USE OF BALLOON VALVOTOMY AS BRIDGE TO SURGERY FOR SEVERE HIGH RISK MITRAL STENOSIS

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USE OF BALLOON VALVOTOMY AS BRIDGE TO SURGERY FOR SEVERE HIGH RISK MITRAL STENOSIS Prof. Gerald Yonga MBChB, MMed, MBA, FRCP(Edin),FESC, FACC Aga Khan University Hospital Nairobi, Kenya.

RHEUMATIC HEART DISEASE IN AFRICA Rheumatic heart disease amongst children and young adults is still prevalent in Africa(7-35cases/ 1000 by echo, 1.7/1000 - clinical) Most earlier were studies hospital based, cross-sectional and nit detailed enough. Population studies and REMEDY will bridge this knowledge gap Many patients have rheumatic fever and/or rheumatic valve dysfunction and are not aware or are not on follow-up. Prevention and timing of intervention is therefore a serious challenge in most African countries Mitral valve is by far the most affected valve. Predominantly mitral regurgitation but stenosis also significant Mitral stenosis represents a subset of rheumatic fever that follows a slower indolent course mostly showing up at severe stenosis stage Inadequate prevention, screening/diagnosis and follow-up

CHALLENGES OF VALVE DISEASE SERVICES IN AFRICA Few Catheter interventions Centres (esp. Valve) Few active facilities for open heart surgery Unable to afford the surgery even when available. Late/advanced presentations with complications Increased high surgical risk/inoperable patients FREQUENT SCENARIO Detailed individual cases analysis/discussions for possible options for helping desperate advanced high risk cases

INDICATIONS FOR PBMV SYMPTOMATIC SEVERE MITRAL STENOSIS - Suitable (MR grade, other valves, Wilkins score) ASYMPTOMATIC SEVERE MITRAL STENOSIS - intended pregnancy/ in pregnancy - atrial fibrillation - thrombo-embolic phenomena - prior to major extra-cardiac surgery

SURGERY IN MITRAL STENOSIS INDICATIONS Unavailability of PBMV capabilities Unsuitable for PBMV (MR grade >2/4, other valves involved, Wilkins score >10) HIGH RISK/CONTRA-INDICATIONS Severe LV dysfunction (LVEF <30%) Severe PHTN (systemic PAP or > 100mmHg) Other organ significant dysfunction (kidney, liver, pulmonary, cerebral)

INDICATIONS FOR PBMV SYMPTOMATIC SEVERE MITRAL STENOSIS - Suitable (MR grade, other valves, Wilkins score) -? Bridge to surgery for high risk patients (not ideal but will benefit on risk-benefit analysis) ASYMPTOMATIC SEVERE MITRAL STENOSIS - intended pregnancy/ in pregnancy - atrial fibrillation - thrombo-embolic phenomena - prior to major extra-cardiac surgery

Percutaneous Balloon Mitral Valvotomy (PBMV) PBMV has been performed in Kenya since 1994 (Bonhoeffer P, Yonga G, et al Mitral dilatation with the new multi-trac technique. Cath Cardiovasc Diagn 36;189,1995.) Author has > 1000 case series REPORT Series shows < 2% procedure mortality & major complications. 10yr event free survival in 84% of cases (Yonga G, Bonhoeffer P et al Long-term results of percutaneous balloon mitral valvotomy using multi-track technique in Kenya. Eur Heart J 2009; 30(suppl), 392) Method used is predominantly Multi-track double balloon (total cost approx. US$ 3,000/case without catheter re-use).

PATHOLOGY OF MITRAL STENOSIS Driver for MS pathophysiology is persistently elevated trans-mitral pressure gradient resulting into:- reduced cardiac output (vital organs hypoperfusion -renal, coronary, cerebral), Lt atrial dilatation, dysfunction, AF & systemic thrombo-embolism pulmonary oedema, pulmonary arterial hypertension, right ventricular failure and system venous congestive pathology (hepatopathy, ascites, venous thrombo-embolism) Without intervention, functional status does not change and mortality is about 50% within 1yr.

Principal of Bridge PBMV Significantly reducing trans-mitral pressure gradient will:- Improve cardiac output, coronary perfusion and LV function, renal & cerebral flow and function. Improve LA function, prevent embolism and atrial fibrillation mechanisms Relieve persistent pulmonary oedema & HTN, improve RV function and reverse/halt hepatopathy Eventually render the patient fit for surgery

Multi-track method of balloon Valvotomy P. Bonhoeffer, G.O. Yonga, et al: Mitral dilatation with the multi-track system. Cath Cardiovasc Diagn 36;189,1995

PRE-PBMV SEVERE MITRAL STENOSIS 2D

PRE-PBMVSEVERE MITRAL STENOSIS DOPPLER

PRE-PBMV SEVERE PULMONARY HTN

POST PBMV MV 2D

POST PBMV MVA

Post PBMV

POST-PBMV MVA DOPPLER

LONGTERM RESULTS EVENT FREE SURVIVAL STUDY No. Av Age (yrs) Follow up (yrs) Survival (%) Cohen (1992) 146 59 5 51** Orange (1997) 132 44 7 65** Ben Farhat (1998) 30 29 7 90* Menevean (1998) 532 54 7.5 52* Stefanadis (1998) 441 44 9 75* Hernandez (1999) 561 53 7 69* Iung (1999) 1024 49 10 56** Palacios (2002) 879 55 12 33* Shaw (2003) 405 61 10 42* Yonga ( EHJ 2009) 422 31 10 84** * = survival without intervention ** = survival without intervention & in NYHA class I-II

Research Methods Retrospective case series of patients who were candidates for surgery but too sick (clinically very sick, severe PHTN, severe LV dysfunction) and not ideal for PMBV (Wilkin s score 8-11 and MR < 2+ ) and underwent bridge PBMV Cases of bridge PBMV done between Jan 2001 to June 2015 and 1yr follow up data available (by mobile phone call & file) were studied. Status at 1 month, 3months, 6 months, and 12 months were recorded where data available. Outcome measures:- NYHA functional class, CV complications/admissions for heart valve related problem, heart surgery and cardiac related death. Analysis (compared to natural hx of severe mitral valve dx here-in referred to as NO PBMV )

RESULTS Mortality data (main outcome) available for 98% Majority of PBMV (80-87%) became eligible for surgery within 3-6mths (NYHA 2, PAP <60mmHg at rest, LVEF>40%, no significant vital organ dysfunction) 61% were able to have surgery All had mitral valve replacement (MVR) by mechanical prosthesis. At 12mths, mortality was significantly reduced (9.9% vs expected 48.5%), complication rates (6.6% vs 18.7%) and NYHA III-IV much less (10% vs 86%)

Mortality (comparatoris natural hx of severe MVD) 60% 50% 40% 43.90% 48.50% 30% 20% 34.40% PBMV NO PBMV 10% 0% 9% 5.50% 5.70% 6.60% 0% 0.80% 0 MONTH 1 MONTH 3 MONTHS 6 MONTHS 12 MONTHS

Follow-up Complication rates (CV & other) 16% 14% 14.10% 12% 10% 8% 8.10% 8.70% 6% 4% 4.50% 4.90% 5.70% 6.60% 2% 1.60% PBMV NO PBMV 0% 0% 0 MONTH 1 MONTH 3 MONTHS 6 MONTHS 12 MONTHS

Proportions of patients in NYHA class III-IV 100% 90% 80% 87% 83% 85% 86% 84% 86% 70% 60% 50% 40% 30% 39% PBMV NO PBMV 20% 10% 20% 13% 10.00% 0% 0 MONTH 1 MONTH 3 MONTHS 6 MONTHS 12 MONTHS

Conclusions Late presentation of severe valve disease remains a significant problem in in Sub-Sahara Africa. This is complicated by scarce facilities for cardiac surgery, cardiac intervention and inability to afford. Need for innovative approaches to improve survival Modification of PBMV indications is needed.

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