Intraoperative and intermediate-term angiographic results of coronary artery bypass surgery with Symmetry proximal anastomotic device

Bergsland, Jacob; Hol, Per Kristian; Lingås, Per Snorre; Lundblad, Runar; Rein, Kjell Arne; Andersen, Rune; Mørk, Bjørn Erik; Halvorsen, Steinar; Mujanovic, Emir; Kabil, Emir; Svennevig, Jan; Fosse, Erik

doi:10.1016/j.jtcvs.2004.07.001

Cited by 31 publications

(8 citation statements)

References 23 publications

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“…The Björk–Shiley experience led to stricter testing procedures and clinical follow-up of heart valve devices, which is of benefit to patients, but serves as a barrier to innovation since new claims can surface more than 20 years after implantation of a device 12. Initial approval and successful implantation of a device is certainly not a guarantee against later complications 13. For the developing world and for poor countries it may be unreasonable to expect the same level of sophistication and safety features of medical devices as those demanded by Western regulative bodies.…”

Section: Randd and Materials Failuresmentioning

confidence: 99%

Barriers to medical device innovation

Bergsland

Elle

Fosse

2014

MDER

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The US Food and Drug Administration (FDA) has defined a medical device as a health care product that does not achieve it’s purpose by chemical action or by being metabolized. This means that a vast number of products are considered medical devices. Such devices play an essential role in the practice of medicine. The FDA classifies medical devices in three classes, depending on the risk of the device. Since Class I and II devices have relatively simple requirements for getting to the market, this review will focus on “implantable devices”, which, in general, belong to Class III. The European Union and Canada use a slightly different classification system. While early generations of medical devices were introduced without much testing, either technical or clinical, the process of introducing a Class III medical device from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing. The modern era of implantable medical devices may be considered to have started in the 1920s with development of artificial hips. The implantable pacemaker was another milestone and pacemakers and cardioverters/defibrillators have since saved millions of lives and created commercial giants in the medical device industry. This review will include some examples of cardiovascular devices. Similar considerations apply to the total implantable device market, although clinical and technological applications obviously vary considerably.

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Section: Randd and Materials Failuresmentioning

confidence: 99%

Barriers to medical device innovation

Bergsland

Elle

Fosse

2014

MDER

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“…The angiographic controls raised suspicions, and after having used the device in 23 patients, a sequential group of 23 OPCAB patients served as a control group, having the proximal anastomosis performed with traditional technique. The Symmetry R cases were found to have high occlusion- and stenosis- rates (102) compared to the control group. …”

Section: Discussionmentioning

confidence: 95%

Safe Introduction and Quality Control of New Methods in Coronary Surgery

Bergsland

2011

Acta Inform Med

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Introduction:The first part of the paper analyses off pump coronary bypass surgery (OPCAB), which is compared with traditional on-pump procedures (ONCAB). Furthermore ,the paper evaluates the use of a new automatic device for performance of the proximal anastomosis and finally the effect of intracoronary shunt on myocardial ischemia during OPCAB. The main goal of the paper is to demonstrate the importance of careful clinical studies during introduction of the new techniques in cardiac surgery.Methods:Statistical analysis was performed on a large clinical database from Buffalo, NY, USA comparing OPCAB and ONCAB. Subsequently, a sequential controlled clinical study compared patients operated with a new automatic connector device to patients operated with classic suture technique. Finally a randomized study was performed to evaluate the effect of the use of an intracoronary shunt during construction of distal anastomosis.Results:The studies from Buffalo demonstrated reduced complications rates in high risk patients when OPCAB techniques were used. The use of connector devices in saphenous venous anastomosis was clearly inferior to standard technique. Intracoronary shunt was found to be beneficial by preventing ischemia.Discussion:Numerous studies have studied the results of OPCAB vs ONCAB and although results are variable it seems that OPCAB is advantageous in high risk patients, while in low risk patients there are much less if any benefit. The results of the studies of connector devices caused the product to be taken off the market. The value of shunt in OPCAB was clearly demonstrated by the randomized studies.Conclusion:The investigations presented in this paper clearly demonstrates the importance of well-designed studies when new surgical methods are introduced. In the present period of rapid technological development, carefully controlled, un-biased clinical trials are crucial to preserve patient safety and avoid unjustified societal cost.

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“…Multiple devises have been developed to address this problem. Most of these tools, however, have either fallen out of favor for significant concerns about graft patency 13,14 or they have not been popularized because they are cumbersome. 15,16 The Heartstring device was also developed to decrease aortic manipulation, while allowing conventional handsewn proximal anastomosis.…”

Section: Discussionmentioning

confidence: 99%

“Beyond Beating Heart Surgery” Heartstring Device Protects against Perioperative Neurological Events

Sakopoulos

Jacobson

Wilson

et al. 2010

Innovations�(Phila)

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Objective There is a growing body of evidence favoring off-pump coronary artery bypass surgery (OPCAB) over traditional coronary artery bypass surgery (CABG) with cardiopulmonary bypass as a method for reducing perioperative neurologic events. Aortic manipulation, whether with OPCAB or coronary artery bypass surgery with cardiopulmonary bypass, is strongly linked with adverse neurologic outcomes. Although the aortic “no-touch” technique has merit, most cardiac surgeons are reluctant to base entire myocardial revascularization exclusively on mammary pedicles. The purpose of this study was to analyze our experience with OPCAB combined with the use of a Heartstring proximal anastomotic device, as a strategy for reducing clinically evident cerebrovascular accidents. Methods Two hundred twenty-seven consecutive isolated OPCAB were performed without the use of a side-biting aortic clamp. In all these operations, a Heartstring device was used, permitting clampless hand-sutured proximal anastomoses. All patients were managed in this fashion regardless of the status of their ascending aorta. A mean of 3.4 bypasses were performed during each operation, with one or two mammary arteries harvested routinely. In 98% of patients, a single proximal anastomosis was performed; there was liberal use of sequential bypass grafts. Results Mean age was 69.3 years, with 17% octogenarians. Preexisting cerebrovascular disease was present in 22.4% of patients. There were no clinically evident perioperative neurologic events in any patients. There were no operative deaths. Conclusions This series suggests that OPCAB performed with a single, clampless, proximal aortic anastomosis, and with a Heartstring device may protect against perioperative strokes.

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Intraoperative and intermediate-term angiographic results of coronary artery bypass surgery with Symmetry proximal anastomotic device

Abstract: Saphenous vein grafts anastomosed to aorta with the Symmetry proximal connector have low intermediate patency compared with those with traditionally sutured anastomoses. We do not recommend the routine use of this device in coronary artery bypass operations.

Cited by 31 publications

References 23 publications

Barriers to medical device innovation

Barriers to medical device innovation

Safe Introduction and Quality Control of New Methods in Coronary Surgery

“Beyond Beating Heart Surgery” Heartstring Device Protects against Perioperative Neurological Events

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