Implantation of the Melody Transcatheter Pulmonary Valve - Miami ...

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JACC Vol. 54, No. 18, 2009October 27, 2009:1722–9Zahn et al.Early Results From the Transcatheter Pulmonary Valve Trial1725Clinical Characteristics of Study Patients (n 34)Table 4 Clinical Characteristics of Study Patients (n 34)Variable/CategoryWeight, kg 61.1 15.3SexMale 26 (77)Female 8 (23)Age, yrs 19.4 7.7Original diagnosisTetralogy of Fallot 18 (52)Truncus arteriosus 4 (12)Aortic valve disease (Ross procedure) 4 (12)Transposition of the great arteries 3 (9)Other 5 (15)NYHA functional classificationI 6 (18)II 23 (67)III 5 (15)IV 0 (0)RVOT conduit typeHomograft 27 (79)Biologic valved conduit 3 (9)Other* 4 (12)RVOT conduit size 20.0 2.1Primary indication for implantationStenosis 6 (18)Regurgitation 23 (67)Mixed stenosis and regurgitation 5 (15)Pre-existing stents in RVOT conduitNo pre-existing stents in RVOT conduit 19 (56)Single stent in RVOT conduit 12 (35)Multiple stents in RVOT conduit 3 (9)Number of previous open surgeries 2.2 1.0PR by echocardiographyNone 0 (0)Trace 0 (0)Mild 1 (3)Moderate 12 (35)Severe 20 (59)Unable to assess 1 (3)Average conduit Doppler mean gradient (mm Hg) 28.4 11.4Data are presented as mean SD for continuous data or n (%) of subjects for categorical data.*Other conduit types were nonvalved “tube grafts,” nonvalved homograft, and bioprosthesis.Abbreviations as in Table 1.discharged within 7 days. Criteria for procedural successwere met in 93% (28 of 30) of attempted implantations. Inaddition to the patient with conduit rupture, the otherpatient categorized as a procedural failure had a postimplantationRV-PA peak gradient of 37 mm Hg. Thegradient across the Melody valve was only 5 mm Hg, butthere was subvalvar muscular obstruction, which resulted inthe elevated RV-PA gradient. In subsequent follow-up, thispatient’s conduit Doppler mean gradient was consistently25 mm Hg, and no further intervention was performed.Short-term effectiveness. In terms of the short-term effectivenesscriteria defined in Table 3, 29 patients retainedthe Melody valve at 24 h, and 24 (83%) had acceptablehemodynamics at the 6-month time point. Follow-up dataare presented for the 29 patients who retained a Melodyvalve at 24 h.ACUTE HEMODYNAMIC RESULTS. After valve implantation,RV systolic pressure, RV-PA gradient, and the RV/aorticpressure ratio were significantly lower, and the PA diastolicpressure was significantly higher than before implantation(Table 5). Pre-discharge echocardiography demonstrated noPR or trivial PR in 86% of patients and mild PR in 14%.CLINICAL ASSESSMENT. NYHA functional class improvedafter Melody valve implantation (Fig. 1). Of 24 patientswho were NYHA functional class II or III before implantation,19 (79%) had an improvement of at least 1 class; nopatient experienced a decline in NYHA functional class.ECHOCARDIOGRAPHY. Valve competence was maintainedduring follow-up, with 93% of patients having no/trivialPR and no patient having more than mild PR 6 monthsafter implantation. Improvement of conduit obstructionwas maintained for the group as a whole, with averageDoppler mean gradient improving from 28.8 10 mmHg before implantation to 22.4 8.1 mm Hg at 6months (p 0.001). Five patients had Doppler meangradients 30 mm Hg at 6-month follow-up. One ofthese patients had a major stent fracture and underwent asuccessful second Melody valve implantation, 1 hadasymmetric expansion of the Melody valve and wastreated successfully using high-pressure balloon angioplasty,1 was discovered at subsequent catheterization tohave obstruction below the conduit, 1 had stent fracturebut had not undergone repeat catheterization, and in 1patient there was no obvious explanation. All 5 were inNYHA functional class I at most recent follow-up.cMRI. Twenty-five patients (83%) had paired cMRI databefore and 6 months after implantation (Table 6). Significantreductions in PR fraction and RV end-diastolic volumewere seen. The median PR fraction was 3.1% at 6 monthsAcute Hemodynamic Catheterization Data (n 29)Table 5 Acute Hemodynamic Catheterization Data (n 29)Variable Pre-Implantation Post-Implantation p ValueRV systolic pressure, mm Hg 67.7 16.1 (68; 32–108) 48.9 13.7 (46; 26–82) 0.001RV/aortic systolic pressure ratio 0.7 0.2 (0.7; 0.3–1.0) 0.4 0.1 (0.4; 0.3–0.75) 0.001RV-PA gradient, mm Hg 37.2 16.3 (39; 9–69) 17.3 7.3 (18; 5–37) 0.001PA diastolic pressure, mm Hg 11.0 5.2 (10; 1–28) 14.7 5.1 (15; 4–28) 0.001Data are presented as mean SD (median; minimum–maximum).Abbreviations as in Table 3.
1726 Zahn et al. JACC Vol. 54, No. 18, 2009Early Results From the Transcatheter Pulmonary Valve Trial October 27, 2009:1722–9Figure 1New York Heart Association Functional Classification as a Functionof Time for Patients Receiving a Melody Valve (Medtronic, Inc.) (n 29)and was no higher than 11.6% in any patient. No significantchanges were noted in RV or left ventricular ejectionfraction or left ventricular end-diastolic volume.CPET. Twenty-nine patients had paired CPET data frombefore and 6 months after implantation. There were nodifferences between pre-implantation and 6-month follow-uppeak VO 2 (21.6 6.8 ml/kg/min vs. 22.7 7.1 ml/kg/min,p 1.0) or anaerobic threshold (15.0 4.7 ml/kg/min vs.15.5 5.6 ml/kg/min, p 1.0).CT PULMONARY ANGIOGRAPHY. Twenty-nine patients hadpaired CT pulmonary angiography before and 6 monthsafter implantation, and no new findings of pulmonaryemboli were discovered. One patient had findings of chronicpulmonary emboli in the right upper lobe noted on thepre-implantation CT, which remained unchanged at6-month follow-up.RADIOGRAPHY/CINEFLUOROSCOPY. Stent fractures wereobserved in 8 of 29 patients (28%) during follow-up, 1 at 3months and the others at 6 months. When diagnosed, all 8patients were NYHA functional class I, and all but 1 hadless than trace PR and a conduit Doppler mean gradient30 mm Hg. Although most of these fractures were minor(i.e., a single wire break with no loss of stent integrity), 3patients had a second Melody valve implanted 11, 12, and14 months after the initial implantation to treat progressiveconduit obstruction associated with multiple fracture points,loss of stent integrity, and progression to NYHA functionalclass II. Implantation of a second Melody valve was uncomplicatedand preceded by placement of bare-metal stainlesssteel stents in all 3 cases. Hemodynamic results after repeatMelody valve implantation were similar to initial implantation.The other 5 patients with minor stent fracturesremained stable in NYHA functional class I without evidenceof a loss of stent integrity or progressive RVOTobstruction. Freedom from re-intervention for stent fractureassociated with recurrent RVOT obstruction was 96.6% at 1year (Fig. 2).Safety. Aside from the procedural adverse events, stentfractures, and re-interventions summarized above, no otherCardiac 6 Months Magnetic After Cardiac Melody Resonance Magnetic Valve (Medtronic, Imaging Resonance Results Inc.) Imaging Before Implantation Results and Before (n 25) andTable 66 Months After Melody Valve (Medtronic, Inc.) Implantation (n 25)Variable Pre-Implantation Post-Implantation p ValuePR fraction, % 27.6 13.3 (29.8; 4.3–61.0) 3.3 3.6 (3.1; 0.0 - 11.6) 0.001RV EDV index, ml/m 2 144.7 54.8 (133.5; 72.5–290.8) 117.3 48.3 (109.5; 54.3–256.1) 0.001RV ejection fraction, % 40.8 14.6 (39.8; 10.5–72.7) 42.0 12.1 (39.8; 23.8–63.8) 0.86LV EDV index, ml/m 2 84.5 18.9 (85.7; 43.9–121.4) 90.7 20.4 (90.8; 58.5–132.9) 0.30LV ejection fraction, % 52.6 10.5 (54.3; 31.3–68.8) 52.4 8.6 (52.1; 33.3–68.5) 1.0Data are presented as mean SD (median; minimum–maximum).EDV end-diastolic volume; LV left ventricle; PR pulmonary regurgitation; RV right ventricle.
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