PDA closure: device selection

Transcription

1 PDA & ASD CLOSURE: DEVICE SELECTION Dr. Alejandro Peirone, FSCAI Hospital Privado y Hospital de Niños de Córdoba Argentina. October 5, Buenos Aires.

2 Conflicts of interest: AGA St Jude pfm Medical Cardia Occlutech Consultor y proctor Consultor y proctor Proctor Proctor

3 PDA closure: device selection Background: PDA 3rd most frecuent CHD (Carlgreen et al. 1959) 12% of all types of CHD (Anderson et al. 1954) Female predominance 3:1 (Zetterquist et al. 1972) Percutaneous closure modality of choice in children > 5 kgs and adults

4 PDA closure: device selection Indications for closure Severe LV overload - CHF Endarteritis prophylaxis Pulmonary hypertension: - Infant: low PVR - Older child and adult: vasoreactivity test / balloon occlusion Silent PDA? Endarteritis associated with a clinically silent PDA. Balzer y col. Am H J 1993

5 PDA closure: device selection Guidelines for percutaneous closure PDA must be well seen on angio: Lateral RAO 45º projections 100º rotation with some cranial angulation (oblique course) Difficult delineation (large adults; right sided): balloon sizing Useful measurments: minimal diameter at PA side (D1) maximal ampulla diameter (D2) depth of the ampulla (device accommodation) length of the PDA (L)

6 PDA closure: device selection Where is the PDA? Importance of PDA delineation Left lateral RAO 45º

7 Procedure PDA closure: device selection General anesthesia (except adults) Vacular access and full heparinization - retrograde approach: femoral artery - antegrade approach: femoral vein Angiography: left lateral - RAO (45º) Select proper device: Coils - at least 2x the narrowest portion of PDA loops in PA - If significant residual leak, put 2nd coil (avoid hemolysis) Devices sits in the Ao ampulla. Distal diameter should not exceed > 2 mm Ao ampulla diameter

8 PDA closure: device selection Technical tips Three K`s of Lee Benson: Keep it simple! Keep the patient safe! Keep you out of trouble! Do not cross the PDA before angio: spasm! Remember that each PDA is different: fingerprints! Cost / benefit (not only in developing countries ) Be prepared for challenging cases and nightmares

9 PDA closure: device selection Guidelines for device selection Types A, D, E < 2.5 mm: Gianturco coils (uncontrolled release) Flipper coils (controlled release) Nit Occlud (flex, medium, PDA Amplatzer family (ADO I (flex, medium, PDA-R) (ADO I - II, AS) Types A, D, E > 2.5 mm: Nit Occlud (medium, PDA Amplatzer family (ADO I Types B, C: (medium, PDA-R) (ADO I - II) Amplatzer family, Nit Occlud (PDA-R)

10 PDA closure: device selection Gianturco Embolization Coils (Cook Medical) Stainless steel coil with attached synthetic fibers Supplied preloaded in a loading cartridge Uncontrolled release Delivered using a soft, straight wire through a standard 4F and 5F angiographic catheters ; ; coil size Loop number : Length (diameter)

11 PDA closure: device selection Gianturco Embolization Coils (Cook Medical) coil; loop 2x minimal PDA diameter fitting in ampulla; at least 3 loops, better 4-5 if depth of ampulla permits

12 PDA closure: device selection Flipper Embolization Coils (Cook Medical) Stainless steel coil with attached synthetic fibers Detachable system for controlled release w/ interlocking screws between spring coil and delivery wire Delivered through 4-5F angiographic catheter Manipulation of coil prior to detachment allowed coil size; mm diameter; configuration loops.

13 PDA closure: device selection Flipper Embolization Coils (Cook Medical)

14 PDA closure: device selection Nit-Occlud PDA Occlusion System (pfm Medical) Spiral nitinol coil - S type - (reinforced reverse cone) Graduated stiffness from aorta to proximal windings Repositionable, retrievable Types: Flexible 4 x 4 mm, 5 x 4 mm, 6 x 5 mm Medium 7 x 6 mm, 9 x 6 mm, 11 x 6 mm Disposable delivery system

15 PDA closure: device selection Nit-Occlud PDA Occlusion System (pfm Medical)

16 PDA closure: device selection Amplatzer Duct Occluder I & II (St Jude - AGA) Conical shaft shape with retention skirt and polyester fabric inserts (I) Multi-layered layered mesh lobes with two symmetrical retention discs (II) Self-expandable, expandable, repositionable and recapturable Delivery catheter/sheath: 4-7 F Sizes: 5/4 to 16/14 ADO I 3/4 to 6/6 ADO II

17 PDA closure: device selection New Amplatzer Duct Occluder AS (St. Jude - AGA) Self-expanding, expanding, 144 wires, tightly-woven nitinol. Symmetrical design: central waist & two flat retention discs. 4F delivery system 3 waist diameter: 3, 4, 5 mm 3 waist lengths: 2, 4, 6 mm PDA 3 mm in length and 4 mm in diameter

18 PDA closure: device selection Amplatzer (ADO) family PDA diameter <1mm 2 mm 4 mm 6 mm 12 mm ADO II AS PDA length 3 mm 5 mm 8 mm >12 mm >3 * 8^ mm de longitud < 4 mm de diámetro en la medición central más grande ADO II >5 * 12^ mm de longitud > mm de diámetro en la medición central más grande ADO >5 * mm de longitud >3 12 mm de diámetro en medición más angosta dentro del DAP

19 PDA closure: device selection Amplatzer Duct Occluder I & II (St Jude - AGA) ADO I ADO II

20 PDA closure: device selection Amplatzer Duct Occluder II (St Jude - AGA) PRE POST

21 PDA closure: device selection Nit-Occlud PDA-R (pfm Medical, Germany) Single nitinol wire with a single layer layer LA disc w/o welding or hubs Reverse configuration of LA disc Snare-like release mechanism Pre-mounted device Sizes: 4, 5.5, 7, 8.5, 10, 11.5, 13.

22 PDA closure: device selection Nit-Occlud PDA-R (pfm Medical, Germany)

23 PDA closure: device selection Device: Nit-Occlud PDA-R

24 PDA closure: device selection Challenging cases: Very large type C PDA closed using an Amplatzer muscular VSD device

25 PDA closure: device selection Conclusions I Percutaneous intervention is the method of choice for PDA closure in pts > 5 kgs Coils are effective and economical for closing small PDA`s Devices have shown to be also safe and effective occluding moderate - large PDA`s Using these tools, success rate is very high and complications are rare

26 ASD closure: device selection Background: ASD 4rd most frequent CHD (Nora et al. 1959) 8.5% of all types of CHD (Hoffman et al. 1995) 30% of all CHD in adults (Kaplan et al. 2001) Percutaneous closure modality of choice in children and adults

27 ASD closure: device selection Indications for closure Significant RA / RV overload (Qp/Qs > 1.5:1) Symptoms Pulmonary arterial hypertension Prevention: arrhythmias, HTP in adulthood Post TIA-stroke: paradoxical embolism?

28 ASD closure: device selection Outcomes: FDA-MAUDE database High technical success and closure rate Improvement in both right ventricular dilatation and supraventricular arrhythmias Rate of major and minor complications is lower in interventional pts compared with surgical pts Overall safety and effectiveness of the percutaneous technique has compared favourably with surgical repair

29 ASD closure: device selection Current problem: Erosion! Ruiz Lera y col. Rev Esp Cardiol. 2007

30 ASD closure: device selection Implanted ASD devices. Period Multicenter experience in Córdoba Amplatzer Septal Occluder (St Jude AGA) 320 Figulla device (Occlutech) 54 Nit Occlud ASD-R (pfm Medical) 37 Solysafe device (Swissimplknat AG) 4 Ultrasept device (Cardia) 4 Total 419

31 ASD closure: device selection Amplatzer device (AGA - St Jude, USA) Advantages: Septal occluder device Proven outcomes (f/u > 15 years) Low profile User-friendly Low thrombus formation rate Excellent TorqVue sheath (curve/maneuverability) Echo-friendly Self-centering, retrievable, repositionable High closure rate Versatility: can close almost all types and sizes ASD s! Disadvantages: Cribriform device Erosion Rigidity: delivery cable and wire mesh Pin LA disc

32 ASD closure: device selection Amplatzer device (AGA St Jude, USA)

33 ASD closure: device selection Figulla flex II device (Occlutech, Germany) Advantages: Figulla device Low profile User-friendly More flexible than ASO (important in adult ASD s) Low thrombus formation rate Cook sheath avoids prolapse LA disc Echo-friendly Self-centering, retrievable, repositionable High closure rate Delivery system w/ bioptom (more flexible) No LA pin (faster endothelization?) Versatility: can close almost all types and sizes ASD s! Disadvantages: No LA pin Limited f/u time Unknown erosion rate Larger delivery sheats (rescue after embolization?)

34 ASD closure: device selection Figulla flex II device (Occlutech, Germany)

35 ASD closure: device selection Helex device (W. L Gore, USA) Advantages: Helex device Proven outcomes (f/u > 10 years) Low profile Soft tissue - like Less metal Erosion exceptional Easier to rescue after embolization Low thrombus formation rate Very flexible system Smaller delivery sheaths Retrievable, repositionable Disadvantages: To close small to moderate size ASD s (up to 18 mm) More complex system for implantation Less echo-friendly and less predictable final position Higher residual shunts Not self-centering

36 ASD closure: device selection Helex device (W. L Gore, USA)

37 ASD closure: device selection Ultrasept device (Cardia, USA) Advantages: Low profile User-friendly Self-centering, retrievable, repositionable Echo-friendly High closure rate No LA pin Ultrasept device Disadvantages: Frequent development of new generation devices (currently 7th generation of septal occluders) Erosion Larger delivery sheats Limited f/u time Higher thrombus formation rate (first generation) Not suitable for very large ASD s

38 ASD closure: device selection Ultrasept device (Cardia, USA)

39 ASD closure: device selection Nit Occlud ASD-R device (pfm, Germany) Advantages: Nit Occlud ASD-R device Low profile User-friendly Self-centering, retrievable, repositionable Echo-friendly High closure rate No RA-LA pin Less metal in LA disc. Less thrombus formation? Simple release mechanism Very flexible Disadvantages: Erosion unknown Larger delivery sheats Limited f/u time Not suitable for very large ASD s (up to 28 mm) Difficult to rescue after embolization?

40 ASD closure: device selection Nit-Occlud ASD-R device (pfm, Germany)

41 ASD closure: device selection Conclusions II Percutaneous closure is the method of choice for the majority of the ostium secundum type ASD s Compares favourably with surgery regarding incidence of minor and major complications, safety and effectiveness ASD anatomy (specially size, location and rims) is crucial for device selection

42 PDA - ASD closure: device selection Córdoba, Argentina Thank you!