K.M. Cherian MS FRACS DSc (Hons) DSc (HC)

Frontier Lifeline & Dr.K.M.Cherian Heart Foundation, Chennai

Experience with Ross Procedure in India

Frontier LifelineChennai

Ross Summit II - 2009 Atlanta

India is a country full of paradoxes. Be it economic stratas in the society, culture, climate or the terrain. A nation of 1.2 billion people with contradictions, that is India. 

Parumala,,

Chennai

Top 10 Economies

Ranking CountryApproximate GDP- Purchasing Power Parity

1 USA $13,860,000,000,000

2 China $7,043,000,000,000

3 Japan $4,305,000,000,000

4 India $2,965,000,000,0005 Germany $2,833,000,000,000

6 United Kingdom $2,147,000,000,000

7 Russia $2,076,000,000,000

8 France $2,067,000,000,000

9 Brazil $1,838,000,000,000

10 Italy $1,800,000,000,000

Below Poverty Line is a benchmark used by the Government of India to indicate economic disadvantage

Internationally, an income of < $1 / day/head of PPP is defined as extreme poverty – 37% of Indians are extremely poor and therefore below the poverty line

Our experience

Special situations

RVOT Reconstruction with xenografts

Mr.Donald Ross conducted the

first workshop for us in

September 1987 (Chennai)

CLASSICAL ROSS Procedures

(2)

Top hat for Tricuspid valve

replacement (for SBE) (1)

Frontier Conclave 2005 Frontier Conclave 2006

Prof Zohair Al-Halees

7 Ross Procedures & 1 Ross

Kono in 2 days with no mortality

Severe Aortic Valve diseases in:

New born infants

Children

Young adults

Women of child bearing age

Patients with infective endocarditis

Patients with complex LVOT obstruction

16th December 1974

Mr. Donald Ross

arrange but at the age of 23, I would be much happier putting in a homograft valve and would certainly use it if it were my own son.

“COST CONTAINMENT”

DOS:22.12.1995

From 1990 till date

No. of patients 160

Age 3 months - 51 years

Males 121

Females 39

Aortic stenosis - 65 pts

Aortic stenosis with Regurgitation - 45 “

Aortic regurgitation - 40 “

Associated CAD - 4 “

Mitral Valve Repair(MV repair 2 and OMV 1) - 3 “

VSD Closure - 2 “

Cong.AS with previous BAV - 1 “

CPB timeRange:101 - 325 minutes

Mean: 124 . 19 minutes

ACC timeRange; 59 - 129 minutes

Mean: 86.46 minutes

Re-exploration within 24 hrs : 12 patients

Delayed sternal closure : 8 patients

Additional CABG for suspected coronary insufficiency : 7 patients

Mortality : 6 patients

Antibiotics for 3 days Aspirin for 6 months Blood culture on 5th post-operative day Follow up echo at 7 days, 3 months and at annual

check up Penicillin prophylaxis till 45 years of age for RHD

patients

Seventh post-op day

Acceptable aortic valve function

Acceptable pulmonary valve function

Three months old child weighing 3.2 kg Ross with reconstruction of RVOT using aortic homograft Two years later came back with severe PR Underwent replacement of the homograft with decelluarised xenograft

11 year old boy

Aortic regurgitation

Both coronaries arising from posterior sinus

Intraluminal angioscopic view showing the orifice of coronaries

19 year old female

Severe calcific AS with root disease

Abscess cavity projecting into RVOT

Abscess cavity exteriorized with indigenous bovine pericardium and Ross procedure performed

Post-op Echo

50 year old man 5 years post-op Ross Chest x-ray : widened aortic

shadow 2-D Echocardiogram : Normally

functioning autograft valve, normally functioning pulmonary homograft and dilated ascending aorta

64-slice CT delineated the aneurysm of the autograft with dissection

Coronary arteries : normal autograft

Intra-operatively, the dissection flap was extending from the level of previous aortotomy to the sino-tubular junction

The left and right coronary buttons were intact

The valve leaflets and the annulus were normal

The native ascending aorta beyond the autograft was normal

Valve sparing root replacement with 28mm Hemashield Dacron graft was performed

Histological examination of the excised autograft wall showed focal loss of elastic fibres and proteoglycan deposition

Presence of a suture line between the native aorta and the pulmonary autograft as well as around the coronary buttons limits the extension of the dissection

Conclusion: Dissection of the pulmonary autograft can occur without neo-aortic valve involvement. Valve sparing root replacement can be done in this situation

The number of Ross procedures performed all over the world is declining due to scarcity or non- availability of Homografts

The Redfern Report, which investigated postmortem practices at Alder Hey Children’s Hospital, identified malpractice

Number of functioning homograft banks in the country: 3

Restrictions from government Delays in post mortem examination Third party insurance necessitates “request” for autopsy from

Police as the body belongs to state Unacceptable mortuary conditions Medico legal cases only come for post mortem Multi religious, multiracial, multilingual and Superstitious

society

We have used indigenously prepared xenografts for RVOT reconstruction in 23 patients undergoing ROSS so far.

The hemodynamic performance, in-hospital results and follow up results are comparable to homograft

Tensile strength testing Stress, strain, Young’s modulus

Burst test

Differential scanning calorimetry

FT-IR

Microscopy

To prove acellularity, collagen architecture, shelf life determination etc

H & E staining Von Giessons staining High resolution optical

microscopy Confocal microscopy Transmission electron

microscopy Scanning electron

Cytotoxicity studies

In vivo In vitro

Guinea pig maximization studies

Retrovirus detection by genomic studies

Acellularity studies by DNA detection

Large animal experiment proving autologous cell deposition and trizonation of the fibrous matrix

Thrombogenicity studies shows no thrombosis

Collagenase digestion tests - resistant to digestion

DSC showing collagen stability of Tissue (>80°°C)

FT-IR Showing largely collagen conformity by presence of amide (CO=NH at 1450-1650 range and non heparin treated BP has shown presence of large spike at 1740 suggesting free-COOH group(arrow)

No spike at 1740-BP(H+)

BP( H-)

Operative photograph showing processed BP implanted as an interposition graft in the internal jugular vein of sheep

Group A explanted from the sheep after 6 months showing thickening of the vessel wall

TESI VIIIth annual congress in Shanghai, China. 2005 October (22nd – 25th) Decellularization of xenografts for clinical use. Soma Guhathakurta, Susan Verghese, Sushma Nayar, Ravi Agarwal, B S Murthy, S Veerappan, P Padmaja, V Balasubramanian, KM Cherian

S. Guhathakurta, S Verghese, V Balasubramanian R Agarwal, BS Murthy, S. Veerappan, P Padmaja, KM Cherian “ Technique to process xenogenic tissues for cardiovascular implantation – preliminary report”, Current Science, Volume 91 No.8, 25 October 2006.

Cherian K M ., Soma Guhathakurta., Susan Verghese., Murthy B S., Ravi Agarwal., Versatile Use Of Indigenously Prepared Bovine Jugular Vein Conduit In Pediatric Cardiac Surgery; 4th World Congress Of Pediatric Cardiology And Cardiac Surgery, Sept. 18-22,2005. Buenos Aires Argentina

R Balasundari, E Kurien, R Gupta, S

Veerappan, S Warrier, V Balasubramanian, K

M Cherian, S Guhathakurta, “ Post

processing complete microbe free Porcine

xenograft suitable for clinical use"

IJTCVS2007;23:240-245. Radha Chandrasekaran ,Balasundari Ramesh

Veerappan Sivasubramanian, Cherian

Kotturathu Mammen, Vijaya Nayak , Soma

Guhathakurta: Cytotoxicity and

Sensitization Studies of Processed Porcine

Xenografts IJTCVS2007;23:240-245. S Guhathakurta, V Balasubramanian, B.V.R

Tata,  KM Cherian, “Effect of Gamma

Irradiation on Xenogenic Tissue Property

” (Revised manuscript under review) S. Guhathakurta “Processing Of Xenografts

for Cardiovascular use”-Nagarjun

University-Stem 2006- Society for

Regenerative Medicine &Tissue Engineering

Guhathakurta, “ Xenografts For Cardiovascular Implants” ; Frontier Conclave - an International Update in Cardiovascular Medicine. December 2005, International Centre For Cardio Thoracic And Vascular Diseases, Frontier Life Line

S. Guhathakurta,,” Processing Of Xenografts As Alternative Cardiovascular Implants”- INDO-US workshop, Sri Chitra Thirunal Institute of Medical Sciences, Thiruvananthapuram, India, Feb 1-3, 2007

Dr. Soma Guhathakurta, Director, Frontier Lifeline, Chennai, India,CLRI – Diamond Jubilee celebration; international conference on RECENT TRENDS IN COLLAGEN- Session 3: Diseases. Jan24-25, 2008.

Guhathakurta, Soma1; Balasubramanian, Venkatesh2; Agarwal, Ravi1; Cherian,KotturathuMammen1Indigenously Processed Bovine Pericardium For Cardiovascular Use), Oral presentation at the 18th World Congress of the World Society of Cardio-Thoracic Surgeons, held at Kos Island , Greece from April 30th to May 3rd 2008.

Soma Guhathakurta, Balasundari R, Sadasiv Santosh Mathapaty, Satish Galla, Ravi Agarwal, Prashant Vyjyanath,K M Cherian, Indigenously processed xenografts for clinical cardiovascular surgical use ;Indo-Aus Biomedical Device Conference, New Delhi,5th March 2009

S. Guhathakurta, V Balasubramanian, B V R Tata, B Anathakrishnan, S Veerappan, R Balasundari, KM Cherian, “Thrombogenicity studies of three different variants of processed bovine pericardium,” Innovation and Technology in Biology and Medicine (in press)IRBM, Volume 29,Issue 4, September 2008, Pages 223 - 230, Elsevier Masson; Science Direct.

50 year old male

Severe calcific aortic stenosis

Ross procedure in February 2004

RVOT reconstruction with porcine xenograft

64 CT MRI Reconstruction on 18/9/09

Ross procedure is a suitable alternative for prosthetic valve replacement in young patients and those with contraindications for anticoagulant therapy

Our initial learning curve has been traumatic from high incidence of reopening for bleeding, delayed sternal closure and coronary insufficiency

At present we have satisfactorily overcome these difficulties

Ross Operation - 3 Age - 12 to 15 yrs Mortality - Nil

Ideal indication (RHD) with good results (no mortality), in unusual location – a small village (non-metropolis or university hospitals) is now possible

Xenografts:

Cost effectiveness makes it suitable for developing nations – US$ 500 as against US$ 2000

No structural failure or SBE so far in this small series

Satisfactory mid term follow-up with functions comparable to homografts. Few of the procedures employing xenograft, have also been performed by surgeons from other countries as well, with similar results.

‘Xenowrap’

Electrospun nano reinforcement of conduits

Hybrid valved conduit

National Medical Science Park

Welcome to Chennai

20.10.2010