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Research Article| Volume 377, P26-32, April 15, 2023

Reducing cardiac tamponade caused by temporary pacemaker perforation in transcatheter aortic valve replacement

Open AccessPublished:January 11, 2023DOI:https://doi.org/10.1016/j.ijcard.2023.01.015

      Highlights

      • A subset of TAVR patients need stable, peri-operative temporary right ventricular pacing.
      • Standard temporary pacing wires may perforate and cause tamponade.
      • Incident tamponade was 2.1% with standard temporary RV pacing.
      • Temporary pacing with permanent, passive pacemaker leads significantly reduced tamponade risk.

      Abstract

      Background

      Cardiac tamponade caused by temporary right ventricular (RV) pacemaker perforation is a rare but serious complication in transcatheter aortic valve replacement (TAVR).

      Aims

      To study the incidence of temporary pacemaker related cardiac tamponade in TAVR, and the relation to the type of pacemaker lead used in periprocedural temporary transvenous pacing.

      Methods

      A single center registry of transfemoral TAVRs in 2014–2020. Main inclusion criterion was peri-operative use of a temporary RV pacing lead. Main exclusion criteria were a preoperatively implanted permanent pacemaker or the exclusive use of left ventricular guidewire pacing. Incident cardiac tamponade was classified as pacemaker lead related, or other. Patients were grouped according to type of temporary RV pacing wire.

      Results

      810 patients were included (age 80.5 ± 7.3 [mean ± standard deviation], female 319, 39.4%). Of these, 566 (69.9%) received a standard RV temporary pacing wire (RV-TPW), and 244 (30.1%) received temporary RV pacing through a permanent, passive pacemaker lead (RV-TPPL). In total, 18 (2.2%) events of cardiac tamponade occurred, 12 (67%) were pacemaker lead related. All pacemaker lead-related cardiac tamponades occurred in the group who received a standard RV-TPW and none in the group who received RV-TPPL (n = 12 [2.1%] vs. n = 0 [0%], p = 0.022). No difference in cardiac tamponade due to other causes was seen between the groups (p = 0.82).

      Conclusions

      The use of soft-tip RV-TPPL was associated with a lower risk of pacemaker related cardiac tamponade in TAVR. When perioperative pacing is indicated, temporary RV-TPPL may contribute to a significant reduction of cardiac tamponade in TAVR.

      Keywords

      Abbreviations:

      TAVR (Transcatheter Aortic Valve Replacement), RV (Right Ventricle), TPW (Temporary Pacing Wire), TPPL (Temporary Pacing with Permanent passive Lead), LV-GW (Left Ventricular Guide Wire)

      1. Introduction

      Increasing life expectancy and improved procedural results in transcatheter aortic valve replacement (TAVR) have led to the steady rise in the numbers of TAVR [
      • Goldsweig A.M.
      • Tak H.J.
      • Chen L.W.
      • et al.
      The evolving management of aortic valve disease: 5-year trends in SAVR, TAVR, and medical therapy.
      ]. Particularly, the results of recent trials with low- and intermediate risk surgical candidates [
      • Leon M.B.
      • Smith C.R.
      • Mack M.J.
      • et al.
      Transcatheter or surgical aortic-valve replacement in intermediate-risk patients.
      ,
      • Mack M.J.
      • Leon M.B.
      • Thourani V.H.
      • et al.
      Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients.
      ,
      • Popma J.J.
      • Deeb G.M.
      • Yakubov S.J.
      • et al.
      Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients.
      ] have made TAVR a viable treatment option for most patients with severe aortic stenosis. This expansion has also seen a reduction in significant paravalvular aortic, vascular access site bleedings, and TAVR related permanent pacemaker implantations [
      • Mauri V.
      • Abdel-Wahab M.
      • Bleiziffer S.
      • et al.
      Temporal trends of TAVI treatment characteristics in high volume centers in Germany 2013-2020.
      ,
      • Abugroun A.
      • Daoud H.
      • Abdel-Rahman M.E.
      • et al.
      National trends of outcomes in Transcatheter aortic valve replacement (TAVR) through transapical versus endovascular approach: from the National Inpatient Sample (NIS).
      ,
      • Rück A.
      • Saleh N.
      • Glaser N.
      Outcomes following permanent pacemaker implantation after transcatheter aortic valve replacement: SWEDEHEART observational study.
      ]. Thus, as TAVR is increasingly being offered for younger and healthier patient populations, the focus of clinical improvements is naturally shifting towards improved prosthesis hemodynamics and durability, coronary re-access, as well as the mitigation of rare but clinically significant complications.
      One such complication is TAVR related cardiac tamponade/pericardial effusion, which affects approximately 0.5–4% of patients who undergo TAVR [
      • Rezq A.
      • Basavarajaiah S.
      • Latib A.
      • et al.
      Incidence, management, and outcomes of cardiac tamponade during transcatheter aortic valve implantation: a single-center study.
      ,
      • Ahuja K.R.
      • Gad M.M.
      • Bazarbashi N.
      • et al.
      Impact of hospital transcatheter aortic valve replacement volume on incidence and outcomes of cardiac tamponade.
      ,
      • Kotronias R.A.
      • Scarsini R.
      • De Maria G.L.
      • et al.
      Ultrasound guided vascular access site management and left ventricular pacing are associated with improved outcomes in contemporary transcatheter aortic valve replacement: insights from the OxTAVI registry.
      ]. An important proportion of cardiac tamponade/pericardial effusion in TAVR is caused by perforation of right ventricular temporary pacing wires (RV-TPW), evidenced by a significant decline in the risk of cardiac tamponade by peri-procedural rapid pacing through a ventricular guide wire (LV-GW) instead of RV-TPW [
      • Kotronias R.A.
      • Scarsini R.
      • De Maria G.L.
      • et al.
      Ultrasound guided vascular access site management and left ventricular pacing are associated with improved outcomes in contemporary transcatheter aortic valve replacement: insights from the OxTAVI registry.
      ,
      • Burzotta F.
      • Aurigemma C.
      • Romagnoli E.
      • et al.
      A less-invasive totally-endovascular (LITE) technique for trans-femoral transcatheter aortic valve replacement.
      ]. Nonetheless, patients at high risk for peri-procedural conduction disturbances still warrant a conventional approach to temporary pacing [
      • Siontis G.C.
      • Jüni P.
      • Pilgrim T.
      • et al.
      Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis.
      ]. Since cardiac tamponade is exceedingly rare among recipients of permanent pacemakers, with a reported incidence of 0.25–0.36% [
      • Moazzami K.
      • Dolmatova E.
      • Kothari N.
      • Mazza V.
      • Klapholz M.
      • Waller A.H.
      Trends in cardiac tamponade among recipients of permanent pacemakers in the United States: from 2008 to 2012.
      ], we hypothesized that the use of permanent, passive pacemaker leads connected to an external pulse generator for temporary pacing would decrease cardiac tamponade events in TAVR. The aim of the present study is therefore to compare the incidence of pacemaker lead related cardiac tamponade in TAVR, depending on the type of pacemaker lead: either a standard temporary RV pacemaker lead or a temporarily employed permanent, passive pacemaker lead.

      2. Methods

      2.1 Study population

      This a retrospective, nonrandomized, registry study from a high-volume single center. All patients who underwent transfemoral TAVR requiring temporary RV pacemaker back-up at Karolinska University Hospital from January 2014 to October 2020 were eligible for inclusion. Patients with non-transfemoral TAVR access (n = 52 [subclavian access n = 45, transapical access n = 7]), preoperative permanent pacemaker (n = 122) as well as other patients who did not receive a temporary pacemaker wire at the time of TAVR (n = 605), were excluded from the analysis (Fig. 1). Patient care was per institutional standard of care during the period of study, which involved use of RV-TPW until April 2018, when the use of right ventricular temporary pacing with a permanent, passive lead (RV-TPPL) became the standard option for peri-procedural pacing. The study was reported in accordance to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines [
      • von Elm E.
      • Altman D.G.
      • Egger M.
      • et al.
      The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies.
      ] and approved by the Regional Human Research Ethics Committee, Stockholm, Sweden (registration number: 2017/1700–32).
      Fig. 1
      Fig. 1Diagram with inclusion and exclusion criteria, and the resulting selection of the study cohort.

      2.2 Data variables and definitions

      2.2.1 Baseline characteristics

      Demographic and clinical baseline characteristics were extracted from the Swedish TAVR Registry (SWEDEHEART, Uppsala Clinical Research center, Uppsala, Sweden), and information on pre- and post-procedural medications and pacemaker lead type was extracted with 100% capture from the electronic health records at the Karolinska University Hospital. Chronic lung disease was defined as a diagnosis of chronic obstructive pulmonary disease or pulmonary fibrosis, requiring treatment. Critical preoperative state was specified as any intensive care or need of continuous invasive monitoring of vital parameters preceding TAVR. Extracardiac arteriopathy was defined as porcelain aorta or any severe stenosis of the aorta, carotids, subclavian or iliofemoral arteries. Dialysis was defined as any intermittent hemodialysis or continuous hemodiafiltration preceding TAVR. Functional status was assessed according to the New York Heart Association (NYHA) classification and was further categorized as either NYHA class I-II or III-IV, respectively. Left ventricular ejection fraction (LVEF) was categorized as either normal (>50%), mildly-moderately impaired (30–49%), or severely impaired (<30%). Pre- and peri-operative (up to 24 h hours after TAVR) intake of corticosteroids (oral or parenteral), or aspirin, P2Y12 platelet inhibitors, warfarin, low molecular weight heparins, non-vitamin K oral anticoagulants (NOACs) were extracted from the patients' electronic health records. The implanted TAVR prostheses were categorized as either balloon- or self-expandable.

      2.2.2 Pacemaker leads

      The use of (TAVR) procedure-related right ventricular temporary transvenous pacing (intra- or post-operative) was categorized according to the type of pacemaker lead: either a standard 5F PACEL™ Bipolar Pacing Catheter (St. Jude Medical, Minnetonka, MN, USA) as a right ventricular temporary pacemaker wire (RV-TPW) without a fixation mechanism; or right ventricular temporary pacing with the use of a Fineline™ II Sterox (Boston Scientific, St. Paul, MN, USA) permanent, passive pacemaker lead (RV-TPPL). The latter was inserted through ultrasound guided puncture of the right external jugular vein and connected to an external pacemaker generator, which was fixated close to the patient's jugular puncture site (Fig. 2). The standard RV-TPW was inserted by ultrasound guided puncture of either the external jugular vein or the femoral vein and was connected to a standard temporary pacing generator outside the patient. Temporary RV pacing was recommended for up to 24 h for all patients with preprocedural or procedural 12‑lead EKG showing a PQ-interval of >210 msec or QRS-duration of >120 msec, or for patients who needed procedural rapid pacing (before April 2018), or other reasons expected to increase the risk of intra- or postprocedural conduction abnormity – such as a very calcified valve landing zone, or a low implantation depth [
      • Boerlage-Van Dijk K.
      • Kooiman K.M.
      • Yong Z.Y.
      • et al.
      Predictors and permanency of cardiac conduction disorders and necessity of pacing after transcatheter aortic valve implantation.
      ,
      • Katsanos S.
      • van Rosendael P.
      • Kamperidis V.
      • et al.
      Insights into new-onset rhythm conduction disorders detected by multi-detector row computed tomography after transcatheter aortic valve implantation.
      ,
      • Maeno Y.
      • Abramowitz Y.
      • Kawamori H.
      • et al.
      A highly predictive risk model for pacemaker implantation after TAVR.
      ]. If no additional conduction abnormities ensued during the first 24 h of monitoring, the temporary RV pacemaker was removed. In case of episodes of bradycardia, AV-block or prolonged QRS-interval/new onset bundle branch block the temporary pacing was prolonged for an additional 24-h period or until implantation of a permanent pacemaker system – much like recent recommendations from international expert panels [
      • Rodés-Cabau J.
      • Ellenbogen K.A.
      • Krahn A.D.
      • et al.
      Management of conduction disturbances associated with transcatheter aortic valve replacement: JACC scientific expert panel.
      ]. Patients who required only transient rapid pacing over a left ventricle guidewire (LV-GW) but did not otherwise receive any form of temporarily implanted pacemaker leads, were excluded from this analysis (n = 605), as mentioned above.
      Fig. 2
      Fig. 2The soft tip of a permanent, passive pacemaker lead (Left). After insertion through ultrasound guided puncture of the right external jugular vein, the pacemaker lead is connected to a pacemaker generator outside the patient (Middle). The external pacemaker generator is dressed and kept under a plastic film during the time when temporary pacing back-up is considered necessary, typically up to 24–48 h (Right).

      2.2.3 Outcome measures

      The primary outcome measure was temporary pacemaker related cardiac tamponade, which was defined as pericardial effusion due to pacemaker lead perforation into the pericardial space leading to hemodynamic compromise (tamponade). Pericardial effusion was verified by echocardiography or cardiac computed tomography, at any time between pacemaker wire implantation and the day of explant, up to 7 days post-TAVR. Other outcome measures were any other cardiac tamponade (i.e., left ventricular wire-related cardiac tamponade or aortic or annular rupture related cardiac tamponade), peri-operative myocardial infarction, post-operative permanent pacemaker implantation, post-operative stroke and mortality related to temporary pacing within 30 days after TAVR.
      Left ventricular wire-related cardiac tamponade was defined as pericardial effusion/cardiac tamponade arising due to perforation of a catheter/sheath inserted into the left ventricular cavity at any time during the TAVR procedure, verified by contrast angiography/fluoroscopy or echocardiography. Annular rupture related cardiac tamponade was defined as pericardial effusion/cardiac tamponade due to rupture of the aortic annulus (or an adjacent structure) at the time of, or shortly after expansion and deployment of the transcatheter aortic valve device.

      2.3 Statistical analysis

      Numerical variables (age, body mass index) were expressed as means and standard deviations or medians and interquartile ranges (IQR), and categorical variables were expressed as percentages (proportions). Categorical variables were analysed using Chi-square test or Fisher's exact test and presented as counts with percentages. Continuous data were analysed with independent samples t-test or Mann-Whitney U test. Normality was tested using the Shapiro-Wilk test. Analyses were performed using Stata v.17 statistical software (StataCorp LP, College Station, Texas, USA).

      3. Results

      A total of 810 patients who received transfemoral TAVR with temporal pacing were included: 566 (69.9%) patients received a standard RV-TPW; and 244 patients (30.1%) received a soft tip RV-TPPL. All the latter were implanted through jugular venous access with achievement of stable capture, starting from April 2018 and onwards. Of the former, 477 (84.3%) were inserted through jugular access, and 89 (15.7%) through femoral vein puncture. As the use of a standard RV-TPW was the institutional standard until April 2018, most of these (97.5%) were implanted between 2014 and April 2018 (Supplementary Table S2).

      3.1 Baseline characteristics

      As seen in Table 1, the group receiving a standard RV-TPW was slightly older (mean age 81.1 vs. 79.1 years, p < 0.001) with a higher proportion of female patients (46.1% vs. 23.8%, p < 0.001), and a higher prevalence of chronic lung disease (20.3% vs. 12.7%, p = 0.01). Also, a higher proportion had NYHA class III-IV functional status (77.0% vs. 55.7%, p < 0.001) albeit with no difference in LVEF. Although peri-procedural clopidogrel use was balanced between the groups, a higher number of patients were pre-treated with aspirin in the standard temporary pacemaker group (79.3% vs. 64.3%, p < 0.001). As would be expected, warfarin was significantly more often used in the beginning of the study period whereas NOAC use increased over time. Therefore, the proportion of warfarin treated patients was higher among subjects who received a standard RV-TPW (22.3% vs. 9.4%, p < 0.001) whereas the frequency of NOAC use was higher in the RV-PPL group (24.6% vs. 9.7%, p < 0.001). Taken together, the total use of any anticoagulant was balanced between the groups (33.7% vs. 38.9%, p = 0.16). Moreover, as per institutional standard, warfarin dosing was regularly halved three days prior to TAVR (with target INR < 2.0) and NOACs were discontinued two days prior to TAVR.
      Table 1Patient and procedural characteristics according to type of temporary pacemaker lead used during transcatheter aortic valve implantation.
      Standard temporary pacemaker wire

      n = 566
      Permanent passive

      pacemaker lead

      n = 244
      p-value
      Age, years,81.1 ± 7.579.1 ± 6.8<0.001
      Female sex261 (46.1%)58 (23.8%)<0.001
      Body mass index, kg/m226.3 ± 5.026.2 ± 4.30.83
      Recent myocardial infarction24 (4.2%)4 (1.6%)0.063
      Hypertension408 (72.1%)182 (74.6%)0.46
      Diabetes mellitus114 (20.1%)63 (25.8%)0.073
      Previous cardiac surgery100 (17.7%)38 (15.6%)0.47
      Previous percutaneous coronary intervention132 (23.3%)66 (27.0%)0.26
      Chronic lung disease115 (20.3%)31 (12.7%)0.010
      Prior stroke59 (10.4%)27 (11.1%)0.79
      Critical preoperative state18 (3.2%)5 (2.0%)0.37
      Extracardiac arteriopathy67 (11.8%)33 (13.5%)0.50
      Atrial fibrillation209 (36.9%)84 (34.4%)0.50
      Dialysis11 (1.9%)6 (2.5%)0.64
      NYHA Class III or IV436 (77.0%)136 (55.7%)<0.001
      LVEF0.71
       > 50%342 (60.4%)140 (57.4%)
       30–49%185 (32.7%)85 (34.8%)
       < 30%39 (6.9%)19 (7.8%)
      Pre−/peri-operative medication (within 24 h)
       corticosteroid51 (9.0%)27 (11.1%)0.36
       aspirin449 (79.3%)157 (64.3%)<0.001
       P2Y12 inhibitor361 (63.8%)155 (63.5%)0.94
       warfarin
      Peri-procedural INR-goal was <2.0 for patients treated with warfarin.
      126 (22.3%)23 (9.4%)<0.001
       low molecular weight heparin14 (2.5%)14 (5.7%)0.020
       Non-vitamin K oral anticoagulant
      Non-vitamin K oral anticoagulants (NOAC) were paused >48 h before TAVR.
      55 (9.7%)60 (24.6%)<0.001
       warfarin
      Peri-procedural INR-goal was <2.0 for patients treated with warfarin.
      /non-vitamin K oral anticoagulant
      Non-vitamin K oral anticoagulants (NOAC) were paused >48 h before TAVR.
      /low molecular weight heparin
      195 (34.4%)97 (39.7%)0.16
      Temporary pacemaker access<0.001
       Femoral vein89 (15.7%)0
       Jugular vein477 (84.3%)244 (100%)
       General anesthesia13 (2.3%)4 (1.6%)0.55
      Type of prosthetic valve<0.001
       Balloon-expandable61 (10.9%)101 (45.3%)
       Self-expandable499 (89.1%)122 (54.7%)
      Values are n (%) or mean ± standard deviation, depending on variable distribution. NYHA = New York Heart Association functional class. LVEF = Left ventricular ejection fraction.
      a Peri-procedural INR-goal was <2.0 for patients treated with warfarin.
      b Non-vitamin K oral anticoagulants (NOAC) were paused >48 h before TAVR.
      Finally, the proportion of balloon-expandable valves increased over time and the inverse was true for self-expandable valve prostheses, which accounted for 89.1% among those who received a standard RV-TPW and 54.7% (p < 0.001) among the subjects who received a soft- tip RV-TPPL.

      3.2 Cardiac tamponade outcomes

      In total, 18 (2.2%) events of cardiac tamponade occurred. Of these, 12 (67%) were pacemaker lead related (mean age 83.3 ± 6.6 years; 7 [58%] women), 4 (22%) were caused by annular rupture and 2 (11%) occurred due to left ventricular wire perforation. In the group of 12 patients with pacemaker‑lead related cardiac tamponade 10 occurred on the post-operative ward within three days after TAVR, one occurred on the sixth post-operative day, and one event of pacemaker lead perforation with tamponade occurred intra-operatively. All pacemaker lead-related cardiac tamponades occurred in the group who received a standard RV-TPW (n = 12 [2.1%] vs. n = 0 [0%], p = 0.022), and thus no pacemaker lead-associated cardiac tamponade occurred in the group who received the soft tip RV-TPPL (Fig. 3). Of the twelve patients with pacemaker lead perforation leading to tamponade all were pre-treated with aspirin, eleven received clopidogrel loading, and none was treated with oral anticoagulation. All but one of the pacemaker caused tamponades were treated with pericardial drainage through pericardiocentesis, and one underwent conversion to median sternotomy. Two of the patients (16.7%) died as a result of pacemaker related cardiac tamponade. The first suffered circulatory collapse with cardiac arrest 15 min after pacemaker lead withdrawal and bedside echocardiography showed severe pericardial effusion. The other died as a result of pacemaker lead perforation during pacing of third-degree atrioventricular block, and the ensuing pericardial drainage was not successful to avert tamponade related death.
      Fig. 3
      Fig. 3Central illustration. The use of a permanent passive pacemaker lead in peri-operative temporary right ventricular (RV) pacing in TAVR was associated with a significant reduction in cardiac tamponade caused by lead perforation compared to a standard RV temporary pacemaker lead.
      Other causes of TAVR related cardiac tamponade amounted to three cases (0.5%) in the cohort who received a standard RV-TPW (two caused by perforation of a left ventricular wire, and one instance of annular rupture); and three cases (1.2%) of annular rupture in the cohort who received a soft-tip RV-TPPL (p = 0.29). No statistically significant differences were seen in the rates of perioperative myocardial infarction, post-operative stroke, permanent pacemaker implantation, or duration of temporary RV pacing before permanent pacemaker implantation (Table 2). Overall mortality at 30 days was 0.9% in the RV-TPPL group and 3.5% among those who received a standard RV-TPW (p = 0.042), but death related to RV pacing complications amounted only to two cases (0.4%) in those who received standard RV-TPW and none in the RV-TPPL group (p = 0.35). Other than cardiac tamponade, only one major vascular complication associated with pacemaker lead placement was reported: an accidental carotid puncture occurred in the group who received RV-TPW (0.18%), resulting in a percutaneous sealing procedure performed by a vascular surgeon.
      Table 2Peri- and post-procedural clinical outcomes according to type of temporary pacemaker lead used during transcatheter aortic valve implantation.
      Standard temporary pacemaker wire

      n = 566
      Permanent passive pacemaker lead

      n = 244
      p-value
      Temporary pacemaker-related cardiac tamponade12 (2.1%)00.022
      Other periprocedural cardiac tamponade3 (0.5%)3 (1.2%)0.29
      Perioperative myocardial infarction1 (0.2%)1 (0.4%)0.53
      Postoperative stroke12 (2.2%)8 (3.3%)0.34
      Postoperative permanent pacemaker implantation64 (11.6%)27 (17.4%)0.054
      Duration of temporary pacing before permanent pacemaker implantation56.8 ± 40.157.6 ± 24.50.93
      Death related to RV pacing complications2 (0.4%)0 (0%)0.35
      Cardiac tamponade and perioperative myocardial infarction are within 7 days of the procedure. Postoperative stroke and permanent pacemaker implantation are within 30 days of the procedure. Duration of temporary pacing before permanent pacemaker implantation is in hours (mean ± standard deviation). Both cases of death related to RV pacing complications occurred due to cardiac tamponade.

      4. Discussion

      This large, single center, real-world cohort of transfemoral TAVR demonstrates that the adoption of right ventricular temporary pacing through a permanent, passive pacemaker lead with a soft tip decreases the rate of pacemaker related cardiac tamponade. This finding is in line with what has been reported from studies were similar leads have been used during permanent PM implantation [
      • Moazzami K.
      • Dolmatova E.
      • Kothari N.
      • Mazza V.
      • Klapholz M.
      • Waller A.H.
      Trends in cardiac tamponade among recipients of permanent pacemakers in the United States: from 2008 to 2012.
      ], or where a soft-tip active fixation temporary pacing lead has been used in structural heart interventions [
      • Nazif T.M.
      • Chen S.
      • Codner P.
      • et al.
      The initial U.S. experience with the tempo active fixation temporary pacing lead in structural heart interventions.
      ], or with externalized active fixation leads in temporary pacing after transvenous lead extractions [
      • Cipriano R.
      • Gupta A.
      • Subzposh F.
      • et al.
      Outcomes of standard permanent active fixation leads for temporary pacing.
      ]. Our findings add to the recent introduction of minimalistic TAVR techniques [
      • Attizzani G.F.
      • Alkhalil A.
      • Padaliya B.
      • et al.
      Comparison of outcomes of Transfemoral Transcatheter aortic valve implantation using a minimally invasive versus conventional strategy.
      ], such as pacing through left ventricular guidewire, which has already improved procedural efficiency and reduced the risk of TAVR related cardiac tamponade [
      • Kotronias R.A.
      • Scarsini R.
      • De Maria G.L.
      • et al.
      Ultrasound guided vascular access site management and left ventricular pacing are associated with improved outcomes in contemporary transcatheter aortic valve replacement: insights from the OxTAVI registry.
      ,
      • Faurie B.
      • Abdellaoui M.
      • Wautot F.
      • et al.
      Rapid pacing using the left ventricular guidewire: reviving an old technique to simplify BAV and TAVI procedures.
      ,
      • Lefèvre G.
      • Jégou A.
      • Dambrin G.
      • et al.
      Comparison of TransFemoral transcatheter aortic valve replacement performed with a minimally invasive simplified technique: “FAST” versus a standard approach.
      ]. Notwithstanding the advance of LV-GW pacing, right ventricular temporary pacing is still warranted when there is a high risk for conduction disturbances that require stable pacing, such as baseline right bundle branch block, left anterior hemiblock, first- and second-degree AV block, a short membranous septum, or bulky calcifications in the valve landing zone [
      • Siontis G.C.
      • Jüni P.
      • Pilgrim T.
      • et al.
      Predictors of permanent pacemaker implantation in patients with severe aortic stenosis undergoing TAVR: a meta-analysis.
      ,
      • Maeno Y.
      • Abramowitz Y.
      • Kawamori H.
      • et al.
      A highly predictive risk model for pacemaker implantation after TAVR.
      ,
      • Ullah W.
      • Zahid S.
      • Zaidi S.R.
      • et al.
      Predictors of permanent pacemaker implantation in patients undergoing transcatheter aortic valve replacement; A systematic review and meta analysis.
      ]. This need is reflected in the 6.6–17.4% rate of new permanent pacemaker implantations in the recently published TAVR trials in low-risk cohorts [
      • Mack M.J.
      • Leon M.B.
      • Thourani V.H.
      • et al.
      Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients.
      ,
      • Popma J.J.
      • Deeb G.M.
      • Yakubov S.J.
      • et al.
      Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients.
      ], as well as in the mean rate of 18.9% in a recent meta-analysis reflecting TAVR practice over the last decade [
      • Ullah W.
      • Zahid S.
      • Zaidi S.R.
      • et al.
      Predictors of permanent pacemaker implantation in patients undergoing transcatheter aortic valve replacement; A systematic review and meta analysis.
      ].
      In this prospective TAVR cohort, the choice of standard RV-TPW or the soft-tip RV-TPPL for peri-procedural pacing was not operator specific. Rather, we compared patients receiving RV-TPPL to a cohort who underwent standard RV-TPW implantation during the period immediately prior to the introduction of the soft-tip RV-TPPL strategy. Therefore, selection bias should be reduced because the procedures were performed with one strategy for RV pacing during each period, and the decision to use a soft-tip RV-TPPL after the introduction of the new strategy of peri-procedural pacing was not operator-specific but determined by general institutional directives. The only change in the institutional directives was the gradual introduction of LV-GW pacing which paralleled increased annual numbers of TAVR. Thus, the overall (relative) likelihood of peri-procedural RV-pacing dropped paralleling the increased proportion of patients receiving LV-GW pacing (see Supplementary Fig. S2). The main criteria for selecting RV-TTPL with an externalized generator instead of LV-GW pacing were either baseline PQ-duration >210 milliseconds or QRS-duration >120 milliseconds, or other features increasing the risk for post-procedural pacing such as bulky calcifications in the valve landing zone. Consequently, patients receiving RV-TPPL likely had a higher overall proportion of underlying conduction abnormities resulting in the observed trend of more permanent post-operative pacemaker implantations in this group (Table 2) compared to those who received RV-TPW. For the same reason, and despite the moderate differences that were observed in age, gender and NYHA class at baseline between respective RV temporary pacing strategy, it is likely that the exclusion of patients who received LV-GW yielded a cohort with a reasonably sustained degree of frailty over the study period. Also, no difference was seen in the duration of temporary RV pacing in those requiring a permanent pacemaker implantation (Table 2).
      Lastly, an experienced group of TAVR operators performed the procedures during the timeline of the study. Both the annual incidence of pacemaker related cardiac tamponade, and the cumulative incidence of cardiac tamponade per TAVR operator appear homogenously distributed (see supplementary Tables S1 and S3). Thus, it is unlikely that a TAVR procedure learning curve influenced the main finding.
      Cardiac tamponade in TAVR is a serious complication that affects 1–4% of patients who undergo TAVR [
      • Rezq A.
      • Basavarajaiah S.
      • Latib A.
      • et al.
      Incidence, management, and outcomes of cardiac tamponade during transcatheter aortic valve implantation: a single-center study.
      ,
      • Walther T.
      • Hamm C.W.
      • Schuler G.
      • et al.
      Perioperative results and complications in 15,964 Transcatheter aortic valve replacements: prospective data from the GARY registry.
      ,
      • Auffret V.
      • Lefevre T.
      • Van Belle E.
      • et al.
      Temporal trends in transcatheter aortic valve replacement in France: France 2 to France Tavi.
      ] with a reported in-hospital mortality of 19.1–36.1% [
      • Ahuja K.R.
      • Gad M.M.
      • Bazarbashi N.
      • et al.
      Impact of hospital transcatheter aortic valve replacement volume on incidence and outcomes of cardiac tamponade.
      ]. In the minimally invasive interventional era in which the numbers of structural interventions are increasing, and the patient populations are spanning from the very frail to the surgical low risk, the aim for the lowest possible complication rate should entail even small and simple technical details that can make a difference in the outcome. Based on our results, incorporating RV-TPPL in cases where the need for stable pacing may be anticipated reduces pacemaker related cardiac tamponade, possibly bringing this avoidable and serious complication to close to zero. Additionally, the difference in cost between a permanent pacemaker electrode and a standard temporary pacing wire was <100 USD.
      If confirmed by adequately powered multi-center studies, the adoption of this simple technique may further improve procedural safety in TAVR. Taken together with the recent advances in alternative, active fixation temporary pacing wires [
      • Belardi J.A.
      • Lamelas P.M.
      The new era of ventricular pacing during structural interventions.
      ] these new options of temporary pacing will indeed render the standard design temporary wire obsolete in structural interventions.

      4.1 Limitations

      As all observational studies, our study poses the limitations of several potential biases. Changes in TAVR practice over the years yield a natural imbalance of baseline variables between the groups, reflected in the demography and comorbidities as well as the decreased use of aspirin loading over time. In addition, the outcome of pacemaker related cardiac tamponade is a low frequency event, and as such reduces the statistical power of the analysis. Nevertheless, our data consists of a prospectively registered cohort with systematically collected variables in a real world setting at baseline, during, and after the procedure. Despite a few baseline parameters, such as chronic lung disease or NYHA class differing somewhat between the groups, we believe this is of limited clinical importance with regards to the outcome of cardiac tamponade. Moreover, we don't believe residual confounding can be completely ruled out with propensity score matching or multivariate adjusting when comparing two different time intervals, especially when the groups are already reasonably balanced (as seen in Table 1) and no other major changes in patient monitoring or the duration of temporary pacing have taken place.
      In this study, we describe a reduction of pacemaker wire related cardiac tamponade from 2.1% in RV-TPW pacing to 0% in RV-TPPL, with equal rates in the peri-procedural use of clopidogrel and anticoagulation. Concretely, 11/12 patients (92%) experiencing cardiac tamponade received double antiplatelet therapy (DAPT). This may represent a limitation in generalizability since DAPT is no longer standard of care in TAVR without other existing indications for DAPT. However, since clopidogrel loading was balanced between the groups, and DAPT was routinely used in TAVR during the study period we don't believe this introduced a bias that would significantly affect our main finding. Furthermore, not a single case of pacemaker related cardiac tamponade occurred in a warfarin or NOAC treated patient, which further underlines the causation of pacemaker lead perforation mainly due to mechanistic rather than pharmacological reasons, or frailty.

      5. Conclusions

      The use of right ventricular temporary pacing through a permanent, passive pacemaker lead was associated with a reduced risk of pacemaker related cardiac tamponade in TAVR as compared to the use of standard right ventricular temporary pacing wires.

      Funding

      Magnus Dalén was supported by donations from Mr. Fredrik Lundberg and The Schörling Foundation.

      Declaration of Competing Interest

      Dr. Feldt has received consulting/speaker fees from Abbott Vascular, Astra Zeneca, Anteris Technologies and Alleviant Medical. Dr. Dalén, Dr. Kastengren, Dr. Hörnsten, and Dr. Omar report no relationships that could be construed as a conflict of interest. Dr. Rück has served as a proctor for Boston Scientific and has received consulting fees from Medtronic and Edwards. Dr. Meduri has received consulting fees from Boston Scientific, Abbott Vascular, Cardiovalve, Vdyne, Alleviant and Anteris Technologies. Dr. Saleh and Dr. Linder report no relationships that could be construed as a conflict of interest. Dr. Settergren has served as a proctor for Boston Scientific, Abbott Vascular and has received consulting fees from Medtronic, Anteris Technologies, Holistic Medical, Cardiomech and Teleflex.

      Appendix A. Supplementary data

      • Supplementary Appendix with additional information about the study data: Supplementary Table S1, Pacemaker related cardiac tamponade per year; Supplementary Figure S2 and Table S2, type of temporary procedural pacing in TAVR by year (2014-2020); Supplementary Table S3, cumulative rate of pacemaker related cardiac tamponade per TAVR operator during the study.

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      Linked Article

      • Right ventricular pacing during TAVR: Make the things as simple as possible but not simpler
        International Journal of CardiologyVol. 377
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          Transcatheter aortic valve replacement (TAVR) has evolved at high speed and many centers have adopted strategic methods intended to maximize cost-effectiveness while maintaining patient safety and satisfaction. To this regard, minimalist programs include also a shift to a peri-procedural rapid pacing through the left ventricular (LV) guidewire, instead of a pacing lead into the right ventricle (RV), to reduce the risk of vascular complications and pacing lead-related cardiac tamponade. [1] However, there are conditions in which RV temporary pacing is still needed in patients at high risk for advanced atrio-ventricular (AV) block, [2,3] or in those who require prolonged temporary pacing or for monitoring [4].
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