Prospective Evaluation of Extracorporeal Shockwave Lithotripsy in Renal and Upper Ureteric Stone Treatment: Clinical Assessment and Results.

INTRODUCTION: Extracorporeal shockwave lithotripsy (ESWL) is a widely accepted non-invasive treatment for renal and upper ureteric stones smaller than 2 cm due to its safety and efficacy. Despite advancements in minimally invasive techniques, extracorporeal shockwave lithotripsy remains an important modality. AIMS AND OBJECTIVE: This prospective observational study aimed to evaluate the outcomes of ESWL in managing renal and upper ureteric stones measuring less than 2 cm in terms of stone clearance. MATERIAL AND METHODS: In a study conducted at a university-affiliated tertiary care hospital, 119 patients with renal and upper ureteric stones underwent extracorporeal shockwave lithotripsy over a 12-month period. Data on patient demographics, stone characteristics, treatment procedures, and complications were collected. Follow-up assessments were performed at two-week intervals for up to two months post-treatment. RESULTS: The mean age of patients was 39.78 years, with a mean stone size of 1.2 cm. Right kidney stones were more prevalent (61.3% [n=76]). Complications included fever (19.3% [n=23]), gross haematuria (24.3% [n=29]), and steinstrasse (21.8% [n=26]). The success rate of extracorporeal shockwave lithotripsy was 81.5% (n=97), with 18.5% (n=22) of patients requiring surgical intervention due to incomplete fragmentation or residual fragments >4 mm. Stone size and density played significant roles in treatment success. CONCLUSION: Despite advancements in minimally invasive techniques, ESWL retains its significance as a noninvasive and effective treatment option for renal and upper ureteric stones smaller than 2 cm. Its success depends on various factors, including the stone site, size, and composition. ESWL offers advantages such as minimal morbidity, shorter hospital stays, and better patient compliance. Complications such as steinstrasse are manageable with conservative measures or ancillary procedures. While ESWL may be losing ground in some cases, its noninvasive nature and favourable outcomes make it a valuable option in the armamentarium for stone management.

Burden of Readmissions Among Patients With Critical Limb Ischemia.

BACKGROUND: Readmissions constitute a major health care burden among critical limb ischemia (CLI) patients. OBJECTIVES: This study aimed to determine the incidence of readmission and factors affecting readmission in CLI patients. METHODS: All adult hospitalizations with a diagnosis code for CLI were included from State Inpatient Databases from Florida (2009 to 2013), New York (2010 to 2013), and California (2009 to 2011). Data were merged with the directory available from the American Hospital Association to obtain detailed information on hospital-related characteristics. Geographic and routing analysis was performed to evaluate the effect of travel time to the hospital on readmission rate. RESULTS: Overall, 695,782 admissions from 212,241 patients were analyzed. Of these, 284,189 were admissions with a principal diagnosis of CLI (primary CLI admissions). All-cause readmission rates at 30 days and 6 months were 27.1% and 56.6%, respectively. The majority of these were unplanned readmissions. Unplanned readmission rates at 30 days and 6 months were 23.6% and 47.7%, respectively. The major predictors of 6-month unplanned readmissions included age, female sex, black/Hispanic race, prior amputation, Charlson comorbidity index, and need for home health care or rehabilitation facility upon discharge. Patients covered by private insurance were least likely to have a readmission compared with Medicaid/no insurance and Medicare populations. Travel time to the hospital was inversely associated with 6-month unplanned readmission rates. There was a significant interaction between travel time and major amputation as well as travel time and revascularization strategy; however, the inverse association between travel time and unplanned readmission rate was evident in all subgroups. Furthermore, length of stay during index hospitalization was directly associated with the likelihood of 6-month unplanned readmission (odds ratio for log-transformed length of stay: 2.39 [99% confidence interval: 2.31 to 2.47]). CONCLUSIONS: Readmission among patients with CLI is high, the majority of them being unplanned readmissions. Several demographic, clinical, and socioeconomic factors play important roles in predicting readmissions.

Degenerative Mitral Stenosis: Unmet Need for Percutaneous Interventions.

Degenerative mitral stenosis (DMS) is an important cause of mitral stenosis, developing secondary to severe mitral annular calcification. With the increase in life expectancy and improved access to health care, more patients with DMS are likely to be encountered in developed nations. These patients are generally elderly with multiple comorbidities and often are high-risk candidates for surgery. The mainstay of therapy in DMS patients is medical management with heart rate control and diuretic therapy. Surgical intervention might be delayed until symptoms are severely limiting and cannot be managed by medical therapy. Mitral valve surgery is also challenging in these patients because of the presence of extensive calcification. Hence, there is a need to develop an alternative percutaneous treatment approach for patients with DMS who are otherwise inoperable or at high risk for surgery. In this review, we summarize the available data on the epidemiology of DMS and diagnostic considerations and current treatment strategies for these patients.

Trends in the Burden of Adult Congenital Heart Disease in US Emergency Departments.

BACKGROUND: We assessed trends in incidence, in-hospital mortality, and admission among patients with adult congenital heart disease (ACHD) presenting to the emergency department (ED) from 2006 to 2012. HYPOTHESIS: There is a considerable burden of ACHD in the US EDs. METHODS: We used the 2006-2012 US Nationwide Emergency Department Sample. All ED visits with ACHD were identified using standard International Classification of Diseases, Ninth Edition, Clinical Modification codes. RESULTS: The number of patients presenting to the ED with simple (40.6%) as well as complex (37.6%) ACHD across 2006-2012 increased significantly. Also, there was a considerable increase in prevalence of traditional cardiovascular risk factors among ACHD patients, including hypertension, diabetes, smoking, obesity, and chronic kidney disease. Besides miscellaneous noncardiovascular conditions, nonspecific chest pain (15.9%) and respiratory disorders (15.0%) were the most common reasons for ED visits among patients with simple and complex ACHD, respectively. Although there was a trend toward decrease in admissions across 2006-2012 (Ptrend < 0.001), the proportion of patients with ACHD presenting to ED requiring admission remained substantial (63.4%). Finally, there was significant variation in admission trends across different geographic locations, hospital types, insurance status, and ED volume among ACHD patients presenting to the ED. CONCLUSIONS: There has been a progressive increase in number of ED visits among ACHD patients across 2006-2012 in the United States. Moreover, the cardiovascular risk-factor profile of ACHD patients has changed, adding to complexity in management. Current health care delivery to ACHD patients also shows significant geographical, hospital-based, and insurance status-based disparities.

Impact of lean six sigma process improvement methodology on cardiac catheterization laboratory efficiency.

BACKGROUND: Operational inefficiencies are ubiquitous in several healthcare processes. To improve the operational efficiency of our catheterization laboratory (Cath Lab), we implemented a lean six sigma process improvement initiative, starting in June 2010. We aimed to study the impact of lean six sigma implementation on improving the efficiency and the patient throughput in our Cath Lab. METHODS: All elective and urgent cardiac catheterization procedures including diagnostic coronary angiography, percutaneous coronary interventions, structural interventions and peripheral interventions performed between June 2009 and December 2012 were included in the study. Performance metrics utilized for analysis included turn-time, physician downtime, on-time patient arrival, on-time physician arrival, on-time start and manual sheath-pulls inside the Cath Lab. RESULTS: After implementation of lean six sigma in the Cath Lab, we observed a significant improvement in turn-time, physician downtime, on-time patient arrival, on-time physician arrival, on-time start as well as sheath-pulls inside the Cath Lab. The percentage of cases with optimal turn-time increased from 43.6% in 2009 to 56.6% in 2012 (p-trend<0.001). Similarly, the percentage of cases with an aggregate on-time start increased from 41.7% in 2009 to 62.8% in 2012 (p-trend<0.001). In addition, the percentage of manual sheath-pulls performed in the Cath Lab decreased from 60.7% in 2009 to 22.7% in 2012 (p-trend<0.001). CONCLUSIONS: The current longitudinal study illustrates the impact of successful implementation of a well-known process improvement initiative, lean six sigma, on improving and sustaining efficiency of our Cath Lab operation. After the successful implementation of this continuous quality improvement initiative, there was a significant improvement in the selected performance metrics namely turn-time, physician downtime, on-time patient arrival, on-time physician arrival, on-time start as well as sheath-pulls inside the Cath Lab.

Nationwide Hospitalization Trends in Adult Congenital Heart Disease Across 2003-2012.

BACKGROUND: We aimed to assess trends in hospitalization, outcomes, and resource utilization among patients admitted with adult congenital heart disease (ACHD). METHODS AND RESULTS: We used the 2003-2012 US Nationwide Inpatient Sample for this study. All admissions with an ACHD were identified using standard ICD codes. Resource utilization was assessed using length of stay, invasive procedure utilization, and cost of hospitalization. There was a significant increase in the number of both simple (101%) as well as complex congenital heart disease (53%)-related admissions across 2003-2012. In addition, there was a considerable increase in the prevalence of traditional cardiovascular risk factors including older age, along with a higher prevalence of hypertension, diabetes, smoking, obesity, chronic kidney disease, and peripheral arterial disease. Besides miscellaneous causes, congestive heart failure (11.8%), valve disease (15.5%), and cerebrovascular accident (26.1%) were the top causes of admission to the hospital among patients with complex ACHD, simple ACHD without atrial septal defects/patent foramen ovale and simple atrial septal defects/patent foramen ovale patients, respectively. In-hospital mortality has been relatively constant among patients with complex ACHD as well as simple ACHD without atrial septal defects/patent foramen ovale. However, there has been considerable increase in the average length of stay and cost of hospitalization among the ACHD patients during 2003-2012. CONCLUSIONS: There has been a progressive increase in ACHD admissions across 2003-2012 in the United States, with increasing healthcare resource utilization among these patients. Moreover, there has been a change in the cardiovascular comorbidities of these patients, adding a layer of complexity in management of ACHD patients.

Gender Disparities in Outcomes and Resource Utilization for Acute Pulmonary Embolism Hospitalizations in the United States.

Current data regarding gender disparities in outcomes after acute pulmonary embolism (PE) are limited and controversial. We sought to assess the gender-specific rates and trends in treatment, outcomes, and complications after acute PE. We used the 2003 to 2011 Nationwide Inpatient Sample database for this analysis. All hospital admissions with a principal diagnosis of acute PE were identified using the International Classification of Diseases, Ninth Edition, codes. Inhospital mortality and discharge to nursing facility were co-primary outcomes of our study. Secondary outcomes included shock, transfusion of blood products, utilization of thrombolysis, inferior vena cava filter placement, and cost of hospitalization. Over a 9-year period, a total of 276,484 discharges with acute PE were identified. Compared with men, there was significantly higher inhospital mortality in women admitted with acute PE (odds ratio [OR] 1.09, 95% confidence interval [CI] 1.03 to 1.15). In addition, there was a significantly higher need for discharge to nursing facility among women compared with men (OR 1.30, 95% CI 1.27 to 1.34). Besides this, women experienced a higher need for transfusion (OR 1.38, 95% CI 1.33 to 1.44) and occurrence of shock (OR 1.10, 95% CI 1.01 to 1.18) during hospitalization. Furthermore, there was a significantly lower utilization of vena cava filters (OR 0.86, 95% CI 0.84 to 0.89) in women compared with men. Among patients in shock who were eligible for thrombolysis (age <75 years, no previous stroke, no bleeding on presentation, and not pregnant), the utilization of thrombolysis was similar between men and women (OR 1.19, 95% CI 0.93 to 1.53). Lastly, the cost of hospitalization after acute PE was significantly higher in men than women (adjusted mean difference $425, 95% CI $304 to $546). In conclusion, among patients admitted with acute PE, women tend to have more adverse outcomes and higher incidence of complications compared with men.

Length of stay and long-term mortality following ST elevation myocardial infarction.

BACKGROUND: Over the last few decades, there has been a significant reduction in hospital length of stay (LOS) among patients undergoing percutaneous intervention (PCI) for ST elevation myocardial infarction (STEMI). Although studies have looked at predictors of long hospital stay after STEMI, the impact of LOS on long-term outcomes after PCI remains unknown. We aimed to evaluate the association between LOS at the time of index hospitalization for PCI and long-term mortality among patients presenting with STEMI. METHODS: We examined all patients undergoing PCI for STEMI at the Cleveland Clinic Catheterization Laboratory between 2002 and 2011. Long-term all-cause mortality was assessed using the Social Security Death Index and electronic medical record review. LOS was extracted from the discharge summary of the index hospitalization. RESULTS: A total of 1,963 patients were included in the study. Of these 1,963 patients undergoing PCI for STEMI, 126 (6.4%) died during the index hospitalization. Among survivors of this hospitalization, we observed a significant increase in long-term mortality with an increase in LOS during index hospitalization (P < 0.001). Adjustment for demographic and clinical characteristics yielded statistically significant increased mortality among patients with LOS of 6-10 days [HR (95% CI): 2.2 (1.3-3.5)] and LOS > 10 days [HR (95% CI): 2.6 (1.6-4.3)], in comparison with patients with LOS of 1-2 days. CONCLUSIONS: Long hospital stay after PCI among patients with STEMI was associated with an increased long-term mortality. A long hospital stay may be used as a marker to identify patients at higher risk for long-term mortality.

Renin-Angiotensin System Antagonists in Patients Without Left Ventricular Dysfunction After Percutaneous Intervention for ST-Segment Elevation Myocardial Infarction.

There is a paucity of evidence on the impact of angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) on long-term outcomes in patients with ejection fraction (EF) >40% after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). We compared long-term all-cause mortality between patients with left ventricular ejection fraction (LVEF) >40% discharged on ACEi/ARB with patients who were discharged on neither of these agents. Patients discharged after percutaneous intervention for STEMI from our catheterization laboratories from January 2002 to December 2011 were considered for inclusion. Patients were excluded if they had LVEF <40% or chronic kidney disease or hypotension (systolic blood pressure <90 mm Hg any time after the procedure). Long-term mortality and discharge medications were determined using the Social Security Death Index and electronic medical record review, respectively. A total of 988 patients were included. The median follow-up duration was 4.6 years. Kaplan-Meier analysis showed no significant difference in long-term all-cause mortality in patients discharged on ACEi/ARB compared with those who were not discharged on these medications. The number needed to treat to prevent 1 death at 1 year was 714. In addition, multivariable Cox proportional hazard modeling failed to demonstrate any beneficial effect of ACEi/ARB similar to Kaplan-Meir analysis (hazard ratio 0.88, 95% confidence interval 0.57 to 1.36). In conclusion, we found no significant benefit in long-term mortality using ACEi/ARB in patients with LVEF >40% after primary percutaneous coronary intervention for STEMI.

Quantitative assessment of pericardial delayed hyperenhancement predicts clinical improvement in patients with constrictive pericarditis treated with anti-inflammatory therapy.

BACKGROUND: Delayed hyperenhancement (DHE) of the pericardium usually represents ongoing inflammation and may identify patients with constrictive pericarditis that will improve with anti-inflammatory therapy. However, a quantitative assessment of pericardial DHE has not been performed, and the hierarchical relationship among clinical factors, inflammatory markers, and pericardial DHE is unknown. METHODS AND RESULTS: We identified 41 consecutive patients with constrictive pericarditis who had a cardiovascular magnetic resonance study with DHE prior to the initiation of anti-inflammatory medications. Pericardial inflammation was quantified on short-axis DHE sequences by contouring the pericardium, selecting normal septal myocardium as a reference region, and then quantifying the pericardial signal that was >6 SD above the reference. Our primary outcome was clinical improvement with anti-inflammatory therapy. The mean age of our patients was 58 years, most patients were male (83%) with New York Heart Association Class II or III (59%) heart failure, and the median follow-up was 1 year. Chest pain, lower New York Heart Association class, higher Westergren sedimentation rates, and increased pericardial DHE were all significantly associated with clinical improvement (P<0.01 for all). When quantitative pericardial DHE was added to a model that included age, chest pain, New York Heart Association class, and Westergren sedimentation rates, the global χ(2) improved significantly (P=0.04 for DHE), and the area under the receiver operating characteristic curve was 0.96. CONCLUSIONS: In patients with constrictive pericarditis treated with anti-inflammatory therapy, a quantitative assessment of pericardial DHE can provide incremental information to predict clinical improvement when added to clinical factors and Westergren sedimentation rates.

Outcomes after acute ischemic stroke in the United States: does residential ZIP code matter?

BACKGROUND: We sought to analyze the impact of socioeconomic status (SES) on in-hospital outcomes, cost of hospitalization, and resource use after acute ischemic stroke. METHODS AND RESULTS: We used the 2003-2011 Nationwide Inpatient Sample database for this analysis. All admissions with a principal diagnosis of acute ischemic stroke were identified by using International Classification of Diseases, Ninth Revision codes. SES was assessed by using median household income of the residential ZIP code for each patient. Quartile 1 and quartile 4 reflect the lowest-income and highest-income SES quartile, respectively. During a 9-year period, 775,905 discharges with acute ischemic stroke were analyzed. There was a progressive increase in the incidence of reperfusion on the first admission day across the SES quartiles (P-trend<0.001). In addition, we observed a significant reduction in discharge to nursing facility, across the SES quartiles (P-trend<0.001). Although we did not observe a significant difference in in-hospital mortality across the SES quartiles in the overall cohort (P-trend=0.22), there was a significant trend toward reduced in-hospital mortality across the SES quartiles in younger patients (<75 years) (P-trend<0.001). The mean length of stay in the lowest-income quartile was 5.75 days, which was significantly higher compared with other SES quartiles. Furthermore, the mean adjusted cost of hospitalization among quartiles 2, 3, and 4, compared with quartile 1, was significantly higher by $621, $1238, and $2577, respectively. Compared with the lowest-income quartile, there was a significantly higher use of echocardiography, invasive angiography, and operative procedures, including carotid endarterectomy, in the highest-income quartile. CONCLUSIONS: Patients from lower-income quartiles had decreased reperfusion on the first admission day, compared with patients from higher-income quartiles. The cost of hospitalization of patients from higher-income quartiles was significantly higher than that of patients from lowest-income quartiles, despite longer hospital stays in the latter group. This might be partially attributable to a lower use of key procedures among patients from lowest-income quartile.

Trends and burden of firearm-related hospitalizations in the United States across 2001-2011.

BACKGROUND: Firearm-related hospitalizations are a major burden to the current health care infrastructure. We examined the trends in the incidence and case-fatality rates of firearm-related hospitalizations over the past decade. We also hypothesized that major national economic perturbations would be partly responsible and correlate temporally with national firearm-related hospitalization trends. METHODS: We used the 2001-2011 Nationwide Inpatient Sample for analysis. Firearm-related hospitalizations were identified using International Classification of Diseases, 9(th) Revision codes. In addition, we examined the relationship between the US stock market performance (Dow Jones Industrial Average) and the annual firearm-related hospitalization incidence rates. RESULTS: In the last decade, there has been a modest decline in firearm-related hospitalizations, interrupted by spikes in the annual incidence that closely corresponded to periods of national economic instability. In addition, the overall case-fatality rate following firearm-related hospitalization has been stable at ∼8%; the highest rates being present among those who attempted suicide using firearms. Also, there has been an increase in the prevalence of mental health disorders among individuals admitted with firearm-related injuries. Moreover, there was an increase in the length of stay and the cost/charges associated with hospitalization over the last decade. CONCLUSION: Over 2001-2011, the national incidence of firearm-related hospitalizations has closely tracked the national stock market performance, suggesting that economic perturbations and resultant insecurities might underlie the perpetuation of firearm-related injuries. Although the case-fatality rates have remained stable, the length of stay and hospitalization costs have increased, imposing additional burden on existing health care resources.

Outcomes and resource utilization in ST-elevation myocardial infarction in the United States: evidence for socioeconomic disparities.

BACKGROUND: Socioeconomic status (SES) as reflected by residential zip code status may detrimentally influence a number of prehospital clinical, access-related, and transport variables that influence outcome for patients with ST-elevation myocardial infarction (STEMI) undergoing reperfusion. We sought to analyze the impact of SES on in-hospital mortality, timely reperfusion, and cost of hospitalization following STEMI. METHODS AND RESULTS: We used the 2003-2011 Nationwide Inpatient Sample database for this analysis. All hospital admissions with a principal diagnosis of STEMI were identified using ICD-9 codes. SES was assessed using median household income of the residential zip code for each patient. There was a significantly higher mortality among the lowest SES quartile as compared to the highest quartile (OR [95% CI]: 1.11 [1.06 to 1.17]). Similarly, there was a highly significant trend indicating a progressively reduced timely reperfusion among patients from lower quartiles (OR [95% CI]: 0.80 [0.74 to 0.88]). In addition, there was a lower utilization of circulatory support devices among patients from lower as compared to higher zip code quartiles (OR [95% CI]: 0.85 [0.75 to 0.97]). Furthermore, the mean adjusted cost of hospitalization among quartiles 2, 3, and 4, as compared to quartile 1 was significantly higher by $913, $2140, and $4070, respectively. CONCLUSIONS: Patients residing in zip codes with lower SES had increased in-hospital mortality and decreased timely reperfusion following STEMI as compared to patients residing in higher SES zip codes. The cost of hospitalization of patients from higher SES quartiles was significantly higher than those from lower quartiles.

Burden of cardiovascular disease in chronic obstructive pulmonary disease.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) and atherosclerotic vascular disease share several etiopathogenic factors. PURPOSE: To compare the prevalence of self-reported cardiovascular and cerebrovascular disease (CCVD) between COPD and non-COPD subjects using the National Health and Nutrition Examination Survey (NHANES) database. Among subjects without pre-existent CCVD, the short-term and lifetime risks of future CCVD were also compared between the two groups. METHODS: Pooled NHANES 2007-2010 data were analyzed in May 2012 and April 2013. Based on predicted Framingham risk, subjects without self-reported CCVD were classified as follows: high short-term risk, low short-term/high lifetime risk, and low short-term/low lifetime risk for future CCVD. RESULTS: Estimated self-reported CCVD prevalence was 20.0% and 7.4% in COPD and non-COPD groups, respectively (p<0.001). On multivariable analysis, COPD was an independent risk factor for prevalent self-reported CCVD (prevalence ratio=1.4, 95% CI=1.1, 1.8). Among subjects without CCVD, there were significant differences in predicted future CCVD risk between the two groups. In the non-COPD group, prevalence of high short-term risk, low short-term/high lifetime risk, and low short-term/low lifetime risk was 18.9%, 62.7%, and 18.4%, respectively. In the COPD group, corresponding prevalence estimates were 35.8%, 53.2%, and 11.1%, respectively. Men and women had significantly different risk factor profiles for future CCVD. CONCLUSIONS: The prevalence of self-reported CCVD was significantly higher in subjects with COPD than in those without COPD. Among subjects without pre-existent CCVD, the risk of future CCVD was significantly higher in the COPD group than in the non-COPD group.

Significance of aortic valve calcification in patients with low-gradient low-flow aortic stenosis.

BACKGROUND: Assessment of patients with aortic stenosis (AS) and impaired left ventricular function remains challenging. Aortic valve calcium (AVC) scoring with computed tomography (CT) and fluoroscopy has been proposed as means of diagnosing and predicting outcomes in patients with severe AS. HYPOTHESIS: Severity of aortic valve calcification correlates with the diagnosis of true severe AS and outcomes in patients with low-gradient low-flow AS. METHODS: Echocardiography and CT database records from January 1, 2000 to September 26, 2009 were reviewed. Patients with aortic valve area (AVA)<1.0 cm2 who had ejection fraction (EF)≤25% and mean valvular gradient≤25 mmHg with concurrent noncontrast CT scans were included. AVC was evaluated using CT and fluoroscopy. Mortality and aortic valve replacement (AVR) were established using the Social Security Death Index and medical records. The role of surgery in outcomes was evaluated. RESULTS: Fifty-one patients who met the above criteria were included. Mean age was 75.1±9.6 years, and 15 patients were female. Mean EF was 21%±4.6% with AVA of 0.7±0.1 cm2. The peak and mean gradients were 35.5±10.6 and 19.0±5.1 mmHg, respectively. Median aortic valve calcium score was 2027 Agatston units. Mean follow-up was 908 days. Patients with calcium scores above the median value were found to have increased mortality (P=0.02). The benefit of surgery on survival was more pronounced in patients with higher valvular scores (P=0.001). Fluoroscopy scoring led to similar findings, where increased AVC predicted worse outcomes (P=0.04). CONCLUSIONS: In patients with low-gradient low-flow AS, higher valvular calcium score predicts worse long-term mortality. AVR is associated with improved survival in patients with higher valve scores.

Percutaneous coronary revascularization in coronary artery disease: lessons from a single center experience.

OBJECTIVES: To determine the role of percutaneous coronary intervention (PCI) and its impact on mortality in coronary artery disease (CAD). BACKGROUND: It's unclear whether PCI provides benefit in patients with CAD outside of acute settings. We sought to determine the role of PCI and its effect on mortality in patients with similar entry criteria to prior RCTs and compare outcomes with medical treatment. METHODS: Using institutional diagnostic catheterization database of consecutive patients undergoing coronary angiography from 1/2004 to 1/2010, we examined records for patients with a positive stress test and >70% coronary stenosis or symptoms of angina and >80% coronary stenosis. We excluded those with acute coronary syndromes, low ejection fraction (EF), history of CABG, and CABG following index catheterization. We stratified patients by treatment and performed unadjusted and propensity matched analyses. The outcome was all-cause mortality obtained from the social security death index. RESULTS: We identified 3,375 patients using study inclusion criteria. Mean age was 65 ± 11 years and 69% (n = 2,332) were men. Mean EF was 55% ± 8%. In the unadjusted cohort, 1,265 patients received medical management and 2,110 received PCI. The unadjusted analysis revealed significantly better survival in PCI patients (P < 0.0001) (HR: 0.51; 95% confidence interval (CI), 0.41-0.63). Propensity matching was performed for 1,580 patients and analysis showed better survival among patients receiving PCI (0 = 0.04) (HR: 0.74; 95% CI, 0.55-0.98). PCI continued to show better survival after excluding patients with malignancy (P = 0.03) and unstable angina (P = 0.007). CONCLUSIONS: This single center registry analysis demonstrated better survival in stable CAD patients undergoing PCI compared to medical management alone. These data suggest there may be a benefit of PCI beyond symptom relief. Future randomized trials are needed to further understand the role of PCI in broader patient populations.

Impact of diabetes on long-term mortality following multivessel percutaneous interventions: an insight into optimal statistical analysis.

BACKGROUND: Several studies have demonstrated better long-term outcomes with drug eluting stents (DES) as compared to bare metal stents (BMS) among diabetics with coronary artery disease (CAD). A significant heterogeneity exists with respect to the optimal statistical strategy to analyze stent related data. METHODS: We used our percutaneous intervention (PCI) registry to identify all diabetics with CAD, who underwent PCI on two or more vessel territories between 2003 and 2009. Long-term mortality was assessed using the social security death index. Six different analytical strategies were applied. RESULTS: A total of 1568 DES and 336 BMS interventions were encountered in 756 diabetics. Considerable differences were observed in the results between the methods applied. Generalized estimating equation (GEE) approach with an autoregressive correlation structure (GEE) was a robust method to account for the cluster structure, since the measurements taken through time on the same person were assumed to be highly correlated, if they were spaced more closely in time. Diabetics undergoing PCI with BMS had a significantly higher long-term mortality as compared to the patients undergoing DES-PCI [Hazard ratio (95% CI): 1.47 (1.04-2.09)]. CONCLUSION: There is a great potential for erroneous interpretation of PCI data due to complex spatial and temporal clustering. Use of GEE with autoregressive correlation matrix and robust variance is most optimal to account for the clustered nature of the PCI related data. Using GEE, we observed that there is a 47% (4%-119%) higher hazard for mortality among diabetics undergoing BMS-PCI as compared to diabetics undergoing DES-PCI.

Perspective on the cost-effectiveness of transapical aortic valve implantation in high-risk patients: Outcomes of a decision-analytic model.

BACKGROUND: The incremental cost-effectiveness of transapical transcatheter aortic valve implantation (TAVI) is ill-defined in high-risk patients where aortic valve replacement (AVR) is an option, and has not been ascertained outside a randomized controlled trial. METHODS: We developed a Markov model to examine the progression of patients between health states, defined as peri- and post-procedural, post-complication, and death. The mean and variance of risks, transition probabilities, utilities and cost of transapical TAVI, high-risk AVR, and medical management were derived from analysis of relevant registries. Outcome and cost were derived from 10,000 simulations. Sensitivity analyses further evaluated the impact of mortality, stroke, and other commonly observed outcomes. RESULTS: In the reference case, both transapical TAVI and high-risk AVR and TAVI were cost-effective when compared to medical management ($44,384/QALY and $42,637/QALY, respectively). Transapical TAVI failed to meet accepted criteria for incremental cost-effectiveness relative to AVR, which was the dominant strategy. In sensitivity analyses, the mortality rates related to the two strategies, the utilities post-AVR and post-transapical TAVI, and the cost of transapical TAVI, were the main drivers of model outcome. CONCLUSION: Transapical TAVI did not satisfy current metrics of incremental cost-effectiveness relative to high-risk AVR in the reference case. However, it may provide net health benefits at acceptable cost in selected high-risk patients among whom AVR is the standard intervention.

Comparison of outcomes of unprotected left main versus multivessel coronary artery interventions.

Left main coronary artery (LMCA) percutaneous coronary intervention (PCI) has emerged as an appealing alternative to bypass surgery for significant LMCA disease, especially in high-risk candidates. PCI for unprotected LMCA stenosis is currently designated a class IIb indication. Direct comparisons between unprotected LMCA PCI and multivessel PCI are lacking. We aimed to determine the incremental risk associated with unprotected LMCA PCI compared to multivessel PCI. We queried the Cleveland Clinic PCI database to identify patients who underwent unprotected LMCA PCI from 2003 through 2009 and compared these to patients undergoing multivessel PCI in the same period. Patients undergoing PCI for acute myocardial infarction were excluded. Mortality was derived using the Social Security Death Index. Short-term (≤30-day) mortality rates in the LMCA PCI group (n = 468, 1.9%) were similar to the death rate in the multivessel PCI group (n = 1,973, 1.3%, p = 0.3). There was no significant difference in adjusted mortality between the 2 study groups. Stratifying LMCA PCI by the number of concomitant vessel territories treated, there was no significant difference in mortality in any LMCA PCI category (LMCA only, LMCA + 1-vessel PCI, LMCA + multivessel PCI) compared to multivessel PCI. In conclusion, there was comparable short-term and long-term mortality in the LMCA PCI and multivessel PCI groups. LMCA stenting did not appear to incur incremental risk compared to multivessel PCI.