Satish Jacob Chacko

A Decade of Reversal: An Analysis of 146 Contradicted Medical Practices

OBJECTIVE To identify medical practices that offer no net benefits. METHODS We reviewed all original articles published in 10 years (2001-2010) in one high-impact journal. Articles were classified on the basis of whether they addressed a medical practice, whether they tested a new or existing therapy, and whether results were positive or negative. Articles were then classified as 1 of 4 types: replacement, when a new practice surpasses standard of care; back to the drawing board, when a new practice is no better than current practice; reaffirmation, when an existing practice is found to be better than a lesser standard; and reversal, when an existing practice is found to be no better than a lesser therapy. This study was conducted from August 1, 2011, through October 31, 2012. RESULTS We reviewed 2044 original articles, 1344 of which concerned a medical practice. Of these, 981 articles (73.0%) examined a new medical practice, whereas 363 (27.0%) tested an established practice. A total of 947 studies (70.5%) had positive findings, whereas 397 (29.5%) reached a negative conclusion. A total of 756 articles addressing a medical practice constituted replacement, 165 were back to the drawing board, 146 were medical reversals, 138 were reaffirmations, and 139 were inconclusive. Of the 363 articles testing standard of care, 146 (40.2%) reversed that practice, whereas 138 (38.0%) reaffirmed it. CONCLUSION The reversal of established medical practice is common and occurs across all classes of medical practice. This investigation sheds light on low-value practices and patterns of medical research.

Clinical Characteristics and Prevalence of Early Repolarization Associated With Ventricular Arrhythmias Following Acute ST-Elevation Myocardial Infarction

Early repolarization (ER) on a 12-lead electrocardiogram has recently been associated with ventricular tachyarrhythmias (VTAs) in patients without structural heart disease and in patients with healed myocardial infarction (MI). An association between ER and VTAs in the setting of acute ST-segment elevation MI (STEMI) has not been explored. In a single-center retrospective case-control design, 50 patients with STEMI complicated by VTAs (cases), defined as ventricular fibrillation, sustained ventricular tachycardia, or nonsustained ventricular tachycardia within 72 hours of the index hospitalization, were matched for age and gender with 50 subjects with STEMI without VTAs (controls). Electrocardiograms obtained an average of 1 year before STEMI were analyzed for ER pattern, defined as notching or slurring of the terminal QRS complex or J-point elevation >0.1 mV above baseline in ≥ 2 contiguous leads. A higher prevalence of ER was associated with VTAs overall in cases compared to controls (26% vs 4%, p = 0.01) and localized to anterior (16% vs 0%) and inferior (14% vs 2%, p = 0.07) leads but not lateral limb leads. Notching (10% vs 2%, p = 0.1) and J-point elevation (16% vs 0%) were more common in cases. Slurring was uncommon. ER was associated with VTAs (odds ratio [OR] 6.5, 95% confidence interval [CI] 1.5 to 28.8, p = 0.01), even after adjustment for creatine kinase-MB (OR 9.2, 95% CI 1.6 to 53.4, p = 0.01) and ejection fraction (OR 5.7, 95% CI 1.2 to 27.1, p = 0.03). In conclusion, ER is associated with VTAs in patients with STEMI even after adjustment for left ventricular ejection fraction or creatine kinas-MB levels. Larger prospective studies exploring potential associations and mechanisms of ventricular arrhythmogenesis with ER pattern are needed.

Prosthesis-patient mismatch in bovine pericardial aortic valves: Evaluation using 3 different modalities and associated medium-term outcomes

Background— The prevalence of prosthesis-patient mismatch (PPM) and its impact on survival after aortic valve replacement have not been clearly defined. Historically, the presence of PPM was identified from postoperative echocardiograms or preoperative manufacturer-provided charts, resulting in wide discrepancies. The 2009 American Society of Echocardiography (ASE) guidelines proposed an algorithmic approach to calculate PPM. This study compared PPM prevalence and its impact on survival using 3 modalities: (1) the ASE guidelines–suggested algorithm (ASE PPM); (2) the manufacturer-provided charts (M PPM); and (3) the echocardiographically measured, body surface area–indexed, effective orifice area (EOAi PPM) measurement. Methods and Results— A total of 614 patients underwent aortic valve replacement with bovine pericardial valves from 2004 to 2009 and had normal preoperative systolic function. EOAi PPM was severe if EOAi was ≤0.60 cm2/m2, moderate if EOAi was 0.60 to 0.85 cm2/m2, and absent (none) if EOAi was ≥0.85 cm2/m2. ASE PPM was severe in 22 (3.6%), moderate in 6 (1%), and absent (none) in 586 (95.4%). ASE PPM was similar to manufacturer-provided PPM ( P =1.00). ASE PPM differed significantly from EOAi PPM ( P <0.001), which identified severe mismatch in 170 (29.7%), moderate in 191 (33.4%), and absent (none) in 211 patients (36.9%). Irrespective of the PPM classification method, PPM did not adversely affect midterm survival (average follow-up, 4.1±1.8 years; median, 3.9 years; range, 0.01–8 years). There were no reoperations for PPM. Conclusions— In patients with normal systolic function undergoing bovine pericardial aortic valve replacement, the prevalence of PPM using the algorithmic-ASE approach was low and correlated well with manufacturer-provided PPM. Independent of the method of PPM assessment, PPM was not associated with medium-term mortality.Background— The prevalence of prosthesis-patient mismatch (PPM) and its impact on survival after aortic valve replacement have not been clearly defined. Historically, the presence of PPM was identified from postoperative echocardiograms or preoperative manufacturer-provided charts, resulting in wide discrepancies. The 2009 American Society of Echocardiography (ASE) guidelines proposed an algorithmic approach to calculate PPM. This study compared PPM prevalence and its impact on survival using 3 modalities: (1) the ASE guidelines–suggested algorithm (ASE PPM); (2) the manufacturer-provided charts (M PPM); and (3) the echocardiographically measured, body surface area–indexed, effective orifice area (EOAi PPM) measurement. Methods and Results— A total of 614 patients underwent aortic valve replacement with bovine pericardial valves from 2004 to 2009 and had normal preoperative systolic function. EOAi PPM was severe if EOAi was ⩽0.60 cm2/m2, moderate if EOAi was 0.60 to 0.85 cm2/m2, and absent (none) if EOAi was ≥0.85 cm2/m2. ASE PPM was severe in 22 (3.6%), moderate in 6 (1%), and absent (none) in 586 (95.4%). ASE PPM was similar to manufacturer-provided PPM (P=1.00). ASE PPM differed significantly from EOAi PPM (P<0.001), which identified severe mismatch in 170 (29.7%), moderate in 191 (33.4%), and absent (none) in 211 patients (36.9%). Irrespective of the PPM classification method, PPM did not adversely affect midterm survival (average follow-up, 4.1±1.8 years; median, 3.9 years; range, 0.01–8 years). There were no reoperations for PPM. Conclusions— In patients with normal systolic function undergoing bovine pericardial aortic valve replacement, the prevalence of PPM using the algorithmic-ASE approach was low and correlated well with manufacturer-provided PPM. Independent of the method of PPM assessment, PPM was not associated with medium-term mortality.

Prosthesis-Patient Mismatch in Bovine Pericardial Aortic ValvesClinical Perspective

Background— The prevalence of prosthesis-patient mismatch (PPM) and its impact on survival after aortic valve replacement have not been clearly defined. Historically, the presence of PPM was identified from postoperative echocardiograms or preoperative manufacturer-provided charts, resulting in wide discrepancies. The 2009 American Society of Echocardiography (ASE) guidelines proposed an algorithmic approach to calculate PPM. This study compared PPM prevalence and its impact on survival using 3 modalities: (1) the ASE guidelines–suggested algorithm (ASE PPM); (2) the manufacturer-provided charts (M PPM); and (3) the echocardiographically measured, body surface area–indexed, effective orifice area (EOAi PPM) measurement. Methods and Results— A total of 614 patients underwent aortic valve replacement with bovine pericardial valves from 2004 to 2009 and had normal preoperative systolic function. EOAi PPM was severe if EOAi was ≤0.60 cm2/m2, moderate if EOAi was 0.60 to 0.85 cm2/m2, and absent (none) if EOAi was ≥0.85 cm2/m2. ASE PPM was severe in 22 (3.6%), moderate in 6 (1%), and absent (none) in 586 (95.4%). ASE PPM was similar to manufacturer-provided PPM ( P =1.00). ASE PPM differed significantly from EOAi PPM ( P <0.001), which identified severe mismatch in 170 (29.7%), moderate in 191 (33.4%), and absent (none) in 211 patients (36.9%). Irrespective of the PPM classification method, PPM did not adversely affect midterm survival (average follow-up, 4.1±1.8 years; median, 3.9 years; range, 0.01–8 years). There were no reoperations for PPM. Conclusions— In patients with normal systolic function undergoing bovine pericardial aortic valve replacement, the prevalence of PPM using the algorithmic-ASE approach was low and correlated well with manufacturer-provided PPM. Independent of the method of PPM assessment, PPM was not associated with medium-term mortality.Background— The prevalence of prosthesis-patient mismatch (PPM) and its impact on survival after aortic valve replacement have not been clearly defined. Historically, the presence of PPM was identified from postoperative echocardiograms or preoperative manufacturer-provided charts, resulting in wide discrepancies. The 2009 American Society of Echocardiography (ASE) guidelines proposed an algorithmic approach to calculate PPM. This study compared PPM prevalence and its impact on survival using 3 modalities: (1) the ASE guidelines–suggested algorithm (ASE PPM); (2) the manufacturer-provided charts (M PPM); and (3) the echocardiographically measured, body surface area–indexed, effective orifice area (EOAi PPM) measurement. Methods and Results— A total of 614 patients underwent aortic valve replacement with bovine pericardial valves from 2004 to 2009 and had normal preoperative systolic function. EOAi PPM was severe if EOAi was ⩽0.60 cm2/m2, moderate if EOAi was 0.60 to 0.85 cm2/m2, and absent (none) if EOAi was ≥0.85 cm2/m2. ASE PPM was severe in 22 (3.6%), moderate in 6 (1%), and absent (none) in 586 (95.4%). ASE PPM was similar to manufacturer-provided PPM (P=1.00). ASE PPM differed significantly from EOAi PPM (P<0.001), which identified severe mismatch in 170 (29.7%), moderate in 191 (33.4%), and absent (none) in 211 patients (36.9%). Irrespective of the PPM classification method, PPM did not adversely affect midterm survival (average follow-up, 4.1±1.8 years; median, 3.9 years; range, 0.01–8 years). There were no reoperations for PPM. Conclusions— In patients with normal systolic function undergoing bovine pericardial aortic valve replacement, the prevalence of PPM using the algorithmic-ASE approach was low and correlated well with manufacturer-provided PPM. Independent of the method of PPM assessment, PPM was not associated with medium-term mortality.

Prosthesis-Patient Mismatch in Bovine Pericardial Aortic ValvesClinical Perspective: Evaluation Using 3 Different Modalities and Associated Medium-Term Outcomes

Background— The prevalence of prosthesis-patient mismatch (PPM) and its impact on survival after aortic valve replacement have not been clearly defined. Historically, the presence of PPM was identified from postoperative echocardiograms or preoperative manufacturer-provided charts, resulting in wide discrepancies. The 2009 American Society of Echocardiography (ASE) guidelines proposed an algorithmic approach to calculate PPM. This study compared PPM prevalence and its impact on survival using 3 modalities: (1) the ASE guidelines–suggested algorithm (ASE PPM); (2) the manufacturer-provided charts (M PPM); and (3) the echocardiographically measured, body surface area–indexed, effective orifice area (EOAi PPM) measurement. Methods and Results— A total of 614 patients underwent aortic valve replacement with bovine pericardial valves from 2004 to 2009 and had normal preoperative systolic function. EOAi PPM was severe if EOAi was ≤0.60 cm2/m2, moderate if EOAi was 0.60 to 0.85 cm2/m2, and absent (none) if EOAi was ≥0.85 cm2/m2. ASE PPM was severe in 22 (3.6%), moderate in 6 (1%), and absent (none) in 586 (95.4%). ASE PPM was similar to manufacturer-provided PPM ( P =1.00). ASE PPM differed significantly from EOAi PPM ( P <0.001), which identified severe mismatch in 170 (29.7%), moderate in 191 (33.4%), and absent (none) in 211 patients (36.9%). Irrespective of the PPM classification method, PPM did not adversely affect midterm survival (average follow-up, 4.1±1.8 years; median, 3.9 years; range, 0.01–8 years). There were no reoperations for PPM. Conclusions— In patients with normal systolic function undergoing bovine pericardial aortic valve replacement, the prevalence of PPM using the algorithmic-ASE approach was low and correlated well with manufacturer-provided PPM. Independent of the method of PPM assessment, PPM was not associated with medium-term mortality.Background— The prevalence of prosthesis-patient mismatch (PPM) and its impact on survival after aortic valve replacement have not been clearly defined. Historically, the presence of PPM was identified from postoperative echocardiograms or preoperative manufacturer-provided charts, resulting in wide discrepancies. The 2009 American Society of Echocardiography (ASE) guidelines proposed an algorithmic approach to calculate PPM. This study compared PPM prevalence and its impact on survival using 3 modalities: (1) the ASE guidelines–suggested algorithm (ASE PPM); (2) the manufacturer-provided charts (M PPM); and (3) the echocardiographically measured, body surface area–indexed, effective orifice area (EOAi PPM) measurement. Methods and Results— A total of 614 patients underwent aortic valve replacement with bovine pericardial valves from 2004 to 2009 and had normal preoperative systolic function. EOAi PPM was severe if EOAi was ⩽0.60 cm2/m2, moderate if EOAi was 0.60 to 0.85 cm2/m2, and absent (none) if EOAi was ≥0.85 cm2/m2. ASE PPM was severe in 22 (3.6%), moderate in 6 (1%), and absent (none) in 586 (95.4%). ASE PPM was similar to manufacturer-provided PPM (P=1.00). ASE PPM differed significantly from EOAi PPM (P<0.001), which identified severe mismatch in 170 (29.7%), moderate in 191 (33.4%), and absent (none) in 211 patients (36.9%). Irrespective of the PPM classification method, PPM did not adversely affect midterm survival (average follow-up, 4.1±1.8 years; median, 3.9 years; range, 0.01–8 years). There were no reoperations for PPM. Conclusions— In patients with normal systolic function undergoing bovine pericardial aortic valve replacement, the prevalence of PPM using the algorithmic-ASE approach was low and correlated well with manufacturer-provided PPM. Independent of the method of PPM assessment, PPM was not associated with medium-term mortality.

Prosthesis-Patient Mismatch in Bovine Pericardial Aortic Valves: Evaluation Using Three Different Modalities and Associated Medium Term Outcomes

Background— The prevalence of prosthesis-patient mismatch (PPM) and its impact on survival after aortic valve replacement have not been clearly defined. Historically, the presence of PPM was identified from postoperative echocardiograms or preoperative manufacturer-provided charts, resulting in wide discrepancies. The 2009 American Society of Echocardiography (ASE) guidelines proposed an algorithmic approach to calculate PPM. This study compared PPM prevalence and its impact on survival using 3 modalities: (1) the ASE guidelines–suggested algorithm (ASE PPM); (2) the manufacturer-provided charts (M PPM); and (3) the echocardiographically measured, body surface area–indexed, effective orifice area (EOAi PPM) measurement. Methods and Results— A total of 614 patients underwent aortic valve replacement with bovine pericardial valves from 2004 to 2009 and had normal preoperative systolic function. EOAi PPM was severe if EOAi was ≤0.60 cm2/m2, moderate if EOAi was 0.60 to 0.85 cm2/m2, and absent (none) if EOAi was ≥0.85 cm2/m2. ASE PPM was severe in 22 (3.6%), moderate in 6 (1%), and absent (none) in 586 (95.4%). ASE PPM was similar to manufacturer-provided PPM ( P =1.00). ASE PPM differed significantly from EOAi PPM ( P <0.001), which identified severe mismatch in 170 (29.7%), moderate in 191 (33.4%), and absent (none) in 211 patients (36.9%). Irrespective of the PPM classification method, PPM did not adversely affect midterm survival (average follow-up, 4.1±1.8 years; median, 3.9 years; range, 0.01–8 years). There were no reoperations for PPM. Conclusions— In patients with normal systolic function undergoing bovine pericardial aortic valve replacement, the prevalence of PPM using the algorithmic-ASE approach was low and correlated well with manufacturer-provided PPM. Independent of the method of PPM assessment, PPM was not associated with medium-term mortality.Background— The prevalence of prosthesis-patient mismatch (PPM) and its impact on survival after aortic valve replacement have not been clearly defined. Historically, the presence of PPM was identified from postoperative echocardiograms or preoperative manufacturer-provided charts, resulting in wide discrepancies. The 2009 American Society of Echocardiography (ASE) guidelines proposed an algorithmic approach to calculate PPM. This study compared PPM prevalence and its impact on survival using 3 modalities: (1) the ASE guidelines–suggested algorithm (ASE PPM); (2) the manufacturer-provided charts (M PPM); and (3) the echocardiographically measured, body surface area–indexed, effective orifice area (EOAi PPM) measurement. Methods and Results— A total of 614 patients underwent aortic valve replacement with bovine pericardial valves from 2004 to 2009 and had normal preoperative systolic function. EOAi PPM was severe if EOAi was ⩽0.60 cm2/m2, moderate if EOAi was 0.60 to 0.85 cm2/m2, and absent (none) if EOAi was ≥0.85 cm2/m2. ASE PPM was severe in 22 (3.6%), moderate in 6 (1%), and absent (none) in 586 (95.4%). ASE PPM was similar to manufacturer-provided PPM (P=1.00). ASE PPM differed significantly from EOAi PPM (P<0.001), which identified severe mismatch in 170 (29.7%), moderate in 191 (33.4%), and absent (none) in 211 patients (36.9%). Irrespective of the PPM classification method, PPM did not adversely affect midterm survival (average follow-up, 4.1±1.8 years; median, 3.9 years; range, 0.01–8 years). There were no reoperations for PPM. Conclusions— In patients with normal systolic function undergoing bovine pericardial aortic valve replacement, the prevalence of PPM using the algorithmic-ASE approach was low and correlated well with manufacturer-provided PPM. Independent of the method of PPM assessment, PPM was not associated with medium-term mortality.