Prospective Study of Tailored Management Strategies for Malperfusion Syndrome

Aortic Dissection Clinical Trial

Official title:

PRospective Study of tailOred Management Strategies fOr Acute Type A Aortic Dissection complicatEd With Malperfusion Syndrome (PROMOTE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05517356
• Other study ID #: 2022YLK19
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2022
• Source: Xiamen Cardiovascular Hospital, Xiamen University
• Contact: Xijie Wu, PhD
• Phone: +86-13799959630
• Email: wxjusa[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Management strategy of malperfusion syndrome in acute type A aortic dissection (ATAAD) patients remains controversial, with different views on when the surgery should be offered. At present, the mortality of ATAAD patients complicated with malperfusion is stubbornly high.

The purpose of this study is to improve the outcomes of ATAAD with malperfusion syndrome. The investigators formulated tailored management strategies for malperfused patients based on the duration of symptoms onset.

Description:

ATAAD complicated with malperfusion syndrome Malperfusion syndrome is the most devastating complication of acute type A aortic dissection (ATAAD), which has a poor clinical outcome and has operative mortality ranging from 29% to 89%. However, different views on management of malperfusion exist, with debating on addressing the dissection or the organ malperfusion in priority.

Current different treatment strategies for ATAAD with malperfusion syndrome Immediate central repair, restoration of true lumen flow and depressurization of the false lumen, is the most widely practiced approaches for treating ATAAD regardless of malperfusion syndrome. Nevertheless, with very high operative mortality by the conventional approach for patients with malperfusion, several studies have suggested that patients undergo endovascular reperfusion first until the malperfusion resolves, followed by delayed central repair. This strategy has produced better outcomes for patients, however, it also carries risks of interim mortality due to aortic rupture or multiple-organ failure before central repair. Moreover, a recent study suggested an alternative strategy, which performed aortic surgery and endovascular reperfusion in a hybrid approach for static malperfusion or dynamic malperfusion symptoms more than 6 hours symptoms onset. This alternative strategy improved outcomes with a mortality rate of 16.7%, which was still a little bit high. Overall, the outcomes of ATAAD patients with malperfusion syndrome still need to be improved.

Tailored management strategies The tailored management strategies were: for malperfused patients with symptom onset within 6 hours, the immediate central repair was performed followed by repeat CTA postoperatively, and endovascular reperfusion was applied if the malperfusion persisted. While for patients with symptom onset beyond 6 hours, delayed central repair were performed after the organ functions improved.

Study Rationale As noted above, malperfusion syndrome is a rapidly lethal condition that every cardiovascular surgeon is faced with at some point. Despite the optimization of approaches for ATAAD presented with malperfusion in recent years, there appears to be some room to improve our outcomes even further. The investigators believe that the tailored management strategies, which aimed at reducing the duration of end-organ ischemia, may provide a promising treatment option for these patients. However, further prospective study and follow-up data are necessary to confirm the efficacy and safety of this new strategy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Acute type A aortic dissection is confirmed by CTA;

• The symptoms onset time < 2 weeks;

• Patients diagnosed with an ATAAD , with a new diagnosis of malperfusion syndrome, by meeting both of the following criteria:

1. Radiographic findings reveal occlusion of the corresponding arteries (including either coronary artery, either carotid artery, celiac trunk, superior mesenteric artery or either iliac artery)

2. Clinical features of end organ ischemia (abnormal left ventricular wall motion, disorder of consciousness or paralysis, abdominal pain, distended abdomen, pulselessness, loss of sensory or motor function of the lower extremities) OR Laboratory findings suggestive of end organ ischemia (elevated troponin, elevated creatine kinase, lactic acidosis, elevated myoglobin).

Exclusion Criteria:

• The branch arteries did not involved by ATAAD (non-malperfusion);

• Patients presented with bloody stools or melena on admission;

• Patients presented with bilaterally fixed dilated pupils, hemorrhagic infarction or herniation of brain;

• Patients and (or) their families refused surgery;

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Aortic Dissection

Intervention

Procedure:
• Tailored management strategies
Our basic surgical strategies for the central repair operations for ATAAD are as follows. As arterial lines for cardiopulmonary bypass, side branches of the axillary and femoral arteries were used. Circulatory arrest was established when the nasopharyngeal temperature reached 25°C. Anterograde selective cerebral perfusion was performed through the right axillary artery, and the brain was perfused at approximately 5 mL/kg/min. The extent of aortic replacement was determined according to the extent of dissection involvement. For malperfused patients with symptom onset within 6 hours, the immediate central repair was performed followed by repeat CTA postoperatively, and endovascular reperfusion was applied if the malperfusion persisted. While for patients with symptom onset beyond 6 hours, delayed central repair were performed after the organ functions improved.

Locations

Country	Name	City	State
China	Department of Cardiac Surgery, Xiamen Cardiovascular Hospital of Xiamen University, School of Medicine, Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Xiamen Cardiovascular Hospital, Xiamen University

Country where clinical trial is conducted

China, 

References & Publications (11)

Ahmed Y, van Bakel PAJ, Patel HJ. Addressing malperfusion first before repairing type A dissection. JTCVS Tech. 2021 May 4;10:1-5. doi: 10.1016/j.xjtc.2021.04.029. eCollection 2021 Dec. — View Citation

Chiu P, Tsou S, Goldstone AB, Louie M, Woo YJ, Fischbein MP. Immediate operation for acute type A aortic dissection complicated by visceral or peripheral malperfusion. J Thorac Cardiovasc Surg. 2018 Jul;156(1):18-24.e3. doi: 10.1016/j.jtcvs.2018.01.096. Epub 2018 Feb 21. — View Citation

Deeb GM, Williams DM, Bolling SF, Quint LE, Monaghan H, Sievers J, Karavite D, Shea M. Surgical delay for acute type A dissection with malperfusion. Ann Thorac Surg. 1997 Dec;64(6):1669-75; discussion 1675-7. — View Citation

Ehrlich MP, Ergin MA, McCullough JN, Lansman SL, Galla JD, Bodian CA, Apaydin A, Griepp RB. Results of immediate surgical treatment of all acute type A dissections. Circulation. 2000 Nov 7;102(19 Suppl 3):III248-52. — View Citation

Fann JI, Sarris GE, Mitchell RS, Shumway NE, Stinson EB, Oyer PE, Miller DC. Treatment of patients with aortic dissection presenting with peripheral vascular complications. Ann Surg. 1990 Dec;212(6):705-13. — View Citation

Geirsson A, Szeto WY, Pochettino A, McGarvey ML, Keane MG, Woo YJ, Augoustides JG, Bavaria JE. Significance of malperfusion syndromes prior to contemporary surgical repair for acute type A dissection: outcomes and need for additional revascularizations. Eur J Cardiothorac Surg. 2007 Aug;32(2):255-62. Epub 2007 May 17. — View Citation

Girardi LN, Krieger KH, Lee LY, Mack CA, Tortolani AJ, Isom OW. Management strategies for type A dissection complicated by peripheral vascular malperfusion. Ann Thorac Surg. 2004 Apr;77(4):1309-14; discussion 1314. — View Citation

Girdauskas E, Kuntze T, Borger MA, Falk V, Mohr FW. Surgical risk of preoperative malperfusion in acute type A aortic dissection. J Thorac Cardiovasc Surg. 2009 Dec;138(6):1363-9. doi: 10.1016/j.jtcvs.2009.04.059. Epub 2009 Sep 5. — View Citation

Tsagakis K, Jánosi RA, Frey UH, Schlosser T, Chiesa R, Rassaf T, Jakob H. True Lumen Stabilization to Overcome Malperfusion in Acute Type I Aortic Dissection. Semin Thorac Cardiovasc Surg. 2019 Winter;31(4):740-748. doi: 10.1053/j.semtcvs.2018.11.012. Epub 2018 Dec 8. — View Citation

Uchida K, Karube N, Kasama K, Minami T, Yasuda S, Goda M, Suzuki S, Imoto K, Masuda M. Early reperfusion strategy improves the outcomes of surgery for type A acute aortic dissection with malperfusion. J Thorac Cardiovasc Surg. 2018 Aug;156(2):483-489. doi: 10.1016/j.jtcvs.2018.02.007. Epub 2018 Feb 13. — View Citation

Yang B, Rosati CM, Norton EL, Kim KM, Khaja MS, Dasika N, Wu X, Hornsby WE, Patel HJ, Deeb GM, Williams DM. Endovascular Fenestration/Stenting First Followed by Delayed Open Aortic Repair for Acute Type A Aortic Dissection With Malperfusion Syndrome. Circulation. 2018 Nov 6;138(19):2091-2103. doi: 10.1161/CIRCULATIONAHA.118.036328. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality (number of all cause death)	All cause death	12 months
Secondary	Low cardiac output syndrome	Number of participants complicated with low cardiac output syndrome after surgery	30 days
Secondary	New cerebrovascular events	Number of participants complicated with new cerebrovascular events after surgery	30 days
Secondary	Intestinal necrosis	Number of participants complicated with intestinal necrosis after surgery	30 days
Secondary	Lower limb necrosis	Number of participants complicated with lower limb necrosis after surgery	30 days
Secondary	Multiple organ failure	Number of participants complicated with multiple organ failure after surgery	30 days
Secondary	Extracorporeal membrane oxygenation	Number of participants requiring extracorporeal membrane oxygenation after surgery	30 days