Inferior Vena Cava—Balloon Occlusion and Its Effect on the Myocardium During Endograft Deployment in the Arch

Abstract

Purpose:

To evaluate the impact of cava balloon occlusion on the myocardium during endovascular repair of thoracic aortic pathologies.

Material and methods:

A prospective observational cohort study of 21 patients who underwent endovascular repair of aortic arch and thoracic aorta in a single tertiary referral center with use of inferior vena cava (IVC) balloon occlusion as a method of intraoperative cardiac output reduction. Pre-, intra-, and postoperative measurements of heart rate, blood pressure, stroke volume index, and central venous oxygen saturation were noted. High-sensitive serum troponin levels were also analyzed according to a pre-established protocol. Endpoints were cardiac troponin T levels after induced hypotension and left ventricular ejection fraction during follow-up. Secondary endpoints were procedure technical success and overall survival.

Results:

Twenty-one patients (18 male, median age 69, (62-75, IQR)) enrolled in the study between May 2015 and January 2019. Indication for endovascular treatment was an aortic arch aneurysm (n=10), descending aortic aneurysm (n=8), lusorian artery aneurysm (n=2), and thoracoabdominal aortic aneurysm (n=1). Median time to reach half mean arterial pressure was 60 seconds while median recovery time of blood pressure was 135 seconds. In 5 (24%) cases, we observed a > 50% change of Troponin T on the reference level. Technical success was achieved in all cases. Two (10%) patients developed new and persistent atrial fibrillation and 1 (5%) suffered a peri-operative ST-elevation myocardial infarction.

Conclusion:

The use of IVC balloon occlusion is a feasible technique for cardiac output reduction during endovascular repair of thoracic aortic pathologies. One fourth of the patients develop significant troponin leakage but the significance of the finding needs further studies.

Keywords

aortic arch aneurysm thoracic aneurysm endovascular repair inferior vena cava balloon cardiac stress myocardium

Introduction

Thoracic endovascular repair (TEVAR) of aortic arch and thoracic aortic aneurysms during the past years has become the predominant method of treatment leaving open surgical repair to be considered in patients with unsuitable anatomy for TEVAR.¹ Precise positioning of the thoracic stent-graft is crucial during TEVAR. To avoid inaccurate stent-graft deployment caused by the systolic jet, methods to reduce cardiac output (CO) have been developed including pharmacologically induced systemic hypotension, rapid ventricular pacing (RVP), and recently the Munich Valsalva Implantation Technique (MuVIT).^2–4 The technique of inferior vena cava (IVC)-balloon occlusion is an alternative technique for CO reduction in TEVAR used for many years.^5–7 Partial inflow occlusion from IVC to the right atrium with a compliance balloon pulled into the IVC-atrial junction (ICAJ) leads to a reduction in stroke volume (SV) and CO due to reduced venous return and consequently reduced preload. However, information about the impact of IVC-balloon occlusion on the myocardium and the overall cardiac function is lacking. The impact of this drastic reduction of CO on the myocardium may include an imbalance between oxygen supply and oxygen demand and has not been previously investigated. The aim of this study is to report the results of a prospective cohort study with focus on the cardiac stress of partial occlusion of right atrial inflow and the impact on myocardium during TEVAR complying with the STROBE guidelines for cohort studies.⁸

Material and Methods

Study Design

Patients receiving TEVAR electively for aortic arch and thoracic aortic pathologies requiring CO reduction were enrolled in a single tertiary center between May 2015 and January 2019 according to a preestablished dedicated protocol (Supplementary Data 1). The protocol included pre-, peri- and postprocedural measurements of arterial blood pressure, CO and SV. Arterial blood pressure was measured invasively through a radial arterial line. CO and SV were continuously measured using EV1000 (Edwards Lifesciences, USA) and noted as indexed values—cardiac index (CI) and stroke volume index (SVI)—to facilitate relating cardiac performance to the size of the patient as estimated by body surface area (BSA). Central venous oxygen saturation (ScvO2) was continuously recorded (Edwards oximetry central venous catheter X3816ST, Edwards Lifesciences, USA). ScvO2 is a surrogate for mixed venous oxygen saturation (SvO2) and reflects the balance between oxygen delivery (DO2) and oxygen consumption (VO2). Measurement of ScvO2 instead of SvO2 was chosen to avoid the complications that may follow the insertion of a Swan-Ganz catheter.⁹

Inclusion criteria included an age of ≥18 years and a planned TEVAR for aortic arch and proximal descending pathologies from Zone 0 to 3, according to SVS reporting standards.¹⁰ Patients with aortic arch and thoracic aortic aneurysms without the necessity for reduction of cardiac output, defined as proximal landing zone of the first stentgraft distally to Zone 3, and patients with genetic aortic syndromes were excluded.

Data were collected prospectively from electronic medical records and imaging was reviewed for the purpose of the study. The study was approved by the local ethical committee (Dnr 2016/79) and conducted in accordance with the declaration of Helsinki for medical research involving human subjects. The local ethical committee waived the need for a written informed consent.

Procedure

Preoperative workup included a transthoracic echocardiogram (TTE) and a spirometry with additional coronary angiography when indicated. All procedures were performed under general anesthesia. Systemic heparin was administrated during the procedure at a dose of 100 IU/kg with target active clotting time (ACT) >250 seconds. Hemodynamic parameters were continuously measured using peripheral arteries lines, and a 3-lead ECG with the ability for perioperative transesophageal echocardiography if needed. Arterial blood pressure, heart rate, CI, SVI, and ScvO2 were noted before onset of the right atrial inflow occlusion. The time needed from balloon inflation to reaching half of mean arterial pressure (MAP) was recorded. The duration of balloon inflation and the recovery time until MAP, SVI, and ScvO₂ returned to the same level as before onset of the occlusion were noted. Complications related to right atrial inflow occlusion with balloon inflation and overall peri-procedural complications were noted.

Details of TEVAR techniques have been published previously.¹¹ Ultrasound-guided percutaneous arterial and venous access was used with the exception of open exposure mainly on upper extremities for debranching of subclavian arteries. A compliant balloon (46 mm CODA, COOK Incorporated, Bloomington, IN, USA) was advanced into the right atrium with the support of a 45 cm 16F sheath. The stentgraft was placed at the intended position with the help of previously adjusted CT-fusion guidance over an extra-stiff wire (Lunderquist, COOK Incorporated, Bloomington, IN, USA) with both, the stiff-wire and the tip of the device crossing though the aortic valve when the proximal stentgraft was deployed in zone 0. The IVC balloon was manually inflated with 30 to 50 ml of diluted iodine contrast and saline mixture (1:3) before being retracted into the atriocaval junction to prevent inflow from the inferior vena cava. This was done under fluoroscopy and the inflated balloon was kept in position under mild traction to avoid damage of the junction, Figure 1. When mean arterial pressure declined to half of the initial value the stentgraft was deployed. With the completion of stentgraft deployment, the balloon was pushed upward and deflated to allow venous return from the IVC and raise of CO to initial levels. Follow-up consisted of clinical examination, TTE and CT-angiography at 30 days.

Biomarker Sampling

High sensitivity cardiac troponin T (hs-cTnT) was analyzed 3, 6, and 24 hours after induced hypotension and daily thereafter in venous bloodsamples until hs-cTnT returned to the individual preoperative value in case of increased hs-cTnT value. Hs-cTnT levels were measured using a high-sensitivity electrochemiluminescence immunoassay (Roche Elecsys 2010 5th-generation assay; Roche Diagnostics, Mannheim, Germany) with an upper reference limit (URL) of 14 ng/l corresponding to the 99th percentile of a healthy reference population, a limit of blank set at 3 ng/l, and a limit of detection of 5 ng/l. The assay properties have been described previously.¹² All blood sample analyses were performed in certified clinical chemistry lab of a tertiary university hospital.

Endpoints

Primary endpoints of this study were cardiac troponin T levels after induced hypotension and left ventricular ejection fraction during follow-up. Secondary endpoints were technical success and overall survival.

Statistical Analysis

Categorical data are presented as absolute number and percentages. Continuous variables were expressed as mean (± standard deviation) or median (interquartile range) when not normally distributed and analyzed with the paired samples t-test. Survival estimates was estimated with life tables according to Kaplan–Meier and presented as percentage provided with a 95% confidence interval (CI). A p value <.05 defined as statistical significance. Analyses were performed using SPSS software (version 27; IBM Corporation, Somers, NY, USA).

Results

A total of 21 patients were enrolled in this study. Baseline demographics and clinical characteristics are reported in Table 1; anatomical characteristics and clinical indication for treatment are reported in Table 2.

Table 1.

Baseline Characteristics of 21 Patients Treated With Cava Balloon Occlusion Under Endovascular Repair of Arcus and Thoracic Aortic Aneurysms.

	(N=21)
Age, years	68 ± 9
Male sex	18 (86)
BMI, kg/m²	26.6 ± 4.6
Smoking, current	1 (5)
Smoking, prior	2 (10)
Hypertension	18 (86)
Hyperlipidemia	3 (14)
Congestive heart failure	3 (14)
Coronary artery disease	5 (24)
CABG	3 (14)
PCI	2 (10)
Atrial fibrillation	3 (14)
COPD	3 (14)
Peripheral artery disease	1 (5)
Diabetes mellitus	0
Stroke or TIA	4 (1)
Chronic kidney disease
Stage III-V	0
Hemoglobin, g/L	136 ± 20
Creatinine, µmol/L	92 ± 25
eGFR, mL/min/1.73 m²	66 ± 17
Preoperative LVEF (%)	54 ± 3
Preoperative spirometry
VC	3.7 ± 1
FEV₁	2.5 ± 0.8

Categorical variables are presented as number (%). Continuous variables are presented as mean ± standard deviation.

Abbreviations: BMI, body mass index; CABG, coronary artery bypass graft; COPD, chronic obstructive pulmonary disease; eGFR, estimated glomerular filtration; FEV₁, forced expiratory volume during the first second; LVEF, left ventricular ejection fraction; PCI, percutaneous coronary intervention; TIA, transient ischemic attack; VC, vital capacity.

Table 2.

Anatomic Characteristics for Repair of 21 Patients Treated With Partial Right Atrial Inflow Occlusion Under Endovascular Repair of Arcus and Thoracic Aortic Aneurysms.

	(N=21)
Anatomical characteristics (mm)
Max aneurysm diameter	62 ± 8
Distance from highest coronary artery to BCT	67 ± 14
Proximal sealing zone
Zone 0	10 (48)
Zone 1	2 (10)
Zone 2	8 (38)
Zone 3	1 (5)
Thoracic stentgraft
Custom-made arch graft	12 (57)
Zenith TX2	4 (19)
Zenith Alpha	2 (10)
Valiant	2 (10)
TAG	1 (5)
Length of proximal stentgraft (mm)	202 ± 49
Length of total aortic coverage (mm)	273 ± 99
Arterial access
Percutaneous femoral	21 (100)
Open carotis	13 (62)
Percutaneous carotis	1 (5)
Open subclavian	7 (33)
Percutaneous axillaris	3 (14)

Categorical variables are presented as number (%). Continuous variables are presented as mean ± standard deviation.

Abbreviation: BCT, brachiocephalic trunk; TAG, thoracic stent graft.

In 18 male and 3 female patients with mean age of 68 ± 9 years, TEVAR was performed using IVC-balloon occlusion. The indication for TEVAR was aortic arch aneurysm (n=10), descending aortic aneurysm (n=8), thoracoabdominal aortic aneurysm (n=1), and lusorian artery aneurysm (n=2). The mean maximum aneurysm diameter was 62 ± 8 mm with a mean distance from the most distal coronary artery to brachiocephalic trunk of 67 ± 14 mm. In 10 (48%) patients, the proximal stentgraft was deployed in zone 0, in 2 (10%) patients in zone 1, in 8 (38%) patients in zone 2 and in 1 (5%) patient in zone 3. The most commonly used proximal stentgraft was a custom made arch graft with inner branches (Zenith Branched Arch Endograft, Cook Incorporated, Bloomington, IN, USA).

As the proximal stentgraft was aligned, IVC-balloon occlusion reduced the median MAP to 43 (35-47) mmHg in 60 (40-90) seconds (Table 3). Induced median SVI to 31 (20-40) ml/m²/beat during IVC-balloon occlusion achieved on 58 (37-80) seconds. Mean recovery time to preintervention values of blood pressure and SVI was 135 (69-198) and 140 (66-243) seconds, respectively. The median balloon inflation time, defined as the maneuver time, was 97 (76-149) seconds. Major periprocedural complications occurred in 2 (10%) patients with retrograde type A aortic dissection after the deployment of the proximal stentgraft of which one also had an acute myocardial infarction. One patient was treated by emergent open surgical supracoronary hemiarch repair and the other one with a Bentall procedure, both successfully. No patient showed a type 1A endoleak. No ST-segment changes were encountered perioperatively with the exception of the 1 patient with retrograde type A aortic dissection and subsequently development of acute myocadiac ischemia. Two (10%) patients developed postoperatively new onset atrial fibrillation. No arterial or venous access site related complications were noted with all percutaneous accesses closed with Proglide closure devices. Technical success was achieved in all cases with accurate stent graft deployment for all target vessels.

Table 3.

Peri- and Post-Operative Measurements of Cardiac Stress of 21 Patients Treated With Partial Right Atrial Inflow Occlusion Under Endovascular Repair of Arcus and Thoracic Aortic Aneurysms.

	(N=21)
Systolic BP before onset, mmHg	127 (112-135)
Diastolic BP before onset, mmHg	62 (53-71)
Pulse before onset	59 (54-73)
Cardiac index before onset, L/min/m²	2.6 (2.0-2.9)
ScvO₂ before onset	81 (80-84)
Time (s) onset to half of MAP	60 (40-90)
Time (s) onset to half of SVI	58 (37-80)
ScvO₂ lowest	72 (65-76)
Time(s) until MAP returns to preintervention value	135 (69-198)
Time(s) until SVI returns to preintervention value	140 (66-243)
Time (s) until ScvO₂ returned to preintervention value	192 (118-250)
Troponin T 3 hours after induced hypotension	76 (23–107)
Troponin T 6 hours after induced hypotension	68 (28-78)
Troponin T 24 hours after induced hypotension	55 (28-74)
Troponin T 48 hours after induced hypotension (n=5)*	38 (15-67)
Troponin T 62 hours after induced hypotension (n=1)*	12 ng/l
Cases with >50% change of Troponin T on the reference level	5 (24)
ST-Elevation Myocardial Infarction (STEMI) peri-operative	1 (5)
New-onset atrial fibrillation	2 (10)

Categorical variables are presented as number (%). Continuous variables are presented as median and interquartile range.

Abbreviations: BP, blood pressure; MAP, mean arterial pressure; ScvO₂, central venous oxygen saturation; SVI, stroke volume index.

Troponin T measured every day until normal value.

Median hs-cTnT values at 3, 6, and 24 hours post maneuver were 37 (23-107), 36 (28-78), and 36 (28-74), respectively, Figure 2. Five (24%) patients had a significant, >50%,¹³ change of Troponin T on the reference change interval, Table 3. The mean ejection fraction measured during preoperative workup was 54% ± 3% with the value of 55% being the maximum value in our lab meanwhile the mean postprocedural LVEF was 52% ± 6% at a mean follow-up time of 30 ± 17 months (p=0.208) both samples were not normally distributed. Clinical follow-up duration was 48 ± 18 months, with an estimated overall survival at 1, 2, and 5 years was 100%, 95% (95% CI=70.7-99.3), and 90% (95% CI=67.0-97.5), respectively. Two deaths, both no aneurysm-related, registered under follow-up, Figure 3.

Discussion

To our knowledge, this study is the first to investigate the cardiac stress and impact on myocardium of TEVAR using IVC-balloon occlusion for CO reduction, which establishes a baseline for comparison with other methods of cardiac output reduction during TEVAR. IVC-balloon occlusion induces systemic hypotension through a significant reduction of cardiac preload and can easily be controlled by the operator. Rapid recovery of systemic blood pressure and SVI is needed to reduce the risk of complications such as ischemic stroke and spinal cord ischemia. It remains unknown whether IVC-balloon occlusion increases myocardial oxygen demand during hypotension similar to rapid ventricular pacing which increases the oxygen consumption and is related with a significant risk for ventricular fibrillation with reports of perioperative rhythm disorders up to 12.5% as well perioperative rise in troponin on 83.3% of the patients.¹⁴ IVC-balloon occlusion does not appear to be without cardiac risk with 2 cases of new onset atrial fibrillation and significant Troponin T leakage in the immediate postoperative period in a quarter of the patients indicating myocardial stress and tissue damage. These findings may suggest that risks of IVC-balloon occlusion should be weighed against benefits especially for patients with ischemic heart disease, unstable coronary artery disease or recent myocardial infarction. However, postoperative TTE showed no significant changes of the left ventricular ejection fraction suggesting that the myocardial stress of IVC-balloon occlusion is short and may not have long-term sequels.

The pathophysiological mechanism behind these findings is not yet well understood. Myocardial stress can be anticipated due to hypotension and increased myocardial oxygen demand. Patients with new onset of atrial fibrillation, however, cannot be directly associated to the use of IVC-balloon occlusion and need further investigation. The need for accurate proximal landing in TEVAR with methods of cardiac output reduction appears crucial despite the short-term cardiac compromise. In cases with a contraindication for the use of IVC-balloon occlusion other methods of CO reduction may be chosen such as the more recently described MuVIT technique.⁴ Reduction of CO with this technique is achieved by a modified Valsalva maneuver due to controlled manual ventilation without the need for an additional venous access. A prospective comparative study of different techniques for CO reduction would be helpful to better understand their respective impact on the myocardium.

Current experience with RVP builds mainly on transcatheter aortic valve implantation (TAVI). In our experience RVP is more time-consuming compared to IVC-balloon occlusion in addition to its inherent difficulties such as lack of stability and lead dislodgement in comparison. RVP is furthermore associated with vascular complications such as hematoma, thrombosis, arterio-venous fistula, cardiac, and pericardial complications with reported major vascular complications up to 6% and minor up to 8.4%.¹⁵

This study reported a high incidence of retrograde type A aortic dissection of 10%, which may be due to the high proportion of patients with landing zone 0. A causative relationship with the IVC balloon occlusion appears unlikely but close future observation is warranted.

The limitations of the current study include the small number of patients, the risk of confounders, the variety of the indications as well the procedures and the lack of a control group. Ideally a well-designed randomized controlled trial including alternative methods of CO reduction should be conducted to study cardiac impact of different techniques.

Conclusions

IVC-balloon occlusion during aortic arch and descending thoracic TEVAR is a feasible technique with no documented procedure-related complications but is associated with cardiac compromise documented by a significant Troponin T leakage. Further studies are needed to study in depth the cardiac stress caused by cava balloon occlusion and to compare to alternative techniques of CO reduction.

Supplemental Material

sj-docx-1-jet-10.1177_15266028221105183 – Supplemental material for Inferior Vena Cava—Balloon Occlusion and Its Effect on the Myocardium During Endograft Deployment in the Arch

Supplemental material, sj-docx-1-jet-10.1177_15266028221105183 for Inferior Vena Cava—Balloon Occlusion and Its Effect on the Myocardium During Endograft Deployment in the Arch by Angelos Karelis, Nuno V. Dias, Anders Holmström, Tilo Kölbel and Björn Sonesson in Journal of Endovascular Therapy

Footnotes

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by Hulda Almroth Foundation.

ORCID iDs

Angelos Karelis

Nuno V. Dias

Tilo Kölbel

Björn Sonesson

Supplemental Material

Supplemental material for this article is available online.

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