Biomedical subjects

E H Blackstone

Publications and source records attributed to E H Blackstone.

At least 19 recordsLinked to original sources

PubMed2001

Heart rate recovery immediately after treadmill exercise and left ventricular systolic dysfunction as predictors of mortality: the case of stress echocardiography.

BACKGROUND: An attenuated heart rate recovery after exercise has been shown to be predictive of mortality. In prior studies, recovery heart rates were measured while patients were exercising lightly, that is, during a cool-down period. It is not known whether heart rate recovery predicts mortality when measured in the absence of a cool-down period or after accounting for left ventricular systolic function. METHODS AND RESULTS: We followed 5438 consecutive patients without a history of heart failure or valvular disease referred for exercise echocardiography for 3 years. Heart rate recovery was defined as the difference in heart rate between peak exercise and 1 minute later; a value </=18 beats per minute was considered abnormal. Patients assumed the left lateral decubitus position after exercise. An abnormal heart rate recovery was present in 805 patients (15%); during follow-up, 190 died. An abnormal heart rate recovery was predictive of death (9% versus 2%, hazard ratio [HR] 3.9, 95% CI 2.9 to 5.3, P<0.0001) and predicted death whether or not left ventricular systolic dysfunction (ejection fraction </=40%) was present. After adjusting for age, sex, exercise capacity, left ventricular systolic function, presence or absence of myocardial ischemia, and other confounders, an abnormal heart rate recovery remained predictive of death (adjusted HR 2.09, 95% CI 1.49 to 2.82, P<0.001). CONCLUSIONS: Even in the absence of a cool-down period and even after accounting for left ventricular systolic function, heart rate recovery is a powerful and independent predictor of death.

Adult↗

PubMed2001

Are outcomes of surgical versus transcatheter balloon valvotomy equivalent in neonatal critical aortic stenosis?

BACKGROUND: For neonates with critical aortic valve stenosis who are selected for biventricular repair, valvotomy can be achieved surgically (SAV) or by transcatheter balloon dilation (BAV). METHODS AND RESULTS: Data regarding 110 neonates with critical aortic valve stenosis were evaluated in a study by the Congenital Heart Surgeons Society from 1994 to 1999. Reduced left ventricular function was present in 46% of neonates. The initial procedure was SAV in 28 patients and BAV in 82 patients. Mean percent reduction in systolic gradient was significantly greater with BAV (65+/-17%) than SAV (41+/-32%; P<0.001). Higher residual median gradients were present in the SAV versus BAV group (36 mm Hg [range, 10 to 85 mm Hg] versus 20 mm Hg [0 to 85 mm Hg], P<0.001). Important aortic regurgitation was more often present after BAV (18%) than SAV (3%; P=0.07). Time-related survival after valvotomy was 82% at 1 month and 72% at 5 years, with no significant difference for SAV versus BAV, even after adjustment for differences in patient and disease characteristics. Independent risk factors for mortality were mechanical ventilation before valvotomy, smaller aortic valve annulus (z score), smaller aortic diameter at the sinotubular junction (z score), and a smaller subaortic region. A second procedure was performed in 46 survivors. Estimates for freedom from reintervention were 91% at 1 month and 48% at 5 years after the initial valvotomy and did not differ significantly between groups. CONCLUSIONS: SAV and BAV for neonatal critical aortic stenosis have similar outcomes. There is a greater likelihood of important aortic regurgitation with BAV and of residual stenosis with SAV.

Acute Disease↗

PubMed2001

Aspirin use and all-cause mortality among patients being evaluated for known or suspected coronary artery disease: A propensity analysis.

CONTEXT: Although aspirin has been shown to reduce cardiovascular morbidity and short-term mortality following acute myocardial infarction, the association between its use and long-term all-cause mortality has not been well defined. OBJECTIVES: To determine whether aspirin is associated with a mortality benefit in stable patients with known or suspected coronary disease and to identify patient characteristics that predict the maximum absolute mortality benefit from aspirin. DESIGN AND SETTING: Prospective, nonrandomized, observational cohort study conducted between 1990 and 1998 at an academic medical institution, with a median follow-up of 3.1 years. PATIENTS: Of 6174 consecutive adults undergoing stress echocardiography for evaluation of known or suspected coronary disease, 2310 (37%) were taking aspirin. Patients with significant valvular disease or documented contraindication to aspirin use, including peptic ulcer disease, renal insufficiency, and use of nonsteroidal anti-inflammatory drugs, were excluded. MAIN OUTCOME MEASURE: All-cause mortality according to aspirin use. RESULTS: During 3.1 years of follow-up, 276 patients (4.5%) died. In a simple univariable analysis, there was no association between aspirin use and mortality (4.5% vs 4.5%). However, after adjustment for age, sex, standard cardiovascular risk factors, use of other medications, coronary disease history, ejection fraction, exercise capacity, heart rate recovery, and echocardiographic ischemia, aspirin use was associated with reduced mortality (hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.51-0.87; P =.002). In further analysis using matching by propensity score, 1351 patients who were taking aspirin were at lower risk for death than 1351 patients not using aspirin (4% vs 8%, respectively; HR, 0.53; 95% CI, 0.38-0.74; P =.002). After adjusting for the propensity for using aspirin, as well as other possible confounders and interactions, aspirin use remained associated with a lower risk for death (adjusted HR, 0.56; 95% CI, 0.40-0.78; P<.001). The patient characteristics associated with the most aspirin-related reductions in mortality were older age, known coronary artery disease, and impaired exercise capacity. CONCLUSION: Aspirin use among patients undergoing stress echocardiography was independently associated with reduced long-term all-cause mortality, particularly among older patients, those with known coronary artery disease, and those with impaired exercise capacity.

Aspirin↗

PubMed2001

A propensity analysis of cigarette smoking and mortality with consideration of the effects of alcohol.

Although it is well established that cigarette smoking causes excess mortality, the extent of the increased risk has been challenged because self-selection biases and confounding factors may not have been adequately accounted for in prior studies. We therefore performed a propensity analysis on a population-based cohort. A logistic regression model was used to generate a propensity score for current smoking in 6,099 adults (mean age 46 years, 54% men, 36% current smokers) participating in the National Heart Lung and Blood Institute's (NHLBI) Lipid Research Clinic Prevalence Study. During 12 years of follow-up, 513 subjects (8%) died. After adjusting for age, current smoking was strongly associated with death (compared with never and former smokers, relative risk [RR] 2.69, 95% confidence interval [CI] 1.98 to 0.64, p <0.0001 and RR 1.79, 95% CI 1.26 to 2.55, p = 0.001, respectively). After adjusting for a propensity score based on 27 covariates and the covariates themselves, current smoking remained strongly and independently predictive of excessive death risk in smokers compared with never and former smokers (adjusted RR 2.96, 95% CI 2.16 to 4.05, p <0.0001 and adjusted RR 1.87, 95% CI 1.31 to 2.67, p = 0.0006, respectively). Although smokers were more likely to also drink alcohol, an interaction was noted, whereby, after adjustment for propensity score and other covariates, current smoking was associated with a moderately strong increase in mortality among drinkers (adjusted RR 2.00, 95% CI 1.42 to 2.82, p <0.0001), but was also associated with a markedly increased death risk among nondrinkers (adjusted RR 4.74, 95% CI 3.24 to 6.92, p <0.0001). The independent association of smoking with death even after a rigorous propensity analysis argues that it is highly unlikely that the link between smoking and mortality is materially biased or confounded.

Adult↗

PubMed2001

Prognostic importance of concomitant heparin with eptifibatide in acute coronary syndromes. PURSUIT Investigators. Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy.

Platelet glycoprotein IIb/IIIa inhibitors have been extensively studied in the treatment of patients with ischemic heart disease. Data regarding the use of these agents in the absence of concomitant intravenous heparin have been conflicting. We sought to determine, using propensity analysis, whether the benefit of eptifibatide, a IIb/IIIa inhibitor, in the treatment of acute coronary syndromes is affected by the concurrent administration of heparin. By trial design, patients were randomized to either eptifibatide or placebo, whereas use of intravenous heparin was left to the discretion of treating physicians. The effect of eptifibatide on the 30-day composite end point of death or myocardial infarction was studied in patients who received heparin and those who did not. Propensity analysis methods were used to control for confounding and presumed selection biases. Among 5,576 patients who were receiving heparin when the bolus dose of the study drug was administered, eptifibatide was associated with a reduced composite end point rate (13%) compared with that of placebo (14.5% vs 16.6%, p = 0.03). In contrast, among 1,441 patients who were not receiving heparin, there was no difference in 30-day event rates with eptifibatide compared with placebo (13.7% vs 13.1%, p > 0.7). After a propensity score for use of heparin was developed, however, use of heparin did not affect the reduced risk associated with eptifibatide (adjusted relative risk [RR] for heparin-eptifibatide interaction term 0.90, 95% confidence interval [CI] 0.61 to 1.32, p > 0.5), but the propensity for heparin use was a strong predictor of events (adjusted RR 1.76, 95% CI 1.42 to 2.17, p < 0.001). The use of eptifibatide independently predicted a lower risk of events (adjusted RR 0.31, 95% CI 0.10 to 0.93, p = 0.04). Thus, the apparent positive impact of heparin on the benefits of eptifibatide therapy was largely due to confounding and bias.

Aged↗

PubMed2001

Complete bundle branch block as an independent predictor of all-cause mortality: report of 7,073 patients referred for nuclear exercise testing.

PURPOSE: Complete left bundle branch block is a well-established independent risk factor for mortality, but the prognostic importance of right bundle branch block is unclear. We determined whether left and right bundle branch block was associated with all-cause mortality risk after adjustment for potential confounders, including clinical, exercise, and nuclear scintigraphic variables. SUBJECTS AND METHODS: We studied 7,073 adults who were referred for symptom-limited nuclear exercise testing. Patients with heart failure or pacemakers were excluded. The presence or absence of bundle branch block was determined from resting electrocardiograms. The main outcome measure was all-cause mortality during a mean of 6.7 years of follow-up. RESULTS: One hundred ninety patients (3%) had complete right bundle branch block, and 150 (2%) had complete left bundle branch block. There were 825 deaths (12%). Mortality was greater in patients with complete right bundle branch block (24% [46 of 190]) or left bundle branch block (24% [36 of 150]) than in those without these findings (11% [779 of 6,883 and 789 of 6,923, respectively]; both P <0.0001). After adjustment for potential confounders, right bundle branch block was as strong an independent predictor of mortality (hazard ratio [HR] 1.5; 95% confidence interval [CI]: 1.1 to 2.1; P = 0.007) as left bundle branch block (HR 1.5; 95% CI: 1.0 to 2.0; P = 0.017). Incomplete right bundle branch block was not associated with mortality. CONCLUSION: Complete right and left bundle branch block are independent predictors of all-cause mortality risk even after adjustment for exercise capacity, nuclear perfusion defects, and other risk factors.

Adult↗

PubMed2001

Postcardiotomy mechanical support: risk factors and outcomes.

BACKGROUND: The need for postcardiotomy mechanical support is uncommon, with an incidence of 0.5%. METHODS: Multivariable logistic regression analysis of factors associated with postcardiotomy extracorporeal membrane oxygenation (ECMO) support was investigated in 19,985 patients, of whom, 97 required ECMO. RESULTS: Younger age, number of reoperations, emergency operation, higher creatinine, greater left ventricular dysfunction, and history of myocardial infarction were significant predictors. Overall survival was 35%, but significantly better (72%) in the subgroup converted to an implantable system and then bridged to transplantation. CONCLUSIONS: Patients at increased risk for mechanical support can be identified preoperatively and patient management modified as indicated. Improvement in postcardiotomy survival has been realized by bridging to transplantation. In nontransplant candidates, permanent support may be the only option for increasing survival.

Adolescent↗

PubMed2001

Double valve endocarditis.

BACKGROUND: There are little data concerning surgical outcomes in patients with native valve endocarditis affecting both the aortic and mitral valves. METHODS: From 1977 to 1998, 54 patients had simultaneous aortic and mitral valve grafting for native valve endocarditis. In 78%, mitral valve involvement was limited to the anterior leaflet, suggesting a jet lesion from the aortic valve. Surgical strategies included 31 valve repairs and valve replacement with mechanical (34), bioprosthetic (34), or allograft (9) prostheses. Three hundred twenty-five patient-years of follow-up were available for analysis (mean 6.0 +/- 4.8 years). RESULTS: There were no hospital deaths. Ten-year survival was 73%. Ten-year freedom from recurrent endocarditis was 84%, with risk peaking at 3 months, followed by a constant risk of 1.3%/yr. Choice of valvar procedure did not influence mortality or reinfection risk. CONCLUSIONS: The most common pattern of double valve infection was a jet lesion on the anterior mitral leaflet. Surgical treatment has late survival and freedom from reinfection similar to those of patients with single heart valve infection.

Adolescent↗

PubMed2001

Durability of combined aortic and mitral valve repair.

BACKGROUND: This study was undertaken to determine the durability of combined aortic and mitral valve repair. METHODS: From 1979 through 1999, 158 patients underwent simultaneous aortic and mitral valve repair. Multivariable, multi-phase hazard function analysis was used to determine risk factors for the outcomes of death and reoperation. RESULTS: Hospital mortality was 3%. Survival after operation was 97%, 93%, 82%, and 62% after 30 days and 1, 5, and 10 years, respectively. Risk factors for late death included aortic stenosis (p = 0.0001), older age (p = 0.002), and abnormal left ventricular function (p = 0.007). Thirty-six patients required reoperation for valvular dysfunction, and freedom from reoperation was 94%, 82%, and 65% after 1, 5, and 10 years, respectively. Risk factors for reoperation included severe aortic regurgitation (p = 0.004), aortic cusp shaving (p = 0.05), mitral valve chordal transfer (p = 0.004), and bovine pericardial annuloplasty (p = 0.002). Five-year freedoms from endocarditis, thromboembolism, and hemorrhage were 97%, 98%, and 99%, respectively, with freedom from any of these valve-related morbidities of 99%, 95%, and 94% after 1, 5, and 10 years, respectively. CONCLUSIONS: Double valve repair is associated with acceptable late survival and excellent freedom from valve-related morbidity, but limited durability. Therefore, double valve repair should be reserved for patients who cannot be anticoagulated, and should be used with caution in patients with aortic stenosis, rheumatic valve disease, or anterior mitral leaflet pathology.

Adolescent↗

PubMed2001

Safety and efficacy of hypothermic cardiopulmonary bypass and circulatory arrest for operations on the descending thoracic and thoracoabdominal aorta.

BACKGROUND: Hypothermic cardiopulmonary bypass with circulatory arrest is an important adjunct for operations on the distal aortic arch and the descending thoracic and thoracoabdominal aorta. Its safety and efficacy compared with other techniques (eg, simple aortic clamping, partial cardiopulmonary bypass, and regional hypothermia) are not clearly established. METHODS: One hundred sixty-one patients (ranging from 20 to 83 years old) with descending thoracic or thoracoabdominal aortic disease had resection and graft replacement of the involved aortic segments using hypothermic cardiopulmonary bypass usually with intervals of circulatory arrest (mean interval, 38 minutes). RESULTS: The 30-day mortality rate was 6.2% (10 patients). It was 41% (7 of 17) for patients having emergent operations (rupture or acute dissection) and 2.1% (3 of 144) for all other patients (p < 0.001). The 90-day mortality rate was 11.8% (19 patients). Paraplegia occurred in 4 and paraparesis in 1 of the 156 operative survivors whose lower limb function could be assessed postoperatively (3.2%). Among the 91 survivors with thoracoabdominal aortic disease, early paraplegia occurred in 1 of 33 patients with Crawford type I disease, 0 of 34 with type II disease, and 2 of 24 with type III disease. One patient (type II disease) had development of paraplegia on the tenth postoperative day. None of the 50 patients with aortic dissection experienced paralysis. Renal dialysis was required in 4 (2.5%) of the 157 operative survivors, prolonged inotropic support (> 48 hours) in 17 (11%), reoperation for bleeding in 8 (5%), mechanical ventilation (> 48 hours) in 31 (20%), and tracheostomy in 13 (8%). Three patients (1.9%) sustained a stroke. CONCLUSIONS: Hypothermic cardiopulmonary bypass provides safe and substantial protection against paralysis and renal, cardiac, and visceral organ system failure that equals or exceeds that of other currently used techniques but without the need of other adjuncts.

Adult↗

PubMed2001

Age and valve size effect on the long-term durability of the Carpentier-Edwards aortic pericardial bioprosthesis.

BACKGROUND: Bioprosthesis durability decreases with time and younger age. However, the time-scale and determinants of durability of the aortic Carpentier-Edwards stented bovine pericardial prosthesis are incompletely characterized. METHODS: Between September 1981 and January 1984, 267 patients underwent implantation of the pericardial aortic prosthesis at four centers. Mean age at implant was 65 +/- 12 years (range 21 to 86 years). Follow-up averaged 12 +/- 4.5 years. The primary end point was explant for structural valve dysfunction (SVD), which was analyzed multivariably in the context of death as a competing risk. RESULTS: Freedom from explant due to SVD was 99%, 94%, and 77% at 5, 10, and 15 years. Risk of SVD increased exponentially with time and younger age (p = 0.0001) at implantation; an increased risk of small valve size was not reliably demonstrated (p = 0.1). Considering the competing risk of death, patients aged 65 years or older had a less than 10% chance of explant for SVD by 15 years. CONCLUSIONS: Durability of this stented pericardial aortic bioprosthesis is excellent and justifies its use in patients aged 65 or older.

Actuarial Analysis↗

PubMed2001

Surgical anterior ventricular endocardial restoration (SAVER) in the dilated remodeled ventricle after anterior myocardial infarction. RESTORE group. Reconstructive Endoventricular Surgery, returning Torsion Original Radius Elliptical Shape to the LV.

OBJECTIVES: The goal of this study was to evaluate the safety and efficacy of surgical anterior ventricular endocardial restoration (SAVER). The procedure excludes noncontracting segments in the dilated remodeled ventricle after anterior myocardial infarction. BACKGROUND: Anterior infarction leads to change in ventricular shape and volume. In the absence of reperfusion, dyskinesia develops. Reperfusion by thrombolysis or angioplasty leads to akinesia. Both lead to congestive heart failure by dysfunction of the remote muscle. The akinetic heart rarely undergoes surgical repair. METHODS: A new international group of cardiologists and surgeons from 11 centers (RESTORE group) investigated the role of SAVER in patients after anterior myocardial infarction. From January 1998 to July 1999, 439 patients underwent operation and were followed for 18 months. Early outcomes of the procedure and risk factors were investigated. RESULTS: Concomitant procedure included coronary artery bypass grafting in 89%, mitral valve (MV) repair in 22% and MV replacement in 4%. Hospital mortality was 6.6%, and few patients required mechanical support devices such as intraaortic balloon counterpulsation (7.7%), left ventricular assist device (0.5%) or extracorporeal membrane oxygenation (1.3%). Postoperatively, ejection fraction increased from 29 +/- 10.4 to 39 +/- 12.4%, and left ventricular end systolic volume index decreased from 109 +/- 71 to 69 +/- 42 ml/m2 (p < 0.005). At 18 months, survival was 89.2%. Time related survival at 18 months was 84% in the overall group and 88% among the 421 patients who had coronary artery bypass grafting or MV repair. Freedom from readmission to hospital for congestive heart failure at 18 months was 85%. Risk factors for death at any time after the operation included older age, MV replacement and lower postoperative ejection fraction. CONCLUSIONS: Surgical anterior ventricular endocardial restoration is a safe and effective operation in the treatment of the remodeled dilated anterior ventricle after anterior myocardial infarction.

Adult↗

PubMed2001

Independent contribution of myocardial perfusion defects to exercise capacity and heart rate recovery for prediction of all-cause mortality in patients with known or suspected coronary heart disease.

OBJECTIVES: The goal of this study was to determine the value of thallium201 single photon emission computed tomography (SPECT) imaging for prediction of all-cause mortality when considered along with functional capacity and heart rate recovery. BACKGROUND: Myocardial perfusion defects identified by thallium201 SPECT imaging are predictive of cardiac events. Functional capacity and heart rate recovery are exercise measures that also have prognostic implications. METHODS: We followed 7,163 consecutive adults referred for symptom-limited exercise thallium SPECT (mean age 60 +/- 10, 25% women) for 6.7 years. Using information theory, we identified a probable best model relating nuclear findings to outcome to calculate a prognostic nuclear score. RESULTS: There were 855 deaths. Intermediate- and high-risk prognostic nuclear scores were noted in 28% and 10% of patients. Compared with those with low-risk scans, patients with an intermediate-risk score were at increased risk for death (14% vs. 9%, hazard ratio: 1.67, 95% confidence interval [CI]: 1.44 to 1.95, p < 0.0001), while those with high-risk scores were at greater risk (24%, hazard ratio: 2.98, 95% CI: 2.49 to 3.56, p < 0.0001). In multivariable analyses that adjusted for clinical characteristics, functional capacity and heart rate recovery, an intermediate-risk nuclear score remained predictive of death (adjusted hazard ratio: 1.50, 95% CI: 1.28 to 1.76, p < 0.0001), as did a high-risk score (adjusted hazard ratio: 2.76, 95% CI: 2.13 to 2.56, p < 0.0001). Impaired functional capacity and decreased heart rate recovery provided additional prognostic information. CONCLUSIONS: Myocardial perfusion defects detected by thallium SPECT imaging are independently predictive of long-term all-cause death, even after accounting for exercise capacity, heart rate recovery and other potential confounders.

Activities of Daily Living↗

PubMed2001

Does the completeness of revascularization affect early survival after coronary artery bypass grafting in elderly patients?

OBJECTIVE: Usefulness and risks of incomplete versus complete revascularization are still matters of ongoing discussions. Because an increasing number of elderly patients are undergoing coronary artery bypass grafting (CABG), the question arises whether a less extensive surgical approach is more prudent than complete revascularization. METHODS: Of 6531 patients undergoing isolated CABG, 859 were 75 and older at the time of operation. Mean age of the 859 patients was 77+/-2.7 years (median: 76 years); 65% were men. Follow-up enquiry by questionnaire was performed at the 180th postoperative day with a completeness of 95.6%. Assessment of the impact of incomplete revascularization utilized both multivariable analysis and propensity score matching to account for selection factors. RESULTS: Incomplete revascularization was performed in 133 patients (16%). The most common reasons for incomplete revascularization were small vessels (55%) and massive calcification (32%). Mortality until 180 days after CABG was higher (n=32; 24%) after incomplete than after complete revascularization (n=105; 15%; P=0.005). By logistic multivariable regression, incomplete revascularization was identified as an independent risk factor for death (Odds ratio, 1.8; P=0.015). By time-related analysis, incomplete revascularization predominantly affected the early period after CABG (P=0.001). Aortic cross clamping time was only slightly shorter for the group with incomplete (59+/-27 min (median: 55 min) vs. 63+/-26 min (median: 58 min); P=0.1). CONCLUSIONS: Incomplete revascularization increases the early risk of death after CABG in patients aged 75 years and older. The potential compensating benefit of the shorter aortic cross clamping time does not outweigh the advantages of complete revascularization. Thus, in the era of high-volume interventional approaches and minimally invasive techniques, the advantages of complete revascularization need to be considered.

Aged↗

PubMed2001

International Council of Emboli Management (ICEM) Study Group results: risk adjusted outcomes in intraaortic filtration.

BACKGROUND: The Multicenter Study of Perioperative Ischemia (McSPI) developed and validated a Stroke Risk Index for estimating the likelihood that patients undergoing isolated coronary artery bypass grafting will experience major perioperative neurologic events. The International Council of Emboli Management (ICEM) Study Group has suggested that use of intraaortic filtration reduces adverse neurologic events. OBJECTIVE: The objective of the present study was to compare predicted and observed neurologic outcomes in patients receiving intraaortic filtration. PATIENTS AND METHODS: From February 1999 to August 2000, 962 patients were enrolled consecutively in a prospective, nonvoluntary registry of intraaortic filtration in 15 European centers. Of these, 447 underwent isolated coronary artery bypass grafting, the target population for applying the McSPI Stroke Risk Index. Forty-five had incomplete data, yielding a study group of 402 patients. The Stroke Risk Index was calculated for each patient, and the sum across patients yielded an expected number of neurologic events. These were compared to observed events by confidence limits and goodness of fit. RESULTS: Six neurologic events were observed (1.5%; 95% confidence limits 0.6-3.4%), roughly half the 13.7 predicted by the Stroke Risk Index (3.4%; 95% confidence limits 2.0-5.8%), P=0.03. CONCLUSIONS: Adverse neurologic events associated with coronary artery bypass grafting in which intraaortic filtration was used were rare and fewer than expected on the basis of the Stroke Risk Index. Rare occurrence of clinically relevant events precludes their use as primary endpoints for randomized clinical studies; however, the Stroke Risk Index provides a valuable benchmark in the absence of such studies.

Aorta↗

PubMed2001

Critical aortic stenosis in the neonate: a multi-institutional study of management, outcomes, and risk factors. Congenital Heart Surgeons Society.

OBJECTIVES: We sought to determine factors that would predict whether a biventricular repair or Norwood procedure pathway would give the best survival in neonates with critical aortic stenosis. METHODS: Survival and risk factors were determined with parametric time-dependent event analysis for patients undergoing either the Norwood procedure or biventricular repair, and predicted optimal pathway and survival benefit were derived from multivariable linear regression. RESULTS: From 1994 to 2000, 320 neonates with critical left ventricular outflow obstruction were entered into a prospective multi-institutional study. Patients who died without intervention (n = 19) and those with primary cardiac transplantation (n = 6) were excluded. An initial intended biventricular repair pathway was indicated in 116 patients, with survival of 70% at 5 years. An initial Norwood procedure was performed in 179 patients, with survival of 60% at 5 years. Using predictions from separate multivariable hazard models for survival with each of the 2 pathways, we determined predicted optimal pathway and survival benefit for each patient. Significant independent factors associated with greater survival benefit for the Norwood procedure versus biventricular repair included younger age at entry, lower z-score of the aortic valve and left ventricular length, higher grade of endocardial fibroelastosis, absence of important tricuspid regurgitation, and larger ascending aorta. Predicted survival benefit favored the Norwood procedure in 50% of patients who had biventricular repair, and it favored biventricular repair in 20% of patients who had the Norwood procedure. CONCLUSIONS: Morphologic and functional factors can be used to predict optimal pathway and survival benefit in neonates with critical left ventricular outflow obstruction.

Aortic Valve Stenosis↗

PubMed2001

N1 esophageal carcinoma: the importance of staging and downstaging.

OBJECTIVE: To evaluate the effects of clinical staging and downstaging by induction chemoradiation therapy in patients with N1 esophageal carcinoma. METHODS: Sixty-nine consecutive patients with regional lymph node metastases (cN1) according to clinical staging received induction therapy before surgery. These were compared to 75 patients both clinically and pathologically N1 (cN1/pN1) who underwent surgery without induction therapy and 79 patients clinically and pathologically not N1 (cN0/pN0) who underwent surgery without induction therapy. Analyses focused on survival and the cost and benefit of therapy. RESULTS: For comparison, the extremes of 5-year survival were 69% for cN0/pN0 patients who underwent surgery alone and 12% for cN1/pN1 patients who underwent surgery alone. Of 69 patients who received induction therapy, 37 were pN0 at resection (downstaged); they had an intermediate survival of 37% at 5 years. Those patients not downstaged with induction therapy had a 12% 5-year survival, similar to patients with cN1/pN1 who underwent surgery alone. After adjusting for the strongest predictors of poor outcome, pN1, and increasing N1 burden, a modest increased risk of death after induction therapy was identified. However, this cost of induction therapy was more than counterbalanced by the benefit of improved survival of downstaging to pN0. CONCLUSIONS: (1) pN1 is the strongest determinant of poor outcome. (2) cN1 patients who are downstaged by induction chemoradiation therapy to pN0 have an intermediate outcome. (3) cN1 patients who are not downstaged by induction therapy have a poor outcome.

Adenocarcinoma↗

PubMed2001

Partial left ventriculectomy for dilated cardiomyopathy: is this an alternative to transplantation?

OBJECTIVE: To determine the late effectiveness of partial left ventriculectomy and risk factors for failure. METHODS: Between May 1996 and December 1998, partial left ventriculectomy and concomitant mitral valve surgery were performed in 62 patients (95% transplant candidates) with a mean age of 54 years (range 17-72 years). All patients were in New York Heart Association functional class III (38%) or IV (62%) because of idiopathic dilated cardiomyopathy (59 patients) or ischemic, valvular, or familial cardiomyopathy (1 patient each). Outcomes considered for multivariable analysis included implantation of left ventricular assist device, return to class IV heart failure, relisting for transplantation, and death. RESULTS: Partial left ventriculectomy reduced the left ventricular end-diastolic diameter immediately preoperatively to immediately postoperatively (from 8.4 +/- 1.1 cm to 5.92 +/- 0.8 cm; P =.01), reduced the left ventricular end-diastolic volume index (from 133 +/- 48.6 mL to 64.1 +/- 26 mL; P <.0001), and increased the left ventricular ejection fraction (from 16 +/- 7.6 to 31.5 +/- 10.9; P <.0001). Survival was 80% and 60% at 1 and 3 years after surgery and freedom from failure was 49% and 26%, respectively. Increased systolic pulmonary artery pressure, decreased maximum exercise oxygen consumption, and increased left atrial pressure were associated with failure and/or death. The degree of preoperative mitral regurgitation did not correlate with clinical outcome. CONCLUSIONS: Early and late failures preclude the widespread use of partial left ventriculectomy. However, in view of its sometimes beneficial effect, use in situations that do not allow for transplantation or as a biologic bridge to transplantation may be appropriate.

Adolescent↗