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Transcatheter aortic valve insertion in patients with hostile ascending aorta calcification

Open ArchivePublished:April 07, 2018DOI:https://doi.org/10.1016/j.jtcvs.2018.03.125

      Abstract

      Objective

      Calcification of the ascending aorta complicates aortic valve replacement. Transcatheter aortic valve replacement is an alternative procedure in this situation, but it requires manipulation through the hostile area in the ascending aorta. We reviewed our transcatheter aortic valve insertion experience to better understand the surgical mortality risk of valve insertion in patients with extensive calcification of the ascending aorta.

      Methods

      We retrospectively reviewed the records of 665 consecutive patients who received transcatheter aortic valve insertion from November 2008 through December 2015. We defined a hostile ascending aorta on the basis of preoperative computed tomography scan documenting significant aortic calcification that the surgeon believed precluded safe aortic cross-clamp application. There were 36 patients (5%) who met our definition of a hostile ascending aorta (hostile aorta group) and 629 (95%) who did not (control group).

      Results

      Surgical mortality occurred in 2 patients (6%) in the hostile aorta group and in 18 (3%) in the control group (P = .296). There were no strokes in the hostile aorta group, whereas there were 15 (2%) in the control group (P = 1.00). There was no difference in mortality at 3 years for patients in the hostile aorta (48.5% ± 9.0%) and control groups (35.9% ± 2.3%; P = .484). Alternative access was associated with an increased risk of mortality (hazard ratio, 1.41; 95% confidence interval, 1.09-1.82; P = .009).

      Conclusions

      Transcatheter aortic valve insertion can be performed with low procedure-related morbidity and mortality in patients with hostile calcification of the ascending aorta. Our data support a transfemoral-first paradigm in this patient population.

      Key Words

      Abbreviations and Acronyms:

      CI (confidence interval), HR (hazard ratio), IQR (interquartile range), STS (Society of Thoracic Surgeons)
      Figure thumbnail fx1
      Transcatheter valve insertion in hostile ascending aorta.
      Transcatheter aortic valve insertion can be done with low risk of morbidity and mortality in patients with hostile ascending aortic calcification.
      Transcatheter aortic valve replacement is an alternative procedure in patients with significant calcification of the ascending aorta, but it requires manipulation of the delivery device through the hostile area of the ascending aorta. In this series of such patients, transcatheter aortic valve insertion was performed without occurrence of stroke and with low procedure-related mortality.
      See Editorial Commentary page 1035.
      Atherosclerosis and calcification of the ascending aorta complicates surgical aortic valve replacement for aortic valve stenosis.
      • Abramowitz Y.
      • Jilaihawi H.
      • Chakravatry T.
      • Mack M.J.
      • Makkar R.R.
      Porcelain aorta: a comprehensive review.
      The hostile nature of the calcified ascending aorta can add to the surgical burden with need for focal endarterectomy and/or ascending aorta replacement, which might even require circulatory arrest. These additional procedures can be associated with increased risk of stroke and mortality.
      • Zingone B.
      • Rauber E.
      • Gatti G.
      • Pappalardo A.
      • Benussi B.
      • Forti G.
      • et al.
      Diagnosis and management of severe atherosclerosis of the ascending aorta and aortic arch during cardiac surgery: focus on aortic replacement.
      • van der Linden J.
      • Hadjinikolaou L.
      • Bergman P.
      • Lindblom D.
      Postoperative stroke in cardiac surgery is related to the location and extent of atherosclerotic disease in the ascending aorta.
      • Blauth C.I.
      • Cosgrove D.M.
      • Webb B.W.
      • Ratliff N.B.
      • Boylan M.
      • Piedmonte M.R.
      • et al.
      Atheroembolism from the ascending aorta. An emerging problem in cardiac surgery.
      • Amarenco P.
      • Cohen A.
      • Tzourio C.
      • Bertrand B.
      • Hommel M.
      • Besson G.
      • et al.
      Atherosclerotic disease of the aortc arch and the risk of ischemic stroke.
      Considering the surgical risks associated with valve replacement in this setting, it is understandable that upward of 30% of patients had a hostile aorta in many of the transcatheter aortic valve insertion studies.
      • Zingone B.
      • Rauber E.
      • Gatti G.
      • Pappalardo A.
      • Benussi B.
      • Forti G.
      • et al.
      Diagnosis and management of severe atherosclerosis of the ascending aorta and aortic arch during cardiac surgery: focus on aortic replacement.
      • Urbanski P.P.
      • Raad M.
      • Wagner M.
      • Heinz N.
      • Reents W.
      • Diegeler A.
      Cardiac surgery in patients with a porcelain aorta in the era of transcatheter valve implantation.
      • Webb J.G.
      • Pasupati S.
      • Humphries K.
      • Thompson C.
      • Altwegg L.
      • Moss R.
      • et al.
      Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis.
      • Zahn R.
      • Schiele R.
      • Gerckens U.
      • Linke A.
      • Sievert H.
      • Kahlert P.
      • et al.
      Transcatheter aortic valve implantation in patients with “porcelain” aorta (from a Multicenter Real World Registry).
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      • Svensson L.G.
      • et al.
      Transcather aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.
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      • Moses J.W.
      • Svensson L.G.
      • et al.
      Transcatheter versus surgical aortic-valve replacement in high-risk patients.
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      • Lefèvre T.
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      • et al.
      Thirty-day results of the SAPIEN aortic bioprosthesis European outcome (SOURCE) registry: a European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve.
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      • Ettori F.
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      • et al.
      Incidence and predictors of early and late mortality after transcatheter aortic valve implantation in 663 patients with severe aortic stenosis.
      In those studies, however, the hostile aorta was not well defined, and its influence on outcomes was not specifically analyzed. The aim of this study was to determine what influence the hostile ascending aorta had on surgical mortality after transcatheter aortic valve insertion.

      Methods

      The study was approved by the Mayo Clinic Rochester institutional review board (date and number of approval: February 23, 2016, and 15-009632). We retrospectively reviewed the records of 665 consecutive patients who received transcatheter aortic valve insertion from November 2008 through December 2015. We defined a hostile aorta on the basis of computed tomography scan evidence of a calcified ascending aorta that the surgeon (A.N. or K.L.G.) believed would preclude safe aortic cross-clamp placement anywhere in the ascending aorta. The aortic arch was not included in the assessment. There were 36 patients (5%) who met our definition of hostile ascending aorta and who formed the hostile aorta study group. Patients in the control group (n = 629; 95%) were believed by the surgeons to be candidates for safe aortic cross-clamp placement.
      Baseline patient characteristics, surgical, and outcome data were abstracted from the medical record and Department database. Data were recorded on the basis of definitions set forth in the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (Chicago, Ill) and the Valve Academic Research Consortium Consensus Document (VARC-2).
      • Kappatein A.P.
      • Head S.J.
      • Genereux P.
      • Piazza N.
      • van Meighem N.M.
      • Blackstone E.H.
      • et al.
      Updated standardized endpoint definitions for transcatheter aortic valve implantation: the valve academic research consortium-2 consensus document.
      The primary end point of the study was surgical death defined as death during the acute episode of care or within 30 days of the procedure. Secondary outcomes included procedure-related complications and long-term mortality. Vital status was determined by review of the database, electronic medical record, and a Social Security death index and general internet obituary search performed June 1, 2017.
      Descriptive statistics for categorical variables are reported as count (percentage) and continuous variables as median (interquartile range [IQR]). Statistical analysis used the χ2 or Fischer exact test for categorical variables, the Cochran-Armitage trend test for ordinal variables, and the nonparametric rank sum test for continuous data. Follow-up was calculated with the reverse Kaplan–Meier estimator methods, whereas mortality data were calculated with Kaplan–Meier estimator methods. Differences in mortality rates were analyzed with Cox proportional hazards methods. Data analysis was done with JMP Pro 10.0.0 statistical discovery software (SAS Institute, Inc, Cary, NC).

      Results

      The mean age of all patients was 82 years (IQR, 76-87), sex was female in 270 patients (41%), and STS predicted risk of mortality was 7.9% (IQR, 5.3%-11.4%). Baseline patient characteristics stratified according to study cohort are reported in Table 1. Female sex distribution (P = .894) and STS predicted risk of mortality (P = .326) were similar in both study cohorts; however, the hostile aorta group was younger (P = .018), had lower body mass index (P = .031), and had a greater prevalence of previous percutaneous coronary intervention (69% vs 45%; P = .004) compared with the control group. There was also a trend for more peripheral vascular disease in the hostile aorta group compared with control patients (81% vs 65%; P = .054; Table 1).
      Table 1Baseline patient characteristics stratified according to presence of hostile aorta
      Continuous Variable
      Frailty defined as 3 or more of the following metrics: weakened hand drip, prolonged 5-meter walk test, serum albumin <3.5 g/dL, or <4 of 6 KATZ activities of daily living that include independence in bathing, dressing, toileting, transferring, continence, and feeding.
      Missing dataHostile aorta (n = 36)Control group (n = 629)P value
      Age, y081 (IQR, 70-84)82 (IQR, 77, 87).018
      Body mass index027 (IQR, 24-30)29 (IQR, 25-33).031
      Creatinine, mg/dL01.1 (IQR, 0.9-1.7)1.2 (IQR, 0.9-1.5).874
      STS score, %07.4 (IQR, 4.4-11.2)8.0 (IQR, 5.3-11.4).326
      Categorical variablesn (%)
      Female sex015 (42)255 (41).894
      Diabetes mellitus09 (25)250 (40).078
      Hemodialysis00 (0)13 (2)1.00
      Hypertension030 (83)568 (90).163
      Previous infectious endocarditis01 (3)2 (<1).154
      Chronic lung disease0.927
       None14 (39)220 (35)
       Mild5 (14)173 (28)
       Moderate11 (31)106 (17)
       Severe6 (17)130 (21)
      Immunosuppression05 (14)120 (19).438
      Peripheral vascular disease029 (81)408 (65).054
      Cerebrovascular disease011 (31)161 (26).509
      Previous pacemaker07 (19)115 (18).861
      Previous coronary bypass016 (44)245 (39).511
      Previous valve procedure09 (25)145 (23).788
      Previous percutaneous coronary intervention025 (69)283 (45).004
      Previous myocardial infarction030 (83)462 (73).189
      NYHA functional class0.634
       I0 (0)3 (<1)
       II4 (11)97 (15)
       III27 (75)376 (60)
       IV5 (14)153 (24)
      Cardiogenic shock00 (0)0 (0)
      Resuscitation00 (0)0 (0)
      Arrhythmia010 (28)180 (29).914
      Medical inotropes00 (0)5 (1)1.00
      Number of diseased vessels0.080
       None6 (17)183 (29)
       15 (14)113 (18)
       28 (22)91 (15)
       317 (47)242 (38)
      Left main coronary artery stenosis08 (22)100 (16).317
      Aortic stenosis036 (100)629 (100)
      Mitral valve stenosis010 (28)160 (25).754
      Aortic valve regurgitation, severe04 (11)22 (3).046
      Mitral valve regurgitation, severe01 (3)6 (1).324
      Tricuspid valve regurgitation, severe01 (3)47 (7).505
      Status of surgery, elective034 (94)593 (94)1.000
      Incidence of cardiac surgery0.067
       115 (42)346 (55)
       217 (47)243 (39)
       33 (8)37 (6)
       4 or more1 (3)3 (1)
      Mechanical circulatory support01 (3)8 (1).396
      Frailty
      Frailty defined as 3 or more of the following metrics: weakened hand drip, prolonged 5-meter walk test, serum albumin <3.5 g/dL, or <4 of 6 KATZ activities of daily living that include independence in bathing, dressing, toileting, transferring, continence, and feeding.
      01 (3)36 (6).714
      IQR, Interquartile range; STS, Society of Thoracic Surgeons; NYHA, New York Heart Association; KATZ,.
      Frailty defined as 3 or more of the following metrics: weakened hand drip, prolonged 5-meter walk test, serum albumin <3.5 g/dL, or <4 of 6 KATZ activities of daily living that include independence in bathing, dressing, toileting, transferring, continence, and feeding.
      Baseline computed tomography showed similar aortic valve calcium scores in the hostile aorta group compared with the control group (2677 vs 2565 Agatston units; P = .778). Echocardiography showed similar ejection fraction in the hostile aorta group compared with the control group (62% vs 60%; P = .246). The 2 groups also had comparable aortic valve peak velocity (P = .478), mean systolic transvalvular valve gradient (P = .748), and valve area (P = .343). Specific computed tomography and echocardiography data are reported in Table 2.
      Table 2Baseline computed tomography and echocardiography data stratified according to presence of hostile aorta
      Computed tomographyMissing dataHostile aorta (n = 36)Control group (n = 629)P value
      Aortic valve calcium score, Agatston units74 (11)2677 (IQR, 1836-3342)2565 (IQR, 1813-3572).778
      Echocardiography
       Ejection fraction, %062 (IQR, 51-68)60 (IQR, 47-66).246
       Aortic valve velocity, m/s7 (1)4.1 (IQR, 3.6-4.3)4.1 (IQR, 3.7-4.5).478
       Mean gradient, mm Hg4 (1)41 (IQR, 34-48)42 (IQR, 35-50).748
       Aortic valve area, cm212 (2)0.75 (IQR, 0.65-0.90)0.80 (IQR, 0.68-0.92).343
      IQR, Interquartile range.
      Transfemoral access was the most common method of arterial access and was done in 408 patients (61%); importantly, alternative access was more common in the hostile aorta group (n = 25; 69%) compared with the control group (n = 232; 37%; P < .001). Balloon expandable valves were inserted in 531 patients (80%) and self-expanding valves in 134 (20%). Valve types and sizes were similarly distributed among the 2 groups (Table 3).
      Table 3Surgery data stratified according to presence of hostile aorta
      Arterial accessHostile aorta (n = 36)Control group (n = 629)P value
      Transfemoral11 (31)397 (63)
      Transapical23 (64)201 (32)<.001
      Transaxillary1 (3)3 (<1)
      Transaortic1 (3)28 (4)
      Valve type
      Sapien, Sapien XT, and Sapien S3 valves (Edwards Life Sciences, Irvine, Calif); CoreValve and Evolut valves (Medtronic, Minneapolis, Minn); and Lotus valve (Boston Scientific, Marlborough, Mass).
       Edwards Sapien20 (56)262 (42)
       Edwards Sapien XT8 (22)154 (25)
       Edwards Sapien S33 (8)84 (13).379
       Medtronic CoreValve3 (8)108 (17)
       Medtronic Evolut2 (6)18 (3)
       Lotus0 (0)3 (<1)
      Valve size, mm
       200 (0)4 (<1)
       2310 (28)172 (27)
       2620 (56)295 (47).497
       270 (0)2 (<1)
       294 (11)99 (16)
       312 (6)57 (9)
      Data are presented as n (%) except where otherwise noted.
      Sapien, Sapien XT, and Sapien S3 valves (Edwards Life Sciences, Irvine, Calif); CoreValve and Evolut valves (Medtronic, Minneapolis, Minn); and Lotus valve (Boston Scientific, Marlborough, Mass).
      Intraoperative transesophageal echocardiography showed paravalvular leak grade of moderate in 1 patient in the hostile aorta group (3%) and in 9 in the control group (1%; P = .218), with no episodes of severe paravalvular regurgitation noted. Moderate paravalvular regurgitation was similarly distributed across all valve types (P = .849) and for first-generation valves (P = .501). Valve Academic Research Consortium 2-defined procedural success was achieved in 27 patients (75%) in the hostile aorta group and in 528 in the control group (84%; P = .160).
      Procedure-related complications were similarly distributed among the 2 treatment groups and included stroke (P = 1.00), new onset dialysis (P = .071), new permanent pacemaker implantation (P = .803), and vascular injury (P = .577; Table 4). There were 11 patients in the hostile aorta group who received transfemoral access of whom 4 (36%) experienced a vascular complication. In 2 of the patients, the complications were relatively minor. In 1 patient, a thrill was noted after primary suture repair of the surgically exposed femoral artery. The artery was reopened and no abnormality noted. A patch angioplasty was performed. In the other patient, a 1-cm pseudoaneurysm was noted after percutaneous closure of the femoral artery. The 2 major vascular complications were related to iliac artery rupture during Sapien valve insertion.
      Table 4Procedure-related complication data stratified according to presence of hostile aorta
      Accessn (%)P value
      Hostile aorta (n = 36)Control group (n = 629)
      Procedure failure9 (25)101 (16).160
      Complication, any13 (36)194 (31).507
      Cardiopulmonary bypass support2 (6)26 (4).659
      Stroke0 (0)15 (2)1.000
      New requirement hemodialysis3 of 36 (8)15 of 616 (2).071
      Received permanent pacemaker placement4 of 29 (14)93 of 514 (18).803
      Vascular injury5 (14)67 (11).577
      In-hospital death2 (6)12 (2).172
      Operative death2 (6)18 (3).296
      Complication, any or procedure failure16 (44)258 (41).685
      Hostile aorta
      Adjusted for factors related to hostile aorta or complication, any at 0.05 level of significance: age, body mass index, creatinine, previous permanent pacemaker, previous percutaneous coronary intervention, peripheral vascular disease, aortic valve calcium score, aortic valve velocity, and alternative access.
      Adjusted odds ratio95% confidence intervalWald P value
      Complication, any1.980.92 to 4.27.081
      Complication, any or procedure failure1.800.78 to 4.15.169
      Adjusted for factors related to hostile aorta or complication, any at 0.05 level of significance: age, body mass index, creatinine, previous permanent pacemaker, previous percutaneous coronary intervention, peripheral vascular disease, aortic valve calcium score, aortic valve velocity, and alternative access.
      Surgical death occurred in 2 patients (6%) in the hostile aorta group. Death was from cardiac causes in both patients and included ventricular fibrillation after intraoperative root angiography in 1 patient and acute coronary artery stent thrombosis on postoperative day 1 in another patient. Surgical death occurred in 18 patients in the control group (3%) and was defined as cardiac in 9 patients, neurologic, renal, vascular, and pulmonary in 2 each, and infection in 1. Surgical death rates were similar in the hostile aorta and control groups (P = .296; Table 4).
      Postoperative echocardiography was available in 654 patients (98%) at 0.6 years (IQR, 0.1-1.3). On the last follow-up transthoracic echocardiogram, the median ejection fraction was 60% (IQR, 46%-66%) in the hostile aorta group and 59% (IQR, 48%-65%) in the control group (P = .801); the mean systolic transvalvular gradient was 9 (IQR, 7-12) mm Hg in the hostile aorta group and 10 (IQR, 8-14) mm Hg in the control group (P = .019); and paravalvular regurgitation grade moderate or worse was present in 6 patients in the hostile aorta group (17%) compared with 60 in the control group (10%; P = .247). There was only 1 case of severe paravalvular regurgitation, and that occurred in the control group (Table 5). The occurrence of moderate or severe paravalvular regurgitation was similarly distributed across all valve types (P = .644) and first- versus other generation valves (P = .110).
      Table 5Last follow-up echocardiography data stratified according to grade of paravalvular regurgitation
      Groupn (%)P value
      NoneTrivialMildModerateSevere
      Hostile aorta8 (22)9 (25)13 (36)6 (17)0 (0).132
      Control195 (32)157 (25)206 (33)59 (10)1 (<1)
      Total203 (31)166 (25)219 (33)65 (10)1 (<1)
      Mild or lessModerate or worseP value
      Hostile aorta30 (83)6 (17).247
      Control558 (90)60 (10)
      During a median follow-up of 2.5 (IQR, 1.5-3.7) years, there were 240 deaths (36%). Kaplan–Meier mortality estimates showed no difference in 3-year mortality rates between patients who received transcatheter aortic valve insertion in the setting of a hostile aorta (48.5% ± 9.0%) or in the control group (35.9% ± 2.3%; log-rank, P = .484; Figure 1).
      Figure thumbnail gr1
      Figure 1Kaplan–Meier estimate of mortality after transcatheter aortic valve insertion, stratified according to presence or absence of porcelain aorta.
      A multivariable Cox proportional hazards regression model of confounders of mortality was created with STS predicted risk of mortality, hostile aorta, and alternate access. The model identified mortality association with STS predicted risk of mortality (hazard ratio [HR], 1.03; 95% confidence interval [CI], 1.02-1.04; P < .001) and alternative access (HR, 1.41; 95% CI, 1.09-1.82; P = .009); however, there was no association with hostile aorta (HR, 1.22; 95% CI, 0.73-1.93; P = .419).

      Discussion

      This study defined a hostile aorta on the basis of computed tomography scan evidence of a calcified ascending aorta that the surgeon determined would preclude safe aortic cross-clamp placement. Using this definition, we identified a 5% rate of hostile aorta in a group of 665 patients who received transcatheter aortic valve insertion. As expected, there was a trend toward a higher prevalence of peripheral vascular disease in the hostile aorta group compared with control patients (81% vs 65%; P = .054); and as such, patients with a hostile aorta more commonly received alternative access. Despite the differences in baseline characteristics and arterial access, outcomes were similar among the 2 groups.
      The presence of ascending aorta calcification is a difficult problem for the cardiovascular surgeon at the time of surgical aortic valve replacement. One of the challenges pertains to placement of the aortic cross-clamp, which runs the risk of stroke and/or mortality from embolization by material from the aorta.
      • Zingone B.
      • Rauber E.
      • Gatti G.
      • Pappalardo A.
      • Benussi B.
      • Forti G.
      • et al.
      Diagnosis and management of severe atherosclerosis of the ascending aorta and aortic arch during cardiac surgery: focus on aortic replacement.
      • van der Linden J.
      • Hadjinikolaou L.
      • Bergman P.
      • Lindblom D.
      Postoperative stroke in cardiac surgery is related to the location and extent of atherosclerotic disease in the ascending aorta.
      • Blauth C.I.
      • Cosgrove D.M.
      • Webb B.W.
      • Ratliff N.B.
      • Boylan M.
      • Piedmonte M.R.
      • et al.
      Atheroembolism from the ascending aorta. An emerging problem in cardiac surgery.
      • Amarenco P.
      • Cohen A.
      • Tzourio C.
      • Bertrand B.
      • Hommel M.
      • Besson G.
      • et al.
      Atherosclerotic disease of the aortc arch and the risk of ischemic stroke.
      To prevent this catastrophic complication, the surgeon often has to perform deep hypothermic circulatory arrest and ascending aortic replacement as well as the aortic valve replacement.
      • van der Linden J.
      • Hadjinikolaou L.
      • Bergman P.
      • Lindblom D.
      Postoperative stroke in cardiac surgery is related to the location and extent of atherosclerotic disease in the ascending aorta.
      • Amarenco P.
      • Cohen A.
      • Tzourio C.
      • Bertrand B.
      • Hommel M.
      • Besson G.
      • et al.
      Atherosclerotic disease of the aortc arch and the risk of ischemic stroke.
      • Urbanski P.P.
      • Raad M.
      • Wagner M.
      • Heinz N.
      • Reents W.
      • Diegeler A.
      Cardiac surgery in patients with a porcelain aorta in the era of transcatheter valve implantation.
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      The safety of deep hypothermic circulatory arrest in aortic valve replacement with unclampable aorta in non-octogenarians.
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      The additional surgical burden adds to the risk of the surgery. In one study of 122 such patients by Kaneko and colleagues, the procedure-related stroke rate was 12% and mortality rate was 8%.
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      These rates should be compared with those reported in the present study of 0% and 6%, respectively.
      Transcatheter aortic valve insertion would seem an ideal option to circumvent the issue of the hostile ascending aorta. Indeed, the presence of a hostile aorta is a common indication for transcatheter valve insertion. Anywhere from 5% to 33% of the patients who received transcatheter aortic valve insertion have a diagnosis of hostile aorta.
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      • Thompson C.
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      Percutaneous transarterial aortic valve replacement in selected high-risk patients with aortic stenosis.
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      Feasibility and initial results of percutaneous aortic valve implantation including selection of the transfemoral or transapical approach in patients with severe aortic stenosis.
      One reason for the variability in occurrence is that there are no uniform diagnostic criteria for what determines a hostile aorta.
      • Gillinov A.M.
      • Lytle B.W.
      • Hoang V.
      • Cosgrove D.M.
      • Banbury M.K.
      • McCarthy P.M.
      • et al.
      The atherosclerotic aorta at aortic valve replacement: surgical strategies and results.
      We classified an aorta as hostile on the basis of computed tomography scan evidence of a heavily calcified ascending aorta that the surgeon believed would preclude safe aortic cross-clamp placement during aortic valve replacement. We think this is a reasonable definition and know of no studies that prospectively assessed computed tomography scan findings and ability to apply the aortic cross-clamp. Our own anecdotal experience is that the computed tomography scan tends to underestimate the degree of calcification and hostility in the ascending aorta.
      We noted no difference in procedure failure in patients with and without a hostile aorta. Several other investigators have also reported successful transcatheter valve insertion in this situation.
      • Zahn R.
      • Gerckens U.
      • Grube E.
      • Linke A.
      • Sievert H.
      • Eggebrecht H.
      • et al.
      Transcatheter aortic valve implantation: first results from a multi-centre real-world registry.
      • Pascual I.
      • Avanzas P.
      • Muñoz-García A.J.
      • López-Otero D.
      • Jimenez-Navarro M.F.
      • Cid-Alvarez B.
      • et al.
      Percutaneous implantation of the CoreValve self-expanding valve prosthesis in patients with severe aortic stenosis and porcelain aorta: medium-term follow-up.
      In a multicenter, observational prospective study by Pascual and colleagues, 36 of 449 patients (8%) carried a diagnosis of hostile aorta.
      • Pascual I.
      • Avanzas P.
      • Muñoz-García A.J.
      • López-Otero D.
      • Jimenez-Navarro M.F.
      • Cid-Alvarez B.
      • et al.
      Percutaneous implantation of the CoreValve self-expanding valve prosthesis in patients with severe aortic stenosis and porcelain aorta: medium-term follow-up.
      In that study, procedural success with a self-expanding valve (94% vs 97%) and prevalence of procedure-related complication (19% vs 12%) were similar in patients with a hostile aorta compared with patients without a hostile aorta (P = nonsignificant in both analyses). In another study, Kempfert and colleagues noted procedural success was 100% in 29 patients with transapical access with a balloon expandable valve.
      • Kempfert J.
      • Van Linden A.
      • Linke A.
      • Schuler G.
      • Rastan A.
      • Lehmann S.
      • et al.
      Transapical aortic valve implantation: therapy of choice for patients with aortic stenosis and porcelain aorta?.
      We found no association between the presence of a hostile aorta and specific VARC-2 complications. This might be an effect, however, of the small number of events. To address this issue, we analyzed the data using the combined end point of any complication and any complication/procedure failure. The adjusted odds ratios for any complication and any complication/procedure failure were both greater than 1 (1.98 and 1.80, respectively), however, the differences were still not significant with both P values being >.05 (Table 4). Similar findings were also reported in the study from Pascual and colleagues. They noted acute complications occurred in 19% of patients with a hostile aorta and in 12% of patients without a hostile aorta, but the difference was not significant (P = .200); furthermore, there were no differences for the specific complications of death, major hemorrhage, or vascular injury.
      • Pascual I.
      • Avanzas P.
      • Muñoz-García A.J.
      • López-Otero D.
      • Jimenez-Navarro M.F.
      • Cid-Alvarez B.
      • et al.
      Percutaneous implantation of the CoreValve self-expanding valve prosthesis in patients with severe aortic stenosis and porcelain aorta: medium-term follow-up.
      The presence of severe peripheral vascular disease is generally more common in patients with a hostile aorta as noted in the present analysis and in a study by Zahn and colleagues (35% vs 20%, respectively; P < .001).
      • Zahn R.
      • Schiele R.
      • Gerckens U.
      • Linke A.
      • Sievert H.
      • Kahlert P.
      • et al.
      Transcatheter aortic valve implantation in patients with “porcelain” aorta (from a Multicenter Real World Registry).
      The finding is likely the impetus behind an increased need for alternative access in patients with a hostile aorta in the present study (68% vs 37%: P < .001), as well as in the study from Zahn and colleagues (18% vs 12%: P = .03).
      • Zahn R.
      • Schiele R.
      • Gerckens U.
      • Linke A.
      • Sievert H.
      • Kahlert P.
      • et al.
      Transcatheter aortic valve implantation in patients with “porcelain” aorta (from a Multicenter Real World Registry).
      Several investigators have reported transapical access to be safe and effective in these extreme high-risk surgical patients.
      • Rodés-Cabau J.
      • Webb J.G.
      • Cheung A.
      • Ye J.
      • Dumont E.
      • Feindel C.M.
      • et al.
      Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience.
      • Svensson L.G.
      • Dewey T.
      • Kapadia S.
      • Roselli E.E.
      • Stewart A.
      • Williams M.
      • et al.
      United States feasibility study of transcatheter insertion of a stented aortic valve by the left ventricular apex.
      • Zahn R.
      • Gerckens U.
      • Grube E.
      • Linke A.
      • Sievert H.
      • Eggebrecht H.
      • et al.
      Transcatheter aortic valve implantation: first results from a multi-centre real-world registry.
      • Ferrari E.
      • Namasivayam J.
      • Marcucci C.
      • Gronchi F.
      • Berdais D.
      • Niclauss L.
      • et al.
      Transapical aortic valve replacement in extreme-risk patients: outcome, risk factors and mid-term results.
      • Eltchaninoff H.
      • Prat A.
      • Gilard M.
      • Lequerrier A.
      • Blanchard D.
      • Fournial G.
      • et al.
      Transcatheter aortic valve implantation: early results of the FRANCE (FRench Aortic National CoreValve and Edwards) registry.
      • Moat N.E.
      • Ludan P.
      • de Belder M.A.
      • Bridgewater B.
      • Cunningham A.D.
      • Young C.P.
      • et al.
      Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) registry.
      We agree with that general assessment, but our mortality outcome data support a transfemoral first paradigm. Judgment is paramount in that regard as noted by our high vascular injury rate in the hostile aorta transfemoral access group (36%).
      Paravalvular aortic regurgitation is a major concern with any transcatheter valve insertion. We noted similar rates of intraoperative moderate paravalvular regurgitation in patients with and without a hostile aorta (3% vs 1%; P = .430), which is similar to that reported by Zahn and colleagues (5% vs 4%, respectively; P = .29).
      • Zahn R.
      • Schiele R.
      • Gerckens U.
      • Linke A.
      • Sievert H.
      • Kahlert P.
      • et al.
      Transcatheter aortic valve implantation in patients with “porcelain” aorta (from a Multicenter Real World Registry).
      At approximately 6 months follow-up, however, we noted paravalvular regurgitation grade moderate or severe increased to 17% in patients with a hostile aorta and to 10% in patients without hostile aorta, although the difference between the 2 groups was not significant. The temporal increase is a noteworthy finding. We hypothesize that it might be related to remodeling of the transcatheter prosthesis-native aortic valve annulus interface. It remains conjecture whether it results from changes related to the transcatheter valve (eg, migration, collapse, etc) or native annulus (eg, calcium fracture, scar remodeling, etc).

      Limitation

      This study has several limitations. It is a single-center, retrospective analysis, which is subject to local biases that might not apply to other centers. We believe the main bias is in what constitutes a hostile aorta. In that regard, there is no universal definition. We believe our classification of a hostile aorta is reasonable, but we also believe that the computed tomography scan images tend to underestimate the amount of hostility in the ascending aorta. To subject patients to surgery just to confirm the inability to place an aortic cross-clamp, however, seems excessive. The number of patients in the present analysis is small, and thus we believe that matching on a propensity score would not be feasible. With only a total of 20 surgical mortalities, regression adjustment is not feasible for this outcome. The study is at risk of type II statistical error in that we concluded no difference in outcomes after transcatheter valve insertion between patients with and without hostile aorta.

      Conclusions

      Transcatheter aortic valve replacement seems a safe option to treat symptomatic severe aortic valve stenosis requiring aortic valve replacement in patients with a hostile aorta. The technique is associated with acceptable outcomes that included low procedure-related stroke, paravalvular regurgitation, and mortality rates, as well as subsequent intermediate-term mortality rate. Paravalvular regurgitation rates appear to increase with time after surgery, and the finding is of concern. Newer valve designs have the hope of reducing the occurrence of temporally related paravalvular regurgitation. Our mortality outcome data support a transfemoral-first paradigm in this patient population.

      Conflict of Interest Statement

      Authors have nothing to disclose with regard to commercial support.

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      Linked Article

      • Another crack at the porcelain aorta
        The Journal of Thoracic and Cardiovascular SurgeryVol. 156Issue 3
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          The language of medicine and surgery is replete with a colorful and descriptive lexicon. Terminology that is used to confer information to others may not have a fixed definition, leaving room for variable interpretation. For the surgeon, the words “hostile aorta” are such a term, reflecting a clinical situation that may directly affect the conduct of the operation. In general, the hostile aorta may describe the inability to safely crossclamp and/or cannulate the aorta, but it may also include anatomic considerations such as the aorta being stuck to the posterior plate of the sternum.
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