Percutaneous pulmonary and tricuspid valve implantations: An update

Table 1 Devices and delivery systems for percutaneous pulmonary valve implantation

	The MELODYTM transcatheter pulmonary valve	The SAPIENTM pulmonic transcatheter heart valve
Manufactor	Medtronic Inc., MN, United States	Edwards Lifesciences LLC, Irvine, CA, United States
Regulatory approval	CE 9/2006 FDA 01/2010	CE 5/2010 FDA 10/2012
(Tissue) characteristics	Segment of bovine jugular vein with a central valve hand-sewn inside a stent	Trileaflet bovine pericardial valve hand-sewn inside a stent
Stent type	Cheatham platinum stent (NuMED CP Stent CP8Z34) Length 34 mm Expandable up to 22 mm	Stainless-steel stent Length of 14 or 16 mm
Available sizes	18, 20, 22 mm (depending on the favoured EnsembleTM delivery (system)	23, 26, (XT 29a ) mm
Delivery system	EnsembleTM (Medtronic, MN) with balloon in balloon (BiB) deployment design	Edwards RetroflexTM III containing a balloon catheter and a deflectable guiding catheter
Sheats for implantation	One-piece 22 Fr Teflon sheath	(18 Frb) 22 Fr for 23 mm valves (19 Frb) 24 Fr for 26 mm valves (16 Frb) 24 Fr for 29 mm XT valves

Technical comparision of the commercially available devices for percutaneous pulmonary valve implantation: the MELODY^TM device and the SAPIEN^TM pulmonic transcatheter heart valve as non-surgical treatment options for RV outflow tract dysfunction (^a“Off label-use” in pulmonary position;

^bManufacturer’s data given for the Edwards eSheath^TM). RV: Right ventricle.

Table 2 Clinical and morphological requirements for percutaneous pulmonary valve implantation

Clinical indications in the context of RV pressure overload/pulmonary stenosis

RV systolic pressure > 65% of systemic pressure in symptomatic patients

RV systolic pressure > 75% of systemic pressure in asymptomatic patients

Clinical indications in the context of RV volume overload/pulmonary regurgitation

Severe pulmonary regurgitation on echocardiography or MR imaging and

Severe RV dilatation > 150 mL/m2 or the RV to LV end-diastolic ratio of > 1.7 and/or

Rapid progressiv RV dilatation and/or

Severe RV dysfunction and/or

Symptoms and/or

Sustained atrial or venticular arrhythmia and/or

Impaired exercise capacity [ < 65% compared to norm peak oxygen consumption related to bodyweight (VO2/kg)]

Morphological indications

Circumferential RV to PA conduit with dimensions ranging from 16 to 22 mm (MelodyTM)

Circumferential RV to PA conduit with dimension at surgical implantation of at least 18 mm but no larger than 29 mm (with some degree of conduit narrowing) (SAPIENTM)

Exclusion of risk for coronary compression

RV: Right ventricle; PA: Pulmonary artery.

Table 3 Haemodynamic outcome immediately post-percutaneous pulmonary valve implantation

	US Melody Valve Trial (n = 124)		London Melody experience(n = 151)		Munich/Berlin Melody experience (n = 102)		Philadelphia Melody experience(n = 104)		Early Edwards experience(n = 7)		Later Edwards experience(n = 36)
Parameter	Pre (median)	Post (median)	Pre (mean)	Post (mean)	Pre (mean)	Post (mean)	Pre (mean)	Post (mean)	Pre (mean)	Post (mean)	Pre (mean)	Post (mean)
RV systolic pressure, mmHg	65	41b	63	45b	NA	NA	72	47b	NA	NA	55	42b
Peak RV to PA gradient, mmHg	37	12b	37	17b	37	14	39	11b	NA	NA	27	12b
RV to systemic pressure, %	0.74	0.42b	0.69	0.4b	0.62	0.3b	NA	NA	0.78	0.3b	0.6	0.4b

Invasively measured pressures and gradients pre and post percutaneous pulmonary valve implantation within the largest trials (n > 100) of the MELODY^{TM[18,19,21,33]} and of SAPIEN^TM implants[28,30] in pulmonary position. In all studies, a profound improvement in RV to systemic pressure ratio in response to PPVI was seen (^bP≤ 0.001) (all parameters expressed by medians). RV: Right ventricular; PA: Pulmonary artery. NA: Not available.