Consensus document: management of heart failure in type 2 diabetes mellitus.

Type 2 diabetes mellitus (T2DM) is a known predisposing factor for heart failure (HF). The growing burden of these two conditions and their impact on health of the individual and on society in general needs urgent attention from the health care professionals. Availability of multiple treatment choices for managing T2DM and HF may make therapeutic decisions more complex for clinicians. Recent cardiovascular outcome trials of antidiabetic drugs have added very robust evidence to effectively manage subjects with this dual condition. This consensus statement provides the prevalence trends and the impact of this dual burden on patients. In addition, it concisely narrates the types of HF, the different treatment algorithms, and recommendations for physicians to comprehensively manage such patients.

Validation of the OPtimal Treatment of Angina (OPTA) Questionnaire in Indian Patients with Chronic Stable Angina.

BACKGROUND: A rising burden of coronary artery disease (CAD) in India is a major cause of concern, with angina being the leading manifestation. Hence a questionnaire to sensitize the clinicians about stable angina management and to assist in risk stratification is imperative. OBJECTIVE: To evaluate the content and face validity of a modified questionnaire adapted from the 7-item Seattle Angina Questionnaire (SAQ). MATERIALS AND METHODS: A panel of six experts in the field of evidence-based practice reviewed and rated the modified instrument for content clarity and relevance based on the 4-point ordinal scale. Face validity was assessed based on the trichotomous rating of "disagreed", "agree" or "neutral". Items on which ≥75% of patients "disagreed" were subjected to further review and revision. RESULTS: A total of six experts and 51 patients participated in the content and face validity, respectively. As no question received a score ≤2 by two or more experts for either content clarity or relevance, no modification in the questionnaire was required post content validation. During face validation, all patients agreed that the questions correctly measured the specific area of cardiovascular health status and response options correctly captured the answers provided. Demographic and baseline data of the patients were collected. CONCLUSION: The newly developed 5-item questionnaire demonstrated content and face validity, suggesting it to be a potential instrument to improve management decision and care of angina patients in India.

Asymptomatic chronic traumatic aortic valve perforation with severe aortic regurgitation.

Here, we present a young asymptomatic male patient incidentally diagnosed to have aortic regurgitation (AR). The patient had a history of a blunt trauma to the thorax two years back but did never have any symptoms. Transthoracic echocardiography showed a moderately dilated left ventricle with normal systolic function and severe AR with normal nondilated aortic root and tri-leaflet aortic valve. To diagnose the etiology of the AR, a transesophageal echocardiogram (TEE) was done, which revealed a perforation in the nonadjacent leaflet (NAL) and confirmed severe AR with two AR jets being clearly visualized, one through the point of incomplete coaptation and other one through the perforated area in the NAL. The patient was treated with aortic valve replacement and was doing well on follow-up.

Digital Health Solutions: An Important Tool in Patient Engagement.

Hospitals and health systems are facing increased pressure to improve quality and outcomes while reducing expense. Quality-based reimbursement models are providing the necessary incentives for health care institutions to focus on issues such as avoidable hospital-acquired conditions and 30-day readmission rates. While our health care facilities certainly play a vital role in achieving optimal outcomes, patient engagement remains at the center of these efforts.

Clinical and Business Intelligence: Why It's Important to Your Pharmacy.

According to the Healthcare Information Management and Systems Society, "Clinical & Business Intelligence (C&BI) is the use and analysis of data captured in the healthcare setting to directly inform decision-making" (http://www.himss.org/library/clinical-business-intelligence). Some say that it is the right information given to the right person at the right time in the right way. No matter how you define it, the fact remains that timely access, synthesis, and visualization of clinical data have become key to how health professionals make patient care decisions and improve care delivery.

Effectiveness and safety of optical coherence tomography-guided PCI in Indian patients with complex lesions: A multicenter, prospective registry.

BACKGROUND: Optical coherence tomography (OCT) is reported to be a feasible and safe imaging modality for the guidance of percutaneous coronary intervention (PCI) of complex lesions. METHODS: This multicenter, prospective registry assessed the minimum stent area (MSA) achieved under OCT guidance. A performance goal of 24% improvement in MSA over and above the recommendation set by the European Association of Percutaneous Cardiovascular Interventions Consensus 2018 (4.5 mm2 MSA for non-left main and 3.5 mm2 for small vessels). The incidence of contrast-induced nephropathy was also assessed. Core lab analysis was conducted. RESULTS: Five hundred patients (average age: 59.4 ± 10.1 years; 83% males) with unstable angina (36.8%), NSTEMI (26.4%), and STEMI (22%) were enrolled. The primary endpoint was achieved in 93% of lesions with stent diameter ≥2.75 mm (average MSA: 6.44 mm2) and 87% of lesions with stent diameter ≤2.5 mm (average MSA: 4.56 mm2). The average MSA (with expansion ≥80% cutoff) was 6.63 mm2 and 4.74 mm2 with a stent diameter ≥2.75 mm and ≤2.5 mm, respectively. According to the core lab analysis, the average MSA achieved with a stent diameter ≥2.75 mm and ≤2.5 mm was 6.23 mm2 and 3.95 mm2, respectively (with expansion ≥80% cutoff). Clinically significant serum creatinine was noted in two patients (0.45%). Major adverse cardiac events at 1 year were noted in 1.2% (n = 6) of the patients; all were cardiac deaths. CONCLUSION: PCI under OCT guidance improves procedural and long-term clinical outcomes in patients with complex lesions not just in a controlled trial environment but also in routine clinical practice.

ACEI-induced cough: A review of current evidence and its practical implications for optimal CV risk reduction.

Cough is one of the common adverse effects in patients receiving angiotensin-converting enzyme inhibitors (ACEIs). This review presents the current evidence on incidence and mechanisms of cough associated with ACEIs use, and proposes a practical approach for managing the same for optimal cardiovascular (CV) risk reduction. The incidence of dry cough in patients receiving ACEIs vary among individual ACEIs, and is the lowest with perindopril. Cough is thought to originate from multiple mechanisms, bradykinin theory is the most commonly appealed hypothesis. The strategies for optimal management could be temporarily discontinuation of ACEI upon a reported incidence of cough and reintroduction after its remission. However, studies have reported disappearance of cough despite continuing treatment. Another important approach could be adding calcium channel blockers to ACEIs. Switching to alternative drugs such as angiotensin receptor blockers should be suggested in case intolerable symptoms recur and after exclusion of all other possible causes of cough.

Self-blood pressure measurement as compared to office blood pressure measurement in a large Indian population; the India Heart Study.

OBJECTIVE: India Heart Study (IHS) is aimed at investigating the agreement between office blood pressure measurement (OBPM) and self (S)BPM in a hypertension-naive population. METHODS: A total of 18 918 individuals (aged 42.6 ±â€Š11.7 years, 62.7% men), visiting 1237 primary care physicians across India, underwent OBPM. They performed SBPM for a period of 1 week using a validated oscillometric BP monitor that was preprogrammed to adhere to a guideline-based SBPM-schedule and blinded to the results. Thereafter, individuals underwent a second OBPM. Available laboratory results were obtained. Thresholds for elevated OBPM and SBPM were 140/90 and 135/85 mmHg, respectively. RESULTS: On the basis of first-visit OBPM and SBPM, there were 5787 (30.6%) individuals with normotension; 5208 (27.5%) with hypertension; 4485 (23.7%) with white-coat hypertension (WCH) and 3438 (18.2%) with masked hypertension. Thus, a diagnosis contradiction between SBPM and first-visit OBPM was seen in 9870 (41.9%) individuals. On the basis of second-visit OBPM, the normotension, hypertension, WCH and masked hypertension prevalence values were 7875 (41.6%); 4857 (25.7%); 2397 (12.7%) and 3789 (20.0%). There was poor agreement (kappa value 0.37) between OBPM of visit 1 and 2 with a diagnosis difference in 6027 (31.8%) individuals. The majority of masked hypertension and WCH individuals had BP values close to thresholds. CONCLUSION: There was a poor agreement between OBPM of visit1 and visit 2. Likewise, the agreement between OBPM at both visits and SBPM was poor. SBPM being considered to have a better correlation with patient prognosis should be the preferred method for diagnosing hypertension.

Safety and efficacy of indigenously developed and manufactured bivalirudin in moderate/high-risk Indian patients undergoing percutaneous coronary intervention: the Bivaflo Registry.

BACKGROUND: Current treatment strategies for percutaneous coronary intervention (PCI) and acute coronary syndrome (ACS) include concomitant use of glycoprotein IIb/IIIa inhibitors (GPI) and antithrombotic therapy such as aspirin, clopidogrel, and unfractionated or low-molecular-weight heparin. The "direct thrombin inhibitor" bivalirudin has been associated with better efficacy and safety than heparin. OBJECTIVE: The present study is performed to evaluate the safety and efficacy of an indigenously developed and manufactured bivalirudin (Bivaflo; Sun Pharmaceutical Industries Ltd., Mumbai) as the primary anticoagulation strategy during PCI in moderate-high risk patients with only provisional use of GPI. METHODS: This prospective multicentered registry enrolled 439 patients in 11 tertiary care centers across India. Patients who had ACS or other clinical/angiographic characteristics, which increase risk during PCI, were enrolled in the registry. Bivaflo was administered as a bolus dose of 0.75 mg/kg, followed by infusion at a rate of 1.75 mg/kg/h during the procedure and optionally 0.25 mg/kg/h for 4 hours after the procedure at investigator's discretion. GPI use was discouraged except as bailout. The primary endpoints were composite and individual incidences of death, myocardial infarction (MI), urgent revascularization, subacute stent thrombosis (SAT), or bleeding at day 7/hospital discharge, whichever was earlier. The secondary endpoints were 30-day composite and individual incidences of death, MI, urgent revascularization, and SAT. RESULTS: The mean age of the group was 58 +/- 10 years and 83% were males. Bivaflo was administered for a mean duration of 102 +/- 79 minutes, and 65% patients received Bivaflo infusion post-PCI. ACT values measured at 10 minutes after bolus and at the end of the PCI were found to be 339 +/- 110 and 336 +/- 104 seconds, respectively. GPI was provisionally used in only 4% (16) patients mostly due to new or suspected thrombus and obstructive dissection with decreased flow. At day 7/hospital discharge, there were no incidences of major adverse cardiac events or major bleeding. Minor bleeding occurred in only 4 patients (0.9%). The 30-day composite major adverse cardiac event rate was 0.68%. One death and two subacute thrombosis occurred during the 30-day follow-up. CONCLUSION: Bivaflo is safe and effective sole anticoagulation strategy during PCI of moderate-high risk patients. Bivaflo administration was associated with no major bleeding events and extremely low in hospital and 30-day MACE rate. These rates were lower than expected MACE rates for such a subgroup of patients based on historical controls.

Transradial access for coronary diagnostic and interventional procedures: Consensus statement and recommendations for India: Advancing Complex CoronariES Sciences through TransRADIAL intervention in India - ACCESS RADIAL™: Clinical consensus recommendations in collaboration with Cardiological Society of India (CSI).

Radial access for cardiac catheterization and intervention in India has been growing steadily over the last decade with favorable clinical outcomes. However, its usage by interventional cardiologists varies greatly among Indian operators and hospitals due to large geographic disparities in health care delivery systems and practice patterns. It also remains unclear whether the advantages, as well as limitations of transradial (TR) intervention (as reported in the western literature), are applicable to developing countries like India or not. An evidence-based review involving various facets of radial procedure for cardiac catheterization, including practical, patient-related and technical issues was conducted by an expert committee that formed a part of Advancing Complex CoronariES Sciences through TransRADIAL intervention (ACCESS RADIAL™) Advisory Board. Emerging challenges in redefining TR management based on evidence supporting practices were discussed to formulate these final recommendations through consensus.

Impact of Displaying Inpatient Pharmaceutical Costs at the Time of Order Entry: Lessons From a Tertiary Care Center.

BACKGROUND: A lack of cost-conscious medication use is a major contributor to excessive healthcare expenditures in the inpatient setting. Expensive medicines are often utilized when there are comparable alternatives available at a lower cost. Increasing prescriber awareness of medication cost at the time of ordering may help promote cost-conscious use of medications in the hospital. OBJECTIVE: To evaluate the impact of cost messaging on the ordering of 9 expensive medications. DESIGN: Retrospective analysis of an institutional cost-transparency initiative. SETTING: A 1145-bed, tertiary care, academic medical center. PARTICIPANTS: Prescribers who ordered medications through the computerized provider order entry system at the Johns Hopkins Hospital. METHODS: Interrupted time series and segmented regression models were used to examine prescriber ordering before and after implementation of cost messaging for 9 highcost medications. RESULTS: Following the implementation of cost messaging, no significant changes were observed in the number of orders or ordering trends for intravenous (IV) formulations of eculizumab, calcitonin, levetiracetam, linezolid, mycophenolate, ribavirin, and levothyroxine. An immediate and sustained reduction in medication utilization was seen in 2 drugs that underwent a policy change during our study, IV pantoprazole and oral voriconazole. IV pantoprazole became restricted at our facility due to a national shortage (-985 orders per 10,000 patient days; 𝑃 < 0.001), and oral voriconazole was replaced with an alternative antifungal in oncology order sets (-110 orders per 10,000 patient days; 𝑃 = 0.001). CONCLUSIONS: Prescriber cost transparency alone did not significantly influence medication utilization at our institution. Active strategies to reduce ordering resulted in dramatic reductions in ordering.

Paclitaxel-eluting stents versus everolimus-eluting coronary stents in a diabetic population: two-year follow-up of the TUXEDO-India trial.

AIMS: The aim of this study was to report whether the superiority of the everolimus-eluting stent (EES) vs. the paclitaxel-eluting stent (PES) at one-year follow-up in the Taxus Element versus Xience Prime in a Diabetic Population (TUXEDO)-India trial was sustained at longer-term follow-up. METHODS AND RESULTS: One thousand eight hundred and thirty (1,830) patients with diabetes mellitus and coronary artery disease were randomised to EES vs. PES. Follow-up data up to two years were available in 1,701 (92.9%) patients. The primary endpoint was target vessel failure (TVF), defined as the composite of cardiac death, target vessel myocardial infarction (TV-MI), or ischaemia-driven target vessel revascularisation (TVR). Treatment with EES had a lower two-year rate of TVF (4.3% vs. 6.6%, p=0.03). Of the secondary endpoints, EES significantly reduced any MI (1.6% vs. 3.5%, p=0.01), TV-MI (0.7% vs. 3.1%, p=0.0001), ST (0.4% vs. 2.2%, p=0.001), cardiac death or target vessel MI (2.9% vs. 4.8%, p=0.04) and TLR (1.9% vs. 3.7%, p=0.02), compared with PES. Between one year and two years, no significant differences in the clinical outcomes were observed (pinteraction >0.05). CONCLUSIONS: In this adequately powered trial, the benefits of EES vs. PES in a diabetic population seen at one year were maintained at two years.

National survey of dietary supplement policies in acute care facilities.

PURPOSE: Policies on the use of dietary supplements in acute care facilities were studied. METHODS: A national online survey was conducted in 2004 to determine institutional policies and practices related to the use of dietary supplements. Directors of pharmacy in acute care settings were asked about the role of the pharmacy and therapeutics committee, the use of a nonformulary request process, the use of informed consent, requirements for written orders, mechanisms to identify dietary supplements, recording of supplement use in the pharmacy database, recording of supplement use in the medication administration record, prohibitions on dietary supplement use, storage of dietary supplements, reporting of adverse events, and the use of published references. RESULTS: Usable responses were received from 302 (25.4%) of 1189 pharmacy directors. Policies on dietary supplements were developed and implemented in 62% of facilities, with 38% of respondents indicating that no such policy existed. Policies most commonly required a written order by an authorized prescriber, documentation of use in the medication administration record, and a mechanism for identification of dietary supplements by a health care practitioner prior to use. Thirty percent of respondents with policies reported that they prohibited dietary supplement use, and 9% of those without policies prohibited use in practice. Most institutions allowed the use of a patient's own supply of supplements if ordered by an authorized prescriber. Supplements were most commonly stored at the nurses' station or in a patient drawer. The most commonly used reference was the Internet. Pharmacists had concerns about the consistency of dietary supplement formulations, the lack of FDA review of supplements, and the difficulty of identifying supplements and distinguishing reputable manufacturers. CONCLUSION: A survey of pharmacy directors in acute care facilities revealed that many had no formal policy regarding dietary supplements and had not implemented planning for such a policy.

Total arterial anaortic off-pump coronary artery bypass grafting in a patient with heart failure - Case report.

A 69-year-old male diabetic patient of heart failure underwent successful off-pump coronary artery bypass grafting (CABG) using both internal thoracic arteries and left radial artery. There was improvement of left ventricular ejection fraction within 4 days. This is the first ever case report of off-pump CABG in a heart failure patient.

Percutaneous Coronary Intervention in Patients With Insulin-Treated and Non-Insulin-Treated Diabetes Mellitus: Secondary Analysis of the TUXEDO Trial.

IMPORTANCE: Prior studies have shown that patients with insulin-treated diabetes mellitus (ITDM) have a higher risk of cardiovascular events. However, this finding is controversial, as other studies have shown that the increased risk of cardiovascular events disappears after risk adjustment. In addition, the choice of a drug-eluting stent (limus- vs taxol-eluting) in ITDM is controversial, with studies showing worse outcomes with an everolimus-eluting stent compared with a paclitaxel-eluting stent. OBJECTIVES: To assess the outcomes of patients with ITDM vs non-ITDM who underwent percutaneous coronary intervention and to assess the efficacy and safety of an everolimus-eluting stent vs a paclitaxel-eluting stent based on insulin use status. DESIGN, SETTING, AND PARTICIPANTS: A prespecified analysis was conducted of the Taxus Element vs Xience Prime in a Diabetic Population (TUXEDO) clinical trial, which enrolled 1830 patients with ITDM and non-ITDM from June 23, 2011, to March 12, 2014. Patients were randomized 1:1 to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. MAIN OUTCOMES AND MEASURES: The primary end point was target vessel failure, defined as the composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target vessel revascularization at 1 year after the intervention. RESULTS: Among the 1830 patients (1377 male) in the TUXEDO trial, 747 patients (40.8%) were receiving insulin (ITDM group). Compared with the 1083 patients with non-ITDM, those with ITDM had a significant increase in target vessel failure (42 [5.6%] vs 36 [3.3%]; P = .02), death or myocardial infarction (43 [5.8%] vs 35 [3.2%]; P = .009), death (26 [3.5%] vs 18 [1.7%]; P = .01), and subacute stent thrombosis (8 [1.1%] vs 3 [0.3%]; P = .03). However, in a propensity score-adjusted analysis to account for baseline differences between the 2 groups, the differences in outcomes were no longer significant. In patients with ITDM, everolimus-eluting stents reduced the rate of target vessel failure (13 of 382 [3.4%] vs 29 of 365 [7.9%]; P = .007), major adverse cardiac events (15 of 382 [3.9%] vs 30 of 365 [8.2%]; P = .01), myocardial infarction (5 of 382 [1.3%] vs 16 of 365 [4.4%]; P = .01), stent thrombosis (2 of 382 [0.5%] vs 11 of 365 [3.0%]; P = .009), target lesion revascularization (4 of 382 [1.0%] vs 19 of 365 [5.2%]; P = .001), and target vessel revascularization (4 of 382 [1.0%] vs 19 of 365 [5.2%]; P = .001) when compared with paclitaxel-eluting stents. The results largely trended in the same direction in patients with non-ITDM (P > .05 for the interaction). CONCLUSIONS AND RELEVANCE: Patients with ITDM had a significant increase in the risk of cardiovascular events in unadjusted models that was largely attenuated after propensity score adjustment. Everolimus-eluting stents reduced the rate of cardiovascular events, including stent thrombosis, when compared with paclitaxel-eluting stents in patients with ITDM. TRIAL REGISTRATION: ctri.nic.in Identifier: CTRI/2011/06/001830.

Time to shift from contemporary to high-sensitivity cardiac troponin in diagnosis of acute coronary syndromes.

Early rule-in and rule-out of non-ST-segment elevation myocardial infarction (NSTEMI) is a challenge. In patients with inconclusive findings on ECG, cardiac biomarkers play a crucial role in the diagnosis. The introduction of the new high-sensitive cardiac troponin test (hs-TnI assay) has changed the landscape of NSTEMI diagnosis. The new hs-TnI assay can detect troponin values at a lower level compared with a contemporary cardiac troponin (cTn) assay. The hs-cTnI assay has a coefficient of variation of ≤10%, well below the 99th percentile value. It reduces the time to diagnose acute myocardial infarction from 6h to 3h. A recent study has demonstrated that hs-cTnI can further reduce the time to 1h in 70% of all patients with chest pain. The European Society of Cardiology 2015 guidelines recommend including a second sample of hs-cTnI within 3h of presentation This increases the sensitivity of the hs-TnI assay from 82.3% (at admission) to 98.2% and negative predictive value from 94.7% (at admission) to 99.4%. Combining the 99th percentile at admission with serial changes in troponin increases the positive predictive value to rule in acute coronary syndrome from 75.1% at admission to 95.8% after 3h. The 2015 ESC Guidelines recommend the use of a rapid rule out protocol (0h and 1h) when hs-cTnI with a validated 0 to1h algorithm is available. Training and displaying the clinical algorithm depicting the role of hs-TnI assay in acute cardiac care units and in EDs are an efficient way to deliver the new standard of care to patients. Compared with contemporary troponin assays, the hs-cTn assay accelerates the diagnostic pathway to 0-1h, thus reducing the time for diagnosis of NSTEMI and hence, its management.

The nuances of atherogenic dyslipidemia in diabetes: focus on triglycerides and current management strategies.

Diabetes mellitus (DM) is a pandemic disease and an important cardiovascular (CV) risk factor. The atherogenic dyslipidemia in diabetes (ADD) is characterized by high serum triglycerides, high small dense LDL levels, low HDL levels and postprandial lipemia. Insulin resistance is a primary cause for ADD. Though statins are highly effective for CVD prevention in DM but a significant residual CV risk remains even after optimal statin therapy. Fibrates, niacin and omega-3 fatty acids are used in addition to statin for treatment of ADD (specifically hypertriglyceridemia). All these drugs have some limitations and they are far from being ideal companions of statins. Many newer drugs are in pipeline for management of ADD. Dual PPAR α/γ agonists are in most advanced stage of clinical development and they have a rational approach as they control blood glucose levels (by reducing insulin resistance, a primary factor for ADD) in addition to modulating ADD. Availability of dual PPAR α/γ agnosits and other drugs for ADD management may improve CV outcomes and decrease morbidity and mortality in diabetic patients in future.