Fewer Patients Require 'Surgical Bailout' After TAVR

Batya Swift Yasgur MA, LSW

September 16, 2019

The need for unplanned conversion to open heart surgery during transcatheter aortic valve replacement (TAVR) — often called "surgical bailout" — has been decreasing over time, a new study suggests.

Investigators analyzed a database of more than 47,500 patients who underwent TAVR over a 4-year period and found that the incidence of surgical bailout significantly decreased over time — from 1.25% and 1.43% in the first and second tertiles to 1.04% in the third tertile.

Surgical bailout after TAVR was associated with poor outcomes, including 55% of major adverse cardiovascular events (MACE) at 30 days and almost 64% at 1 year, as well as a 50% all-cause mortality rate at 30 days and almost 60% at 1 year.

Female sex, higher hemoglobin, higher left ventricular ejection fraction (LVEF), nonelective cases, and nonfemoral access were independent predictors of surgical bailout; larger body surface area was an independent predictor of survival after surgical bailout.

"The incidence of surgical bailout due to major complications during TAVR has decreased over time with operator experience and improvements in technology," lead author Andres M. Pineda, MD, assistant professor of medicine, Division of Cardiology, University of Florida College of Medicine, Jacksonville, told theheart.org | Medscape Cardiology.

"Predictors of surgical bailout could be used to plan the TAVR procedure and to inform patients and their families about risks," he said.

The study was published in the September 23 issue of JACC Cardiovascular Interventions.

Learning Curve

TAVR still carries a risk for major intraoperative complications, which may require surgical bailout, the authors write.

"Available data suggest an important learning curve with TAVR, with significant improvements over time in the rates of procedural success and complications, and it is possible that the need for surgical bailout may have also decreased over time," they speculate.

To investigate the question, the researchers drew on data from the National Cardiovascular Data Registry Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry from November 2011 to September 2015.

Clinical end points were assessed at hospital discharge, 30 days, and 1 year after TAVR.

Patients (n = 47,546; 48.2% female; 94.1% white) were stratified into three time periods, based on the date of their procedure: November 1, 2011 to February 22, 2013; February 23, 2013 to June 13, 2014; and June 14, 2014 to September 20, 2015.

More Than Tenfold Higher Risk

Surgical bailout was performed in 1.7% of patients, with the most common reason being ventricular rupture, followed by prosthetic valve dislodgement into the left ventricle, annular rupture, aortic dissection, and coronary occlusion (19.89%, 19.35%, 14.16%, 8.24%, and 6.09%, respectively).

Baseline and procedural characteristics of the surgical bailout cohort included older age, female sex, smaller body surface area, higher median LVEF, general anesthesia, use of inotropes, emergent and salvage procedures, longer fluoroscopy times, nonfemoral access, and lower total institutional TAVR volume.

Patients who required surgical bailout had a significantly higher all-cause in-hospital mortality rate than those who did not (49.64% vs 3.52%; P < .0001).

In particular, ventricular rupture was associated with the highest risk for in-hospital all-cause mortality (66.7%).

All-cause mortality and the incidence of nonfatal complications — including MACE — were significantly higher in patients requiring surgical bailout at 30 days than in those who did not (50.0% vs 4.98% and 54.64% vs 7.36%, respectively; P < .0001 for both).

Likewise, the 1-year incidence of all adverse clinical outcomes was significantly higher in the surgical-bailout cohort (MACE: 63.92% vs 20.29%; all-cause mortality: 59.79% vs 17.06%; P < .0001 for both).

Surgical bailout is "associated with an increased incidence of adverse clinical outcomes, including 30-day and 1-year mortality rates of about 50% and 60%, respectively, which is more than tenfold higher than in patients not requiring emergent conversion to open heart surgery," the authors comment.

Higher Risk in Women

A significant decrease in the incidence of surgical bailout was found during the third time period (first tertile, 1.25%; second tertile, 1.43%; third tertile 1.04%; P = .0088).

Although most in-hospital and 30-day clinical outcomes were similar in the three time periods, the 1-year incidence of MACE, stroke, myocardial infarction, and all-cause mortality significantly improved over time.

A logistic regression model showed that female sex, higher hemoglobin level, increased LVEF, cardiogenic shock, use of a left ventricular assist device, salvage procedures, and nonfemoral access were independent predictors of the need for surgical bailout.

"Female gender has been previously shown to be associated with an increased risk of nonfatal complications after TAVR," Pineda commented.

"The increased risk may be due to anatomical differences…which could increase the risk of complications leading to surgical bailout," he speculated.

"Additionally, women may have small femoral vessels and often require alternative access (nonfemoral) to perform their TAVR," he said.

Increased body surface area was found to be the only predictor of survival after surgical bailout, both in the overall cohort and in the transfemoral access.

"Higher body surface area (higher BMI, obesity) has been consistently found to be protective for patients with certain diseases and those undergoing cardiac surgery — a phenomenon known as the 'obesity paradox'," Pineda explained.

"Although the mechanism of this finding is still not well understood, it is possible that higher body surface area/BMI confer patients a better reserve during times of stress like major surgery," he suggested.

Global Picture

Commenting on the study for theheart.org | Medscape Cardiology. Josep Rodés-Cabau, MD, director, Catheterization and Interventional Laboratories, Quebec Heart and Lung Institute, Quebec City, Canada, said: "Fortunately, the need for surgical bailouts is low and seems to go down over time, which is normal and related to more experience of the [surgical] teams and better transcatheter valve systems."

In addition, "we know more and more about the risk factors involved and, for sure, this has led to the decrease in some of these factors," he noted.

However, he warned, "studies like these are useful as a global picture, but trying to determine global risk factors is a bit misleading because the complications requiring surgical bailout are very different from one another."

Surgical Standby?

Rodés-Cabau questioned whether TAVR can be performed in centers with cardiac surgical capabilities because the patient cannot undergo surgical bailout should the need arise.

The issue is "being debated," he said.

"I agree that the mortality when you need conversion to surgery is high, but the other side of the coin is that half the patients [who had surgical bailout] survived, and they would have died without the surgery."

Moreover, TAVR is being used in younger, lower-risk patients.

"Although the rate of complications requiring open surgery is low in this age group, if the patient needs surgery and does not have it, the patient probably will die, which I'm not sure is something we can permit," he added.

In an accompanying editorial, Fabian Nietlispach, MD, PhD, and Osmund Bertel, MD, Hirslanden Klinik Im Park, Zurich, come to a different conclusion.

"With a 50% in-hospital mortality rate reported in these patients, the potential for improving mortality with on-site surgery is about 0.5%," they write.

"From a statistical perspective, and given the fact that patients can now be transferred with mobile biventricular assist devices to nearby hospitals…, surgical standby probably is no longer a justifiable requirement to perform TAVR."

"From an individual standpoint, however, many of us would opt for surgical stand-by if we ourselves needed TAVR," they acknowledged.

No source of funding listed. Pineda has received consulting fees from Pfizer and TZ Medical. The other authors' disclosures are listed in the publication. Nietlispach is a consultant for Abbott, Edwards Lifesciences, and Medtronic. Bertel reported no relevant financial relationships. Rodés-Cabau has received institutional research grants from Edwards Lifesciences, Boston Scientific, and Medtronic, and holds the Research Chair "Fondation Famille Jacques Larivière" for the Development of Structural Heart Disease Interventions.

JACC Cardiovasc Interv. 2019;18:1751-1764, 1765-1767. Abstract, Editorial

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