Cardiovascular Revascularization Medicine 16 (2015) 290–293
Contents lists available at ScienceDirect
Cardiovascular Revascularization Medicine
Percutaneous endovascular treatment of peripheral arterial disease in Germany☆ Theodoros Moysidis a, Dirk Opdenplatz b, Victor Kulendik b, Ralf Ritter c, Hinrich Böhner d, Bernd Luther a, Knut Kröger a,⁎ a
Department of Vascular Medicine, HELIOS Klinikum Krefeld Deparment of Medicine Controlling, HELIOS Klinikum Krefeld Department of Vascular and Endovascular Surgery, Klinikum Bielefeld d Department of Surgery, St. Rochus-Hospital, Castrop-Rauxel, for the Gefäßgesellschaft West (GG West), Germany b c
a r t i c l e
i n f o
Article history: Received 3 December 2014 Received in revised form 4 May 2015 Accepted 8 May 2015 Keywords: Peripheral arterial disease Balloon angioplasty Stenting Thrombolysis
a b s t r a c t Purpose: The general distribution of balloon angioplasty, stenting and other endovascular interventions in treating peripheral arterial disease (PAD) is unclear. Methods and results: We used national statistics (DRG statistics) published by the Federal Statistical Office including data from almost all hospitals in Germany to calculate the rates and types of lower extremity endovascular procedures in 2012. In 2012 150,503 peripheral endovascular procedures were documented in Germany. The predominant procedures were percutaneous transluminal angioplasty (PTA) with 86.0% followed by thrombolysis with 7.2% and thrombectomy with 2.9%. In 50,092 (33.3%) of all peripheral endovascular procedures performed in the lower limb arteries a stent was placed: 66.7% in iliac, 34.3% in femoro-popliteal and 9.7% in cruro-pedal procedures. From these 50,092 procedures DES were coded in 3063 (6.1%) and covered stents in 1841 (3.7%). The highest rate of covered stents was placed in the aorta (8.6%) but the highest rate of DES was in the cruro-pedal arteries (23.1%). Conclusion: Pure PTA is still the most frequently performed procedure in peripheral arteries and in only one third of all procedures was a stent placed in Germany in 2012. © 2015 Elsevier Inc. All rights reserved.
1. Introduction Technical success of endovascular treatment of peripheral arterial disease (PAD) has increased in the last decades. With the introduction of new technology (hydrophilic guide-wires, stents, stent grafts) success rates up to 100% are reported in the literature [1–4]. Stent placement has been established in case of failure of primary angioplasty or early restenosis. But also primary stenting is accepted because of higher patency rates and lower complication rates [5–7]. Although residual stenosis, elastic recoil or dissections are accepted indications for stent placement, the decision to place a stent is the individual decision of the interventionalist based on his education and experiences. There are no guidelines that strictly recommend stent placement in specific situations. Randomized controlled studies present only selected patients and studies reporting the results of single centers do not necessarily represent the global country. Exact data about the general frequency of stent placement in peripheral arteries are missing until today. Such data are necessary to estimate
☆ No conflicts of interest. ⁎ Corresponding author at: Klinik für Gefäßmedizin, Helios Klinikum Krefeld, Lutherplatz 40, 47805 Krefeld, Germany. Tel.: +49 2151 32 1669; fax: +49 2151 32 2669. E-mail address: [email protected] (K. Kröger). http://dx.doi.org/10.1016/j.carrev.2015.05.003 1553-8389/© 2015 Elsevier Inc. All rights reserved.
relevant changes in the global treatment strategies over years or in different countries. Therefore we analyzed the numbers and types of percutaneous endovascular procedures of peripheral arteries (PA) in a nationwide survey to get an overview of treatment strategies in Germany.
2. Material and methods In Germany Diagnosis Related Groups (DRGs) were implemented for reimbursement in 2003. The national statistics (DRG statistics) published by the Federal Statistical Office includes data from all hospitals in Germany that use the DRG system which covers more than 99% of all German hospitals. These institutions are legally obliged to document extensive data on hospital treatment, including demographic data, diagnoses, co-morbidities, complications, and procedures to the "Institute for the Hospital Remuneration System" (InEK) which uses the data for a yearly adaptation of the German DRG system and transmits them to the Federal Statistical Office. For the year 2012 all procedures were coded with the International Statistical Classification of Diseases and Related Health Problems, which was adapted for Germany by the German Institute for Medical Documentation and Information (DIMDI). Codes for stent placement were introduced in 2009 for the first time.
T. Moysidis et al. / Cardiovascular Revascularization Medicine 16 (2015) 290–293 Table 1 Systematic of OPS-codes for documentation of endovascular treatment of PAD separated by the 5th and 6th figure. 8-836.** 8-836.0* 8-836.1* 8-836.2* 8-836.3* 8-836.6* 8-836.7* 8-836.p* 8-836.r* 8-836.w* 8-836.*4 8-836.*9 8-836.*b 8-836.*c 8-840.** 8-841.** 8-842.** 8-840.0* 8-840.1* 8-840.2* 8-840.3* 8-840.4* 8-840.5*
Percutaneous trans luminal angioplasty Balloon Angioplasty (Balloon) Blade-Angioplasty (scoring- or cutting-balloon) Laser Angioplasty Atherectomy Distraction of foreign body Selective Thrombolysis Rotational thrombectomy Cryoplasty Atherectomy with embolism protection device Aorta Other abdominal arteries (predominantly iliac arteries) Femoro-popliteal arteries Cruro-pedal arteries Percutaneous trans luminal placement of BMS Percutaneous trans luminal placement of DES Percutaneous trans luminal placement of covert stent 1 stent 2 stents 3 stents 4 stents 5 stents 6 or more stents
2.1. Statistics Detailed lists of all cases with a documented peripheral percutaneous procedures performed in 2012 separated by the 5th and 6th figure of the OPS-code were provided by the Federal Statistical Office (Table 1). The lists were analyzed in detail to extract data regarding the aorta (6th figure 4) and other abdominal arteries (representing the iliac arteries predominantly) (6th figure 9), femoro-popliteal (6th figure b) and cruro-pedal arteries (6th figure c). All other codes were excluded. These codes were further analyzed for the 5th figure encoding the type of procedure. For those cases that had a code 8.836.*4, 8.836.*9, 8.836.*b, 8.836.*c defining a percutaneous transluminal angioplasty (PTA) we had detailed lists of coded stents in addition. Stent coding differentiates in bare metal stents (8.840.**, BMS), drug eluting stents (8.841.**, DES) and covered stents (8.842.**, CS) and in the number of placed stents within one specific procedure. The figures presented express
291
cases so that a single patient undergoing multiple interventions within one year can occur more than once. Calculations of sums and percentages were done using Microsoft® Excel 2003 and Microsoft® Access 2003.
3. Results In 2012 150,503 percutaneous procedures for revascularization of the aorta, other abdominal arteries, the femoro-popliteal and the cruro-pedal arteries were documented in Germany. The predominant percutaneous procedures were balloon angioplasty (PTA) with 86.0% followed by thrombolysis with 7.2% and thrombectomy with 2.9%. All other techniques including the use of LASER, cutting balloon, atherectomy devices or cryoplasty summed up to only 3.9%. Some of these procedures were done within the same treatment process within one patient to achieve an effective lumen. Thus the number of affected patients should be lower (Table 2). The femoro-popliteal arteries were the most frequently treated segment with 76,453 (50.8%) percutaneous procedures followed by the cruro-pedal arteries with 43,789 (29.1%). Balloon angioplasty was the most frequently used technique in all peripheral arterial segments, but the rate of thrombolysis and thrombectomy increased from proximal to distal. Thus, in the cruro-pedal arteries thrombolysis was documented in 10.0% of the cases and thrombectomy in 5.4%. In 50,092 (33.3%) of all percutaneous procedures performed in the lower limb arteries a stent was placed. From these 50,092 procedures DES were coded in 3063 (6.1%) and covered stents in 1841 (3.7%). The rate of procedures associated with stent placement decreased from proximal to distal. In two thirds (66.7%) of all percutaneous procedures performed in the other abdominal arteries (predominately iliac arteries) a stent was placed, but only in one third (34.3%) of procedures performed in the femoro-popliteal arteries and in one tenth (9.7%) of the cruro-pedal procedures. In the aorta the proportion of covered stents was highest (8.6% of all procedures with stent) while the highest rate of DES was found in the cruro-pedal arteries (23.1%). If a stent was placed, in 24.9% (n = 12,495) two or more stents were placed and in 4.9% (n = 2473) three or more stents respectively (Table 3). Although 62.4% of all procedures were performed in male patients we did not find any gender difference in treatment regarding the rate of thrombolysis, rate of stents and kind of stents.
Table 2 Type of procedure, absolute numbers and rates of procedures separated for the different peripheral arterial segments (all includes all procedures coded as 8-836.0, 8-836.1, 8-836.2, 8836.3, 8-836.6, 8-836.7, 8-836.8, 8-836.p, 8-836.r, 8-836.w for this segment). Type of Procedure Segment/OPS Codes Aorta 8-836.*4 8-836.04 8.836.74 8.836.84 other abdominal arteries 8-836.*9 8-836.09 8.836.79 8.836.89 Femoro-popliteal arteries 8.836.*b 8-836.0b 8.836.7b 8.836.8b Cruro-pedal arteries 8-836.*c 8-836.0c 8.836.7c 8.836.8c
Total
Males
Females
n N/%
Stents N/%
n N/%
Stents N/%
n N/%
Stents N/%
all Balloon angioplasty Thrombolysis Thrombectomy
1414 1328 (93.9) 15 (1.1) 10 (0.7)
405 (28.6)
923 874 (94.7) 7 (0.5) 7 (0.5)
206 (22.3)
491 453 (92.3) 8 (0.6) 3 (0.2)
199 (40.5)
all Balloon angioplasty Thrombolysis Thrombectomy
28,874 27,565 (95.5) 624 (2.2) 170 (0.6)
19,252 (66.7)
19,594 18,664 (95.3) 383 (2.0) 106 (0.5)
13,007 (66.4)
9373 8898 (94.9) 241 (2.6) 64 (0.7)
6234 (66.5)
all Balloon angioplasty Thrombolysis Thrombectomy
76,453 64,718 (84.7) 5740 (7.5) 1840 (2.4)
26,199 (34.3)
46,057 39,061 (84.8) 3431 (7.4) 1307 (2.8)
15,613 (33.9)
29,654 25,652 (86.5) 2309 (7.8) 859 (2.9)
9933 (33.5)
all Balloon angioplasty Thrombolysis Thrombectomy
43,789 35,780 (81.7) 4395 (10.0) 2352 (5.4)
4236 (9.7)
27,287 22,559 (82.7) 2622 (9.6) 1307 (4.8)
2659 (9.7)
16,438 13,217 (80.4) 1773 (10.8) 1045 (6.4)
1577 (9.6)
292
T. Moysidis et al. / Cardiovascular Revascularization Medicine 16 (2015) 290–293
Table 3 Type and number of stents placed in the different arterial segments (BMS bare metal stent, DES drug eluting stents, CS covered stent). Segment and number of stents
8-840 BMS
8-841 DES
8-842 CS
total
Aorta 1 2 3 4 and more Other abdominal arteries 1 2 3 4 and more Femoro-popliteal arteries 1 2 3 4 and more Cruro-pedal arteries 1 2 3 4 and more total (% from 50,092)
252 (62.2) 72 (17.8) 5 (1.2) 5 (1.2) 13,898 (72.2)
1 (0.2)
204 (1.1)
35 (8.6) 25 5 (1.2) 5 (1.2) 427 (2.2)
288 (71.1) 97 (24.0) 10 (2.5) 10 (2.5) 14,529 (75.5)
3688 (19.2) 650 (3.4) 194 (1.0) 17,274 (65.9)
35 (0,2) 4 1 1264 (4.8)
121 (0,6) 21 (0.1) 8 842 (3.2)
3844 (20.0) 675 (3.5) 203 (1.1) 19,380 (74.0)
5 015 (19.1) 1 018 (3.9) 290 1.1) 2304 (54.4) 415 (9.8) 83 (2.0) 24 (0.6) 45,187 (90.2)
223 (0.9) 46 (0.2) 14 (0.1) 978 (23.1) 226 (5.3) 49 (1.2) 18 (0.4) 3063 (6.1)
185 (0.7) 28 (0.1)
5423 (20.7) 1092 (4.2) 304 (1.2) 3399 (80.2) 658 (15.5) 137 (3.2) 42 (1.0) 50,092
117 (2.8) 17 (0.4) 5 (0.1) 1841 (3,7)
4. Discussion The presented analysis gives an overview into the real life of percutaneous peripheral endovascular procedures and the rate of stent placements in addition to percutaneous procedures in lower limb arteries in Germany in 2012. The most striking features are - that in one third of all percutaneous procedures a stent is placed, - in almost one fifth of all procedures ending up with stent placement two or more stents were placed, - 6.1% of all placed stents were DES - and thrombolysis was used in 7.2% of all peripheral endovascular procedures. Interpretation of the presented data has to consider some uncertainties. Although we focus on percutaneous procedures that are usually used for treatment of peripheral arterial stenosis and occlusion in patients suffering from PAD we did not define PAD as selection criteria. Thus some procedures could be performed primarily for percutaneous treatment of popliteal aneurysm, spontaneous dissection or acute ischemia associated with peripheral arterial thrombosis or embolism. Nevertheless these vascular alterations are less frequent than PAD; we cannot exactly address the numbers. The absolute number of stents placed in peripheral arteries could be higher as we looked for percutaneous procedures only. We did not include angioplasties and stent placement during open surgical treatment. Iliac arteries are not specifically coded. They are included in “other abdominal arteries” which also include some renal artery procedures. So we are not able to separate for this. As there are no comparable data from other countries we cannot objectify whether the reported rates of stent placements associated with lower limb PTA are high or low. On the one hand we expected higher rates of stent placement in the iliac and thigh arteries and on the other hand we were surprised to see that in 6.1% of all procedures DES were used. The ESC Guidelines on the diagnosis and treatment of PAD [8] say that “Based on an older meta-analysis, stenting can be recommended as the primary therapy for common and external iliac stenosis and occlusions.” [9–11]. And for the femoral artery the ESC guidelines state that “However, according to an increasing number of randomized studies, primary nitinol stenting can now be recommended as the firstline treatment for intermediate length superficial femoral artery lesions due to improvement of at least mid-term patency.” [6,7]. The use of DES
is recommended only for the infrapopliteal arteries according to this guideline: “Stent implantation in infrapopliteal vessels is generally reserved for cases with a suboptimal outcome after PTA. The use of drug-eluting stents is associated with a favourable restenosis rate.” [12–14]. Unfortunately we cannot provide any information regarding drug eluting balloons (DEB) as their use could not be specifically coded in 2012. According to these ESC guidelines we expected that in 2012 the majority of percutaneous procedures in the iliac and femoro-popliteal segments should have used stent placement. Thus it can be assumed that the majority of PTA procedures are primarily planned as pure PTA and stents are used as secondary procedure. Despite the above mentioned guidelines primary stenting seems to be not the first choice. The reported rates of stent placement might be influenced by multiple effects. The decision to place a stent should be based on clinical considerations and long-term patency, but reimbursement of the costs of the used stents might be a very important aspect. In 24.9% of all percutaneous procedures two and more stents were placed within the same procedure. This figure raises the question of whether rather long lesions were treated and the adequate length of stents were not available or whether short stents were used for spot stenting or different arterial segments were treated within the same procedure. In 7.1% of all procedures thrombolysis was performed. We do not know which thrombolytic drug is used or whether these procedures are performed as a short term (just one bolus) or as a long term thrombolysis up to several days, for native arteries or bypasses or in acute or chronic occlusion. As thrombolysis is recommended for acute occlusion it can be assumed that most of the procedures are performed in such a setting [15,16]. Thrombectomy is the third most frequently used technique in Germany with 2.9% of all percutaneous procedures. It included simple thrombus aspiration as well as rotational thrombectomy and atherectomy. However, percutaneous atherectomy plays a minor role. This seemed to be different in the United States. An analysis published by Goodney et al. in 2009 reported that in the Medicare population in the U.S. beginning from 2003 especially percutaneous atherectomy developed dramatically (from 3 to 118 per 100,000) [17]. As this device is expensive and the hospitals did not get an additional reimbursement in 2012 the interest in this technique in Germany was low. The nature of this analysis is a descriptive depiction of national, “real-world” use of revascularization procedures obtained from billing data. Thus we cannot give information regarding the indication for treatment, the quality of treatment or the patients’ outcome. The coding of PTA only in 86% of procedures raises the question of what happened to the remaining 14%. PTA is the basic treatment of almost all peripheral interventions, even if stents, atherectomy devices or thrombectomy devices are used. We do not know whether these figures are true and especially in the distal arteries thrombolysis und thrombectomy was used as stand-alone procedure or final PTA were just undercoded with specific procedures. Although routine data in the electronic patient record are frequently used for secondary purposes, there is currently no systematic analysis of coding quality in Germany [18]. Whether coding matches reality as a prerequisite for further use of the data in medicine and health politics has to be investigated in controlled trials. Thus, we cannot estimate the rate of wrong coding of vascular procedures. In conclusion, pure PTA is still the most frequently performed procedure in peripheral arteries and in only one third of all procedures was a stent placed in Germany in 2012.
Acknowledgement We thank Referat VIII A 1 from the Federal Statistical Office for extracting and providing the data from the DRG-Statistik.
T. Moysidis et al. / Cardiovascular Revascularization Medicine 16 (2015) 290–293
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Contents lists available at ScienceDirect
Cardiovascular Revascularization Medicine
Percutaneous endovascular treatment of peripheral arterial disease in Germany☆ Theodoros Moysidis a, Dirk Opdenplatz b, Victor Kulendik b, Ralf Ritter c, Hinrich Böhner d, Bernd Luther a, Knut Kröger a,⁎ a
Department of Vascular Medicine, HELIOS Klinikum Krefeld Deparment of Medicine Controlling, HELIOS Klinikum Krefeld Department of Vascular and Endovascular Surgery, Klinikum Bielefeld d Department of Surgery, St. Rochus-Hospital, Castrop-Rauxel, for the Gefäßgesellschaft West (GG West), Germany b c
a r t i c l e
i n f o
Article history: Received 3 December 2014 Received in revised form 4 May 2015 Accepted 8 May 2015 Keywords: Peripheral arterial disease Balloon angioplasty Stenting Thrombolysis
a b s t r a c t Purpose: The general distribution of balloon angioplasty, stenting and other endovascular interventions in treating peripheral arterial disease (PAD) is unclear. Methods and results: We used national statistics (DRG statistics) published by the Federal Statistical Office including data from almost all hospitals in Germany to calculate the rates and types of lower extremity endovascular procedures in 2012. In 2012 150,503 peripheral endovascular procedures were documented in Germany. The predominant procedures were percutaneous transluminal angioplasty (PTA) with 86.0% followed by thrombolysis with 7.2% and thrombectomy with 2.9%. In 50,092 (33.3%) of all peripheral endovascular procedures performed in the lower limb arteries a stent was placed: 66.7% in iliac, 34.3% in femoro-popliteal and 9.7% in cruro-pedal procedures. From these 50,092 procedures DES were coded in 3063 (6.1%) and covered stents in 1841 (3.7%). The highest rate of covered stents was placed in the aorta (8.6%) but the highest rate of DES was in the cruro-pedal arteries (23.1%). Conclusion: Pure PTA is still the most frequently performed procedure in peripheral arteries and in only one third of all procedures was a stent placed in Germany in 2012. © 2015 Elsevier Inc. All rights reserved.
1. Introduction Technical success of endovascular treatment of peripheral arterial disease (PAD) has increased in the last decades. With the introduction of new technology (hydrophilic guide-wires, stents, stent grafts) success rates up to 100% are reported in the literature [1–4]. Stent placement has been established in case of failure of primary angioplasty or early restenosis. But also primary stenting is accepted because of higher patency rates and lower complication rates [5–7]. Although residual stenosis, elastic recoil or dissections are accepted indications for stent placement, the decision to place a stent is the individual decision of the interventionalist based on his education and experiences. There are no guidelines that strictly recommend stent placement in specific situations. Randomized controlled studies present only selected patients and studies reporting the results of single centers do not necessarily represent the global country. Exact data about the general frequency of stent placement in peripheral arteries are missing until today. Such data are necessary to estimate
☆ No conflicts of interest. ⁎ Corresponding author at: Klinik für Gefäßmedizin, Helios Klinikum Krefeld, Lutherplatz 40, 47805 Krefeld, Germany. Tel.: +49 2151 32 1669; fax: +49 2151 32 2669. E-mail address: [email protected] (K. Kröger). http://dx.doi.org/10.1016/j.carrev.2015.05.003 1553-8389/© 2015 Elsevier Inc. All rights reserved.
relevant changes in the global treatment strategies over years or in different countries. Therefore we analyzed the numbers and types of percutaneous endovascular procedures of peripheral arteries (PA) in a nationwide survey to get an overview of treatment strategies in Germany.
2. Material and methods In Germany Diagnosis Related Groups (DRGs) were implemented for reimbursement in 2003. The national statistics (DRG statistics) published by the Federal Statistical Office includes data from all hospitals in Germany that use the DRG system which covers more than 99% of all German hospitals. These institutions are legally obliged to document extensive data on hospital treatment, including demographic data, diagnoses, co-morbidities, complications, and procedures to the "Institute for the Hospital Remuneration System" (InEK) which uses the data for a yearly adaptation of the German DRG system and transmits them to the Federal Statistical Office. For the year 2012 all procedures were coded with the International Statistical Classification of Diseases and Related Health Problems, which was adapted for Germany by the German Institute for Medical Documentation and Information (DIMDI). Codes for stent placement were introduced in 2009 for the first time.
T. Moysidis et al. / Cardiovascular Revascularization Medicine 16 (2015) 290–293 Table 1 Systematic of OPS-codes for documentation of endovascular treatment of PAD separated by the 5th and 6th figure. 8-836.** 8-836.0* 8-836.1* 8-836.2* 8-836.3* 8-836.6* 8-836.7* 8-836.p* 8-836.r* 8-836.w* 8-836.*4 8-836.*9 8-836.*b 8-836.*c 8-840.** 8-841.** 8-842.** 8-840.0* 8-840.1* 8-840.2* 8-840.3* 8-840.4* 8-840.5*
Percutaneous trans luminal angioplasty Balloon Angioplasty (Balloon) Blade-Angioplasty (scoring- or cutting-balloon) Laser Angioplasty Atherectomy Distraction of foreign body Selective Thrombolysis Rotational thrombectomy Cryoplasty Atherectomy with embolism protection device Aorta Other abdominal arteries (predominantly iliac arteries) Femoro-popliteal arteries Cruro-pedal arteries Percutaneous trans luminal placement of BMS Percutaneous trans luminal placement of DES Percutaneous trans luminal placement of covert stent 1 stent 2 stents 3 stents 4 stents 5 stents 6 or more stents
2.1. Statistics Detailed lists of all cases with a documented peripheral percutaneous procedures performed in 2012 separated by the 5th and 6th figure of the OPS-code were provided by the Federal Statistical Office (Table 1). The lists were analyzed in detail to extract data regarding the aorta (6th figure 4) and other abdominal arteries (representing the iliac arteries predominantly) (6th figure 9), femoro-popliteal (6th figure b) and cruro-pedal arteries (6th figure c). All other codes were excluded. These codes were further analyzed for the 5th figure encoding the type of procedure. For those cases that had a code 8.836.*4, 8.836.*9, 8.836.*b, 8.836.*c defining a percutaneous transluminal angioplasty (PTA) we had detailed lists of coded stents in addition. Stent coding differentiates in bare metal stents (8.840.**, BMS), drug eluting stents (8.841.**, DES) and covered stents (8.842.**, CS) and in the number of placed stents within one specific procedure. The figures presented express
291
cases so that a single patient undergoing multiple interventions within one year can occur more than once. Calculations of sums and percentages were done using Microsoft® Excel 2003 and Microsoft® Access 2003.
3. Results In 2012 150,503 percutaneous procedures for revascularization of the aorta, other abdominal arteries, the femoro-popliteal and the cruro-pedal arteries were documented in Germany. The predominant percutaneous procedures were balloon angioplasty (PTA) with 86.0% followed by thrombolysis with 7.2% and thrombectomy with 2.9%. All other techniques including the use of LASER, cutting balloon, atherectomy devices or cryoplasty summed up to only 3.9%. Some of these procedures were done within the same treatment process within one patient to achieve an effective lumen. Thus the number of affected patients should be lower (Table 2). The femoro-popliteal arteries were the most frequently treated segment with 76,453 (50.8%) percutaneous procedures followed by the cruro-pedal arteries with 43,789 (29.1%). Balloon angioplasty was the most frequently used technique in all peripheral arterial segments, but the rate of thrombolysis and thrombectomy increased from proximal to distal. Thus, in the cruro-pedal arteries thrombolysis was documented in 10.0% of the cases and thrombectomy in 5.4%. In 50,092 (33.3%) of all percutaneous procedures performed in the lower limb arteries a stent was placed. From these 50,092 procedures DES were coded in 3063 (6.1%) and covered stents in 1841 (3.7%). The rate of procedures associated with stent placement decreased from proximal to distal. In two thirds (66.7%) of all percutaneous procedures performed in the other abdominal arteries (predominately iliac arteries) a stent was placed, but only in one third (34.3%) of procedures performed in the femoro-popliteal arteries and in one tenth (9.7%) of the cruro-pedal procedures. In the aorta the proportion of covered stents was highest (8.6% of all procedures with stent) while the highest rate of DES was found in the cruro-pedal arteries (23.1%). If a stent was placed, in 24.9% (n = 12,495) two or more stents were placed and in 4.9% (n = 2473) three or more stents respectively (Table 3). Although 62.4% of all procedures were performed in male patients we did not find any gender difference in treatment regarding the rate of thrombolysis, rate of stents and kind of stents.
Table 2 Type of procedure, absolute numbers and rates of procedures separated for the different peripheral arterial segments (all includes all procedures coded as 8-836.0, 8-836.1, 8-836.2, 8836.3, 8-836.6, 8-836.7, 8-836.8, 8-836.p, 8-836.r, 8-836.w for this segment). Type of Procedure Segment/OPS Codes Aorta 8-836.*4 8-836.04 8.836.74 8.836.84 other abdominal arteries 8-836.*9 8-836.09 8.836.79 8.836.89 Femoro-popliteal arteries 8.836.*b 8-836.0b 8.836.7b 8.836.8b Cruro-pedal arteries 8-836.*c 8-836.0c 8.836.7c 8.836.8c
Total
Males
Females
n N/%
Stents N/%
n N/%
Stents N/%
n N/%
Stents N/%
all Balloon angioplasty Thrombolysis Thrombectomy
1414 1328 (93.9) 15 (1.1) 10 (0.7)
405 (28.6)
923 874 (94.7) 7 (0.5) 7 (0.5)
206 (22.3)
491 453 (92.3) 8 (0.6) 3 (0.2)
199 (40.5)
all Balloon angioplasty Thrombolysis Thrombectomy
28,874 27,565 (95.5) 624 (2.2) 170 (0.6)
19,252 (66.7)
19,594 18,664 (95.3) 383 (2.0) 106 (0.5)
13,007 (66.4)
9373 8898 (94.9) 241 (2.6) 64 (0.7)
6234 (66.5)
all Balloon angioplasty Thrombolysis Thrombectomy
76,453 64,718 (84.7) 5740 (7.5) 1840 (2.4)
26,199 (34.3)
46,057 39,061 (84.8) 3431 (7.4) 1307 (2.8)
15,613 (33.9)
29,654 25,652 (86.5) 2309 (7.8) 859 (2.9)
9933 (33.5)
all Balloon angioplasty Thrombolysis Thrombectomy
43,789 35,780 (81.7) 4395 (10.0) 2352 (5.4)
4236 (9.7)
27,287 22,559 (82.7) 2622 (9.6) 1307 (4.8)
2659 (9.7)
16,438 13,217 (80.4) 1773 (10.8) 1045 (6.4)
1577 (9.6)
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Table 3 Type and number of stents placed in the different arterial segments (BMS bare metal stent, DES drug eluting stents, CS covered stent). Segment and number of stents
8-840 BMS
8-841 DES
8-842 CS
total
Aorta 1 2 3 4 and more Other abdominal arteries 1 2 3 4 and more Femoro-popliteal arteries 1 2 3 4 and more Cruro-pedal arteries 1 2 3 4 and more total (% from 50,092)
252 (62.2) 72 (17.8) 5 (1.2) 5 (1.2) 13,898 (72.2)
1 (0.2)
204 (1.1)
35 (8.6) 25 5 (1.2) 5 (1.2) 427 (2.2)
288 (71.1) 97 (24.0) 10 (2.5) 10 (2.5) 14,529 (75.5)
3688 (19.2) 650 (3.4) 194 (1.0) 17,274 (65.9)
35 (0,2) 4 1 1264 (4.8)
121 (0,6) 21 (0.1) 8 842 (3.2)
3844 (20.0) 675 (3.5) 203 (1.1) 19,380 (74.0)
5 015 (19.1) 1 018 (3.9) 290 1.1) 2304 (54.4) 415 (9.8) 83 (2.0) 24 (0.6) 45,187 (90.2)
223 (0.9) 46 (0.2) 14 (0.1) 978 (23.1) 226 (5.3) 49 (1.2) 18 (0.4) 3063 (6.1)
185 (0.7) 28 (0.1)
5423 (20.7) 1092 (4.2) 304 (1.2) 3399 (80.2) 658 (15.5) 137 (3.2) 42 (1.0) 50,092
117 (2.8) 17 (0.4) 5 (0.1) 1841 (3,7)
4. Discussion The presented analysis gives an overview into the real life of percutaneous peripheral endovascular procedures and the rate of stent placements in addition to percutaneous procedures in lower limb arteries in Germany in 2012. The most striking features are - that in one third of all percutaneous procedures a stent is placed, - in almost one fifth of all procedures ending up with stent placement two or more stents were placed, - 6.1% of all placed stents were DES - and thrombolysis was used in 7.2% of all peripheral endovascular procedures. Interpretation of the presented data has to consider some uncertainties. Although we focus on percutaneous procedures that are usually used for treatment of peripheral arterial stenosis and occlusion in patients suffering from PAD we did not define PAD as selection criteria. Thus some procedures could be performed primarily for percutaneous treatment of popliteal aneurysm, spontaneous dissection or acute ischemia associated with peripheral arterial thrombosis or embolism. Nevertheless these vascular alterations are less frequent than PAD; we cannot exactly address the numbers. The absolute number of stents placed in peripheral arteries could be higher as we looked for percutaneous procedures only. We did not include angioplasties and stent placement during open surgical treatment. Iliac arteries are not specifically coded. They are included in “other abdominal arteries” which also include some renal artery procedures. So we are not able to separate for this. As there are no comparable data from other countries we cannot objectify whether the reported rates of stent placements associated with lower limb PTA are high or low. On the one hand we expected higher rates of stent placement in the iliac and thigh arteries and on the other hand we were surprised to see that in 6.1% of all procedures DES were used. The ESC Guidelines on the diagnosis and treatment of PAD [8] say that “Based on an older meta-analysis, stenting can be recommended as the primary therapy for common and external iliac stenosis and occlusions.” [9–11]. And for the femoral artery the ESC guidelines state that “However, according to an increasing number of randomized studies, primary nitinol stenting can now be recommended as the firstline treatment for intermediate length superficial femoral artery lesions due to improvement of at least mid-term patency.” [6,7]. The use of DES
is recommended only for the infrapopliteal arteries according to this guideline: “Stent implantation in infrapopliteal vessels is generally reserved for cases with a suboptimal outcome after PTA. The use of drug-eluting stents is associated with a favourable restenosis rate.” [12–14]. Unfortunately we cannot provide any information regarding drug eluting balloons (DEB) as their use could not be specifically coded in 2012. According to these ESC guidelines we expected that in 2012 the majority of percutaneous procedures in the iliac and femoro-popliteal segments should have used stent placement. Thus it can be assumed that the majority of PTA procedures are primarily planned as pure PTA and stents are used as secondary procedure. Despite the above mentioned guidelines primary stenting seems to be not the first choice. The reported rates of stent placement might be influenced by multiple effects. The decision to place a stent should be based on clinical considerations and long-term patency, but reimbursement of the costs of the used stents might be a very important aspect. In 24.9% of all percutaneous procedures two and more stents were placed within the same procedure. This figure raises the question of whether rather long lesions were treated and the adequate length of stents were not available or whether short stents were used for spot stenting or different arterial segments were treated within the same procedure. In 7.1% of all procedures thrombolysis was performed. We do not know which thrombolytic drug is used or whether these procedures are performed as a short term (just one bolus) or as a long term thrombolysis up to several days, for native arteries or bypasses or in acute or chronic occlusion. As thrombolysis is recommended for acute occlusion it can be assumed that most of the procedures are performed in such a setting [15,16]. Thrombectomy is the third most frequently used technique in Germany with 2.9% of all percutaneous procedures. It included simple thrombus aspiration as well as rotational thrombectomy and atherectomy. However, percutaneous atherectomy plays a minor role. This seemed to be different in the United States. An analysis published by Goodney et al. in 2009 reported that in the Medicare population in the U.S. beginning from 2003 especially percutaneous atherectomy developed dramatically (from 3 to 118 per 100,000) [17]. As this device is expensive and the hospitals did not get an additional reimbursement in 2012 the interest in this technique in Germany was low. The nature of this analysis is a descriptive depiction of national, “real-world” use of revascularization procedures obtained from billing data. Thus we cannot give information regarding the indication for treatment, the quality of treatment or the patients’ outcome. The coding of PTA only in 86% of procedures raises the question of what happened to the remaining 14%. PTA is the basic treatment of almost all peripheral interventions, even if stents, atherectomy devices or thrombectomy devices are used. We do not know whether these figures are true and especially in the distal arteries thrombolysis und thrombectomy was used as stand-alone procedure or final PTA were just undercoded with specific procedures. Although routine data in the electronic patient record are frequently used for secondary purposes, there is currently no systematic analysis of coding quality in Germany [18]. Whether coding matches reality as a prerequisite for further use of the data in medicine and health politics has to be investigated in controlled trials. Thus, we cannot estimate the rate of wrong coding of vascular procedures. In conclusion, pure PTA is still the most frequently performed procedure in peripheral arteries and in only one third of all procedures was a stent placed in Germany in 2012.
Acknowledgement We thank Referat VIII A 1 from the Federal Statistical Office for extracting and providing the data from the DRG-Statistik.
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