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Transcaval Access and Closure for Transcatheter Aortic Valve Replacement: AProspective Investigation
Adam B. Greenbaum, MD, Vasilis C. Babaliaros, MD, Marcus Y. Chen, MD, AnnetteM. Stine, RN, Toby Rogers, PhD, BM BCh, William W. O’Neill, MD, Gaetano Paone,MD, Vinod H. Thourani, MD, Kamran I. Muhammad, MD, Robert A. Leonardi, MD,Stephen Ramee, MD, James F. Troendle, PhD, Robert J. Lederman, MD
PII: S0735-1097(16)36769-9
DOI: 10.1016/j.jacc.2016.10.024
Reference: JAC 23129
To appear in: Journal of the American College of Cardiology
Received Date: 8 October 2016
Revised Date: 21 October 2016
Accepted Date: 24 October 2016
Please cite this article as: Greenbaum AB, Babaliaros VC, Chen MY, Stine AM, Rogers T, O’Neill WW,Paone G, Thourani VH, Muhammad KI, Leonardi RA, Ramee S, Troendle JF, Lederman RJ, TranscavalAccess and Closure for Transcatheter Aortic Valve Replacement: A Prospective Investigation, Journal ofthe American College of Cardiology (2016), doi: 10.1016/j.jacc.2016.10.024.
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Transcaval Access and Closure for Transcatheter Aortic Valve Replacement: A Prospective Investigation
Adam B. Greenbaum, MDa; Vasilis C. Babaliaros, MDb; Marcus Y. Chen, MDc; Annette M. Stine, RNc
; Toby Rogers, PhD, BM BChc; William W. O’Neill, MDa; Gaetano Paone, MDa; Vinod H. Thourani, MDb; Kamran I. Muhammad, MDd; Robert A. Leonardi, MDe; Stephen Ramee, MDf; James F. Troendle, PhDc; Robert J. Lederman, MDc
aHenry Ford Hospital, Detroit, Michigan; bEmory University, Atlanta, Georgia; cNational Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland; dOklahoma Heart Institute, Tulsa, Oklahoma; eLexington Medical Center, West Columbia, South Carolina; fOchsner Medical Center, New Orleans, Louisiana Running title: Transcaval TAVR prospective trial Acknowledgements: Supported by the NHLBI Division of Intramural Research Z01-HL006040. Relationships with Industry: ABG is a proctor for Edwards Lifesciences and St Jude Medical and his employer receives research support from St Jude Medical VCB is a consultant for Edwards Lifesciences and for Abbott Vascular, and his employer receives research support from Edwards Lifesciences, Abbott Vascular, Medtronic, St Jude Medical, and Boston Scientific. WWO is a consultant to Edwards Lifesciences, Medtronic, and St Jude Medical. GP is a consultant and proctor for Edwards Lifesciences. VHT is a consultant for Edwards Lifesciences and Abbott Vascular. His employer receives research support from Edwards Lifesciences, Boston Scientific, Medtronic, St Jude Medical, and Abbott Medical. KM is a proctor for Edwards Lifesciences. RAL is a consultant for St Jude Medical and a paid speaker for Edwards Lifesciences. SR is an investigator for Edwards Lifesciences and St Jude Medical, and reports honoraria from Edwards Lifesciences and Medtronic. ABG, TR, and RJL are co-inventors of devices, not tested in this protocol, intended to close transcaval access. All other authors report no financial conflict of interest. Address for Correspondence Robert J. Lederman, MD Cardiovascular and Pulmonary Branch Division of Intramural Research National Heart Lung and Blood Institute National Institutes of Health Building 10, Room 2c713, MSC 1538 Bethesda, Maryland 20892-1538 Telephone: (301) 402-6769 Fax: 301-451-5451 E-mail: [email protected]
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ABSTRACT Background: Transcaval access may enable fully percutaneous transcatheter aortic valve replacement (TAVR) without the hazards and discomfort of transthoracic (transapical or transaortic) access. Objectives: We performed a prospective, independently-adjudicated, multi-center, single-arm Investigational Device Exemption trial of transcaval access for TAVR in patients ineligible for femoral artery access and high or prohibitive risk of complications from transthoracic access. Methods: 100 subjects underwent attempted percutaneous transcaval access to the abdominal aorta by electrifying a caval guidewire and advancing into a prepositioned aortic snare. After exchanging for a rigid guidewire, conventional TAVR was performed through transcaval introducer sheaths. Transcaval access ports were closed with nitinol cardiac occluders. A core lab analyzed pre-discharge and 30-day abdominal CT. The STS predicted risk of mortality was 9.6 ± 6.3%. Results: Transcaval access was successful in 99/100 subjects. Device success (access and closure with a nitinol cardiac occluder without death or emergency surgical rescue) was 98/99, except for one closed only with a covered stent. Inpatient survival was 96% and 30-day survival was 92%. VARC2 life-threatening bleeding and modified VARC2 major vascular complications possibly related to transcaval access were 7% and 13%, respectively. Median length of stay was 4 (2-6) days. There were no vascular complications after discharge. Conclusion: Transcaval access enabled TAVR in patients who were not good candidates for transthoracic access. Bleeding and vascular complications, using permeable nitinol cardiac occluders to close the access ports, were common but acceptable in this high risk cohort. Transcaval access should be investigated in patients who are eligible for transthoracic access. Purpose-built closure devices are in development that may simplify the procedure and reduce bleeding. Clinical trial: NCT02280824 on clinicaltrials.gov Condensed Abstract Transcaval access is a new fully-percutaneous extra-thoracic technique. We report a prospective, multi-center trial of transcaval TAVR in 100 patients (STS PROM 9.6±6.3%) ineligible for transfemoral and high or prohibitive risk for transthoracic access. Transcaval access was successful in 99/100. Device success (access and closure with a nitinol cardiac occluder without death or emergency surgical rescue) was 98/99. Inpatient survival was 96% and 30-day survival was 92%. Transcaval-related life-threatening bleeding was 7%. Transcaval access enabled TAVR in patients who were not good candidates for transthoracic access. Bleeding and vascular complications were common but acceptable in this high risk cohort. Key words: Non-transfemoral access, Structural heart disease, Caval-aortic access, Transcaval, Transcatheter aortic valve replacement, Vascular access Abbreviations CT Computed tomography IVC Inferior vena cava RPH Retroperitoneal hematoma STS Society of thoracic surgeons
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TAVR Transcatheter aortic valve replacement VARC2 Second valve academic research consortium
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Introduction
Transcatheter aortic valve implantation (TAVR) avoids the morbidity and mortality of
surgical aortic valve replacement in high and intermediate risk patients (1-6). Transthoracic
(transapical and transaortic) access is inferior compared with femoral-artery access (6), perhaps
in part because of the clinical features precluding femoral artery access. Discomfort and
morbidity are more pronounced from transthoracic access for TAVR, probably because of
invasiveness and pulmonary insults. An alternative transfemoral access approach to TAVR
might be desirable in these patients to reduce the hazards and discomfort of transthoracic access
and because of the superior operator ergonomics.
We developed a technique of transfemoral venous access for retrograde TAVR by
entering the abdominal aorta through the adjoining inferior vena cava, which is now called
transcaval access (7) (Central Illustration). Animals tolerate the resulting acute aorto-caval
fistula even without repair, because the retroperitoneal space appears to pressurize and cause
aortic blood to return immediately through the corresponding hole in the vena cava (Figure 2).
Patients tolerate transcaval access after implanting nitinol cardiac occluders to close the aortic
port. Transcaval access and closure was uniformly successful in the first 19 patients, all of
whom had no good TAVR access options (8).
We have refined the technique of transcaval access and closure (9) and tested the early
multi-center experience in a single-arm prospective Investigational Device Exemption trial in
patients deemed to have high or prohibitive risk of complications from transthoracic access for
TAVR. This paper describes 30-day outcomes in 100 patients.
Methods
Patients and study design
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The study evaluated success and complications of transcaval TAVR access and closure
with a nitinol cardiac occluder device. It was designed as a prospective open-label multi-center
single-arm study with on-site monitoring, independent endpoint adjudication, and central core
laboratory analysis of follow-up images (NCT02280824).
Subjects were eligible to participate if (1) they had severe symptomatic native aortic
valve stenosis or bioprosthetic aortic valve failure for which TAVR was indicated, (2) extreme
risk or inoperability for conventional femoral artery, trans-apical, or trans-aortic access as
determined by the institutional multi-disciplinary heart team, and (3) anatomic suitability for
transcaval access according to a baseline CT scan analyzed by the NHLBI core laboratory. These
are further detailed in the Online Appendix. Screening details on ineligible candidates were not
collected.
The US Food and Drug Administration granted Investigational Device Exemption for this
sponsor-investigator study, which had Institutional Research Boards approval from all 20
participating sites and NHLBI. All subjects consented in writing. The NHLBI Data Safety
Monitoring Board provided oversight, and pre-specified endpoints were independently
adjudicated by Medstar Heart and Vascular Institute Clinical Events Committee. Sites received
on-site proctorship by the principal investigator and/or sponsor.
The IDE was sponsored by the senior author on behalf of NHLBI, which was the data
coordination center. Sites participated without NHLBI funding. The manufacturer of the IDE
test article (Amplatzer nitinol occluder devices, St Jude Medical) allowed FDA to cross-
reference the device master file for the IDE but did not otherwise participate in the study.
Subjects were concurrently enrolled into the Society of Thoracic Surgeons / American College of
Cardiology Transcatheter Valve Therapies (TVT) registry(10).
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Technique of transcaval access and closure
The technique has been detailed previously (8,9). Briefly, the procedure is planned from
the baseline TAVR CT (11,12) to identify a calcium-free target on the right aortic wall that
allows safe passage of the TAVR sheath from the inferior vena cava to the abdominal aorta. The
trajectory of the sheath should be free of interposed obstacles (bowel) and the area of aortic entry
should be away from important arterial branches allowing for provisional covered stent bailout if
necessary. After heparin anticoagulation, a loop snare was placed in the aorta to serve as a
target. A coaxial crossing system consisting of a 0.014”x300cm coronary guidewire (Confienza
Pro 12 or Astato XS20, Asahi, Abbott) inside a 0.035”x145cm locking wire convertor
(Piggyback, Vascular Solutions), inside a braided 0.035”x90cm microcatheter, inside a 6-7Fr
renal-length IMA or RDC1 guiding catheter (Figure 3), was positioned into the cava, aimed
towards the aortic snare, and electrified using a monopolar electrosurgery pencil at 50W during
brief guidewire advancement across vascular walls. Once the 0.014” guidewire was snared,
counter-traction allowed the wire convertor and 0.035” microcatheter to be advanced
successively across the aortic wall and then exchanged for a rigid 0.035”x260cm guidewire
(Lunderquist, Cook). The TAVR introducer sheath — Retroflex 3 or eSheath(13) (Edwards
Lifesciences, Irvine CA) or extra-large Check-Flo (Cook, Bloomington IN) for Edwards Sapien
valves, or large Check-Flo 18Fr x 40cm (Cook) for Medtronic Corevalve — was then introduced
from the femoral vein into the aortic lumen over the rigid guidewire. Predilatation with a non-
compliant coronary dilatation balloon (2-3mm x 20cm) was performed when necessary to
advance the microcatheter. Retrograde TAVR was performed using standard transfemoral
technique.
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To close the access port after TAVR, heparin anticoagulation was fully reversed with
protamine, and a nitinol cardiac occluder (Amplatzer Duct Occluder or Amplatzer Ventricular
Septal Defect Occluder, St Jude Medical) was positioned in the aorta through the TAVR
introducer sheath alongside a 0.014” buddy guidewire, rotated sideways using a deflectable
catheter (Agilis NxT SML curl, St Jude Medical), and deployed along the right aortic wall.
Pigtail aortic angiography guided occluder device positioning. Aortocaval fistulas were accepted
unless they caused heart failure from shunting. If retroperitoneal bleeding was evident,
adjunctive balloon aortic tamponade or self-expanding covered stents (typically iliac limb
extenders, Endologix or Trivascular, Irvine, CA) were deployed at physician discretion. Post-
procedure antiplatelet and anticoagulation medications were administered according to local
routine.
Data analysis
Clinical outcomes were entered into electronic case report forms and independently
monitored. Follow-up CT scans, contrast enhanced when renal function permitted, were obtained
before discharge and at 30 days. Angiograms and CT scans were analyzed in central NHLBI
core laboratories. An independent clinical events adjudication committee classified all deaths,
bleeding, vascular complication, major adverse cardiovascular events and their relatedness to
transcaval access and closure according to a modification of VARC-2 (14) (Online Appendix).
NHLBI has custody of all data; the sponsor and the principal investigator are responsible for data
integrity.
The primary endpoint was device success, defined as successful transcaval access and
deployment of a closure device without death or emergency open abdominal surgery. Data are
reported as mean ± standard deviation or median (25tht, 75th percentile) as appropriate.
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Continuous and integer data were compared using a Student t test or Fisher exact test,
respectively. To identify predictors of bleeding or vascular complications, we assessed
association separately for each potential predictor (age, sex, closure device/sheath ratio, sheath
aorta ratio, aortic diameter, fistula patency, balloon aortic tamponade, covered stent, transcaval
procedure volume) and each discrete outcome by fitting a proportional-odds cumulative-logit
model in SAS 9.4 (Cary, NC). Multivariable models were formed using a backwards stepwise
selection of clinical and procedural factors (excluding those thought to be consequents of
bleeding) until only factors with p<0.20 remained. Effects of transcaval experience were
assessed by creating a dichotomous variable indicating the two highest-enrolling sites.
Results
Enrollment
100 subjects enrolled and underwent attempted transcaval TAVR at 17 of 20 sites
between July 2014 and June 2016. 30-day follow-up data were obtained for all. Sites performed
a median of 2 (0,4) transcaval procedures before this study was initiated.
Procedure Outcomes
Transcaval access and closure was successful in 99/100 attempts. A typical procedure is
depicted in Figure 4. Baseline characteristics, including predictors of transthoracic access
complications, are shown in Table 1. Procedure characteristics are shown in Table 2. In one
subject the guidewire failed to cross, and the operator subsequently performed transfemoral
artery TAVR complicated by iliac artery rupture. Device success, the primary endpoint of the
study, was 98/100. This includes the failure to cross and another in whom the operator chose
primary closure using a covered aortic stent instead of repositioning a fully-withdrawn nitinol
occluder. All patients survived the immediate TAVR procedure, and none died as a direct
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consequence of transcaval access and closure, nor did any undergo emergency surgical rescue of
the transcaval access site. Important TAVR complications included one case of THV-related
coronary obstruction that was ultimately fatal, one case of aortic annular hematoma managed
conservatively and successfully, no THV embolization, 16 new permanent pacemakers, and no
case of endocarditis during the 30-day landmark analysis.
Inpatient and one-month follow-up data are shown in Table 3. Four patients died before
hospital discharge, two each of cardiovascular and non-cardiovascular causes. 30-day landmark
survival was 92%. Seven deaths were adjudicated as cardiovascular, and one as non-
cardiovascular. Specific causes of death are elaborated in the Online Appendix.
Bleeding and vascular complications are summarized in Table 4. Transcaval-related
bleeding was adjudicated as VARC2 major or life-threatening in 12/99. Overall 35 patients
received a median of 2.0 (2.0, 4.0) units of red cell transfusions during their transcaval TAVR
admission. Transcaval-related vascular complications were adjudicated as modified VARC2
major in 13/99, typically because of a retroperitoneal hematoma detected on mandatory CT scan
combined with hemoglobin drop. Covered stents were placed in 8 subjects after transcaval access
and closure, all but one during the same procedure. The indication was ongoing extravasation
after deploying the transcaval closure device in the one patient who was receiving apixaban
during the procedure, intolerable left-to-right shunt in two patients manifest as hemodynamic
instability and deterioration in right ventricular function, and one used for primary closure of the
transcaval access site after complete withdrawal of the nitinol occluder device. The indications
for covered stent placement were less clear in the remaining four subjects: one had aortic root
hematoma and the operator placed a covered aortic stent to reduce diagnostic ambiguity should
hemodynamic instability ensue; one had unexplained hypotension not improved by covered stent
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that in retrospect was attributable to anesthesia medications; one was taken back to the cath lab
in the evening after the transcaval procedure for hypotension and evident retroperitoneal
hematoma, and a covered stent was placed out of caution even though there was no
extravasation; and one in whom the operator planned a covered stent to treat a preexisting aortic
dissection at the transcaval access site. Post-hoc multivariate analysis of clinical and procedural
characteristics identified predictors of bleeding (Online Appendix), including small closure
device/sheath diameter ratio, baseline hemodialysis, older age, larger aortas, and lower-enrolling
sites. Post-hoc predictors of vascular complications included larger sheath/aorta diameter ratio,
and lower-enrolling sites. The aorto-caval fistula was occluded immediately after transcaval
TAVR in 36/99 (36%). Among evaluable mandatory CT scans (Table 5), the fistula was
occluded in 38/72 (53%) upon hospital discharge and 48/66 (72%) at 30-days. Incorporating
angiography, 64/99 (64%) of tracts were occluded by 30 days.
Retroperitoneal hematoma (Table 5) was found by the core lab in 24% of subjects before
discharge, and in 5% of subjects after 30 days. Most were graded small or moderate. There
were no vascular complications after discharge.
No patient had a complication related to the transcaval closure device or closure site, nor
aortic pseudoaneurysm, after hospital discharge.
There were two TAVR-related myocardial infarctions, one of which was fatal. There
were five TAVR-related ischemic strokes. Three patients developed acute tubular necrosis
classified as acute kidney index (AKI) scores of 3, including two who required hemodialysis.
There were no cases of hemolytic anemia, nor of infected nitinol occluder device. Five had nadir
platelet counts < 50x109/mL, four of whom had a patent aortocaval fistula on the final
angiogram, and none of whom had evident sequelae.
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There were fewer complications in the half of patients treated at centers with more
transcaval experience, including VARC-2 30-day safety events (17% vs 36%, p=0.03), covered
stents (6% vs 11%, p=0.32), major or life-threatening bleeding (13% vs 28%, p=0.01), major
vascular complications (11% vs 28%, p=0.03), and AKI≥1 (7% vs 15%, p=0.22), although some
differences did not meet statistical significance. There was no difference in outcomes between
the first and second half of patients enrolled.
Discussion
Transcaval access and closure for TAVR was successful in a cohort of patients without
good conventional access options. This is remarkable given that most participating centers had
limited prior transcaval experience, that we employed a permeable closure device, and that the
patients had extensive comorbidity. The observed 30-day mortality was 8%, although no patient
died or required surgical bailout as a direct consequence of transcaval access. Adjudicated
bleeding and vascular complications were common. From a patient-centered outcome
perspective, the primary observed morbidity, of blood transfusions, compares favorably to the
morbidity of surgical transthoracic access.
The included patients were not eligible for femoral artery access and were deemed
poorly-suited or ineligible for transthoracic access. 77% received contemporary low-profile THV
devices. Eligibility for transthoracic access was a subjective clinical determination made by the
local multidisciplinary heart team including cardiac surgeons. The included patients had high
STS predicted risk of mortality (9.7 ± 6.3%) and a heavy burden of co-morbidities. We speculate
that patients with fewer co-morbidities, who might be suitable for transthoracic access, might
suffer fewer complications from transcaval access.
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Despite fears of catastrophic hemorrhage, transcaval access appears well tolerated. We
infer that the retroperitoneal space surrounding the aortic entry site pressurizes during and after
closure, and that aortic bleeding decompresses into the nearby venous hole because
retroperitoneal pressure exceeds venous pressure (Figure 2). In a small number of patients, a
transiently unrepaired aorto-caval fistula was well tolerated after pull-through of a closure device
(Figure 5), or during replacement of the introducer sheath or dilator. Even after device closure,
asymptomatic residual aorto-caval fistulae persisted in two-thirds before discharge and one-third
after the first month.
Life-threatening (also known as “disabling”) bleeding occurred in 12% of high or
prohibitive risk patients after transcaval TAVR in this study (mean STS score 9.6), compared
with 22.6% of intermediate-risk patients after transthoracic TAVR and 6.7% after transfemoral
TAVR using the Sapien 3 THV in PARTNER-II (mean STS score 5.8)(6). In the other major
pivotal TAVR trials for which data are available according to type of access, non-transfemoral
access (transapical or transaortic) was associated with major vascular complication rates of 3.8-
5.9% and life-threatening or major bleeding rates of 8.7-22.6%(3,6,15). In large non-adjudicated
single center and national TAVR registries, the rate of life-threatening and major bleeding with
non-transfemoral access ranges from 3.6-37.3%, the rate of transfusion ranges from 8.9-25.4%
and the rate of major vascular complications ranges from 0.6-2.4% (16-21).
Despite a paucity of randomized data on alternate extra-thoracic access such as trans-
carotid, subclavian or trans-axillary, single center experience suggests these approaches compare
favorably to transthoracic, with acceptable rates of bleeding and vascular access complications
(17,22,23). None of these had systematic follow-up imaging or independent adjudication.
Compared with carotid, subclavian, and axillary artery access, transcaval access may provide: (1)
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superior operator ergonomics, in that the operators work from the standard right groin puncture
site; (2) less tortuous sheath trajectory; (3) less risk of brachial plexus injury; (4) no surgical
dissection. That said, all of these extra-thoracic access methods appear to work well.
In this study, adjudicators classified transcaval-related vascular and bleeding
complications according to modified VARC-2 standards (14). Because we obtained CT scans
systematically before discharge, and because blood transfusions were common (35%), VARC-2
classified vascular complications as “major” even when patients had otherwise uneventful
clinical courses. For example, a patient who had a small retroperitoneal blood collection on CT
and who had a 2 unit blood transfusion without “an overt source of bleeding” would be classified
as having major bleeding, yet would have been classified as having no bleeding had there not
been systematic follow-up imaging.
Covered stents were employed in 8% of subjects, fewer than half for extravasation or
intolerable shunt through the permeable nitinol occluder devices, and none for catastrophic aortic
disruption or hemodynamic collapse. Covered stents are considered a “failure” only because this
study was designed to evaluate the specific permeable nitinol cardiac occluder devices in the
closure of transcaval access ports. By contrast, in clinical practice a provisional strategy of
nitinol occluder implantation and bail-out covered stenting seems prudent and practical.
Outcomes after transcaval access have improved since the first human experience (8).
Bleeding and vascular complications have declined because of technique refinements such as
complete reversal of heparin anticoagulation before closure, consistent implantation of slightly
oversized closure devices, use of a deflectable sheath to rotate the closure device horizontally
during deployment, and liberal use of balloon aortic tamponade, even though the closure devices
have not changed. In this prospective trial, centers with more transcaval experience trended
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toward fewer complications. Outcomes may improve further using a purpose-built closure device
that is immediately hemostatic.
Limitations of this investigation include the absence of a control group, the inclusion of
patients without other good options who have expected high morbidity and mortality not
necessarily reflected in their risk score, the employment of a permeable nitinol occlude device,
the participation of sites with little or no prior experience, the large proportion (18%) of missing
follow-up CT, and limited data collection including cost, quality of life, and frailty. Some
countervailing strengths include independent clinical event adjudication and data monitoring,
and careful centralized analysis of follow-up CT. Compared with femoral artery access,
transcaval procedures impart additional logistical complexity of planning, crossing, and closure.
The extra expense of closure devices may possibly be offset by reduced morbidity and length of
stay compared with transthoracic access.
Transcaval access may prove valuable for other clinical applications. It has been
employed successfully as part of thoracic endovascular aneurysm repair (24) and to introduce 5.0
L percutaneous left ventricular assist devices (Impella, Abiomed) (25). The transcaval approach
may allow transcatheter implantation of other large devices, for example to treat aortic
regurgitation.
Conclusion
Transcaval access is a realistic alternative for TAVR. These data support cautious clinical
adoption in patients without good access options, and comparison against more established
alternative access routes in lower risk patients. Outcomes and applicability might improve with
more experience and using a purpose-built, impermeable closure device to achieve immediate
hemostasis.
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19. Frohlich GM, Baxter PD, Malkin CJ et al. Comparative survival after transapical, direct
aortic, and subclavian transcatheter aortic valve implantation (data from the UK TAVI registry).
Am J Cardiol 2015;116:1555-9.
20. Schymik G, Wurth A, Bramlage P et al. Long-term results of transapical versus
transfemoral TAVI in a real world population of 1000 patients with severe symptomatic aortic
stenosis. Circ Cardiovasc Interv 2015;8.
21. Kodali S, Thourani VH, White J et al. Early clinical and echocardiographic outcomes
after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-
risk patients with aortic stenosis. Eur Heart J 2016;37:2252-62.
22. Mylotte D, Sudre A, Teiger E et al. Transcarotid Transcatheter Aortic Valve
Replacement: Feasibility and Safety. JACC Cardiovasc Interv 2016;9:472-80.
23. Ciuca C, Tarantini G, Latib A et al. Trans-subclavian versus transapical access for
transcatheter aortic valve implantation: A multicenter study. Catheter Cardiovasc Interv
2016;87:332-8.
24. Uflacker A, Lim S, Ragosta M et al. Transcaval Aortic Access for Percutaneous Thoracic
Aortic Aneurysm Repair: Initial Human Experience. J Vasc Interv Radiol 2015;26:1437-41.
25. Atkinson TM, Ohman EM, O'Neill WW, Rab T, Cigarroa JE, Interventional Scientific
Council of the American College of C. A Practical Approach to Mechanical Circulatory Support
in Patients Undergoing Percutaneous Coronary Intervention: An Interventional Perspective.
JACC Cardiovasc Interv 2016;9:871-83.
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26. Edwards FH, Cohen DJ, O'Brien SM et al. Development and Validation of a Risk
Prediction Model for In-Hospital Mortality After Transcatheter Aortic Valve Replacement.
JAMA Cardiol 2016;1:46-52.
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Figure Legends
Central Illustration: Transcaval access technique. Transcaval access is obtained over an
electrified guidewire directed from the IVC towards a snare in the abdominal aorta (A). After
delivering a microcatheter to exchange for a stiff guidewire (B), the transcatheter heart valve
introducer sheath is advanced from the femoral vein into the abdominal aorta for conventional
transfemoral retrograde TAVR (C). The aorto-caval access site is closed with a nitinol cardiac
occluder (D). Courtesy of A Hoofring, NIH Medical Arts Branch.
Figure 2: Proposed mechanism of hemodynamic stability after transcaval access using
permeable nitinol occluder devices. Higher pressure in the relatively confined retroperitoneal
space exceeds venous pressure (Inset) and causes aortic blood to return to the venous circulation
through a nearby hole in the IVC (inset). The result is aortocaval fistula rather than
hemodynamic collapse. Courtesy of A Hoofring, NIH Medical Arts Branch.
Figure 3: Crossing equipment. A. Coaxial crossing system consisting of (1) 0.014” guidewire
inside of a (2) Piggyback 0.035” wire convertor insider of a (3) braided microcatheter, inside of a
(4) 55cm guiding catheter. B. An electrosurgery pencil (5) is connected to the back end of the
0.014” guidewire (6) using a hemostatic forceps (7).
Figure 4: A representative transcaval TAVR procedure. (A-E) A suitable target (yellow
arrow) is identified on CT and displaced in axial (C) reconstruction to show crossing point,
sagittal reconstruction (D) to show lumbar level, and coronal thick-slab projection to simulate
fluoroscopy (E). Under fluoroscopy, the transvenous crossing catheter is aligned with the aortic
snare in a lateral projection (F), and the guidewire is electrified during advancement into the
aorta (G) and then snared (H) and exchanged for a stiff guidewire. The THV sheath is advanced
from the femoral vein into the aorta (I). After TAVR, a nitinol cardiac occluder device is
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positioned across the aortic wall (J-L). In this case, completion angiography shows complete
occlusion of the aorto-caval fistula (M). Predischarge CT (N-O) shows the device in position
with a small retroperitoneal hematoma and an occluded tract.
Figure 5: Unconstrained aorto-caval shunt after inadvertent pull-through of a closure
device. A: This angiogram was performed while preparing a new closure device. The blood
pressure was not changed. The arrow points to the unrepaired aorto-caval fistula. B: A fistula
persists on the completion angiogram after a closure device was implanted. C-D: On pre-
discharge CT, there is no retroperitoneal hematoma, and the fistula is reduced but persistent. It is
occluded on follow-up CT (E-F)
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Table 1. Baseline characteristics
n 100
Age, years 79.5, (73.0-85.0)
Female sex 58
Race White=84; Black=9; Other=7
Left ventricular ejection fraction (%) 52.8 ± 15.6
CHF (NYHA class) 3.2 ± .6
Right ventricular enlargement or dysfunction 24
Coronary artery disease 89
Prior cardiac surgery 44
End stage renal disease or dialysis 10
eGFR (mL/min/1.73m2) 52.6 ± 23.6
NT-pro-BNP/BNP (pg/mL) 421 (183-1070)
Chronic anticoagulation 42
STS predicted risk of mortality 9.6 ± 6.3%
Euroscore II predicted risk of mortality 10.9 ± 9.8%
TVT Risk Score (26) 9.2 ± 7.2%
Site-reported reasons unsuitable for conventional access
Clinical 86/100 Technical 91/100
Frailty 54
Factors impeding transaortic access: Porcelain aorta, threatened grafts, prior chest radiation, prior sternal wound infection, inadequate working length 53
Advanced pulmonary disease
39 Factors impeding transapical access: failed prior transapical, chest radiation, chest wound infection, fatty myocardium 11
Advanced age and predicted mortality
44 Inadequate ilio-femoral artery diameter irrespective of calcification or tortuosity 82
Immunosuppression 8
Morbid obesity 7
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Abbreviations: eGFR, estimated glomerular filtration rate; CHF, congestive heart failure; NYHA, New York Heart Association; STS, Society of Thoracic Surgeons; TVT, Transcatheter valve therapy registry
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Table 2. Procedure characteristics
Characteristic Observation
n 100
"Valve-in-valve" TAVR 6
Crossing Duration, from snare to introducer sheath (min)
21.1 ± 17.5
Need for tract balloon dilatation after initial guidewire crossing
40
Valve Type
Edwards Sapien XT = 23; Edwards Sapien 3 = 57 Medtronic Corevalve = 11; Medtronic Corevalve Evolut R = 9;
Valve Size nominal (mm) 20mm = 3; 23mm = 37; 26mm = 41; 29mm = 19
Sheath model
Edwards Retroflex 3 = 6; Edwards eSheath = 73; Cook Large Check-Flo = 13; Cook Extra-Large Check-Flo = 8;
Sheath size OD mm 8.0 ± 0.7
TAVR Success * 100% *
Closure Duration, from introducing device to completion angiogram (min)
14.1 ± 9.5
Closure device ADO = 58; VSD = 40; None = 2
Final Closure Device Size
Amplatzer Duct Occluder = 58:
8/6mm = 7; 10/8mm = 51; Amplatzer Muscular VSD Occluder = 40: 6mm = 10; 8mm = 27; 10mm = 3;
Covered stent only = 1
Angiographic closure score(8) 1.0 ± 0.8
Adjunctive balloon aortic tamponade
17
Total contrast volume (mL) 166 ± 87
Anesthesia technique
General anesthesia with endotracheal intubation = 84 (52 (62%) extubated on-table); Moderate Sedation = 16
* All TAVR procedures were successful, however 1/100 was performed via a femoral artery route, complicated by iliac artery rupture.
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Table 3. Outcomes through 30 days
Characteristic Observation
n 100
Death within 30-days 7 Cardiovascular; 1 Non-cardiovascular
Stroke 5 Ischemic
Myocardial infarction 2 Peri-procedural
Contrast nephropathy requiring dialysis 2
Acute Kidney Injury Classification
Grade 0 = 87; Grade 1 = 9; Grade 2 = 0; Grade 3 = 3
Thrombocytopenia < 50k 5 (4 with patent fistula)
Non-access-related bleeding (e.g. gastrointestinal) 15
Transfusion during TAVR / after TAVR / during or after TAVR 14 / 30 / 35
Transfusion units among those transfused (median), n=35/100 2.0 (2.0, 4.0)
Follow-Up CT scan prior to discharge 87
Post-TAVR length of stay, days (median, quartiles) 4 (2-6)
Post-TAVR Intensive care unit length of stay, days (median, quartiles) 1 (1-3)
VARC-2 composite early safety * 75
*VARC-2 composite early safety is 30-day freedom from mortality, stroke, life-threatening bleeding, acute kidney injury stage 2 or 3, coronary artery obstruction requiring intervention, major vascular complication, valve-related dysfunction requiring repeat procedure.
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Table 4. Key Complications
New Transcaval-related
Count
n=99
Details
BLEEDING
Life-Threatening
Yes 6 5 RPH (Large=2, Moderate=2, Small=1)
1 Covered aortic & iliac stents, no RPH
Indeterminate 1 1 Thoracic aortic dissection from Corevalve Evolut R
No 5
2 Pericardial tamponade
1 Femoral artery closure device failure
1 Epistaxis related to anesthesia care
1 GI Hemorrhage
Major Yes 5
5 RPH (4 moderate, 1 small) including 1 concurrent GI & jugular access hemorrhage
No 1
Minor Yes 11
No 8
None - 62
VASCULAR COMPLICATIONS
Major
Yes 12
9 RPH (any size) + major or life-threatening bleeding
1 Covered stent for extravasation
1 Primary closure with covered aortic & femoral artery stents
1 Non-covered aortic stent for local dissection
Indeterminate 1 1 Thoracic aortic dissection from Corevalve Evolut R
No 6
2 Pericardial tamponade
1 Aortic root hematoma
1 Lower extremity revascularization
1 Femoral artery closure device failure
1 Other
Minor Yes 13
No 4
None - 63
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Bleeding and vascular complications are classified as the most serious event for each patient. One patient is excluded because of unsuccessful transcaval access. Abbreviations: RPH = retroperitoneal hematoma; Hb = Hemoglobin; GI = gastrointestinal
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Table 5: CT Findings
Aorto-caval fistula
Timepoint Occluded Patent Indeterminate (non-contrast or poor contrast timing)
Pre-discharge, n=87 38 34 15
30-Day, n=76 48 18 10
Retroperitoneal hematoma
Timepoint None Small Moderate Large
Pre-discharge, n=88 67 (76%) 12 (14%) 7 (8%) 2 (2%)
30-days n=76 72 (95%) 3 (4%) 0 1 (1%)
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Data Supplement: Transcaval TAVR prospective trial Page 1 of 6
Data Supplement: Transcaval TAVR prospective trial
Participating sites, staff, (number enrolled)
Henry Ford Hospital, Detroit, MI: AB Greenbaum, WW O'Neill, M Eng, G Paone, S Alexander, T Aka (37);
Emory University, Atlanta, GA: VC Babaliaros, VH Thourani, BG Leshnower, L Wheeler, M Mungai, P
Keegan, JF Condado, A Simone, K McWhorter, M Nelms, V Smith, J Huggins (17); Oklahoma Heart, Tulsa,
OK: KI Muhammad, W Leimbach, M Phillips, E Coleman, G Tokarchik, J Durham (8); Lexington Medical
Center, West Columbia, SC: RA Leonardi, RM Malanuk, JA Travis, D Prastein, J Davis, H Fulcher (7);
Ochsner Clinic, New Orleans, LA: S Ramee, M Bates, L Ventura, B Hirstius, B Butitta, S St. Pe (7); Wake
Forest University, Winston-Salem, NC: DX Zhao, RJ Applegate, T Kincaid, A Morgan (4); Edward Hospital,
Naperville, IL: MJ Goodwin, B. Foy, S Clark, A Ramanthan, W Stephan, S Black, S Wallace, K Paprockas, JM
Yanz (4); Vanderbilt University, Nashville, TN: JL Fredi, S Ball, S Madell (3); Washington Hospital Center,
Washington, DC: LF Satler, R Waksman, T Rogers, CC Shults, P Okubagzi (2); Evanston Northwestern: TE
Feldman, ME Guerrero, M Salinger, P Pearson, L Smalley (2); St Vincent, Indianapolis, IN: JB Hermiller Jr, S
Moainie, L Burkert (2); Roanoke Carilion: J Foerst, JF Rowe, V Wilson (2); Columbia University, New York,
NY: S Kodali, MB Leon, TM Nazif, TP Vahl, I George, M Hawkey (1); University of Virginia, Charlottesville,
VA: DS Lim, M Ragosta, G Ailawadi, J Morris (1); York Wellspan, York, PA: WJ Nicholson, L Shears, K
Hutcheson (1); Toledo Promedica Hospital, Toledo, OH: JR Letcher, PK Ramanathan, D Crescenzo, T
Barnhizer (1); Terrebonne Hospital, Houma, Louisiana: PS Fail, E Feinberg, K Arceneaux, J Aucoin (1);
Trial Leadership
National principal investigator: AB Greenbaum
Study Sponsor (on behalf of NHLBI): RJ Lederman
Study steering and writing committee: RJ Lederman (Chair), AB Greenbaum, T Rogers, VC Babaliaros
Study management (NHLBI): AM Stine (Study Manager), A Byrnes
NHLBI DSMB: JM Bourque (Chair); T Aversano, MF Marshall, D Follman, DJ Malenka
Clinical events adjudication committee (Medstar Heart and Vascular Institute): HM Garcia-Garcia (Chair),
E McFadden, A Kajita, S Kiramijyan
CT Core Lab (NHLBI): MY Chen
AX Core Lab (NHLBI): RJ Lederman
Statistical analysis (NHLB Office of Biostatistics ResearchI): JF Troendle
Supplemental information about the protocol
Selection criteria
Inclusion Criteria
• Adults age ≥ 21 years
• Severe symptomatic de novo aortic valve stenosis or bioprosthetic aortic valve failure
for which transcatheter aortic valve replacement (TAVR) is felt beneficial according to
the consensus of the institutional multidisciplinary heart team
• Extreme risk or inoperability for TAVR via conventional femoral artery, trans-apical, or
trans-aortic access in the determination of the multidisciplinary heart team. This
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determination includes an in-person consultation by at least one cardiac surgeon
member of the heart team.
• Anatomic eligibility for caval-aortic TAVR, graded as “favorable” or “feasible” based on
NHLBI core lab assessment of the baseline CT examination.
Exclusion criteria
• Subjects unable to consent to participate, unless the subject has a legally authorized
representative
• Subjects unwilling to participate.
• Anatomic eligibility for caval-aortic TAVR graded as “unfavorable” based on NHLBI core
lab assessment of the baseline CT examination
• Unlikely to benefit from caval-aortic TAVR
• Pregnancy or intent to become pregnant prior to completion of all protocol follow-up
requirements.
Anatomic eligibility on baseline CT
FavorableFavorableFavorableFavorable: All of the following
• A clear access point in the aorta from the neighboring IVC
• 8mm away or less lateral distance between aorta and caval lumens
• Calcification grade 0-2
• No important interposed structures (hemiazygos or lumbar plexus veins OK; lumbar
artery not OK; renal vein not OK)
• Centerline distance from femoral vein at lower femoral head to aortic entry less than 28
cm for eSheath (or 7cm less than working length of other intended sheath)
• No aortic aneurysm, severe ectasia, atherosclerosis, or thrombus at proposed entry site
• Target is > 10mm below lowest renal artery and > 10mm above aortic bifurcation
FeasibleFeasibleFeasibleFeasible: Any of the following
• Caval-aortic lumen distance 8-15mm at proposed target
• Aortic aneurysm, severe ectasia, atherosclerosis, or thrombus at proposed entry site
• Centerline distance from femoral vein at lower femoral head to aortic entry less than 28-
30 cm for eSheath (or 5-7cm less than working length of other intended sheath)
• Aortic target is a fabric graft
• Planned on non-contrast CT
UnfavorableUnfavorableUnfavorableUnfavorable: Any of the following
• Calcification grade 3
• Centerline distance from femoral vein at lower femoral head to aortic entry >30 cm for
eSheath (<5cm less than working length of other intended sheath)
• Caval-aortic lumen distance > 15 mm at proposed target
• Target is < 10mm below lowest renal artery or < 10mm above aortic bifurcation
• Leftward aortic angulation > ~20o
• Other high risk features (e.g., permanent IVC filter, threatens 2/3 of mesenteric arteries,
etc)
CalcificationCalcificationCalcificationCalcification
• 3333: Circumferential heavy calcification throughout the abdominal aorta, “porcelain
abdominal aorta”
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• 2222: Moderate or heavy calcification with a clear calcium-spared window (see below)(see below)(see below)(see below) on the
caval face at a suitable target location
• 1111: Mild or moderate multifocal calcification
• 0000: No calcification
CalciumCalciumCalciumCalcium----spared WINDOW on caval face of aortaspared WINDOW on caval face of aortaspared WINDOW on caval face of aortaspared WINDOW on caval face of aorta
• Circumferential calcium window:
– Diameter must be ≥ 2mm + outer diameter of intended introducer sheath when
fully expanded
• Non-circumferential calcium window:
– Smallest dimension must be ≥ outer diameter of intended introducer sheath
when fully expanded
Modified VARC-2 classification of transcaval vascular complications
ClassClassClassClass VARCVARCVARCVARC----2 definitions (tra2 definitions (tra2 definitions (tra2 definitions (transcavalnscavalnscavalnscaval----specific modifications are boldfaced)specific modifications are boldfaced)specific modifications are boldfaced)specific modifications are boldfaced) Common classification criteria for this studyCommon classification criteria for this studyCommon classification criteria for this studyCommon classification criteria for this study
MajorMajorMajorMajor • Any aortic dissection (requiring interventionrequiring interventionrequiring interventionrequiring intervention), aortic rupture, annulus rupture,
left ventricle perforation, or new apical aneurysm/pseudoaneurysm
OR
• Access site or access-related vascular injury (dissection, stenosis, perforation,
rupture, arteriovenous fistula (except aortoexcept aortoexcept aortoexcept aorto----caval fistulacaval fistulacaval fistulacaval fistula), pseudoaneurysm
requiring interventionrequiring interventionrequiring interventionrequiring intervention, hematoma, irreversible nerve injury, compartment
syndrome, percutaneous closure device failure) leading to death, life-
threatening or major bleeding, visceral ischemia, or neurological impairment
(arteriovenous fistula at the transcaval site is not a complication)
OR
• Distal embolization (non-cerebral) from a vascular source requiring surgery
or resulting in amputation or irreversible end-organ damage
OR
• The use of unplanned endovascular or surgical intervention associated with
death, major bleeding, visceral ischemia or neurological impairment. Early or Early or Early or Early or
delayed endograft therapy for catastrophic or urgent or persistent bleeding delayed endograft therapy for catastrophic or urgent or persistent bleeding delayed endograft therapy for catastrophic or urgent or persistent bleeding delayed endograft therapy for catastrophic or urgent or persistent bleeding
would be considered a major vascular complication; Extensive aortic dissection would be considered a major vascular complication; Extensive aortic dissection would be considered a major vascular complication; Extensive aortic dissection would be considered a major vascular complication; Extensive aortic dissection
would be considered a major vascular complication). would be considered a major vascular complication). would be considered a major vascular complication). would be considered a major vascular complication). Covered stent indication
codes 1-2 {urgent covered stent for hemorrhagic shock, or for ongoing bleeding}
constitutes major vascular complications; other covered stent indications
(including late endograft therapy) do not constitute major vascular
complications
OR
• Any new ipsilateral lower extremity ischemia documented by patient symptoms,
physical exam, and/or decreased or absent blood flow on lower extremity
angiogram
OR
• Surgery for access site-related nerve injury
OR
• Permanent access site-related nerve injury
• Large retroperitoneal hematoma
OR
• [Small or moderate retroperitoneal hematoma
AND
Hemoglobin drop and transfusion meeting
criteria for MAJOR bleeding]
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ClassClassClassClass VARCVARCVARCVARC----2 definitions (tra2 definitions (tra2 definitions (tra2 definitions (transcavalnscavalnscavalnscaval----specific modifications are boldfaced)specific modifications are boldfaced)specific modifications are boldfaced)specific modifications are boldfaced) Common classification criteria for this studyCommon classification criteria for this studyCommon classification criteria for this studyCommon classification criteria for this study
MinorMinorMinorMinor • Access site or access-related vascular injury (dissection, stenosis, perforation,
rupture, arteriovenous fistula (except (except (except (except aortoaortoaortoaorto----caval fistula)caval fistula)caval fistula)caval fistula), pseudoaneurysms,
hematomas, percutaneous closure device failure) not leading to death, life-
threatening or major bleeding, visceral ischemia, or neurological impairment.
Late endograft therapy for shunt would be considered a minor vasLate endograft therapy for shunt would be considered a minor vasLate endograft therapy for shunt would be considered a minor vasLate endograft therapy for shunt would be considered a minor vascular cular cular cular
complication. Focal and stable aortic dissection would be considered a minor complication. Focal and stable aortic dissection would be considered a minor complication. Focal and stable aortic dissection would be considered a minor complication. Focal and stable aortic dissection would be considered a minor
vascular complication.vascular complication.vascular complication.vascular complication. Arteriovenous fistula at the transcaval site is not a Arteriovenous fistula at the transcaval site is not a Arteriovenous fistula at the transcaval site is not a Arteriovenous fistula at the transcaval site is not a
complication. Small or moderate retroperitoneal hematoma is a minor vascular complication. Small or moderate retroperitoneal hematoma is a minor vascular complication. Small or moderate retroperitoneal hematoma is a minor vascular complication. Small or moderate retroperitoneal hematoma is a minor vascular
complication; Lacomplication; Lacomplication; Lacomplication; Large retroperitoneal hematoma is a major vascular complication. rge retroperitoneal hematoma is a major vascular complication. rge retroperitoneal hematoma is a major vascular complication. rge retroperitoneal hematoma is a major vascular complication.
Covered stent indication codes 3Covered stent indication codes 3Covered stent indication codes 3Covered stent indication codes 3----7 {because of for intolerable shunt, because of 7 {because of for intolerable shunt, because of 7 {because of for intolerable shunt, because of 7 {because of for intolerable shunt, because of
pullpullpullpull----through or malposition of closure device, because of hemodynamic through or malposition of closure device, because of hemodynamic through or malposition of closure device, because of hemodynamic through or malposition of closure device, because of hemodynamic
uncertaintly or prophylactic placement, oruncertaintly or prophylactic placement, oruncertaintly or prophylactic placement, oruncertaintly or prophylactic placement, or theranostic covered stent placement} theranostic covered stent placement} theranostic covered stent placement} theranostic covered stent placement}
constitute minor and not major vascular complications.constitute minor and not major vascular complications.constitute minor and not major vascular complications.constitute minor and not major vascular complications.
OR
• Distal embolization treated with embolectomy and/or thrombectomy and not
resulting in amputation or irreversible end-organ damage
OR
• Any unplanned endovascular stenting or unplanned surgical intervention not
meeting the criteria for a major vascular complication
OR
• Vascular repair or the need for vascular repair (via surgery, ultrasound guided
compression, transcatheter embolization, or stent-graft)
• Small or moderate retroperitoneal hematoma
AND
• Hemoglobin drop and transfusion not meeting
criteria for MAJOR bleeding
NoneNoneNoneNone • Retroperitoneal stranding
AND
• Hemoglobin drop and transfusion not meeting
criteria for MAJOR bleeding
NHLBI CT Core Lab definitions of retroperitoneal hematoma
Grade Characteristics
Small localized extravasation outside the aorta or vena cava wall but not extending into the paracolic
gutters
Moderate not small but no organ displacement
Large With organ displacement
Stranding Is not classified as retroperitoneal hematoma
Follow-up CT scans were recommended to be contrast-enhanced, arterial-phase, abdomen and pelvis
examinations with thin-slice reconstructions. Non-contrast examinations were accepted for assessment
of retroperitoneal hematoma.
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Supplemental Data
Specific causes of death
Cause of death Days after TAVR
Heart failure in hospice 17
Sudden pulseless electrical activity and food aspiration, possibly heart block; No autopsy
permitted
2
Heart failure and recurrent pulmonary edema, failure to wean, withdrawal of care 24
Complete heart block on home telemetry 10
TAVR caused left main obstruction 19
MI unrecognized autopsy-confirmed 1
Type B thoracic aortic dissection caused by Evolut R delivery 22
Stroke post TAVR with intraprocedure LAA thrombus 28
Post-hoc predictors of bleeding and vascular complications
Bleeding
Model of VARC-2 Major + Life Threatening bleeding
Potential Predictor
Endograft p=.03 May increase risk of bleeding
Closure device/sheath ratio p=.05 Larger values may decrease risk of bleeding
Balloon tamponade p=.003 May increase risk of bleeding
Min aortic diameter p=.08 Larger values may increase risk of bleeding
Fistula patency angiography p=.10 Larger values may decrease risk of bleeding
High volume enrolling site p=.09 High volume sites may have lower risk of bleeding
Multivariable Model of VARC-2 Major + Life Threatening bleeding
Predictors in Final Model
High volume enrolling site p=.01 High volume sites may have lower risk of bleeding
Closure device/sheath ratio p=.01 Larger values may decrease risk of bleeding
Hemodialysis p=.02 May increase risk of bleeding
Age p=.03 Older subjects may increase risk of bleeding
Min aortic diameter p=.04 Larger values may increase risk of bleeding
Sex p=.08 Males may have lower risk of bleeding
The c statistic is 0.825 including site volume, and 0.761 without
Model of Corrected Hb drop (>= median value of 2.4 g/dL)
Potential Predictor
Sheath/aorta ratio p=.08 Larger values may increase corrected drop in Hb
Retroperitoneal hematoma
Model of Retroperitoneal hematoma is moderate or large)
Potential Predictor
Age p=.10 Larger values may increase RPH score
Sex p=.06 Males may have lower RPH scores
Vascular complications
Model of VARC-2 Vascular Complications (Minor or greater)
Potential Predictor
Balloon tamponade p=.003 May increase risk of vascular complication
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Aortic diameter p=.09 Larger values may decrease risk of vascular complication
Endograft p=.01 May increase risk of vascular complication
Sheath/aorta ratio p=.02 Larger values may increase risk of vascular complication
High volume enrolling site p=.02 High volume sites may have lower risk of vascular complication
Multivariable Model of VARC-2 Vascular Complications (Minor or greater)
Predictors in Final Model
Sheath/aorta ratio p=.02 Larger values may increase risk of vascular complication
High volume enrolling site p=.03 High volume sites may have lower risk of vascular complication
Age p=.12 May increase risk of vascular complication
Recommendation=Feasible p=.19 May decrease risk of vascular complication
The c statistic is 0.733
