Puncture Versus Surgical Cutdown Complications of Transfemoral Aortic Valve Implantation (from the Spanish TAVI Registry)

doi:10.1016/j.amjcard.2016.05.054

The American Journal of Cardiology

Volume 118, Issue 4, 15 August 2016, Pages 578-584

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Vascular complications in transcatheter aortic valve implantation using transfemoral approach are related to higher mortality. Complete percutaneous approach is currently the preferred technique for vascular access. However, some centers still perform surgical cutdown. Our purpose was to determine complications related to vascular access technique in the population of the Spanish TAVI National Registry. From January 2010 to July 2015, 3,046 patients were included in this Registry. Of them, 2,465 underwent transfemoral approach and were treated with either surgical cutdown and closure (cutdown group, n = 632) or percutaneous approach (puncture group, n = 1,833). Valve Academic Research Consortium-2 definitions were used to assess vascular and bleeding complications. Propensity matching resulted in 615 matched pairs. Overall, 30-day vascular complications were significantly higher in the puncture group (109 [18%] vs 42 [6.9%]; relative risk [RR] 2.60; 95% confidence interval [CI] 1.85 to 3.64, p <0.001) due mostly by minor vascular events (89 [15%] vs 25 [4.1%], RR 3.56, 95% CI 2.32 to 5.47, p <0.001). Bleeding rates were lower in the puncture group (18 [3%] vs 40 [6.6%], RR 0.45, 95% CI 0.26 to 0.78, p = 0.003) mainly driven by major bleeding (9 [1.5%] vs 21 [3.4%], RR 0.43, 95% CI 0.20 to 0.93, p = 0.03). At a mean follow-up of 323 days, complication rates remained significantly different between groups (minor vascular complications 90 [15%] vs 31 [5.1%], hazard ratio 2.99, 95% CI 1.99 to 4.50, p <0.001 and major bleeding 10 [1.6%] vs 21 [3.4%], hazard ratio 0.47, 95% CI 0.22 to 1.0, p = 0.04, puncture versus cutdown group, respectively). In conclusion, percutaneous approach yielded higher rates of minor vascular complications but lower rates of major bleeding compared with the surgical cutdown, both at 30-day and at mid-term follow-up in our population.

Section snippets

Methods

The Spanish TAVI National Registry was initiated in 2010¹⁴ and includes all patients treated by TAVI in a total of 41 Spanish centers. For the purpose of this study, we analyzed patient data from all TAVI procedures using a transfemoral approach (TF-TAVI) that were included in the Registry from January 2010 to July 2015. Procedures using a transapical or other accesses were excluded from the analysis.

The Spanish TAVI National Registry is a joint collaboration between the Working Group on

Results

From January 2010 to July 2015, 3,046 patients were included in the Registry. Of them, 2,465 patients underwent TF-TAVR and were finally included in this analysis. Complete percutaneous approach (puncture group) was performed in 1,833 (74.3%) of them and surgical cutdown and closure (cutdown group) in the remaining 632 (25.6%). The flow chart of the study is depicted in Figure 1. Baseline characteristics are reported in Table 1. There were no differences in terms of gender, body mass index, and

Discussion

Major findings of the study are summarized as follows: complete percutaneous approach in patients with TF-TAVI was associated with higher incidence of minor vascular complications but lower incidence of major bleeding rates than in the surgical cutdown population, both at 30 days and at mid-term follow-up. Most of the complications were access site related.

To date, this is the largest study comparing transfemoral vascular access methods in TAVI, including both balloon-expandable and

Acknowledgment

The authors would like to thank Dr. María José Pérez-Vizcayno, MD for her assistance in the statistical analysis and Elaine Lilly for her assistance in writing the manuscript. The authors are very grateful to all physicians, nurses, and study coordinators from the participant centers involved in the Spanish TAVI National Registry.

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Cited by (23)

Selection of Vascular Closure Devices in Transcatheter Aortic Valve Replacement: Systematic Review and Network Meta-Analysis
2023, Cardiovascular Revascularization Medicine
Citation Excerpt :
Since the establishment of its safety and effectiveness, transcatheter aortic valve replacement (TAVR) has been shifting toward a streamlined and even less invasive treatment modality. With the introduction of vascular closure devices (VCD) for closure of large-bore arteriotomy, TAVR is now available as a completely percutaneous procedure, making it the least invasive option [1,2]. However, even after the advent of VCD, vascular complication (VC) occur in up to 20 % of patients undergoing TAVR [3], and additional procedures and interventions for VC compromise the minimally invasive nature of TAVR.
Various vascular closure devices (VCDs) are commonly used for percutaneous transcatheter aortic valve replacement (TAVR). However, superiority and safety profile among them remain unclear. We compared periprocedural complications among various VCDs in patients undergoing TAVR. PubMed and EMBASE were searched through January 2022 to identify clinical studies comparing any 2 VCDs of Prostar, Proglide and MANTA in patients who underwent TAVR. Studies using surgical cut-down or alternative access other than transfemoral approach were excluded. We analyzed the odds ratios (ORs) of vascular complications (VC), bleeding, acute kidney injury and all-cause mortality using a network meta-analysis. All outcomes were defined by Valve Academic Research Consortium 2 criteria. Two randomized controlled trials and 15 observational studies were identified, yielding a total of 11,344 patients including Prostar (n = 4499), Proglide (n = 5705), or MANTA group (n = 1140). The rates of major VC and life-threatening and major bleeding were significantly lower in Proglide compared to Prostar (OR [95 % CI] = 0.54 [0.32–0.89], 0.68 [0.52–0.90], and 0.49 [0.26–0.95], respectively). There was no significant difference in major VC and bleeding between Proglide and MANTA groups. Proglide was associated with a lower rate of acute kidney injury (0.56 [0.34–0.92]) and red blood cell transfusion (0.39 [0.16–0.98]) compared to Prostar. There was no significant difference in additional interventions and 30-day overall mortality among three groups. In this network meta-analysis of VCD in patients undergoing TAVR, MANTA and Proglide had comparable outcomes while Proglide appears superior to Prostar in terms of major VC and bleeding.
Incidence, predictors, impact, and treatment of vascular complications after transcatheter aortic valve implantation in a modern prospective cohort under real conditions
2020, Journal of Vascular Surgery
Vascular complications (VCs) occurring in transcatheter aortic valve implantation (TAVI) procedures have frequently been reported in the past. Considering significant technical improvements in delivery systems and vascular closure devices, the goal of this study was to determine the incidence, impact, and prognostic factors of VCs in a recent real-world cohort.
We report a bicentric prospective analysis of 479 consecutive patients who underwent TAVI between January 2017 and December 2017. VCs were defined according to criteria set out by the Valve Academic Research Consortium (VARC)-2.
The incidence of VCs was 26.1% (n = 125 patients), of which 2.9% were major (n = 14) and 23.2% were minor (n = 111). VCs were related to the primary puncture point in 69% of cases compared with 31% at the secondary puncture site. Treatments implemented were medical in 76% of cases and surgical in 24% of cases. The risk factors for VCs were as follows: iliac morphology score, sheath to iliofemoral artery ratio (SIFAR), and moderate-severe iliofemoral calcifications or tortuosity. In the case of major VCs, only sheath to iliofemoral artery ratio was a risk factor. Major VCs significantly increased intrahospital mortality (30.7% vs 1.1% for minor VCs and 1.3% for no VCs; log-rank, P < .0001) and 1-year mortality (40.6% vs 5.6% for minor VCs and 5.6% for no VCs; log-rank, P < .0001).
Using strictly VARC-2 end point definitions, more than one-quarter of TAVI procedures were associated with VCs, primarily minor ones. Secondary puncture points were responsible for one-third of VCs and should therefore also be actively monitored. Major VCs have a significant impact on short-term and midterm survival.
Trends in vascular complications and associated treatment strategies following transfemoral transcatheter aortic valve replacement
2020, Journal of Vascular Surgery
Citation Excerpt :
Percutaneous and open surgical femoral exposure have been shown to be safe and effective in TAVR. Although access type was not correlated with VCs in our analysis, other reports have cited higher rates of perioperative VCs, most often in the form of isolated iliofemoral arterial stenosis or dissection, with percutaneous access.37,38 Wound infections requiring prolonged antimicrobial therapy and/or additional surgery have been reported to be higher in the surgical cutdown group, along with increased risk of bleeding complications and longer lengths of stay.25,37
Vascular complications (VC) and bleeding complications impact morbidity and mortality after transfemoral transcatheter aortic valve replacement (TF-TAVR). Few contemporary studies have detailed these complications, associated treatment strategies, or clinical outcomes. We examined the incidence, predictors, treatment strategies, and outcomes of VCs in a multicenter cohort of patients undergoing TF-TAVR.
We performed a retrospective registry and chart review of all nonclinical trial TF-TAVR patients from seven centers within a five-state hospital system from 2012 to 2016. Bleeding and VC were recorded as defined by the Valve Academic Research Consortium recommendations. Procedural and 30-day outcomes and 1-year mortality were compared between patients with no, minor, or major VC. Multivariable logistic and Cox regressions were used to identify predictors of major VC and mortality, respectively.
Over the study period, 1573 patients underwent TF-TAVR, with 96 (6.1%) experiencing a major VC and 77 (4.9%) experiencing a minor VC. The majority of VCs were access site related (74.2%), occurred intraoperatively (52.6%), and required interventional treatment (73.2%). The site, timing, and treatment method of VCs did not significantly change over the study period. Patients with VCs had a greater need for blood transfusion, longer postoperative length of stay, higher rates of cardiac events, increased vascular-related 30-day readmission, and higher 30-day mortality. Female sex (odds ratio [OR], 3.00; 95% CI, 1.91-4.72) and prior percutaneous coronary intervention (OR, 2.14 ; 95% CI, 1.38-3.31) were the strongest predictors of major VC. VCs modestly decreased over the study period: every 90-day increase in surgery date decreased the odds of major VC by 6% (95% CI, 1%-10%). Patients with major VCs had worse 1-year survival (OR, 79%; 95% CI, 69%-86%) compared with patients with minor VCs (OR, 92%; 95% CI, 82%-96%) or no VCs (OR, 88%; 95% CI, 87%-90%; P = .002). However, for patients who survived more than 30 days, the 1-year survival did not differ between groups For patients who survived more than 30 days, male sex (hazard ratio, 1.84; 95% CI, 1.30-2.60) and the logit of STS mortality risk score (hazard ratio, 1.98; 95% CI, 1.48-2.65) were the strongest predictors of mortality. After adjusting for other factors, minor and major VC were not predictors of 1-year mortality for patients who survived more than 30 days.
In our contemporary cohort, VCs after TF-TAVR have modestly decreased in recent years, but continue to impact perioperative outcomes. Patient selection, consideration of alternative access routes, and prompt recognition and treatment of VCs are critical elements in optimizing early clinical outcomes after TF-TAVR.
Incidence, Prognosis and Predictors of Major Vascular Complications and Percutaneous Closure Device Failure Following Contemporary Percutaneous Transfemoral Transcatheter Aortic Valve Replacement
2020, Cardiovascular Revascularization Medicine
Citation Excerpt :
Consistent with this trend, in the PARTNER continued access registry, surgical cut-down use decreased from two-thirds of cases enrolled early to only one third of cases enrolled later in the study [11]. Although small observational studies suggest that percutaneous TF-TAVR may be associated with more residual stenosis and dissections than TF-TAVRs performed with surgical cut-down technique, the less invasive nature of the former facilitates conscious sedation and has been associated with less bleeding, lower rates of infection, earlier recovery, lower procedural costs and shorter hospital lengths of stay (LOS) [10,12,13]. Despite this, vascular complications (VCs) and percutaneous vascular closure device failure (PCDF) continue to limit the overall safety of percutanous TF-TAVR.
To determine the incidence, prognosis, and predictors of major Valve Academic Research Consortium (VARC-2) vascular complications (VCs) and percutaneous vascular closure device failure (PCDF) following contemporary percutaneous transfemoral transcatheter aortic valve replacement (TF-TAVR).
Limited data exists on the incidence and predictors of VCs and PCDFs following percutaneous TF-TAVR using contemporary 14–16 French (F) sheaths.
We recorded clinical and procedural characteristics, computer tomography (CT) angiographic data, 30-day VCs, mortality, and length of stay (LOS) in all consecutive percutaneous TF-TAVRs at a single center from June 2016 to October 2018. CT measures included common femoral artery (CFA) and external iliac artery (EIA) diameters, sheath to CFA and EIA ratios (SFAR and SEIAR), depth of CFA, extent and location of CFA calcification and pelvic vessel tortuosity (2 bends ≥90°). Multivariable regression was used to predict major VCs and percutaneous closure device failure (PCDF), respectively.
The final sample consisted of 303 percutaneous TF-TAVRs. Median age was 80 years, 51% were male, 86% Caucasian, 33% had diabetes mellitus (DM) and mean STS score was 5.8 ± 3.8%. Baseline characteristics were similar in patients with vs. without VCs, other than coronary artery disease (CAD) (69% vs. 54%, respectively; p = 0.029) and DM (21% vs. 36%, respectively; p = 0.02). There were 65 (21%) vascular complications: 19 major VCs [6.3%], 29 minor [VCs 9.6%] and 17 PCDFs [5.6%]. Overall, 30-day mortality was low (2.6%). Major VCs were associated with higher mortality (42% vs. 0%, p < 0.0001) while minor VCs (3% vs. 0%, mortality p = 0.99) and PCDFs (3% vs. 0% mortality, p = 0.99) were not. PCDFs were associated with a longer median LOS (4 vs. 3 days, p = 0.02). The independent predictors of major VCs were pelvic vessel tortuosity (OR 3.1; 95% CI 1.1–9.2) and presence of CAD (OR 8.2; 95% CI 1.8–37). Female gender showed a strong trend toward increased risk (OR 3.4; CI 0.84–14; p = 0.086). There were no independent predictors of PCDF.
Contemporary percutaneous TF-TAVR is associated with a low risk of mortality, major VCs and PCDFs. Major VCs confer increased mortality and PCDFs prolong LOS. Pelvic vessel tortuosity and a history of CAD predict major VCs; there were no predictors of PCDFs. These results provide a contemporary update on the incidence and implications of these important vascular complications in the current era of percutaneous TF-TAVR using 14-16F vascular sheaths.
Meta-Analysis Comparing Percutaneous to Surgical Access in Trans-Femoral Transcatheter Aortic Valve Implantation
2020, American Journal of Cardiology
Citation Excerpt :
Our search yielded 9,849 citations. A total of 13 studies (1 RCT7 and 12 observational cohort studies8-19) involving 5,859 patients (PC = 3447, SC = 2,412) were finally included in the analysis. The majority of the studies utilized VARC-2 definition for the outcomes.
To compare the outcomes in trans-femoral transcatheter aortic valve implantation (TF-TAVI) performed with percutaneous approach (PC) versus surgical cut-down (SC). In 13 trials including 5,859 patients (PC = 3447, SC = 2412), the outcomes based on Valve Academic Research Consortium criteria were compared between PC and SC in TF-TAVI. Compared with SC, PC was associated with similar major vascular complications (VCs) (8.7% vs 8.5%; odds ratio [OR] = 0.93, 95% confidence interval [CI] = 0.76 to 1.15, p = 0.53), major bleeding (OR = 1.09, 95% CI = 0.66 to 1.8, p = 0.73), perioperative mortality (5.7% vs 5.2%; OR = 1.13, 95% CI = 0.85 to 1.49, p = 0.4), urgent surgical repair (OR = 1.27, 95% CI = 0.81 to 2.02, p = 0.3), stroke (3.3% vs 3.9%; OR = 0.85, 95% CI = 0.53 to 1.36, p = 0.5), myocardial infarction (1.3% vs 1.1%; OR = 1.06, 95% CI = 0.53 to 2.12, p = 0.86), and renal failure (5.2% vs 5.9%; OR = 0.68, 95% CI = 0.38 to 1.22, p = 0.2), but shorter hospital stay (9.1 ± 8.5 vs 9.6 ± 9.5 days; mean difference = -1.07 day, 95% CI = -2.0 to -0.15, p = 0.02) and less blood transfusion (18.5% vs 25.7%; OR = 0.61, 95% CI = 0.43-0.86, p = 0.005). Minor VCs occurred more frequently in PC compared to SC (11.9% vs 6.9%; OR = 1.67, 95% CI = 1.04-2.67, p = 0.03). In conclusion, in TF-TAVI, PC is a safe and feasible alternative to SC, and adopting either approach depends on operator experience after ensuring that vascular access could be safely achieved with that specific technique.
2019 Canadian Cardiovascular Society Position Statement for Transcatheter Aortic Valve Implantation
2019, Canadian Journal of Cardiology
Citation Excerpt :
There has been a shift from the practice of general anaesthesia and transesophageal echocardiography during TAVI to a more “minimalist” approach using conscious sedation and local anaesthesia with transthoracic echocardiography guidance, as required. A transition from vascular cutdown to a fully percutaneous approach using closure devices to obtain hemostasis has facilitated this approach and has been shown to be associated with less bleeding and major vascular complications.63-67 In appropriately selected patients, minimalist TAVI has been associated with improved early outcomes, reduced intensive care unit and hospital length of stay, and reduced cost.68-70
Transcatheter aortic valve implantation (TAVI) or replacement has rapidly changed the treatment of patients with severe symptomatic aortic stenosis. It is now the standard of care for patients believed to be inoperable or at high surgical risk, and a reasonable alternative to surgical aortic valve replacement for those at intermediate surgical risk. Recent clinical trial data have shown the benefits of this technology in patients at low surgical risk as well. This update of the 2012 Canadian Cardiovascular Society TAVI position statement incorporates clinical evidence to provide a practical framework for patient selection that does not rely on surgical risk scores but rather on individual patient evaluation of risk and benefit from either TAVI or surgical aortic valve replacement. In addition, this statement features new wait time categories and treatment time goals for patients accepted for TAVI. Institutional requirements and recommendations for operator training and maintenance of competency have also been revised to reflect current standards. Procedural considerations such as decision-making for concomitant coronary intervention, antiplatelet therapy after intervention, and follow-up guidelines are also discussed. Finally, we suggest that all patients with aortic stenosis might benefit from evaluation by the heart team to determine the optimal individualized treatment decision.
L’implantation valvulaire aortique par cathéter (TAVI) a rapidement modifié le traitement des patients atteints de sténose aortique symptomatique grave. Elle constitue maintenant la norme de soins chez les patients jugés inopérables ou présentant un risque chirurgical élevé, de même qu’une solution de rechange raisonnable à la chirurgie de remplacement valvulaire aortique en présence d’un risque chirurgical intermédiaire. Les données d’essais cliniques récents ont aussi montré les avantages de cette technologie dans un contexte de faible risque chirurgical. Cette mise à jour de l’énoncé de position sur le TAVI publié en 2012 par la Société canadienne de cardiologie (SCC) intègre des données cliniques probantes constituant un cadre de référence pratique pour la sélection des patients, fondé non pas sur le score de risque chirurgical, mais plutôt sur l’évaluation individualisée des risques et des avantages respectifs de l’intervention TAVI et de la chirurgie de remplacement valvulaire aortique chirurgicale. En outre, cet énoncé de position intègre de nouvelles catégories de temps d’attente et de nouveaux objectifs en matière de calendrier de traitement pour les patients sélectionnés en vue d’une intervention TAVI. Les exigences des établissements et les recommandations en matière de formation et de maintien des compétences des chirurgiens ont également été révisées de manière à refléter les normes courantes. Diverses considérations liées à l’intervention sont également examinées, notamment la prise de décisions touchant une intervention coronarienne concomitante, la mise en route d’un traitement antiplaquettaire après l’intervention et les lignes directrices en matière de suivi. Enfin, nous abordons le concept d’une évaluation effectuée par l’équipe de cardiologie qui permettrait d’optimiser les décisions thérapeutiques sur une base individuelle et qui pourrait s’avérer avantageuse dans tous les cas de sténose aortique.

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Valvular Heart DiseasePuncture Versus Surgical Cutdown Complications of Transfemoral Aortic Valve Implantation (from the Spanish TAVI Registry)

Section snippets

Methods

Results

Discussion

Acknowledgment

J Am Coll Cardiol

Am J Cardiol

JACC Cardiovasc Interv

J Vasc Surg

Rev Esp Cardiol (Engl Ed)

Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery

N Engl J Med

Transcatheter versus surgical aortic-valve replacement in high-risk patients

N Engl J Med

Transcatheter aortic-valve replacement with a self-expanding prosthesis

N Engl J Med

Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial

JAMA

Valvular Heart Disease
Puncture Versus Surgical Cutdown Complications of Transfemoral Aortic Valve Implantation (from the Spanish TAVI Registry)