A critical appraisal of current models of risk stratification for percutaneous coronary interventions.
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Publications and source records attributed to Mandeep Singh.
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OBJECTIVES: We compared American College of Cardiology/American Heart Association (ACC/AHA) lesion classification with the recently proposed Mayo Clinic risk score to predict complications following percutaneous coronary intervention (PCI). BACKGROUND: The ability of the ACC/AHA classification system to predict complications following PCI has been modest. With the inclusion of patient demographics, acuity of presentation, and measure of left ventricular function, models with better discriminatory accuracy are presently available. METHODS: The Mayo Clinic risk score is constructed by adding integer scores for the presence of eight variables. We mapped the lesion-specific risk levels to a patient level by counting the number of lesions in each class (A, B1, B2, C, and unknown). RESULTS: In 5,064 PCIs, 183 patients (4%) had the primary end point (death, Q-wave myocardial infarction, stroke, emergency coronary artery bypass graft). Of the 7,632 treated lesions, 891 (12%) were unsuccessfully treated with PCI (residual stenosis >20%). The discriminatory ability of the Mayo Clinic risk score model for prediction of the primary end point, as measured by the c-statistic, was 0.78 (95% confidence interval [CI] 0.74 to 0.81). The Mayo Clinic risk score offered significantly better risk stratification than the ACC/AHA lesion classification counts (95% CI for c-statistic difference: 0.05 to 0.15). Regarding angiographic success, the ACC/AHA lesion classification was a better system (95% CI for c-statistic difference: -0.08 to -0.03 favoring ACC/AHA classification), although its absolute ability was modest (c = 0.58). CONCLUSIONS: Mayo Clinic risk score offers significantly better prediction for cardiovascular complications than the ACC/AHA classification. However, lesion classification by ACC/AHA classification is a better predictor for angiographic success.
BACKGROUND: Restenosis prediction from published studies is hampered by inadequate sample size and incomplete angiographic follow-up. The prediction of restenosis with the existing variables is poor. The aim of the present study was to include the clinical and angiographic variables commonly associated with angiographic restenosis and develop a prediction model for restenosis from the PRESTO database. METHODS AND RESULTS: This study included 1312 patients with a single lesion enrolled in the angiographic substudy of the PRESTO trial. We constructed 2 risk scores. The first used preprocedural variables (female gender, vessel size [< or =2.5 mm, 2.5 to 3 mm, 3 to 3.5 mm, 3.5 to 4 mm, >4 mm], lesion length >20 mm, diabetes, smoking status, type C lesion, any previous percutaneous coronary intervention [PCI], and unstable angina) derived from previous studies. Estimated restenosis rates and corresponding variability for each possible level of the resultant risk score were obtained via bootstrapping techniques. The area under the receiver-operator characteristic (ROC) curve was 0.63, indicating modest discriminatory ability to predict restenosis. The second approach constructed a multiple logistic regression model considering significant univariate clinical and angiographic predictors of restenosis identified from the PRESTO database (treated diabetes mellitus, nonsmoker, vessel size, lesion length, American College of Cardiology/American Heart Association type C lesion, ostial location, and previous PCI). The area under the ROC curve for this risk score was also 0.63. CONCLUSIONS: The preprocedural clinical and angiographic variables from available studies and from the PRESTO trial have only modest predictive ability for restenosis after PCI.
PURPOSE: We used the Simplified Urinary Incontinence Outcome Score (SUIOS) to retrospectively assess the continence outcomes following 107 consecutive autologous rectus fascia pubovaginal sling procedures. This outcome score requires completion of a questionnaire, voiding diary and pad test. The voiding diary and pad test provide objective data but require a degree of patient effort and motivation. We determine if the voiding diary and pad test requirements would significantly reduce the rate of followup. MATERIALS AND METHODS: After recruitment letters were mailed to all eligible patients, followup telephone calls were made to ask them to complete the SUIOS protocol. Those who agreed were mailed a packet containing the pre-weighed pads, voiding diary and questionnaire. Patients who refused were asked to complete a telephone questionnaire instead. Patients were given 1 month to complete and return the study materials. If the materials were not returned, repeat telephone reminders were made. If patients were unwilling to complete the protocol at this point, they were offered the option of completing only the questionnaire by telephone. Treatment outcomes were classified according to the SUIOS protocol, and the followup rate for the full protocol was compared with that for the questionnaire only responses. RESULTS: Of the 107 patients 18 were lost to followup and 10 refused to participate, leaving 79 (74%) evaluable patients. Mean followup interval was 31 months (range 9 to 66). Of the 79 women 38 (48%) completed the questionnaire portion but were unwilling to complete the voiding diary and pad test. The remaining 41 patients (52%) completed the entire protocol. Complete SUIOS scores were 59% cured, 24% good response, 10% fair response, 2% poor response and 5% failure. Questionnaire response results were similar, with 61% cured, 32% improved and 8% failed. CONCLUSIONS: The majority of our patients were unwilling to complete a pad test and voiding diary for the purpose of assessing outcomes after anti-incontinence surgery. The possible increased accuracy of these outcome measures needs to be weighed against the lower followup rate associated with their use.
OBJECTIVE: To compare the safety and efficacy of percutaneous coronary intervention (PCI) for acute myocardial infarction performed at a hospital without cardiac surgical capability with PCI performed for acute myocardial infarction at a center with on-site surgery. PATIENTS AND METHODS: We included patients with acute myocardial infarction in whom PCI was performed from March 1, 2000, through May 31, 2002, at a community hospital (Immanuel St Joseph's) without on-site surgery. The procedural success, in-hospital adverse cardiac events, and 6-month follow-up were compared with those of PCI performed for acute myocardial infarction in matched controls from January 1, 2000, through February 28, 2002, at a center with cardiac surgery (Saint Marys Hospital). RESULTS: One hundred sixty patients (and 160 matched controls) underwent PCI for acute myocardial infarction. The procedural success rate was high and similar for the 2 groups (96% vs 95%; P=.79). In-hospital mortality, Q-wave myocardial infarction, and target vessel revascularization were low and similar for the 2 groups. No patient was referred for emergency coronary artery bypass graft surgery for failed PCI. Six-month survival from all-cause mortality was 96% for the Immanuel St Joseph's group and 94% for the Saint Marys Hospital group (P=.92). Subgroup analysis of patients with primary PCI for ST-segment elevation acute myocardial infarction revealed high procedural success and low and similar rates of major cardiac adverse events in the 2 groups. CONCLUSION: This study shows that PCI for acute myocardial infarction can be performed safely and effectively in a community hospital without on-site cardiac surgery.
OBJECTIVE: To compare the short-term and long-term outcomes of patients with coronary artery disease and peripheral arterial disease (PAD) who underwent intracoronary (IC) stent Implantation during percutaneous coronary intervention (PCI) with the outcomes of patients with isolated coronary artery disease but without PAD who underwent IC stent implantation. PATIENTS AND METHODS: We analyzed the outcomes of 7696 patients who underwent IC stent implantation during PCI at the Mayo Clinic in Rochester, Minn, between January 1996 and December 2002. Outcomes of 6299 patients (82%) with Isolated coronary artery disease and without PAD who underwent IC stent implantation (group 1) were compared with outcomes of 1397 patients (18%) with coronary artery disease and PAD (group 2) who underwent PCI with IC stent implantation. RESULTS: Patients in group 2 were older (71.1+/-10.2 years vs 65.0+/-12.0 years; P<.001) and had a higher prevalence of hypertension (79% vs 61%; P<.001), diabetes mellitus (33% vs 20%; P<.001), hyperlipidemia (76% vs 70%; P<.001), and history of smoking (70% vs 63%; P<.001) compared with group 1. Prevalence of multivessel disease was higher in group 2 (79% vs 68%; P<.001). Procedural success was significantly lower In group 2 (95% vs 97%; P<.001). In-hospital complications were higher in group 2: death (3% vs 1%; P<.001), any myocardial Infarction (MI) (8% vs 5%; P<.001), death/MI/coronary artery bypass grafting (CABG)/target vessel revascularization (11% vs 7%; P<.001), and blood loss requiring transfusion (11% vs 5.8%; P<.001). After adjustment for other risk factors, the odds ratio for in-hospital death was 1.84 (95% confidence interval [CI], 1.16-2.90; P=.009), and for death/MI/CABG/target vessel revascularization, the odds ratio was 1.25 (95% CI, 1.00-1.55; P=.048) in patients with PAD treated with IC stents. Median follow-up was 3.1 years. Six-month, 1-year, and 2-year Kaplan-Meier estimates of survival free of death/MI/CABG/target vessel revascularization were 84%, 77%, and 69%, respectively, for group 2 and were significantly worse compared with group 1 (89%, 85%, and 80%, respectively; P<.001). This effect remained after adjustment for other risk factors (hazard ratio, 1.36; 95% CI, 1.22-1.51). CONCLUSIONS: Compared with patients who had isolated coronary artery disease but no PAD, patients with coronary artery disease and PAD had lower procedural success and higher in-hospital major cardiovascular complications, including higher blood loss requiring transfusion, after PCI with stent Implantation. On follow-up, the short-term and long-term outcomes of patients with PAD were worse, with higher mortality, MI, and need for repeated target vessel revascularization.
OBJECTIVES: We sought to validate the recently proposed Mayo Clinic risk score model for complications after percutaneous coronary interventions (PCI), using an independent data set. BACKGROUND: The Mayo Clinic risk score has eight simple clinical and angiographic variables for the prediction of complications defined as either death, Q-wave myocardial infarction, emergent or urgent coronary artery bypass graft surgery, or cerebrovascular accident after PCI. External validation using an independent data set is lacking. METHODS: A total of 3,264 patients undergoing PCI at each of the 17 sites in the National Heart, Lung, and Blood Institute's Dynamic Registry during two enrollment periods (July 1997 to February 1998 and February to June 1999) were studied. Logistic regression was used to model the calculated risk score and major procedural complications. The expected number of complications, with 95% confidence bounds (CBs), was also calculated. RESULTS: There were 96 (2.94%) observed procedural complications, and the Mayo Clinic risk score predicted 93.5 events (2.86%; 95% CB 2.32% to 3.41%; p = NS). The Hosmer-Lemeshow goodness-of-fit p value was 0.28, and the area under the receiver operating curve was 0.76, indicating excellent overall discrimination. There were no statistical differences between observed and predicted procedural complications using the Mayo Clinic risk score among the most selected high- and low-risk subgroups. CONCLUSIONS: Eight variables were combined into a convenient risk scoring system that accurately predicts cardiovascular complications after PCI. The Mayo clinic predictive model for procedural complications yielded excellent results when applied to a multi-center external data set.
BACKGROUND: Percutaneous coronary interventions (PCIs) in saphenous vein grafts (SVGs) with thrombus have a high frequency of distal embolization. Acolysis (therapeutic ultrasound) can break up thrombus in vitro in animal models and humans. Whether this is beneficial during percutaneous SVG interventions is unknown. METHODS AND RESULTS: We performed a trial of coronary ultrasound thrombolysis in which patients with an acute coronary syndrome undergoing PCI in SVGs were randomly assigned to receive acolysis or abciximab. The primary end point was a successful procedure, defined as final luminal diameter stenosis 30% or less with Thrombolysis In Myocardial Infarction grade 3 flow and freedom from major adverse cardiac events (composite of death, Q-wave, and non-Q-wave myocardial infarction [MI], emergency bypass procedure, disabling stroke, and target lesion revascularization). Of 181 enrolled, 92 received acolysis and 89 abciximab. Angiographic procedural success was achieved in 63% of acolysis patients and 82% of abciximab patients (P=0.008). Incidence of major adverse cardiac events at 30 days was 25% with acolysis and 12% with abciximab (P=0.036), attributable mainly to a greater frequency of non-Q-wave MI with acolysis (19.6% versus 7.9%, P=0.03). The incidence of Q-wave MI was also higher with acolysis (5.4% versus 2.2%, P=nonsignificant). The primary end point was achieved in 53.8% of acolysis patients and 73.1% of abciximab patients (P=0.014). CONCLUSIONS: Use of therapeutic ultrasound in vein graft lesions in patients with acute coronary syndrome had poor angiographic outcome and increased the incidence of acute ischemic complications.
In this theoretical study we show that by removing or depositing additional multilayer (ML) periods of a thin-film interference coating, distortions in the reflected wave front induced by surface figure errors can be corrected. At lambda = 13.4 nm in the extreme-ultraviolet region the removal or deposition of a single period of the standard two-component molybdenum-silicon (Mo/Si) ML interference coating induces an effective phase change of magnitude 0.043pi with respect to an identical optical thickness in vacuum. The magnitude of this wave-front shift can be enhanced with multicomponent MLs optimized for phase change on reflection. We briefly discuss the contributions of the shift in the effective reflection surface of the ML on the phase change. We also predict the feasibility of novel phase-shifting mask for subwavelength imaging applications.
BACKGROUND: We studied the safety and efficacy of performing low-risk elective and acute infarct percutaneous coronary interventions at a community hospital without cardiac surgical capability. METHODS: Immanuel St Joseph's Hospital is located 85 miles from St Mary's Hospital, which is the nearest center with on-site cardiac surgery. All components of the Mayo Clinic percutaneous coronary intervention program were replicated at Immanuel St Joseph's Hospital, including a telemedicine system to enable real-time consultation with interventional and cardiac surgical colleagues during procedures. RESULTS: From March 1999 to June 2001, 196 patients underwent elective percutaneous coronary intervention at Immanuel St Joseph's Hospital. Procedural success was achieved in 195 (99.5%) patients, with 1 (0.5%) inhospital death. At mean follow-up of 8.2 months, 2 (1.0%) additional patients died of noncardiac causes and 15 (7.7%) patients required target vessel revascularization. From March 2000 to June 2001, 89 patients underwent primary percutaneous coronary intervention for acute myocardial infarction. Procedural success was achieved in 83 (93.3%) patients, with 3 (3.4%) inhospital deaths. At 30-day follow up, no additional patients died, had recurrent myocardial infarction, or required target vessel revascularization. No patients required transfer to another facility for emergent cardiac surgery for a procedure-related complication. CONCLUSIONS: Low-risk elective and acute infarct percutaneous coronary interventions can be performed with safety and efficacy at a community hospital without cardiac surgical capability by following rigorous standards.
BACKGROUND: Several scores, most of which were derived from clinical trials, have been proposed for stratifying risk after myocardial infarctions (MIs). Little is known about their generalizability to the community, their respective advantages, and whether the ejection fraction (EF) adds prognostic information to the scores. The purpose of this study is to evaluate the Thrombolysis in Myocardial Infarction (TIMI) and Predicting Risk of Death in Cardiac Disease Tool (PREDICT) scores in a geographically defined MI cohort and determine the incremental value of EF for risk stratification. METHODS AND RESULTS: MIs occurring in Olmsted County were validated with the use of standardized criteria and stratified with the ECG into ST-segment elevation (STEMI) and non-ST-segment elevation (NSTEMI) MI. Logistic regression examined the discriminant accuracy of the TIMI and PREDICT scores to predict death and recurrent MI and assessed the incremental value of the EF. After 6.3+/-4.7 years, survival was similar for the 562 STEMIs and 717 NSTEMIs. The discriminant accuracy of the TIMI score was good in STEMI but only fair in NSTEMI. Across time and end points, irrespective of reperfusion therapy, the discriminant accuracy of the PREDICT score was consistently superior to that of the TIMI scores, largely because PREDICT includes comorbidity; EF provided incremental information over that provided by the scores and comorbidity. CONCLUSION: In the community, comorbidity and EF convey important prognostic information and should be included in approaches for stratifying risk after MI.
OBJECTIVES: Our goals were to identify clinical and angiographic risk factors associated with major cardiovascular complications of percutaneous coronary intervention (PCI) (in-hospital death, Q-wave myocardial infarction, urgent or emergent coronary artery bypass surgery and stroke) and to construct a simple score for risk stratification. BACKGROUND: Both clinical and angiographic features influence risk of PCIs. METHODS: Percutaneous coronary interventions performed between January 1, 1996, and December 31, 1999, were analyzed. Logistic regression and bootstrap methods were used to create an integer risk score for estimating the risk of procedural complications using baseline, angiographic and procedural characteristics. The risk score was tested in a validation-set consisting of all procedures performed in the year 2000. RESULTS: Among 5,463 procedures, 5 clinical and 3 angiographic variables were significantly correlated with procedural complications: cardiogenic shock, left main coronary artery disease, severe renal disease, urgent or emergent procedure, congestive heart failure class III or higher, thrombus, multivessel disease and older age. In the validation-set, the model fitted the data adequately; the average receiver operating characteristic curve area was 0.782 (standard deviation, 0.018). CONCLUSIONS: Eight variables were combined into a convenient bedside risk scoring system that estimates the risk of complications after PCIs.
Since the early 1990s, with significant improvement in the procedural success of percutaneous coronary interventions (PCIs), there has been a concomitant reduction in the need for emergency coronary artery bypass graft surgery. This review article focuses on the need for on-site cardiac surgery in patients with acute myocardial infarction undergoing primary angioplasty at centers without on-site cardiac surgical backup. It gives an overview of the need for emergency bypass surgery in both the large trial setting and the community hospital setting. Special consideration is also given to the risks and benefits of primary angioplasty compared with thrombolytic therapy, transfer to an institution with an on-site cardiac surgical facility compared with primary PCI, the frequency and indications for emergency cardiac surgery related and unrelated to primary angioplasty and the requirements for primary angioplasty that must be met in hospitals without the capability of on-site cardiac surgery.
BACKGROUND: In patients undergoing percutaneous coronary intervention (PCI) in the modern era, the incidence and prognostic implications of acute renal failure (ARF) are unknown. METHODS AND RESULTS: With a retrospective analysis of the Mayo Clinic PCI registry, we determined the incidence of, risk factors for, and prognostic implications of ARF (defined as an increase in serum creatinine [Cr] >0.5 mg/dL from baseline) after PCI. Of 7586 patients, 254 (3.3%) experienced ARF. Among patients with baseline Cr <2.0, the risk of ARF was higher among diabetic than nondiabetic patients, whereas among those with a baseline Cr >2.0, all had a significant risk of ARF. In multivariate analysis, ARF was associated with baseline serum Cr, acute myocardial infarction, shock, and volume of contrast medium administered. Twenty-two percent of patients with ARF died during the index hospitalization compared with only 1.4% of patients without ARF (P<0.0001). After adjustment, ARF remained strongly associated with death. Among hospital survivors with ARF, 1- and 5-year estimated mortality rates were 12.1% and 44.6%, respectively, much greater than the 3.7% and 14.5% mortality rates in patients without ARF (P<0.0001). CONCLUSIONS: The overall incidence of ARF after PCI is low. Diabetic patients with baseline Cr values <2.0 mg/dL are at higher risk than nondiabetic patients, whereas all patients with a serum Cr >2.0 are at high risk for ARF. ARF was highly correlated with death during the index hospitalization and after dismissal.
The AngioJet thrombectomy device removes thrombus by creating a negative pressure and causing fragmentation of the thrombus. The objective was to study the safety and efficacy of this thrombectomy device during coronary interventions and to report the results of our experience. We studied 72 patients (mean age, 64.9 +/- 12.6 years; 79% males) who had an AngioJet procedure during coronary intervention; 33 (46%) had vein graft intervention. All patients had angiographic thrombus. Most patients presented either with unstable angina (54%) or acute myocardial infarction (32%) within 24 hr. The procedural success was high with AngioJet (93%). TIMI grade 3 flow was achieved in 79% of lesions treated with AngioJet. In-hospital mortality was 1.4%, death/Q-wave myocardial infarction was 4.2%, and the composite endpoint of death and Q-wave myocardial infarction/revascularization was 5.6% for patients undergoing AngioJet. Subgroup analysis of patients with vein graft intervention demonstrated high procedural success in those undergoing AngioJet (91%). At 1-year follow-up of the successful percutaneous interventions with AngioJet, the mortality, death/Q-myocardial infarction, and composite endpoint rates were 10%, 13.3%, and 35.5%, respectively. Long-term event-free survival was worse in vein graft interventions. The incidence of death, death/myocardial infarction, or composite endpoints at 1 year was 16%, 19%, and 46%, respectively. High procedural success can be achieved with the AngioJet thrombectomy device in lesions containing thrombus. It is effective in both native coronary arteries and vein graft interventions. However, the long-term outcome of patients with vein graft intervention was worse.
Water scarcity is the major issue in all parts of world. Wastewater reuse is one alternative. SAT proves to efficient, economical and feasible method for wastewater treatment. SAT system achieves an excellent reduction of biochemical oxygen demand, suspended solids, and fecal coliform. About 90% of water applied to SAT site is returned to watershed. A case study has been made by the authors to increase the efficiency of this system.