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Sometimes Less is More

A 64-year-old male presented to emergency room (ER), with complaints of shortness of breath for one day. He had a past medical history of hypertension, end stage renal disease on hemodialysis (HD), and grade I obesity. He reported that he missed his last HD session, which was two days prior to presentation. He denied any chest pain, palpitations, cough, or fever. Patient further mentioned that he was able to walk >10 blocks without any chest pain or shortness of breath until a couple days ago. In the ER, examining physician documented presence of a systolic ejection murmur heard best at the second right intercostal space and bilateral rales, 1+ pedal edema; jugular venous distention of 4cm. Urgent transthoracic echocardiogram (TTE) was ordered by ER physician to further investigate the aortic stenosis (AS) murmur. TTE showed aortic valve area 0.98cm2, mean gradient 32mmHg, aortic jet velocity 3.5m/s; mild left ventricle (LV) concentric hypertrophy with grade 1 diastolic dysfunction, and LV ejection fraction of 60-65%. Subsequently, patient was admitted to cardiac telemetry and primary team consulted renal and cardiothoracic (CT) team for HD and for aortic valve replacement (AVR), respectively.

CT surgery team requested cardiology consult as a part of pre-operative assessment for possible surgical AVR. Physical examination by the attending cardiologist was remarkable for II/VI mid-systolic peaking crescendo-decrescendo murmur with normal carotid pulse upstrokes. Cardiac catheterization was recommended for further evaluation as there was discrepancy between the findings on noninvasive testing and physical examination regarding severity of the AS. Cardiac catheterization revealed non obstructive coronary artery disease (30% stenosis of mid RCA) and moderate AS (aortic valve area 1.38cm2, mean gradient 28mmHg, aortic jet velocity 3.3m/s). During recovery period patient developed hematoma at access site (right groin), which was managed conservatively but resulted in prolongation of his hospital stay by 48 hours. In the meantime, the patient underwent hemodialysis and had symptomatic relief in his dyspnea. He was discharged home to follow up with his outpatient hemodialysis center.

 

Perspective:

This gentleman presented to ER with complain of shortness of breath after missing a HD session. Although, not incorrect, the systolic murmur heard by ED physician led to a cascade of downstream testing. In fact, the ‘benign’ ‘non-invasive’ testing ordered as a part of comprehensive work-up led to a delay for patient getting the HD session. Physical examination is an essential part of accurate assessment of a patient’s disease process. However, our daily practice has been increasingly occupied by ‘tunneled vision’ of things.

Aortic stenosis (AS) is one of the most common valvular diseases associated with systolic murmur in the elderly population1. An essential part of physical exam of AS is assessing the severity. Munt et al, found significant correlation of physical exam findings like grade of murmur and timing of murmur peak with severity of AS2. Further, delay in carotid upstroke and decreased amplitude was well associated with increasing grade of AS severity as measured by aortic valve area (AVA). Although, one may argue that physical exam is limited by observer expertise and inter-observed variability3, echocardiographic parameters have their own pitfalls. The AVA measurement depends on accurate evaluation of LVOT diameter, which has a variability rate of 5-8% thus providing a significant potential for error4. Further, co-existing LV dysfunction or valvular jets (e.g. MR, AR) can interfere with precise interpretation of echocardiographic parameters.

In summary, the patient should have received urgent HD on presentation. The work up for systolic murmur would have been more appropriate on an outpatient basis. This particular scenario also brings into picture the rising health care costs in the United States, contributed by both additional testing and prolonged hospitalizations. Overall, it is worth concluding that careful physical examination and assessment of the patient is foremost to efficient and ‘do not harm’ philosophy of medicine.

 

References:

1) Osnabrugge R, Mylotte D, Head SJ, Van Mieghem NM, et al. Aortic Stenosis in the Elderly Disease Prevalence and Number of Candidates for Transcatheter Aortic Valve Replacement: A Meta-Analysis and Modeling Study. J Am Coll Cardiol. 2013;62(11):1002-1012.

2) Munt B, Legget ME, Kraft CD, Miyake-Hull CY, et al. Physical examination in valvular aortic stenosis: Correlation with stenosis severity and prediction of clinical outcome. Am Heart J 1999;137:298-306.

3) Stout KK, Otto CM. Quantification of Valvular Aortic Stenosis. ACC current journal review Mar/Apr 2003.

4) Baumgartner H, Hung J, Bermejo J, Chambers JB, et al. Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice.

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Success Does Not Always Leave A ‘Footprint’

Stroke is one of the leading causes of mortality and morbidity in the United States (US). Approximately one‐third of all ischemic strokes are considered cryptogenic, i.e not attributed to large‐vessel atherosclerosis, small‐artery disease, or embolism despite extensive vascular, serological, and cardiac evaluation. Until recently, the relationship between patent foramen ovale (PFO) and cryptogenic stroke was highly debated. Prior to 2006, use of transcatheter based PFO closure procedures were only permitted under Food and Drug Administration (FDA) Humanitarian Device Exemption for recurrent cryptogenic stroke from a PFO after failed conventional medical therapy1. However, the number of eligible patients exceeded the regulatory mandated annual limit of 4,000 patients in 2006. Thus, the Humanitarian Device Exemption process was voluntarily withdrawn1.

In the past two decades, several randomized clinical trials using the Amplatzer PFO Occluder, the Starflex Septal Occluder (NMT Medical Inc, Boston, MA), and the Gore Cardioform Septal Occluder were conducted. Based on long term follow up results of the RESPECT [Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment] and REDUCE [GORE® Septal Occluder Device for PFO Closure in Stroke Patients] trials, US FDA approved the Amplatzer PFO Occluder in 2016 and the Gore Cardioform Septal Occluder in 20181,2.  FDA approval for these devices for PFO closure in the United States is to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke2.”

Despite proven efficacy, the use of device based PFO closure techniques have potential risks of several early and late complications, including infection, thrombosis, device dislodgement, atrial wall erosion, perforation, fracture, migration-embolization, allergic reaction to nickel used in PFO occluder device, and induction of arrhythmias3,4. Further, there is need of post procedure antiplatelet therapy after implantation of these devices. These concerns lead to need for a ‘deviceless’ transcatheter system to close PFO. Ruiz et al have performed first-in-man transcatheter suture closure of a PFO in an 18-year-old female with chronic migraine with aura in 2008 without leaving ‘footprint’5.  Results of this novel approach were exciting; however, safety and efficacy of ‘deviceless’ transcatheter techniques on large scale was not established until early results of the NobleStitch EL Italian Registry were reported few months ago6. In this prospective registry, investigators successfully used suture based PFO closure system in 186 (out of 192) patients across 12 sites in Italy with no device related complication on 206±130 days follow-up6. FDA approves the NobleStitch™ EL for Vascular and Cardiovascular suturing in the US (interestingly the technique is not specifically labeled for treating PFOs).

Due to projected increase in numbers of left sided transcatheter interventions (e.g. left atrial appendage closure, arrhythmia ablation and mitral valve interventions), the deviceless technique could be a very attractive option in selected patient population as presence of interatrial septal prosthesis make trans-septal puncture more challenging. Though this technology has huge potential, we should still wait for long term data on safety and efficacy of this no foot print PFO closure system before advocating and supporting its widespread use.

 

References:

  1. Writing Group Members , American Heart Association Statistics Committee; Stroke Statistics Subcommittee . Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016; 133:e38–e360
  2. .https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm527096.htm
  3. Luermans JG, Post MC, Yilmaz A. Late device thrombosis after atrial septal defect closure. Eur Heart J. 2010;31:142
  4. Merkler AE, Gialdini G, Yaghi S, Okin PM, Iadecola C, Navi BB, Kamel H. Safety Outcomes After Percutaneous Transcatheter Closure of Patent Foramen Ovale. Stroke. 2017;48:3073-7
  5. Ruiz CE, Kipshidze N, Chiam PT, et al. Feasibility of patent foramen ovale closure with no-device left behind: first-in-man percutaneous suture closure. Catheter Cardiovasc Interv. 2008 Jun 1;71(7):921-6.
  6. Gaspardone A, De Marco F, Sgueglia GA, et al. Novel percutaneous suture-mediated patent foramen ovale closure technique: early results of the NobleStitch EL Italian Registry. EuroIntervention. 2018 Jun 8;14(3):e272-e279.

 

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Durability of Transcatheter Aortic Bioprosthesis

“On résiste à l’invasion des armées; on ne résiste pas à l’invasion des idées” (No one can resist an idea whose time has come) – Victor Marie Hugo

Transcatheter aortic valve replacement (TAVR) has been established as an appropriate treatment option for patients with symptomatic severe aortic stenosis who are at intermediate, high, or prohibitive surgical risk. While we all are eagerly waiting for the results of large scale randomized trial evaluating “The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis” (PARTNER-3), Nordic Aortic Valve Intervention Trial (NOTION) results did provide an insight into potential role of TAVR in low risk populations. This small randomized trial compared TAVR (using self-expanding bioprosthesis–Corevalve) with surgical aortic valve replacement (SAVR) in an all-comers patient cohort in 3 Nordic centers1. Among 280 patients, 81.8% of patients in this study were low risk, as assessed by Society of Thoracic Surgeons score (<4%). In the low risk cohort, at 6 years, the rates of all-cause mortality were similar for TAVR (42.5%) and SAVR (37.7%) patients (p = 0.58)1.

These results are very encouraging and might play an important role in providing non-surgical option to low risk patient populations. However, this also raises an important question regarding the long-term durability of transcatheter bioprosthetic valve in relatively healthy and low-intermediate risk patients with longer life expectancies, especially when compared with SAVR. Interestingly, in studies reporting long-term outcomes and performance of SAVR, the definition of durability of surgical bioprosthetic valves has wide variation spanning from the need for re-operation to integration of clinical and echocardiographic outcomes. Such variations make it difficult to compare durability of SAVR and TAVR. To overcome this, standardized definitions of structural valve deterioration (SVD) and nonstructural valve deterioration (NSVD) have been proposed2. In this European task force committee guidelines consensus statement, severe SVD have been defined as either mean gradient ≥40 mm Hg and/or ≥20 mm Hg increase from baseline; AND/OR  peak velocity ≥4 m/s and/or ≥2 m/s increase from baseline; AND/OR severe new or worsening intraprosthetic aortic regurgitation (AR).

Using above criteria, Blackman and colleagues have reported incidence of SVD 5 to 10 years post-procedure using U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) registry data3.  Among 241 patients who underwent TAVR from 2007 to 2011, severe SVD was observed in <1% patients. 91% of patients remained free of SVD on median follow up period of 5.8 years (range 5 to 10 years)3.

Thus, transcatheter bioprosthetic aortic valves are durable. But how do they fare when compared to surgical bioprosthesis?  Søndergaard and colleagues provided answer to this question using 6-year follow up data from NOTION trial1. The effective orifice area was larger and mean gradient was lower after TAVR when compared to SAVR. Further, this significant difference was sustained on 6 years follow-up. Using standardized definitions, authors have reported higher rate of SVD for SAVR than TAVR (24.0% vs. 4.8%; p < 0.001), whereas there were no differences in NSVD (57.8% vs. 54.0%; p = 0.52); endocarditis (5.9% vs. 5.8%; p = 0.95) or bioprosthetic valve failure rates through 6 years (6.7% vs. 7.5%; p = 0.89)1.

These results are convincing, but caution should be exercised while extrapolating them to clinical practice. In report from U.K TAVI registry, data was analyzed for only 241 patients (from >1500 patients) due to lack of echocardiographic data both at baseline and >5 years. Further, <15% patients had follow-up beyond 8 years. Later is relevant as SVD of porcine and pericardial aortic bioprostheses have been reportedly begins 8 years after implantation4. Similarly in report from NOTION trial, 6-year follow-up data was available only in 50 TAVR and 50 SAVR patients. Also, a core lab did not adjudicate these echocardiographic measurements.

Despite limitations, data from the UK TAVI registry and NOTION trial are very encouraging and supportive to extend indications of TAVR to a relatively younger and healthier patient population. This is especially important as global numbers of TAVR cases are projected to be double by 2025.

 

References:

  1. Søndergaard L, Ihlemann N, Capodanno D, et al. Durability of transcatheter and surgical bioprosthetic aortic valves in patients at lower surgical risk. J Am Coll Cardiol, 73 (2019), pp. 546-553
  2. Capodanno DM, Petronio AS, Prendergast B, et al. Standardised definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical bioprosthetic valves. A consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) in collaboration with the European Society of Cardiology (ESC). Eur Heart J, 38 (2017), pp. 3382-3390
  3. Blackman DJ, Saraf S, MacCarthy PA, et al. Long-term durability of transcatheter aortic valve prostheses. J Am Coll Cardiol, 73 (2019), pp. 537-545
  4. Foroutan F, Guyatt GH, O’Brien K, et al. Prognosis after surgical replacement with a bioprosthetic aortic valve in patients with severe symptomatic aortic stenosis: systematic review of observational studies. BMJ, 354 (2016), p. i5065

 

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To Clip or Not to Clip

Evidence based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of the individual patient. It means integrating individual clinical expertise with the best available external clinical evidence from systematic research.” Dr.David Sackett, 1996

 

Randomized controlled clinical trials (RCTs) have been long considered as highest level evidence and have formed the basis of most current treatments in cardiovascular medicine. Despite their strengths, the limitations of RCTs are increasingly recognized in applying evidence in the clinical practice; this is especially true when various RCTs report conflicting findings. We have encountered this frequently in interventional cardiology where new technologies and treatments have to face intense scrutiny before becoming part of routine practice.

Last year two large much awaited RCTs–COAPT and MITRA-FR report their findings1, 2. To a cursory eye the results look conflicting and few of my colleagues in general internal medicine even describe them as ‘confusing’.

Larger of the two–the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) is a RCT conducted across 78 centers in the United States and Canada1. COAPT investigators randomized 614 patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite the use of maximal doses of guideline-directed medical therapy1. Patient in device group had significantly lower rate of hospitalization for heart failure [35.8% per patient-year in the device group as compared with 67.9% per patient-year in the control group (hazard ratio, 0.53; 95% confidence interval [CI], 0.40 to 0.70; P<0.001)  and  all-cause mortality [29.1% of the patients in the device group as compared with 46.1% in the control group (hazard ratio, 0.62; 95% CI, 0.46 to 0.82; P<0.001)] within 24 months of follow-up1. Further, rate of freedom from device-related complications exceeded a prespecified safety threshold1. Whereas investigators in MITRA-FR trial (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) randomized 152 patients with heart failure and severe secondary mitral regurgitation in a 1:1 ratio, to undergo percutaneous mitral-valve repair in addition to receiving medical therapy (intervention group) or to receive medical therapy alone (control group)2. At 12 month follow authors reported no significant difference in the rate of death [24.3% in the intervention group and 22.4% in the control group (hazard ratio, 1.11; 95% CI, 0.69 to 1.77)] or unplanned hospitalization for heart failure [48.7% in the intervention group and 47.4% in the control group (hazard ratio, 1.13; 95% CI, 0.81 to 1.56)] between patients who underwent percutaneous mitral-valve repair in addition to receiving medical therapy and those who received medical therapy alone2.

A closer look and detailed analysis of both RCTs can explain the differences in outcomes.

First, patient populations enrolled in these RCTs were different in terms of baseline valvular and ventricular characteristics1,2. Compared to MITRA-FR, COAPT enrolled patients with more severe mitral regurgitation [effective regurgitant orifice area-41 mm2 vs. 31 mm2]. Further, in COAPT the left ventricular end-diastolic volume (reflecting the status of the left ventricle) was smaller. Second, patient selection in COAPT was more stringent and only patients who are truly refractory to medical therapy [at the maximum tolerated dose before randomization] were included. This is reflected in higher baseline N-terminal pro–B-type natriuretic peptide levels among patients in COAPT trial. Also, percentage of patients who received more than a single clip was higher in COAPT. Whether this contributes to higher proportion of patients with moderate to severe MR at end of follow up in MITRA-FR remains unclear. Furthermore, the follow up period in MITRA-FR was 12 months, which could also contribute to difference in its finding with COAPT, where the Kaplan–Meier survival curves start diverging after 12 months. Long term follow up data from MITRA-FR can further clarify this.

In this era of evidence based medicine, results of COAPT and MITRA-FR once again exemplified how critical it is for clinicians to understand the methodology and patient characteristics enrolled in RCTs before extrapolating the finding to their patients. Not every secondary mitral regurgitation patient is a candidate for Clip. Patient selection is the key. The answer to ‘clip or not to clip’ is in knowing our patient well, including and not limited to their baseline clinical and echocardiographic parameters and optimal medical management of their heart failure before offering them this novel therapy.  Sir William Osler has summarized it well more than a century ago, “He who studies medicine without books sails an uncharted sea, but he who studies medicine without patients does not go to sea at all3.

 

References:

  1. Stone GW, Lindenfeld J, Abraham WT, et al. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318.
  2. Obadia JF, Messika-Zeitoun D, Leurent G et al. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306.
  3. Osler W. (1904) Aequanimitas, With Other Addresses to Medical Students, Nurses and Practitioners of Medicine, Books and men (P Blakiston, Philadelphia, PA)]

 

 

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AHA18: Notes From a Structural Heart Disease Specialist

How can one experience science and scenic beauty together? You know the answer to this, if you attended this year’s annual Scientific Sessions of the American Heart Association (AHA) in the beautiful city of Chicago. AHA18 showcased the latest advancements and studies in the field of cardiovascular medicine and stroke.

 

AHA Coming Back To The Center Stage

I attended AHA Scientific Sessions for the first time when I was an intern. Science from different sub-specialties of cardiovascular and stroke was truly inspiring and triggered curiosity. However, over the years as I specialized in general cardiology, then interventional cardiology and structural heart disease (SHD), it became increasingly difficult to attend all major scientific meetings every year.  Meetings focused on sub-cardiovascular specialties had taken priority in my schedule in last few years. However, this has changed in 2018. As a SHD specialist I realized the need and importance of a multidisciplinary approach, and science that cuts across various specialties. With widespread adoption of heart team and brain team models, we have realized the importance and benefits of collaboration between physician and surgeons across different specialties.  AHA provides a perfect platform to present and promote such multidisciplinary science.

 

How Far We Came in the TAVR World

Two separate studies using national administrative databases reported significant reduction in the complications rates associated with transcatheter aortic valve replacement (TAVR).

In the first study, Dr. Sameer Arora and his colleagues at University of North Carolina School of Medicine, Chapel Hill, evaluated the complication rates following both TAVR and surgical aortic valve replacement (SAVR) using the Nationwide Inpatient Sample1.  They included more than 90,000 patients and reported reduction in all cause mortality (4% to 1%), vascular complications (8% to 5%), acute kidney injury (12% to 10%), need for blood transfusions (31% to 10%), and cardiogenic shock (3% to 1%) in patients who underwent TAVR between 2012 and 2015 [P < 0.001 for all].

However, there was an increase in the need for a permanent pacemaker implantation (2% to 12% %; P < 0.001). They also noted trends towards improvement in outcomes with SAVR during same period. Improvement in device profile and valve design, operator experience, and inclusion of patients with lower baseline risk could explain these outcomes with TAVR.

In the second study, Dr. Rajat Kalra, MBChB and colleagues at University of Minnesota, Minneapolis, analyzed rates of new-onset atrial fibrillation and its association with clinical outcomes among patients who underwent TAVR (N=48,715) and SAVR (N=122,765), also using the Nationwide Inpatient Sample from 2012 to 20152. The study reported rates of new-onset atrial fibrillation as 50.4% and 50.1% for TAVR and SAVR respectively. They also noted higher in-hospital mortality, and post procedure stroke, among patients who had new-onset AFib post TAVR or SAVR.

Results from both of these studies are in coherence with findings from clinical trials and our experience with TAVR. However, due to lack of randomization, long term follow up, potential confounders and potential of inappropriate coding, caution should be exercise in extrapolating results of these studies or comparing TAVR with SAVR based on such data.

 

Flyer from Future

In addition to various studies and presentations from all across the nation and the international scientific community, AHA18 had dedicated sessions for Structural Heart Disease, 3D imaging, and Artificial Intelligence, giving us a glimpse of the near future for SHD. Cardiac imaging is critical to plan and perform any transcatheter based structural heart disease procedure, and 3D printing has potential to revolutionize the treatment planning of patients with SHD as highlighted by Dr. Frank Rybicki (University of Ottawa) during his presentation at AHA18. A potential role of 3D bioprinting for preoperative planning for TAVR and SAVR and the future of this technology was further emphasized in another interesting talk “Personalized Care: Print your own valve,” by Dr. Kamal Khabbaz (Beth Israel Deaconess Medical Center, Harvard Medical School, MA).

My experience during 2018 session has reinforced my believe that AHA has the potential to be ‘The Platform’ to present and promote SHD science.

 

References:

  1. Arora S. Trends in inpatient complications after transcatheter and surgical aortic valve replacement in the TAVR era. Presented at: AHA 2018. November 11, 2018. Chicago, IL.
  2. Kalra R. New-onset atrial fibrillation after aortic valve replacement: evaluation of a national cohort. Presented at: AHA 2018. November 12, 2018. Chicago, IL.

 

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Yoga CaRe: When Evidence-Based Science Meets Ancient Wisdom

Yoga can be vaguely defined as group of ‘mind-body’ exercises. Though exact timing remains debatable, origin of yoga can be traced back to more than 3,000 years ago when it was first mentioned in ancient Indian text ‘Rigveda’. Yoga is among one of six fundamental ‘Darshanas’ of Hindu philosophy. Various yoga practices were integral part of Indian sages’ routine, who taught and propagate various yogic practices across ancient India.

In western society, yogic practices involving ‘Asanas’ (stretching/body posture), ‘Pranayama’ (breathing exercise), and Meditation have become popular as mean of reducing stress and improving physical well-being.  Several small studies have reported beneficial effects of yoga in primary and secondary prevention of cardiovascular disease (CVD) [1-3]. Yoga based cardiac rehabilitation program post coronary artery bypass graft surgery has been reported to be associated with improvement in left ventricle function, lipid profile, stress reduction and quality of life [1, 2]. However, studies reported beneficial effects of yoga have been limited by small sample size, lack of adequate control, and non-uniform methodologies. Thus, utility of yoga based rehabilitation program in patients with pre-existing CVD remains uncertain.

Against this background, group of Indian physicians conducted a multi-center randomized controlled trial, to evaluate effectiveness of yoga-based cardiac rehab (yoga-CaRe) in patients with acute myocardial infarction. Dr. Dorairaj Prabhakaran from Center for Chronic Disease Control (New Delhi, India) presented the results of this study in a late-breaking science session at the American Heart Association 2018 Scientific Sessions. Study randomized 3,959 patients with acute MI patients from 24 Indian centers to 14 weeks of either Yoga-CaRe or enhanced standard care (ESC). Patients in Yoga-CaRe group underwent 13 sessions of yoga (3 health rejuvenating exercises, 15 postures, 5 breathing techniques & 5 meditative techniques) under trained yoga instructor guidance. ‘Asanas’ (body posture) in Yoga-CaRe group were carefully selected to avoid significant tachycardia.  ESC was comprised of 3 educational sessions (before discharge from the hospital and subsequently at weeks 5 and 12) and printed leaflet delivered by nurse or another member of cardiac care team either individually or in groups to avoid contamination. At 42-month follow up, compared to ESC, patients in Yoga-CaRe had numerically fewer composite endpoint events (death, nonfatal MI, nonfatal stroke, or emergency cardiovascular hospitalization) in the intention-to-treat analysis; however this difference was not statistically significant. The secondary endpoint of self-rated quality of life, and rate of patient return to pre-infarct daily activities were better in Yoga-CaRe group at three months. As per Dr. Prabhakaran ‘.. it (yoga) improve quality of life and made patient return to pre-infarct activities as quickly as possible….wherever people adhere to yoga i.e they attend more than 10 sessions there was reduction in composite end point particularly in death..’

Despite been a class I recommendation cardiac rehabilitation remains highly underutilized in post MI patients.  Situation is even worse in underdeveloped countries where structured cardiac rehabilitation post MI is almost nonexistent due to limited resources. In this context, results of this study are very relevant as yoga is relatively inexpensive and can be delivered by trained instructor to group of patients without further straining already overburden health care system. As pointed out by Dr. Prabhakaran ‘Yoga is feasible, and it can be ambitiously scaled up in term of cardiac rehabilitation..’. This could have far reaching benefits in low- and middle-income countries with limited health staff and resources, and high CVD burden.

However, due to lack of standardized physical exercise component in control arm of Yoga-CaRe trial, it remains unclear if yoga offers any additional benefits over traditional exercise performed for equal duration. Further, Yoga-CaRe enrolled relatively younger patients (mean age ~53yr) and predominately males (>85%). Thus, potential role of yoga in post MI elderly and females patients remains unexplored. Future, large-scale studies addressing these limitations and evaluating yoga based cardiac rehab in other CVD like heart failure would be useful in testing utility of these age old ‘mind-body’ exercises in modern world.

 

References:

  1. Raghuram N, Parachuri VR, Swarnagowri MV et al. Yoga based cardiac rehabilitation after coronary artery bypass surgery: one-year results on LVEF, lipid profile and psychological states–a randomized controlled study. Indian Heart J. 2014 Sep-Oct;66(5):490-502.
  2. Amaravathi E, Ramarao NH, Raghuram N et al. Yoga-Based Postoperative Cardiac Rehabilitation Program for Improving Quality of Life and Stress Levels: Fifth-Year Follow-up through a Randomized Controlled Trial. Int J Yoga. 2018 Jan-Apr;11(1):44-52.
  3. Yeung A, Kiat H, Denniss AR, Cheema BS et al. Randomised controlled trial of a 12 week yoga intervention on negative effective states, cardiovascular and cognitive function in post-cardiac rehabilitation patients. BMC Complement Altern Med. 2014 Oct 24;14:411.
  4. Prabhakaran D, et al “Effectiveness of a yoga-based cardiac rehabilitation (Yoga-CaRe) program: a multi-centre randomised controlled trial of patients with acute myocardial infarction from India” AHA 2018.