Table 2.

Outcomes

Case (Reference)	Author(s)	Outcomes
142	Garatti et al	After cardiac transplantation, no further bleeding.
27	Miller et al	No further bleeding found.
348	Hou et al	No further GIB, but later on found that LVAD had perforated through gastric wall. Patient had a closure of the defect without any complications.
411	Fenkel et al	No further bleeding found.
512	Seow and Zimmerman	No further bleeding found.
646	Tulchinsky	Embolized and no further bleeding. Used Tc‐99m RBC scan to identify the GIB. No problems noted.
713	Bechtel et al	A wireless capsule (PillCam SB) was used successfully to determine bleeding. No further bleeding.
814	Girelli et al	No interference was found between the capsule and LVAD. No bleeding noted.
949	Gogas et al	No further bleeding noted.
1050	Aleksic et al	Not mentioned.
1119	Letsou et al	(1) After cardiac transplantation, no further GIB. (2) Another patient had an ex‐lap; adhesions were lysed and burned, but continued bleeding. The patient died from multiorgan failure. (3) Received transplant and no further GIB.
1216	Grasso et al	Final outcome not known for each set of patients. When considering GIB from AVMs, there was 1 (4%) event in the nonpulsatile group and 2 (7%) in the pulsatile group (P = 0.607). For GIB from all sources, there were 2 (8%) in the nonpulsatile group and 6 (22%) in the pulsatile group (P = 0.16). Of the 10 subjects who received preimplant colonoscopies, 7 had pathologic findings (4 polyps, 2 diverticulosis, 1 colitis) and 3 went on to develop postimplant GIB (P = 1.000). On multivariate analysis, only age was found to be an independent predictor of GIB (P = 0.001). In conclusion, the authors noted that the nonpulsatile LVADs were not associated with an increase in AVMs or GIB.
133	Crow et al	Event rate was 63/100 patient‐years for nonpulsatile devices after 15 days; 6.8/100 patient‐years. All bleeding events after 15 d for pulsatile devices (P < 0.0004). This difference persisted for bleeding occurring ≥31 d after device implantation with 46.5 events/100 patient‐years for nonpulsatile devices vs 4.7 events/100 patient‐years for pulsatile events (P = 0.0028). Mortalities were similar between the 2 groups (15% for nonpulsatile vs 17% for pulsatile, P = 0.69). In conclusion, the authors noted that nonpulsatile LVADs have a higher rate of GIB than pulsatile LVADs.
1410	Stern et al	No significant changes in P value. HeartMate II patients who bled were significantly older and more likely to have been taking ASA preoperatively than those without GIB. The 2 HeartMate II patients who had a prior hx of GIB did not bleed postoperatively, whereas all GIB had no previous hx of GIB. Of the 8 HeartMate II patients who bled, 2 had heart transplants. Neither patient has had a recurrent episode of GIB since transplantation. Three HeartMate II patients who had implantation for destination therapy developed GIB within 3 mo of implantation. Three patients had recurrent episodes of GIB.
1515	Daas et al	No further bleeding after treatment of GIB.
1641	John et al	Stopped anticoagulation and reduced the pump speed. No further recurrence of GIB.
1751	Hetzer et al	Had consistent GIB, had to be hospitalized, and needed transfusion therapy.
1843	McCarthy et al	One resolution with endoscopic therapy. Another had massive upper GIB; taken to OR to oversew a bleeding ulcer.
1923	Frazier et al	One patient had GIB that was seen; had to stop anticoagulation and all antiplatelet therapy. The patient eventually died from cardiac thrombus. No other patients had GIB.
2044	Siddiqui et al	Not mentioned.
2152	Wang et al	Postoperative anticoagulation/antiplatelet regiments same for both GIB and non‐GIB. GIB patients were older (age 60.5 vs 49 y, P = 0.051) and had to be intubated preoperatively (38% vs 12%, P = 0.038). Perioperative morbidity and mortality showed no difference except for longer median ventilator support (184 vs 50 h, P = 0.001) and longer median hospital stay (37 vs 19 d, P < 0.001) for GIB. No bleeding in VentrAssist.
2232	Uriel et al	Patients with the HeartMate II had a high incidence of bleeding events during device support and at heart transplantation. All HeartMate II patients had reduced HMW vWF multimers. Eighteen of these (58%) had bleeding. Anticoagulation was similar in both groups.
2333	Crow et al	All CF‐LVAD recipients had AVWS after LVAD placement, demonstrated by reduced or absent HMW vWF multimers levels. However, not all recipients had bleeding complications.
2434	Heilmann et al	Nine patients underwent placement of an LVAD, whereas 3 underwent placement of a TAH, which is connected directly to the heart and large cardiac vessels without cannulas. Within 1 d of LVAD implantation, 4 of 5 patients evaluated demonstrated loss of HMW multimers and impaired vWF function. AVWS was present within 2 wks of implantation in 8 of 9 patients, and in all 7 tested patients after ≥3 mo. Patients with different LVAD types developed varying severities of AVWS. After LVAD explanation, HMW multimers were detectable and vWF function normalized in all patients. AVWS was not observed in the TAH patients studied. These results suggest that shear stress associated with exposure of blood to VAD cannulas and tubes may contribute to the development of AVWS.
2553	Meyer et al	Twenty‐six outpatients received an axial‐flow LVAD (HeartMate II; Thoratec) for a median support time of 4.5 mo. In all patients on devices, severe impairment of platelet aggregation as well as a loss of large vWF multimers were found. In 10 patients, a decreased vWF:CB/vWF:Ag ratio was observed. Bleeding episodes occurred with an incidence of 0.17 per patient‐year. After removal of the device, normal patterns of platelet aggregation, multimers analysis, and vWF:CB/vWF:Ag ratio were recorded. The authors concluded that a diagnosis of vWF syndrome type 2 was established in all patients after LVAD implantation, and bleeding events confirmed this finding. Reversibility of this condition was found after removal of the device.
2654	Aggarwal et al	There was high recurrence rate of bleeding after device implantation, the majority from the same site. Management strategies for bleeding included temporarily withholding anticoagulation, decreasing the speed of LVADs, and using octreotide. One patient died as direct consequence of GIB.
2755	Schaffer et al	Management strategies for bleeding included blood‐product administration.
2856	Tarzia et al	Early postoperative course was uneventful. Management strategies for bleeding included argon plasma coagulation during endoscopy.
293	Crow et al	There was high recurrence rate of bleeding after device implantation. Mortalities were similar between nonpulsatile (15%) and pulsatile (17%) groups (P = 0.69).
3057	Demirozu et al	All GIB episodes were successfully managed medically, without the need for surgical intervention.
3158	Kushnir et al	Overall mortality was 35%, none directly from GIB.
3259	Morgan et al	There were no deaths referable to GIB. Recurrent bleeding occurred in 4 patients. Hx of GIB prior to LVAD implantation was the only variable significantly different between patients with and without postimplant GIB, indicating the need of better understanding the pathophysiology and management of GIB prior to device implantation.
3360	John et al	Overall, 30‐d, 6‐mo, and 1‐yr survival for the BTT patients was 95.1%, 83.5%, and 78.8%, respectively. Major adverse events among BTT patients included RV failure (5%), LVAD driveline infections (24.5%), neurologic events (9.8%), and GIB (17.6%).

Abbreviations: ASA, aspirin; AVM, arteriovenous malformation; AVWF, acquired von Willebrand syndrome; BTT, bridge to transplant; CF, continuous‐flow; ex‐lap, exploratory laparotomy; GIB, gastrointestinal bleeding; HMW, high molecular weight; hx, history; LVAD, left ventricular assist device; OR, operating room; RBC, red blood cell; RV, right ventricular; TAH, total artificial heart; Tc‐99m, technetium 99m; VAD, ventricular assist device; vWF, von Willebrand factor; vWF:Ag, plasma von Willebrand factor antigen; vWF:CB, von Willebrand factor collagen binding assay.