Ann Thorac Surg 2000;70:1054-1059
© 2000 The Society of Thoracic Surgeons
Supplement: cardiothoracic techniques & technologies
Predictors of outcome in a multicenter port-access valve registry
Donald D. Glower, MDa,
Lawrence C. Siegel, MDb,
Karen J. Frischmeyer, DVM,
Aubrey C. Galloway, MDc,
Greg H. Ribakove, MDc,
Eugene A. Grossi, MDc,
Newell B. Robinson, MDd,
William H. Ryan, MDe,
Stephen B. Colvin, MDc
a Duke University Medical Center, Durham, North Carolina, USA
b Heartport, Inc, Redwood City, California, USA
c New York University Medical Center, New York, New York, USA
d St. Francis Hospital, Roslyn, New York, USA
e Presbyterian Hospital, Dallas, Texas, USA
Address reprint requests to Dr Glower, Duke University Medical Center, Box 3851, Durham, NC 27710
e-mail: glowe001{at}mc.duke.edu
Presented at the Sixth Annual Cardiothoracic Techniques and Technologies Meeting 2000, Fort Lauderdale, FL, Jan 27–29, 2000.
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Abstract
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Background. The aim of this study was to examine the predictors of outcome in patients undergoing isolated valve operation using port-access techniques.
Methods. Logistic regression analysis was performed in a prospective, multi-institutional registry of patients undergoing isolated aortic valve replacement (AVR, n = 252), mitral repair (MVP, n = 491), or mitral replacement (MVR, n = 568) using port-access techniques from 1997 to 1999.
Results. Endoaortic balloon occlusion was used in 2% (AVR), 93% (MVP), and 90% (MVR) of cases. Conversion to full sternotomy occurred in 3.8% of all cases. For all patients, early mortality was 50 of 1,311 (3.8%) and onset of new atrial fibrillation occurred in 140 of 1,311 (11%) patients. The determinants of 30-day mortality were redo, age, and MVR or AVR. The determinants of reoperation for bleeding were age, reoperation, and MVR. Age was a predictor for stroke, and age and low or medium volume center were predictors of new atrial fibrillation.
Conclusions. Excellent short-term results can be obtained using port-access techniques in isolated mitral or aortic valve operations. Patient outcome is not related to institutional case volume, and the primary determinants of outcome after port-access valve procedures are generally patient-related factors.
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Introduction
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Port-access was introduced as a technique to perform valvular operations using cardiopulmonary bypass, and combinations of a small right thoracotomy and/or endovascular aortic occlusion [1]. Since the introduction of this technique, several series of mitral valve [2–11] or aortic valve [12, 13] operations have been reported, generally representing the initial experiences of single institutions. Although the results of port-access for mitral or aortic valve operation have been good, controversy persists as to whether the results of port-access differ from those of median sternotomy [5, 13, 14] and whether factors such as institutional volume or learning curves influence the results of port-access procedures [15]. Furthermore, few results from aortic valve replacement using port-access have been reported [12, 13]. To address these issues, a multi-institutional registry of port-access procedures (the Port-Access International Registry [PAIR]) was initiated in 1997 and terminated in 1999. This report contains the results of this PAIR registry for isolated aortic or mitral valve operation.
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Material and methods
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The PAIR database was used to conduct a detailed analysis of patient demographics, comorbid conditions, valvular disease, operative techniques, and clinical outcomes for consecutive patients undergoing isolated aortic or mitral valve surgery. The PAIR is a prospective observational, consecutive cohort registry that was initiated in June 1997, managed by an independent contract research organization, and sponsored by Heartport, Inc (Redwood City, CA) [8]. All institutions trained in port-access minimally invasive cardiac surgery were eligible to participate. In all, 104 institutions elected to participate at one of three levels: (1) a brief case report form (CRF) with in-hospital follow-up; (2) brief CRF with 30-day follow-up; or (3) comprehensive CRF with 30-day follow-up (see Appendix). Patient exclusion criteria included age greater than 85 years; need for emergent operation; illness limiting life expectancy to less than 2 years; and any significant femoral, iliac, or aortic arterial disease
The brief CRF collected core patient data (including gender, height, weight, age, hospitalization and procedure dates, operative and reoperative status, and procedure) and perioperative complications in the following categories: reoperation, pulmonary, vascular, neurologic, infection, cardiac, multisystem failure, renal failure, other major morbidity, and death. In addition to the fields on the brief form, the comprehensive CRF collected data on patients’ history and comorbid conditions, preoperative status, operative technique, transfusions, and postoperative care. Perioperative complication fields were identical on all forms. The data incorporated a coding system to ensure that the patients and surgeons were not identified and institutional identities were maintained as confidential. Missing or inconsistent data were queried. Only patients with complete forms were included in an analysis data set. In all, 3,586 forms were submitted and 3,436 forms were included in the analysis data set. The analysis data set contained 1,311 isolated mitral or aortic valve surgery patients. A comprehensive report form was available for 738 patients, and the brief report form was available for remaining patients. Unless otherwise stated, all data refer to all 1,311 patients.
Patient demographic and operative data were summarized as mean plus or minus standard deviation, median, and 25th to 75th percentiles, or prevalence, as appropriate. Perioperative morbidity and mortality incidence and 95% confidence interval [16] were analyzed on an intention-to-treat basis. Independent predictors of mortality (in-hospital or 30-day), stroke, reoperation for bleeding, and new-onset atrial fibrillation were determined using multivariable logistic regression analysis. The effect of institutional case volume was examined by dividing the reporting institutions into three groups based on the total volume of port-access cases reported in this series. Thus, three institutions had high volume (
75 cases), 11 institutions had medium volume (20 to 74 cases), and 90 institutions had low volume (1 to 19 cases). In addition to institutional case volume, other categorical independent variables that were examined were age (
65 years, > 65 years), previous cardiac operation (yes, no), heart failure (New York Heart Association classes I to III, New York Heart Association class IV), and procedure (aortic valve replacement, mitral valve repair, mitral valve replacement).
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Results
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Port-access cardiac surgery techniques have been reported extensively [1–11] and will not be described here. A total of 1,311 isolated port-access aortic valve (AVR) surgery, mitral valve repair (MVP), and mitral valve replacement (MVR) cases reported between July 1997 and August 1999 were analyzed. This report includes cases from 104 institutions [8], with a distribution of aortic or mitral cases contributed per institution (Fig 1). Of these 1,311 cases, 252 (19%) were AVR, 491 (37%) were MVP, and 568 (43%) were MVR. Follow-up was at hospital discharge in 23% of cases and at 30 days in 77%.
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Fig 1. Distribution of cases contributed by 104 institutions. Volume represents aortic and mitral cases combined.
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Demographic characteristics of patients who under went port-access valve surgery are reported in Table 1. There was a high proportion of reoperation patients for mitral valve replacement and significant preoperative comorbidity in all three patient groups (Table 2). Of the MVR cases reported on the comprehensive form, 32% were reoperation patients. Aortic valve disease in AVR patients was characterized as stenotic in 74% of patients and as insufficient (rating of 3 or 4 out of 4) in 42% of patients. The most frequently indicated aortic valve disease etiologies were calcific (46%) and myxomatous degenerative (26%). Mitral valve disease in MVP patients was predominantly insufficiency (rating 3 or 4, 75%) whereas mitral valve disease in MVR patients was stenotic (44%) or insufficient (rating 3 or 4, 76%). The most frequently reported valve disease etiologies for MVP were myxomatous degeneration (58%) and mitral valve prolapse (22%), whereas those for mitral valve disease etiologies in MVR patients were rheumatic (41%) and myxomatous degeneration (24%).
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Table 1. Demographic Characteristics of Patients Who Underwent Port-Access Isolated Mitral or Aortic Valve Surgery
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Aortic valve procedures were performed predominantly by means of a partial sternotomy (40%) [17] or right anterior thoracotomy (47%) [12, 13, 18, 19]. Mitral valve operations were performed through a right anterior (87%) or lateral (10%) thoracotomy [3, 5–7]. Median length of chest incisions for AVR, MVP, and MVR procedures were 8 cm, 6 cm, and 6 cm, respectively. Median (25th to 75th percentile) skin-to-skin operative times for AVR, MVP, and MVR were 3.6 (range, 2.9 to 4.3), 4.7 (4.0 to 5.5), and 5.0 (4.0 to 5.8) hours, respectively. Median cardiopulmonary bypass times (25th to 75th percentile) for AVR, MVP, and MVR were 103 (range, 80–123), 127 (110–158), and 137 (108–180) minutes, and median aortic occlusion times were 73 (range, 61–90), 92 (75–115), and 89 (70–116) minutes, respectively. Endoaortic balloon occlusion was used in 2% of AVR, 93% of MVP, and 90% of MVR cases. In all, 86% of mitral valve repair procedures were performed with an annuloplasty ring (67% Baxter, 9% Medtronic, 8% St Jude). Of the mitral valve replacements, 19% were completed with a bioprosthetic valve (54% Baxter, 38% Medtronic) and 77% with a mechanical valve (90% St Jude, 4% ATS).
A total of 1,261 cases (96%) were successfully completed as port-access, which was defined as use of the EndoCPB or EndoDirect System (Heartport, Inc, Redwood City, CA) without conversion to a total median sternotomy. Multiple reasons for conversion to median sternotomy were captured on the comprehensive form for 17 patients and included patient anatomy (4 patients), vascular injury (6), poor visualization/exposure (4), inability to place system catheter (1), inadequate cardiopulmonary bypass (1), calcific aorta on palpation (1), and other (4 patients).
Intraoperative or postoperative transfusion therapy including homologous red blood cells (RBC), platelets, fresh frozen plasma, or cryoprecipitate, was administered to 57% of AVR, 58% of MVP, and 66% of MVR patients. A total of 109 AVR, 172 MVP, and 150 MVR patients received RBC and the median (25th to 75th percentile) number of units administered were 3 (range, 2 to 5), 2 (2 to 5), and 3.5 (2 to 6) units, respectively. Median (25th to 75th percentile) postoperative ventilation times for AVR, MVP, and MVR were 6 (range, 4 to 12), 8 (5 to 13), and 7 (5 to 15) hours, respectively. Intensive care unit stays for AVR, MVP, and MVR were 21 (range, 18 to 36), 22 (17 to 28), and 23 (19 to 48) hours, respectively. In all, 79% of AVR patients, 81% of MVP patients, and 67% of MVR patients were walking within 48 hours of surgery. Patients walked within 24 hours of surgery in the case of 48% of AVR, 53% of MVP, and 37% of MVR procedures.
In the United States, the median (25th to 75th percentile) postoperative length of stay for AVR, MVP, and MVR were 6 (range, 5 to 10), 5 (4 to 7), and 7 (5 to 11) days, respectively. Most patients were discharged home without services (82% AVR, 83% MVP, 74% MVR). Rates of readmission within 30 days were low in all groups at 6.0% for AVR patients, 8.4% for MVP patients, and 7.5% for MVR patients. Major perioperative morbidity and mortality rates are shown in Table 3. Operative mortality was 11/252 (4.4%) for AVR, 8/491 (1.6%) for MVP, and 31/568 (5.5%) for MVR. Causes of death were generally unrelated to the port-access approach (Table 4).
Multivariable analysis showed that the major predictors of death were reoperation, older age, MVR, and AVR (Table 5). Older age was the only predictor of stroke. Older age, MVR, and reoperation were all predictors for reoperation for bleeding (Table 5). The predictors for new onset atrial fibrillation were older age and not being a high-volume center (Table 5). Institutional case volume did not significantly affect mortality, stroke, or reoperation for bleeding.
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Table 5. Predictors of Selected Outcomes by Logistic Regression Analysis After Port-Access Mitral or Aortic Valve Operation
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Comment
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The purposes of this study were to examine prospectively the results of port-access aortic or mitral valve surgery at a number of institutions, and to examine the determinants of short-term outcome. Like any new technique that is evolving rapidly, port-access has a learning curve [9, 15]. One might therefore expect patient outcome to be influenced by the volume of port-access cases performed by the operating team. These issues have only been partially addressed for port-access by one study, which found that procedure time decreased with experience but at different rates at different institutions [15]. To date several reports have described results from port-access mitral or aortic valve procedures. Mohr and colleagues [7] reported the first large series of port-access mitral procedures (N = 51) and reported higher mortality and morbidity rates in port-access mitral operations (Table 6) than those seen here, in an initial experience. Others have reported more recent results that were similar to those reported here (Table 6). Thus, results from port-access mitral operation have been stable or have improved despite expansion of the patient pool. At the same time, the port-access technique has evolved to include greater use of indirect video to visualize the mitral valve [9], as well as selective aortic (instead of femoral) cannulation, with improved stability of the endoclamp and with fewer groin complications [20].
This report examines the influence of institutional case volume upon patient outcome after port-access mitral of aortic valve operation. Institutional case volume did not affect mortality, stroke, or reoperation for bleeding. The reason that high institutional volume decreased the likelihood of new-onset atrial fibrillation is unclear but may, for example, involve the routine use of antiarrhythmic agents in mitral valve patients at higher volume institutions. Similar patient outcomes from a variety of institutions suggest that port-access can be mastered with a relatively short learning curve in a variety of institutional circumstances and in a variety of patient populations. Nonetheless, the results reported here tended not to include the initial 10 to 15 cases (initial learning curve) at the participating institutions. Thus, this study cannot exclude the possibility that results might not be similar among institutions in the initial learning curve (first 15 cases) [15].
The mortality and morbidity in this series of port-access procedures are similar to those reported by means of a sternotomy [21]. Although the patient population is not obviously different from those described in sternotomy series, few studies have directly compared the results of sternotomy to those of port-access in a controlled fashion [5, 13]. In retrospective analyses, faster return to normal activity, lower incidence of sepsis or wound complications, less fresh plasma transfusion, and shorter hospital stay have been reported for port-access relative to sternotomy [5, 13].
In addition, the multivariable predictors of adverse outcome identified for port-access (Table 5) include factors such as age that have previously been reported as risk factors for death, stroke, or new atrial fibrillation in sternotomy patients. Interestingly, the incidence of new onset of atrial fibrillation for port-access in this series (10.0%–12.7%) is somewhat lower than that previously reported for sternotomy in mitral valve patients.
This is the largest series of port-access applied to aortic valve replacement using a variety of techniques (partial sternotomy, right thoracotomy) advocated by Colvin and associates, Grossi and coworkers, and Cohn and coworkers [12, 13, 17]. Results of aortic valve replacement were not significantly different from those of mitral valve operation. The potential advantages of port-access for aortic valve replacement include avoidance of sternotomy and elimination of arterial, venous, and coronary sinus cannulas from the operative field.
In conclusion, port-access is a viable option for isolated aortic or mitral valve surgery. Results are comparable to those of sternotomy in terms of early morbidity and mortality, and are primarily determined by patient characteristics and not by the case volume of the operating institution. Results will need to be reassessed as port-access techniques and patient selection criteria evolve. Outcomes, cost, and technical aspects with port-access valve procedures will also need to be compared, both to standard sternotomy and to other minimally invasive approaches that do not use an endoaortic clamp or percutaneous retrograde cardioplegia [17, 22, 23].
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Footnotes
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Doctor Lawrence C. Siegel and Karen J. Frischmeyer are employees of Heartport Inc, Redwood City, CA
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Appendix
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Participating Center
|
City
|
State
|
Participating Center
|
City
|
State
|
|
| Allegheny General Hospital |
Pittsburgh |
PA |
St. Francis Hospital Center |
Beech Grove |
IN |
| Baptist Medical Center |
Oklahoma City |
OK |
and Health Centers |
|
|
| Baptist Medical Center |
Little Rock |
AR |
St. John Medical Center |
Tulsa |
OK |
| Baptist Medical Center Montclair |
Birmingham |
AL |
St. Joseph Medical Center |
Towson |
MD |
| Baptist Memorial Hospital |
Memphis |
TN |
St. Luke's Hospital |
Milwaukee |
WI |
| Barnes-Jewish Hospital |
St. Louis |
MO |
St. Mary's Hospital |
Richmond |
VA |
| Boston Medical Center |
Boston |
MA |
St. Thomas Hospital |
Nashville |
TN |
| Brigham and Women’s Hospital |
Boston |
MA |
Stanford University Hospital |
Stanford |
CA |
| Bryn Mawr Hospital |
Bryn Mawr |
PA |
The Sanger Clinic, PA and |
Charlotte |
NC |
| Cedars-Sinai Medical Center |
Los Angeles |
CA |
Carolinas Medical Center |
|
|
| Central Baptist Hospital |
Lexington |
KY |
Union Memorial Hospital |
Baltimore |
MD |
| Chippenham Medical Center |
Richmond |
VA |
University Community Hospital |
Tampa |
FL |
| Cleveland Clinic Foundation |
Cleveland |
OH |
University Hospital |
Augusta |
GA |
| Deborah Heart and Lung Center |
Brown Mills |
NJ |
University of Louisville |
Louisville |
KY |
| Doctors Medical Center |
Modesto |
CA |
Department of Thoracic and |
Philadelphia |
PA |
| Duke University Hospital |
Durham |
NC |
Cardiovascular Surgery and Jewish |
|
|
| Encino-Tarzana Regional |
Encino |
CA |
Hospital Heart/Lung Institute, |
|
|
| Medical Center |
|
|
University of Pennsylvania |
|
|
| Florida Hospital Medical Center |
Orlando |
FL |
University of Southern California |
Pasadena |
CA |
| Fresno Community Hospital |
Fresno |
CA |
University of Utah, |
Salt Lake City |
UT |
| and Medical Center |
|
|
School of Medicine |
|
|
| Georgetown University Hospital |
Washington |
DC |
University of Virginia Medical Center |
Charlottesville |
VA |
| Grant-Riverside Methodist Hospitals |
Columbus |
OH |
Veterans Affairs Medical Center |
San Diego |
CA |
| Henrico Doctors’ Hospital |
Richmond |
VA |
San Diego |
|
|
| Hermann Hospital |
Houston |
TX |
Wake Medical Center |
Raleigh |
NC |
| Inova Fairfax Hospital |
Falls Church |
VA |
Walter O. Boswell Memorial Hospital |
Sun City |
AZ |
| Johns Hopkins Hospital |
Baltimore |
MD |
Westchester County Medical Center |
Valhalla |
NY |
| Latter Day Saints Hospital |
Salt Lake City |
UT |
Willis Knighton Medical Center |
Shreveport |
LA |
| Lehigh Valley Hospital |
Allentown |
PA |
Akademiska Sjukhuset Uppsala |
Uppsala |
Sweden |
| Little Company of Mary Hospital |
Torrance |
CA |
Bergmannshell-Universitatsklinikum |
Bochum |
Germany |
| Los Robles Regional Medical Ctr. |
Thousand Oaks |
CA |
C.H.U. Lyon Louis Pradel |
Lyon |
France |
| Loyola University Medical Center |
Maywood |
IL |
C.H.U.R. Metz Hospital Bon Secours |
Metz |
France |
| Massachusetts General Hospital |
Boston |
MA |
Clinique Clairval |
Marseille |
France |
| Medical Center Hospital |
Odessa |
TX |
Dresden University |
Dresden |
Germany |
| Medical College of Ohio Hospital |
Toledo |
OH |
Freeman Hospital |
Newcastle |
UK |
| Mission St. Joseph’s Health System |
Asheville |
NC |
|
upon tyne |
|
| New Mexico Heart Institute |
Albuquerque |
NM |
Harley Stree Hospital, |
London |
UK |
| New York University Medical Ctr. |
New York |
NY |
Columbia Health Group |
|
|
| Ochsner Foundation Hospital |
New Orleans |
LA |
Her-kreislaufzentrum |
Leipzig |
Germany |
| Palo Alto Veterans Affairs |
Palo Alto |
CA |
Hopital Broussais |
Paris |
France |
| Medical Center |
|
|
Hopital Europeen de Paris- |
Aubervilliers |
France |
| Presbyterian Hospital of Dallas |
Dallas |
TX |
La Roseraie |
|
|
| Redding Medical Center |
Redding |
CA |
Hospital do Meixoeiro |
Vigo |
Spain |
| Research Medical Center |
Kansas City |
MO |
Hospital Doce de Octubre |
Madrid |
Spain |
| Rochester General Hospital |
Rochester |
NY |
Hospital Santa Cruz |
Linda-a-Velha |
Portugal |
| Rush-Presbyterian-St. Luke’s |
Chicago |
IL |
Klinikum Grosshadern |
Munich |
Germany |
| Medical Center |
|
|
Krankenhaus Links der Wesser |
Bremen |
Germany |
| Saint Francis Hospital |
Tulsa |
OK |
Lille/Hospital Cardiologique |
Lille |
France |
| St. Joseph’s Hospital of Atlanta |
Atlanta |
GA |
Onze Lieve Vrouw Clinic |
Aalst |
Belgium |
| Schumpert Medical Center |
Shreveport |
LA |
Policlinico San Matteo |
Pavia |
Italy |
| Southern Illinois University |
Springfield |
IL |
Royal Infirmary of Edinburgh |
Edinburgh |
Spain |
| School of Medicine |
|
|
University of Barcelona |
Barcelona |
Spain |
| Spectrum Health |
Grand Rapids |
MI |
University of Frankfurt |
Frankfurt a.M. |
Germany |
| St. Francis Health Care System |
Hartfort |
CT |
Escorts Heart Institute and Research |
New Delhi |
India |
St. Francis Hospital
|
Roslyn
|
NY
|
National Heart Institute
|
Kuala Lampur
|
Malaysia
|
|
Data are given as absolute numbers of patients.
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W. R. Chitwood Jr. and E. Rodriguez
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W. R. Chitwood Jr. and L. W. Nifong
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Top
Abstract
Introduction
