GLG News by Cardiac Surgeons who Implant HeartMate XVE Left Ventricular Assist Device

Keith AllenDirector, Cardiothoracic Vascular Surgery ResearchMid America Heart & Lung Surgeons, PC

Drug Eluting Stents:The Next Vioxx

December 14, 2006

Analysis of:Trading restenosis for Thrombosis? New questions about drug-eluding stents. | content.nejm.org

1. DES whether used on or off label will likely require life long anticoagulation with Plavix like drugs.

2. The incidence of late thrombosis is significant when anticoagulation is interrupted for events such as elective surgery.

3. Unlike restenosis following insertion of a bare metal stent which rarely results in death to the patient, late thrombosis following use of a DES results in a 50% mortality.

4.  Hints of this problem were present during FDA presentations prior to DES approval which may lead to significant liability as this problem becomes more apparent.

Dale MuellerVice-Chairman of Cardiovascular MedicineOSF SAINT FRANCIS MEDICAL CTR

Surgery does it better

December 4, 2006

Analysis of:Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis | content.nejm.org

This study investigated carotid endarterectomy versus carotid stenting in patients with severe carotid stenosis. The study was stopped prematurely due to safety and futility. The 30-day incidence of stroke or death was 3.9% versus 9.6% for endarterectomy versus carotid stenting. This data implies that carotid stenting with cerebral protection is inferior to surgical endarterectomy, and therefore will not be as widely adopted as previous thought.

Dale MuellerVice-Chairman of Cardiovascular MedicineOSF SAINT FRANCIS MEDICAL CTR

The forecast clears for drug eluding stents.

December 4, 2006

Analysis of:Trading restenosis for Thrombosis? New questions about drug-eluding stents. | content.nejm.org

This is a general commentary regarding coronary stent thrombosis and highlights the difficulties which Medtronic (Endeavor), Abbott (Xience V and Conor Medsystem (CoStar) may soon face with FDA approval of their new stents which are currently unavailable in the US. It also highlights that drug-coated stent sales have decreased while bare metal stents sales have accelerated.

Dale MuellerVice-Chairman of Cardiovascular MedicineOSF SAINT FRANCIS MEDICAL CTR

Increased use of ventricular assist devices

December 4, 2006

Analysis of:Left Ventricular Assist Device and Drug Therapy for the Reversal of Heart Failure | content.nejm.org

In a series of 15 patients, the Thoratec ventricular assist device was utilized with associated medical treatment for severe non-ischemic heart failure. Eleven of the fifteen patients recovered and avoided transplantation. Key implications include increased utilization of ventricular assist devices for the indication: "bridge to recovery." This could allow patients to avoid transplantation by temporary use of a left ventricular assist device.

Dale MuellerVice-Chairman of Cardiovascular MedicineOSF SAINT FRANCIS MEDICAL CTR

Percutaneous valves: the future is upon us!

December 4, 2006

Analysis of:AHA Scientific Sessions - Percutaneous Devices for Aortic Valve Disease | www.cardiosource.com

Percutaneous valves are technically feasible.

Complications are currently not comparable to the traditional open valve replacement/repair.

Dale MuellerVice-Chairman of Cardiovascular MedicineOSF SAINT FRANCIS MEDICAL CTR

Less is more

September 19, 2006

Analysis of:NEJM Articles on DES in MI | content.nejm.org

Implications:

- primary percutaneous interventions provide improved reperfusion therapy for acute myocardial infarction compared to thrombolysis

- many medical centers are focusing on the time it takes to actually perform PCI as a major focus for both patient care and a marketing technique

- Data are limited regarding the safety and efficacy of drug eluding stents in this setting, but they are clearly associated with an improved restenosis rate vs. uncoated bare metal stents

- The primary end point (target-vessel failure at 1 year after the procedure) was significantly reduced in the sirolimus-stent group compared to the uncoated stent group

- Drug eluding stents significantly reduce the risks of both restenosis and target-vessel revascularization after PCI due to acute myocardial infarction which could greatly expand the use of drug eluding stents    

Dale MuellerVice-Chairman of Cardiovascular MedicineOSF SAINT FRANCIS MEDICAL CTR

Daptomycin. A one hit wonder?

August 18, 2006

Analysis of:Daptomycin versus standard therapy for bacteremia and endocarditis caused by staphylococcus aureus | www.nejm.org

Daptomycin which is essentially the sole agent made by Cubist was recently evaluated for blood stream and heart infections caused by staph. and found to be as effective as traditional antibiotics used.  The medication was also found to have less side effects when used for this indication.  More patients who received the standard treatment compared to daptomycin also had kidney problems including kidney failure. 
Abstract

Dale MuellerVice-Chairman of Cardiovascular MedicineOSF SAINT FRANCIS MEDICAL CTR

Bioglue: Another indication strikes again

July 31, 2006

Analysis of:A prospective, randomized trial of the effectiveness of BioGlue in treating alveolar air leaks | vascsurg.org

Pulmonary air leaks after lung resection remain an indicator for prolonged hospitalizations.  Efforts are constantly made to decrease length of stay after pulmonary resections.  This study demonstrates that use of BioGlue can decrease the duration of air leaks and hospital stay with bioGlue usage.

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WMF-4K7T5SW-W&_coverDate=07%2F31%2F2006&_alid=429284858&_rdoc=1&_fmt=&_orig=search&_qd=1&_cdi=6933&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=fe61a671ccaa2280636fd338d1df4f87

Dale MuellerVice-Chairman of Cardiovascular MedicineOSF SAINT FRANCIS MEDICAL CTR

Percutaneous valve replacement: Are we there yet?

July 28, 2006

Analysis of:Transapical aortic valve implantation: An animal feasibility study | ats.ctsnetjournals.org

Intense interest is abound for percutaneous valve replacement while other minimally invasive approaches are being developed in conjunction with this technique.  Most poor results with percutaneous valve implantation are due to technical difficulties.  This technique allows for an alternative delivery route.

http://ats.ctsnetjournals.org/cgi/reprint/82/1/110?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=transapical&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HWCIT

Dale MuellerVice-Chairman of Cardiovascular MedicineOSF SAINT FRANCIS MEDICAL CTR

Endovascular treatment of thoracic aneurysms

June 8, 2006

Analysis of:Midterm outcomes in 158 consecutive gore tag thoracic endoprothesis: Single Center experience | www.ctsnetjournal.org

This manuscript demonstrates the safety and effacacy of endografting the thoracic aorta in high risk patients.  The gore tag endoprosthesis was succcessfully delivered with low morbidity and mortality in a group of patients who were so ill that they could not tolerate a open surgical intervention.  The next step would allow expansion of the eligible patient pool to include all descending thoracic aneurysms, disruptions, dissections, and ruptured atherosclerotic plaques and possibly extending the patient pool to include all locations in the thoracic aorta. 

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