interventional

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Clinical trials in interventional cardiology to watch out for at the virtual AHA20!!

Lina Ya'qoub, MD

Our virtual AHA20 has started with all of the science, engagement and excitement!!! Since many of us are working and still want to squeeze in some time to check out what is going on at AHA20, I have decided to summarize clinical trials to look out for at AHA20 with their brief description.

Friday 11/13/2020

Trial Name Arrest Trial

 
Trial title Advanced Reperfusion Strategies For Refractory Ventricular Fibrillation Out-of-hospital Cardiac Arrest

 
Description In this trial,  patients (18-75 years old) with refractory ventricular fibrillation/pulseless ventricular tachycardia out-of hospital cardiac arrest, who are transferred by emergency medical services (EMS) with ongoing mechanical cardiopulmonary resuscitation (CPR) or who are resuscitated, were randomized to receive either early Extracorporeal Membrane Oxygenation (ECMO) or standard Advanced Cardiac Life Support (ACLS) Resuscitation [1]

 

Saturday 11/14/2020:

ALPHEUS, ATLANTIS, and RIVER Trials

Trial Name Alpheus Trial

 
Trial title Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting.

 
Description This is a multicenter study in stable patients undergoing elective PCI with a randomization between clopidogrel and ticagrelor. The primary ischemic endpoint is peri-procedural MI and myocardial injury and safety endpoint is bleeding by BARC definition [2].

 

Trial Name Atlantis Trial

 
Trial title Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation (TAVI) for Aortic Stenosis

 
Description This trial looks at the strategy of anticoagulation with novel anticoagulant, apixaban, compared to the current standard of care in patients who had a successful TAVI. The randomization is performed according to the presence or absence of a mandatory indication for anticoagulation, including atrial fibrillation or venous thromboembolic disease [3].

 

Trial Name RIVER Trial

 
Trial title RIvaroxaban for Valvular Heart diseasE and atRial Fibrillation Trial

 
Description This trial compares Rivaroxaban Versus Warfarin In Patients With Bioprosthetic Mitral Valves And Atrial Fibrillation [4].

 

Sunday 11/15/2020:

One-Month DAPT

Trial Name One-Month DAPT

 
Description One month dual antiplatelet Therapy Followed By Aspirin Monotherapy After Drug Eluting Stent Implantation.

 

 

 

References:

  • ARREST trial: https://www.clinicaltrials.gov/ct2/show/NCT03880565
  • ALPHEUS trial: https://clinicaltrials.gov/ct2/show/NCT02617290
  • ATLANTIS trial: https://clinicaltrials.gov/ct2/show/NCT02664649
  • RIVER trial: https://clinicaltrials.gov/ct2/show/NCT02303795

 

“The views, opinions and positions expressed within this blog are those of the author(s) alone and do not represent those of the American Heart Association. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them. The Early Career Voice blog is not intended to provide medical advice or treatment. Only your healthcare provider can provide that. The American Heart Association recommends that you consult your healthcare provider regarding your personal health matters. If you think you are having a heart attack, stroke or another emergency, please call 911 immediately.”
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Cardiac Intensivist – Just an Extension of an Interventionist?

Saurav Chatterjee, MD

Three pathways encompassing an intersection of the established subspecialties of critical care and cardiology have been proposed as a training framework for an aspiring ‘critical care cardiologist’ by the authors in a recent article1.  However, focusing specifically on the skill set outlined in the article,  a different and accelerated pathway for duly trained and interested interventionists may merit consideration.   With additional training in end of life/palliative care, intubation skills and advanced ventilator management a interventional cardiologist may likely fill the shoes in a modern ICU better than cardiologists from other subspecialties, including even those with additional critical care training.

Among the skill sets outlined in1, accredited interventional training likely prepares an individual to the greatest extent.  Issues of vascular access, sedation management and escalation of vasopressors for ‘crashing patients’ are daily routine in a busy catheterization suite.  Point-of-care ultrasounds (POCUS) should enhance the armamentarium of every thoughtful interventionist to identify regional wall motion abnormality and direct appropriate revascularization in area of myocardial dyskinesis/’stunning’. Additionally POCUS helps identify tamponade expediently,as well as potential advanced valvulopathy needing urgent invasive intervention. Pulmonary artery catheter insertion, monitoring of the hemodynamics, and management has gained resurgence in the era of valvular interventions and percutaneous mechanical circulatory support(MCS) for cardiogenic shock.  Post-procedure care for revascularized patients is one of the most important lesson for Fellowship trainees, as is early identification, and directed action in case of development of complications. Being integral to a heart team2 for complex decision making also allows contemporary interventional trainees to be involved in complex decision making, and working closely with the surgical team. With more patients requiring complex interventions in contemporary practice-often with need for atherectomy of a dominant coronary artery, and those with advanced conduction system disease-transvenous pacemaker placement is increasingly performed in the Cath Lab. Also pacemaker placement during transcatheter aortic valve replacements (TAVRs) forms an essential step of the procedure enabling deployment of the valve.  Assessment of managing patients with acute coronary syndrome including interpreting EKGs to identify hemodynamically significant arrhythmias emergently is definitely in the ‘day’s work’ for most interventional trainees,

When looking at structured training, the the COCATS 4 document3 has outlined some competencies for a budding cardiac critical care professional-and recognizes the importance of cath lab rotations in forming the foundation of solid procedural skills. The only skills outlined as those outside the realm of a general cardiology Fellowship were ‘Skill to place intra-aortic balloon pump emergently’-which most interventional trainees become competent at, and ‘Skill to perform endotracheal intubation’-which in most tertiary care institutions is done by anesthesia-and interventionists may acquire competency with additional training.

The Acute Cardiovascular Care Association (ACCA) of the European Society of Cardiology (ESC) have come-up with their own certification exam and a core curriculum4. In addition to the above, they have outlined need for identifying and appropriately managing renal dysfunction in critically ill patients. The focused interventional trainee gets ample exposure to preventing, identifying and treating acute kidney injury almost on a regular basis in this era of heightened awareness of limiting contrast, and contrast-sparing interventions. Also the document outlines the importance of early, aggressive and adequate treatment for pulmonary embolism(PE)-and most PE response teams across the nation are staffed and often led by an interventionist.

In summary, with additional training –interventional cardiologists, and those in-training, with appropriate interest should potentially be integral, and possibly in a leadership position in a critical care team of the future.

References:

  1. Miller PE, Kenigsberg BB, Wiley BM. Cardiac Critical Care: Training Pathways and Transition to Early Career. J Am Coll Cardiol. 2019 Apr 9;73(13):1726-1730.
  2. Neumann FJ, Sousa-Uva M, Ahlsson A, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. EuroIntervention. 2019 Feb 20;14(14):1435-1534.
  3. O’Gara PT, Adams JE, Drazner MH, et al. Journal of the American College of Cardiology May 2015, 65 (17) 1877-1886.
  4. https://www.escardio.org/static_file/Escardio/Education-Subspecialty/Certification/ACCA/Documents/ACCA_Core_Curriculum.pdf . Last accessed April 19, 2019.
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Women & TAVR: “I Don’t Want Any Procedure”

Mirvat Alasnag, MD

Round 1…

Patient’s son-in-law: “My mother has been turned down for surgery. They tell me her mortality rate at 2 years is high since she had fluids collecting in her lungs. They told me to ask you about catheterization.”

Me: “Yes, she does have a tight aortic valve and did develop heart failure. She is also very high risk for surgery. Percutaneous or catheter-based replacement may be an option. She will need a CT Scan first to determine if she is suitable for that treatment.”

The patient’s son-in-law asked me only one question, but a number of questions rushed through my head.

When is a good time to give the patient a contrast load after her recent admission with pulmonary edema? How safe is contrast given her borderline renal dysfunction and recent pulmonary edema? What is the outcome of trans-catheter aortic valve replacement (TAVR) in women?

I realized that there were no concrete answers. Irrespective of risk of contrast induced nephropathy, she needs the CT Angiogram. Irrespective of the timing, she remains high risk for recurrent pulmonary edema with or without the 50-60 cc of contrast given during the CT scan. Irrespective of her gender, TAVR maybe her only option. So, the CT scan was done with a small amount of contrast & her renal function remained unchanged and she did not develop pulmonary edema. She had borderline parameters with a short distance from the aortic valve annulus to left main, significant calcification into her LVOT, small tortuous and calcified common iliac arteries bilaterally. She was not an “ideal” candidate.

 

Round 2…

 

Me: “You are at a higher risk of coronary occlusion. We can place an undeployed stent preemptively in the coronary artery. Your risk of requiring a pacemaker is high and we’ve notified our electrophysiologist. Your risk of rupture is high, so we plan to use a self-expanding valve. We may need to use an alternative access like your armpit artery.”

Patient: “I don’t want any procedure.”

Patient’s son-in-law: “Is there anything else that we can do that is less risky?”

Me: “Palliative balloon valvuloplasty, but the gradient will increase again in 6-12 months.”

Patient: “I don’t want any procedure.”

Patient’s son (in-law): “Can we repeat this valvuloplasty every 6 months if need be?”

Patient: “I don’t want procedure.”

*Awkward silence.*

Me: “She does not want any procedure. It is time you and I listen to her.”

 

This patient was referred to me by a colleague from another hospital. She had no sons of her own but had her son-in-law to accompany her. She was a small, frail, soft spoken, elderly lady. She was also grateful for the care she received. We immediately had the surgeons evaluate her. While the surgeons were examining her, I did a quick literature review:

Data from Vancouver demonstrated that the mortality rate at 30 days after TAVR was 6.5% in women and 11.2% in men after accounting for other variables.1 This advantage for the female gender was maintained at 1 year as confirmed by the PARTNER Trial sub-analysis. Whether this was due to worse surgical outcomes in women or an advantage of TAVR in women was further explored by Humphries et al. Although vascular complications were higher in women, the overall survival rate at 2 years was 72.1% for women and 61.7% for men. Real world international registry and the first WIN TAVR registry further confirmed that high risk women had low 30-day and one-year mortality and stroke rates.2-4

Naturally, I picked up the conversation where the surgeons left off. In retrospect, even as a woman interventional cardiologist, was I dismissive of my patient’s own preference? Do we have a tendency to ignore female patients’ wishes more than men? Do we have a tendency to ignore elderly patients’ wishes more than younger ones? Or do we find it difficult to resolve to hospice care even before exhausting all options? It may be a combination of all of these. I don’t normally dismiss my patients’ wishes, but this time, I was clearly not listening. Maybe I listened to my colleague (a physician) and maybe I just grew attached to this soft spoken grateful woman…and I couldn’t resign myself to writing hospice care for her. Women..men..no matter, we make imperfect choices at times driven by our humanity. May that imperfection continue to drive us to care.

 

References:

1. Humphries KH, Toggweiler S, Rodés-Cabau J, et al. Sex differences in mortality after transcatheter aortic valve replacement for severe aortic stenosis. J Am Coll Cardiol 2012;60:882–6.

2. Williams M, et al. Sex-related differences in outcomes after transcatheter or surgical aortic valve replacement in patients with severe aortic stenosis: Insights from the PARTNER Trial (Placement of Aortic Transcatheter Valve). J Am Coll Cardiol. 2014 Apr 22;63(15):1522-8.

3. Chieffo A, et al. 1-Year Clinical Outcomes in Women After Transcatheter Aortic Valve Replacement: Results From the First WIN-TAVI Registry. JACC Cardiovasc Interv. 2018 Jan 8;11(1):1-12.

4. Chieffo A, et al. Acute and 30-Day Outcomes in Women After TAVR: Results From the WIN-TAVI (Women’s INternational Transcatheter Aortic Valve Implantation) Real-World Registry. JACC Cardiovasc Interv. 2016 Aug 8;9(15): 1589-600.