211

Chapter 28 Growth of Interventional Cardiology in India: The Relevance of National Interventional Council (CSI–NIC) N.N. KHANNA • SUPARNA RAO

keenly watched by the device and pharmaceutical industries worldwide.

GLOBAL GROWTH TRENDS

India and China are two emerging markets for interventional cardiology. It is estimated that from 2016 to 2022, total worldwide volume of cardiovascular interventions is going to increase by an average of 3.7% per year. The largest abso-lute gains are expected in peripheral/endovascular interventions (because of explosive utilization of drug-coated balloons) followed by coronary inter-ventions (because of strong and continued growth in China and India) and endovenous interven-tions (because of strong and continued growth in China and India) ( Fig. 28-1 ).

Venous indications are expected to register the fastest growth (5.1%) followed by peripheral and vascular interventions (4% and 3.6%) 5 . Globally, Asia Pacifi c (APAC) market accounts for slightly higher shares of global cardiovascular interven-tional volumes as compared to the USA and Europe (29.5% vs. 29.3%). The share of APAC region is ex-pected to increase to 33.5% by the end of 2022 ( Figs 28-2 and 28-3 ). However, in relative per capita terms, the covered APAC regions (China and India) continue to lag far behind the West in the utiliza-tion of cardiovascular interventions with roughly 1.57 procedures per million population performed in 2015 for APAC region versus 13.4 and 12.3 car-diovascular interventions done per million popula-tion in the USA and Western European countries.

GROWTH OF INTERVENTIONAL CARDIOLOGY IN INDIA

Since 1990, the science and art of interventional cardiology has percolated far and wide to the entire

INTRODUCTION

Since the time the fi rst coronary angioplasty was done in India in 1984, interventional cardiology has made an amazing progress 1 . The fi rst cardiac cathe-terization laboratory for haemodynamics was estab-lished in Delhi, under the stewardship of Dr Sujay B. Roy. He was the founder of invasive cardiology in India and under him, lot of invasive and interven-tional cardiologists were trained.

The interest in interventional cardiology in India began after visits of Dr Andreas Gruentzig and Dr Geoffrey Hartzler in Mumbai, in early 1980s (see ref 2 ). Many Indian cardiologists got trained abroad, some under Dr Andreas Gruentzig, and started cor-onary interventions in India. Dr A.B. Mehta, Dev B. Pahalajani, Samuel Mathews, Ashok Seth, Upendra Kaul, Soma Raju, Ashok Dhar, K.K. Sethi, D.S. Gambhir, Manotosh Panja and few others who were concerned about the future of coronary interven-tions met informally at Hinduja Hospital in Mumbai, in 1985, and formed a group called PTCA Registry of India. The soul purpose of the group was to share experiences and discuss complications, which used to be quite high because of unfriendly devices and hardware and absence of stents. More and more cardiologists and cardiologists in training learnt from each other during the PTCA registry meetings.

The PTCA registry ultimately became the National Interventional Council of the Cardiologi-cal Society of India (NIC–CSI) and since then has grown to be the main platform for the interven-tional cardiologists of India with its annual mid-term meeting attracting close to 2000 attendees 3 , 4 . The NIC–CSI has become more mature and has expanded its activities beyond this fl agship confer-ence. The data and scientifi c content of NIC are

212 SECTION IV — Interventional Cardiology

20150

1,000

2,000

3,000

4,000

Th

ou

san

ds

of

pro

ced

ure

s

5,000

6,000

Global cardiovascular surgical and interventional procedures volume

2016 2017 2018 2019 2020 2021 2022

Coronary revascularization

Lower extremity arteryrevascularization

CRM management procedures

Venous interventions

Structural heart procedures

Stroke prophylaxis/treatment

AAA/TAA repair procedures

Cardia support procedures

Figure 28-1. Global cardiovascular surgical and interventional procedures volume.

20150

1,000

Th

ou

san

ds

of

pro

ced

ure

s

Global cardiovascular surgical and interventional procedure volumes,by region, 2015–2022

2,000

3,000

4,000

5,000

6,000

7,000

2016 2017 2018 2019 2020 2021 2022

United States Largest Western European States Major Asian-Pacific States Rest-of-the-World

Figure 28-2. Global cardiovascular surgical and interventional procedures volumes, by regions (2015–2022).

213Chapter 28 — Growth of Interventional Cardiology in India: The Relevance of NIC

country and now India has more than 1200 cardiac catheterization laboratories in about 1000 cardiac facilities in metropolitan cities and tier-1 and tier-2 cities.

Interventional cardiology has grown exponen-tially in India since last 33 years. The growth is seen in the following areas 6 :

1. Increase in the number of cardiac catheterization laboratories

2. Increase in the number of coronary interven-tions

3. Expansion of noncoronary interventions – endovascular, paediatric, structural, electrophysiology

4. Growth of primary angioplasties 5. Sustained growth and improvement in NIC data

collection (both qualitative and quantitative) 6. Growth in interventional research (multinational

trials, national trials and registries and investigator-initiated trials and registries)

7. Growth in educational aspects of interventional cardiology • Growth of NIC mid-term meeting with spe-

cial emphasis on scientifi c content, live cases and workshops

• Dedicated interventional meetings on electro-physiology, paediatric interventions, endovas-cular interventions, structural heart disease, primary angioplasty

8. International collaborations of NIC, now with 13 international interventional societies

RELEVANCE OF NIC IN GROWTH IN INTERVENTIONAL PROCEDURES IN INDIA

The data on coronary and other interventional pro-cedures in India are largely available through the data collected by the NIC every year. The NIC data are presented every year in the mid-term NIC meet-ing. A comprehensive pro forma captures not only the number and type of interventions but also the prevailing practice in PCI and other interventions. The NIC data are collected in three ways:

1. A web-based system ( http://www.nicregistry.org ) 2. Emailing complete PDF questionnaires 3. Postal collections

The data are collected, collated and analysed by an independent agency (JVS Enterprise) and re-ported by the NIC 7 , 8 . Over the past few years, there has been a sustained growth and improve-ment in NIC data collection (both qualitative and quantitative). The data are also collected from sec-ondary sources. The secondary sources of inter-ventional data collections are from cath labs, companies, medical device companies, corporate group hospitals, internet and representative data ( Figs 28-4 and 28-5 ).

2015

0

1,000

Th

ou

san

ds

Global cardiovascular surgical and interventional procedure

2,000

3,000

4,000

5,000

6,000

7,000

2016 2017 2018 2019 2020 2021 2022

Coronary revascularization Cardiac support procedures LE artery revascularization

AAA/TAA repair procedures Venous interventions Stroke prophylaxis/treatment

Structural heart procedures CRM management procedures

Figure 28-3. Global cardiovascular surgical and interventional procedures.

214 SECTION IV — Interventional Cardiology

The last 5 years have seen a major growth in the number of cath labs and coronary interventions increasing from 539 cardiac catheterization labs and 177,240 coronary interventions in 2012 to about 1200 cardiac catheterization labs and 373,579 coronary interventions in 2016 (as per the NIC data presented in 2016) ( Fig. 28-6 ). There has also been a responsive increase in the number of cen-tres reporting their data, which has increased from 369 in 2012 to 698 in 2016. There is a wide varia-tion in the number of procedure done in different centres (ranging from 4.9% to 32.3%) ( Fig. 28-7 ). A total of 13.4% of high-volume centres perform more than 1000 angioplasties per year contribute to 43.9% of the interventions done in the country ( Fig. 28-8 ).

Many centres are now performing more complex coronary angioplasties and the use of newer devices like rotablator, IVUS, FFR, OCT is increasing over the last 5 years ( Fig. 28-9 ). The number of complex angioplasties including bifurcations, CTO, retro-grade PCI has increased in numbers in large-volume hospitals ( Fig. 28-10 ).

However, smaller centres with less experienced operators and lack of surgical backup do not per-form many complex procedures. The use of bivali-rudin has decreased signifi cantly. Interestingly in India, coronary artery disease is common in younger age and 12.6% of PCIs are done in patient less than 40 years of age. The most common indi-cation of PCI in India is unstable angina followed by stable angina followed by acute myocardial in-farction.

Most of the angioplasties done in India are for single-vessel disease, which is usually LAD. There has been a consistent increase in the number of stents from 215,662 in 2012 to 478,770 in 2016 ( Fig. 28-11 ). The use of DES has gone up from

74.5% to 94.8% in the last 5 years. Bioabsorbable scaffolds could not fi nd a good penetration in India. The PCIs have become markedly safer in over the last 5 years and the complication rates have dropped signifi cantly. There has also been a consistent increase in peripheral and carotid in-terventions, interventions for structural heart dis-ease, balloon valvotomy, paediatric interventions, pacemaker, ICD and CRT-D implantations in the last 5 years ( Fig. 28-12 ).

Primary angioplasty has seen growth from 21,343 primary PCIs done in 2012 to 56,276 pri-mary PCIs done in 2016, which has grown from 12.04% to 15.06% of the total volume of PCIs done in India. The interesting fact is that the cath labs in smaller hospitals and cities are doing more primary cases than the large hospitals in metro towns ( Fig. 28-13 ).

The growth of coronary interventions over the years is mainly attributed to the following causes:

1. Increase in the availability of cath labs and trained operators

2. The pride and charm associated with coronary interventions (which motivates young and up-coming interventional cardiologist)

3. Easy availability of cutting-edge technology 4. Recent reduction in the cost of stents 5. Better outcomes because of good training and

knowledge exchange during meetings like NIC 6. Availability of various insurance schemes

(both private and government-/state-sponsored schemes)

7. Increased awareness of patients and public at large

8. Trend towards better STEMI care and special rel-evance of Consensus Statement on STEMI by Cardiological Society of India which was pre-sented in NIC meeting in 2017

9. Preferential and exponential growth of interven-tional cardiology training, facilities and effi -ciency in private and corporate hospitals

NIC has been widely contributing to the growth of interventional cardiology in India for the last many years by providing a platform for exchange of interventional knowledge by organizing the NIC mid-term meetings with an internationally ac-claimed academic programme, which includes

a. Optimal use and critical appraisal of cutting-edge technology

b. Live case demonstrations of complex coronary and vascular interventions

c. Complication sessions

Rate of growth in data collection

80

70

60

50

40

20

30

0

398

614

698698698698

2014 2015 2016

10

Figure 28-4. Growth in data collection.

215Chapter 28 — Growth of Interventional Cardiology in India: The Relevance of NIC

J & KTotal centers: 8Participation: 3

Punjab & ChandigarhTotal centers: 63 Participation: 32

Himachal pradeshTotal centers: 5Participation: 4

UttarakhandTotal centers: 9Participation: 4

DelhiTotal centers: 50Participation: 44

HaryanaTotal centers: 31Participation: 18

RajasthanTotal centers: 43Participation: 32

GujaratTotal centers: 58Participation: 53

Madhya PradeshTotal centers: 42Participation: 27

MaharashtraTotal centers: 163Participation: 116

GoaTotal centers: 6Participation: 5 Karnataka

Total centers: 68Participation: 53

KeralaTotal centers: 95Participation: 70

TamilnaduTotal centers: 83Participation: 56

PondicherryTotal centers: 8Participation: 5

Andhra PradeshTotal centers: 60Participation: 37

TelanganaTotal centers: 60Participation: 42

OdishaTotal centers: 10Participation: 7

West BengalTotal centers: 36Participation: 26

BiharTotal centers: 9Participation: 7

Arunachal Pradesh,Assam, Nagaland,Manipur, Mizoram,

Sikkim, Tripura,Meghalaya

Total centers: 8Participation: 5

Utter PradeshTotal centers: 52Participation: 35

ChattisgarhTotal centers: 15Participation: 11

JharkhandTotal centers: 7Participation: 6

State wise centers & NIC registryparticipation

Figure 28-5. State-wise centres and NIC registry participation, 2016.

d. How To Do sessions e. Training villages f. Interventional quiz g. Discussion on recent trials h. Back to Basics sessions i. Interactive joint sessions with different Interna-

tional Interventional Societies like SCAI, TCT

(USA), TCTAP, EuroPCR, CCT, APVS/APVIC, AsiaPCR, AICT, Taiwan Society of Interventional Cardiology, Indonesian Society of Interventional Cardiology, BIT and 4TS

The NIC also attracts a large number of globally acclaimed international faculty, which is very im-portant for exchange of knowledge.

216 SECTION IV — Interventional Cardiology

040,00080,000

1,20,0001,60,0002,00,0002,40,0002,80,0003,20,0003,60,0004,00,000

2012 2013 2014 2015 2016

Total coronaryIntervention

2012 2013 2014 2015

Centers 369 404 396 620

CoronaryIntervention

1,77,240 2,16,817 2,48,152 3,55,451

2016

698

3,73,579

Coronary intervention

Coronary intervention (2012–2016)

Figure 28-6. Coronary intervention data for 2012–2016.

2012 2013 2014 2015 2016

201–500

501–1000

1001–2000

2001 >

<200 4.9%

19.4%

25.9%

32.3%

17.5%

3.16

23.67

29.05

26.78

17.34

3.16

23.67

29.05

26.78

17.34

5.34

18.12

25.55

27.50

23.48

5.14%

19.57%

31.66%

25.40%

18.22%

Coronary intervention (2012–2016)

Procedure wise volume share

0.00 10.00 20.00 30.00 40.00

<200

200–500

500–1,000

1,000–2,000

>2,000

2016

0.00

<200

200–500

500–1,000

,000–2,000

>2,000

2015

10.00 20.00 30.00 40.00

Like last year, the top 15% hospitals still do around 45%of the cases and 30% hospitals only do 5% of the cases

Volume share PercentagePercentage

Coronary intervention (2016)

Figure 28-8. Coronary intervention data for the year 2016.

2012% of total PCI 2013 2014 2015 2016

IVUS

FFR

Rotablator 478

545

1,962

717

715

3,373

1,053

1,915

2,554

2,413

4,239

5,078

3,004

5,724

5,452

Coronary intervention (2012–2016)

Other devices used

Figure 28-9. Coronary intervention (2012–2016): other devices used.

Figure 28-7. Coronary intervention data for 2012–2016: procedure-wise volume share.

217Chapter 28 — Growth of Interventional Cardiology in India: The Relevance of NIC

VISION OF NIC IN THE FUTURE GROWTH OF INTERVENTIONAL CARDIOLOGY IN INDIA

The NIC has a vision for 4 years, which includes:

Vision 2017 • Collection of registry data by prospective web-

based model and its audit by reputed audit research groups

• Allotment of codes to each cath lab in the coun-try and making it mandatory to quote these codes while submitting interventional data

• Software upgradation in all cath labs for the ease of fi ling data

Vision 2018 • 100% compliance in reporting interventional

data on standardized formats • Quarterly reports to all cath labs benchmark-

ing them against the National Standard • Working with Ministry of Health for manda-

tory reporting of Adverse Events and Product Failures

• Establishing working groups on STEMI/diabetic patients/bifurcations/CTO to collect data and present separate registries

Vision 2019–2020 • NIC Guidelines for Transcatheter Interven-

tions: It shall include PCI and interventions for valvular and structural heart disease

• NIC shall present region-wise data catching trends for specifi c disease pattern

TAPPING THE TRUE POTENTIAL OF CORONARY INTERVENTIONS IN INDIA IN BACKGROUND OF PRICE CAPPING OF DES

As per the Indian data, there are 30 lakhs STEMI in India, out of which only 12 lakhs are thrombolysed (as per industry data) and only 64,000 receive pri-mary PCI. Almost 60% patients remain untreated and deserve primary PCI and pharmaco-invasive approach to coronary reperfusion. NIC–CSI can map cath labs present in all parts of India and this

Figure 28-10. Coronary intervention (2012–2016): PCI details.

2012% of total PCI 2013 2014 2015 2016

CTO

Instentrestenosis PCI

Retrograde PCI

Bifurcation PCI 4.44%(N: 16584)

3.89%(N: 14530)

2.33%(N: 8689)

0.53%(N: 1978)

3.71%(N: 13093)

3.74%(N: 13232)

1.33%(N: 4682)

0.32%(N: 1121)

5.96%(N: 8000)

–

–

–

–

–

–

–

–

5.39%(N: 7274)

1.96%(N: 2522)

0.32%(N: 427)

Coronary intervention (2012–2016)

PCI details

Figure 28-11. Coronary intervention data for the year 2012–2016: total stents and DES used.

2012 2013 2014 2015 2016

Drug eluting stents (DES)

% of DES in total stents

Bioresorable stents

Total stents used 4,78,770

4,54,159

94.86%

2205

4,33,650

4,15,350

95.78%

3,10,1902,62,349

2,05,419

78.30%

2,15,662

1,60,668

74.5%

2,57,148

82.90%

Coronary intervention (2012–2016)

Total stents & DES used

218 SECTION IV — Interventional Cardiology

Figure 28-12. Peripheral intervention data (2014–2016).

2014 2015 2016 SAD

Renal 2,832 1,947 2,172

Carotid 1,624 1,721 1,848

Peripheral 3,938 8,047 10,745 32,235

Peripheral intervention (2012–2016)

The actual numbers aremuch higher as the casesperformed by Radiologists/vascular surgeons are not

reported

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

Figure 28-13. Coronary intervention data for the year 2016: interventions in acute MI.

Coronary Intervention (2016)

Interventions in acute MI

2014 2015 2016 SAD

Total no. of primary PCI 41,057 44,054 56,276 64,000

% of total interventions 16.55% 12.47% 15.06% 16%

SAD* Statistically Adjudicated data

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

2014 2015 2016 SAD

Primary PCI

Cath labs in smaller hospitalsand cities are doing moreprimary cases than the largehospitals in metro towns.

219Chapter 28 — Growth of Interventional Cardiology in India: The Relevance of NIC

may create a win-win situation for health care de-livery and industry to treat acute MI by primary PCI. This alone has the potential to increase the number of PCI in our country by threefolds. The availability of cath labs in smaller cities will also create huge job opportunities for paramedical staff. The cath lab industry must tap this huge potential by offering innovative fi nancial packages for lease and deferred payments. Domestic and multina-tional companies must re-invent their R&D model to explore the possibility of providing their best technologies to Indian patients. Increased afford-ability might push multivessel angioplasty. It would be interesting to note the impact of price capping on the overall number and quality of PCI in coming years. It is advisable that government decisions pertaining to interventional treatment of cardiovas-cular disease should involve NIC–CSI as it is the representative body of cardiologist of India.

2. Pahlajani, D. ( 2016 ). Down the memory lane – The Cardiological Society of India . Indian Heart Journal , 68 , 243 – 245 .

3. Koduganti, S. C., Hiremath, S., Tiwari, S., Raghu, T., Kahali, D., & Danis, S. ( 2006 ). Coronary interventions data in India for the year 2005 . Indian Heart Journal , 58 , 279 – 281 .

4. Dani, S., Sinha, N., Bhargava, B., Jain, V., Reddy, V. Y., Biswas, P. , et al . ( 2007 ). The report of the Coronary Car-diac Interventions Registry of India. The Cardiological Society of India for the year 2006 . Indian Heart Journal , 59 , 528 – 530 .

5. Advanced Medical Technologies . Insights, perspectives and inside data from medtech analysis at MedMarket Diligence, LLC. Cardiovascular Procedure. https://blog.mediligence.com/2017/02/13/cardiovascular-procedure-volume-growth-interventional-and-surgical/.

6. Kaul, U., & Bhatia, V. ( 2010 ). Perspective on coronary interventions & cardiac surgeries in India . Indian Journal of Medical Research , 132 , 543 – 548 .

7. Mishra, S., Chakraborty, R., & Ramakrishnan, S. Coro-nary Interventional Data 2012 . www.nationalinterven-tionalcouncil.org

8. Mishra, S., & Reddy, S. E. ( 2012 ). The future importance of devices from emerging countries: The butterfl y effect . EuroIntervention , 8 ( 8 ), 887 – 889 .

REFERENCES

1. Das, M. K., Kumar, S., Deb, P. K., & Mishra, S. ( 2015 ). CSI Forum History of Cardiology in India . Indian Heart Jour-nal , 67 , 163 – 169 .