• Outcomes of rotational atherectomy in patients with severe left ventricular dysfunction without hemodynamic support

    Abstract

    Introduction

    Elective insertion of a percutaneous circulatory assist device (PCAD) in high-risk patients is considered a reasonable adjunct to percutaneous coronary intervention (PCI). There is limited data examining the safety and efficacy of rotational atherectomy (RA) without hemodynamic support in patients with reduced left ventricular ejection fraction (LVEF).

    Methods

    We retrospectively identified 131 consecutive patients undergoing RA without elective PCAD over a three-year period. Patients were categorized into three groups: LVEF ≤30%, LVEF 31–50%, and LVEF >50%. The incidence of procedural hypotension, major adverse cardiac events (MACE), and mortality were recorded.

    Results

    Statistical analysis included 18, 42, and 71 patients with LVEF ≤30%, 31–50%, and >50%, respectively. Bailout hemodynamic support was required in four cases. Analysis revealed a significant trend as bailout hemodynamic support was required in 11.1% vs 2.4% ( = 0.1551) in the ≤30% vs 31–50% and 11.1% vs 1.4% ( = 0.0416) in the ≤30% vs >50% subgroups. Combined subgroup analysis also demonstrated statistical significance 11.1% vs 1.8% ( = 0.0324) in the ≤30% vs >30% subgroups. No-reflow phenomenon was more prevalent in patients with reduced LVEF (LVEF ≤30%: 11.1%, LVEF 31–50%: 2.4%, LVEF >50%: 0%; = 0.0190). Otherwise, no significant differences in in-hospital MACE, or mortality were observed.

    Conclusion

    RA can be effectively utilized in patients with severely reduced LVEF; however, these patients are at increased risk of prolonged procedural hypotension requiring bailout hemodynamic support. If indicated, prompt implementation of hemodynamic support mitigated any impact of procedural hypotension on in-hospital MACE and mortality.

    Highlights

     

    •  

      Retrospective analysis of rotational atherectomy with reduced left ventricular ejection fraction (LVEF).

    •  

      Rotational atherectomy can be performed without hemodynamic support in most cases.

    •  

      Bailout hemodynamic support was more common in patients with LVEF ≤30%.

    •  

      In-hospital major adverse cardiac events (MACE) and mortality were not increased by procedural hypotension.

    •  

      Prompt implementation of hemodynamic support may mitigate the impact of procedural hypotension on MACE.

     

    Introduction

    Coronary artery calcium is a marker of advanced coronary artery disease and is a predictor of adverse clinical outcomes including stroke and myocardial infarction [  ]. Severely calcified coronary lesions exist in 5.9% to 20% of patients receiving percutaneous coronary intervention (PCI) [  ,  ]. Such lesions increase the intricacy of PCI and are associated with additional procedural risk and adverse clinical outcomes [ ]. These lesions can be resistant to adequate predilatation, impair stent delivery and expansion, and lead to an increased rate of stent thrombosis and/or restenosis [  ,  ]. Current guidelines indicate that rotational atherectomy (RA) is a reasonable approach to heavily calcified lesions which cannot be crossed by a balloon catheter or adequately dilated before stent implantation [  ]. In addition to severe coronary artery calcification, advanced age, elevated creatinine, and reduced left ventricular ejection fraction (LVEF) can predict adverse outcomes in PCI and RA [  ,  ]. Reduced LVEF is reported to be an independent predictor of all-cause mortality following PCI [  ]. RA is inherently riskier in this population and limited data exists to define its use [ ].

    Percutaneous circulatory assist devices (PCAD), including intra-aortic balloon pump (IABP) and the Impella 2.5 system (Abiomed Inc., Danvers, Massachusetts), are commonly utilized in high-risk PCI [  ]. The proposed intraoperative benefit of PCADs is derived from improved hemodynamics and coronary flow secondary to left ventricular systolic unloading and diastolic augmentation, dependent on the device selected [  ]. Due to limited available data, the ideal role of PCADs in high-risk patients undergoing elective RA remains uncertain, and contemporary conclusions must be extrapolated from studies targeting high-risk PCI. One large multicenter randomized controlled trial (RCT) concluded that elective IABP placement prior to high-risk PCI did not demonstrate a significant reduction in major adverse cardiac events (MACE) at 6 months [  ]. Meta-analyses of available data have not reported any significant differences in in-hospital and 30-day mortality with elective use of IABP [  ,  ]. Impella 2.5 failed to demonstrate superior outcomes compared to IABP in patients undergoing elective high-risk PCI [  ]. Subgroup analysis of the PROTECT II trial targeting RA reported no meaningful differences in 90-day mortality with Impella 2.5 vs IABP [  ]. At this time, data does not support the elective use of PCADs in all patients undergoing high-risk PCI [  ,  ]. Current guidelines recommend elective insertion of appropriate devices in carefully selected high-risk patients [  ].

    High-risk PCI in patients with reduced LVEF is associated with reverse left ventricular remodeling and improved clinical outcomes [  ]. Despite a growing body of literature, data for RA in patients with reduced LVEF remains scarce. One retrospective study of 23 patients with LVEF ≤30%, published in 2006, reports excellent 30-day outcomes [  ]. Long-term outcomes for RA in this population have not been reported. We sought to evaluate periprocedural and in-hospital outcomes in patients undergoing RA without elective PCAD placement at our institution.

    Methods

    Study population

    Following institutional review board approval, we identified all patients who underwent RA without elective placement of a PCAD at the Medical College of Georgia/Augusta University Medical Center between January 1st 2014 and December 31st 2016. One hundred and thirty-one patients met inclusion criteria and data was extracted from the electronic medical record system in accordance to the study protocol. Patients were grouped based on LVEF: ≤30%, 31–50%, and >50%. Nine, one, and three patients in the LVEF: ≤30%, 31–50%, and >50% groups were excluded from the study due to placement of a PCAD prior to PCI. While this decision was operator dependent, the most common patient and procedural characteristics within the LVEF ≤30% group were: acute coronary syndrome (ACS) (8), cardiogenic shock (5), ventricular arrhythmia (3), Left main intervention (3), severe valvular disease (2), and concurrent valvuloplasty (1).

    Procedural technique and medical intervention

    All patients underwent PCI with the Rotablator Rotational Atherectomy System (Boston Scientific, Marlborough, MA). PCI was performed using standard techniques via a transradial or transfemoral approach. Dual-antiplatelet therapy with a P2Y 12 inhibitor and aspirin was administered prior to PCI. Unfractionated heparin was administered intravenously throughout the procedure to achieve an activated clotting time (ACT) >250 s. Fractional flow reserve (FFR) was utilized to evaluate coronary lesions with 50–70% stenosis and intravascular ultrasound (IVUS) was performed in all but one case. IVUS was routinely performed both before and after RA with stenting. The selection of arterial access sheath, burr size, and stent type (drug-eluting vs bare-metal) was operator dependent, based on target lesion profile and patient characteristics. A target burr to vessel ratio of 0.6 is routinely utilized at our institution. In addition, intraprocedural implementation of bailout hemodynamic support was provided at the discretion of the operating physician.

    Data extraction

    A detailed chart review was conducted in accordance with the study protocol targeting demographic data including cardiac risk factors, cardiac imaging studies, procedural characteristics and outcomes. All physician notes were reviewed up until the time of discharge in order to extract both subjective and objective data such as the development of anginal symptoms or hematoma at arterial access site. All data was entered into a dedicated rotational atherectomy database.

    Study endpoints

    The primary endpoint was the utilization of bailout hemodynamic support defined as the intraoperative addition of vasopressor agents or PCADs (IABP or Impella). Secondary endpoints were procedural success, incidence of major adverse cardiac events (MACE), and development of minor periprocedural complications. Procedural success defined as Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 and residual stenosis ≤30% after final percutaneous transluminal coronary angioplasty (PTCA) and/or stent placement. If stent loss, death, or an indication for emergent PCI and/or coronary artery bypass graft surgery developed during the first 24 h, the procedure was considered a failure. Major adverse cardiac events were defined as: hypotension requiring vasopressors or placement of PCAD, sustained ventricular arrhythmia, bradycardia requiring transvenous pacing, need for target lesion revascularization, non-fatal myocardial infarction, stroke, and cardiac death.

    Acute and subacute stent thrombosis was defined in accordance with the Academic Research Consortium definition [  ]. Myocardial infarction was defined as the development of new ST-segment elevation and/or a rise in cardiac biomarkers above the previously documented value in addition to ischemic symptoms. Target lesion revascularization was defined as the manifestation of ischemic symptoms due to a stenosis of ≥50% of the luminal diameter either within the stent or within 5 mm of its borders, which required surgical or percutaneous revascularization. Death was to be considered cardiac in origin unless a non-cardiac origin was clearly documented in the electronic medical record. Minor periprocedural complications were defined as: development of hematoma or pseudoaneurysm at the vascular access site or reported systemic blood loss from any source.

    Statistical analysis

    Statistical analysis was performed with SAS (Version 9.4, The SAS institute, Cary, NC). The difference between means for continuous variables was tested by two-tailed -test. For categorical values, the Chi-Square test was utilized in testing the significance of dependent variables on independent variables. -values <0.05 were considered statistically significant. Descriptive statistics were used to analyze procedural characteristics. Continuous variables are reported as a mean and standard deviation while categorical variables are reported as a value and percentage.

    Results

    Population demographics and procedural characteristics

    Patient demographics, cardiac risk factors, and baseline hemodynamics for all three subgroups are documented inTable 1 . The prevalence of ACS was similar amongst each subgroup ( = 0.2671); however, prior myocardial infarction ( ≤0.0001) and concurrent non-ST elevation myocardial infarction ( = 0.0026) were most common in the groups with reduced LVEF. A total of 256 lesions (LVEF ≤30%: 36, LVEF 31–50%: 87, LVEF >50%: 133) were targeted for intervention and the distribution of target lesions are listed in Table 2 . Unprotected left main disease was targeted in 4 (22.2%), 10 (23.8%), and 9 (12.7%) cases in the LVEF ≤30%, LVEF 31–50%, and LVEF >50% groups, respectively ( = 0.2762). A complete list of procedural characteristics including: burr size, number of stents utilized, and type of stent deployed is provided in Table 3 . IVUS was utilized (99.1%) in the majority of cases. 

    Table 1
    Population Demographics.
    LVEF ≤ 30% ( = 18)LVEF 30–50% ( = 42)LVEF > 50% ( = 71)value
    Ejection fraction22.22 ± 4.6142.00 ± 6.1359.84 ± 5.01<0.001
    DemographicsResult ± SD (%)Result ± SD (%)Result ± SD (%) 
    Age 69.61 ± 11.69 66.64 ± 11.15 67.85 ± 8.94 0.5718
    Gender (male) 14 (77.8) 32 (76.2) 43 (60.6) 0.1433
    Diabetes 11 (61.1) 23 (54.8) 38 (53.5) 0.8695
    HTN 18 (100) 40 (95.2) 61 (85.9) 0.1254
    HLD 13 (72.2) 28 (66.7) 60 (84.5) 0.0535
    Hx of stroke 3 (16.7) 7 (16.7) 4 (5.6) 0.1331
    Hx of MI 13 (72.2) 16 (38.1) 11 (15.5) <0.0001
    Hx of PCI 5 (27.8) 15 (35.7) 28 (39.4) 0.6196
    Hx of CABG 4 (22.2) 11 (26.2) 23 (32.4) 0.5886
     
    Clinical setting
    ACS 14 (77.8) 24 (57.1) 48 (67.6) 0.2671
    UA 5 (27.8) 15 (35.7) 41 (57.7) 0.0173
    NSTEMI 8 (44.4) 9 (21.4) 7 (9.9) 0.0026
    STEMI 1 (5.6) 0 (0) 0 (0) 0.0422
    Decompensated heart failure 7 (38.9) 4 (9.5) 2 (2.8) 0.3995
     
    Baseline hemodynamics 
    Systolic (mm Hg) 111.06 ± 18.12 125.85 ± 21.86 133.04 ± 27.38 0.0036
    Diastolic (mm Hg) 61.33 ± 11.62 60.17 ± 11.43 59.90 ± 11.97 0.8992
    MAP (mm Hg) 79.50 ± 12.82 85.83 ± 12.96 88.23 ± 14.88 0.0631
    Borderline blood pressure 5 (27.8) 5 (11.9) 5 (7.0) 0.2158

    Abbreviations: ACS: acute coronary syndrome; HLD: hyperlipidemia; HTN: hypertension; Hx: history; LVEF: left ventricular ejection fraction; MAP: mean arterial pressure; NSTEMI: non-ST elevation myocardial infarction; STEMI: ST elevation myocardial infarction; UA: unstable angina.

    Reported hemodynamics reflect the first recorded central aortic pressure at the time of intervention. Borderline blood pressure defined as Systolic <100 mm Hg or MAP <70 mm Hg.

    Table 2
    Distribution of Target Lesions.
     
    Lesion locationLVEF ≤ 30% (N = 18)LVEF 30–50% (N = 42)LVEF > 50% (N = 71)value
    Prox RCA 4 (22.2) 9 (21.4) 16 (22.5) 0.9906
    Mid RCA 4 (22.2) 10 (23.8) 20 (28.2) 0.8138
    Distal RCA 3 (16.7) 6 (14.3) 16 (22.5) 0.5374
    PDA 0 (0) 0 (0) 1 (1.4) 0.6533
    Left main 4 (22.2) 10 (23.8) 9 (12.7) 0.2762
    Prox LAD 8 (44.4) 18 (42.9) 28 (39.4) 0.8972
    Mid LAD 8 (44.4) 19 (45.2) 26 (36.6) 0.6215
    Distal LAD 1 (5.6) 2 (4.8) 2 (2.8) 0.8010
    Ramus 0 (0) 1 (2.4) 0 (0) 0.3438
    Prox LCx 2 (11.1) 3 (7.1) 11 (15.5) 0.8937
    Mid LCx 2 (11.1) 2 (4.8) 4 (5.6) 0.4609
    Distal LCx 0 (0) 1 (2.4) 0 (0) 0.3438
    Total lesions 36 87 133
     
    Abbreviations: LAD: left anterior descending artery; LCx: left circumflex artery; LM: left main; PDA: posterior descending artery; RCA: right coronary artery.
     
    Table 3
    Procedural Characteristics.
     
    LVEF ≤ 30% (N = 18)LVEF 30–50% (N = 42)LVEF > 50% (N = 71)value
    IVUS 18 (100) 42 (100) 70 (98.6) 0.6533
    Access        
    Femoral 17 (94.4) 41 (97.6) 67 (94.4) 0.7102
    Radial 1 (5.6) 1 (2.4) 4 (5.6) 0.7102
    Number of vessels targeted per case        
    1 15 (83.3) 35 (83.3) 63 (88.7) 0.6704
    2 3 (16.7) 7 (16.7) 8 (11.3) 0.6704
    Burr size        
    1.25 2 (11.1) 8 (19.0) 6 (8.5) 0.2481
    1.5 6 (33.3) 10 (23.8) 25 (35.2) 0.3672
    1.75 5 (27.8) 8 (19.0) 21 (29.6) 0.4587
    2.0 5 (27.8) 7 (16.7) 10 (14.1) 0.3814
    2.15 0 (0) 5 (11.9) 3 (4.2) 0.1306
    2.25 0 (0) 4 (9.5) 5 (7.0) 0.4079
    Type of stent        
    DES 15 (83.3) 32 (76.2) 65 (92) 0.0110
    BMS 2 (11.1) 5 (11.9) 0 (0) 0.0110
    Stent diameter (mm) 2.97 ± 0.45 3.02 ± 0.52 3.06 ± 0.49 0.7674
    Stent length (mm) 31.14 ± 7.43 32.25 ± 7.07 32.76 ± 7.42 0.6974
    Stents per case        
    0 1 (5.6) 5 (11.9) 6 (8.5) 0.7032
    1 5 (27.8) 11 (26.2) 26 (36.6) 0.4739
    2 6 (33.3) 13 (31.0) 25 (35.2) 0.8980
    3 5 (27.8) 11 (26.2) 11 (15.5) 0.2864
    4 1 (5.6) 1 (2.4) 3 (4.2) 0.8121
    5 0 (0) 1 (2.4) 0 (0) 0.3438
    Sheath size (Fr)        
    6 4 (22.2) 11 (26.2) 26 (36.6) 0.3440
    7 7 (38.9) 13 (31.0) 18 (25.4) 0.4988
    8 7 (38.9) 18 (42.9) 26 (36.6) 0.8058
    6.5 sheathless 0 (0) 0 (0) 1 (1.4) 0.6533
    Temp pacemaker 0 (0) 5 (11.9) 4 (5.6) 0.2058
    TIMI 3 flow 18 (100) 42 (100) 71 (100) 0.6533

    Abbreviations: BMS: bare-metal stent; DES: drug-eluting stent; IVUS: intravascular ultrasound; TIMI: Thrombolysis in Myocardial Infarction.

     

    Clinical outcomes

    The primary endpoint of bailout hemodynamic support was met in four cases (LVEF ≤30%: 2, LVEF 31–50%: 1, LVEF >50%: 1; = 0.0972) amongst all subgroups and did not meet statistical significance. Analysis of each subgroup revealed a significant trend as bailout hemodynamic support was required in 11.1% vs 2.4% ( P= 0.1551) and 11.1% vs 1.4% ( = 0.0416) in the ≤30% vs 31–50% and ≤30% vs >50% subgroups, respectively. Combined subgroup analysis also demonstrated statistical significance as bailout hemodynamic support was utilized in 2 of 18 (11.1%) vs 2 of 113 (1.8%) cases in patients with LVEF ≤30% and LVEF >30%, respectively ( P= 0.0324). Rescue IABP for prolonged hypotension was required in 1 of 18 (5.6%) vs 1 of 113 (0.9%) cases in the LVEF ≤30% and LVEF >30% subgroups ( = 0.1334). Statistical analysis for all procedural and clinical outcomes is provided in Table 4 . 

    Table 4
    Procedural and Clinical Outcomes.
     
    LVEF ≤ 30% (N = 18)LVEF 30–50% (N = 42)LVEF > 50% (N = 71)P-Value
    Bailout hemodynamic support required 2 (11.1) 1 (2.4) 1 (1.4) 0.0972
    2 (11.1)   1 (1.4) 0.0416
      1 (2.4) 1 (1.4) 0.7048
    2 (11.1) 1 (2.4)   0.1551
    IABP 1 (5.6) 1 (2.4) 0 (0) 0.1971
    1 (5.6)   0 (0) 0.0458
      1 (2.4) 0 (0) 0.1916
    1 (5.6) 1 (2.4)   0.5302
    Vasopressors 2 (11.1) 1 (2.4) 1 (1.4) 0.0972
    2 (11.1)   1 (1.4) 0.0416
      1 (2.4) 1 (1.4) 0.7048
    2 (11.1) 1 (2.4)   0.1551
    Combined MACE 2 (11.1) 4 (9.5) 3 (4.2) 0.4180
    2 (11.1)   3 (4.2) 0.2572
      4 (9.5) 3 (4.2) 0.2588
    2 (11.1) 4 (9.5)   0.8510
    Minor complication 2 (11.1) 5 (11.9) 3 (4.2) 0.2773
    2 (11.1)   3 (4.2) 0.4078
      6 (14.3) 3 (4.2) 0.1176
    2 (11.1) 6 (14.3)   0.7403
    Procedural success 18 (100) 42 (100) 69 (97.2) 0.4239
    Deaths 0 (0) 1 (2.4) 0 (0) 0.3438
    0.5      
    Combined subgroups LVEF ≤ 30% (N = 18) LVEF > 30% (N = 113)  
    Bailout hemodynamic support required 2 (11.1) 2 (1.8) 0.0324
    IABP 1 (5.6) 1 (0.9) 0.1334
    Vasopressors 2 (11.1) 2 (1.8) 0.0324
    Combined MACE 2 (11.1) 7 (6.2) 0.4437
    Minor complication 2 (11.1) 8 (7.1) 0.4770
    Procedural success 18 (100) 111 (98.2) 0.5695
    Deaths 0 (0) 1 (0.9) 0.6887

     

    Abbreviations: IABP, intra-aortic balloon pump; LVEF, left ventricular ejection fraction; MACE, major adverse cardiac events.

     

    The incidence of in-hospital MACE was statistically similar amongst all three subgroups (LVEF ≤30%: 11.1%, LVEF 31–50%: 9.5%, LVEF >50%: 4.2%; = 0.4180). Combined subgroup analysis did not meet statistical significance (LVEF ≤30%: 11.1%, LVEF >30%: 6.2%; = 0.4437). No-reflow phenomenon was more common in the LVEF ≤30% subgroup (LVEF ≤30%: 11.1%, LVEF 31–50%: 2.4%, LVEF >50%: 0%; = 0.0190). Otherwise, no significant differences in individual components of in-hospital MACE were observed and the incidence of each component is provided in Table 5 . Hypotension requiring the addition of vasopressors and/or PCAD (LVEF ≤30%: 11.1%, LVEF 31–50%: 4.8%, LVEF >50%: 1.4%; = 0.1471) and bradycardia (LVEF ≤30%: 0%, LVEF 31–50%: 7.1%, LVEF >50%: 1.4%; = 0.1662) were the two most common components of in-hospital MACE. Of note, a temporary pacemaker was pre-emptively placed in 9 (6.9%) of cases. 

    Table 5
    Major Adverse Cardiac Events and Minor Periprocedural Complications.
     
    LVEF ≤ 30% (N = 18)LVEF 30–50% (N = 42)LVEF >50% (N = 71)value
    Major adverse cardiac events 2 (11.1) 4 (9.5) 3 (4.2) 0.4180
    Hypotension 2 (11.1) 2 (4.8) 1 (1.4) 0.1471
    Bradycardia 0 (0) 3 (7.1) 1 (1.4) 0.1662
    Ventricular arrhythmia 0 (0) 0 (0) 0 (0) Cannot be calculated
    No reflow 2 (11.1) 1 (2.4) 0 (0) 0.0190
    Tamponade 0 (0) 0 (0) 1 (1.4) 0.6533
    Dissection 0 (0) 0 (0) 1 (1.4) 0.6533
    Recurrent angina 0 (0) 0 (0) 1 (1.4) 0.6533
    Minor complications 2 (11.1) 5 (11.9) 3 (4.2) 0.2773
    Blood loss 0 (0) 1 (2.4) 1 (1.4) 0.7829
    Pseudoaneurysm 1 (5.6) 0 (0) 1 (1.4) 0.2724
    Hematoma 1 (5.6) 4 (9.5) 1 (1.4) 0.1338
    Deaths 0 (0) 1 (2.4) 0 (0) 0.3438

    No significant differences in the incidence of minor periprocedural complications or individual components was observed (LVEF ≤30%: 11.1%, LVEF 31–50%: 11.9%, LVEF >50%: 4.2%; = 0.2773). The incidence of each minor periprocedural complication is documented in Table 5 .

    Of one hundred and thirty-one patients included in our study, procedural success was achieved in 129 (98.5%) cases with no significant observations between subgroups (LVEF ≤30%: 100%, LVEF 31–50%: 100%, LVEF >50%: 97.2%; = 0.4239). In all cases, the burr was successfully delivered to the target lesion and subsequently removed without complication. One in-hospital death was observed in our study population, as the result of refractory conduction system abnormalities beginning forty hours post-intervention. Autopsy was declined.

    Discussion

    Clinical outcomes

    The primary endpoint of our study was to report the incidence of bailout hemodynamic support in patients undergoing RA and evaluate its association with ejection fraction. Analysis of each subgroup revealed a significant trend as bailout hemodynamic support was required more often in patients with reduced systolic function (LVEF ≤30%: 11.1% vs LVEF >30%: 1.8%; = 0.0324). Both instances of procedural hypotension in the LVEF ≤30% group were associated with transient no-reflow. The first patient had a good hemodynamic response to dopamine and no further intervention was required. The second case resulted in cardiogenic shock for which dopamine was provided, IABP placed, and mechanical ventilation initiated. In both cases, TIMI III flow was achieved prior to departure from the catheterization laboratory.

    The incidence of in-hospital MACE was not statistically different amongst all three subgroups nor did combined subgroup analysis meet statistical significance. Amongst all subgroups, hypotension and bradycardia were the most common components of in-hospital MACE. Two adverse events were reported in patients with LVEF ≤30%. Both cases involved procedural hypotension temporally associated with no-reflow phenomenon on coronary angiography, as previously described.

    Procedural success was achieved in all but two cases (LVEF ≤30%: 100%, LVEF 31–50%: 100%, LVEF >50%: 97.2%; = 0.4239). The first failed case, involved RA targeting the left main (unprotected), proximal, and middle left anterior descending (LAD) arteries. RA was performed without complication using a maximum burr size of 2.25 mm. In this case, the mid LAD stent could only be partially expanded due to hard underlying plaque and resulted in a residual 50% stenosis. There was good flow distal to the lesion and the stent remained patent at 7 months follow up. The second failed case involved a patient who developed recurrent angina following successful RA. Subsequent coronary angiogram revealed a 50% stenosis due to a soft plaque at the distal edge of a middle LAD stent which prompted additional intervention, which was successful. One death was observed in our study population. This patient presented with a non-ST elevated myocardial infarction prompting PCI with two drug-eluting stents to the proximal and middle LAD. Procedural success was achieved without intraoperative complication. Approximately forty hours post procedure, the patient developed 2:1 AV block followed by asystole which was unresponsive to resuscitative efforts. Autopsy was declined.

    Application of study findings

    Available data regarding RA and the necessity for PCADs in patients with reduced LVEF is minimal as most studies have utilized more encompassing inclusion criteria targeting high-risk PCI as a whole. Randomized controlled trials have failed to demonstrate meaningful differences in short term outcomes and would argue against the blanket use of PCAD in high-risk PCI. PROTECT II failed to demonstrate a meaningful difference in 30-day MACE between IABP or Impella 2.5 [  ]. BCIS-1 reported no benefit of elective IABP placement on in-hospital MACE or all-cause mortality at 6 months follow up [  ]. In addition, meta-analyses have not identified any benefit of IABP on early mortality [  ,  ]. Currently, only one guideline has established standardized criteria to define high-risk PCI and published recommendations on elective use of PCADs in this population [  ]. At this time, elective insertion of an appropriate hemodynamic support device is considered reasonable in carefully selected high-risk patients [  ].

    With regard to long-term outcomes, the BCIS-1 trial as well as a meta-analysis targeting more contemporary studies have reported a statistically significant reduction in long-term all-cause mortality with elective placement of an IABP [  ,  ]. The impact that long-term outcome data will have on future guideline recommendations and practice habits remains to be seen. Furthermore, the extent to which the aforementioned findings can be applied to RA is uncertain. The necessity for RA may select for a higher risk population with advanced age, additional comorbidities, and severe underlying cardiac pathology [  ]. This alone may result in worse overall outcomes despite optimal intervention.

    Short term outcomes of RA in patients with reduced LVEF have been reported by one previous study [  ]. Our study, along with data published by Ramana et al. in 2006, reports excellent periprocedural and in-hospital outcomes and demonstrates the feasibility of RA in patients with reduced LVEF (≤30%) with minimal need for bailout hemodynamic support. The prevalence of prolonged procedural hypotension requiring rescue IABP insertion in our study population was slightly less than a large multicenter RCT targeting high-risk PCI (5.6% vs 12.0%) [  ]. The increased utilization of bailout IABP (1 of 18 (5.5%) vs 0 of 23) compared to Ramana et al. is likely representative of small sample sizes as well as a natural progression of the clinical utility of RA. We feel that RA is presently utilized in patients with more complex and diffuse coronary lesions as well as more extensive revascularization procedures than what was targeted even 10 years ago. While our study reports similar prevalence of unprotected left main intervention (18.5% vs 17.6% in Ramana et al. vs Whiteside et al., respectively), our patients underwent more extensive revascularization procedures with 1.95 lesions/case (total population) and 2.0 lesions/case (LVEF ≤30%) compared to 1.17 lesions/case reported by Ramana et al. In-hospital MACE was comparable between the two studies (17.3% vs 11.1% in Ramana et al. vs Whiteside et al., respectively).

    Outcomes following hospital discharge in patients undergoing RA with reduced LVEF remains uncertain. While Romana et al. report no MACE at 30 days, their study was limited by its retrospective nature and would have missed events which took place outside of their respective medical record system. Our data, validates the peri-procedural and in-hospital findings of Ramana et al., however cannot validate their findings at 30 days. In addition to RA, orbital atherectomy has been studied in a similar population. A recently published study evaluating orbital atherectomy in reduced systolic function (LVEF 26–40%) reports excellent outcomes at one year [  ]. However, long term outcomes of orbital atherectomy in patients with LVEF ≤25% remains uncertain.

    Study limitations

    Our study is limited by the retrospective nature of the data collected. It is a non-randomized study and was conducted at a single center. Data was solely collected from the electronic medical record system at our institution. Our study is also limited by its sample size and short follow up period. Further investigation of long term outcomes in a similar patient population would be of benefit.

    Conclusion

    Patients with severely reduced LVEF (≤ 30%) are inherently at increased risk of MACE due to underlying cardiac pathology. Rotational atherectomy, performed by an experienced operator, can be safely and effectively utilized in this population. However, these patients are at increased risk of prolonged procedural hypotension requiring bailout hemodynamic support. In our population, no significant differences in in-hospital MACE or mortality were observed in patients with severely reduced LVEF (≤ 30%) despite a statistically significant increase in prolonged procedural hypotension. If indicated, prompt implementation of hemodynamic support may mitigate the impact of procedural hypotension on short term outcomes.

     

    Acknowledgments

    No additional acknowledgements beyond the individuals listed as authors who meet the specified conditions for authorship.

    The authors have no financial relationships to disclose.

     

     

    Author bio

    Cardiovascular Revascularization Medicine, 2018-09-01, Volume 19, Issue 6, Pages 660-665, Copyright © 2018 Elsevier Inc.

     

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