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A review was performed of the available information.This patient underwent sole therapy tmr via left anterolateral thoracotomy without cardiopulmonary bypass on (b)(6) 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.At 30-day follow-up on (b)(6) 2016, the patient¿s reported angina score was ccs class iv.Two days later, on (b)(6) 2016, ems was called and the patient was subsequently rehospitalized after experiencing angina at rest that did not resolve after receiving.4mg ntg x4.A cardiac catheterization was performed on (b)(6) 2016 which revealed a 70% lesion of the lad.A successful ptca (percutaneous transluminal coronary angioplasty) of the lad (left anterior descending coronary artery) was performed with the lesion decreasing from 70% to 0%.Per notes provided by the site, ¿primary angioplasty was performed in the mid lad with 3.0 mm x 12 mm noncompliant trek balloon.Satisfactory results were observed.¿ the patient was discharged on (b)(6) 2016.Hospitalization for reported syncope and angina.No significant st segment elevation or arrhythmia noted.Troponin negative.Echocardiogram showed ef (ejection fraction) of 40-45% with mild inferior hypokinesis.Presented to er on (b)(6) 2017 with chest pain, with radiation to arm, shortness of breath and nausea and vomiting.Chest pain was unresponsive to nitroglycerin.Morphine iv provided relief.Initial troponin was negative.Cardiac catheterization was done on 2/9/17 which showed global hypokinesis with estimated ef 50%, severe multi-vessel coronary artery disease, widely patient lima (left internal mammary artery) to distal lad and luxuriant wispy collateralization observed from injection of left coronary artery and right coronary artery.Mild elevation in serial troponins up to 0.11 was felt to be due to strain and not due to ulcerated plaque occlusion.Patient was discharged on (b)(6) 2017 to be medically managed.Presented with 1 day history of chest pain described as pressure in the center of his chest radiating to his back consistent with previous episodes of angina.Patient stated he was eating at a restaurant and suddenly had 8/10 chest pain.He complains of dizziness and nausea with two episodes of vomiting.Complained of epigastric pain as well.Pain was relieved with rest after onset.Serial troponins were negative.Slight tachycardia noted.Since the patient had a recent cardiac catheterization, no cath was done at this admission.Conservative medical management was deemed appropriate and patient's coreg was increased from 12.5mg bid to 25 mg bid.Patient was discharged to home on (b)(6) 2017.Presented to ed with "burning chest pain" with some nausea and vomiting over previous 2 days.Ecg showed no st segment elevation.Started on a heparin and nitroglycerin drip which provided no relief of his chest pain.Cardiac catheterization on (b)(6) 2017 showed global hypokinesis with ef 45 %, severe multi-vessel coronary artery disease.Lima to lad has 50% proximal stenosis but fills the distal lad.Serial troponins were negative.Patient was discharged on (b)(6) 2017 to home.Was to follow up with cardiologist in one week to complete last of 35 total treatments of eecp.One-year follow-up was completed on (b)(6) 2017 at which time the patient reported ccs class iv angina.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.An investigation has been initiated and reported per regulatory guidelines for each adverse event reported.Please reference report numbers (this report included) 1063481-2016-00074, 1063481-2018-00013, 1063481-2018-00015, 1063481-2018-00016, and 1063481-2018-00017 for further details.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.
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