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Salvage of Nonmaturing Native Fistulas by Using Angioplasty¹

¹ From the Department of Radiology, Division of Interventional Radiology (T.W.I.C., A.K., S.W.S., A.A.P., M.C.S., J.I.M., R.D.S., S.O.T.) and Departments of Medicine (R.A.C., S.K.) and Surgery (J.F.M.), University of Pennsylvania School of Medicine, Philadelphia, Pa. Received October 27, 2005; revision requested December 14; revision received January 30, 2006; accepted February 21, 2006; final version accepted May 23. Address correspondence to T.W.I.C., Department of Radiology, New York University School of Medicine, NYU Medical Center, 560 First Ave, HE-221, New York, NY 10016 (e-mail: timothy.clark{at}med.nyu.edu).

	ABSTRACT

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Purpose: To retrospectively review outcomes following angioplasty of nonmaturing autogenous hemodialysis fistulas.

Materials and Methods: Institutional review board exemption was received for this HIPAA-compliant retrospective study; informed consent was waived. During 48 months, 101 patients underwent fistulography for percutaneous salvage of nonmaturing native fistulas. Clinical and technical success, need for secondary interventions, and complications were recorded according to consensus definitions. Patency following angioplasty was estimated with the Kaplan-Meier technique. Patient age, sex, ethnicity, fistula age, fistula type, number of stenoses, maximal angioplastic balloon diameter used, and presence of palpable thrill following angioplasty were examined as predictors of primary patency of the fistula following intervention by using Cox proportional hazards model.

Results: Mean patient age was 58 years; 35% were women. Median time from fistula creation to fistulography was 2.5 months. Hemodynamically significant (>50%) stenoses were identified in 88% (89 of 101) of patients; angioplasty was attempted in 96% (85 of 89). Technical success was achieved in 92% (78 of 85) of fistulas following angioplasty; clinical success of normal hemodialysis with total access blood flow of more than 500 mL/min occurred following 88% (75 of 85) of angioplastic interventions. No major and two minor complications occurred. Mean primary unassisted patency at 3, 6, and 12 months was 60% ± 6% (95% confidence interval), 45% ± 6%, and 34% ± 6%, respectively. Additional angioplasty (n = 12), stent placement (n = 1), or thrombectomy (n = 1) during subsequent interventions resulted in mean secondary patency at 3, 6, and 12 months of 82% ± 4%, 79% ± 5%, and 75% ± 6%, respectively. Patients without thrill following angioplasty were more than twice as likely to lose patency as patients with thrill (P = .035). No relationship was seen between primary patency and other predictors examined.

Conclusion: Early fistulography enables identification of underlying areas of stenosis in nonmaturing fistulas, which can be safely and effectively treated with angioplasty. With continued surveillance and repeat interventions, functional patency can be sustained in the majority of fistulas.

© RSNA, 2006

	INTRODUCTION

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Autogenous fistulas are the superior form of access for hemodialysis because of longer duration of patency, fewer infections, lower all-cause mortality, and higher quality of life (1). Since the introduction of the Kidney/Dialysis Outcomes Quality Initiative guidelines, the United States has seen an increase in the prevalence of hemodialysis patients with native fistulas (2). Programs that increase awareness of the advantages of native fistulas among patients and providers, such as the Fistula First Initiative of the Centers for Medicare and Medicaid Services, Baltimore, Md, have also been implemented. As many as 30% of native fistulas, however, will never mature to enable cannulation and successful hemodialysis (3–6). Preoperative venous imaging can reduce the proportion of patients with nonmaturing fistulas (7,8). Nevertheless, even with thorough patient evaluation and meticulous surgical technique, there will remain an important subset of patients with fistulas that do not mature and that eventually require abandonment.

Percutaneous treatments that include angioplasty and obliteration of competing venous collateral vessels have been used to salvage nonmaturing native fistulas (9–12). In our practice, a multidisciplinary relationship among access surgeons, nephrologists, and interventional radiologists allows identification of patients with native fistulas that fail to mature to a usable state within 3 months of creation. These patients are referred to interventional radiologists for fistulography and percutaneous salvage. Thus, the purpose of our study was to report outcomes following angioplasty of nonmaturing autogenous hemodialysis fistulas.

	MATERIALS AND METHODS

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An institutional review board exemption was received for this retrospective study; informed consent was waived. The study was performed in compliance with the Health Insurance Portability and Accountability Act. By using a computerized quality assurance database, we identified 101 patients who underwent attempted percutaneous salvage of nonmaturing native fistulas during a 48-month period from April 2001 to April 2005. All interventions were performed in one of three hospitals staffed by the same group of 11 fellowship-trained and Certificate of Added Qualifications–certified interventional radiologists who had postfellowship experience of 1–15 years. Information was collected by three authors (T.W.I.C., S.O.T., R.A.C.) and included age, sex, and ethnicity of the patient; age of the fistula; location of the fistula; location of the stenosis; diameters of the angioplastic balloons; and outcomes of the procedures.

Immediate postprocedural outcomes were captured by interventional radiologists who performed the interventions (T.W.I.C., A.K., S.W.S., A.A.P., M.C.S., J.I.M., R.D.S., S.O.T.) through a computerized quality assurance database, and these outcomes included technical success, presence of a thrill, residual stenosis, and procedural complications. Long-term outcomes (clinical success in initiation of hemodialysis, duration of primary patency, number of secondary interventions) were captured from a quality assurance database by nephrologists (R.A.C., S.K.), the lead author (T.W.I.C.), and a research coordinator. All study definitions are in accordance with the reporting standards published by the Society of Interventional Radiology (13) unless otherwise noted.

Patients
In our practice, after creation, all native fistulas are evaluated at 4–6 weeks by a member of the surgical or nephrology team. At that time, a physical examination is performed, as well as a single attempt at cannulation. If the fistula is readily visible and can be cannulated at that time, no further evaluation is performed, and the fistula is allowed to continue to mature until it is ready to be used (usually 3 months after creation). If the fistula is not maturing sufficiently, the patient is referred to an interventional radiologist for diagnostic fistulography and attempted percutaneous salvage. Some patients from outside our health care network are referred to us for evaluation and treatment of nonmaturing fistulas. In general, these patients are referred to interventional radiology after a much longer period (>3 months after creation of the fistula) of expected maturation of the fistula.

Fistulographic Technique
The interval from surgical creation to the time of fistulography was recorded. Fistulography was performed as previously described (14). For the subset of 22 (22%) of 101 patients in whom a segment of the fistula could not be palpated for puncture, the brachial artery was punctured in a retrograde direction with a 21-gauge needle, followed by placement of the 3-F inner core from a micropuncture set (Cook, Bloomington, Ind). This enabled a micropuncture arteriogram to be obtained to rapidly delineate the fistula. Any subsequent interventions were then treated through a fluoroscopically or ultrasonographically guided puncture of the fistula. When residual renal function was present, fistulography was performed with gadolinium-based contrast medium or iso-osmolar iodinated contrast medium diluted to 25%. Otherwise, nondiluted nonionic iodinated contrast medium was used.

Once the inflow artery and anastomosis had been visualized, puncture of the draining vein, either antegrade or retrograde as appropriate, was performed to complete the central portion of the diagnostic study and to perform any interventions. Central venous evaluation in patients with residual renal function was performed with CO₂, since opacification of the central veins with gadolinium-based contrast medium or diluted iodinated contrast medium would have required larger volumes of these agents.

Treatment
Hemodynamically significant stenoses (>50%) identified with fistulography were treated with balloon angioplasty at the time of the fistulography. All interventions were performed through a venous approach, and the arterial puncture was reserved for diagnostic purposes only. When multiple stenoses were present, both antegrade and retrograde sheaths were placed in the fistula to enable treatment of all lesions. Location of the stenosis (or location of the most severe stenosis when multiple stenoses were treated) was classified according to the system used by Clark et al (14). Stenoses in the anastomotic and juxtaanastomotic area were treated with 3–6-mm-diameter balloons (median diameter, 5 mm); stenoses in the draining vein were treated with 6–9-mm-diameter balloons (median diameter, 7 mm), and stenoses in the central veins were treated with 10–14-mm-diameter balloons (median diameter, 12 mm).

For most patients, angioplasty was performed by using conventional angioplastic balloons for lesions at or adjacent to the arteriovenous anastomosis (juxtaanastomotic stenoses); high-pressure balloons capable of exceeding 20 atm of pressure were frequently required for stenoses in the remaining segments of the draining vein to produce complete effacement of the waist of the balloon (15). Cutting balloons were used infrequently for stenoses that were resistant to high-pressure balloons. Because the surgical reports did not always include a record of which type of balloon was used during each intervention, we were unable to determine the exact prevalence of the specific type of balloon used.

Competing collateral veins were marked on the skin with an indelible marker in preparation for surgical ligation or, in the event of multiple collateral veins, embolization. When surgical ligation was performed, it was scheduled as quickly as possible to ensure that the indelible marking was not lost.

After percutaneous intervention for augmentation, the fistula was allowed to mature further until it was ready for use. If the fistula failed to mature within an additional 4–6 weeks, the fistula was retreated with angioplasty (n = 5) or was abandoned (n = 5).

Initial anatomic success (<30% residual diameter of the stenosis) was recorded in the interventional radiology quality assurance database following angioplasty. Clinical success of normal hemodialysis with total access blood flow of greater than 500 mL/min (or successful cannulation in patients who had not yet started hemodialysis) was determined from the information in the nephrology quality assurance database and from follow-up information collected by the interventional radiology research coordinator.

Complications
Complications were classified as major or minor in accordance with the recommendations of the Society of Interventional Radiology (16).

Statistical Analysis
Primary, assisted primary, and secondary patency durations were estimated by using the Kaplan-Meier technique and was determined from the time of the initial intervention to the last known status of the fistula. Patients who underwent renal transplantation (n = 3) were censored from subsequent calculations, even though the fistula remained functional. To evaluate the outcomes of angioplasty as the sole therapy for nonmaturing fistulas, the small subset of patients who underwent embolization (n = 1) or surgical ligation (n = 3) also was censored from patency calculations. An intent-to-treat basis was used for all other patients, including those in whom angioplasty was deemed impossible and was not performed. Kaplan-Meier curves were compared by using the log-rank test.

Age, sex, and ethnicity of the patient; age of the fistula; type of fistula; number of stenoses; maximal diameter of the angioplastic balloon used; and presence of a palpable thrill following angioplasty were examined as predictors of primary patency of the fistula following intervention by using the Cox proportional hazards model.

For all analyses, a P value of .05 was considered the threshold value for statistical significance. Statistical analyses were performed with software (Prism, GraphPad Software, San Diego, Calif; Stata, version 7, Stata, College Station, Tex).

	RESULTS

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Patient Characteristics
Baseline demographic variables for the 101 consecutive patients with native hemodialysis fistulas who underwent fistulography because of nonmaturation are summarized in Table 1. The mean interval from surgical creation to fistulography was 3.5 months, and the median time to fistulography (age of fistula) was 2.5 months (range, 0.7–14 months).

Multiple stenoses were present in 42% (37 of 89) of patients with stenotic fistulas. The distribution of stenosis (or dominant stenosis in patients with multiple stenoses), according to the classification system of Clark et al (14), included arterial (6.1%), anastomotic (4.3%), juxtaanastomotic (37.9%), venous outflow (future cannulation zone) (44.8%), distal outflow beyond cannulation zone (4.3%), and central venous system (2.6%) stenoses. An example of a patient from this study who harbored multiple stenoses is shown in Figure 1.

View larger version (35K): [in this window] [in a new window] [Download PPT slide]   Figure 1a: Percutaneous salvage of nonmaturing radiocephalic fistula in 47-year-old man. (a) Initial anteroposterior fistulogram shows radial artery (arrowheads) and completely occluded cephalic vein (arrow) approximately 3 cm beyond anastomosis. (b) Anteroposterior fistulogram after antegrade access shows diffusely narrowed (arrows) forearm segment of cephalic vein. (c) Fluoroscopic image shows angioplasty with a 9-mm-diameter high-pressure balloon. The juxtaanastomotic segment was dilated through retrograde puncture with a 5-mm-diameter balloon. (d) Completion anteroposterior fistulogram after creation of a strong thrill. The patient commenced hemodialysis 2 days later. The fistula remained fully functional 8 months later.

View larger version (46K): [in this window] [in a new window] [Download PPT slide]   Figure 1b: Percutaneous salvage of nonmaturing radiocephalic fistula in 47-year-old man. (a) Initial anteroposterior fistulogram shows radial artery (arrowheads) and completely occluded cephalic vein (arrow) approximately 3 cm beyond anastomosis. (b) Anteroposterior fistulogram after antegrade access shows diffusely narrowed (arrows) forearm segment of cephalic vein. (c) Fluoroscopic image shows angioplasty with a 9-mm-diameter high-pressure balloon. The juxtaanastomotic segment was dilated through retrograde puncture with a 5-mm-diameter balloon. (d) Completion anteroposterior fistulogram after creation of a strong thrill. The patient commenced hemodialysis 2 days later. The fistula remained fully functional 8 months later.

View larger version (48K): [in this window] [in a new window] [Download PPT slide]   Figure 1c: Percutaneous salvage of nonmaturing radiocephalic fistula in 47-year-old man. (a) Initial anteroposterior fistulogram shows radial artery (arrowheads) and completely occluded cephalic vein (arrow) approximately 3 cm beyond anastomosis. (b) Anteroposterior fistulogram after antegrade access shows diffusely narrowed (arrows) forearm segment of cephalic vein. (c) Fluoroscopic image shows angioplasty with a 9-mm-diameter high-pressure balloon. The juxtaanastomotic segment was dilated through retrograde puncture with a 5-mm-diameter balloon. (d) Completion anteroposterior fistulogram after creation of a strong thrill. The patient commenced hemodialysis 2 days later. The fistula remained fully functional 8 months later.

View larger version (37K): [in this window] [in a new window] [Download PPT slide]   Figure 1d: Percutaneous salvage of nonmaturing radiocephalic fistula in 47-year-old man. (a) Initial anteroposterior fistulogram shows radial artery (arrowheads) and completely occluded cephalic vein (arrow) approximately 3 cm beyond anastomosis. (b) Anteroposterior fistulogram after antegrade access shows diffusely narrowed (arrows) forearm segment of cephalic vein. (c) Fluoroscopic image shows angioplasty with a 9-mm-diameter high-pressure balloon. The juxtaanastomotic segment was dilated through retrograde puncture with a 5-mm-diameter balloon. (d) Completion anteroposterior fistulogram after creation of a strong thrill. The patient commenced hemodialysis 2 days later. The fistula remained fully functional 8 months later.

On an intent-to-treat basis for the 97 patients in whom embolization or ligation was not performed, the mean primary unassisted patency rate (± 95% confidence interval) at 3, 6, and 12 months was 60% ± 6%, 45% ± 6%, and 34% ± 6%, respectively (Fig 2). Angioplasty (n = 12) and stent placement (n = 1) during additional interventions resulted in a 3-, 6-, and 12-month mean assisted primary patency rate of 81% ± 4%, 77% ± 5%, and 72% ± 6%, respectively. Mean secondary patency rates (Fig 2) from one fistula in which thrombectomy was performed during follow-up increased patency rates at 3, 6, and 12 months to 82% ± 4%, 79% ± 5%, and 75% ± 6%, respectively. Three patients with patent fistulas underwent renal transplantation and were censored from analysis at the time of transplantation.

View larger version (19K): [in this window] [in a new window] [Download PPT slide]   Figure 2: Kaplan-Meier curves show primary and secondary patency rates of 97 patients with nonmaturing hemodialysis fistulas after intended angioplasty. Secondary interventions produced a significant increase in patency rates (P < .001).

Predictors of Patency
With the Cox proportional hazards model (Table 2), we found no relationship between primary patency and age, sex, and ethnicity of the patient or age of the fistula at the time of intervention. When brachiobasilic and brachiocephalic fistulas were combined as fistulas of the upper arm, no difference in primary patency was seen when we compared the data with data from patients with radiocephalic fistulas. Patients with multiple stenoses had equivalent patency compared with patients with single lesions. Use of larger balloons to treat stenosis was not associated with longer primary patency. The only variable predictive of longer patency was the presence of a thrill at completion of the procedure. Patients who did not have a continuous thrill at the completion of angioplasty were more than twice as likely to lose patency as patients with a thrill (P = .035). Kaplan-Meier curves that were used to compare the patency in patients with a thrill at completion of angioplasty with the patency in patients with a pulsatile or weak thrill at completion of angioplasty are shown in Figure 3.

View larger version (18K): [in this window] [in a new window] [Download PPT slide]   Figure 3: Kaplan-Meier curves show primary patency rates according to whether a thrill was present following angioplasty. Median duration of primary patency was 9.9 months for fistulas with strong thrill at completion; that for fistulas with a pulsatile or weak thrill was 2.2 months (P < .001).

	DISCUSSION

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In order to realize the benefits of native fistulas, efforts must be directed to increasing the proportion of patients with functional fistulas. Although experience continues to accumulate for percutaneous treatment of established fistulas that fail, a relative paucity of information exists about the role of percutaneous techniques in the salvage of fistulas that fail to mature to a usable state.

The optimal percutaneous approach to treating patients with nonmaturing native fistulas remains a matter of debate. Turmel-Rodrigues et al (10) maintain that lack of maturation is caused by underlying venous stenosis in 100% of patients, and they advocate angioplasty in all nonmaturing fistulas. In contrast, Faiyaz et al (11) and Beathard et al (12) argue that lack of maturation is commonly caused by competing veins. Embolization or ligation of these veins will ostensibly augment flow within the intended outflow vein and thereby enable maturation. Difficulty exists in weighing these viewpoints because the decision about what is excessive competing vein filling versus decompressive filling secondary to outflow stenosis is largely subjective.

By using angioplasty, we achieved a primary patency rate of 45% at 6 months and 34% at 12 months. Secondary interventions that included angioplasty, stent placement, and thrombectomy helped increase the patency rate to 79% at 6 months, 75% at 12 months, and 63% at 18 months. Our results are comparable to those of Turmel-Rodrigues et al (10), who achieved primary and secondary 12-month patency rates of 39% and 79%, respectively. Their series included 17 of 69 fistulas with thrombosis, whereas we did not attempt percutaneous thrombectomy in nonmaturing fistulas. Turmel-Rodrigues et al, however, excluded patients with immature fistulas of the upper arm because of a perceived lack of benefit of percutaneous interventions in this location. In our series, we found no significant differences in patency among patients with radiocephalic, brachiobasilic, or brachiocephalic fistulas. This equivalence in effectiveness of percutaneous interventions among anatomic locations has been observed by other investigators who reported outcomes in series of patients with mature fistulas (14,18).

We did not achieve the primary patency rate of 68% at 12 months that was reported by Beathard et al (12), who used a combination of angioplasty (in 78% of patients) and collateral vein obliteration (in 46% of patients). Despite the use of brachial arteriography during initial fistulography in 20% of patients, we could not document competing collateral veins in more than 4% of patients. The degree to which greater use of collateral vein obliteration would have increased primary patency in our series of patients remains unknown and can only be ascertained in a randomized prospective trial.

The presence of a strong thrill after initial intervention was associated with a significant increase in primary patency in our series of patients. Previously, this has been shown to be the main determinant of patency following angioplasty of hemodialysis stenoses (19).

More than 40% of patients in our series harbored multiple lesions, and recanalization was successful in some patients with completely occluded or diffusely narrowed outflow veins that spanned the entire forearm or upper arm. Performance of such extensive modifications to create a large-diameter hemodialysis circuit during a single treatment encounter may be neither realistic nor appropriate. Approaching patients who harbor multifocal and long stenoses in a staged fashion may be a more optimal approach. Secondary patency, which incorporates any additional interventions, may be a more meaningful outcome in this patient population.

A substantial proportion of patients harbored stenoses in the venous outflow within the future cannulation zone or in the draining vein beyond the future cannulation zone. It is possible that preoperative venography and/or vein mapping with ultrasonography may have aided in the identification of some of these stenoses and enabled use of alternate placement sites for the fistula. In the last 2 years, our clinical practice has evolved in that preoperative evaluation now includes performance of bilateral venography (through venous cannulas placed in the dorsum of the hands) of the arms. Further experience is needed to determine whether this approach results in a smaller proportion of patients with nonmaturing fistulas.

Delaying intervention in patients with nonmaturing fistulas did not seem to confer an advantage. With the Cox proportional hazards model, we found no difference between patients in whom angioplasty was performed early (less than 3 months after placement of the fistula) and those in whom it was performed late (more than 3 months after placement of the fistula) (Table 2). The natural history of maturation of the fistula is not well characterized, so the underlying denominator of patients in whom maturation of the fistula occurs beyond 3 months, without intervention, is unknown but is expected to be small. On the basis of our experience, we would advocate fistulography and intervention for all fistulas that fail to mature within 3 months of creation.

Two technical observations in our series of patients were the routine need for high-pressure-inflation balloons and double (antegrade and retrograde) puncture in many patients. Unlike arterial stenoses, venous stenoses are frequently resistant to conventional angioplastic balloons, which are capable of achieving maximal pressures in the range of 15–20 atm. Many lesions in patients in this series failed to respond to conventional balloons and required high-pressure balloons; these balloons can be routinely inflated to more than 30 atm of pressure and are particularly useful for treatment of long-segment stenoses in nonmaturing fistulas. In a recent prospective study of pressures required to efface hemodialysis access stenoses, Trerotola et al (20) found that 20% of lesions in native fistulas required balloon inflation pressures that exceeded 20 atm compared with 9% of lesions in synthetic grafts that required these pressures.

There were limitations to this study. Data were gathered retrospectively through a computerized quality assurance database. Because patients had undergone creation of the fistula at multiple regional medical centers, the denominator that included how many fistulas were created during our study interval and, therefore, the proportion of patients with nonmaturing fistulas are unknown. Interventions were performed by multiple interventional radiologists, and thus a strictly uniform approach to angioplasty was not present. It is also possible that, had no intervention been performed, with additional time some of the fistulas in patients in our series may have eventually matured. The optimal balloon size for dilation of stenoses at each anatomic location was not established, and some operators routinely used larger balloons than others used. We were also unable to define the earliest point in time at which percutaneous salvage can be safely undertaken.

In summary, through an aggressive and multidisciplinary treatment strategy, nonmaturing native hemodialysis fistulas in patients can be identified, evaluated, and salvaged with angioplasty. With continued surveillance and repeat percutaneous interventions, functional patency can be sustained in the majority of fistulas.

	ADVANCES IN KNOWLEDGE

TOP ABSTRACT INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION ADVANCES IN KNOWLEDGE References

 

• When percutaneous angioplasty is performed, it can aid the salvage of the majority (75 of 85, 88%) of native hemodialysis fistulas that fail to mature.
  
• Most patients (89 of 101, 88%) with nonmaturing fistulas in our series harbored venous stenoses, which were treated with angioplasty.
  
• The presence of a strong thrill after initial intervention was associated with a significant (P = .035) increase in primary pa-tency.
  

	ACKNOWLEDGMENTS

 
The invaluable assistance of Evelyn E. Stainthorpe, BS, CCRC, in obtaining data is gratefully acknowledged.

	FOOTNOTES

 
Author contributions: Guarantor of integrity of entire study, T.W.I.C.; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; manuscript final version approval, all authors; literature research, T.W.I.C., S.W.S.; clinical studies, T.W.I.C., R.A.C., A.K., S.W.S., A.A.P., M.C.S., J.I.M., S.K., R.D.S., S.O.T.; statistical analysis, T.W.I.C.; and manuscript editing, all authors

Authors stated no financial relationship to disclose.

	References

TOP ABSTRACT INTRODUCTION MATERIALS AND METHODS RESULTS DISCUSSION ADVANCES IN KNOWLEDGE References

 

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This Article Abstract Figures Only Full Text (PDF) All Versions of this Article: 2421051718v1 242/1/286    most recent Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Clark, T. W. I. Articles by Trerotola, S. O. Search for Related Content PubMed PubMed Citation Articles by Clark, T. W. I. Articles by Trerotola, S. O.