Characteristics of Gastrointestinal Bleeding (GIB) and Subsequent Endoscopic Therapy after Implantation of Left Ventricular Assist Device (LVAD) for End Stage Heart Failure

Sandeep Mahajan, David T. Majure, Amir Taefi, Julio Salcedo, Maria E. Rodrigo, Mark Hofmeyer, George Ruiz, Ezequiel J. Molina, Steven W. Boyce, Samer S. Najjar, Farooq H. Sheikh

Digestive Disease Week

May 16th, 2015

LVAD Therapy Improves Survival in Advanced Heart Failure (AHF) Patients

Rose et al., N Engl J Med. 2001;345:1435-43.

Continuous Flow LVADs

HeartMate II HeartWare

GI Bleeding and LVAD Therapy

~15-30% of LVAD recipients develop GIB1-3 Multiple mechanisms of bleeding have been

postulated including: 1. Acquired Von Willebrand Syndrome

2. Chronic low pulse pressure (resulting in AVM formation)

3. Need for chronic anticoagulation

1. Boyle et al. J Am Coll Cardiol 2014;63:880-8.2. Goldstein et al. J Am Coll Cardiol HF 2015;3:303-13.3. Uriel et al. J Am Coll Cardiol 2010;56:1207-1213.

Purpose

To characterize GIB events in LVAD recipients implanted with one of two FDA

approved LVADs at our institution

Thoratec HeartMate II, HMII

HeartWare HVAD

Methods

Single center retrospective review of patients implanted with a LVAD

(MedStar Washington Hospital Center)

Study period – 1/1/2011 – 10/27/2014

GIB defined as melena, hematochezia, hematemesis, or anemia requiring endoscopy

Methods (cont’d)

We characterized GIB events by:1. Presenting signs or symptoms

2. Location and type of lesion

3. Type of endoscopy performed

4. Type of endoscopic therapy provided

ResultsStudy Characteristics

Number of patients - (no.) 170

Total follow up – (patient years) 153

Incidence of GIB – (no.) % 35 (21)

Number of GIB events – (no.) 73

Incidence GIB rate - (events per patient year) 0.22

Overall GIB event rate – (events per patient year) 0.39

Median time to first GIB event (months)HMIIHVAD

8.2 ± 3.5 3.5 ± 0.98 (p = 0.07)

Results (cont’d)

9% of HMII and 10% of HVAD patients experienced more than one GIB

Results (cont’d)

Baseline Demographics of the GIB Study Patients (N = 35)

Age (years) 59 ± 11

Sex – no. (%)MaleFemale

26 (75)9 (25)

Race – no. (%)African AmericanCaucasianOther

25 (71)9 (26)1 (3)

BMI - median 27 ± 5

Ischemic Cardiomyopathy – no. (%) 14 (40)

Diabetes – no. (%) 13 (37)

CKD > Stage 2 – no. (%) 13 (37)

Smoker (ever) – no. (%) 22 (65)

History of GIB prior to LVAD implantation 1 of 35

Results (cont’d)

Anticoagulation and presenting INR of all GIB events (N = 73)

On Warfarin Total

On ASA No Yes

No 10 17 27

Yes 4 42 (58%) 46 (63%)

Total 14 59 (81%) 73

Mean INR on admission - 2.56 ± 2.07

Mean INR at the time of GIB did not differ between the 2 LVAD groups

Results (cont’d)

Presenting symptoms of all GIB events– No. (%)

Melena 34 (46)

Anemia 31 (42)

Hematemesis 4 (6)

Hematochezia 4 (6)

Results (cont’d)

Type of GIB identified - No. (%)

Angioectasias/AVM 40 (85)

Ulcer 3 (6)

Gastritis/Duodenitis 3 (6)

Polyp 1 (2)

Hemorrhoidal 0 (0)

Diverticular 0 (0)

A culprit lesion was identified in only 47 of 73 GIB events (67%)

Characteristic Image of AVM

Results (cont’d)

Esophagus = 0

Stomach- Fundus = 4- Body = 16 (34%)- Antrum/Pylorus = 6

Small Intestine- Duodenum = 4- Jejunum = 9 (19%)- Ileum = 0- Cecum = 3

Colon- Colon = 5 - Rectum = 0

Results (cont’d)

Types of procedures of all GIB events

Time to Endoscopy – mean (days) 2.56 ± 2.85

EGD – no. (%) 66 (90)

Colonoscopy – no. (%) 33 (45)

Enteroscopy – no. (%) 36 (49)

Video Capsule Endoscopy – no. (%) 5 (7)

Results (cont’d)

Type of intervention with culprit lesions (N = 47)

Argon Plasma Coagulation – no. (%) 38 (81)

Cautery – no. (%) 4 (9)

Clipping – no. (%) 1 (2)

Polyp resected – no. (%) 2 (4)

None – no. (%) 2 (4)

Limitations

Single center Retrospective review Use of antiplatelet therapy differs between

the 2 LVAD devices at our center Conclusions are dependent on the accuracy

and completeness of the recorded events

Conclusion

GIB is a common complication of LVAD therapy which frequently necessitates upper endoscopy

Angioectasias/AVM are the most common lesions found

Gastric body is the most common site of GIB in our cohort

Bleeding source could not be identified in up to 33% of cases

Future Directions Future studies should evaluate optimal

strategies for identifying the source of bleeding – standardized protocols

Success of primary endoscopic therapy New investigational LVADs (introduction of

pulsatility)

Thank You

Dr. Farooq Sheikh Dr. David T. Majure Dr. Samer Najjar

Dr. Julio Salcedo Dr. Amir Taefi