A review was performed of the available information.This patient underwent sole therapy tmr via left anterolateral thoracotomy without cardiopulmonary bypass on 10/14/2016.The patient had a history of previous myocardial infarction, hypercholesterolemia, hypertension, previous cabg, previous pci, and smoking.The preoperative ef (ejection fraction) was 45%.The total procedure time was 110 minutes and 31 tmr channels were placed on following locations of the heart: 4 to the apex, 8 anterolateral, 7 posterior, 5 inferior, and 7 anterior.The patient was discharged from the hospital on (b)(6) 2016.According to medical records provided by the site, the patient had a rather extensive cardiac history, significant for multiple stents, acute mi (myocardial infarction) in 2006, and sextuple coronary bypass which included: ima to lad, vein graft to posterior descending branch of rca (right coronary artery) and vein grafts to multiple circumflex branches.Operative notes from the tmr procedure indicate that since undergoing a previous cabg (coronary artery bypass graft) procedure in 2006: ¿the patient has since required multiple (coronary) interventions.Latest cardiac cath performed several weeks prior to tmr demonstrated a patent left mammary to the distal left anterior descending.The lad itself was patent down to a moderate-sized diagonal and then was severely stenotic beyond that diagonal and then a segment beyond the stenosis was perfused with the mammary graft.There was a vein graft to the right posterior descending branch which required stents but was widely patent.There was no collateralization to the circumflex branches but still fairly good lv (left ventricular) function with ef of about 45% with global hypokinesis.Myocardial perfusion scan showed photon attenuation of the anterolateral, basal lateral, interior lateral with peri-infarct ischemia and ef of 56%.(the patient) comes to the operating room (at this time) for tmr as there were no graftable vessels in the large circumflex distribution.¿ tmr is indicated for the treatment of ccs class iv angina.The patient¿s reported angina score at 30-day follow-up was ccs class iv at 30-day follow-up, indicating no change in pre-tmr angina score.According to the literature, 76-88% of patients who underwent sole therapy tmr improved by 2 or more angina classes at 3 month follow-up (allen 1999, jones 1999).However, there is evidence to support that some patients may not experience any change in baseline angina score.In a study by jones et al, 5 patients reported no change in baseline angina scores 3 months post-tmr (jones 1999).Another 4 patients who were ccs class i at 3 month follow-up progressed to ccs class iv at 12 months.Repeat angiograms of these patients demonstrated new graft lesions in areas that were previously not treated with tmr (jones 1999).Both frazier et al.And jones et al.Observed that patients with more pre-tmr comorbidities experienced less relief of angina symptoms than patients with fewer comorbidities.
the patient has a history of severe pre-existing coronary artery disease, which had been previously treated with multiple stents and previous cabg x6, including lima graft to the lad.The patient in this reported event had numerous pre-operative comorbidities and very advanced cad which could have limited relief of angina symptoms.However, a definitive root cause is unknown.The reported adverse event, angina, is a known potential complication associated with the use of tmr and is properly noted in the products ifu (instructions for use).This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
