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1 원저 Korean Circulation J 2003;33(7): 관동맥시술환자에서안지오실 의효과와합병증 영남대학교의과대학순환기내과학교실 석준호 박용호 김민경 이상희 김웅홍그루 박종선 신동구 김영조 심봉섭 Efficacy and Complications of Angio-Seal Coronary Angiography and Angioplasty Device in Patients Undergoing Jun Ho Seok, MD, Yong Ho Park, MD, Min Kyeong Kim, MD, Sang Hee Lee, MD, Woong Kim, MD, Gue Ru Hong, MD, Jong Seon Park, MD, Dong Gu Shin, MD, Young Jo Kim, MD and Bong Sup Shim, MD Division of Cardiology, Department of Internal Medicine, Yeungnam University, Daegu, Korea ABSTRACT Background and Objectives:The Angio-Seal (a St. Jude Medical Co., USA) hemostatic puncture closure device produces direct femoral arterial hemostasis, by anchoring a collagen plug to the anterior vascular wall, through a sheath delivery system. The rapid and effective hemostasis leads to earlier ambulation, minimized hospital stay, patient discomfort and vascular complications. This study was performed to evaluate the efficacy and complications of an Angio-Seal in patients undergoing coronary angiography and angioplasty. Subjects and Methods:A total 228 consecutive patients, admitted to our hospital for percutaneous coronary intervention, between October 2001 and May 2002, were enrolled and randomized into 2 groups. 116 patients were treated with an Angio-Seal and the other 112 with manual compression only (control group). The clinical characteristics, procedure related factors, time to ambulation, times to outpatient discharge and complications were analyzed in each patient. All the clinical and procedure-related factors, leading to oozing and delayed bleeding, were also analyzed in the 113 patients who had a successfully completed Angio-Seal deployment. Results:The times to ambulation (7.96±5.81 hours vs ±3.35 hours) and times to outpatient discharge (2.00±0.94 days vs ±3.61 days) were significantly shorter in the Angio-Seal compared to the control group (p=0.001 & p=0.001, respectively). There was oozing in 20 patients (17.7%) and delayed bleeding in 6 (5.3%) of the successful Angio- Seal deployment group. The occurrence of oozing was significantly higher in the heparin infusion cases (40% vs. 18.3%, p=0.034), and was correlated with a later hematoma formation rate and the size of the hematoma (30% vs. 9.7%, 0.68±1.26 cm vs. 0.17±0.70 cm, p=0.015 & p=0.001, respectively). Delayed bleeding was correlated to the hematoma occurrence rate (50% vs. 11.2%, p=0.006). Conclusion:The Angio-Seal resulted in earlier ambulation and shorten the patients hospital stay. Oozing, delayed bleeding, hematomas were noted as complications. Oozing and delayed bleeding were correlated with a high hematoma occurrence rate. Careful inspection of the puncture sites, following an Angio-Seal deployment, should be performed. (Korean Circulation J 2003;33 (7): ) KEY WORDS:Angio-seal;Cardiac catheterization;coronary angiography. 논문접수일 :2003 년 2 월 24 일심사완료일 :2003 년 5 월 23 일교신저자 : 신동구, 대구광역시남구대명동 영남대학교의과대학순환기내과학교실전화 :(053) 전송 :(053) dgshin@medical.yeungnam.ac.kr 574

2 서론 기술들의발전으로인해경피적관상동맥시술은과거에비해많은빈도로시행되고있으며과정도복잡해지고있다. 시술의과정에서반드시동맥의통로가필요하게되는데통상적으로시술후지혈을시행한뒤에도오랜시간동안누워서안정을취해야하므로조기보행이어려워지고입원기간의연장도불가피하여환자의불편감이증가된다. 또한, 출혈, 혈종, 가성동맥류등과같은혈관합병증이나타날수있는데때때로수혈과외과적수술이필요한경우도발생할수있다. 일반적으로동맥의천자를통한통로의생성시발생하는혈관합병증은약 1~3% 정도로다양하게보고되고있으며 1) 많은양의항응고제를사용하는관상동맥중재시술시에는합병증이 2~3 배정도더증가하는것으로보고되고있다. 2) 이러한관점에서최근에동맥도관의제거시효과적지혈과조기보행을가능하게하여환자의불쾌감과입원기간을감소시키기위한여러장치들이발달되어왔는데기계적겸자, 3) 공기팽창압력장치, 4) 용수압력보조기구, 5) 삽입형교원질충전물을이용한혈관폐쇄장치등 6)7) 이대표적이다. 특히, 혈관폐쇄장치들은높은성공률과효과, 낮은합병증을나타내는것으로보고되고있는데안지오실 (Daig, a St. Jude Medical Co., St. Paul, Minnesota, USA) 도이러한동맥폐쇄장치중의하나이다. 안지오실은직접적으로혈관내에유도되어혈관전벽에서흡수성중합고정체 (polymer anchor) 와교원질충전물을사용하여대퇴동맥을지혈시키는장치인데시술후지혈시간의감소, 조기보행, 입원기간의감소, 낮은합병증등이여러연구에서보고되고있다. 8-12) 저자들은심혈관촬영과관상동맥중재시술을시행받은환자에서용수지혈법 (manual compression) 과비교하여안지오실의효과및합병증에대해알아보고자하였다. 또한, 성공적안지오실시술이이루어진환자에서합병증유무에따른인자들의차이를알아보고자하였다. 대상및방법 대상 2001년 10월부터 2002년 5월까지영남대학교의 과대학부속병원순환기내과에입원하여심혈관촬영술단독혹은경피적관상동맥중재시술을병행하여시행받은뒤천자부위지혈을위해안지오실을시술받은 116 명의환자와같은시기에용수지혈방법을시행받은 112 명의환자들을대상으로하였다. 18세미만, 이전에존재하는 6 cm 이상의혈종, 낮은혈소판수 (<75,000/μL), 출혈성질병체질, 와르파린을사용한경우, 심도자시행 24시간이내혹은시술도중혈전용해치료를시행받은경우, 조절되지않는고혈압, 교원질이나중합체에알레르기반응이있는경우, 임상적으로혹은초음파적으로현저한말초혈관질환이있는경우, 파행이나혈관수술의과거력이있는경우, 족부맥박이없는경우, 대퇴동맥잡음이들리는경우등의환자들은제외시켰다. 또한, 안지오실시술전시행한대퇴동맥조영에서심재성대퇴동맥이나대퇴동맥의분지점에천자가된경우도제외시켰다. 방법연구는전향적으로이루어졌으며심도자술후천자부위지혈을위해안지오실을시술받은 116 명과같은시기에용수지혈법을시행받은대조군 112 명을대상으로임상적특성및시술과연관된여러인자들을조사하였다. 임상적특성으로진단명, 환자의나이, 몸무게, 키, 과거력 ( 당뇨, 고혈압, 혈관촬영, 중재시술등의유무 ), 투약정보, 헤파린사용여부등을조사하였고, 시술과연관된인자로시술당시혈압, 시술의종류, 피포 (sheath) 의크기, 시술중사용한헤파린의양, 피포제거전측정한활성화된혈액응고시간 (ACT) 등을조사하였다. 안지오실의효과를알아보기위해시술후보행가능시간, 시술후재원기간, 시술후나타난합병증도조사하였다. 또한, 성공적안지오실이시술된 113 명의환자에서합병증인삼출성출혈과지연출혈유무에따른인자들도각각비교하였다. 안지오실은지혈성천자폐쇄기구로써흡수성교원질충전물부분과유도장치로구성된다. 충전물은유산을가지며글라이콜고정체 (10 2 1) 는흡수성덱손에의해 12~19 mg의 P0176 교원질스폰지에부착된다. 기구는의학용나일론운반관에담겨지게된다. 우선도자철사를넣고그전의피포를제거하며기구유도를위한다른피포를삽입한다. 충전물이담긴운반관을피포내로삽입하고혈관벽에고정체를고정시킨다. 575

A B C Locate the artery Set the anchor Seal the puncture Fig. 1. Mechanism of Angio-Seal device A:after catherization, the procedure sheath is replaced with the locator system.

B: arrow to arrow markers ensure the correct orientation of the Angio-Seal TM device. The monofold sheath tip is designed for easy positioning of the anchor.

Tamping the sponge secures the seal, creating virtually instantaneous hemostasis without time-consuming manual pressure, tract dilation or surgical suturing. 장력을유지하면서충전관은밀고피포와운반관은당긴다.

3 A B C Locate the artery Set the anchor Seal the puncture Fig. 1. Mechanism of Angio-Seal device A:after catherization, the procedure sheath is replaced with the locator system. Upon entering the artery, blood flow through the locator offers immediate visual confirmation of precise arterial positioning. B: arrow to arrow markers ensure the correct orientation of the Angio-Seal TM device. The monofold sheath tip is designed for easy positioning of the anchor. C:controlled tension, applied by the sealing system to the suture, draws the small collagen sponge and anchor together, sandwiching the arteriotomy. Tamping the sponge secures the seal, creating virtually instantaneous hemostasis without time-consuming manual pressure, tract dilation or surgical suturing. 장력을유지하면서충전관은밀고피포와운반관은당긴다. 장력스프링을이용하여장력을유지시키는데이때고정체와교원질충전물에의해천자부위의혈관전벽이채워지게된다. 약 20분후장력스프링을제거하고피부표면에서실을자른다 (Fig. 1). 용수지혈법은국소적지혈이완전히이루어질때까지시행되었으며환자의평균압박시간은 31.96±17.19 분이었다. 합병증으로출혈, 단순혈종, 삼출성출혈 (oozing), 가성동맥류, 동정맥루, 하지허혈, 파행, 국소적알레르기반응등을조사하였고출혈은다시조기출혈과지연출혈로구분하여조사하였다. 조기출혈은안지오실시술이끝난직후부터장력스프링을제거하기전까지나타나는 30분이상의용수지혈법이필요한출혈로정의하였고수혈과중재시술이필요한 6 cm 이상의혈종도포함시켰다. 본연구에서는안지오실이시술된 116 명의환자중 3명의환자에서나타났으며모두시술후바로나타난경우로시술실패로분류하였다. 지연출혈에는안지오실군에서는장력스프링을제거하고난후, 비교군에서는완전한지혈이이루어지고난후에정도에상관없이발생하는모든출혈로정의하였다. 삼출성출혈은안지오실군에서는시술이끝난직후부터장력스프링을제거하기전까지나타나는 30분이내의 576 용수지혈법이필요한출혈로정의하였고비교군에서는완전한지혈을이루기전에발생하는출혈로정의하였다. 혈종은만져지는모든경우의응어리로, 가성동맥류는이학적검사나도플러초음파검사로발견된동맥주위종괴로정의하였다. 통계모든결과는평균 ± 표준편차로나타내었으며각군간의비교는 SPSS 통계프로그램 (SPSS for windows, USA) 을이용하여독립표본 T검정과 Chi Square 분석을시행하였고 p값이 0.05 이하인경우를통계적인의미가있다고보았다. 결과 안지오실시술군과대조군간의비교 (Table 1) 나이는안지오실군 60.86±9.75세, 대조군 60.69± 세로양군의차이는없었으며남녀비는안지오실군 81명과 32명, 대조군 60명과 52명으로대조군에서여자의비가높게나타났다 (p=0.005). 몸무게와키, 당뇨와고혈압의과거력, 과거혈관촬영유무, 과거중재시술시행유무등의인자에서는양군의차이는없었다. Korean Circulation J 2003;33(7):

4 Table 1. Clinical characteristics and procedure related factors in all patients Angio-Seal (n=113) Manual compression (n=112) p Age (years) 60.9± ± Sex (M:F) 81:32 60: Weight (kg)/height (cm) 66.1±9.8/164.6± ±10.8/162.0± /0.054 Diagnosis Chronic stable angina 40 (35.4) 33 (29.5) Unstable angina 12 (10.6) 22 (19.6) Acute myocardial infarction 26 (23.0) 25 (22.3) Old myocardial infarction 10 (08.8) 12 (10.7) Diabetes mellitus 25 (22.1) 29 (25.9) Hypertension 27 (23.9) 32 (28.6) Previous CAG history 11 (09.7) 12 (10.7) Heparin infusion before procedure 25 (22.1) 33 (29.5) Procedure Simple CAG 37 (32.7) 51 (45.5) PTCA/stenting 32 (28.3)/44 (38.9) 25 (22.3)/36 (32.1) At procedure Systolic BP (mmhg) 138.2± ± Diastolic BP (mmhg) 68.8± ± Final ACT (sec) 255.8± ± Used heparin dose (IU) ± ± Ambulation time (hours) 8.0± ± Hospital stay after procedure (days) 2.0± ± Complications Delayed bleeding 06 (05.3) 05 (04.5) Access site oozing 20 (17.7) 13 (11.6) Hematoma occurrence 15 (13.3) 17 (15.2) Hematoma size (cm) 0.3± ± Data presented are number of lesions (%) or mean± SD. CAG:coronary angiography, PTCA:percutaneous transluminal coronary angioplasty, BP:blood pressure, ACT:activated clotting time 내원당시진단과시행받은시술도양군에서차이는없었으며시술전헤파린을투여받은경우와시술전측정한혈압에서도양군의차이는없었다. 시술시피포내로투여한헤파린의양과피포제거전시행한활성화된혈액응고시간도양군에서차이가없었다. 보행가능시간과재원기간에서안지오실군에서 7.96±5.81 시간, 2.00± 0.94 일, 대조군에서 23.32±3.35시간, 3.47±3.61일로유의있는차이를보였다 (p=0.001, p=0.001). 합병증으로지연출혈, 삼출성출혈, 혈종발생유무, 혈종크기등에서는양군에서큰차이는없었다. 안지오실을시술받은환자에서삼출성출혈발생유무에따른비교 (Table 2) 안지오실을시술받은 113 명의환자들중삼출성 출혈은모두 20명의환자 (17.7%) 에서발생하였는데나이, 성별, 몸무게, 키, 진단명, 당뇨혹은고혈압의과거력, 과거혈관촬영유무, 과거중재시술유무, 시술의종류등에서삼출성출혈이발생하지않은환자들과유의한차이는없었다. 안지오실시술직전측정한수축기혈압이삼출성출혈발생군에서 ±15.13 mmhg로 ±27.59 mmhg 의출혈이발생하지않은군보다높게나타났으나통계학적유의성은없었으며이완기혈압, 시술직전측정한혈액응고시간, 시술중사용한헤파린양, 보행가능시간, 시술후재원기간등에서도차이가없었다. 그러나, 시술직전헤파린을투여받은경우가삼출성출혈이발생한환자군에서 8예 (40%) 로출혈이발생하지않은군의 17예 (18.3%) 보다유의있게많았으며 (p=0.034) 혈종발생율과크 577

5 Table 2. Clinical characteristics related to the occurrence of oozing in 113 patients who completed Angio-Seal deployment successfully Oozing (n=20) No oozing (n=93) p Age (years) 59.5± ± Sex (M:F) 67:26 14: Weight (kg)/height (cm) 66.3±7.8/166.0± ±10.2/164.3± /0.373 Diagnosis Chronic stable angina 7 (35.0) 33 (35.5) Unstable angina 2 (10.0) 10 (10.8) Acute myocardial infarction 3 (15.0) 23 (24.7) Old myocardial infarction 3 (15.0) 07 (07.5) Diabetes mellitus 3 (15.0) 22 (23.7) Hypertension 5 (25.0) 22 (23.7) Previous CAG history 2 (10.0) 09 (09.7) Heparin infusion before procedure 2 (10.0) 16 (17.2) Before procedure heparin infusion 8 (40.0) 17 (18.3) Procedure Simple CAG 8 (40.0) 29 (31.2) PTCA/stenting 3 (15.0)/9 (45.0) 29 (31.2)/35 (37.6) At procedure Systolic BP (mmhg) 149.0± ± Diastolic BP (mmhg) 67.9± ± Final ACT (sec) 266.7± ± Used heparin dose (IU) ± ± Ambulation time (hours) 10.1± ± Hospital stay after procedure (days) 1.9± ± Complications Hematoma occurrence 6 (30.0) 09 (09.7) Hematoma size (cm) 0.7± ± Data presented are number of lesions (%) or mean±sd. CAG:coronary angiography, PTCA:percutaneous transluminal coronary angioplasty, BP:blood pressure, ACT:activated clotting time 기도 30% 와 0.68±1.26 cm로 9.7% 와 0.17±0.70 cm보다유의있게높았다 (p=0.015, p=0.001). 안지오실을시술받은환자에서지연출혈의발생유무에따른비교 (Table 3) 안지오실을시술받은 113 명의환자들중지연출혈은모두 6명의환자 (5.3%) 에서발생하였는데나이, 성별, 키, 진단명, 당뇨혹은고혈압의과거력, 과거혈관촬영유무, 과거중재시술유무, 시술의종류, 시술직전측정한혈압, 시술직전측정한혈액응고시간, 보행가능시간, 시술후재원기간등에서출혈이발생하지않은환자들과유의한차이는없었다. 지연출혈이발생한환자군에서혈종발생율이 50% 로나타나출혈이발생하지않은환자군의 11.2% 에비해유의있게높 게나타났으며 (p=0.006) 몸무게, 시술중사용한헤파린의양에서는약간의차이를보였으나통계학적유의성은없었다. 고찰 경피적관상동맥시술후천자부위에대한빠르고효과적인지혈은조기보행을이루어환자의불편감을줄여주고혈관의합병증을최소화시킬수있으며환자의입원기간을줄일수있다. 15) 현재노인인구의증가와더불어노인환자에서의심도자술이증가하고있는시점에서조기보행으로인한환자의불편감개선효과는매우크다고할수있다. 그러나, 과거부터사용되어온용수지혈법은시행방법자체가환자에게불편감을주 578 Korean Circulation J 2003;33(7):

6 Table 3. Clinical characteristics leading to the occurrence of delayed bleeding in 113 patients who completed Angio-Seal deployment successfully Delayed bleeding (n=6) No delayed bleeding (n=107) p Age (years) 62.0± ± Sex (M:F) 3:3 78: Weight (kg) 66.2± ± Height (cm) 160.3± ± Diabetes mellitus 1 (16.7) 24 (22.4) Hypertension 3 (50.0) 24 (22.4) Previous CAG history 0 11 (10.3) Previous intervention histoy 1 (16.7) 17 (15.9) Before procedure heparin infusion 1 (16.7) 24 (22.4) Procedure Simple CAG 1(16.7) 36 (33.6) PTCA/stenting 3 (50.0)/2 (33.3) 29 (27.1)/42 (39.3) At procedure Systolic BP (mmhg) 129.5± ± Diastolic BP (mmhg) 79.0± ± Final ACT (sec) 295.5± ± Used heparin dose (IU) ± ± Ambulation time (hours) 8.0± ± Hospital stay after procedure (days) 2.5± ± Complications Hematoma occurrence 3 (50.0) 12 (11.2) Hematoma size (cm) 1.2± ± Data presented are number of lesions (%) or mean±sd. CAG:coronary angiography, PTCA:percutaneous transluminal coronary angioplasty, BP:blood pressure, ACT:activated clotting time 고많은시간이소모되며완전히지혈이된후에도장시간의절대안정이필요하고합병증등의문제점을가지고있다. 13) 용수지혈법으로지혈한환자들중단순심도자술을시행한경우는 1.0%, 복잡한중재시술을시행한경우는 3.0% 에서주요혈관합병증이발생한다고보고되고있으며 17-20) 헤파린의사용, 섬유소용해성치료, 동맥에삽입한피포의크기, 말초혈관질환의존재유무등이합병증발생에영향을준다고한다. 20) 이러한관점에서빠르고효과적인지혈을통한조기보행을이루고합병증을줄이기위한여러지혈보조기구들이발달되어왔다. 현재까지소개된동맥지혈보조기구들에는기계적겸자, 3) 공기팽창압력장치, 4) 용수압력보조기구, 5) 삽입형교원질충전물을이용한혈관폐쇄장치등 6)7) 이있다. 이들은용수지혈법에비해지혈시간과보행가능시간, 합병증등에있어매우효과적인것으로보고되고있으며 9-12) 이러한효과들은진단적시술은물론많은양의항응고제를사용하는중 재적시술에도적용되는것으로보고되고있다. 14)15) 특히, 이들중혈관폐쇄를위한다양한봉인 (sealing) 기구들이좋은효과로현재임상에많이응용되고있는데 15) 안지오실도이러한봉인기구의일종으로고정체와충전물을사용한대퇴동맥지혈기구이며현재여러임상결과가보고되고있다. 안지오실의성공률은현재까지약 91~96% 로 8)9) 다른봉인기구들과차이는없는것으로보고되고있다. 본연구에서는안지오실이시행된 116 명의환자중 3명의시술실패환자를제외한 113명의환자에서성공적인시술이이루어져 97.41% 의성공률을나타내었다. 시술실패요인은기구실패, 시술자실수등이있을수있으며다른방법으로지혈을하게되는데본연구에서도시술실패환자들은모두용수지혈법으로지혈을시행하였다. 안지오실의짧은지혈시간과빠른보행가능시간을통한환자의불편감해소와입원기간의감소효과는여러연구에서보고되고있는데 8)9)24) 본연구에서도보행가능시간과시술 579

7 후재원기간에서의미있는감소를나타내었다. 안지오실시술후발생하는합병증으로는출혈, 단순혈종, 삼출성출혈, 가성동맥류, 동정맥루, 하지허혈, 파행, 국소적알레르기반응등이있다. 출혈, 가성동맥류, 동정맥루, 하지허혈등과같은주요혈관합병증의발생은용수지혈법에비해많은감소를나타낸것으로보고되고있는데연구마다차이를보이며대개약 1~4% 의빈도를나타내는것으로보고있다. 9)10)25) 특히, 항응고제가많이사용되는중재적시술시에도단순혈관촬영에비해별다른차이가없는것으로보고되고있다. 그러나, 삼출성출혈, 단순혈종같은작은합병증은용수지혈법에비해의미있는감소는없는것으로보고되고있다. 8) 본연구에서는단순혈종과삼출성출혈, 지연출혈등이합병증으로발생하였으며발생빈도에있어용수지혈법과비교해의미있는감소는없었다. 본연구에서삼출성출혈이안지오실시술후가장흔한합병증으로나타났는데시술이성공한 113 명의환자중약 20명 (17.7%) 의환자에서발생하였고모든환자에서수분의용수지혈법과모래주머니를통한압박처치로지혈되었다. 삼출성출혈이발생한환자들의특징을살펴보면시술직전까지헤파린이사용된경우가유의하게많았으며유의성은없었지만수축기혈압이출혈이발생하지않은군에비해높게나타났다. 또한혈종의발생율및혈종의크기에서유의한연관성이있는것으로관찰되었다. 지연출혈은성공적안지오실시술후완전한지혈을확인한다음장력스프링을제거한뒤에발생하는모든출혈을말하는데주로밤사이에많이나타난다. Ward 등 9) 은안지오실이시행된 202명의환자중 10명 (5%) 의환자에서지연출혈이발생하였다고보고하였으며본연구에서도성공적안지오실이시술된 113 명의환자중 6명의환자에서발생하여약 5% 의발생율을나타내었다. 지연출혈이발생한환자들의특징을살펴보면유의성은없었지만몸무게, 고혈압병력, 시술시사용된헤파린양, 시술후마지막측정한활성화혈액응고시간등에서약간의차이를보였고혈종의발생율은유의있는증가소견을보였다. 여러연구에서안지오실의효과적인지혈과조기보행으로인한입원기간의단축은보고되고있으나이러한결과가환자의입원에대한전체비용의감소에효과가있는지는아직알려져있지않다. 그러나, 안지오 580 실이아닌다른봉인기구를이용한비용감소의효과는몇몇보고되고있으며 22)23) 안지오실도같은효과를낼것으로예측되고있다. 본연구에서도빠른보행가능시간을통한시술후재원기간의감소를경험하였으나이것이비용의감소를가져오는지는알아보지못했다. 향후입원기간의감소, 합병증의발생율, 환자의만족도, 보험제도등을모두고려한비용감소효과가논의되어져야할것으로사료된다. 결론적으로안지오실의사용은빠른보행가능시간과단축된재원기간을나타내었으며합병증은용수지혈법과유사한빈도로발생하였다. 합병증으로는삼출성출혈과지연출혈, 혈종등이나타났으며삼출성출혈은시술전헤파린의사용유무와연관성이있었다. 삼출성출혈과지연출혈모두향후높은혈종발생율을나타내었으며주의깊은관찰이필요할것으로사료된다. 본연구의제한점첫째, 대상환자들에대해기본적천자부위초음파검사를시행하지않았다는것이다. 임상적으로나타나지않은가성동맥류, 동정맥루등의혈관손상을놓칠수있다는것이다. 둘째, 혈전용해제와와르파린을사용한경우를제외한상대적으로합병증의위험도가낮은환자들에게시술되었다는것이다. 향후합병증의위험도가높은환자들에대한안지오실의효과에대해서도연구가필요할것으로사료된다. 셋째, 최근혈관에대한합병증빈도를줄이기위한방안으로 radial approach 가많이이루어지고있는실정이나본원에서연구기간내에 radial intervention시안지오실을이용한사례가없어이와의비교가이루어지지못했다. 넷째, 현재국내에서안지오실의가격은 34만원정도로비교적고가이며본연구에서는조기퇴원의이득과안지오실의가격과의 cost-effectiveness에대한비교가이루어지지못했으나향후이점에대한연구가더필요할것으로생각된다. 요약 배경및목적 : 안지오실은혈관전벽에서흡수성중합고정체와교원질충전물을사용하여대퇴동맥을지혈시키는장치이며지혈시간의감소, 조기보행, 입원기간의감소, 합 Korean Circulation J 2003;33(7):

8 병증의감소등을나타내고있다. 저자들은심혈관촬영과관상동맥중재시술을시행받은환자에서용수지혈법과비교하여안지오실의효과및합병증에대해알아보고자하였다. 방법 : 2001년 10월부터 2002년 5월까지본원순환기내과에입원하여심도자술후천자부위지혈을위해안지오실을시술받은 116 명의환자와같은시기에용수지혈방법을시행받은 112 명의환자들을대상으로하였다. 양군의환자에서임상적특성및시술과연관된여러인자들을분석하였고시술후보행가능시간, 시술후재원기간, 합병증등도조사하였다. 또한, 성공적안지오실이시술된 113 명의환자에서합병증인삼출성출혈과지연출혈유무에따른인자들도각각분석하였다. 결과 : 보행가능시간과재원기간에서안지오실을시술받은환자들에서 7.96±5.81 시간과 2.00±0.94 일로용수지혈법을시행받은환자들의 23.32±3.35 시간과 3.47± 3.61 일에비해유의있는감소를보였다 (p=0.001 & p=0.001). 성공적안지오실을시술받은환자들중삼출성출혈은 20명의환자 (17.7%) 에서발생하였고지연출혈은 6명의환자 (5.3%) 에서발생하였다. 삼출성출혈은시술직전헤파린을투여받은경우가많았으며 (40% vs 18.3%, p=0.034) 향후혈종발생율및크기와연관성이있었고 (30% & 0.68±1.26 cm vs 9.7% & 0.17±0.70 cm, p=0.015 & p=0.001) 지연출혈도향후혈종발생율과연관성이있었다 (50% vs 11.2%, p=0.006). 결론 : 안지오실시술로조기보행과단축된재원기간을나타내었고합병증으로는삼출성출혈과지연출혈, 혈종등이나타났으며삼출성출혈과지연출혈모두향후높은혈종발생율을나타내어주의깊은관찰이필요할것으로사료된다. 중심단어 : 안지오실 ; 심도자술 ; 관동맥성형술. REFERENCES 1) Wyman RM, Safian RD, Portway V. Skillman JJ, Mckay RG, Baim DS. Current complications of diagnostic and therapeutic cardiac catheterization. J Am Coll Cardiol 1988;12: ) Popma JJ, Satler LF, Pichard AD, Kent KM, Campbell A, Chuang YC, Clark C, Merritt AJ, Bucher TA, Leon MB. Vascular complications after balloon and new device angioplasty. Circulation 1993;88: ) Semler HJ. Transfemoral catheterization: mechanical versus manual control of bleeding. Radiology 1985;154: ) Nordrehaug JE, Chronos NA, Foran J, Wainwright R, Rickards AF, Buller NP, Sigwart U. Randomized evaluation of a new inflatable femoral artery compression device after coronary angiography. Circulation 1992;86: ) Roth R, Modrisic K, Brown M, Kern MJ. Initial experience with a new compression device for hemostasis after femoral arterial puncture. Cathet Cardiovasc Diagn 1992;26: ) Sanborn TA, Gibbs HH, Brinker JA, Knopf WD, Kosinski EJ, Roubin GS. A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty. J Am Coll Cardiol 1993;22: ) Ernst SM, Tjonjoegin RM, Schrader R, Kaltenbach M, Sigwart U, Sanborn TA, Plokker HW. Immediate sealing of arterial puncture sites after cardiac catheterization and coronary angioplasty using a biodegradable collagen plug: results of an international registry. J Am Coll Cardiol 1993; 21: ) Kapadia SR, Raymond R, Knopf W, Jenkins S, Chapekis A, Ansel G, Rothbaum D, Kussmaul W, Teirstein P, Reisman M, Casale P, Oster L, Simpfendorfer C. The 6 Fr angioseal arterial closure device: results from a multicenter prospective registry. Am J Cardiol 2001;87: ) Ward SR, Casale P, Raymond R, Kussmaul WG 3rd, Simpfendorfer C. Efficacy and safety of a hemostatic puncture closure device with early ambulation after coronary angiography. Am J Cardiol 1998;81: ) Henry M, Amor M, Allaoui M, Tricoche O. A new access site management tool: the angio-seal hemostatic puncture closure device. J Endovasc Surg 1995;2: ) Silber S, Gershony G, Schon B, Schon N, Jensen T, Schramm W. A novel vascular sealing device for closure of percutaneous arterial access sites. Am J Cardiol 1999;83: ) Broderick JN. Use of a collagen hemostatic closure device to achieve hemostasis after arterial puncture. J Vasc Interv Radiol 1997;8: ) Bogart DB, Bogart MA, Miller JT, Farrar MW, Barr WK, Montgomery MA. Femoral artery catheterization complications: a study of 503 consecutive patients. Cathet Cardiovasc Diagn 1995;34: ) Brachmann J, Ansah M, Kosinski EJ, Schuler GC. Improved clinical effectiveness with a collagen vascular hemostasis device for shortened immobilization time following diagnostic angiography and percutaneous transluminal coronary angioplasty. Am J Cardiol 1998;81: ) Carere RG, Webb JG, Miyagishima R, Djurdev O, Ahmed T, Dodek A. Groin complications associated with collagen plug closure of femoral arterial puncture sites in anticoagulated patients. Cathet Cardiovasc Diagn 1998;43: ) Shrake KL. Comparison of major complication rates associated with four methods of arterial closure. Am J Cardiol 2000;85: ) Babu SC, Piccorelli GO, Shah PM, Stein JH, Clauss RH. Incidence and results of arterial complications among 16,350 patients undergoing cardiac catheterization. J Vasc Surg 1989;10: ) Johnson LW, Lozner EC, Johnson S, Krone R, Pichard AD, 581

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untitled 대한내과학회지 : 제 72 권부록 2 호 2007 Angio-seal 사용후발생한가성동맥류를초음파유도하트롬빈주입으로치료한 1예 부산대학교의과대학내과학교실, 영상의학과교실 2 황기원 전국진 안성규 김경엽 김창원 2 홍택종 신영우 =Abstract= A case of ultrasound-guided thrombin injection therapy for pseudoaneurysm