Sunday, February 3, 2019

Revisiting 2018 clinical practice guidelines: ESC Syncope guidelines




The European Society of Cardiology (ESC) guidelines on syncope say that the challenge for doctors is to identify the small number of patients in whom syncope is caused by a potentially life-threatening heart problem. ESC also recommends that intermediate or high risk patients should be evaluated in the emergency department or an outpatient syncope clinic. These guidelines were released in March 2018.

Syncope has been defined in the guidelines as “transient loss of consciousness (TLOC) due to cerebral hypoperfusion, characterized by a rapid onset, short duration, and spontaneous complete recovery”.

TLOC has been defined as “a state of real or apparent LOC with loss of awareness, characterized by amnesia for the period of unconsciousness, abnormal motor control, loss of responsiveness, and a short duration”.

The initial evaluation of syncope should answer four key questions.

  • Was the event TLOC?
  • In it is a TLOC, is it syncopal or non-syncopal?
  • In case of suspected syncope, is there a clear etiological diagnosis?
  • Is there evidence to suggest a high risk of cardiovascular events or death?

The initial diagnostic evaluation should comprise of careful history taking, physical examination (BP, both supine and standing) and standard ECG. The findings from the initial evaluation will direct further diagnostic evaluation via echocardiography, immediate ECG monitoring, head-up tilt testing, carotid sinus massage, electrophysiology studies.

Blood tests should be performed when clinically indicated such as,

  • Hematocrit or hemoglobin when hemorrhage is suspected
  • Oxygen saturation and blood gas analysis when hypoxia is suspected
  • Troponin when cardiac ischemia-related syncope is suspected
  • D-dimer when pulmonary embolism is suspected

Management depends on evaluation of the patient in the emergency department, which should address the following questions:

  • Is there a serious underlying cause that can be identified?   
  • If the cause is uncertain, what is the risk of a serious outcome?   
  • Should the patient be hospitalized? 

High risk patients are more likely to have cardiac syncope and need urgent hospital admission and comprehensive evaluation. Whereas, syncope in low risk patients is likely to be reflex, situational, or orthostatic; hence, they do not need further evaluation.

The guideline also recommends that friends and relatives use their smartphones to film the attack and recovery.

The following treatments are recommended based on the clinical severity:

  • Education regarding lifestyle maneuvers
  • Adequate hydration and salt intake
  • Discontinuation/reduction of hypotensive therapy
  • Counter-pressure maneuvers
  • Abdominal binders and/or support stockings
  • Head-up tilt sleeping
  • Midodrine or fludrocortisone

An implantable cardioverter-defibrillator (ICD) should be considered in patients with unexplained syncope at high risk of sudden cardiac death.

(Source: ESC Press release, Eur Heart J. 2018 Jun 1;39(21):1883-1948)


Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA


Budgetary allocation for health in the budget this year: The ups and downs




The total budget for health has been increased this year and is the highest in the last two financial years. With Rs 61,398 crore allocated for 2019-20, this is a 16% increase over the Rs 52,800 crore in the current financial year (2018-19).

As expected, the Ayushman Bharat scheme gets a major share of this.

Rs. 6,400 crore has been set aside for the Ayushman Bharat scheme for 2019-20. Of this, Rs. 250 crores are for setting up Ayushman Bharat Health and Wellness Centres under the National Urban Health Mission and Rs. 1350 crore are for the Health and Wellness Centres under the National Rural Health Mission. 

The allocation for National Health Mission for 2019-20 increased to Rs 31,745 crore.

Some national health programs have benefited.

·         The allocation for the National AIDS and STD Control Programme has been increased by Rs. 575 crore and it now stands at Rs. 2,500 crore vs Rs. 1,925 crore in the last budget. Is this justified? 
·         Allocation for the National Programme for Health Care for the Elderly increased from Rs. 80 crore to Rs. 105 crore. The same should have been more. 

Some national health programs had their budget cut back this year.

·         The National Mental Health Programme budget was reduced to Rs 40 crore this year as opposed to Rs 50 crore last year. What is the reason?
·         The budgetary allocation for the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Disease and Stroke was reduced to Rs 175 crore from Rs 295 crore. This should have been doubled.
·         Allocation to the Tobacco Control Programme and Drug Deaddiction Programme was Rs. 65 crores, a decline by Rs. 2 crore.
·         The allocation of immunization or vaccination programme was cut 7% to Rs 6758.46 crore. This also should have been doubled with all vaccines given free to all.

India continues to have the highest burden of both TB and MDR TB patients and accounts for about a quarter of the global TB burden.

A suitable budget should be allocated to eradicate TB from the country. The treatment to all should be made free of cost and be available only through the government.

(Source: NDTV, Economic Times, India Today)

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA


Saturday, February 2, 2019

Climate change will increase the number of babies born with congenital heart defects



It has been well-recognised that human activities account for most of the global warming. And, in turn, climate change affects the health of the people.

Global warming is associated with extreme weather events, variable climates that affect food and water supplies and ecosystem changes and thereby adversely affects the social determinants of health (food, water and environment). Natural disasters such as floods, heat waves, cold waves, changing epidemiology of many infectious diseases are attributed to climate change.

Now, a new study has added another dimension of reproductive health to the effect of climate change on human health.

The study published online Jan. 30, 2019 in the Journal of the American Heart Association has suggested that rising temperatures associated with climate change could trigger heart defects in babies.

The number of babies born with congenital heart defects (CHD) throughout the United States would be higher in the projection period (2025–2035) due the exposure of pregnant women to more intense and longer‐lasting heat events, due to climate change.

The study also observed that the Midwestern states in the US will potentially have the highest increase in maternal exposure to excessively hot days, heat event frequency and heat event duration during the spring and summer months. Large increases in specific CHD subtypes during spring, including a 34.0% increase in conotruncal CHD in the South and a 38.6% increase in atrial septal defect in the Northeast were found in the matching season at the baseline (1995–2005)

Hence, pregnant women should avoid exposure to extreme heat, especially during early pregnancy (3–8 weeks post conception).

(Source: J Am Heart Assoc. 2019 Feb 5;8(3):e010995, WHO)


Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

Interim Budget 2019: Implications for health



The interim Budget 2019 was presented by the Finance Minister yesterday in the Parliament. There was not much in it for the health sector, as probably all of us would have been expecting.

The government has increased the defence budget to beyond Rs 3 lakh crore to ensure preparedness. It has also proposed a single window clearance for ease of shooting of films now also for Indian filmmakers (earlier available only for foreign filmmakers). But nothing specific for health was mentioned in the Budget. We have been demanding single-window accountability system as well as a single-window registration of our establishments.

But, the government has announced major tax benefits for the poor and the middle class, which should relieve mental stress, at least as far as finances are concerned.

Chronic stress has a negative effect on health and well-being, which can manifest as irritability, anxiety, headaches, and insomnia. It promotes behavioural changes in the form of overeating or undereating, alcohol or substance use, tobacco use, sedentary life and social withdrawal. This way, stress has been implicated in diseases such as diabetes, heart disease, asthma, obesity, asthma, depression.

Physical and mental health, both are important for well-being of a person. Poor mental health is not conducive to optimum physical health.

So, this budget should come as a relief for several thousands of citizens and promote good mental health in them as they would be stress-free.

Here are the key highlights from the Budget 2019.

·         Setting up of 22nd news AIIMS in Haryana; presently 21 AIIMS are operating or being established
·         ESI eligibility increased from Rs 15,000/- per month to Rs 21,000/- per month.
·         Honorarium of ASHA and Anganwadi workers increased by 50%
·         Allocation for ICDS increased from Rs 23,357 Cr in 2018-19 to Rs 27,548 Cr in 2019-20.
·         Tax free gratuity increased from 10 lakh to 20 lakh.
·         GST on some goods has been reduced from 28% to 18%.
·         Govt. will launch a Mega pension yojana “PM Shram Yogi Maandhan” for the organized sector with income up to Rs 15,000/- per month on a monthly contribution, which will assure pension of Rs 3000/- per month after 60 years of age; Govt. will deposit equal matching share.
·         India has become the 2nd largest hub of start-ups. Job seekers have now turned job creators.
·         National Programme on Artificial Intelligence has been envisaged by our government. This would be catalysed by the National Center on Artificial Intelligence as a hub along with Centers of Excellence. Nine priority areas have been identified. A National Artificial Intelligence portal will be established soon.

Individual income tax proposals

·         Existing Income tax rates to continue
·         Individual taxpayers with annual taxable income of up to Rs 5 lakh will get full tax rebate
·         No tax for individuals with gross income up to Rs 6.5 lakh if investments in provident funds and specified savings
·         TDS for tax deduction on rent increased from Rs 1,80,000/- to Rs 2,40,000/-
·         Increase in standard deduction from Rs 40,000/- from Rs 50,000/-
·         TDS on interest earned on investments (FDs, post office savings, banks) for small depositors and non-working spouses increased from Rs. 10,000 to Rs 40,000/-.
·         Benefit of rollover of capital tax gains to be increased from investment in one residential house to that in two residential houses, for a taxpayer having capital gains up to Rs 2 crore; can be exercised once in a lifetime
·         Exempt levy on income tax on notional rent on second self-occupied house.
·         Income tax relief on Notional Rent from unsold houses extended to 2 years

10 most important dimensions that will guide the government in Vision 2030

1.    Build next-gen infrastructure - physical as well as social to become a $10 trillion economy and to provide ease of living.
2.    Create a Digital India that reaches every sector of economy and every corner of India by creating innumerable startups and jobs
3.    Clean and Green India - an India that drives electric vehicles, with renewables becoming major source of energy
4.    Expand rural industrialization using modern industrial technologies, based on Make in India
5.    Clean Rivers - with safe drinking water to all Indians and sustaining and nourishing life, using micro-irrigation techniques; long coastline can be pivotal for the economy, using strength of blue economy and sagar mala
6.    Oceans and coastlines
7.    Space program with the aim to place an Indian astronaut in space by 2022
8.    Self-sufficiency in food and improving agricultural productivity with emphasis on organic food
9.    To have a healthy India in environment of health assurance with support of necessary infrastructure. Work towards distress-free health care and functional and comprehensive wellness system for all
10. Transforming India into a Minimum Government Maximum Governance

(Source: Lok Sabha TV, TOI)

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA


Friday, February 1, 2019

E-cigarettes to assist with smoking cessation




Excerpts from an editorial published January 30, 2019 (Belinda Borrelli and George T. O’Connor; DOI: 10.1056/NEJMe1816406)

·         The prevalence of tobacco smoking in the United States has declined to 14.0% but still exceeds 25% among high-risk subgroups (1,2).

·         Electronic cigarettes (e-cigarettes) are not approved by FDA for smoking cessation, but Americans trying to quit smoking use these products more frequently than FDA-approved cessation aids (3).

·         Hajek et al (4) now report in the NEJM the results of a multi-center, pragmatic, randomized trial of e-cigarettes, as compared with nicotine-replacement therapy, as a smoking-cessation treatment within the U.K. National Health Service smoking-cessation program. In addition to behavioral support, participants received either a second-generation refillable e-cigarette or a 3-month supply of whichever nicotine-replacement products they preferred. After 1 year, the rate of abstinence from smoking tobacco, validated by exhaled carbon monoxide concentration, was higher in the e-cigarette group (18.0%) than in the nicotine-replacement group (9.9%).

o   Trial limitations: possibility that smoking-cessation counsellors who were aware of the treatment assignments may have influenced patient expectations.

·         These findings must be considered in the context of FDA-approved medications for smoking cessation that have acceptable safety profiles.  Treatment with nicotine-replacement therapy and bupropion achieves abstinence rates of approximately 25 to 26% at 6 months and 20% at 1 year, (5) with slightly higher abstinence rates for combination therapy than for monotherapy (6). Varenicline has been shown to outperform bupropion, all forms of nicotine-replacement therapy, and placebo, with a 26% abstinence rate through 24 weeks of follow-up among participants without psychiatric diagnoses (7). The 1-year abstinence rate of 18% reported by Hajek et al. for the e-cigarette group is similar to these outcomes.

·         This evidence of effectiveness must be balanced against the short-term and long-term safety of e-cigarettes. The data from Hajek et al. are reassuring: the e-cigarette group had greater declines in the incidence of cough and phlegm than the nicotine-replacement group, no excess wheezing or dyspnea, and only a small incidence of oropharyngeal irritation. More frequent respiratory serious adverse events in the e-cigarette group than in the nicotine-replacement group (5 vs. 1) did not appear to be related to e-cigarette use.

·         Previous reports have suggested short-term clinical benefit among patients with these conditions who switch from tobacco smoking to e-cigarette use (8). 

·         The use of e-cigarettes by pregnant women, who were excluded from the trial by Hajek et al., raises special safety concerns.

·         Nicotine-patch use during pregnancy is associated with a higher rate of smoking cessation and better child-development outcomes than placebo, (9) there are no such reassuring data for e-cigarettes.

·         A key finding of Hajek et al. is that among participants with sustained abstinence at 1 year, 63 of 79 (80%) in the e-cigarette group were still using e-cigarettes, whereas only 4 of 44 (9%) in the nicotine-replacement group were still using nicotine replacement.

·         E-cigarette vapor contains many toxins and exerts potentially adverse biologic effects on human cells in vitro or in animal models, although toxin levels and biologic effects are generally lower than those of tobacco smoke (10). 

·         A study involving humans showed an altered bronchial epithelial proteome in association with e-cigarette use, including some protein alterations also seen among tobacco smokers (11). In a mouse model, inhalational exposure to nebulized e-cigarette liquid containing nicotine resulted in distal airspace enlargement that was consistent with pulmonary emphysema (12). These findings argue against complacency in accepting the transition from tobacco smoking to indefinite e-cigarette use as a completely successful smoking-cessation outcome.

·         An additional societal consideration is the effect of adult e-cigarette use on children and young adults.

·         There is substantial evidence that e-cigarette use by youth increases the risk of smoking combustible tobacco cigarettes, (10) and the U.S. Surgeon General has recently declared e-cigarette use among youth “an epidemic.” (13)

·         A consensus has emerged that e-cigarettes are safer than traditional combustible cigarettes, (10) but it remains controversial whether e-cigarettes should be recommended as a first-line treatment to assist smoking cessation, alongside FDA-approved treatments.

·         The appropriate duration of e-cigarette “treatment” for smokers trying to quit is also uncertain.

·         e-cigarettes be used only when FDA-approved treatments (combined with behavioral counseling) fail, that patients be advised to use the lowest dose needed to manage their cravings, and that there be a clear timeline and “off ramp” for use.

·         Use of e-cigarettes should be monitored by health care providers

·         The efficacy and safety of e-cigarettes need to be evaluated in high-risk subgroups

·         Further research on the health consequences of long-term e-cigarette use is needed.

(Source: This editorial was published on January 30, 2019, at NEJM.org)

References

1.     Wang TW, Asman K, Gentzke AS, et al. Tobacco product use among adults — United States, 2017. MMWR Morb Mortal Wkly Rep. 2018;67:1225-1232.
2.     Borrelli B, Busch A, Dunsiger S. Cigarette smoking among adults with mobility impairments: a US population-based survey. Am J Public Health 2014;104:1943-9.
3.     Benmarhnia T, Pierce JP, Leas E, et al. Can e-cigarettes and pharmaceutical aids increase smoking cessation and reduce cigarette consumption? Findings from a nationally representative cohort of American smokers. Am J Epidemiol 2018;187:2397-2404.
4.     Hajek P, Phillips-Waller A, Przulj D, et al. A randomized trial of e-cigarettes versus nicotine-replacement therapy. N Engl J Med. DOI: 10.1056/NEJMoa1808779.
5.     Rosen LJ, Galili T, Kott J, et al. Diminishing benefit of smoking cessation medications during the first year: a meta-analysis of randomized controlled trials. Addiction 2018;113:805-16.
6.     Windle SB, Filion KB, Mancini JG, et al. Combination therapies for smoking cessation: a hierarchical Bayesian meta-analysis. Am J Prev Med 2016;51:1060-71.
7.     Anthenelli RM, Benowitz NL, West R, et al. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet 2016;387:2507-20.
8.     Polosa R, Morjaria JB, Caponnetto P, et al. Evidence for harm reduction in COPD smokers who switch to electronic cigarettes. Respir Res 2016;17:166.
9.     Cooper S, Taggar J, Lewis S, et al. Effect of nicotine patches in pregnancy on infant and maternal outcomes at 2 years: follow-up from the randomised, double-blind, placebo-controlled SNAP trial. Lancet Respir Med 2014;2:728-37.
10.  Stratton K, Kwan LY, Eaton DL, eds. Public health consequences of e-cigarettes. Washington, DC: National Academies Press, January 2018.
11.  Ghosh A, Coakley RC, Mascenik T, et al. Chronic e-cigarette exposure alters the human bronchial epithelial proteome. Am J Respir Crit Care Med 2018;198:67-76.
12.  Garcia-Arcos I, Geraghty P, Baumlin N, et al. Chronic electronic cigarette exposure in mice induces features of COPD in a nicotine-dependent manner. Thorax 2016;71:1119-29.
13.  Stein R. Surgeon General warns youth vaping is now an “epidemic.” NPR. December 18, 2018(https://www.npr.org/sections/health-shots/2018/12/18/677755266/surgeon-general-warns-youth-vaping-is-now-an-epidemic).

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

NEJM study provides evidence of greater efficacy of e-cigarettes vis-à-vis conventional NRTs



One of the most pressing unanswered questions in public health has been "Do e-cigarettes actually help smokers quit?"

The first, large rigorous assessment now answers this question.

A study, published Wednesday in the New England Journal of Medicine, found that e-cigarettes were nearly twice as effective as conventional nicotine replacement products, like patches and gum, for quitting smoking, reports New York Times. The success rate was 18% among the e-cigarette group, compared to 9.9% among those using traditional nicotine replacement therapy.

The study was conducted in Britain and funded by the National Institute for Health Research and Cancer Research UK. For a year, it followed 886 smokers assigned randomly to use either e-cigarettes or traditional nicotine replacement therapies. Both groups also participated in at least four weekly counseling sessions, an element regarded as critical for success.

E-cigarettes provide the nicotine smokers crave without the toxic tar and carcinogens that come from inhaling burning tobacco. But, it is still not approved as smoking cessation tools. 

Doctors up till now were reluctant to recommend their use because of the lack of clear evidence from randomized controlled trials. This is now likely to change.

The New England Journal devoted much of its current issue to e-cigarettes, publishing two editorials and a letter, and the collection embodies the tangled public health debate over the devices.  One editorial — written by Belinda Borrelli, a behavioral health expert and Dr. George T. O’Connor, a pulmonologist — pumped the brakes on inclinations to embrace e-cigarettes.

The editorial recommended that e-cigarettes be taken up when other cessation approaches, including behavioral counselling have failed; that patients use the lowest dose of nicotine possible and that health care providers establish a clear timeline for
e-cigarette use.

The clinical trial took place from May 2015 to February 2018. Because the smokers were recruited at the clinics, they were already predisposed to quitting, a feather on the scale that could slightly have affected results. The participants were typically middle-aged, smoked between half a pack and a pack a day and had already tried quitting.

Because self-reports of smoking abstinence are not considered reliable, researchers measured the quantities of carbon monoxide in the participants’ breath, a more precise validation. Higher quit rates and compliance among e-cigarette users could be additionally explained because those subjects expressed more satisfaction with the devices than did the other group with their products.
Some researchers hypothesize that because a body takes in only the amount of nicotine it needs to maintain a certain level, high-nicotine products could have the advantage of delivering that power punch with fewer puffs, decreasing the amount of harmful aerosol a vaper would inhale.

(Source: New York Times)




NEJM Abstract

A randomized trial of e-cigarettes vs nicotine-replacement therapy

Hajek P, Phillips-Waller A, Przulj D, et al. N Engl J Med. 2019 Jan 3. Epub ahead of print

Background: E-cigarettes are commonly used in attempts to stop smoking, but evidence is limited regarding their effectiveness as compared with that of nicotine products approved as smoking-cessation treatments.

Methods: We randomly assigned adults attending U.K. National Health Service stop-smoking services to either nicotine-replacement products of their choice, including product combinations, provided for up to 3 months, or an e-cigarette starter pack (a second-generation refillable e-cigarette with one bottle of nicotine e-liquid [18 mg per milliliter]), with a recommendation to purchase further e-liquids of the flavor and strength of their choice. Treatment included weekly behavioral support for at least 4 weeks. The primary outcome was sustained abstinence for 1 year, which was validated biochemically at the final visit. Participants who were lost to follow-up or did not provide biochemical validation were considered to not be abstinent. Secondary outcomes included participant-reported treatment usage and respiratory symptoms.

Results: A total of 886 participants underwent randomization. The 1-year abstinence rate was 18.0% in the e-cigarette group, as compared with 9.9% in the nicotine-replacement group (relative risk, 1.83; 95% confidence interval [CI], 1.30 to 2.58; P<0.001). Among participants with 1-year abstinence, those in the e-cigarette group were more likely than those in the nicotine-replacement group to use their assigned product at 52 weeks (80% [63 of 79 participants] vs. 9% [4 of 44 participants]). Overall, throat or mouth irritation was reported more frequently in the e-cigarette group (65.3%, vs. 51.2% in the nicotine-replacement group) and nausea more frequently in the nicotine-replacement group (37.9%, vs. 31.3% in the e-cigarette group). The e-cigarette group reported greater declines in the incidence of cough and phlegm production from baseline to 52 weeks than did the nicotine-replacement group (relative risk for cough, 0.8; 95% CI, 0.6 to 0.9; relative risk for phlegm, 0.7; 95% CI, 0.6 to 0.9). There were no significant between-group differences in the incidence of wheezing or shortness of breath.

Conclusions: E-cigarettes were more effective for smoking cessation than nicotine-replacement therapy, when both products were accompanied by behavioral support.
(Funded by the National Institute for Health Research and Cancer Research UK; Current Controlled Trials number, ISRCTN6047760) 


Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA