PMC:4913875 / 11009-26553 JSONTXT

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total of 69 patients underwent AVR using a DAH in the period between February 2008 and September 2015. The mean time from allograft harvesting until implantation was 41 ± 11 days. Postoperative follow-up was complete, except for 3 Moldavian patients, where only clinical follow-up was available. However, CMR imaging has been initiated for these patients. The observation time was 140.4 years in total, mean 2.0 ± 1.8 years, maximum 7.6 years. The demographic data of the patients stratified by age subgroups are presented in Table 1.\nTable 1: Patient cohort description according to age groups\nPatient age groupDAH diameter All \u003c10 years \u003c10 years \u003e10 years\n\u003c15 mm ≥15 mm ≥19 mm\nNumber of patients 69 4 12 53\nMean age at implantation (years) 19.7 ± 14.6 1.4 ± 1.2 6.4 ± 2.1 24.1 ± 13.8\nMean follow-up (years) 2.0 ± 1.8 3.3 ± 1.1 1.9 ± 2.2 2.0 ± 1.7\nTotal follow-up (years) 140.4 13.0 22.6 104.8\nSex, male (%) 64 50 75 62\nCongenital AS/AI/AS + AI 24/2/5 3/0/0 6/1/0 15/1/5\nAcquired AS/AI/AS + AI 10/5/13 0/0/0 0/0/0 10/5/3\nPrevious procedures\n Commissurotomy 7 2 1 4\n Aortic valve reconstruction 12 0 4 8\n Ascending aortic aneurysm 1 0 0 3\n Mitral valve disease 3 1 0 2\n Subvalvular aortic stenosis 7 0 3 4\n Pulmonary valve disease 3 0 0 3\n Ross 2 0 0 2\nNo. of previous cardiac surgeries/with ECC/with AVR\n 1 25/25/12 3/3/0 4/4/2 18/17/10\n 2 5/5/4 0/0/0 1/1/0 4/4/4\n 3 and more 9/7/0 0/0/0 2/2/0 7/5/0\nPrevious catheter interventions\n Balloon dilatation 18 2 5 11\nDAH diameter (mm)\n 10–18 7 4 3 0\n 19–22 22 0 8 14\n 23–29 40 0 1 39\nOperation time (min)\n Mean OP time 359.2 ± 101.3 417.3 ± 108.6 387.6 ± 72.8 348.5 ± 104.9\n Extracorporeal circulation 220.8 ± 74.6 266.3 ± 103.1 234.7 ± 58.7 214.0 ± 75.3\n Aortic cross-clamp time 139.0 ± 45.5 138.3 ± 52.5 147.9 ± 40.9 137.1 ± 46.6\nAt last follow-up\n Mean DAH diameter (mm) 21.8 ± 4.4 12.5 ± 1.7 17.3 ± 3.2 23.4 ± 3.2\n Mean peak gradient (mmHg) 13.9 ± 15.3 58.0 ± 33.4 9.5 ± 6.8 11.5 ± 8.4\n Mean regurgitation, grade 0.6 ± 0.5 1.4 ± 1.1 0.7 ± 0.4 0.5 ± 0.4\n Mean LVEF (%) 62.8 ± 7.2 65.1 ± 6.5 68.0 ± 0.0 62.3 ± 7.5\n Mean LV EDVi (ml/m2) 77.8 ± 15.7 69.0 ± 18.4 − 78.8 ± 15.5\n Aortic valve z-values 0.7 ± 1.3 −0.4 ± 0.7 0.3 ± 1.3 0.63 ± 1.2\nAVR: aortic valve replacement; AS: aortic stenosis; AI: aortic insufficiency; ECC: extracorporeal circulation; OP: operation; LVEF: left ventricle ejection fraction; LV EDVi: left ventricle end diastolic volume index.\nThe mean aortic cross-clamp time for isolated AVR was 129 ± 41 min and the mean cardiopulmonary bypass time was 200 ± 68 min when used as the first aortic valve prosthesis. More information about operation times for subgroups is provided in Tables 1 and 2. There was no operative mortality.\nTable 2: Characteristics of patients who underwent extended aortic root replacement\nPatient group EARR\nNumber of patients 18\nMean age at implantation (years) 29.1 ± 15.7\nMean follow-up (years) 1.9 ± 1.2\nTotal follow-up (years) 34.1\nSex, male (%) 83\nCongenital AS/AI/AS + AI 5/0/3\nAcquired AS/AI/AS + AI 3/2/0\nPrevious procedures\n Commissurotomy 0\n Aortic valve reconstruction 3\n Ascending aortic aneurysm 2\n Mitral valve disease 2\n Subvalvular aortic stenosis 0\n Pulmonary valve disease 2\n Ross 1\nNo. of previous cardiac surgeries/with ECC/with AVR\n 1 6/6/4\n 2 2/2/2\n 3 and more 1/0/0\nPrevious catheter interventions­\n Balloon dilatation 4\nDAH diameter (mm)\n 10–18 0\n 19–22 1\n 23–29 17\nOperation time (min)\n Mean OP time 306.9 ± 68.0\n Extracorporeal circulation 195.1 ± 48.6\n Aortic cross-clamp time 125.3 ± 31.7\nAt last follow-up\n Mean DAH diameter (mm) 24.9 ± 2.9\n Mean EOA (cm2) 3.2 ± 0.6\n Mean peak gradient (mmHg) 9.4 ± 4.9\n Mean regurgitation, grade 0.6 ± 0.3\n Mean LVEF (%) 61.7 ± 7.3\n Mean LV EDVi (ml/m2) 80.9 ± 16.1\n Aortic valve z-values 0.9 ± 0.8\nEARR: extended aortic root replacement; EOA: effective orifice area; AVR: aortic valve replacement; AS: aortic stenosis; AI: aortic insufficiency; ECC: extracorporeal circulation; OP: operation; LVEF: left ventricle ejection fraction; LV EDVi: left ventricle end diastolic volume index.\n\nPerioperative complications\nIn 2 patients (2.9%), a coronary bypass surgery was required as a result of intraoperative (n = 1) or postoperative (n = 1) myocardial ischaemia. In 1 patient, a single coronary artery bypass graft to the right coronary artery was performed as preoperatively intended due to coronary artery anomaly.\nIntraoperative ischaemia was suspected in 1 patient due to ECG changes and right ventricular dysfunction during weaning from cardiopulmonary bypass (CBP). The patient received a venous aorto-coronary bypass graft to the right coronary artery in the first segment and had an uneventful recovery after the operation.\nOne other patient showed a progressive increase in cardiac enzymes and ECG changes during the first postoperative day. An urgent coronary angiography revealed a stenosis of the common trunk of the left coronary artery, which was difficult to prepare and reimplant following a previous aortic valve-sparing procedure. The left internal mammary artery on left anterior descending artery and a venous graft on a postero-lateral branch were used as left coronary artery bypasses for myocardial revascularization. The patient's subsequent course was uneventful and he was discharged on the 12th postoperative day.\nIn the third patient with truncus arteriosus communis type I and origin anomalies of both coronary arteries, a venous aorto-coronary bypass to the proximal right coronary artery was performed before CBP weaning due to poor right ventricular contractility, the further intra- and postoperative course was uneventful.\n\nPostoperative endocarditis\nOne patient with hypoplastic left heart syndrome, discharged on the 7th and readmitted on the 18th postoperative day for cardiac tamponade, required emergency surgical intervention. Intraoperatively, severe infective endocarditis of the native ascending aorta with a secondary rupture of the wall 3 cm above the distal DAH anastomosis was identified. The DAH with superficial endocarditic vegetations was explanted and replaced by a biological valved conduit. The patient died in septic multiorgan failure on the third postoperative day. Microbiological investigation revealed invasive aspergillosis (Aspergillus flavus) of the native aorta within the area of previous aortic reconstructive surgery (Norwood repair) and superficial DAH infection.\nThe infection was classified as sporadic as preoperative sterility testing of the DAH was inconspicuous and no other aspergillus infections were observed during that period. In addition, a DPH of the same donor showed no signs of aspergillosis in another patient 2 years after implantation.\n\nHaemodynamic performance of DAH\nThe mean diameter of implanted DAHs was 22.4 ± 3.7 mm (range, 10–29 mm), the average peak gradient was 14 ± 15 mmHg and the mean aortic regurgitation grade (0.5 = trace and 1 = mild) was 0.6 ± 0.5. The last mean left ventricle ejection fraction (LVEF) and left ventricle end diastolic volume index (LV EDVi) was 63 ± 7% and 78 ± 16 ml/m2 body surface area (BSA), respectively. The mean effective orifice area (EOA) of a 25-mm diameter DAH was 3.07 ± 0.7 cm2.\nFigures 1 and 2 show the development of mean gradients and regurgitation in the DAH over time.\nFigure 1: Echocardiographic mean gradient over time in the DAH. Different colours represent different patients; loess-smoothed lines are interpolated between the measurements for each individual. Some individuals show gradients that decrease over time.\nFigure 2: Valvular regurgitation over time in DAH (0 = none, 0.5 = trace, 1 = mild, 1.5 = mild to moderate, 2 = moderate, 2.5 = moderate to severe and 3 = severe). This figure shows the individual aortic valve insufficiency development and loess-smoothed interpolation lines. The decrease of insufficiency is not uncommon.\nFigure 3 summarizes the portion of explanted, well-functioning and dysfunctional grafts (\u003e49 mm Hg peak gradient and/or at least moderate regurgitation) at the various examination intervals. For 3 Moldavian patients, only clinical follow-up was available.\nFigure 3: Freedom from explantation including the percentage of conduits with degeneration signs for the DAH (peak gradient \u003e49 mmHg and/or at least moderate regurgitation). For 3 Moldavian patients, only clinical follow-up was available.\n\nDAH in very young patients\nTo determine growth potential of the DAH, we divided patients younger than 10 years in two subgroups, in patients having received a small DAH (\u003c15 mm; n = 4, mean age 1.4 ± 1.2 years) and in patients with larger DAH diameters (valve diameter \u003e15 mm; n = 12, mean age 6.4 ± 2.1 years).\nThe first subgroup includes the patients with the smallest grafts of our study with diameters of 10, 11, 12 and 14 mm implanted at the respective ages of 0.2, 0.8, 2.9 and 1.7 years. In all 4 patients, after a follow-up of 4.5, 1.8, 2.9 and 2.6 years and an increase of body surface area from 0.25–0.55, 0.35–0.4, 0.52–0.63 and 0.5–0.62 m2, respectively, no corresponding increase in valve annulus diameter could be observed so far (Fig. 4, black lines).\nFigure 4: z-Value development of DAH annulus size for subgroups over time. Black lines delineate patients younger than 10 years with a DAH smaller than 15 mm at implantation, green—patients younger than 10 years with a DAH bigger than 15 mm and red—patients older than 10 years. z-Value development of DAH annulus size over time. Package labelled annulus diameter was rounded to z-value integers, and each postoperative measurement is again expressed as a z-value according to the actual height and weight of the patient. A loess fit curve was then drawn for each implant size group. The green area shows the normal range in the middle of which the lines should converge.\nIn 2 of these patients, the gradient was caused by inadequate growth of the subvalvular area, a common issue in severe congenital aortic stenosis.\nOne of these 2 patients, with the smallest implanted DAH (10 mm), developed progressive LVOT obstruction at subvalvular level within the first year after operation with a constant increase in the gradient across the LVOT, which caused progressing valvular regurgitation (Fig. 5A). This patient underwent reoperation 4.5 years after DAH implantation. Intraoperatively, only slight adhesions around the DAH were observed that permitted easy graft preparation and explantation. No macroscopic calcification was noticed. Jet-lesion destruction of the right coronary cusp was the reason for the regurgitation. After LVOT enlargement by resection of subvalvular tissue, a 17-mm DAH was implanted without complications (Fig. 5C) and the patient was discharged 7 days after the operation. Histological analysis revealed good recellularization of the graft with lesser cells in the non-coronary cusp. Cells found were mainly fibroblasts, few myofibroblasts and only rarely inflammatory cells. No calcification was found microscopically (Fig. 5E and H).\nFigure 5: (A) Preoperative echocardiography demonstration subvalvular stenosis and sufficient annulus size; (B) intraoperative aspect of the DAH before explantation (explantation performed after completion of the patients enrolment in the study); (C) postoperative echocardiography after implantation of a 17-mm DAH and resection of subvalvular stenosis; (D) HE staining of the non-coronary cusp; (E) Pentachrom staining of the non-coronary cusp; (F) Van Kossa staining of the non-coronary cusp; (G) HE staining of the non-coronary sinus; (H) Pentachrom staining of the non-coronary sinus; (I) Van Kossa staining of the non-coronary sinus.\nOne of the 4 smallest patients showed a supravalvular stenosis at the distal anastomosis after previous aorta ascendens and aortic arch procedures.\nThe fourth patient, with a Konno enlargement of the LVOT, had normal DAH function with stable trivial valve regurgitation and no stenosis 1 year after implantation.\nIn the second subgroup, 12 patients with a mean age of age 6.4 ± 2.1 years received grafts with diameters of 15–25 mm. At a mean follow-up of 1.9 ± 2.2 years for this subgroup, none of the patients in this subgroup showed an increase in transvalvular gradients and the grafts have not revealed significant regurgitation during this time. Echocardiographic and CMR examination of DAHs did not reveal any signs of structural graft degeneration either.\nFigure 4 shows the z-value development of DAH annulus size in subgroups over time. Black lines delineate patients younger than 10 years with a DAH smaller than 15 mm at implantation, green lines delineate patients younger than 10 years with a DAH bigger than 15 mm and red lines patients older than 10 years.\n\nExtended aortic root replacement with a long DAH\nIn 18 patients, with associated dilatation of the ascending aorta, extended aortic root replacement (EARR) with a long DAH was performed to avoid the use of any vascular prosthesis. Characteristics are summarized in Table 2.\nIn this subgroup, the mean diameter of the DAH at implantation was 25.8 ± 1.8 mm resulting in a mean EOA of 3.2 ± 0.6 cm2, an average peak gradient at the latest follow-up (mean: 1.9 ± 1.2 years, total 31.1 years) of 9.4 ± 4.9 mmHg and a mean aortic regurgitation grade of 0.6 ± 0.3 (0 = none, 0.5 = trace and 1 = mild). The last mean LVEF was 61.7 ± 7.3% and the LV EDVi was 81 ± 16 ml/m2 BSA. Aortic valve z-values were 1.1 ± 0.8 at implantation and 0.9 ± 0.8 at the last follow-up. No dilatation was observed at any level of the graft (annulus, sinus of Valsava, sinotubular junction or at the level of the main pulmonary artery) during follow-up so far.\nOne of these was a patient who had a Ross procedure, who experienced a rapidly failing autograft and therefore underwent secondary autograft replacement using a mechanical valve in combination with aortic root repair using a conventional homograft in an overseas institution. Ten years later, he developed bacterial endocarditis with critical stenosis of the homograft used for pulmonary valve replacement during the initial Ross procedure. Because of the concomitant severe calcification of the aortic allograft used during the second operation to replace the ascending aorta and the patient's wish to cease anticoagulation therapy, the pulmonary valve, the aortic valve and the ascending aorta were replaced by decellularized allografts in one operation (Fig. 6). Three years after the operation both grafts show no signs of degeneration, there is no dilatation of the ascending aorta and the patient is free from anticoagulation therapy.\nFigure 6: Preoperative aspects of the severely calcified and stenotic conventional pulmonary homograft and calcified dilated aortic bulbus in a Ross patient are shown in the first row. The second row shows the intraoperative aspect after double valve replacement with decellularized homografts including EARR by a long DAH and CMR images after 14 months.\nIn 4 patients, double valve replacement with DAH and DPH was performed in total.\n\nPregnancy with a DAH\nA DAH was implanted in a 35-year old female patient suffering from severe aortic regurgitation after repair of a ventricular septal defect in childhood with subsequent AV block necessitating permanent pacemaker stimulation. Owing to severe histamine intolerance and the wish for a second child, she opted for AVR with a DAH. She became pregnant 3 months after the AVR and gave birth to a healthy girl. DAH function and subsequently LV function were regular during and after pregnancy up to 28 months after DAH implantation."}