Can You Have Babies With an Onyx Mechanical Valve

Abstract

Objectives

There are little recent data on the outcomes of mechanical aortic valve replacement (AVR) in children and young adults with congenital aortic valve disease. We sought to review the survival and associated thromboembolic or haemorrhage complications after mechanical AVR at a single eye.

Methods

Data were retrospectively nerveless for 121 patients undergoing prosthetic AVR from 2000 to 2014. Kaplan-Meier estimates and Cox proportional hazards were employed.

Results

Median age at AVR was 16 years (interquartile range, 12-22.eight years). The valves implanted were the St Jude valve (St Jude Medical Inc, St Paul, Minn) in 79 patients (62%), the On-X valve (On-X Life Technologies Inc, Austin, Tex) in 45 patients (35%), and CarboMedics (Sorin SpA, Milan, Italia) in 3 patients (two.4%). Median valve size was 23 mm (range, 21-25 mm). There were 5 early deaths (3.nine%). Median follow-up was 5 years (range, one.vi-9.two years; 600 patient-years). There were 14 deaths during follow-up. Survival was 90.6% ± 2.8% at 1 year, 85.4% ± iii.seven% at five years, and 81.5% ± 4.5% at ten years. Liberty from aortic valve reoperation was 98% ± 1.4% at ane and 5 years, 91.v% ± 3.9% at 7 years, and 78.4% ± 6.9% at 10 years and at latest follow-upwardly. Univariable assay identified younger age, lower weight, and use of a 16-mm CarboMedics valve equally predictors of reoperation. Valve sizes of 16 or 17 mm have a significantly higher take a chance of reoperation compared with larger valves (log-rank test, P < .001). At multivariable analysis, simply younger age was a pregnant contained predictor of reoperation (run a risk ratio, 0.84; 95% confidence interval, 0.71-0.99; P = .038). All patients were treated with warfarin to a goal international normalized ratio of two.0 to 3.0. Four patients (3.1%; 0.66% per patient-year) had thromboembolic complications, and five patients (three.9%; 0.83% per patient-year) had bleeding events during follow-upwardly.

Conclusions

Mechanical AVR in patients with congenital heart disease has excellent short- and midterm outcomes. Younger age was an independent predictor of reoperation.

Key Words

• aortic valve replacement
• pediatric cardiac surgery
• mechanical valve
• aortic valve

Abbreviations and Acronyms:

AVR (aortic valve replacement), BSA (trunk expanse), CHD (congenital heart disease), INR (international normalized ratio)

Central Message

Mechanical AVR in patients with CHD has excellent short- and midterm outcomes. Younger age is an independent predictor of reoperation.

Perspective

1 hundred xx-i patients with CHD underwent AVR with a mechanical prosthesis. Early on and late bloodshed was 3.9% and 11.1%. There were 9 aortic valve reoperations. The incidences of thromboembolic and bleeding complications were 0.66% and 0.83% per patient-year. Age was an independent predictor of reoperation.

See Editorial Commentary folio 341.

Aortic valve replacement (AVR) in children and young adults with built center disease (CHD) is sometimes required, despite improvements in aortic valve reconstruction.

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Surgical aortic valvuloplasty in children and adolescents with aortic regurgitation: acute and intermediate effects on aortic valve role and left ventricular dimensions.

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Open up valvotomy for aortic valve stenosis in newborns and infants.

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Although the benefits and risks of mechanical valve replacement in the adult population are extensively described, there are picayune recent data available in patients with CHD.

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Controversy exists regarding the outcomes among the various surgical options and there are express data available regarding newer prostheses. The aim of this study was to review our single-center experience with mechanical AVR in children and young adults with CHD, place risk factors for reoperations, and review the results of different valves.

Methods

This was a retrospective review of all consecutive patients with CHD who underwent mechanical AVR at Boston Children'south Hospital betwixt January 2000 and January 2014. The study was canonical by the institutional review board, and individual patient consent was waived. Patients were identified in the cardiac surgery and cardiology databases. The inclusion benchmark was AVR during the report period with a mechanical prosthesis. Exclusion criteria were aortic valve reconstruction without valve replacement, or valve replacement with a nonmechanical valve (eg, a bioprosthetic valve, homograft, or autograft). The main end points were re-intervention on the aortic valve and mortality. Secondary finish points were thromboembolic or haemorrhage complications.

Demographic data collected included date of birth, gender, intraoperative height, weight, and torso surface area (BSA). The patient's principal diagnosis and previous interventions, including aortic valve interventions, were recorded, including aortic valve catheterization interventions, aortic valve repair or AVR, pacemaker, echocardiography, and prior procedures. Surgical data were obtained from operative notes. Variables of involvement include the date of access, date of AVR process, indication for AVR, date of belch, morbidity, and whatsoever complications before discharge. In addition, the specific valve type, valve size, and valve insertion methods besides as concomitant procedures were recorded.

The post-obit mechanical aortic valve prostheses were used: On-X (On-X Life Technologies Inc, Austin, Tex), St Jude (St Jude Medical Inc, St Paul, Minn), and 16 mm CarboMedics (Sorin SpA, Milan, Italy).

Patients were followed in our outpatient clinic at ane, iii, half-dozen, and 12 months later surgery, and so annually, unless closer follow-up was necessary. Follow-upwardly was documented as their latest visit in January 2014. Follow-up includes appointment of most recent follow-up and/or echocardiogram reports every bit part of a routine exam and whatsoever aortic valve interventions. Comorbidity, major complications, and anticoagulation data were nerveless from the patient records.

Definitions

The nature of the aortic valve pathology was divers equally either stenosis, regurgitation, or mixed disease according to the 2014 American Center Clan/American College of Cardiology guideline for the management of patients with valvular heart affliction.

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2014 AHA/ACC guideline for the management of patients with valvular heart illness: a report of the American Higher of Cardiology/American Heart Clan task forcefulness on practice guidelines.

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 Structural valve failure was defined as evolution of a significant stenosis or regurgitation that was non present during the firsthand postoperative flow. Reintervention on the aortic valve was defined as a surgical process for valve re-replacement.

Statistical Analysis

Descriptive statistics used were frequency and pct for categorical variables and hateful ± standard departure or median (interquartile range [IQR]) when appropriate for continuous variables. The overall survival and freedom from aortic valve reintervention was calculated using Kaplan-Meier estimates from the determination of surgery to death or the latest follow-upward. Differences between curves were assessed using the log-rank examination. The duration of freedom from intervention was calculated from the operation to the offset day when the beginning intervention was noted. Predictors of aortic valve reoperation were assessed by comparison the prevalence (for categorical variables) or medians (for continuous variables) of these predictors, and differences were assessed using the independent-samples Mann-Whitney U statistic or Fisher exact exam as appropriate. Variables with a P value ≤ .1 or deemed clinically relevant were entered into univariable and multivariable Cox proportional hazards models. All statistical tests were 2-tailed. Analyses were performed using SPSS version 23.0 for Windows (IBM-SPSS Inc, Armonk, NY).

Results

Patient Demographic Characteristics

I hundred xx-i patients were included during the study period. Patient baseline and operative characteristics are summarized in Tabular array ane. Seventy percent of patients were male, and the median age at operation was sixteen.iii years (IQR, 12-22.8 years). 74 patients (58.three%) were younger than age 18 years. A majority of patients (northward = 80; 63%) had undergone at least 1 prior aortic valve operation, although a majority still had their native aortic valve (northward = 105; 82.7%). The primal diagnosis was predominantly built aortic stenosis and borderline hypoplastic left heart syndrome or Shone's circuitous (n = 64; 50.three%), followed past conotruncal anomalies (due north = 24; xviii.9%). Of note, viii patients (vi.3%) had unmarried ventricle physiology at different stages (eg, Glenn or Fontan), and 7 patients (5.5%) had undergone a previous arterial switch operation and required replacement of their neoaortic valve. Aortic regurgitation (n = 53; 41.7%) or mixed aortic disease (n = 53; 41.7%) were the most frequent indications for operation. Ane patient had recurrent embolic events with a Starr-Edwards ball-valve prosthesis without testify of stenosis or regurgitation, and was referred for reoperation due to suspected recurrent thrombosis and embolism from this valve.

Table 1 Baseline characteristics

Characteristic	Overall population
Patients
Number	121
Male person	90 (70.9)
Weight (kg)	59.0 (34.iii-72.1)
Native aortic valve anatomy
Unicuspid	7 (5.5)
Bicuspid	44 (34.6)
Tricuspid	65 (54)
Quadricuspid	v (3.9)
Underlying diagnosis
Congenital aortic stenosis	51 (42)
Conotruncal anomalies	22 (xviii)
Shone'southward circuitous	6 (5)
Other congenital	10 (eight.3)
Connective tissue disorder	12 (9.nine)
Subacute bacterial endocarditis–acute rheumatic fever	vi (5)
Atrioventricular culvert	6 (5)
Single ventricle	8 (6.half-dozen)
Operative
Valve implants	127
Age (y)	16.3 (12.0-22.8)
i-6	6 (four.seven)
6-12	26 (20.5)
12.1-eighteen	42 (33.1)
> 18	53 (41.7)
Nature of aortic valve lesion
Stenosis	7 (5.v)
Regurgitation	49 (39)
Mixed aortic valve illness	47 (37)
Prosthetic aortic valve disease	21 (17)
Other	3 (two.4)
Prior aortic valve surgery	80 (63)
ane	50 (39.4)
two	26 (xx.v)
three	4 (3.1)
Aortic valve at replacement
Native	93 (73)
Mechanical prosthesis	xix (fifteen)
Homograft	iv (3.one)
Biological prosthesis	three (2.four)
Ross procedure	2 (1.6)
Neoaortic valve after arterial switch	half dozen (iv.vii)
Single ventricle physiology	8 (6.3)

Values are presented as n, n (%), or median (interquartile range).

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Operative Characteristics

Operative characteristics are detailed in Tabular array 2. The valve types used were St Jude in 79 patients (62%), On-X in 45 patients (35%), and CarboMedics in 3 patients (two.4%). The On-X valves were implanted from 2004 or afterwards, whereas St Jude valves were implanted throughout the report flow. The median valve size was 23 mm (IQR, 21-25 mm). The almost normally used sizes for St Jude valves were 21 mm (23.eight%) and 23 mm (23.8%), On-X valves were 21 mm (31.1%) and 23 mm (26.vii%) and all 3 patients who received CarboMedics valves had 16 mm valves implanted (P = .001). Patients who received a CarboMedics valve were younger (median age, 4.6 years; IQR, three.4-4.six years) than those who received On-Ten (median, 18.vii years; IQR, fourteen.iv-24.0 years) and St Jude valves (median, 15.7 years; IQR, 11.7-21.8 years).

Tabular array 2 Operative data

Operative variable	Value
Mechanical valve implanted ∗ St Jude; St Jude Medical Inc, St Paul, Minn; On-Ten; On-X Life Technologies Inc, Austin, Tex; CarboMedics; Sorin SpA, Milan, Italia.
St Jude	79 (62.2)
On-X	45 (35.4)
CarboMedics	3 (2.4)
Valve size (mm)	23 (21-25)
St Jude	21 (17-31)
On-X	23 (19-29)
CarboMedics	xvi
Associated procedures
Aortic root enlargement	42 (33)
Konno † Four of these patients also had an additional root enlargement procedure.	25 (xx)
Nicks	6 (4.7)
Manougian	6 (four.seven)
Other	five (4)
Ascending aortic procedures
Aortic root replacement (Bentall)	xviii (14)
Ascending aorta replacement	iii (ii.4)
Ascending aorta or root patch enlargement	30 (24)
Reduction aortoplasty	five (four)
Other associated procedures
Mitral valve replacement	14 (11)
Mitral valvuloplasty	8 (six.3)
ASD repair	7 (six)
Tricuspid valve repair	two (i.half-dozen)
PPM or AICD placement, revision	7 (5.five)
Subaortic stenosis resection	8 (vi.3)
Endocardial fibroelastosis resection	1 (0.8)
RV-PA conduit, RVOT enlargement, PA plasty	12 (9.iv)
Maze	iv (3)
Coronary procedure (CABG, intramural unroofing)	ii (1.6)
Residual VSD repair	2 (1.half dozen)
Fontan conversion or revision	2 (1.6)
LVOT aneurysm repair	1 (0.viii)

Values are presented every bit n (%) or medial (interquartile range). ASD, Atrial septal defect; PPM, permanent pacemaker; AICD, automatic implantable cardioverter-defibrillator; RV, right ventricular; PA, pulmonary artery; RVOT, right ventricular outflow tract; CABG, coronary avenue featherbed grafting; VSD, ventricular septal defect; LVOT, left ventricular outflow tract.

∗ St Jude; St Jude Medical Inc, St Paul, Minn; On-X; On-Ten Life Technologies Inc, Austin, Tex; CarboMedics; Sorin SpA, Milan, Italy.

† Four of these patients likewise had an additional root enlargement procedure.

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Concomitant operations were frequent and are listed in Table 2. Twoscore-ii patients (33%) required aortic root enlargement: 25 patients (xx%) using a Konno procedure and 17 patients (13%) using another blazon of annulus enlarging procedure. These procedures were used in 6 young children (aged 1-6 years; 14%), ten preadolescent children (aged 6-12 years; 24%), 12 adolescents (anile 12-18 years; 29%), and fourteen adults (33%; Fisher exact exam assessing distribution between age groups P = .57). Eighteen patients (14%) underwent an aortic root replacement with a Bentall procedure.

Early Outcomes

There were vii early deaths (5.5%), 2 due to neurologic injury, 2 due to left ventricle failure, 1 due to sepsis, 1 due to tamponade, and 1 due to coronary ischemia. Use of an aortic root enlargement process did not significantly increase early mortality, with 2 deaths in patients with root enlargement (ii out of 42; 5%), compared with 5 deaths without enlargement (5 out of 85; 5.eight%; P = .60). Perioperative complications included unplanned reoperation in 10 (7.9%), of which 6 were re-explorations for bleeding (four.vii%), pacemaker placement in 6 (4.seven%), and paravalvular leak in seven patients (5.5%). Of these 7 patients with paravalvular leaks, 5 required no reintervention, 1 died acutely from cardiac tamponade, and ane required redo AVR 7 years subsequently due to prosthethic valve failure.

Follow-up

8 patients were lost to follow-upwardly following belch and were excluded from farther assay. The median follow-upward was four.eight years (IQR, 0.6-eight years; 581 patient-years), and was 6.one years for patients with a St Jude valve, iii.9 years with an On-X valve, and 8.six years with a CarboMedics valve. There were 10 late deaths and survival was 91.4% ± two.6% at 1 yr, 83.eight% ± 3.8% at 5 years, and 81.5% ± 4.4% at 10 years (Effigy 1). Five patients died from unknown causes, and ane patient died from each of the following causes: mechanical mitral valve failure at ane.2 years, autoimmune disease at 3 years, following heart transplant at 5 years, redo AVR at seven.5 years, and sepsis at x years.

Figure 1 Kaplan-Meier estimates of survival. A, Unstratified. B, Stratified by valve type. The median follow-up was five years (interquartile range, 1.vi-9.2 years; 600.two patient-years), specifically vi.one years for patients with a St Jude valve (St Jude Medical Inc, St Paul, Minn), three.9 years with an On-X valve (On-10 Life Technologies Inc, Austin, Tex), and 8.6 years with a CarboMedics valve (Sorin, SpA, Milan, Italian republic). CI, Confidence interval.

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9 patients (7.5%) underwent reoperation to replace the prosthetic aortic valve, 7 having had a St Jude valve (8.viii%), ii with a sixteen mm CarboMedics valve (66%), and none with an On-X valve (Table iii). Reoperations occurred at a median of 7.1 years (IQR, 3-8.9 years) after AVR, and the intervals were like for St Jude and CarboMedics valves (vii.1 vs vii.3 years, respectively). Six patients had aortic stenosis primarily due to pannus formation that resulted in a median mean gradient of 50 mm Hg and left ventricular end diastolic pressure of 22 mm Hg. At that place were three patients in whom thrombus formation was present; 1 patient had astute thrombosis of the valve due to inadequate warfarin levels that resulted in astringent aortic stenosis, i patient receiving extracorporeal membrane oxygenation had acute valve thrombosis likely related to poor menstruum across the aortic valve and inadequate anticoagulation, and 1 patient had the valve explanted and replaced for unexplained thrombotic events. An boosted patient had the valve removed from presumed endocarditis and a significant paravalvular leak.

Table 3 Patients requiring aortic valve reoperation

Patient	Fundamental diagnosis	Valve type ∗ CarboMedics; Sorin SpA, Milan, Italy; St Jude; St Jude Medical Inc, St Paul, Minn.	Valve size	Reason for aortic valve replacement reoperation	Fourth dimension from initial to aortic valve replacement reoperation (y)
1	Endocarditis	CarboMedics	sixteen	Aortic stenosis/fibrosis (pannus germination)	6.3
2	Interrupted aortic arch	CarboMedics	16	Aortic stenosis/fibrosis (pannus formation)	8.7
3	Endocarditis	St Jude	17	Endocarditis, paravalvular leak	0.3
4	Congenital aortic stenosis	St Jude	17	Aortic stenosis/fibrosis (pannus formation)	6.7
v	Transposition, double-outlet right ventricle, ventricular septal defect	St Jude	19	Aortic stenosis/fibrosis (pannus formation)	seven.0
six	Marfan syndrome	St Jude	21	Aortic stenosis/fibrosis (pannus formation)	eight.half dozen
7	Truncus arteriosus	St Jude	23	Aortic stenosis/fibrosis (pannus formation)	9.one
viii	Interrupted aortic arch	St Jude	23	Thrombus	one.0
9	Congenital aortic stenosis	St Jude	25	Thrombus	8.9

∗ CarboMedics; Sorin SpA, Milan, Italy; St Jude; St Jude Medical Inc, St Paul, Minn.

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Equally shown in Figure 2, freedom from aortic valve reoperation was 98% ± i.3% at one and five years, 91.four% ± 3.ix% at vii years, and 78.3% ± half-dozen.9% at 10 years and at latest follow-upward. Freedom from aortic valve reoperation was significantly meliorate with the On-Ten valve (P < .001). As shown in Effigy 3, smaller sized valves (sixteen to 17 mm) accept significantly higher risk of reoperation compared with larger sized valves (19 to 27 mm) (Log-rank examination P < .001).

Figure ii Liberty from reoperation. A, Freedom from aortic valve reoperation was 98% ± 1.3% at 1 and 5 years, 91.4% ± 3.nine% at 7 years, and 78.3% ± 6.9% at 10 years to latest follow-up. B, Freedom from aortic valve reoperation was significantly better with the On-10 valve (On-X Life Technologies Inc, Austin, Tex) (P < .001). CI, Confidence interval.

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Univariable predictors of reoperation are detailed in Table iv. Younger age, lower weight, a diagnosis of subacute bacterial endocarditis or acute rheumatic fever, and use of a 16-mm CarboMedics valve were all significantly associated with aortic valve reoperation. Time-dependent predictors of reoperation are detailed in Table 5. At univariable analysis, younger age (hazard ratio [Hr], 0.8 for each increase in year; P = .002) and in detail children aged one to 6 years (Hr, 28.9; P = .005), lower weight (HR, 0.96 for each increase in 1 kg; P = .04), and the valve type (P = .028) were predictors of reoperation. At multivariable Cox proportional hazards analysis, only age was an independent predictor of reoperation (Hr, 0.84; 95% confidence interval, 0.71-0.99; P = .038).

Tabular array 4 Univariable predictors of reoperation

Clinical characteristic	Without a reoperation	Reoperation	P value
Patients	118 (92.9)	9 (7.ane)	–
Age (y)	18.6 (4.5 to 48.1)	13.7 (9.6 to 22.8)	.001
one-6	iii (50)	three (l)
vi-12	23 (88.v)	3 (11.5)
12-18	40 (95.2)	2 (four.eight)
> eighteen	52 (98.1)	1 (1.9)
Weight (kg)	threescore (8 to 121)	64.9 (25 to 91)	.018
BSA (m2)	1.67 (0.53 to 2.47)	ane.70 (0.94 to 2.0)	>.99
Key diagnosis			.03
Congenital Every bit	48 (96)	2 (iv)
Borderline HLHS, Shone'south complex	14 (100)	0 (0)
Conotruncal anomalies	twenty (83.3)	iv (xvi.vii)
Other congenital	21 (100)	0 (0)
Connective tissue disorder	xi (91.7)	ane (viii.3)
SBE–ARF	4 (66.seven)	two (33.3)
Aortic valve disease			.32
Stenosis	20 (100)	0 (0)
Regurgitation	l (94.3)	3 (five.vii)
Mixed disease	47 (88.seven)	6 (11.3)
Native valve anatomy			.45
Unicuspid	7 (100)	0 (0)
Bicuspid	42 (95.v)	two (4.v)
Tricuspid	64 (92.viii)	five (7.two)
Quadricuspid	iv (80)	1 (20)
No. of prior aortic valve procedures			.27
0	46 (97.ix)	ane (2.1)
1	44 (88)	6 (12)
2	24 (92.3)	two (7.7)
3	4 (100)	0 (0)
CPB fourth dimension (min)	164 (60 to 386)	171 (137 to 333)	.63
Aortic crossclamp time (min)	105 (42 to 259)	113 (97 to 174)	.97
Valve blazon ∗ St Jude; St Jude Medical Inc, St Paul, Minn; On-Ten; On-X Life Technologies Inc, Austin, Tex; CarboMedics; Sorin SpA, Milan, Italy.			.001
St Jude	72 (91.i)	7 (eight.nine)
On-X	45 (100)	0 (0)
CarboMedics	i (33.iii)	2 (66.6)
Valve size (mm)	23 (xvi to 31)	23 (17 to 25)	.018
Valve size			.014
sixteen-17	6 (lx)	4 (40)
19	15 (93.8)	1 (half dozen.3)
21	31 (96.nine)	1 (3.1)
23	28 (93.three)	2 (6.vii)
24-25	20 (95.ii)	1 (iv.eight)
≥ 27	16 (100)	0 (0)
Estimated valve z score † 1 case excluded from analysis due to lacking data on body surface area and calculation of estimated z score.	0.99 (–ane.32 to four.24)	1.33 (0.89 to four.46)	.04
–ii to 0	13 (100)	0 (0)	.45
0 to +two	84 (93.3)	6 (6.7)
> 2	20 (87)	iii (13)
Aortic root enlargement			.23
Yes	28 (87.5)	four (12.five)
No	90 (94.7)	5 (5.iii)
Aortic root enlargement type			.22
Konno	xix (86.4)	3 (13.vi)
Manougian	4 (100)	0 (0)
Nicks	5 (100)	0 (0)
Other	0 (0)	1 (100)
Bentall			.60
Yes	12 (100)	0 (0)
No	106 (92.2)	9 (7.8)
MVR			.23
Yes	11 (84.6)	2 (15.4)
No	107 (93.9)	seven (6.1)
MVP			>.99
Yes	8 (100)	0 (0)
No	110 (92.4)	9 (7.half-dozen)
Subaortic stenosis resection			.06
Yes	4 (66.7)	two (33.iii)
No	114 (94.2)	seven (five.8)

Values are presented as median (range) or n (%). Continuous variables were compared using the independent-samples Mann-Whitney U test, and categorical variables with Fisher exact examination. BSA, Body area; AS, aortic stenosis; HLHS, hypoplastic left eye syndrome; SBE, subacute bacterial endocarditis; ARF, acute rheumatic fever; CPB, cardiopulmonary bypass; MVR, mitral valve replacement; MVP, mitral valvuloplasty.

∗ St Jude; St Jude Medical Inc, St Paul, Minn; On-X; On-X Life Technologies Inc, Austin, Tex; CarboMedics; Sorin SpA, Milan, Italy.

† One case excluded from analysis due to lacking data on body area and calculation of estimated z score.

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Table 5 Cox-regression analysis of predictors of aortic valve reoperation

Variable	Univariable assay		Multivariable analysis
	Hazard ratio (95% Confidence interval)	P value	Hazard ratio (95% Confidence interval)	P value
Age (y) ∗ Age was entered as a continuous variable in 1 model, and categorical variable in separate models.	0.lxxx (0.69-0.92)	.002	0.84 (0.71-0.99)	.038
1-6	28.nine (2.76-302.9)	.005	16.three (0.93-285)	.056
6-12	4.i (0.4-39.half-dozen)	.22	3.15 (0.33-thirty.four)	.32
12-18	1.5 (0.i-16.2)	.76	one.15 (0.1-12.vii)	.91
>18	† Indicator.		† Indicator.
Weight (kg)	0.96 (0.93-0.99)	.04	1.00 (0.96-1.05)	.94
Fundamental diagnosis		.eighteen		.63
Borderline HLHS – Shone's complex	<0.001 (0-)	.99	0 (0-)	.98
Conotruncal anomalies	two.98 (0.55-sixteen.three)	.21	2.06 (0.35-12.one)	.42
Other congenital	<0.001 (0-)	.98	0 (0-)	.97
Connective tissue disorder	1.12 (0.i-12.iv)	.93	0.59 (0.04-8.32)	.70
SBE–ARF	16.53 (1.95-140)	.01	6.03 (0.57-63.6)	.fourteen
Congenital AS	† Indicator.		† Indicator.
Valve blazon ‡ St Jude; St Jude Medical Inc, St Paul, Minn; On-10; On-X Life Technologies Inc, Austin, Tex; CarboMedics; Sorin SpA, Milan, Italy.		.028		.70
St Jude	0.eleven (0.02-0.55)	.008	0.44 (0.07-ii.99)	.40
On-10	<0.001 (0-)	.96	0 (0-)	.96
CarboMedics	† Indicator.		† Indicator.
Valve z score	2.39 (0.67-8.63)	.18

HLHS, Hypoplastic left eye syndrome; SBE, subacute bacterial endocarditis; ARF, acute rheumatic fever; As, aortic stenosis.

∗ Historic period was entered equally a continuous variable in ane model, and categorical variable in separate models.

† Indicator.

‡ St Jude; St Jude Medical Inc, St Paul, Minn; On-X; On-X Life Technologies Inc, Austin, Tex; CarboMedics; Sorin SpA, Milan, Italy.

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5 patients experienced early perioperative haemorrhage events. Iv patients (0.66% per patient-year) presented thromboembolic complications (3 strokes), and 5 patients (0.83% per patient-twelvemonth) experienced haemorrhage events during follow-up.

There were no belatedly haemorrhage events. All patients were treated with warfarin (goal international normalized ratio [INR], 2.0-3.0). Twoscore-two patients likewise received aspirin (33.i%), and 1 received clopidogrel (0.8%). I poorly compliant patient presented with "seizure-like activity" but workup was negative. I patient developed prosthetic valve endocarditis that required reoperation.

The interaction between implant size and BSA was investigated using both indexed valve size (implanted valve size divided by BSA), and an estimated implanted aortic valve z score, calculated using the rated valve size compared with BSA, as reported previously in the mitral position.

The median indexed valve size was larger in patients who required a reoperation: 21.v mm/yard² (range, 11.five-42 mm/mⁱⁱ) compared with 14.5 mm/m² (range, eight.iii-32.8 mm/g²) in patients who did not require a reoperation (P = .01). The same interaction was found regarding median estimated z score, which was larger in patients who required a reoperation: i.33 (range, 0.89- 4.46) compared with 0.99 (range, –one.32 to 4.24; P = .04) in patients who did not require a reoperation. Stratifying these z score or indexed valve size by quartiles, reoperations occurred slightly more than frequently in the highest z score or indexed valve size quartile (xvi.1% in the highest quartile, with an indexed valve size > eighteen.viii mm/m² vs 4.2% for the lower quartiles with an indexed valve size < 18.8 mm/m²), although not to a significant level (P = .24). The difference was not significant in median estimated z score in terms of bloodshed (P = .16 and P = .45 for the difference between median indexed valve size and estimated z score in survivors vs nonsurvivors, respectively). Oversizing thus appears to increase the risk of reoperation, but non mortality.

Word

Aortic valve illness is amidst the most common congenital cardiac defects, occurring in upwards to 5% of all children with heart disease.

When feasible, aortic valve reconstruction is currently preferred over valve replacement. However, valve repair may not always be possible and replacement becomes necessary. Replacement in children and young adults poses a difficult problem given the smaller patient size and limited valve choices.

^,

¹¹

• Karamlou T.
• Jang G.
• Williams W.G.
• Caldarone C.A.
• Van Arsdell One thousand.
• Coles J.Yard.
• et al.

Outcomes and associated risk factors for aortic valve replacement in 160 children: a competing-risks analysis.

• Crossref
• PubMed
• Scopus (96)
• Google Scholar

^,

Homograft and bioprosthetic valves proceed to have high rates of degeneration in pediatric populations.

^,

¹⁴

• Saleeb South.F.
• Newburger J.Due west.
• Geva T.
• Baird C.W.
• Gauvreau K.
• Padera R.F.
• et al.

Accelerated degeneration of a bovine pericardial bioprosthetic aortic valve in children and young adults.

• Crossref
• PubMed
• Scopus (89)
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The Ross process provides splendid hemodynamic results, superior longevity, freedom from anticoagulation, and a decreased susceptibility to endocarditis.

^,

All the same, the pulmonary valve is not e'er suitable for translocation into the aortic position. Some examples include after a repair of truncus arteriosus or tetralogy of Fallot, or in patients with connective tissue disorders. The Ross procedure remains a technically enervating procedure, which is associated with a low, but measurable, rate of autograft failure or reoperations on the correct ventricle to pulmonary artery conduit. Despite the drawbacks of potential thromboembolic complications and lifelong anticoagulation, mechanical AVR has been recommended

⁸

• Nishimura R.A.
• Otto C.M.
• Bonow R.O.
• Carabello B.A.
• Erwin III, J.P.
• Guyton R.A.
• et al.

2014 AHA/ACC guideline for the direction of patients with valvular heart disease: a report of the American Higher of Cardiology/American Middle Association chore force on practice guidelines.

• Abstract
• Full Text
• Full Text PDF
• PubMed
• Scopus (743)
• Google Scholar

and is routinely performed in children and young people. Structural valve deterioration is substantially nonexistent, although there is the cost of lifelong anticoagulation and potential for pannus ingrowth or endocarditis. Overall, reports advise mechanical AVR is a rubber and durable option in children,

¹¹

• Karamlou T.
• Jang K.
• Williams Due west.G.
• Caldarone C.A.
• Van Arsdell G.
• Coles J.G.
• et al.

Outcomes and associated risk factors for aortic valve replacement in 160 children: a competing-risks analysis.

• Crossref
• PubMed
• Scopus (96)
• Google Scholar

^,

^,

¹⁷

• Vosa C.
• Renzulli A.
• Lombardi P.F.
• Damiani G.

Mechanical valve replacement nether 12 years of historic period: fifteen years of feel.

• PubMed
• Google Scholar

^,

and newer prostheses and longer follow-upward are at present bachelor.

The current report assessed reoperations, thromboembolic or haemorrhage complications, endocarditis, and deaths post-obit mechanical AVR in patients with CHD who were treated at Boston Children's Hospital betwixt 2000 and 2014. The study population was relatively heterogeneous, spanning the breadth of CHD, including patients afterward single ventricle palliation, neoaortic valve disease after arterial switch, and truncus arteriosus repair. These patients had a median age of 16 years, with only i-quarter of patients younger than age 12 years. In that location were no infants or newborn infants. These operations were complex procedures, with 63% of patients having had a prior aortic valve procedure, and almost one-quarter having had 2 or three prior aortic valve procedures. The AVR process required aortic root replacement or enlargement in 35% of patients, and a concomitant additional cardiac procedure in the majority of patients. Survival was 81% at x years, and freedom from aortic valve reoperation was 78% at ten years. Well-nigh late deaths were due to the underlying CHD; that is, from issues with other valves (eg, mechanical mitral valve dysfunction) or with transplantation for cease-phase affliction. Information technology is worthy of note that most patients were non undergoing reoperation for structural valve deterioration—the majority were for pannus formation (66%). This may assistance explicate why patients with an On-10 valve had fewer reoperations, considering the leaflet housing of this device is higher and may limit or filibuster the pannus ingrowth. We constitute that indicators of smaller children (ie, younger age, lower weight, and the utilise of a 16 mm CarboMedics valve) were predictors of reoperation. Multivariable analyses merely found young age equally an independent predictor of reoperation. All of these univariable predictors most likely interacted and were dissimilar indicators that the group of small children was at higher risk of reoperation. Information technology is not surprising that the multivariable analyses did not identify whatever of these other factors equally independent predictors of reoperation.

Associated procedures, such every bit aortic root enlargement or replacement, were not significant predictors of reoperation. There was a trend for increased rate of reoperation in patients with aortic root enlargement (12.5% vs 5.3% reoperation rate without enlargement; P = .23), specially Konno aortic root enlargement (thirteen.6%; P = .22), and MVR (fifteen.4% vs 6.1% reoperation rate without mitral valve replacement; P = .23) or subaortic stenosis resection (33.3% vs 5.8% reoperation rate without resection; P = .06), although this did non achieve statistical significance.

Placement of a prosthesis that is as large as technically possible seems to be desirable at the fourth dimension of AVR because the prosthesis volition non abound with the child and may pb to patient–prosthesis mismatch with somatic growth. This oftentimes requires aortic root enlargement in smaller children. The Manouguian

¹⁹

• Manouguian S.
• Seybold-Epting W.

Patch enlargement of the aortic valve band by extending the aortic incision into the inductive mitral leaflet. New operative technique.

• Abstract
• Total Text PDF
• PubMed
• Google Scholar

and Konno

²⁰

• Konno South.
• Imai Y.
• Iida Y.
• Nakajima M.
• Tatsuno K.

A new method for prosthetic valve replacement in congenital aortic stenosis associated with hypoplasia of the aortic valve ring.

• Abstract
• Full Text PDF
• PubMed
• Google Scholar

procedures are reported to enable placement of a prosthesis 2 sizes larger than valve replacement without root enlargement, whereas the Nicks procedure,

with a more limited enlargement, is reported to enable placement of a prosthesis 1 size larger.

²²

• Bortolotti U.
• Celiento M.
• Milano A.D.

Enlargement of the aortic annulus during aortic valve replacement: a review.

• PubMed
• Google Scholar

Although our study population includes older patients with congenital aortic valve illness, besides every bit patients with conotruncal anomalies (such as truncus arteriosus) that are associated with a larger aortic annulus than within the normal population, 29% of patients did crave an aortic root enlargement, with a mix of techniques used. The distribution of aortic root enlargement was relatively uniform between the historic period groups (P = .threescore), all the same slightly more prevalent in older patients. This finding is likely due to the heterogeneous patient population, which included patients with aortic stenosis and a small aortic annulus and root who were referred at an older age. Aortic root enlargement was not associated with increased early or late mortality or reoperations on the aortic valve. This is consistent with reported data on aortic root enlargement both in pediatric and developed populations.

²²

• Bortolotti U.
• Celiento K.
• Milano A.D.

Enlargement of the aortic annulus during aortic valve replacement: a review.

• PubMed
• Google Scholar

Other than procedures on the aorta, the most frequent associated procedure was to accost the mitral valve in 22 patients (17.3%), with a mitral valve replacement in xiv patients and repair in 8 patients. Mitral valve replacement was associated with a trend toward increased tardily aortic valve reoperations (15.4% vs 6.one% without mitral valve replacement; P = .23). In that location are relatively few reports on aortic and mitral valve procedures in children bachelor. Alsoufi and colleagues

⁷

• Alsoufi B.
• Al-Halees Z.
• Fadel B.
• Al-Wesabi A.
• Al-Ahmadi M.
• Joufan Yard.
• et al.

Simultaneous aortic and mitral valve replacement in children: fourth dimension-related outcomes and take chances factors.

• PubMed
• Google Scholar

reported the outcomes of double valve replacement in 84 children, with an early on mortality of four%, 78% xv-year survival, and 59% freedom from reoperation at fifteen years. The majority of patients (94%) had rheumatic heart affliction.

^seven

• Alsoufi B.
• Al-Halees Z.
• Fadel B.
• Al-Wesabi A.
• Al-Ahmadi One thousand.
• Joufan M.
• et al.

Simultaneous aortic and mitral valve replacement in children: time-related outcomes and risk factors.

• PubMed
• Google Scholar

Although they did not include a direct control group of single aortic valve replacement, the authors ended that although the take chances of reoperation was increased, operative risk and freedom from other valve-related complications were comparable to patients with single valve replacement.

^vii

• Alsoufi B.
• Al-Halees Z.
• Fadel B.
• Al-Wesabi A.
• Al-Ahmadi M.
• Joufan Thousand.
• et al.

Simultaneous aortic and mitral valve replacement in children: time-related outcomes and risk factors.

• PubMed
• Google Scholar

Given the limited sample size, our findings unfortunately cannot provide more than information regarding this point, although the data seem to indicate that patients with concomitant mitral valve procedures were among a group at higher run a risk for reoperation during long-term follow-upwards.

A major drawback of mechanical prostheses is the need for anticoagulation. Current guidelines include a class I recommendation for warfarin to attain an INR of 2.0 to iii.0 subsequently AVR with a mechanical prosthesis without take a chance factors for thrombosis.

^viii

• Nishimura R.A.
• Otto C.One thousand.
• Bonow R.O.
• Carabello B.A.
• Erwin Three, J.P.
• Guyton R.A.
• et al.

2014 AHA/ACC guideline for the management of patients with valvular heart illness: a report of the American College of Cardiology/American Centre Association job force on practise guidelines.

• Abstruse
• Full Text
• Full Text PDF
• PubMed
• Scopus (743)
• Google Scholar

The addition of aspirin decreases the take chances of thromboembolism, with a slight increase in the gamble of bleeding.

²³

• Cappelleri J.C.
• Fiore L.D.
• Brophy M.T.
• Deykin D.
• Lau J.

Efficacy and safety of combined anticoagulant and antiplatelet therapy versus anticoagulant monotherapy subsequently mechanical middle-valve replacement: a metaanalysis.

• Crossref
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Thromboembolism has been reported to occur in 0% to 0.iii% per patient-year in children, slightly lower than in adults (i.five%-2%), whereas bleeding occurs in 0% to 0.iii% per patient-year (compared with 3% in adults).

Anticoagulation in this written report comprised warfarin with a goal INR of 2.0 to 3.0 in all patients, with the addition of aspirin in 33% and clopidogrel in 1 patient at the discretion of the referring cardiologist and surgeon. The linearized rates of thrombo-embolism (0.66% per patient-year) and bleeding (0.83% per patient-year) were slightly higher than those described previously in children, although significantly lower than those reported in developed patients.

Novel prosthetic valves are regularly being introduced; however, there are very few reports that detail the early on- and midterm outcomes in patients with CHD using these newer prostheses. Valve blueprint has a significant influence on thrombogenicity and the demand for anticoagulation. There are currently 4 Food and Drug Administration-canonical bileaflet mechanical prostheses for use in the aortic position: St Jude Medical, CarboMedics, On-X, and Medtronic Open Pin valve (Medtronic ATS Medical Inc, Minneapolis, Minn).

All of these mechanical valves have been shown to accept first-class and comparable hemodynamic operation both in vitro and in clinical studies. The CarboMedics valve is available in smaller sizes, which allows placement in smaller children and was the just prosthetic valve available in a 16 mm size in the electric current experience. Although the CarboMedics valves (and smaller children) had worse outcomes in this report, information technology should be noted that this finding was based on only 3 implants, and it is noteworthy that these three patients were reoperation-free upwardly to 7 years. The On-X valve has been reported to provide improved effective orifice areas and transvalvular gradients in a randomized controlled trial comparing it with the CarboMedics TopHat valve.

^,

The St Jude valve remains the gold standard mechanical prosthesis, with excellent outcomes confirmed in this series. The St Jude valve was the starting time rigid bileaflet valve that was widely used after its introduction in the late 1970s

²⁷

• Nicoloff D.G.
• Emery R.West.
• Arom K.5.
• Northrup 3, W.F.
• Jorgensen C.R.
• Wang Y.
• et al.

Clinical and hemodynamic results with the St. Jude Medical cardiac valve prosthesis. A three-twelvemonth experience.

• PubMed
• Google Scholar

and has a well-described record of immovability and hemodynamic performance in adults.

^,

The long-term results in patients younger than historic period fifty years have been quite favorable, with a low rate of valve related events with 88% survival and 92% upshot-gratuitous survival at 19 years.

At that place are few reports in the pediatric historic period group, but the reported results accept been favorable, with most valve related bleeding episodes associated with a very prolonged INR.

The basic St Jude bileaflet prosthesis has subsequently been modified to farther ameliorate hemodynamic performance by providing a larger internal orifice to external diameter ratio in the Hemodynamics Plus model or with a supra-annular design (Regent). In the electric current series, the majority of the St Jude valves used were the original design.

The On-10 valve was introduced in 1996 and includes design modifications aimed at decreasing thrombogenicity.

^,

³¹

• Hwang N.H.
• Reul H.
• Reinhard P.

In vitro evaluation of the long-trunk On-X bileaflet heart valve.

• PubMed
• Google Scholar

The relatively high housing around the leaflets may mitigate panus ingrowth, although implantation in a small child is rendered technically more than hard. Mid- to long-term follow-up of the initial adult patients who received this valve have been reported with favorable bloodshed rates and low linearized rates of thromboembolism (0.6% and 1.8% per patient-year, respectively), bleeding (0.four% and 0.9% per patient-yr) and reoperation (0.two% and 1.2% per patient-year).

²⁶

• Chambers J.
• Roxburgh J.
• Blauth C.
• O'Riordan J.
• Hodson F.
• Rimington H.

A randomized comparison of the MCRI On-Ten and CarboMedics Top Hat bileaflet mechanical replacement aortic valves: early on postoperative hemodynamic function and clinical events.

• Abstract
• Full Text
• Full Text PDF
• PubMed
• Scopus (twenty)
• Google Scholar

The Prospective Randomized On-Ten Valve Anticoagulation Clinical Trial randomized 375 patients undergoing AVR with the On-X valve to either standard care (goal INR, 2.0-3.0) with aspirin 81 mg daily, or lower dose warfarin (goal INR, 1.v-2.0) and aspirin.

³²

• Puskas J.
• Gerdisch M.
• Nichols D.
• Quinn R.
• Anderson C.
• Rhenman B.
• et al.

Reduced anticoagulation later on mechanical aortic valve replacement: interim results from the prospective randomized on-X valve anticoagulation clinical trial randomized food and drug administration investigational device exemption trial.

• Abstract
• Full Text
• Full Text PDF
• PubMed
• Scopus (165)
• Google Scholar

Following these results, the Food and Drug Administration has approved expanded labeling of the On-X valve with these lower INR goals. These trials, included but adult patients, and further studies remain to investigate whether these results tin can be replicated in children and young adults with congenital heart disease. All the same, our experience with the On-Ten valve in this patient population, managed with a goal INR of 2.0 to 3.0, has shown similar results.

Limitations

This study has several limitations. Showtime, although our written report reports a large population of patients with CHD who underwent AVR, the sample size remained express and the minor number of events limited our power to place predictors of adverse events and perform multivariable analyses. Furthermore, selection of valve types was associated with patient characteristics (eg, the CarboMedics valves were all a 16-mm size placed in small children, and had worse outcomes) and could confound multivariable analyses, and the differences in the numbers of patients in each valve grouping. Furthermore, this was a nonrandomized, retrospective report. Comparison with bioprosthetic valves was non possible, given these valves are very seldom used at our institution due to very rapid degeneration in young patients. Finally, the period of follow-up for this analysis spanned nearly a decade and a one-half, from 2000 to 2014. It is possible that some aspects of surgical technique changed during that menstruation that are not fully accounted for in our comparisons of fourth dimension to AVR by valve type.

Conclusions

Mechanical AVR in patients with CHD has adequate midterm outcomes, despite younger patients with smaller valves undergoing more reoperations. The newer generation On-X valves perform at to the lowest degree too as St Jude valves and despite the necessary anticoagulation, at that place were very few bleeding or thromboembolic complications in this patient population.

Conflict of Interest Statement

Authors take nothing to disclose with regard to commercial support.

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Article Info

Publication History

Published online: September 21, 2018

Accustomed: August 1, 2018

Received in revised form: April 3, 2018

Received: September 8, 2015

Identification

DOI: https://doi.org/x.1016/j.jtcvs.2018.08.077

Copyright

© 2018 Published by Elsevier Inc. on behalf of The American Association for Thoracic Surgery

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Source: https://www.jtcvs.org/article/S0022-5223%2818%2932353-5/abstract

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