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Ann Thorac Surg 1999;67:51-58
© 1999 The Society of Thoracic Surgeons

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Original Articles

First report of the port access international registry

^a New York University Medical Center, New York, New York, USA
^b Boston University Medical Center, Boston, Massachusetts, USA
^c Duke University Medical Center, Durham, North Carolina, USA
^d Florida Hospital, Orlando, Florida, USA
^e Memorial Mission Hospital, Asheville, North Carolina, USA
^f Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA
^g Stanford University Medical Center, Stanford, California, USA

Address reprint requests to Dr Galloway, New York University Medical Center, 530 First Ave, Suite 9V, New York, NY 10016

Presented at the Poster Session of the Thirty-fourth Annual Meeting of The Society of Thoracic Surgeons, New Orleans, LA, Jan 26–28, 1998.

	Abstract

Top Footnotes Abstract Introduction Material and methods Results Comment Appendix 1 References

 
Background. For minimally invasive cardiac operations to be widely applicable, the risks must be equivalent to those of standard open-chest operations. This study analyzed the outcomes of patients recorded in the multicenter Port Access (PA) International Registry to establish operative risks.

Methods. Data were analyzed for intent to treat in 583 patients who underwent PA coronary artery bypass grafting (CABG), 184 who underwent PA mitral valve replacement, and 137 who underwent PA mitral valve repair at 121 centers.

Results. Port Access was attempted in 1,063 patients and completed in 1,004 (94%). The operative mortality rate was 1% for PA CABG, 3.3% for PA mitral valve replacement, and 1.5% for PA mitral valve repair. Perioperative morbidity was low in all categories: stroke = 1.1% to 3.6%, myocardial infarction = 0 to 1%, primary procedure reoperation = 0 to 0.7%, renal failure = 0.2% to 0.7%, multiorgan failure = 0 to 0.5%, and atrial fibrillation = 5% to 7.3%.

Conclusions. Data on 1,063 patients from 121 centers demonstrate that PA CABG and PA mitral valve operations can be performed safely, with morbidity and mortality rates similar to those associated with open-chest operations. Further studies are indicated to establish the long-term efficacy of this method and to analyze its effect on recovery time.

	Introduction

Top Footnotes Abstract Introduction Material and methods Results Comment Appendix 1 References

 
The potential advantages of minimally invasive cardiac operations, such as diminished pain and trauma, improved cosmetic results, and shorter recovery times, have compelled many centers to explore newly available technologies that facilitate precise and effective minimally invasive techniques. For these approaches to be accepted, however, they must meet the challenge of being less invasive while still achieving safety and efficacy outcomes equivalent to those of established techniques. For most cardiac procedures, this will continue to require the use of cardiopulmonary bypass and cardioplegic arrest.

A major breakthrough in the ability to widen the application of minimally invasive cardiac operations was the development of a system for cardiopulmonary bypass and cardioplegic arrest that did not require a sternotomy incision. This new approach was based on the use of an intraaortic balloon catheter for aortic occlusion and cardioplegia delivery, as proposed independently by Peters [1] and by Stevens and colleagues [2]. The concept was developed technologically by industry (Heartport, Inc., Redwood City, CA) and termed the Port Access System. With this system, cardioplegia is delivered either through the proximal port of the balloon catheter or through a percutaneously placed coronary sinus catheter. A separate set of instruments is designed to provide intracardiac retraction and to allow the surgeon to work through small incisions, or "ports." Thus, the surgeon potentially can achieve standard myocardial protection and perform precise cardiac operations without a sternotomy.

The Port Access approach initially was tested by the research laboratories of Stanford University and New York University [2–7]. These studies experimentally established the safety and efficacy of the myocardial protection system, the feasibility and reproducibility of single-vessel and multivessel coronary artery bypass grafting (CABG), and the applicability of the approach for mitral valve operations. A preliminary clinical trial was reported by Pompili and associates in 1996 [8].

Subsequently, U. S. Food and Drug Administration phase 1 clinical trials were performed at Stanford University for CABG [9], and at Stanford University and the New York University Medical Center for mitral valve operations. After clearance was obtained from the Food and Drug Administration in October 1996, several institutionally based prospective trials were initiated, with excellent early results in terms of safety and efficacy [10–12]. The early Port Access technique for CABG was well described by Ribakove and coworkers [13], and the mitral valve technique was described by Fann and colleagues [14] and by Galloway and associates [11].

To gather scientific information and data from a large number of centers, the Port Access International Registry (PAIR) was established for centers that used the Port Access approach. Data for the PAIR were submitted from participating centers (Appendix 1) for analysis of demographics and morbidity and mortality outcomes. To avoid potential conflicts of interest and maintain intellectual independence, the data were overseen by a scientific steering committee comprised of cardiac physicians and administered by an independent clinical research organization.

The current study, which is the first from the PAIR, was designed to analyze morbidity and mortality outcomes from the 121 centers that were participating in 1997. The study was designed to define the incidence of complications when the Port Access approach was used for CABG or mitral valve operations to establish the safety of the Port Access technique. Data collection began on April 1, 1997, to allow for start-up completion by multiple centers, and was continued through January 1, 1998.

	Material and methods

Top Footnotes Abstract Introduction Material and methods Results Comment Appendix 1 References

 
A total of 1,063 cases from 121 centers were reported to the PAIR between April 1, 1997, and January 1, 1998. This included 904 isolated CABG (n = 583) or mitral valve (n = 321) procedures that are the topic of this analysis. The data represent a relatively early experience with Port Access operations, with only two centers reporting more than 75 cases, 16 centers reporting 25 to 75 cases, and 103 centers reporting fewer than 25 cases.

Outcome data were compiled from registry reports and from the PAIR clinical report forms. Data were collected on patient demographics and perioperative mortality and major morbidity worldwide, and on median postoperative length of stay for patients in the United States. Morbidity analysis included all strokes, Q-wave myocardial infarctions, new-onset atrial fibrillation requiring therapy, primary reoperation for revascularization or valvular dysfunction, and reoperation for other thoracic complications, such as bleeding, pericardial effusion, or tamponade. Renal failure was defined as an elevated creatinine level of greater than 3.0 for 5 days, or as the need for dialysis. The clinical diagnosis of multiorgan failure required serious ongoing compromise of two or more major organ systems. Operative mortality included in-hospital and 30-day events. Both morbidity and mortality data were analyzed for intention to treat using Port Access and were reported as incidence.

	Results

Top Footnotes Abstract Introduction Material and methods Results Comment Appendix 1 References

 
Of the 1,063 procedures in which the surgeon intended to use Port Access, 1,004 (94.4%) were completed successfully, which was defined as successful use of the endoclamp without conversion to sternotomy. Conversions, when necessary, occurred for various reasons, including failure to pass the guidewire or endoclamp, poor exposure, and aortic dissection. Overall, the incidence of major complications leading to abandonment of the Port Access approach and conversion to sternotomy was low. The most worrisome complication, aortic dissection, had an overall incidence of 0.75% (8 of 1,063 patients), but this decreased from an initial incidence of 1.3% (7 of 531 patients) in the first half of the series to an incidence of 0.18% (1 of 532 patients) in the second half of the series.

Coronary artery bypass grafting comprised 55% of Port Access procedures, whereas mitral valve repair or replacement comprised 30%. The remaining 15% of cases were comprised of other procedures, such as multivalve operations, valve operations plus CABG, or atrial septal defect repair (Table 1).

The patients who underwent these procedures ranged in age from 26 to 86 years (mean, 60.5 years) and in weight from 41 to 158 kg (mean, 83.1 kg). Seventy-six percent were male and 34% were female (Table 2). Elective operations accounted for 87.2% of cases; 12.8% were urgent or emergency procedures. First operations accounted for 95.5% and reoperations for 4.5%.

Demographic data for the patients who underwent mitral valve operations are shown in Table 4. The patients ranged in age from 26 to 82 years (mean, 57.5 years) and in weight from 43 to 132 kg (mean, 72.8 kg). Males comprised 47.7% of the patient cohort and females comprised 53.3%. Elective operations accounted for 98% of cases and nonelective operations accounted for 2%. First operations constituted 90.9% of the procedures and reoperations constituted 9.1%.

Postoperative length of stay
Length of stay was recorded for 360 of the patients who underwent CABG procedures and 156 of the patients who underwent mitral valve procedures, all of whom were treated in the United States. The median length of stay was 4 days for Port Access CABG procedures, regardless of the number of vessels grafted. The median length of stay was 6 days for Port Access mitral valve replacement and 5 days for Port Access mitral valve repair.

	Comment

Top Footnotes Abstract Introduction Material and methods Results Comment Appendix 1 References

 
Minimally invasive cardiac operations represent a significant change in the way cardiac surgeons treat certain patients. Their underlying premise is that a smaller incision will cause less postoperative pain, resulting in a quicker overall recovery. If minimally invasive cardiac operations are to be widely applicable, they must be proved as safe and efficacious as standard procedures performed through a median sternotomy.

The Port Access approach with peripheral cardiopulmonary bypass, endovascular aortic occlusion, and cardioplegia arrest allows the surgeon to use standard anastomotic techniques on a still, protected heart, and to perform open heart valvular operations. If patients are selected appropriately for Port Access CABG, this approach should be able to produce patency results similar to those of open-chest methods because the distal anastomotic technique is not significantly different from the one used in standard open-chest procedures. Clinical data reported by Ribakove and associates [10] were encouraging in this regard, demonstrating no deaths and an overall bypass graft anastomotic patency rate of 96%, with 100% patency of left internal mammary-to-left anterior descending grafts, on routine angiographic follow-up in 32 patients.

The data in the current report are similarly encouraging. The 1% incidence of myocardial infarction in the 583 patients who underwent Port Access CABG and the minimal need for primary procedure reoperations are clinical evidence that the technique is reproducible in terms of anastomotic accuracy for coronary revascularization. Because all zones of the heart can be reached for grafting with this arrested-heart approach, Port Access CABG has been used increasingly in a substantial number of patients with multivessel disease. Multivessel CABG procedures accounted for 52% of the Port Access CABG procedures overall in this report, and for 56% of those in the second half of the study period. The technique eventually evolved so that most vein grafts now are brought off the ascending aorta for multivessel CABG, similar to open-chest methods.

An even better experience seems to be evolving with Port Access mitral valve operations, with extremely encouraging institutional reports. The small thoracotomy incision and internal cardiac retraction system provide excellent visualization of the mitral valve in the arrested heart. In some cases, the exposure appears to be better than that obtained with a standard sternotomy incision. The valve repair or replacement procedure is performed similarly to the standard open-chest method, except that the surgeon uses specifically designed long instruments and "knot pushers" to facilitate the technical process. Videoscopic assistance generally has not been necessary for visualization.

The initial New York University series [11] evaluated 131 mitral valve procedures performed using the Port Access technique and demonstrated that valve repair or replacement could be achieved routinely with an efficacy equivalent to that of open-chest methods. The operative mortality rate was 1.1% for isolated Port Access valve operations in that report. Glower and associates [12] reported similar findings, and presented data suggesting that early recovery and quality of life were better with the Port Access approach than with standard open-chest techniques. These encouraging findings need further validation.

In the current report on PAIR data, the morbidity and mortality outcomes of the 583 patients who underwent CABG and the 321 patients who underwent mitral valve procedures demonstrate that the Port Access technique is not associated with any significantly increased risk in appropriately selected patients. Overall, the data reported here suggest that the risks associated with the Port Access technique for both CABG and mitral valve operations are sufficiently low to warrant wider application of this technique, and that the perioperative risks are comparable to those associated with standard open-chest procedures. Speed of recovery, perioperative pain, and quality of life were not addressed in this study.

Two specific potential complications, which were troubling when the Port Access approach first was introduced, deserve particular attention. The first concerns the risk of aortic dissection. Reintroducing the routine use of retrograde perfusion through the femoral artery for extracorporeal perfusion is controversial because the incidence of aortic dissection was high when femoral perfusion was used routinely in the past. We found an overall incidence of aortic dissection of 0.75% (8 of 1,063 patients) in the Port Access study patients. It is of interest that the incidence of aortic dissection decreased as the registry progressed and the risk of aortic dissection was actively addressed.

Factors that minimized the risk of dissection included the progressive development of improved catheters with more flexible guidewires, strict adherence to the Seldinger technique for catheter placement, avoidance of catheter placement and conversion to an open-chest technique when the guidewire would not pass, and selected use of vascular screening techniques when severe peripheral vascular disease was suspected on the basis of the history and physical examination. The introduction of these technical modifications and operative guidelines appears to have had a positive effect because the incidence of aortic dissection dropped from 1.3% in the first half of the study period to 0.18% in the last 532 patients. The risk at this point is comparable to the risk of aortic dissection associated with ascending aortic cannulation and antegrade perfusion.

The second potential concern with the Port Access approach is whether the removal of air will be adequate. Because the chest is not open with the Port Access technique and the surgeon does not have access to the apex of the heart for air removal, techniques had to be designed to ensure adequate removal of air from the heart. Several general techniques were developed for this purpose, one of which is described here.

When the mitral valve procedure is completed, a vent is passed across the valve into the left ventricle and blood return is increased to the heart to displace air through the untied atriotomy suture line while gently inflating the lungs. The proximal port of the endoclamp catheter is placed on gentle suction as the endoclamp is deflated and the heart is reperfused while fibrillating. With the heart fibrillating, both the transvalvular vent and the aortic endoclamp catheter are placed on gentle suction while the lungs are inflated and the heart and chest wall are massaged gently to aid in the removal of air. Transesophageal echocardiography is used to monitor air removal. The endoclamp then is partially reinflated while suction on the aortic root and transvalvular vents is continued and the heart is defibrillated. Finally, after air appears to have been removed adequately on echocardiographic surveillance, the endoclamp again is deflated and the vents are removed. Although this particular technique was not used uniformly by every center, similar strategies for removing air were used by most centers.

Overall, air removal appears to have been successful because the risk of stroke in the patients who underwent Port Access mitral valve procedures in this report was less than 3%, which is not significantly different from the risk associated with open-chest mitral valve procedures. We conclude that, when attention is paid to the use of proper technique, the Port Access approach does not introduce an increased risk of air embolization or stroke.

A somewhat unexpected but relevant finding in this study was the remarkably low incidence of new-onset postoperative atrial fibrillation in the PAIR study population. The incidence was low in both the CABG and the mitral valve populations, and it was dramatically lower than that reported in other large data bases for patients undergoing conventional operations. Proposed mechanisms for this decreased propensity toward atrial fibrillation include the absence of a right atriotomy incision and suture line with the Port Access technique, and the fact that the atrium is manipulated less and is not exposed to light and heat, resulting in less postoperative inflammation. Whatever the mechanism, if this observation is validated in future studies, a decreased incidence of postoperative atrial fibrillation eventually would have an effect on patient morbidity and postoperative length of stay.

In conclusion, the ultimate goal is for minimally invasive cardiac operations to be as safe and effective as standard operations but with less trauma and pain. If this proves to be a valid and achievable goal, the overall morbidity associated with cardiac operations could be decreased progressively, with great benefit to patients. The experience reported here from the PAIR data base suggests that the minimally invasive Port Access approach can be used safely, with overall risks similar to those associated with open-chest methods. The incidence of postoperative atrial fibrillation was especially low, possibly because a right atrial incision was not required.

As minimally invasive cardiac operations are used more widely, both the technologic equipment and the operative techniques should continue to evolve, ultimately resulting in a safer procedure and an improved patient outcome. It is essential that the data be evaluated carefully to determine the scientific validity of these new approaches. The goal of all fields of medicine, and of cardiac surgery in particular, should be to provide improved treatment outcomes with less morbidity. Further studies are indicated to establish the long-term efficacy of Port Access operations and to analyze the effect of these procedures on postoperative recovery and quality of life.

	Footnotes

Top Footnotes Abstract Introduction Material and methods Results Comment Appendix 1 References

 
Drs. Burdon, Groh, and Shemin acted as consultants to Heartport. Dr. Reitz is a member of the Scientific Advisory Board for Heartport and received financial compensation in the form of honoraria, as did Drs. Boyer and Glower. Dr. Ribakove has stock holding in Heartport. Financial contributions made by Heartport were for the Port-Access Surgery Registry, Port-Access International Registry brief case report form, and Comprehensive case report form. NYU Medical Center received partial support for a clinical data coordinator.

	Appendix 1

Top Footnotes Abstract Introduction Material and methods Results Comment Appendix 1 References

 

PARTICIPATING CENTER CITY STATE Allegheny General Hospital Pittsburgh PA Baptist Medical Center Oklahoma City OK Baptist Medical Center Little Rock AR Baptist Medical Center Montclair Birmingham AL Baptist Memorial Hospital Memphis TN Barnes-Jewish Hospital St. Louis MO Boston Medical Center Boston MA Brigham and Women’s Hospital Boston MA Bryn Mawr Hospital Bryn Mawr PA Cedars-Sinai Medical Center Los Angeles CA Central Baptist Hospital Lexington KY Chippenham Medical Center Richmond VA Cleveland Clinic Foundation Cleveland OH Deborah Heart and Lung Center Browns Mills NJ Doctors Medical Center Modesto CA Duke University Hospital Durham NC Encino-Tarzana Regional Medical Center Encino CA Florida Hospital Medical Center Orlando FL Fresno community Hospital and Medical Center Fresno CA Georgetown University Hospital Washington DC Grant-Riverside Methodist Hospitals Columbus OH Henrico Doctors’ Hospital Richmond VA Hermann Hospital Houston TX Inova Fairfax Hospital Falls Church VA Johns Hopkins Hospital Baltimore MD Latter Day Saints Hospital Salt Lake City UT Lehigh Valley Hospital Allentown PA Little Company of Mary Hospital Torrance CA Los Robles Regional Medical Center Thousand Oaks CA Loyola University Medical Center Maywood IL Massachusetts General Hospital Boston MA Medical Center Hospital Odessa TX Medical College of Ohio Hospital Toledo OH Mission St. Joseph’s Health System Asheville NC New Mexico Heart Institute Albuquerque NM New York University Medical Center New York NY Ochsner Foundation Hospital New Orleans LA Palo Alto Veterans Affairs Medical Center Palo Alto CA Presbyterian Hospital of Dallas Dallas TX Redding Medical Center Redding CA Research Medical Center Kansas City MO Rochester General Hospital Rochester NY Rush-Presbyterian-St. Luke’s Medical Center Chicago IL Saint Francis Hospital Tulsa OK Saint Joseph’s Hospital of Atlanta Atlanta GA Schumpert Medical Center Shreveport LA Southern Illinois University School of Medicine Springfield IL Spectrum Health Grand Rapids MI St. Francis Health Care System Hartford CT St. Francis Hospital Roslyn NY St. Francis Hospital Center and Health Centers Beech Grove IN St. John Medical Center Tulsa OK St. Joseph Medical Center Towson MD St. Luke’s Medical Center Milwaukee WI St. Mary’s Hospital Richmond VA St. Thomas Hospital Nashville TN Stanford University Hospital Stanford CA The Sanger Clinic, PA and Carolinas Medical Center Charlotte Nc Union Memorial Hospital Baltimore MD University Community Hospital Tampa FL University Hospital Augusta GA University of Louisville School of Medicine Louisville KY Department of Thoracic and Cardiothoracic Surgery and Jewish Hospital Heart/Lung Institute, University of Pennsylvania Philadelphia PA University of Southern California Pasadena CA University of Utah, School of Medicine Salt Lake City UT University of Virginia Medical Center Charlottesville VA Veterans Affairs Medical Center San Diego San Diego CA Wake Medical Center Raleigh NC Walter O. Boswell Memorial Hospital Sun City AZ Westchester County Medical Center Valhalla NY Willis Knighton Medical Center Shreveport LA Akademiska Sjukhuset Uppsala Uppsala Sweden Bergmannshell-Universitatsklinikum Bochum Germany C.H.U. Lyon Louis Pradel Lyon France C.H.U.R. Metz Hospital Bon Secours Metz France Clinique Clairval Marseille France Dresden University Dresden Germany Freeman Hospital Newcastle Upon Tyne UK Harley Stree Hospital, Columbia Health Group London UK Her-kreislaufzentrum Leipzig Germany Hopital Broussais Paris France Hopital Europeen de Paris-La Roseraie Aubervilliers France Hospital do Meixoeiro Vigo Spain Hospital Doce de Octubre Madrid Spain Hospital Santa Cruz Linda-a-Velha Portugal Klinikum Grosshadern Munich Germany Krankenhaus Links der Wesser Bremen Germany Lille/Hospital Cardiologique Lille France Onze Lieve Vrouw Clinic Aalst Belgium Policlinico San Matteo Pavia Italy Royal Infirmary of Edinburgh Edinburgh Scotland University of Barcelona Barcelona Spain University of Frankfurt Frankfurt a.M. Germany Escorts Heart Institute and Research New Delhi India National Heart Institute Kuala Lampur Malaysia

	References

Top Footnotes Abstract Introduction Material and methods Results Comment Appendix 1 References

 

1. Peters W.S. Minimally invasive cardiac surgery by cardioscopy. Australian J Cardiac Thorac Surg 1993;2:152-154.
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4. Pompili M.F., Stevens J.H., Burdon T.A., et al. Port-access mitral valve replacement in dogs. J Thorac Cardiovasc Surg 1996;112:1268-1274.[Abstract/Free Full Text]
5. Schwartz D.S., Ribakove G.H., Grossi E.A., et al. Minimally invasive mitral valve replacement: port-access technique, feasibility and myocardial functional preservation. J Thorac Cardiovasc Surg 1997;113:1022-1031.[Abstract/Free Full Text]
6. Schwartz D.S., Ribakove G.H., Grossi E.A., et al. Minimally invasive cardiopulmonary bypass with cardioplegic arrest: a closed chest technique with equivalent myocardial protection. J Thorac Cardiovasc Surg 1996;111:556-566.[Abstract/Free Full Text]
7. Schwartz D.S., Ribakove G.H., Grossi E.A., et al. Single and multivessel port-access coronary artery bypass grafting with cardioplegic arrest: technique and reproducibility. J Thorac Cardiovasc Surg 1997;114:46-52.[Abstract/Free Full Text]
8. Pompili M.F., Yakub A., Siegel L.C., Stevens J.H., Awang Y., Burdon T.A. Port-access mitral valve replacement: initial clinical experience. Circulation 1996;94(Suppl 1):533.
9. Reitz B.A., Stevens J.H., Burdon T.A., et al. Port-access coronary artery bypass grafting: lessons learned in a phase 1 clinical trial. Circulation 1996;94(Suppl 1):52.[Abstract/Free Full Text]
10. Ribakove G.H., Miller J.S., Anderson R.V., et al. Minimally invasive port-access coronary artery bypass grafting with early angiographic follow-up: initial clinical experience. J Thorac Cardiovasc Surg 1998;115:1101-1110.[Abstract/Free Full Text]
11. Galloway A.C., Ribakove G.H., Grossi E.A., et al. Minimally invasive port-access valvular surgery: initial clinical experience. Circulation 1997(Suppl 1):508.
12. Glower DD, Landolfo KP, Clements F, et al. Mitral valve operation via port-access versus median sternotomy. Eur J Cardiothorac Surg. In press.
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