Abstract
Background
Several patients undergoing permanent pacemaker (PPM) implantation/upgrade present with difficult access due to sub- or total central vein occlusion. Our institution has used the endovascular approach to recanalize central veins to allow for subsequent PPM implantation. Here we aim to describe the feasibility and safety of using this approach to allow for PPM implantation/upgrade.
Methods
From October 2006 to November 2010, 50 consecutive patients who underwent central vein recanalization prior to PPM implantation were included in this analysis.
Results
The population’s mean age was 70 years, with a high rate of comorbidities including chronic renal failure (52.0%), congestive heart failure (64.0%), diabetes (33.3%) and peripheral vascular disease (36.0%). The endovascular recanalization procedure was performed via femoral access in all patients; however adjuvant brachial access was required in 13 cases and subclavian vein in one. Subclavian vein (74.5%) followed by innominate vein (21.6%) were the most common locations/target for recanalization. Successful vein recanalization followed by successful PPM implantation/upgrade was achieved in 48 patients (96.0%) without peri-procedural complications. Two patients died during the hospitalization, one due to severe respiratory failure and a second due to complicated end-stage renal disease, although neither was related to the endovascular procedure. No other event, including myocardial infarction, cerebral–vascular accident, bleeding/transfusion, or renal failure was identified.
Conclusions
This study proved the feasibility and safety of the endovascular approach to recanalize central veins in patients with poor vascular access to allow for further PPM implantation/upgrade.
1
Introduction
Several patients undergoing permanent pacemaker (PPM) or implantable cardioverter defibrillator (ICD) system implantation/upgrade present with difficult access due to central vein occlusion or severe stenosis . Venous obstruction has been reported in up to 25% of patients undergoing PPM/ICD upgrade, with a particularly high rate in patients with a PPM prior to the initial ICD system implantation . Central venous stenosis/occlusion is also a frequent complication in patients on hemodialysis due to the trauma caused by temporary or permanent central catheter placement . The placement of multiple pacer leads, prior venous trauma (i.e. central venous catheter in patients on hemodialysis), previous PPM to ICD update, the use of dual-coils leads, and history of atrial fibrillation and venous thrombosis have been reported as predisposed conditions for venous stenosis/occlusion . Limited clinical data are available regarding the endovascular approach to recanalize central venous occlusion/stenosis prior to an electrophysiology procedure to allow for subsequent PPM/ICD implantation/upgrade. This study aims to describe the feasibility and safety of using the endovascular approach to recanalize central veins in patients with central venous occlusion/stenosis undergoing PPM/ICD implantation/upgrade.
2
Methods
2.1
Patient population
Fifty consecutive patients who underwent central vein recanalization prior to PPM/ICD implantation/upgrade from October 2006 to November 2010 were included in this analysis. All patients had a failed electrophysiological procedure with venographic demonstration of central venous occlusion/stenosis that precluded the procedure, without other access available. All patients gave written, informed consent for the endovascular procedure and the study was conducted under approval of the Institutional Review Board of the MedStar Health Research Institute/Washington Hospital Center.
2.2
Procedure
All procedures were performed via venous femoral access. Adjuvant venous brachial access was used in selected cases as necessary. Intra-procedural anticoagulation was ensured using unfractionated heparin to achieve an activated clotting time of > 250 s in all patients. The location of the stenosis/occlusion was demonstrated by initial standard venogram performed in the superior vena cava. Subsequently, operators attempted to cross the site of the stenosis/occlusion by using a 0.014” ASAHI MiracleBros 6 or 12 guidewire (Abbott Vascular Inc, Abbott Park, IL, USA) and an 0.018” support catheter system (Quick-Cross [Spectranetics, Colorado Springs, CO, USA] or a CXI [Cook Medical, Bloomington, IN, USA).
In case of guidewire crossing failure, either the Frontrunner XP ® CTO catheter (Cordis Corporation, Bridgewater, NJ, USA) ( Fig. 1 A ) or the ASAHI Tornus device (Abbott Vascular) was used to achieve recanalization. In selective cases of subintimal wire position, the Outback LTD ® Re-Entry Catheter (Cordis Corporation) was used. Crossing the segment of stenosis/obstruction location into the true lumen was ensured by contrast injection through the support catheter ( Fig. 1 B). Subsequently a SteelCore 0.018” Hi-Torque guidewire was exchanged (Abbott Vascular Inc.) and balloon dilatation was performed using standard technique (typically 4–6 × 40–60 mm semi-compliant peripheral balloon) ( Fig. 1 C). Successful recanalization was confirmed by venography 10–15 min after balloon dilatation ( Fig. 1 D). In the rare case of persistent occlusion, a self-expandable stent was deployed at the lesion level.
2.3
Definitions
Venographic success was defined as recanalization of the stenotic or occluded venous segment. Clinical success was defined as venographic success followed by successful electrophysiologic procedure. Death was defined as all-cause mortality. Myocardial infarction was defined as the association of ≥ 1 clinical and ≥ 1 biological criteria: acute onset of chest pain and/or typical ischemic changes on electrocardiogram (ST or T wave changes or new left bundle branch block) and an elevation of troponin-I value above the 99th percentile of the upper reference limit . Cerebral vascular accident was defined as any new major neurologic deficit present for > 48 h and associated with objective evidence of injury on brain CT or magnetic resonance. Major bleeding was defined as a decrease in hematocrit of ≥ 15% and/or the occurrence of hemorrhagic stroke, based on the Thrombolysis In Myocardial Infarction (TIMI) criteria . Acute renal failure was defined as > 25% increase in serum creatinine level within 72 h after the index procedure. Chronic renal insufficiency was defined as the presence of previously documented renal failure and/or a baseline serum creatinine > 2.0 mg/dL.
2.4
End points and follow-up
The primary end point was defined as the rate of venographic recanalization and subsequent successful PPM/ICD implantation/upgrade. Secondary end points included in-hospital mortality, myocardial infarction, cerebral–vascular accident, acute renal failure, rate of major bleeding, and red blood cell transfusion. All causes of in-hospital mortality and cardiovascular events were adjudicated by detailed review of medical charts and of available electronic records.
2.5
Statistical analysis
All data management and analyses were performed by a dedicated data coordinating center (Data Center, Cardiovascular Research Institute, Washington, DC). Continuous variables are expressed as mean ± standard deviation, and as median and interquartile range for non-normally distributed variables. Discrete variables are presented as absolute numbers and percentages.
2
Methods
2.1
Patient population
Fifty consecutive patients who underwent central vein recanalization prior to PPM/ICD implantation/upgrade from October 2006 to November 2010 were included in this analysis. All patients had a failed electrophysiological procedure with venographic demonstration of central venous occlusion/stenosis that precluded the procedure, without other access available. All patients gave written, informed consent for the endovascular procedure and the study was conducted under approval of the Institutional Review Board of the MedStar Health Research Institute/Washington Hospital Center.
2.2
Procedure
All procedures were performed via venous femoral access. Adjuvant venous brachial access was used in selected cases as necessary. Intra-procedural anticoagulation was ensured using unfractionated heparin to achieve an activated clotting time of > 250 s in all patients. The location of the stenosis/occlusion was demonstrated by initial standard venogram performed in the superior vena cava. Subsequently, operators attempted to cross the site of the stenosis/occlusion by using a 0.014” ASAHI MiracleBros 6 or 12 guidewire (Abbott Vascular Inc, Abbott Park, IL, USA) and an 0.018” support catheter system (Quick-Cross [Spectranetics, Colorado Springs, CO, USA] or a CXI [Cook Medical, Bloomington, IN, USA).
In case of guidewire crossing failure, either the Frontrunner XP ® CTO catheter (Cordis Corporation, Bridgewater, NJ, USA) ( Fig. 1 A ) or the ASAHI Tornus device (Abbott Vascular) was used to achieve recanalization. In selective cases of subintimal wire position, the Outback LTD ® Re-Entry Catheter (Cordis Corporation) was used. Crossing the segment of stenosis/obstruction location into the true lumen was ensured by contrast injection through the support catheter ( Fig. 1 B). Subsequently a SteelCore 0.018” Hi-Torque guidewire was exchanged (Abbott Vascular Inc.) and balloon dilatation was performed using standard technique (typically 4–6 × 40–60 mm semi-compliant peripheral balloon) ( Fig. 1 C). Successful recanalization was confirmed by venography 10–15 min after balloon dilatation ( Fig. 1 D). In the rare case of persistent occlusion, a self-expandable stent was deployed at the lesion level.
