Kärlaccess vid koronarangiografi: Femoralis eller radialis?

Kärlaccess – Angio och PCI via arteria radialas eller femoralis

Läs om kärlocklusionssystem på följande sidor: TR-band, femostop.

Historiskt sett (se avsnitt om historisk utveckling nedan) har arteria femoralis i många år varit standardaccess för PCI, men idag används arteria radialis i Sverige i 85 % av fallen för PCI och koronarangiografi (se SWEDEHEART registret). Oftast används höger radialisartär, för att PCI-operatören står på patientens högra sida, man kommer då lättare åt högerarmen. Vänstra radialis används huvudsakligen för CABG-opererade patienter som har fått ett LIMA-graft (enkelt att komma åt via vänster radialas, LIMA avgår från vänstra a subclavia) eller om höger radialas är ockluderad, till exempel efter tidigare punktion. Arteria femoralis används idag för mer komplexa ingrepp som kräver större katetrar (CTO, vissa bifurkartioner, klaffingrepp), patienter i chock när radialispuls saknas, en del av “gammal vana” eller för CABG-opererade patienter när operatören inte vill använda vänstra radialis. Kort sammanfattat är femoralis-stick enklare, ger ofta bättre stöd men har större risker.

Videos

Radialispunktion

Femoralispunktion

Angioseal

Angio-Seal är ett system som implanterar ett ankare på kärlets insida och fäster den via en suturtråd på en kollagenplugg som ligger på kärlets utsida, en s.k. „sandwich system“. Systemet resorberas inom 90 dagar. Finns i 6F och 8F.

Sammanfattning för- och nackdelar

ARTERIA RADIALIS:

  • fördelar:
    • Ingen relevant blödningsrisk
    • Patienten kan mobiliseras direkt efter ingreppet
    • Patienten slipper bli steriltvättad i ljumsken med flera personer i rummet
  • nackdelar:
    • Begränsning till mindre kateterdiameter (7F hos män, ofta mindre hos kvinnor)
    • Vänster radialis: Kräver ibland en för operatören ansträngande kroppshållning (ryggvärk!)
    • Små diametrar hos mindre kvinnor
    • Risk för smärtsam kärlspasm (bästa profylax är god sedering)
    • Olämplig för patienter som är motoriskt oroliga (svårt att kontrollera armen om patienten vill lyfta den)

ARTERIA FEMORALIS:

  • fördelar:
    • Större kateterdiameter passar
    • Enklare åtkomst vid chock
    • Ger ofta bättre kateterstöd än radialis
    • Enklare att hitta alla grafter hos CABG opererade
  • nackdelar:
    • Betydligt större blödningsrisk
    • Kräver (enligt vår uppfattning) kärl-ultraljud (för att minska blödningsrisken)
    • Patienten behöver ligga plant i ett par timmar efter ingreppet
    • Högre kostnad pga ocklusion device som används för att försluta efteråt

Risker/Komplikationer: se “Risker och komplikationer vid koronarangiografi/PCI

Historisk utveckling av kärlpunktion för angio och PCI:

(originalpublikationen- en disputation från 2019 – är på engelska):

While the history of cardiac catheterization began with access in the arm, the annals of PCI start with access in the groin: In the first catheterization of the human heart in a living person, Forssman conducted a self-experiment in 19291 in the form of an antecubital venesection for vascular access. The first selective human coronary catheterization, unintentionally performed by Mason Sones on a patient slated for aortography in 1958,2 was likewise achieved via the arteria brachialis. Later, after the Seldinger technique was developed in Sweden in the 1950s3 and became more widely known in the 1960s, Judkins introduced2 Seldinger access via the arteria femoralis, thus averting the need for surgical cutdown for vascular access. Femoral access (FA) later became the default method for coronary angiography and intervention. So, since the introduction of PCI in 1977, the traditional approach has been the femoral artery45

In 1989, Campeau reported conducting 100 coronary angiographies using the distal radial artery with 5F catheters. In 1992, Ferdinand Kiemeneij, who experienced severe problems with femoral bleeding in heavily anticoagulated patients scheduled for stenting with a Palmaz-Schatz stent, saw the possibility to reduce bleeding and experimented with and then published on PCI that utilized the radial access (RA) technique.6 It then took time for transradial PCI to become more widely used in the 21stcentury. 

Since FA was associated with vascular access site complications causing bleeding, ischemia, anddeath,78910 the initial intention of the investigation into the feasibility of RA in clinical practicewas to reduce access-site-related bleeding. This hope for a reduction in access-site complications and a resulting reduction in bleeding is still the main intention of interventional cardiologists who use the more technically demanding RA.

The patient or medical personnel usually notice subcutaneous bleeding from the radial artery after only a few milliliters and treatment by local compression is mostly easy. In-hospital subcutaneous bleeding from the radial artery can, in sporadic cases, lead to compartment syndrome,11 but is highly improbable to cause hemorrhagic shock. In contrast, in-hospital bleeding from a FA site can be difficult to detect, difficult to treat, and can present with hemorrhagic shock as a first symptom. 

Other advantages of RA include direct ambulation12 (bed rest is mandatory after femoral puncture),13 resulting in earlier or same-day discharge in stable patients same-day 141, 142 141516 and higher patient satisfaction: Fifty percent of RIVAL patients randomized to FA and 90% of those in the RA group would choose RA for their next procedure.17

disadvantage of the radial puncture, compared to FA, is the limit in the catheter lumen-diameter (specific interventions have to be carried out with FA for this reason) and the higher technical difficulty of vessel puncture and catheter advancement (due to the minor vessel size and arterial spasm)1819 that are evident mainly at the beginning of an operator’s learning curve,20 but also for experienced operators in cases of anatomical variations (high radial bifurcation, tortuosity, loops).14 The main risk of RA is, mostly asymptomatically, radial artery occlusion,1421 with critical distal ischemia being extremely rare, and minor bleeding, which in rare cases can cause compartment syndrome. Pseudoaneurysmata and fistulae in the radial artery are rare complications: In RIVAL,17 0.2% of patients randomized to RA had an arterial pseudoaneurysm needing closure, compared to 0.4% in the femoral group. To my knowledge, there is no published case of a lethal local complication after RA. It then took more than two decades to gather scientific evidence to prove the initial clinical hypothesis, namely that RA reduces bleeding. 

In the first decade of the 21st century, two meta-analyses of several smaller RCTs, published before the larger RCT cited below, showed a reduction in the clinical, significant access-site bleeding by RA.2223 Access-site bleeding, mainly stemming from FA, accounted for 30 to 50% of all bleeding complications in a large study from 2011 (only 8% RA in these patients),24 i.e., the improvement of arterial access can influence a large fraction of bleeding complications. One crucial component of this development was the refinement of operator skills, equipment, closure devices, and anticoagulation strategies in performing FA PCI over time. 

In an analysis of 17,900 patients treated with trans-femoral PCI between 1994 and 2005 at the Mayo Clinic,7 major bleeding decreased over time from 8.4 to 3.5% from first to last tertial and retroperitoneal bleeding decreased from 0.8 to 0.3%. The HR for 30-day mortality, adjusted for baseline and procedural characteristics, was 12.8 for major femoral hematoma and 43.8 for retroperitoneal bleeding.  

However, the hypothesis that RA could even further reduce bleeding lived on and since 2011, the interventional community has performed several large RCTs to examine this hypothesis. The first large RCT testing the benefit of RA over FA was the RIVAL study, 17 which included 7,021 patients with ACS, non-STE-ACS and STEMI, who were analysed in 2011 by intention-to-treat and showed no  difference in the composite primary endpoint (death, stroke, MI, non-CABG bleeding at 30 days) or in the secondary endpoint death at 30 days.

But a pre-specified subgroup analysis showed a significant reduction in the primary endpoint in the 1,958 patients STEMI patients included in RIVAL, as well as in the subgroup of centers in the highest tertial of radial volume (mean >146 radial PCI per operator per year). So, one conclusion derived from RIVAL was that a higher RA rate decreases radial complications, but caution is needed in that a very high operator RA rate might lead to more complications in the cases mandating FA, as the operator might lose FA expertise.25

Concerning bleeding, RIVAL found no significant difference in non-CABG-related major bleeding (access-site-related and non-access-site-related) or in access-site-related major bleeding (0.2% in RA group, 0.3% in FA group, n.s.). Interestingly, in a post-hoc analysis that took the actual bleeding site into account, there were no major access-site bleeds from RA at all compared to 18 major bleeds at the FA point (because of cross-over, subsequent procedures after the index procedure, or femoral IABP insertion.)26

In 2012, the next radial study focused on STEMI patients. The  multicenter RIFLESTEACS 27 study randomized 1,001 patients with STEMI to RA versus FA in four high-volume centers and found a significant reduction in the primary composite endpoint (cardiac death, stroke, MI, TLR, and bleeding) as well as a statistically significant decrease from 9.2 to 5.2%  in the 30-day cardiac mortality rate (in the secondary endpoint).

In 2015, the largest vascular access study, the MATRIX studyRadial versus femoral access in patients with acute coronary syndromes undergoing invasive management trial,28 was published: Seventy-eight European centers had randomized 8,404 patients with acute coronary syndromes, non-STE-ACS, and STEMI to RA or FA. The first of the two co-primary endpoints, MACE (death, MI, stroke), was negative (p = 0.03 at a co-primary alpha 0,025), while the second, NACE (net adverse clinical events, defined as MACE plus non-CABG BARC123 major bleeding), was statistically significant (p 0.0092) and clinically significant (RR 0.83, 95% CI 0.73–0.96), driven by a reduction in bleeding and all-cause mortality, with the latter being statistically significant as a predefined secondary endpoint (all-cause mortality 1.6% vs2.2%, RR 0.72, 95% CI 0.53–0.99; p = 0.045). The secondary endpoints were all components of the co-primary endpoints, plus cardiovascular mortality and ST, and significance was defined with a two-sided alpha of 5%, i.e., there was no adjustment for multiple comparisons. 

In 2016, a meta-analysis including 24 RCTs with more than 22,000 patients concluded that RA, compared to FA, reduced all-cause mortality with an OR of 0.71 (95% CI 0.59, 0.87) and a number needed to treat to benefit (NNTB) of 160, MACE with an OR of 0.84 (CI 0.75, 0.94) and a NNTB of 99, major bleeding by a NNTB of 103, and major vascular complications by more than four-fold, with an OR of 0.25 (CI 0.16–0.35) and a NNTB of 117. 29

Accordingly, a Cochrane review concluded in 2018 that a “transradial approach for diagnostic CA or PCI (or both) in CAD might reduce short-term NACE, cardiac death, all-cause mortality, bleeding, and access-site complications.”30

In summary, these trials provided evidence that when utilized by experienced operators, RA for coronary angiography reduced clinical endpoints as well as all-cause mortality.27 3117 In many countries, as in Sweden, radial puncture has, in recent years, evolved as the primary access strategy for coronary angiography and PCI, but large variations between operators, hospitals, and countries still exist.143233 Based on this evidence, the current 2018 ESC guideline on the management of patients with STEMI includes a strong recommendation for RA.34

However, despite all the evidence in favor of RA, there is an ongoing controversy.35 The external validity of the strong evidence for the impact of RA on mortality from the MATRIX study has been questioned 36 and femoral puncture is still the default strategy for the majority of U.S. operators,37 while there is no recommendation for RA in the U.S. STEMI guideline.38

Litteratur

Contemporary Arterial Access in the Cardiac Catheterization Laboratory (Jacc Cardiovasc Interv 2017)39

Relaterade sidor

Last Updated on July 4, 2024 by Christian Dworeck

Christian Dworeck
Latest posts by Christian Dworeck (see all)
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  39. Sandoval Y, Burke MN, Lobo AS, Lips DL, Seto AH, Chavez I, Sorajja P, Abu-Fadel MS, Wang Y, Poulouse A, Gössl M, Mooney M, Traverse J, Tierney D, Brilakis ES. Contemporary Arterial Access in the Cardiac Catheterization Laboratory. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2233-2241. doi: 10.1016/j.jcin.2017.08.058. PMID: 29169493. []