployed were included in this study. Six-month clinical and angiographic follow-up was prospectively collected. Patients with recurrent angina underwent coronary angiography without further testing. Patients who remained asymptomatic at the 6-month follow-up visit underwent positron emission tomographic imaging, and those with results suggestive of ischemia underwent coronary angiography. A combined study end point was defined as death, myocardial infarction, and the need for target vessel revascularization. RESULTS: Only 1 patient (2%) reached a study end point at hospital discharge. An additional 20 patients (total 21 patients [37%]) reached an end point by 6 months. The outcome was not influenced by the clinical presentation (stable or unstable angina) or by the indication for stenting (elective or emergency). Predictors for adverse outcome were multiple stents per narrowing (63% vs 29%, P <. 04), and stents smaller than 3.5 mm (49% vs 22%). Narrowing and stent length were not predictive of a study end point in narrowings that were successfully treated by a single long stent. CONCLUSIONS: Elective stenting provides an effective solution for patients with diffuse coronary disease provided that a single long stent (usually <40 mm) can cover the full length of the narrowing. The results are better when vessels larger than 3 mm are treated. Compared with multiple short stents, implantation of a single long stent is probably at least as effective, and the procedure is quicker and cheaper and thus should be the preferred approach.

Aged↗

PubMed2001

Final results of a randomized trial comparing the NIR stent to the Palmaz-Schatz stent for narrowings in native coronary arteries.

The NIR stent is a novel second generation tubular stent that was designed to overcome some of the limitations of the earlier Palmaz-Schatz (PS) stent design. The NIR Vascular Advanced North American (NIRVANA) trial randomized 849 patients with single coronary lesions to treatment with the NIR stent or the PS stent. The study was an "equivalency" trial, designed to demonstrate that the NIR stent was not inferior to (i.e., equivalent or better than) the PS stent, for the primary end point of target vessel failure (defined as death, myocardial infarction, or target vessel revascularization) by 9 months. Successful stent delivery was achieved in 100% versus 98.8%, respectively, with a slightly lower postprocedural diameter stenosis (7% vs. 9%, p = 0.04) after NIR and PS stent placement, respectively. Major adverse cardiac events (death, myocardial infarction, repeat target lesion revascularization) were not different at 30 days (4.3% vs. 4.4%). The primary end point of target vessel failure at 9 months was seen in 16.0% of NIR versus 17.2% of PS patients, with the NIR proving to be equal or superior to the PS stent (p <0.001 by test for equivalency). Angiographic restudy in 71% of a prespecified cohort showed no significant difference in restenosis (19.3% vs 22.4%). Thus, the NIR stent showed excellent deliverability with slightly better acute angiographic results and equivalent or better 9-month target vessel failure rate when compared with the PS stent.

Aged↗