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Three Part Question

In [patients undergoing radial artery harvest for CABG] is the [harmonic scalpel] superior to standard harvesting techniques in terms of [reducing complications].

Clinical Scenario

You have been approached by a representative of a company who is promoting their harmonic scalpel. They tell you that their scalpel is quicker and safer than the diathermy technique and that it causes less arterial spasm. The representative gives you several brochures to back this up with some references in small type at the bottom of the page. You are keen to try this ultrasonic scalpel but you discover that it is more expensive than your usual technique so you decide to look up the clinical evidence for a benefit for harmonic scalpels before committing to a trial of this new device.

Search Strategy

Medline 1990 to Oct 2005 using the OVID interface.
[exp radial artery/ OR radial.mp] AND [Harmonic.mp OR ultrasonic$.mp] Humans (Limit).

Search Outcome

247 papers were identified of which 10 represented the best evidence to answer the question

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Isomura et al, 1998, Japan	35 patients had radial artery (n=32) and/or gastroepiploic artery (n=15) harvested using the harmonic coagulating shears	Case series (Level 4)	Time for radial artery harvest	Mean 17 mins, (range 15-20mins)	Case series
			Complications	1 case of numbness, no spasm
			Post-op angiogram	All radial arteries patent
Hata et al, 2005, Japan	Ninety patients undergoing first time CABG, without diabetes , good LV, negative Allen's, divided into 3 groups of 30 Gp. 1 Electocautery and clips Gp. 2 Harmonic scalpel Gp. 3 Scissors and clips Angiography was performed at 1 month and 12 months and clinical assessment post-operatively All radial arteries harvested by the same operator	PRCT (level 2b)	Early post harvest site complications:-	Electrocautery 6/30 numbness, 3/30 swelling/bruise. Harmonic 3/30 pain, 9/30numbness, 1 bruise. Scissors and clips No numbness, 1 pain, 1 bruise	Use of questionnaire to evaluate complications rather than examination No patient demographics Unclear as to blinding. Was outcome assessment blinded to method? Harvest time not measured. Randomization technique not described Radial preservation solution not given
			Temperature recovery time (TRT) seconds at:- 1 month ( from ice pack cooling to 5 degrees C back to normal)	Electrocautery 225.1+/-62.5 secs. Harmonic scalpel 210.5+/-54.3 secs. Scissors and clips 17.4+/-11.5 secs p=0.009
			Arm angiography was evaluated at 1 and 12 months for collateral interosseous vessels	Electrocautery 23% 1mth, 73% 12mths. Harmonic Scalpel 37% 1mth, 80% 12mths. Scissors and clips 87% 1mth, 93% 12 mths
Georghoiu et al, 2005, Israel	100 patients undergoing radial artery harvest, randomised to 2 equal groups:- Gp. 1. Harmonic Scalpel ( Curved Shears) (n=50) Gp. 2. Electrocautery, clips and scissors (n=50) All radial arteries harvested by the same operator and stored in phentolamine 10mg/dl	PRCT (level 2b)	Harvest Time (mins) (Skin incision to proximal radial artery ligation)	Harmonic Scalpel 20.2+/-2.5 mins. Electrocautery 37.1+/-5.7 mins	Randomisation techniques not described Patient demographics not given No statistics performed on results All outcome measures are highly subjective No measurement of quality of artery once graft has been placed
			No. of clips used	Harmonic 1.2+/-1.1. Electrocautery 18.1+/-2.1
			Clinical complications	Harmonic scalpel no complications. Electrocautery 5/50 loss of neural sensation, 1 wound infection
			Frequency of spasm (disappearance of visible and palpable pulsation)	Harmonic no causes of spasm. Electrocautery 10/50 cases of spasm
			Internal Diameter (mm) measured before anastomosis	Harmonic 3.5+/-1 mm. Electrocautery 2.5+/-1 mm
Moon et al, 2004, USA	786 radial arteries harvested from 1995 to 2000 by 5 surgical assistants 422 patients underwent the cold scalpel technique (CS). Diathermy to deep fascia then scissors and clips 360 patients underwent the harmonic scalpel technique (HS) with the sharp pointed hook blade from 1998 to 2000 All arteries were bathed in 60mg of papaverine in heparinized blood 602 were available for follow up at mean 4 years post-operatively (CS) 312 (HS) 290	Cohort study (level 3b)	All neurological complications at any time post operatively	Cold scalpel 11.2% +/- 3.5%. Harmonic scalpel 11% +/- 3.6% p=NS	Patients contacted by post and phone for assessment of symptoms. No clinical assessment. No assessment of radial artery quality or time of harvest. Unclear as to whether all surgical assistants used both techniques
			Any hand complications	Cold scalpel 9% +/- 3.2%. Harmonic Scalpel 9% +/- 3.3% p=NS
Rukosujew et al, 2004, Germany	40 consecutive patients undergoing total arterial revascularization divided into 4 equal groups 1. Scissors/clips Skeletonised 2. Scissors/clips Pedicle 3. Harmonic scalpel ( Hooked tip) Skeletonized 4. Harmonic scalpel Pedicle All radials taken by first author and soaked in 50mg in 100mls papaverine Tissue samples taken to assess morphology Grafts assessed with flow probe	PRCT (level 2b )	Time for harvest	Scissors/Clips 1. 37.1 +/- 3.5. 2. 24.4 +/- 3.9. Harmonic scalpel 3. 31.1 +/- 3.5. 4. 25.6 +/- 3.7	Small study size
			Clips used	1. 58.7 +/- 7.1. 2. 38.7 +/- 7.1. 3. 6.7 +/- 1.5. 4. 8.6 +/- 3.9
			Free blood flow through graft	1. 50 +/- 20.1 2. 53.8 +/- 24.3 3. 56.3 +/- 25.1 4. 51.8 +/- 23
			Measure of endothelial lacerations by electron microscopy	1 30 lacerations 2 52 lacerations 3 48 lacerations 4 18 lacerations
			Endothelial damage score	1. 31 2. 55 3. 57 4. 21
Cikirikcioglu et al, 2001, Turkey	Study performed on discarded human radial artery segments collected from 14 patients undergoing RA harvest randomized to 2 groups. Gp 1 Harmonic scalpel harvest (5mm blunt hook blade dissector) Gp. 2 Electrocautery and clips All radial arteries harvested by the first author and soaked in papaverine and diltiazem	PRCT (level 3b)	Morphology of radial artery under electron microscopy	No differences between groups	Used only discarded ends of arteries. No details on patients or randomization
			Vascular reactivity of artery in an organ bath	No difference between groups in response to Nitroglycerin, Acetylcholine, Phenylephrine, 5-HT,
Wright et al, 2001, USA	51 patients undergoing RA harvest for CABG were randomised to:- Gp.1 Harmonic Scalpel ( hook blade) N=26 Gp.2 Cold Steel Scalpel CSS N=25 Radial artery placed in heparinized blood with 2mg/ml papaverine	PRCT (level 2b)	Harvesting Time (mins) median ( min-max)	Harmonic Scalpel 39 (25-96) mins Cold Steel Scalpel 36 (28-56) mins p=0.26	This study was sponsored by a grant from Ethicon, who make the harmonic scalpel used
			No. of clips used Med (min-max)	Harmonic scalpel 0 (0-28) Cold Steel Scalpel 69 (25-102) p <0.001
			Quality of RA and pedicle	All of good quality except 1 in each group
			Success of the graft assessed intra op	All grafts successful intra op.
			No. requiring angiography within 3 months	Harmonic 1 and cold steel 2 (no stenosis > 20% in any graft)
Ronan et al, 2000, USA	62 patients undergoing RA harvest allocated to groups according to availability of harmonic scalpel Gp. 1 Standard harvest (n=21) Gp. 2 Harmonic scalpel harvest (hook blade) (n=41) Radials harvested by 2 surgical assistants. Radials preserved in 60mg of papaverine in 30mls heparinized blood	Cohort study (Level 3b)	Harvest time (skin incision to harvest)	Harmonic 43.6+/- 17.6 mins Standard 48.4 +/- 17.6 mins p=NS	Non randomized study. No patient demographics given. The reason for non-randomization was the lack of availability of the harmonic scalpel but this would result in more patients in the standard harvest group.
			No. of clips used	Harmonic 3.2+/-4.3 Standard 74+/-18
			In situ flow(mL/min)	Harmonic 52.5 +/- 48.1 Standard 17.2 +/- 20.7 p<0.001
			Free flow after proximal anastamosis(mL/min)	Harmonic 50.7 +/- 29.6 Standard 38.5 +/- 60.4 p=0.008
			Free flow after papaverine(mL/min)	Harmonic 103.8 +/- 51.7 Standard 78.5+/- 45.9 p=0.016
Bhan et al, 2001, India	80 patients undergoing CABG, with arterial conduits harvested Gp 1 Harmonic scalpel harvested all arterial conduits including LIMA (42 radials) Gp 2 Electrocautery. (50 radials)	Cohort study (level 3b)	Harvest Time	Harmonic scalpel 10.2 minutes Electrocautery Time not assessed	Retrospective control cohort
			No of clips used	Harmonic Scalpel 3.1+/-1.5. Electrocautery 26+/-8 p<0.001
			Hand numbness	Harmonic Scalpel no patients Electrocautery 7 patients P=0.01
Posacioglu et al, 1998,	20 patients undergoing radial artery harvest, randomised to 2 equal groups:- Gp 1. Harmonic Scalpel (n=10) with dissecting hook Gp 2.Electrocautery, clips and scissors (n=10) Artery covered with a papaverine and diltiazem soaked swab	Cohort study (level 3b)	Harvesting Time	Harmonic 19.8 +/- 2.7 mins Electrocautery 36.6+/- 5.5 mins	No randomization techniques described No patient demographics No Statistical tests used to assess significance
			No. of clips used	Harmonic 1.3 +/- 1.1 Electrocautery 16.1 +/- 2.1
			Frequency of spasm ( assessed on inspection)	Harmonic no patients Electrocautery 2 patients

Comment(s)

Radial artery harvest using the harmonic scalpel is a relatively new technique, with the first reports appearing in 1998, Isomura. We found 5 randomized studies and 5 cohort studies or series that assessed its benefit against electrocautery, scissors and clips. Mitsumasa Hata harvested 90 radial arteries, randomizing to either electrocautery, harmonic scalpel or scissors and clips techniques. He found that 30% of harmonic patients reported hand numbness compared to none of the scissors and clip patients. In addition he performed angiography at 1 and 12 months and interosseous artery recovery and connection to the palmar arch was present in 87% of scissors and clips patients compared to only 37% of harmonic patients. This difference disappeared at 12 months. Georgios Georghiou harvested 100 radial arteries, randomizing to either harmonic scalpel with curved coagulating shears, or electrocautery scissors and clips. He took an average of 37 min with electrocautery compared to only 20 min with the harmonic scalpel. In addition, he reported a 20% spasm rate on inspection with the former technique but none in the harmonic group and larger internal vessel diameter and lower complications with the harmonic scalpel. No statistical tests were performed to assess the significance of the results and no assessment of graft flow after anastomosis were performed. Moon et al contacted 602 patients by phone or post who had had their radial artery harvested with either a standard technique or using a harmonic scalpel. They found no differences in neurological or all types of complication between the two groups, although 9% of patients in both groups suffered long term neurological complications in terms of weakness or numbness. Andreas Rukosujew harvested 40 radial arteries in four combinations of scissors and clips versus harmonic scalpel and pedicle and skeletonized techniques. There was no difference in the time taken to harvest the radial artery or the Doppler flow of the anastomosed vessels. He also performed electron microscopy of samples of the radial artery. The lowest level of damage was found in pedicled arteries using the harmonic scalpel, but skeletonizing with the harmonic was associated with a high level of damage. Mustafa Cikirikcioglu took the discarded ends of 14 radial arteries that were harvested using either the scissors and clips technique or the harmonic scalpel method. They were then placed in an organ bath and subjected to a series of vasoconstrictors and vasodilators. There were no significant differences found. The samples were also examined by electron microscopy and no differences were found. Wright et al randomized 51 patients to harmonic scalpel or 'cold-steel' scalpel techniques. There was no difference in the time taken to harvest the vessel, the quality of the graft or the need for repeat angiography at 3 months. Bhan et al used the harmonic scalpel to harvest all arterial conduits including the LIMA in 80 patients, and compared this to a retrospective cohort. They could not assess the speed of harvest but found that 7 patients had hand-numbness with electrocautery, compared to none in the harmonic group. Ronan et al presented a study that was most in favor of the harmonic scalpel. It was a non-randomized study that compared the harvesting of 21 radials using electrocautery with 41 patients with the harmonic scalpel. While the harvest time was no different, there was a doubling in the in-situ free flow, a near doubling in the free flow after proximal anastomosis and an increase in the free flow after papaverine. Posacioglu et al harvested 10 radial arteries using electrocautery and compared this technique to 10 patients who had harvesting with the harmonic scalpel. They found that harvesting took an average of 36 min compared to 20 min with the harmonic scalpel, and 2 patients in the standard group suffered arterial spasm. No statistical tests were used in this paper. In summary: of 5 studies reporting time to harvest, three report no difference and two report that the harmonic scalpel is quicker. Six studies reported the marked reduction in the number of clips used with the harmonic scalpel. Two papers reported a small benefit in reducing spasm. Two studies looked at the artery electron microscopically but no significant differences were seen. Two studies reported less numbness and two studies no difference in numbness post-operatively. Three studies looked at the results angiographically or by flow assessment, one study showed no difference, one study reported harmonic superiority, and one study reported that scissors and clips were superior. All studies were small and either used a single surgeon or a very small number of surgeons to harvest the radial artery. Highly subjective outcome measures to assess numbness and spasm were employed, together with poor or absent blinding of assessors.

Clinical Bottom Line

From 10 identified studies, 2/5 studies report faster harvesting, 6 studies report reduced requirement for surgical clips, 2 papers report less spasm, 2/4 studies reported less numbness, and 2 studies reported no microscopic differences. Three studies looked at angiography or flow, with one equivocal, one in favor of harmonic and one in favor of scissors and clips. We conclude that there is little convincing evidence in the literature to guide the decision to use a harmonic scalpel over electrocautery for radial artery harvest.

References

1. Isomura T, Suma H, Sato T, Horii T. Use of Harmonic Scalpel for harvesting arterial conduits in coronary artery bypass. Euro J Cardiothoracic Surg 1998; 14:101–103.
2. Hata M, Shiono M, Sezai A, Iida M, Saitoh A, Hattori T, Wakui S, Soeda M, Negishi N, Sezai Y. Determining the best procedure for radial artery harvest: prospective randomized trial for early postharvest complications. J Thorac Cardiovasc Surg 2005; 129:4885–889.
3. Georghiou GP, Stamler A, Berman M, Sharoni E, Vidne BA, Sahar G. Advantages of the ultrasonic harmonic scalpel for radial artery harvesting. Asian Cardiovasc & Thorac Ann 2005; 13:158–60.
4. Moon MR, Barner HB, Bailey MS, Lawton JS, Moazami N, Pasque MK, Damiano RJ, Jr. Long-term neurologic hand complications after radial artery harvesting using conventional cold and harmonic scalpel techniques. Annals of Thoracic Surgery. 2004;78(2):535-8.
5. Rukosujew A, Reichelt R, Fabricius AM, Drees G, Tjan TD, Rothenburger M, Hoffmeier A, Scheld HH, Schmid C. Skeletonization versus pedicle preparation of the radial artery with and without the ultrasonic scalpel. Annals of Thoracic Surgery. 2004;77(1):120-5.
6. Cikirikcioglu M, Yasa M, Kerry Z, Posacioglu H, Boga M, Yagdi T, Topcuoglu N, Buket S, Hamulu A. The effects of the Harmonic Scalpel on the vasoreactivity and endothelial integrity of the radial artery: a comparison of two different techniques. Journal of Thoracic & Cardiovascular Surgery. 2001;122(3):624-6.
7. Wright CB, Barner HB, Gao A, Obial R, Bandy B, Perry L, Ronan J, Kelly CR. The advantages of the Harmonic Scalpel for the harvesting of radial arteries for coronary artery bypass. Heart Surgery Forum. 2001;4(3):226-29.
8. Ronan JW, Perry LA, Barner HB, Sundt TM, III. Radial artery harvest: comparison of ultrasonic dissection with standard technique. Annals of Thoracic Surgery. 2000;69(1):113-4.
9. Bhan A, Choudhary SK, Saikia M, Sharma R, Venugopal P. Harmonic Scalpel: Initial Experience. Asian Cardiovascular & Thoracic Annals 2001;9:3-6.
10. Posacioglu H, Atay Y, Cetindag B, Saribulbul O, Buket S, Hamulu A. Easy harvesting of radial artery with ultrasonically activated scalpel. Annals of Thoracic Surgery. 1998;65(4):984-5.