A Blinded, Randomized, Placebo-Controlled Trial of Percutaneous Laser Myocardial Revascularization to Improve Angina Symptoms in Patients With Severe Coronary Disease

Leon, Martin B.; Kornowski, Ran; Downey, William; Weisz, Giora; Baim, Donald S.; Bonow, Robert O.; Hendel, Robert C.; Cohen, David J.; Gervino, Ernest V.; Laham, Roger J.; Lembo, Nicholas; Moses, Jeffrey W.; Kuntz, Richard E.

doi:10.1016/j.jacc.2005.06.079

Cited by 173 publications

(129 citation statements)

References 46 publications

(49 reference statements)

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“…Although studies of invasive treatments can be difficult to study in a blinded fashion, lack of blinding may overestimate the effectiveness of treatments. 28,29 Thus, the present trial, which evaluated a hemodynamic primary end point in a blinded fashion, is an important step in the development of the IASD as a potential treatment for patients with HF. The finding that the IASD does indeed lower exercise PCWP provides a mechanistic rationale for further randomized *Includes MACE events that were determined by the Clinical Events Committee to be definitely, probably, or possibly related to the procedure or device.…”

Section: Discussionmentioning

confidence: 99%

Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure])

et al. 2018

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Background: In nonrandomized, open-label studies, a transcatheter interatrial shunt device (IASD, Corvia Medical) was associated with lower pulmonary capillary wedge pressure (PCWP), fewer symptoms, and greater quality of life and exercise capacity in patients with heart failure (HF) and midrange or preserved ejection fraction (EF ≥40%). We conducted the first randomized sham-controlled trial to evaluate the IASD in HF with EF ≥40%. Methods: REDUCE LAP-HF I (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure) was a phase 2, randomized, parallel-group, blinded multicenter trial in patients with New York Heart Association class III or ambulatory class IV HF, EF ≥40%, exercise PCWP ≥25 mm Hg, and PCWP-right atrial pressure gradient ≥5 mm Hg. Participants were randomized (1:1) to the IASD versus a sham procedure (femoral venous access with intracardiac echocardiography but no IASD placement). The participants and investigators assessing the participants during follow-up were blinded to treatment assignment. The primary effectiveness end point was exercise PCWP at 1 month. The primary safety end point was major adverse cardiac, cerebrovascular, and renal events at 1 month. PCWP during exercise was compared between treatment groups using a mixed-effects repeated measures model analysis of covariance that included data from all available stages of exercise. Results: A total of 94 patients were enrolled, of whom 44 met inclusion/exclusion criteria and were randomized to the IASD (n=22) and control (n=22) groups. Mean age was 70±9 years, and 50% were female. At 1 month, the IASD resulted in a greater reduction in PCWP compared with sham control ( P =0.028 accounting for all stages of exercise). Peak PCWP decreased by 3.5±6.4 mm Hg in the treatment group versus 0.5±5.0 mm Hg in the control group ( P =0.14). There were no peri-procedural or 1-month major adverse cardiac, cerebrovascular, and renal events in the IASD group and 1 event (worsening renal function) in the control group ( P =1.0). Conclusions: In patients with HF and EF ≥40%, IASD treatment reduces PCWP during exercise. Whether this mechanistic effect will translate into sustained improvements in symptoms and outcomes requires further evaluation. Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifier: NCT02600234.

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Section: Discussionmentioning

confidence: 99%

Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure])

et al. 2018

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“…Surgical and catheter-based techniques have been investigated as stand-alone therapy [6,46] or in combination with conventional revascularization [47], gene therapy [48], or cell transplantation [49]. NOGA®-guided direct myocardial laser revascularization (DMR) utilized the LaserStar™ catheter which combined location sensor with a 300-μm laser fiber [6]. A pulsed Ho:YAG laser served as the energy source, allowing the delivery of targeted single laser pulses (2 J/pulse) to create endomyocardial channels.…”

Section: Direct Myocardial Laser Revascularizationmentioning

confidence: 99%

“…Used predominantly to map the left ventricle (LV), the system creates three-dimensional (3D) electromechanical (EM) reconstructions with minimal utilization of X-ray fluoroscopy. To date, NOGA® XP has had two main experimental and clinical applications: (1) as a diagnostic tool to evaluate myocardial function, viability, and ischemia in the catheterization laboratory [5] and (2) as a therapeutic tool to guide catheter-based, transendocardial delivery of therapies to the myocardium, including laser energy [6], gene [7], and cell transplantation [8].…”

Section: Introductionmentioning

confidence: 99%

Endoventricular Electromechanical Mapping—The Diagnostic and Therapeutic Utility of the NOGA® XP Cardiac Navigation System

Psaltis

Worthley

2008

J. of Cardiovasc. Trans. Res.

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Combined analysis of the electrical and mechanical function of the heart holds promise as a means of acquiring a better understanding of a variety of cardiac diseases that ultimately may lead to heart failure. The NOGA XP Cardiac Navigation System is a unique, nonfluoroscopic, catheter-based technology that achieves real-time acquisition of three-dimensional, endoventricular electromechanical maps. Through the provision of point-by-point measurements of endocardial electrical activation and voltage and mechanical shortening, electromechanical mapping has been evaluated for its ability to identify regional myocardial ischemia and characterize tissue viability. A decade of preclinical and clinical research has verified its safety and feasibility and raised the possibility of its application as a diagnostic adjunct to conventional angiography in the catheterization laboratory. However, this role has not yet been realized outside of the research setting. Instead, a more prominent niche for NOGA XP has emerged as a therapeutic tool for guiding direct myocardial interventions, most notably the targeted administration of regenerative therapies (e.g., cells, genes) to the heart. In this review, we discuss the fundamental aspects of this electromechanical mapping system and the evidence for both its diagnostic and therapeutic utility.

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“…no benefit compared to a similar sham procedure in patient's blinded to their assigned treatment [4]. There was no difference in the primary endpoint of exercise duration nor in the secondary endpoints of exercise time to the onset of chest pain, exercise time to the appearance of ST-segment changes at 6 and 12 months or frequency of angina symptoms.…”

Section: Commentarymentioning

confidence: 89%

Have Sham Trials Put Current Cardiovascular Guidelines to Shame?

Fischman¹,

Savage²

2018

Interventional Cardiology

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A Blinded, Randomized, Placebo-Controlled Trial of Percutaneous Laser Myocardial Revascularization to Improve Angina Symptoms in Patients With Severe Coronary Disease

Abstract: Treatment with percutaneous myocardial laser revascularization provides no benefit beyond that of a similar sham procedure in patients blinded to their treatment status.

Cited by 173 publications

References 46 publications

Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure])

Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure])

Endoventricular Electromechanical Mapping—The Diagnostic and Therapeutic Utility of the NOGA® XP Cardiac Navigation System

Have Sham Trials Put Current Cardiovascular Guidelines to Shame?

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