2.1

Patient population

This study was approved by the Institutional Review Board of the MedStar Health Research Institute. Consecutive patients with symptomatic severe aortic stenosis who underwent retroperitoneal common iliac access for TAVR from May 2007 to September 2011 were analyzed. All patients had minimum luminal measurements adequate for the delivery system (e.g., > 7 mm diameter for 23-mm valve; and > 8 mm diameter for the 26-mm valve). Patients who underwent transapical TAVR were excluded. Patients were divided into two groups: those who underwent surgical retroperitoneal access (retroperitoneal access group) and those who underwent standard percutaneous femoral access (percutaneous access group).

Pre-specified clinical and laboratory data were collected for all patients on admission, immediately post-TAVR, and during the index hospitalization. Collected data included past medical history, medications on admission, computed tomography studies, and lab results.

2.2

Procedure

In all patients, the initial attempt to perform percutaneous transfemoral access was done by introducing sequential dilators with gradual increases in French size. In cases where the advancement of the dilator or sheath encountered resistance, and fluoroscopy confirmed movement of iliac vessels or of the whole iliac–aortic structure, retroperitoneal access was employed (Supplemental video). In such cases, the percutaneous approach was aborted, the access site was closed using two pre-delivered Perclose ProGlide devices (Abbott Vascular, Abbott Park, IL), and a retroperitoneal approach was obtained using standard surgical technique.

Briefly, the retroperitoneal space was accessed through an oblique or para-median skin incision in the ipsilateral lower abdominal quadrant halfway between the umbilicus and inguinal ligament. The external and internal oblique muscles, as well as the posterior transversalis fascia, were then cut. The retroperitoneal space was exposed by freeing the peritoneum from the abdominal wall and retracting the peritoneum and its contents medially, thereby exposing the common or external iliac artery. The artery was separated from the surrounding structures and proximal and distal vessel loops were placed. Either purse-string suture or two figure-of-8 sutures were placed, and the vessel was punctured between these sutures. The wire and introducer sheath were passed through a subcutaneous tunnel in the groin into the iliac artery, thereby achieving coaxial entry. This technique was utilized in order to decrease the risk of uncontrolled damage to the vessel wall, and to eliminate the need for Dacron patch repair ( Fig. 1 ).

Subcutaneous tunneling of the introducer sheath. This technique allows coaxial entry of the delivery sheath into the vessel. (*skin entry site; → sheath inside the common iliac artery).

Following completion of the procedure, attention was directed toward closure of the arteriotomy using the preplaced sutures. If needed, additional sutures were placed to achieve hemostasis. The incision was closed in multiple layers with the fascia being closed in two layers followed by closure of Scarpa’s fascia and the skin. Final angiography confirmed patency.

2.3

End points

In-hospital outcomes were collected retrospectively and included length of intensive care unit stay, blood transfusion, acute kidney injury, stroke, bleeding, and in-hospital death. Intensive care unit stay was defined as the time from procedure day until the day of transfer to medium care. Any neurological deficit, together with evidence of stroke in neuro-imaging was categorized as a stroke event. Acute kidney injury and bleeding were defined according to the definitions provided by the Valve Academic Research Consortium (VARC) .

2.4

Statistics

Statistical analysis was performed using SAS version 8.2 (SAS Institute Inc., Cary, NC). Continuous variables are expressed as mean ± standard deviation. Categorical variables are expressed as percentages. Student’s t-test was used to compare continuous variables, and the chi-square test or Fisher’s exact test was used to compare categorical variables. A p value < 0.05 was considered statistically significant.

2.1

Patient population

This study was approved by the Institutional Review Board of the MedStar Health Research Institute. Consecutive patients with symptomatic severe aortic stenosis who underwent retroperitoneal common iliac access for TAVR from May 2007 to September 2011 were analyzed. All patients had minimum luminal measurements adequate for the delivery system (e.g., > 7 mm diameter for 23-mm valve; and > 8 mm diameter for the 26-mm valve). Patients who underwent transapical TAVR were excluded. Patients were divided into two groups: those who underwent surgical retroperitoneal access (retroperitoneal access group) and those who underwent standard percutaneous femoral access (percutaneous access group).

Pre-specified clinical and laboratory data were collected for all patients on admission, immediately post-TAVR, and during the index hospitalization. Collected data included past medical history, medications on admission, computed tomography studies, and lab results.

2.2

Procedure

In all patients, the initial attempt to perform percutaneous transfemoral access was done by introducing sequential dilators with gradual increases in French size. In cases where the advancement of the dilator or sheath encountered resistance, and fluoroscopy confirmed movement of iliac vessels or of the whole iliac–aortic structure, retroperitoneal access was employed (Supplemental video). In such cases, the percutaneous approach was aborted, the access site was closed using two pre-delivered Perclose ProGlide devices (Abbott Vascular, Abbott Park, IL), and a retroperitoneal approach was obtained using standard surgical technique.

Briefly, the retroperitoneal space was accessed through an oblique or para-median skin incision in the ipsilateral lower abdominal quadrant halfway between the umbilicus and inguinal ligament. The external and internal oblique muscles, as well as the posterior transversalis fascia, were then cut. The retroperitoneal space was exposed by freeing the peritoneum from the abdominal wall and retracting the peritoneum and its contents medially, thereby exposing the common or external iliac artery. The artery was separated from the surrounding structures and proximal and distal vessel loops were placed. Either purse-string suture or two figure-of-8 sutures were placed, and the vessel was punctured between these sutures. The wire and introducer sheath were passed through a subcutaneous tunnel in the groin into the iliac artery, thereby achieving coaxial entry. This technique was utilized in order to decrease the risk of uncontrolled damage to the vessel wall, and to eliminate the need for Dacron patch repair ( Fig. 1 ).

Subcutaneous tunneling of the introducer sheath. This technique allows coaxial entry of the delivery sheath into the vessel. (*skin entry site; → sheath inside the common iliac artery).

Following completion of the procedure, attention was directed toward closure of the arteriotomy using the preplaced sutures. If needed, additional sutures were placed to achieve hemostasis. The incision was closed in multiple layers with the fascia being closed in two layers followed by closure of Scarpa’s fascia and the skin. Final angiography confirmed patency.

2.3

End points

In-hospital outcomes were collected retrospectively and included length of intensive care unit stay, blood transfusion, acute kidney injury, stroke, bleeding, and in-hospital death. Intensive care unit stay was defined as the time from procedure day until the day of transfer to medium care. Any neurological deficit, together with evidence of stroke in neuro-imaging was categorized as a stroke event. Acute kidney injury and bleeding were defined according to the definitions provided by the Valve Academic Research Consortium (VARC) .

2.4

Statistics

Statistical analysis was performed using SAS version 8.2 (SAS Institute Inc., Cary, NC). Continuous variables are expressed as mean ± standard deviation. Categorical variables are expressed as percentages. Student’s t-test was used to compare continuous variables, and the chi-square test or Fisher’s exact test was used to compare categorical variables. A p value < 0.05 was considered statistically significant.