Catheterization and Cardiovascular Interventions 83:465–466 (2014)
Editorial Comment Vascular Complications During TAVR: The Cost of Doing Business Robert D. Safian,* MD Department of Cardiovascular Medicine, Oakland University William Beaumont School of Medicine, Beaumont Health System, Royal Oak, Michigan
Transcatheter aortic valve replacement (TAVR) has proven superiority to standard medical therapy in inoperable patients with symptomatic severe aortic stenosis, and is equivalent to surgical AVR in high-risk patients [1,2]. Although two devices are currently available in the United States for commercial or investigational use, there are more than 15 devices in various stages of investigation or approval outside the United States. Transfemoral (TF) TAVR is the most commonly employed technique, although other arterial (subclavian, axillary, aortic, transapical) and venous (transseptal, cavoaortic) approaches have been utilized in patients who are unsuitable for the TF approach. Large vascular sheaths (18–24 Fr) are required for TF TAVR, and all patients require careful preoperative multimodality imaging to ensure suitability, based on aortiliac and common femoral arterial dimensions, distribution and extent of calcification, tortuosity, and the diameter of the valve implant. Computerized tomography angiography is widely utilized for vascular decision-making, and patients deemed suitable for TF TAVR usually undergo surgical cutdown for arterial access and surgical repair for hemostasis. Unfortunately, vascular complications have been reported in 8–30% of TF TAVR. Despite improvements in operator experience, patient selection, and valve delivery systems, vascular complications still contribute to significant patient morbidity and are strong predictors of TAVR-related mortality. Accordingly, there is considerable interest in converting TAVR to a fully percutaneous procedure, with the hope of reducing the incidence of vascular complications. In this issue of Catheterization and Cardiovascular Intervention, Holper et al. report the results of a randomized trial of surgical cutdown versus percutaneous access in 30 TAVR patients during a 6-month period in 2011 [3]. Hemostasis was achieved using protamine in all C 2014 Wiley Periodicals, Inc. V
patients, surgical repair in the cutdown group, and the preclosure technique with >2 Perclose ProGlide devices (Abbott Vascular, Santa Clara, CA) in the percutaneous group. The primary endpoint of the study, the composite incidence of major and minor vascular complications (as defined by the Valve Academic Research Consortium-2) was 26.7%, and was identical in both groups (using intention-to-treat and as-treated analyses). These complications included dissection, perforation, and new stenosis, and most (75%) were treated with angioplasty or stents. Time to ambulation and narcotic usage were similar in both groups. However, although this study is timely, it may not have broad applicability for several reasons. First, the study is very small and only 14 patients in each group received their intended femoral access. Second, the authors did not distinguish true access site complications related to the common femoral artery from those related to proximal injury to the common or external iliac artery; complications in the latter distribution may be due to the guidewire or the sheath, rather than access site injury per se. Finally, it is not clear whether the authors used the ideal approaches to femoral access and hemostasis in their percutaneous group. Reliable percutaneous femoral access (above the femoral bifiurcation and below the inferior epigastric artery) is achieved with ultrasound-guided micropuncture access or roadmapping the common femoral artery by selective femoral crossover angiography prior to sheath placement [4]. From a hemostasis standpoint, while preclosure with >2 ProGlide devices may be suitable for sheaths 10 French). Looking ahead, the risk of vascular complications after TAVR will decline by decreasing the delivery systems to < 18 Fr, enhancing patient selection, using imaging to ensure access to the common femoral artery, and improving the reliability of vascular closure devices for achieving hemostasis. For the time being, it appears that vascular complications will continue to be part of the cost of doing business.
REFERENCES 1. Leon MB, Smith CR, Mack M, et al. Trnascatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597–1607. 2. Smith CR, Leon MB, Mack M, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187–2198. 3. Holper EM, Kim R, Mack M, et al. Randomized trial of surgical cutdown versus percutaneous access in transfemoral TAVR. Catheter Cardiovasc Interv 2014;83:457–464. 4. Ben Dor I, Maluenda G, Mahmoudi M, et al. A novel, minimally invasive access technique versus standard 18-gauge needle set for femoral access. Catheter Cardiovasc Interv 2012;79:1180–1185. 5. Hayashida K, Lefevre T, Chevalier B, et al. True percutaneous approach for transfemoral aortic valve implantation using the Prostar XL device. J Am Coll Cardiol Cardiovasc Interv 2012:5:207–214.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Editorial Comment Vascular Complications During TAVR: The Cost of Doing Business Robert D. Safian,* MD Department of Cardiovascular Medicine, Oakland University William Beaumont School of Medicine, Beaumont Health System, Royal Oak, Michigan
Transcatheter aortic valve replacement (TAVR) has proven superiority to standard medical therapy in inoperable patients with symptomatic severe aortic stenosis, and is equivalent to surgical AVR in high-risk patients [1,2]. Although two devices are currently available in the United States for commercial or investigational use, there are more than 15 devices in various stages of investigation or approval outside the United States. Transfemoral (TF) TAVR is the most commonly employed technique, although other arterial (subclavian, axillary, aortic, transapical) and venous (transseptal, cavoaortic) approaches have been utilized in patients who are unsuitable for the TF approach. Large vascular sheaths (18–24 Fr) are required for TF TAVR, and all patients require careful preoperative multimodality imaging to ensure suitability, based on aortiliac and common femoral arterial dimensions, distribution and extent of calcification, tortuosity, and the diameter of the valve implant. Computerized tomography angiography is widely utilized for vascular decision-making, and patients deemed suitable for TF TAVR usually undergo surgical cutdown for arterial access and surgical repair for hemostasis. Unfortunately, vascular complications have been reported in 8–30% of TF TAVR. Despite improvements in operator experience, patient selection, and valve delivery systems, vascular complications still contribute to significant patient morbidity and are strong predictors of TAVR-related mortality. Accordingly, there is considerable interest in converting TAVR to a fully percutaneous procedure, with the hope of reducing the incidence of vascular complications. In this issue of Catheterization and Cardiovascular Intervention, Holper et al. report the results of a randomized trial of surgical cutdown versus percutaneous access in 30 TAVR patients during a 6-month period in 2011 [3]. Hemostasis was achieved using protamine in all C 2014 Wiley Periodicals, Inc. V
patients, surgical repair in the cutdown group, and the preclosure technique with >2 Perclose ProGlide devices (Abbott Vascular, Santa Clara, CA) in the percutaneous group. The primary endpoint of the study, the composite incidence of major and minor vascular complications (as defined by the Valve Academic Research Consortium-2) was 26.7%, and was identical in both groups (using intention-to-treat and as-treated analyses). These complications included dissection, perforation, and new stenosis, and most (75%) were treated with angioplasty or stents. Time to ambulation and narcotic usage were similar in both groups. However, although this study is timely, it may not have broad applicability for several reasons. First, the study is very small and only 14 patients in each group received their intended femoral access. Second, the authors did not distinguish true access site complications related to the common femoral artery from those related to proximal injury to the common or external iliac artery; complications in the latter distribution may be due to the guidewire or the sheath, rather than access site injury per se. Finally, it is not clear whether the authors used the ideal approaches to femoral access and hemostasis in their percutaneous group. Reliable percutaneous femoral access (above the femoral bifiurcation and below the inferior epigastric artery) is achieved with ultrasound-guided micropuncture access or roadmapping the common femoral artery by selective femoral crossover angiography prior to sheath placement [4]. From a hemostasis standpoint, while preclosure with >2 ProGlide devices may be suitable for sheaths 10 French). Looking ahead, the risk of vascular complications after TAVR will decline by decreasing the delivery systems to < 18 Fr, enhancing patient selection, using imaging to ensure access to the common femoral artery, and improving the reliability of vascular closure devices for achieving hemostasis. For the time being, it appears that vascular complications will continue to be part of the cost of doing business.
REFERENCES 1. Leon MB, Smith CR, Mack M, et al. Trnascatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597–1607. 2. Smith CR, Leon MB, Mack M, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187–2198. 3. Holper EM, Kim R, Mack M, et al. Randomized trial of surgical cutdown versus percutaneous access in transfemoral TAVR. Catheter Cardiovasc Interv 2014;83:457–464. 4. Ben Dor I, Maluenda G, Mahmoudi M, et al. A novel, minimally invasive access technique versus standard 18-gauge needle set for femoral access. Catheter Cardiovasc Interv 2012;79:1180–1185. 5. Hayashida K, Lefevre T, Chevalier B, et al. True percutaneous approach for transfemoral aortic valve implantation using the Prostar XL device. J Am Coll Cardiol Cardiovasc Interv 2012:5:207–214.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
