Description of tiers

TIER	Indication	Criteria	Location	Duration	Renewable
1	VA-ECMO for cardiogenic shock	All within 24 hours: Systolic BP <90 mmHg Cardiac index <1.8 L/min-m² off inotropes Cardiac index <2 L/min-m² on inotropes PCWP >15 mmHg If no hemodynamics then within 24 hours: CPR or Systolic BP <70 mmHg or Lactate >4 or AST/ALT >1000	Inpatient	7 days	Regional review board for all Must state contraindication to durable device Must demonstrate criteria for failure to wean
1	Non-dischargeable BiVAD		Inpatient	14 days	Renewable till transplant
1	MCSD with VT/VF	Needs BiVAD support Or Not a candidate or failed ablation with ≥3 episodes of VT/VF separated by 1 hour in the setting of nl K and Mg and needing cardioversion despite IV antiarrhythmics	Inpatient	14 days	Renewable if remains in hospitalized on IV antiarrhythmic drugs
2	Supported by non-dischargeable LVAD	Non-FDA-approved device for discharge	Inpatient	14 days	Regional board review needed Center must indicate why patient is not candidate for durable implanted device Failure to wean within 48 hours of renewal as evidenced by: MAP <60 mmHg Cardiac index <2 L/min-m² PCW >15 mmHg SvO₂ <50%
2	Supported by TAH, BiVAD, RVAD or VAD for single ventricle		In- or outpatient	14 days	Resubmit form only
2	MCSD malfunction	Malfunction of at least 1 component of device Malfunction can't be fixed without device exchange Malfunction causes inadequate circulatory support and is in danger of pump stoppage	Inpatient	14 days	Resubmit form only
2	Percutaneous endovascular MCSD	All within 24 hours: Systolic BP <90 mmHg Cardiac index <1.8 L/min-m² off inotropes Cardiac index <2 L/min-m² on inotropes PCW >15 mmHg If no hemodynamics then within 24 hours: CPR or Systolic BP <70 mmHg or Arterial lactate >4 or AST/ALT >1000	Inpatient	14 days	Regional review board Center must indicate why patient is not candidate for durable implanted device Failure to wean within 48 hours of renewal as evidenced by: MAP <60 mmHg Cardiac index <2 L/min-m² PCW >15 mmHg SvO₂ <50%
2	VT/VF no mechanical support	Not a candidate for or failed ablation with ≥3 episodes of VT/VF separated by 1 hour in the setting of normal K and Mg and needing cardioversion despite IV antiarrhythmic	Inpatient	14 days	Resubmit form only
3	Dischargeable LVAD discretionary 30 days	Any time selected by transplant center	In- and outpatient	30 days	Once only unless patient receives a second device
3	Multiple inotropes or single high dose inotrope with hemodynamic monitoring	Patient must have invasive PA catheter or daily hemodynamic monitoring with cardiac output and LV pressures Is in cardiogenic shock wall in a 24-hour period: Systolic BP <90 mmHg PCW >15 mmHg Cardiac index <1.8 L/min-m² on no inotropes or MCSD or <2.2 L/min-m² on support Inotropes at doses: Dobutamine ≥7.5 ucg/kg/min Milrinone ≥0.5 Epi ≥0.02 Or combination of at least 2 inotropes with: Dobutamine ≥3 Milrinone ≥0.25 Epi ≥0.01 Dopamine ≥3	Inpatient	14 days	Renewable as long as patient in hospital with hemodynamic monitoring And meets the following criteria within 48 hours of renewal: Cardiac index <2.2 L/min-m² on current regimen Failed attempt to wean with at least one of the following: Cardiac index <2.2 L/min-m² with decrease inotropes Increase in creatinine by 20% over baseline and 24 hours post-dose reduction Increase lactate >2.5 SvO₂ <50% on CV catheter
3	MCSD with hemolysis	Two criteria must be met: Two separate samples collected within 48 hours of each other with at least 2 criteria: LDH >2.5 upper limit of normal Plasma free Hgb >20 Hemoglobinuria At least 1 attempt to treat with IV anticoagulant, IV antiplatelet agent or thrombolytic	In- or outpatient	14 days	Renewable
3	MCSD with pump thrombosis	Visually detected thrombus in a paracorporeal device; TIA, CVA, or thromboembolic event in patients without intracardiac clot or significant carotid disease	In- or outpatient	14 days	Renewable
3	MCSD with right heart failure	Requires >14 days of support with: Dobutamine ≥5 ucg/kg/min Dopamine ≥4 Epi ≥0.05 Inhaled nitric oxide IV prostacyclin Milrinone ≥0.35 Within past 7 days PCW <20 mmHg and RA >18 mmHg	In- or outpatient	14 days	Renewable
3	MCSD with driveline infection	Erythema/pain along driveline AND leukocytosis or 50% increased WBC + either + driveline culture last 14 days or + fluid collection culture	In- or outpatient	14 days	Renewable
3	MCSD with driveline infection	Debridement with + cultures	In- or outpatient	14 days	Renewable
3	MCSD with driveline infection	Bacteremia treated with antibiotics	In- or outpatient	42 days	Renewable
3	MCSD with driveline infection	Recurrent bacteremia with same organism within 4 weeks post-antibiotic treatment	In- or outpatient	90 days	Renewable
3	MCSD with driveline infection	+ Culture of material from pump pocket	In- or outpatient	90 days	Renewable
3	MCSD with mucosal bleeding	Hospitalized twice within 6 months for mucosal bleeding (excludes hospitalization for initial implant) plus all of the following: Received >2 units PRBCs/hospitalization INR <3 HCT <20 or 20% decrease in HCT	In- and outpatient	14 days	Renewable
3	MCSD with mucosal bleeding	If hospitalized 3 times within 6 months and all of above	In- and outpatient	90 days	Renewable
3	MCSD with AI	Must meet all criteria: Mod AI on echo with MAP <80 mmHg PCW >20 mmHg NYHA Class III-IV	In- or outpatient	90 days	Renewable
3	VA-ECMO after 7 days	Tier 1 for 7 days	Inpatient	7 days	Renewable
3	Non-dischargeable surgically implanted non-endovascular LVAD	Tier 2 previously	Inpatient	14 days	Renewable
3	IABP after 14 days	Tier 2 previously	Inpatient	14 days	Renewable
4	Dischargeable LVAD	On VAD	In- or outpatient	90 days	Renewable
4	Inotropes without hemodynamic monitoring	Cardiac index <2.2 L/min-m² within 7 days and PCW >15 mmHg and on 1 of the following drips: Dobutamine ≥3 Dopamine ≥3 Milrinone ≥0.25 Epi ≥0.01	In- and outpatient	90 days	Renewable
4	Congenital heart disease	OPTN approved qualifying CHD diagnoses	In- and outpatient	90 days	Renewable
4	CAD with intractable angina	Canadian Class IV angina plus myocardial ischemia by imaging	In- and outpatient	90 days	Renewable
4	Restrictive cardiomyopathy Amyloid Hypertrophic cardiomyopathy	One of the following: Canadian Class IV angina NYHA Class III/IV plus CI <2.2 L/min-m² or PCW >20 mmHg VT for 30 seconds or VF Ventricular arrhythmia requiring cardioversion Sudden cardiac death	In- and outpatient	90 days	Renewable
4	Retransplant	ISHLT CAV grade 2-3 or NYHA HF class III/IV	In- or outpatient	90 days	Renewable
5	Multi-organ transplant	Heart plus any other organ	In- and outpatient	180 days	Renewable
6	All other candidates (former Tier 2)		In- or outpatient	180 days	Renewable

VA-ECMO: veno-arterial extracorporeal membrane oxygenation; BP: blood pressure; CI: confidence interval; PCWP: pulmonary capillary wedge pressure; AST: aspartate aminotransferase; ALT: alanine transaminase; BiVAD: biventricular assist device; MCSD: mechanical circulatory support device; VT: ventricular tachycardia; VF: ventricular fibrillation; IV: intravenous; LVAD: left ventricular assist device; MAP: mean arterial pressure; SvO₂: mixed venous oxygen saturation; TAH: total artificial heart; RVAD: right ventricular assist device; VAD: ventricular assist device; PA: pulmonary artery; CV: central venous; LDH: lactate dehydrogenase; TIA: transient ishemic attack; CVA: cerebrovascular accident; RA: right atrium; WBC: white blood cell; PRBC: packed red blood cells; INR: international normalized ratio; HCT: hematocrit; NYHA: New York Heart Association; OPTN: Organ Procurement and Transplantation Network; CHD: coronary heart disease; CAD: coronary artery disease; ISHLT: The Registry of the International Society of Heart and Lung transplantation; CAV: cardiac allograft vasculopathy; CHF: congestive heart failure.

Reference:

Organ Procurement & Transplantation Network. Policy 6: Allocation of Hearts and Heart-Lungs. Available at: https://optn.transplant.hrsa.gov/media/2412/adult_heart_approved_policy_language.pdf (Accessed on November 14, 2018).

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خرید پکیج

Description of tiers