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4. Data to Delivery: CHIP-BCIS3 — Microaxial Flow Pump Support for High-Risk Complex PCI with Dr. Saraschandra Vallabhajosyula

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CathMasters host Dr. Li Pang, member of the CardioNerds Interventional Cardiology Council, and expert faculty Dr. Saraschandra Vallabhajosyula discuss the landmark CHIP-BCIS3 trial (Controlled Trial of High-Risk Coronary Intervention with Percutaneous Left Ventricular Unloading), published in the New England Journal of Medicine in 2026. 

Using a representative case of an 84-year-old man with ischemic cardiomyopathy (LVEF 25%), NSTEMI, and severe multivessel calcified coronary artery disease requiring left main bifurcation PCI and calcium modification in a left-dominant coronary system, the episode walks through the background evidence gap, trial design, key results, limitations, and practical implications for interventional cardiologists managing complex high-risk indicated PCI (CHIP). The discussion contextualizes CHIP-BCIS3 within the broader landscape of mechanical circulatory support trials, including BCIS-1, PROTECT II, DanGer Shock, and the upcoming PROTECT IV.

CathMasters is for educational purposes only.

CathMasters is for educational purposes only. Music by Elijah K from Pixabay

Pearls
  1. CHIP-BCIS3 showed no benefit of elective microaxial flow pump (Impella CP) support over standard care PCI in patients with severely impaired LV function undergoing complex PCI (win ratio 0.85; 95% CI 0.63–1.15). A signal toward higher cardiovascular death was observed in the mAFP arm (26.7% vs 14.5%; HR 1.91; 95% CI 1.11–3.30), warranting caution.
  2. “The pump is not a bulletproof vest.” The presence of a mechanical circulatory support device should not create a false sense of security that leads operators to pursue more aggressive, single-session complete revascularization. Interventionalists have the privilege of staging procedures — and should use it when appropriate.
  3. Right heart catheterization before high-risk PCI provides useful information to fully characterize the hemodynamic substrate (cardiac output, filling pressures, pulmonary hypertension) and guide decision-making regarding MCS, rather than reflexively placing a device based on anatomy alone.
  4. Not all CHIP is created equal. The trial enrolled a heterogeneous population — left main bifurcation PCI, multivessel calcium modification, and retrograde CTO — each carrying different prognostic implications and procedural risk profiles. Retrograde CTO, performed primarily for symptom relief, may not carry the same prognostic weight as left main revascularization.
  5. Vascular access planning matters. CHIP-BCIS3 mandated pre-procedural vascular imaging (CT, ultrasound, or invasive angiography) before mAFP insertion, contributing to record-low vascular complication rates (16.9% mAFP vs 10.6% standard care, mostly minor). This rigorous protocol may underestimate real-world vascular complications but sets a standard for best practice.
Notes

1. Background and Evidence Gap

  • Complex PCI in patients with severely impaired LV function carries a high risk of hemodynamic collapse, periprocedural MI, and death. Percutaneous mechanical circulatory support (pMCS) has been increasingly used to mitigate these risks — a strategy termed “Protected PCI.”
  • Prior to CHIP-BCIS3, no randomized trial had compared the elective use of a microaxial flow pump with PCI without planned MCS. The existing evidence base included:
    • BCIS-1 (2010; long-term follow-up 2013): 301 patients with LVEF ≤30% and BCIS Jeopardy Score ≥8 randomized to elective IABP vs. no planned IABP during high-risk PCI. No difference in the primary composite of MACCE at 28 days (15.2% vs 16.0%). However, long-term follow-up at a median of 51 months showed a 34% relative reduction in all-cause mortality with elective IABP (HR 0.66; 95% CI 0.44–0.98).
    • PROTECT II (2012): 452 patients randomized to Impella 2.5 vs. IABP during high-risk PCI. Stopped early for futility — no difference in 30-day MAE (35.1% vs 40.1%). Impella provided superior hemodynamic support. A trend toward lower 90-day MAE was observed in the per-protocol Impella arm.
    • PROTECT III: A post-marketing registry (not a randomized trial) of 1,143 patients showing lower 90-day MACCE with Impella 2.5/CP compared to historical PROTECT II controls.
  • The 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization gave a Class 2b (Level of Evidence B-R) recommendation: “In selected high-risk patients, elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable.”
  • Despite limited evidence, the FDA approved Impella for high-risk PCI in 2015 (severe LV dysfunction) and expanded the indication in 2018 (mildly reduced EF), leading to rapid adoption.

2. CHIP-BCIS3 Study Design and Methodology

  • Design: Prospective, multicenter, open-label, randomized controlled trial
  • Funder: UK National Institute for Health and Care Research (NIHR) — independent of device manufacturer
  • Sites: 21 NHS hospitals in the United Kingdom
  • Enrollment: August 2021 – December 2024; 300 patients randomized 1:1
  • Intervention: Elective Impella CP insertion prior to PCI (mAFP arm, n=148) vs. standard care PCI without planned MCS (n=152)
  • Inclusion criteria (all three required):
    • Severely impaired LV systolic function: LVEF <35%, or severe MR with LVEF <40%
    • Large area of jeopardized myocardium: BCIS Jeopardy Score >8/12
    • Complex coronary intervention: (a) True left main bifurcation PCI with CTO of RCA or left-dominant system; (b) Multivessel calcium modification involving LM, final patent conduit, or SYNTAX ≥32; or (c) Retrograde CTO PCI
  • Exclusion criteria: Cardiogenic shock or STEMI at randomization
  • Primary outcome: Hierarchical composite analyzed by win ratio — death from any cause, disabling stroke, spontaneous MI, hospitalization for cardiovascular causes, and periprocedural myocardial injury (minimum 12-month follow-up)
  • Key protocol features:
    • Pre-procedural vascular imaging (CT, ultrasound, or invasive angiography) mandated before mAFP insertion
    • Complete revascularization encouraged during the index procedure; staged PCI required pre-specification
    • Bailout MCS (IABP or VA-ECMO) permitted in the standard-care arm

3. Baseline Characteristics

  • Well-balanced between groups (slight excess of diabetes in mAFP arm)
  • 83% male; median age 73 years; 85% Caucasian, 12% South Asian
  • 76% presented with acute coronary syndrome
  • 40% had significant angina (CCS III/IV) or heart failure symptoms (NYHA III/IV)
  • Median LVEF: 27% (both groups)
  • Median BCIS Jeopardy Score: 12/12 (maximum jeopardy)
  • Median SYNTAX score: 38 (high complexity)
  • 72% underwent left main PCI; 81% required atherectomy; 27% underwent retrograde CTO

4. Procedural Details

  • mAFP insertion unsuccessful in 4 patients (3%) due to obstructive PAD
  • Bailout MCS in standard-care arm: 9 patients (6.0%) — 8 IABP, 1 Impella CP
  • Staged PCI: 6.8% in mAFP arm vs. 17.9% in standard-care arm (more single-session complete revascularization in the mAFP arm)
  • Median procedure duration: 188 min (mAFP) vs. 139 min (standard care)
  • Median lesions treated: 3 (mAFP) vs. 2 (standard care)
  • Calcium modification: 71% in both arms; IVL was the primary modality (81% vs 66%), followed by rotational atherectomy (55% vs 59%)
  • Intravascular imaging: 91% vs 93% (high utilization in both arms)
  • Median mAFP support time: 134 min (device removed at end of PCI in most cases)

5. Key Results

  • Primary outcome (win ratio): 0.85 (95% CI 0.63–1.15; P=0.30) — no significant difference between mAFP and standard care. 36.6% of pairwise comparisons favored mAFP; 43.0% favored standard care.
  • All-cause death: 47 patients (32.6%, mAFP) vs. 33 patients (23.4%, standard care); HR 1.54 (95% CI 0.99–2.41) — numerically higher in the mAFP arm, borderline significance.
  • Cardiovascular death (prespecified secondary outcome): 26.7% vs. 14.5%; HR 1.91 (95% CI 1.11–3.30) — significantly higher in the mAFP arm, with an absolute increase of 12.2 percentage points at 24 months.
  • Periprocedural myocardial injury (per patient): 61.7% in the mAFP group compared to 50.0% with standard care (RR 1.23; 95% CI 0.99–1.54). While numerically higher in the pump cohort, this did not reach statistical significance. Note: While the primary manuscript reports per-patient data, the podcast discussion highlights “per procedure” results from Supplementary Table 10 (61% vs 44%; 95% CI 1.11–1.75), suggesting a more pronounced signal of injury per intervention.
  • Vascular complications: 16.9% (mAFP) vs. 10.6% (standard care) — mostly minor; record-low rates attributed to mandated vascular imaging protocol.
  • Procedural complications (VT/VF, CPR, pulmonary edema, prolonged hypotension): similar between groups.

6. Interpretation and Clinical Implications

  • CHIP-BCIS3 challenges the prevailing assumption that elective Impella CP support during high-risk PCI improves outcomes. The trial found no benefit and a concerning signal toward increased cardiovascular death.
  • Several factors may explain the findings:
    • “Go all-in” behavior: The mAFP arm had longer procedures, more lesions treated, and less staged PCI — suggesting operators pursued more aggressive single-session revascularization when the pump was in place. This may have contributed to higher periprocedural myocardial injury.
    • Periprocedural myocardial injury: The mAFP arm had significantly more myocardial injury per procedure, contrary to the hypothesis that the pump would ameliorate ischemia. Whether this contributed to the observed CV mortality difference remains unclear.
    • Short support duration: Median support time of 134 minutes suggests the device was removed at the end of PCI in most cases, without extended post-procedural hemodynamic support — a practice that may not allow recovery from myocardial stunning.
  • The trial does not mean MCS should never be used in high-risk PCI. Rather, it argues against routine, elective use and supports individualized decision-making based on hemodynamic assessment.
  • Importantly, these results apply to elective/non-emergent high-risk PCI and cannot be extrapolated to cardiogenic shock, where the DanGer Shock trial demonstrated a mortality benefit with Impella CP in STEMI-related cardiogenic shock (HR 0.74; 95% CI 0.55–0.99).

7. Limitations

  • Sample size: 300 patients — relatively small, though event rates exceeded pre-trial estimates, reducing the risk of type II error.
  • Open-label design: Operators knew the treatment assignment, which may have influenced procedural behavior (more aggressive revascularization in the mAFP arm).
  • Heterogeneous CHIP population: Retrograde CTO, left main bifurcation PCI, and multivessel calcium modification carry different risk profiles and prognostic implications — lumping them together may dilute or confound treatment effects.
  • Vascular complication rates may be artificially low: The mandated pre-procedural vascular imaging protocol may not reflect real-world practice, potentially underestimating the downside of large-bore access.
  • Short post-procedural support: Most devices were removed at the end of PCI. The trial did not evaluate extended hemodynamic support or standardized weaning protocols.
  • UK-only enrollment: 85% Caucasian population; generalizability to other healthcare systems and demographics requires consideration.
  • No hemodynamic substudy data yet: A prespecified hemodynamic substudy may provide mechanistic insight into the role of LV unloading and myocardial stunning.
  • Diverging mortality curves: Death and adverse event curves appeared to diverge in favor of standard care over time, suggesting longer follow-up is unlikely to reverse the findings.

8. Case Application

  • The case patient (84-year-old, LVEF 25%, NSTEMI, left-dominant system with distal LM 80%, severe multivessel calcified CAD) meets all CHIP-BCIS3 inclusion criteria.
  • The team performed right heart catheterization first (CO 4.3 L/min, CI 2.4, RAP 10, PCWP 15) — confirming compensated hemodynamics.
  • Given the complexity (DK CRUSH bifurcation stenting for LM, IVL in LAD and LCx, left-dominant system with entire coronary circulation dependent on the LM), the team elected to proceed with Impella CP support.
  • Key decision points informed by CHIP-BCIS3:
    • Staging was considered but not feasible for the LM bifurcation component
    • RHC was performed to characterize hemodynamic reserve before committing to MCS
    • Post-PCI hemodynamics were reassessed on Impella P2 support before removal
    • Device was removed with pre-deployed Perclose sutures without complications

9. Future Directions

  • PROTECT IV: Prospective, multicenter, randomized trial (n=1,252) comparing Impella CP supported PCI vs. PCI with or without IABP in patients with LVEF ≤40% and complex CAD deemed at excessive surgical risk. Primary endpoint: composite of all-cause death, stroke, MI, unplanned revascularization, durable LVAD/transplant, or CV hospitalization at 3 years. Results will provide the largest randomized dataset in this space.
  • CHIP-BCIS3 hemodynamic substudy: Prespecified substudy evaluating detailed hemodynamic assessments before and during PCI — may clarify the mechanistic role of LV unloading and myocardial stunning.
  • Intra-procedural hemodynamic monitoring: Future studies should evaluate real-time parameters such as loss of Impella pulsatility (indicating LV standstill during balloon inflation), which may guide procedural strategy (e.g., shorter balloon inflations, switching atherectomy modality).
  • Post-procedural MCS management: Standardized weaning protocols and extended post-procedural support strategies need investigation — the optimal duration of hemodynamic support after high-risk PCI remains undefined.
  • Patient selection refinement: Better tools to identify which CHIP patients may benefit from MCS (e.g., those with the most tenuous hemodynamics, single-vessel-dependent circulations) vs. those who can safely undergo PCI without support.
References
  1. ⭐ Perera D, Ryan M, Ezad SM, et al. Left ventricular unloading in high-risk percutaneous coronary intervention. N Engl J Med. 2026;394(13):1271-1281. doi:10.1056/NEJMoa2415498. https://www.nejm.org/doi/full/10.1056/NEJMoa2415498
  2. ⭐ Ryan M, Ezad SM, Webb I, et al. Percutaneous left ventricular unloading during high-risk coronary intervention: rationale and design of the CHIP-BCIS3 randomized controlled trial. Circ Cardiovasc Interv. 2024;17(3):e013367. doi:10.1161/CIRCINTERVENTIONS.123.013367. https://pubmed.ncbi.nlm.nih.gov/38410944
  3. Perera D, Stables R, Thomas M, et al. Elective intra-aortic balloon counterpulsation during high-risk percutaneous coronary intervention: a randomized controlled trial (BCIS-1). JAMA. 2010;304(8):867-874. doi:10.1001/jama.2010.1190.
  4. ⭐ Perera D, Stables R, Clayton T, et al. Long-term mortality data from the Balloon Pump-Assisted Coronary Intervention Study (BCIS-1): a randomized, controlled trial of elective balloon counterpulsation during high-risk percutaneous coronary intervention. Circulation. 2013;127(2):207-212. doi:10.1161/CIRCULATIONAHA.112.132209. https://pubmed.ncbi.nlm.nih.gov/23224207
  5. O’Neill WW, Kleiman NS, Moses J, et al. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation. 2012;126(14):1717-1727. doi:10.1161/CIRCULATIONAHA.112.098194.
  6. ⭐ Møller JE, Engstrøm T, Jensen LO, et al. Microaxial flow pump or standard care in infarct-related cardiogenic shock. N Engl J Med. 2024;390(15):1382-1393. doi:10.1056/NEJMoa2312572. https://www.nejm.org/doi/full/10.1056/NEJMoa2312572
  7. Lawton JS, Tamis-Holland JE, Bangalore S, et al. 2021 ACC/AHA/SCAI guideline for coronary artery revascularization: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022;79(2):e21-e129. doi:10.1016/j.jacc.2021.09.006.
  8. Rihal CS, Naidu SS, Givertz MM, et al. 2015 SCAI/ACC/HFSA/STS clinical expert consensus statement on the use of percutaneous mechanical circulatory support devices in cardiovascular care. J Am Coll Cardiol. 2015;65(19):e7-e26. doi:10.1016/j.jacc.2015.03.036.
  9. Pahuja M, Johnson A, Kabir R, et al. Randomized trials of percutaneous microaxial flow pump devices: JACC state-of-the-art review. J Am Coll Cardiol. 2022;80(21):2028-2049. doi:10.1016/j.jacc.2022.09.048.
  10. ⭐ Mangner N, Sharma SK, O’Connor C, et al. Mechanical circulatory support in high-risk elective PCI: rationale and design of the PROTECT IV trial. EuroIntervention. 2025;21(15):e1057-e1067. doi:10.4244/EIJ-D-24-00893. https://pubmed.ncbi.nlm.nih.gov/41024656
  11. Protty M, Sharp ASP, Gallagher S, et al. Defining percutaneous coronary intervention complexity and risk: an analysis of the United Kingdom BCIS database 2006-2016. JACC Cardiovasc Interv. 2022;15(1):39-49. doi:10.1016/j.jcin.2021.09.039.
  12. Parikh PB, Bhatt DL, Bhasin V, et al. Impact of percutaneous coronary intervention on outcomes in patients with heart failure: JACC state-of-the-art review. J Am Coll Cardiol. 2021;77(19):2432-2447. doi:10.1016/j.jacc.2021.03.310.
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WEBVTT
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- Yeah. You couldn't have picked a more challenging
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- case. This is literally ticks every box in
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- any complex and high risk definition
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- for coronary disease.
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- Hi, cardio nerds. Welcome to Cathmasters,
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- our new podcast dedicated to interventional cardiology advancement
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- and education.
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- I am B Pan, interventional cardiology fellow at
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- Henry Ford Hospital,
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- previous cardiology fellow at West Virginia University, and
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- a member of the CardioNerd's interventional cardiology council.
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- Today, we are diving into CHEAP thesis three
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- trial,
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- a practice changing study for anyone interested in
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- complex high risk PCI.
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- I'm very excited to be joined by our
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- expert faculty,
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- doctor Saros Chandra Vilabhajasila.
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- And doctor Virabhadrasila
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- is an interventional and critical care cardiologist
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- at Browning University
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- Health Cardiovascular Institute,
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- where he also serves as director of the
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- coronary care unit at Rhode Island and the
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- Merriam Hospital.
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- Doctor Villabadisula's
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- work spans cardiogenic shock, mechanical circulatory support, critical
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- care cardiology,
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- and outcome research. So I can't think of
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- a better person to help us unpack the
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- implications
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- of this trial
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- for contemporary interventional cardiology practice.
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- Thanks, Lee. Thanks for the kind introduction, and,
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- many thanks to Amit and others from CardioNuds
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- for roping me in. Truly my privilege to
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- join you guys, and hopefully,
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- I learn from you guys as much as
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- possible during this next few many minutes discussing
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- the trial.
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- It's such an honor to have you, doctor
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- Vilabhadrasil.
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- Let's get started with the case presentation.
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- We have an 84 year old gentleman
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- with a history of chronic heart failure
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- with a LVEF thirty eight percent
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- and history of complete heart block
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- who received left bundle area pacing.
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- He presented with a known ST elevation MI
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- respiratory distress,
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- worsening up LVF
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- from thirty eight percent to twenty five percent.
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- His high sensitivity
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- troponin was more than 20,000.
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- Primary angiography
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- showed severe multivesome CAD
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- with distal left to main, 80% stenosis,
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- proximal
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- LAD, 90% stenosis,
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- proximal CERC, 90% stenosis,
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- OM 80%
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- stenosis,
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- and distal CERC, 99%
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- stenosis.
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- He has left dominant coronary artery system, and
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- all the vessels were severely calcified.
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- The patient was referred to us for PCI.
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- His respiratory status improved
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- after diuresis.
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- So let's pause here. This is exactly the
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- patient one of us given his,
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- multivessel CED severe reduced EF,
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- and we anticipate he would need extensive calcium
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- modification
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- during the PCI.
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- So what do we know about this population,
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- and how should we plan for his PCI?
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- Before CHIP BC three trial, what did we
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- know about the management of this patient, doctor
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- Virabhadjesula?
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- Yeah. You couldn't have picked a more challenging
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- case. This is literally ticks every box in
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- any complex and high risk definition
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- for, coronary disease.
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- So first things first, I think
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- we need more information.
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- While you did read out the findings of
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- the cat films to me, there's no substitute
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- to actually reviewing the images, as you know,
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- as as do many of our, listeners that
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- every interventionist wants to look at the films
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- before he or she makes up their mind
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- as to what they want to do. Number
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- one. Number two, there is no substitute for
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- actually physically visiting with this patient and speaking
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- with them, understanding their priorities,
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- looking at their makeup,
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- in terms of frailty, in terms of commodities,
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- in terms of just passing what we call
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- the eyeball test. Right? So I think those
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- are two big things I would like to
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- know, number one. Number two is I would
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- like more minds than just mine involved in
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- this case. So this would be a great
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- case to have a heart team discussion where
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- it's the patient's primary not noninvasive cardiologist
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- involving the inpatient cardiologist who's taking care of
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- them. Open the cardiac surgical service and see
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- what their thoughts are. And then as a
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- group, you see what your options are and
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- what the patient's preferences are and try to
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- line it up. The fact that we're discussing
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- an interventional trial makes me biased in the
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- sense that we're going to go down a
115
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- PCI pathway. So from a PCI standpoint, what
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- do we know for such patients, number one?
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- The first thing we know is that this
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- patient's extremely high risk, and high risk is
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- classified in three different categories. And when I
120
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- look at a patient, there is the physical
121
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- presence of the patient, how they look, what
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- they what comorbidities they carry, what their ambulatory
123
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- status is, how functional they were before they
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- walked into the hospital for this particular admission,
125
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- number one. The second thing I look at
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- is what the anatomy is like, which is
127
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- what you described, which sounds pretty high risk
128
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- and sounds like it is the entire coronary
129
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- circulation is coming off this left median with
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- the right being not too contributive.
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- And the third thing I look at is
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- what their, cardiac function is independent of the
133
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- coronary is what their ventricular function is, what
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- their valvular heart disease status is, what their
135
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- obviously what their EF, what their hemodynamics are.
136
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- They're filling pressures, cardiac output, cardiac headache, pulmonary
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- presence of pulmonary hypertension,
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- how compensated or otherwise they are. So these
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- are the big things that I think about
140
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- when I see these patients. And in these
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- patient substrates, historically, we've had trials that have
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- looked at doing nothing as in medical management,
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- which is very reasonable,
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- which may, you know, prevent us from doing
145
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- any harm for the patient.
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- If we were to if this patient were
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- to undergo surgery, there are a whole different
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- set of considerations which we'll try to stay
149
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- away from for now. And if this patient
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- would undergo PCI, then you start thinking what
151
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- is the appropriate way to stress gratify them
152
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- for mechanical circulatory support if they need mechanical
153
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- circulatory support. Again, the data for how to
154
00:05:55.884 --> 00:05:58.605
- pick MCS is very variable. It's very operator
155
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- dependent, patient dependent, practice dependent, local culture, institutional,
156
00:06:02.524 --> 00:06:04.865
- mindsets, etcetera. From a data standpoint,
157
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- the the three devices we know of are
158
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- integrated balloon pump,
159
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- microaxial flow pump or Impella CP, which is
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- for cutaneous,
161
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- and the VA ECMO.
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- The balloon pump hasn't particularly borne out in
163
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- clinical trials. There was the BSIS one trial
164
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- from The UK and then the CRISP AMI
165
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- trial, which is mostly an AMI without shock.
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- And then there's obviously IABP shock, which is
167
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- a cardiogenic shock. So across the spectrum of
168
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- these three subsets of stable coronary disease,
169
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- acute coronary syndrome, and acute coronary syndrome with
170
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- cardiogenic shock, it didn't particularly bear out, to
171
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- have any meaningful outcomes. The cardiac output augmentation
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- is minimal,
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- and the coronary flow improvement is real. It
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- does prevent ischemia. It does prevent the negative
175
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- spiral. Anecdotally, I've used it quite a bit
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- in my practice. I'm sure many dimensionals on
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- this call have, but the the data are
178
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- pretty limited.
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- The microacture flow pop up until BSIS three
180
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- was published.
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- I think we know from the PROTECT series
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- of trials, there were three PROTECT
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- trials, a third of which is a post
184
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- marketing registry, so we'll stay away from that.
185
00:07:03.604 --> 00:07:06.180
- PROTECT one was a feasibility study, and then
186
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- PROTECT two specifically compared it to the intra
187
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- aortic balloon file. Again, PROTECT two one and
188
00:07:11.060 --> 00:07:13.060
- two were both with the impeller 2.5, which
189
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- is not the current iteration. We use a
190
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- CP, which gives you about 3.3 to 3.5
191
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- liters of hemodynamic support.
192
00:07:19.095 --> 00:07:21.654
- Both of these showed comparable outcomes between the
193
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- IBP and the Impella. And then there there
194
00:07:23.975 --> 00:07:24.875
- are no real
195
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- landmark randomized trials of, via ECMO, but, again,
196
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- it's largely more of a bailout device in
197
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- the stable patient rather than an upfront device,
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- which may be the case in shock patients.
199
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- Thank you so much. That's such a nice
200
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- review of the previous evidence and the trials.
201
00:07:41.470 --> 00:07:42.910
- So the CHIP BCS,
202
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- three trial is designed to answer the question
203
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- with the current generation of micro axial flow
204
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- pump IMPELA
205
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- CP
206
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- compared to standard of care. It is a
207
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- prospective
208
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- multicenter open label randomized
209
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- control trial
210
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- conducted across 21 sites in The UK funded
211
00:08:02.814 --> 00:08:03.714
- by NIHCR.
212
00:08:04.620 --> 00:08:08.139
- Its target population is patients who undergo high
213
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- risk PCI.
214
00:08:09.420 --> 00:08:12.240
- High risk was defined by three aspects.
215
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- First,
216
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- severely impaired LV systolic function, which means
217
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- LVEF less than 35%
218
00:08:20.095 --> 00:08:22.035
- or severe mitral regurgitation
219
00:08:22.415 --> 00:08:24.355
- with EF less than 40%.
220
00:08:25.295 --> 00:08:25.795
- Second,
221
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- large area of jeopardized myocardium at risk, which
222
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- was quantified
223
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- by BC's
224
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- jeopardy score more than eight out of twelve
225
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- based on the coronary anatomy.
226
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- For example, for three vessels CAD, at least
227
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- one vessel has proximal lesion
228
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- is, BC's jeopardy score, eight.
229
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- Third, the complexity of coronary intervention,
230
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- including true left main bifurcation PCI with CTO
231
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- of RCA or left dominant
232
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- or multivessel
233
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- calcium modification
234
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- involving left main or final cadence conduit or
235
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- a Cintas score more than 32.
236
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- Third, retrograde CTO.
237
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- Patients who are in cardiogenic shock or having
238
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- ST elevation MI at the time of randomization
239
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- are excluded.
240
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- Doctor Vilabajasila,
241
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- would you say the patient's population enrolled in
242
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- this study
243
00:09:23.639 --> 00:09:26.840
- truly reflects a high risk complex coronary disease
244
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- cohort?
245
00:09:27.960 --> 00:09:30.279
- Most definitely. I think it's a very enriched
246
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- cohort. And as you identified, there are many
247
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- substrates
248
00:09:33.720 --> 00:09:36.040
- that they have picked across the coronary, the
249
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- ventricular,
250
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- and the comorbidity
251
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- spectrum.
252
00:09:39.555 --> 00:09:42.435
- So I think it's, a very meaningful definition
253
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- of chip with the right exclusions of cardiogenic
254
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- shock and STEMI, which are obviously slightly more
255
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- time sensitive,
256
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- indications.
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- Excellent.
258
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- I actually have a question regarding the inclusion
259
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- criteria.
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- Specifically,
261
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- during the inclusion criteria,
262
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- it views retrograde CT or PCI
263
00:10:02.069 --> 00:10:05.004
- equally high risk as the other two, which
264
00:10:05.004 --> 00:10:08.865
- is left main bifurcation PCI and multivessel calcium
265
00:10:08.924 --> 00:10:11.964
- modification. What are your thoughts about that? That's
266
00:10:11.964 --> 00:10:14.625
- a tremendous question. There are so many ways
267
00:10:14.684 --> 00:10:17.565
- that these different subsets are perceived. It's tough
268
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- to say that we are truly comparing apples
269
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- to apples. The reason I say that is
270
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- because, number one, prognostically,
271
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- why are we doing what we are doing?
272
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- Right? So
273
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- CHIP is a mixed spectrum of patients with
274
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- heart failure to either decompensated or chronic compensated.
275
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- It also includes stable CAD with high anatomical
276
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- complexity.
277
00:10:40.235 --> 00:10:42.794
- It includes CTOs, which is a subsection of
278
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- stable CAD, but slightly different in the sense
279
00:10:44.955 --> 00:10:46.990
- of the data just not as strong. And
280
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- then it includes acute coronary syndrome where actually
281
00:10:49.389 --> 00:10:52.190
- PCI has quite a significant role. So the
282
00:10:52.190 --> 00:10:55.309
- problem is in order to improve your sample
283
00:10:55.309 --> 00:10:57.790
- size or improve your generalizability or enrollment for
284
00:10:57.790 --> 00:11:01.170
- a given trial, you are including very diverse
285
00:11:01.230 --> 00:11:01.730
- substrates
286
00:11:02.475 --> 00:11:04.634
- and not every substrate amongst these list of
287
00:11:04.634 --> 00:11:07.214
- sub list of patients actually benefits from PCI.
288
00:11:07.514 --> 00:11:09.115
- And that's the challenge. So I think you've
289
00:11:09.115 --> 00:11:10.954
- identified it very well right up front where
290
00:11:10.954 --> 00:11:11.674
- you said that,
291
00:11:12.475 --> 00:11:14.075
- this left main is not the same as
292
00:11:14.075 --> 00:11:15.695
- a CTO. It's not the same as coronary
293
00:11:15.754 --> 00:11:16.975
- calcification modification.
294
00:11:17.420 --> 00:11:18.080
- And, honestly,
295
00:11:18.540 --> 00:11:20.540
- I would read genuinely say that a retrograde
296
00:11:20.540 --> 00:11:23.420
- CTO probably does not belong in this group
297
00:11:23.420 --> 00:11:25.660
- because, honestly, we do it for symptom relief,
298
00:11:25.660 --> 00:11:28.460
- which is rarely urgent and almost never has
299
00:11:28.460 --> 00:11:31.195
- any prognostic benefit. There's some data that it
300
00:11:31.195 --> 00:11:33.514
- may improve l improve the LVEF, but those
301
00:11:33.514 --> 00:11:34.975
- are pretty, sparse.
302
00:11:35.355 --> 00:11:36.715
- But we we know for a fact that
303
00:11:36.715 --> 00:11:38.715
- distal left main has prognostic benefits. We know
304
00:11:38.715 --> 00:11:40.634
- that these patients do very well both from
305
00:11:40.634 --> 00:11:43.455
- the LVEF standpoint and clinical symptoms and longevity
306
00:11:43.675 --> 00:11:45.295
- standpoint if they were to be revascularized.
307
00:11:45.889 --> 00:11:48.629
- Calcium modification is tricky because I don't think
308
00:11:49.009 --> 00:11:49.509
- we
309
00:11:49.889 --> 00:11:51.649
- again, we are I think we run the
310
00:11:51.649 --> 00:11:53.490
- risk of lumping rather than splitting where I
311
00:11:53.490 --> 00:11:55.090
- believe there is a lot of granularity to
312
00:11:55.090 --> 00:11:55.990
- calcium modification.
313
00:11:56.450 --> 00:11:59.445
- Because use of intravascular lithotripsy in the last,
314
00:11:59.524 --> 00:12:02.825
- you know, five to six years has significantly
315
00:12:02.965 --> 00:12:05.065
- democratized the use of calcium modification.
316
00:12:05.524 --> 00:12:07.524
- Previously, we used to use higher risk tools
317
00:12:07.524 --> 00:12:10.585
- such as, rotation atherectomy or orbital atherectomy,
318
00:12:11.365 --> 00:12:13.259
- but now we have walked away from that
319
00:12:13.259 --> 00:12:14.940
- for a large portion of our patients where
320
00:12:14.940 --> 00:12:17.419
- IVL is really picked up. Again, these are
321
00:12:17.419 --> 00:12:19.899
- all mutually complimentary tools. So we use one
322
00:12:19.899 --> 00:12:21.740
- when we but the other doesn't work and
323
00:12:21.740 --> 00:12:23.679
- comp one complement one with the other,
324
00:12:24.059 --> 00:12:26.985
- but that's also a spectrum of risk. I
325
00:12:26.985 --> 00:12:28.945
- don't think they're all made equal either in
326
00:12:29.065 --> 00:12:31.625
- within calcium modification or all these different substrates
327
00:12:31.625 --> 00:12:34.684
- that you mentioned. I absolutely agree with you.
328
00:12:35.144 --> 00:12:38.985
- The calcium modification tools have different categories as
329
00:12:38.985 --> 00:12:39.485
- well,
330
00:12:39.860 --> 00:12:43.220
- and, we can't just, put them in all
331
00:12:43.220 --> 00:12:44.199
- the same box.
332
00:12:44.740 --> 00:12:47.079
- So for this study, once patients
333
00:12:47.539 --> 00:12:49.159
- met, inclusion criteria,
334
00:12:49.539 --> 00:12:51.480
- they underwent one to one randomization
335
00:12:51.940 --> 00:12:53.320
- to protected PCI
336
00:12:53.815 --> 00:12:54.634
- with the microaxial
337
00:12:55.014 --> 00:12:58.475
- flow pump versus standard care PCI without MCS
338
00:12:58.615 --> 00:12:59.115
- support.
339
00:12:59.575 --> 00:13:02.555
- The microaxial flow pump used in this study
340
00:13:02.615 --> 00:13:05.894
- was Impena CP. All the patients prior to
341
00:13:05.894 --> 00:13:07.595
- microaxial flow pump implant
342
00:13:08.159 --> 00:13:11.440
- underwent imaging to screen for PAD at the
343
00:13:11.440 --> 00:13:13.779
- access site, including CT,
344
00:13:14.159 --> 00:13:16.100
- ultrasound, and invasive angiography.
345
00:13:16.879 --> 00:13:18.579
- If PAD was detected,
346
00:13:19.120 --> 00:13:19.620
- multidisciplinary
347
00:13:20.240 --> 00:13:23.459
- team was involved for vascular access planning.
348
00:13:24.195 --> 00:13:25.175
- Complete revascularization
349
00:13:25.715 --> 00:13:27.975
- was encouraged during the same procedure.
350
00:13:28.514 --> 00:13:31.014
- If planning for stage PCI,
351
00:13:31.394 --> 00:13:34.195
- it needed to be specified before starting the
352
00:13:34.195 --> 00:13:34.695
- procedure.
353
00:13:35.235 --> 00:13:38.139
- The MCS plan for the standard care arm
354
00:13:38.139 --> 00:13:40.940
- was the use of intra aortic balloon pump
355
00:13:40.940 --> 00:13:42.799
- or VE ECMO as bailout.
356
00:13:43.259 --> 00:13:45.580
- The primary outcome of this study was a
357
00:13:45.580 --> 00:13:46.879
- hierarchical composite
358
00:13:47.340 --> 00:13:51.279
- of death from all cause, disabling stroke,
359
00:13:51.644 --> 00:13:53.504
- spontaneous myocardial infarction,
360
00:13:54.045 --> 00:13:54.545
- cardiovascular
361
00:13:54.925 --> 00:13:55.425
- hospitalization,
362
00:13:55.965 --> 00:13:56.705
- and paratranscedural
363
00:13:57.565 --> 00:13:58.785
- myocardial injury,
364
00:13:59.565 --> 00:14:02.545
- analyzed by means of a win ratio calculated
365
00:14:02.764 --> 00:14:04.865
- with all available follow-up data.
366
00:14:05.330 --> 00:14:08.250
- From August 2021 through December
367
00:14:08.250 --> 00:14:09.089
- 2024,
368
00:14:09.090 --> 00:14:12.129
- a total of 300 patients were enrolled across
369
00:14:12.129 --> 00:14:14.149
- 21 hospitals in The UK.
370
00:14:14.610 --> 00:14:17.009
- One hundred and forty eight patients were assigned
371
00:14:17.009 --> 00:14:19.754
- to receive micro axial flow pump and one
372
00:14:19.754 --> 00:14:22.975
- hundred fifty two patients to receive standard cure.
373
00:14:23.195 --> 00:14:25.835
- The median follow-up was twenty two month. All
374
00:14:25.835 --> 00:14:28.634
- the patients had at least twelve months of
375
00:14:28.634 --> 00:14:29.134
- follow-up.
376
00:14:29.835 --> 00:14:30.495
- The demographic
377
00:14:30.795 --> 00:14:32.175
- and clinical characteristics
378
00:14:32.555 --> 00:14:33.215
- of patients
379
00:14:33.940 --> 00:14:36.759
- are mostly well balanced between the two groups,
380
00:14:37.059 --> 00:14:40.360
- except for a slightly higher percentage of diabetes
381
00:14:40.740 --> 00:14:42.839
- in micro axial flow pump arm.
382
00:14:43.699 --> 00:14:46.980
- The patients were eighty three percent male with
383
00:14:46.980 --> 00:14:49.399
- median age of 73 years old.
384
00:14:50.315 --> 00:14:52.575
- Eighty five percent of those patients were Caucasian,
385
00:14:53.434 --> 00:14:54.495
- and twelve percent
386
00:14:54.875 --> 00:14:56.254
- were South Asian.
387
00:14:57.115 --> 00:14:58.975
- For the clinical presentation,
388
00:14:59.915 --> 00:15:02.394
- seventy six percent of the patients had acute
389
00:15:02.394 --> 00:15:03.455
- coronary syndrome.
390
00:15:04.259 --> 00:15:07.059
- For the severity of the symptoms, more than
391
00:15:07.059 --> 00:15:10.279
- forty percent of the patients had significant angina,
392
00:15:10.500 --> 00:15:12.440
- CCS class three or four.
393
00:15:13.220 --> 00:15:16.019
- All patients had heart failure symptoms, and one
394
00:15:16.019 --> 00:15:17.800
- actually class three or four.
395
00:15:18.355 --> 00:15:21.254
- The median LVEF in the two groups were
396
00:15:21.315 --> 00:15:22.455
- twenty seven percent.
397
00:15:22.835 --> 00:15:23.575
- The median
398
00:15:24.115 --> 00:15:24.615
- BCIS
399
00:15:25.154 --> 00:15:27.014
- jeopardy score was 12,
400
00:15:27.475 --> 00:15:27.975
- indicating
401
00:15:28.355 --> 00:15:30.774
- a large area of jeopardized myocardium.
402
00:15:31.730 --> 00:15:34.549
- The median Syntax score was 38,
403
00:15:34.850 --> 00:15:35.350
- indicating
404
00:15:35.730 --> 00:15:36.470
- high complexity
405
00:15:36.850 --> 00:15:38.149
- coronary artery disease.
406
00:15:38.769 --> 00:15:41.669
- Seventy two percent of all the patients underwent
407
00:15:41.730 --> 00:15:42.789
- left main PCI,
408
00:15:43.329 --> 00:15:45.509
- eighty one percent of them needed arthrectomy,
409
00:15:46.225 --> 00:15:48.245
- and twenty seven percent of the patients
410
00:15:48.625 --> 00:15:50.325
- underwent retrograde CTO.
411
00:15:51.184 --> 00:15:53.664
- In the micro axial flow pump arm, the
412
00:15:53.664 --> 00:15:55.845
- insertion of Impella was unsuccessful
413
00:15:56.304 --> 00:15:58.965
- in four patients, which is three percent,
414
00:15:59.540 --> 00:16:00.440
- due to obstructive
415
00:16:00.899 --> 00:16:01.399
- PAD.
416
00:16:02.259 --> 00:16:05.399
- In standard pure arm, bail out mechanical circulatory
417
00:16:05.620 --> 00:16:08.200
- support was performed in nine patients,
418
00:16:08.740 --> 00:16:10.040
- which is six percent,
419
00:16:10.820 --> 00:16:13.700
- eight of whom received an intra aortic balloon
420
00:16:13.700 --> 00:16:16.384
- pump, and one received microaxial
421
00:16:16.764 --> 00:16:17.424
- flow pump.
422
00:16:17.884 --> 00:16:20.365
- There were ten patients, which is six point
423
00:16:20.365 --> 00:16:22.865
- eight percent of the patients in the microaxial
424
00:16:23.165 --> 00:16:24.144
- flow pump arm
425
00:16:24.524 --> 00:16:25.585
- underwent PCI
426
00:16:26.125 --> 00:16:27.345
- in different stages,
427
00:16:28.600 --> 00:16:30.059
- and twenty seven patients,
428
00:16:30.519 --> 00:16:31.019
- which
429
00:16:31.320 --> 00:16:32.699
- is seventeen percent
430
00:16:33.159 --> 00:16:36.699
- in the standard care arm underwent stage PCI.
431
00:16:37.639 --> 00:16:38.860
- The time from randomization
432
00:16:39.240 --> 00:16:41.100
- to last PCI in those
433
00:16:41.554 --> 00:16:44.434
- who have stage PCI was one hundred twenty
434
00:16:44.434 --> 00:16:47.254
- two days in micro axial flow pump arm
435
00:16:47.394 --> 00:16:50.454
- and sixty seven days in standard care arm.
436
00:16:51.075 --> 00:16:52.615
- So it is most likely
437
00:16:53.075 --> 00:16:54.294
- those stage PCI
438
00:16:54.730 --> 00:16:56.990
- were not performed in the same hospitalization.
439
00:16:58.330 --> 00:17:00.669
- The procedure duration appeared longer
440
00:17:00.970 --> 00:17:03.149
- in the micro axial flow pump arm
441
00:17:03.529 --> 00:17:06.809
- compared to standard care arm. It was, one
442
00:17:06.809 --> 00:17:09.404
- hundred eighty eight minutes versus one hundred and
443
00:17:09.404 --> 00:17:10.704
- thirty nine minutes,
444
00:17:11.244 --> 00:17:11.904
- which is
445
00:17:12.204 --> 00:17:15.424
- a six hour procedure versus four hour procedure
446
00:17:15.484 --> 00:17:16.464
- roughly difference.
447
00:17:17.404 --> 00:17:20.204
- More number of lesions were treated, three in
448
00:17:20.204 --> 00:17:22.605
- the micro axial flow pump arm, two in
449
00:17:22.605 --> 00:17:23.910
- the standard care arm.
450
00:17:24.309 --> 00:17:26.250
- The percentage of calcium modification
451
00:17:26.630 --> 00:17:28.730
- was seventy one percent in both groups.
452
00:17:29.269 --> 00:17:29.769
- Intravascular
453
00:17:30.230 --> 00:17:30.730
- lithotripsy
454
00:17:31.990 --> 00:17:33.369
- was the primary modality,
455
00:17:33.670 --> 00:17:36.330
- eighty one percent versus sixty six percent,
456
00:17:36.710 --> 00:17:38.650
- followed by rotational arthrectomy,
457
00:17:39.615 --> 00:17:42.275
- fifty five percent versus fifty nine percent.
458
00:17:43.055 --> 00:17:46.434
- The intravascular imaging was used in both arms,
459
00:17:46.974 --> 00:17:49.855
- ninety one percent versus ninety three percent, with
460
00:17:49.855 --> 00:17:52.434
- an improvement from prior trial data.
461
00:17:53.170 --> 00:17:55.570
- The median micro axial flow pump support time
462
00:17:55.570 --> 00:17:58.210
- was one hundred and thirty four minutes, which
463
00:17:58.210 --> 00:18:01.570
- means micro axial flow pump was removed at
464
00:18:01.570 --> 00:18:02.710
- the end of the PCI.
465
00:18:03.650 --> 00:18:07.190
- The weight ratio for hierarchical composite primary outcome,
466
00:18:07.250 --> 00:18:07.750
- including
467
00:18:08.315 --> 00:18:11.694
- death from all cause, disabling stroke, spontaneous
468
00:18:11.994 --> 00:18:13.134
- MI, cardiovascular
469
00:18:13.515 --> 00:18:14.015
- hospitalization,
470
00:18:14.875 --> 00:18:15.375
- and
471
00:18:15.755 --> 00:18:18.494
- myocardial injury was point eight five
472
00:18:19.194 --> 00:18:21.914
- with a confidence interval of point six three
473
00:18:21.914 --> 00:18:23.535
- to 1.15,
474
00:18:23.769 --> 00:18:25.390
- which is not statistically
475
00:18:26.009 --> 00:18:27.869
- significant between two arms.
476
00:18:28.490 --> 00:18:29.470
- In the prespecified
477
00:18:29.849 --> 00:18:30.990
- secondary outcomes,
478
00:18:31.450 --> 00:18:33.309
- the death from cardiovascular
479
00:18:33.769 --> 00:18:35.230
- cause was significantly
480
00:18:35.609 --> 00:18:38.025
- higher in the micro axial flow pump arm
481
00:18:38.345 --> 00:18:41.464
- compared with standard carrier arm. It was twenty
482
00:18:41.464 --> 00:18:44.904
- six point seven percent versus fourteen point five
483
00:18:44.904 --> 00:18:45.404
- percent
484
00:18:45.865 --> 00:18:48.285
- with a hazard ratio of 1.91,
485
00:18:48.744 --> 00:18:50.585
- confidence interval 1.1
486
00:18:50.585 --> 00:18:51.884
- to 3.3.
487
00:18:52.200 --> 00:18:52.859
- The periprocedural
488
00:18:53.399 --> 00:18:57.419
- myocardial injury per procedure was significantly higher,
489
00:18:57.880 --> 00:18:59.899
- sixty one percent in microaxial
490
00:19:00.200 --> 00:19:03.399
- flow pump arm versus forty four percent in
491
00:19:03.399 --> 00:19:04.619
- standard care arm,
492
00:19:05.595 --> 00:19:07.755
- with a confidence interval 1.1
493
00:19:07.755 --> 00:19:09.134
- to 1.75.
494
00:19:10.154 --> 00:19:13.914
- The results are shocking, especially cardiovascular death was
495
00:19:13.914 --> 00:19:16.575
- higher in the micro axial flow pump arm.
496
00:19:16.795 --> 00:19:19.515
- However, the trial data seems to give a
497
00:19:19.515 --> 00:19:20.015
- clue
498
00:19:20.389 --> 00:19:23.509
- that micro axial flow pump arm conducted more
499
00:19:23.509 --> 00:19:24.569
- complete revascularization
500
00:19:25.990 --> 00:19:28.409
- rather than a stage PCI approach,
501
00:19:28.869 --> 00:19:30.569
- had longer procedure duration,
502
00:19:31.029 --> 00:19:32.250
- treating more lesions,
503
00:19:32.630 --> 00:19:34.325
- and had more periprocedural
504
00:19:34.784 --> 00:19:36.565
- myocardial injury per procedure.
505
00:19:37.825 --> 00:19:39.524
- In terms of vascular complications,
506
00:19:40.065 --> 00:19:41.284
- when we think of micro
507
00:19:41.664 --> 00:19:44.404
- axial flow pump related large bore axis,
508
00:19:44.944 --> 00:19:47.684
- in this trial, it is a record low.
509
00:19:48.210 --> 00:19:50.309
- It was 16.9%
510
00:19:50.529 --> 00:19:52.929
- in the micro axial flow pump arm versus
511
00:19:52.929 --> 00:19:56.369
- 10% in the standard pure arm, reported as
512
00:19:56.369 --> 00:19:57.349
- minor complication.
513
00:19:58.450 --> 00:20:00.950
- The procedural complication, including
514
00:20:01.409 --> 00:20:01.909
- VT,
515
00:20:02.355 --> 00:20:02.855
- VFAB,
516
00:20:03.954 --> 00:20:04.454
- CPR,
517
00:20:04.914 --> 00:20:05.894
- pulmonary edema,
518
00:20:06.355 --> 00:20:07.414
- prolonged hypotension,
519
00:20:07.954 --> 00:20:09.654
- are similar between two groups.
520
00:20:10.275 --> 00:20:12.914
- There were nine patients in the standard care
521
00:20:12.914 --> 00:20:15.255
- arm that required BOL MCS,
522
00:20:16.099 --> 00:20:19.140
- eight of whom received intraorities balloon pump, and
523
00:20:19.140 --> 00:20:21.160
- one received IMPALA CP.
524
00:20:22.180 --> 00:20:23.080
- Doctor Virabajesila,
525
00:20:24.180 --> 00:20:27.059
- there's a lot to unpack here. Taking all
526
00:20:27.059 --> 00:20:29.700
- in, how does it inform what you do
527
00:20:29.700 --> 00:20:32.345
- for the for your patients in your practice?
528
00:20:33.445 --> 00:20:35.305
- Yeah. I know. This is quite the summary.
529
00:20:35.605 --> 00:20:37.305
- Nicely done, Lee. Truly,
530
00:20:38.005 --> 00:20:38.505
- comprehensive
531
00:20:38.805 --> 00:20:41.045
- and thoughtful and hit upon all the high
532
00:20:41.045 --> 00:20:42.585
- points of this particular trial.
533
00:20:43.009 --> 00:20:45.170
- You know, it's definitely eye opening or for
534
00:20:45.170 --> 00:20:47.170
- us in America, I suspect will end up
535
00:20:47.170 --> 00:20:48.309
- being practice changing.
536
00:20:48.690 --> 00:20:50.690
- The reason I mentioned that is a few
537
00:20:50.690 --> 00:20:52.769
- fold. One is there is this false sense
538
00:20:52.769 --> 00:20:54.769
- of security we obtained for putting an impeller
539
00:20:54.769 --> 00:20:57.275
- CP in because we feel that we are
540
00:20:57.275 --> 00:20:59.835
- now invincible and the patient is, quote unquote,
541
00:20:59.835 --> 00:21:00.335
- protected
542
00:21:00.875 --> 00:21:03.434
- from whatever insight they may face from our
543
00:21:03.434 --> 00:21:03.934
- PCI,
544
00:21:04.315 --> 00:21:05.535
- prolonged bone inflation,
545
00:21:06.154 --> 00:21:08.015
- microdebris from rotation atherectomy,
546
00:21:08.394 --> 00:21:11.710
- etcetera, etcetera. Right? So while that has been
547
00:21:11.710 --> 00:21:14.430
- the predominant thinking for many of us, including
548
00:21:14.430 --> 00:21:16.750
- me, I suspect that has been debunked by
549
00:21:16.750 --> 00:21:18.269
- this trial. That I think is the biggest
550
00:21:18.269 --> 00:21:20.750
- gain in knowledge for us as a community
551
00:21:20.750 --> 00:21:22.910
- from this trial. The second point that I've
552
00:21:22.910 --> 00:21:25.089
- noted is there is the need
553
00:21:25.454 --> 00:21:28.015
- to quote, unquote do more because the pump
554
00:21:28.015 --> 00:21:29.775
- is it. You're taking the upfront risk of
555
00:21:29.775 --> 00:21:32.994
- inserting a fourteen French device, large bore vascular
556
00:21:33.214 --> 00:21:33.714
- access
557
00:21:34.015 --> 00:21:35.394
- with associated complications.
558
00:21:36.335 --> 00:21:36.835
- Therefore,
559
00:21:37.214 --> 00:21:39.375
- you feel that this is the time to
560
00:21:39.375 --> 00:21:40.595
- get them maximum revascularization.
561
00:21:41.669 --> 00:21:44.490
- For us, unlike surgeons, we have the privilege
562
00:21:44.549 --> 00:21:46.950
- of staging interventions. We absolutely do not have
563
00:21:46.950 --> 00:21:48.389
- to achieve it all in the first go
564
00:21:48.389 --> 00:21:51.029
- around. We can think this through, discuss it,
565
00:21:51.029 --> 00:21:53.109
- give the patient time to breathe, bring them
566
00:21:53.109 --> 00:21:55.589
- back once they've been medically optimized, etcetera, etcetera.
567
00:21:55.589 --> 00:21:56.889
- So those are some of the
568
00:21:57.404 --> 00:22:00.045
- learning points, cognitive issues that I think we've
569
00:22:00.045 --> 00:22:01.265
- learned from this trial.
570
00:22:01.805 --> 00:22:03.965
- The other things, I think the validity of
571
00:22:03.965 --> 00:22:05.644
- the trial is not in question. The risk
572
00:22:05.644 --> 00:22:07.805
- population at risk that was included was very
573
00:22:07.805 --> 00:22:09.884
- appropriate. Again, it was a small trial, 400
574
00:22:09.884 --> 00:22:11.484
- patients as compared to many of the other
575
00:22:11.484 --> 00:22:14.089
- trials we see in ACS or primary or
576
00:22:14.089 --> 00:22:16.329
- secondary prevention, which are far larger. So definitely
577
00:22:16.329 --> 00:22:18.329
- scope for bigger trials where the signal might
578
00:22:18.329 --> 00:22:18.829
- be
579
00:22:19.130 --> 00:22:21.210
- slightly more pronounced one way or the other,
580
00:22:21.210 --> 00:22:23.690
- but nothing nothing about the trial thus far
581
00:22:23.690 --> 00:22:24.585
- looking at its
582
00:22:24.904 --> 00:22:26.365
- methodology or primary,
583
00:22:26.825 --> 00:22:28.664
- paper that tells me that,
584
00:22:29.144 --> 00:22:31.565
- it doesn't pass the sniff test. Right?
585
00:22:32.024 --> 00:22:32.524
- So
586
00:22:32.825 --> 00:22:35.005
- it's very relevant to the case you discussed.
587
00:22:35.065 --> 00:22:35.565
- Again,
588
00:22:36.184 --> 00:22:38.105
- to me, what this trial tells me is
589
00:22:38.105 --> 00:22:38.605
- that
590
00:22:39.065 --> 00:22:41.250
- it has nothing to do with the pump
591
00:22:41.250 --> 00:22:43.170
- or the otherwise, the pump is a part
592
00:22:43.170 --> 00:22:46.049
- of the algorithm of caring for the patient
593
00:22:46.049 --> 00:22:46.549
- holistically.
594
00:22:47.090 --> 00:22:48.210
- So we need to look at all the
595
00:22:48.210 --> 00:22:49.910
- aspects we just talked about,
596
00:22:50.369 --> 00:22:52.710
- and we also need to look at our
597
00:22:53.284 --> 00:22:53.784
- perceptions,
598
00:22:54.085 --> 00:22:56.404
- biases, and behaviors when we deal with such
599
00:22:56.404 --> 00:22:56.904
- patients
600
00:22:57.525 --> 00:22:58.565
- either in,
601
00:22:58.964 --> 00:23:01.125
- the office or when we meet with them
602
00:23:01.125 --> 00:23:02.644
- in the cath lab and how we behave
603
00:23:02.644 --> 00:23:04.644
- when these patients are on our table. So
604
00:23:04.644 --> 00:23:06.244
- I think those are some of the big
605
00:23:06.244 --> 00:23:09.059
- issues. I'm sure you'll, tell us more about
606
00:23:09.059 --> 00:23:11.079
- how you did your case, and then we'll
607
00:23:11.140 --> 00:23:13.220
- go from there. Thank you so much. That
608
00:23:13.220 --> 00:23:16.200
- was a wonderful point of view. I
609
00:23:16.740 --> 00:23:17.240
- really,
610
00:23:17.859 --> 00:23:19.779
- wanna echo your points on the,
611
00:23:20.945 --> 00:23:23.345
- false sense of security and the go all
612
00:23:23.345 --> 00:23:25.125
- in approach once we have,
613
00:23:25.664 --> 00:23:29.184
- amygdala in implanted in the patient, and this
614
00:23:29.184 --> 00:23:30.085
- trial actually
615
00:23:30.464 --> 00:23:30.964
- challenges
616
00:23:31.345 --> 00:23:32.244
- that concepts.
617
00:23:33.025 --> 00:23:35.329
- So getting back to our patient,
618
00:23:36.190 --> 00:23:37.730
- we plan to perform
619
00:23:38.269 --> 00:23:39.490
- right heart cath first,
620
00:23:39.789 --> 00:23:42.849
- and, our PCI strategy was to perform
621
00:23:43.470 --> 00:23:47.170
- PCI to OM and decay crash bifurcation stunting
622
00:23:47.230 --> 00:23:48.369
- for left main,
623
00:23:48.965 --> 00:23:52.265
- leaning toward without MCS support up front
624
00:23:52.724 --> 00:23:55.445
- as patient was receiving low dose beta blocker
625
00:23:55.445 --> 00:23:58.105
- and losartan on the cardiology floor.
626
00:23:58.484 --> 00:24:00.744
- From the trial data, if possible,
627
00:24:01.230 --> 00:24:04.529
- I would plan for stage PCI for multivessel
628
00:24:04.750 --> 00:24:05.250
- CED.
629
00:24:05.869 --> 00:24:06.369
- However,
630
00:24:06.750 --> 00:24:09.150
- with the decay crush, we couldn't stage the
631
00:24:09.150 --> 00:24:11.869
- PCI. We started with the right heart cath,
632
00:24:11.869 --> 00:24:14.910
- which showed cardiac output of 4.3 meter per
633
00:24:14.910 --> 00:24:17.095
- minute, index of 2.4,
634
00:24:17.474 --> 00:24:20.294
- r e pressure of 10, wedge of 15.
635
00:24:20.595 --> 00:24:21.335
- The hemodynamics
636
00:24:21.714 --> 00:24:25.095
- was consistent with the compensated heart failure condition.
637
00:24:25.554 --> 00:24:26.454
- Doctor Vilabhadjicila,
638
00:24:27.154 --> 00:24:29.519
- what would would be your next step in
639
00:24:29.519 --> 00:24:30.500
- light of CHPBCs
640
00:24:30.880 --> 00:24:31.700
- three results?
641
00:24:32.240 --> 00:24:34.159
- Yeah. First things first, I compliment you for
642
00:24:34.159 --> 00:24:36.159
- picking a right heart catheterization. That, I think,
643
00:24:36.159 --> 00:24:38.880
- is the appropriate step to fully understand this
644
00:24:38.880 --> 00:24:40.419
- patient's hemodynamic substrate.
645
00:24:40.960 --> 00:24:43.034
- I think we, you know, again, in an
646
00:24:43.034 --> 00:24:46.075
- age where impeller is ubiquitously available across most
647
00:24:46.075 --> 00:24:48.575
- cath labs, there is always a sense of
648
00:24:48.714 --> 00:24:51.434
- short circuiting this by getting an EDP and
649
00:24:51.434 --> 00:24:53.994
- getting on and moving along your case. And
650
00:24:53.994 --> 00:24:56.414
- I think that it, that would be, extremely,
651
00:24:57.210 --> 00:25:00.190
- challenging to fully understand somebody's hemodynamics of strength.
652
00:25:00.410 --> 00:25:02.089
- Second thing I want to tell you was
653
00:25:02.089 --> 00:25:03.929
- that your patient actually fits the trial really
654
00:25:03.929 --> 00:25:05.369
- well. They have a very high syntax score.
655
00:25:05.369 --> 00:25:07.069
- I assume they would turn down by surgery.
656
00:25:08.250 --> 00:25:10.755
- I anticipate that you will need calcium modification,
657
00:25:10.755 --> 00:25:12.595
- which is about eighty percent of the patients
658
00:25:12.595 --> 00:25:14.055
- in trial we're discussing.
659
00:25:14.434 --> 00:25:15.795
- Seventy percent of the patients in the trial
660
00:25:15.795 --> 00:25:17.634
- are distal left main or left main involvement
661
00:25:17.634 --> 00:25:19.315
- of some sort, which is clearly on case.
662
00:25:19.315 --> 00:25:20.535
- Now you don't have
663
00:25:20.835 --> 00:25:23.119
- a CTO, which is again the quarter of
664
00:25:23.119 --> 00:25:24.960
- the trial. So for the large part, this
665
00:25:24.960 --> 00:25:27.599
- meets your trial trial indications. And in your
666
00:25:27.599 --> 00:25:28.579
- specific case,
667
00:25:29.599 --> 00:25:31.119
- there are a few things. One is you
668
00:25:31.119 --> 00:25:33.359
- are saying that this patient's left dominant distal
669
00:25:33.359 --> 00:25:35.679
- left main. So, essentially, their entire coronary circulation
670
00:25:35.679 --> 00:25:37.539
- is based on that distal left main lesion.
671
00:25:37.654 --> 00:25:39.494
- And you're right. You don't have the luxury
672
00:25:39.494 --> 00:25:41.575
- of walking away from this to do stage
673
00:25:41.575 --> 00:25:43.815
- PCI. I think you're committed to dealing with
674
00:25:43.815 --> 00:25:44.394
- the entire,
675
00:25:45.494 --> 00:25:47.494
- at least the distal left main bifurcation is
676
00:25:47.494 --> 00:25:48.394
- in its entirety.
677
00:25:48.855 --> 00:25:50.375
- If you want to stage, you know, a
678
00:25:50.375 --> 00:25:53.299
- a distal ID or an OM or something
679
00:25:53.299 --> 00:25:54.579
- else for later date to start the end
680
00:25:54.579 --> 00:25:56.259
- of the world. But out and out, I
681
00:25:56.259 --> 00:25:58.180
- think the biggest lesion needs to be addressed
682
00:25:58.180 --> 00:26:00.180
- in this case. The second thing is your
683
00:26:00.180 --> 00:26:01.700
- right heart cath actually tells you that this
684
00:26:01.700 --> 00:26:03.640
- patient's numbers are very reasonable.
685
00:26:04.019 --> 00:26:06.305
- Right? And there's nothing more to optimize in
686
00:26:06.305 --> 00:26:08.164
- this patient. They are adequately optimized.
687
00:26:08.465 --> 00:26:10.465
- I'm assuming you've already had this conversation where
688
00:26:10.465 --> 00:26:12.465
- you've met with them, discussed their wishes, goals
689
00:26:12.465 --> 00:26:13.285
- of care, etcetera.
690
00:26:13.585 --> 00:26:15.825
- Everybody's onboard. Patients onboard. They understand the risks
691
00:26:15.825 --> 00:26:17.585
- and benefits of a given case. So they're
692
00:26:17.585 --> 00:26:20.119
- all set. Right? Now with that being the
693
00:26:20.119 --> 00:26:22.599
- case, my my bias still would be to
694
00:26:22.599 --> 00:26:24.919
- use an Impella CP upfront. And the primary
695
00:26:24.919 --> 00:26:26.940
- reason is, hey, they're not a surgical candidate
696
00:26:27.079 --> 00:26:27.579
- inactively,
697
00:26:28.279 --> 00:26:30.599
- emergently, god forbid things were to go wrong,
698
00:26:30.599 --> 00:26:32.440
- they'd be much worse or not a candidate
699
00:26:32.440 --> 00:26:33.579
- at all, number one.
700
00:26:33.894 --> 00:26:34.394
- Number
701
00:26:34.775 --> 00:26:36.775
- two, you are calling this a distal left
702
00:26:36.775 --> 00:26:39.335
- main in a patient whose entire coronary circulation
703
00:26:39.335 --> 00:26:42.775
- is coming off your, left main. Number three,
704
00:26:42.775 --> 00:26:45.974
- I'm not sure which atherectomy strategy you'll use,
705
00:26:45.974 --> 00:26:47.434
- either shock wave lithotripsy
706
00:26:47.815 --> 00:26:49.115
- or rotation atherectomy.
707
00:26:49.809 --> 00:26:52.049
- And did regardless of which you use, one
708
00:26:52.049 --> 00:26:54.630
- is associated with, a lot of microdebris
709
00:26:55.009 --> 00:26:57.570
- and may cause no reflow or slow flow
710
00:26:57.570 --> 00:26:59.250
- for a significant period of time, which is
711
00:26:59.250 --> 00:27:01.269
- enough to tip this patient over the edge.
712
00:27:01.570 --> 00:27:03.605
- Or you may have prolonged balloon inflation or
713
00:27:03.605 --> 00:27:05.444
- multiple balloon inflation as in the case of
714
00:27:05.444 --> 00:27:08.164
- IVL, which also decompensates a patient, and you'd
715
00:27:08.164 --> 00:27:10.484
- be shocked how quickly they'll they're able to
716
00:27:10.484 --> 00:27:12.325
- fall off a cliff. So I think this
717
00:27:12.325 --> 00:27:14.325
- patient is as well optimized as it can
718
00:27:14.325 --> 00:27:14.984
- be medically.
719
00:27:15.480 --> 00:27:17.500
- I think they're as well treated,
720
00:27:17.960 --> 00:27:20.440
- from a non cardiac risk factor standpoint as
721
00:27:20.440 --> 00:27:22.200
- they can be, but they're still pretty high
722
00:27:22.200 --> 00:27:23.480
- risk. And then some of that is just
723
00:27:23.480 --> 00:27:23.980
- interprocedural
724
00:27:24.279 --> 00:27:25.960
- risk. So my bias in this case would
725
00:27:25.960 --> 00:27:28.380
- still would be to put an impeller CP.
726
00:27:28.625 --> 00:27:31.585
- But, again, while putting it in is not
727
00:27:31.585 --> 00:27:33.585
- the only decision I'm making. What I'm looking
728
00:27:33.585 --> 00:27:35.744
- for is in the procedure. How often are
729
00:27:35.744 --> 00:27:36.884
- they flatlining?
730
00:27:37.505 --> 00:27:39.585
- What is my, you know, ten second balloon
731
00:27:39.585 --> 00:27:41.525
- inflation doing to their pressures?
732
00:27:42.000 --> 00:27:44.640
- Should I keep on doing lithotripsy or should
733
00:27:44.640 --> 00:27:46.240
- I go, you know, quickly do a quick
734
00:27:46.240 --> 00:27:48.480
- rotor run and be done? Should I maybe
735
00:27:48.480 --> 00:27:50.160
- do quick up and down and see balloon
736
00:27:50.160 --> 00:27:50.660
- inflations?
737
00:27:51.039 --> 00:27:52.880
- Again, vascular access is the other thing. We
738
00:27:52.880 --> 00:27:54.320
- didn't talk about it as much, but as
739
00:27:54.320 --> 00:27:56.240
- you highlighted about seventy percent of the patients
740
00:27:56.240 --> 00:27:58.375
- in the trial got CAT scans. I would
741
00:27:58.375 --> 00:28:00.214
- say that's not my practice. I mean, at
742
00:28:00.214 --> 00:28:02.775
- best, I may have Doppler ultrasounds to guide
743
00:28:02.775 --> 00:28:04.775
- me. Occasionally, I may get a CAT scan,
744
00:28:04.775 --> 00:28:06.934
- but often these patients are limited by chronic
745
00:28:06.934 --> 00:28:08.934
- kidney disease. And you wanna save the contrast
746
00:28:08.934 --> 00:28:11.109
- load for the economy stuff as against, you
747
00:28:11.109 --> 00:28:12.789
- know, bolusing them a 100 CC or something
748
00:28:12.789 --> 00:28:14.549
- for a CT scan. So there are all
749
00:28:14.549 --> 00:28:17.029
- these caveats. And that the last step is
750
00:28:17.029 --> 00:28:18.569
- I don't think we fully understand
751
00:28:18.869 --> 00:28:20.789
- what the post cath lab ICU care for
752
00:28:20.789 --> 00:28:23.355
- these patients is. As you highlighted, a bulk
753
00:28:23.595 --> 00:28:25.914
- of the impellers in the procedure came out
754
00:28:25.914 --> 00:28:27.755
- at the end of the procedure. And we
755
00:28:27.755 --> 00:28:30.234
- know that, often these patients have a significant
756
00:28:30.234 --> 00:28:32.875
- amount of myocardial stunning. They are often,
757
00:28:33.835 --> 00:28:35.994
- worse off in the immediate aftermath of the
758
00:28:35.994 --> 00:28:38.109
- PCI than they first started. But if you
759
00:28:38.109 --> 00:28:39.950
- give them time, if you let them recover,
760
00:28:39.950 --> 00:28:42.690
- they'll come around. And many of us anecdotally
761
00:28:42.750 --> 00:28:45.149
- leave in whatever circular support device we have,
762
00:28:45.149 --> 00:28:46.909
- an IABP or Impella or a VEQ, well,
763
00:28:46.909 --> 00:28:48.269
- we'll leave it in for a few hours,
764
00:28:48.269 --> 00:28:50.429
- if not overnight to the next day to
765
00:28:50.429 --> 00:28:51.404
- see how they do.
766
00:28:51.884 --> 00:28:53.484
- So those are all the things that I'm
767
00:28:53.484 --> 00:28:55.164
- thinking about, and I would still proceed with
768
00:28:55.164 --> 00:28:56.605
- putting in an IMPALA CP in the case
769
00:28:56.605 --> 00:28:58.445
- you described to me. Again, not looking at
770
00:28:58.445 --> 00:29:00.285
- the films, not obviously not having met this
771
00:29:00.285 --> 00:29:02.125
- hypothetical patient, but I think that'd be the
772
00:29:02.125 --> 00:29:04.079
- right thing to do. Thank you so much
773
00:29:04.159 --> 00:29:07.619
- for sharing your strategy and review all the
774
00:29:07.839 --> 00:29:10.159
- step by step points when we are planning
775
00:29:10.159 --> 00:29:12.819
- for a complex high risk p PCI.
776
00:29:13.679 --> 00:29:14.659
- So, yes,
777
00:29:15.039 --> 00:29:17.460
- given the concern of complex intervention,
778
00:29:17.934 --> 00:29:20.414
- large area of myocardium at risk, and poor
779
00:29:20.414 --> 00:29:21.474
- cardiac reserve,
780
00:29:22.494 --> 00:29:25.535
- we proceeded with the protected PCI for this
781
00:29:25.535 --> 00:29:29.055
- patient. We used, Impella CP and seven French
782
00:29:29.055 --> 00:29:31.315
- single axis for coronary intervention.
783
00:29:32.130 --> 00:29:33.830
- And the PCI was uncomplicated.
784
00:29:34.289 --> 00:29:37.570
- We treated, distal left circulation with the balloon
785
00:29:37.570 --> 00:29:38.070
- angioplasty,
786
00:29:38.849 --> 00:29:39.990
- performed the intravascular
787
00:29:41.170 --> 00:29:43.269
- in both LAD and left circumflex,
788
00:29:44.095 --> 00:29:46.815
- and completed decay crush for the left main
789
00:29:46.815 --> 00:29:47.954
- bifurcation lesion.
790
00:29:48.494 --> 00:29:51.214
- At the end of the procedure, ampulla CP
791
00:29:51.214 --> 00:29:54.095
- was went down to p two. On this
792
00:29:54.095 --> 00:29:55.634
- support, we obtained
793
00:29:56.014 --> 00:29:59.099
- the right heart cath hemodynamics again. The wedge
794
00:29:59.099 --> 00:30:02.079
- was 10. Cardio output was 4.4.
795
00:30:02.140 --> 00:30:03.680
- Index was 2.5,
796
00:30:03.980 --> 00:30:07.519
- which was, basically unchanged compared to the start.
797
00:30:07.819 --> 00:30:10.160
- So EMPALA was removed with predeployed
798
00:30:10.700 --> 00:30:12.640
- proposed sutures without complications.
799
00:30:13.835 --> 00:30:16.255
- Our patient, by the inclusion and
800
00:30:16.714 --> 00:30:17.615
- exclusion criteria,
801
00:30:18.875 --> 00:30:20.494
- fits right into the CHIPBCS
802
00:30:20.875 --> 00:30:23.934
- three trial and the PCI treatment he received,
803
00:30:24.234 --> 00:30:26.414
- also similar to the trial practice.
804
00:30:27.200 --> 00:30:29.920
- He was able to come off MCS support
805
00:30:29.920 --> 00:30:32.019
- with preserved cardiac output.
806
00:30:32.400 --> 00:30:34.160
- If this patient were to be enrolled in
807
00:30:34.160 --> 00:30:36.960
- business three, he could be considered as an
808
00:30:36.960 --> 00:30:39.779
- example of the micro axial flow pump arm.
809
00:30:39.955 --> 00:30:40.695
- Doctor Villabajsila,
810
00:30:41.315 --> 00:30:42.615
- besides the hemodynamic
811
00:30:43.234 --> 00:30:45.414
- data of systemic blood pressure,
812
00:30:45.875 --> 00:30:48.295
- fueling pressures, and cardiac output,
813
00:30:48.674 --> 00:30:51.475
- what other parameters would you be interested to
814
00:30:51.475 --> 00:30:53.849
- know and which the trial has study? Yeah.
815
00:30:53.849 --> 00:30:55.849
- It's a good question. I think you guys
816
00:30:55.849 --> 00:30:57.869
- did a great job with this case. Obviously,
817
00:30:58.569 --> 00:31:00.009
- you know, it was a challenging case, and
818
00:31:00.009 --> 00:31:01.849
- you did all the right steps. When I
819
00:31:01.849 --> 00:31:04.190
- look at the trial, I think I really
820
00:31:04.490 --> 00:31:06.170
- enjoyed a lot of the data that they
821
00:31:06.170 --> 00:31:08.744
- presented. The things I would be interested in
822
00:31:08.744 --> 00:31:10.664
- is in things like how often did this
823
00:31:10.664 --> 00:31:13.144
- patient have flat lining of their impeller flow
824
00:31:13.144 --> 00:31:14.984
- or, you know, loss of pulsatility. Because what
825
00:31:14.984 --> 00:31:16.664
- that tells you is that there are periods
826
00:31:16.664 --> 00:31:18.284
- of time when the patient
827
00:31:18.585 --> 00:31:19.484
- goes into,
828
00:31:20.339 --> 00:31:22.660
- LV hypo contractility or even LV stands still
829
00:31:22.660 --> 00:31:23.160
- transiently
830
00:31:23.539 --> 00:31:25.960
- because the balloon inflation is causing profound ischemia.
831
00:31:26.179 --> 00:31:27.779
- And that's when the impeller kicks in. And
832
00:31:27.779 --> 00:31:30.039
- because it's a rotary flow pump without punctility,
833
00:31:30.259 --> 00:31:32.099
- you tend to see a flat line on
834
00:31:32.099 --> 00:31:34.424
- the tracing, but that essentially means that native
835
00:31:34.424 --> 00:31:37.065
- IV contractility is close to negligible. And so
836
00:31:37.065 --> 00:31:38.984
- we have other data which have been published
837
00:31:38.984 --> 00:31:40.664
- that have shown that such a phenomenon is
838
00:31:40.664 --> 00:31:42.984
- associated with terrible outcomes. So that would be
839
00:31:42.984 --> 00:31:44.904
- a very interesting piece of data that I
840
00:31:44.904 --> 00:31:46.610
- would like to know. I would like to
841
00:31:46.610 --> 00:31:49.350
- know how these patients look closer to
842
00:31:49.730 --> 00:31:51.809
- explantation of the umbrella, be it within the
843
00:31:51.809 --> 00:31:53.330
- cath lab or soon after, and what was
844
00:31:53.330 --> 00:31:55.269
- the rationale? What was their renaming protocol?
845
00:31:55.650 --> 00:31:58.345
- How did they watch the vascular access? How
846
00:31:58.345 --> 00:32:01.005
- did they prevent adverse complications such as hemolysis,
847
00:32:01.384 --> 00:32:02.265
- renal failure,
848
00:32:02.985 --> 00:32:05.625
- etcetera? So these are aspects that as an
849
00:32:05.625 --> 00:32:07.945
- interventional and a critical care cardiologist, I feel
850
00:32:07.945 --> 00:32:10.345
- like I put on one put on one
851
00:32:10.345 --> 00:32:11.625
- hand and think of the other set and
852
00:32:11.625 --> 00:32:12.904
- put on the other hand, think of this
853
00:32:12.904 --> 00:32:14.880
- set because I in my head, I'm unable
854
00:32:14.880 --> 00:32:17.119
- to differentiate these two aspects, but clearly, there's
855
00:32:17.119 --> 00:32:19.440
- a dichotomy for this given patient because they
856
00:32:19.440 --> 00:32:21.059
- have a cath lab phase and a CICU
857
00:32:21.200 --> 00:32:23.200
- phase. And it's important to marry the two
858
00:32:23.200 --> 00:32:25.840
- and understand the transitions of care for, such
859
00:32:25.840 --> 00:32:26.820
- complicated patients.
860
00:32:27.575 --> 00:32:29.914
- Absolutely. Those are fascinating points,
861
00:32:30.295 --> 00:32:32.375
- especially the one you mentioned that with the
862
00:32:32.375 --> 00:32:35.414
- loss of pulsatility during the procedure. And I
863
00:32:35.414 --> 00:32:37.414
- believe as already you mentioned,
864
00:32:37.815 --> 00:32:41.115
- during the procedure, also observe different data points.
865
00:32:41.500 --> 00:32:44.159
- You might need to alter your strategy for
866
00:32:44.460 --> 00:32:45.440
- calcium modification
867
00:32:45.900 --> 00:32:48.859
- or just become short balloon inflations. Those are
868
00:32:48.859 --> 00:32:50.000
- the intraprocedural
869
00:32:50.700 --> 00:32:51.200
- parameters,
870
00:32:51.659 --> 00:32:54.240
- that can be associated with the different outcome.
871
00:32:54.380 --> 00:32:56.400
- And, also, like you said, the
872
00:32:56.835 --> 00:32:57.734
- winning protocol,
873
00:32:58.914 --> 00:32:59.414
- some,
874
00:33:00.355 --> 00:33:02.775
- practice would watch the patient for two minute
875
00:33:02.994 --> 00:33:05.575
- on ampulla p tube or for ten minutes.
876
00:33:05.634 --> 00:33:06.855
- What is adequate
877
00:33:07.394 --> 00:33:10.115
- and safe winning strategy for the ampulla at
878
00:33:10.115 --> 00:33:11.960
- the end of the procedure? It will be
879
00:33:11.960 --> 00:33:13.820
- very interesting to know.
880
00:33:14.359 --> 00:33:15.500
- So doctor Virabhadjisil,
881
00:33:16.279 --> 00:33:19.259
- what are your main takeaways for CATH masters
882
00:33:19.400 --> 00:33:20.220
- in applying
883
00:33:20.599 --> 00:33:21.080
- BC's,
884
00:33:21.400 --> 00:33:22.539
- three into practice?
885
00:33:23.080 --> 00:33:25.115
- This is a great trial. I think it's
886
00:33:25.115 --> 00:33:26.174
- definitely changed
887
00:33:26.474 --> 00:33:28.734
- my personal practice. I think I am
888
00:33:29.194 --> 00:33:29.694
- more
889
00:33:30.075 --> 00:33:31.214
- leery of
890
00:33:31.595 --> 00:33:34.075
- doing things that I would not otherwise do,
891
00:33:34.075 --> 00:33:35.994
- where e despite the presence of an impeller
892
00:33:35.994 --> 00:33:37.434
- pump in a given patient. I think that's
893
00:33:37.434 --> 00:33:38.954
- the most important practice is going back to
894
00:33:38.954 --> 00:33:41.509
- the basics of being a good doctor, who
895
00:33:41.730 --> 00:33:43.990
- understands the balance of pragmatism
896
00:33:44.370 --> 00:33:45.590
- with absoluteness
897
00:33:46.289 --> 00:33:50.210
- of dogmatism of, PCI practice, understanding when to
898
00:33:50.210 --> 00:33:51.910
- step back. And this is, again,
899
00:33:52.394 --> 00:33:54.075
- this this is why senior operators who are
900
00:33:54.075 --> 00:33:55.355
- fifteen, twenty years into their career and a
901
00:33:55.355 --> 00:33:57.355
- far better operator operators and people who are,
902
00:33:57.355 --> 00:33:58.634
- you know, three to five years into their
903
00:33:58.634 --> 00:34:00.875
- career because they've seen and done enough to
904
00:34:00.875 --> 00:34:02.894
- know when that fine line between
905
00:34:03.355 --> 00:34:05.835
- pursuing your initial plan versus deviating from it
906
00:34:05.835 --> 00:34:07.710
- for the sake of pragmatism is. And I
907
00:34:07.710 --> 00:34:09.230
- think that's what this teaches us, that we
908
00:34:09.230 --> 00:34:11.630
- are not bulletproof with this pump in place
909
00:34:11.630 --> 00:34:13.230
- and that we need to respect the patient's
910
00:34:13.230 --> 00:34:13.730
- anatomy,
911
00:34:14.109 --> 00:34:17.070
- respect their clinical evolution during the procedure and
912
00:34:17.070 --> 00:34:18.369
- see when to peel back.
913
00:34:18.670 --> 00:34:20.429
- Again, like I said, we are not surgeons.
914
00:34:20.429 --> 00:34:21.905
- We have the privilege of staging stuff, stuff,
915
00:34:21.905 --> 00:34:23.744
- and we absolutely should if there is an
916
00:34:23.744 --> 00:34:26.545
- occasion. It also tells me that while the
917
00:34:26.545 --> 00:34:28.545
- vascular access rates were very low in this
918
00:34:28.545 --> 00:34:29.045
- particular,
919
00:34:29.984 --> 00:34:32.885
- trial, they had a very rigorous pre procedure
920
00:34:33.105 --> 00:34:34.910
- trial protocol where they looked at all the
921
00:34:34.910 --> 00:34:37.869
- vascular anatomy and feasibility before committing the patient.
922
00:34:37.869 --> 00:34:39.329
- I think that's something maybe
923
00:34:39.630 --> 00:34:41.489
- if we have the luxury of time and,
924
00:34:42.349 --> 00:34:42.849
- resources
925
00:34:43.309 --> 00:34:46.430
- and the ability to afford extra die without
926
00:34:46.430 --> 00:34:49.250
- renal dysfunction, I think that'd be great to
927
00:34:49.545 --> 00:34:51.304
- plan not dissimilar to, you know, how we
928
00:34:51.304 --> 00:34:53.464
- do it in TAVR patients or other, you
929
00:34:53.464 --> 00:34:56.505
- know, moderate emergency patients. So that's something I
930
00:34:56.505 --> 00:34:58.264
- think we can learn and do better at,
931
00:34:58.585 --> 00:34:59.405
- as a community.
932
00:34:59.784 --> 00:35:02.469
- I think this tempers the joy with using
933
00:35:02.469 --> 00:35:05.289
- mechanical circulator support. Obviously, the data for cardiogenic
934
00:35:05.349 --> 00:35:07.349
- shock are very different from data for stable
935
00:35:07.349 --> 00:35:07.849
- PCI.
936
00:35:08.150 --> 00:35:11.030
- And so understanding again where this falls into
937
00:35:11.030 --> 00:35:11.769
- our armamentarium
938
00:35:12.070 --> 00:35:14.390
- of priorities is still a work in progress.
939
00:35:14.390 --> 00:35:16.309
- There's obviously other trials that are come that'll
940
00:35:16.309 --> 00:35:18.944
- come through, like PROTECT four that I can
941
00:35:18.944 --> 00:35:20.944
- think of in the immediate aftermath of this.
942
00:35:20.944 --> 00:35:23.105
- And then any any other sub studies that
943
00:35:23.105 --> 00:35:25.105
- come out from median basis three or PROTECT
944
00:35:25.105 --> 00:35:25.924
- four or
945
00:35:26.304 --> 00:35:28.784
- Danger Shock, we'll all continue to inform our
946
00:35:28.784 --> 00:35:30.944
- practice in this space. Thank you so much
947
00:35:30.944 --> 00:35:32.085
- for the nice summary.
948
00:35:33.269 --> 00:35:35.510
- We absolutely applaud for the efforts for the
949
00:35:35.510 --> 00:35:37.610
- trialists who conducted this trial
950
00:35:37.989 --> 00:35:40.949
- and, enlightening us in the future practice. And,
951
00:35:40.949 --> 00:35:43.510
- also, we are looking forward to the future
952
00:35:43.510 --> 00:35:45.670
- data from the PROTECT four to give us
953
00:35:45.670 --> 00:35:47.030
- further guidance on our,
954
00:35:47.675 --> 00:35:48.635
- high risk complex,
955
00:35:49.114 --> 00:35:49.614
- interventions.
956
00:35:50.474 --> 00:35:51.375
- Doctor Benavanteciolas,
957
00:35:51.994 --> 00:35:54.394
- it's such a pleasure to have you, joining
958
00:35:54.394 --> 00:35:56.795
- us for this discussion. I've learned a lot
959
00:35:56.795 --> 00:35:59.295
- from you. Thank you for joining us.
960
00:35:59.994 --> 00:36:01.594
- No. The pleasure is all mine. Thank you
961
00:36:01.594 --> 00:36:02.255
- to CardioNerd.
962
00:36:02.789 --> 00:36:05.349
- Basically, thank you to Yoli for, hosting such
963
00:36:05.349 --> 00:36:07.989
- a wonderful session. And, I hope our listeners
964
00:36:07.989 --> 00:36:08.710
- enjoy and,
965
00:36:09.349 --> 00:36:11.510
- participate in the discussion relating to this complex
966
00:36:11.510 --> 00:36:12.010
- upset.

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