An Initiative to Minimize Amount of Contrast Media Utilizing a Novel Rotational Coronary Sinus Occlusive (FULL TITLE BELOW)

FULL TITLE: An Initiative to Minimize Amount of Contrast Media Utilizing a Novel Rotational Coronary Sinus Occlusive Venography Technique with Ordinary Cath-Lab X-Ray Machine During CRT Implantation

ABSTRACT: Background. Rotational angiography is one of the latest angiographic modalities to map the coronary venous tree anatomy. It provides a significant reduction in both contrast agent usage and radiation dose (up to 30%), without compromising the clinical utility of images. Hence, the present study was conducted to describe a new technique to minimize the amount of contrast media used during cardiac resynchronization therapy (CRT) implantation. Method. The SL3 sheath was inserted into the right atrium via the femoral vein followed by withdrawal of the dilator. The tip of the sheath was manipulated to the vicinity of the coronary sinus (CS) ostium (OS). The CS was entered using a deflated balloon catheter. The sheath was then advanced gently beyond the CS OS. Occlusive venography was performed using 5–8 ml of contrast media in a rotational view starting from 45° LAO to 0° AP while holding the inflated balloon for a few seconds. Result. Data from 30 consecutive patients who underwent CRT implantation were analyzed. The feasibility of rotational angiography, while occluding the CS with a specialized long, preshaped sheath and using an ordinary cath-lab imaging machine, was supported by the correctly delineated CS anatomy of all patients without any complications and death related to the placement of the CS catheters or sheaths. The mean contrast dose used for the entire procedure in all patients undergoing CRT was 14.76 ± 6.8 ml. Conclusion. Use of rotational CS occlusive venography utilizing an ordinary cath-lab X-ray machine minimizes the use of contrast media during CRT implantation without compromising the visualized anatomy.

J INVASIVE CARDIOL 2010;22:428–431

Key words: occlusive venography; contrast media; cardiac resynchronization therapy; rotational angiography

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Contrast nephropathy, defined as an elevation in serum creatinine of 25% or greater, is a serious complication of coronary angiography. It is associated with considerably increased morbidity, including the need for short-term hemodialysis, extended hospitalization and permanent impairment of renal function,^1,2 and the true incidence varies from 3.3% to 50%.^2–4 Cardiac resynchronization therapy (CRT) has recently emerged as a promising therapy for patients with severe congestive heart failure (CHF) and left ventricular (LV) systolic dysfunction who have concomitant LV dyssynchrony. Implanting the LV lead usually involves contrast administration to define the coronary venous anatomy and to help identify and cannulate the coronary sinus ostium (OS). Because of the high prevalence of renal dysfunction, diabetes and low blood pressure in these CHF patients, the incidence of contrast nephropathy following CRT is likely to be high. Moreover, given the possibility of prolonged procedural time for LV lead placement and the difficulty in identifying the best site for resynchronization, visualization of the cardiac venous system is of paramount importance for successful CRT implantation.^5–7 Despite recent advances in other less invasive diagnostic modalities, coronary vein visualization and defining venous anatomy by retrograde coronary venous angiography remained the standard technique for CRT implantation. It is usually performed safely by occlusion of the CS from a femoral approach with the use of a preshaped Swartz SL3 sheath (St. Jude Medical, St Paul, Minnesota).^8,9 Angiographic techniques that limit contrast use and reduce potentially harmful X-ray radiation without compromising the diagnostic accuracy of the procedure may therefore improve patient safety. Rotational angiography is a newly developed angiographic modality in which the X-ray system rotates around the patient during the acquisition of a single run. It provides a significant reduction in both contrast agent usage and radiation dose (up to 30%), without compromising the clinical utility of the images.^10,11 Hence, the purpose of the present study is to describe a new technique to minimize contrast media used during CRT device implantation.

Method

Thirty consecutive patients with LV dysfunction, significant interventricular conduction delay and symptomatic heart failure (New York Heart Association [NYHA] functional class III or IV) who underwent implantation of CRT systems despite optimal medical treatment including ACE-inhibitors, beta-blockers and spironolactone at maximally tolerated doses were enrolled in the study. Signed and dated informed consent was obtained from all patients and the procedures were performed under conscious sedation. After preparing the right groin, an 8.5 French (Fr) long preshaped Swartz SL3 sheath was inserted into the right femoral vein. The SL3 sheath was then advanced into the right atrium over a wire. This was followed by the withdrawal of the dilator and the wire into the sheath to allow it to take its shape. The tip of the sheath was easily manipulated to the posterior point and inferior toward the vicinity of the CS ostium. This was performed by simple clockwise torqueing and gentle traction of the sheath down the intra-atrial septal wall until it fell into the CS ostium. The main CS was entered using a deflated balloon catheter (to be used for angiography). (A steerable diagnostic electrophysiology catheter may be used to cannulate the CS in difficult cases.) The sheath was advanced gently beyond the CS ostium over the balloon catheter for better support and to avoid dissection (in contrast to our previous practice, where two to three views of angiographic images were obtained, which may involve more contrast media). Occlusive venography was performed using 5–8 ml of contrast media (Omnipaque™ 350 mg per ml, GE Healthcare) in a rotational view starting from a 45° left anterior oblique (LAO) to a 0° antero-posterior (AP) view while holding the inflated balloon in a properly selected position for several seconds (Figures 1A, 1B, 1C). After the completion of venography, the balloon was deflated completely and kept in place for further guidance during device implantation. The chest was then prepared, and CRT device implantation proceeded in the typical fashion by a single operator assisted by two nurses and one technician. A second cannulation of CS for LV lead during implantation was able to be performed without contrast media. However, if a further amount of contrast was needed, it was included in the total amount of contrast for the entire procedure. The venography balloon catheter and the SL3 sheath were removed after the final LV lead positioning was established, but before the CS lead’s introducer was removed, in order to avoid dislodging of the LV lead. The assembly was pulled down to the inferior vena cava, and the rest of procedure was completed as usual.

Results

Data from 30 consecutive patients who underwent implantation of CRT systems between June 2008 and November 2009 were analyzed. Clinical characteristics of all the patients are detailed in Table 1. The mean age of patients undergoing CRT was 57 ± 12 years. Seventy percent of the patient population was male (n = 21) and the rest (n = 9) were females. Seventy-seven percent of the patients (n = 23) had dilated cardiomyopathy at the time of presentation, whereas 23% (n = 7) were suffering from coronary artery disease. About 6% of the patients (n = 2) had a previous history of atrial fibrillation, 54% (n = 16) had prior evidence of hypertension, while 43% (n = 13) and 3% (n = 1) of the patients had previous records of diabetes mellitus and cerebrovascular attack, respectively. The mean LV ejection fraction (LVEF) was 19 ± 5.63%. Of the total 30 patients, 7% (n = 2) and 10% of the patients (n = 3) had a previous history of coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI), respectively. The mean baseline creatinine level was 105 ± 43.75 µmol/l, which depicts normal renal function. However, 2 patients had a creatinine level > 200 µmol/l with a LVEF Discussion Radiological procedures that utilize intravascular iodinated contrast media are being widely used for both diagnostic and therapeutic purposes and represent one of the leading causes of contrast-induced nephropathy (CIN) and hospital-acquired renal failure. CIN is recognized as the third leading cause of hospital-acquired acute renal failure, accounting for 11% of all cases and contributing to prolonged hospital stays and increased medical costs.^12,13 The true incidence of CIN is difficult to assess because of the differences among various published studies in the definition of CIN, and depends on the proportion of high-risk patients, the types of contrast media and the use of preventive measures. McCullough et al reported a 14.5% incidence of CIN in patients undergoing coronary intervention, with a mean creatinine of 1.3 mg/dl (115 µmol/l) and a mean LVEF of 48%.² The mean contrast volume used in the study was 248 ml. Gruberg et al evaluated patients with a baseline serum creatinine of > 1.8 mg/dl (159 µmol/l) (mean LVEF of 39%) undergoing coronary intervention, wherein 37% of patients developed contrast nephropathy, while 7.1% of all patients required dialysis.14 The mean contrast volume used was ~230 ml. The in-hospital mortality for patients requiring dialysis in these studies was 35.7% and 22.6%, respectively.^2,14 Owing to the lack of any effective treatment, prevention of this iatrogenic disease is the key strategy. Prevention of CIN continues to elude clinicians and is a main concern during cardiac intervention, as patients often have multiple comorbidities. Giving the fact that intravenous hydration is one of the effective measures that help to prevent CIN, it might not be a suitable option in patients with heart failure because of the associated volume load.¹⁴ On the other hand, CRT has gained acceptance in the cardiology and electrophysiology community as an important adjunct in the treatment of heart failure. It is therefore important to search for ways to facilitate and improve the success rate of this procedure with minimum adverse events. In light of the possibility of prolonged procedural time for LV lead placement, which is the most critical step in CRT, visualization of the cardiac venous system is of paramount importance for successful CRT implantation.⁷ One of the major problems encountered in most CRT cases is the necessity of injecting relatively large amount of contrast media to delineate the CS anatomy.¹⁵ In particular, it is important to look for an acceptable solution for this problem, especially in advanced heart failure patients due to their insufficient renal reserve. Several investigators have reported the use of a rotational technique to reduce the number of acquisitions needed to perform full assessment of the coronary arteries, with a significant reduction in both contrast agent usage and radiation dose (up to 30%), without compromising the clinical utility of the images.^10,16,17 In the study, we obtained detailed CS anatomy using only a small amount of contrast media (mean: 15 ml, range: 5–30 ml) and performing a rotational view from 45° LAO to 0° AP, while occluding the CS using an ordinary cath-lab imaging machine, and was a relatively lower contrast volume compared to the reports by Meisel et al (2001) and Cowbarn et al (2004). Using a single LAO view may successfully limit the use of contrast in many laboratories, but rotational venography offers convenience for the operator who can work in both AP and LAO views with the same amount of contrast. The enhanced ability of rotational venography to resolve smaller branches of the CS was further supported by the observation that rotational coronary venous angiography correctly identified the first/second-order branch, wherein the LV lead was placed in all patients without any complications or deaths. This technique was found to be safe with the use of the SL3 sheath to cannulate the CS from a femoral approach, however, it may also be considered when cannulating CS from above. Study limitations. The present study was conducted in a small number of patients. Furthermore, procedural time and radiation dose were not considered. Further studies with a robust statistical design are recommended to further investigate the efficiency, reliability and validity of the study.

Conclusion

Rotational coronary sinus occlusive venography utilizing an ordinary cath-lab X-ray machine can be used to minimize contrast media during CRT device implantation without compromising the visualized anatomy. This technique is recommended particularly in those patients with impaired renal function trying to minimize the unwanted adverse events.

References

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From the Department of Cardiology, Prince Sultan Cardiac Centre, Riyadh, Kingdom of Saudi Arabia. The authors report no conflicts of interest regarding the content herein. Manuscript submitted March 9, 2010, provisional acceptance April 14, 2010, final version accepted June 10, 2010. Address for correspondence: Ahmed Al Fagih, MD, Department of Adult Cardiology, Prince Sultan Cardiac Center, Riyadh, Kingdom of Saudi Arabia. E-mail: aafagih@yahoo.com