Coronary revascularization for acute myocardial infarction in the HIV population.

OBJECTIVE: To analyze trends in management and outcomes of patients infected with the human immunodeficiency virus (HIV) undergoing percutaneous coronary intervention (PCI) for an acute myocardial infarction (AMI) in the United States. BACKGROUND: Infection with HIV is an independent risk factor for accelerated atherosclerosis associated with higher rates of AMI. Current trends and outcomes of HIV-infected individuals presenting with AMI in the United States remain unknown. METHODS: Using the Healthcare Cost and Utilization Project National Inpatient Sample database we identified HIV-infected individuals who underwent PCI for an AMI from 2002 to 2013. Multivariable logistic regression and propensity-score matching were performed to analyze outcomes. RESULTS: We identified a total of 59 194 patients of which 7841 underwent PCI during index hospitalization (13.3%). Most patients were men (71%), ≥50 years of age (82%), and white (74%). ST-elevation myocardial infarction was present in 21% of cases. Charlson comorbidity index (CCI) was 5.67 ± 0.4. Predictors of post-procedural complications included female sex, black race, higher CCI, and placement of a bare metal stent, whereas predictors of mortality included occurrence of a complication, ST-elevation myocardial infarction, age ≥70 years, and higher CCI. Conversely, placement of a drug-eluting stent was associated with a reduced risk of complications and mortality. After propensity-score matching, HIV-infected individuals were less likely to undergo PCI and receive a drug-eluting stent, while having longer length of stay, higher hospitalization costs, and higher in-hospital mortality when compared to non-infected individuals. CONCLUSION: Significant disparities continue to affect HIV-infected individuals undergoing PCI for AMI in the United States.

Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization: A Post Hoc Analysis of the DELTA Registry.

OBJECTIVES: The study sought to investigate the impact of different computing methods for composite endpoints other than time-to-event (TTE) statistics in a large, multicenter registry of unprotected left main coronary artery (ULMCA) disease. BACKGROUND: TTE statistics for composite outcome measures used in ULMCA studies consider only the first event, and all the contributory outcomes are handled as if of equal importance. METHODS: The TTE, Andersen-Gill, win ratio (WR), competing risk, and weighted composite endpoint (WCE) computing methods were applied to ULMCA patients revascularized by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at 14 international centers. RESULTS: At a median follow-up of 1,295 days (interquartile range: 928 to 1,713 days), all analyses showed no difference in combinations of death, myocardial infarction, and cerebrovascular accident between PCI and CABG. When target vessel revascularization was incorporated in the composite endpoint, the TTE (p = 0.03), Andersen-Gill (p = 0.04), WR (p = 0.025), and competing risk (p < 0.001) computing methods showed CABG to be significantly superior to PCI in the analysis of 1,204 propensity-matched patients, whereas incorporating the clinical relevance of the component endpoints using WCE resulted in marked attenuation of the treatment effect of CABG, with loss of significance for the difference between revascularization strategies (p = 0.10). CONCLUSIONS: In a large study of ULMCA revascularization, incorporating the clinical relevance of the individual outcomes resulted in sensibly different findings as compared with the conventional TTE approach. In particular, using the WCE computing method, PCI and CABG were no longer significantly different with respect to the composite of death, myocardial infarction, cerebrovascular accident, or target vessel revascularization at a median of 3 years.

Influence of hospital volume on outcomes of percutaneous atrial septal defect and patent foramen ovale closure: a 10-years US perspective.

BACKGROUND: Contemporary data regarding percutaneous closure of atrial septal defect/patent foramen ovale (ASD/PFO) are lacking. We evaluated the current trends in utilization of ASD/PFO closure in adults and investigated the effect of annual hospital volume on in-hospital outcomes. METHODS: We queried the Nationwide Inpatient Sample between the years 2001 and 2010 using the International Classification of Diseases (ICD-9-CM) procedure code for percutaneous closure of ASD/PFO with device. Hierarchical mixed effects models were generated to identify the independent multivariate predictors of outcomes. RESULTS: A total of 7,107 percutaneous ASD/PFO closure procedures (weighted n = 34,992) were available for analysis. A 4.7-fold increase in the utilization of this procedure from 3/million in 2001 to 14/million adults in 2010 in US (P < 0.001) was noted. Overall, percutaneous ASD/PFO closure was associated with 0.5% mortality and 12% in-hospital complications. The utilization of intracardiac echocardiography (ICE) increased 15 fold (P < 0.001) during the study period. The procedures performed at the high volume hospitals [2nd (14-37 procedures/year) and 3rd (>38 procedures/year) tertile] were associated with significant reduction in complications, length of stay and cost of hospitalization when compared to those performed at lowest volume centers (<13 procedures/year). Majority (70.5%) of the studied hospitals were found to be performing <10 procedures/year hence deviating from the ACC/AHA/SCAI clinical competency guidelines. CONCLUSIONS: Low hospital volume is associated with an increased composite (mortality and procedural complications) adverse outcome following ASD/PFO closure. In the interest of patient safety, implementation of the current guidelines for minimum required annual hospital volume to improve clinical outcomes is warranted.

Balloon mitral valvuloplasty in the United States: a 13-year perspective.

BACKGROUND: Incidence and prevalence of mitral stenosis is declining in the US. We performed this study to determine recent trends in utilization, complications, mortality, length of stay, and cost associated with balloon mitral valvuloplasty. METHODS: Utilizing the nationwide inpatient sample database from 1998 to 2010, we identified patients using the International Classification of Diseases, 9th Revision, Clinical Modification procedure code for "percutaneous valvuloplasty." Patients ≥18 years of age with mitral stenosis were included. Patients with concomitant aortic, tricuspid, or pulmonic stenosis were excluded. Primary outcome included death and procedural complications. RESULTS: A total of 1308 balloon mitral valvuloplasties (weighted n = 6540) were analyzed. There was a 7.5% decrease in utilization of the procedure from 24.6 procedures/10 million population in 1998-2001 to 22.7 procedures/10 million population in 2008-2010 (P for trend = .098). We observed a 15.9% overall procedural complication rate and 1.7% mortality rate. The procedural complication rates have increased in recent years (P = .001), corresponding to increasing age and burden of comorbidities in patients. The mean cost per admission for balloon mitral valvuloplasty has gone up significantly over the 10 years, from $11,668 ± 1046 in 2001 to $23,651 ± 301 in 2010 (P <.001). CONCLUSIONS: In a large cross-sectional study of balloon mitral valvuloplasty in the US, we have reported trends of decreasing overall utilization and increasing procedural complication rates and cost over a period of 13 years.

Randomized comparison of cost-saving and effectiveness of oral rapamycin plus bare-metal stents with drug-eluting stents: three-year outcome from the randomized oral rapamycin in Argentina (ORAR) III trial.

OBJECTIVES: The Oral Rapamycin in ARgentina (ORAR) III trial is a randomized study comparing a strategy of oral rapamycin (OR) plus bare-metal stent (BMS) versus a strategy of drug-eluting stents (DES) in patients with de novo coronary lesions. The purpose of this study was to assess the 3 years cost-effectiveness outcome of each strategy. BACKGROUND: OR after BMS has been associated with reduction of target vessel revascularization (TVR) although its value in long-term efficacy in comparison with DES is unknown. METHODS: In three hospitals in Buenos Aires, Argentina, 200 patients were randomized to OR plus BMS (n = 100) or DES (n = 100). Primary objectives were costs and effectiveness. Cost analysis included in-hospital and follow-up costs. Safety was defined as the composite of death, myocardial infarction (MI), and stroke. Efficacy was defined as TVR. RESULTS: Baseline characteristics between groups were similar. The 3-year follow-up rate was 99%. Cardiac mortality was 2% and 5% in OR group and DES group, respectively (P = 0.44). The composite of death, MI and stroke rate was 11% in OR group and 20% in DES group (P = 0.078). TVR rate was 14.5% in OR group and 17.6% in DES group (P = 0.50), respectively. Three year cumulative costs were significantly lower in the OR arm as compared to the DES arm (P = 0.0001) and DES strategy did not result cost-effective according to the non-inferiority test. CONCLUSIONS: At 3 years follow-up, there were no differences in effectiveness between the two strategies, and DES strategy was not more cost-effective as compared to OR plus BMS.

Difference in outcome among women and men after percutaneous mitral valvuloplasty.

OBJECTIVE: To analyze the differences in anatomical, clinical and echocardiographic characteristics of women and men undergoing PMV and to evaluate the relationship between sex, PMV success, and immediate and long-term clinical outcome. BACKGROUND: Rheumatic mitral stenosis (MS) is predominantly a disease of middle-aged women. Percutaneous mitral valvuloplasty (PMV) has become the standard of care for suitable patients. However little is known about the relationship between sex, PMV success, and procedural outcome. METHODS AND RESULTS: We evaluated measures of procedural success and clinical outcome in consecutive patients (839 women and 176 men) who underwent PMV. Despite a lower baseline echocardiographic score (7.47 ± 2.15 vs. 8.02 ± 2.18, P = 0.002), women were less likely to achieve PMV success (69% vs. 83%, adjusted OR 0.44, 95% CI 0.27-0.74, P = 0.002), and had a smaller post-procedural MV area (1.86 ± 0.7 vs. 2.07 ± 0.7 cm(2), P < 0.001). Overall procedural and in-hospital complication rates did not differ significantly between women and men. However, women were significantly more likely to develop severe MR immediately post PMV (adjusted OR 2.41, 95% CI 1.0-5.83, P = 0.05) and to undergo MV surgery (adjusted HR 1.54, 95% CI 1.03-2.3, P = 0.037) after a median follow-up of 3.1 years. CONCLUSIONS: Compared to men, women with rheumatic MS who undergo PMV are less likely to have a successful outcome and more likely to require MV surgery on long-term follow-up despite more favorable baseline MV anatomy.

Intervenciones coronarias percutáneas en pacientes diabéticos / Percutaneous Coronary Interventions in Diabetic Patients

Es bien conocido que la diabetes confiere un riesgo mayor de desarrollo de enfermedad coronaria y que conlleva un pronóstico adverso a largo plazo con tratamiento médico en comparación con los pacientes no diabéticos. Los diabéticos presentan además una incidencia mayor de infarto de miocardio con mayor mortalidad frente a los no diabéticos. En consecuencia, es frecuente que los diabéticos con enfermedad coronaria requieran tratamiento mediante revascularización miocárdica. Los resultados a largo plazo del tratamiento médico y de las estrategias intervencionistas o quirúrgicas en los pacientes diabéticos con enfermedad coronaria son peores que en los no diabéticos. Es sumamente importante reconocer este hecho porque la presencia de diabetes aumenta en extremo el riesgo de complicaciones y de reestenosis. El seguimiento a largo plazo de los ensayos clínicos que compararon los resultados de la angioplastia (ATC) con la cirugía de revascularización miocárdica (CRM) demuestran que la cirugía continúa siendo la estrategia recomendada para los pacientes diabéticos con enfermedad multivaso. Sin embargo, los recientes avances en las intervenciones coronarias percutáneas (ICP) han producido un cambio en el paradigma de la revascularización coronaria en los pacientes diabéticos. En el presente artículo de revisión se analizan los resultados de los estudios comparativos entre CRM e IPC realizados en tres etapas diferentes del desarrollo tecnológico de los métodos percutáneos: la angioplastia con balón, con stent convencional y los más recientes con stents farmacológicos, que parecen haber mejorado el pronóstico de la ATC en los pacientes diabéticos. A la luz de estos resultados, se discuten las indicaciones actuales de las guías internacionales para seleccionar el tratamiento de revascularización en estos pacientes. Finalmente, se comentan los resultados de estudios recientes, como BARI 2D y CARDIA, y los que se encuentran en curso (FREEDOM), que probablemente aportarán más evidencia para definir con más precisión las indicaciones de revascularización percutánea en los pacientes diabéticos.

Diabetes confers a greater risk of developing coronary artery disease and harbors a worse long term prognosis with medical therapy compared to non-diabetic patients. Diabetic patients have a higher incidence and greater mortality from myocardial infarction compared to non-diabetics. Accordingly, myocardial revascularization is frequently required to treat diabetic patients with coronary artery disease. The long term outcomes of diabetic patients with coronary artery disease are worse than those of non-diabetic patients whether a medical, interventional or surgical approach is utilized. This is extremely important to recognize, because the presence of diabetes greatly increases the patient's risk for complications and restenosis. The long term follow-up of clinical trials comparing percutaneous transluminal coronary angioplasty (PTCA) versus surgical revascularization illustrates that surgical revascularization remains the recommended strategy for diabetic multivessel coronary heart disease (CHD). However, recent advances in percutaneous coronary interventions (PCI) have resulted in a changing paradigm for coronary artery revascularization in diabetic patients. The present article analyzes the outcomes of the clinical trials comparing CABGS versus PCI in the three different stages of the technological advance in the development of PTCA: balloon angioplasty, conventional stenting, and, more recently, drug eluting stents which seem to have improved the outcomes of PTCA in diabetic patients. In light of these results, current recommendations from international guidelines are discussed in order to choose the revascularization treatment in these patients. Finally, the results of recent studies, as the BARI 2D and CARDIA trials, are reported. Ongoing studies like the FREEDOM trial are mentioned, which will probably provide further evidence to define the indications of percutaneous revascularization in diabetic patients in a more accurate fashion.

Percutaneous coronary intervention with oral sirolimus and bare metal stents has comparable safety and efficacy to treatment with drug eluting stents, but with significant cost saving: long-term follow-up results from the randomised, controlled ORAR III (Oral Rapamycin in ARgentina) study.

AIMS: Previous randomised studies have shown a significant reduction in restenosis when oral rapamycin (OR) is administered to patients undergoing bare metal stent (BMS) implantation. How this regimen compares to drug eluting stents (DES) is unknown. METHODS AND RESULTS: Two-hundred patients with de novo coronary lesions were randomised to treatment with OR plus BMS (100 pts) or with DES (100 pts). OR was given as a bolus of 10 mg per day before PCI followed by daily doses of 3 mg during following 13 days. Primary endpoints were to compare hospital, follow-up and overall cost at one, two, three and five years of follow-up. The secondary endpoints included death, myocardial infarction (MI) and stroke and were analysed as major adverse cardiovascular events (MACCE). Target vessel (TVR) and target lesion revascularisation (TLR) were independently analysed. Costs included procedural resources, hospitalisation, medications, repeat revascularisation procedures and professional fees. Baseline demographic, clinical and angiographic characteristics were similar. At 18.3 +/- 7 months of follow-up, the initial strategy of OR plus BMS resulted in significant cost saving when compared to DES (p=0.0001). TLR rate was 8.2% with DES and 7.0% with OR plus BMS (p=0.84), similarly no differences in TVR rate in both groups was seen (10.6% and 10.5% in OR and DES group respectively, p=0.86). Non-inferiority testing, determined that DES therapy failed to be cost saving compared to OR in all possible cost scenarios. CONCLUSIONS: A strategy of OR plus BMS is cost saving compared to DES in patients undergoing PCI for de novo coronary lesions.

Transthoracic left ventricular puncture for the assessment of patients with aortic and mitral valve prostheses: the Massachusetts General Hospital experience, 1989-2000.

Accurate assessment of suspected prosthetic valve dysfunction is critically important as reoperation carries high risk. Noninvasive methods of hemodynamic assessment of patients with both aortic and mitral mechanical valves continue to be frustrated by the interference created by prosthetic material and direct left ventricular puncture may be required for definitive hemodynamic assessment. We report the hemodynamic and angiographic results and outcomes of 38 consecutive patients with double valve replacement who underwent left ventricular puncture as part of evaluation of possible prosthetic dysfunction. These results were compared with those obtained by noninvasive testing. We found noninvasive assessment alone to be unsatisfactory as measurements of regurgitation and stenosis correlated poorly with those obtained by direct left ventricular puncture. Important information that altered patient management was obtained from invasive assessment in 68% of cases with an acceptable rate of complications. Therefore, hemodynamic and angiographic assessment using transthoracic left ventricular puncture should be entertained in patients with mitral and aortic valve replacement presenting with congestive heart failure and suspected prosthesis dysfunction.