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NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE
 

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE

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    NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE Document Transcript

    • IP 655 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Interventional procedure overview of endoaortic balloon occlusion for cardiac surgery During major heart surgery, the flow of blood through the heart needs to be stopped temporarily. In endoaortic balloon occlusion, a flexible tube (catheter) with a balloon attached to its tip is inserted into an artery in the groin (femoral artery) and threaded up to the heart. When the catheter is in the correct position in the heart, the balloon is filled with saline. As the balloon expands it blocks the aorta, which is the largest artery in the body. With the aorta blocked, the heart surgery can be performed. After heart surgery, the balloon and catheter are removed and the blood flow is restored.IntroductionThis overview has been prepared to assist members of the InterventionalProcedures Advisory Committee (IPAC) in making recommendations aboutthe safety and efficacy of an interventional procedure. It is based on a rapidreview of the medical literature and specialist opinion. It should not beregarded as a definitive assessment of the procedure.Date preparedThis overview was prepared in October 2007.Procedure name• Endoaortic balloon occlusionSpecialty societiesThe following societies were approached to nominate Specialist Advisers• Society for Cardiothoracic Surgery in Great Britain and Ireland• British Cardiovascular Intervention Society• Society of Clinical Perfusion Scientists of Great Britain and Ireland• Association of Cardiothoracic AnaesthetistsIP Overview: Endoaortic balloon occlusion for cardiac surgery Page 1 of 21
    • IP 655DescriptionIndicationsEndoaortic balloon clamping is performed to achieve temporary obstruction ofthe aorta during cardiac surgery including mitral valve repair or replacementand coronary artery bypass grafting (CABG).Current treatment and alternativesOcclusion of the aorta is required in a number of cardiac surgery operations.This is achieved by external application of an aortic cross-clamp, which canbe applied either through conventional ‘open’ surgery approaches, or throughminimally invasive cardiac surgery approaches.What the procedure involvesThis procedure is usually part of a technology for minimally invasive cardiacsurgery (known as port-access) that involves endovascular aortic occlusion,cardioplegia and left ventricular decompression.A balloon catheter is inserted through the skin into an artery (normally thefemoral artery in the groin) and threaded towards the aortic root. The balloonat the tip of the catheter is filled with saline to block blood flow and achieveaortic occlusion. Continuous echocardiographic monitoring is necessary todetect balloon migration. Various devices can be used for this procedure.EfficacyThere were no outcomes reported in the literature that related directly to theefficacy of endoaortic balloon occlusion alone.SafetyMortalityIn a case series of 449 patients, 5% (11/209) of those who had endoaorticballoon occlusion and 3% (7/226) of those who had transthoracic aortic clampocclusion died in hospital1. A case series comparing 117 patients who hadendoaortic balloon occlusion during minimally invasive mitral valve surgerywith 117 matched controls who had conventional aortic cross-clampingreported one perioperative death in each group2.In two case series of 151 and 127 patients who had endoaortic balloonocclusion, there were 6 and 1 in-hospital deaths respectively3,4. In anothercase series, the 30-day mortality rate was 1% (3/306) and the rate of latedeaths (mean follow-up 20 months) was 2% (6/306)5. In a case series of 52patients with aortic atherosclerosis who had endoaortic balloon occlusion, themortality rate was 25% (13/52). This study also reported mortality for 2120IP Overview: Endoaortic balloon occlusion for cardiac surgery Page 2 of 21
    • IP 655patients who had conventional aortic cross-clamping during cardiac surgery,of whom 4% (90/2120) died6.Aortic dissection and balloon ruptureIn three case series, the following rates of aortic dissection were reported inpatients who underwent endoaortic balloon occlusion: 1% (3/209), 1% (3/306)and 1% (1/117)1, 5, 2. One aortic dissection occurred in a case series of 151patients; however, this was said to be unrelated to the endoaortic balloonocclusion device3. In three case series of 58, 120 and 127 patients, no aorticdissections occurred7, 4 8. One case of aortic dissection occurred in a patientwho underwent transthoracic aortic clamping (n = 35)7.Other complicationsIn the case series of 449 patients, there were no significant differences inarrthymias, pulmonary dysfunction, bleeding, renal failure or low cardiacoutput between those who had endoaortic balloon occlusion and those whohad transthoracic clamping. However, the rates of neurological complicationswere higher in the former group (p < 0.05)1.Stroke or transient ischaemic attack was reported in 4% (2/52), 2% (2/127),0.4% (1/306), 1% (1/117) and 1% (1/151) of patients in five case series 6, 4, 5, 23 . Myocardial infarction was reported in two patients in one case series(2/151) and one patient in another (1/306)3,5.Re-exploration for bleeding or tamponade was required in 10% (6/60), 9%(26/306), 7% (14/209), 6% (9/151), 4% (5/117), 4% (1/23) and 2% (3/127) ofpatients who underwent endoaortic balloon occlusion in six case series8, 5, 1, 3,2, 7, 4 .Literature reviewRapid review of literatureThe medical literature was searched to identify studies and reviews relevantto endoaortic balloon clamping for cardiac surgery. Searches were conductedvia the following databases, covering the period from their commencement to12 October 2007: MEDLINE, PREMEDLINE, EMBASE, Cochrane Library andother databases. Trial registries and the Internet were also searched. Nolanguage restriction was applied to the searches. (See appendix C for detailsof search strategy.)The following selection criteria (Table 1) were applied to the abstractsidentified by the literature search. Where these criteria could not bedetermined from the abstracts the full paper was retrieved.IP Overview: Endoaortic balloon occlusion for cardiac surgery Page 3 of 21
    • IP 655Table 1 Inclusion criteria for identification of relevant studies Characteristic Criteria Publication type Clinical studies were included. Emphasis was placed on identifying good quality studies. Abstracts were excluded where no clinical outcomes were reported, or where the paper was a review, editorial, laboratory or animal study. Conference abstracts were also excluded because of the difficulty of appraising methodology. Patient Patients requiring cardiac surgery. Intervention/test Endoaortic balloon occlusion. Outcome Articles were retrieved if the abstract contained information relevant to the safety and/or efficacy. Language Non-English-language articles were excluded unless they were thought to add substantively to the English-language evidence base.List of studies included in the overviewThis overview is based on eight case series.Other studies that were considered to be relevant to the procedure but werenot included in the main extraction table (Table 2) have been listed inAppendix A.Existing reviews on this procedureThere were no published systematic reviews with meta-analysis or evidencebased guidelines identified at the time of the literature search.Related NICE guidanceBelow is a list of NICE guidance related to this procedure. Appendix B detailsthe recommendations made in each piece of guidance listed below.Interventional procedures:In progress:Thoracoscopically-assisted mitral valve surgery. NICE interventionalprocedure consultation. Available from www.nice.org.uk/ip402.IP Overview: Endoaortic balloon occlusion for cardiac surgery Page 4 of 21
    • IP 655Table 2 Summary of key efficacy and safety findings on endoaortic balloon occlusion for cardiac surgeryAbbreviations used: ASD, atrial septal defect, AVR, aortic valve replacement, CABG, coronary artery bypass graft, CPB, cardiopulmonary bypass, ICU, intensive care unit, MV, mitralvalve, MVP, mitral valve repair, MVR, mitral valve replacement, TEE, transoesphageal echocardiographyStudy details Key efficacy findings Key safety findings CommentsOnnasch et al. (2002)1 Conversion to sternotomy Mortality and postoperative complications Study objective:Five years of less invasive mitral • Port-access endoclamp: 2% Endoclamp Transthoracic clamp To review thevalve surgery: From (4/209) In-hospital mortality 5% (11/209) 3% (7/226) authors’experimental to routine approach Reasons for conversion: Arrhythmias 22% (45/209) 19% (43/226) experience in aortic dissection (3), left Pulmonary 10% (21/209) 6% (14/226) less invasive MVCase series ventricular wall injury (1) Bleeding 7% (14/209) 5% (11/226) surgery.Germany • Transthoracic clamp: 0/226 Neurological (stroke, 8% (17/209) 2% (4/226)Study period: 1996–2001 transient hemiplegia)* There is a Operative and hospital Renal failure 2% (4/209) 2% (4/226) discrepancy inn = 449 outcomes Low cardiac output 2% (4/209) 0.5% (1/226) the paper There were no statistically Aortic dissection 1% (3/209) 0 between thePopulation: patients undergoing significant differences in * p < 0.05 between groups numbers ofMVP (n = 327) or MVR (n = 122) operative and hospital patients forMean age: 59 years outcomes between patients whom outcomesMale: 47% who had the Port-access The authors stated that initial results were disappointing and reflected a are reported (n =Reoperation: 9% (42/449) endoclamp method and those learning curve both surgically and technically. Most complications in the 435) and the who had transthoracic clamp port-access group occurred in the early phase of the study and results total number inTechnique: port-access mitral method. improved after modifications to the technique. In particular, no further the series (n =valve surgery. aortic dissections occurred after a new design of endoclamp was 449).Aortic occlusion: endoaortic introduced.balloon catheter (Endoclamp) inthe first 209 patients and all Furthermore, neurological complications in the port-access groupreoperations; transthoracic aortic decreased after the introduction of transcranial Doppler monitoring for theclamp in the latter 226 patients. detection of balloon migration.Mean follow-up: 11 monthsConflict of interest: none statedIP Overview: Endoaortic balloon occlusion for cardiac surgery Page 5 of 21
    • IP 655Abbreviations used: ASD, atrial septal defect, AVR, aortic valve replacement, CABG, coronary artery bypass graft, CPB, cardiopulmonary bypass, ICU, intensive care unit, MV, mitralvalve, MVP, mitral valve repair, MVR, mitral valve replacement, TEE, transoesphageal echocardiographyStudy details Key efficacy findings Key safety findings CommentsCasselman et al. (2003)5 Conversion to 30-day mortality: 1% (3/306) Study objective: ToMitral valve surgery can now sternotomy: 2% (6/306) Causes of death: aortic dissection during procedure; low cardiac output report the authors’routinely be performed Reasons for conversion: syndrome on postoperative day 5; disseminated intravascular coagulation total experience forendoscopically. • Aortic dissection (2) on postoperative day 4 after reinterventions for bleeding MV surgery using a • Inadequate CPB flow (3) minimally invasiveCase series • Iliac artery perforation (1) Late deaths (mean follow-up 20 months): 2.0% (6/306) endoscopicBelgium Causes of death: sudden death, after cholecystectomy; pneumonia; small approach.Study period: 1997–2002 bowel perforation; stroke; sternitis (in a sternotomy patient)n = 306 Postoperative complications Myocardial infarction: 1% (2/306)Population: patients undergoing Stroke: 0.3% (1/306)MVP (n = 226) or MVR (n = 80). Bleeding requiring reintervention: 9% (26/306)Mean age: 62 years New-onset atrial fibrillation: 17% (52/306)Male: 53% Groin lymphocoele: 5% (14/306) Subcutaneous emphysema: 3% (9/306)Technique: port-access MV Renal insufficiency: 3% (8/306)surgery. Pneumonia: 3% (8/306)Aortic occlusion: endoaortic Pacemaker implantation: 2% (7/306)balloon occlusion (EndoClamp) Pleural effusion: 2% (6/306)Mean follow-up: 20 months(range 0–60 months)Conflict of interest: none statedIP Overview: Endoaortic balloon occlusion for cardiac surgery Page 6 of 21
    • IP 655Abbreviations used: ASD, atrial septal defect, AVR, aortic valve replacement, CABG, coronary artery bypass graft, CPB, cardiopulmonary bypass, ICU, intensive care unit, MV, mitralvalve, MVP, mitral valve repair, MVR, mitral valve replacement, TEE, transoesphageal echocardiographyStudy details Key efficacy findings Key safety findings CommentsMurphy et al. (2006)4 Conversion to sternotomy (5) Outcomes are reported here as in the literature, i.e. there is no Study objective:Endoscopic robotic mitral valve or thoracotomy with rib- disaggregation between outcomes that authors attribute to the overall To determine thesurgery. spreading (1): 5% (6/127) cardiac procedure or the aortic occlusion method used. safety and efficacy Reasons for conversion: of endoscopic MVCase series • Ruptured breast implant Mortality surgery usingUSA • Insufficient venous return • One in-hospital death (the patient had a stroke after sternotomy and roboticStudy period: Dec 2002–Nov • Vision system failure died in hospital on postoperative day 48). instruments2005 • Femoral arterial disease • One late death 2 months after surgery (the patient had mild • Insufficient working space regurgitation: autopsy showed intact MV repair).n = 127 • Marked aortic tortuosity Complications (of 121 patients treated endoscopically)Population: patients undergoing PerioperativeMVR (n = 7), or MVP (n = 114) • Blood transfusion: 31% (37/121)(procedures could not be • Re-exploration for bleeding: 2% (3/121)completed for 6 patients)Mean age: 54 years (range 21– Postoperative78 years) • Stroke: 2% (2/121)Male: 58% • New-onset atrial fibrillation: 18% (22/121) • Groin lymphocoele: 2% (2/121)Technique: endoscopic robotic • Right pleural effusion: 2% (2/121)MV surgery (Da Vinci robotic • Pneumonitis: 2% (2/121)surgical system)Aortic occlusion: endoaortic • Ventilation > 24 hours: 2% (2/121)balloon occlusion • Prolonged air leak: 1% (1/121) • Transient renal dysfunction: 1% (1/121)Mean follow-up: 14 months • Groin wound cellulitis: 1% (1/121)(± 9 months) • Paravalvular leak: 1% (1/121) – occurred 6 weeks after surgery: repaired successfully via minithoracotomy.Conflict of interest: none stated There were no cases of aortic dissection, myocardial infarction, low cardiac output, chest incision infection, limb ischaemia or deep vein thrombosis.IP Overview: Endoaortic balloon occlusion for cardiac surgery Page 7 of 21
    • IP 655Abbreviations used: ASD, atrial septal defect, AVR, aortic valve replacement, CABG, coronary artery bypass graft, CPB, cardiopulmonary bypass, ICU, intensive care unit, MV, mitralvalve, MVP, mitral valve repair, MVR, mitral valve replacement, TEE, transoesphageal echocardiographyStudy details Key efficacy findings Key safety findings CommentsColvin et al. (1998)3 No conversions to sternotomy or Mortality Study objective: ToPort-access mitral valve other aortic occlusion methods Operative deaths: 4% (6/151) review short-term resultssurgery: summary of results. were reported of an initial experience Complications with minimally invasiveCase series Reoperation for bleeding or tamponade: 6% (9/151) cardiac valve surgeryUSA Myocardial infarction: 1% (2/151) using the port-accessStudy period: Oct 1995–Oct Transient ischaemic attack: 1% (1/151) approach1997 Wound infection: 1% (1/151) Aortic dissection leading to death of patient: 1% (1/151)n = 151 (Resulting from femoral cannulation and not related to Endoclamp)Population: patientsundergoing MVR (n = 36), MVP(n = 56), aortic valvereplacement (n = 35) orcomplex valve procedures (n =24)Mean age: 58 years (range 21-–91 years)Male: 50%Technique: Minimally invasiveport-access valve surgeryAortic occlusion: endoaorticballoon occlusionMean follow-up: 14 months(± 9 months)Conflict of interest: none statedIP Overview: Endoaortic balloon occlusion for cardiac surgery Page 8 of 21
    • IP 655Abbreviations used: ASD, atrial septal defect, AVR, aortic valve replacement, CABG, coronary artery bypass graft, CPB, cardiopulmonary bypass, ICU, intensive care unit, MV, mitralvalve, MVP, mitral valve repair, MVR, mitral valve replacement, TEE, transoesphageal echocardiographyStudy details Key efficacy findings Key safety findings CommentsReichenspurner H (2005)8 Conversion to sternotomy Intra- and post-operative complications Study objective: ToVideo and robotic-assisted None in either group Endo- Trans- p-value retrospectively compareminimally invasive mitral valve clamp thoracic the port-access MVsurgery: a comparison of the Operative and hospital clamp surgery techniquePort-Access and transthoracic outcomes Re-exploration for 10% 2% 0.11 (including endoaorticclamp techniques. There were no statistically bleeding (6/60) (1/60) balloon occlusion) with significant differences in Impaired wound 7% 0 0.12 the transthoracic cross-Case series operative and hospital healing (4/60) clamp technique.Germany outcomes between patients Lymphatic fistula 3% 0 0.50Study period: May 1997 – Nov who had the endoclamp (groin) (2/60) The authors do not state2002 occlusion method and those Femoral artery 3% 0 0.50 whether the patient who had transthoracic injury (2/60) groups (endoaortic vsn = 120 clamping. Ventricle 2% 0 Not significant transthoracic occlusion) perforation by (1/60) differed in any wayPopulation: patients Echocardiographic endopulmonary except for the stage ofundergoing combined or outcomes at discharge vent the series in which theyisolated MVR (n = 39) or MVP There were no statistically Tracheal injury 0 2% 1/60) Not significant had the operation (first 60(n = 81) significant differences in Total 15 2 0.001 vs latter 60).Mean age: 62 years (range SD regurgitation grade between complications10.5 years) patients who had the There were no reported cerebrovascular accidents or aorticMale: 29% endoclamp occlusion method dissections in either group. and those who had theTechnique: video- and robot- transthoracic clamping. Results at dischargeassisted (75%) port-access MV Endo- Trans- p-valuesurger. clamp thoracicAortic occlusion: endoaortic clampballoon catheter for the first 60 Hospital mortality 0 0 0patients and transthoracic Minor paravalvular 2% 0 1.00aortic clamp for last 60. leak (1/60) New-onset atrial 18% 15% Not significantMean follow-up: 3 months fibrillation (11/60) (9/60) Minor/no 72% 73% Not significantConflict of interest: none stated postoperative pain (43/60) (44/60) Moderate 28% 25% Not significant postoperative pain (17/60) (15/60)IP Overview: Endoaortic balloon occlusion for cardiac surgery Page 9 of 21
    • IP 655Abbreviations used: ASD, atrial septal defect, AVR, aortic valve replacement, CABG, coronary artery bypass graft, CPB, cardiopulmonary bypass, ICU, intensive care unit, MV, mitralvalve, MVP, mitral valve repair, MVR, mitral valve replacement, TEE, transoesphageal echocardiographyStudy details Key efficacy findings Key safety findings CommentsRyan et al (2005) Conversion to sternotomy Mortality , perioperative and 30-day outcomes Study objective: ToMitral valve surgery using the One case (1%) of aortic dissection by retrospectively compareClassical Heartport Technique the wire was recognised by TEE. The Endoaortic Standard p-value consecutive patients procedure was terminated and open occlusion aortic undergoing minimallyCase series MV repair was performed 3 weeks occlusion invasive MV surgery withUSA later. 1% (1/117) 1% (1/117) Not consecutive patients MortalityStudy period: Dec 1997–Dec significant undergoing MV surgery2004 Conversion to alternative occlusion 24% 24% Not by conventional method Atrial fibrillation sternotomy during the (28/117) (28/117) significantn = 117 No patients required conversion to Reoperative 4% (5/117) 2% (2/117) Not same period. transthoracic aortic cross-clamping. bleed significantPopulation: patients 1% (1/117) 3% (3/117) Not The authors do not stateundergoing MVR (n = 25) or Operative and hospital outcomes Stroke whether the patient significantMVP (n = 92) There were no statistically significant Prolonged 4% (5/117) 2% (2/117) Not groups (endoaortic vsPlus 117 matched controls who differences in duration of hospital stay, ventilation significant transthoracic occlusion)had MVR or MVP by ICU stay, ventilation between patients Readmission 8% (9/117) 3% (4/117) Not differed in any way.conventional sternotomy who had the endoclamp occlusion within 30 days significant(matched for age, ejection method and matched controls whofraction, presence of had a conventional sternotomy for MVcerebrovascular disease and surgery.inotrope use)Mean age: 54 years • For both patients who had MVR(± 14 years) and those who had MVP, meanMale: 53% cross-clamp time was significantly longer than for matched controls (pTechnique: minimally invasive = 0.02 and p < 0.001)‘Heartport’ MV surgery. • Perfusion time was significantlyAortic occlusion: endoaortic longer in patients who had MVPballoon catheter. than matched controls (p < 0.001)Follow-up: not reportedConflict of interest: none statedIP Overview: Endoaortic balloon occlusion for cardiac surgery Page 10 of 21
    • IP 655Abbreviations used: ASD, atrial septal defect, AVR, aortic valve replacement, CABG, coronary artery bypass graft, CPB, cardiopulmonary bypass, ICU, intensive care unit, MV, mitralvalve, MVP, mitral valve repair, MVR, mitral valve replacement, TEE, transoesphageal echocardiographyStudy details Key efficacy findings Key safety findings CommentsAybek et al (2000)7 Conversion to alternative Mortality Study objective: toThe micro-mitral operation comparing occlusion method • No intraoperative deaths in either group. compare the port-accessthe Port-access technique and the 4 patients for whom endoaortic • 1 patient who underwent endoaortic occlusion died technique (includingtransthoracic clamp technique. occlusion was intended were on postoperative day 14 from septic multiorgan endoaortic balloon converted to transthoracic aortic failure (following explantation of an infected occlusion) with theCase series clamp occlusion because of pacemaker probe) transthoracic cross-clamp endoclamp dysfunction • 1 patient who underwent transthoracic clamp technique.Germany occlusion died from low output syndrome after Intraoperative outcomes complex MV surgery The authors do not stateStudy period: Sep 1996–Nov 1999 3 patients who underwent whether the patient endoaortic occlusion and 2 patients Intra- and post-operative complications groups (endoaortic vsn = 58 who underwent transthoracic Endoaortic Tranthoracic transthoracic occlusion) occlusion had an unacceptable occlusion clamp differed in any wayPopulation: intraoperative result and were (n = 23) ( n = 35) except to say that Endoaortic Trans- converted to secondary MVR Rexploration for 4% (1/23) 6% (2/35) patients were assigned to occlusion thoracic intraoperatively bleeding either technique in a (n = 23) clamp Wound infection 0 6% (2/35) nonrandomised fashion. (n = 35) Operative and hospital outcomes Retrograde aortic 0 3% (1/35) Mean 58 (± 16) 56 (± 13) Mean operating time, aortic dissection age occlusion time, CPB duration and (years) postoperative blood loss were lower Male (%) 48 54 in the group that had transthoracic clamp (p < 0.05).Technique: minimally invasive MV There were no statisticallysurgery. significant differences between theAortic occlusion: patients were assigned groups in mean ICU stay andnon-randomly to either the port-access hospital stay.technique with an endoaortic balloonclamp (n = 23) or the same procedurebut with a specially designedtransthoracic aortic clamp (Chitwoodclamp) (n = 35)Follow-up: 12 monthsConflict of interest: none statedIP Overview: Endoaortic balloon occlusion for cardiac surgery Page 11 of 21
    • IP 655Abbreviations used: ASD, atrial septal defect, AVR, aortic valve replacement, CABG, coronary artery bypass graft, CPB, cardiopulmonary bypass, ICU, intensive care unit, MV, mitralvalve, MVP, mitral valve repair, MVR, mitral valve replacement, TEE, transoesphageal echocardiographyStudy details Key efficacy findings Key safety findings CommentsZingone et al (2006)6 Conversion to standard Comparison with other patients in the series Study objective: ToSurgical management of the atherosclerotic cross-clamp: 19% (10/52) retrospectively assessascending aorta: is endoaortic balloon occlusion Reasons for conversion: Endoaortic Other p-value the outcomessafe? • incomplete occlusion (5) occlusion patients associated with the use • hindered exposure (2) (n = 52) (n = 2120) of endoaortic occlusion.Case series • balloon rupture (3) Hospital 25% (13/52) 4% p < 0.0001 mortality (90/2120) This study does notItaly Early 4% (2/52) 1% p = 0.067 report outcomes for the stroke (16/2120) port-access or aStudy period: Jan 2000–Aug 2004 minimally invasive EuroSCORE (risk prediction system for patients technique.n = 52 undergoing cardiac surgery) expected mortality was 10.5% for the 52 patients treated with endoaortic Authors state: “WhilePopulation: patients were selected for endoaortic occlusion and 6.6% for all other patients (p=0.16), coronary artery graftingballoon occlusion if they had calcified aortas. This indicating that patients treated with balloon on the beating heart,was determined by preoperative diagnosis of occlusion were at higher relative risk (though this with or without CPB,porcelain aorta or intraoperative findings at epiaortic was not statistically significant) assistance, wasultrasonographic scanning (replaced by aortic generally adopted topalpation from Jan 2001 onwards). The operations Risk-adjusted EuroSCORE estimates showed that avoid aorticwere conducted within a series of 2172 patients, in the increased risk profile of the patients who manipulations oftotal, undergoing various cardiac operations. underwent endoaortic balloon occlusion partly atherosclerotic aortas,Mean age: Not reported explained this difference in death rates. surgeons sometimes feltMale: Not reported Patients undergoing endoaortic occlusion were uncomfortable with that significantly older and had a greater prevalence of: and resorted toTechnique: Various cardiac operations: isolated serum creatinine ≥ 2.3mg/dL, history of neoplastic endoaortic occlusion inCABG (n = 27), isolated valve surgery (n = 13), disease, extracardiac arteriopathy and carotid artery the few patientscombined valve surgery and CABG (n = 12). disease. included in this report”Aortic occlusion: endoaortic balloon catheter (Foley [n= 30] or Pruitt catheter [n = 22]). In multivariate analysis, the use of endoaorticFor the remaining 2120 patients in the series, a balloon occlusion was independently associatedconventional aortic cross-clamp was used for aortic with in-hospital deaths (OR: 5.61, 95% CI: 2.68 toocclusion. 11.72)Follow-up: not statedConflict of interest: none statedIP Overview: Endoaortic balloon occlusion for cardiac surgery Page 12 of 21
    • IP 655Validity and generalisability of the studies• Only efficacy outcomes that were specifically related to the method of aortic occlusion were included in Table 2. All relevant safety outcomes were reported.• Studies were selected for inclusion in Table 2 if they specifically addressed the efficacy or safety of endoaortic balloon occlusion. In addition, any literature that reported on the safety of a cardiac procedure that incorporated endoaortic balloon occlusion and had sufficiently large patient numbers was also included.• All but one study relate to the use of the procedure in the context of minimally invasive mitral valve surgery. This study (Zingone et al) used endoaortic balloon occlusion outside a ‘minimally invasive’ cardiothoracic surgery setting.• There were several relevant studies that assessed other cardiac operations (such as coronary artery bypass grafting and atrial septal defect repair); however, these were included in the Appendix because they reported on small numbers of patients.• Many studies were comparative, but patients were typically consecutive in a case series (most commonly with earlier patients in the series undergoing endoaortic occlusion and latter patients undergoing transthoracic aortic clamp). Only one study (Aybek et al) assigned patients to a treatment group and this was in a ’nonrandomised fashion’.• Some studies compared an endoaortic balloon catheter with a transthoracic aortic cross-clamp and others compared this technique with a standard external aortic clamp which is used in mitral valve surgery through a median sternotomy.Specialist advisers’ opinionsSpecialist advice was sought from consultants who have been nominated orratified by their Specialist Society or Royal College. The advice received istheir individual opinion and does not represent the view of the societyMr Venkatachalam Chandrasekaran, Mr Steven Hunter, Mr Simon Kendall, MrSteven Livesey, Mr Russell Millner, Mr David Richens (Society forCardiothoracic Surgery in Great Britain and Ireland)Dr John Kneeshaw (Association of Cardiothoracic Anaesthetists)Mr Olaf Wendler (British Cardiovascular Intervention SocietySafety• Theoretical adverse events included: death, aortic dissection or rupture, stroke, inadequate myocardial protection or cerebral ischaemia due to balloon misplacement and arterial embolism.• Anecdotal adverse events included: aortic dissection, puncture of balloon during the procedure, balloon migration, death due to failure to deliver cardioplegia, damage to aortic intima, device movement causing loss ofIP Overview: Endoaortic balloon occlusion for cardiac surgery Page 13 of 21
    • IP 655 occlusion, inability to complete planned surgery due to failure to occlude aorta, femoral artery damage, difficulty positioning the balloonEfficacy• Major efficacy outcomes included: the ability to perform less invasive/minimal access cardiac surgery, efficiency of cardioprotection, reduced length of hospital stay, reduced duration of cardiac arrest, avoidance of the use of a cross-clamp from outside and therefore reduced stroke risk in patients with very calcified aorta.Current status• One Specialist Adviser stated that this was the first in a new class of procedures. Two stated that it was novel and of uncertain safety and efficacy and four thought it was established practice and no longer new.• Four Specialist Advisers stated that they stopped using this technique (or its use was stopped at their Institution). One Specialist Adviser stated that he stopped using this technique when in his opinion a safer technique became available. Another said he stopped following negative clinical experience. One Specialist Adviser stated that he was unhappy with the outcome despite appropriate positioning of the device.• One Specialist Adviser stated that this technique has been supplanted by transthoracic aortic cross-clamping, which is perceived as being safer and easier to use, and less expensive.• One Specialist Adviser stated that the technique has been available for over 10 years. He noted that there was an initial learning curve, but otherwise thought it was safe and effective when performed by those with special training in the use of the relevant equipment.Comparator• The main comparator is open heart cardiac surgery with conventional bypass via median sternotomy and external aortic cross-clamping. In minimally invasive surgery the comparator is the transthoracic aortic clamp (Chitwood clamp).Impact• The potential impact is minor with fewer than 10 specialist centres in the UK likely to perform this technique.Training• All Specialist Advisers thought there was a significant learning curve and several stated that specific training in the use of the device and balloon deployment is necessary. The procedure should be carried out with good transoesophageal echocardiographic views to allow correct positioning of the clamp.IP Overview: Endoaortic balloon occlusion for cardiac surgery Page 14 of 21
    • IP 655References1. Onnasch JF, Schneider F, Falk V et al. (2002) Five years of less invasive mitral valve surgery: from experimental to routine approach. Heart Surgery Forum 5: 132-135.2. Ryan WH, Dewey TM, Mack MJ et al. (714) Mitral valve surgery using the classical heartport technique. Journal of Heart Valve Disease 14: 709-714.3. Colvin SB, Galloway AC, Ribakove G et al. (1998) Port-Access mitral valve surgery: summary of results. Journal of Cardiac Surgery 13: 286- 289.4. Murphy DA, Miller JS, Langford DA et al. (2006) Endoscopic robotic mitral valve surgery.[see comment]. Journal of Thoracic & Cardiovascular Surgery 132: 776-781.5. Casselman FP, Van Slycke S, Wellens F et al. (2003) Mitral valve surgery can now routinely be performed endoscopically. Circulation Vol. 108: 09-6. Zingone B. (2006) Surgical Management of the Atherosclerotic Ascending Aorta: Is Endoaortic Balloon Occlusion Safe? Annals of Thoracic Surgery 82: 1709-1714.7. Aybek T, Doss M, Abdel-Rahman U et al. (2005) Echocardiographic assessment in minimally invasive mitral valve surgery. Medical Science Monitor 11: MT27-MT32.8. Reichenspurner H, Detter C, Deuse T et al. (2005) Video and robotic- assisted minimally invasive mitral valve surgery: a comparison of the Port-Access and transthoracic clamp techniques. Annals of Thoracic Surgery 79: 485-490.IP Overview: Endoaortic balloon occlusion for cardiac surgery Page 15 of 21
    • IP 655Appendix A: Additional papers on endoaortic balloonocclusion for cardiac surgery not included insummary Table 2The following table outlines the studies that are considered potentially relevantto the overview but were not included in the main data extraction table(table 2). It is by no means an exhaustive list of potentially relevant studies.Article title Number of Direction of conclusions Reasons for non- patients/ inclusion in follow-up Table 2Ak K, Aybek T, Wimmer- n = 64 No hospital deaths or Studies with moreGreinecker G et al. (2007) major complications patients wereEvolution of surgical included in Table 2techniques for atrial septal 2 conversions to minithoracotomy due todefect repair in adults: a 10- endoaortic balloon failureyear single-institutionexperience. Journal of Thoracic& Cardiovascular Surgery 134:757–64.Argenziano M, Katz M, Bonatti n = 85 No hospital deaths or Studies with moreJ et al. (2006) Results of the strokes patients wereprospective multicenter trial of 5 conversions to open included in Table 2robotically assisted totally techniques 1 myocardial infarctionendoscopic coronary arterybypass grafting. Annals ofThoracic Surgery 81: 1666–74.Byrne JG, Aklog L, Adams DH n = 50 Results not reported separately for patients whoet al. (2001) Reoperative (endoaortic had endoaortic balloon occlusion and those whoCABG using left thoracotomy: balloon had other methods of aortic occlusiona tailored strategy. Annals of occlusion = 4)Thoracic Surgery 71: 196–200.Casselman FP, Meir ML, n = 80 3 deaths within 30 days Studies with moreJeanmart H et al (2007) 5 conversions to patients wereEndoscopic mitral and tricuspid sternotomy (due to lung included in Table 2valve surgery after previous adhesions (5), cannulation problems (1)cardiac surgery. Circulation 2 strokes116: 270-275. n = 50 No conversions to Studies with moreDe Mulder W, Vanermen H. sternotomy patients were(2002) Repair of atrial septal No hospital mortality included in Table 2defects via limited right No thromboembolic oranterolateral thoracotomy. Acta peripheral ischaemicChirurgica Belgica 102: 450–4. complicationsDiegeler A, Falk V, Krahling K n = 114 No complications in Studies with moreet al. (1998) Less-invasive (endoaortic patients who had patients werecoronary artery bypass balloon endoaortic balloon included in Table 2grafting: different techniques occlusion = occlusion 9)and approaches. EuropeanJournal of Cardio-ThoracicSurgery 14: Suppl-9. S13–S19.IP Overview: Endoaortic balloon occlusion for cardiac surgery Page 16 of 21
    • IP 655Dogan S, Aybek T, Andressen n = 45 10 conversions to open Studies with moreE et al. (2002) Totally techniques due to: patients wereendoscopic coronary artery bleeding (4), prolonged included in Table 2bypass grafting on cross-clamp time (2), intraoperative diagnosis ofcardiopulmonary bypass with peripheral vascularrobotically enhanced disease (3), graft injury (1)telemanipulation: report offorty-five cases.[see comment]. 1 case each of: aorticJournal of Thoracic & dissection, hypoxic brainCardiovascular Surgery 123: damage, myocardial1125–31. infarctionGalloway AC, Grossi EA, n = 64 Results not reported separately for patients whoBizekis CS et al. (2002) had endoaortic balloon occlusion and those whoEvolving techniques for mitral had other methods of aortic occlusionvalve reconstruction.[seecomment]. Annals of Surgery236: 288–93.Glower DD et al. (1998) Mitral n = 41 Port-access operation Studies with morevalve operation via Port Access provided smaller incision patients wereversus median sternotomy. and faster return to included in Table 2European Journal of Cardio- normal activity than sternotomyThoracic Surgery 14: Suppl-1S143–S147.Glower DD, Siegel LC, n = 64 Results not reported separately for patients whoFrischmeyer KJ et al. (2000) had endoaortic balloon occlusion and those whoPredictors of outcome in a had other methods of aortic occlusionmulticenter port-access valveregistry. Annals of ThoracicSurgery 70: 1054–9.Glower DD, Siegel LC, n = 64 Study focuses on predictors of operative onlyGalloway AC et al. (2001)Predictors of operative time inmulticenter port-access valveregistry: institutionaldifferences in learning. HeartSurgery Forum 4: 40–6.Glower DD, Clements FM, n = 165 Results not reported separately for patients whoDebruijn NP et al. (1999) (endoaortic had endoaortic balloon occlusion and those whoComparison of direct aortic and balloon had other methods of aortic occlusionfemoral cannulation for port- occlusion = 36)access cardiac operations.Annals of Thoracic Surgery 68:1529–31.Grossi EA, LaPietra A, n = 100 Awaiting full articleRibakove GH et al (2001)Minimally invasive versussternotomy approaches formitral reconstruction:comparison of intermediate-term results. Journal ofThoracic and CardiovascularSurgery 121: 708–13.Gulielmos V, Dangel M, n = 29 Awaiting full articleSolowjowa N et al (1998)Clinical experiences withminimally invasive mitral valvesurgery using a simplified Port-access technique. EuropeanJournal of Cardio-ThoracicSurgery 14: 141–7IP Overview: Endoaortic balloon occlusion for cardiac surgery Page 17 of 21
    • IP 655Gulielmos V, Wunderlich J, n = 21 Awaiting full articleDangel M et al (1998)Minimally invasive mitral valvesurgery – clinical experienceswith a Port-access system.European Journal of Cardio-Thoracic Surgery 14: S148–53.Hesselvik JF, Ortega RA, n=1 Case report of a rupture ofTreanor P et al. (1999) the endoaortic clampIntraoperative rupture of the balloon during MV surgeryendoaortic clamp balloon in apatient undergoing port-accessmitral valve repair. Journal ofCardiothoracic & VascularAnesthesia 13: 462–5.Mishra YK, Khanna SN, Wasir n = 64 Results not reported separately for patients whoH et al. (2005) Port-access had endoaortic balloon occlusion and those whoapproach for cardiac surgical had other methods of aortic occlusionprocedures: Our experience in776 patients. Indian HeartJournal 57: 688–93.Mohr FW, Onnasch JF, Falk V n = 129 7 deaths More recent studyet al. (238) The evolution of 6 reexplorations for from the sameminimally invasive valve bleeding centre included insurgery – 2 year experience. 3 aortic dissections Table 2 8 neurologicalEuropean Journal of Cardio- complicationsThoracic Surgery 15: 233–8.Murphy D, Smith JM, Siwek L n = 64 Results not reported separately for patients whoet a.l (2007) Multicenter mitral had endoaortic balloon occlusion and those whovalve study: a lateral approach had other methods of aortic occlusionusing the da Vinci surgicalsystem. Innovations 2: 56–61. n = 39 No conversions toOnnasch JF, Schneider F, Falk sternotomy 2 deaths due to: aorticV et al. (2002) Minimally dissection and sepsisinvasive approach for redo 1 transient hemiplegia duemitral valve surgery: a true to endoclamp migrationbenefit for the patient. Journal 2 reexplorations forof Cardiac Surgery 17: 14–9. bleedingSchroeyers P, Wellens F, De n = 121 2 conversions to Another study fromGeest R et al. (2001) Minimally sternotomy due to aortic the same centre withinvasive video-assisted mitral dissection caused by the same patients isvalve repair: short and mid- Endoclamp included in Table 2 1 hospital deathterm results. Journal of Heart 9 revisions for bleedingValve Disease 10: 579–83.Schroeyers P, Wellens F, De n = 175 Mortality: 2/175 More recent studyGeest R et al. (2001) Minimally Conversion to sternotomy: from the sameinvasive video-assisted mitral 4/175 centre included invalve surgery: our lessons after NYHA class: All improved Table 2 at F/Ua 4-year experience. Annals ofThoracic Surgery 72: S1050-S1054.IP Overview: Endoaortic balloon occlusion for cardiac surgery Page 18 of 21
    • IP 655Vanermen H, Farhat F, n = 121 1 operative death and 2 More recent studyWellens F et al. (2000) early postoperative deaths from the sameMinimally invasive video- 5 conversions to centre included inassisted mitral valve surgery: sternotomy: due to aortic Table 2 dissection (2)From Port-Access towards a 1 neurologicaltotally endoscopic procedure. complicationsJournal of Cardiac Surgery 15: 3 cases of balloon being51–60. hit with needle and requiring replacementVanermen H, Wellens F, De n = 75 2 conversions to More recent studyGeest R et al. (1999) Video- sternotomy due to aortic from the sameassisted Port-Access mitral dissection centre included invalve surgery: from debut to 2 deaths Table 2 1 minor cerebrovascularroutine surgery. Will Trocar- deficitPort-Access cardiac surgery 5 revisions for bleedingultimately lead to roboticcardiac surgery? Seminars inThoracic & CardiovascularSurgery 11: 223–34.Yozu R, Shin H, Maehara T et n = 34 No hospital or late deaths Studies with moreal. (2001) Port-access cardiac 1 intraoperative balloon patients weresurgery. Experience with 34 rupture requiring included in Table 2cases at Keio University conversion alternative clamping methodHospital. Japanese Journal ofThoracic & CardiovascularSurgery 49: 360–4.IP Overview: Endoaortic balloon occlusion for cardiac surgery Page 19 of 21
    • IP 655Appendix B: Related NICE guidance for endoaorticballoon occlusion for cardiac surgeryGuidance programme RecommendationInterventional procedures IP402 Thoracoscopically assisted mitral valve surgery (in progress) 1.1 Evidence from large case series supports the safety and efficacy of thoracoscopically- assisted mitral valve surgery. Therefore, clinicians wishing to use this procedure should do so with normal arrangements for clinical governance and consent. 1.2 Thoracoscopically-assisted mitral valve surgery is technically demanding. Surgeons undertaking it should have special expertise and specific training in thoracoscopic cardiac surgery, and should perform their initial procedures with an experienced mentor. 1.3 Clinicians undertaking thoracoscopically- assisted mitral valve surgery should submit data on all patients to the Central Cardiac Audit Database (www.ccad.org.uk).Technology appraisals None applicableClinical guidelines None applicablePublic health None applicableIP Overview: Endoaortic balloon occlusion for cardiac surgery Page 20 of 21
    • IP 655Appendix C: Literature search for endoaortic balloonocclusion for cardiac surgeryDatabase Date searched Version/filesCRD databases (DARE &HTA)CENTRAL 12/10/2007 Issue 3, 2007EMBASE 12/10/2007 1980 to 2007 Week 40Medline 12/10/2007 1950 to October Week 1 2007Premedline 12/10/2007 October 11, 2007CINAHL 12/10/2007 1982 to October Week 1 2007BLICNational Research RegisterControlled Trials RegistryThe following search strategy was used to identify papers in Medline. A similarstrategy was used to identify papers in other databases.1. (endoaortic or endo-aortic).tw. (82)2. (endoballoon or endo-balloon).tw. (10)3. 1 or 2 (92)4. (occlu$ or clamp$).tw. (173242)5. 3 and 4 (68)6. (aort$ adj3 balloon$ adj3 (occlu$ or clamp$)).tw. (117)7. (balloon$ adj3 (occlu$ or clamp$) adj3 aort$).tw. (136)8. 6 or 7 (146)9. endovascular$.tw. (11105)10. (aort$ adj occlusion$).tw. (1137)11. 9 and 10 (36)12. (endoclamp or endo-clamp).tw. (18)13. 5 or 8 or 11 or 12 (240)14. Animal/ (4220069)15. Human/ (10034045)16. 14 not (14 and 15) (3194259)17. 13 not 16 (174)IP Overview: Endoaortic balloon occlusion for cardiac surgery Page 21 of 21